US20080065212A1 - Interspinous process implants and methods of use - Google Patents
Interspinous process implants and methods of use Download PDFInfo
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- US20080065212A1 US20080065212A1 US11/768,223 US76822307A US2008065212A1 US 20080065212 A1 US20080065212 A1 US 20080065212A1 US 76822307 A US76822307 A US 76822307A US 2008065212 A1 US2008065212 A1 US 2008065212A1
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- implant
- spinous process
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- spacer
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- 0 CC[C@@]1C(*)=C(*)C1(C)C(F)(F)F Chemical compound CC[C@@]1C(*)=C(*)C1(C)C(F)(F)F 0.000 description 8
- XDTMQSROBMDMFD-UHFFFAOYSA-N C1CCCCC1 Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7053—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7047—Clamps comprising opposed elements which grasp one vertebra between them
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/842—Flexible wires, bands or straps
Abstract
Description
- This application is a continuation of each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179), each entitled “Interspinous Process Implants and Methods of Use,” and filed May 31, 2007; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 10/694,103, entitled “Interspinous Process Implant with Radiolucent Spacer and Lead-in Tissue Expander,” filed Oct. 27, 2003, which claims priority to U.S. Provisional Application Ser. No. 60/421,915, entitled “Interspinous Process Implant with Radiolucent Spacer and Lead-in Tissue Expander,” filed Oct. 29, 2002; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/234,555, entitled “Interspinous Process Implant and Method of Implantation,” filed Sep. 23, 2005, which claims priority to U.S. Provisional Application Ser. No. 60/612,582, entitled “Interspinous Process Implant and Method of Implantation,” filed Sep. 23, 2004 and which is a continuation-in-part of U.S. patent application Ser. No. 10/850,267, entitled “Distractible Interspinous Process Implant and Method of Implantation,” filed May 20, 2004, which claims priority to U.S. Provisional Application Ser. No. 60/472,817, entitled “Cervical Interspinous Process Implant and Method of Implantation,” filed May 22, 2003; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/378,893, entitled “Interspinous Process Implant with Slide-in Distraction Piece and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/664,311, entitled “Interspinous Process Implant with Slide-in Distraction Piece and Method of Implantation,” filed Mar. 22, 2005 and which is a continuation-in-part of U.S. patent application Ser. No. 10/850,267, entitled “Distractible Interspinous Process Implant and Method of Implantation,” filed May 20, 2004, which claims priority to U.S. Provisional Application Ser. No. 60/472,817, entitled “Cervical Interspinous Process Implant and Method of Implantation,” filed May 22, 2003; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/384,055, entitled “Interspinous Process Implant with Slide-in Distraction Piece and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/664,049, entitled “Interspinous Process Implant with Slide-in Distraction Piece and Method of Implantation,” filed Mar. 22, 2005 and which is a continuation-in-part of U.S. patent application Ser. No. 10/850,267, entitled “Distractible Interspinous Process Implant and Method of Implantation,” filed May 20, 2004, which claims priority to U.S. Provisional Application Ser. No. 60/472,817, entitled “Cervical Interspinous Process Implant and Method of Implantation,” filed May 22, 2003; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 10/850,267 entitled “Distractible Interspinous Process Implant and Method of Implantation,” filed Apr. 1, 2004, which claims priority to U.S. Provisional Application Ser. No. 60/472,817, entitled “Cervical Interspinous Process Implant and Method of Implantation,” filed May 22, 2003; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/095,440, entitled “Interspinous Process Implant Including a Binder and Method of Implantation,” filed Mar. 31, 2005, which claims priority to U.S. Provisional Application Ser. No. 60/612,465, entitled “Interspinous Process Implant Including a Binder and Method of Implantation,” filed Sep. 23, 2004; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/095,680, entitled “Interspinous Process Implant Including a Binder and Method of Implantation,” filed Mar. 31, 2005, which claims priority to U.S. Provisional Application Ser. No. 60/612,465, entitled “Interspinous Process Implant Including a Binder and Method of Implantation,” filed Sep. 23, 2004; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/378,108, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/663,918, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 21, 2005; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/377,971, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/663,885, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 21, 2005; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/378,894, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/664,076, entitled “Interspinous Process Implant Having Deployable Wing and Method of Implantation,” filed Mar. 22, 2005; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/389,002, entitled “Interspinous Process Implant Having Deployable Wings and Method of Implantation,” filed Mar. 24, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/672,402, entitled “Interspinous Process Implant Having Deployable Wings and Method of Implantation,” filed Apr. 18, 2005; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. Nos. 11/806,528 (Attorney Docket No. KYPH-038/15US 305363-2175) and 11/806,526 (Attorney Docket No. KYPH-038/18US 305363-2179) is a continuation-in-part of U.S. patent application Ser. No. 11/378,892, entitled “Interspinous Process Implant Having A Thread-Shaped Wing and Method of Implantation,” filed Mar. 17, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/663,922, entitled “Interspinous Process Implant Having Deployable Wings and Method of Implantation,” filed Mar. 21, 2005; each of which is incorporated herein by reference in its entirety.
- The spinal column is a bio-mechanical structure composed primarily of ligaments, muscles, vertebrae and intervertebral disks. The bio-mechanical functions of the spine include: (1) support of the body, which involves the transfer of the weight and the bending movements of the head, trunk and arms to the pelvis and legs, (2) complex physiological motion between these parts, and (3) protection of the spinal cord and the nerve roots.
- As the present society ages, it is anticipated that there will be an increase in adverse spinal conditions which are characteristic of older people. By way of example only, with aging comes an increase in spinal stenosis (including, but not limited to, central canal and lateral stenosis), and facet arthropathy. Spinal stenosis results in a reduction foraminal area {i.e., the available space for the passage of nerves and blood vessels) which compresses the cervical nerve roots and causes radicular pain. Humpreys, S. C. et al, Flexion and traction effect on C5-C6 foraminal space, Arch. Phys. Med. Rehabil., vol. 79 at 1105 (September 1998). Another symptom of spinal stenosis is myelopathy, which results in neck pain and muscle weakness. Id. Extension and ipsilateral rotation of the neck further reduces the foraminal area and contributes to pain, nerve root compression and neural injury. Id.; Yoo, J. U. et al., Effect of cervical spine motion on the neuroforaminal dimensions of human cervical spine, Spine, vol. 17 at 1131 (Nov. 10, 1992). In contrast, neck flexion increases the foraminal area. Humpreys, S. C. et al, at 1105.
- Pain associated with stenosis can be relieved by medication and/or surgery. It is desirable to eliminate the need for major surgery for all individuals, and in particular, for the elderly.
- Accordingly, a need exists to develop spine implants that alleviate pain caused by spinal stenosis and other such conditions caused by damage to, or degeneration of, the spine. Such implants would distract, or increase the space between, the vertebrae to increase the foraminal area and reduce pressure on the nerves and blood vessels of the spine. A further need exists for development of a minimally invasive surgical implantation method for spine implants that preserves the physiology of the spine.
- Further, a need exists for an implant that accommodates the distinct anatomical structures of the spine, minimizes further trauma to the spine, and obviates the need for invasive methods of surgical implantation. Additionally, a need exists to address adverse spinal conditions that are exacerbated by spinal extension and/or flexion.
- Systems and method in accordance with an embodiment of the present invention can includes an implant comprising a first wing, a spacer extending from the first wing, and a distraction guide. The distraction guide is arranged in a first configuration to pierce and/or distract tissue associated with adjacent spinous processes extending from vertebrae of a targeted motion segment. The implant can be positioned between the adjacent spinous processes and once positioned, the implant can be arranged in a second configuration. When arranged in a second configuration, the distraction guide can act as a second wing. The first wing and the second wing can limit or block movement of the implant along a longitudinal axis of the implant.
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FIGS. 1 a-1 f.FIG. 1 a is a front plan view of an embodiment of an assembled implant of the invention;FIG. 1 b is a left side view of the embodiment of the invention ofFIG. 1 a;FIG. 1 e is a front plan view of the embodiment of the invention ofFIG. 1 a including a spacer, a main body and a first wing;FIG. 1 d is a left side view of the second wing of the embodiment of the invention ofFIG. 1 a;FIG. 1 e is a front plan view of the second wing of the embodiment of the invention ofFIG. 1 a;FIG. 1 f is an end view of the spacer of the embodiment of the invention ofFIG. 1 a. -
FIG. 2 a is a perspective view of an embodiment of the frame of the tissue expander or distraction guide of the invention.FIG. 2 b is a perspective view of an embodiment of the lead-in tissue expander or distraction guide of the invention. -
FIGS. 3 a and 3 b are an end and a perspective view of still another embodiment of the spacer of the invention.FIG. 3 c is a front view of the spacer ofFIG. 3 a. -
FIGS. 4 a and 4 b are an end and a perspective view of yet another embodiment of the spacer of the invention. -
FIGS. 5 a and 5 b are an end and a perspective view of still another embodiment of the spacer of the invention. -
FIGS. 6 a and 6 b are an end and a perspective view of a further embodiment of the spacer of the invention. -
FIG. 7 is a perspective view of an embodiment of an implant in accordance with the present invention having a spacer, a distraction guide, and a wing with an elliptical cross-section. -
FIG. 8 is an end view of the implant ofFIG. 7 . -
FIG. 9 is a perspective view of another embodiment of an implant in accordance with the present invention having a wing with a teardrop-shaped cross-section. -
FIG. 10 is an end view of a second wing for use with the implant ofFIG. 9 . -
FIG. 11 is a perspective view of an embodiment of an implant in accordance with the present invention having a rotatable spacer and a wing with an elliptical cross-section. -
FIG. 12 is a perspective view of an embodiment of an implant in accordance with the present invention having a rotatable spacer with two wings that are teardrop-shaped in cross-section. -
FIG. 13 depicts the axis of rotation of the implant ofFIG. 6 as seen from an end view. -
FIG. 14 is a perspective view of an embodiment of an implant in accordance with the present invention having a wing that is truncated at a posterior end. -
FIG. 15A is an end view of an embodiment of an implant in accordance the present invention having a wing truncated at a posterior end and a rotatable spacer. -
FIG. 15B is a truncated second wing for use with the implant ofFIG. 15A . -
FIG. 16 is a plan view of an embodiment of an implant in accordance with the present invention wherein a screw is used to secure a second wing to the spacer. -
FIG. 17 is a perspective view of the second wing ofFIG. 16 . -
FIG. 18 is a perspective view of the implant ofFIG. 16 . -
FIG. 19A is a front view of a second wing for use with some embodiments of implants of the present invention having a flexible hinge mechanism for securing the second wing to an implant. -
FIG. 19B is a side-sectional view of the second wing ofFIG. 19A . -
FIG. 20A is a plan view of an embodiment of an implant for use with the second wing ofFIGS. 19A and 19B . -
FIG. 20B is a front view of the second wing ofFIGS. 19A and 19B . -
FIG. 21A is a top view of an embodiment of an implant in accordance with the present invention positioned between the spinous processes of adjacent cervical vertebrae. -
FIG. 21B is a top view of the implant ofFIG. 21A . -
FIG. 22 is a top view of two such implants of the invention as seen inFIG. 21 , positioned in the cervical spine. -
FIG. 23 is a side view of two implants of the invention positioned in the cervical spine, with stops or keeps at the distal ends of the spinous processes. -
FIG. 24 is a perspective view of an alternative embodiment of an implant for use with systems and methods of the present invention. -
FIG. 25A is an end view of an implant in accordance with still another embodiment of the present invention having a first part shaped to conform roughly with a contact surface of the spinous process. -
FIG. 25B is a cross-sectional view of a spacer and a distracting insert in accordance with one embodiment of the present invention. -
FIG. 25C is a cross-sectional view of a spacer and a distracting insert in accordance with an alternative embodiment of the present invention. -
FIG. 25D is a cross-sectional view of a spacer and a distracting insert in accordance with still another embodiment of the present invention. -
FIG. 26A is a front view of the implant ofFIG. 24 inserted between spinous processes. -
FIG. 26B is a front view of the implant ofFIG. 26A having a distracting insert positioned within cavities of the implant. -
FIG. 27A is a cross-sectional side view of the implant ofFIG. 24 showing a distracting insert partially inserted in a cavity of the implant having pins for aligning a first portion with a second portion. -
FIG. 27B is a top view of the implant ofFIG. 27A showing positioning of pins for alignment of the first part and second part. -
FIG. 28A is a perspective view of an alternative embodiment of an implant for use with systems and methods of the present invention, wherein the distracting insert includes a clip. -
FIG. 28B is a side view of the implant ofFIG. 28A showing a distracting insert mated with the implant. -
FIG. 28C is a side view of an alternative embodiment of an implant mated with an alternative embodiment of a distracting insert. -
FIG. 28D is a side view of still another embodiment of an implant mated with still another embodiment of a distracting insert. -
FIG. 29 is a perspective view of an embodiment of a distractible implant in accordance with the present invention having a second wing for limiting or blocking shifting along the longitudinal axis. -
FIG. 30 illustrates an embodiment of a method for implanting an interspinous implant in accordance with the present invention. -
FIG. 31 illustrates an alternative embodiment of a method for implanting an interspinous implant in accordance with the present invention. -
FIG. 32 is a perspective view of an interspinous implant capable of limiting or blocking relative movement of adjacent spinous processes during extension of the spine. -
FIG. 33A is a posterior view of the implant ofFIG. 32 positioned between adjacent spinous processes. -
FIG. 33B is a cross-sectional side view of a spacer of the interspinous implant ofFIGS. 32 and 33 A positioned between spinous processes. -
FIG. 33C is a cross-sectional view of the spacer ofFIG. 33B during flexion of the spine. -
FIG. 34A is a side view of an embodiment of an implant in accordance with the present invention having a distraction guide, a spacer, a brace, and a binder associated with the brace and fixable in position by a capture device. -
FIG. 34B is a side view of an alternative embodiment of an implant in accordance with the present invention including a brace wall having recesses for receiving lobes of a capture device. -
FIG. 34C is a side view of still another embodiment of an implant in accordance with the present invention including a capture device having a spring-loaded cam for securing a binder against a brace wall. -
FIG. 34D is a side view of a still further embodiment of an implant in accordance with the present invention including a capture device having dual spring-loaded cams for securing a binder in position. -
FIG. 35A is an end view of the implant ofFIG. 34A positioned between adjacent spinous processes. -
FIG. 35B is an end view of the implant ofFIG. 34A positioned between adjacent spinous processes. -
FIG. 35C is an end view of the implant ofFIG. 34A positioned between adjacent spinous processes wherein the spinous processes are surgically modified to receive a binder. -
FIG. 36 is an end view of an alternative embodiment of an implant in accordance with the present invention having a binder that varies in shape along the binder's length. -
FIG. 37A is an end view of the implant ofFIG. 36 positioned between adjacent spinous processes. -
FIG. 37B is an opposite end view of the implant ofFIG. 37A . -
FIG. 37C is an end view of still another embodiment of an implant in accordance with the present invention having a cord for a binder. -
FIG. 38A is a side view of an embodiment of an implant in accordance with the present invention including a wing associated with the distraction guide to further limit or block movement of the implant. -
FIG. 38B is a partial cross-sectional side view of an alternative embodiment of an implant in accordance with the present invention include an extendable wing associated with the distraction guide, the extendable wing being in a retracted position. -
FIG. 38C is a partial cross-sectional side view of the implant ofFIG. 38B wherein the extendable wing is in an extended position. -
FIG. 38D is a partial cross-sectional side view of still another embodiment of an implant in accordance with the present invention including a spring-loaded wing associated with the distraction guide, the wing being in an extended position. -
FIG. 38E is a partial cross-sectional side view of the implant ofFIG. 38D wherein the spring-loaded wing is in a collapsed position. -
FIG. 39 is a top view of two implants in accordance with an embodiment of the present invention positioned between the spinous processes of adjacent vertebrae, one of the implants having a binder arranged around the adjacent spinous processes. -
FIG. 40A is a perspective view of a further embodiment of an implant in accordance with the present invention having a distraction guide, a spacer, a brace, and a binder associated with the brace and fixable in position by a capture device. -
FIG. 40B is a perspective view the implant ofFIG. 40A wherein the capture device is arranged to secure a binder between the capture device and the brace. -
FIG. 40C is a side view of the implant ofFIGS. 40A and 40B . -
FIG. 41A is a cross-sectional top view of a binder loosely positioned within the capture device of the implant ofFIGS. 40A and 40B . -
FIG. 41B is a cross-sectional top view of the binder secured to the brace by the capture device of the implant ofFIGS. 40A and 40B . -
FIG. 41C is a cross-sectional top view of a binder loosely positioned within an alternative embodiment of a capture device of the implant ofFIGS. 40A and 40B . -
FIG. 41D is a cross-sectional top view of the binder and capture device ofFIG. 41C wherein the binder is secured to the brace. -
FIG. 42 is an end view of the implant ofFIGS. 40A and 40B positioned between adjacent spinous processes. -
FIG. 43 is a block diagram illustrating a method of positioning the implant ofFIG. 40A between adjacent spinous processes. -
FIG. 44A is a perspective view of an still another embodiment of an implant in accordance with the present invention having a distraction guide, a spacer, a first wing, and a second wing including a capture device. -
FIG. 44B is a perspective view of the implant ofFIG. 44A in accordance with the present invention having a distraction guide, a spacer, a first wing, and a second wing including a capture device. -
FIG. 45 is a perspective view of an still another embodiment of an implant in accordance with the present invention having a distraction guide, a spacer, a first wing, and a second wing including a capture device. -
FIG. 46 is a perspective view of an still another embodiment of an implant in accordance with the present invention having a distraction guide, a spacer, a first wing, and a second wing including a capture device. -
FIG. 47 is a block diagram illustrating a method of positioning the implant ofFIGS. 44A-46 between adjacent spinous processes. -
FIG. 48A is a perspective view of an implant including a spacer having a tear-drop shaped cross-section, a distraction guide, a first wing, and a second wing connectable with the distraction guide. -
FIG. 48B is a perspective view of an implant including a rotatable spacer having an elliptical cross-section, a distraction guide, a first wing, and a second wing connectable with the distraction guide. -
FIG. 49A is a perspective view of an implant in accordance with an embodiment of the present invention including a main body and an insert, the main body having a distraction guide, a spacer, and a first wing. -
FIG. 49B is a perspective view of the implant ofFIG. 49A wherein the insert is positioned within the main body, causing the distraction guide associated with the main body to limit or block movement of the implant when positioned between adjacent spinous processes. -
FIG. 50A is a side view of the main body of the implant ofFIGS. 49A and 49B positioned between adjacent spinous processes. -
FIG. 50B is a side view of the implant ofFIG. 50A wherein the insert is positioned within the main body. -
FIG. 51 is a perspective view of an implant in accordance with an alternative embodiment wherein the main body includes hooks to limit relative movement of adjacent spinous processes during flexion motion. -
FIG. 52 is a side view of the implant ofFIG. 51 positioned between adjacent spinous processes and arranged so that the hooks confine the adjacent spinous processes. -
FIG. 53A is a perspective view of still another embodiment of an implant in accordance with the present invention, wherein a first section and a second section of a distraction guide are deployable to form a second wing. -
FIG. 53B is a perspective view of the implant ofFIG. 53A wherein the insert is positioned within the main body, causing the first section and the second section of the distraction guide to deploy. -
FIG. 54A is a perspective view of a still further embodiment of an implant in accordance with the present invention including a rotatable spacer. -
FIG. 54B is a perspective view of the implant ofFIG. 54A wherein the insert is positioned within a central body so that the distraction guide deploys as a second wing. -
FIG. 54C is a cross-sectional side view of distraction guide ofFIG. 54A . -
FIG. 54D is a cross-sectional side view of distraction guide ofFIG. 54B . -
FIG. 55 is a side view of the implant ofFIGS. 54A-54D positioned between adjacent spinous processes. -
FIG. 56A is a side view of an alternative embodiment of the implant positioned between adjacent spinous processes. -
FIG. 56B is a partial cross-section side view of the implant ofFIG. 56A showing deployable winglets disposed within a distraction guide of the implant. -
FIG. 56C is a partial cross-sectional side view of the implant ofFIG. 56B wherein the winglets deployed. -
FIG. 57A is a side view of an alternative embodiment of the implant positioned between adjacent spinous processes. -
FIG. 57B is a side view of the implant ofFIG. 57A positioned between adjacent spinous processes wherein the winglets deployed. -
FIG. 57C is a partial cross-sectional end view of the implant ofFIG. 57A showing deployable winglets disposed within a distraction guide of the implant. -
FIG. 57D is a partial cross-sectional end view of the implant ofFIGS. 57A-57C showing the winglets deployed so that the winglets extend from the distraction guide of the implant. -
FIG. 57E is an end view of the implant ofFIGS. 57A-57D showing the distraction guide and the deployed winglets relative to the distraction guide. -
FIG. 58A is a partial cross-sectional end view of an alternative embodiment of an implant in accordance with the present invention including an alternative actuator arrangement. -
FIG. 58B is an partial cross-sectional end view of the implant ofFIG. 58A showing the winglets deployed so that the winglets extend from the distraction guide of the implant. -
FIG. 59A is a partial cross-sectional end view of still another embodiment of an implant in accordance with the present invention having an alternative actuator arrangement wherein the winglets comprise two hinged portions. -
FIG. 59B is a partial cross-sectional end view of the implant ofFIG. 59A showing the winglets deployed so that the winglets extend from the distraction guide of the implant. -
FIG. 60 is a partial cross-sectional end view of a still further embodiment of an implant in accordance with the present invention wherein implants are arranged at adjacent motion segments. -
FIG. 61 illustrates an embodiment of a method for implanting the implant ofFIGS. 49A-55 between adjacent spinous processes in accordance with the present invention. -
FIG. 62 illustrates an embodiment of a method for implanting the interspinous implant ofFIGS. 49A-55 between adjacent spinous processes in accordance with the present invention. -
FIG. 63 illustrates an embodiment of a method for implanting the interspinous implant ofFIGS. 56A-60 between adjacent spinous processes in accordance with the present invention. -
FIG. 64A is a perspective view of an alternative embodiment of an implant in accordance with the present invention having a first wing and a second wing that can be deployed after arranging the implant between adjacent spinous processes. -
FIG. 64B is a perspective view of the implant ofFIG. 64A in a deployed configuration. -
FIG. 65A is a posterior view of the implant ofFIGS. 64A and 64B positioned between adjacent spinous processes in an undeployed configuration. -
FIG. 65B is a posterior view of the implant ofFIGS. 64A and 64B positioned between adjacent spinous processes in a deployed configuration. -
FIG. 66A is a perspective view of still another embodiment of an implant in accordance with the present invention having a first wing and a second wing that can be deployed after arranging the implant between adjacent spinous processes. -
FIG. 66B is a perspective view of the implant ofFIG. 66A in a deployed configuration. -
FIG. 67 is a posterior view of the implant ofFIGS. 66A and 66B positioned between adjacent spinous processes in a deployed configuration. -
FIG. 68A is a perspective view of an alternative embodiment of an implant in accordance with the present invention having a first wing and a second wing that can be deployed after arranging the implant between adjacent spinous processes. -
FIG. 68B is a perspective view of the implant ofFIG. 68A in a partially deployed configuration. -
FIG. 68C is a perspective view of the implant ofFIG. 68A in a fully deployed configuration. -
FIG. 69A is a perspective view of the implant ofFIG. 68A including a cannula within which the implant is disposed for insertion into desired location between adjacent spinous processes. -
FIG. 69B is a perspective view of the implant ofFIG. 69A in a partially deployed configuration. -
FIG. 69C is a perspective close-up view of the implant ofFIG. 69A showing hinged structures connected by cords. -
FIG. 70 illustrates an embodiment of a method for implanting an interspinous implant as shown inFIGS. 7-23 in accordance with the present invention. -
FIG. 71 illustrates an embodiment of a method for implanting an interspinous implant as shown inFIGS. 64A-67 having deployable first and second wings in accordance with the present invention. -
FIG. 72 illustrates an alternative embodiment of a method for implanting an interspinous implant as shown inFIGS. 68A-69B having deployable first and second wings by way of a cannula inserted between adjacent spinous processes in accordance with the present invention. -
FIG. 73A is a perspective view of an implant including a spacer having a tear-drop shaped cross-section, a distraction guide, a first wing, and a second wing connectable with the distraction guide. -
FIG. 73B is a perspective view of an implant including a rotatable spacer having an elliptical cross-section, a distraction guide, a first wing, and a second wing connectable with the distraction guide. -
FIG. 74A is a perspective view of a frame of an implant in accordance with an embodiment of the present invention. -
FIG. 74B is a perspective view of a spacer for use with the frame ofFIG. 74A . -
FIG. 74C is a perspective view of the spacer ofFIG. 74B seated within the frame ofFIG. 74A . -
FIG. 75A is a partial cross-sectional posterior view of the frame of the implant ofFIGS. 74A-74C positioned adjacent to an interspinous ligament disposed between adjacent spinous processes. -
FIG. 75B partial cross-sectional posterior view of the frame of the implant ofFIGS. 74A-74C rotated so that the interspinous ligament is disposed between a portion of the helical shaped second wing and the first wing along a longitudinal axis of the implant. -
FIG. 75C partial cross-sectional posterior view of the frame of the implant ofFIGS. 74A-74C rotated so that the interspinous ligament is disposed between the entire helical shaped second wing and the first wing along the longitudinal axis. -
FIG. 75D partial cross-sectional posterior view of the frame of the implant ofFIGS. 74A-74C wherein a spacer is partially arranged over a central body of the frame so that a portion of the spacer partially distracts the interspinous ligament. -
FIG. 75E partial cross-sectional posterior view of the frame of the implant ofFIGS. 74A-74C wherein the spacer is seated over the central body of the frame so that a portion of the spacer partially distracts the interspinous ligament. -
FIG. 76A is an end view of the implant ofFIG. 75E positioned between adjacent spinous processes. -
FIG. 76B is an front view of the implant ofFIG. 75E positioned between adjacent spinous processes. -
FIG. 77A is a perspective view of a frame from an alternative embodiment of an implant in accordance the present invention. -
FIG. 77B is a perspective view of a spacer for use with the frame ofFIG. 77A . -
FIG. 77C is a perspective view of the spacer ofFIG. 77B seated within the frame ofFIG. 77A . -
FIG. 78 is a side view of the implant ofFIGS. 77A-77C positioned between adjacent spinous processes. -
FIG. 79A is a perspective view of a frame from a still further embodiment of an implant in accordance with the present invention. -
FIG. 79B is a side view of the frame ofFIG. 79A positioned between adjacent spinous processes. -
FIG. 79C is a side view of the frame ofFIG. 79A positioned between adjacent spinous processes and retracted to collapse the second wing. -
FIG. 80 is a perspective view of a frame from a still further embodiment of an implant in accordance with the present invention. -
FIG. 81 illustrates an embodiment of a method for implanting an interspinous implant between adjacent spinous processes of the cervical region in accordance with the present invention. -
FIG. 82 is a flowchart of a method for implanting an interspinous implant between adjacent spinous processes of the lumbar region in accordance with the present invention. -
FIG. 83 is a perspective view of an alternative embodiment of an implant for use with systems and methods of the present invention, the implant including an distraction piece mated with a initiating piece. -
FIG. 84A is a perspective view of the initiating piece of the implant ofFIG. 83 . -
FIG. 84B is a perspective view of a proximal end of an insertion tool having prongs positioned within cavities of the initiating piece. -
FIG. 84C is a perspective view of the prongs arranged in a locked position within the cavities of the initiating piece. -
FIGS. 85A-85D are posterior views of the initiating piece ofFIG. 84A as the initiating piece is urged into position with the interspinous ligament disposed between a lower portion of first wing and a lower portion of the second wing. -
FIG. 86 is a perspective view of the slide-in distraction piece of the implant ofFIG. 83 . -
FIGS. 87A-87D are posterior views showing the slide-in distraction piece ofFIG. 86 mating with the initiating piece positioned as shown inFIG. 85D so that an implant as shown inFIG. 83 is disposed between the adjacent spinous processes. -
FIG. 88A is a perspective view of an alternative embodiment of an implant for use with systems and methods of the present invention, the implant including an distraction piece mated with a initiating piece. -
FIG. 88B is a perspective view of the implant ofFIG. 88A , the implant including an distraction piece mated with a initiating piece. -
FIGS. 89A-89C are posterior views of the initiating piece ofFIG. 88A as the initiating piece is urged in position with the interspinous ligament disposed between the first wing and the second wing. -
FIGS. 89D and 89E are posterior views showing the distraction piece ofFIG. 88A urged so that the distraction piece is mated with the initiating piece. -
FIG. 90 illustrates an embodiment of a method in accordance with the present invention for implanting the interspinous implant ofFIG. 83 . -
FIG. 91 illustrates an embodiment of a method in accordance with the present invention for implanting the interspinous implant ofFIG. 88A . - The following description is presented to enable any person skilled in the art to make and use the invention. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. To the extent necessary to achieve a complete understanding of the invention disclosed, the specification and drawings of all patents and patent applications cited in this application are incorporated herein by reference.
- An embodiment of an
implant 100 of the invention is depicted inFIG. 1 a. - This
implant 100 includes afirst wing 104 and aspacer 150 and a lead-in tissue expander ordistraction guide 110. This embodiment further can include, as required, asecond wing 132. As can be seen inFIG. 1 a, ashaft 102 extends from thefirst wing 104 and is the body that connects thefirst wing 104 to the tissue expander ordistraction guide 110. Also, as can be seen inFIGS. 1 a and 1 b, thedistraction guide 110 in this particular embodiment acts to distract the soft tissue and the spinous processes when theimplant 100 is inserted between adjacent spinous processes. In this particular embodiment, theguide 110 has an expanding cross-section from thedistal end 111 to the area where thesecond wing 132 is secured to theguide 110. In this embodiment theguide 110 is wedge-shaped. - Additionally, as can be seen in
FIGS. 1 a and 1 f, thespacer 150 is elliptical-shaped in cross-section. Thespacer 150 can have other shapes such as circular, oval, ovoid, football-shaped, and rectangular-shaped with rounded corners and other shapes, and be within the spirit and scope of the invention. In this preferred embodiment, thespacer 150 includes abore 152 which extends the length of thespacer 150. Thespacer 150 is received over theshaft 102 of theimplant 100 and can rotate thereon about theshaft 102. In these embodiments, thespacer 150 can have minor and major dimensions as follows:Minor Dimension (116a) Major Dimension (116b) 6 mm 13.7 mm 8 mm 14.2 mm 10 mm 15.2 mm 12 mm 16.3 mm 14 mm 17.8 mm - The advantage of the use of the
spacer 150 as depicted in the embodiment ofFIG. 1 a, is that thespacer 150 can be rotated and repositioned with respect to thefirst wing 104, in order to more optimally position theimplant 100 between spinous processes. It is to be understood that the cortical bone or the outer bone of the spinous processes is stronger at an anterior position adjacent to the vertebral bodies of the vertebra than at a posterior position distally located from the vertebral bodies. Also, biomechanically for load bearing, it is advantageous for thespacer 150 to be close to the vertebral bodies. In order to facilitate this and to accommodate the anatomical form of the bone structures, as the implant is inserted between the spinous processes and/or urged toward the vertebral bodies, thespacer 150 rotates relative to the wings, such aswing 104, so that thespacer 150 is optimally positioned between the spinous processes, and thewing 104 is optimally positioned relative to the spinous processes. Further, the broad upper and lower surfaces of thespacer 150 helps spread the load that the spinous processes place on thespacer 150. - As may be required for positioning the
implant 100 between the spinous processes, theimplant 100 can also include asecond wing 132 which fits over theguide 110 and is secured by abolt 130 placed through anaperture 134 provided in atongue 136 ofsecond wing 132. Thebolt 130 is received and secured in the threaded bore 112 located in theguide 110. As implanted, thefirst wing 104 is located adjacent to first sides of the spinous processes and thesecond wing 132 is located adjacent to second sides of the same spinous processes. - In another embodiment, the
spacer 150 has a cross-section with a major dimension and a minor dimension, wherein the major dimension is greater than the minor dimension, and, for example, less than about two times the minor dimension. - It is to be understood that the
spacer 150 can be fabricated from somewhat flexible and/or deflectable material. - In this embodiment the spacer is made out of a polymer, more specifically, the polymer is a thermoplastic. Still more specifically, the polymer is a polyketone known as polyetheretherketone (PEEK). Still more specifically, the material is PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex of Lancashire, Great Britain. (Victrex is located at www.matweb.com or see Boedeker www.boedeker.com). Other sources of this material include Gharda located in Panoli, India (www.ghardapolymers.com). The
spacer 150 can be formed by extrusion, injection, compression molding and/or machining techniques. This material has appropriate physical and mechanical properties and is suitable for carrying and spreading the physical load between the spinous process. Further in this embodiment, the PEEK has the following additional approximate properties:Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - In a preferred embodiment, the
implant 100 is comprised in part of titanium or other suitable implant material which may be radiopaque and in part of a radiolucent material that does not show up under x-ray or other type of imaging. In a preferred embodiment, the first and second wings and the shaft are comprised of such a radiopaque material such as titanium and the spacer and the distraction guide or tissue expander are comprised of a radiolucent material such as, for example, PEEK or PEKK or other radiolucent materials described herein. In an embodiment which includes the first wing, the spacer and the tissue expander, under imaging, the implant looks like an “T”. In an embodiment which includes both a first and a second wing, the spacer and the tissue expander, under imaging, the implant looks like a “H”. This embodiment allows the doctor to have a clearer view of the spine under imaging without the implant interfering as much with the view of the bone structure. - It should be noted that the material selected may also be filled. For example, other grades of PEEK are also available and contemplated, such as 30% glass-filled or 30% carbon-filled, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to that which is unfilled. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to enhance the compressive strength and stiffness of PEEK and lower its expansion rate. Carbon-filled PEEK offers wear resistance and load carrying capability.
- In this embodiment, as described above, the
spacer 150 is manufactured from polyetheretherketone (PEEK), available from Victrex. As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. The spacer can also be comprised of polyetherketoneketone (PEKK). - Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), and polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. The spacer can also be made of titanium.
- Reference to appropriate polymers that can be used in the spacer can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.”
- Other materials such as Bionateg, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
-
FIG. 2 a andFIG. 2 b shown an embodiment of the distraction guide ortissue expander 110.FIG. 2 a shows aframe 200 for adistraction guide 110. Theframe 200 is typically manufactured from radiopaque material such as titanium. Theframe 200 has afirst end 202 and asecond end 204. Thefirst end 202 has ashaft 102 which can be threaded withthreads 234 at one end to facilitate connection to, for example, afirst wing 104. The remaining end of the shaft connects to adistraction head frame 230 for thedistraction guide 110. Alternatively, theshaft 102 and thedistraction head frame 230 can be formed integral to each other. - Further, the
distraction head frame 230, theshaft 102 and thefirst wing 104 can be formed as one unit. Still further in an embodiment with ascrew thread 234 formed at one end of theshaft 102, whichthread 234 is received in a threaded bore of thefirst wing 102, thethread 234 can be laser welded into the threaded bore of thefirst wing 102, if desired. - The
distraction head frame 230 is formed to take on a relatively low profile because, as described above, it is typically formed of radiopaque material. As shown inFIG. 2 a,distraction head frame 230 has two pairs of parallel sides. The first pair ofparallel sides flanges recess 236. The second pair ofparallel sides parallel sides 214 abuts theshaft 102. As will be appreciated by those of skill in the art, neither the first or second pair of parallel sides need be parallel to each other, nor do the first pair of parallel sides need to be perpendicular to the second pair of parallel sides in order to practice the invention. - With respect to the
frame 200 inFIG. 2 a, thedistraction head frame 230 has anupper surface 218 within therecess 236 with a threadedbore 112 therein. The threaded bore 112 receives, for example, abolt 130 to secure thesecond wing 132 to thedistraction guide 110 via thetongue 136 on the second wing 132 (shown in more detail with respect toFIG. 1 a). The profile of thebolt 130 is such that the height of thebolt 130 and thetongue 136 fits within therecess 236. - The
lower surface 220 opposing theupper surface 218 can have a first portion 222 that is parallel, or substantially parallel, to theupper surface 218. - Additionally, a
second portion 224 can be angled from the first portion 222 toward one of the secondparallel sides 216. The angled configuration of thelower surface 220 is designed to facilitate the angled profile of the distraction guide. -
FIG. 2 b shows a perspective view of thedistraction guide 110. Theframe 200, as described above, is manufactured from radiopaque material. Acap 260 is formed of radiolucent material, such as a suitable polymer, around theframe 200. - Suitable polymers include, but are not limited to the polyketones discussed above with respect to the spacer configurations. Accordingly, for example, PEEK, PEKK, PEK, PEKEKK and PEEKK can be used as well as the other materials that are suitable for the
spacer 150. As will be appreciated by those of skill in the art, thecap 260 can be associated with theframe 200 by a variety of techniques such that thecap 260 is formed to theframe 200 or is adhered to theframe 200 using a suitable method. As illustrated inFIG. 2 b, thecap 260 has a higher profile than theframe 200 and is shaped to facilitate thesecond end 204 of thedistraction guide 110 acting to expand tissue when the distraction guide is implanted between spinous processes or used to distract adjacent spinous processes. - Referring now to
FIGS. 3 a-6 b, various embodiments of spacers are depicted. - In
FIGS. 3 a, 3 b and 3 c, thespacer 350 includes anouter spacer 352 and aninner spacer 354.Inner spacer 354 has abore 360 therethrough that enables thespacer 350 to rotate about theshaft 102 ofimplant 100 shown inFIG. 1 a. - Each of the inner and outer spacers of the
spacer 350 can have a cross-section that is elliptical, oval, ovoid, football-shaped, circular-shaped, rectangular with rounded ends (where the cross-section has two somewhat flattened surfaces and two rounded surfaces similar to the effect of a flattened ellipse). Further, the inner spacer and outer spacer can have different cross-sectional shapes relative to each other. At least the minor outer diameter of the outer spacer is between 6 mm and 14 mm. Typically, the minor outer dimension is one of 6 mm, 8 mm, 10 mm, 12 mm, and 14 mm. The different sizes enable the spacer to accommodate different sized patients. - As depicted in
FIG. 3 a, thespacer 350 is a rectangle with rounded ends or a flattened ellipse, as it has two sides that are almost parallel to each other, and the ends connecting the parallel sides are curved, similar to a “race-track.” Thus, in this and other embodiments, the two sides or surfaces of the spacer, including the upper and the lower spacer, can also be flattened or slightly radiused. Thebore 360 is located in the center of theinner spacer 354 and there is agap 362 between the upper and lower portions of theouter spacer 352 and theinner spacer 354. Agap 370 is provided between the inner and outer spacers at the rounded ends 356,358. In a preferred embodiment, for about an 8millimeter spacer 350, the upper andlower gaps 362 are about 0.012 of an inch or about a quarter of a millimeter each for a total combined gap of about one half of a millimeter. Thegaps 370 at the curved ends 356,358 are about 0.002 of an inch or slightly less than a tenth of a millimeter each in a preferred embodiment. Thegap 370 for all of the other spacers is preferably, as specified above, for the 8 mm spacer. For the 6 millimeter spacer, generally this is made of one piece such as seen inFIG. 1 f. - However, for the other spacers, these spacers are preferably made of two pieces as seen for example in
FIG. 3 a. The table below sets our preferred dimensions for the combined upper and lower gap dimension for the spacers.Spacer Minor Dimension Total Combined Gap Dimension 6 mm n/a 8 mm 0.020 in (0.51 mm) 10 mm 0.025 in (0.64 mm) 12 mm 0.030 in (0.76 mm) 14 mm 0.035 in (0.89 mm) - The
gap 362 closed and the inner and outer spacers touch each other when the spacer is loaded with 800 Newtons of force. The design is made to take repeated loading at 1200 Newtons of force. - In the above embodiment, the
outer spacer 352 is movably or slidably mounted on theinner spacer 354, and theinner spacer 354 is rotatably mounted on theshaft 102 of theimplant 100. - As discussed above, the spacer, including either the inner spacer or outer spacer, or both, can be made of deflectable and flexible material. As discussed above, suitable material is a polymer such as for example polyetheretherketone (PEEK). Other suitable materials can include those described above. Further, titanium can be used.
- Further, the deflectable or flexible material can have a graduated stiffness to help gradually distribute the load when the spinous processes place a force upon the exterior surface of the
outer spacer 352. This can be accomplished by forming multiple layers of the deflectable or flexible material with decreasing stiffness or hardness from the center of thespacer 350 outwardly. Alternatively, the material can have a higher stiffness or hardness in the center of the inner spacer. - Persons of skill in the art will appreciate that the embodiments shown in
FIGS. 4 a-6 b, can be made of the materials similar to those emphasized in the embodiment shown inFIGS. 1 a and 3 a. - Now referring to
FIGS. 4 a and 4 b, again thespacer 450 is depicted as a somewhat flattened ellipse withrounded ends 456,458, where two sides are somewhat parallel to each other and the ends connecting the parallel sides are curved, similar to a “race-track.” Thebore 460 is located off-center within theinner spacer 454. Further, there aregaps 462,470 between theouter spacer 452 and theinner spacer 454. Except for the location of thebore 460, the dimensions and materials of the embodiment ofFIGS. 4 a and 4 b are similar to that ofFIG. 3 a andFIG. 3 b. - The off-center bore 460 allows a greater portion of the
spacer 450 to be positioned close to the vertebral bodies. With an ovoid (“egg-shaped”) spacer, off-set thebore 460 is preferably close to the bulbous end of the spacer with the more pointed end directed toward the vertebral bodies in order to attain the advantages of the spacer being closer to the vertebral bodies and enhanced distributed load bearing. - Turning now to
FIG. 5 , thespacer 550 is depicted as having a circular cross-section. Thebore 560 is located within theinner spacer 554. Further, there are gaps 562,570 between theouter spacer 552 and theinner spacer 554. The dimensions of the gap would be the same as those discussed with respect to the embodiment shown inFIG. 3 a. The embodiment ofFIG. 3 a can have a diameter that is the minor diameter of the embodiments shown inFIGS. 1 a, 3 a, and 4 a. - Also, as will be appreciated by those in skill in the art, the
outer spacer 552 can be movably mounted on theinner spacer 554 and theinner spacer 554 can be rotatably mounted on theshaft 102 of theimplant 100 or any other suitable implant. - In
FIGS. 6 a and 6 b, thespacer 650 is depicted as having anouter spacer 652 and aninner spacer 654 of two different cross-sectional shapes. In this embodiment, theouter spacer 652 is elliptical and the inner spacer is football-shaped in cross-sections. Thebore 660 is located off-center within theinner spacer 654. However, as will be appreciated by those of skill in the art, thebore 660 can be located centrally within the inner spacer without departing from the scope of the invention. - The
gaps 662 between theouter spacer 652 and theinner spacer 654 are crescent-shaped as a result of the inner and outer spacers having different cross-sectional shapes. Thus, the gap can have a width ranging from approximately between 0.25 mm at the minor diameter (greatest vertical height) to just enough space at theapexes inner spacer 654 so that the outer spacer can slide over the inner spacer. Theinner spacer 654 can be rotatably mounted on theshaft 102 of theimplant 100. - The embodiment of this implant as well as the several other implants described herein act to limit extension (backward bending) of the spine. These implants, however, do not inhibit the flexion (forward bending) of the spinal column.
- The foregoing description of embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to the practitioner skilled in the art.
- The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention and the various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and its equivalence.
- Interspinous Implants
-
FIGS. 7 and 8 illustrate animplant 700 in accordance with an embodiment of the present invention. Theimplant 700 comprises awing 730, aspacer 720, and a lead-in tissue expander (also referred to herein as a distraction guide) 710. Thedistraction guide 710 in this particular embodiment is wedge-shaped, i.e., the implant has an expanding cross-section from a proximal end of theimplant 740 to aregion 750 where theguide 710 joins with the spacer 720 (referencing for the figures is based on the point of insertion of the implant between spinous processes). As such, the distraction guide functions to initiate distraction of the soft tissue and the spinous processes when theimplant 700 is surgically inserted between the spinous processes. It is to be understood that the distraction guide can be pointed and the like, in order to facilitate insertion of the implant between the spinous processes of adjacent cervical vertebrae. It is advantageous that the insertion technique disturb as little of the bone and surrounding tissue or ligaments as possible in order to reduce trauma to the site and promote early healing, and prevent destabilization of the normal anatomy. In the embodiment ofFIGS. 7 and 8 , there is no requirement to remove any of the bone of the spinous processes and no requirement to sever, or remove from the body, ligaments and tissues immediately associated with the spinous processes. For example, it is unnecessary to sever the ligamentum nuchae, (supraspinous ligament) which partially cushions the spinous processes of the upper cervical vertebrae. - As can be seen in
FIGS. 7-9 , thespacer 720 can be teardrop-shaped in cross-section perpendicular to alongitudinal axis 725 of the implant. In this way, the shape of thespacer 720 can roughly conform to a wedge-shaped space, or a portion of the space, between adjacent spinous processes within which theimplant 700 is to be positioned. In other embodiments, thespacer 720, can have alternative shapes such as circular, wedge, oval, ovoid, football-shaped, and rectangular-shaped with rounded corners and other shapes, and be within the spirit and scope of the invention. The shape of the spacer can be selected for a particular patient so that the physician can position the implant as close as possible to the anterior portion of the surface of the spinous process. The shape selected for thespacer 720 can effect the contact surface area of theimplant 700 and the spinous processes that are to be subject to distraction. Increasing the contact surface area between the implant and the spinous processes can distribute the force and load between the spinous frame and the implant. - As can be seen in
FIGS. 7 and 8 , thewing 730 in thisembodiment 700 is elliptically-shaped in cross-section perpendicular to alongitudinal axis 725 of thespacer 720 anddistraction guide 710. The dimensions of thewing 730 can be larger than that of thespacer 720, particularly along the axis of the spine, and can limit or block lateral displacement of the implant in the direction of insertion along thelongitudinal axis 725. As illustrated in the embodiment ofFIG. 9 , thewing 730 can have other cross-sectional shapes, such as teardrop, wedge, circular, oval, ovoid, football-shaped, and rectangular-shaped with rounded corners and other shapes, and be within the spirit and scope of the invention. Thewing 730 has ananterior portion 733 and aposterior portion 735. - In other embodiments, the
implant 700 can have two wings, with a second wing 760 (shown inFIG. 10 ) separate from thedistraction guide 710,spacer 720 andfirst wing 730. The second wing can be connected to the proximal end of thespacer 720. Thesecond wing 760, similar to thefirst wing 730, can limit or block lateral displacement of theimplant 700, however displacement is limited or blocked in the direction along thelongitudinal axis 725 opposite insertion. When both thefirst wing 730 andsecond wing 760 are connected with the implant and the implant is positioned between adjacent spinous processes, a portion of the spinous processes can be sandwiched between the first and second wing, limiting any displacement along thelongitudinal axis 725. - As can be seen in
FIG. 10 , thesecond wing 760 can be teardrop-shaped in cross-section. The wider section or end 762 of the teardrop shape is the posterior end of thesecond wing 760 and the narrower section or end 769 is the anterior end of thesecond wing 760. Unlike thefirst wing 730, however, the sides of thesecond wing 760 define aspace 770 with alip 780 that allows thesecond wing 760 to pass over thedistraction guide 710 to meet and connect with thespacer 720. Thesecond wing 760 is then secured to thespacer 720 toward the end of the spacer located distally from thefirst wing 740. Thesecond wing 760 is connected with the implant after theimplant 700 is positioned between the spinous processes. - It is to be understood that the implant can be made in two pieces. The first piece can include the
first wing 730, thespacer 720, and thedistraction guide 710. The second piece can include thesecond wing 760. Each piece can be manufactured using technique known in the art (e.g., machining, molding, extrusion). Each piece, as will be more fully discussed below, can be made of a material that is bio-compatible with the body of the patient. For example the implants can be made of stainless steel and titanium. Additionally, a shape memory metal such as Nitinol, which is a combination of titanium and nickel, can also be used. Further polymers can also be used. The implant can be formed with multiple pieces and with the pieces appropriately joined together, or alternatively, the implant can be formed as one piece or joined together as one piece. - Further embodiments of implants in accordance with the present invention are depicted in
FIGS. 11-13 . In such embodiments, thespacer 810 can be rotatable about thelongitudinal axis 840 relative to thefirst wing 730, or relative to a first andsecond wing spacer 810 can be rotatable or fixed relative to thedistraction guide 710. Where thespacer 810 is rotatable, thespacer 810 can include abore 820 running the length of thelongitudinal axis 840, and ashaft 830 inserted through thebore 820 and connecting thedistraction guide 710 with thefirst wing 730. It can be advantageous to position any of the implants taught herein as close as possible to the vertebral bodies. Therotatable spacer 810 can rotate to conform to or settle between the bone structures of the cervical spine as the implant is inserted between the spinous processes, so that on average the contact surface area between thespacer 810 and both of the spinous processes can be increased over the contact surface area between afixed spacer 810 and the spinous processes. Thus, therotatable spacer 810 improves the positioning of the spacer independent of the wings relative to the spinous processes. The embodiment ofFIG. 12 has afirst wing 730 and if desired, asecond wing 760 similar to the wing depicted in the embodiment ofFIG. 9 . As discussed below, the shape of the wings inFIGS. 9 and 12 is such that the implants accommodate the twisting of the cervical spine along its axis as, for example, the head of a patient turning from side to side. -
FIG. 14 is a perspective view andFIG. 15A is an end view of still another embodiment of an implant in accordance with the present invention, wherein theposterior portion 735 of the teardrop-shapedfirst wing 730 is truncated 910, making thefirst wing 730 more ovoid in shape. In this configuration, theanterior portion 733 of thefirst wing 730 can be longer than the truncatedposterior end 910 of thefirst wing 730. As in previous embodiments, thespacer 810 ofsuch implants 900 can be a rotatable spacer rather than a fixed spacer.FIG. 15B illustrates a second wing for use withsuch implant 900 having a truncatedposterior end 940. Truncation of the posterior ends 910,940 of the first andsecond wings implants 900 having such first andsecond wings - During rotation of the neck, the spinous process move past each other in a scissor-like motion. Each cervical vertebra can rotate relative to the next adjacent cervical vertebra in the general range of about 6°-12°. In addition, about 50 percent of the rotational movement of the neck is accomplished by the top two neck vertebrae. Thus, such embodiments can accommodate neck rotation without adjacent embodiments interfering with each other.
- With respect to the prior embodiments which have first and second wings, the
second wing 760, can be designed to be interference-fit onto the spacer 720 (where the spacer is fixed) or a portion of thedistraction guide 710 adjacent to the spacer 720 (where the spacer is rotatable). Where thesecond wing 760 is interference-fit, there is no additional attachment device to fasten thesecond wing 760 relative to the remainder of the implant. - Alternatively, various fasteners can be used to secure the
second wing 760 relative to the remainder of the implant. For example,FIGS. 16-17 illustrate an embodiment of animplant 1000 including a teardrop-shaped second wing 1010 having abore 1020 through atongue 1030 at the posterior end of thesecond wing 760. The bore on thesecond wing 1020 is brought into alignment with acorresponding bore 1040 on thespacer 720 when thesecond wing 760 is brought into position by surgical insertion relative to the rest of the implant. A threadedscrew 1050 can be inserted through the aligned bores in a posterior-anterior direction to secure thesecond wing 760 to thespacer 720. The direction of insertion from a posterior to an anterior direction has the screw engaging the bores and the rest of the implant along a direction that is generally perpendicular to thelongitudinal axis 725. This orientation is most convenient when the surgeon is required to use ascrew 1050 to secure thesecond wing 760 to the rest of the implant. Other securing mechanisms using a member inserted intocorresponding bores spacer 720 andsecond wing 760 are within the spirit of the invention. - It should be understood that a
rotatable spacer 810 also can be accommodated by this embodiment. With arotatable spacer 810, thesecond wing 760 would be attached to a portion of thedistraction guide 710 that is located adjacent to therotatable spacer 810. -
FIGS. 19A-20B depict afurther embodiment 1100 wherein thesecond wing 760 is secured to thespacer 720 by a mechanism including aflexible hinge 1115, with aprotrusion 1130 on the end of the hinge 1110 adjacent to thelip 780 of thehole 770 defined by portions of thesecond wing 760. The securing mechanism also encompasses anindentation 1140 on thespacer 720, wherein the indentation accommodates theprotrusion 1130 on the end of theflexible hinge 1115. During surgery, after insertion of thedistraction guide 710,spacer 720, andfirst wing 730, thesecond wing 760 is received over thedistraction guide 710 and thespacer 720. As thesecond wing 760 is received by thespacer 720, theflexible hinge 1115 and itsprotrusion 1130 deflect until theprotrusion 1130 meets and joins with theindentation 1140 in thespacer 720, securing thesecond wing 760 to thespacer 720. Again in embodiments where the spacer can rotate, theindentation 1140 is located on an end of thedistraction guide 710 that is adjacent to 750 therotatable spacer 810. With respect to theflexible hinge 1115, this hinge is in a preferred embodiment formed with thesecond wing 760 and designed in such a way that it can flex as thehinge 1115 is urged over thedistraction guide 710 and thespacer 720 and then allow theprotrusion 1130 to be deposited into theindentation 1140. - Alternatively, it can be appreciated that the
indentation 1140 can exist in thesecond wing 760 and theflexible hinge 1115 and theprotrusion 1130 can exist on thespacer 720 in order to mate thesecond wing 760 to thespacer 720. Still alternatively, theflexible hinge 1115 can be replaced with a flexible protrusion that can be flexed into engagement with theindentation 1140 in the embodiment with theindentation 1140 in thespacer 720 or in the embodiment with theindentation 1140 in thesecond wing 760. -
FIGS. 21A-22 illustrate an embodiment of animplant 1200 wherein anterior ends of afirst wing 730 andsecond wing 760 flare out at an angle away from thespacer 720 and away from each other. The cervical spinous processes are themselves wedge-shaped when seen from a top view. That theimplant 1200 can roughly conform with the wedge shape so that theimplant 1200 can be positioned as close as possible to the vertebral bodies of the spine where the load of the spine is carried. Thus the first 730 and thesecond wings 760 are positioned relative to the spacer, whether the spacer is fixed 720 or rotatable 810, so that the wings flare out as the wings approach the vertebral body of the spine.FIG. 21B depicts a top view of theimplant 1200 ofFIG. 21A . As is evident fromFIG. 21B , thefirst wing 730 is aligned at an angle with respect to a line perpendicular to the longitudinal axis. In one embodiment, the angle is about 30°, however, the angle Θ can range from about 15° to about 45°. In other embodiments, other angles of thefirst wing 730 relative to thespacer 720 outside of this range are contemplated and in accordance with the invention. Likewise, thesecond wing 760 can be aligned along a similar, but oppositely varying range of angles relative to the line perpendicular to the longitudinal axis. The first andsecond wing spacer 720 in this embodiment. Thesecond wing 760 defines aninner hole 770 which is outlined by thelip 780. As is evident, thelip 780 can be provided at an angle relative to the rest of thesecond wing 760 so that when thelip 780 is urged into contact with thespacer 720, thesecond wing 760 has the desired angle relative to thespacer 720. As discussed above, there are various ways that thesecond wing 760 is secured to thespacer 720.FIG. 21A depicts a top view of onesuch implant 1200 placed between the spinous processes of adjacent cervical vertebrae.FIG. 22 is a top view illustrating two layers of distractingimplants 1200 with flared wings. - Systems and methods in accordance with the present invention can include devices that can be used in cooperation with implants of the present invention.
FIG. 23 illustrates “stops” (also referred to herein as “keeps”) 1310, which are rings of flexible biocompatible material, which can be positioned around the spinous processes of adjacent cervical vertebrae and located posteriorly to the implant. The keeps 1310 can prevent posterior displacement of the implants. In one embodiment, the keeps can include aring 1310 having aslit 1320. The keeps 1310 can be somewhat sprung apart, so that thekeep 1310 can be fit over the end of the spinous process and then allowed to spring back together in order to hold a position on the spinous process. The keep 1310 can act as a block to thespacer 720 in order to prevent the implant from movement in a posterior direction. - Distractible Interspinous Implants
- In still other embodiments, implants in accordance with the present invention can be distractible in situ.
FIG. 24 is a perspective view of one such implant. Theimplant 1800 comprises abody 1801 adapted to be inserted between the spinous processes, and adistracting insert 1806. Thebody 1801 can include two substantially mirror parts: afirst part 1802 adapted to contact and support an upper spinous process and asecond part 1804 adapted to contact and support a lower spinous process. When positioned such that the first andsecond parts body 1801 can resemble implants described above in reference toFIGS. 7-23 . In other embodiments, thebody 1801 can have a shape other than those shown inFIGS. 7-23 . Further, in some embodiments thefirst part 1802 andsecond part 1804 can have different shapes, such that when thefirst part 1802 andsecond part 1804 align with and abut one another, thebody 1801 is nonsymmetrical about the plane of contact. For example, as shown inFIG. 25A , thefirst part 1802 can have a saddle-like, or concave shape conforming roughly with a shape of a contact surface of the second cervical, while thesecond part 1804 has a substantially convex shape. - The
body 1801 can include awing 1830 having a first andsecond portion spacer 1820 having a first andsecond portion second portion distraction guide 1810 as shown is wedge-shaped, i.e., thedistraction guide 1810 has an expanding cross-section from the proximal end of thebody 1801 to a region where thedistraction guide 1810 joins with thespacer 1820. As such, thedistraction guide 1810 functions to initiate distraction of the soft tissue and the spinous processes when thebody 1801 is surgically inserted between the spinous processes. - The
spacer 1820, as shown, is teardrop-shaped in a cross-section perpendicular to the spacer'slongitudinal axis 1825. Thespacer 1820 can be shaped to roughly conform to a wedge-like space, or a portion of the space, between adjacent spinous processes, for example as between the spinous processes of the fourth and fifth cervical vertebrae. The shape of thespacer 1820 can be selected for a particular patient, and/or a particular pair of adjacent spinous processes, and can vary substantially. Thus, in other embodiments, thespacer 1820 can have other cross-sectional shapes, such as circular, wedge, oval, ovoid, football-shaped, and rectangular-shaped with rounded corners and other cross-sectional shapes and/or can be custom fabricated for the particular patient and the anatomy of the particular spinal processes between which theimplant 1800 is to be placed. - In still other embodiments, the
spacer 1820 can have a nonsymmetrical cross-sectional shape, for example where a space between adjacent spinous processes is nonsymmetrical. - The ability to select a size and shape of the
spacer 1820 to suit a patient allows the physician to choose animplant 1800 that can be placed closer to the vertebral bodies than farther away for additional support. The shape selected for thespacer 1820 can define the contact surface area between theimplant 1800 and the spinous processes that are subject to distraction. - Increasing the contact surface area between the
implant 1800 and the spinous processes distributes the force and load between the spinous frame and theimplant 1800. Generally, a teardrop or wedge-shapedspacer 1820 can allow for more load-bearing contact between thespacer 1820 and the spinous processes of the cervical vertebrae, and embodiments having such shapes will be more particularly described. - As shown, the
wing 1830 can be tear-drop shaped in cross-section, although having a minor dimension that is larger than that of thespacer 1820, and can limit or block lateral displacement of theimplant 1800 in the direction of insertion along thelongitudinal axis 1825. However, thewing 1830 need not be teardrop shaped. In other embodiments, thewing 1830 can have some other shape, for example thewing 1830 can be elliptical, wedge, circular, oval, ovoid, football-shaped, and rectangular-shaped with rounded corners and other shapes, and be within the spirit and scope of the invention. Further, as with thespacer 1820, thewing 1830 can have a nonsymmetrical cross-sectional shape. The shape of thewing 1830 can be chosen to most easily fit into place while avoiding obstructions, such as soft tissue or bone, or other implants, while still blocking or limiting lateral displacement. - The
wing 1830 can include one ormore cavities wing 1830 and through at least a portion of thespacer 1820. The one ormore cavities first part 1802 and a second groove formed in thesecond part 1804, so that the cross-section of thecavity distracting insert 1806, as described below. Thebody 1801 ofFIG. 24 includes afirst cavity 1852 and asecond cavity 1854 to receive afirst insert 1842 and asecond insert 1844 of thedistracting insert 1806. Having two or more cavities and corresponding inserts can prevent relative rotation between thebody 1801 and thedistracting insert 1806. In the embodiment shown in cross-section inFIG. 25B , each cavity has a substantially circular cross-section, and is sized roughly in proportion to the width of thespacer 1820, so that thefirst cavity 1852 is larger in diameter than thesecond cavity 1854. - However, in other embodiments, the cavities need not be shaped as shown. For example, the cavities can be elliptical, dual-lobed, or otherwise shaped. Further, the cavities need not be sized as shown. For example, the cavities can be roughly the same size. As shown in
FIG. 25C , in still further embodiments, thebody 1801 can include more than twocavities FIG. 25D , in still other embodiments thebody 1801 can include asingle cavity 1852, such as a wedge-shaped cavity roughly corresponding to a shape of thespacer 1820. Myriad different cavity shapes and cavity configurations can be employed to achieve separation of abody 1801 positioned between spinous processes. However, it can be preferable that the shape of thecavities inserts distracting insert 1806, so that, as shown inFIG. 25B-25D , a load applied to thebody 1801 can be distributed relatively evenly over the surface of thecavities - Once the
body 1801 is positioned between adjacent spinous processes, the first andsecond parts body 1801 can be separated, thereby expanding the width of thebody 1801 and distracting the adjacent spinous processes. In one embodiment, separation of the first andsecond parts body 1801 such that the first andsecond parts distracting insert 1806 can include one or more inserts associated with the one or more cavities, the one or more inserts being fixedly connected to acap 1808. As shown inFIG. 24 , thedistracting insert 1806 includes afirst insert 1842 and asecond insert 1844, each of the inserts being fixedly connected with acap 1808 having a shape roughly corresponding to a shape of thewing 1830.Inserts implant 1800 apart. In other words, theinserts cavities insert body 1801 apart. Thus, the tips of theinsert cavities cavities more inserts more cavities first part 1802 andsecond part 1804 of thebody 1801 are separated by the difference in height of the inserts and the diameter (or height) of the cavities (i.e., an additional distraction height). - As shown in
FIG. 26A , thebody 1801 can be inserted between adjacent spinous processes by piercing and/or displacing the soft tissue (i.e., the interspinous ligament) with thedistraction guide 1810 and stretching and/or displacing the tissue so that thespacer 1820 fits between the spinous processes. The height of thefirst part 1802 andsecond part 1804 of thebody 1801 can be minimized by abutting thefirst part 1802 and thesecond part 1804 so that thebody 1801 can be positioned between the spinous processes. - As described above, and as can be seen in
FIG. 26A , the shape of thebody 1801 can resemble the shape of a space between adjacent spinous processes. With thebody 1801 in place, thedistracting insert 1806 can be inserted into thebody 1801, causing thefirst part 1802 andsecond part 1804 to separate, as described above and shown inFIG. 26B . As discussed above, proximal ends of theinserts distracting insert 1806 can be tapered to assist in guiding theinserts cavities second parts distracting insert 1806 can haveinserts - As with the
body 1801, multipledistracting inserts 1806 can be made available to a physician, the physician choosing adistracting insert 1806 sized to suit a particular patient. A system in accordance with one embodiment of the present invention can comprise a plurality ofbodies 1801, eachbody 1801 having different shape and/or height. - Such a system can further comprise a plurality of
distracting inserts 1806, having inserts corresponding to cavities of thebodies 1801, and having different heights to achieve different amounts of distraction. Methods in accordance with embodiments of the present invention can apply such systems so that a physician can select implant components appropriate to the patient at the time of surgery, and can further substitute different bodies and/or different distracting inserts based on evaluation or reevaluation during surgery. -
FIG. 27A is a cross-sectional side view of adistractible implant 1800 in accordance with one embodiment of the present invention positioned between adjacent spinous processes, and having aninsert 1842 of thedistracting insert 1806 partially inserted within acavity 1852 of thebody 1801. As described above, when inserted between spinous processes, thefirst part 1802 of thebody 1801 is aligned and abutted with thesecond part 1804 of thebody 1801. Thefirst part 1802 andsecond part 1804 should remain aligned while thebody 1801 is inserted between the spinous processes, and further should remain aligned while thedistracting insert 1806 is mated with thebody 1801. In order to maintain proper alignment, one of the first andsecond parts corresponding holes 2119 of the other of the first andsecond parts pins 2118 can be made of the same or different material as thebody 1801, and can be integrally formed or mated with the corresponding part. For example, where thepins 2118 are made of titanium, and thebody 1801 is made of a biocompatible thermoplastic, thepins 2118 can be press fit into thesecond part 1804. Thepins 2118 are free to slide in and out of theholes 2119, but are prevented from separating from theholes 2119 by pressure of the spinous processes. As aninsert 1842 enters acavity 1852 of thebody 1801, the distal end of thebody 1801 begins to separate, as shown. As the spinous processes are distracted, thepins 2118 move within theholes 2119, allowing separation of thefirst part 1802 andsecond part 1804. Thepins 2118 prevent relative shifting or sliding along the longitudinal axis or along the length of the spinous process. The pins 2118 (and corresponding holes 2119) preferably have a height larger than the maximum distraction height, thereby preventing thepins 2118 from separating from theholes 2119 and allowing relative shifting of the first andsecond parts FIG. 27B is a top view showing the position of thepins 2118 relative to a first andsecond cavity pins 2118 are shown extending throughholes 2119 of thesecond part 1802, however, in other embodiments, any number ofpins 2118 or protrusions can be integrally formed or connected with one of the first andsecond parts - In an alternative embodiment (not shown), the
first part 1802 andsecond part 1804 of thebody 1801 can be bound together by a flexible, artificial ligament or suture material. For example, the material can be a bio-compatible polymer having flexible properties. The artificial ligament or suture material can limit the shifting between thefirst part 1802 andsecond part 1804. In still other embodiments, some other device can be employed to maintain alignment of the first andsecond parts second parts second parts body 1801. - As shown in
FIGS. 28A and 28B , thedistracting insert 1806 can be secured to thebody 1801 by aclip 2260. Thebody 1801 as shown inFIGS. 28A-28D is the same as thebody 1801 ofFIG. 24 . Commonly labeled components are as described above. However, it should be noted that other embodiments of abody 1801 can be used withdistracting inserts 1806 described with reference toFIG. 28A-28D . In one embodiment, theclip 2260 can include afirst tab 2262 and asecond tab 2264. Eachtab wing 1830 along thelongitudinal axis 1825. When thedistracting insert 1806 is mated with thebody 1801, thewing 1830 can be interference-fit with thedistracting insert 1806 so that thewing 1830 is held between thetabs wing 1830 should create sufficient frictional force to prevent relative movement between thebody 1801 and distractinginsert 1806. In other embodiments, theclip 2260 can comprise a single lip along a portion of, or the entire periphery of the cap (and wing 1830) and can extend across at least a portion of the width of thewing 1830 along thelongitudinal axis 1825. - As shown in
FIG. 28C , in still other embodiments, eachtab protrusion tab wing 1830 can includeindentations protrusions clip 2260 is locked in place. Alternatively, thetab ledged wing 1830, so that theclip 2260 can be locked in place when theprotrusions wing 1830. As described above, thedistracting insert 1806 is mated with the positionedbody 1801 by gradually urging the inserts of thedistracting insert 1806 along the length of the cavities of thespacer 1820. Theprotrusions wing 1830, thetabs distracting insert 1806 to continue moving into position along the longitudinal axis. When theprotrusions indentations clasp 2260 locks into place and thedistracting insert 1806 is mated with thebody 1801. - In still further embodiments, the
distracting insert 1806 need not include a clip, but can be mated with thebody 1801 using some other device. For example, as shown inFIG. 28D , aninsert 1842 can include one ormore pegs holes 2282,2284 (or cavities) within thefirst wing 1830. The one ormore pegs more pegs holes distracting insert 1806 and thebody 1801, holding thedistracting insert 1806 seated in place, and limiting the relative movement of thefirst part 1802 andsecond part 1804. - Referring to
FIG. 29 , theimplant 1800 can further include asecond wing 2360, similar to previously described embodiments. Thesecond wing 2360 can be connected to the proximal end of thespacer 1820 so that portions of the adjacent spinous processes are sandwiched between thesecond wing 2360 and thefirst wing 1830. Thesecond wing 2360, like thefirst wing 1830, can prevent lateral displacement of thebody 1801 relative to the spinous processes. Thesecond wing 2360 can be teardrop-shaped and sized to approximate the shape and size of thefirst wing 1830 when thedistracting insert 1806 is mated with thebody 1801. Likewise, the sides of thesecond wing 2360 define aspace 2370 with alip 2380 that allows thesecond wing 2360 to pass over thedistraction guide 1810 to meet and connect with thespacer 1820. Thespace 2370 defined within thesecond wing 2360 should correspond with the distracted height of thebody 1801. As described above, systems and methods in accordance with the present invention can comprise a plurality ofbodies 1801 and a plurality ofdistracting inserts 1806 to suit a particular patient. Likewise, systems and methods in accordance with the present invention can further comprise a plurality ofsecond wings 2360 corresponding in size and shape to the plurality ofbodies 1801 and the plurality ofdistracting inserts 1806. Thesecond wing 2360 can be secured to thespacer 1820, for example as described above. Thesecond wing 2360 is implanted once thedistraction guide 1810,spacer 1820, andfirst wing 1830 are inserted as a unit between the spinous processes of adjacent cervical vertebrae. - It is to be understood that the various features of the various embodiments can be combined with other embodiments of the invention and be within the spirit and scope of the invention. Thus, for example only, the embodiment of
FIG. 24 can have truncated wings as depicted in other embodiments. - Materials for Use in Implants of the Present Invention
- It is to be understood that implants in accordance with the present invention, and/or portions thereof can be fabricated from somewhat flexible and/or deflectable material.
- In these embodiments, the implant and/or portions thereof can be made out of a polymer, such as a thermoplastic. For example, in one embodiment, the implant can be made from polyketone, known as polyetheretherketone (PEEK). Still more specifically, the implant can be made from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex of Lancashire, Great Britain. Other sources of this material include Gharda located in Panoli, India. PEEK has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - The material specified has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques.
- In some embodiments, the implant can comprise, at least in part, titanium or stainless steel, or other suitable implant material which is radiopaque, and at least in part a radiolucent material that does not show up under x-ray or other type of imaging. For example, in one embodiment, a first wing, a second wing and a shaft can comprise a radiopaque material (e.g., titanium) and a rotatable spacer and a lead-in tissue expander can comprise a radiolucent material (e.g., PEEK). In such an embodiment, under imaging the implant looks like an “H”. The physician can have a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- It should be noted that the material selected can also be filled. For example, other grades of PEEK are also available and contemplated, such as 30% glass-filled or 30% carbon-filled, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to that which is unfilled. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to enhance the compressive strength and stiffness of PEEK and lower its expansion rate. Carbon-filled PEEK offers wear resistance and load carrying capability.
- In this embodiment, as described above, the implant is manufactured from PEEK, available from Victrex. As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention.
- The spacer can also be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), and polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- Methods for Implanting Interspinous Implants
- A minimally invasive surgical method for implanting an
implant FIG. 30 , preferably aguide wire 2480 is inserted through aplacement network 2490 into the neck of the implant recipient. Theguide wire 2480 is used to locate where the implant is to be placed relative to the cervical spine, including the spinous processes. Once theguide wire 2480 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that an implant in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 2480 and directed at the end of theguide wire 2480. In one embodiment, the implant can be a sized implant 100 (i.e., having a body that is not distractible), such as described above inFIGS. 7-23 and including adistraction guide 710, aspacer 720, and afirst wing 730. Theimplant 700 is inserted into the neck of the patient. Preferably during insertion, the distraction end pierces or separates the tissue without severing the tissue. - Once the
implant 700 is satisfactorily positioned, asecond wing 760 can be optionally inserted along a line that is generally collinear with the line over which theimplant 700 is inserted but from the opposite side of the neck. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theimplant 700 and thesecond wing 760. Thesecond wing 760 is mated to the implant and in this particular embodiment, thesecond wing 760 is snapped into engagement with theimplant 700. In an alternative embodiment, thesecond wing 760 is attached to the implant by the use of a fastener, for example by ascrew 1050. Where a screw is used, thescrew 1050 can be positioned using a screw driving mechanism that is directed along a posterior to anterior line somewhat parallel to theguide wire 2480. This posterior to anterior line aids the physician in viewing and securing the second wing 160 to the implant. - In other embodiments of methods in accordance with the present invention, the implant can be a
distractible implant 1800, such as described above inFIGS. 24-29 . In such embodiments, as shown inFIG. 31 , preferably aguide wire 2580 is inserted through aplacement network 2590 into the neck of the implant recipient (as shown and described above). Once theguide wire 2580 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that adistractible body 1801 in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to the guide wire 880 and directed at the end of the guide wire. Thedistractible body 1801 can include adistraction guide 1810, aspacer 1820, and afirst wing 1830. Thebody 1801 is inserted into the neck of the patient, between adjacent spinous processes. Preferably during insertion, thedistraction guide 1810 pierces or separates the tissue without severing the tissue, and thebody 1801 is positioned so that thespacer 1820 is between the adjacent spinous processes. Adistracting insert 1806 is then positioned within the incision and urged into one or more cavities of thebody 1801, distracting the spinous processes between which the body is positioned. As thedistracting insert 1806 mates with thebody 1801, thedistracting insert 1806 locks in place. - Once the
distractible implant 1800 is satisfactorily positioned and distracted, asecond wing 2360 can optionally be inserted along a line that is generally collinear with the line over which thebody 1801 is inserted but from the opposite side of the neck. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to thebody 1801 and thesecond wing 2360. Thesecond wing 2360 can be mated to thebody 1801 through an interference fit, or alternatively by attaching to thebody 1801 by the use of a fastener, or by some other device, as described above. For example, where a screw is employed, the screw can be positioned using a screw driving mechanism that is directed along a posterior to anterior line somewhat parallel to the guide wire. This posterior to anterior line aids the physician in viewing and securing thesecond wing 2360 to thebody 1801. - The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.
-
FIG. 32 is a perspective view of an implant as described in U.S. Pat. No. 6,695,842 to Zucherman, et al. and U.S. Pat. No. 6,712,819 to Zucherman et al., both incorporated herein by reference. Theimplant 3100 has amain body 3101. Themain body 3101 includes aspacer 3102, afirst wing 3108, a lead-in tissue expander 3106 (also referred to herein as a distraction guide) and analignment track 3103. Themain body 3101 is inserted between adjacent spinous processes. Preferably, themain body 3101 remains (where desired) in place without attachment to the bone or ligaments. - The
distraction guide 3106 includes a tip from which thedistraction guide 3106 expands, the tip having a diameter sufficiently small such that the tip can pierce an opening in an interspinous ligament and/or can be inserted into a small initial dilated opening. The diameter and/or cross-sectional area of thedistraction guide 3106 then gradually increases until it is substantially similar to the diameter of themain body 3101 andspacer 3102. The tapered front end eases the ability of a physician to urge theimplant 3100 between adjacent spinous processes. When urging themain body 3101 between adjacent spinous processes, the front end of thedistraction guide 3106 distracts the adjacent spinous processes and dilates the interspinous ligament so that a space between the adjacent spinous processes is approximately the diameter of thespacer 3102. - The shape of the
spacer 3102 is such that for purposes of insertion between the spinous processes, the spinous processes need not be altered or cut away in order to accommodate thespacer 3102. Additionally, associated ligaments need not be cut away and there is little or no damage to the adjacent or surrounding tissues. As shown inFIG. 32 , thespacer 3102 is elliptically shaped in cross-section, and can swivel about a central body (also referred to herein as a shaft) extending from thefirst wing 3108 so that thespacer 3102 can self-align relative to the uneven surfaces of the spinous processes. Self-alignment can ensure that compressive loads are distributed across the surface of the bone. As contemplated in Zucherman '842, thespacer 3102 can have, for example, a diameter of six millimeters, eight millimeters, ten millimeters, twelve millimeters and fourteen millimeters. These diameters refer to the height by which the spacer distracts and maintains apart the spinous process. For an elliptically shaped spacer, the selected height (i.e., diameter) is the minor dimension measurement across the ellipse. The major dimension is transverse to the alignment of the spinous process, one above the other. - The
first wing 3108 has alower portion 3113 and anupper portion 3112. As shown inFIG. 32 , theupper portion 3112 is shaped to accommodate the anatomical form or contour of spinous processes (and/or laminae) of the L4 (for an L4-L5 placement) or L5 (for an L5-S1 placement) vertebra. The same shape or variations of this shape can be used to accommodate other motion segments. Thelower portion 3113 can also be rounded to accommodate the spinous processes. Thelower portion 3113 andupper portion 3112 of thefirst wing 3108 act as a stop mechanism when theimplant 3100 is inserted between adjacent spinous processes. Theimplant 3100 cannot be inserted beyond the surfaces of thefirst wing 3108. Additionally, once theimplant 3100 is inserted, thefirst wing 3108 can prevent side-to-side, or posterior-to-anterior movement of theimplant 3100. Thefirst wing 3108 can further include one ormore alignment holes 3103 and one or morelocking pin holes 3104 for receiving pins of a main body insertion instrument (not shown). - The
implant 3100 further includes an adjustable wing 3150 (also referred to herein as a second wing). Theadjustable wing 3150 has alower portion 3152 and anupper portion 3153. Similar to thefirst wing 3108, theadjustable wing 3150 is designed to accommodate the anatomical form or contour of the spinous processes and/or lamina. Theadjustable wing 3150 is secured to themain body 3101 with afastener 3154. Theadjustable wing 3150 also has analignment tab 3158. When theadjustable wing 3150 is initially placed on themain body 3101, thealignment tab 3158 engages thealignment track 3103. Thealignment tab 3158 slides within thealignment track 3103 and helps to maintain theadjustable wing 3150 substantially parallel with thefirst wing 3108. When themain body 3101 is inserted into the patient and theadjustable wing 3150 has been attached, theadjustable wing 3150 also can prevent side-to-side, or posterior-to-anterior movement.FIG. 33A illustrates animplant 3100 positioned between adjacent spinous processes extending from vertebrae of the lumbar region. Theimplant 3100 is positioned between inferiorarticular processes 10 associated with the upper vertebrae and superiorarticular processes 12 associated with the lower vertebrae. Thesupraspinous ligament 6 connects the upper and lowerspinous processes implant 3100 can be positioned without severing or otherwise destructively disturbing thesupraspinous ligament 6. - Referring to
FIG. 33B , thespacer 3102 of theimplant 3100 ofFIG. 33A is shown in cross-section. Thespacer 3102 defines a minimum space between adjacentspinous processes - During extension the
spacer 3102 limits or blocks relative movement between the adjacentspinous processes spinous processes FIG. 33C , theimplant 3100 permits flexion, which in some degenerative disorders (for example in cases of spinal stenosis) can relieve some symptoms. As can be seen, during flexion thespacer 3102 can float between the spinous processes, held in position by theinterspinous ligament 8, and/or other tissues and structures associated with the spine. The ability to float between thespinous processes - In some circumstances, for example where a patient develops spondylosis or other degenerative disorder that makes both flexion and extension painful and uncomfortable, it can be desired that the spinous processes be further immobilized, while providing the same ease of implantation as provided with implants described above. Referring to
FIG. 34A , an embodiment of animplant 3300 in accordance with the present invention is shown. Theimplant 3300 includes adistraction guide 3306, aspacer 3302, and abrace 3308. As shown, thespacer 3302 is rotatable about acentral body 3301 extending from thebrace 3302, although in other embodiments thespacer 3302 can be fixed is position. Abinder 3330 can be fixedly connected with thebrace 3308 at aproximal end 3332 of thebinder 3330. Thebinder 3330 is flexible, or semi-flexible, and can be positioned around adjacent spinous processes so that thebinder 3308 engages the spinous processes during flexion of the spine. Once positioned around adjacent spinous processes, tension of thebinder 3330 can be set when thebinder 3330 is secured to thebrace 3308 so that relative movement of the adjacent spinous processes during flexion is limited or prevented, as desired. - As can be seen in
FIG. 34A , in an embodiment thebrace 3308 can include a first end having aslot 3341 through which theproximal end 3332 of thebinder 3330 can be threaded and subsequently sutured, knotted or otherwise bound so that theproximal end 3332 of thebinder 3330 cannot be drawn through theslot 3341. In other embodiments (not shown), theproximal end 3332 can be looped or can include a connector, such as a clasp or other device, and can be fixed to thebrace 3308 via a fastener that engages the connector. One of ordinary skill in the art can appreciate the myriad different ways in which theproximal end 3332 of thebinder 3330 can be associated with thebrace 3308 so that tension can be applied to thebinder 3330, and implants in accordance with the present invention are not intended to be limited to those schemes described in detail herein. Thebrace 3308 can include a height along the spine greater than a height of thespacer 3302 so that movement along a longitudinal axis L in the direction of insertion is limited or blocked by thebrace 3308 when thebrace 3308 contacts the lateral surfaces of the spinous processes. In this way, thebrace 3308 can function similarly to thewing 3108 of the above describedimplant 3300. In other embodiments, thebrace 3308 can have a height greater or smaller than as shown. Once thebinder 3330 is positioned around the spinous processes and secured, movement of theimplant 3300 relative to the spinous processes is limited by thebinder 3330 along the longitudinal axis as well as along the spinous processes (i.e., anterior-to-posterior movement). - A free end of the
binder 3330 can be secured to thebrace 3308 by acapture device 3320 associated with thebrace 3308. Thebrace 3308 can include aflange 3310 from which thecapture device 3320 can extend, in the embodiment shown inFIG. 34A , thecapture device 3320 comprises arotatable cam 3321 having afastener 3322 and one or more cut-outs 3324. A tool can be mated with the cut-outs 3324 and rotated to pivot therotatable cam 3321. When thecam 3321 is rotated, the eccentric shape of thecam 3321 causes a gap to close between thecam 3321 and awall 3314 of thebrace 3330 from which theflange 3310 extends. When thebinder 3330 is positioned between thecam 3321 and thewall 3314, the rotation of thecam 3321 can pinch thebinder 3330 between thecam 3321 and thewall 3314, defining asecured end 3336 of thebinder 3330. Optionally, thefastener 3322 can be screwed (i.e., rotated) so that thefastener 3322 is further seated, tightening against thecam 3321 to fix thecam 3321 in position. Further, optionally, one or both of thewall 3314 and therotatable cam 3321 can include knurls, or some other texture (e.g., teeth) to prevent slippage (i.e., the slipping of thebinder 3330 between thecam 3321 and the wall 3314). Thebrace 3308 can further include aguide 3312, such as a channel or slot (a slot as shown) at a second end of thebrace 3308 to align thebinder 3330 with thecapture device 3320. Thebinder 3330 can comprise a strap, ribbon, tether, cord, or some other flexible (or semi-flexible), and preferably threadable structure. Thebinder 3330 can be made from a biocompatible material, in an embodiment, thebinder 3330 can be made from a braided polyester suture material. Braided polyester suture materials include, for example, Ethibond, Ethiflex, Mersilene, and Dacron, and are nonabsorbable, having high tensile strength, low tissue reactivity and improved handling. In other embodiments, thebinder 3330 can be made from stainless steel (i.e., surgical steel), which can be braided into a tether or woven into a strap, for example. In still other embodiments, thebinder 3330 can be made from some other material (or combination of materials) having similar properties. - The
distraction guide 3306 can optionally include a slot, bore, cut-out orother cavity 3309 formed in thedistraction guide 3306 through which thebinder 3330 can be threaded or positioned. Such a cavity can allow on-axis positioning of the binder 3330 (i.e., the binder can be substantially aligned with the longitudinal axis L of the implant 3300). Further, capturing thebinder 3330 within a slot or bore can prevent or limit shifting of thedistraction guide 3306 relative to thebinder 3330 to further secure theimplant 3300 between the spinous processes. - As will be readily apparent to one of skill in the art, implants in accordance with the present invention provide significant benefits to a physician by simplifying an implantation procedure and reducing procedure time, while providing an implant that can limit or block flexion and extension of the spine. A physician can position an implant between adjacent spinous processes and can position a
binder 3330 connected with thebrace 3308 around the spinous processes without requiring the physician to measure an appropriate length of thebinder 3330 prior to implantation. Thecapture device 3320 allows thebinder 3330 to be secured to thebrace 3308 anywhere along a portion of thebinder 3330, the portion being between adistal end 3334 of thebinder 3330 and theproximal end 3332. The physician can secure thebinder 3330 to thebrace 3308 to achieve the desired range of movement (if any) of the spinous processes during flexion. - The
capture device 3320 andbrace 3308 can have alternative designs to that shown inFIG. 34A . A side view of animplant 3400 in accordance with an alternative embodiment of the present invention is shown inFIG. 34B , theimplant 3400 including acapture device 3420 comprising acam 3421 positioned within aring 3426 having one ormore lobes 3423 corresponding with one ormore recesses 3413 in awall 3414 of thebrace 3408. Thebinder 3330 is positioned between thecapture device 3420 and thebrace 3408. Once thebinder 3330 is positioned as desired, thefastener 3422 andcam 3421 can be rotated using an appropriate tool, with thecam 3421 forcing thelobes 3423 of thering 3426 to mate with therecesses 3413 of thebrace 3408, preventing thering 3426 from shifting in position and defining asecure end 3336 of thebinder 3330. Rotating thefastener 3422 rotates and optionally tightens down thecam 3421. Such acapture device 3420 can provide a physician a visual indication that thebinder 3330 is properly secured to thebrace 3408, as well as preventing slippage. - Referring to
FIGS. 34C and 34D , in still other embodiments, the implant can include a capture device comprising a spring-loaded mechanism.FIG. 34C illustrates animplant 3500 including acapture device 3520 comprising a single spring-loadedcam 3521 pivotally connected with theflange 3310 and biased to rotate in one direction. The distance between the pivot point of the cam 3510 and thewall 3314 is sufficiently narrow that the rotation of thecam 3521 in the direction of bias is blocked (or nearly blocked) by thewall 3314. The eccentricity of thecam 3521 is large enough that a maximum gap between thewall 3314 and thecam 3521 is sufficiently wide as to allow thebinder 3330 to be threaded between thecam 3521 and thewall 3314. A physician can position thebinder 3330 between thecam 3521 and the wall 3514 by overcoming the spring-force of the spring-loadedcam 3521. Once thebinder 3330 is position as desired, the physician need only allow the bias force of the spring-loadedcam 3520 to force thecam 3521 against thewall 3314, so that thecam 3521 pinches and secures thebinder 3330 between thecam 3521 and thewall 3314. Optionally, one or both of thecam 3521 and thewall 3314 can be knurled or otherwise textured to limit or prevent slippage. Further, thewall 3314 can optionally include a recess (not shown) to receive thecam 3521 so that thebinder 3330 is pinched within the recess (similar to the lobe and recess arrangement ofFIG. 34B ), thereby further limiting slippage.FIG. 34D illustrates animplant 3600 including acapture device 3620 comprising dual spring-loadedcams 3621, the dual spring-loadedcams 3621 being pivotally connected with theflange 3310. The dual spring-loadedcams 3621 are biased in opposition to one another so that thecams 3621 abut one another, similar to cam cleats commonly used for securing rope lines on boats. During surgery, thebinder 3330 can be loosely positioned around the adjacent spinous processes and threaded between thecams 3621. Tension can be applied to thebinder 3330, as desired, by drawing thebinder 3330 through thecams 3621. The force of thebinder 3330 being pulled through thecams 3621 can overcome the bias force to allow thebinder 3330 to be tightened, while releasing thebinder 3330 can define asecure end 3336 of thebinder 3330 as thecams 3621 swivel together. As above, one or both of thecams 3621 can be knurled or otherwise textured to limit or prevent slippage. - Embodiments of implants have been described in
FIGS. 34A-34D with some level of specificity; however, implants in accordance with the present invention should not be construed as being limited to such embodiments. Any number of different capture devices can be employed to fix a binder to a brace by defining a secure end of the binder, and such capture devices should not be construed as being limited to capture devices including cams, as described above. The capture device need only be a device that allows a physician to fit a binder having a generic size, or estimated size, around adjacent spinous processes with a desired level of precision in tension. -
FIGS. 35A and 35B are an opposite end views of the implant ofFIG. 34A positioned between adjacent spinous processes extending from vertebrae of the lumbar region. The contours of a space between adjacent spinous processes can vary between patients, and between motion segments. Arotatable spacer 3302 can rotate to best accommodate the shape of the space so that theimplant 3300 can be positioned as desired along the spinous processes. For example, it can be desirable to position thespacer 3302 as close to the vertebral bodies as possible (or as close to the vertebral bodies as practicable) to provide improved support. Once theimplant 3300 is positioned as desired, thebinder 3330 can be threaded through interspinous ligaments associated with motion segments (i.e., pairs of adjacent vertebrae and associated structures and tissues) above and below the targeted motion segment so that thebinder 3330 is arranged around the upper and lowerspinous processes binder 3330 can then be threaded through theslot 3312 of thebrace 3308 and positioned between thecapture device 3320 and thebrace wall 3314. A first tool (not shown) can be inserted into the incision formed to insert theimplant 3300 between thespinous processes spacer 3302 can include a notch, similar to anotch 3190 of thespacer 3102 ofFIG. 32 , and thebrace 3308 can include recesses, similar torecesses 103,104 of thefirst wing 3108 ofFIG. 32 , that can be engaged by the first tool for grasping and releasing theimplant 3300 during insertion. (See U.S. Pat. No. 6,712,819, which is incorporated herein by reference.) Alternatively, some other technique for grasping and releasing theimplant 3300 can be employed. Once theimplant 3300 is positioned and thebinder 3330 is arranged as desired, a second tool (not shown), such as a forked tool having spaced apart tines, can engage thecam 3321 of thecapture device 3320 to rotate thecam 3321, thereby securing thebinder 3330 to thebrace 3308. A hex wrench can tighten down thefastener 3322 if desired. Alternatively, a single tool can be employed to perform both the function of insertion of theimplant 3300 and rotation of thecam 3321, as depicted in the above referenced patent. Optionally, thebinder 3330 can then be trimmed so that thedistal end 3334 of thebinder 3330 does not extend undesirably away from thebrace 3308. - As can be seen, the
spacer 3302 is rotated relative to thedistraction guide 3306 and thebrace 3308. Because thespacer 3302 can rotate relative to thedistraction guide 3306 and thebrace 3308, thebrace 3308 can be positioned so that thebinder 3330 can be arranged around the upper and lowerspinous processes binder 3330. Thebinder 3330 is positioned around the lowerspinous process 4, threaded or positioned at least partially within aslot 3309 of thedistraction guide 3306, and positioned around the upperspinous process 2 so that thebinder 3330 can be secured to thebrace 3308, as described above. - Implants in accordance with the present invention can enable a physician to limit or block flexion and extension in a targeted motion segment while minifying invasiveness of an implantation procedure (relative to implantation procedures of the prior art). However, such implants can also be used where more extensive implantation procedures are desired. For example, as shown in
FIG. 35C , it can be desired that the adjacentspinous processes binder 3330, thereby insuring that thebinder 3330 does not shift or slide relative to thespinous processes binder 3330 is threaded directly through the respectivespinous processes spinous processes binder 3330 rather than a strap. While such applications fall within the contemplated scope of implants and methods of implantation of the present invention, such application may not realize the full benefit that can be achieved using such implants due to the modification of the bone. - Still another embodiment of an
implant 3700 in accordance with the present invention is shown in the end view ofFIG. 36 . In such an embodiment thebinder 3430 can comprise afirst portion 3431 formed as a strap for arrangement around one of the upper and lowerspinous processes second portion 3433 formed as a cord. Thedistraction guide 3406 can include abore 3409 or other cavity for receiving thesecond portion 3433. As can be seen inFIG. 37A , once thebinder 3430 is threaded through thedistraction guide 3406, apad 3436 of biocompatible material can be associated with thebinder 3430, for example by slidably threading thebinder 3430 through a portion of thepad 3436, and thepad 3436 can be arranged between thebinder 3430 and the respectivespinous process 2 so that a load applied by thebinder 3430 is distributed across a portion of the surface of thespinous process 2. Referring toFIG. 37B , once thebinder 3430 is arranged as desired relative to the adjacentspinous processes binder 3330 can be secured by thebrace 3708. Thebrace 3708 as shown is still another embodiment of a brace for use with implants of the present invention, in such an embodiment, thebrace 3708 includes acapture device 3720 comprising a clip including a spring-loadedbutton 3721 having a first hole therethrough and ashell 3723 in which thebutton 3721 is disposed, theshell 3723 having a second hole. A physician depresses thebutton 3721 so that the first and second holes align. Thebinder 3430 can then be threaded through the holes, and thebutton 3721 can be released so that the spring forces the holes to misalign, pinching thebinder 3430 and defining a secure end of thebinder 3430. -
FIG. 37C is an end view of a still further embodiment of animplant 3800 in accordance with the present invention, in such an embodiment thebinder 3530 can comprise a cord. Anupper pad 3536 and a lower pad 3538 can be slidably associated with thebinder 3530 and arranged so that a load applied by thebinder 3530 is distributed across a portion of the upper and lowerspinous processes brace 3808 having a substantially different shape than braces previously described. It should be noted that thebrace 3808 ofFIG. 37C is shown, in part, to impress upon one of ordinary skill in the art that a brace and capture device for use with implants of the present invention can include myriad different shapes, mechanisms and arrangements, and that the present invention is meant to include all such variations. As shown, the footprint of thebrace 3808 is reduced by shaping thewall 3814 of thebrace 3808 to taper at an upper end to form aguide 3812 for aligning thebinder 3530 and to taper at a lower end to aneyelet 3841 for capturing aproximal end 3532 of thebinder 3530. Thebrace 3808 includes a height fromeyelet 3841 to guide 3812 such that movement of theimplant 3800 in the direction of insertion is blocked or limited by thebrace 3808. - Use of a binder to limit or prevent flexion can provide an additional benefit of limiting movement along the longitudinal axis L (shown in
FIG. 34A ). However, implants in accordance with the present invention can optionally further include a second wing for limiting or blocking movement in the direction opposite insertion. Inclusion of such a structure can ensure that the implant remains in position, for example where the binder slips out of a slot of the distraction guide, or where the binder becomes unsecured. - Referring to
FIG. 38A , an implant in accordance with an embodiment can include asecond wing 3450 connected with thedistraction guide 3406 of the implant 3900 by afastener 3454. Thesecond wing 3450 is similar to thesecond wing 3150 described above in reference toFIG. 32 . Thesecond wing 3450 can include analignment tab 3458 allowing a position of thesecond wing 3450 to be adjusted along a longitudinal axis L of the implant 3900, and a fastener 3454 (for example a hex headed bolt) for affixing thesecond wing 3450 to the implant 3900 in the position along the longitudinal axis L desired. Thedistraction guide 3406 can include an alignment groove (not shown) corresponding to thealignment tab 3458. Thealignment tab 3458 fits within, and is movable along, the alignment groove so that acontact surface 3455 of thesecond wing 3450 can be arranged as desired. As shown, thesecond wing 3450 includes a substantially planar contact surface arranged so that thecontact surface 3455 of thesecond wing 3450 is perpendicular to the longitudinal axis L. However, in other embodiments, thecontact surface 3455 need not be planar, and can be shaped and oriented to roughly correspond with a contact surface of the upper and lower spinous processes. Likewise, acontact surface 3315 of thebinder 3308 can be shaped and oriented to roughly correspond with a contact surface of the upper and lower spinous processes. As shown, theupper portion 3453 and thelower portion 3452 of thesecond wing 3450 do not extend from thedistraction guide 3406 as substantially as theupper portion 3153 andlower portion 3152 of thesecond wing 3150 ofFIG. 32 . As such, thesecond wing 3450 includes a height H along the spine smaller than that of thesecond wing 3150 ofFIG. 32 . It has been observed that benefits can be gained by including awing 3450, though thewing 3450 does not extend from thedistraction guide 3406 as significantly as shown inFIG. 32 (i.e., thewing 3450 includes “nubs” extending above and/or below the height of the spacer 3302).Such wings 3450 will also be referred to herein as winglets. Including asecond wing 3450 having an overall height along the spine smaller than that ofFIG. 32 can limit movement along the longitudinal axis without interfering with (or being interfered by) the arrangement of thebinder 3330. - In other embodiments, implants in accordance with the present invention can include a second wing (or an upper portion and/or lower portion) extendable from the distraction guide. In this way an implant and a device for limiting or blocking movement along a longitudinal axis of the implant can be included in a single piece, possibly simplifying implantation. Referring to
FIGS. 38B and 38C ,implants 1500 in accordance with the present invention can include adistraction guide 3506 having a selectably extendableupper portion 3553 andlower portion 3552 disposed within a cavity of thedistraction guide 3506. The upper andlower portions gear 3556 so that thegear 3556 rotates. The teeth of thegear 3556 engage teeth of the upper andlower portions lower portions lower portions implant 1500 in a direction opposite insertion (shown inFIG. 38C ). Rotating thegear 3556 in an opposite direction can retract the upper andlower portions - In an alternative embodiment,
implants 1600 in accordance with the present invention can include spring-loaded upper and/orlower portions FIGS. 38D and 38E . In such an embodiment the upper andlower portions FIG. 38D . As theimplant 1600 is positioned between adjacent spinous processes, the spinous processes and/or related tissues can contact theforward surface lower portions lower portions respective hinge points distraction guide 3606, as shown inFIG. 38E . Once theimplant 1600 clears the obstruction, the upper andlower portions distraction guide 3650. A slot andpin mechanism lower portion lower portion lower portions implant 1600 in an a direction opposite insertion. - In still further embodiments, implants in accordance with the present invention can optionally employ some other additional mechanism for limiting or blocking motion along the longitudinal axis of the implant. Mechanisms shown and described in
FIGS. 38A-38E are merely provided as examples of possible mechanisms for use with such implants, and are not intended to be limiting. -
FIG. 39 is a top-down view of still another embodiment of an implant in accordance with the present invention including abrace 3708 arranged at an angle along the spinous process relative to the longitudinal axis L of theimplant 1700. Thebrace 3708 is arranged at such an angle to roughly correspond to a general shape of the adjacent spinous processes. Such a general shape can commonly be found in spinous processes extending from vertebrae of the cervical and thoracic region, for example. Theimplant 1700 further includes asecond wing 3752 extending fromdistraction guide 3706 at an angle roughly corresponding to a general shape of the adjacent spinous processes.Identical implants 1700, one above the other, are shown. Thelower implant 1700 includes abinder 3330 arranged around the adjacent spinous processes (only the upper spinous process is shown) and positioned in aslot 3309 of thedistraction guide 3706. Thebinder 3330 includes acapture device 3320 for securing thebinder 3330 to thebrace 3708, and a channel formed byguides 3712 on thebrace 3708 for aligning thebinder 3330 with thecapture device 3320. Unlike previously illustrated embodiments, the brace wall includes arecess 3717 to accommodate rotation of therotatable spacer 3302. Alternatively, the implants can include fixed spacers, for example integrally formed with thebrace 3708 and thedistraction guide 3706. -
FIGS. 40A and 40B are perspective views, andFIG. 40C is a side view of a still further embodiment of an implant in accordance with the present invention. Theimplant 2600 includes a distraction guide 806, arotatable spacer 3302, and abrace 3908. As above, abinder 3330 can be fixedly connected with thebrace 3908 at aproximal end 3332 of thebinder 3330. Once positioned around adjacent spinous processes, tension of thebinder 3330 can be set when thebinder 3330 is secured to thebrace 3908 so that relative movement of the adjacent spinous processes during flexion is limited or prevented, as desired. - As can be seen in
FIG. 40A , the brace 33908 can include a first end having aneyelet 3941 through which theproximal end 3332 of thebinder 3330 can be threaded and subsequently sutured, knotted or otherwise bound, or alternatively looped through theeyelet 3941 and secured to itself (e.g., using a clasp) so that theproximal end 3332 of thebinder 3330 cannot be drawn through theeyelet 3941. One of ordinary skill in the art can appreciate the myriad different ways in which theproximal end 3332 of thebinder 3330 can be associated with thebrace 3908 so that tension can be applied to thebinder 3330. As in previous embodiments, a free end of thebinder 3330 can be secured to thebrace 3908 by acapture device 3820 associated with thebrace 3908. Thecapture device 3820 ofFIGS. 40A-42 is arranged at a second end of thebrace 3908 opposite theeyelet 3941, rather than approximately centered along thebrace wall 3914. Thebrace 3908 can optionally include alocking pin hole 3915 that can be engaged by a locking pin of an insertion instrument (not shown), for example as described in U.S. Pat. No. 6,712,819 to Zucherman, et al., incorporated herein by reference. Further, similar to implants described in Zucherman '819, thebrace wall 3914 can optionally include one or more holes 3916 (shown inFIG. 42 ) adapted to receive alignment pins of such an insertion instrument, and thespacer 3402 can include a spacer engagement hole 3403 adapted to receive a spacer engagement pin of such an insertion instrument. When a spacer engagement pin engages the spacer engagement hole 3403, rotation of thespacer 3402 can be limited or blocked. Once the spacer engagement pin is released from the spacer engagement hole 3403, thespacer 3402 can rotate and/or swivel about acentral body 3917 without impedance from the spacer engagement pin. Such an arrangement can provide a physician additional control over the positioning of theimplant 2600, although in other embodiments thespacer 3402 need not include an engagement hole 3403. Arranging the captureddevice 3820 at a second end of thebrace 3908 can allow an insertion instrument, having a configuration as described in Zucherman '819 or having some other configuration, to releasably engage theimplant 2600 to assist in implantation without interference from thecapture device 3820. - The
distraction guide 3806 of theimplant 2600 can be wedge-shaped, as described above, or approximately conical, as shown inFIGS. 40A-40C , and can include aslot 3809 disposed through thedistraction guide 3806 and adapted to receive thebinder 3330 during implantation. Also as described above, therotatable spacer 3402 can be elliptical in cross-section, or otherwise shaped, and can rotate relative to thedistraction guide 3806 to roughly conform with a contour of a space between the targeted adjacent spinous processes. - The
capture device 3820 is shown in cross-section inFIGS. 41A and 41B . Thecapture device 3820 can comprise, for example, two pieces slidably associated with one another by an adjustable fastener 3822 (as shown, the adjustable fastener is a hex screw). A fixedpiece 3821 of the capture device can extend from thebrace wall 3914. The fixedpiece 3821 can include abeveled surface 3823 that can function as a ramp. Aslidable piece 3827 of the capture device can be slidably associated with the fixedpiece 3821, and can likewise included abeveled surface 3829 positioned in opposition to thebeveled surface 3823 of the fixedpiece 3821. As shown, theslidable piece 3827 is associated with the fixedpiece 3821 via anadjustable fastener 3822. Thefastener 3822 can be positioned within slots 3890,3892 of the fixedpiece 3821 and theslidable piece 3827 and can include a threadedshaft 3880, ahead 3882, and anut 3884. Thehead 3882 of thefastener 3822 can engage ananterior surface 3894 of the fixedpiece 3821 and thenut 3884 can be threaded onto the threadedshaft 3880 so that thenut 3884 can engage aposterior surface 3896 of theslidable piece 3827. Theslidable piece 3827 is free to slide along thebeveled surface 3823 of the fixedpiece 3821 until both thenut 3884 engages theposterior surface 3896 and thehead 3882 engages theanterior surface 3894, blocking further movement in one direction. The distance between theanterior surface 3894 and theposterior surface 3896 increases or decreases as theslidable piece 3827 slides along thebeveled surface 3823 and a distance between acapture surface 3898 of theslidable piece 3827 and thebrace wall 3914 likewise increases or decreases. The maximum distance theslidable piece 3827 can travel can be defined by the distance between thenut 3884 and thehead 3882. A physician can adjust the maximum distance by rotating thenut 3884 so that thenut 3884 travels closer to, or farther from thehead 3882 along the threadedshaft 3880, possibly urging thecapture surface 3898 toward thebrace wall 3914. Thus, when theimplant 2600 is positioned between spinous processes, the physician can set the maximum distance so that the free end of thebinder 3330 can be threaded between thecapture surface 3898 and thebrace wall 3914. As shown inFIG. 41B , the physician can then adjust thefastener 3822 so that theposterior surface 3896 and theanterior surface 3894 are urged together, the maximum distance decreases and the distance between thecapture surface 3898 and thebrace wall 3914 decreases, thereby pinching thebinder 3330 between thecapture surface 3898 and thebrace wall 3914 and defining a secure end of thebinder 3330. In some embodiments, one or both of thecapture surface 3898 and thebrace wall 3914 can include texture so that thebinder 3330 is further prevented from sliding when thebinder 3330 is placed under increasing tension (e.g., during flexion). - The
slidable piece 3827 can optionally further include aguide 3912 extending from theslidable piece 3827 so that theguide 3912 overlaps a portion of thebrace 3908. Theguide 3912 can extend, for example, a distance roughly similar to the maximum distance between thecapture surface 3898 and thebrace wall 3914, and can help ensure that thebinder 3330 is captured between thecapture surface 3898 and thebrace wall 3914. In other embodiments, thecapture device 3820 ofFIGS. 40A-41B can include some other shape or configuration and still fall within the contemplated scope of the invention. For example, the fastener need not include a nut. In one embodiment, shown inFIGS. 41C and 41D , thefastener 3922 can include a threadedshaft 3980 associated with asleeve 3984. As one of the threadedshaft 3980 and thesleeve 3984 is rotated, the distance between ahead 3982 of the threadedshaft 3980 and thehead 3985 of thesleeve 3984 can decrease or increase. In still other embodiments, the fastener need not include a threaded shaft, but rather can include a smooth shaft having a retaining clip frictionally associated with the smooth shaft. One of ordinary skill in the art will appreciate the myriad different devices that can be employed to selectively close a gap between acapture surface 3898 and thebrace wall 3914. -
FIG. 42 is an end view of theimplant 2600 ofFIGS. 40A-41D positioned between adjacent spinous processes. As shown, thebinder 3530 is a cord, but in other embodiments can have some other geometry. As described above in reference to previous embodiments, where a cord, a tether, or the like is used as a binder, apad 3536 can be arranged along a contact surface of the respective spinous process so that a load applied to the contact surface by the tension in thebinder 3530 can be distributed across a portion of the contact surface wider than thebinder 3530, thereby reducing stress on the portion. Thecapture device 3820 is arranged so that theslidable piece 3827 is posteriorly located relative to the fixedpiece 3821. Afastener 3822 can be accessed by the physician using a substantially posterior approach. - A method of surgically implanting an
implant 2600 in accordance with an embodiment as described above inFIGS. 40A-42 of the present invention is shown as a block diagram inFIG. 43 . The method can include forming an incision at the target motion segment, and enlarging the incision to access the target motion segment (Step 2700). The interspinous ligament between targeted adjacent spinous processes can then be distracted by piercing or displacing the interspinous ligament with the distraction guide 3106 (Step 2702) and urging theimplant 2600 between the adjacent spinous processes (Step 2704). As the interspinous ligament is displaced, thespacer 3302 can be positioned between the spinous processes such that thespacer 3302 can rotate to assume a preferred position between the spinous processes (Step 2706). - Once the
implant 2600 is positioned, thebinder 3330 can be threaded between interspinous ligaments of adjacent motion segments so that the targeted adjacent spinous processes are disposed within a loop formed by the binder 3330 (Step 2708). The physician can then thread thebinder 3330 between thecapture surface 3898 of thecapture device 3820 and the brace wall 3914 (Step 2710). Once a desired tension of thebinder 3330 is applied (Step 2712), the physician can adjust thefastener 3822 of thecapture device 3820 so that thebinder 3330 is secured between the capturedsurface 3898 and the brace wall 3914 (Step 2714). The incision can subsequently be closed (Step 2716). -
FIGS. 44A and 44B are perspective views of still another embodiment of animplant 5400 in accordance with the present invention. In such an embodiment, theimplant 5400 can include amain body 3101 similar to themain body 3101 described above in reference toFIG. 32 . As above, the main body 3101 (also referred to herein as a first unit) includes aspacer 3102, afirst wing 3108, adistraction guide 3106 and analignment track 3103. Themain body 3101 is inserted between adjacent spinous processes. Preferably, themain body 3101 remains (where desired) in place without attachment to the bone or ligaments. - The
alignment track 3103 includes a threaded hole for receiving a fastener. Thealignment track 3103 need not include a threaded hole, but rather alternatively can include some other mechanism for fixedly connecting an additional piece (such as a second wing for limiting or blocking movement of an implant along the longitudinal axis). For example, in an alternative embodiment, the alignment track 5403 can include a flange so that thesecond wing 5450 can be slidably received, as shown inFIG. 46 . - As further shown in
FIGS. 44A and 44B , theimplant 5400 includes asecond wing 5450 removably connectable with theimplant 5400. Thesecond wing 5450 includes analignment tab 5458 adapted to be received in thealignment track 3103 of themain body 3101, thealignment tab 5458 optionally including a slot for receiving the fastener so that thealignment tab 5458 is disposed between the fastener and thealignment track 3103. In alternative embodiments, thealignment tab 5458 need not include a slot but rather can include some other mechanism for mating with themain body 3101. Thesecond wing 5450 can include a first end having a slot (or eyelet) 5441 through which the proximal end (also referred to herein as an anchored end) 3332 of abinder 3330 can be threaded and subsequently sutured, knotted or otherwise bound, or alternatively looped through theslot 5441 and secured to itself (e.g., using a clasp) so that theproximal end 3332 of thebinder 3330 cannot be withdrawn through theslot 5441. One of ordinary skill in the art can appreciate the myriad different ways in which theproximal end 3332 of thebinder 3330 can be associated with thesecond wing 5450 so that tension can be applied to thebinder 3330. Thebinder 3330 can be disposed around adjacent spinous processes and a portion of the length of the binder 3330 (the length of the binder being that portion of the binder extending from the proximal end of the binder) can be secured to thesecond wing 5450 by acapture device 5420 associated with thesecond wing 5450. - The
capture device 3820 ofFIGS. 44A and 44B is arranged at a second end of thesecond wing 5450 opposite theslot 5441. Thecapture device 5420 can be substantially similar to capturedevices 5420 as described above in reference toFIGS. 41A and 41B , and can comprise, for example, two pieces slidably associated with one another by an adjustable fastener. As above, a fixedpiece 5421 of the capture device can extend from thesecond wing 5450. The fixedpiece 5421 can include a beveled surface that can function as a ramp. Aslidable piece 5427 of the capture device can be slidably associated with the fixed piece 5421 (for example, via the adjustable fastener) and can likewise included a beveled surface positioned in opposition to the beveled surface of the fixedpiece 5421. As theslidable piece 5427 slides along the beveled surface of the fixedpiece 5421, a distance between acapture surface 5498 of theslidable piece 5427 and thesecond wing 5450 increases or decreases. As above, theslidable piece 5427 can optionally further include aguide 5412 extending from theslidable piece 5427 so that theguide 5412 overlaps a portion of thesecond wing 5450. Theguide 5412 can extend, for example, a distance roughly similar to the maximum distance between thecapture surface 5498 and thesecond wing 5450, and can help ensure that thebinder 3330 is arranged between thecapture surface 5498 and thesecond wing 5450. A physician can position thebinder 3330 so that thebinder 3330 is disposed between adjacent spinous processes, threading thebinder 3330 between theslidable piece 5427 and thesecond wing 5450. The physician can then adjust thefastener 5422 so that the distance between thecapture surface 5498 and thesecond wing 5450 decreases, thereby pinching thebinder 3330 between thecapture surface 5498 and thesecond wing 5450 and defining a secure end of thebinder 3330. In some embodiments, one or both of thecapture surface 5498 and thesecond wing 5450 can include texture so that thebinder 3330 is further prevented from sliding when thebinder 3330 is placed under increasing tension (e.g., during flexion). - The
implant 5400 can further include abinder aligner 5470 selectably connectable with thefirst wing 3108 of themain body 3101. Thebinder aligner 5470 can be connected with thefirst wing 3108 by fastening thebinder aligner 5470 to thelocking pin hole 3104 of thefirst wing 3108. In such embodiments where afastener 5455 is used to connect thebinder aligner 5470 with thefirst wing 3108 through ahole 5471 in thebinder aligner 5470, it is desirable that the lockingpin hole 3104 be threaded, or otherwise adapted to receive thefastener 5455. The lockingpin hole 3104 can thus be adapted to function as a hole to slidably (and temporarily) receive a locking pin of an insertion tool (not shown), thereby facilitating insertion and positioning of themain body 3101, and can also be adapted to function to fixedly receive afastener 5455 for positioning thebinder aligner 5470. Thebinder aligner 5470 can optionally includepins 5474 corresponding to thealignment holes 3192 of themain body 3101 to further secure thebinder aligner 5470 to themain body 3101 and limit undesired movement of thebinder aligner 5470 relative to themain body 3101. - The
binder aligner 5470 includes aguide 5472 extending from thebinder aligner 5470 to limit or block shifting of thebinder 3330 in a posterior-anterior direction. Theguide 5472 can include a loop, as shown inFIG. 44A , or alternatively some other structure, closed or unclosed, for limiting or blocking shifting of thebinder 3330. Such a structure can prevent undesired relative movement between thebinder 3330 and themain body 3101, and can additionally ease arrangement of thebinder 3330 during an implantation procedure, by helping to aid proper positioning of thebinder 3330. - In other embodiments, the capture device of
FIGS. 44A and 44B can include some other shape, configuration, and mechanism and still fall within the contemplated scope of the invention. For example, referring toFIG. 45 , in other embodiments, aflange 5514 can extend from thesecond wing 5550, from which arotatable cam 5521 extends so that thebinder 3330 can be captured between thesecond wing 5550 and thecam 5521. Such a capture device can resemblecapture devices 5520 as described above inFIGS. 34C and 34B . Referring toFIG. 46 , in still other embodiments, a spring-loadedcam 5621 extends from theflange 5514 so that thebinder 3330 can be captured between thesecond wing 5514 and the spring-loadedcam 5621. Such a capture device can resemblecapture devices 5520 as described above inFIGS. 34C and 34D . In still further embodiments in accordance with the present invention, some other mechanism can be employed as a capture device associated with thesecond wing 5550 for securing the length of thebinder 3330, for example as otherwise described in herein, and other obvious variations. One of ordinary skill in the art will appreciate the myriad different mechanisms for securing thebinder 3330 to thesecond wing 5450. A system in accordance with the present invention can comprise asecond wing 5450 including acapture device 5420 as described above and optionally abinder aligner 5470. The system can be used with amain body 3101 in substitution for asecond wing 3150 as described above inFIG. 32 . Alternatively, the system can optionally be used to modify amain body 3101 previously implanted in a patient, for example by removing an existingsecond wing 3150 and replacing thesecond wing 3150 with the system, to additionally limit flexion as well as extension. Such a system can provide flexibility to a physician by allowing the physician to configure or reconfigure an implant according to the needs of a patient. Further, such a system can reduce costs by reducing the variety of components that need be manufactured to accommodate different procedures and different treatment goals. A method of surgically implanting animplant 5400 in accordance with an embodiment as described above inFIGS. 44A-46 of the present invention is shown as a block diagram inFIG. 47 . The method can include forming an incision at the target motion segment, and enlarging the incision to access the target motion segment (Step 2700). The interspinous ligament between targeted adjacent spinous processes can then be distracted by piercing or displacing the interspinous ligament with the distraction guide 106 (Step 2702) and urging theimplant 5400 between the adjacent spinous processes (Step 2704). As the interspinous ligament is displaced, thespacer 3102 can be positioned between the spinous processes such that thespacer 3102 can rotate to assume a preferred position between the spinous processes (Step 2706). - Once the
implant 5400 is positioned, thesecond wing 5450 can be fixedly connected with the distraction guide 3106 (Step 2708). Abinder 3330 associated with thesecond wing 5450 can be threaded between interspinous ligaments of adjacent motion segments so that the targeted adjacent spinous processes are disposed within a loop formed by the binder 3330 (Step 2710). - The physician can then thread the
binder 3330 between thecapture surface 5498 of thecapture device 5420 and the second wing 5450 (Step 2712). Once a desired tension of thebinder 3330 is applied (Step 2714), the physician can adjust thefastener 5422 of thecapture device 5420 so that thebinder 3330 is secured between the capturedsurface 5498 and the second wing 5450 (Step 2716). The incision can subsequently be closed (Step 2718). - Material for Use in Implants of the Present Invention
- In some embodiments, the implant can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, or other suitable implant material having similar high strength and biocompatible properties. Additionally, the implant can be at least partially fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. Such materials are typically radiopaque, and appear during x-ray imaging, and other types of imaging. Implants in accordance with the present invention, and/or portions thereof can also be fabricated from somewhat flexible and/or deflectable material, m these embodiments, the implant and/or portions thereof can be fabricated in whole or in part from medical grade biocompatible polymers, copolymers, blends, and composites of polymers. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer. Many polymers, copolymers, blends, and composites of polymers are radiolucent and do not appear during x-ray or other types of imaging. Implants comprising such materials can provide a physician with a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- One group of biocompatible polymers is the polyaryletherketone group which has several members including polyetheretherketone (PEEK), and polyetherketoneketone (PEKK).
- PEEK is proven as a durable material for implants, and meets the criterion of biocompatibility. Medical grade PEEK is available from Victrex Corporation of Lancashire, Great Britain under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. These medical grade materials are also available as reinforced polymer resins, such reinforced resins displaying even greater material strength, hi an embodiment, the implant can be fabricated from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - PEEK 450G has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques.
- It should be noted that the material selected can also be filled. Fillers can be added to a polymer, copolymer, polymer blend, or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers can be added to reinforce polymers mechanically to enhance strength for certain uses, such as for load bearing devices. In some embodiments, other grades of PEEK are available and contemplated for use in implants in accordance with the present invention, such as 30% glass-filled or 30% carbon-filled grades, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to unfilled PEEK. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and stiffness, and a lower expansion rate relative to unfilled PEEK. Carbon-filled PEEK also offers wear resistance and load carrying capability.
- As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. As mentioned, the implant can be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- As described above, the binder can be made from a biocompatible material. In an embodiment, the binder can be made from a braided polyester suture material. Braided polyester suture materials include, for example, Ethibond, Ethiflex, Mersilene, and Dacron, and are nonabsorbable, having high tensile strength, low tissue reactivity and improved handling. In other embodiments, the binder can be made from stainless steel (i.e., surgical steel), which can be braided into a tether or woven into a strap, for example. In still other embodiments, the binder can be made from some other material (or combination of materials) having similar properties. The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.
- Interspinous Implants
-
FIG. 48A is a perspective view of an implant as described in U.S. patent application Ser. No. 10/850,267, filed May 20, 2004, incorporated herein by reference. Theimplant 4100 comprises afirst wing 4130, aspacer 4120, and a lead-in tissue expander (also referred to herein as a distraction guide) 4110. - The
distraction guide 4110 in this particular embodiment is wedge-shaped, i.e., the implant has an expanding cross-section from a proximal end of theimplant 100 to a region 4150 where theguide 4110 joins with the spacer 4120 (referencing for the figures is based on the point of insertion of the implant between spinous processes). As such, thedistraction guide 4110 functions to initiate distraction of the soft tissue and the spinous processes when theimplant 4100 is surgically inserted between the spinous processes. It is to be understood that thedistraction guide 4110 can be pointed and the like, in order to facilitate insertion of theimplant 4100 between the spinous processes of adjacent cervical vertebrae. It is advantageous that the insertion technique disturb as little of the bone and surrounding tissue or ligaments as possible in order to reduce trauma to the site and promote early healing, and prevent destabilization of the normal anatomy. For embodiments such as those ofFIGS. 48A and 48B , there is no requirement to remove any of the bone of the spinous processes and no requirement to sever, or remove from the body, ligaments and tissues immediately associated with the spinous processes. For example, it is unnecessary to sever the supraspinal ligament of the lower vertebrae or the ligamentum nuchae (which corresponds to the supraspinal ligament) which partially cushions the spinous processes of the upper cervical vertebrae. - As can be seen, the
spacer 4120 can be teardrop-shaped in cross-section perpendicular to alongitudinal axis 4125 of theimplant 4100. In this way, the shape of thespacer 4120 can roughly conform to a wedge-shaped space, or a portion of the space, between adjacent spinous processes within which theimplant 4100 is to be positioned. As shown inFIG. 48A , the spacer 4120 (and the first wing 4108) is shaped to accommodate the anatomical form or contour of spinous processes (and/or laminae) of preferably the C6 and C7 vertebra for placement between such spinous processes (i.e., the C6-C7 motion segment). The same shape or variations of this shape can be used to accommodate other motion segments, for example in the thoracic or lumbar regions. In other embodiments thespacer 4120 can have alternative shapes such as circular, wedge, oval, ovoid, football, and rectangular with rounded corners, and other shapes. The shape of thespacer 4120 can be selected for a particular patient so that the physician can position theimplant 4100 as close as possible to the anterior portion of the surface of the spinous process. The shape selected for thespacer 4120 can affect the contact surface area of theimplant 4100 and the spinous processes that are to be subject to distraction. Increasing the contact surface area between theimplant 4100 and the spinous processes can distribute a load force between the spinous frame and theimplant 4100. - The
first wing 4130 is likewise teardrop-shaped in cross-section perpendicular to alongitudinal axis 4125 of thespacer 4120 anddistraction guide 4110. The dimensions of thefirst wing 4130 can be larger than that of thespacer 4120, particularly along the axis of the spine, and can limit or block lateral displacement of theimplant 4100 in the direction of insertion along thelongitudinal axis 4125. As with thespacer 4120, thefirst wing 4130 can have other cross-sectional shapes, such as elliptical, wedge, circular, oval, ovoid, football, and rectangular with rounded corners and other shapes. - The
implant 4100 ofFIG. 48A further includes an adjustable wing 4160 (also referred to herein as a second wing) separate from thedistraction guide 4110, thespacer 4120 and thefirst wing 4130. Thesecond wing 4160 is connectable with the distraction guide 4110 (and/or the spacer 4120) once theimplant 4100 is positioned between adjacent spinous processes. Thesecond wing 4160, similar to thefirst wing 4130, can limit or block lateral displacement of theimplant 4100, however displacement is limited or blocked in the direction opposite insertion. When both thefirst wing 4130 and thesecond wing 4160 are connected with theimplant 4100 and theimplant 4100 is positioned between adjacent spinous processes, a portion of the spinous processes can be sandwiched between thefirst wing 4130 and thesecond wing 4160, limiting displacement along thelongitudinal axis 4125. As can be seen, thesecond wing 4160 can be teardrop-shaped in cross-section. Alip 4180 defining aspace 4170 through thesecond wing 4160 allows thesecond wing 4160 to pass over thedistraction guide 4110 to meet and connect with thedistraction guide 4110 and/or thespacer 4120. Thesecond wing 4160 is then secured to thedistraction guide 4110 and/or thespacer 4120. Thesecond wing 4160, can be designed to be interference-fit onto thespacer 4120 or a portion of thedistraction guide 4110 adjacent to thespacer 4120. Where thesecond wing 4160 is interference-fit, there is no additional attachment device to fasten thesecond wing 4160 relative to the remainder of theimplant 4100. - Alternatively, various fasteners can be used to secure the
second wing 4160 relative to the remainder of theimplant 4100. For example,FIG. 48A illustrates an embodiment of animplant 4100 including a teardrop-shapedsecond wing 4160 having atongue 4158 at the posterior end of thesecond wing 4160. Abore 4155 is disposed through thetongue 4158, and is aligned with acorresponding bore 4156 on thespacer 4120 when thesecond wing 4160 is brought into position by surgical insertion relative to the rest of theimplant 4100. A threadedscrew 4154 can be inserted through the aligned bores 4155,4156 in a posterior-anterior direction to secure thesecond wing 4160 to thespacer 4120. The direction of insertion from a posterior to an anterior direction has thescrew 4154 engaging thebores implant 4100 along a direction that is generally perpendicular to thelongitudinal axis 4125. This orientation is most convenient when the physician is required to use ascrew 4154 to secure thesecond wing 4160 to the rest of theimplant 4100. Thesecond wing 4160 can further be secured to thespacer 4120 by some other mechanism, for example such as a flexible hinge (not shown) with a protrusion that engages an indentation of one of thedistraction guide 4110 and thespacer 4120. Alternatively, thesecond wing 4160 can be secured to one of thedistraction guide 4110 and thespacer 4120 by still some other mechanism. -
FIG. 48B is a perspective view of an implant as described in U.S. Pat. No. 6,695,842 to Zucherman, et al, incorporated herein by reference. Theimplant 4200 has a main body that includes aspacer 4220, afirst wing 4230, a lead-in tissue expander 4210 (also referred to herein as a distraction guide) and analignment track 4203. The main body of theimplant 4200 is inserted between adjacent spinous processes and remains in place (where desired) without attachment to the bone or ligaments. The distraction guide 4210 includes a tip from which the distraction guide 4210 expands, the tip having a diameter sufficiently small such that the tip can pierce an opening in an interspinous ligament and/or can be inserted into a small initial dilated opening. The diameter and/or cross-sectional area of the distraction guide 4210 gradually increases until it is substantially similar to the diameter of thespacer 4220. The tapered front end eases the ability of a physician to urge theimplant 4200 between adjacent spinous processes. When urging the main body of theimplant 4200 between adjacent spinous processes, the front end of the distraction guide 4210 distracts the adjacent spinous processes and dilates the interspinous ligament so that a space between the adjacent spinous processes is approximately the diameter of thespacer 4220. - As shown in
FIG. 48B , thespacer 4220 is elliptically shaped in cross-section, and can swivel so that thespacer 4220 can self-align relative to the uneven surfaces of the spinous processes. Self-alignment can ensure that compressive loads are distributed across the surface of the bone. As contemplated in Zucherman '842, thespacer 4220 can have, for example, a diameter of six millimeters, eight millimeters, ten millimeters, twelve millimeters and fourteen millimeters. These diameters refer to the height by which thespacer 4220 distracts and maintains apart the spinous process. For an elliptically shaped spacer 4220, the selected height (i.e., diameter) is the minor dimension measurement across the ellipse. The major dimension is transverse to the alignment of the spinous process, one above the other. - The
first wing 4230 has alower portion 4231 and anupper portion 4232. Theupper portion 4232 is shaped to accommodate the anatomical form or contour of spinous processes (and/or laminae) of preferably the L4 (for an L4-L5 placement) or L5 (for an L5-S1 placement) vertebra. The same shape or variations of this shape can be used to accommodate other motion segments, such as motion segments in the cervical and thoracic regions. Thelower portion 4231 can also be rounded to accommodate the spinous processes. Thelower portion 4231 andupper portion 4232 of thefirst wing 4230 act as a stop mechanism when theimplant 4200 is inserted between adjacent spinous processes. Theimplant 4200 cannot be inserted beyond the surfaces of thefirst wing 4230. Additionally, once theimplant 4200 is inserted, thefirst wing 4230 can prevent some side-to-side, or posterior-to-anterior movement of theimplant 4200. - As with the
implant 4100 ofFIG. 48A , theimplant 4200 ofFIG. 48B further includes asecond wing 4260. Similar to thefirst wing 4230, thesecond wing 4260 includes alower portion 4261 and anupper portion 4262 sized and/or shaped to accommodate the anatomical form or contour of the spinous processes and/or lamina. Thesecond wing 4260 can be secured to the main body of theimplant 4200 with afastener 4254. Thesecond wing 4260 also has analignment tab 4268. When thesecond wing 4260 is initially placed on the main body of theimplant 4200, thealignment tab 4268 engages thealignment track 4203. Thealignment tab 4268 slides within thealignment track 4203 and helps to maintain theadjustable wing 4260 substantially parallel with thefirst wing 4230. When the main body of theimplant 4200 is inserted into the patient and thesecond wing 4260 has been attached, displacement along thelongitudinal axis 4225 in either the direction of insertion or the direction opposite insertion can be limited or blocked. - Further, the
second wing 4260 also can prevent some side-to-side, or posterior-to-anterior movement. - For both the
implant 4100 ofFIG. 48A and theimplant 4200 ofFIG. 48B , where asecond wing implant implant implant second wing implant implant first wing second wing second wing - Implants Having Deployable Second Wing
- Referring to
FIGS. 49A through 49B ,implants 4300 and methods for positioning such implants in accordance with the present invention can, in an embodiment, include a deployablesecond wing 4360 associated with amain body 4301 such that thesecond wing 4360 can be deployed with a physician needing only to access a first side of spinous processes to limit or block movement along thelongitudinal axis 4325. As shown inFIG. 49A , theimplant 4300 includes a main body 301 having a fixed spacer 4320 and adistraction guide 4310. Thedistraction guide 4310 comprises a first winglet (also referred to herein as an upper winglet) 4312 and a second winglet (also referred to herein as a lower winglet) 4314, and when arranged in a first configuration can include a tip from which thedistraction guide 4310 expands, the tip having a diameter sufficiently small such that the tip can pierce an opening in an interspinous ligament and between spinous processes and/or can be inserted into a small initial dilated opening. The diameter and/or cross-sectional area of thedistraction guide 4310 is then gradually increased until it is substantially similar to the diameter of thespacer 4320. In this respect, thedistraction guide 4310 ofFIG. 49A can resemble a distraction guide as described above when arranged in the first configuration. Thewinglets main body 4301 such that thewinglets FIG. 49B ) once theimplant 4300 is positioned between spinous processes. In a second configuration one or both of thewinglets longitudinal axis 4325. Thus when arranged in a second configuration, thedistraction guide 4310 becomes asecond wing 4360, as shown inFIG. 49B . - The
implant 4300 includes aninsert 4370 having an insert body 4372 and afirst wing 4330. As shown inFIG. 49B , theinsert 4370 can be mated with themain body 4301 to arrange thedistraction guide 4310 of theimplant 4300 in the second configuration, thereby deploying thesecond wing 4360. To facilitate mating of themain body 4301 and theinsert 4370, thespacer 4320 includes a cavity sized and shaped for receiving the insert body 4372 and accessible from a distal end of themain body 4301. A portion of theupper winglet 4312 and thelower winglet 4314 can extend at least partially into the cavity so that when the insert body 4372 is received within the cavity, the insert body 4372 displaces the portions, causing thedistraction guide 4310 to be arranged in the second configuration. In the embodiment shown, theupper winglet 4312 and thelower winglet 4314 each include alever distraction guide 4310 is in the first configuration. As the insert body 4372 of theinsert 4370 fills the cavity, the insert body 4372 contacts thefirst lever 4316 and thesecond lever 4318, applying a force to thefirst lever 4316 and thesecond lever 4318 which translates into a pivoting motion of the hingedupper winglet 4312 and the hingedlower winglet 4314. The insert body 4372 can optionally have a taperedproximal end 4374 having afirst groove 4376 and asecond groove 4378 corresponding to thefirst lever 4316 and thesecond lever 4318, respectively. The tapered shape of theproximal end 4374 allows theupper winglet 4312 andlower winglet 4314 to be deployed gradually, fully deploying as the insert body 4372 is fully seated within the cavity. Themain body 4301 is shown including aflange 4303 in which is formednotches 4305 to receive an insertion tool (not shown), for example. As the insert body 4372 is seated within the cavity, anupper tab 4332 and alower tab 4331 of thefirst wing 4330 seats within cut-outs 4322 of theflange 4303. - Referring to
FIG. 50A , themain body 4301 of theimplant 4300 is shown positioned between adjacent spinous processes of the targeted motion segment. The motion segment shown is within the lumbar region, but in other embodiments, particularly where a fixedspacer 4320 is used,implants 4300 in accordance with the present convention can be positioned at motion segments of the thoracic and cervical region. Themain body 4301 is positioned as shown by initially approaching the interspinous ligament between the upper and lower adjacentspinous processes articular facet 6 of the vertebrae from which the upperspinous process 2 extends. Themain body 4301 can be associated with one or more insertion tools (not shown), and thedistraction guide 4310 can be arranged in the first configuration. The tip of thedistraction guide 4310 is positioned roughly adjacent to a point along the interspinous ligament, and thedistraction guide 4310 is then urged through the interspinous ligament, piercing the interspinous ligament and/or separating and distracting fibers of the interspinous ligaments. Themain body 4301 is then urged through the interspinous ligament until thespacer 4320 is positioned between the adjacentspinous processes spacer 4320 supports a load applied by thespinous processes - Referring to
FIG. 50B , once theimplant 4300 is positioned as desired, the insertion tools can be removed from the opening and theinsert 4370 can be positioned at the distal end of themain body 4301. The insert body 4372 can be urged into the cavity within themain body 4301 until theproximal end 4374 of the insert body 4372 contacts thefirst lever 4316 and thesecond lever 4318. Theinsert 4370 can then be further urged along thelongitudinal axis 4325 so that the insert body 4372 urges thefirst lever 4316 and thesecond lever 4318 away from the insert body 4372, causing theupper winglet 4312 and thelower winglet 4314 to pivot about thefirst hinge 4313 and thesecond hinge 4315, respectively. As thefirst lever 4316 and thesecond lever 4318 are displaced from the cavity, thefirst lever 4316 and thesecond lever 4318 are guided along correspondinggrooves proximal end 4374. As the insert body 4372 seats within the cavity of themain body 4301, theupper winglet 4312 and thelower winglet 4314 deploy as asecond wing 4360. The insertion tool can be removed from the incision once the insert body 4372 is seated within themain body 4301. As can be seen a portion of the upper spinous process and a portion of the lower spinous process are sandwiched between the first wing 330 and thesecond wing 4360, limiting motion along thelongitudinal axis 4325. Implants and methods for positioning such implants between spinous processes in accordance with the present invention are not meant to be limited to embodiments as described above and otherwise herein, but rather are meant to include any implant having a second wing deployable by urging an insert within a main body positioned between adjacent spinous processes. Myriad different variations maybe readily apparent to one of ordinary skill in the art. For example, in an alternative embodiment, themain body 4301 of theimplant 4300 ofFIGS. 49A through 50B can include alower winglet 4314 pivotably associated with themain body 4301 while anupper winglet 4312 is fixedly associated with themain body 4301. Aninsert 4370 can be adapted to deploy only thelower winglet 4314 when seated within the cavity of themain body 4301. - In other embodiments, a
first wing 4310 can extend from themain body 4301 rather than, or in addition to, a first wing extending from theinsert 4370. When themain body 4301 is initially positioned between the adjacent spinous processes, movement of themain body 4301 along thelongitudinal axis 4325 can be limited in the direction of insertion. As thefirst wing 4310 extending from themain body 4301 contacts one or both of the adjacent spinous processes, further movement of themain body 4301 in the direction of insertion can be limited or blocked. Thefirst wing 4310 can thus act as a hard stop, allowing themain body 4301 to be positioned without requiring a position of themain body 4301 along the spinous processes to be estimated, thereby easing implantation. - Referring to
FIG. 51 , in stillfurther embodiments implants 4400 in accordance with the present invention can include one or both of a first engagement element (also referred to herein as an upper hook) 4480 and a second engagement element (also referred to herein as a lower hook) 4482 for limiting flexion motion in a motion segment. For example, similar hooks have been described in greater detail in U.S. Pat. No. 6,451,019 issued Sep. 17, 2002 to Zucherman et al. and U.S. Pat. No. 6,652,527 issued Nov. 25, 2003 to Zucherman et al., both incorporated herein by reference. Implants in accordance with the present invention can include such arrangements. Theimplant 4400 shown inFIGS. 51 and 52 includes anupper hook 4480 extending from anupper connection rod 4484 rotatably associated with themain body 4401 and alower hook 4482 extending from alower connection rod 4486 rotatably associated with themain body 4401. Alternatively, theconnection rods main body 4401. - The
hooks main body 4401 is positioned between adjacent spinous processes, the tapered proximal ends 4481,4483 of the upper andlower hooks lower hooks main body 4401 is in place. As shown, thehooks connection rods hooks connection rods hooks spinous processes upper connection rod 4484 andlower connection rod 4486 can provide flexibility in placement, so that where an anatomy varies between patients and varies between motion segments such that the arrangement of a minor dimension and major dimension of the implant 44400 about thelongitudinal axis 4425 varies, theimplant 4400 can be accommodated. -
FIG. 52 is a posterior view of theimplant 4400 positioned between adjacentspinous processes upper hook 4480 and alower hook 4482 arranged so that both flexion and extension is limited as desired. Further, thesecond wing 4460 is deployed to limit movement of theimplant 4400 along thelongitudinal axis 4425. Theupper hook 4480 and thelower hook 4482 prevent movement along thelongitudinal axis 4425 in the direction opposite insertion, making a first wing unnecessary. - Referring to
FIGS. 53A and 53B , in stillother embodiments implants 4500 and methods for positioningsuch implants 4500 between spinous processes in accordance with the present invention can include adistraction guide 4510 wherein portions of the distraction guide 510 can be extended from thedistraction guide 4510 to form anupper winglet 4512 and a lower winglet 4514, respectively, of asecond wing 4560 by positioning aninsert 4570 within a cavity of themain body 4501. This is in contrast to the above embodiment where the entire distraction guide is formed by the winglets. In this embodiment, thewinglet 4512,4514 extend out the side of thedistraction guide 4510. When not extended, as seen inFIG. 53A , thewinglet 4512,4514 partially form the sides of thedistraction guide 4510. Such embodiments are contemplated to be useful where it is desired that thesecond wing 4560 have a limited height relative toimplants entire distraction guide 4310 is deployed (seeFIG. 49A through 50B ). For example, whereimplants 4500 are to be positioned at adjacent motion segments, it can be desired that thesecond wings 4560 of theimplants 4500 do not interfere with one another implant, for example during an extension motion when compressive loads are applied to theimplants 4500. As with implants described above, one of ordinary skill in the art can appreciate the myriad different variations of theimplant 4500 ofFIGS. 53A and 53B . For example, in alternative embodiments theupper winglet 4512 and the lower winglet 4514 can have some other shape. For example, the positions of theupper winglet 4512 and lower winglet 4514 are staggered so thatimplants 4500 positioned at adjacent motion segments can be more easily positioned without interfering with one another. Such staggering can also accommodate anatomies where one of the upper and lower spinal processes is wider than the other. With staggering, for example, theupper winglet 4512 can be pivotably mounted on thedistraction guide 4510 at a position less distant from the distraction end 4511 than the location where the lower winglet 4514 is pivotably mounted on thedistraction guide 4510. In still other embodiments, theupper winglet 4512 and the lower winglet 4514 can have some other shape. Referring toFIGS. 54A through 55 , in still further embodiments ofimplants 4600 in accordance with the present invention, themain body 4601 can include a hollow central body 4605 (shown inFIGS. 54C and 54D ) extending from afirst wing 4630. Arotatable spacer 4620 is disposed about the hollowcentral body 4605. Theimplant 4600 can include aspacer 4620 that resembles spacers, for example, as described above inFIG. 48B . Adistraction guide 4610 can extend from the hollowcentral body 4605 and can include anupper winglet 4612 and alower winglet 4614, one or both of which can be pivotably associated with amain portion 4611 of thedistraction guide 4610 so that theupper winglet 4612 and/or thelower winglet 4614 can be deployed as asecond wing 4660. Apin 4606 can be inserted into the hollowcentral body 4605 to deploy thesecond wing 4630. Referring toFIG. 54B , once thepin 4606 is seated within themain body 4601, theupper winglet 4612 and thelower winglet 4614 can be pivoted away from each other so that theupper winglet 4612 and thelower winglet 4614 limit or block motion along thelongitudinal axis 4625 in the direction opposite from insertion. Theupper winglet 4612 and thelower winglet 4614 thus act as asecond wing 4660. - Referring to the partial cross-sections of
FIGS. 54C and 54D , in an embodiment thedistraction guide 4610 can include acup 4616 structure sized and arranged to receive thepin 4606.Bar structures cup structure 4616 and one or both of theupper winglet 4612 and thelower winglet 4614 so that when a force is applied to thecup structure 4616 by thepin 4606, the force is further transferred to theupper winglet 4612 and thelower winglet 4614, causing theupper winglet 4612 and thelower winglet 4614 to pivot onhinges main portion 4611 of thedistraction guide 4610 so that thesecond wing 4660 is deployed. As can be seen, the pivot points 4613,4615 of theupper winglet 4612 and thelower winglet 4614 are arranged proximally relative to the mount points 4617,4619 of thebar structures upper winglet 4612 and thelower winglet 4614 to pivot away from one another when the mount points 4617,4619 are urged together by the insertion of the pin 4606 (as seen inFIG. 54D ). In other embodiments, theupper winglet 4612 and thelower winglet 4614 can be caused to pivot away from one another using some other mechanism. Implants in accordance with the present invention are not intended to be limited to such second wing deployment mechanisms as are described in detail herein. - Referring to
FIG. 55 , theimplant 4600 is shown positioned between adjacentspinous processes second wing 4660 as shown is sized such that when arranged in a first configuration (i.e., as a distraction guide 4610) theupper winglet 4612 and thelower winglet 4614 do not extend undesirably into the adjacent tissues. However, theupper winglet 4612 and thelower winglet 4614 can be sized and shaped other than as shown inFIG. 55 . Theupper winglet 4612 and thelower winglet 4614 need only be sized and shaped such that when arranged in a second configuration, the upper andlower winglets longitudinal axis 4625 in a direction opposite from insertion.FIGS. 56A through 56C illustrate a further embodiment of animplant 4700 in accordance with the present invention arranged between adjacentspinous processes lower winglets distraction guide 4710 and can be deployed by actuating an actuator arrangement including a shaft connected with acam 4707, the shaft having anengageable head 4706, or alternatively including some other mechanism such as a gear. As can be seen inFIG. 56A theimplant 4700 can be disposed between adjacentspinous processes FIG. 50 . Thedistraction guide 4710 of theimplant 4700 can be employed to pierce and/or distract aninterspinous ligament 6 connected between the adjacentspinous process implant 4700 can then be urged between thespinous processes distraction guide 4710 further distracts theinterspinous ligament 6 to form a space within which aspacer 4220 can be disposed. In the embodiment shown, thespacer 4220 can pivot about a central body extending from thefirst wing 4230 of theimplant 4700. Thefirst wing 4230 limits and/or blocks movement along alongitudinal axis 4725 of theimplant 4700 in the direction of insertion. - Once the
implant 4700 is arranged as desired, the actuator arrangement can be actuated to deploy the upper and lower winglets, 4712,4714, thereby forming a second wing 4760 as shown inFIG. 56C . The second wing 4760 limits and/or blocks movement along thelongitudinal axis 4725 in a direction opposite the direction of insertion. With the second wing 4760 deployed, the adjacentspinous processes implant 4800 from becoming undesirably dislodged from the space between the adjacentspinous processes FIG. 56C , the first wing 4730 and the second wing 4760 can be arranged sufficiently far apart that the adjacentspinous processes -
FIGS. 56B and 56C are partial cross-sectional posterior views of theimplant 4700 shown inFIG. 56A . In an embodiment, thedeployable winglets distraction guide 4710 using an actuator arrangement comprising ashaft 4707 andcam 4716. Thecam 4716 can be rotated to force thewinglets distraction guide 4710. As shown, thewinglets distraction guide 4710. -
FIGS. 56A through 57E illustrate a still further embodiment of animplant 4800 in accordance with the present invention arranged between adjacentspinous processes lower winglets distraction guide 4810 and can be deployed by actuating an actuator arrangement including ascrew 4807 having anengageable head 4806, or alternatively including some other mechanism such as a gear. As can be seen inFIG. 57A theimplant 4800 can be disposed between adjacentspinous processes FIG. 50 . Thedistraction guide 4810 of theimplant 4800 can be employed to pierce and/or distract aninterspinous ligament 6 connected between the adjacentspinous process implant 4800 can then be urged between thespinous processes distraction guide 4810 further distracts theinterspinous ligament 6 to form a space within which aspacer 4220 can be disposed. In the embodiment shown, thespacer 4220 can pivot about a central body extending from thefirst wing 4230 of theimplant 4800. Thefirst wing 4230 limits and/or blocks movement along alongitudinal axis 4825 of theimplant 4800 in the direction of insertion. - Once the
implant 4800 is arranged as desired, the actuator arrangement can be actuated to deploy the upper and lower winglets, 4812,4814, thereby forming asecond wing 4860 as shown inFIG. 56B . Thesecond wing 4860 limits and/or blocks movement along thelongitudinal axis 4825 in a direction opposite the direction of insertion. With thesecond wing 4860 deployed, the adjacentspinous processes wings 4830,4860, preventing theimplant 4800 from becoming undesirably dislodged from the space between the adjacentspinous processes FIG. 56B , the first wing 4830 and thesecond wing 4860 can be arranged sufficiently far apart that the adjacentspinous processes -
FIGS. 57C and 57D are partial cross-sectional end views of theimplant 4800 shown inFIGS. 57A and 57B . In an embodiment, thedeployable winglets distraction guide 4810 using an actuator arrangement comprising ascrew 4806 and threadedcollar 4816. The threadedcollar 4816 can be driven along thescrew 4806 to force thewinglets distraction guide 4810. As shown, thewinglets distraction guide 4810. Thewinglets collar 4816 at anupper pivot point 4817 and alower pivot point 4819.Pins pins winglets collar 4816 travels along thescrew 4806 in a posterior-to-anterior direction, the inner surface of thewinglets pins winglets distraction guide 4810. If desired thewinglets posts winglets posts - As shown in
FIGS. 57D and 57E , when the threadedcollar 4816 has traveled a distance along thescrew 4806, thewinglets second wing 4860. Thewinglets spinous processes longitudinal axis 4825 in a direction opposite the direction of insertion, thewinglets spinous processes FIG. 57E is an end view of theimplant 4800 with thesecond wing 4860 deployed. As shown, thescrew head 4806 extends from thedistraction guide 4810; however, when implemented, it is preferable for thescrew head 4806 to be either flush with the surface of thedistraction guide 4810 or slightly receded from the surface of thedistraction guide 4810 so that movement of theimplant 4800 is not obstructed during distraction of theinterspinous ligament 6 and/or thespinous processes screw head 4806 is shown extending from thedistraction guide 4810 to demonstrate possible arrangement relative to the proximal end of thedistraction guide 4810. -
FIGS. 58A and 58B illustrate yet another embodiment of the implant 4900 having an alternative actuation arrangement. In such an embodiment, thewinglets winglets collar 4916 toward thescrew head 4806.FIGS. 59A and 59B illustrate a still further embodiment of theimplant 5000 having an alternative actuation arrangement. In such embodiments, thewinglets winglet - As mentioned above, in other embodiments in accordance with the present invention, the winglets can be deployed from the distraction guide using a mechanism other than a screw and threaded collar. For example, one or more gears can be employed. Further, in still other embodiments the upper and lower winglets can have a shape along other than those shapes shown in
FIGS. 57A through 57B . The invention is not intended to be limited to winglets having shapes such as shown. In still further embodiments, such as shown inFIG. 60 , theimplant 5100 can include only one of the upper and lower winglets. For example, where implants are positioned at adjacent motion segments it can be advantageous to have alower winglet 4814, thereby preventing undesired contact ofadjacent implants 5100. As will be obvious to one of ordinary skill in the art, myriad different actuation arrangements can be employed to form a second wing. Implants in accordance with the present invention are not intended to be limited to those described in detail herein. - Materials for Use in Implants of the Present Invention
- In some embodiments, the implant, and components of the implant (i.e., the spacer, the distraction guide, etc.) can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, or other suitable implant material having similar high strength and biocompatible properties. Additionally, the implant can be at least partially fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. Such materials are typically radiopaque, and appear during x-ray imaging, and other types of imaging. Implants in accordance with the present invention, and/or portions thereof can also be fabricated from somewhat flexible and/or deflectable material. In these embodiments, the implant and/or portions thereof can be fabricated in whole or in part from medical grade biocompatible polymers, copolymers, blends, and composites of polymers. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer. Many polymers, copolymers, blends, and composites of polymers are radiolucent and do not appear during x-ray or other types of imaging. Implants comprising such materials can provide a physician with a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- One group of biocompatible polymers is the polyaryletherketone group which has several members including polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK is proven as a durable material for implants, and meets the criterion of biocompatibility. Medical grade PEEK is available from Victrex Corporation of Lancashire, Great Britain under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. These medical grade materials are also available as reinforced polymer resins, such reinforced resins displaying even greater material strength. In an embodiment, the implant can be fabricated from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - PEEK 450G has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques. It should be noted that the material selected can also be filled. Fillers can be added to a polymer, copolymer, polymer blend, or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers can be added to reinforce polymers mechanically to enhance strength for certain uses, such as for load bearing devices. In some embodiments, other grades of PEEK are available and contemplated for use in implants in accordance with the present invention, such as 30% glass-filled or 30% carbon-filled grades, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to unfilled PEEK. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and stiffness, and a lower expansion rate relative to unfilled PEEK. Carbon-filled PEEK also offers wear resistance and load carrying capability.
- As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. As mentioned, the implant can be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK)5 and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1 dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A11, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- Methods for Implanting Interspinous Implants
- A minimally invasive surgical method for implanting an
implant 4300 as shown inFIGS. 49A-55 in the cervical spine is disclosed and taught herein. In this method, as shown inFIG. 61 , preferably a guide wire 4780 is inserted through a placement network 4790 into the neck of the implant recipient. The guide wire 4780 is used to locate where theimplant 4300 is to be placed relative to the cervical spine, including the spinous processes. Once the guide wire 4780 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that animplant 4300 in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to the guide wire 4780 and directed at the end of the guide wire 4780. Themain body 4301 of theimplant 4300 is inserted into the neck of the patient. Preferably during insertion, thedistraction guide 4310 pierces or separates the tissue without severing the tissue. Once themain body 4301 is satisfactorily positioned, aninsert 4370 can be positioned within a cavity of themain body 4301, causing thedistraction guide 4310 of themain body 4301 to be arranged in a second configuration so that at least a portion of thedistraction guide 4310 forms a second wing. Theinsert 4370 can be inserted along a line that is generally collinear with the line over which themain body 4301 is inserted. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to themain body 4301 and theinsert 4370. - Further, a minimally invasive surgical method for implanting an implant as described in
FIGS. 49A-55 in the lumbar spine is disclosed and taught herein. In this method, as shown in the flowchart ofFIG. 62 , preferably a unilateral incision or opening can be made using a posterior-anterior approach (Step 2802). The unilateral incision can be made, for example, at a location some distance to the left of an axis along the spinous process. The incision or opening can be enlarged, and a distraction tool can be positioned within the incision so that the proximal end of the distraction tool (Step 2804) can access an exposed side of the interspinous ligament. The distraction tool can be urged through the interspinous ligament, thereby distracting the interspinous ligament so as to receive the implant (Step 2806). Once the interspinous ligament is sufficiently distracted, the distraction tool can be disengaged and removed from the incision (Step 2808). - Once the distraction tool has been removed from the incision, the implant can be positioned at the dilated opening, and the distraction guide of the implant can be urged through the dilated opening (Step 2810). The implant can be further urged through the opening until the spacer is positioned as desired between the adjacent spinous processes of the targeted motion segment (Step 2812). The spacer is free to rotate so that the load is distributed more evenly over the surface of the spinous processes. Optionally, the implant can be urged through the dilated opening until the first wing contacts the adjacent spinous processes, thereby blocking further movement in the direction of insertion. Once the implant is properly arranged, the insert can be positioned at the distal end of the implant so that the insert can be urged into and through the hollow cavity of the hollow central body (Step 2814). As the insert is seated inside of the cavity, the distraction guide splits, and the upper winglet and the lower winglet deploy as a second wing. The remaining tools can be removed from the incision, and the incision can be closed (Step 2816). Preferably during insertion, the distraction end pierces or separates the tissue without severing the tissue. Further, a minimally invasive surgical method for implanting an implant as shown in
FIGS. 56A-60 in the lumbar spine is disclosed and taught herein. In this method, as shown in the flowchart ofFIG. 63 , an incision or opening can be made using a posterior-anterior approach (Step 2852). The incision or opening can be enlarged, and a distraction tool can be positioned within the incision so that the proximal end of the distraction tool (Step 2854) can access an exposed side of the interspinous ligament. The distraction guide can be urged through the interspinous ligament and distracted, thereby distracting the interspinous ligament so as to receive the implant (Step 2856). Once the interspinous ligament is sufficiently distracted, the distraction tool can be disengaged and removed from the incision (Step 2858). - Once the distraction guide has been removed from the incision, the implant can be positioned at the dilated opening, and the distraction guide of the implant can be urged through the dilated opening (Step 2860). The implant can be further urged through the opening until the spacer is positioned as desired between the adjacent spinous processes of the targeted motion segment (Step 2862). The spacer is free to rotate so that the load is distributed more evenly over the surface of the spinous processes. Optionally, the implant can be urged through the dilated opening until the first wing contacts the adjacent spinous processes, thereby blocking further movement in the direction of insertion. Once the implant is properly arranged, an actuation tool can be inserted within the incision at an opposite side of the adjacent spinous processes from the point of insertion (Step 2864). The actuation tool can engage the actuation arrangement, and can actuate the actuation arrangement so that the upper winglet and the lower winglet deploy as a second wing, as described above (Step 2866). The remaining tools can be removed from the incision, and the incision can be closed (Step 2868). Preferably during insertion, the distraction end pierces or separates the tissue without severing the tissue.
- The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.
- Implants Having Deployable Wings
- In other embodiments, implants in accordance with the present invention can comprise a “matchbox”-like structure having a first configuration (as shown in
FIG. 64A ) and a second, deployed configuration (as shown inFIG. 64B ). Arranged in the first configuration,such implants 6700 can have a substantially flat profile having an approximately uniform thickness. - The uniform thickness approximates the thickness of a
spacer 6720 of theimplant 6700. Theimplant 6700 can comprise adistraction guide 6710 at a proximal end of the implant, thedistraction guide 6710 having a slightly rounded or tapered shape to pierce and/or distract a space between adjacent spinous processes. Theimplant 6700 can further comprise a plurality of hinged structures 6750-6757, the hinged structures 6750-6757 being collapsed so as to facilitate the substantially flat profile. The hinged structures 6750-6757 are pivotally connected with thespacer 6720 and extend from both sides of thespacer 6720. As shown inFIG. 64A , asupport structure 6722 extends from thespacer 6720 toward the distal end of theimplant 6700. A rod 6715 (or alternatively some other mechanism such as a tab) can be connected with the proximal end of theimplant 6700 and can extend through the hinged structures 6750-6753, through the spacer 66720, and through thesupport structure 6722 so that therod 6715 is accessible. - Referring to
FIG. 64B , once theimplant 6700 is positioned as desired between adjacent spinous processes, therod 6715 can be drawn in a direction opposite the direction of insertion along thelongitudinal axis 6725 so that the hinged structures 6750-6757 fold outward to form afirst wing 6730 and asecond wing 6760 between which is arranged thespacer 6720 and a portion of the spinous processes. As the hinged structures 6750-6757 fold outward, the height of the first andsecond wings spacer 6720 to a height such that the first andsecond wing implant 6700 along thelongitudinal axis 6725 when positioned between adjacent spinous processes. As can be seen, thesecond wing 6760 includes four hinged structures 6750-6753: an upperfirst structure 6750 connected by a hinge to an uppersecond structure 6752, and a lowerfirst structure 6751 connected by a hinge to a lowersecond structure 6753. The hinged structures 6750-6753 pivot outward to form anupper end 6762 of the second wing and alower end 6764 of the second wing. Likewise, thefirst wing 6730 includes four hinged structures 6754-6757: an upperfirst structure 6754 connected by a hinge to an uppersecond structure 6756, and a lowerfirst structure 6755 connected by a hinge to a lowersecond structure 6757. However, unlike thesecond wing 6760, thefirst wing 6730 is (effectively) bisected by thesupport structure 6722 so that thefirst wing 6730 comprises four winglets 6731-6734. The hinged structures 6754-6757 pivot outward to formupper winglets lower winglets - As mentioned above, the
support structure 6722 extends from thespacer 6720 toward the distal end of theimplant 6700. Thespacer 6720 and thesupport structure 6722 include a bore or other cavity through which therod 6715 can travel. Applying resistive force to thesupport structure 6722 can fix thespacer 6720 in place between spinous processes when drawing therod 6715 through the bore. As therod 6715 is drawn through the bore, the hingedstructures rod 6715 is connected are drawn with therod 6715. As therod 6715 is drawn through thespacer 6720, the hingedstructures spacer 6720. The hinged structures 6750-6753 pivot outward to accommodate the relative movement between therod 6715 and the spacer 66720. Accordingly, thesecond wing 6760 has been satisfactorily deployed. - The hinged
structures first wing 6730 can cause deployment of thefirst wing 6730 by applying resistive force to the hingedstructures structures spacer 6720. The resistive force or urging can be applied by asecond stop 6784 that can fit around thesupport structure 6722 and can be interference fit or otherwise selectively fixed with thesupport structure 6722. As thesecond stop 6784 is pushed along thelongitudinal axis 6725, along thesupport structure 6722, the hinged structures 6754-6757 pivot outward to accommodate the relative movement between thesecond stop 6784 and thespacer 6720. Accordingly, thefirst wing 6730 has been satisfactorily deployed. -
FIGS. 65A and 65B are posterior views of theimplant 6700 positioned between adjacentspinous processes implant 6700 between thespinous processes implant 6700 can be positioned so that adistraction guide 6710 of theimplant 6700 is arranged at a space between thespinous processes implant 6700 can then be urged between thespinous processes spacer 6720 is positioned as desired. The substantially flat profile of theimplant 6700 can ease positioning of thespacer 6720 by reducing potential obstructing surfaces that can resist movement of theimplant 6700 during implantation. Thesecond wing 6760 and thefirst wing 6730 can then be deployed to limit movement of theimplant 6700. To deploy thesecond wing 6760 therod 6715 is drawn in a direction opposite the direction of insertion along thelongitudinal axis 6725. Theupper end 6762 andlower end 6764 of the second wing extend outward as described above. Once thesecond wing 6760 is deployed, therod 6715 can be fixed in position relative to thespacer 6720. This can be accomplished using myriad different mechanisms. For example, as shown afirst stop 6782 can be interference fit to therod 6715 and positioned against thesupport structure 6722 along therod 6715. Thefirst stop 6782 can grip therod 6715, as with a friction fit between thefirst stop 6782 and therod 6715, so that therod 6715 is prevented from moving through the bore of thesupport structure 6722 by interference between thefirst stop 6782 and thesupport structure 6722. In other embodiments, some other mechanism can be used, such as a pin (e.g., a cotter pin), a latch system, etc. One of ordinary skill in the art will appreciate the myriad different mechanisms for fixing arod 6715 in position relative to thespacer 6720. The uppersecond structure 6756 and the lowersecond structure 6757 can be urged toward thespacer 6720 in the direction of insertion along thelongitudinal axis 6725 using asecond stop 6784 as described above, causing theupper winglets lower winglets first wing 6730. Once thefirst wing 6730 is deployed, the hinged structures 6754-6757 can be fixed in position using thesecond stop 6784 or some other mechanism. Thesecond stop 6784 can grip thesupport structure 6722, as with a friction fit or pin, and resist movement of the hinged structures 6754-6757, thereby preventing collapse. As above, one of ordinary skill in the art will appreciate the myriad different mechanisms for fixing thefirst wing 6730 in a deployed position. With thefirst wing 6730 and thesecond wing 6760 deployed, movement of theimplant 6700 along thelongitudinal axis 6725 can be limited or blocked, thereby resisting undesirable displacement of theimplant 6700. - It should be noted that with implants as described above in reference to
FIGS. 64A-67 therod 6715 can optionally be trimmed or otherwise partially detached to decrease a space required to accommodate theimplant rod 6715 can be beveled or otherwise weakened near a distal end of therod 6715 to allow therod 6715 to be snapped off when the first andsecond wings rod 6715 is fixed in place. In other embodiments, a tool (not shown) can be used to cut therod 6715 after the first andsecond wings rod 6715 is fixed in place. Still further, therod 6715 need not comprise a rigid structure, but rather alternatively can include a tether, string, or similarly flexible structure that can be placed in tension to retain thesecond wing first wing - Referring to
FIGS. 66A and 66B , a still further embodiment of animplant 6800 in accordance with the present invention is shown. In such an embodiment, aflexible strap 6890 can be connected between pairs of hinged structures (i.e., 6850 and 6852, 6851 and 6853, 6854 and 6856, 6855 and 6857). Theflexible strap 6890 can limit the relative movement of the hinged structures 6850-6857 so thatfirst wing 6830 andsecond wing 6860 have increased rigidity when fully deployed. Theimplant 6800 need not include thesupport structure 6722 of the previous embodiment. A resistive force can be applied to the hingedstructures rod 6715 is drawn in a direction opposite the direction of insertion along thelongitudinal axis 6825 the resistive force causes the hinged structures 6854-6857 to extend outward to form thefirst wing 6830. As the hinged structures 6854-6857 extend outward theflexible strap 6890 connected opposite the hinge unfolds. Once the hinged structures 6854-6857 reach a maximum extension, theflexible strap 6890 becomes taut and resists further extension, locking thefirst wing 6830 in place. Theflexible straps 6890 can provide thefirst wing 6830 with sufficient rigidity to resist movement of thespacer 6720, so that as therod 6715 is further drawn therod 6715 moves through thespacer 6720 and the hingedstructures 6852,6853 connected with therod 6715 are drawn toward thespacer 6720. As the hingedstructures 6852,6853 connected with therod 6715 are drawn toward thespacer 6720, all of the hinged structures 6850-6853 extend outward to deploy thesecond wing 6860. Theflexible strap 6890, connected opposite the hinge, unfolds. Once the hinged structures 6854-6857 reach a maximum extension theflexible strap 6890 becomes taut and resists further extension, locking thefirst wing 6830 in place. A stop 6882 (or alternatively some other mechanism such as a pin) can be fixed to therod 6715 to create interference between thestop 6882 and the hingedstructures first wing 6830 that resists movement of therod 6715. Theflexible straps 6890 can be made from a biocompatible material. In an embodiment, theflexible straps 6890 can be made from a braided polyester suture material. Braided polyester suture materials include, for example, Ethibond, Ethiflex, Mersilene, and Dacron, and are non-absorbable, having high tensile strength, low tissue reactivity and improved handling. In other embodiments, theflexible straps 6890 can be made from stainless steel (i.e., surgical steel), which can be woven into a strap, for example. In still other embodiments,flexible straps 6890 can be made from some other material (or combination of materials) having similar properties. -
FIG. 67 is a posterior view of theimplant 6800 positioned between adjacentspinous processes implant 6800 between thespinous processes first wing 6830 can be deployed to limit movement of theimplant 6800 relative to thespinous processes first wing 6830 therod 6715 can be held fixed in position or urged in a direction opposite the direction of insertion along thelongitudinal axis 6825 while a force is applied to the hinged structures 6854-6857 (FIG. 66A ) of thefirst wing 6830 to cause theupper end 6832 of the first wing and thelower end 6834 of the first wing to extend away from therod 6715, thereby deploying thefirst wing 6830. Therod 6715 can be further urged in the direction opposite the direction of insertion so that the proximal end of therod 6715 pivotably connected with the hingedstructures 6852,6853 that comprise thedistraction guide 6710, is drawn toward thespacer 6720, causing theupper end 6862 of the spacer, and thelower end 6864 of the spacer to extend away from therod 6715. Once thesecond wing 6860 and thefirst wing 6830 are deployed, therod 6715 can be fixed in position relative to thespacer 6720. As above, this can be accomplished using myriad different mechanisms. For example, as shown afirst stop 6882 can be interference fit to therod 6715 and positioned against thefirst wing 6830 along therod 6715. Thefirst stop 6882 can grip therod 6715 so that therod 6715 is prevented from moving by a friction fit between thefirst stop 6882 and therod 6715. In other embodiments, some other mechanism can be used, such as a pin (e.g., a cotter pin), a latch system, etc. One of ordinary skill in the art will appreciate the myriad different mechanisms for fixing arod 6715 in position relative to thespacer 6720. With thefirst wing 6830 and thesecond wing 6860 deployed, movement of theimplant 6800 along thelongitudinal axis 6825 can be limited or blocked, thereby resisting undesirable displacement of theimplant 6800. - Referring to
FIGS. 68A and 68B , in still other embodiments, implants in accordance with the present invention can comprise a “matchbox”-like structure having a rounded, collapsed first configuration and a second, deployed configuration. Arranged in the first configuration,such implants 6900 can have a shape allowing theimplant 6900 to be more naturally inserted through a cannula. As shown, such a shape includes a substantially circular cross-section, though in other embodiments the implant can have an ovoid or elliptical cross-section, thereby allowing a spacer shape to be employed that generally accommodates a space between adjacent spinous processes. However, it will be appreciated that animplant 6900 having a circular cross-section can most efficiently use the space of a cannula, where the cannula includes a circular cross-section; therefore, it may be preferable to employ animplant 6900 having a circular cross-section where a physician desired to minify the diameter of the cannula inserted into the surgical site. - The cross-section of the
implant 6900 in a first configuration is generally consistent along the implant's length, having a diameter generally the thickness of aspacer 6920 of theimplant 6900. Theimplant 6900 can comprise adistraction guide 6910 at a proximal end of theimplant 6900, thedistraction guide 6910 having a rounded (as shown) or tapered shape to pierce and/or distract a space between adjacent spinous processes. However, where a cannula is employed to deliver an implant to a surgical site, theimplant 6900 can optionally include adistraction guide 6910 at the proximal end. The surgical site, and associated tissues and structures can be distracted and repositioned by the cannula, allowing substantially unobstructed access to the surgical site by theimplant 6900. In such circumstance adistraction guide 6910 may not be necessary. - The
implant 6900 can further comprise a plurality of hinged structures 6950-6957, the hinged structures 6950-6957 being collapsed so as to facilitate the substantially collapsed profile. The hinged structures 6950-6957 are pivotally connected with thespacer 6920 and extend from both sides of thespacer 6920. A rod 6915 (or alternatively some other mechanism such as a tab) can be connected with the proximal end of theimplant 900 and can extend through the hinged structures 6950-6953, and through thespacer 6920 so that therod 6915 is accessible to a physician. Referring toFIGS. 68B and 68C , once theimplant 6900 is positioned as desired between adjacent spinous processes, therod 6915 can be drawn in a direction opposite the direction of insertion along thelongitudinal axis 6925 so that the hinged structures 6950-6957 fold outward to form afirst wing 6930 and asecond wing 6960 between which is arranged thespacer 6920 and a portion of the spinous processes. As the hinged structures 6950-6957 fold outward, the height of the first andsecond wings spacer 6920 to a height such that the first andsecond wing implant 6900 along thelongitudinal axis 6925 when positioned between adjacent spinous processes. As can be seen, thesecond wing 6960 includes four hinged structures 6950-6953: an upperfirst structure 6950 connected by a hinge to an uppersecond structure 6952, and a lowerfirst structure 6951 connected by a hinge to a lowersecond structure 6953. The hinged structures 6950-6953 pivot outward to form anupper end 6962 of the second wing and alower end 6964 of the second wing. Likewise, thefirst wing 6930 includes four hinged structures 6954-6957: an upperfirst structure 6954 connected by a hinge to an uppersecond structure 6956, and a lowerfirst structure 6955 connected by a hinge to a lowersecond structure 6957. - Embodiments as described above in reference to
FIGS. 64A and 64B included asupport structure 6722 extending from thespacer 6720. Likewise, a support structure can optionally extend from thespacer 6920 of the cannula deliveredimplant 6900. However, such a structure need not be necessary where thefirst wing 6930 is prevented from deploying during deployment of thesecond wing 6960 by thecannula 6995 itself (seeFIG. 69B ). Referring toFIGS. 69A and 69B , once the cannula is positioned at the surgical site, theimplant 6900 can be urged through the cannula so that the hinged structures 6950-6953 are clear of the cannula. Therod 6915 can then be urged in an opposite direction (relative to insertion) along thelongitudinal axis 6925 to deploy thesecond wing 6960. As therod 6915 is drawn through thespacer 6920, the hingedstructures spacer 6920. The hinged structures 6950-6953 pivot outward to accommodate the relative movement between therod 6915 and thespacer 6920. Accordingly, thesecond wing 6960 has been satisfactorily deployed. - Once the
second wing 6960 is deployed, thecannula 6995 can be retracted from the surgical site, thereby allowing the hingedstructures first wing 6930 to deploy by urging the hingedstructures spacer 6920. The urging can be applied by astop 6982 that can fit around therod 6915 and can be interference fit or otherwise selectively fixed with therod 6915. As thestop 6982 is pushed along thelongitudinal axis 6925, along therod 6915, the hinged structures 6954-6957 pivot outward to accommodate the relative movement between thestop 6982 and thespacer 6920. Accordingly, thefirst wing 6930 has been satisfactorily deployed. - Once the
second wing 6960 and thefirst wing 6930 are deployed, therod 6915 can be fixed in position relative to thespacer 6920. As above, this can be accomplished using myriad different mechanisms. For example, as shown astop 6982 can be interference fit to therod 6915 and positioned against thefirst wing 6930 along therod 6915. Thestop 6982 can grip therod 6915 so that therod 6915 is prevented from moving by a friction fit between thestop 6982 and therod 6915. In other embodiments, some other mechanism can be used, such as a pin (e.g., a cotter pin), a latch system, etc. One of ordinary skill in the art will appreciate the myriad different mechanisms for fixing arod 6915 in position relative to thespacer 6920. With thefirst wing 6930 and thesecond wing 6960 deployed, movement of theimplant 6900 along thelongitudinal axis 6925 can be limited or blocked, thereby resisting undesirable displacement of theimplant 6900. - It should be noted that with implants as described above in reference to
FIGS. 68A-69B therod 6915 can optionally be trimmed or otherwise partially detached to decrease a space required to accommodate theimplant 6900 within the patient's spine. For example, the structure of therod 6915 can be beveled or otherwise weakened near a distal end of therod 6915 to allow therod 6915 to be snapped off when the first andsecond wings rod 6915 is fixed in place. In other embodiments, a tool (not shown) can be used to cut therod 6915 after the first andsecond wings rod 6915 is fixed in place. Still further, therod 6915 need not comprise a rigid structure, but rather alternatively can include a tether, string, or similarly flexible structure that can be placed in tension to retain thesecond wing 6960 and/orfirst wing 6930 in a deployed position. - Referring to
FIGS. 68B, 68C and 69B, theimplant 6900 is shown having operably connected “hinged” structures 6950-6957. Such structures can be hinged in any way that permits relative movement. For example, the structures may be hinged by way of flexible straps, for example as described above in reference toFIG. 66B . Alternatively, the structures can be hinged using some other technique. For example, referring toFIG. 70C , one or a pair ofcords 6996 can connect pairs of hinged structures so that relative movement is restricted, thereby permitting hinging motion, while resisting separation of the structures. In still other embodiments, some other mechanism can be employed to define a range of movement of the hinged structures 6950-6957. One of ordinary skill in the art will appreciate the myriad different techniques for defining a range of motion of two mechanical parts. - As with the
flexible straps 6890 above, thecord 6996 can be made from a biocompatible material. In an embodiment, the cord 996 can be made from a braided polyester suture material. Braided polyester suture materials include, for example, Ethibond, Ethiflex, Mersilene, and Dacron, and are non-absorbable, having high tensile strength, low tissue reactivity and improved handling. In other embodiments, thecords 6996 can be made from stainless steel (i.e., surgical steel), which can be woven into a strap, for example. In still other embodiments, thecords 6996 can be made from some other material (or combination of materials) having similar properties. - Materials for Use in Implants of the Present Invention
- In some embodiments, the implant can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, or other suitable implant material having similar high strength and biocompatible properties. Additionally, the implant can be at least partially fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. Such materials are typically radiopaque, and appear during x-ray imaging, and other types of imaging. Implants in accordance with the present invention, and/or portions thereof can also be fabricated from somewhat flexible and/or deflectable material. In these embodiments, the implant and/or portions thereof can be fabricated in whole or in part from medical grade biocompatible polymers, copolymers, blends, and composites of polymers. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer. Many polymers, copolymers, blends, and composites of polymers are radiolucent and do not appear during x-ray or other types of imaging. Implants comprising such materials can provide a physician with a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- One group of biocompatible polymers are the polyaryl ester ketones which has several members including polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK is proven as a durable material for implants, and meets the criterion of biocompatibility. Medical grade PEEK is available from Victrex Corporation of Lancashire, Great Britain under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. These medical grade materials are also available as reinforced polymer resins, such reinforced resins displaying even greater material strength. In an embodiment, the implant can be fabricated from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - PEEK 450G has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques.
- It should be noted that the material selected can also be filled. Fillers can be added to a polymer, copolymer, polymer blend, or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers can be added to reinforce polymers mechanically to enhance strength for certain uses, such as for load bearing devices. In some embodiments, other grades of PEEK are available and contemplated for use in implants in accordance with the present invention, such as 30% glass-filled or 30% carbon-filled grades, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to unfilled PEEK. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and stiffness, and a lower expansion rate relative to unfilled PEEK. Carbon-filled PEEK also offers wear resistance and load carrying capability.
- As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. As mentioned, the implant can be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/0215S A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- As described above, the binder can be made from a biocompatible material. In an embodiment, the binder can be made from a braided polyester suture material. Braided polyester suture materials include, for example, Ethibond, Ethiflex, Mersilene, and Dacron, and are nonabsorbable, having high tensile strength, low tissue reactivity and improved handling. In other embodiments, the binder can be made from stainless steel (i.e., surgical steel), which can be braided into a tether or woven into a strap, for example. In still other embodiments, the binder can be made from some other material (or combination of materials) having similar properties. It is to be understood that embodiments in accordance with the present invention can be constructed without a pliant material. It is also to be understood that the embodiments in accordance with the present invention can have other dimensions.
- Methods for Implanting Interspinous Implants
- A minimally invasive surgical method for implanting an
implant 6400 in the cervical spine is disclosed and taught herein. In this method, as shown inFIG. 70 , preferably aguide wire 80 is inserted through a placement network or guide 90 into the neck of the implant recipient. Theguide wire 80 is used to locate where the implant is to be placed relative to the cervical spine, including the spinous processes. Once theguide wire 80 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that an implant in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 80 and directed at the end of theguide wire 80. In one embodiment, the implant can be a sized implant 400 (i.e., having a body that is not distractible), such as described above inFIGS. 7-23 and including adistraction guide 6410, aspacer 6420, and afirst wing 6430. Theimplant 6400 is inserted into the neck of the patient. Preferably during insertion, thedistraction guide 6410 pierces or separates the tissue without severing the tissue. - Once the
implant 6400 is satisfactorily positioned, asecond wing 6460 can be optionally inserted along a line that is generally collinear with the line over which theimplant 6400 is inserted but from the opposite side of the neck. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theimplant 6400 and thesecond wing 6460. Thesecond wing 6460 is mated to the implant and in this particular embodiment, thesecond wing 6460 is attached to theimplant 6400 by the use of a fastener, for example by ascrew 6442. Where a screw is used, thescrew 6442 can be positioned using a screw driving mechanism that is directed along a posterior to anterior line somewhat parallel to theguide wire 80. This posterior to anterior line aids the physician in viewing and securing thesecond wing 6460 to the implant. Thesecond wing 6460 is positioned so that abore 6463 formed in alip 6461 of thesecond wing 6460 is aligned with abore 6440 of theimplant 6400, as described above. Thescrew 6442 is positioned within both bores and secured, at least, to thebore 6440 of theimplant 6400. In other embodiments, the second wing can be interference fit with the implant, as described above, or fastened using some other mechanism, such as a flexible hinge and protrusion. - A minimally invasive surgical method for implanting an alternative embodiment of an
implant 6700 in the cervical spine is disclosed and taught herein. In this method, as shown inFIG. 25 , preferably aguide wire 80 is inserted through a placement network or guide 90 into the neck of the implant recipient. Theguide wire 80 is used to locate where theimplant 6700 is to be placed relative to the cervical spine, including the spinous processes. Once theguide wire 80 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that animplant 700 in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 80 and directed at the end of theguide wire 80. In an embodiment, theimplant 6700 can include adistraction guide 6710, aspacer 6720, arod 6715 extending through thespacer 6720, and deployable first andsecond wings implant 6700 can have a substantially flat profile to ease implantation, as described above. Theimplant 6700 is inserted into the neck of the patient. Preferably during insertion, thedistraction guide 6710 pierces or separates the tissue without severing the tissue. - Once the
implant 6700 is satisfactorily positioned, thefirst wing 6730 and thesecond wing 6760 can be deployed. As described above, thesecond wing 6760 can be deployed by urging therod 6715 in a direction opposite the direction of insertion along thelongitudinal axis 6725. As therod 6715 travels through thespacer 6720, hinged structures 6750-6753 contact the spacer 66720, buckle and extend away from therod 6715 two form anupper end 6762 of the second wing and alower end 6764 of the second wing. Whensecond wing 6760 is satisfactorily deployed, therod 6715 can be fixed in place relative to thespacer 6720 using afirst stop 6782, a pin, or some other mechanism. Thefirst wing 6730 can be deployed by urging the hinged structures 6754-6757 toward thespacer 6720, causing the hinged structures 6754-6757 to buckle and extend away from one another to form anupper end 6732 of the second wing and alower end 6734 of the second wing. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theimplant 6700. A minimally invasive surgical method for implanting an alternative embodiment of animplant 6900 in the cervical spine is disclosed and taught herein. In this method, as shown inFIG. 72 , preferably aguide wire 80 is inserted through a placement network or guide 90 into the neck of the implant recipient. Theguide wire 80 is used to locate where theimplant 6900 is to be placed relative to the cervical spine, including the spinous processes. Once theguide wire 80 is positioned with the aid of imaging techniques, an incision is made on the side of the neck along a line that is about perpendicular to theguide wire 80 and directed at the end of theguide wire 80. Thecannula 6995 is fed through the incision and positioned between the targeted adjacent spinous processes. In an embodiment, theimplant 6900 can include adistraction guide 6910, aspacer 6920, arod 6915 extending through thespacer 6920, and deployable first andsecond wings implant 6900 can have a substantially circular cross-section to roughly conform with an inside surface of thecannula 6995. Theimplant 6900 is urged through thecannula 6995 and into position between the adjacent spinous processes so that thesecond wing 6960 hinge structures are clear of thecannula 6995, as described above in reference toFIG. 68B . Thesecond wing 6960 is then deployed by urging therod 6915 in a direction opposite the direction of insertion along thelongitudinal axis 6925. As therod 6915 travels through thespacer 6920, hinged structures 6950-6953 contact thespacer 6920, buckle and extend away from therod 6915 two form anupper end 6962 of the second wing and alower end 6964 of the second wing. Whensecond wing 6960 is satisfactorily deployed, thecannula 6995 can be retracted to expose the hinged structures 6954-6957 of thefirst wing 6930. Thefirst wing 6930 can be deployed by urging the hinged structures 6954-6957 toward thespacer 6920, causing the hinged structures 6954-6957 to buckle and extend away from one another to form anupper end 6932 of the second wing and alower end 6934 of the second wing. Once thefirst wing 6930 is deployed, therod 6915 can optionally be shortened, and thecannula 6995 can be withdrawn from the incision. The incision can then be closed. - The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.
- Interspinous Implants
-
FIG. 73A is a perspective view of an implant as described in U.S. patent application Ser. No. 10/850,267, filed May 20, 2004, incorporated herein by reference. Theimplant 7100 comprises afirst wing 7130, aspacer 7120, and a lead-in tissue expander (also referred to herein as a distraction guide) 7110. Thedistraction guide 7110 in this particular embodiment is wedge-shaped, i.e., the implant has an expanding cross-section from a proximal end of theimplant 7100 to a region 7150 where theguide 7110 joins with the spacer 7120 (referencing for the figures is based on the point of insertion of the implant between spinous processes). As such, thedistraction guide 7110 functions to initiate distraction of the soft tissue and the spinous processes when theimplant 7100 is surgically inserted between the spinous processes. It is to be understood that thedistraction guide 7110 can be pointed and the like, in order to facilitate insertion of theimplant 7100 between the spinous processes of adjacent cervical vertebrae. It is advantageous that the insertion technique disturb as little of the bone and surrounding tissue or ligaments as possible in order to reduce trauma to the site and promote early healing, and prevent destabilization of the normal anatomy. For embodiments such as those ofFIGS. 73A and 73B , there is no requirement to remove any of the bone of the spinous processes and no requirement to sever, or remove from the body, ligaments and tissues immediately associated with the spinous processes. For example, it is unnecessary to sever the supraspinal ligament of the lower vertebrae or the ligamentum nuchae (which corresponds to the supraspinal ligament) which partially cushions the spinous processes of the upper cervical vertebrae. As can be seen, thespacer 7120 can be teardrop-shaped in cross-section perpendicular to alongitudinal axis 7125 of theimplant 7100. In this way, the shape of thespacer 7120 can roughly conform to a wedge-shaped space, or a portion of the space, between adjacent spinous processes within which theimplant 7100 is to be positioned. As shown inFIG. 1A , the spacer 7120 (and the first wing 7108) is shaped to accommodate the anatomical form or contour of spinous processes (and/or laminae) of the C6 and C7 vertebra for placement between such spinous processes (i.e., the C6-C7 motion segment). The same shape or variations of this shape can be used to accommodate other motion segments, for example in the thoracic or lumbar regions. In other embodiments thespacer 7120 can have alternative shapes such as circular, wedge, oval, ovoid, football, and rectangular with rounded corners, and other shapes. The shape of thespacer 7120 can be selected for a particular patient so that the physician can position theimplant 7100 as close as possible to the anterior portion of the surface of the spinous process. The shape selected for thespacer 7120 can affect the contact surface area of theimplant 7100 and the spinous processes that are to be subject to distraction. Increasing the contact surface area between theimplant 7100 and the spinous processes can distribute a load force between the spinous frame and theimplant 7100. Thefirst wing 7130 is likewise teardrop-shaped in cross-section perpendicular to alongitudinal axis 7125 of thespacer 7120 anddistraction guide 7110. The dimensions of thefirst wing 7130 can be larger than that of thespacer 7120, particularly along the axis of the spine, and can limit or block lateral displacement of theimplant 7100 in the direction of insertion along thelongitudinal axis 7125. As with thespacer 7120, thefirst wing 7130 can have other cross-sectional shapes, such as elliptical, wedge, circular, oval, ovoid, football, and rectangular with rounded corners and other shapes. - The
implant 7100 ofFIG. 73A further includes an adjustable wing 7160 (also referred to herein as a second wing) separate from thedistraction guide 7110, thespacer 7120 and thefirst wing 7130. Thesecond wing 7160 is connectable with the distraction guide 7110 (and/or the spacer 7120) once theimplant 7100 is positioned between adjacent spinous processes. Thesecond wing 7160, similar to thefirst wing 7130, can limit or block lateral displacement of theimplant 7100, however displacement is limited or blocked in the direction opposite insertion. When both thefirst wing 7130 and thesecond wing 7160 are connected with theimplant 7100 and theimplant 7100 is positioned between adjacent spinous processes, a portion of the spinous processes can be sandwiched between thefirst wing 7130 and thesecond wing 7160, limiting displacement along thelongitudinal axis 7125. As can be seen, thesecond wing 7160 can be teardrop-shaped in cross-section. Alip 7180 defining aspace 7170 through thesecond wing 7160 allows thesecond wing 7160 to pass over thedistraction guide 7110 to meet and connect with thedistraction guide 7110 and/or thespacer 7120. Thesecond wing 7160 is then secured to thedistraction guide 7110 and/or thespacer 7120. Thesecond wing 7160, can be designed to be interference-fit onto thespacer 7120 or a portion of thedistraction guide 7110 adjacent to thespacer 7120. Where thesecond wing 7160 is interference-fit, there is no additional attachment device to fasten thesecond wing 7160 relative to the remainder of theimplant 7100. - Alternatively, various fasteners can be used to secure the
second wing 7160 relative to the remainder of theimplant 7100. For example,FIG. 73A illustrates an embodiment of animplant 7100 including a teardrop-shapedsecond wing 7160 having atongue 7158 at the posterior end of thesecond wing 7160. Abore 7155 is disposed through thetongue 7158, and is aligned with acorresponding bore 7156 on thespacer 7120 when thesecond wing 7160 is brought into position by surgical insertion relative to the rest of theimplant 7100. A threadedscrew 7154 can be inserted through the aligned bores 7155,7156 in a posterior-anterior direction to secure thesecond wing 7160 to thespacer 7120. The direction of insertion from a posterior to an anterior direction has thescrew 7154 engaging thebores implant 7100 along a direction that is generally perpendicular to thelongitudinal axis 7125. This orientation is most convenient when the physician is required to use ascrew 7154 to secure thesecond wing 7160 to the rest of theimplant 7100. Thesecond wing 7160 can further be secured to thespacer 7120 by some other mechanism, for example such as a flexible hinge (not shown) with a protrusion that engages an indentation of one of thedistraction guide 7110 and thespacer 7120. Alternatively, thesecond wing 7160 can be secured to one of thedistraction guide 7110 and thespacer 7120 by still some other mechanism. -
FIG. 73B is a perspective view of an implant as described in U.S. Pat. No. 6,695,842 to Zucherman, et al, incorporated herein by reference. Theimplant 7200 has a main body that includes aspacer 7220, afirst wing 7230, a lead-in tissue expander 7210 (also referred to herein as a distraction guide) and analignment track 7203. The main body of theimplant 7200 is inserted between adjacent spinous processes and remains in place (where desired) without attachment to the bone or ligaments. - The
distraction guide 7210 includes a tip from which thedistraction guide 7210 expands, the tip having a diameter sufficiently small such that the tip can pierce an opening in an interspinous ligament and/or can be inserted into a small initial dilated opening. The diameter and/or cross-sectional area of thedistraction guide 7210 gradually increases until it is substantially similar to the diameter of thespacer 7220. The tapered front end eases the ability of a physician to urge theimplant 7200 between adjacent spinous processes. When urging the main body of theimplant 7200 between adjacent spinous processes, the front end of thedistraction guide 7210 distracts the adjacent spinous processes and dilates the interspinous ligament so that a space between the adjacent spinous processes is approximately the diameter of thespacer 7220. - As shown in
FIG. 73B , thespacer 7220 is elliptically shaped in cross-section, and can swivel so that thespacer 7220 can self-align relative to the uneven surfaces of the spinous processes. Self-alignment can ensure that compressive loads are distributed across the surface of the bone. As contemplated in Zucherman '842, thespacer 7220 can have, for example, a diameter of six millimeters, eight millimeters, ten millimeters, twelve millimeters and fourteen millimeters. These diameters refer to the height by which thespacer 7220 distracts and maintains apart the spinous process. For an elliptically shaped spacer 7220, the selected height (i.e., diameter) is the minor dimension measurement across the ellipse. The major dimension is transverse to the alignment of the spinous process, one above the other. - The
first wing 7230 has alower portion 7231 and anupper portion 7232. Theupper portion 7232 is shaped to accommodate the anatomical form or contour of spinous processes (and/or laminae) of the L4 (for an L4-L5 placement) or L5 (for an L5-S1 placement) vertebra. The same shape or variations of this shape can be used to accommodate other motion segments, such as motion segments in the cervical and thoracic regions. Thelower portion 7231 can also be rounded to accommodate the spinous processes. Thelower portion 7231 andupper portion 7232 of thefirst wing 7230 act as a stop mechanism when theimplant 7200 is inserted between adjacent spinous processes. Theimplant 7200 cannot be inserted beyond the surfaces of thefirst wing 7230. Additionally, once theimplant 7200 is inserted, thefirst wing 7230 can prevent some side-to-side, or posterior-to-anterior movement of theimplant 7200. As with theimplant 7100 ofFIG. 73A , theimplant 7200 ofFIG. 73B further includes asecond wing 7260. Similar to thefirst wing 7230, thesecond wing 7260 includes alower portion 7261 and anupper portion 7262 sized and/or shaped to accommodate the anatomical form or contour of the spinous processes and/or lamina. Thesecond wing 7260 can be secured to the main body of theimplant 7200 with afastener 7254. Thesecond wing 7260 also has analignment tab 7268. When thesecond wing 7260 is initially placed on the main body of theimplant 7200, thealignment tab 7268 engages thealignment track 7203. Thealignment tab 7268 slides within thealignment track 7203 and helps to maintain theadjustable wing 7260 substantially parallel with thefirst wing 7230. When the main body of theimplant 7200 is inserted into the patient and thesecond wing 7260 has been attached, displacement along thelongitudinal axis 7225 in either the direction of insertion or the direction opposite insertion can be limited or blocked. - Further, the
second wing 7260 also can prevent some side-to-side, or posterior-to-anterior movement. - For both the
implant 7100 ofFIG. 73A and theimplant 7200 ofFIG. 73B , where asecond wing implant implant implant second wing implant implant first wing second wing second wing - Implants Having a Lead-in Screw
- Referring to
FIGS. 74A through 75C ,implants 7300 and methods for positioning such implants in accordance with the present invention can include, in an embodiment, aframe 7302 having acentral body 7304 extending along alongitudinal axis 7325 of theimplant 7300. Thecentral body 7304 can include adistraction guide 7306 at a proximal end of thecentral body 7304. Thedistraction guide 7306 can have a tapered shape so that thedistraction guide 7306 can pierce and/or distract an interspinous ligament associated with the targeted motion segment. Afirst wing 7330 extends from a distal end of thecentral body 7304 and acts to limit or block movement of theimplant 7300 along thelongitudinal axis 7325 in the direction of insertion. - A substantially thread-shaped lead-in screw (also referred to herein as a second wing) 7360 extends from the periphery of the
central body 7304 distally located relative to thedistraction guide 7306. For example, the second wing can be helical shaped, wherein a helical shape is generally a three-dimensional curve that lies on a cylinder or a cone, so that its angle to a plane perpendicular to the axis is constant. Helical shapes as described herein need not lie along a constant angle, but rather can lie along an angle that varies. A helical shape need only include a curve that has a gap 7361 (also referred to herein as a groove) between overlapping surfaces such that structures related to the adjacent spinous processes and the spinous processes can pass within thegroove 7361. It is to be understood that a lead-in screw shape other than helical is within the spirit and scope of the invention. For example, a shape with a constant diameter thread, or with different or constant thread pitches can be used. Generally and preferably thesecond wing 7360 can have an outer diameter that steadily increases from near the proximal end of thecentral body 7304 distally toward thefirst wing 7330. Thesecond wing 7360 terminates so that a spacer 7320 (FIG. 74B ) can be arranged between thesecond wing 7360 and thefirst wing 7330. The helical shape of thesecond wing 7360 can facilitate implantation between adjacentspinous processes 2,4 (shown inFIGS. 75A-75E ) from one or more incisions formed on one side of aninterspinous ligament 6 extending between the adjacentspinous processes - Implantation can be accomplished in such embodiments as described above by initially piercing or distracting the
interspinous ligament 6 with thedistraction guide 7306, and subsequently rotating thecentral body 7304. One or both of theinterspinous ligament 6 and the adjacentspinous processes groove 7361 of the helically shapedsecond wing 7360 as thecentral body 7304 is rotated and thecentral body 7304 is drawn or urged along thelongitudinal axis 7325 in the direction of insertion. Theinterspinous ligament 6 and/or associatedspinous processes groove 7361 and therefore along thecentral body 7304, causing thesecond wing 7360 to be positioned, when theimplant 7300 is seated, at an opposite side of theinterspinous ligament 6 from thefirst wing 7330 such that theinterspinous ligament 6 is disposed between thefirst wing 7330 and thesecond wing 7360 along thelongitudinal axis 7325. Arranging theinterspinous ligament 6, and/or the associatedspinous processes first wing 7330 and thesecond wing 7360 limits or blocks movement along thelongitudinal axis 7325. In some embodiments, thedistraction guide 7306 can have a generally conical shape, rather than a wedge-shape as described above in reference toFIGS. 73A and 73B . Where thedistraction guide 7306 includes a wedge-shape, rotation of thecentral body 7304 can cause thedistraction guide 7306 to distract the adjacentspinous processes distraction guide 7306. Referring toFIG. 74A , as with thedistraction guide 7306, thefirst wing 7330 has a rounded shape, having substantially the same minor and major dimension. Thefirst wing 7330 is shaped so that thefirst wing 7330 can rotate along with thecentral body 7304 while minifying interference from surrounding structures. Further, the rounded shape of thefirst wing 7330 can accommodate slots as described below, while providing a surface to contact the adjacentspinous processes longitudinal axis 7325 in the direction of insertion. However, in other embodiments, thefirst wing 7330 need not have a rounded shape. - The
first wing 7330 can include one or more slots to receive aspacer 7320 so that thespacer 7320 can be arranged over thecentral body 7304 between thesecond wing 7360 and thefirst wing 7330. As shown, thefirst wing 7330 includes twoslots slots spacer 7320. Theslots central body 7304, so that when aspacer 7320 is urged through theslots spacer 7320 abuts thecentral body 7304, thereby allowing a portion of a load to be transferred to thecentral body 7304. In other embodiments, one or more slots can be disposed through thefirst wing 7330 and can be shaped as desired, such that the one or more slots having the same or different geometries. -
FIG. 74B is a perspective view of thespacer 7320 having a geometry adapted to be received over theframe 7302 described above. Thespacer 7320 includes atop portion 7322 and abottom portion 7324. (It should be noted that some components of the implant are referred to herein as “top” and “bottom” components; however, positional modifiers are attached merely to distinguish between similar components and are not meant to limit use of the invention.) Thetop portion 7322 and thebottom portion 7324 have outer surfaces that support a respective adjacentspinous process central body 7304. As shown, a portion of the inner surfaces of thetop portion 7322 and thebottom portion 7324 are grooved so as to approximately conform with a shape of thecentral body 7304, thereby spreading a load across the outer surface of thecentral body 7304. The outer surfaces are arced, and generally shaped to resemble the outer periphery of theslots first wing 7330. In other embodiments, for example where the central body is trapezoidal, or otherwise shaped, thetop portion 7322,bottom portion 7324, and correspondingslots central body 7304. Alternatively, thecentral body 7304 can have an irregular or non-symmetrical shape to prevent incorrect mating of thespacer 7320 with theframe 7302. One of ordinary skill in the art will appreciate the myriad variations with which the structures can be shaped. - As can be seen, the
top portion 7322 and thebottom portion 7324 include respective lead-intissue expanders 7321,7323 (also referred to herein as a distraction guides). Thedistraction guide top portion 7322 and thebottom portion 7324 can taper at the proximal end of thespacer 7320, thereby allowing thedistraction guide 7306 to distract one or both of the adjacentspinous processes interspinous ligament 6. - As can be seen, the
top portion 7322 and thebottom portion 7324, taken together in cross-section perpendicular to alongitudinal axis 7325, can have a split teardrop shape, similar to a cross-section of thespacer 7120 ofFIG. 73A . In this way, the shape of thespacer 7320 can roughly conform to a wedge-shaped space, or a portion of the space, between adjacent spinous processes within which theimplant 7300 is to be positioned. The same shape or variations of this shape can be used to accommodate different motion segments and/or different patients, as described above. In other embodiments thespacer 7320 can have alternative shapes such as circular, elliptical, wedge, oval, ovoid, football, and rectangular with rounded corners, and other shapes. The shape of thespacer 7320 can be selected for a particular patient so that the physician can position theimplant 7300 as close as possible to the anterior portion of the surface of the spinous process. The shape selected for thespacer 7320 can affect the contact surface area of theimplant 7300 and the spinous processes that are to be subject to distraction. Increasing the contact surface area between theimplant 7300 and the spinous processes can distribute a load force between the spinous frame and theimplant 7300. - The
top portion 7322 and thebottom portion 7324 extend from abase 7326 and are fixed in relative position by thebase 7326. As can be seen, thebottom portion 7324 extends farther than thetop portion 7322. As will be described in further detail below, thetop portion 7322 is truncated in length along thelongitudinal axis 7325 relative to thebottom portion 7324 to avoid contacting thesecond wing 7360 which in the embodiment shown inFIG. 74A spirals to a termination point at the upper surface of thecentral body 7304. An additional advantage with the truncatedtop portion 7322 is that the spinous processes are distracted more gradually, first with thebottom portion 7324 and then with thetop portion 7322 as thespacer 7320 is inserted into theframe 7302. Thebase 7326 can have a length along thelongitudinal axis 7325 as desired, and preferably having a length sufficient to support thetop portion 7322 and thebottom portion 7324 in an at least semi-rigid position relative to one another. Thebase 7326 can include acavity 7329 for receiving one or both of an insertion tool and a fastener (not shown). Thecavity 7329 can correspond to a threadedcavity 7309 disposed in thecentral body 7304 so that, for example, theframe 7302 and thespacer 7320 can be fixedly attached, with by way of example only a screw, once thespacer 7320 is seated. -
FIG. 74C is a perspective view of theimplant 7300 wherein thespacer 7320 is seated within theframe 7302 and arranged over thecentral body 7304. As can be seen, thebottom portion 7324 of thespacer 7320 extends further than thetop portion 7322, and is unobstructed by thesecond wing 7360, which spirals partially above thebottom portion 7324. Thefirst wing 7330 and thesecond wing 7360 have major dimensions approximately along the axis of the spine that are larger than the major dimension of thespacer 7320, thereby blocking or limiting movement of theimplant 7300 along thelongitudinal axis 7325. -
FIGS. 75A through 75E are partial cross-sectional posterior views illustrating theimplant 7300 being positioned between adjacent spinous processes.FIG. 75A illustrates the distraction guide of theframe 7302 positioned adjacent to theinterspinous ligament 6 of the targeted motion segment. Theframe 7302 can be urged against theinterspinous ligament 6 to pierce and/or distract theinterspinous ligament 6. Theframe 7302 can further be urged into theinterspinous ligament 6 along thelongitudinal axis 7325 until thesecond wing 7360 contacts theinterspinous ligament 6. Referring toFIG. 75B , theframe 7302 can then be rotated and urged toward theinterspinous ligament 6 so that thesecond wing 7360 passes through theinterspinous ligament 6, which is thereby positioned between a portion of thesecond wing 7360 and thefirst wing 7330 along thelongitudinal axis 7325. Theinterspinous ligament 6 and the adjacentspinous processes groove 7361 between the surfaces of thesecond wing 7360 that overlap along thelongitudinal axis 7325. Referring toFIG. 75C , theframe 7302 can be further rotated and urged into theinterspinous ligament 6 until the entiresecond wing 7360 is substantially arranged so that theinterspinous ligament 6 is disposed between thefirst wing 7330 and thesecond wing 7360. Theframe 7302 can be further rotated so that theslots spacer 7320 such that a load applied to thespacer 7320 is sufficiently distributed across the surface of the spacer 7320 (i.e., thespacer 7320 approximately conforms to a space between the contact surfaces of adjacentspinous processes FIGS. 75D and 75E , once theframe 7304 is arranged as desired, thetop portion 7322 and thebottom portion 7324 can be positioned within the correspondingslots central body 7304 so that thetop portion 7322 andbottom portion 7324 further distract theinterspinous ligament 6 and/or the adjacentspinous processes spacer 7320 can be urged in the direction of insertion until thebase 7326 is seated against thefirst wing 7330. In a preferred embodiment, thetop portion 7322 and thebottom portion 7324 can be arranged so that thetop portion 7322 andbottom portion 7324 are approximately in contact or near-contact with thesecond wing 7360, so that thespacer 7320 fully supports a load applied by the adjacentspinous processes -
FIG. 76A is an end view of theimplant 7300 positioned between the adjacentspinous processes base 7326 is arranged at a slight angle relative to the axis of the spine. As can be seen, the upperspinous process 2 includes a lower contact surface that arcs slightly downward, and the lowerspinous process 4 includes an upper contact surface that also arcs slightly downward. Arranging theimplant 7300 as shown can increase the overall contact surface between the adjacentspinous processes spacer 7320 over, for example, inserting theimplant 7300 so that thebase 7326 is aligned perpendicular to the axis of the spine. Increasing overall contact surface can reduce the stress applied from the motion segment to thespacer 7320, and from the spacer to the adjacentspinous processes - As can further be seen, the
base 7326 can include acavity 7329 that in an embodiment is a bore having a diameter larger than a diameter of acorresponding cavity 7309 of thefirst wing 7330. Such a feature can be receive an insertion tool (not shown) for assisting in implantation, or such a feature can receive a fastener (not shown), such as a screw or bolt to secure thespacer 7320 to theframe 7302. Abore 7329 having a larger diameter than thecavity 7309 of theframe 7302 can allow a head of the fastener to be received so that the head does not extend beyond a distal face of thebase 7326. In other embodiments, thebase 7326 can include one or more additional cavities for receiving lock pins, or other features of an insertion tool (not shown), for example as described in U.S. Pat. No. 6,712,819, entitled “Mating Insertion Instruments for Spinal Implants and Methods of Use,” issued Mar. 30, 2004 to Zucherman, et al. -
FIG. 76B is a front view of theimplant 7300 positioned between the adjacentspinous processes second wing 7360 is helical in shape and can limit or block motion in a direction opposite insertion by contacting the upperspinous process 2. - Further, a portion of the
second wing 7360 can contact the lowerspinous process 4. Although thesecond wing 7360 as shown includes a helical shape somewhat similar to that of a conch shell, in other embodiments thesecond wing 7360 can have a shape that varies from the shape shown. For example, the distal end of thesecond wing 7360 can overlap the proximal end of thesecond wing 7360 more or less than as shown. Alternatively, thesecond wing 7360 can be formed in two or more broken sections, rather than an unbroken spiral. Still further, thesecond wing 7360 can include slots for receiving a proximal piece of the upper andlower portions spacer 7320. Myriad different variations of the shape shown inFIGS. 75A-76B will be readily apparent to one of skill in the art upon understanding the structure shown. Implants in accordance with the present invention are not intended to be limited to those described and shown herein, but rather apply to all such implants that utilize a wing having a major dimension larger than a major dimension of a space between spinous processes, wherein the wing can be appropriately positioned by rotating the implant while urging the implant in a direction of insertion. - Referring now to
FIGS. 77A through 77C , an alternative embodiment of animplant 7400 in accordance with an embodiment of the present invention is shown.FIG. 77A is a perspective view of theframe 7402 including acentral body 7404 having adistraction guide 7406 at a proximal end, and analignment protrusion 7408 at a distal end. As can be seen, thesecond wing 7460 is similar to thesecond wing 7460 described above. Thealignment protrusion 7408 extends from thecentral body 7404 to align aspacer 7420 as thespacer 7420 is arranged over thecentral body 7404, and to prevent thespacer 7420 from subsequently rotating relative to theframe 7402 once implanted. Thus, thealignment protrusion 7408 corresponds to a notch 7427 within thespacer 7420 within which thecentral body 7404 is partially disposed. -
FIG. 77B is a perspective view of thespacer 7420. Thespacer 7420 includes abore 7428 disposed at least partially through thespacer 7420, and including a notch 7427 along the length of thebore 7428 to receive thealignment protrusion 7408 of theframe 7402. The proximal end of thespacer 7420 can be tapered to form adistraction guide 7426 to distract theinterspinous ligament 6 and/or the adjacentspinous processes rotatable spacer 7220 ofFIG. 73B , and theimplant 7300 ofFIGS. 74A-74C , theimplant 7400 can be further rotated or adjusted to distribute a load once thespacer 7420 is positioned over theframe 7404 and between thespinous processes spacer 7420 can have a cross-section perpendicular to thelongitudinal axis 7425 that is teardrop-shaped, similar to a cross-section of thespacer FIGS. 73A and 74A . In this way, the shape of thespacer 7420 can roughly conform to a wedge-shaped space, or a portion of the space, between adjacentspinous processes implant 7400 is to be positioned. The same shape or variations of this shape can be used to accommodate different motion segments and/or different patients, as described above. In other embodiments thespacer 7420 can have alternative shapes such as circular, elliptical, wedge, oval, ovoid, football, and rectangular with rounded corners, and other shapes. The shape of thespacer 7420 can be selected for a particular patient so that the physician can position theimplant 7400 as close as possible to the anterior portion of the surface of thespinous process spacer 7420 can affect the contact surface area of theimplant 7400 and thespinous processes implant 7400 and thespinous processes implant 7400. - The
spacer 7420 ofFIG. 77B extends from afirst wing 7430 integrally formed or connected with thespacer 7420. As can be seen, a proximal end of thespacer 7420 varies in length, extending farther near the bottom section of thespacer 7420 to correspond roughly with the helical shape of thesecond wing 7460, thereby avoiding contacting thesecond wing 7460 which in the embodiment shown inFIG. 77A spirals to a termination point at the upper surface of thecentral body 7404. As above, once theframe 7404 is arranged as desired, thespacer 7420 can be positioned over the central body 404 and urged over thecentral body 7404 so that thespacer 7420 further distracts the interspinous ligament and/or the adjacent spinous processes. Thespacer 7320 can be urged in the direction of insertion until thecentral body 7404 is seated within thebore 7428. In a preferred embodiment, the shape of the proximal end of thespacer 7420 is shaped such that when seated, the proximal end is approximately in contact or near-contact with thesecond wing 7460, so that thespacer 7420 fully supports a load applied by the adjacent spinous processes, without slippage. - The
first wing 7430 can have a depth along thelongitudinal axis 7425 as desired, and a width such that thefirst wing 7430 can contact one or both of the adjacentspinous processes implant 7400 in the direction of insertion along thelongitudinal axis 7425. As shown, thefirst wing 7430 has a rounded shape, having substantially the same minor and major dimension. Unlike the embodiment of theimplant 7300 ofFIGS. 74A-74C , thefirst wing 7430 need not rotate to properly arrange thesecond wing 7460, therefore thefirst wing 7430 need not have a round shape, where it is desired that thesecond wing 7460 have some other shape. For example, thefirst wing 7430 can include a shape similar to that shown inFIG. 73B . Thefirst wing 7430 can include a cavity 7429 for receiving one or both of an insertion tool (not shown). Further, thecentral body 7404 can optionally include a cavity 7409 so that, for example, theframe 7402, thespacer 7420, and thefirst wing 7430 can be fixedly attached once thespacer 7420 is seated. -
FIG. 77C is a perspective view of theimplant 7400 wherein thespacer 7420 is positioned to be seated on theframe 7402 and arranged over thecentral body 7404. Thefirst wing 7430 and thesecond wing 7460 have major dimensions approximately along the axis of the spine that are larger than the major dimension of thespacer 7420, thereby blocking or limiting movement of theimplant 7400 along thelongitudinal axis 7425.FIG. 78 is a posterior view of animplant 7400 as described inFIGS. 77A-77C disposed between the adjacent spinous processes. - In some embodiments of
systems including implants FIGS. 74A-77C , multipledifferent spacers single frame central body 7304 extending from afirst wing 7330, the distance between the outer peripheries of the twoslots central body 7404 having analignment protrusion 7408, a series ofspacer 7420 can have varying dimensions and/or shapes, and can have similarlysized cavities 7428 to receive thecentral body 7404. As can be readily understood from this description, a system in accordance with embodiments of the present invention can include aframe spacers - As mentioned above, implants, and systems and methods for positioning such implants between spinous processes in accordance with the present invention are not meant to be limited to embodiments as described above and otherwise herein, but rather are meant to include all such implants that utilize a wing having a major dimension larger than a major dimension of a space between spinous processes, wherein the wing can be appropriately positioned by rotating the implant while urging the implant in a direction of insertion. Myriad different variations may be readily apparent to one of ordinary skill in the art. For example, as shown in
FIGS. 79A through 79C , in still another embodiment of an implant 7500 in accordance with the present invention, theframe 7502 can include an innercentral body 7504 disposed within an outercentral body 7505, with a proximal portion of asecond wing 7560 being connected with, or extending from the innercentral body 7504, and the distal portion of thesecond wing 7560 being connected with, or extending from the outercentral body 7505. Once theframe 7502 is arranged as desired, such that the interspinous ligament is disposed between afirst wing 7330 and thesecond wing 7560, the innercentral body 7504 can be shifted to a position more fully received in the outercentral body 7505 so that thesecond wing 7560 collapses, reducing the space occupied by thesecond wing 7560. - In such embodiments as shown in
FIGS. 79A through 79C , thesecond wing 7560 can be made from a more ductile material so that thesecond wing 7560 can be readily collapsed. Alternatively, thesecond wing 7560 can be made from a shape memory material, for example such as Nitinol, so that once the frame is positioned thesecond wing 7560 collapses, urging the innercentral body 7504 to shift within the outercentral body 7505. Additionally thesecond wing 7560 can be made in two parts, one part fastened to the innercentral body 7504, and one part fastened to the outercentral body 7505. When the innercentral body 7504 is more fully received into the outercentral body 7505, the portion of thesecond wing 7560 secure to the innercentral body 7504 becomes nested in the portion of thesecond wing 7560 connected to the outercentral body 7505. - As shown in
FIG. 80 , in a still further embodiment an implant 7600 in accordance with the present invention can include adistraction guide 7606 that tapers more gradually, so that the adjacent spinous processes and/or related tissues are distracted as the lead-in screw 7660 is rotated and urged toward a direction of insertion, as described above. - In still further embodiments, the spacer need not be fixed, but rather can be rotatably disposed over the central body. For example, the spacer can include an alignment notch, as described above with reference to
FIG. 73B , so that when the central body is rotated, thereby threading the adjacent spinous processes and related structures within the groove of the thread-shaped wing and positioning the thread-shaped wing on an opposite side of the adjacent spinous processes, the spacer can be held in a fixed positioned. By fixing the spacer is position, the spacer can be arranged as desired between the adjacent spinous processes. Once the implant is positioned between adjacent spinous processes, the rotatable spacer can be released to conform within the space between spinous processes. These and other variations are within the scope of the invention as contemplated. - Materials for Use in Implants of the Present Invention
- In some embodiments, the implant, and components of the implant (i.e., the spacer, the frame) can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, or other suitable implant material having similar high strength and biocompatible properties. Additionally, the implant can be at least partially fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. Such materials are typically radiopaque, and appear during x-ray imaging, and other types of imaging. Implants in accordance with the present invention, and/or portions thereof can also be fabricated from somewhat flexible and/or deflectable material. In these embodiments, the implant and/or portions thereof can be fabricated in whole or in part from medical grade biocompatible polymers, copolymers, blends, and composites of polymers. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer. Many polymers, copolymers, blends, and composites of polymers are radiolucent and do not appear during x-ray or other types of imaging. Implants comprising such materials can provide a physician with a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- One group of biocompatible polymers is the polyaryletherketone group which has several members including polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK is proven as a durable material for implants, and meets the criterion of biocompatibility. Medical grade PEEK is available from Victrex Corporation of Lancashire, Great Britain under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name
- OXPEKK, and also from CoorsTek under the name BioPEKK. These medical grade materials are also available as reinforced polymer resins, such reinforced resins displaying even greater material strength.
- In an embodiment, the implant can be fabricated from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - PEEK 450G has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques.
- It should be noted that the material selected can also be filled. Fillers can be added to a polymer, copolymer, polymer blend, or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers can be added to reinforce polymers mechanically to enhance strength for certain uses, such as for load bearing devices. In some embodiments, other grades of PEEK are available and contemplated for use in implants in accordance with the present invention, such as 30% glass-filled or 30% carbon-filled grades, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to unfilled PEEK. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and stiffness, and a lower expansion rate relative to unfilled PEEK. Carbon-filled PEEK also offers wear resistance and load carrying capability.
- As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. As mentioned, the implant can be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;”PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- Methods for Implanting Interspinous Implants
- A minimally invasive surgical method for implanting an
implant 7300 in the cervical spine is disclosed and taught herein. In this method, as shown inFIG. 81 , preferably aguide wire 7680 is inserted through aplacement network 7690 into the neck of the implant recipient. Theguide wire 7680 is used to locate where theimplant 7300 is to be placed relative to the cervical spine, including the spinous processes. Once theguide wire 7680 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that animplant 7300 in accordance with an embodiment of the present invention, can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 7680 and directed at the end of theguide wire 7680. Aframe 7302 of theimplant 7300 is inserted into the neck of the patient. Theframe 7302 includes adistraction guide 7306 extending from the proximal end of acentral body 7304 and afirst wing 7330 extending from the distal end of thecentral body 7304. Theframe 7302 further includes a helical-shapedsecond wing 7360 extending distally from thedistraction guide 7306 some distance along thecentral body 7304. Preferably during insertion, thedistraction guide 7306 pierces or separates the tissue without severing the tissue. Theframe 7302 can be arranged so that thesecond wing 7360 extending from thecentral body 7304 is in contact or near contact with the interspinous ligament. Theframe 7302 is then rotated in a direction so that the spiraling extension of thesecond wing 7360 “grows” and theframe 7302 is urged forward such that the adjacent spinous processes fit within a groove between spiraled surfaces of thesecond wing 7360. Theframe 7302 is continuously rotated until thesecond wing 7360 has passed the adjacentspinous processes - The
frame 7302 can be further rotated untilslots first wing 7330 are arranged as desired between the adjacentspinous processes frame 7302 is satisfactorily positioned, aspacer 7320 can be mated with theframe 7302 so that anupper portion 7322 and alower portion 7324 of thespacer 7320 is received through therespective slot central body 7304 for example where thefirst wing 7330 extends from thespacer 7320 rather than extending form the central body 7304). Thespacer 7320 can be inserted along a line that is generally collinear with the line over which theframe 7302 is inserted. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theframe 7302 and thespacer 7320. - Further, a minimally invasive surgical method for implanting an
implant 7300 in the lumbar spine is disclosed and taught herein. In this method, as shown in the flowchart ofFIG. 82 , preferably a unilateral incision can be made using a posterior-anterior approach. The unilateral incision can be made, for example, at a location some distance to the right of an axis along thespinous process 2,4 (Step 7702). The incision can be enlarged, and a distraction tool can be positioned within the incision so that the proximal end of the distraction tool can access an exposed side of theinterspinous ligament 6. The distraction tool can be urged through theinterspinous ligament 6 and distracted, thereby distracting theinterspinous ligament 6 so as to receive the implant 7300 (Step 7704). Once theinterspinous ligament 6 is sufficiently distracted, the distraction tool can be disengaged and removed from the incision. - Once the distraction tool has been removed from the incision, the
frame 7302 can be positioned at the dilated opening, and thedistraction guide 7306 of theframe 7302 can be urged through the dilated opening (Step 7706). As above, theframe 7302 can be arranged so that thesecond wing 7360 extending from thecentral body 7304 is in near contact with theinterspinous ligament 6. Theframe 7302 is then rotated in direction so that the spiraling extension of thesecond wing 7360 “grows”, and theframe 7302 urged forward such that the adjacentspinous processes frame 7302 is continuously rotated until thesecond wing 7360 has passed the adjacentspinous processes frame 7300 can be further rotated until theslots frame 7302 is free to rotate so that the load can be distributed more evenly over the surface of the spinous processes. Once theframe 7302 is satisfactorily positioned, aspacer 7320 can be inserted withslots first wing 7330 extending from the distal end of the central body 7304 (or simply received over the central body for example where the first wing extends from the spacer). Thespacer 7320 can be inserted along a line that is generally collinear with the line over which theframe 7302 is inserted (Step 7710). The remaining tools can be removed from the incision, and the incision can be closed. Preferably during insertion, the distraction end pierces or separates the tissue without severing the tissue (Step 7712). The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents. - Interspinous Implant Having Slide-in Distraction Piece
-
FIG. 83 is a perspective end view of an alternative embodiment of animplant 8700 in accordance with the present invention. Theimplant 8700 can include an initiatingpiece 8704 and a slide-indistraction piece 8702 adapted to be slidably coupled with the initiatingpiece 8704. - The initiating
piece 8704 and the slide-indistraction piece 8702, when positioned between adjacent spinous processes and coupled together, can resembleimplants 7100 as described above with reference toFIGS. 7-23 . For example, theimplant 8700 ofFIG. 83 includes afirst wing 8730 at a distal end of theimplant 8700, a fixed spacer 8720 extending from thefirst wing 8730, asecond wing 8760 extending from thespacer 8720 so that thespacer 8720 is disposed between thefirst wing 8730 and thesecond wing 8760, and adistraction guide 8710 at aproximal end 8716 of theimplant 8700.FIG. 84A is a perspective view of the initiatingpiece 8704. The initiatingpiece 8704 includes aslot 8784 within a lower slidingsurface 8794 that extends through a substantial portion of the length of the initiatingpiece 8704, theslot 8784 being adapted to receive arail 8782 of the slide-indistraction piece 8702. Theslot 8784 extends a length at least as long as therail 8782 and preferably does not extend through the entire initiatingpiece 8704 so that thedistraction piece 8702 is prevented from sliding out of position in the direction of insertion. As shown, theslot 8784 includes aflange 8785 along the periphery of theslot 8784 to retain therail 8782 within theslot 8784. Theslot 8784 is thus shaped to substantially conform with a “T” shaped cross-section of therail 8782 so that when the slide-indistraction piece 8702 is mated with the initiatingpiece 8704 and therail 8782 is seated within theslot 8784, relative movement between thedistraction piece 8702 and the initiatingpiece 8704 is limited or substantially blocked, except along the longitudinal axis 8725 in a direction opposite the direction of insertion. To limit or block movement along the longitudinal axis 8725 in a direction opposite the direction of insertion, theslot 8784 can include arecess 8787 adapted to receive acatch 8781 of therail 8782 so that when thecatch 8781 passes over therecess 8787, thecatch 8781 is extended, locking thedistraction piece 8702 in place, and limiting or blocking movement in a direction opposite insertion. Alternatively, thecatch 8781 can be extendably associated with theslot 8784, while therecess 8787 is formed within therail 8782 for receiving thecatch 8781. - The initiating
piece 8704 includes alower distraction element 8714 having a contact surface that tapers to theproximal end 8716 from above as well as below theproximal end 8716 so that thelower distraction element 8714 has a “V” shape in cross-section along an axis of the spine. Such a geometry can ease implantation when compared with adistraction element 8714 that tapers to the proximal end only from below (or above) theproximal end 8716 by more evenly distributing a load force applied to thelower distraction element 8714 by theinterspinous ligament 6 during initial piercing and/or distraction of theinterspinous ligament 6. The initiatingpiece 8704 further includes alower portion 8734 of the first wing, alower portion 8764 of the second wing, and alower portion 8724 of the spacer. In an embodiment, thelower portions lower distraction element 8714, thereby avoiding discontinuities in a lower slidingsurface 8794 of theinitiation piece 8704. The lower slidingsurface 8794 of the initiatingpiece 8704 is substantially flat and preferably smooth to ease receipt of therail 8782 within theslot 8784. The lower slidingsurface 8794 slopes upward relative to the longitudinal axis 8725 from the distal end of the initiatingpiece 8704 to the proximal end of the initiatingpiece 8704. The slope of the lower slidingsurface 8794 causes variation in thickness of thelower portion 8724 of the spacer from the distal end of the spacer to the proximal end of the spacer. This slope aids in the distraction of the spinous processes upon insertion of thedistraction piece 8702. Referring again toFIG. 83 , the contact surfaces of theimplant 8700 include relatively smooth transitions from thedistraction guide 8710 to thesecond wing 8760, and from thesecond wing 8760 to thespacer 8720. As described in greater detail below, during implantation the initiatingpiece 8704 and thedistraction piece 8702 are positioned as separate, single pieces. A relatively continuous surface with smooth transitions improves ease of implantation and minifies obstruction of the initiatingpiece 8704 and thedistraction piece 8702 by the adjacent spinous processes and/or related tissues. In contrast to implants as described with reference toFIGS. 7-23 , it is preferable that thedistraction piece 8702 and the initiatingpiece 8704 have smoother transitions between thedistraction guide 8710, thesecond wing 8760, and thespacer 8720, as such transitions even further lessen the obstruction to the movement of the implant during implantation. - The
lower portion 8734 of the first wing can further optionally include one ormore cavities 8770 for receiving prongs of an insertion tool. As shown inFIGS. 84A through 84C , the initiatingpiece 8704 includes twocavities 8770 extending from the distal end of the initiatingpiece 8704 toward theproximal end 8716, with onecavity 8770 being arranged on each side of thelower portion 8734 of the first wing. Eachcavity 8770 can be sized to receive a prong of the insertion tool. Thecavity 8770 can further include agroove 8772 extending perpendicular to thecavity 8770. Referring toFIGS. 84B and 84C , aprong 8795 of aninsertion tool 8794 can include, in an embodiment, aprotrusion 8796 that fits within thegroove 8772. When the prong is inserted into thecavity 8770 and rotated approximately 90 degrees (FIG. 84C ) so that the protrusion is rotated into thegroove 8772, the prong is “locked” within thecavity 8770. Once the prongs of the insertion tool are arranged in a locked configuration, theimplant 8700 can be releasably guided into position between the adjacent spinous processes. -
FIG. 85A is a posterior view of the initiatingpiece 8704 positioned adjacent to theinterspinous ligament 6. As can be seen, the initiatingpiece 8704 has a maximum thickness T from the lower slidingsurface 8794 to thelower portion 8764 of the second wing. In a preferred embodiment, the maximum thickness T of the initiatingpiece 8704 is approximately the same as, or less than the thickness of thespacer 8720 when the initiatingpiece 8704 and thedistraction piece 8702 are mated and theimplant 8700 is positioned between the adjacentspinous processes FIG. 85B , as the initiatingpiece 8704 is urged into theinterspinous ligament 6, thelower distraction element 8714 pierces and/or distracts the fibers of theinterspinous ligament 6. As shown inFIG. 85C , the initiatingpiece 8704 is further urged through theinterspinous ligament 6 so that thelower portion 8764 of the second wing passes between the adjacentspinous processes spinous processes spacer 8720. As shown inFIG. 85D , the initiatingpiece 8704 is further urged through theinterspinous ligament 6 so that thelower portion 8724 of the spacer is approximately positioned between the adjacentspinous processes surface 8794 to thelower portion 8764 of the second wing can be greater than the ultimate thickness of thespacer 8720 so that when the initiatingpiece 8704 is positioned between adjacentspinous processes spinous processes spacer 8720. In such embodiments, thesecond wing 8760 can potentially provide greater range of flexion motion (wherein the space between adjacent spinous processes increases) while assuring that the movement of theimplant 8700 will be limited or blocked in a direction opposite insertion by thesecond wing 8760. -
FIG. 86 is a flipped perspective end view of the slide-indistraction piece 8702. Thedistraction piece 8702 includes arail 8782 extending over a substantial portion of the length of thedistraction piece 8702, roughly corresponding to a length of theslot 8784 of the initiatingpiece 8704, within which therail 8782 is adapted to be received. The height of therail 8782 from the upper slidingsurface 8792 to theflange 8783 of therail 8782 approximately corresponds to the depth of theslot 8784 from the lower slidingsurface 8794 to the bottom of theflange 8785 of the slot, so that when therail 8782 is received within theslot 8784, the upper slidingsurface 8792 of thedistraction piece 8702 is substantially flush with the lower slidingsurface 8794. In other embodiments, a gap can exist between the upper slidingsurface 8792 and the lower slidingsurface 8794. As described above, the surface of therail 8782 includes acatch 8781 arranged along the length of therail 8782 so that thecatch 8781 roughly corresponds to therecess 8787 disposed within theslot 8784. Thecatch 8781 can have a sloped leading edge (from the proximal end to a distal end of the catch 8781) and can be spring loaded, or otherwise biased so that thecatch 8781 collapses when thedistraction piece 8702 slides along the lower slidingsurface 8794 of the initiatingpiece 8704 and extends when passing over therecess 8787. Thecatch 8781 can have a trailing edge substantially perpendicular to theslot 8784 so that thecatch 8781 resists movement of thedistraction piece 8702 in a direction opposite insertion. In other embodiments, thecatch 8781 can be some other mechanism. For example, in an alternative embodiment, thecatch 8781 can be a flexible hinge and protrusion similar in operation to that described inFIGS. 19A-20B . Still further thepieces catch 8781 is molded into thepiece recess 8787 in theother piece distraction piece 8702 includes anupper distraction element 8712 having a contact surface that tapers so that the upper distraction element 712 has a ramp shape. Thedistraction piece 8702 further includes anupper portion 8732 of the first wing, anupper portion 8762 of the second wing, and anupper portion 8722 of the spacer. In an embodiment, theupper portions upper distraction element 8712, thereby avoiding discontinuities in an upper slidingsurface 8792 of thedistraction piece 8702. As with the lower sliding surface 8790, the upper slidingsurface 8792 of thedistraction piece 8702 is substantially flat and preferably smooth to ease positioning of therail 8782 within theslot 8784. The upper slidingsurface 8792 slopes upward relative to the longitudinal axis 8725 from the distal end of thedistracting piece 8702 to the proximal end of thedistraction piece 8702, the slope of the upper slidingsurface 8792 being substantially similar to the slope of the lower slidingsurface 8794 so that the twosurfaces rail 8782 is positioned within theslot 8784. The slope of the upper slidingsurface 8792 causes variation in thickness of theupper portion 8722 of the spacer from the distal end of the spacer to the proximal end of the spacer so that theupper portion 8722 of the spacer is thicker at the distal end. When thedistraction piece 8702 is mated with the initiatingpiece 8704 so that therail 8782 is seated within theslot 8784, the thickness of thespacer 8720 is approximately the same across the length of thespacer 8720. -
FIGS. 87A through 87D are a series of posterior views of thedistraction piece 8702 mating with the initiatingpiece 8704 so that theimplant 8700 is positioned between adjacentspinous processes spinous processes distraction piece 8702 is positioned so that the proximal end of therail flange 8783 fits within theslot 8784. Thedistraction piece 8702 can then be urged toward theinterspinous ligament 6 so that therail 8782 is further received within theslot 8784. The thickness of theimplant 8700 increases as the initiatingpiece 8704 is mated with thedistraction piece 8702.FIG. 87B illustrates thedistraction piece 8702 arranged so that theupper distraction element 8782 is adjacent to theinterspinous ligament 6. As thedistraction piece 8702 is urged further toward theinterspinous ligament 6, theupper distraction element 8782 wedges between the lower slidingsurface 8794 and theinterspinous ligament 6 and/or the adjacentspinous processes interspinous ligament 6 and the adjacentspinous processes distraction piece 8702 is further urged in the direction of insertion. As shown inFIG. 87C , as theupper portion 8762 of the second wing passes between the adjacentspinous processes spinous processes spacer 8720. Thedistraction piece 8702 is further urged in the direction of insertion until therail 8782 is seated within theslot 8784 and theupper portion 8762 of the second wing is arranged so that theinterspinous ligament 6 and/or adjacentspinous processes upper portion 8762 of the second wing and theupper portion 8732 of the first wing (seeFIG. 87D ). As thecatch 8781 passes over therecess 8787, thecatch 8781 extends into therecess 8787, locking thedistraction piece 8702 in position, mated with theinitiation piece 8704. - Interspinous Implant Having Slide-In Distraction Piece
-
FIGS. 88A and 88B are perspective end views of an alternative embodiment of animplant 8800 in accordance with the present invention. Theimplant 8800 can include an initiatingpiece 8804 and a slide-indistraction piece 8802 that can be slidably coupled with the initiatingpiece 8804. The initiatingpiece 8804 and the slide-indistraction piece 8802, when positioned between adjacent spinous processes and coupled together as shown inFIG. 88B , has a saddle shape including afirst wing 8830 and asecond wing 8860 that straddle one of the adjacent spinous processes. Theimplant 8800 approximates implants as shown above inFIGS. 7-23 . For example, theimplant 8800 includes thefirst wing 8830 at a distal end of theimplant 8800, a fixed spacer 8820 extending from thefirst wing 8830, thesecond wing 8860 extending from thespacer 8820 so that thespacer 8820 is disposed between thefirst wing 8830 and thesecond wing 8860, and adistraction guide 8810 at aproximal end 8816 of theimplant 8800. - The initiating
piece 8804 includes aslot 8884 within a lower slidingsurface 8886 that extends through a substantial portion of the length of the initiatingpiece 8804, theslot 8884 being adapted to receive arail 8882 of the slide-indistraction piece 8802. Theslot 8884 can optionally include a flange or some other structure to retain therail 8882 within theslot 8884. One of theslot 8884 and therail 8882 can further optionally include a recess (not shown) adapted to receive a catch (not shown) of the other of theslot 8884 and therail 8882 so that when the catch passes over the recess, the catch is extended, locking thedistraction piece 8802 in place, and limiting or blocking movement along the longitudinal axis 8825. - As shown, the initiating
piece 8804 includes afirst tab 8894 extending from thefirst wing 8834, thefirst tab 8894 including afirst perforation 8893. Thedistraction piece 8802 likewise includes asecond tab 8892 including asecond perforation 8891 adapted to be aligned with thefirst perforation 8893 so that when the slide-indistraction piece 8802 is mated with the initiatingpiece 8804 and therail 8882 is seated within theslot 8884, thefirst perforation 8893 and thesecond perforation 8891 are aligned and can be pegged together so that relative movement between thedistraction piece 8802 and the initiatingpiece 8804 is limited or substantially blocked, in other embodiments, the initiatingpiece 8804 anddistraction piece 8802 need not includetabs first tab 8894 or other structure protrudes from the initiatingpiece 8804, thedistraction piece 8802 can include a slot for receiving thetab 8894, rather than asecond tab 8892 abutting thefirst tab 8894. As will be obvious to one of ordinary skill in the art, tabs having myriad different shapes and sizes can extend from one or both of the initiatingpiece 8804 and thedistraction piece 8802, and perforations having myriad different shapes and sizes can be formed within such tabs to limit relative movement between the initiatingpiece 8804 and thedistraction piece 8802. Further, myriad different locking mechanisms (e.g., a tab and slot arrangement) can be employed with one or both of the initiatingpieces 8804 and thedistraction piece 8802 to limit relative movement. Embodiments ofimplants 8800 in accordance with the present invention are not intended to be limited to those arrangements shown inFIGS. 88A-89E . - The initiating
piece 8804 includes alower distraction element 8814 having a contact surface that tapers to theproximal end 8816 from above as well as below theproximal end 8816 so that thelower distraction element 8814 has a “V” shape in cross-section along an axis of the spine. The initiatingpiece 8804 further includes afirst portion 8834 of the first wing, thesecond wing 8860, and alower portion 8824 of the spacer. In an embodiment, thelower portions second wing 8860 can be integrally formed with thelower distraction element 8814, thereby avoiding discontinuities in a lower slidingsurface 8888 of the initiatingpiece 8804. - A relatively continuous sliding
surface 8888 with smooth transitions improves ease of implantation and minifies obstruction of the initiatingpiece 8804 by the adjacent spinous processes and/or related tissues. It is preferable that the initiatingpiece 8804 include smooth transitions between thelower distraction element 8814, thesecond wing 8860, and thelower portion 8824 of the spacer, as such transitions can increase obstruction of implant movement during implantation. The lower slidingsurface 8888 of the initiatingpiece 8804 is substantially flat and preferably smooth to ease receipt of therail 8882 within theslot 8884. - As described above, the slide-in
distraction piece 8802 includes therail 8882 extending over a substantial portion of the length of thedistraction piece 8802, roughly corresponding to a length of theslot 8884 of the initiatingpiece 8804 within which therail 8882 is adapted to be received. The height of therail 8882 from the upper slidingsurface 8886 approximately corresponds to the depth of theslot 8884 so that when therail 8882 is received within theslot 8884, the upper slidingsurface 8886 of thedistraction piece 8802 is substantially flush with the lower slidingsurface 8888. In other embodiments, a gap can exist between the upper slidingsurface 8886 and the lower slidingsurface 8888. As described above, the surface of therail 8882 can include a catch (or a recess) arranged along the length of therail 8882 so that the catch (or recess) roughly corresponds to the recess (or catch) disposed within theslot 8884. In other embodiments, therail 8882 andslot 8884 need not include a catch and recess arrangement, but rather the initiatingpiece 8804 and thedistraction piece 8802 can be held in relative position along the longitudinal axis 8825 when the first andsecond holes piece 8804 and thedistraction piece 8802. - The
distraction piece 8802 further includes anupper distraction element 8812, asecond portion 8832 of the first wing and anupper portion 8822 of the spacer. Theupper distraction element 8812 has a contact surface that tapers at a proximal end of thedistraction piece 8802 so that theupper distraction element 8812 has a ramp shape. Thesecond portion 8832 of the first wing can have a shape that roughly conforms to the shape of thefirst portion 8834 of the first wing so that when thedistraction piece 8802 is coupled to the initiatingpiece 8804, the first andsecond portions first wing 8830, as shown inFIG. 88B . Theupper portion 8822 of the spacer can have a thickness greater or less than that of thelower portion 8824 of the spacer. As shown, theupper portion 8822 is thicker than thelower portion 8824. By minifying the thickness of thelower portion 8824, distraction of the adjacent spinous processes during implantation of theinitiation piece 8804 can be minified to cause less distraction at the surgical site by thesecond wing 8860 as thesecond wing 8860 is urged between the adjacent spinous processes. Alternatively, a plurality ofdistraction pieces 8802 can be provided each having anupper portion 8822 of the spacer having a different thickness. Thus the doctor can select theappropriate distraction piece 8802 for the amount of distraction desired. As with the lower slidingsurface 8888, the upper slidingsurface 8886 of thedistraction piece 8802 is substantially flat and preferably smooth to ease positioning of therail 8882 within theslot 8884. Embodiments of systems in accordance with the present invention can include a initiatingpiece 8804 and a plurality ofdistraction pieces 8802, thedistraction pieces 8802 having a variety of thicknesses. In such a system, adistraction piece 8802 can be chosen so that theoverall spacer 8820 thickness is suitable for the patient and the motion segment targeted. -
FIG. 89A is a posterior view of the initiatingpiece 8804 positioned adjacent to theinterspinous ligament 6. As can be seen, the initiatingpiece 8804 has a maximum thickness from the lower slidingsurface 8888 to thesecond wing 8860. As the initiatingpiece 8804 is urged into theinterspinous ligament 6, thelower distraction element 8814 pierces and/or distracts the fibers of theinterspinous ligament 6. As shown inFIG. 89B , the initiatingpiece 8804 is further urged through theinterspinous ligament 6 so that thesecond wing 8860 passes between the adjacentspinous processes spinous processes second wing 8860. The distraction of the space between the adjacent spinous processes is reduced by positioning the initiatingpiece 8804 prior to coupling thedistraction piece 8802 to the initiatingpiece 8804. Referring toFIG. 89C , the initiatingpiece 8804 is further urged through theinterspinous ligament 6 so that thelower portion 8824 of the spacer is positioned between the adjacentspinous processes second wing 8860 and thefirst portion 8834 of the first wing straddle the lowerspinous process 4. Once the initiatingpiece 8804 is properly positioned, therail 8882 of thedistracting piece 8802 can be positioned within the distal end of theslot 8884, as shown inFIG. 89D . Thedistraction piece 8804 can then be urged along the lower slidingsurface 8888 so that theupper distraction element 8812 distracts the space between the adjacent spinous processes. As shown inFIG. 89E , the initiatingpiece 8804 is further urged along the lower slidingsurface 8888 until thedistraction piece 8802 is mated with the initiatingpiece 8804. - Materials for Use in Implants of the Present Invention
- In some embodiments, the implant can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, or other suitable implant material having similar high strength and biocompatible properties. Additionally, the implant can be at least partially, fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. Such materials are typically radiopaque, and appear during x-ray imaging, and other types of imaging. Implants in accordance with the present invention, and/or portions thereof can also be fabricated from somewhat flexible and/or deflectable material. In these embodiments, the implant and/or portions thereof can be fabricated in whole or in part from medical grade biocompatible polymers, copolymers, blends, and composites of polymers. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer. Many polymers, copolymers, blends, and composites of polymers are radiolucent and do not appear during x-ray or other types of imaging. Implants comprising such materials can provide a physician with a less obstructed view of the spine under imaging, than with an implant comprising radiopaque materials entirely. However, the implant need not comprise any radiolucent materials.
- One group of biocompatible polymers are the polyaryletherketone group which has several members including polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK is proven as a durable material for implants, and meets the criterion of biocompatibility. Medical grade PEEK is available from Victrex Corporation of Lancashire, Great Britain under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. These medical grade materials are also available as reinforced polymer resins, such reinforced resins displaying even greater material strength. In an embodiment, the implant can be fabricated from PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties:
Property Value Density 1.3 g/cc Rockwell M 99 Rockwell R 126 Tensile Strength 97 MPa Modulus of Elasticity 3.5 GPa Flexural Modulus 4.1 GPa - PEEK 450G has appropriate physical and mechanical properties and is suitable for carrying and spreading a physical load between the adjacent spinous processes. The implant and/or portions thereof can be formed by extrusion, injection, compression molding and/or machining techniques. It should be noted that the material selected can also be filled. Fillers can be added to a polymer, copolymer, polymer blend, or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers can be added to reinforce polymers mechanically to enhance strength for certain uses, such as for load bearing devices, in some embodiments, other grades of PEEK are available and contemplated for use in implants in accordance with the present invention, such as 30% glass-filled or 30% carbon-filled grades, provided such materials are cleared for use in implantable devices by the FDA, or other regulatory body. Glass-filled PEEK reduces the expansion rate and increases the flexural modulus of PEEK relative to unfilled PEEK. The resulting product is known to be ideal for improved strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and stiffness, and a lower expansion rate relative to unfilled PEEK. Carbon-filled PEEK also offers wear resistance and load carrying capability.
- As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible, and/or deflectable, have very low moisture absorption, and good wear and/or abrasion resistance, can be used without departing from the scope of the invention. As mentioned, the implant can be comprised of polyetherketoneketone (PEKK). Other material that can be used include polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK), and generally a polyaryletheretherketone. Further, other polyketones can be used as well as other thermoplastics. Reference to appropriate polymers that can be used in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10, 2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002, entitled “Bio-Compatible Polymeric Materials.” Other materials such as Bionate®, polycarbonate urethane, available from the Polymer Technology Group, Berkeley, Calif., may also be appropriate because of the good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be used.
- It is to be understood that embodiments in accordance with the present invention can be constructed without a pliant material. It is also to be understood that the embodiments in accordance with the present invention can have other dimensions
- Methods for Implanting Interspinous Implants
- In other embodiments of methods in accordance with the present invention, the implant can include an initiating
piece 8704 and adistraction piece 8702, such as described above inFIGS. 83-87D . In such embodiments, as shown inFIG. 90 , preferably aguide wire 80 is inserted through a placement network or guide 90 into the neck of the implant recipient (as shown and described above). Once theguide wire 80 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that an initiatingpiece 8704 of theimplant 8700 can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 80 and directed at the end of the guide wire. The initiatingpiece 8704 can include alower distraction element 8714, alower portion 8764 of the second wing, alower portion 8724 of the spacer, and alower portion 8734 of the first wing. Theimplant 8700 is inserted into the neck of the patient, between adjacent spinous processes. Preferably during insertion, thelower distraction element 8714 pierces or separates the tissue without severing the tissue, and theimplant 8700 is positioned so that theupper portion 8724 of the spacer is disposed between the adjacent spinous processes. - Once the initiating
piece 8704 is satisfactorily positioned, adistracting piece 8702 can be inserted along a line that is approximately collinear with the line over which the initiatingpiece 8704 is inserted, but positioned so that arail 8782 of thedistracting piece 8702 mates with aslot 8784 of the initiatingpiece 8704. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theimplant 8700. Thedistracting piece 8702 can be mated to the initiatingpiece 8704 through an interference fit, or using acatch 8781 andrecess 8787 as described above, alternatively by connecting thedistracting piece 8704 with the initiatingpiece 8702 using a fastener, or by some other device, as described above. It is to be understood that the embodiment described herein can be used between any of the spinous processes of the spine. - In other embodiments of methods in accordance with the present invention, the implant can include an initiating
piece 8804 and adistraction piece 8802, such as described above inFIGS. 88A-89E . In such embodiments, as shown inFIG. 91 , preferably aguide wire 80 is inserted through a placement network or guide 90 into the neck of the implant recipient (as shown and described above). Once theguide wire 80 is positioned with the aid of imaging techniques, an incision is made on the side of the neck so that an initiatingpiece 8804 of theimplant 8800 can be positioned in the neck thorough an incision and along a line that is about perpendicular to theguide wire 80 and directed at the end of the guide wire. The initiatingpiece 8804 can include alower distraction element 8814, thesecond wing 8860, alower portion 8824 of the spacer, and alower portion 8834 of the first wing. Theimplant 8800 is inserted into the neck of the patient, between adjacent spinous processes. Preferably during insertion, thelower distraction element 8814 pierces or separates the tissue without severing the tissue, and theimplant 8800 is positioned so that theupper portion 8824 of the spacer is disposed between the adjacent spinous processes. Once the initiatingpiece 8804 is satisfactorily positioned, adistracting piece 8802 can be inserted along a line that is approximately collinear with the line over which the initiatingpiece 8804 is inserted, but positioned so that arail 8882 of thedistracting piece 8802 mates with aslot 8884 of the initiatingpiece 8804. The anatomy of the neck is such that it is most convenient and minimally invasive to enter the neck from the side with respect to theimplant 8800. Thedistracting piece 8802 can be mated to the initiatingpiece 8804, by pegging the first andsecond perforations catch 8881 and recess 8887 as described above, or, alternatively by connecting thedistracting piece 8804 with the initiatingpiece 8802 using a fastener, or by some other device, as described above. - The foregoing description of the present invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to practitioners skilled in this art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.
Claims (43)
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US10/694,103 US20050075634A1 (en) | 2002-10-29 | 2003-10-27 | Interspinous process implant with radiolucent spacer and lead-in tissue expander |
US10/816,173 US7549999B2 (en) | 2003-05-22 | 2004-04-01 | Interspinous process distraction implant and method of implantation |
US10/850,267 US7695513B2 (en) | 2003-05-22 | 2004-05-20 | Distractible interspinous process implant and method of implantation |
US61258204P | 2004-09-23 | 2004-09-23 | |
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US11/095,680 US7909853B2 (en) | 2004-09-23 | 2005-03-31 | Interspinous process implant including a binder and method of implantation |
US11/095,440 US20060064165A1 (en) | 2004-09-23 | 2005-03-31 | Interspinous process implant including a binder and method of implantation |
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US11/234,555 US8048117B2 (en) | 2003-05-22 | 2005-09-23 | Interspinous process implant and method of implantation |
US11/378,894 US20060271194A1 (en) | 2005-03-22 | 2006-03-17 | Interspinous process implant having deployable wing as an adjunct to spinal fusion and method of implantation |
US11/377,971 US7931674B2 (en) | 2005-03-21 | 2006-03-17 | Interspinous process implant having deployable wing and method of implantation |
US11/378,108 US7749252B2 (en) | 2005-03-21 | 2006-03-17 | Interspinous process implant having deployable wing and method of implantation |
US11/384,055 US20060264939A1 (en) | 2003-05-22 | 2006-03-17 | Interspinous process implant with slide-in distraction piece and method of implantation |
US11/378,892 US8147548B2 (en) | 2005-03-21 | 2006-03-17 | Interspinous process implant having a thread-shaped wing and method of implantation |
US11/378,893 US8070778B2 (en) | 2003-05-22 | 2006-03-17 | Interspinous process implant with slide-in distraction piece and method of implantation |
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Also Published As
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US20080046081A1 (en) | 2008-02-21 |
US20080051899A1 (en) | 2008-02-28 |
US8454659B2 (en) | 2013-06-04 |
US8894686B2 (en) | 2014-11-25 |
US8007537B2 (en) | 2011-08-30 |
US8092535B2 (en) | 2012-01-10 |
US8221463B2 (en) | 2012-07-17 |
US20080065214A1 (en) | 2008-03-13 |
US20080033558A1 (en) | 2008-02-07 |
US20080027545A1 (en) | 2008-01-31 |
US7662187B2 (en) | 2010-02-16 |
US20080033553A1 (en) | 2008-02-07 |
US20080033560A1 (en) | 2008-02-07 |
US20080021468A1 (en) | 2008-01-24 |
US20080065213A1 (en) | 2008-03-13 |
US20080051898A1 (en) | 2008-02-28 |
US20080039947A1 (en) | 2008-02-14 |
US20080033559A1 (en) | 2008-02-07 |
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