WO2006047562A2 - Interspinous distraction devices and associated methods of insertion - Google Patents

Interspinous distraction devices and associated methods of insertion Download PDF

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Publication number
WO2006047562A2
WO2006047562A2 PCT/US2005/038489 US2005038489W WO2006047562A2 WO 2006047562 A2 WO2006047562 A2 WO 2006047562A2 US 2005038489 W US2005038489 W US 2005038489W WO 2006047562 A2 WO2006047562 A2 WO 2006047562A2
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WO
WIPO (PCT)
Prior art keywords
body assembly
distraction device
interspinous distraction
spinous processes
adjacent spinous
Prior art date
Application number
PCT/US2005/038489
Other languages
French (fr)
Other versions
WO2006047562A3 (en
Inventor
Robert E. Lins
Loren E. Lins
Harvey Simovitch
Original Assignee
Lins Robert E
Lins Loren E
Harvey Simovitch
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lins Robert E, Lins Loren E, Harvey Simovitch filed Critical Lins Robert E
Priority to CA002614133A priority Critical patent/CA2614133A1/en
Priority to EP05820768.9A priority patent/EP1807012B1/en
Publication of WO2006047562A2 publication Critical patent/WO2006047562A2/en
Publication of WO2006047562A3 publication Critical patent/WO2006047562A3/en

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Classifications

    • 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
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0256—Joint distractors for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the present invention relates generally to the medical and surgical fields. More specifically, the present invention relates to a plurality of novel interspinous distraction devices and associated methods of insertion.
  • the interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease.
  • the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.
  • Lumbar spinal stenosis is characterized by a tightening of or decrease in the cross-sectional diameter of the spinal canal and neural foramen, through which the spinal cord and nerve roots of the lumbar (lower) spine pass, caused by the degeneration of the lumbar discs (through fluid loss and collapse) and the facet joints of the spinal column.
  • the lumbar discs deteriorate and the lumbar disc spaces collapse, resulting in a portion of the lumbar discs protruding into the ventral or anterior (front) portion of the spinal canal.
  • the two facet joints associated with each lumbar vertebrae become arthritic, growing in size, and protruding into the dorsal or posterior (back) portion of the spinal canal.
  • the cross-sectional diameter of the spinal canal is decreased, impinging on the spinal cord and nerve roots of the lumbar spine.
  • the ligamentum flavum that connect the bases of the spinous processes of the spinal column and the lamina tend to buckle with lumbar disc collapse, further decreasing the cross-sectional diameter of the spinal canal.
  • the neural foramen, through which the nerve roots exit, are pinched with disc collapse and facet joint arthropathy.
  • This condition is especially common in the elderly and symptoms may include remitting or unremitting pain and/or weakness/numbness in the middle to lower back and/or legs when moving and/or stationary. It should be noted that similar problems can occur in the cervical (upper) spine as well.
  • Conventional treatments for lumbar spinal stenosis include oral and/or injectable analgesic and/or anti-inflammatory medications (non-steroidal and/or steroidal), activity avoidance and/or physical therapy, braces, and/or surgical procedures.
  • Surgical procedures for lumbar spinal stenosis include laminectornies/laminotomies and/or spinal fusions. In a laminectomy/laminotomy, all or a portion of a given facet joint, lamina, and ligamentum flavum are removed to alleviate compression of the spinal canal. This procedure basically "unroofs" or enlarges a portion of the spinal canal. Additionally, a spinal fusion may be performed.
  • a connecting bar and a bone graft are used to join or fuse adjacent vertebrae via a plurality of pedicle screws, thus stabilizing the vertebral segment.
  • Much, if not all, of a given lumbar disc is removed in conjunction with a spinal fusion.
  • a spinal fusion is most suitable when there is instability or translation between adjacent vertebrae (spondylolisthesis).
  • the plurality of pedicle screws used to perform a spinal fusion may become loose with the passage of time if a nonunion develops.
  • Both laminectomies/laminotomies and spinal fusions are major, open procedures, typically requiring a relatively large incision and a general anesthetic. This may be dangerous for the elderly or the sick. In addition, both procedures are very expensive.
  • the interspinous process distractor for lumbar spinal stenosis disclosed and described by Lee et al. (J. Spinal Disord. Tech., Vol. 17, No. 1, Feb. 2004) provides a main body assembly including a spacer and a universal wing assembly.
  • the main body assembly is disposed between adjacent interspinous processes, distracting them, and the universal wing assembly is used to lock the main body assembly in place.
  • the interspinous process distractor utilizes a nut that must be engaged and tightened, the interspinous process distractor must be inserted using a conventional open procedure. Again, this may be dangerous for the elderly or the sick and requires a general anesthetic.
  • Other conventional interspinous process distractors known to those of ordinary skill in the art suffer the same shortcoming.
  • interspinous distraction devices and associated methods of insertion that are designed and configured to effectively treat such conditions as lumbar spinal stenosis.
  • the interspinous distraction devices should be capable of being inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic.
  • the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion.
  • the interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease.
  • the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.
  • an interspinous distraction device for treating such conditions as lumbar spinal stenosis includes a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart.
  • the interspinous distraction device also includes a plurality of attachment arms selectively extending outwardly from the body assembly in the direction of each of the adjacent spinous processes, the plurality of attachment arms configured to be disposed about a portion of each of the adjacent spinous processes and securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
  • a dilation tube system for providing minimally-invasive surgical access to a portion of the spinal column or the like includes a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube includes a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.
  • the dilation tube system also includes a hollow guide tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube includes an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.
  • the dilation tube system further includes a plurality of additional hollow dilation tubes having graduated diameters.
  • a method for inserting an interspinous distraction device for treating such conditions as lumbar spinal stenosis includes disposing a body assembly between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart.
  • the method for inserting the interspinous distraction device also includes extending a plurality of attachment arms outwardly from the body assembly, the plurality of attachment arms disposed about a portion of each of the adjacent spinous processes and securely holding the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
  • the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube includes a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.
  • the body assembly is also disposed between adjacent spinous processes of the spinal column of the patient through a hollow guide tube having a first end, a second end, a given cross- sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube includes an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.
  • the interspinous distraction device also includes a band configured to be disposed about the adjacent spinous processes of the spinal column of the patient and engage the body assembly, wherein the band is sized such that the adjacent spinous processes are stabilized with respect to one another.
  • a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a cutting portion attached to the second end of the shaft portion, the cutting portion including a cutting edge that is substantially directed towards the first end of the shaft portion.
  • a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a plurality of paddles attached to the second end of the shaft portion, the plurality of paddles operable for distracting apart adjacent spinous processes of a spinal column of a patient in response to selective actuation of the handle portion.
  • a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a sizing portion attached to the second end of the shaft portion, the sizing portion selectively sized to fit between adjacent spinous processes of a spinal column of a patient, thereby determining the size of a space between the adjacent spinous processes of the spinal column of the patient.
  • Figure 1 is a cross-sectional side view illustrating the spinal column of a patient and the placement of one exemplary embodiment of the interspinous distraction device of the present invention
  • Figure 2 is a cross-sectional side view illustrating one exemplary embodiment of the interspinous distraction device of the present invention
  • Figure 3 is a planar top view illustrating the interspinous distraction device of Figure 2;
  • Figure 4 is a planar front view illustrating the interspinous distraction device of Figures 2 and 3;
  • Figure 5 is a longitudinal cross-sectional side view illustrating one exemplary embodiment of the dilation tube system of the present invention, the dilation tube system used to insert the interspinous distraction device of Figures 2-4 into the spinal column of a patient;
  • Figure 6 is a longitudinal cross-sectional side view illustrating a conventional dilation tube system used in conjunction with the dilation tube system of Figure 5, as well as a novel cross-sectional shape of the dilation tube system;
  • Figure 7 a planar dorsal or anterior (back) view illustrating another exemplary embodiment of the interspinous distraction device of the present invention, the interspinous distraction device incorporating a stabilizing band;
  • Figure 8 is a planar view illustrating a plurality of enabling tools and instruments used in conjunction with the interspinous distraction devices of the present invention.
  • the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion.
  • the interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease.
  • the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures, and related enabling devices, are also disclosed and described herein.
  • the interspinous distraction device 10 of the present invention is disposed between adjacent spinous processes 12 of the spinal column 14 of a patient.
  • the spinal column 14 also includes a plurality of vertebral bodies 16 present on a plurality of levels of the lumbar (lower) and cervical (upper) spine and a plurality of discs 18 separating the plurality of vertebral bodies 16. It is these discs 18 and the facet joints 20 associated with the ligamentum flavum that deteriorate and protrude into the spinal canal 22, impinging on the spinal cord 24 and neural foramen, in conditions such as lumbar spinal stenosis.
  • the interspinous distraction device 10 is sized such that it distracts adjacent spinous processes 12 apart, alleviating the protrusion and impingement described above.
  • the interspinous distraction device 10 of the present invention includes a body assembly 26 consisting of a circumferential wall 28 defining an interior void 30.
  • the body assembly 26 has a shape that is substantially rectangular, substantially square, substantially oval, substantially circular, a combination thereof, or any other suitable shape.
  • the body assembly 26 has a height 32 of between about 4 mm and about 20 mm, a width 34 of between about 10 mm and about 25 mm, and a thickness 36 of between about 10 mm and about 20 mm.
  • the body assembly 26 and other components of the interspinous distraction device 10 are made of a medically-implantable, corrosion-resistant metal; a medically-implantable, corrosion- resistant metal alloy; a medically-implantable plastic; a medically-implantable ceramic; or a combination thereof.
  • the body assembly 26 of the interspinous distraction device 10 also includes a plurality of attachment arms 38 selectively extending outwardly from the circumferential wall 28 of the body assembly 26 in the direction of each of the adjacent spinous processes 12, the plurality of attachment arms 38 configured to be disposed about a portion of each of the adjacent spinous processes 12 and securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12.
  • each of the plurality of attachment arms 38 is at least partially disposed within the interior void 30 defined by the circumferential wall 28 of the body assembly 26 and is selectively extendable outwardly from/retractable inwardly into the interior void 30.
  • Each of the plurality of attachment arms 38 has a length of between about 4 mm and about 20 mm.
  • the plurality of attachment arms 38 resemble a plurality of staple- like structures.
  • the body assembly 26 of the interspinous distraction device 10 incorporates a filler plug (not shown) selectively disposed within the interior void 30 defined by the circumferential wall 28 when the plurality of attachment arms 38 have been extended.
  • the body assembly 26 of the interspinous distraction device 10 further includes one or more friction surfaces 40 consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, or a combination thereof, the one or more friction surfaces 40 configured to securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12.
  • the body assembly 26 of the interspinous distraction device 10 still further includes one or more fin structures 42 also configured to securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12. Specifically, the one or more fin structures 42 prevent the body assembly 26 from "overshooting" the gap between the adjacent spinous processes 12 when the interspinous distraction device 10 is inserted.
  • the one or more fin structures 42 may be of any suitable size and/or shape to achieve this purpose.
  • the body assembly 26 and the plurality of attachment arms 38 of the interspinous distraction device 10 may be configured such that the plurality of attachment arms 38 rotatably engage the adjacent spinous processes 12 when the body assembly 26 is rotated.
  • the dilation tube system 44 of the present invention provides minimally-invasive surgical access to a portion of the spinal column or the like.
  • the dilation tube system 44 includes a hollow dilation tube 46 having a first end, a second end, a given cross-sectional shape, and a longitudinal axis.
  • the first end of the dilation tube 46 includes a cut-away portion 48 for providing access from an interior portion of the dilation tube 46 to an exterior portion of the dilation tube 46 in a direction perpendicular to the longitudinal axis of the dilation tube 46.
  • the dilation tube system 44 also includes a hollow guide tube 50 having a first end, a second end, a given cross-sectional shape, and a longitudinal axis.
  • the hollow guide tube 50 is disposed concentrically within the dilation tube 46.
  • the first end of the guide tube 50 includes an elbow portion 52 for providing access from an interior portion of the guide tube 50 to an exterior portion of the guide tube 50 in a direction perpendicular to the longitudinal axis of the guide tube 50 through the cut-away portion 48 of the dilation tube 46.
  • the dilation tube 46 and the guide tube 50 each have a cross-sectional shape that is substantially circular, substantially semi-circular, substantially oval, substantially square, substantially rectangular, substantially triangular, a combination thereof, or any other suitable shape.
  • the dilation tube 46 and the guide tube 50 each have a diameter of between about 18 mm and about 22 mm.
  • the dilation tube 46 and the guide tube 50 are each made of a material such as a medically-implantable, corrosion- resistant metal; a medically-implantable, corrosion-resistant metal alloy; a medically- implantable plastic; a medically-implantable ceramic; a combination thereof; or the like.
  • the dilation tube 46 and the guide tube 50 are inserted through the skin 54 of a patient, as described in greater detail below, and seated in an area of interest or on a surface of interest 56.
  • the dilation tube 46 provides access to the area of interest and the cut-away portion 48 of the dilation tube 46 provides access to the area of interest in a direction perpendicular to the longitudinal axis of the dilation tube 46.
  • the guide tube 50 provides access to the area of interest and the elbow portion 52 of the guide tube 50 provides access to the area of interest in a direction perpendicular to the longitudinal axis of the guide tube 50.
  • the dilation tube 46 and the guide tube 50 of the present invention provide novel lateral access to an area of interest.
  • the elbow portion 52 of the guide tube 50 helps to guide devices and instruments inserted through the guide tube 50 into a lateral position for placement.
  • the dilation tube system 44 of the present invention is preferably used in conjunction with a conventional dilation tube system 58, well known to those of ordinary skill in the art, that includes a plurality of additional dilation tubes 60, each of the plurality of additional dilation 60 tubes having a diameter that is smaller than the diameter of the dilation tube 46 of the present invention.
  • a conventional dilation tube system 58 well known to those of ordinary skill in the art, that includes a plurality of additional dilation tubes 60, each of the plurality of additional dilation 60 tubes having a diameter that is smaller than the diameter of the dilation tube 46 of the present invention.
  • Each of the plurality of additional dilation tubes 60 is selectively and temporarily disposed concentrically within a space or hole of increasing diameter that is eventually large enough to receive the dilation tube 46 and guide tube 50 of the present invention.
  • a method for inserting the interspinous distraction device 10 includes disposing the body assembly 26 ( Figure 2-4) described above between adjacent spinous processes 12 ( Figure 1-4) of the spinal column 14 ( Figure 1) of a patient. Again, the body assembly 26 is sized such that the body assembly 26 distracts the adjacent spinous processes 12 apart. The method also includes extending the plurality of attachment arms 38 ( Figures 2-4) described above outwardly from the body assembly 26, the plurality of attachment arms 38 disposed about a portion of each of the adjacent spinous processes 12 and securely holding the body assembly 26 in place relative to each of the adjacent spinous processes 12 of the spinal column 14 of the patient. The body assembly 26 is disposed between adjacent spinous processes 12 of the spinal column 14 of the patient through the dilation tube 46 ( Figure 5) and the guide tube 50 ( Figure 5) described above.
  • an interspinous distraction device 62 for treating such conditions as lumbar spinal stenosis and degenerative disc disease includes a body assembly 26 configured to be disposed between adjacent spinous processes 12 of the spinal column 14 ( Figure 1) of a patient. Again, the body assembly 26 is sized such that the body assembly 26 distracts the adjacent spinous processes 12 apart.
  • the body assembly 26 may be the same as that described above, incorporating a plurality of attachment arms 38 ( Figures 2-4), etc., or it may be a simple anchored or floating spacer device.
  • the interspinous distraction device 62 also includes a band 64 configured to be disposed about the adjacent spinous processes 12 of the spinal column 14 of the patient and engage the body assembly 26, via crimping or otherwise.
  • the band may initially be a simple strip of medically- implantable material or it may be a closed loop of medically-implantable material.
  • the band 64 is sized such that the adjacent spinous processes 12 are stabilized with respect to one another.
  • the band 64 maybe be substantially elastic or non-elastic and typically has a circumferential length of between about 60 mm and about 150 mm.
  • the interspinous distraction device 62 is inserted into the spinal column 14 of the patient using an open procedure.
  • the present invention also contemplates a plurality of enabling tools and instruments.
  • Such tools include extended handles and holding tools for feeding the interspinous distraction device 10 (Figures 2-4) through the dilation tube 46 ( Figure 5) and guide tube ( Figure 5) and anchoring the interspinous distraction device 10 between the adjacent spinous processes ( Figure 1).
  • Such tools also include actuating and ratcheting tools for engaging the plurality of attachment arms 38 ( Figures 2-4) of the interspinous distraction device 10 and placing the filler plug (not shown) in the interior void 30 ( Figure 2) defined by the circumferential wall 28 ( Figures 2-4) of the body assembly 26 ( Figures 2-4) of the interspinous distraction device 10, for example.
  • Such tools further include visualization and cutting tools for preparing and distracting the area of interest for receiving the interspinous distraction device 10. Several of these tools are illustrated in Figure 8.

Abstract

In various exemplary embodiments, the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion. The interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease. Advantageously, the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.

Description

INTERSPINOUS DISTRACTION DEVICES AND ASSOCIATED METHODS OF INSERTION
CROSS-REFERENCE TO RELATED APPLICATION^)
[0001] The present non-provisional patent application claims the benefit of priority of U.S. Provisional Patent Application No. 60/621,712, entitled "INTERSPINOUS DISTRACTION DEVICES AND ASSOCIATED METHODS OF INSERTION," and filed on October 25, 2004, which is incorporated in full by reference herein.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the medical and surgical fields. More specifically, the present invention relates to a plurality of novel interspinous distraction devices and associated methods of insertion. The interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease. Advantageously, the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.
BACKGROUND OF THE INVENTION
[0003] Lumbar spinal stenosis is characterized by a tightening of or decrease in the cross-sectional diameter of the spinal canal and neural foramen, through which the spinal cord and nerve roots of the lumbar (lower) spine pass, caused by the degeneration of the lumbar discs (through fluid loss and collapse) and the facet joints of the spinal column. In lumbar spinal stenosis, the lumbar discs deteriorate and the lumbar disc spaces collapse, resulting in a portion of the lumbar discs protruding into the ventral or anterior (front) portion of the spinal canal. At the same time, the two facet joints associated with each lumbar vertebrae become arthritic, growing in size, and protruding into the dorsal or posterior (back) portion of the spinal canal. Thus, the cross-sectional diameter of the spinal canal is decreased, impinging on the spinal cord and nerve roots of the lumbar spine. In addition, the ligamentum flavum that connect the bases of the spinous processes of the spinal column and the lamina tend to buckle with lumbar disc collapse, further decreasing the cross-sectional diameter of the spinal canal. The neural foramen, through which the nerve roots exit, are pinched with disc collapse and facet joint arthropathy. This condition is especially common in the elderly and symptoms may include remitting or unremitting pain and/or weakness/numbness in the middle to lower back and/or legs when moving and/or stationary. It should be noted that similar problems can occur in the cervical (upper) spine as well.
[0004] Conventional treatments for lumbar spinal stenosis include oral and/or injectable analgesic and/or anti-inflammatory medications (non-steroidal and/or steroidal), activity avoidance and/or physical therapy, braces, and/or surgical procedures. Surgical procedures for lumbar spinal stenosis include laminectornies/laminotomies and/or spinal fusions. In a laminectomy/laminotomy, all or a portion of a given facet joint, lamina, and ligamentum flavum are removed to alleviate compression of the spinal canal. This procedure basically "unroofs" or enlarges a portion of the spinal canal. Additionally, a spinal fusion may be performed. In a spinal fusion, a connecting bar and a bone graft are used to join or fuse adjacent vertebrae via a plurality of pedicle screws, thus stabilizing the vertebral segment. Much, if not all, of a given lumbar disc is removed in conjunction with a spinal fusion. In general, a spinal fusion is most suitable when there is instability or translation between adjacent vertebrae (spondylolisthesis). Disadvantageous^, the plurality of pedicle screws used to perform a spinal fusion may become loose with the passage of time if a nonunion develops. Both laminectomies/laminotomies and spinal fusions are major, open procedures, typically requiring a relatively large incision and a general anesthetic. This may be dangerous for the elderly or the sick. In addition, both procedures are very expensive.
[0005] What has been observed clinically is that many patients, when they flex forward, experience an increase in the cross-sectional diameter of the spinal canal and neural foramen, thus alleviating or eliminating their pain and/or weakness/numbness caused by lumbar spinal stenosis. This is caused by the temporary distraction of the spinous processes and the "stretching out" of the ligamentum flavum that connect the bases of the spinous processes and lamina. The collapsed neural foramen are also increased in height and cross-sectional area by the distraction. In other words, the lumbar discs and other structures of the spinal column are temporarily decompressed. This observation has led to improved treatments for lumbar spinal stenosis.
[0006] The interspinous process distractor for lumbar spinal stenosis disclosed and described by Lee et al. (J. Spinal Disord. Tech., Vol. 17, No. 1, Feb. 2004) provides a main body assembly including a spacer and a universal wing assembly. The main body assembly is disposed between adjacent interspinous processes, distracting them, and the universal wing assembly is used to lock the main body assembly in place. Because the interspinous process distractor utilizes a nut that must be engaged and tightened, the interspinous process distractor must be inserted using a conventional open procedure. Again, this may be dangerous for the elderly or the sick and requires a general anesthetic. Other conventional interspinous process distractors known to those of ordinary skill in the art suffer the same shortcoming.
[0007] Thus, what is needed are simple, inexpensive interspinous distraction devices and associated methods of insertion that are designed and configured to effectively treat such conditions as lumbar spinal stenosis. The interspinous distraction devices should be capable of being inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic.
BRIEF SUMMARY OF THE INVENTION
[0008] In various embodiments, the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion. The interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease. Advantageously, the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.
[0009] In one exemplary embodiment of the present invention, an interspinous distraction device for treating such conditions as lumbar spinal stenosis includes a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart. The interspinous distraction device also includes a plurality of attachment arms selectively extending outwardly from the body assembly in the direction of each of the adjacent spinous processes, the plurality of attachment arms configured to be disposed about a portion of each of the adjacent spinous processes and securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
[0010] In another exemplary embodiment of the present invention, a dilation tube system for providing minimally-invasive surgical access to a portion of the spinal column or the like includes a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube includes a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube. The dilation tube system also includes a hollow guide tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube includes an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube. The dilation tube system further includes a plurality of additional hollow dilation tubes having graduated diameters.
[0011] In a further exemplary embodiment of the present invention, a method for inserting an interspinous distraction device for treating such conditions as lumbar spinal stenosis includes disposing a body assembly between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart. The method for inserting the interspinous distraction device also includes extending a plurality of attachment arms outwardly from the body assembly, the plurality of attachment arms disposed about a portion of each of the adjacent spinous processes and securely holding the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient. Optionally, the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube includes a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube. Optionally, the body assembly is also disposed between adjacent spinous processes of the spinal column of the patient through a hollow guide tube having a first end, a second end, a given cross- sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube includes an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.
[0012] In a still further exemplary embodiment of the present invention, an interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease includes a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart. The interspinous distraction device also includes a band configured to be disposed about the adjacent spinous processes of the spinal column of the patient and engage the body assembly, wherein the band is sized such that the adjacent spinous processes are stabilized with respect to one another.
[0013] In a still further exemplary embodiment of the present invention, a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a cutting portion attached to the second end of the shaft portion, the cutting portion including a cutting edge that is substantially directed towards the first end of the shaft portion. [0014] In a still further exemplary embodiment of the present invention, a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a plurality of paddles attached to the second end of the shaft portion, the plurality of paddles operable for distracting apart adjacent spinous processes of a spinal column of a patient in response to selective actuation of the handle portion.
[0015] In a still further exemplary embodiment of the present invention, a tool for inserting an interspinous distraction device through a dilation tube having a laterally- oriented opening includes a shaft portion having a first end and a second end; a handle portion attached to the first end of the shaft portion; and a sizing portion attached to the second end of the shaft portion, the sizing portion selectively sized to fit between adjacent spinous processes of a spinal column of a patient, thereby determining the size of a space between the adjacent spinous processes of the spinal column of the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The present invention is illustrated and described herein with reference to various figures, in which like reference numbers denote like components and/or parts, and in which:
[0017] Figure 1 is a cross-sectional side view illustrating the spinal column of a patient and the placement of one exemplary embodiment of the interspinous distraction device of the present invention;
[0018] Figure 2 is a cross-sectional side view illustrating one exemplary embodiment of the interspinous distraction device of the present invention;
[0019] Figure 3 is a planar top view illustrating the interspinous distraction device of Figure 2; [0020] Figure 4 is a planar front view illustrating the interspinous distraction device of Figures 2 and 3;
[0021] Figure 5 is a longitudinal cross-sectional side view illustrating one exemplary embodiment of the dilation tube system of the present invention, the dilation tube system used to insert the interspinous distraction device of Figures 2-4 into the spinal column of a patient;
[0022] Figure 6 is a longitudinal cross-sectional side view illustrating a conventional dilation tube system used in conjunction with the dilation tube system of Figure 5, as well as a novel cross-sectional shape of the dilation tube system;
[0023] Figure 7 a planar dorsal or anterior (back) view illustrating another exemplary embodiment of the interspinous distraction device of the present invention, the interspinous distraction device incorporating a stabilizing band; and
[0024] Figure 8 is a planar view illustrating a plurality of enabling tools and instruments used in conjunction with the interspinous distraction devices of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0025] In various exemplary embodiments, the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion. The interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease. Advantageously, the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures, and related enabling devices, are also disclosed and described herein.
[0026] Referring now to Figure 1, in one exemplary embodiment, the interspinous distraction device 10 of the present invention is disposed between adjacent spinous processes 12 of the spinal column 14 of a patient. The spinal column 14 also includes a plurality of vertebral bodies 16 present on a plurality of levels of the lumbar (lower) and cervical (upper) spine and a plurality of discs 18 separating the plurality of vertebral bodies 16. It is these discs 18 and the facet joints 20 associated with the ligamentum flavum that deteriorate and protrude into the spinal canal 22, impinging on the spinal cord 24 and neural foramen, in conditions such as lumbar spinal stenosis. The interspinous distraction device 10 is sized such that it distracts adjacent spinous processes 12 apart, alleviating the protrusion and impingement described above.
[0027] Referring now to Figures 2-4, the interspinous distraction device 10 of the present invention includes a body assembly 26 consisting of a circumferential wall 28 defining an interior void 30. The body assembly 26 has a shape that is substantially rectangular, substantially square, substantially oval, substantially circular, a combination thereof, or any other suitable shape. The body assembly 26 has a height 32 of between about 4 mm and about 20 mm, a width 34 of between about 10 mm and about 25 mm, and a thickness 36 of between about 10 mm and about 20 mm. Preferably, the body assembly 26 and other components of the interspinous distraction device 10 are made of a medically-implantable, corrosion-resistant metal; a medically-implantable, corrosion- resistant metal alloy; a medically-implantable plastic; a medically-implantable ceramic; or a combination thereof.
[0028] The body assembly 26 of the interspinous distraction device 10 also includes a plurality of attachment arms 38 selectively extending outwardly from the circumferential wall 28 of the body assembly 26 in the direction of each of the adjacent spinous processes 12, the plurality of attachment arms 38 configured to be disposed about a portion of each of the adjacent spinous processes 12 and securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12. Preferably, each of the plurality of attachment arms 38 is at least partially disposed within the interior void 30 defined by the circumferential wall 28 of the body assembly 26 and is selectively extendable outwardly from/retractable inwardly into the interior void 30. Each of the plurality of attachment arms 38 has a length of between about 4 mm and about 20 mm. In one exemplary embodiment of the interspinous distraction device 10 of the present invention, the plurality of attachment arms 38 resemble a plurality of staple- like structures. Optionally, the body assembly 26 of the interspinous distraction device 10 incorporates a filler plug (not shown) selectively disposed within the interior void 30 defined by the circumferential wall 28 when the plurality of attachment arms 38 have been extended.
[0029] The body assembly 26 of the interspinous distraction device 10 further includes one or more friction surfaces 40 consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, or a combination thereof, the one or more friction surfaces 40 configured to securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12.
[0030] The body assembly 26 of the interspinous distraction device 10 still further includes one or more fin structures 42 also configured to securely hold the body assembly 26 in place relative to each of the adjacent spinous processes 12. Specifically, the one or more fin structures 42 prevent the body assembly 26 from "overshooting" the gap between the adjacent spinous processes 12 when the interspinous distraction device 10 is inserted. The one or more fin structures 42 may be of any suitable size and/or shape to achieve this purpose.
[0031] Although one specific embodiment of the interspinous distraction device 10 of the present invention has been illustrated and described above, other embodiments may perform similar functions and/or achieve similar results. For example, the body assembly 26 and the plurality of attachment arms 38 of the interspinous distraction device 10 may be configured such that the plurality of attachment arms 38 rotatably engage the adjacent spinous processes 12 when the body assembly 26 is rotated.
[0032] Referring now to Figure 5, in one exemplary embodiment, the dilation tube system 44 of the present invention provides minimally-invasive surgical access to a portion of the spinal column or the like. The dilation tube system 44 includes a hollow dilation tube 46 having a first end, a second end, a given cross-sectional shape, and a longitudinal axis. The first end of the dilation tube 46 includes a cut-away portion 48 for providing access from an interior portion of the dilation tube 46 to an exterior portion of the dilation tube 46 in a direction perpendicular to the longitudinal axis of the dilation tube 46. [0033] The dilation tube system 44 also includes a hollow guide tube 50 having a first end, a second end, a given cross-sectional shape, and a longitudinal axis. The hollow guide tube 50 is disposed concentrically within the dilation tube 46. The first end of the guide tube 50 includes an elbow portion 52 for providing access from an interior portion of the guide tube 50 to an exterior portion of the guide tube 50 in a direction perpendicular to the longitudinal axis of the guide tube 50 through the cut-away portion 48 of the dilation tube 46.
[0034] The dilation tube 46 and the guide tube 50 each have a cross-sectional shape that is substantially circular, substantially semi-circular, substantially oval, substantially square, substantially rectangular, substantially triangular, a combination thereof, or any other suitable shape. The dilation tube 46 and the guide tube 50 each have a diameter of between about 18 mm and about 22 mm. The dilation tube 46 and the guide tube 50 are each made of a material such as a medically-implantable, corrosion- resistant metal; a medically-implantable, corrosion-resistant metal alloy; a medically- implantable plastic; a medically-implantable ceramic; a combination thereof; or the like.
[0035] In operation, the dilation tube 46 and the guide tube 50 are inserted through the skin 54 of a patient, as described in greater detail below, and seated in an area of interest or on a surface of interest 56. The dilation tube 46 provides access to the area of interest and the cut-away portion 48 of the dilation tube 46 provides access to the area of interest in a direction perpendicular to the longitudinal axis of the dilation tube 46. Likewise, the guide tube 50 provides access to the area of interest and the elbow portion 52 of the guide tube 50 provides access to the area of interest in a direction perpendicular to the longitudinal axis of the guide tube 50. In other words, the dilation tube 46 and the guide tube 50 of the present invention provide novel lateral access to an area of interest. Advantageously, the elbow portion 52 of the guide tube 50 helps to guide devices and instruments inserted through the guide tube 50 into a lateral position for placement.
[0036] Referring now to Figure 6, the dilation tube system 44 of the present invention is preferably used in conjunction with a conventional dilation tube system 58, well known to those of ordinary skill in the art, that includes a plurality of additional dilation tubes 60, each of the plurality of additional dilation 60 tubes having a diameter that is smaller than the diameter of the dilation tube 46 of the present invention. Each of the plurality of additional dilation tubes 60 is selectively and temporarily disposed concentrically within a space or hole of increasing diameter that is eventually large enough to receive the dilation tube 46 and guide tube 50 of the present invention.
[0037] In one exemplary embodiment of the present invention, a method for inserting the interspinous distraction device 10 (Figures 2-4) described above includes disposing the body assembly 26 (Figure 2-4) described above between adjacent spinous processes 12 (Figure 1-4) of the spinal column 14 (Figure 1) of a patient. Again, the body assembly 26 is sized such that the body assembly 26 distracts the adjacent spinous processes 12 apart. The method also includes extending the plurality of attachment arms 38 (Figures 2-4) described above outwardly from the body assembly 26, the plurality of attachment arms 38 disposed about a portion of each of the adjacent spinous processes 12 and securely holding the body assembly 26 in place relative to each of the adjacent spinous processes 12 of the spinal column 14 of the patient. The body assembly 26 is disposed between adjacent spinous processes 12 of the spinal column 14 of the patient through the dilation tube 46 (Figure 5) and the guide tube 50 (Figure 5) described above.
[0038] Referring now to Figure 7, in an alternative embodiment of the present invention, an interspinous distraction device 62 for treating such conditions as lumbar spinal stenosis and degenerative disc disease includes a body assembly 26 configured to be disposed between adjacent spinous processes 12 of the spinal column 14 (Figure 1) of a patient. Again, the body assembly 26 is sized such that the body assembly 26 distracts the adjacent spinous processes 12 apart The body assembly 26 may be the same as that described above, incorporating a plurality of attachment arms 38 (Figures 2-4), etc., or it may be a simple anchored or floating spacer device. The interspinous distraction device 62 also includes a band 64 configured to be disposed about the adjacent spinous processes 12 of the spinal column 14 of the patient and engage the body assembly 26, via crimping or otherwise. Thus, the band may initially be a simple strip of medically- implantable material or it may be a closed loop of medically-implantable material. The band 64 is sized such that the adjacent spinous processes 12 are stabilized with respect to one another. The band 64 maybe be substantially elastic or non-elastic and typically has a circumferential length of between about 60 mm and about 150 mm. The interspinous distraction device 62 is inserted into the spinal column 14 of the patient using an open procedure.
[0039] The present invention also contemplates a plurality of enabling tools and instruments. Such tools include extended handles and holding tools for feeding the interspinous distraction device 10 (Figures 2-4) through the dilation tube 46 (Figure 5) and guide tube (Figure 5) and anchoring the interspinous distraction device 10 between the adjacent spinous processes (Figure 1). Such tools also include actuating and ratcheting tools for engaging the plurality of attachment arms 38 (Figures 2-4) of the interspinous distraction device 10 and placing the filler plug (not shown) in the interior void 30 (Figure 2) defined by the circumferential wall 28 (Figures 2-4) of the body assembly 26 (Figures 2-4) of the interspinous distraction device 10, for example. Such tools further include visualization and cutting tools for preparing and distracting the area of interest for receiving the interspinous distraction device 10. Several of these tools are illustrated in Figure 8.
[0040] Although the present invention has been illustrated and described with reference to preferred embodiments and examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments and examples may perform similar functions and/or achieve similar results. All such equivalent embodiments and examples are within the spirit and scope of the present invention and are intended to be covered by the following claims.

Claims

CLAIMSWhat is claimed is:
1. An interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the interspinous distraction device comprising:
a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and
a plurality of attachment arms selectively extending outwardly from the body assembly in the direction of each of the adjacent spinous processes, the plurality of attachment arms configured to be disposed about a portion of each of the adjacent spinous processes and securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
2. The interspinous distraction device of claim 1, wherein the body assembly has a height of between about 4 mm and about 20 mm, a width of between about 10 mm and about 25 mm, and a thickness of between about 10 mm and about 20 mm.
3. The interspinous distraction device of claim 1, wherein the body assembly has a shape selected from the group consisting of substantially rectangular, substantially square, substantially oval, substantially circular, and a combination thereof.
4. The interspinous distraction device of claim 1, wherein the body assembly comprises a circumferential wall defining an interior void.
5. The interspinous distraction device of claim 4, wherein a portion of each of the plurality of attachment arms passes through an opening in the circumferential wall of the body assembly.
6. The interspinous distraction device of claim 4, wherein the body assembly further comprises a filler plug disposed within the interior void defined by the circumferential wall of the body assembly.
7. The interspinous distraction device of claim 1, wherein the exterior of the body assembly comprises one or more friction surfaces selected from the group consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, and a combination thereof, the one or more friction surfaces configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
8. The interspinous distraction device of claim 1, wherein the exterior of the body assembly comprises one or more fin structures configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
9. The interspinous distraction device of claim 1, wherein each of the plurality of attachment arms has a length of between about 4 mm and about 20 mm.
10. The interspinous distraction device of claim 1, wherein each of the plurality of attachment arms is selectively extendable outwardly from/retractable inwardly into the body assembly.
11. The interspinous distraction device of claim 1, wherein the body assembly and the plurality of attachment arms each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal; a medically- implantable, corrosion-resistant metal alloy; a medically-implantable plastic; a medically-implantable ceramic; and a combination thereof.
12. A dilation tube system for providing minimally-invasive surgical access to a portion of the spinal column or the like, the dilation tube system comprising:
a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube comprises a cut- away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.
13. The dilation tube system of claim 12, further comprising a hollow guide tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the guide tube comprises an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.
14. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each have a cross-sectional shape selected from the group consisting of substantially circular, substantially oval, substantially square, substantially rectangular, substantially triangular, and a combination thereof.
15. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each have a diameter of between about 18 mm and about 22 mm.
16. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal; a medically-implantable, corrosion-resistant metal alloy; a medically-implantable plastic; a medically-implantable ceramic; and a combination thereof.
17. The dilation tube system of claim 13, further comprising a plurality of additional dilation tubes, each of the plurality of additional dilation tubes having a diameter that is smaller than the diameter of the dilation tube, wherein each of the plurality of additional dilation tubes is selectively and temporarily disposed concentrically within the dilation tube.
18. A method for inserting an interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the method for inserting the interspinous distraction device comprising: disposing a body assembly between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and
extending a plurality of attachment arms outwardly from the body assembly, the plurality of attachment arms disposed about a portion of each of the adjacent spinous processes and securely holding the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
19. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly has a height of between about 4 mm and about 20 mm, a width of between about 10 mm and about 25 mm, and a thickness of between about 10 mm and about 20 mm.
20. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly has a shape selected from the group consisting of substantially rectangular, substantially square, substantially oval, substantially circular, and a combination thereof.
21. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly comprises a circumferential wall defining an interior void.
22. The method for inserting the interspinous distraction device of claim 21, wherein a portion of each of the plurality of attachment arms passes through an opening in the circumferential wall of the body assembly.
23. The method for inserting the interspinous distraction device of claim 21, further comprising disposing a filler plug within the interior void defined by the circumferential wall of the body assembly.
24. The method for inserting the interspinous distraction device of claim 18, wherein the exterior of the body assembly comprises one or more friction surfaces selected from the group consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, and a combination thereof, the one or more friction surfaces configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
25. The method for inserting the interspinous distraction device of claim 18, wherein the exterior of the body assembly comprises one or more fin structures configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.
26. The method for inserting the interspinous distraction device of claim 18, wherein each of the plurality of attachment arms has a length of between about 4 mm and about 20 mm.
27. The method for inserting the interspinous distraction device of claim 18, wherein each of the plurality of attachment arms is selectively extendable outwardly from/retractable inwardly into the body assembly.
28. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly and the plurality of attachment arms each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal; a medically-implantable, corrosion-resistant metal alloy; a medically-implantable plastic; a medically-implantable ceramic; and a combination thereof.
29. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube comprises a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.
30. The method for inserting the interspinous distraction device of claim 29, wherein the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow guide tube having a first end, a second end, a given cross- sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube comprises an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.
31. An interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the interspinous distraction device comprising:
a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and
a band configured to be disposed about the adjacent spinous processes of the spinal column of the patient and engage the body assembly, wherein the band is sized such that the adjacent spinous processes are stabilized with respect to one another.
32. The interspinous distraction device of claim 31, wherein the band has a circumferential length of between about 60 mm and about 150 mm.
33. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising:
a shaft portion having a first end and a second end;
a handle portion attached to the first end of the shaft portion; and
a cutting portion attached to the second end of the shaft portion, the cutting portion comprising a cutting edge that is substantially directed towards the first end of the shaft portion.
34. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising: a shaft portion having a first end and a second end;
a handle portion attached to the first end of the shaft portion; and
a plurality of paddles attached to the second end of the shaft portion, the plurality of paddles operable for distracting apart adjacent spinous processes of a spinal column of a patient in response to selective actuation of the handle portion.
35. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising:
a shaft portion having a first end and a second end;
a handle portion attached to the first end of the shaft portion; and
a sizing portion attached to the second end of the shaft portion, the sizing portion selectively sized to fit between adjacent spinous processes of a spinal column of a patient, thereby determining the size of a space between the adjacent spinous processes of the spinal column of the patient.
36. The tool of claim 35, wherein the sizing portion is attached to the second end of the shaft portion at a non-parallel angle to the shaft portion.
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EP1807012A4 (en) 2010-12-29
WO2006047562A3 (en) 2006-09-08
EP1807012A2 (en) 2007-07-18
US20060089654A1 (en) 2006-04-27
CA2614133A1 (en) 2006-05-04
EP1807012B1 (en) 2016-07-06
US8007517B2 (en) 2011-08-30

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