US20050154462A1 - Laterally insertable artificial vertebral disk replacement implant with translating pivot point - Google Patents
Laterally insertable artificial vertebral disk replacement implant with translating pivot point Download PDFInfo
- Publication number
- US20050154462A1 US20050154462A1 US10/981,863 US98186304A US2005154462A1 US 20050154462 A1 US20050154462 A1 US 20050154462A1 US 98186304 A US98186304 A US 98186304A US 2005154462 A1 US2005154462 A1 US 2005154462A1
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- United States
- Prior art keywords
- implant
- end plate
- keel
- spacer
- articulating element
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- Abandoned
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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Definitions
- This field of art of this disclosure is directed to an artificial vertebral disk replacement and method.
- the spinal column is a biomechanical structure composed primarily of ligaments, muscles, vertebrae and intervertebral disks.
- the biomechanical 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 nerve roots.
- spinal stenosis including, but not limited to, central canal and lateral stenosis
- facet joint degeneration typically results from the thickening of the bones that make up the spinal column and is characterized by a reduction in the available space for the passage of blood vessels and nerves.
- Facet joint degeneration results from the constant load borne by the facet joints, and the eventual wear that results. Pain associated with both conditions can be relieved by medication and/or surgery.
- the primary purpose of the intervertebral disk is to act as a shock absorber.
- the disk is constructed of an inner gel-like structure, the nucleus pulposus (the nucleus), and an outer rigid structure comprised of collagen fibers, the annulus fibrosus (the annulus).
- the disk At birth, the disk is 80% water, and then gradually diminishes with time, becoming stiff. With age, disks may degenerate, and bulge, thin, herniate, or ossify. Additionally, damage to disks may occur as a result disease, trauma or injury to the spine.
- the damage to disks may call for a range of restorative procedures. If the damage is not extensive, repair may be indicated, while extensive damage may indicate full replacement. Regarding the evolution of restoration of damage to intervertebral disks, rigid fixation procedures resulting in fusion are still the most commonly performed surgical intervention. However, trends suggest a move away from such procedures.
- areas evolving to address the shortcomings of fusion for remediation of disk damage include technologies and procedures that preserve or repair the annulus, that replace or repair the nucleus, and that advance implants for total disk replacement.
- the trend away from fusion is driven both by issues concerning the quality of life for those suffering from damaged intervertebral disks, as well as responsible health care management. These issues drive the desire for procedures that are minimally invasive, can be tolerated by patients of all ages, especially seniors, and can be performed preferably on an out patient basis.
- FIG. 1A is a posterior view of an embodiment of the assembled implant of the invention.
- FIG. 1B is a cross-section of the device shown in FIG. 1A .
- FIG. 1C is a posterior view of two bottom plates of the implant of the embodiment of the invention.
- FIGS. 1D and 1E are posterior views of the embodiment of the implant of the invention shown in FIG. 1A illustrating the operation of the device in bending to the left and bending to the right, respectively.
- FIG. 2A is a side view of the implant of FIG. 1A showing the implant in flexion.
- FIG. 2B is a side view of the implant showing the implant in extension.
- FIG. 2C is a partial cross-sectional view of a side view of the implant of an embodiment of the invention.
- FIG. 2D is a partial cross-sectional view of an alternative embodiment of the implant of the invention having a protuberance adjacent the socket.
- FIG. 3A is a top view of a portion of an embodiment of the assembled implant of the invention.
- FIG. 3B is a top view of an embodiment of the implant of the invention showing a rotation to the right.
- FIG. 3C is a top view of an embodiment of the implant of the invention showing a rotation to the left.
- FIG. 4A and FIG. 4B show perspective views of the first and second inner surfaces of the first end plate and the second end plate of an embodiment of implant 100 .
- FIG. 5A is a posterior view of the embodiment of the implant of the invention after being implanted between two vertebral bodies.
- FIG. 5B is a side view of the embodiment of the implant of the invention after being implanted between two vertebral bodies.
- FIG. 6A is a rear view of an alternate embodiment of the invention having two plates.
- FIG. 6B and FIG. 6C show perspective views of the first and second inner surfaces of the first end plate and the second end plate of an alternative embodiment of implant 600 .
- FIG. 6D is a cross sectional view of the embodiment shown in FIG. 6A .
- FIG. 7A is a top view of an embodiment of a cutting tool of the invention used to prepare the vertebral bodies for the implant.
- FIG. 7B is a side view of the embodiment of the cutting tool of the invention from the distal end.
- FIG. 7C is a distal end view of an embodiment of the cutting tool of the invention.
- FIG. 8A is a side view of an embodiment of the implant lateral insertion tool of the invention.
- FIG. 8B is a top view of the embodiment of the implant lateral insertion tool of the invention.
- FIG. 8C is a distal end view of the embodiment of the implant lateral insertion tool of the invention.
- FIG. 8D is a top view of an embodiment of the implant lateral insertion tool holding an embodiment of the implant.
- FIG. 9 is a block diagram illustrating the steps of a method for inserting the implant between vertebral bodies.
- FIG. 1A shows an embodiment of the implant 100 having a four-piece configuration.
- the designations, “A” for anterior, “P” for posterior, “RL” for right lateral, and “LL” for left lateral are given in the drawings for spatial orientation. These designations give the relationship of all faces of embodiments of the disclosed intervertebral implant from the superior perspective; i.e. looking down the axis of the spine.
- the implant 100 has a pair 131 of first end plates, or upper end plates 110 that are configured to mate with a first vertebra.
- the upper end plate 110 of implant 100 has a first outer surface 112 from which a first keel 114 extends with a first set of teeth 115 .
- the implant 100 has a pair 133 of second end plates, or lower end plates 120 that are configured to mate with a second vertebra.
- the lower end plate 120 has a second outer surface 122 from which a keel 124 extends with a second set of teeth 125 .
- a pair of pivoting or articulating elements or spacers 130 that are part of the pair 133 of lower end plates 120 acts as an articulating element, or spacer between the first end plate 110 and the second end plate 120 and facilitates pivotal or rotational and also twisting movement of the first end plate 110 and the second end plate 120 , relative to each other.
- the pair of articulating elements, or spacers 130 is curved or convex, as will be discussed in more detail below.
- FIG. 6A illustrates a posterior view of an alternate embodiment of the implant shown in FIG. 1A .
- the implant 600 of FIG. 6A is in the form of a two-piece implant 600 having a first end plate 610 and a second end plate 620 .
- the first end plate, or upper end plate 610 is configured to mate with a first vertebra
- a second end plate, or lower end plate 620 is configured to mate with a second vertebra.
- the first inner surface 616 of the upper end plate 610 has a socket or first cavity 636 formed therein.
- a pivoting or articulation element, or spacer 630 is formed on second end plate 620 .
- the spacer 630 at least partially engages the first socket 636 , and facilitates pivotal or rotational and also twisting movement of the first end plate 610 and the second end plate 620 , relative to each other.
- the spacer 630 and corresponding socket 636 are dimensioned so that they are hemi-cylindrical ( FIG. 6D ), while in another embodiment shown in FIG. 6B and FIG. 6C , the articulating element, or spacer 630 and corresponding socket 636 are hemispherical.
- the upper end plate 610 of implant 600 has a first outer surface 612 from which a first keel 614 extends with a first set of teeth 615 .
- first keel 614 when implant 600 is inserted between vertebrae, the first keel 614 extends longitudinally across the first outer surface 612 , about perpendicular to the sagittal plane of the spine. In another embodiment, the first keel 614 extends longitudinally only partially across the first outer surface 612 , about perpendicular to the sagittal plane of the spine.
- the teeth 615 in the two embodiments with complete or partial extension of the keel 614 across the first outer surface 612 of the upper end plate 610 point towards the left lateral face of implant 600 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine.
- This orientation is shown in the figures, and is particularly evident where the keel 614 is fully displayed, as in FIG. 1A and FIG. 6A , for example.
- the teeth 615 point towards the right lateral face of implant 600 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine.
- the first outer surface 612 abuts the vertebral body when the implant 600 is implanted.
- the first keel 614 extends into the vertebral body to anchor implant 600 into position, and is perpendicular to the median sagittal plane of the spine, in which extension and flexion occur.
- the first keel 614 in this orientation offers substantial stability during extension and flexion for the implant 600 inserted between the vertebrae of a patient.
- the first keel 614 in this embodiment is preferably aligned with and supports the articulation of implant 600 .
- the first inner surface 616 with socket 636 at least partially engages the spacer 630 of the implant and opposes the second end plate 620 .
- the first inner surface 616 can form a planar surface that is parallel to the first outer surface 612 , or can form a planar surface that is not parallel to the first outer surface 612 .
- the lower end plate 620 has a second outer surface 622 from which a keel 624 extends with a second set of teeth 625 .
- the second keel 624 when implant 600 is inserted between vertebrae, is about perpendicular to the sagittal plane of the spine.
- the second keel 624 extends longitudinally across the second outer surface 622
- the second keel 624 extends longitudinally partially across the second outer surface 622 .
- the teeth 625 in the two embodiments with complete or partial extension of the second keel 624 across the second outer surface 622 of the lower end plate 620 point towards the left lateral face of implant 600 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine.
- This orientation is shown in the figures, and is particularly evident where the second keel 624 is fully displayed, as in FIG. 1A and FIG. 6A , for example.
- the teeth 625 point towards the right lateral face of implant 600 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine.
- the second outer surface 622 abuts the vertebral body when the implant 600 is implanted.
- the second keel 624 extends into the vertebral body to anchor implant 600 into position, and is perpendicular to the median sagittal plane of the spine, in which extension and flexion occur.
- the second keel 624 in this orientation offers substantial stability during extension and flexion for the implant 600 inserted between the vertebrae of a patient.
- the second keel 624 in this embodiment is aligned with and supports the articulation of implant 600 .
- the second end plate 620 with second inner surface 626 having the spacer 630 opposes the first end plate 610 with first inner surface 616 having socket 636 .
- the spacer 630 of second inner surface 626 at least partially engages socket 636 of first upper surface.
- the second inner surface 626 can form a planar surface that is parallel to the second outer surface 622 , or can form a planar surface that is not parallel to the second outer surface 622 .
- the first inner surface 616 of the first end plate 610 can be parallel to the second inner surface 626 of the second end plate 620 when the implant 600 is assembled and is in a neutral position (i.e., the position where the first end plate 610 has not rotated relative to the second end plate 620 ).
- the first inner surface 616 of the first end plate 610 can be non-parallel to the planar surface of the second inner surface 626 of the second end plate 620 when the implant 600 is assembled and in a neutral position. This non-parallel orientation of the first end plate 610 and the second end plate 620 allows the plates to pivot to a greater degree with respect to each other.
- factors such as the height and position of the spacer 630 , and the, can also be adjusted in order to increase the degree that the first end plate 610 and the second end plate 620 can pivot relative to each other. Other factors that effect the degree of movement of the first end plates 110 or 610 relative to the second end plates 120 or 620 for implant 100 or implant 600 will discussed below.
- the planar surfaces corresponding to the first and second outer surfaces 612 , 622 and the first and second inner surfaces 616 , 626 of the first and second end plates 610 , 620 lie within, or substantially within, the axial plane of the body.
- the first and second keels 614 , 624 are aligned in the axial plane, or perpendicular to the sagittal plane of the vertebrae.
- the first and second keels 614 , 624 extend into the vertebral bodies to anchor implant 600 into position, and are perpendicular to the median sagittal plane of the spine, in which extension and flexion occur.
- the first and second keels 614 , 624 in this orientation offer substantial stability during extension and flexion for implant 600 inserted between the vertebrae of a patient. Additionally, the first and second keels 614 , 624 in this embodiment are aligned with and support the axis of articulation of implant 600 defined by an RL to LL orientation.
- the lateral orientation of the keels allow the implants to be inserted into the spine using a lateral approach as opposed to an anterior or posterior approach.
- the lateral approach is advantageous, because the spinal nerves in the spinal cavity are minimally undisturbed when the implants are inserted laterally into the spine. In comparison to a posterior insertion approach in which the spinal nerves can be substantially disturbed, the spinal nerves are bypassed and relatively undisturbed when the implant is inserted laterally between the vertebral bodies from the side of the spine.
- an anterior insertion approach has its benefits
- the lateral insertion approach can allow the present implant and associated implantation tools, to be inserted into the spine with less disturbance of the patient's internal organs. This can translate into less time and risk associated with preparing the spine for insertion as well as inserting the implant itself into the spine.
- the laterally oriented keels offer substantial stability to the vertebral bodies during extension, flexion and lateral bending of the spine.
- the first and second keels 114 , 124 and 614 , 624 include ports 148 , 152 and 648 , 652 , respectively, that facilitate bone ingrowth.
- bone from the vertebral bodies can grow thorough the ports 148 , 152 and 648 , 652 , and aid in securing the first and second keels 114 , 124 and 614 , 624 , and thereby for securing implants 100 and 600 once inserted between vertebral bodies.
- surfaces defined by the first and second keels 114 , 124 and 614 , 624 and the first and second outer surfaces 112 , 122 and 612 , 622 of implants 100 and 600 can be roughened in order to promote bone ingrowth into these defined surfaces of implants 100 and 600 .
- the ports 148 , 152 and 648 , 652 , the first and second keels 114 , 124 and 614 , 624 , and the first and second outer surfaces 112 , 122 and 612 , 622 of implant 600 can be coated with materials that promote bone growth such as for example bone morphogenic protein, BMP, or structural materials such as hyaluronic acid, HA, or other substance which promotes growth of bone relative to and into the keels 614 , 624 , keel ports 648 , 652 , and other external surfaces of the implant 600 .
- materials that promote bone growth such as for example bone morphogenic protein, BMP, or structural materials such as hyaluronic acid, HA, or other substance which promotes growth of bone relative to and into the keels 614 , 624 , keel ports 648 , 652 , and other external surfaces of the implant 600 .
- FIG. 1A and FIG. 6A can be used to create a three-piece implant as will also be appreciated by those of ordinary skill in the art.
- the first end plate 610 of FIG. 6A with its socket 636 from a two-piece embodiment can be combined with two second end plates 120 of FIG. 1A from a four-piece embodiment to form an implant.
- the second end plate 620 with spacer 630 of a two piece embodiment, such as FIG. 6A can be combined with two first end plates 110 from a four-piece design, such as FIG. 1A , to achieve an implant.
- the features described herein for an interspinous implant for lateral insertion between adjacent vertebrae are applicable to two-, three-, or four-piece embodiments. None of these configurations depart from the scope of the invention.
- FIG. 1B depicts the pair 131 of first or upper end plates 110 and the pair 133 of second or lower end plates 120 in cross-section.
- Each upper and lower end plate 110 , 120 has a keel 114 , 124 with a set of teeth 115 , 125 .
- different embodiments of implant 100 may have complete or partial extension of the first and second keels 114 , 124 across the first and second outer surfaces 112 , 122 of the upper and lower end plates 110 , 120 .
- the teeth 115 , 125 point towards the left lateral face of implant 100 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine, and alternatively, the teeth 115 , 125 point towards the right lateral face of implant 100 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine.
- the socket 136 formed in the first inner surface 116 of first end plate 110 has a first elongated sidewall 150 , a corresponding second elongated sidewall 152 (shown in FIG. 3B ), an end wall 154 , and an open end 156 .
- the open ends 156 of each of the first end plates 110 are oriented so that the open ends 156 face each other.
- Each of the first and second end plates 110 , 120 has a first end 138 , 141 and a second end 139 , 143 .
- the ends 139 of the first end plate 110 face each other, as do the ends 143 of the second end plate 120 .
- the lower plates 120 each have an articulating element, or spacer 130 , which is convex and hemi-cylindrical, that engage the socket 136 .
- the concave hemi-cylindrical inner surface 135 of the socket 136 is sloped to allow the pair 131 of first or upper end plates 110 to easily slide, or rock, side-to-side on the articulating element, or spacer 130 and slide, or ride, forward and backward with enough looseness of fit to allow for some twisting in order to emulate the motion of the vertebral bone and intervertebral disk tissue.
- This arrangement thus, has a sliding or translating pivot point. It is evident from FIG.
- first and second keels 114 , 124 are aligned with and support the axis of articulation of the upper end plate 110 about the spacer 130 for this embodiment.
- This axis of articulation is longitudinally oriented with respect to the vertebrae, or about perpendicular to the sagittal plane of the spine.
- the alignment of the first and second keels 114 , 124 with the axis of articulation offers substantial stability during flexion and extension when implant 100 is inserted between the vertebrae of a patient.
- the articulating element, or spacer 130 has four sides: a first elongated sidewall 140 , a second elongated sidewall 142 , a third end wall 143 , and a fourth end wall 146 .
- the third end wall 144 is flush with the end 143 of the lower end plate 120 of the implant.
- the third end wall 144 has a profile height 160 and the fourth end wall 146 has a profile height 162 . Comparing the profile heights 160 , 162 to each other at the same point on the second inner surface 126 of the second end plate 120 , the overall profile height of the third end wall 144 is greater than the fourth end wall 146 (i.e., 160 >162).
- socket 136 slopes downwardly from the end wall 144 to the end wall 146 .
- spacers 130 comprise an articulating element that has a high surface where the third end walls 144 abut each other and slope to a lower surface adjacent to fourth end walls 146 .
- the edges of the articulating element or spacer 130 are eased or rounded to allow for further range of motion of the pair 131 of upper end plates 110 relative to the pair 133 of lower end plates 120 .
- the overall height of the third end wall 144 and the fourth end wall 146 can be equivalent while still having an effective third end wall height 160 that is greater than the effective fourth end wall height 162 due to the overall slope of the second inner surface 126 .
- the overall height of the third end wall 144 and the fourth end wall 146 can be different with the third end wall 144 having a height greater than the fourth end wall 146 , thus eliminating the need for the second inner surface 126 to have a slope or further increasing the net difference between the height of the third end wall and the forth end wall.
- the spacer 130 is depicted such that the third end wall 144 is flush with the second end 143 , those of skill in the art will appreciate that the spacer 130 could also be configured such that the third end wall 144 is recessed relative to the end 143 of the second end plate. In such a configuration, the third end wall 144 and the end 143 would not be flush.
- FIGS. 1D and 1E illustrate posterior views of the implant 100 showing the clearance for left and right lateral bending.
- left and right lateral bending ranges from 3-5°.
- the length of the spacer 130 can be less than the length of the socket 136 .
- the open ends 156 of the sockets facilitate movement of the articulating elements, or spacers 130 within the socket 136 to accommodate side-bending movement.
- FIG. 2A and FIG. 2B are views of the intervertebral implant 100 , which depict the motion of the first end plate 110 relative to the second end plate 120 .
- a side view of implant 100 is depicted, showing first end plate 110 with socket 136 and the second end plate 120 with the articulating element or spacer 130 .
- the sloping of the first inner surface 116 of the first end plate 110 facilitates rotation of the spacer and socket in an anterior A direction and a posterior P direction.
- the first inner surface 116 slopes from a high point at about where the socket is located to low points at the ends 111 and 113 of the upper end plate 110 .
- the implant 100 is positioned to achieve flexion (i.e., forward bending) in a range up to about 15°, but more preferably 10°, while in FIG. 2B , the implant 100 is positioned to achieve extension (i.e., backward bending) in a preferable range of up to about 5°.
- flexion i.e., forward bending
- extension i.e., backward bending
- FIG. 2C and FIG. 2D show cross sections of implant 100 through the sagittal plane of the vertebrae.
- FIG. 2C is a cross-section of the side view of the intervertebral implant 100 showing the mating of the spacer 130 to the socket 136 .
- FIG. 2D illustrates an alternate embodiment of the first end plate 110 wherein the socket 136 has ridges 268 , 269 forming a protuberance that extends into the channel 264 , 265 respectively on the second end plate 120 .
- the protuberances 268 , 269 can extend partially into the channel, such as the configuration shown, or can have a channel conforming shape such that when the spacer and socket are moved to achieve flexion 272 or extension 274 the protuberance or ridge 268 , 269 extends into the channels 264 , 265 .
- This embodiment allows the first inner surface 116 and second inner surface 126 of the first end plate 110 and the second end plate 120 to be flat and non-sloping as shown while still allowing for the implant to emulate forward and backward bending and allow for the blocking of the motion of the socket relative to the spacer.
- first and second keels 114 , 124 are aligned with and support the articulation of first end plate 110 about the spacer 130 for this embodiment, and where the articulation is about perpendicular to the sagittal plane of the spine.
- FIG. 3A a top view of one-half of the intervertebral implant 100 is shown.
- Each of the top first end plate 110 and the bottom second end plate 120 have a bores 376 for receiving pins of an implant tool.
- the first keel 114 on the first end plate 110 is positioned so that it is aligned in the same plane with the second keel 124 on the second end plate 120 .
- the length of spacer 130 from the third end wall 144 to the fourth end wall 146 is shorter than the length of the socket 136 from the end wall 154 to the open end 156 , so that the fit of the spacer with the socket is somewhat loose.
- implant 100 of this embodiment allows the spine to have movement in three orthogonal degrees of freedom, namely (1) forward and backward bending movement, (2) lateral side-to-side bending, and (3) twisting movement.
- FIGS. 3B and 3C show the relative rotation of the first or upper end plate 110 to the second or lower end plate 120 to achieve rotation about a central axis 378 . This rotation results in about a 3°-6° rotation about the axis (i.e., 3° of torso twisting in each direction).
- FIG. 4A and FIG. 4B show views of the first and second end plates, 110 , 120 .
- FIG. 4A shows a perspective view of a second end plate 120 of the intervertebral implant 100 .
- the second inner surface 126 of the second end plate 120 is shown with a hemi-cylindrical spacer 130 formed therefrom, and channels or grooves 264 , 265 extending about the spacer 130 .
- the channels 264 , 265 are formed on two sides of the spacer 130 .
- the channels 264 , 265 can alternatively surround the spacer 130 .
- FIG. 4B shows a perspective view of the first end plate 110 , with a first inner surface 116 that opposes the second inner surface 126 .
- the first inner surface 116 has a hemi-cylindrical socket 136 formed therein.
- the socket 136 of FIG. 4B is configured to mate with the spacer 130 of FIG. 4A .
- FIG. 4 c and FIG. 4 d show views of the first and second end plates, 110 , 120 for an alternative embodiment of implant 100 .
- FIG. 4 c shows a perspective view of an embodiment of the second inner surface 126 of the second or lower end plate 120 of implant 100 .
- the second inner surface 126 of the lower end plate 120 has a hemispherical spacer 130 formed therefrom.
- FIG. 4 d shows a perspective view of an embodiment of the first inner surface 116 of the first or upper end plate 110 of implant 100 , which opposes the second inner surface 126 .
- the first inner surface 116 of the upper end plate 110 has a socket or cavity 136 formed therein.
- the socket 136 has a concave hemispherical surface.
- the socket 136 allows the first end plate 110 to pivot or rotate on spacer 130 .
- first and second keels 114 , 124 are aligned with and support the articulation of the first end plate 110 about the spacer 130 , relative to the second end plate 120 .
- the first and second keels 114 , 124 in this orientation offer substantial stability during extension and flexion for implant 100 inserted between the vertebrae of a patient.
- the first and second keels 114 , 124 in these embodiments are aligned with and support the lateral axis of articulation of implant 100 , which is perpendicular to the sagittal plane of the spine. Additionally, as evidenced from the perspective views of FIG. 4A and FIG.
- the perimeter shape of the upper and lower end plates 110 , 120 can be configured to correspond to the perimeter shape of a vertebral disk. As will be appreciated by those of ordinary skill in the art, the perimeter shape of the upper end plate 110 and the lower end plate 120 can be the same.
- FIG. 5A and FIG. 5B show the implant after insertion between the vertebrae of a patient.
- FIG. 5A illustrates a posterior view of the implant shown in FIG. 1A implanted between vertebral bodies in a spine.
- FIG. 5A illustrates the spinal column 500 and the cauda equina 504 (a collection of lumbar and sacral nerve roots that fill the caudal end of the spinal cord) with individual nerves 506 exiting the cord between lumbar vertebrae.
- the implant 100 is positioned between two vertebral bodies 520 , 521 such that the first and second keels 114 , 124 lie in a plane parallel to coronal or frontal plane of the body, or perpendicular to the sagittal plane of the vertebrae.
- FIG. 5B illustrates a side view of the implant inserted between vertebral bodies 520 , 521 , for embodiments of the implant as that shown in FIG. 1A , or FIG. 6A .
- the gap between the first end plate 110 and the second end plate 120 at the anterior “A” face of implants 100 , 600 is greater than at the posterior “P” face of implants 100 , 600 .
- the greater gap at the anterior face vs. the posterior face of implants 100 , 600 results in the flexion (forward bending) movement being facilitated to a greater degree than extension (backward bending) movement.
- flexion forward bending
- backward bending extension
- These embodiments show implants 100 , 600 inserted between two vertebrae with two first keels 114 extending from the first end plate 110 , and two second keels 124 extending from the second end plate 120 .
- the first and second keels 114 , 124 are about perpendicular to the sagittal plane of the spine, and support the articulation of the first end plate 110 relative to the second end plate 120 , about the spacer 130 .
- implants 100 , 600 can be made of medical grade titanium, stainless steel or cobalt chrome. Other materials that have appropriate structural strength and that are suitable for implantation into a patient can also be used.
- One class of materials contemplated for use in implant 100 is the class of biocompatible polymers. Copolymers, blends and composites of polymers are also contemplated for fabrication of parts of the disclosed device.
- 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.
- biocompatible polymers are the polyaryl ester ketones which has several members, which include polyetheretherketone (PEEK), and polyetherketoneketone (PEKK).
- PEEK has proven as a durable material for implants, as well as meeting criteria of biocompatibility.
- Medical grade PEEK is available from Victrex Corporation 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.
- Still another interesting group of biocompatible polymers are polyalkyl biocompatible polymers, such as polyethylenes, polypropylenes, and the like.
- These medical grade biocompatible polymers are also available as reinforced polymer materials.
- fillers are added to a polymer, copolymer, polymer blend, or polymer composite. Fillers are added to modify properties, such as mechanical, optical, and thermal properties. In this case, fillers, such as carbon fibers, are added to reinforce the polymers mechanically to enhance strength for certain uses, such as load bearing devices.
- FIG. 7A through 7D show an embodiment of a tool for preparing vertebral bodies to receive implants 100 , 600
- FIG. 8A through FIG. 8D show an embodiment of a tool for inserting embodiments of the disclosed intervertebral implants 100 , 600 .
- FIG. 7A through FIG. 7C are the top view, the side view, and an end view of the cutting tool 700 .
- the cutting tool 700 has a handle 710 at its proximal end for controlling the tool during operation.
- the handle 710 can be removable or affixed to the cutting end.
- the distal end 702 of the tool 700 is solid head has an upper surface 705 , and a lower surface 706 .
- the upper surface 705 has a first blade 712 mounted thereon, and the lower surface 706 has a second blade 714 mounted thereon.
- the first blade 712 is about centered with the upper surface 705
- the second blade 714 is about centered with the lower surface 706 .
- the first and second blades 712 , 714 are oriented to cut a space in a first and second intervertebral body for the first and second keels 114 , 124 of implants 100 , 600 .
- the space is perpendicular to the sagittal plane of the vertebrae, and allows for the lateral insertion of the implants 100 , 600 .
- FIG. 7C is a view of the distal end of the cutting tool 700 showing the beveled end 716 and the first and second blades 712 , 714 .
- the height h of the head 702 of the cutting tool 700 approximates the distance between two vertebral bodies or the height of the disk space. In this embodiment of cutting tool 700 , the blades 712 , 714 extend above and below the head 702 .
- the tool shown in FIG. 7A can be modified such that instead of cutting keel-receiving channels in the upper and lower vertebral bodies at the same time, two tools are provided so that only one vertebral body is cut for keel-receiving channels at a time.
- an alternative embodiment of cutting tool 700 has a first tool with a single blade mounted on the head 702 .
- a second tool could be provided having a single blade mounted on the head 702 , and additionally on the opposing surface, a guide. The guide on the surface opposite the surface with the blade is designed to engage with the first keel receiving channel cut the first vertebrae with the first tool to ensure that the second cut is optimally aligned with the first cut.
- FIG. 8A through FIG. 8D depict an embodiment of the implanting tool used to insert the implant 600 of FIG. 6A between vertebral bodies.
- FIG. 8A is a side view of the implantation tool 800 that has a handle 810 and an implant holder 820 .
- the implant holder 820 has an implant conforming surface 824 and four pins 822 for holding the first end plate 610 and the second end plate 620 implant 600 .
- the conforming surface 824 is curved to follow the convex outer LL edges of the first and second end plates 610 , 620 , respectively, for an implant inserted from the left lateral side of a patient.
- the implant 600 nests within a conforming surface 824 and is held by pins 822 .
- FIG. 8C shows the distal view of the end of the tool with four pins 822 for securing the first and second end plate of the implant.
- kits can be assembled that include an implant 100 (or 600 ) sized for a particular patient.
- the kit could also include several cutting tools 700 and several implanting tools 800 or a single handle that cooperates with cutting ends 702 and implantation ends 820 .
- FIG. 9 is a block diagram showing the basic steps of the method for laterally inserting the embodiments of implants 100 , 600 .
- a tool, such as the one depicted in FIG. 7A is inserted laterally between the vertebral bodies to create channels in the bodies to receive the keels of the implant.
- the implant is then inserted laterally 930 between two vertebrae and the wound is closed 940 . This procedure can be followed for either a left lateral approach or right lateral approach.
- the teeth 115 , 125 of upper and lower keels 114 , 124 would be pointed towards the left lateral face of the device in order to aid in retaining embodiments of implants 100 , 600 in place.
- the teeth would point towards the right lateral face of the device.
Abstract
Description
- This application claims priority under 35 USC 119 to U.S. Patent Application No. 60/526,724, filed on Dec. 2, 2003 and entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT AND LATERAL IMPLANT METHOD,” which is hereby incorporated by reference.
- This application is related to U.S. Provisional Application No. 60/422,039, filed Oct. 29, 2002, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT AND METHOD,” U.S. patent application Ser. No. 10/684,668, filed Oct. 14, 2003, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH CROSSBAR SPACER AND METHOD,” U.S. patent application Ser. No. 10/684,669, filed Oct. 14, 2003, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT AND METHOD,” U.S. Provisional Application No. 60/422,011, filed Oct. 29, 2002, entitled “TOOLS FOR IMPLANTING AN ARTIFICIAL VERTEBRAL DISK AND METHOD,” U.S. patent application Ser. No. 10/685,134, filed Oct. 14, 2003, entitled “TOOLS FOR IMPLANTING AN ARTIFICIAL VERTEBRAL DISK AND METHOD,” U.S. Provisional Application No. 60/422,022, filed Oct. 29, 2002, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A SPACER AND METHOD,” U.S. Provisional Application No. 60/422,021, filed Oct. 29, 2002, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH CROSSBAR SPACER AND METHOD,” U.S. patent application Ser. No. 10/685,011, filed Oct. 14, 2003, entitled “ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH SPACER AND METHOD,” U.S. patent application Ser. No. ______, filed ______, entitled “METHOD OF LATERALLY INSERTING AN ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT,” (KLYCD-05007US6), U.S. patent application Ser. No. ______, filed ______, entitled “LATERALLY INSERTABLE ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A CROSSBAR SPACER,” (KLYCD-05008US6), U.S. patent application Ser. No. ______, filed ______, entitled “METHOD OF LATERALLY INSERTING AN ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A CROSSBAR SPACER,” (KLYCD-05008US7), U.S. patent application Ser. No. ______, filed ______, entitled “LATERALLY INSERTABLE ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A SPACER,” (KLYCD-05010US4), U.S. patent application Ser. No. ______, filed ______, entitled “METHOD OF LATERALLY INSERTING AN ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A SPACER,” (KLYCD-05010US5), all of which are incorporated herein by reference.
- This field of art of this disclosure is directed to an artificial vertebral disk replacement and method.
- The spinal column is a biomechanical structure composed primarily of ligaments, muscles, vertebrae and intervertebral disks. The biomechanical 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 nerve roots.
- As the present society ages, it is anticipated that there will be an increase in adverse spinal conditions which are characteristic of aging. For example, with aging comes an increase in spinal stenosis (including, but not limited to, central canal and lateral stenosis), and facet joint degeneration. Spinal stenosis typically results from the thickening of the bones that make up the spinal column and is characterized by a reduction in the available space for the passage of blood vessels and nerves. Facet joint degeneration results from the constant load borne by the facet joints, and the eventual wear that results. Pain associated with both conditions can be relieved by medication and/or surgery.
- In addition, to spinal stenosis, and facet joint degeneration, the incidence of damage to the intervertebral disks is also common. The primary purpose of the intervertebral disk is to act as a shock absorber. The disk is constructed of an inner gel-like structure, the nucleus pulposus (the nucleus), and an outer rigid structure comprised of collagen fibers, the annulus fibrosus (the annulus). At birth, the disk is 80% water, and then gradually diminishes with time, becoming stiff. With age, disks may degenerate, and bulge, thin, herniate, or ossify. Additionally, damage to disks may occur as a result disease, trauma or injury to the spine.
- The damage to disks may call for a range of restorative procedures. If the damage is not extensive, repair may be indicated, while extensive damage may indicate full replacement. Regarding the evolution of restoration of damage to intervertebral disks, rigid fixation procedures resulting in fusion are still the most commonly performed surgical intervention. However, trends suggest a move away from such procedures. Currently, areas evolving to address the shortcomings of fusion for remediation of disk damage include technologies and procedures that preserve or repair the annulus, that replace or repair the nucleus, and that advance implants for total disk replacement. The trend away from fusion is driven both by issues concerning the quality of life for those suffering from damaged intervertebral disks, as well as responsible health care management. These issues drive the desire for procedures that are minimally invasive, can be tolerated by patients of all ages, especially seniors, and can be performed preferably on an out patient basis.
- Most recently, there has been an increased interest in total disk replacement technology. A number of artificial disks are beginning to appear in the medical device marketplace. These artificial disks vary greatly in shape, design and functionality. With these devices go tools and methods for insertion between vertebrae thereof.
- Accordingly, there is a need in the art for innovation in technologies and methods that advance the art in the area of minimally invasive intervertebral disk replacement. This not only enhances the quality of life for those suffering from the condition, but is responsive to the current needs of health care management.
-
FIG. 1A is a posterior view of an embodiment of the assembled implant of the invention.FIG. 1B is a cross-section of the device shown inFIG. 1A .FIG. 1C is a posterior view of two bottom plates of the implant of the embodiment of the invention.FIGS. 1D and 1E are posterior views of the embodiment of the implant of the invention shown inFIG. 1A illustrating the operation of the device in bending to the left and bending to the right, respectively. -
FIG. 2A is a side view of the implant ofFIG. 1A showing the implant in flexion.FIG. 2B is a side view of the implant showing the implant in extension.FIG. 2C is a partial cross-sectional view of a side view of the implant of an embodiment of the invention.FIG. 2D is a partial cross-sectional view of an alternative embodiment of the implant of the invention having a protuberance adjacent the socket. -
FIG. 3A is a top view of a portion of an embodiment of the assembled implant of the invention.FIG. 3B is a top view of an embodiment of the implant of the invention showing a rotation to the right.FIG. 3C is a top view of an embodiment of the implant of the invention showing a rotation to the left. -
FIG. 4A andFIG. 4B show perspective views of the first and second inner surfaces of the first end plate and the second end plate of an embodiment ofimplant 100. -
FIG. 5A is a posterior view of the embodiment of the implant of the invention after being implanted between two vertebral bodies.FIG. 5B is a side view of the embodiment of the implant of the invention after being implanted between two vertebral bodies. -
FIG. 6A is a rear view of an alternate embodiment of the invention having two plates.FIG. 6B andFIG. 6C show perspective views of the first and second inner surfaces of the first end plate and the second end plate of an alternative embodiment ofimplant 600.FIG. 6D is a cross sectional view of the embodiment shown inFIG. 6A . -
FIG. 7A is a top view of an embodiment of a cutting tool of the invention used to prepare the vertebral bodies for the implant.FIG. 7B is a side view of the embodiment of the cutting tool of the invention from the distal end.FIG. 7C is a distal end view of an embodiment of the cutting tool of the invention. -
FIG. 8A is a side view of an embodiment of the implant lateral insertion tool of the invention.FIG. 8B is a top view of the embodiment of the implant lateral insertion tool of the invention.FIG. 8C is a distal end view of the embodiment of the implant lateral insertion tool of the invention.FIG. 8D is a top view of an embodiment of the implant lateral insertion tool holding an embodiment of the implant. -
FIG. 9 is a block diagram illustrating the steps of a method for inserting the implant between vertebral bodies. - The following description is presented to enable any person skilled in the art to make and use what is disclosed. 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 what is disclosed and defined by the appended claims. Thus, what is disclosed 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 what is disclosed herein, the specification and drawings of all patents and patent applications cited in this application are incorporated herein by reference.
-
FIG. 1A shows an embodiment of theimplant 100 having a four-piece configuration. The designations, “A” for anterior, “P” for posterior, “RL” for right lateral, and “LL” for left lateral are given in the drawings for spatial orientation. These designations give the relationship of all faces of embodiments of the disclosed intervertebral implant from the superior perspective; i.e. looking down the axis of the spine. Theimplant 100 has apair 131 of first end plates, orupper end plates 110 that are configured to mate with a first vertebra. Theupper end plate 110 ofimplant 100 has a firstouter surface 112 from which afirst keel 114 extends with a first set ofteeth 115. Additionally, theimplant 100 has apair 133 of second end plates, orlower end plates 120 that are configured to mate with a second vertebra. Thelower end plate 120 has a secondouter surface 122 from which akeel 124 extends with a second set ofteeth 125. A pair of pivoting or articulating elements orspacers 130 that are part of thepair 133 oflower end plates 120 acts as an articulating element, or spacer between thefirst end plate 110 and thesecond end plate 120 and facilitates pivotal or rotational and also twisting movement of thefirst end plate 110 and thesecond end plate 120, relative to each other. In the embodiments described, the pair of articulating elements, orspacers 130 is curved or convex, as will be discussed in more detail below. - Several configurations of
implant 100 are contemplated. For instance,FIG. 6A illustrates a posterior view of an alternate embodiment of the implant shown inFIG. 1A . Theimplant 600 ofFIG. 6A is in the form of a two-piece implant 600 having afirst end plate 610 and asecond end plate 620. The first end plate, orupper end plate 610 is configured to mate with a first vertebra, and a second end plate, orlower end plate 620 is configured to mate with a second vertebra. The firstinner surface 616 of theupper end plate 610 has a socket orfirst cavity 636 formed therein. A pivoting or articulation element, orspacer 630 is formed onsecond end plate 620. Thespacer 630 at least partially engages thefirst socket 636, and facilitates pivotal or rotational and also twisting movement of thefirst end plate 610 and thesecond end plate 620, relative to each other. Thespacer 630 andcorresponding socket 636 are dimensioned so that they are hemi-cylindrical (FIG. 6D ), while in another embodiment shown inFIG. 6B andFIG. 6C , the articulating element, orspacer 630 andcorresponding socket 636 are hemispherical. - The
upper end plate 610 ofimplant 600 has a firstouter surface 612 from which afirst keel 614 extends with a first set ofteeth 615. In one embodiment, whenimplant 600 is inserted between vertebrae, thefirst keel 614 extends longitudinally across the firstouter surface 612, about perpendicular to the sagittal plane of the spine. In another embodiment, thefirst keel 614 extends longitudinally only partially across the firstouter surface 612, about perpendicular to the sagittal plane of the spine. Theteeth 615 in the two embodiments with complete or partial extension of thekeel 614 across the firstouter surface 612 of theupper end plate 610 point towards the left lateral face ofimplant 600 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine. This orientation is shown in the figures, and is particularly evident where thekeel 614 is fully displayed, as inFIG. 1A andFIG. 6A , for example. Alternatively, theteeth 615 point towards the right lateral face ofimplant 600 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine. - The first
outer surface 612 abuts the vertebral body when theimplant 600 is implanted. Thefirst keel 614 extends into the vertebral body to anchorimplant 600 into position, and is perpendicular to the median sagittal plane of the spine, in which extension and flexion occur. Thefirst keel 614 in this orientation offers substantial stability during extension and flexion for theimplant 600 inserted between the vertebrae of a patient. Additionally, thefirst keel 614 in this embodiment is preferably aligned with and supports the articulation ofimplant 600. The firstinner surface 616 withsocket 636 at least partially engages thespacer 630 of the implant and opposes thesecond end plate 620. The firstinner surface 616 can form a planar surface that is parallel to the firstouter surface 612, or can form a planar surface that is not parallel to the firstouter surface 612. - The
lower end plate 620 has a secondouter surface 622 from which akeel 624 extends with a second set ofteeth 625. In one embodiment, whenimplant 600 is inserted between vertebrae, thesecond keel 624 is about perpendicular to the sagittal plane of the spine. As described above for the firstupper end plate 610, in one embodiment, thesecond keel 624 extends longitudinally across the secondouter surface 622, while in another embodiment, thesecond keel 624 extends longitudinally partially across the secondouter surface 622. Theteeth 625 in the two embodiments with complete or partial extension of thesecond keel 624 across the secondouter surface 622 of thelower end plate 620 point towards the left lateral face ofimplant 600 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine. This orientation is shown in the figures, and is particularly evident where thesecond keel 624 is fully displayed, as inFIG. 1A andFIG. 6A , for example. Alternatively, theteeth 625 point towards the right lateral face ofimplant 600 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine. - The second
outer surface 622 abuts the vertebral body when theimplant 600 is implanted. Thesecond keel 624 extends into the vertebral body to anchorimplant 600 into position, and is perpendicular to the median sagittal plane of the spine, in which extension and flexion occur. Thesecond keel 624 in this orientation offers substantial stability during extension and flexion for theimplant 600 inserted between the vertebrae of a patient. Additionally, thesecond keel 624 in this embodiment is aligned with and supports the articulation ofimplant 600. Thesecond end plate 620 with secondinner surface 626 having thespacer 630 opposes thefirst end plate 610 with firstinner surface 616 havingsocket 636. Thespacer 630 of secondinner surface 626 at least partially engagessocket 636 of first upper surface. The secondinner surface 626 can form a planar surface that is parallel to the secondouter surface 622, or can form a planar surface that is not parallel to the secondouter surface 622. - The first
inner surface 616 of thefirst end plate 610 can be parallel to the secondinner surface 626 of thesecond end plate 620 when theimplant 600 is assembled and is in a neutral position (i.e., the position where thefirst end plate 610 has not rotated relative to the second end plate 620). Alternatively, the firstinner surface 616 of thefirst end plate 610 can be non-parallel to the planar surface of the secondinner surface 626 of thesecond end plate 620 when theimplant 600 is assembled and in a neutral position. This non-parallel orientation of thefirst end plate 610 and thesecond end plate 620 allows the plates to pivot to a greater degree with respect to each other. Additionally, factors such as the height and position of thespacer 630, and the, can also be adjusted in order to increase the degree that thefirst end plate 610 and thesecond end plate 620 can pivot relative to each other. Other factors that effect the degree of movement of thefirst end plates second end plates implant 100 orimplant 600 will discussed below. - When
implant 600 is inserted between vertebrae the planar surfaces corresponding to the first and secondouter surfaces inner surfaces second end plates second keels second keels implant 600 into position, and are perpendicular to the median sagittal plane of the spine, in which extension and flexion occur. The first andsecond keels implant 600 inserted between the vertebrae of a patient. Additionally, the first andsecond keels implant 600 defined by an RL to LL orientation. - The lateral orientation of the keels allow the implants to be inserted into the spine using a lateral approach as opposed to an anterior or posterior approach. The lateral approach is advantageous, because the spinal nerves in the spinal cavity are minimally undisturbed when the implants are inserted laterally into the spine. In comparison to a posterior insertion approach in which the spinal nerves can be substantially disturbed, the spinal nerves are bypassed and relatively undisturbed when the implant is inserted laterally between the vertebral bodies from the side of the spine. Although an anterior insertion approach has its benefits, the lateral insertion approach can allow the present implant and associated implantation tools, to be inserted into the spine with less disturbance of the patient's internal organs. This can translate into less time and risk associated with preparing the spine for insertion as well as inserting the implant itself into the spine. Further, the laterally oriented keels offer substantial stability to the vertebral bodies during extension, flexion and lateral bending of the spine.
- In the embodiment shown in
FIG. 1A andFIG. 6A , the first andsecond keels ports ports second keels implants second keels outer surfaces implants implants ports second keels outer surfaces implant 600 can be coated with materials that promote bone growth such as for example bone morphogenic protein, BMP, or structural materials such as hyaluronic acid, HA, or other substance which promotes growth of bone relative to and into thekeels keel ports implant 600. - Further, a combination of the two embodiments shown in
FIG. 1A andFIG. 6A can be used to create a three-piece implant as will also be appreciated by those of ordinary skill in the art. For example, thefirst end plate 610 ofFIG. 6A with itssocket 636 from a two-piece embodiment can be combined with twosecond end plates 120 ofFIG. 1A from a four-piece embodiment to form an implant. Similarly, thesecond end plate 620 withspacer 630 of a two piece embodiment, such asFIG. 6A , can be combined with twofirst end plates 110 from a four-piece design, such asFIG. 1A , to achieve an implant. The features described herein for an interspinous implant for lateral insertion between adjacent vertebrae are applicable to two-, three-, or four-piece embodiments. None of these configurations depart from the scope of the invention. -
FIG. 1B depicts thepair 131 of first orupper end plates 110 and thepair 133 of second orlower end plates 120 in cross-section. Each upper andlower end plate keel teeth implant 600, different embodiments ofimplant 100 may have complete or partial extension of the first andsecond keels outer surfaces lower end plates teeth implant 100 when the embodiment is meant to be put into a slot in a vertebral body from the left lateral approach to the spine, and alternatively, theteeth implant 100 when the embodiments are meant to be put into a slot in a vertebral body from the right lateral approach to the spine. - In
FIG. 1B , thesocket 136 formed in the firstinner surface 116 offirst end plate 110 has a firstelongated sidewall 150, a corresponding second elongated sidewall 152 (shown inFIG. 3B ), anend wall 154, and anopen end 156. The open ends 156 of each of thefirst end plates 110 are oriented so that the open ends 156 face each other. Each of the first andsecond end plates first end second end first end plate 110 face each other, as do theends 143 of thesecond end plate 120. Thelower plates 120 each have an articulating element, orspacer 130, which is convex and hemi-cylindrical, that engage thesocket 136. The concave hemi-cylindricalinner surface 135 of thesocket 136 is sloped to allow thepair 131 of first orupper end plates 110 to easily slide, or rock, side-to-side on the articulating element, orspacer 130 and slide, or ride, forward and backward with enough looseness of fit to allow for some twisting in order to emulate the motion of the vertebral bone and intervertebral disk tissue. This arrangement, thus, has a sliding or translating pivot point. It is evident fromFIG. 1B that the first andsecond keels upper end plate 110 about thespacer 130 for this embodiment. This axis of articulation is longitudinally oriented with respect to the vertebrae, or about perpendicular to the sagittal plane of the spine. The alignment of the first andsecond keels implant 100 is inserted between the vertebrae of a patient. - As shown in
FIG. 1C , the articulating element, orspacer 130 has four sides: a firstelongated sidewall 140, a secondelongated sidewall 142, athird end wall 143, and afourth end wall 146. Thethird end wall 144 is flush with theend 143 of thelower end plate 120 of the implant. Thethird end wall 144 has aprofile height 160 and thefourth end wall 146 has aprofile height 162. Comparing theprofile heights inner surface 126 of thesecond end plate 120, the overall profile height of thethird end wall 144 is greater than the fourth end wall 146 (i.e., 160>162). Thus, it is evident that theupper surface 135 ofsocket 136 slopes downwardly from theend wall 144 to theend wall 146. Together spacers 130 comprise an articulating element that has a high surface where thethird end walls 144 abut each other and slope to a lower surface adjacent tofourth end walls 146. - In
FIG. 1C , the edges of the articulating element orspacer 130 are eased or rounded to allow for further range of motion of thepair 131 ofupper end plates 110 relative to thepair 133 oflower end plates 120. As will be appreciated by those of skill in the art, the overall height of thethird end wall 144 and thefourth end wall 146 can be equivalent while still having an effective thirdend wall height 160 that is greater than the effective fourthend wall height 162 due to the overall slope of the secondinner surface 126. Alternatively, the overall height of thethird end wall 144 and thefourth end wall 146, can be different with thethird end wall 144 having a height greater than thefourth end wall 146, thus eliminating the need for the secondinner surface 126 to have a slope or further increasing the net difference between the height of the third end wall and the forth end wall. Further, although thespacer 130 is depicted such that thethird end wall 144 is flush with thesecond end 143, those of skill in the art will appreciate that thespacer 130 could also be configured such that thethird end wall 144 is recessed relative to theend 143 of the second end plate. In such a configuration, thethird end wall 144 and theend 143 would not be flush. -
FIGS. 1D and 1E illustrate posterior views of theimplant 100 showing the clearance for left and right lateral bending. Typically, left and right lateral bending ranges from 3-5°. As evident from these figures, the length of thespacer 130 can be less than the length of thesocket 136. As shown, the open ends 156 of the sockets facilitate movement of the articulating elements, orspacers 130 within thesocket 136 to accommodate side-bending movement. -
FIG. 2A andFIG. 2B are views of theintervertebral implant 100, which depict the motion of thefirst end plate 110 relative to thesecond end plate 120. InFIG. 2A andFIG. 2B , a side view ofimplant 100 is depicted, showingfirst end plate 110 withsocket 136 and thesecond end plate 120 with the articulating element orspacer 130. As is apparent from the figures, the sloping of the firstinner surface 116 of thefirst end plate 110 facilitates rotation of the spacer and socket in an anterior A direction and a posterior P direction. As depicted, the firstinner surface 116 slopes from a high point at about where the socket is located to low points at theends upper end plate 110. As shown inFIG. 2A , theimplant 100 is positioned to achieve flexion (i.e., forward bending) in a range up to about 15°, but more preferably 10°, while inFIG. 2B , theimplant 100 is positioned to achieve extension (i.e., backward bending) in a preferable range of up to about 5°. -
FIG. 2C andFIG. 2D show cross sections ofimplant 100 through the sagittal plane of the vertebrae.FIG. 2C is a cross-section of the side view of theintervertebral implant 100 showing the mating of thespacer 130 to thesocket 136.FIG. 2D illustrates an alternate embodiment of thefirst end plate 110 wherein thesocket 136 hasridges channel second end plate 120. As will be appreciated by those of skill in the art, theprotuberances flexion 272 or extension 274 the protuberance orridge channels inner surface 116 and secondinner surface 126 of thefirst end plate 110 and thesecond end plate 120 to be flat and non-sloping as shown while still allowing for the implant to emulate forward and backward bending and allow for the blocking of the motion of the socket relative to the spacer. In this embodiment, it is noted that the first andsecond keels first end plate 110 about thespacer 130 for this embodiment, and where the articulation is about perpendicular to the sagittal plane of the spine. - Turning now to
FIG. 3A , a top view of one-half of theintervertebral implant 100 is shown. Each of the topfirst end plate 110 and the bottomsecond end plate 120 have abores 376 for receiving pins of an implant tool. Thefirst keel 114 on thefirst end plate 110 is positioned so that it is aligned in the same plane with thesecond keel 124 on thesecond end plate 120. Additionally, the length ofspacer 130 from thethird end wall 144 to thefourth end wall 146 is shorter than the length of thesocket 136 from theend wall 154 to theopen end 156, so that the fit of the spacer with the socket is somewhat loose. The loose fit of thespacer 130 in thesocket 136 allows thefirst end plate 110 to be able to twist somewhat relative to thesecond plate 120. This twisting action would generally be about an axis that is perpendicular to the first and secondinner surfaces second end plates implant 100 of this embodiment allows the spine to have movement in three orthogonal degrees of freedom, namely (1) forward and backward bending movement, (2) lateral side-to-side bending, and (3) twisting movement.FIGS. 3B and 3C show the relative rotation of the first orupper end plate 110 to the second orlower end plate 120 to achieve rotation about acentral axis 378. This rotation results in about a 3°-6° rotation about the axis (i.e., 3° of torso twisting in each direction). -
FIG. 4A andFIG. 4B show views of the first and second end plates, 110,120.FIG. 4A shows a perspective view of asecond end plate 120 of theintervertebral implant 100. The secondinner surface 126 of thesecond end plate 120 is shown with a hemi-cylindrical spacer 130 formed therefrom, and channels orgrooves spacer 130. As illustrated inFIG. 4A , thechannels spacer 130. However, as will be appreciated by those of skill in the art, thechannels spacer 130. The channels allow the sides of thespacer 130 to be made more perpendicular so as to create a greater blocking wall thus preventing the socket of theupper plate 100 from moving too much anteriorly or posteriorly relative to thelower plate 120.FIG. 4B shows a perspective view of thefirst end plate 110, with a firstinner surface 116 that opposes the secondinner surface 126. The firstinner surface 116 has a hemi-cylindrical socket 136 formed therein. Thesocket 136 ofFIG. 4B is configured to mate with thespacer 130 ofFIG. 4A . -
FIG. 4 c andFIG. 4 d show views of the first and second end plates, 110, 120 for an alternative embodiment ofimplant 100.FIG. 4 c shows a perspective view of an embodiment of the secondinner surface 126 of the second orlower end plate 120 ofimplant 100. The secondinner surface 126 of thelower end plate 120 has ahemispherical spacer 130 formed therefrom.FIG. 4 d shows a perspective view of an embodiment of the firstinner surface 116 of the first orupper end plate 110 ofimplant 100, which opposes the secondinner surface 126. The firstinner surface 116 of theupper end plate 110 has a socket orcavity 136 formed therein. In the embodiment ofFIG. 4 d, thesocket 136 has a concave hemispherical surface. Thesocket 136 allows thefirst end plate 110 to pivot or rotate onspacer 130. - In the embodiments shown in
FIG. 4A andFIG. 4B , it is noted that the first andsecond keels first end plate 110 about thespacer 130, relative to thesecond end plate 120. The first andsecond keels implant 100 inserted between the vertebrae of a patient. Additionally, the first andsecond keels implant 100, which is perpendicular to the sagittal plane of the spine. Additionally, as evidenced from the perspective views ofFIG. 4A andFIG. 4B , the perimeter shape of the upper andlower end plates upper end plate 110 and thelower end plate 120 can be the same. -
FIG. 5A andFIG. 5B show the implant after insertion between the vertebrae of a patient.FIG. 5A illustrates a posterior view of the implant shown inFIG. 1A implanted between vertebral bodies in a spine.FIG. 5A illustrates thespinal column 500 and the cauda equina 504 (a collection of lumbar and sacral nerve roots that fill the caudal end of the spinal cord) withindividual nerves 506 exiting the cord between lumbar vertebrae. Theimplant 100 is positioned between twovertebral bodies second keels FIG. 5B illustrates a side view of the implant inserted betweenvertebral bodies FIG. 1A , orFIG. 6A . The gap between thefirst end plate 110 and thesecond end plate 120 at the anterior “A” face ofimplants implants implants implants first keels 114 extending from thefirst end plate 110, and twosecond keels 124 extending from thesecond end plate 120. The first andsecond keels first end plate 110 relative to thesecond end plate 120, about thespacer 130. - The embodiments of
implants - One class of materials contemplated for use in
implant 100 is the class of biocompatible polymers. Copolymers, blends and composites of polymers are also contemplated for fabrication of parts of the disclosed device. 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. - One group of biocompatible polymers are the polyaryl ester ketones which has several members, which include polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK has proven as a durable material for implants, as well as meeting criteria of biocompatibility. Medical grade PEEK is available from Victrex Corporation 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. Still another interesting group of biocompatible polymers are polyalkyl biocompatible polymers, such as polyethylenes, polypropylenes, and the like.
- These medical grade biocompatible polymers are also available as reinforced polymer materials. To reinforce a polymeric material, fillers, are added to a polymer, copolymer, polymer blend, or polymer composite. Fillers are added to modify properties, such as mechanical, optical, and thermal properties. In this case, fillers, such as carbon fibers, are added to reinforce the polymers mechanically to enhance strength for certain uses, such as load bearing devices.
- In addition to disclosure of embodiments of an intervertebral implant, tools for preparing and inserting an intervertebral implant are also disclosed.
FIG. 7A through 7D show an embodiment of a tool for preparing vertebral bodies to receiveimplants FIG. 8A throughFIG. 8D show an embodiment of a tool for inserting embodiments of the disclosedintervertebral implants -
FIG. 7A throughFIG. 7C are the top view, the side view, and an end view of thecutting tool 700. Thecutting tool 700 has ahandle 710 at its proximal end for controlling the tool during operation. As will be appreciated by those of skill in the art, thehandle 710 can be removable or affixed to the cutting end. Thedistal end 702 of thetool 700 is solid head has anupper surface 705, and alower surface 706. Theupper surface 705 has afirst blade 712 mounted thereon, and thelower surface 706 has asecond blade 714 mounted thereon. Preferably thefirst blade 712 is about centered with theupper surface 705, and thesecond blade 714 is about centered with thelower surface 706. The first andsecond blades second keels implants implants FIG. 7C is a view of the distal end of thecutting tool 700 showing thebeveled end 716 and the first andsecond blades head 702 of thecutting tool 700 approximates the distance between two vertebral bodies or the height of the disk space. In this embodiment of cuttingtool 700, theblades head 702. - As will be appreciated by those of skill in the art, the tool shown in
FIG. 7A can be modified such that instead of cutting keel-receiving channels in the upper and lower vertebral bodies at the same time, two tools are provided so that only one vertebral body is cut for keel-receiving channels at a time. For example, an alternative embodiment of cuttingtool 700 has a first tool with a single blade mounted on thehead 702. A second tool could be provided having a single blade mounted on thehead 702, and additionally on the opposing surface, a guide. The guide on the surface opposite the surface with the blade is designed to engage with the first keel receiving channel cut the first vertebrae with the first tool to ensure that the second cut is optimally aligned with the first cut. -
FIG. 8A throughFIG. 8D depict an embodiment of the implanting tool used to insert theimplant 600 ofFIG. 6A between vertebral bodies.FIG. 8A is a side view of theimplantation tool 800 that has ahandle 810 and animplant holder 820. Theimplant holder 820 has animplant conforming surface 824 and fourpins 822 for holding thefirst end plate 610 and thesecond end plate 620implant 600. The conformingsurface 824 is curved to follow the convex outer LL edges of the first andsecond end plates implant 600 nests within a conformingsurface 824 and is held bypins 822.FIG. 8C shows the distal view of the end of the tool with fourpins 822 for securing the first and second end plate of the implant. - A variety of kits can be assembled that include an implant 100 (or 600) sized for a particular patient. The kit could also include
several cutting tools 700 and several implantingtools 800 or a single handle that cooperates with cutting ends 702 and implantation ends 820. -
FIG. 9 is a block diagram showing the basic steps of the method for laterally inserting the embodiments ofimplants lateral access 910, then the intervertebral disk is removed laterally 920, if necessary. A tool, such as the one depicted inFIG. 7A is inserted laterally between the vertebral bodies to create channels in the bodies to receive the keels of the implant. The implant is then inserted laterally 930 between two vertebrae and the wound is closed 940. This procedure can be followed for either a left lateral approach or right lateral approach. For a left lateral approach, theteeth lower keels implants - What has been disclosed herein has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit what is disclosed to the precise forms described. Many modifications and variations will be apparent to the practitioner skilled in the art. What is disclosed was chosen and described in order to best explain the principles and practical application of the embodiments described herein, thereby enabling others skilled in the art to understand the various embodiments and various modifications that are suited to the particular use contemplated. It is intended that the scope of what is disclosed be defined by the following claims and their equivalence.
Claims (27)
Priority Applications (1)
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US10/981,863 US20050154462A1 (en) | 2003-12-02 | 2004-11-05 | Laterally insertable artificial vertebral disk replacement implant with translating pivot point |
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US10/981,863 US20050154462A1 (en) | 2003-12-02 | 2004-11-05 | Laterally insertable artificial vertebral disk replacement implant with translating pivot point |
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US20050154462A1 true US20050154462A1 (en) | 2005-07-14 |
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US10/981,863 Abandoned US20050154462A1 (en) | 2003-12-02 | 2004-11-05 | Laterally insertable artificial vertebral disk replacement implant with translating pivot point |
US10/981,807 Expired - Fee Related US7503935B2 (en) | 2003-12-02 | 2004-11-05 | Method of laterally inserting an artificial vertebral disk replacement with translating pivot point |
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US10/981,807 Expired - Fee Related US7503935B2 (en) | 2003-12-02 | 2004-11-05 | Method of laterally inserting an artificial vertebral disk replacement with translating pivot point |
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US20050033435A1 (en) * | 2003-08-04 | 2005-02-10 | Spine Next | Intervertebral disk prosthesis |
US20050143820A1 (en) * | 2003-12-02 | 2005-06-30 | St. Francis Medical Technologies, Inc. | Method of laterally inserting an artificial vertebral disk replacement implant with translating pivot point |
US20050154467A1 (en) * | 2004-01-09 | 2005-07-14 | Sdgi Holdings, Inc. | Interconnected spinal device and method |
US20050171609A1 (en) * | 2004-01-09 | 2005-08-04 | Sdgi Holdings, Inc. | Spinal arthroplasty device and method |
US20060089654A1 (en) * | 2004-10-25 | 2006-04-27 | Lins Robert E | Interspinous distraction devices and associated methods of insertion |
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Owner name: KYPHON, INC., CALIFORNIA Free format text: TERMINATION/RELEASE OF SECURITY INTEREST;ASSIGNOR:BANK OF AMERICA, N.A.;REEL/FRAME:020679/0107 Effective date: 20071101 Owner name: KYPHON, INC.,CALIFORNIA Free format text: TERMINATION/RELEASE OF SECURITY INTEREST;ASSIGNOR:BANK OF AMERICA, N.A.;REEL/FRAME:020679/0107 Effective date: 20071101 |
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AS | Assignment |
Owner name: MEDTRONIC SPINE LLC, CALIFORNIA Free format text: CHANGE OF NAME;ASSIGNOR:KYPHON INC;REEL/FRAME:020993/0042 Effective date: 20080118 Owner name: MEDTRONIC SPINE LLC,CALIFORNIA Free format text: CHANGE OF NAME;ASSIGNOR:KYPHON INC;REEL/FRAME:020993/0042 Effective date: 20080118 |
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AS | Assignment |
Owner name: KYPHON SARL, SWITZERLAND Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDTRONIC SPINE LLC;REEL/FRAME:021070/0278 Effective date: 20080325 Owner name: KYPHON SARL,SWITZERLAND Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDTRONIC SPINE LLC;REEL/FRAME:021070/0278 Effective date: 20080325 |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |