WO2004039241A2

WO2004039241A2 - Artificial vertebral disk replacement implant with crossbar spacer and method

Info

Publication number: WO2004039241A2
Application number: PCT/US2003/033942
Authority: WO
Inventors: Steve Mitchell
Original assignee: St. Francis Medical Technologies, Inc.
Priority date: 2002-10-29
Filing date: 2003-10-27
Publication date: 2004-05-13
Also published as: US20070208425A1; WO2004039241A3; AU2003286694A1; US7452379B2; US20040172135A1; AU2003286694A8; US20050010296A1; US7273496B2

Abstract

The present invention is directed to a device with that can be placed between two vertebrae. The implant is characterized by having a first plate (110) and a second plates (120) with a crossbar (130) therebetween. The crossbar fits within cavities (150) on each of the first and second plate and allows for pivotal or rotational motion and also for twisting.

Description

ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH CROSSBAR SPACER AND METHOD

CLAIM OF PRIORITY

[0001] This application claims priority to U.S. Provisional Application No.

60/422,021, filed on October 29, 2002, entitled "ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH CROSSBAR SPACER AND METHOD" (Attorney Docket No. KLYC-01065US1), which is included herein by reference.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to U.S. Provisional Application No.

60/422,039, filed October 29, 2002, entitled "ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT AND METHOD," (Attorney Docket No. KLYCD-05007USO), U.S. Patent Application No.

10/ , , filed October 14, 2003, entitled "ARTIFICIAL VERTEBRAL DISK

REPLACEMENT IMPLANT WITH TRANSLATING PIVOT POINT AND METHOD" (Attorney Docket No. KLYCD-05007US1), U.S. Provisional Application No. 60/422,011, filed October 29, 2002, entitled "TOOLS FOR IMPLANTING AN ARTIFICIAL VERTEBRAL DISK AND METHOD" (Attorney Docket No.

KLYCD-05009US0), U.S. Patent Application No. 10/ , , filed October 14,

2003, entitled "TOOLS FOR IMPLANTING AN ARTIFICIAL VERTEBRAL DISK AND METHOD" (Attorney Docket No. KLYCD-05009US1), U.S. Provisional Application No. 60/422,022, filed October 29, 2002, entitled "ARTIFICIAL VERTEBRAL DISK REPLACEMENT IMPLANT WITH A SPACER AND METHOD," (Attorney Docket No. KLYCD-05010US0), and U.S. Patent Application

No. 10/ , , filed October 14, 2003, entitled "ARTIFICIAL VERTEBRAL DISK

REPLACEMENT IMPLANT WITH SPACER AND METHOD," (Attorney Docket No. KLYCD-05010US1), which are incorporated herein by reference. FIELD OF THE INVENTION

[0003] This invention relates to an artificial vertebral disk replacement and method.

BACKGROUND OF THE INVENTION

[0004] 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.

[0005] As the present society ages, it is anticipated that there will be an increase in adverse spinal conditions which are characteristic of older people. Pain associated with such conditions can be relieved by medication and/or surgery. Of course, it is desirable to eliminate the need for major surgery for all individuals, and, in particular, for the elderly.

[0006] More particularly, over the years, a variety of intervertebral implants have been developed in an effort to relieve the pain associated with degenerative and dysfunctional disk conditions. For example, U.S. Patent 4,349,921 to Kuntz discloses an intervertebral disk prosthesis. The Kuntz prosthesis is designed to restore the space between the disks.

[0007] U.S. Patent 4,714,469 to Kenna discloses a spinal implant that fuses vertebrae to the implant. The implant has a rigid body that fits between the vertebra with a protuberance extending from a vertebral contacting surface and extends into the vertebral body.

[0008] U.S. Patent 5,258,031 to Salib et al. discloses another prosthetic disk with a ball that fits into a socket. [0009] U.S. Patents 5,425,773 and 5,562,738 are related patents to Boyd et al. that disclose a disk arthroplasty device for replacement of the spinal disk. A ball-and- socket are provided to enable rotation.

[0010] U.S. Patent 5,534,029 to Shima discloses an articulated vertebral body spacer with a pair of upper and lower joint pieces inserted between the vertebra. An intermediate layer is provided to allow for movement between the upper joint piece and the lower joint piece.

[0011] U.S. Patent 5,782,832 to Larsen et al. discloses a two-piece ball-and- socket spinal implant with upper and lower plates for insertion within the intervertebral space.

[0012] U.S. Patent 6,156,067 to Bryan et al. discloses a prosthesis having two plates with a nucleus therebetween.

[0013] None of these solutions provide an implant that restores a wide range of natural movement.

[0014] Accordingly, there needs to be developed implants for alleviating such conditions and restoring natural movement.

SUMMARY OF THE INVENTION

[0015] Embodiments of the present invention are directed to providing an implant for alleviating discomfort associated with the spinal column. One embodiment of the implant is characterized by having a first plate and a second plate with a crossbar therebetween.

[0016] Other aspects, objects, features and elements of embodiments of the invention are described or are evident from the accompanying specification, claims and figures. Brief Description of the Drawines

[0017] Fig. la is a front view of an embodiment of an implant of the invention. Fig. lb is a side view of an embodiment of an implant of the invention. Fig. lc is a top view of an embodiment of the implant of the invention. Fig. Id is a top view of an embodiment of the first surface of the top plate of the implant of the invention. Fig. le is a perspective view of an embodiment of the upper plate of the implant of the invention. Fig. If is a plan view of the first surface of the lower plate of an embodiment of the implant of the invention. Fig. lg is a perspective view of the lower plate of an embodiment of the implant of the invention. Fig. lh is a cross- sectional view of the upper and lower plates of an embodiment of the implant of the invention taken at H-H in Fig. la.

[0018] Fig. 2a is an upper view of a crossbar of an embodiment of the implant of the invention. Fig. 2b is a side view of a crossbar of an embodiment of the implant of the invention. Fig. 2c is a lower view of a crossbar of an embodiment of the implant of the invention. Fig. 2d is a perspective view of a crossbar of an embodiment of the implant of the invention.

[0019] Fig. 3 is a perspective view of an assembled implant of an embodiment the invention.

[0020] Fig. 4 is a side view of the implant implanted between the vertebral bodies.

[0021] Fig. 5 is a block diagram showing the method steps for implanting the implant of the invention. Detailed Description of the Preferred Embodiments of the Invention

[0022] The following description is presented to enable any person skilled in the art to make and use the invention. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. To the extent necessary to achieve a complete understanding of the invention disclosed, the specification and drawings of all patents and patent applications cited in this application are incorporated herein by reference.

[0023] Fig. la shows an embodiment of the implant 100 of the invention. The implant 100 has a first part or plate 110 that is configured to mate with a first vertebra and a second part or plate 120 that is configured to mate with a second vertebra. The first plate 110 is an upper plate and the second plate 120 is a lower plate. A third part 130 that sits between the first plate 110 and the second plate 120 is also provided. The third part 130 acts as a spacer between the first plate 110 and the second plate 120 and facilitates pivotal or rotational and also twisting movement of the first plate 110 and the second plate 120, relative to each other. The third part 130 is in the form of a crossbar as discussed in more detail below.

[0024] The upper plate 110 has a first surface 112 from which a keel 114 extends with teeth 115. The teeth in this embodiment point forward or anteriorly when the embodiment is meant to be put into a slot in a vertebral body from the anterior of the spine. The teeth in an alternative embodiment would point rearward or posteriorly when the embodiment is meant to be put into a slot in a vertebral body from the posterior of the spine. The first surface 112, or upper surface, abuts the vertebral body when the implant 100 is implanted. The first keel 114 extends into the vertebral body to anchor the implant into position. The second surface 116, or lower surface, engages the spacer 130 of the implant and faces the second plate 120. The second surface 116 can form a planar surface that is parallel to the first surface 112, or can form a planar surface that is not parallel to the first surface 112.

[0025] When the implant is implanted between spinous processes the planar surfaces corresponding to the first surface 112 and the second surface 116 of the first plate 110 lie within, or substantially within, the axial plane of the body, while the first keel 114 (which is at or near a 90° angle from the surfaces 112, 116) is aligned within the sagittal plane of the body.

[0026] The lower plate 120 has a first surface 122 from which a keel 124 extends with teeth 125. The first surface 122, or lower surface, abuts the vertebral body when the implant 100 is implanted. The second keel 124 extends into the vertebral body to anchor the implant into position. The second surface 126, or upper surface, engages the spacer 130 of the implant and faces the first plate 110. The second surface 126 can form a planar surface that is parallel to the first surface 122, or can form a planar surface that is not parallel to the first surface. The first surface 112 of the first plate 110 can be parallel to the first surface 122 of the second plate 120 when the implant 100 is assembled and is in a neutral position (i.e., the position where the first plate 110 has not rotated relative to the second plate 120). Alternatively, the first surface 112 of the first plate 110 can be non-parallel to the planar surface of the first surface 122 of the second plate 120 when the implant 100 is assembled and in a neutral position.

[0027] As with the first plate, when the implant is implanted between vertebral bodies the planar surfaces corresponding to the first surface 122 and the second surface 126 of the second plate 120 lie within, or substantially within, the axial plane of the body while the second keel 124 (which is at or near a 90° angle from the surfaces 122, 126) is aligned within the sagittal plane of the body.

[0028] Fig. lb shows a side view of an embodiment of the implant 100 of the invention shown in Fig. la. Again, the implant 100 has a first plate 110 that is configured to mate with a first vertebra and a second plate 120 that is configured to mate with a second vertebra. The spacer 130 separates the first plate 110 from the second plate 120. Fig. lc shows a top view of the upper plate 110 with the upper surface 112 and the upper keel 114. As evidenced from the upper view, the perimeter shape of the upper plate 110 can be configured to correspond to the perimeter shape of a vertebral disk. This is particularly advantageous where a single implant is placed between two vertebral bodies from an anterior approach. As will be appreciated by those of skill in the art, the perimeter shape of the upper plate 110 and the lower plate 120 can be the same.

[0029] Fig. Id and Fig. le show an embodiment of the first or upper plate 110 of the implant 100 of the invention. The upper plate 110 has a second surface 116 having a channel 150 therein. As will be discussed below, the spacer includes a beam which can be placed into the channel 150 in order to allow the first and second plates of the assembled implant to pivot or rotate relative to each other. The curved side 152 of the first plate 110 is oriented to be anterior A after the device is implanted. The flat side 154 of the first plate 110 is oriented to be posterior P after the device is implanted. As shown in Fig. le, the second surface 116 can be formed so that it is received with a ridge 117 surrounding the second surface 116.

[0030] Fig. If and Fig. lg show the second or lower plate 120 of the implant

100 of the invention. The lower plate 120 has a second surface 126 having a channel 160 therein. As will be discussed below, the spacer includes a beam which can be placed into the channel 160 in order to allow the first and second plates of the assembled implant to pivot or rotate relative to each other. The curved side 162 of the second plate 120 is oriented to be anterior A after the device is implanted. The flat side 164 of the second plate 120 is oriented to be posterior P after the device is implanted. As shown in Fig. lg, the second surface 126 can be formed so that it is recessed with a ridge 127 surrounding the second surface 126. [0031] Fig. lh is a cross-section of the upper plate 110 and the lower plate 120 taken along the lines H-H of Fig. la. As shown in Fig. lh, the second surface 116 of the first plate 110 faces the second surface 126 of the second plate 120.

[0032] In Fig. 2, the crossbar or spacer 130 is shown. Fig. 2a is an upper view of an embodiment of a crossbar or spacer 130 of the implant of the invention. The crossbar 130 has a first beam 210 and a second beam 220. Each beam 210, 220, has a first end 212, 222, and a second end 214, 224, and a midpoint 216, 226, respectively. Fig. 2b shows a side view of a crossbar 130 of the implant 100 of the invention. As is apparent from the side view, the first beam 210 can be configured to sit above the second beam 220. Fig. 2c shows the crossbar 130 of the implant of the invention from a bottom view with the first beam 210 configured to sit above the second beam 220.

[0033] The first beam 210 can be configured to be positioned transversely along the length of the second beam 220 at a point preferably corresponding about the midpoint 226 of the second beam 220. The second beam 220 can be configured to be positioned along the length of the first beam 210 at a point preferably corresponding about the midpoint 216 of the first beam 210. Where both beams are positioned at the respective midpoints 216, 226 the crossbar forms a "+".

[0034] In the alternative embodiment, the first beam 210 can also be configured to be positioned transversely along the length of the second beam 220 at a point corresponding to a location between the midpoint 226 and an end (222, 224). The second beam 220 can be configured to be positioned transversely along the length of the first beam 210 at a point corresponding to about the midpoint 216 of the first beam 210. Where one beam 210, 220 is positioned along the length between the midpoint and an end of the other beam, the crossbar forms "T".

[0035] In constructing the crossbar 130, the first beam 210 can be formed integrally with the second beam 220 such that is unitary in construction. Alternatively, the first beam 210 can be adhered to the second beam 220 using a suitable method, such as spot welding. [0036] Fig. 2d shows a perspective view of a crossbar or spacer 130 of the implant of the invention. As shown in Fig. 2d, the first beam 210 and the second beam 220 are configured so that the second beam 220 is positioned along the length of the first beam 210 at a point between the midpoint 226 of the second beam 220 and an end 222 of the second beam 220.

[0037] Viewing Figs, la, lb and 3, an assembled embodiment of the implant

100 of the invention is depicted. The implant 100 has a first plate 110 that is configured to mate with a first vertebra and a second plate 120 that is configured to mate with a second vertebra. A crossbar 130 that sits between the first plate 110 and the second plate 120 is also provided. As is evident from the figures, the upper beam 210 is placed in the channel 150 of the upper plate 110 such that the upper beam is about perpendicular to the keels 114 and 124. As can be seen from Fig. lb, the upper beam is positioned toward the posterior of the implant 100. In alternative embodiments the upper beam can be positioned midway between the posterior and the anterior of the implant 100. The lower beam 220 is placed in the channel 160 of the lower plate 120 such that the lower beam is about parallel to the keels 114 and 124. The crossbar 130 acts as a spacer between the first plate 110 and the second plate 120 and facilitates pivotal or rotational movement of the first plate 110 and the second plate 120, relative to each other. With the implant 100 placed between vertebral bodies of a patient, the keels 114 and 124 are directed along a posterior to anterior line or in the sagittal plane of the patient. Accordingly as the patient bends forward or backward the upper plate 110 can pivot or rotate about the beam 210. When the patient bends laterally or side to side, the lower beam 220 can pivot or rotate in the lower channel 160, allowing the upper beam 210 to pivot or rotate about the lower beam 220 and also allowing the upper plate 110 to pivot or rotate about the lower beam 220, and, thus, relative to the lower plate 120. In an alternative embodiment, there is a loose fit between the spacer 130 and the first and second plates, and, in particular, there is a loose fit between the upper beam 210 and the upper channel 150 and also between the lower beam 220 and the lower channel 160. This loose fit allows for a twisting motion about an axis that is perpendicular to the plates as, for example, perpendicular to the surface 112 of the upper plate. Thus, this loose fit allows for twisting about the length of the spine.

[0038] As illustrated in Figs, lb, lg and 3, the ridge 127 adjacent to the second surface 126 of the lower plate is not parallel to the first surface 122 of the lower plate nor to the upper plate.

[0039] The orientation of the plates 110, 120 in Figs, la, lb and 3, show the implant 100 assembled in a neutral position (i.e., the position where the first plate 110 has not rotated relative to the second plate 120). The distance between the first plate 110 and the second plate 120 enable the implant to achieve movement in forward, backward, lateral and rotational directions.

[0040] Fig. 4 shows a side view of an implant 100 of the invention implanted between two vertebrae 410, 420. Given the difference between the first plate 110 and the second plate 120 at its anterior end A and its posterior end P, i.e., the distance between the plates is greater at the anterior A end than the posterior P end, forward (bending) movement is facilitated to a greater degree than backward (bending) movement. Thus, for this embodiment, an example of a forward bending movement of up to 10° can be achieved while a backward bending movement of 5° will be achieved. By sloping the lower plate and/or the upper plate toward the posterior portion, the amount of backward bending can be increased.

[0041] In a preferred embodiment, the implant can be made of titanium or a stainless steel that is approved for implantation into a patient. Other materials that have appropriate structural strength and that are suitable for implantation into a patient can also be used.

[0042] Fig. 6 is a block diagram showing the basic steps of the method of inserting the implant 100 of this invention. First the spine is exposed 610, then the intervertebral disk is removed 620 and the implant is inserted 630. Finally, the wound is closed 640. This procedure can be followed for either an anterior approach or posterior-lateral approach. Additional steps, such as cutting channels into the vertebral bodies to accept the keels of the plates and assembling the implant by inserting the crossbar member between the upper and lower plates prior to installation can also be performed without departing from the scope of the invention.

[0043] The foregoing description of embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to the practitioner skilled in the art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention and the various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and its equivalence.

Claims

What is claimed:

1. An implant with a first piece having a first socket, a second piece having a second socket and a crossbar member that is at least partially received in the first socket and the second socket.

2. The implant of claim 1 wherein the crossbar member has first and second bars that are perpendicular.

3. The implant of claim 1 wherein the crossbar member has a first bar that is mounted above the second bar.

4. The implant of claim 1 wherein the crossbar member can pivot on itself.

5. The implant of claim 1 wherein one of the first and second socket is sloped to allow a rocking motion.

6. The implant of claim 1 wherein the crossbar forms a cross.

7. The implant of claim 1 wherein the crossbar forms a "T".

8. The implant of claim 1 wherein the crossbar forms a "+".

9. The implant of claim 1 wherein the crossbar has a first beam and a second beam and further wherein the first beam of the crossbar crosses the second beam of the crossbar at a midpoint along the second beam.

10. The implant of claim 9 wherein the first beam of the crossbar and the second beam of the crossbar are formed integrally.

11. The implant of claim 9 wherein the first beam of the crossbar and the second beam of the crossbar are adhered to each other.

12. The implant of claim 9 wherein the first beam of the crossbar abuts the second beam of the crossbar.

13. The implant of claim 9 wherein the first beam of the crossbar is positioned at least partially above the second beam of the crossbar.

14. The implant of claim 1 wherein the crossbar has a first beam and a second beam and further wherein the first beam of the crossbar crosses the second beam of the crossbar between a midpoint of the second beam and an end point of the second beam.

15. The implant of claim 1 wherein the first piece has a first surface and a second surface wherein the first socket is located on the first surface and a keel extends from the second surface.

16. The implant of claim 15 wherein the keel is oriented in a first plane and the first socket is oriented in a second plane, and further wherein the first plane and the second plane are perpendicular to each other.

17. The implant of claim 15 wherein the keel is oriented in a first plane and the first socket is oriented in a second plane, and further wherein the first plane and the second plane are parallel to each other.

18. The implant of claim 15 wherein the second piece has a first surface and a second surface wherein the second socket is located on the first surface and a keel extends from the second surface.

19. The implant of claim 18 wherein the keel is oriented in a first plane and the first socket is oriented in a second plane, and further wherein the first plane and the second plane are perpendicular to each other.

20. The implant of claim 18 wherein the keel is oriented in a first plane and the first socket is oriented in a second plane, and further wherein the first plane and the second plane are parallel to each other.

21. An implant adapted to be placed between two vertebral bodies comprising: an upper implant further comprising, a first surface that is adapted to contact a bottom surface of an upper vertebral body, and a second surface having a first concave socket; a lower implant further comprising, a first surface that is adapted to contacting an upper surface of a lower vertebral body, and a second surface having a first concave socket; and a crossbar member with a first beam that is received in the first socket of the upper implant and a second beam that is received in the first socket of the lower implant.

22. The implant of claim 21 wherein the concave socket in the upper implant is oriented to lie in a plane parallel to a sagittal plane of a patient.

23. The implant of claim 21 wherein the concave socket in the upper implant is oriented to lie in a plane peφendicular to a sagittal plane of a patient.

24. A method of implanting a device between an upper and lower vertebral body in a spine, the method comprising: a. exposing an affected region of the spine anteriorly; b. removing an affected disk; c. cutting a keel receiving channel into the upper and lower vertebral body using a keel cutting tool; d. assembling the implant by inserting a crossbar member between an upper implant and a lower implant; and e. inserting the assembled implant between the vertebral bodies.

25. A method of implanting a device between an upper and lower vertebral body in a spine, the method comprising: a. exposing an affected region of the spine posteriorly; b. removing an affected disk; c. cutting a keel receiving channel into the upper and lower vertebral body using a keel cutting tool; d. assembling the implant by inserting a crossbar member between an upper implant and a lower implant; and e. inserting the assembled implant between the vertebral bodies.

26. An implant adapted to be mounted between adjacent vertebral bodies comprising: an upper plate having a first surface that is adapted to engage a lower surface of an upper vertebral body, and a second surface with a socket; a lower plate having a first surface that is adapted to engage an upper surface of a lower vertebral body, and a second surface with a socket; a crossbar member having a first beam that is mounted at least partially above and across a second beam; and wherein the first beam is positioned in one of the socket of the upper plate and the socket of the lower plate, and the second beam is positioned in the other of the socket of the upper plate and the socket of the lower plate.

27. The implant of claim 26 wherein one of the socket of the upper plate and the socket of the lower plate is oriented in a plane parallel to a sagittal plane of a patient and the other of the socket of the upper plate and the socket of the lower plate is oriented in a plane that is peφendicular to a sagittal plane of a patient.

28. The implant of claim 26 including a first keel extending from the first surface of the upper plate and adapted to engage the upper vertebral body, and a second keel extending from the first surface of the lower plate and adapted to engage the lower vertebral body.

29. The implant of claim 26 wherein said second surface of the upper plate and the second surface of the lower plate slope away from each other.

30. The implant of claim 26 wherein at least one of the second surface of the upper plate and the second surface of the lower plate has a portion that slopes away from the socket in order to allow for a greater freedom of motion between the upper and the lower plates.

31. The implant of claim 26 wherein at least one of the second surface of the upper plate and the second surface of the lower plate has a portion that slopes away from the socket.

32. The implant of claim 26 wherein a fit between the crossbar and the sockets of the upper and lower plates is loose in order to allow for a twisting motion between the upper and the lower plates.

33. The implant of claim 26 wherein said upper plate can rotate on one of the beams of the crossbar and the lower plate can rotate on the other of the beams of the crossbar.

34. The implant of claim 26 wherein said upper plate can rotate about a first axis on one of the beams of the crossbar and the lower plate can rotate about a second axis that is peφendicular to the first axis on the other of the beams of the crossbar.

35. An implant adapted to be positioned between vertebral bodies comprising: a first member with a first socket; a second member with a second socket; a spacer received in the first socket and the second socket with the spacer spacing the first member from the second member and allowing the first member to rotate about the spacer about a first axis and allowing the second member to rotate about the spacer about a second axis that is not parallel to the first axis.

36. An implant to be positioned between vertebral bodies comprising: a first member adapted to engage a first vertebral body; a second member adapted to engage a second vertebral body; a spacer that spaces the first member from the second member; the spacer having a first axis about which the first member can rotate and a second axis about which the second member can rotate, with the first axis and the second axis not being parallel.