Prosthetic spinal disc replacement

• US 7,621,956 B2
• Filed: 04/20/2004
• Issued: 11/24/2009
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Angelucci, Christopher, Paul, David C.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Woodall; Nicholas
• Application Number:
  US10/827,642
• Publication Number:
  US 20050043800A1
• Time in Patent Office: 2,044 Days
• Field of Search: 606/61, 623/17.11, 623/17.14, 623/17.15, 623/17.16
• US Class Current: 623/17.15
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1735 for rasps or chisels
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30365 with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30568 Multiple spring systems including two or more helical springs
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30649 : Ball-and-socket joints
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30769 : madreporic
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

The present invention relates generally to a prosthetic spinal disc for replacing a damaged disc between two vertebrae of a spine. The present invention also relates to a method for implanting a prosthetic spinal disc via posterior or posterior lateral implantation. Other surgical approaches for implanting the prosthetic disc may also be used. The present invention also involves a method for implanting the prosthetic spinal disc while either avoiding or minimizing contact with the spinal cord and nerve rootlets, or reducing the time and extent that they need to be repositioned during implantation.

Claims

1. An intervertebral artificial disc for replacement of a damaged spinal disc between two vertebrae having facing endplates comprising:

a first rigid plate having a first surface configured and adapted to substantially engage with a first endplate of a first vertebral body, wherein said first rigid plate comprises a contoured, partially spherical seating surface;

a second rigid plate having a second surface configured and adapted to engage with a second endplate of a second vertebral body, wherein said second rigid plate comprises a contoured, partially cylindrical seating surface;

first core elements at least partially disposed between the first and second rigid plates, wherein said first core element comprises a first contoured surface in communication with and substantially corresponding to the curvature of the first rigid plate seating surface, and a second contoured surface substantially in communication with and substantially corresponding to the curvature of the second rigid plate seating surfaces,

wherein the contact between the second rigid plate seating surface and the second contoured surface of the first core element forms a line of contact

a third rigid plate configured and adapted to engage with the first endplate of the first vertebral body, wherein said third rigid plate comprises a contoured, partially spherical seating surface having substantially the same radius of curvature as the first rigid plate seating surface;

a fourth rigid plate configured and adapted to engage with the second endplate of the second vertebral body, wherein said fourth rigid plate comprises a contoured, partially cylindrical seating surface having substantially the same radius of curvature as the second rigid plate seating surface; and

a second core element at least partially disposed between the third and fourth rigid plates, wherein said second core element comprises a first contoured surface substantially corresponding to the curvature of the third rigid plate seating surface, and a fourth contoured surface substantially corresponding to the curvature of the fourth rigid plate seating surface;

wherein said third rigid plate, fourth rigid plate, and second core element form a second assembly

wherein the first rigid plate having one portion of the semi-spherical curvature and the third rigid plate having a second portion of the semi-spherical curvature and the first and second portions define a complete spherical curvature

wherein the first rigid plate and the third rigid plate are spaced apart to maintain a constant diameter of the spherical curvature of the first and third rigid plates,

wherein the second rigid plate comprises a constraining element for retaining the first core element within the contoured cylindrical seating surface;

wherein the fourth rigid plate comprises a constraining element for retaining the second core element within the contoured cylindrical seating surface.

2. The artificial disc of claim 1, wherein the first surface of the first rigid plate is configured to correspond to the natural curvature and shape of the first endplate of the first vertebral body.

3. The artificial disc of claim 2, wherein the second surface of the second rigid plate is configured to correspond to the natural curvature and shape of the second endplate of the second vertebral body.

4. The artificial disc of claim 1, wherein the first surface of the first rigid plate or the second surface of the second rigid plate is configured to correspond to a predetermined cut shape or contour.

5. The artificial disc of claim 4, wherein the first or second surface is substantially flat.

6. The artificial disc of claim 1, wherein the second rigid plate seating surface and the core element second contoured surface permit rotation of the core element relative to the second rigid plate substantially in the sagittal plane.

7. The artificial disc of claim 6, wherein the second rigid plate has a longitudinal axis and wherein the axis of rotation of the core element forms an angle from about 20°

to about 70°

.

8. The artificial disc of claim 7, wherein the angle between the second rigid plate longitudinal axis and the core element axis of rotation forms an angle from about 30°

to about 60°

.

9. The artificial disc of claim 7, wherein the second rigid plate has a longitudinal axis and wherein the axis of rotation of the core element is substantially perpendicular to the longitudinal axis.

10. The artificial disc of claim 6, wherein the second rigid plate has a longitudinal axis and wherein the axis of rotation of the core element is substantially parallel to the longitudinal axis.

11. The artificial disc of claim 6, wherein the artificial disk is capable of providing a moving JAR in the sagittal plane.

12. The artificial disc of claim 1, wherein contact between the first rigid plate seating surface and the first contoured surface of the first core element extends over an area.

13. The artificial disc of claim 12, wherein the contact between the second rigid plate seating surface and the second contoured surface of the first core element extends over an area.

14. The artificial disc of claim 1, wherein the contact between the second rigid plate seating surface and the second contoured surface of the first core element extends over an area.

15. The artificial disc of claim 1, wherein the first rigid plate is disposed above the first core element and the second rigid plate is disposed below the first core element.

16. The artificial disc of claim 1, wherein the first rigid plate comprises a first raised ridge of material that extends at least partially into the first endplate of the first vertebral body.

17. The artificial disc of claim 16, wherein the second rigid plate comprises a second raised ridge of material that extends at least partially into the second endplate of the second vertebral body.

18. The artificial disc of claim 1, wherein the first core element is at least partially formed of an elastomeric material.

19. The artificial disc of claim 1, further comprising mechanical stops that prevent lateral bending greater than 10 degrees in each direction.

20. The artificial disc of claim 1, further comprising mechanical stops that prevent total axial rotation greater than 5 degrees.

21. The artificial disc of claim 1, wherein the curvature of the second rigid plate seating surface is convex.

22. The artificial disc of claim 1, wherein the curvature of the second rigid plate seating surface is concave.

23. The artificial disc of claim 1, wherein the first rigid plate has a length from about 18 to about 35 mm.

24. The artificial disc of claim 23, wherein the first rigid plate has a length from about 22 to about 26 mm.

25. The artificial disc of claim 23, wherein the first rigid plate has a width from about 9 mm to about 18 mm.

26. The artificial disc of claim 25, wherein the first rigid plate has a width from about 12 to about 14 mm.

27. The artificial disc of claim 1, wherein the first rigid plate has a width from about 7 mm to about 15 mm.

28. The artificial disc of claim 27, wherein the first rigid plate has a width from about 8 to about 12 mm.

29. The artificial disc of claim 1, wherein the first rigid plate has a width from about 12 mm to about 36 mm.

30. The artificial disc of claim 29, wherein the first rigid plate has a width from about 16 mm to about 28 mm.

31. The artificial disc of claim 1, wherein the core element and first rigid plate are formed from substantially similar materials.

32. The artificial disc of claim 31, wherein the core comprises a high molecular weight polymeric material.

33. The artificial disc of claim 32, wherein the core comprises a high molecular weight polyethylene.

34. The artificial disc of claim 32, wherein the core further comprises a radio opaque marker that is capable of indicating the orientation of the core.

35. The artificial disc of claim 34, wherein the radio opaque marker comprises two metallic pins.

36. The artificial disc of claim 1, wherein the core element is formed from a different material that the first rigid plate.

37. A method for replacing a damaged spinal disc between two vertebrae having facing endplates with an artificial disc comprising the steps of:

removing a damaged spinal disc disposed between a first vertebral body and a second vertebral body;

providing a first artificial disc assembly comprising;

a first rigid plate configured and adapted to engage with a first endplate of the first vertebral body, wherein said first rigid plate comprises a contoured, partially spherical seating surface;

a second rigid plate configured and adapted to engage with a second endplate of the second vertebral body, wherein said second rigid plate comprises a contoured, partially cylindrical seating surface; and

a first core element at least partially disposed between the first and second rigid plates, wherein said first core element comprises a first contoured surface in communication with and substantially corresponding to the curvature of the first rigid plate seating surface, and a second contoured surface substantially in communication with and substantially corresponding to the curvature of the second rigid plate seating surface;

a third rigid plate configured and adapted to engage with the first endplate of the first vertebral body, wherein said third rigid plate comprises a contoured, partially spherical seating surface having substantially the same radius of curvature as the first rigid plate seating surface;

a fourth rigid plate configured and adapted to engage with the second endplate of the second vertebral body, wherein said fourth rigid plate comprises a contoured, partially cylindrical seating surface having substantially the same radius of curvature as the second rigid plate seating surface; and

a second core element at least partially disposed between the third and fourth rigid plates, wherein said second core element comprises a first contoured surface substantially corresponding to the curvature of the third rigid plate seating surface, and a fourth contoured surface substantially corresponding to the curvature of the fourth rigid plate seating surface;

wherein said third rigid plate, fourth rigid plate, and second core element form a second assembly

wherein the first rigid plate having one portion of the semi-spherical curvature and the third rigid plate having a second portion of the semi-spherical curvature and the first and second portions define a, complete spherical curvature,

wherein the first rigid plate and the third rigid plate are spaced apart to maintain a constant diameter of the spherical curvature of the first and third rigid plates,

wherein the second rigid plate comprises a constraining element for retaining the first core element within the contoured cylindrical seating surface;

wherein the fourth rigid plate comprises a constraining element for retaining the second core element within the contoured cylindrical seating surface

removing at least a portion of a posterior element of the spine, preparing the first endplate and second endplate for receiving the artificial disc assembly;

positioning the first artificial disc assembly between the first and second vertebral bodies such that the first rigid plate at least partially engages with the first endplate of the first vertebral body and the second rigid plate at least partially engages with the second endplate of the second vertebral body.

38. The method of claim 37, wherein the first disc assembly and the second disc assembly cooperate to provide bending, rotation, and translation of the first vertebral body relative to the second vertebral body.

39. The method of claim 37, wherein the step of preparing the first endplate and second endplate for receiving the artificial disc assembly comprises the steps of:

providing a trial comprising;

a first protrusion on its superior surface that is capable of cutting a portion of the first endplate; and

a second protrusion on its inferior surface that is capable of cutting a portion of the second endplate;

cutting a portion of the first endplate where the first rigid plate will be received;

cutting a portion of the second endplate where the second rigid plate will he received;

extending a guide a predetermined distance from one side of the trial toward a location where the second assembly will be disposed;

providing a cutting tool in communication with the guide;

cutting a portion of the first endplate where the third rigid plate will be received; and

cutting a portion of the second endplate where the fourth rigid plate will be received.

40. The method of claim 37, further comprising the step of removing at least a portion of a posterior facet of the spine.

41. The method of claim 40, wherein the step of removing at least a portion of the transverse process preserves the structure of the vertebral foramen.

42. The method of claim 40, further comprising providing an insertion path for the first assembly, wherein the first vertebral body has an anterior-posterior axis, and wherein an angle formed between the direction of the insertion path for the assemblies and the anterior-posterior axis is from about 20°

to about 70°

.

43. The method of claim 42, wherein the angle formed between the insertion path and anterior-posterior axis is from about 30°

to about 60°

.

44. An intervertebral artificial disc for replacement of a damaged spinal disc between two vertebrae having facing endplates comprising:

a first rigid plate having a first surface configured and adapted to substantially engage with a first endplate of a first vertebral body, wherein said first rigid plate comprises a contoured, partially spherical seating surface;

a second rigid plate having a second surface configured and adapted to engage with a second endplate of a second vertebral body, wherein said second rigid plate comprises a contoured, partially spherical seating surface;

a first core element at least partially disposed between the first and second rigid plates, wherein said first core element comprises a first contoured surface in communication with and substantially corresponding to the curvature of the first rigid plate seating surface, and a second contoured surface substantially in communication with and substantially corresponding to the curvature of the second rigid plate seating surface;

a third rigid plate configured and adapted to engage with the first endplate of the first vertebral body, wherein said third rigid plate comprises a contoured, partially spherical seating surface having substantially the same radius of curvature as the first rigid plate seating surface;

a fourth rigid plate configured and adapted to engage with the second endplate of the second vertebral body, wherein said fourth rigid plate comprises a contoured, partially cylindrical seating surface having substantially the same radius of curvature as the second rigid plate seating surface; and

a second core element at least partially disposed between the third and fourth rigid plates, wherein said second core element comprises a first contoured surface substantially corresponding to the curvature of the third rigid plate seating surface, and a fourth contoured surface substantially corresponding to the curvature of the fourth rigid plate seating surface;

wherein said third rigid plate, fourth rigid plate, and second core element form a second assembly

wherein the first rigid plate having one portion of the semi-spherical curvature and the third rigid plate having a second portion of the semi-spherical curvature and the first and second portions define a complete spherical curvature,

wherein the first rigid plate and the third rigid plate are spaced apart such that the spherical curvature of the first and third rigid plates are maintained at a constant diameter,

wherein the second rigid plate comprises a constraining element for retaining the first core element within the contoured cylindrical seating surface;

wherein the fourth rigid plate comprises a constraining element for retaining the second core element within the contoured cylindrical seating surface;

wherein the contact between the second rigid plate seating surface and the second contoured surface of the first core element forms a line of contact

wherein the intervertebral artificial disc is capable providing of a moving instantaneous axis of rotation substantially in the sagittal plane.

45. The artificial disc of claim 44, further comprising a stop extending from the seating surface of the first rigid plate toward a channel formed in the core.

46. The artificial disc of claim 44, further comprising a stop extending from the seating surface of the second rigid plate toward a channel formed in the core.

47. The artificial disc of claim 44, further comprising a stop extending from the first or second seating surface toward a channel formed in the core, wherein the channel and stop cooperate to limit the range of motion of the core relative to one of the rigid plates.

48. The artificial disc of claim 47, wherein the channel and stop cooperate to limit motion of the core relative to one rigid plate substantially to the sagittal plane.

49. The artificial disc of claim 48, wherein the channel and stop are capable of preventing the core from being inadvertently expelled from between the first and second rigid plates.