Artificial disc prosthesis

• US 7,771,478 B2
• Filed: 04/02/2004
• Issued: 08/10/2010
• Est. Priority Date: 04/04/2003
• Status: Expired due to Fees

• Current Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Original Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Inventors: Theken, Randall R., Navarro, Richard R., Ananthan, Bharadwaj
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US10/552,094
• Publication Number:
  US 20060136061A1
• Time in Patent Office: 2,321 Days
• Field of Search: 606/61, 623 1711- 1716
• US Class Current: 623/17.15
• 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 2002/30372 with additional means for limiting said translation
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• 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 2002/30604 modular
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

Abstract

A visco-elastic motion-limiting artificial intervertebral disc prosthesis is provided that mimics the physiologic function of a normal spinal disc. The disc comprises upper and lower endplates having therewithin channels or openings for optionally receiving one or more motion-limiting members fitted on each end with an enlarged portion. One or more compression stops is provided between the upper and lower endplates. Additionally, an elastomeric cushion is disposed between the endplates and surrounds the motion-limiting members. Also, force transducers and microelectronics can be utilized to provide data to the surgeon or the patient regarding the load state of the disc.

Claims

1. An artificial intervertebral disc prosthesis having an anterior portion and a posterior portion, comprising:

a first endplate having an upper surface and a lower relatively flat, uninterrupted surface;

a second endplate having an upper surface and a lower surface, wherein an axis perpendicular to said first endplate and said second endplate is a longitudinal axis;

a visco-elastic cushion interposed between and adhered to said first and second endplates, wherein said visco-elastic cushion is annular and comprises a cavity therein defining a visco-elastic cushion internal space bounded by a visco-elastic cushion internal surface substantially parallel to said longitudinal axis;

a first projection extending from said lower surface of said first endplate terminating in a first distal end, said first projection having at least one side wall parallel to said visco-elastic cushion internal surface;

a second projection extending from said upper surface of said second endplate and into said cavity and substantially aligned with said first projection, said second projection having at least one side wall parallel to said visco-elastic cushion internal surface, said second projection terminating at a second distal end to form, in an unloaded condition, a gap between said first distal end and said second distal end, said gap having a predetermined dimension; and

wherein direct contact between first distal end of said first projection and said second distal end of said second projection limits said first endplate and said second endplate from moving relatively closer to one another.

2. The artificial intervertebral disc prosthesis of claim 1 wherein said first projection of said first endplate extends a distance of approximately 1 to approximately 3 millimeters from said lower surface of said first endplate.

3. The artificial intervertebral disc prosthesis of claim 1 wherein said first projection of said first endplate is substantially cylindrically shaped.

4. The artificial intervertebral disc prosthesis of claim 1 wherein said first distal end has a radius of approximately 2 millimeters to approximately 15 millimeters.

5. The artificial intervertebral disc prosthesis of claim 1 wherein said second projection of said second endplate extends a distance of approximately 3 millimeters to approximately 6 millimeters from said upper surface of said second endplate to said second distal end.

6. The artificial intervertebral disc prosthesis of claim 1 wherein said gap between said first distal end and said second distal end is approximately 1 millimeters to approximately 2 millimeters.

7. The artificial intervertebral disc prosthesis of claim 1 wherein said upper surface of said first endplate and said lower surface of said second endplate further comprise appurtenances that aid in securing the prosthesis to adjacent vertebrae.

8. The artificial intervertebral disc prosthesis of claim 1, further comprising a force or pressure transducer located within said prosthesis for allowing the measurement and transmittal of information about loads experienced by the prosthesis.

9. The artificial intervertebral disc prosthesis of claim 8, wherein said second projection of said second endplate houses at least a portion of a package of signal conditioning and amplification electronics that is connected to said force or pressure transducer placed within said second projection and at other peripheral locations around said second endplate.

10. The artificial intervertebral disc prosthesis of claim 8, wherein said second projection of said second endplate houses electronics connected to said force or pressure transducer placed within said second projection and at other peripheral locations around said second endplate.

11. The artificial intervertebral disc prosthesis of claim 8, wherein said second endplate further comprises a flex circuit including a load sensor embedded onto said upper surface of said second endplate.

12. The artificial intervertebral disc prosthesis of claim 1 wherein said first endplate and said second endplate comprise a biocompatible material suitable for implantation.

13. The artificial intervertebral disc prosthesis of claim 12 wherein said first endplate and said second endplate comprise materials selected from the group consisting of stainless steel, stainless steel alloys, titanium, titanium alloys, cobalt chromium molybdenum alloys, and composite materials.

14. The artificial intervertebral disc prosthesis of claim 13 wherein said material is an alloy comprising approximately 66 percent cobalt, approximately 28 percent chromium, and approximately 6 percent molybdenum, by weight.

15. The artificial intervertebral disc prosthesis of claim 1,

wherein said first endplate and said second endplate each comprise a posterior portion;

wherein said posterior portion of each of said first and second endplates further comprises a concavity that defines posterior lobes projecting from said posterior portions of each of said first and second endplates.

16. The artificial intervertebral disc prosthesis of claim 1 wherein each of said first and second endplates have an external surface therearound defining a generally “

D”

shape.

17. The artificial intervertebral disc prosthesis of claim 1, wherein said first distal end of said first projection and said second distal end of said second projection are substantially planar.

18. The artificial intervertebral disc prosthesis of claim 1, wherein contact between said first distal end of said first projection and said second distal end of said second projection permits at least some motion in a direction perpendicular to a direction that brings said first endplate and said second endplate closer to each other.

19. The artificial intervertebral disc prosthesis of claim 1 wherein at least one of said first distal end and said second distal end comprises a relatively flat, uninterrupted surface.

20. An artificial intervertebral disc prosthesis having an anterior portion and a posterior portion, comprising:

a first endplate having an upper surface and a lower relatively flat, uninterrupted surface;

a second endplate having an upper surface and a lower surface, wherein an axis perpendicular to said first endplate and said second endplate is a longitudinal axis;

a projection extending from said upper surface of said second endplate toward said first endplate, said projection being at least partially cylindrical and having at least one side wall parallel to a longitudinal axis of said prosthesis, said projection terminating at a distal end to form a gap between said distal end and said first endplate lower surface, said gap having a predetermined dimension; and

a visco-elastic cushion interposed between and adhered to said first and second endplates having a cavity for receiving said projection;

wherein said distal end of said projection is substantially planar; and

wherein direct contact between said projection and said first endplate stops compressive motion but allows at least some amount of shear motion.

21. The artificial intervertebral disc prosthesis of claim 20, wherein said projection of said second endplate extends a distance of approximately 3 millimeters to approximately 6 millimeters from said upper surface of said second endplate to said distal end.

22. The artificial intervertebral disc prosthesis of claim 20, wherein said predetermined dimension of said gap between said distal end and said first endplate is approximately 1 millimeters to approximately 2 millimeters.

23. The artificial intervertebral disc prosthesis of claim 20, wherein said upper surface of said first endplate and said lower surface of said second endplate further comprise appurtenances that aid in securing the prosthesis to adjacent vertebrae.

24. The artificial intervertebral disc prosthesis of claim 20, further comprising a force or pressure transducer located within said prosthesis for allowing the measurement and transmittal of information about loads experienced by the prosthesis.

25. The artificial intervertebral disc prosthesis of claim 24, wherein said projection of said second endplate houses at least a portion of a package of signal conditioning and amplification electronics that is connected to said force or pressure transducer placed within said projection and at other peripheral locations around said second endplate.

26. The artificial intervertebral disc prosthesis of claim 24, wherein said projection of said second endplate houses electronics connected to said force or pressure transducer placed within said projection and at other peripheral locations around said second endplate.

27. The artificial intervertebral disc prosthesis of claim 24, wherein said second endplate further comprises a flex circuit including a load sensor embedded onto said upper surface of said second endplate.

28. The artificial intervertebral disc prosthesis of claim 20, wherein said first endplate and said second endplate comprise a biocompatible material suitable for implantation.

29. The artificial intervertebral disc prosthesis of claim 28, wherein said first endplate and said second endplate comprise materials selected from the group consisting of stainless steel, stainless steel alloys, titanium, titanium alloys, cobalt chromium molybdenum alloys, and composite materials.

30. The artificial intervertebral disc prosthesis of claim 28, wherein said material is an alloy comprising approximately 66 percent cobalt, approximately 28 percent chromium, and approximately 6 percent molybdenum, by weight.

31. The artificial intervertebral disc prosthesis of claim 20,

wherein said first endplate and said second endplate each comprise a posterior portion;

wherein said posterior portion of each of said first and second endplates further comprises a concavity that defines posterior lobes projecting from said posterior portions of each of said first and second endplates.

32. The artificial intervertebral disc prosthesis of claim 20, wherein each of said first and second endplates have an external surface therearound defining a generally “

D”

shape.

33. An artificial intervertebral disc prosthesis having an anterior portion and a posterior portion, comprising:

a first endplate having an upper surface and a lower relatively flat, uninterrupted surface;

a second endplate having an upper surface and a lower surface, wherein an axis perpendicular to said first endplate and said second endplate is a longitudinal axis;

a projection extending from said upper surface of said second endplate toward said first endplate, said projection being at least partially cylindrical and having at least one side wall parallel to a longitudinal axis of said prosthesis, said projection terminating at a distal end to form a gap between said distal end and said first endplate lower surface, said gap having a predetermined dimension; and

a visco-elastic cushion interposed between and adhered to said first and second endplates having a cavity for receiving said projection;

wherein direct contact between said distal end of said projection and said first endplate permits at least some motion in a direction perpendicular to a direction that brings said first endplate and said second endplate closer to each other.

34. An artificial intervertebral disc prosthesis comprising:

a first endplate having a first surface for engaging a vertebra and a second surface opposite said first surface;

a second endplate having a first surface for engaging a different vertebra and a second surface opposite said first surface;

a longitudinal axis defined between said first endplate and said second endplate and normal thereto;

an annular polymeric member having an upper surface and a lower surface and having a cavity defining a polymeric member internal space that is bounded along said longitudinal axis by said second surface of said first endplate and by said second surface of said second endplate, and is bounded in a plane normal to said longitudinal axis by a polymeric member internal surface;

a projection from said second surface of said second endplate having a distal end located within said polymeric member internal space, said distal end having a contact surface thereon for directly contacting a portion of said second surface of said first endplate;

wherein said upper surface and said lower surface of said annular polymeric member are adhered to, respectively, said second surface of said first endplate at a first adhesion layer and to said second surface of said second endplate at a second adhesion layer;

wherein at least one of said first adhesion layer and said second adhesion layer is parallel to said contact surface of said projection.

35. The artificial intervertebral disc prosthesis of claim 34 wherein said lower surface of said first endplate is substantially parallel to said upper surface of said first endplate.

36. The artificial intervertebral disc prosthesis of claim 34 wherein said upper surface of said second endplate is substantially parallel to said lower surface of said second endplate.