Prosthetic Intervertebral Discs

• US 20100114318A1
• Filed: 01/07/2008
• Published: 05/06/2010
• Est. Priority Date: 09/01/2005
• Status: Abandoned Application

• Current Assignee: Spinal Kinetics Incorporated (Orthofix Medical Inc.)
• Original Assignee: Spinal Kinetics Incorporated (Orthofix Medical Inc.)
• Inventors: Ashley, John E., Wistrom, Elizabeth V., Robinson, Janine C., Koske, Nicholas C., Chee, Uriel Hiram, Reo, Michael L., Gittings, Darin C., Richman, Roxanne L.
• Application Number:
  US11/970,156
• Publication Number:
  US 20100114318A1
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• 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 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30168 L-shaped
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• 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 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2002/3055 for adjusting length
• 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 2002/30566 : Helical springs
• CPC Class Codes: A61F 2002/30576 : with extending fixation tabs
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• 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 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30889 : Arcuate pegs
• CPC Class Codes: A61F 2002/30897 : Stepped protrusions, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30899 : Protrusions pierced with apertures
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• 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 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2210/0061 : swellable
• 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 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0043 : L-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 : differing in fibre orientations

Abstract

Prosthetic intervertebral discs, systems including such prosthetic intervertebral discs, and methods for using the same are described. The subject prosthetic discs include upper and lower endplates separated by a compressible core member. The subject prosthetic discs exhibit stiffness in the vertical direction, torsional stiffness, bending stiffness in the sagittal plane, and bending stiffness in the front plane, where the degree of these features can be controlled independently by adjusting the components, construction, and other features of the discs.

Claims

1. In combination, a prosthetic intervertebral disc and intervertebral stabilization device comprising:

the prosthetic intervertebral disc configured to be placed between two adjacent vertebrae and replace a natural disc, comprising;

a first endplate;

a second endplate attached either directly or indirectly to said first endplate separated by a first distance; and

a compressible core member positioned between said first and second endplates, the compressible core member being expandable between a contracted condition and an expanded condition, said first distance being greater in said expanded condition than in said contracted condition, and

the intervertebral stabilization member comprising

an upper fixation member affixable to an upper vertebral member,

a lower fixation member affixable to a lower vertebral member,

a compressible fluid member containing a fluid chamber extending between and attached to the upper fixation member and the lower fixation member, and

a fluid communication channel

providing fluid flow between the prosthetic disc compressible core member and the fluid chamber of the compressible fluid member.

2. The combination of claim 1 where the compressible core member comprises a single hollow member.

3. The combination of claim 1 where the compressible core member comprises a plurality of chambers.

4. The combination of claim 3 where at least two of said plurality of chambers are in fluid communication with one another.

5. The combination of claim 1 where the upper fixation member and the lower fixation member are configured to be affixable to transverse processes of the upper and lower vertebral member.

6. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a substantially cylindrical, compressible core member having a longitudinal axis and a diameter, the core member positioned between the first and second endplates with the diameter contacting the first and second endplates.

7. The prosthetic intervertebral disc of claim 6 where the compressible core comprises a first portion having a first stiffness and a second portion having a second stiffness, said first stiffness being greater than said second stiffness.

8. The prosthetic intervertebral disc of claim 7 where the first portion comprises an annular shape and the second portion is within the center of the first portion.

9. The prosthetic intervertebral disc of claim 6 where the compressible core comprises a single material.

10. The prosthetic intervertebral disc of claim 6 where the first endplate is attached to the second endplate by at least one fiber woven between the first endplate and the second endplate.

11. The prosthetic intervertebral disc of claim 6 where the first endplate and the second endplate are rotatable about the longitudinal axis of the substantially cylindrical, compressible core member.

12. The prosthetic intervertebral disc of claim 6 where the core member is inflatable.

13. The prosthetic intervertebral disc of claim 6 where the core member is comprises an outer member and a filled inner polymer.

14. The prosthetic intervertebral disc of claim 6 where the first endplate and the second endplate each include recesses for receiving the substantially cylindrical, compressible core member.

15. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate;

and a core structure comprising a plurality of compressible core members, each core member configured to provide different load bearing properties from the other and to provide a varying center of rotation to the disc.

16. The prosthetic vertebral disc of claim 15 where the core structure comprises a posterior core member having a comparatively higher compressibility and an anterior core member having a comparatively lower compressibility.

17. The prosthetic vertebral disc of claim 15 where the core structure comprises a posterior and an anterior core member each having a comparatively lower compressibility and a center core member having a comparatively higher compressibility.

18. The prosthetic intervertebral disc of claim 15 where each of the plurality of core members includes a first end and a second end and the first end is attached to the second end by at least one fiber woven between the first end and the second end.

19. The prosthetic intervertebral disc of claim 15 where the first endplate is attached to the second endplate by at least one fiber woven between the first endplate and the second endplate.

20. The prosthetic intervertebral disc of claim 15 where the first endplate is attached to the second endplate by at least one fiber woven between the first endplate and the second endplate and where each of the plurality of core members includes a first end and a second end and the first end is attached to the second end by at least one fiber woven between the first end and the second end.

21. A prosthetic assemblage, posteriorly insertable to an intervertebral site in a spine, comprising:

a left prosthetic disc comprising an upper endplate, a lower endplate, a compressible anterior core member, and a compressible posterior core member, and

a right prosthetic disc comprising an upper endplate, a lower endplate, a compressible anterior core member, and a compressible posterior core member.

22. The prosthetic assemblage of claim 21 where each of the endplates is substantially bullet-shaped.

23. The prosthetic assemblage of claim 21 where each of the endplates is substantially elbow-shaped.

24. The prosthetic assemblage of claim 21 where the anterior core members are substantially cylindrical.

25. The prosthetic assemblage of claim 24 where the anterior core members are stiffer than the posterior core members.

26. The prosthetic assemblage of claim 25 where, in each prosthetic disc and for each of the anterior and the posterior core members, the first endplate is attached to the second endplate by at least one fiber woven between the first endplate and the second endplate.

27. The prosthetic assemblage of claim 26 where, in each prosthetic disc the fiber woven between the first endplate and the second endplate of each anterior core member is relatively more vertical than the fiber woven between the first endplate and the second endplate of each posterior core member.

28. The prosthetic assemblage of claim 21 where the upper endplates in each prosthetic disc include extensions toward their respective lower endplates, and the lower endplates in each prosthetic disc include extensions toward their respective upper endplates, and wherein the upper endplate extensions and the lower endplate extensions are configured to cooperate by contact between those upper and lower endplate extensions to mimic, in the prosthetic assemblage, the translational limiting function of natural facets upon movement of the prosthetic assemblage after implantation.

29. The prosthetic assemblage of claim 28 where the upper endplate extensions and the lower endplate extensions are located posteriorly on the respective endplates.

30. The prosthetic assemblage of claim 29 where the upper endplate extensions and the lower endplate extensions are located posteriorly and laterally on the respective endplates and are configured to mimic, in the prosthetic assemblage, the torsional limiting function of natural facets upon movement of the prosthetic assemblage after implantation.

31. The prosthetic assemblage of claim 24 where the posterior core members are configured to be located relatively more laterally than the anterior core members in the prosthetic assemblage after implantation.

32. The prosthetic assemblage of claim 24 where, in each prosthetic disc, the anterior core member is shorter than the posterior core member.

33. The prosthetic assemblage of claim 26 where, in each prosthetic disc, the anterior core member is wound with more fiber windings than is the posterior core member.

34. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a compressible core member having regions of different compressibility.

35. The prosthetic intervertebral disc of claim 34 where the compressible core is substantially cylindrical, with an anterior region and a posterior region, and where the anterior region has a first stiffness and the posterior region has a second stiffness.

36. The prosthetic intervertebral disc of claim 35 where the first stiffness is greater than the second stiffness.

37. The prosthetic intervertebral disc of claim 36 where a region between the anterior region and a posterior region has a stiffness between the first stiffness and the second stiffness.

38. The prosthetic intervertebral disc of claim 34 where the compressible core member comprises a first region adjacent the first endplate and a second region adjacent the second endplate each having a stiffness that is relatively stiffer than a central region situated between the first region and the second region.

39. The prosthetic intervertebral disc of claim 34 where the compressible core is substantially cylindrical with a periphery, and further comprises a plurality of grooves in the periphery each having depth and width, where each such depth and width are selected to provide at least one of a selected compressible core torsional resistance and load bearing capacity.

40. The prosthetic intervertebral disc of claim 34 where the compressible core member comprises a plurality of regions, where each such region comprises a layer and wherein the layers alternately comprise materials having a relatively higher stiffness and materials having a relatively lower stiffness.

41. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a compressible core member having exterior wrapping.

42. The prosthetic intervertebral disc of claim 41 where the exterior wrapping comprises a coiled member adapted to prevent radial expansion of the core member during loading of the core member.

43. The prosthetic intervertebral disc of claim 41 where the exterior wrapping comprises a corrugated member adapted to prevent radial expansion of the core member during loading of the core member.

44. The prosthetic intervertebral disc of claim 41 where the exterior wrapping comprises a first region adjacent the first endplate and a second region adjacent the second endplate each having a stiffness that is relatively stiffer than a central coupling region situated between the first region and the second region.

45. The prosthetic intervertebral disc of claim 41 where the exterior wrapping comprises a string member coiled about the core member and adapted to prevent radial expansion of the core member during loading of the core member.

46. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a compressible core member situated between the first and second endplates, the core member further comprising an expandable element adjustably expanding the compressible core member.

47. The prosthetic intervertebral disc of claim 46 where the expandable element is threaded and expandable upon twisting.

48. The prosthetic intervertebral disc of claim 46 where the expandable element comprises two inter-threaded cylinders that expand the core member when the two cylinders are twisted with respect to each other.

49. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a compressible core member situated between the first and second endplates, the compressible core member having first and second ends respectively adjacent the first and second endplates, the compressible core member further comprising having multiple furrows in the first and second ends suitable for allowing passage of gaseous sterilant through the furrows.

50. The prosthetic intervertebral disc of claim 49 where the furrows are defined by a plurality of raised, elongated, radially situated raised portions extending from the first and second ends.

51. The prosthetic intervertebral disc of claim 49 where the furrows are defined by a plurality of raised bumps extending from the first and second ends.

52. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate; and

a compressible core member situated between the first and second endplates, the compressible core member having first and second ends respectively adjacent the first and second endplates, the compressible core member further comprising an integrated mesh providing a plurality of non-geometric raised portions providing unoccupied space between the core member and each of the first and second endplates suitable for allowing passage of gaseous sterilant between the core member and each of the first and second endplates.

53. The prosthetic intervertebral disc of claim 52 where the integrated mesh comprises polyethylene terephthalate.

54. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate;

a compressible core member situated between the first and second endplates, the compressible core member having first and second ends respectively adjacent the first and second endplates,

wherein the first and second endplates have a curved profile configured for implantation into an intervertebral space situated between two adjacent vertebrae via a posterior approach, and each first and second endplate further comprising two parallel keels configured to attach the prosthetic intervertebral disc to the vertebrae adjacent the intervertebral space.

55. A kit comprising exactly two of the prosthetic intervertebral discs of claim 54.

56. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate;

a core structure comprising at least one compressible core member, and wherein each endplate comprises an inner endplate member having a periphery and having peripheral wings extending radially from that periphery and an outer endplate having mating recesses configured to receive and retain the peripheral wings of the inner endplate.

57. The prosthetic vertebral disc of claim 56 wherein each inner endplate member is welded to an outer endplate member at an interface between the inner endplate peripheral wings and outer endplate mating recesses.

58. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate; and

a core structure comprising at least one compressible core member having a periphery, and further comprising a plurality of fiber layers extending outwardly from the compressible core member, and wherein fibers comprising each fiber layer have a stiffness different than the fibers in each other layer and extend between and are connected to the first endplate and the second endplate.

59. The prosthetic vertebral disc of claim 58 wherein the fibers in the fiber layer adjacent the compressible core member are comparatively stiffest.

60. The prosthetic vertebral disc of claim 58 wherein the fibers in the fiber layer most distant from compressible core member are comparatively stiffest.

61. An endplate configured to be attached, directly or indirectly to another endplate, and form with a compressible core member, a prosthetic vertebral disc, wherein the endplate has a peripheral surface and a surface configured to be placed adjacent a surface on a vertebral bone, and wherein the endplate further comprises a plurality of anchoring spikes extendible from the peripheral surface and into vertebral bone after the endplate has been introduced adjacent a vertebral bone.

62. The endplate of claim 61 further comprising a spring mechanism configured to extend the plurality of spikes after the endplate has been introduced adjacent a vertebral bone.

63. The endplate of claim 61 further comprising a screw mechanism configured to extend the plurality of spikes after the endplate has been introduced adjacent a vertebral bone.

64. A prosthetic intervertebral disc comprising:

a first endplate;

a second endplate attached either directly or indirectly to the first endplate;

a core structure comprising at least one compressible core member, and

a retention mechanism extending between the first and second endplates and configured to compress the disc to a height that is reduced relative to its operational height.

65. The prosthetic vertebral disc of claim 64 wherein the retention mechanism extends through openings in the first and second endplates and through a tunnel in the core structure.

66. The prosthetic vertebral disc of claim 65 wherein the retention mechanism comprises a shaft that extends through openings in the first and second endplates and through a tunnel in the core structure and is releasably attached to the first and second endplates.

67. The prosthetic vertebral disc of claim 66 wherein the retention mechanism comprises a shaft having notches at opposing ends, that extends through openings in the first and second endplates and through a tunnel in the core structure and is releasably attached to the first and second endplates by keyholes in locking plates, and further comprising those locking plates.

68. A prosthetic intervertebral disc comprising:

a first endplate having a surface contacting a compressible core member and a plurality of projections extending into that compressible core member;

a second endplate having a surface contacting a compressible core member and a plurality of projections extending into that compressible core member;

that compressible core member situated between the first and second endplates and having openings extending into the core member and accepting plurality of projections from the first and second endplates.

69. The prosthetic vertebral disc of claim 68 wherein the plurality of projections comprises two projections extending from each endplate.

70. The prosthetic vertebral disc of claim 68 wherein the plurality of projections comprises more than two projections extending from each endplate.

71. A pair of interlockable prosthetic disc implants configured to be placed together within a space between adjacent vertebrae wherein the discs comprise cooperative interlocking mechanisms configured to align the interlockable prosthetic disc implants together within the intervertebral space.

72. The pair of interlockable prosthetic disc implants of claim 71 wherein the cooperative interlocking mechanisms comprise one or more grooves on one disc and one or more tongues on the other disc configured to interlock in a tongue and groove relationship.

73. The pair of interlockable prosthetic disc implants of claim 71 wherein each disc comprises a first endplate and a second endplate attached either directly or indirectly to that first endplate and wherein the first endplate and a second endplate of one disc each have a periphery and further include a multiplicity of pins extending from those peripheries and wherein the first endplate and a second endplate of the other disc include complementary interlocking members configured to interlock with said pins.

74. The pair of interlockable prosthetic disc implants of claim 73 wherein the other disc complementary interlocking members comprise aligning ramps.

75. The pair of interlockable prosthetic disc implants of claim 73 wherein the other disc complementary interlocking members comprise C-shaped receptacles.

76. A kit for introducing prosthetic disc implants posteriorly into an intervertebral space between adjacent vertebrae comprising:

two intervertebral implants each comprising a first endplate, a second endplate, at least one core member extending between and attached to the first and second endplates, and wherein each endplate includes a guide channel, and

two guidewires for passage through the guide channels in the first and second endplates.

77. The kit of claim 76 wherein the two intervertebral implants each comprise two core members.

78. The kit of claim 76 wherein the two intervertebral implants are J-shaped.

79. The kit of claim 78 wherein the two J-shaped intervertebral implants include interlocking members configured to join the two implants after their implantation in the intervertebral space.

80. The kit of claim 76 wherein the two intervertebral implants additionally comprise members for attachment to the intervertebral bone.

81. The kit of claim 76 further comprising two cannulae.