Artificial intervertebral disc

• US 6,960,232 B2
• Filed: 04/25/2003
• Issued: 11/01/2005
• Est. Priority Date: 04/25/2002
• Status: Expired due to Term

• Current Assignee: Orthofix US LLC (Orthofix Medical Inc.)
• Original Assignee: Blackstone Medical Incorporated (Orthofix Medical Inc.)
• Inventors: Lyons, Matthew, Keary, Matthew A., Green, Stephen M.
• Primary Examiner(s): Prebliic, Paul B.
• Application Number:
  US10/423,414
• Publication Number:
  US 20040034423A1
• Time in Patent Office: 921 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.13, 623/17.14, 623/17.15, 623/17.16
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30451 soldered or brazed or welded
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30517 using a locking plate
• 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 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30883 dovetail-shaped
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• 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 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

The present invention is directed to the field of prosthetic devices. More particularly, one embodiment of the present invention is directed to an artificial disc that can be used as a replacement for an intervertebral disc (e.g., a human intervertebral lumbar disc).

Claims

1. An artificial intervertebral disc for implantation in a spine between a first vertebral body and a second vertebral body, wherein the first vertebral body has a first vertebral body endplate, the second vertebral body has a second vertebral body endplate and the first vertebral body endplate and the second vertebral body endplate oppose one another, comprising:

a composite structure, which composite structure includes a column comprising ePTFE and a column filler comprising an elastomer;

a first anchor member having an outer surface configured for placement against the first vertebral body endplate and an inner surface having a recess for receiving the composite structure, including both the ePTFE column and the elastomer column filler;

a second anchor member having an outer surface configured for placement against the second vertebral body endplate and an inner surface having a recess for receiving the composite structure, including both the ePTFE column and the elastomer column filler;

wherein the composite structure is attached to the first anchor member in the recess in the inner surface of the first anchor member; and

wherein the composite structure is attached to the second anchor member in the recess in the inner surface of the second anchor member.

2. The artificial intervertebral disc of claim 1, wherein the composite structure is configured such that the composite structure has associated therewith, in at least one axis, a load versus deflection behavior substantially similar to that of a substantially healthy human intervertebral disc.

3. The artificial intervertebral disc of claim 2, wherein the load versus deflection behavior is selected from the group consisting of:

(a) dynamic behavior, which dynamic behavior is a function of a time rate application of load, (b) kinematic behavior; and

(c) static behavior.

4. The artificial intervertebral disc of claim 2, wherein the load versus deflection behavior includes a non-linear relationship between an amount of force required to compress the composite structure and a deflection of the composite structure.

5. The artificial intervertebral disc of claim 4, wherein a stiffness of the composite structure increases as the composite structure is compressed.

6. The artificial intervertebral disc of claim 2, wherein the column has a hole therethrough.

7. The artificial intervertebral disc of claim 6, wherein at least one of the column and the hole in the column has a substantially circular cross-section.

8. The artificial intervertebral disc of claim 7, wherein each of the column and the hole in the column has a substantially circular cross-section.

9. The artificial intervertebral disc of claim 8, wherein the column filler is disposed within the hole in the column.

10. The artificial intervertebral disc of claim 9, wherein the elastomer is selected from the group consisting of:

(a) a silicone, (b) a urethane, and (c) a thermoplastic elastomer.

11. The artificial intervertebral disc of claim 6, wherein the composite structure is attached at a first end of the composite structure to the first anchor member and the composite structure is attached at a second end of the composite structure to the second anchor member.

12. The artificial intervertebral disc of claim 11, wherein the composite structure is attached to each of the first anchor member and the second anchor member by a mechanism selected from the group consisting of:

(a) compressing a portion of the column radially between a compression ferrule fitted in the hole in the column and a first mating surface of a respective one of the first anchor member and the second anchor member, which first mating surface is formed by a hole through a respective one of the first anchor member and the second anchor member, and

(b) flaring an end of the column and compressing the flared portion of the column between a capturing component and a second mating surface of a respective one of the first anchor member and the second anchor member.

13. The artificial intervertebral disc of claim 12, wherein the flaring the end of the column and compressing the flared portion of the column between the capturing component and the second mating surface of the respective one of the first anchor member and the second anchor member comprises inserting the column through the hole in a respective one of the first anchor member and the second anchor member before the end of the column is flared.

14. The artificial intervertebral disc of claim 12, wherein the capturing component is attached to a respective one of the first anchor member and the second anchor member by a mechanism selected from the group consisting of:

(a) a mechanism for threading the capturing component to a respective one of the first anchor member and the second anchor,

(b) a mechanism for adhesively bonding the capturing component to a respective one of the first anchor member and the second anchor member,

(c) a mechanism for press-fitting the capturing component to a respective one of the first anchor member and the second anchor member, and

(d) a mechanism for affixing the capturing component to a respective one of the first anchor member and the second anchor member via at least one threaded fastener.

15. The artificial intervertebral disc of claim 6, wherein the column has a first end and a second end and at least one end of the column is attached to a flange by a mechanism selected from the group consisting of:

(a) fusion welding, (b) chemical bonding, and (c) ultrasonic welding.

16. The artificial intervertebral disc of claim 15, wherein the column is treated with a material which aids in the attachment to the flange, which treatment is selected from the group consisting of:

(a) impregnating the column with the material, and (b) coating the column with the material.

17. The artificial intervertebral disc of claim 15, wherein the flange is attached to at least one of the first anchor member and the second anchor member by a mechanism selected from the group consisting of:

(a) capture behind a press-fit capture ring,

(b) threading the flange onto at least one of the first anchor member and the second anchor member, and

(c) attaching the flange to at least one of the first anchor member and the second anchor member via at least one threaded fastener.

18. The artificial intervertebral disc of claim 1, wherein the column is impregnated with a material selected from the group consisting of:

(a) a material that aids in preventing biological ingrowth into the column, and (b) a material that aids in preventing biological attachment to the column.

19. The artificial intervertebral disc of claim 1, wherein the column is coated with a material selected from the group consisting of:

(a) a material that aids in preventing biological ingrowth into the column, and (b) a material that aids in preventing biological attachment to the column.

20. The artificial intervertebral disc of claim 1, wherein the artificial intervertebral disc is configured to be implanted by at least one method selected from the group consisting of:

(a) posterior implantation; and

(b) anterior implantation.

21. An artificial intervertebral disc, comprising:

a first anchor member;

a second anchor member; and

at least two composite structures disposed side-by-side adjacent one another between the first anchor member and the second anchor member, wherein a first one of the composite structures is attached to both the first anchor member and the second anchor member and is comprised of a first column formed of ePTFE and a first column filler formed of an elastomer and wherein a second one of the composite structures is attached to both the first anchor member and the second anchor member and is comprised of a second column formed of ePTFE and a second column filler formed of an elastomer.

22. The artificial intervertebral disc of claim 21, wherein the first composite structure and the second composite structure are configured such that the first composite structure and the second composite structure have associated in combination therewith, in at least one axis, a load versus deflection behavior substantially similar to that of a substantially healthy human intervertebral disc.

23. The artificial intervertebral disc of claim 22, wherein the load versus deflection behavior is selected from the group consisting of:

(a) dynamic behavior, which dynamic behavior is a function of a time rate application of load, (b) kinematic behavior, and (c) static behavior.

24. The artificial intervertebral disc of claim 22, wherein the load versus deflection behavior includes a non-linear relationship between an amount of force required to compress the first composite structure and the second composite structure and a deflection of the first composite structure and the second composite structure.

25. The artificial intervertebral disc of claim 24, wherein a stiffness of each of the first composite structure and the second composite structure increases as each of the first composite structure and the second composite structure is compressed.

26. The artificial intervertebral disc of claim 21, wherein the artificial intervertebral disc is configured to be implanted by at least one method selected from the group consisting of:

(a) posterior implantation, and (b) anterior implantation.

27. An artificial intervertebral disc for implantation in a spine between a first vertebral body and a second vertebral body, wherein the first vertebral body has a first vertebral body endplate, the second vertebral body has a second vertebral body endplate and the first vertebral body endplate and the second vertebral body endplate oppose one another, comprising:

a first assembly including;

(a) a first anchor member;

(b) a second anchor member; and

(c) a composite structure disposed between the first anchor member of the first assembly and the second anchor member of the first assembly, wherein the composite structure of the first assembly is attached to both the first anchor member of the first assembly and the second anchor member of the first assembly, and the composite structure of the first assembly includes a column comprised of ePTFE and a column filler comprised of an elastomer; and

a second assembly including;

(a) a first anchor member;

(b) a second anchor member; and

(c) a composite structure disposed between the first anchor member of the second assembly and the second anchor member of the second assembly, wherein the composite structure of the second assembly is attached to both the first anchor member of the second assembly and the second anchor member of the second assembly, and the composite structure of the second assembly includes a column comprised of ePTFE and a column filler comprised of an elastomer;

wherein the first assembly and the second assembly are disposed side-by-side adjacent one another between the first vertebral body endplate and the second vertebral body endplate.