Intervertebral disc nucleus implants and methods

• US 7,520,900 B2
• Filed: 07/11/2005
• Issued: 04/21/2009
• Est. Priority Date: 08/30/2000
• Status: Expired due to Fees

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H.
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US11/178,945
• Publication Number:
  US 20050278029A1
• Time in Patent Office: 1,380 Days
• Field of Search: 623 1711- 1716, 606 60- 63
• US Class Current: 623/17.16
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• 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 2002/30594 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 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30838 Microstructures
• CPC Class Codes: A61F 2002/30891 Plurality of protrusions
• CPC Class Codes: A61F 2002/30906 shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Nucleus pulposus implants that are resistant to migration in and/or expulsion from an intervertebral disc space are provided. In one form of the invention, an implant includes a load bearing elastic body surrounded in the disc space by an anchoring, preferably resorbable, outer shell. In certain forms of the invention, the elastic body is surrounded by a supporting member, such as a band or jacket, and the supporting member is surrounded by the outer shell. Kits for forming such implants are also provided. In another form of the invention, an implant is provided that has locking features and optional shape memory characteristics. In yet another aspect of the invention, nucleus pulposus implants are provided that have shape memory characteristics and are configured to allow short-term manual, or other deformation without permanent deformation, cracks, tears, breakage or other damage. Methods of forming and implanting the implants are also described, as are delivery devices and components thereof for delivering the implants.

Claims

1. An intervertebral disc nucleus pulposus implant, comprising:

a load bearing elastic body having shape memory and sized for placement into an intervertebral disc space, said body having a first end, a second end, and a central portion located between the first and second ends;

wherein said shape memory biases said body to a first configuration in which said first end and said second end are folded into contact with the central portion, wherein the first end in contact with the central portion forms a first aperture and the second end in contact with the central portion forms a second aperture;

said elastic body configurable into a second, straightened configuration for insertion through an opening in an intervertebral disc annulus fibrosis;

wherein said shape memory is effective for returning said body to said first configuration after said insertion.

2. The implant of claim 1, wherein said elastic body is comprised of a hydrogel material.

3. The implant of claim 2, wherein said hydrogel is a member selected from the group consisting of natural hydrogels, hydrogels formed from polyvinyl alcohol, acrylamides, polyacrylic acid, poly(acrylonitrile-acrylic acid), polyurethanes, polyethylene glycol, poly(N-vinyl-2-pyrrolidone), acrylates, poly(2-hydroxy ethyl methacrylate), copolymers of acrylates with N-vinyl pyrrolidone, N-vinyl lactams, acrylamide, polyurethanes and polyacrylonitrile.

4. The implant of claim 1, wherein said elastic body is comprised of an elastomer.

5. The implant of claim 4, wherein said elastomer is selected from the group consisting of silicone, polyurethane, copolymers of silicone and polyurethane, polyolefins, nitrile and combinations thereof.

6. The implant of claim 1, wherein said body further includes an inner surface with projections extending therefrom, said projections extending into said first aperture.

7. The implant of claim 1, wherein said elastic body has an outer surface, said outer surface having projections extending therefrom, said projections configured for enhancing fixation of said body in said intervertebral disc space.

8. The implant of claim 1, wherein said elastic body includes an outer surface, the outer surface of said elastic body is microtexturized.

9. The implant of claim 1, wherein said body further comprises a reinforcing material at said inner fold surface.

10. The implant of claim 9, wherein said reinforcing material comprises fibers.

11. The implant of claim 1, wherein said elastic body is comprised of a hydrogel material, said material having at least one growth factor dispersed therein.

12. The implant of claim 11, wherein said growth factor is selected from the group consisting of transforming growth factor β

, bone morphogenetic proteins, fibroblast growth factors, platelet-derived growth factors, insulin-like growth factors and combinations thereof.

13. The implant of claim 11, wherein said growth factor comprises a recombinant protein.

14. The implant of claim 13, wherein said recombinant protein is a human protein.

15. The implant of claim 1, wherein said body has at least one surface depression in its second configuration, said first aperture formed from said surface depression.

16. The implant of claim 1 wherein said first end is formed from a first arm, said second end is formed from a second arm and one of said arms of said implant has a length greater than the other of said arms.

17. The implant of claim 1, wherein said first aperture has a cross-sectional shape selected from the group consisting of annular-shaped, elliptical-shaped, and star-shaped.

18. The implant of claim 1, wherein said body is substantially elliptical- or ring-shaped in its folded configuration.

19. The implant of claim 1 wherein said body has a top surface for contacting an upper vertebral endplate of an intervertebral disc and a bottom surface for contacting a lower vertebral endplate of an intervertebral disc;

said top and bottom surface configured to be complementary to the endplate they are in contact with.

20. The implant of claim 19, wherein said top and bottom surface of said body are convex.

21. The implant of claim 1, wherein said first end and said second end each have an inner edge and an outer edge, at least one of said inner edges having a rounded configuration.

22. The implant of claim 21, wherein said rounded edge may be an inner edge or an outer edge.

23. The implant of claim 1, wherein said body has a top surface for contacting an upper vertebral endplate of an intervertebral disc;

a bottom surface for contacting a lower vertebral endplate of an intervertebral disc, and an external side surface, said body having at least one groove on said side surface, said groove extending between said top surface and said bottom surface.

24. The implant of claim 1, wherein said load bearing elastic body conforms to and substantially fills the space that is vacated by removal of the disc nucleus pulposus.

25. The implant of claim 1, wherein said load bearing elastic body further includes metal beads or wires embedded therein to facilitate x-ray identification.

26. The implant of claim 25 wherein said pharmacological agent is a member selected from the group consisting of antibiotics, analgesics, anti-inflammatories, steroids, and combinations thereof.

27. The implant of claim 25, wherein said pharmacological agent is chemically attached to the surface of the implant.

28. The implant of claim 27, wherein said hydrogel is cross-linked to provide further strength to the implant.

29. The implant of claim 1, wherein said load bearing elastic body further includes at least one pharmacological agent.

30. The implant of claim 1, wherein said load bearing elastic body comprises a hydrophilic polymer.

31. The implant of claim 1, wherein said load bearing elastic body comprises a member selected from the group consisting of silicone, polyurethane, copolymers of silicone and polyurethane, polyolefins, neoprene, nitrile, vulcanized rubber and combinations thereof.

32. The implant of claim 31, wherein said polyurethane is a member selected from the group consisting of thermoplastic polyurethanes, aliphatic polyurethanes, segmented polyurethanes, hydrophilic polyurethanes, polyether-urethane, polycarbonate-urethane and silicone polyether-urethane.

33. The implant of claim 1, wherein said load bearing elastic body comprises a member selected from the group consisting of glucomannan gel.

34. An intervertebral disc nucleus pulposus implant comprising a load bearing body sized for placement into an intervertebral disc space, said body having a first end, a second end, and a central portion;

wherein said body assumes a first, folded configuration in which said first end and said second end are positioned adjacent to said central portion to provide an implant having a substantially solid center when the implant is not subjected to straightening forces, and wherein said body assumes a second, straightened configuration in which said central portion is between said first end and said second end to provide an implant having a substantially linear shape when said body is subjected to straightening forces;

wherein said first end and said second end are each approximately one half the length of said central portion so that the first end and the second end abut near the middle of said central portion when the body assumes its first, folded configuration; and

wherein said body includes a plurality of grooves to prevent cracking or tearing of the implant when the implant is manipulated to its straightened configuration.