STRUCTURALLY REINFORCED SPINAL NUCLEUS IMPLANTS

• US 20090149958A1
• Filed: 11/03/2008
• Published: 06/11/2009
• Est. Priority Date: 11/01/2007
• Status: Abandoned Application

• Current Assignee: Replication Medical, Inc.
• Original Assignee: Replication Medical, Inc.
• Inventors: Gontarz, Gerald, Prewett, Ann
• Application Number:
  US12/263,797
• Publication Number:
  US 20090149958A1
• Time in Patent Office: Days
• US Class Current: 623/17.160
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2002/2817 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 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: B29C 70/24 oriented in at least three directions forming a three dimensional structure
• CPC Class Codes: B29C 70/46 using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A spinal nucleus implant is provided which includes a braided three-dimensional reinforcement member having a polymeric matrix imbued therein, the implant configured to have a shape consistent with a cavity within an intervertebral disc space. The polymeric matrix may be a fluid absorbing polymer, e.g., a hydrogel or a substantially non-fluid absorbing in-situ curable elastic polymer. A method of making a spinal nucleus implant is provided which includes providing a braided three-dimensional reinforcement member configured and dimensioned to have a shape consistent with a cavity in an intervertebral space and infusing the braided three-dimensional reinforcement member with a liquid polymer capable of forming a polymeric matrix. Also provided is a spinal nucleus implant including a three-dimensional reinforcement member adapted and configured to undergo anisotropic expansion, the implant configured to have a shape consistent with a cavity within an intervertebral disc space. A method of treating a degenerating intervertebral disc includes creating an incision in an annulus; removing at least a portion of a nucleus pulposus; and inserting, through the incision, a spinal nucleus implant according to the present disclosure.

Claims

1. A spinal nucleus implant comprising a braided three-dimensional reinforcement member having a polymeric matrix imbued therein, the implant configured to have a shape consistent with a cavity within an intervertebral disc space.

2. A spinal nucleus implant according to claim 1 wherein the polymeric matrix is made of a fluid absorbing polymer.

3. A spinal nucleus implant according to claim 2 wherein the polymer is a hydrogel.

4. A spinal nucleus implant according to claim 3 wherein the hydrogel is selected from the group consisting of polyacrylonitrile, polyvinyl alcohol, polyacrylamide, silicone, polyurethane, poly(ethylene glycol), poly(ethylene oxide)-poly(propylene oxide) copolymer, polymethacrylate, polyhydroxyethylmethacrylate, hydroxyethylmethacrylate-methylmethacrylate copolymer, polyvinylpyrrolidone, hyaluronic acid, chondroitin sulfate, carboxymethyl cellulose, hydroxypropylmethyl cellulose, collagen, fibrin, alginate, and agar.

5. A spinal nucleus implant according to claim 1 wherein the braided three-dimensional reinforcement member is made of a fiber selected from the group consisting of monofilament, multifilament and combinations thereof.

6. A spinal nucleus implant according to claim 1 wherein the braided three-dimensional reinforcement member is made of a fiber made from a material selected from the group consisting of polyamide, polyethylene terephthalate, polypropylene, polyethylene, PEET, carbon, ceramic, glass and combinations thereof.

7. A spinal nucleus implant according to claim 1 wherein the braided three-dimensional reinforcement member is configured to correspond to the exterior shape of the implant.

8. A spinal nucleus implant according to claim 7 wherein wherein the braided three-dimensional reinforcement member is configured in the shape of a cylinder having an enlarged central portion and tapered ends.

9. A spinal nucleus implant according to claim 1 wherein the braided three-dimensional reinforcement member is encapsulated by a further polymeric matrix which may be the same or different than the polymeric matrix imbued therein.

10. A spinal nucleus implant according to claim 1 wherein the void ratio in the braided three-dimensional reinforcement member ranges from about 0.3 to about 3.0.

11. A spinal nucleus implant according to claim 1 further comprising a medicinal agent.

12. A spinal nucleus implant according to claim 1 wherein the braided three-dimensional reinforcement member defines a core which contains at least a portion of the polymeric matrix.

13. A spinal nucleus implant according to claim 1 wherein the implant is configured to transform from a first configuration to a second configuration, the first configuration having a smaller cross-section than the second configuration.

14. A spinal nucleus implant according to claim 13 wherein the first configuration is bullet shaped and the second configuration is an expanded cylindrical ellipsoid configured to substantially fill an intervertebral disc space and exert positive pressure against the vertebral endplates which define opposing surfaces of the disc space.

15. A spinal nucleus implant according to claim 1 wherein the polymeric matrix is made of a substantially non-fluid absorbing in-situ curable elastic polymer.

16. A spinal nucleus implant according to claim 1 further comprising a medicinal agent.

23. A method of treating a degenerating intervertebral disc comprising creating an incision in an annulus;

removing at least a portion of a nucleus pulposus; and

inserting, through the incision, a spinal nucleus implant according to claim 1.

17. A method of making a spinal nucleus implant comprising providing a braided three-dimensional reinforcement member configured and dimensioned to have a shape consistent with a cavity in an intervertebral space and infusing the braided three-dimensional reinforcement member with a liquid precursor of a polymeric matrix.

18. A method of making a spinal nucleus implant according to claim 17 wherein the polymeric matrix if formed from a fluid absorbing polymer.

19. A method of making a spinal nucleus implant according to claim 18 wherein the fluid absorbing polymer is selected from the group consisting of polyacrylonitrile, polyvinyl alcohol, polyacrylamide, silicone, polyurethane, poly(ethylene glycol), poly(ethylene oxide)-poly(propylene oxide) copolymer, polymethacrylate, polyhydroxyethylmethacrylate, hydroxyethylmethacrylate-methyhnethacrylate copolymer, polyvinylpyrrolidone, hyaluronic acid, chondroitin sulfate, carboxymethyl cellulose, hydroxypropylmethyl cellulose, collagen, fibrin, alginate, and agar.

20. A method of making a spinal nucleus implant according to claim 17 wherein the braided three-dimensional reinforcement member is placed within a mold cavity which has dimensions greater than the braided three-dimensional reinforcement member to allow the fluid absorbing polymer to be absorbed into and saturate the braided three-dimensional reinforcement member and to encapsulate the braided three-dimensional reinforcement member with a layer of the same or different fluid absorbing polymer.

21. A method of making a spinal nucleus implant according to claim 17 further comprising dehydrating the spinal nucleus implant to reduce the dimensions if the implant.

22. A method of making a spinal nucleus implant according to claim 21 wherein the spinal nucleus implant is subjected to equilateral radial compression to provide a bullet shaped dehydrated implant.

24. A spinal nucleus implant comprising a three-dimensional reinforcement member adapted and configured to undergo anisotropic expansion, the implant configured to have a shape consistent with a cavity within an intervertebral disc space.

25. A spinal nucleus implant according to claim 24 wherein the three-dimensional reinforcement member is a braided fabric.

26. A spinal nucleus implant according to claim 24 further comprising a polymeric matrix.