Materials, devices and methods for implantation of transformable implants

• US 20060095134A1
• Filed: 10/28/2004
• Published: 05/04/2006
• Est. Priority Date: 10/28/2004
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Sherman, Michael C., Trieu, Hai H.
• Application Number:
  US10/975,049
• Publication Number:
  US 20060095134A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/701 Longitudinal elements with a non-circular, e.g. rectangular, cross-section A61B17/7005, A61B17/7007 take precedence
• CPC Class Codes: A61B 17/7031 made wholly or partly of flexible material
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 2017/00831 Material properties
• 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 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30304 nose-shaped
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes

Abstract

A transformable implantable device is disclosed comprising primary and secondary phases or materials. The secondary phase or material is relatively rigid compared to the primary phase or material and also renders the transformable implantable device relatively rigid compared to the primary phase or material. The secondary phase or material, upon implantation, becomes more flexible, thereby rendering the transformable implantable device more flexible also.

Claims

1. A transformable implantable device comprising:

at least one flexible primary phase or material and a secondary phase or material that is relatively rigid, when compared to the primary phase or material;

wherein the secondary phase or material renders the transformable implantable device relatively rigid compared to the primary phase or material; and

wherein the secondary phase or material, upon implantation, becomes more flexible, thereby rendering the transformable implantable device more flexible.

2. The device of claim 1, wherein the secondary phase or material, before implantation, is in a substantially dehydrated state.

3. The device of claim 1, wherein the secondary phase or material, upon implantation, becomes more flexible because of partial, substantial, or complete rehydration of the secondary phase or material.

4. The device of claim 3, wherein the secondary phase or material is partially, substantially, or completely rehydrated by contact with bodily or surgical fluids.

5. The device of claim 1, wherein the primary phase or material is selected from the group consisting of ceramics, metals, polymers, and composites and mixtures thereof.

6. The device of claim 1, wherein the primary phase or material is a fiber.

7. The device of claim 6, wherein the fiber is selected from the group consisting of polyethylene fibers, polyester fibers, polyaryletherketone fibers, stainless steel filaments, shape-memory metal alloy filaments, and combinations and mixtures thereof.

8. The device of claim 6, wherein the fibers are braided, woven, or non-woven tether, cord, band, or tubing.

9. The device of claim 6, wherein the fiber comprises a braid of fibers of polyethylene and polyester.

10. The device of claim 6, wherein the fiber comprises a braid of fibers of polyethylene and polyaryletherketone.

11. The device of claim 6, wherein the fiber comprises a braid of fibers of polyethylene and stainless steel filaments.

12. The device of claim 6, wherein the fiber comprises a braid of fibers of polyethylene and shape-memory metal alloy filaments.

13. The device of claim 1, wherein the primary phase or material is manufactured by braiding, weaving, knitting, sewing, extrusion, injection molding, compression molding, casting, bonding, or laminating.

14. The device of claim 1, manufactured by solution casting, dispersion dipping, extrusion, injection molding, compression molding, bonding, laminating or machining.

15. The device of claim 1, wherein the secondary phase or material is a polymer or ceramic.

16. The device of claim 15, wherein the polymer is a hydrophilic polymer or hydrogel.

17. The device of claim 16, wherein the hydrophilic polymer or hydrogel is selected from the group consisting of polyethylene oxide, polyethylene glycol, polyvinyl alcohol, polyacrylic acid, polyacrylamide, cellulose, collagen, polysaccharides, gelatin, elastin, silk, keratin, albumin, and copolymers, blends, composites, and laminates thereof.

19. The device of claim 1, wherein the secondary phase or material, before implantation, is in a substantially dehydrated state.

26. The device of claim 1, wherein the secondary phase or material, before implantation, is in a substantially dehydrated state.

34. The device of claim 1, wherein the secondary phase or material, before implantation, is in a substantially dehydrated state.

18. A transformable spinal fixation device comprising:

at least one flexible primary phase or material and a secondary phase or material that is relatively rigid, when compared to the primary phase or material;

wherein the secondary phase or material renders the transformable spinal fixation device relatively rigid compared to the primary phase or material; and

wherein the secondary phase or material, upon implantation, becomes more flexible, thereby rendering the transformable spinal fixation device more flexible.

20. The device of claim 18, wherein the secondary phase or material, upon implantation, becomes more flexible because of partial, substantial, or complete rehydration of the secondary phase or material.

21. The device of claim 20, wherein the secondary phase or material is partially, substantially, or completely rehydrated by contact with bodily or surgical fluids.

22. The device of claim 18, wherein the primary and secondary phases or materials form a stabilizing element that is secured to two or more vertebrae by anchoring means.

23. The device of claim 22, wherein the stabilizing element is in the form of a pyramidal, triangular, ovular, square, rectangular, circular, or irregularly shaped plate.

24. The device of claim 22, wherein the stabilizing element is in the form of a elongated rod.

25. A transformable intervertebral disc implant device comprising:

at least one flexible primary phase or material and a secondary phase or material that is relatively rigid, when compared to the primary phase or material;

wherein the secondary phase or material renders the transformable intervertebral disc implant device relatively rigid compared to the primary phase or material; and

wherein the secondary phase or material, upon implantation, becomes more flexible, thereby rendering the transformable intervertebral disc implant device more flexible.

27. The device of claim 25, wherein the secondary phase or material, upon implantation, becomes more flexible because of partial, substantial, or complete rehydration of the secondary phase or material.

28. The device of claim 27, wherein the secondary phase or material is partially, substantially, or completely rehydrated by contact with bodily or surgical fluids.

29. The device of claim 25, wherein the transformable intervertebral disc implant is used to replace the nucleus of an intervertebral disc, replace a portion of or entire intervertebral disc, or maintain or increase the interspinous spacing of an intervertebral disc.

30. The device of claim 25, wherein the transformable intervertebral disc implant is in the form of a disc-like shape and additionally comprises two end plates disposed on opposite faces of the disc.

31. The device of claim 30, wherein the end plates comprise a metal chosen from the group consisting of stainless steel, 316L stainless steel, cobalt-chrome alloys, cobalt-nickel-chrome alloys, MP35N cobalt-nickel-chrome alloy, titanium, titanium alloys, Ti-6A1-4V titanium alloy, nickel-titanium shape memory alloys, and composites or mixtures thereof.

32. The device of claim 25, wherein the transformable intervertebral disc implant device is in the form of short rods.

33. A transformable spinal ligament repair and reinforcement device comprising:

at least one flexible primary phase or material and a secondary phase or material that is relatively rigid, when compared to the primary phase or material;

wherein the secondary phase or material renders the transformable spinal ligament repair and reinforcement device relatively rigid compared to the primary phase or material; and

wherein the secondary phase or material, upon implantation, becomes more flexible, thereby rendering the transformable spinal ligament repair and reinforcement device more flexible.

35. The device of claim 33, wherein the secondary phase or material, upon implantation, becomes more flexible because of partial, substantial, or complete rehydration of the secondary phase or material.

36. The device of claim 33, wherein the secondary phase or material is partially, substantially, or completely rehydrated by contact with bodily or surgical fluids.

37. The device of claim 33, wherein the primary and secondary phases or materials are in the form of a tether, cord, band, rope, chain, or tube.

38. The device of claim 37, wherein the tether, cord, band, rope, chain, or tube is affixed to two or more vertebrae by anchoring means.