Expandable implant for repairing a defect in a nucleus of an intervertebral disc

• US 20060155379A1
• Filed: 10/25/2005
• Published: 07/13/2006
• Est. Priority Date: 10/25/2004
• Status: Abandoned Application

• Current Assignee: James C. Thomas Jr
• Original Assignee: James C. Thomas Jr
• Inventors: Heneveld, Scott H. Sr., Thomas, James C. Jr.
• Application Number:
  US11/258,678
• Publication Number:
  US 20060155379A1
• 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 2/441 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30522 releasable, e.g. using a releasable ratchet
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• 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 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

Expandable implants for repairing a nuclear defect of an intervertebral disc, and methods and apparatuses for delivering the same into the disc. The implants generally have a compressed form having a size adapted for insertion into the intervertebral disc, and a composition that allows the implant to expand from the compressed form into an expanded form after the implant is inserted into the nucleus. The expanded form of the implant has a configuration that fills the nuclear defect. The composition used to make the implant can include a shape memory alloy (SMA) or any other suitable material. Various devices can be used to insert the implants into the area being treated.

Claims

1. An expandable implant for repair of a defect in a nucleus of an intervertebral disc, the expandable implant comprising:

a pre-insertion shape having a generally cylindrical shape and adapted for insertion into the defect in the nucleus;

a composition that allows the pre-insertion shape to be transformed to a post-insertion shape after the expandable implant is inserted into the defect; and

the post-insertion shape having the generally cylindrical shape and defining a larger volume than the pre-insertion shape, such that the expandable implant substantially fills the periphery of the defect.

2. The expandable implant of claim 1, wherein the pre-insertion shape comprises a spirally wound sheet.

3. The expandable implant of claim 1, wherein the pre-insertion shape comprises a plurality of spirally wound sheets nested within one another.

4. The expandable implant of claim 1, wherein a helical shape is inserted into the defect for receiving the expandable implant.

5. The expandable implant of claim 1, wherein a pliable pouch is inserted into the defect for receiving the expandable implant.

6. The expandable implant of claim 5, wherein at least one portion of the pliable pouch comprises a fine metallic mesh or woven fabric composites.

7. The expandable implant of claim 2, wherein at least one edge of the spirally wound sheet is fabricated to lessen a degree of sharpness of the edge.

8. The expandable implant of claim 7, wherein the fabrication of the edge comprises producing a lattice-like configuration at the edge.

9. The expandable implant of claim 7, wherein the fabrication of the edge comprises adhering a protective material to the edge.

10. The expandable implant of claim 2, wherein the spirally wound sheet comprises one or more dimples and a plurality of mating windows, and wherein each of the one or more dimples interlocks with one of the plurality of mating windows upon the insertion of the spirally wound sheet into the defect and the transformation of the spirally wound sheet.

11. The expandable implant of claim 1, wherein the expandable implant is inserted into the defect via a delivery device.

12. The expandable implant of claim 3, where each of the plurality of spirally wound sheets is individually inserted into the defect via a delivery device, such that the post-insertion shape comprises a nested configuration of the plurality of spirally wound sheets.

13. The expandable implant of claim 11, wherein the delivery device comprises an outer tube into which the expandable implant is inserted and a plunger that drives the inserted implant through the outer tube until the inserted implant is released into the defect.

14. The expandable implant of claim 11, wherein the delivery device comprises an outer sheath coupled with a proximal collet and a distal collet, wherein a default position of the outer sheath is changed in relation to respective positions of the proximal collet and the distal collet in order to insert the expandable implant into the defect.

15. The expandable implant of claim 1, wherein the composition of the expandable implant comprises a shape memory alloy.

16. The expandable implant of claim 15, wherein the shape memory alloy is nitinol.

17. The expandable implant of claim 15 wherein the pre-insertion shape is a non-memory shape that is retained until the expandable implant is activated by temperature or electrical current, such that the activation transforms the expandable implant to a predetermined memory shape that defines the post-insertion shape.

18. The expandable implant of claim 1 wherein the composition of the expandable implant is a superelastic shape memory alloy that changes from the pre-insertion shape to the post-insertion shape automatically after the expandable implant is inserted into the defect.

45. An expandable implant according to claims 1 or 27, wherein the implant comprises a plurality of spirally wound sheets nested within one another wherein adjacent sheets are oriented parallel to one another.

46. An expandable implant according to claims 1 or 27, wherein the implant comprises a plurality of spirally wound sheets nested within one another wherein adjacent sheets are oriented perpendicular to one another.

47. An expandable implant according to claims 1 or 27, wherein the implant further comprises a wear prevention barrier.

48. The expandable implant of claim 47 wherein the wear prevention barrier comprises a low friction polymer.

49. An expandable implant according to claims 1 or 27, wherein the implant exerts a predetermined force to gradually restore the height of the intervertebral disc.

19. A method of inserting an implant into a defect in a nucleus of an intervertebral disc comprising:

loading the implant into a delivery device adapted for insertion into the defect, wherein the implant is in a compressed form having a generally cylindrical shape;

inserting the delivery device into the intervertebral disc; and

releasing the implant from the delivery device into the defect, wherein the implant transforms from the compressed form to an expanded form having the generally cylindrical shape and designed to generally fill the periphery of the defect.

20. The method of claim 19, wherein the implant comprises a spirally wound sheet.

21. The method of claim 19, wherein the implant comprises a plurality of spirally wound sheets nested within one another.

22. The method of claim 21, wherein each of the plurality of spirally wound sheets are individually loaded into the delivery device and individually released from the delivery device into the defect.

23. The method of claim 20, wherein at least one edge of the spirally wound sheet is fabricated to lessen a degree of sharpness of the edge.

24. The method of claim 20, wherein the spirally wound sheet comprises one or more dimples and a plurality of mating windows, and wherein each of the one or more dimples interlocks with one of the plurality of mating windows upon the releasing of the spirally wound sheet into the defect and the transformation of the spirally wound sheet.

25. The method of claim 19, wherein the delivery device comprises an outer tube into which the implant is loaded and a plunger that drives the loaded implant through the outer tube until the loaded implant is released from the outer tube into the defect.

26. The method of claim 19, wherein the delivery device comprises an outer sheath coupled with a proximal collet and a distal collet, wherein a default position of the outer sheath is changed in relation to respective positions of the proximal collet and the distal collet in order to release the implant into the defect.

27. An expandable implant for repair of a defect in a nucleus of an intervertebral disc, the expandable implant comprising:

a pre-insertion shape having a first generally cylindrical shape and adapted for insertion into the defect in the nucleus;

a composition that allows the pre-insertion shape to be transformed to a post-insertion shape after the expandable implant is inserted into the defect;

the post-insertion shape having a second generally cylindrical shape and defining a larger volume than the pre-insertion shape, such that the expandable implant substantially fills the periphery of the defect; and

wherein the post-insertion shape has a non-constant diameter that is larger near the center of the implant and smaller near each of the two ends of the implant.

28. The expandable implant of claim 27, wherein the pre-insertion shape comprises a spirally wound sheet.

29. The expandable implant of claim 27, wherein the pre-insertion shape comprises a plurality of spirally wound sheets nested within one another.

30. The expandable implant of claim 27, wherein a helical shape is inserted into the defect for receiving the expandable implant.

31. The expandable implant of claim 27, wherein a pliable pouch is inserted into the defect for receiving the expandable implant.

32. The expandable implant of claim 31, wherein at least one portion of the pliable pouch comprises a fine metallic mesh or woven fabric composites.

33. The expandable implant of claim 28, wherein at least one edge of the spirally wound sheet is fabricated to lessen a degree of sharpness of the edge.

34. The expandable implant of claim 33, wherein the fabrication of the edge comprises producing a lattice-like configuration at the edge.

35. The expandable implant of claim 33, wherein the fabrication of the edge comprises adhering a protective material to the edge.

36. The expandable implant of claim 28, wherein the spirally wound sheet comprises one or more dimples and a plurality of mating windows, and wherein each of the one or more dimples interlocks with one of the plurality of mating windows upon the insertion of the spirally wound sheet into the nucleus and the transformation of the spirally wound sheet.

37. The expandable implant of claim 27, wherein the expandable implant is inserted into the defect via a delivery device.

38. The expandable implant of claim 29, where each of the plurality of spirally wound sheets is individually inserted into the defect via a delivery device, such that the post-insertion shape comprises a nested configuration of the plurality of spirally wound sheets.

39. The expandable implant of claim 37, wherein the delivery device comprises an outer tube into which the expandable implant is inserted and a plunger that drives the inserted implant through the outer tube until the inserted implant is released into the defect.

40. The expandable implant of claim 37, wherein the delivery device comprises an outer sheath coupled with a proximal collet and a distal collet, wherein a default position of the outer sheath is changed in relation to respective positions of the proximal collet and the distal collet in order to insert the expandable implant into the defect.

41. The expandable implant of claim 27, wherein the composition of the expandable implant comprises a shape memory alloy.

42. The expandable implant of claim 41, wherein the shape memory alloy is nitinol.

43. The expandable implant of claim 41 wherein the compressed form is a non-memory shape that is retained until the expandable implant is activated by temperature or electrical current, such that the activation transforms the expandable implant to a predetermined memory shape that defines the post-insertion shape.

44. The expandable implant of claim 27 wherein the composition of the expandable implant is a superelastic shape memory alloy that changes from the pre-insertion shape to the post-insertion shape automatically after the expandable implant is inserted into the defect.