Apparatus for treating spinal discs

• US 20020147496A1
• Filed: 04/06/2001
• Published: 10/10/2002
• Est. Priority Date: 04/06/2001
• Status: Abandoned Application

• Current Assignee: Core Medical Incorporated
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Belef, W. Martin, Aldrich, William N., Ginn, Richard S., Jabba, Ronald J., Salmon, Stephen M.
• Application Number:
  US09/827,427
• Publication Number:
  US 20020147496A1
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30589 Sealing means
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• 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 2002/465 : using heating means
• 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 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

Apparatus and methods for treating a spinal disc are disclosed. An opening is created in the annulus fibrosis, and nucleus pulposus is removed from the interior of the disc. The interior is lined with a nonporous, bioabsorbable liner, and filled with a fill material, such as nucleus pulposus, to cause the liner to expand to engage tissue surrounding the interior. The liner may be a sheet of extra-cellular matrix material that is introduced into-the interior, or a bladder of extra-cellular matrix material including a neck communicating with an interior region of the bladder. The sheet or bladder may be carried by a delivery device, e.g., a catheter or rod. After the interior region is filled, the opening is closed using a plug or other closure device. The plug may include threads on its external surface for securing the plug in the opening.

Claims

1. An apparatus for treating an interior region of a spinal disc that is accessed through an opening in an annulus fibrosis of the disc, comprising:

an elongate member comprising proximal and distal ends, the distal end having a size for insertion into an opening into a spinal disc;

a sheet of bioabsorbable material on the distal portion of the elongate member such that a peripheral edge of the sheet is disposed generally against the distal portion, the sheet having sufficient surface area for substantially lining an interior region of a spinal disc; and

a closure device for substantially engaging tissue surrounding an opening into a spinal disc, whereby the closure device may substantially seal the opening.

2. The apparatus of claim 1, further comprising a source of fill material for filling an interior region of a spinal disc after the interior region has been lined by the sheet.

3. The apparatus of claim 2, wherein the fill material comprises at least one of nucleus pulposus, an autologous therapeutic agent, and an extra-cellular matrix material.

4. The apparatus of claim 2, wherein the elongate member comprises a tubular member including a lumen communicating between the proximal and distal ends of the tubular member.

5. The apparatus of claim 4, wherein the source of fill material is connectable to the proximal end of the tubular member for delivering fill material through the lumen into an interior region defined by the sheet.

6. The apparatus of claim 1, wherein the closure device comprises a threaded plug.

7. The apparatus of claim 1, further comprising a sheath slidably disposed over the elongate member, thereby disposing the sheet generally against the distal portion of the elongate member.

8. The apparatus of claim 1, wherein the sheet comprises a naturally occurring extra-cellular matrix material.

9. The apparatus of claim 8, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa and bladder submucosa.

10. The apparatus of claim 1, wherein the sheet is substantially nonporous.

11. An apparatus for treating a spinal disc, comprising:

a tubular member including a proximal end, a distal end having a size for insertion through an opening into a spinal disc, and a lumen extending between the proximal and distal ends;

a substantially nonporous bladder comprising a neck defining an opening communicating with an interior of the bladder, the neck being detachably connected to the distal end of the tubular member such that the interior of the bladder communicates with the lumen via the opening; and

a source of fill material communicating with the lumen, the fill material comprising nucleus pulposus.

12. The apparatus of claim 11, further comprising a sheath slidably disposed over the tubular member, the sheath comprising a distal region for receiving the bladder therein in a collapsed configuration.

13. The apparatus of claim 11, wherein the bladder further comprises a sealing member for securing the neck over the distal end of the tubular member.

14. The apparatus of claim 13, wherein the sealing member comprises an elastic ring biased to constrict the neck upon withdrawal of the distal end of the tubular member from within the neck.

15. The apparatus of claim 13, wherein the neck is everted within the interior space of the bladder, and wherein the sealing member is disposed around the neck within the interior space.

16. The apparatus of claim 11, further comprising a pusher member slidable along the tubular member, the pusher member configured for directing the neck off of the distal end of the tubular member.

17. The apparatus of claim 16, wherein the pusher member comprises a substantially blunt distal end for engaging the neck when the distal end of the tubular member is withdrawn from within the neck.

18. The apparatus of claim 11, wherein the bladder comprises bioabsorbable material.

19. The apparatus of claim 11, wherein the bladder comprises a naturally occurring extra-cellular matrix material.

20. The apparatus of claim 19, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa and bladder submucosa.

21. The apparatus of claim 11, wherein the bladder comprises a substantially inelastic material.

22. The apparatus of claim 11, wherein the bladder is expandable from a collapsed configuration to facilitate introduction into a spinal disc to an enlarged configuration for filling a cavity created within the spinal disc.

23. The apparatus of claim 22, wherein the bladder comprises a disc shape including convex opposing surfaces in the enlarged configuration.

24. The apparatus of claim 11, wherein the distal end of the tubular member comprises an electrode for delivering energy to tissue surrounding a passage through which the tubular member is inserted for closing the passage upon withdrawal of the tubular member.

25. The apparatus of claim 11, wherein the distal end of the tubular member comprises a radiopaque marker.

27. The apparatus of claim 26, wherein the elongate member comprises a tubular member comprising a lumen extending between the proximal and distal ends, and wherein the interior of the bladder communicates with the lumen via the opening.

28. The apparatus of claim 27, further comprising a source of fill material communicating with the lumen, the fill material comprising at least one of nucleus pulposus, an extra-cellular matrix, an autologous therapeutic agent, an nsaid, a genetic material, a proteoglycan, a proteoglycan recruiting material, a material for inhibiting nerve ingrowth, an antibiotic, a steroid, and saline.

29. The apparatus of claim 26, further comprising a sheath slidably disposed over the elongate member, the sheath comprising a distal region for receiving the bladder therein in a collapsed configuration.

30. The apparatus of claim 26, wherein the bladder further comprises a sealing member for securing the neck over the distal end of the elongate member.

31. The apparatus of claim 30, wherein the sealing member comprises an elastic ring biased to constrict the neck upon withdrawal of the distal end of the elongate member from within the neck.

32. The apparatus of claim 30, wherein the neck is everted within the interior space of the bladder, and wherein the sealing member is disposed around the neck within the interior space.

33. The apparatus of claim 26, further comprising a pusher member slidable along the elongate member, the pusher member configured for directing the neck off of the distal end of the elongate member.

34. The apparatus of claim 33, wherein the pusher member comprises a substantially blunt distal end for engaging the neck when the distal end of the elongate member is withdrawn from within the neck.

35. The apparatus of claim 26, wherein the bladder comprises a naturally occurring extra-cellular matrix material.

36. The apparatus of claim 35, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa and bladder submucosa.

37. The apparatus of claim 26, wherein the bladder comprises a substantially inelastic material.

38. The apparatus of claim 26, wherein the bladder is expandable from a collapsed configuration to facilitate introduction into a spinal disc to an enlarged configuration for filling a cavity created within the spinal disc.

39. The apparatus of claim 26, wherein the bladder comprises a disc shape including convex opposing surfaces in the enlarged configuration.

40. The apparatus of claim 26, wherein the distal end of the elongate member comprises an electrode for delivering energy to tissue surrounding a passage through which the elongate member is inserted for closing the passage upon withdrawal of the elongate member.

41. The apparatus of claim 26, wherein the distal end of the elongate member comprises a radiopaque marker.

26. An apparatus for treating a spinal disc, comprising:

an elongate member including a proximal end and a distal end having a size for insertion through an opening into a spinal disc; and

a substantially nonporous, bioabsorbable bladder comprising a neck defining an opening communicating with an interior of the bladder, the neck being detachably connected to the distal end of the tubular member.

42. An apparatus for treating a spinal disc, comprising a substantially nonporous, bioabsorbable bladder comprising a neck defining an opening communicating with an interior of the bladder, the bladder being expandable from a collapsed configuration to an enlarged configuration, the bladder having a size and shape to fit within an interior of a spinal disc in the enlarged configuration.

43. The apparatus of claim 42, wherein the bladder further comprises a sealing member for substantially sealing the neck from fluid flow therethrough.

44. The apparatus of claim 43, wherein the sealing member comprises an elastic ring biased to constrict the neck.

45. The apparatus of claim 43, wherein the neck is everted within the interior space of the bladder, and wherein the sealing member is disposed around the neck within the interior space.

46. The apparatus of claim 42, wherein the bladder comprises a naturally occurring extra-cellular matrix material.

47. The apparatus of claim 46, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa and bladder submucosa.

48. The apparatus of claim 42, wherein the bladder comprises a substantially inelastic material.

49. The apparatus of claim 42, wherein the bladder comprises a disc shape including convex opposing surfaces in the enlarged configuration.

50. The apparatus of claim 42, wherein the interior of the bladder is filled with material comprising at least one of nucleus pulposus, an extra-cellular matrix, an autologous therapeutic agent, an nsaid, a genetic material, a proteoglycan, a proteoglycan recruiting material, a material for inhibiting nerve ingrowth, an antibiotic, a steroid, and saline.

51. The apparatus of claim 42, further comprising a plug member attached to the neck, the plug member comprising a body having a size for insertion into an opening in a spinal disc, and a connector for engaging tissue surrounding the opening.

52. The apparatus of claim 51, wherein the body comprises a lumen therethrough communicating with the interior of the bladder.

53. The apparatus of claim 51, further comprising a plug element within the body, the plug element deployable for opening and closing the lumen to fluid flow therethrough.

54. A device for closing an opening in a spinal disc, comprising:

an elongate body formed from biocompatible material and comprising a connector on an exterior surface of the body for substantially engaging tissue surrounding the opening, the body comprising a lumen extending between its proximal and distal ends; and

a plug element within the body, the plug element being movable from a pocket within the body into the lumen for substantially sealing the lumen from fluid flow therethrough.

55. The device of claim 54, further comprising a substantially nonporous bladder comprising a neck defining an opening communicating with an interior of the bladder, the neck being attached to the distal end of the body such that the lumen communicates with the interior of the bladder.

56. The device of claim 55, wherein the bladder comprises substantially nonporous material.

57. The device of claim 55, wherein the bladder comprises bioabsorbable material.

58. The device of claim 54, wherein the connector comprises a thread pattern on an exterior of the body.

59. The device of claim 54, wherein the connector comprises a plurality of tissue engaging elements expandable from a contracted condition to an expanded condition.

60. An implant for treating an interior of a spinal disc, comprising:

an elongate body of fill material comprising at least one of nucleus pulposus and naturally occurring extra-cellular matrix material; and

a plug member connected to one end of the elongate body, the plug member comprising a connector on an exterior portion thereof for engaging tissue surrounding an opening through which the body of fill material is introduced for substantially closing the opening.

61. The implant of claim 60, wherein the body of fill material may be cut into a predetermined length corresponding to a volume of an interior of spinal disc within which the body of fill material is introduced.

62. The implant of claim 60, wherein the connector comprises a thread pattern on an exterior of the body.

63. The implant of claim 60, wherein the connector comprises a plurality of tissue engaging elements expandable from a contracted condition to an expanded condition.

64. The implant of claim 60, wherein the fill material further comprises at least one of an autologous therapeutic agent, an nsaid, a genetic material, a proteoglycan, a proteoglycan recruiting material, a material for inhibiting nerve ingrowth, an antibiotic, a steroid, and saline.