Methods for treating spinal discs

• US 20020147497A1
• 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: Aldrich, William N., Jabba, Ronald J., Belef, William Martin, Salmon, Stephen M.
• Application Number:
  US09/828,039
• Publication Number:
  US 20020147497A1
• 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. A method for treating a spinal disc of a patient, the spinal disc comprising annulus fibrosis and nucleus pulposus within an interior region defined by the annulus fibrosis, the method comprising:

removing at least a portion of the nucleus pulposus material from the interior region to define a space;

lining the space with a substantially nonporous, bioabsorbable liner material; and

filling the space with a fill material sufficient to cause the liner material to expand to substantially engage tissue surrounding the space.

2. The method of claim 1, wherein the fill material comprises nucleus pulposus.

3. The method of claim 2, wherein the nucleus pulposus used to fill the space comprises nucleus pulposus removed from the disc.

4. The method of claim 1, wherein the fill material comprises a naturally occurring extra-cellular matrix.

5. The method of claim 4, wherein the extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa, or bladder submucosa.

6. The method of claim 1, wherein the fill material comprises an autologous therapeutic agent.

7. The method of claim 6, wherein the autologous therapeutic agent comprises a concentrated growth factor derived from centrifuged plasma of the patient.

8. The method of claim 1, wherein the space is filled with a material comprising interpenetrating polymer network (IPN) material.

9. The method of claim 1, wherein the liner material comprises a substantially nonporous, bioabsorbable bladder, wherein the step of lining the space comprises introducing the bladder within the space, and wherein the step of filling the space comprises filling the bladder with a fill material sufficient to cause the bladder to expand to substantially occupy the space.

10. The method of claim 9, wherein the bladder comprises an extra-cellular matrix material.

11. The method of claim 10, wherein the extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa, or bladder submucosa.

12. The method of claim 9, wherein the bladder comprises a neck defining an opening for introducing the fill material into the bladder.

13. The method of claim 12, wherein the bladder further comprises a sealing member for sealing the neck to prevent leakage of the material used to fill the bladder.

14. The method of claim 13, wherein the bladder is disposed on a distal portion of a delivery device that is inserted into the neck such that the neck is everted within an interior of the bladder, and wherein the step of introducing the bladder comprises introducing the distal portion of the delivery device into the space.

15. The method of claim 14, further comprising:

engaging the neck of the bladder with a pusher member; and

removing the delivery device from the neck, the sealing member closing the neck to substantially seal the fill material within the interior of the bladder.

16. The method of claim 9, wherein the bladder is inserted through the opening in a collapsed configuration, and wherein the bladder expands to an enlarged configuration to engage surrounding tissue as it is filled.

17. The method of claim 9, wherein the bladder comprises a tubular plug member, the plug member comprising a lumen communicating with an interior region of the bladder, and wherein the step of introducing the bladder within the space comprises securing the plug member within the opening.

18. The method of claim 17, wherein the plug member comprises a thread pattern on its external surface, and wherein the step of securing the plug member comprises threading the plug member into the opening.

19. The method of claim 17, wherein a distal portion of an elongate tubular member is disposed within the lumen of the plug member, and wherein the fill material is delivered into the bladder via a lumen in the tubular member from a source of fill material coupled to a proximal end of the tubular member.

20. The method of claim 19, further comprising closing the lumen of the plug member upon removal of the tubular member.

21. The method of claim 20, wherein the step of closing the lumen of the plug member comprises deploying an internal plug element within the lumen of the plug member.

22. The method of claim 1, wherein the liner material comprises a sheet of naturally occurring extra-cellular matrix material.

23. The method of claim 22, wherein the extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa, or bladder submucosa.

24. The method of claim 1, further comprising introducing a flowable fill material into the space before lining the space.

25. The method of claim 24, wherein the flowable fill material comprises naturally occurring extra-cellular matrix material.

26. The method of claim 25, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa and bladder submucosa.

27. The method of claim 25, wherein the flowable fill material comprises a slurry further comprising at least one of saline, an antibiotic, a steroid, and an nsaid.

28. The method of claim 24, wherein the step of filling the space with a fill material causes the flowable fill material within the space to flow into cracks or fissures in the annulus fibrosis.

29. The method of claim 24, wherein the flowable fill material comprises an autologous therapeutic agent.

30. The method of claim 1, wherein the step of removing the nucleus pulposus comprises creating an opening in the annulus fibrosis to access the interior region of the annulus fibrosis.

31. The method of claim 30, wherein the liner material comprises a sheet of substantially nonporous, bioabsorbable material.

32. The method of claim 31, further comprising introducing a plug into the opening, the plug substantially closing the opening.

33. The method of claim 31, wherein the plug comprises a thread pattern on its external surface, and wherein the step of introducing the plug comprises threading the plug into the opening.

34. The method of claim 30, and wherein the step of lining the space comprises introducing the sheet into the space such that an outer edge of the sheet extends through the opening.

35. The method of claim 34, further comprising trimming excess sheet material extending from the opening.

36. The method of claim 34, further comprising introducing a plug into the opening, the plug engaging the sheet to substantially close the opening.

37. The method of claim 30, further comprising closing the opening after filling the space with fill material.

38. The method of claim 37, wherein the closing step comprises applying energy to annular fibrosis tissue surrounding the opening.

39. The method of claim 37, wherein the closing step comprises deploying a closure element to close the opening.

40. The method of claim 39, wherein the closure element comprises a threaded plug, and wherein the step of deploying a closure element comprises threading the plug into the opening.

41. A method for treating a spinal disc of a patient, the spinal disc comprising annulus fibrosis and nucleus pulposus within an interior region defined by the annulus fibrosis, the method comprising:

removing at least a portion of the nucleus pulposus material from the interior region to define a space;

lining the space with a substantially nonporous liner material; and

filling the space with a fill material sufficient to cause the liner material to expand to substantially engage tissue surrounding the space, the fill material comprising at least some of the nucleus removed from the disc.

42. The method of claim 41, wherein the fill material further comprises at least one of naturally occurring extracellular matrix material, saline, a pharmaceutical, an autologous therapeutic agent, a concentrated growth factor derived from centrifuged plasma of the patient, or genetic material.

43. The method of claim 41, wherein the liner material comprises bioabsorbable material.

44. The method of claim 41, wherein the liner material comprises naturally occurring extra-cellular matrix material.

45. The method of claim 44, wherein the naturally occurring extra-cellular matrix material comprises at least one of intestinal submucosa, stomach submucosa, or bladder submucosa.

46. The method of claim 41, wherein the step of lining the space comprises introducing a substantially nonporous bladder within the space, and wherein the step of filling the space comprises filling the bladder with a fill material sufficient to cause the bladder to expand to substantially occupy the space.

47. The method of claim 46, wherein the bladder comprises a neck defining an opening for introducing the fill material into the bladder.

48. The method of claim 47, wherein the bladder further comprises a sealing member for sealing the neck to prevent leakage of the material used to fill the bladder.

49. The method of claim 41, wherein the step of removing the nucleus pulposus comprises creating an opening in the annulus fibrosis to access the interior region of the annulus fibrosis.

50. The method of claim 49, wherein the step of lining the space comprises introducing a sheet of substantially nonporous, bioabsorbable material into the space.

51. The method of claim 49, further comprising closing the opening after filling the bladder with fill material.

52. The method of claim 51, wherein the closing step comprises applying energy to annular fibrosis tissue surrounding the opening.

53. The method of claim 51, wherein the closing step comprises deploying a closure element to close the opening.

54. The method of claim 41, further comprising introducing a flowable fill material into the interior region before introducing the lining the interior region.

55. The method of claim 54, wherein the flowable fill material comprises naturally occurring extra-cellular matrix material.

56. The method of claim 55, wherein the flowable fill material comprises a slurry further comprising at least one of saline, an antibiotic, a steroid, and an nsaid.

57. The method of claim 54, wherein the flowable fill material comprises an autologous therapeutic agent.