Spinal disc annulus reconstruction method

• US 7,670,379 B2
• Filed: 02/16/2006
• Issued: 03/02/2010
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Cauthen, Joseph C.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): SWIGER III, JAMES L
• Application Number:
  US11/355,426
• Publication Number:
  US 20060142864A1
• Time in Patent Office: 1,475 Days
• Field of Search: 623 1711- 1716, 623/902, 623/11.11, 606246-248, 606/151, 606153-156, 128/898
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30158 trapezoidal
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 623/902 : Method of implanting

Abstract

A stent, or device for repair and reconstruction of the spinal disc wall, or annulus fibrosus, after surgical incision or pathologic rupture, which is inserted through an aperture into the subannular space. The stent has radial extensions which are caused or allowed to expand into an expanded configuration to bridge the aperture. The stent thereby occludes the defective region from the inside of the vertebral disc and prevents the migration of nucleus pulposus therethrough, while also providing a scaffold for tissue growth.

Claims

1. A method of treating an aperture in the wall of the annulus fibrosus of an intervertebral disc, said method comprising the steps of:

(a) providing a patch member in a compressed condition, said patch member being at least in part compressible;

(b) placing a portion of said patch member in proximity of said aperture;

wherein said patch member is smaller or equal to the size of said aperture;

(c) expanding said compressed patch member such that a portion of said expanded patch member is in proximity to an inner portion of the wall of said annulus fibrosus; and

(d) reducing the size of said aperture by drawing tissue surrounding said aperture toward said patch member.

2. The method of claim 1, wherein said patch is comprised of fascia.

3. The method of claim 1, wherein said patch is comprised of a biocompatible material.

4. The method of claim 1, wherein said patch is comprised of a biodegradable or bioresorbable material.

5. The method of claim 1, wherein said patch is comprised of a form fitting filler material.

6. The method of claim 1, wherein said patch is comprised of a non-form fitting filler material.

7. The method of claim 1, wherein said patch is comprised of bioactive materials which assist in regeneration of disc tissues.

8. The method of claim 7, wherein said bioactive materials are tissue growth factors.

9. The method of claim 1, wherein said patch member is comprised of a porous matrix or a mesh of biocompatible fibers adapted to support the regeneration of a disc tissue.

10. The method of claim 1, wherein said aperture is pathologic.

11. The method of claim 1, wherein said aperture is formed at least in part by surgical incision.

12. The method of claim 1, wherein said patch is adapted to fill said aperture sufficient to prevent migration of intradiscal material through the aperture.

13. The method of claim 1, wherein said patch is adapted to be fastened to said annulus fibrosus.

14. The method of claim 1, wherein said patch is sized and shaped so as to form a barrier to the migration of intradiscal material through said aperture upon completion of steps (b) through (d).

15. The method of claim 1, wherein said patch comprises barbs for fixation to an inner surface of said annulus fibrosus.

16. The method of claim 1, wherein said patch comprises a flexible resilient material.

17. The method of claim 1, wherein said patch comprises an expandable polymer.

18. The method of claim 1, wherein said patch comprises a hygroscopic material for controlled limited expansion to fill a disc space cavity.

19. The method of claim 1, wherein the step of drawing together further comprises the placement of at least one fixation device.

20. The method of claim 19 wherein said at least one fixation device further comprises sutures, staples or tension bands.

21. A method of treating an aperture in the wall of the annulus fibrosus of an intervertebral disc, said method comprising the steps of:

(a) providing a patch member;

(b) placing at least a portion of said patch member within said aperture;

wherein said patch member is smaller or equal to the size of said aperture;

(c) placing a first fixation device into or through the annular tissue to fix said patch member to said annulus fibrosus; and

(d) drawing together tissue surrounding said aperture to said patch member using at least one of said first fixation device and a second fixation device to reduce the size of the aperture.

22. The method of claim 21, wherein said first and second fixation devices comprise sutures, staples, or tension bands.

23. The method of claim 21, wherein said first and second fixation devices are tension bands.

24. The method of claim 21, wherein said patch member comprises barbs for fixation to an inner surface of said annulus fibrosus.

25. The method of claim 24, wherein at least one of said first and second fixation devices is a barb of said patch member.

26. The method of claim 21, wherein said patch member is comprised of fascia.

27. The method of claim 21, wherein said patch member is comprised of a biocompatible material.

28. The method of claim 21, wherein said patch member is comprised of a biodegradable or bioresorbable material.

29. The method of claim 21, wherein said patch member is comprised of a form fitting filler material.

30. The method of claim 21, wherein said patch member is comprised of a non-form fitting filler material.

31. The method of claim 21, wherein said patch member is comprised of bioactive materials which assist in regeneration of disc tissues.

32. The method of claim 31, wherein said bioactive materials are tissue growth factors.

33. The method of claim 21, wherein said patch member is comprised of a porous matrix or a mesh of biocompatible fibers adapted to support the regeneration of a disc tissue.

34. The method of claim 21, wherein said aperture is pathologic.

35. The method of claim 21, wherein said aperture is formed at least in part by surgical incision.

36. The method of claim 21, wherein said patch member is adapted to fill said aperture sufficient to prevent migration of intradiscal material through said aperture.

37. The method of claim 21, wherein said patch member is sized and shaped so as to form a barrier to the migration of intradiscal material through said aperture upon completion of steps (b) through (d).

38. The method of claim 21, wherein said patch member comprises a flexible resilient material.

39. The method of claim 21, wherein said patch member comprises an expandable polymer.

40. The method of claim 21, wherein said patch member comprises a hygroscopic material for controlled limited expansion to fill a disc space cavity.

41. The method of claim 21, wherein said patch member is at least in part compressible and is provided in a compressed condition, said method further comprising the step of:

expanding said compressed patch member after step (b) such that said expanded patch member conforms to an inner portion of the wall of said annulus fibrosus.

42. The method of claim 21, wherein at least partially closing said aperture by drawing together tissue surrounding said aperture using at least one of said first fixation device and a second fixation device includes drawing toward one another tissue surrounding said aperture and said patch member.