METHOD AND APPARATUS FOR THE TREATMENT OF THE INTERVERTEBRAL DISC ANNULUS

• US 20090259260A1
• Filed: 10/14/2008
• Published: 10/15/2009
• Est. Priority Date: 10/20/1999
• Status: Active Grant

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: DUKART, BRIAN L., WESSMAN, BRADLEY J., BURNS, MATTHEW M., CAUTHEN, JOSEPH C. III, WALES, LAWRENCE W., HOUFBURG, RODNEY L., BENTLEY, ISHMAEL
• Granted Patent: US 8,128,698 B2
• Time in Patent Office: Days
• US Class Current: 606/300
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2090/036 : abutting on tissue or skin
• 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 2/442 : 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 2/4603 : for insertion or extraction of endoprosthetic joints or of accessories thereof
• 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 2002/3008 : 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 2002/30158 : trapezoidal
• CPC Class Codes: A61F 2002/30299 : umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• 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 2002/4662 : for measuring penetration depth
• 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 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• 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 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys

Abstract

This disclosure presents methods and devices for treating a tear, rent, incision, defect, aperture or delamination of the annulus fibrosus of an intervertebral disc. The methods and devices can employ fixation delivery apparatuses, fixation apparatuses, patch delivery tools and patches positioned, at least in part, in or on aspects of an intervertebral disc for treatment of the intervertebral disc or its components. In some aspects, these techniques include the use of this includes a fixation apparatus that includes at least one bone anchor connected to at least one disc anchor by a shortenable elongate member.

Claims

1. A method of intervertebral disc repair for treating a disc having a defect in the wall of the disc'"'"'s annulus fibrosus, the method comprising:

providing a bone anchor having a shortenable elongate member attached thereto;

inserting the bone anchor into a vertebra that is contiguous to a disc having a defect in the wall of the disc'"'"'s annulus fibrosus;

disposing a portion of the elongate member proximate to the defect in the wall of the annulus fibrosus;

providing a fixation device having a first member, a second member, and a connecting element therebetween;

placing the first member of the fixation device into, or through, the wall of the annulus fibrosus on a first side of the portion of the elongate member;

placing the second member of the fixation device into, or through, the wall of the annulus fibrosus on a second side of the portion of the elongate member so that the connecting element between the first member and the second member extends across the portion of the elongate member; and

shortening the elongate member to an extent sufficient to cause the connecting element between the first member and the second member to be drawn in tension to pull, wholly or partially, annulus fibrosus tissue toward the bone anchor in the vertebra.

2. The method of claim 1 wherein the elongate member comprises a loop or tether.

3. The method of claim 2 wherein the loop comprises a line, wire, filament, band or suture.

4. The method of claim 3 wherein the tether comprises a line, wire, filament, band or suture.

5. The method of claim 1 wherein the fixation device has a third member connected to the connecting element.

6. The method of claim 1 wherein the step of placing the first member further comprises:

disposing the first member proximate to the defect in the wall of the annulus fibrosus.

7. The method of claim 6 wherein the step of placing the second member further comprises:

disposing the second member proximate to the defect in the wall of the annulus fibrosus.

8. The method of claim 1, and further comprising:

after the second member is placed, shortening a length of the connecting element between the first member and second member.

9. The method of claim 1 wherein the connecting element comprises a line, wire, filament, band or suture.

10. The method of claim 1 wherein the first member is placed before the second member is placed.

11. The method of claim 1 wherein the placing steps occur simultaneously.

12. The method of claim 1 wherein the bone anchor comprises a bone screw, a T-anchor, a barb, an expandable element or an adhesive.

13. A method for repair of a defect in the annulus fibrosus tissue of an intervertebral disc, the method comprising:

inserting a bone anchor having a shortenable elongate member attached thereto into a vertebra that is contiguous to a disc having a defect to be repaired in the disc'"'"'s annulus fibrosus tissue;

aligning a portion of the elongate member proximate to the defect;

inserting a first anchor member having a first elongate element attached thereto into or through annulus fibrosus tissue on one side of the portion of the elongate member;

inserting a second anchor member having a second elongate element attached thereto into or through the annulus fibrosus tissue on the other side of the portion of the elongate member;

providing an adjustable coupling that extends over the portion of the elongate member between the first elongate element of the first anchor member and the second elongate element of the second anchor member;

applying tension to the coupling between the first and second elongate elements; and

shortening a length of the elongate member between the bone anchor and the coupling.

14. The method of claim 13 wherein the elongate member comprises a loop or tether.

15. The method of claim 14 wherein the loop comprises a line, wire, filament, band or suture.

16. The method of claim 14 wherein the tether comprises a line, wire, filament, band or structure.

17. The method of claim 13, and further comprising:

inserting a third anchor member having a third elongate element attached thereto into or through the annulus fibrosus tissue at a location spaced from the insertions of the first and second anchor members, wherein the adjustable coupling also extends to the third elongate element; and

prior to the shortening step, applying tension to the coupling between the first, second and third elongate elements.

18. The method of claim 13 wherein the step of inserting the first anchor member further comprises disposing the first anchor member proximate to the defect in the annulus fibrosus tissue.

19. The method of claim 18 wherein the step of inserting the second anchor member further comprises disposing the second anchor member proximate to the defect in the annulus fibrosus tissue.

20. The method of claim 13 wherein the step of applying tension to the coupling comprises shortening a length of the coupling.

21. The method of claim 13 wherein the coupling comprises a loop.

22. The method of claim 21 wherein the loop comprises a line, wire, filament, band or suture.

23. The method of claim 13 wherein the first anchor member is inserted before the second anchor member.

24. The method of claim 13 wherein the first anchor and second anchor inserting steps occur simultaneously.

25. The method of claim 13 wherein the bone anchor comprises a bone screw, a T-anchor, a barb, an expandable element or an adhesive.

26. A method for repair of a defect in the annulus fibrosus tissue of an intervertebral disc, the method comprising:

inserting a bone anchor having a shortenable elongate member thereto into a vertebra that is contiguous to a disc having a defect to be repaired in the disc'"'"'s annulus fibrosus tissue;

aligning a portion of the elongate member proximate to the defect;

inserting a first anchor member having a first elongate element attached thereto into or through annulus fibrosus tissue on one side of the portion of the elongate member;

inserting a second anchor member having a second elongate element attached thereto into or through annulus fibrosus tissue on the other side of the portion of the elongate member;

providing a coupling that extends over the portion of the elongate member between the first elongate element of the first anchor member and the second elongate element of the second anchor member; and

shortening a length of the elongate member between the bone anchor and the coupling.

27. The method of claim 26, and further comprising:

shortening a length of the coupling that extends over the portion of the elongate member between the first anchor member and second anchor member.

28. The method of claim 26 wherein the elongate member comprises a loop or tether.

29. The method of claim 28 wherein the loop comprises a line, wire, filament, band or suture.

30. The method of claim 38 wherein the tether comprises a line, wire, filament, band or suture.

31. The method of claim 26, and further comprising:

inserting a third anchor member having a third elongate element attached thereto into or through the annulus fibrosus tissue at a location spaced from the insertions of the first and second anchor members, wherein the coupling also extends to the third elongate element.

32. The method of claim 31, and further comprising:

shortening a length of the coupling that extends over the portion of the elongate member, after the first, second and third anchor inserting steps.

33. The method of claim 26 wherein the step of inserting the first anchor member further comprises disposing the first anchor member proximate to the defect in the annulus fibrosus tissue.

34. The method of claim 33 wherein the step of inserting the second anchor member further comprises disposing the second anchor member proximate to the defect in the annulus fibrosus tissue.

35. The method of claim 26 wherein the coupling comprises a loop.

36. The method of claim 35 wherein the loop comprises a line, wire, filament, band or suture.

37. The method of claim 26 wherein the first anchor member is inserted before the second anchor member.

38. The method of claim 26 wherein the first anchor and second anchor inserting steps occur simultaneously.

39. The method of claim 26 wherein the bone anchor comprises a bone screw, a T-anchor, a barb, an expandable element or an adhesive.