Method and apparatus for enhanced delivery of treatment device to the intervertebral disc annulus

• US 7,935,147 B2
• Filed: 09/26/2005
• Issued: 05/03/2011
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Wales, Lawrence W.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): FISHER, ELANA BETH
• Application Number:
  US11/235,764
• Publication Number:
  US 20070198021A1
• Time in Patent Office: 2,045 Days
• Field of Search: 606/86, 606/148, 606/151, 623/17.16
• US Class Current: 623/17.16
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• 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: 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 2/3872 : Meniscus for implantation between the natural bone surfaces
• 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 2002/30171 : rosette- or star-shaped
• CPC Class Codes: A61F 2002/30172 : T-shaped
• 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 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/305 : Snap connection
• 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 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/3097 : using laser
• 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 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0052 : T-shaped
• 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

The present invention provides methods and devices for enhancing the delivery of treatment devices for treating the annulus of an intervertebral disc. The methods and devices may employ delivery support elements to delivery tools used to deliver expandable treatment devices to the intervertebral disc. Fixation devices and methods are also disclosed, which may help to secure the treatment device in place.

Claims

1. A method for deploying a therapeutic device to treat intervertebral disc tissue comprising:

providing a therapeutic device and a longitudinal delivery tool having a proximal end and a distal end, the therapeutic device releasably attached to the distal end of said tool, said tool comprising;

at least one proximal actuating member; and

at least one delivery support element connected to the therapeutic device in a first, pre-deployment configuration, and adapted to facilitate lateral deployment of the therapeutic device from the longitudinal axis of the delivery tool;

said at least one delivery support element movable in the longitudinal direction under tension to facilitate lateral expansion and deployment of the therapeutic device in a second, post-deployment configuration, wherein the therapeutic device is attached to the distal end of the delivery tool in the first, pre-deployment configuration;

inserting the therapeutic device into the intervertebral disc;

at least partially actuating the at least one proximal actuating member so that said therapeutic device begins to laterally expand;

moving said at least one delivery support element in the proximal direction under tension thereby allowing or causing said therapeutic device to further laterally expand relative to the longitudinal axis of the delivery tool so as to be deployed proximate to intervertebral disc tissue;

deploying said therapeutic device in the second, post-deployment configuration; and

removing said longitudinal delivery tool.

2. The method according to claim 1, further comprising a step of preparing intervertebral disc tissue, wherein said step of preparing comprises:

identifying a damaged section of tissue; and

removing the damaged section of tissue.

3. The method according to claim 1, wherein said step of inserting the therapeutic device comprises making a surgical incision into intervertebral disc tissue to provide access into intervertebral disc tissue.

4. The method according to claim 1, wherein said at least one delivery support element comprises a suture line having a first end and a second end.

5. The method according to claim 4, wherein the first end and the second end of said suture line are attached to the proximal actuating member of said delivery tool.

6. The method according to claim 4, wherein the first end is attached to the proximal actuating member of said delivery tool, and the second end is attached to the proximal end of said delivery tool.

7. The method according to claim 4, wherein the first end is attached to a first proximal actuating member and the second end is attached to a second proximal actuating member.

8. The method according to claim 4, wherein said longitudinal delivery tool further comprises a finger grip assembly, wherein said proximal actuating member abuts said finger grip assembly, and wherein the second end is releasably affixed to a juncture between the proximal actuating member and the finger grip assembly.

9. The method according to claim 4, wherein said suture line extends from said tool through a therapeutic device releasably attached to the distal end of said tool.

10. The method according to claim 4, wherein the second end of said suture line is releasable from said delivery tool.

11. The method according to claim 1, wherein said longitudinal delivery tool comprises two or more delivery support elements.

12. The method according to claim 1, wherein said at least one delivery support element is releasable from said delivery tool.

13. The method according to claim 1, wherein said at least one delivery support element is constructed from biocompatible polymeric materials, polyamide, polyamide derivatives, polyketones, polyketone derivatives, PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates, acetate derivatives, polysulfones, polysulfone derivatives, biocompatible metallic materials, biodegradable/bioresorbable materials, naturally derived materials, or synthetically derived materials.

14. The method according to claim 1, wherein said longitudinal delivery tool further comprises at least one delivery support element collar configured to distally hold said at least one delivery support element.

15. The method according to claim 14, wherein said at least one delivery support element collar is configured to allow said at least one delivery support element to movably pass through said collar.

16. The method according to claim 14, wherein said at least one delivery support element collar is affixed to said delivery tool.

17. The method according to claim 14, wherein said at least one delivery support element collar is movable in the longitudinal direction, wherein said method further comprises moving said at least one delivery support element collar in the longitudinal direction.

18. The method according to claim 14, wherein said at least one delivery support element collar comprises a tube affixed to the shaft of said tool.

19. The method according to claim 14, wherein said at least one delivery support element collar is constructed from a biocompatible material.

20. The method according to claim 19, wherein said biocompatible material is a polymer, a metal, a metallic alloy, a ceramic, a synthetic material, an engineered material, a shape memory material, or a biodegrable/bioresorbable material.

21. The method according to claim 1, wherein said at least one delivery support element comprises a tether, a rod, beam, wire, band, tube, or actuating element.

22. The method according to claim 1, wherein said at least one delivery support element comprises a suture line having at least on knot along its length.

23. The method according to claim 1, wherein said at least one delivery support element is integrated with the therapeutic device.

24. The method according to claim 1, wherein at least a portion of said at least one delivery support element is exterior to said delivery tool.

25. The method according to claim 1, further comprising releasing said at least one delivery support element from said longitudinal delivery device.

26. A method for deploying a therapeutic device to treat intervertebral disc tissue comprising:

providing a therapeutic device and a longitudinal delivery tool having a proximal end and a distal end, the therapeutic device releasably attached to the distal end of the delivery tool and including a proximal end, a distal end, and an intermediate portion between the proximal and distal ends, the proximal and distal ends of the therapeutic device having a fixed outer dimension such that they are not laterally expandable, the intermediate portion being laterally expandable, the tool comprising;

at least one proximal actuating member; and

at least one delivery support element connected to the therapeutic device in a first, pre-deployment configuration, and adapted to facilitate lateral deployment of the intermediate portion of the therapeutic device from the longitudinal axis of the delivery tool;

the at least one delivery support element movable in the longitudinal direction under tension to facilitate lateral expansion and deployment of the therapeutic device in a second, post-deployment configuration, wherein the therapeutic device is attached to the distal end of the delivery tool in the first, pre-deployment configuration;

inserting the therapeutic device into the intervertebral disc;

at least partially actuating the at least one proximal actuating member to urge the proximal and distal ends of the therapeutic device toward one another so that the intermediate portion of said therapeutic device begins to laterally expand;

moving the at least one delivery support element in the proximal direction under tension thereby allowing or causing the intermediate portion of the therapeutic device to further laterally expand relative to the longitudinal axis of the delivery tool so as to be deployed proximate to intervertebral disc tissue;

deploying the therapeutic device in the second, post-deployment configuration; and

removing the longitudinal delivery tool.

27. The method according to claim 26, wherein the at least one delivery support element comprises a suture line having a first end and a second end.

28. The method according to claim 27, wherein the first end and the second end of the suture line are attached to the proximal actuating member of the delivery tool.

29. The method according to claim 27, wherein the first end is attached to the proximal actuating member of said delivery tool, and the second end is attached to the proximal end of said delivery tool.

30. The method according to claim 27, wherein the first end is attached to a first proximal actuating member and the second end is attached to a second proximal actuating member.

31. The method according to claim 27, wherein the longitudinal delivery tool further comprises a finger grip assembly, wherein the proximal actuating member abuts the finger grip assembly, and wherein the second end is releasably affixed to a juncture between the proximal actuating member and the finger grip assembly.

32. The method according to claim 27, wherein the suture line extends from the delivery tool through a therapeutic device releasably attached to the distal end of the delivery tool.

33. The method according to claim 27, wherein the second end of the suture line is releasable from the delivery tool.

34. The method according to claim 26, wherein the longitudinal delivery tool comprises two or more delivery support elements.

35. The method according to claim 26, wherein the at least one delivery support element is releasable from the delivery tool.

36. The method according to claim 26, wherein the at least one delivery support element is constructed from biocompatible polymeric materials, polyamide, polyamide derivatives, polyketones, polyketone derivatives, PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates, acetate derivatives, polysulfones, polysulfone derivatives, biocompatible metallic materials, biodegradable/bioresorbable materials, naturally derived materials, or synthetically derived materials.

37. The method according to claim 26, wherein the longitudinal delivery tool further comprises at least one delivery support element collar configured to distally hold the at least one delivery support element.

38. The method according to claim 37, wherein the at least one delivery support element collar is configured to allow the at least one delivery support element to movably pass through said collar.

39. The method according to claim 37, wherein the at least one delivery support element collar is affixed to the delivery tool.

40. The method according to claim 37, wherein the at least one delivery support element collar is movable in the longitudinal direction, wherein the method further comprises moving the at least one delivery support element collar in the longitudinal direction.

41. The method according to claim 37, wherein the at least one delivery support element collar comprises a tube affixed to the shaft of the tool.

42. The method according to claim 37, wherein the at least one delivery support element collar is constructed from a biocompatible material.

43. The method according to claim 42, wherein the biocompatible material is a polymer, a metal, a metallic alloy, a ceramic, a synthetic material, an engineered material, a shape memory material, or a biodegrable/bioresorbable material.

44. The method according to claim 26, wherein the at least one delivery support element comprises a tether, a rod, beam, wire, band, tube, or actuating element.

45. The method according to claim 26, wherein the at least one delivery support element comprises a suture line having at least on knot along its length.

46. The method according to claim 26, wherein the at least one delivery support element is integrated with the therapeutic device.

47. The method according to claim 26, wherein at least a portion of the at least one delivery support element is exterior to the delivery tool.

48. The method according to claim 26, further comprising releasing the at least one delivery support element from the longitudinal delivery device.