Method and apparatus for the treatment of the intervertebral disc annulus

• US 7,963,992 B2
• Filed: 10/08/2008
• Issued: 06/21/2011
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Dukart, Brian L., Bentley, Ishmael, Wessman, Bradley J., Wales, Lawrence W., Burns, Matthew M., Houfburg, Rodney L., Cauthen, Joseph C. III
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Hammond; Ellen C
• Application Number:
  US12/247,637
• Publication Number:
  US 20090036989A1
• Time in Patent Office: 986 Days
• Field of Search: 623 1711- 1716, 606/902
• US Class Current: 623/17.11
• 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 2017/0061 Implements located only on one side of the opening
• 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• 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 2/30767 : Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2002/0072 : Delivery tools therefor
• 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
• CPC Class Codes: Y10S 623/902 : Method of implanting

Abstract

The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices can employ an expandable treatment device which is deployed at least partially in the subannular space. Fixation devices and methods are also disclosed, which help to secure the treatment device in place.

Claims

1. A method of treating an intervertebral disc having an annulus, the method comprising:

providing a first delivery tool having a proximal portion and a distal portion, the distal portion carrying a treatment device;

providing at least one second delivery tool having a proximal portion and a distal portion, the distal portion carrying at least one fixation device configured to affix said treatment device to the intervertebral disc tissue, wherein said fixation device comprises two anchor portions and a connecting assembly connecting said anchor portions, said connecting assembly configured to be shortened and comprising a locking element;

introducing the distal portion of the first delivery tool at least partially into the intervertebral disc through an aperture in the annulus, and expanding the treatment device so as to span across the aperture within the intervertebral disc;

introducing the distal portion of said at least one second delivery tool at least partially into the intervertebral disc and through the annulus at a location adjacent to the aperture;

delivering at least a portion of said at least one fixation device into, or through, a portion of the annulus and a portion of the treatment device, including disposing one of the anchor portions within the disc and against an internally oriented portion of the treatment device, and disposing the other of the anchor portions at and in engagement with an outer surface of the annulus;

actuating said at least one second delivery tool, said actuating step causing shortening of the connecting assembly disposed between the anchor portions so as to apply tension to the connecting assembly and thereby secure the treatment device to the annulus between the anchor portions;

securing said connecting assembly in a shortened configuration with a locking element; and

removing said at least one second delivery tool; and

removing said first delivery tool.

2. The method of claim 1, wherein said affixation fixation device is comprised of one or more bands, filaments, lines, wires, tethers or sutures.

3. The method of claim 2, wherein said anchor portion disposed within the intervertebral disc comprises a t-anchor configuration.

4. The method of claim 1, wherein said treatment device comprises material to facilitate regeneration of tissue.

5. The method of claim 4, wherein said material to facilitate regeneration of tissue comprises a growth factor.

6. The method of claim 1, wherein said fixation device comprises material to facilitate regeneration of tissue.

7. The method of claim 6, wherein said material to facilitate regeneration of tissue comprises a growth factor.

8. The method of claim 1, wherein said treatment device comprises polymeric material.

9. The method of claim 1, wherein said affixation fixation device comprises polymeric material.

10. The method of claim 1, wherein said treatment device comprises a mesh, patch, scaffold, stent, barrier or membrane.

11. The method of claim 1, wherein said anchor portion disposed at the outer surface of the annulus comprises a pledget configuration.

12. The method of claim 1, wherein at least one anchor portion comprises a T-anchor.

13. The method of claim 1, wherein at least one anchor portion comprises a barb.

14. The method of claim 1, wherein at least one anchor portion comprises an element configured as a pledget.

15. The method of claim 1, wherein that the portion of said connecting assembly that is contiguous with said anchor portions is of a smaller girth than a portion of the connecting assembly disposed in between said anchor portions.

16. The method of claim 1, wherein said locking element of said connecting assembly comprises a retainer, clip, or knot.

17. The method of claim 1, wherein said treatment device comprises a braided mesh.

18. The method of claim 17, wherein said treatment device comprises multiple braided meshes configured in series or in parallel.

19. The method of claim 1, wherein said treatment device obtains a deployed configuration by actuating said first delivery tool so as to shorten the treatment device dimension along the axis of the delivery tool.

20. The method of claim 1, wherein said treatment device obtains a deployed configuration by actuating said first delivery tool so as to laterally expand the treatment device dimension away from the axis of the delivery tool.

21. The method of claim 20, wherein said treatment device comprises portions or elements of the device that facilitate non-uniform expansion of the treatment device away from the axis of the delivery tool.

22. The method of claim 1, wherein multiple treatment devices and multiple fixation devices are used to treat an intervertebral disc.

23. The method of claim 1, wherein said treatment device comprises a retention element so as to secure the treatment device in a deployed configuration.

24. The method of claim 1, wherein said treatment device is configured to be attached by compression to the distal portion of the first delivery tool, and capable of being released from the distal portion of the first delivery tool upon relief of said compression.