Methods of reinforcing an intervertebral disc annulus

• US 7,553,330 B2
• Filed: 08/22/2006
• Issued: 06/30/2009
• Est. Priority Date: 08/18/1999
• Status: Expired due to Fees

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Redmond, Russel J., Moore, Robert Kevin, Banks, Thomas, Vidal, Claude A., Lambrecht, Gregory H.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/508,068
• Publication Number:
  US 20060282167A1
• Time in Patent Office: 1,043 Days
• Field of Search: 623/1, 623/11, 623/1.2, 623/1.17, 623/23.7, 623/16.11, 623 1711- 1716, 606/60, 606/246, 606/279, 606215-217, 606228-231, 606/233, 604/500
• 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 17/0487 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/22077 : with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4514 : Cartilage
• CPC Class Codes: A61F 2/2846 : Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30723 : Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• 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 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• 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 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
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• CPC Class Codes: A61F 2002/30571 : Leaf springs
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• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• 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 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

Methods of reinforcing annulus fibrosis tissue within an intervertebral disc include the implantation of a support member also functioning as a barrier to resist damage to the tissue or herniation of tissue outside the disc. The device may be anchored to the surrounding tissue. The device is compressible and may be delivered in a minimally invasive manner through a cannula.

Claims

1. A method of reinforcing an annulus of an intervertebral disc comprising:

identifying a pre-existing defect in the annulus;

wherein the defect is bordered by an outermost layer of the annulus and an innermost layer of the annulus, the method comprising;

providing a biocompatible support member; and

implanting the biocompatible support member along an innermost surface of the annulus without removing a substantial portion of the nucleus pulposus;

positioning said biocompatible support member entirely beyond said defect;

positioning said biocompatible support member to span said defect, thereby closing said defect and minimizing leakage of a naturally-occurring nucleus pulposus material into the defect;

anchoring the biocompatible support member;

wherein said biocompatible support member extends entirely along the innermost layer of the annulus, and

wherein said biocompatible support member is positioned in front of said defect and disposed against said innermost layer, thereby reinforcing the annulus.

2. The method of claim 1, wherein the step of anchoring the biocompatible support member comprises anchoring said biocompatible support member to the annulus or a vertebral body.

3. The method of claim 1, further comprising the steps of attaching the biocompatible support member to a connector and anchoring the connector to a wall of the annulus.

4. The method of claim 1, further comprising the steps of attaching the biocompatible support member to a connector and anchoring the connector to a vertebral endplate.

5. The method of claim 1, further comprising the step of attaching a connector to a wall of the annulus, wherein said connector is coupled to said support member.

6. The method of claim 1, further comprising the step of attaching a connector to a vertebral endplate, wherein said connector is coupled to said biocompatible support member.

7. The method of claim 1, further comprising displacing a herniated annulus segment to approximately its pre-herniated location.

8. The method of claim 1, wherein the step of providing a biocompatible support member comprises providing a barrier.

9. The method of claim 1, wherein the step of implanting the biocompatible support member comprises placing said support member to substantially seal a defect in the intervertebral disc.

10. The method of claim 1, further comprising securely establishing the biocompatible support member to, within, or posterior to a herniated segment in the disc.

11. The method of claim 10, further comprising returning at least a portion of the herniated segment of the annulus to a site substantially within its pre-herniated borders.

12. The method of claim 1, further comprising distributing pressure within the disc space.

13. The method of claim 1, further comprising facilitating tissue ingrowth of disc tissue.

14. The method of claim 1, further comprising providing augmentation material operable to augment the nucleus pulposus of the disc.

15. A method of treating an intervertebral disc comprising an annulus fibrosis and a nucleus pulposus, said disc comprising a defect in a wall of the annulus fibrosis, wherein the defect is bordered by an outermost layer of the annulus and an innermost layer of the annulus, the method comprising:

providing at least one support member;

providing at least one fixation device;

inserting said at least one fixation device through and beyond said defect and into a vertebra adjacent to said defect;

inserting said support member through and entirely beyond said defect without removing a substantial portion of the nucleus pulposus;

positioning said support member entirely against the innermost surface of the annulus to close said defect; and

securing said support member using said at least one fixation device.

16. The method of claim 15, wherein the defect is a naturally occurring defect.

17. The method of claim 15, wherein the support member comprises a patch.

18. The method of claim 15, wherein said at least one fixation device comprises a bone anchor.

19. The method of claim 15, wherein said at least one fixation device comprises a suture.

20. The method of claim 15, further comprising inserting a second fixation device into a second vertebra adjacent to said defect, wherein the second vertebra and the first vertebra are opposing vertebrae.

21. The method of claim 15, further comprising partially or fully closing the defect by pulling together surrounding tissue.