Methods of intervertebral disc augmentation

• US 8,257,437 B2
• Filed: 01/10/2011
• Issued: 09/04/2012
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Lambrecht, Greg H., Moore, Robert Kevin, Einhorn, Jacob
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US12/987,970
• Publication Number:
  US 20110106264A1
• Time in Patent Office: 603 Days
• Field of Search: 623 1711- 1716, 606 92- 94, 606222-233
• US Class Current: 623/17.11
• 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 17/320016 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 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• 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 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• 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
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30571 : Leaf springs
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2002/4615 : of spacers
• 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 2002/4635 : 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

Systems for minimally invasive disc augmentation include an anulus augmentation implant suited for minimally invasive deployment. A nucleus augmentation component may be included. The anulus augmentation implant shields weakened regions of the anulus fibrosus and/or resists escape of natural nucleus pulposus and/or the augmentation component. Methods and deployment devices are also disclosed. Several embodiments cause or allow fibrosus or bony ingrowth in or around the augmentation.

Claims

1. A method of containing an augmentation material within a weakened disc between two adjacent vertebral bodies to facilitate fusion, comprising:

identifying a weakened intervertebral disc located between two adjacent vertebral bodies;

inserting one or more solid augmentation materials within said intervertebral disc;

placing said one or more solid augmentation materials against a healthy region of the intervertebral disc;

inserting a barrier into the intervertebral disc to partially encapsulate said one or more solid augmentation materials, thereby preventing extrusion of said one or more solid augmentation materials from the intervertebral disc;

anchoring said barrier to a vertebral endplate with a bone anchor, wherein anchoring said barrier comprises inserting said bone anchor within the vertebral endplate such that no part of the bone anchor protrudes beyond a circumferential border of the vertebral endplate; and

causing or allowing fibrous or bony ingrowth in or around said one or more solid augmentation materials.

2. The method of claim 1, wherein at least one of said solid augmentation materials comprises autologous, allograft, or xenograft materials.

3. The method of claim 1, further comprising inserting at least one of said solid augmentation materials and the barrier through and beyond a defect in the anulus fibrosus.

4. The method of claim 1, wherein the barrier is expandable.

5. The method of claim 4, further comprising expanding the barrier.

6. The method of claim 1, further comprising positioning the barrier along an innermost layer of the anulus fibrosus.

7. The method of claim 1, wherein at least one of said solid augmentation materials comprises titanium.

8. The method of claim 1, wherein the barrier comprises a polymer.

9. The method of claim 1, wherein at least one of said solid augmentation materials comprises PEEK and wherein the anchor comprises metal.

10. The method of claim 1, wherein at least one of said solid augmentation materials is resorbable.

11. The method of claim 1, wherein said solid augmentation materials comprise a first augmentation material and a second augmentation material.

12. The method of claim 11, wherein the first augmentation material comprises PEEK and the second augmentation material comprises bone.

13. The method of claim 11, wherein the first augmentation material comprises titanium and the second augmentation material comprises bone.

14. The method of claim 11, wherein the first augmentation material comprises titanium or PEEK and the second augmentation material comprises one or more growth factors.

15. The method of claim 1, wherein at least one of said solid augmentation materials is soaked in one or more growth factors.

16. The method of claim 1, wherein at least one of said solid augmentation materials comprises at least one of morselized bone or block bone.

17. The method of claim 1, wherein the barrier and the bone anchor are integral.

18. The method of claim 1, wherein the barrier is coupled to at least one of said solid augmentation materials.

19. The method of claim 1, wherein at least one of said solid augmentation materials is a rigid device comprising channels or slits.

20. The method of claim 1, wherein at least one of said solid augmentation materials is a rigid cylindrical device comprising at least one of titanium or PEEK and further comprising slits.

21. The method of claim 1, wherein at least one of said solid augmentation materials is a rigid cube-like device comprising at least one of titanium or PEEK and further comprising slits.

22. A method of containing an augmentation material within a weakened disc between two adjacent vertebral bodies to facilitate fusion, comprising:

inserting one or more solid augmentation materials within an intervertebral disc,

wherein at least one of said solid augmentation materials is rigid;

placing said one or more solid augmentation materials against a healthy region of an anulus fibrosus of the intervertebral disc;

providing an anchor and a barrier, wherein said anchor is configured to be inserted within bone tissue of at least one of the adjacent vertebral bodies or within soft tissue of the intervertebral disc;

inserting the barrier into the intervertebral disc to partially encapsulate said one or more solid augmentation materials, thereby preventing extrusion of said one or more solid augmentation materials from the intervertebral disc;

anchoring said barrier to a portion of a functional spine unit, wherein anchoring said barrier comprises inserting said anchor within a disc space of the intervertebral disc such that no part of the anchor protrudes beyond a circumferential border of the disc space; and

causing or allowing fibrous or bony ingrowth in or around said one or more solid augmentation materials, thereby facilitating fusion of the two adjacent vertebral bodies.

23. The method of claim 22, wherein the portion of the functional spine unit is an adjacent superior vertebral body or adjacent inferior vertebral body.

24. The method of claim 22, wherein the portion of the functional spine unit comprises anulus tissue of the intervertebral disc.

25. The method of claim 22, wherein at least one of said solid augmentation materials is a rigid cube-like or cylindrical device comprising at least one of titanium or PEEK and further comprising slits.

26. The method of claim 22, wherein said solid augmentation materials comprise a first augmentation material and a second augmentation material.

27. The method of claim 26, wherein the first augmentation material comprises PEEK or titanium and the second augmentation material comprises bone.