Intervertebral anulus and nucleus augmentation

• US 7,959,679 B2
• Filed: 01/15/2007
• Issued: 06/14/2011
• Est. Priority Date: 08/18/1999
• Status: Expired due to Fees

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Einhorn, Jacob, Moore, Robert Kevin, Lambrecht, Greg H.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/653,662
• Publication Number:
  US 20070118226A1
• Time in Patent Office: 1,611 Days
• Field of Search: 623 1711- 1716, 623 2372- 2374, 606/279
• 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 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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
• 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 2002/4627 : 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 component and a nucleus augmentation component. Both are suited for minimally invasive deployment. The nucleus augmentation component restores disc height and/or replaces missing nucleus pulposus. The anulus augmentation component shields weakened regions of the anulus fibrosis and/or resists escape of natural nucleus pulposus and/or the nucleus augmentation component. Methods and deployment devices are also disclosed.

Claims

1. A method of preserving a herniated segment of an anulus of a functional spine unit, the method comprising:

providing an anchor;

providing a support member;

providing a connection member operable to connect the anchor to the support member, wherein the connection member is operable to transmit tensile forces along its length;

positioning the support member on, within, or posterior to a herniated segment of the anulus without resecting the herniated segment;

securely establishing said anchor in a location within the functional spine unit;

tightening the connection member so as to induce the herniated segment to move towards the anchor; and

securing the connection member between the anchor and the support member so as to restrict motion of the herniated segment.

2. The method of claim 1, further comprising restricting a motion of the herniated segment to a pre-herniated border of an intervertebral disc.

3. The method of claim 1, comprising arranging the connection member so as to at least partially traverse a disc space.

4. The method of claim 1, wherein the method is performed without removing the nucleus pulposus.

5. The method of claim 1, wherein the connection member comprises one or more of a suture, wire, woven tube, web, and band of material.

6. The method of claim 1, further comprising:

inserting augmentation material into the disc; and

attaching the augmentation material to or along the connection member so as to limit the movement of the augmentation material within the disc.

7. The method of claim 1, wherein the connection member is integral to the support member.

8. The method of claim 1, wherein at least one of the support member and the connection member is resorbable.

9. The method of claim 1, wherein the anchor comprises at least one of a barbed anchor, bone anchor, soft tissue anchor, coil, or screw.

10. The method of claim 1, wherein the support member is shaped like a bar, plate, bead, or cap.

11. The method of claim 1, wherein the support member is affixed to the anulus with cement or adhesive.

12. The method of claim 1, further comprising:

providing a second anchor;

securely establishing said second anchor in a location within the functional spine unit;

providing a second connection member operable to connect the second anchor to the support member,

wherein the second connection member is operable to transmit tensile forces along its length;

tightening the second connection member so as to induce the herniated segment to move towards the second anchor; and

securing the second connection member between the second anchor and the support member so as to restrict motion of the herniated segment.

13. The method of claim 1, wherein said support member comprises one or more of the following materials:

plastic, metal, resorbable material, polylactic acid or polyglycolic acid.

14. The method of claim 1, wherein the connection member comprises a suture and the anchor comprises a bone anchor.

15. The method of claim 1, wherein the connection member comprises a suture and the anchor comprises a soft tissue anchor.

16. The method of claim 1, wherein said providing an anchor comprises providing a plurality of anchors and wherein said providing a connection member comprises providing a plurality of connection members.

17. The method of claim 1, wherein securely establishing said anchor in a location within the functional spine unit comprises positioning said anchor within an inferior or superior vertebral body adjacent an intervertebral disc.

18. The method of claim 1, wherein securely establishing said anchor in a location within the functional spine unit comprises positioning said anchor within a portion of the anulus.

19. A method of preserving a herniated segment of an anulus of a functional spine unit, the method comprising:

providing one or more anchors;

providing a support member;

providing a connection member operable to connect the anchor to the support member, wherein the connection member is operable to transmit tensile forces along its length;

implanting at least a portion of the support member to contact a herniated segment of the anulus without resecting the herniated segment;

anchoring said anchor in a location within the functional spine unit;

tightening the connection member so as to induce the herniated segment to move towards said one or more anchors; and

securing the connection member between the anchor and the support member so as to restrict motion of the herniated segment to a natural border of the anulus.

20. The method of claim 19, wherein anchoring said one or more anchors in a location within the functional spine unit comprises anchoring said one or more anchors within an inferior or superior vertebral body adjacent an intervertebral disc of the functional spine unit.

21. The method of claim 19, wherein anchoring said one or more anchors in a location within the functional spine unit comprises anchoring said one or more anchors within a portion of the anulus.