Method of supporting nucleus pulposus

• US 7,563,282 B2
• Filed: 05/21/2003
• Issued: 07/21/2009
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Einhorn, Jacob, Moore, Robert Kevin, Lambrecht, Greg H.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/442,659
• Publication Number:
  US 20040030392A1
• Time in Patent Office: 2,253 Days
• Field of Search: 623 1711- 1716
• 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 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. Method of supporting and augmenting a nucleus pulposus by inserting a flexible biocompatible material into the disc space using an anchoring means are also provided.

Claims

1. A method of supporting and augmenting a nucleus pulposus of an intervertebral disc in a spine comprising:

inserting a flexible one-piece biocompatible nucleus augmentation device into the disc space through and entirely beyond a defect in a posterior portion of an anulus;

wherein said nucleus augmentation device comprises an anchor, a connection member and a nucleus augmentation material, the nucleus augmentation material being at least partially attached to an anchor;

anchoring said nucleus augmentation material to a site within an anterior portion of the anulus or a vertebral body adjacent said anterior portion of the anulus;

providing a connection member;

wherein the connection member provides stiffness under tension and partially or fully prevents said nucleus augmentation material from migrating farther posterior with respect to the anchor; and

wherein the augmentation material comprises a channel or slit that receives the connection member and permits sliding along the connection member.

2. The method of claim 1, wherein one or more additional nucleus augmentation devices or nucleus augmentation materials are inserted into the disc.

3. A method of supporting and augmenting a nucleus pulposus of an intervertebral disc in a spine comprising:

inserting a flexible one-piece biocompatible nucleus augmentation device into the disc space through and entirely beyond a defect in a posterior portion of an anulus;

wherein said nucleus augmentation device comprises an anchor, a connection member and a nucleus augmentation material, the nucleus augmentation material being at least partially attached to an anchor;

anchoring said nucleus augmentation material to a site within an anterior portion of the anulus or a vertebral body adjacent said anterior portion of the anulus;

providing a connection member;

wherein the connection member provides stiffness under tension and partially or fully prevents said nucleus augmentation material from migrating farther posterior with respect to the anchor; and

threading the connection member through the augmentation material.

4. The method of claim 3, wherein the nucleus augmentation material is disc-shaped, cube-like, spheroid, ellipsoid, rhombohedral, cylindrical, or amorphous.

5. The method of claim 3, further comprising supporting at least one portion of an anulus fibrosus of the disc.

6. The method of claim 5, wherein the step of supporting at least one portion of an anulus fibrosus comprises supporting at least one portion of a region selected from the group consisting of one or more of following regions:

anterior, anterior medial, anterior lateral, posterior, and lateral portion of the anulus fibrosus.

7. The method of claim 3, wherein the nucleus augmentation material comprises collagen.

8. The method of claim 3, wherein the nucleus augmentation material comprises hydrogel.

9. The method of claim 3, wherein the nucleus augmentation material comprises cellulose.

10. The method of claim 3, wherein the step of providing at least one connection member comprises providing at least one connector selected from the group consisting of:

sutures, wires, rigid rods, broad bands, pins, woven tubes and webs.

11. The method of claim 3, wherein one or more additional nucleus augmentation devices or nucleus augmentation materials are inserted into the disc.

12. A method of supporting and augmenting a nucleus pulposus of an intervertebral disc in a spine comprising:

installing a first anchor in a site in an anterior portion of an anulus or a vertebral body adjacent said anterior portion of the anulus;

coupling at least one connector to said anchor;

positioning at least one plug of nucleus augmentation material entirely within the volume of the disc nucleus;

coupling said plug with said at least one connector;

wherein the connector provides stiffness under tension and partially or fully prevents nucleus augmentation material from migrating further posterior with respect to the anchor; and

inserting a barrier into an interior of the disc, entirely within the disc nucleus, and proximal to a defect in an anulus, thereby preventing passage of nucleus augmentation material through said defect.

13. The method of claim 12, further comprising affixing said barrier to said anulus.

14. The method of claim 12, wherein inserting said barrier comprises inserting a barrier with a larger area than an area of said defect.

15. The method of claim 12, wherein inserting said barrier comprises inserting a barrier comprising at least one of woven material, polyamide, polyester, polyethylene, an expanded material, expanded polytetrafluoroethylene, a biologic material, cross-linked collagen, and cellulose.

16. The method of claim 12, wherein inserting said barrier comprises inserting a barrier comprising an expandable component.

17. A method of supporting and augmenting a nucleus pulposus of an intervertebral disc in a spine comprising:

installing a first anchor in an anterior portion of the spine within a first endplate;

inserting a nucleus augmentation support member entirely within the region occupied by a disc nucleus;

coupling a connection member to said anchor, wherein the connection member is stiff under tension and partially or fully prevents the nucleus augmentation material from migrating further posterior with respect to the anchor;

coupling said nucleus augmentation support member to said connection member; and

wherein coupling said nucleus augmentation support member to said connection member comprises threading the connection member into said nucleus augmentation support member.

18. A method of supporting and augmenting a nucleus pulposus of an intervertebral disc in a spine comprising:

installing a first anchor in an anterior portion of the spine within a first endplate;

inserting a nucleus augmentation support member entirely within the region occupied by a disc nucleus;

coupling a connection member to said anchor;

wherein the connection member is stiff under tension and partially or fully prevents the nucleus augmentation material from migrating further posterior with respect to the anchor;

coupling said nucleus augmentation support member to said connection member; and

wherein coupling said nucleus augmentation support member to said second connection member comprises sliding the connection member into a slit or channel contained in said nucleus augmentation support member.