Devices and methods of vertebral disc augmentation

• US 6,482,235 B1
• Filed: 08/18/2000
• Issued: 11/19/2002
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Orthopedics, Inc.
• Inventors: Moore, Robert Kevin, Banks, Thomas, Vidal, Claude A., Lambrecht, Gregory H., Redmond, Russel J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Barrett, Thomas C.
• Application Number:
  US09/642,450
• Time in Patent Office: 823 Days
• Field of Search: 623/17.16, 128/898
• US Class Current: 623/17.16
• 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 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• 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 2002/30062 (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 2002/30589 : 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 2002/4635 : 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 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 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• 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

Devices for implantation into an intervertebral disc can include a membrane support member to augment a disc having a defect. A defect in the annulus of a disc can be repaired using a prosthesis such as a barrier. The barrier can include a sealant and an enlarger. The barrier can be implanted into the disc using a delivery cannula, an advancer and at least one control filament to control the positioning of the barrier. A stiffening element can be included within the barrier to impart stiffness to the barrier. The support member can also be connected to an anchor.

Claims

1. A method of closing off a defect in an anulus of an intervertebral disc, said intervertebral disc being part of a spine, including the steps of:

inserting a barrier through an opening into a disc; and

positioning said barrier between native nucleus tissue and an interior surface of a anulus lamella such that said barrier spans beyond the periphery of said defect in more than one direction.

2. The method of claim 1 wherein said opening is spacially separated from said defect.

3. The method of claim 1 wherein the barrier comprises a frame and a membrane;

and further comprising the steps of positioning said barrier proximate to said defect; and

expanding said barrier such that said barrier obstructs passage of material from the interior of said disc into said defect.

4. The method of claim 1 wherein said annulus has multiple layers, said method comprising the steps of:

inserting a first portion of the barrier between at least two layers of said annulus on a first side of said defect; and

inserting a second portion of said barrier between at least two layers of said annulus fibrosis on a second side of said defect, such that said barrier spans said defect and is maintained in position at least in part by the annulus fibrosis on each side of said defect, said barrier acting to obstruct passage of material from the interior of said disc to the exterior of said disc through said defect.

5. The method of claim 1, wherein the opening is through the defect.

6. The method of claim 1, further comprising the step of inserting biocompatible material into the interior of the disc to aid in restoring disc height.

7. The method of claim 6, wherein the material comprises a fibrous material including collagen or cellulous.

8. The method of claim 6, wherein the material comprises a hydrogel.

9. The method of claim 1, wherein the barrier comprises a frame and a membrane.

10. The method of claim 9, wherein the membrane covers at least a portion of the frame.

11. The method of claim 9, wherein the membrane has a thickness in a range between 0.025 mm and 2.5 mm.

12. The method of claim 9, wherein the membrane comprises a material selected from the group consisting of synthetic polyamide, synthetic polyester, polyethylene, collagen, PTFE and e-PTFE.

13. The method of claim 1, wherein the barrier has concavity such that upon implantation into the disc the concavity is directed toward the interior of the disc.

14. The method of claim 13, wherein the barrier comprises a frame that elastically changes from a compressed state to an expanded state upon insertion into the disc.

15. The method of claim 1, wherein the barrier further comprises a plurality of pores, the pores having an average size in a range from 0.05 mm² and 0.75 mm².

16. The method of claim 15, wherein the barrier comprises a frame having a thickness in a range between 0.1 mm and 0.6 mm.

17. The method of claim 1, wherein the barrier comprises a frame that comprises a material selected from the group consisting of nickel and titanium, stainless steel, cobalt, chrome, titanium, polyethylene, and silicone rubber.

18. A method of obstructing a defect in an anulus of an intervertebral disc, said intervertebral disc being part of a spine and including a native nucleus tissue comprising the steps of:

inserting a barrier through an opening into the disc; and

positioning a first portion of the barrier between the native nucleus tissue and the defect, and a second portion of the barrier between the native nucleus tissue and an interior surface of an anulus lamella adjacent to the defect such that said barrier spans beyond the periphery of said defect in more than one direction.

19. A method of obstructing a defect in an anulus of an intervertebral disc as in claim 18, wherein the opening is the defect.

20. A method of obstructing a defect in an anulus of an intervertebral disc as in claim 18, wherein the opening is spaced apart from the defect.

21. A method of inserting a membrane into an intervertebral disc to obstruct a defect in an anulus fibrosus, comprising the steps of:

providing a membrane on an insertion device;

inserting the insertion device trough an opening in the anulus fibrosus and into the intervertebral disc; and

deploying the membrane within the intervertebral disc to obstruct the defect, wherein said membrane is positioned between a native nucleus tissue and an interior surface of an annulus lamella substantially in front of said defect such that said membrane spans beyond the periphery of said defect.

22. The method of claim 21 further comprising affixing the membrane to tissue in or surrounding the intervertebral disc.

23. The method of claim 21 further comprising expanding the membrane from a reduced state for the insertion step to an expanded state to occlude the defect.

24. The method of claim 21 further comprising removing the insertion device from the intervertebral disc.

25. The method of claim 21 wherein the inserting step comprises inserting the insertion device into the intervertebral disc at a point located a distance away from the defect in the annular fibrosis of the intervertebral disc and advancing the membrane across the defect.

26. The method of claim 21 wherein the providing step further comprises providing a frame on which the membrane is mounted.

27. The method of claim 26 wherein the providing step comprises providing a frame including an alloy of nickel and titanium.

28. The method of claim 26 wherein the providing step further comprises providing a frame including a longitudinal strut and a plurality of radial elements.