Methods and apparatus for treating disc herniation and preventing the extrusion of interbody bone graft

• US 9,241,796 B2
• Filed: 05/13/2011
• Issued: 01/26/2016
• Est. Priority Date: 05/28/1999
• Status: Expired due to Term

• Current Assignee: Bret A. Ferree
• Original Assignee: Bret A. Ferree
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/107,785
• Publication Number:
  US 20110264224A1
• Time in Patent Office: 1,719 Days
• Field of Search: 606/151, 606/246, 606/279, 623/23.76, 600/30, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• 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 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/3028 : polyhedral different from parallelepipedal and pyramidal
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30576 : with extending fixation tabs
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30828 : parallel
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/30975 : made of two halves
• 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 2002/4445 : Means for culturing intervertebral disc tissue
• CPC Class Codes: A61F 2002/445 : Intervertebral disc tissue harvest sites
• 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 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0069 : Sealing means
• 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: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3856 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442

Abstract

Methods and apparatus for treating disc herniation provide a conformable device which assumes a first shape associated with insertion and a second shape or expanded shape to occlude the defect which typically follows partial discectomy. The device may take different forms according to the invention, including patches size to cover the defect or plugs adapted to fill the defect. In a preferred embodiment, however, the device is a gel or other liquid or semi-liquid which solidifies to occlude the defect from within the body of the disc itself. In another preferred embodiment, a mesh screen is collapsed into an elongated form for the purposes of insertion, thereby minimizing the size of the requisite incision while avoiding delicate surrounding nerves. Such a configuration also permits the use of instrumentation to install the device, including, for example, a hollow tube or sheath adapted to hold the collapsed screen, and a push rod to expel the collapsed device out of the sheath for use in occluding the disc defect. A device according to the invention may further include one or more anchors to assist in permanently affixing the device with respect to the defect.

Claims

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

inserting a barrier through an opening into a disc;

wherein the barrier comprises an expandable membrane; and

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

wherein said annulus has multiple layers, the method comprising;

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 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 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.

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

3. The method of claim 1 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 the opening is through the defect.

5. 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.

6. The method of claim 5, wherein the material comprises a fibrous material including collagen or cellulose.

7. The method of claim 5, wherein the material comprises a hydrogel.

8. The method of claim 1, wherein the membrane has a thickness in a range between 0.025 mm and 2.5 mm.

9. The method of claim 1, wherein the membrane comprises a material selected from the group consisting of synthetic polyamide, synthetic polyester, polyethylene, collagen, PTFE and e-PTFE.

10. 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.

11. The method of claim 10, wherein the barrier elastically changes from a compressed state to an expanded state upon insertion into the disc.

12. 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.

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

14. 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, wherein the barrier comprises an expandable membrane; 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 annulus lamella adjacent to the defect such that said barrier spans beyond the periphery of said defect in more than one direction;

wherein said annulus has multiple layers, the method comprising;

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 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 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.

15. A method of obstructing a defect in an anulus of an intervertebral disc as in claim 14, wherein the opening is the defect.

16. A method of obstructing a defect in an anulus of an intervertebral disc as in claim 14, wherein the opening is spaced apart from the defect.

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

providing a membrane on an insertion device;

inserting the insertion device through 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 in more than on direction;

wherein said annulus fibrosis has multiple layers, the method comprising;

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

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

18. The method of claim 17 further comprising affixing the membrane to tissue in or surrounding the intervertebral disc.

19. The method of claim 17 further comprising expanding the membrane from a reduced state for the insertion step to an expanded state to occlude the defect.

20. The method of claim 17 further comprising removing the insertion device from the intervertebral disc.

21. The method of claim 17 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.

22. The method of claim 17 wherein the membrane comprises an alloy of nickel and titanium.

23. A method of inserting a membrane into an intervertebral disc, comprising:

providing a membrane on an insertion device;

inserting the insertion device into the intervertebral disc along a first axis; and

deploying the membrane laterally from the insertion device within the intervertebral disc between the nucleus pulposus and the annulus fibrosis along a second axis which is transverse to the first axis;

wherein said annulus fibrosis has multiple layers, the method comprising;

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

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

24. The method of claim 23 further comprising affixing the membrane to tissue in or surrounding the intervertebral disc.

25. The method of claim 23 further comprising expanding the membrane to an expanded state.

26. The method of claim 23 further comprising removing the insertion device from the intervertebral disc.

27. The method of claim 23 further comprising 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.

28. The method of claim 23 wherein the membrane comprise an alloy of nickel and titanium.

29. A method of inserting a membrane into an intervertebral disc, the method comprising:

providing a membrane on an insertion device;

inserting the insertion device into the intervertebral disc along a first axis, at a point located a distance away from a defect in the annulus fibrosis of the intervertebral disc and advancing the membrane across the defect; and

deploying the membrane laterally from the insertion device within the intervertebral disc along a second axis which is transverse to the first axis;

wherein the membrane is deployed between the nucleus pulposus and the annulus fibrosis of the intervertebral disc;

wherein said annulus fibrosis has multiple layers, the method comprising;

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

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

30. The method of claim 29 further comprising affixing the membrane to tissue in surrounding the intervertebral disc.

31. The method of claim 29 further comprising expanding the membrane to an expanded state.

32. The method of claim 29 further comprising removing the insertion device from the intervertebral disc.

33. The method of claim 29 wherein the membrane comprises an alloy of nickel and titanium.