Annulus fibrosis augmentation methods and apparatus

• US 6,969,404 B2
• Filed: 04/11/2002
• Issued: 11/29/2005
• Est. Priority Date: 10/08/1999
• Status: Expired due to Term

• Current Assignee: Anova Corp.
• Original Assignee: Anova Corp.
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US10/120,763
• Publication Number:
  US 20020165542A1
• Time in Patent Office: 1,328 Days
• Field of Search: 606/53, 606/61, 606/76, 606/78, 606/99, 623/17.11, 623/17.12, 623/17.13, 623/17.15, 623/17.16, 623/23.52, 623/23.53, 623/23.54, 623/23.55, 623/23.61, 623/23.63, 623/23.67
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/1671 for the spine
• 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 2/30771 applied in original prostheses, e.g. holes or grooves
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• 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 2002/30133 kidney-shaped or bean-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 2002/30331 : made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• 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 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• 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 2002/30584 : filled with gas
• 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 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30879 : Ribs
• 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 2002/4445 : 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 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 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0015 : Kidney-shaped, e.g. bean-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 2300/00 : Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/38 : containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3856 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

A device and method are used in fortifying an intervertebral disc having an annulus fibrosis with an inner wall. According to the method, a hole is formed through the annulus fibrosis, and a collapsed bag is inserted into the disc through the hole. The bag is inflated, or allowed to expand within the disc space, then filling with one or more biocompatible materials. The hole in the annulus fibrosis is then closed. In one preferred embodiment, the bag includes an inflatable bladder or balloon which is filled with a gas or liquid to expand the bag. In an alternative preferred embodiment, the bag includes a self-expanding frame that assumes a collapsed state for introduction into the disc space and an expanded state once inserted through the hole in the annulus. The self-expanding frame is composed of a shape-memory material, for example. The bag preferably features a wall which is porous to allow for the diffusion of body fluids therethrough, and the bag and/or frame may be fastened to the inner wall of the annulus at one or more points. The biocompatible material may include autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis. In the preferred embodiment, the biocompatible material includes morselized nucleus or annulus from the same disc.

Claims

1. An augmentation device for an intervertebral disc having an annulus fibrosis, comprising:

a bag which is porous to allow for the diffusion of body fluids therethrough;

a self-expanding frame within the bag; and

wherein the bag and frame combination exhibits a compression state facilitating introduction into the disc through a hole formed in the annulus, and an expanded state assumed after the bag and frame combination is inserted into the disc.

2. The device of claim 1, wherein the self-expanding frame is composed of a shape-memory material.

3. The device of claim 1, further including a biocompatible material within the bag and frame combination.

4. The device of claim 3, wherein the biocompatible material includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis.

5. The device of claim 3, wherein the biocompatible material includes morselized nucleus or annulus from the same disc.

6. The device of claim 1, further including a biologic material within the bag and frame combination.

7. The device of claim 6, wherein the biologic material includes tissues, cells, or extracellular matrix components.

8. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall between opposing vertebral endplates, comprising the steps of:

forming a hole through the annulus fibrosis while preserving the vertebral endplates;

inserting a collapsed bag into the disc through the hole in the annulus fibrosis, the bag including a self-expanding frame that assumes a collapsed state for introduction into the disc space and an expanded state once inserted through the hole in the annulus;

inflating or allowing the bag to expand within the disc space;

filling the expanded bag with one or more biologic or biocompatible materials; and

closing the hole in the annulus fibrosis.

9. The method of claim 8, wherein the bag includes an inflatable bladder or balloon which is filled with a gas or liquid to expand the bag.

10. The method of claim 8, wherein the self-expanding frame is composed of a shape-memory material.

11. The method of claim 8, wherein the bag features a wall which is porous to allow for the diffusion of body fluids therethrough.

12. The method of claim 8, further including the step of fastening the bag to the inner wall of the annulus at one or more points.

13. The method of claim 8, further including the step of fastening the frame to the inner wall of the annulus at one or more points.

14. The method of claim 8, wherein the biologic material includes tissues, cells, or extracellular matrix components.

15. The method of claim 8, wherein the biocompatible material includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis.

16. The method of claim 8, wherein the biocompatible material includes morselized nucleus or annulus from the same disc.

17. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

providing an implant in the form of a covered frame having a collapsed state and an expanded state;

inserting the implant in the collapsed state into the disc through the hole in the annulus fibrosis;

filling the implant with a gas or liquid to expand the covered frame within the disc space;

filling the expanded implant with one or more biologic or biocompatible materials; and

closing the hole in the annulus fibrosis.

18. The method of claim 17, wherein the frame is a self-expanding frame composed of a shape-memory material.

19. The method of claim 17, wherein the covering is porous to allow for the diffusion of body fluids therethrough.

20. The method of claim 17, further including the step of fastening the covering of the frame to the inner wall of the annulus at one or more points.

21. The method of claim 17, further including the step of fastening the frame to the inner wall of the annulus at one or more points.

22. The method of claim 17, wherein the biologic material includes tissues, cells, or extracellular matrix components.

23. The method of claim 17, wherein the biocompatible material includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis.

24. The method of claim 17, wherein the biocompatible material includes morselized nucleus or annulus from the same disc.

25. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

inserting a collapsed bag into the disc through the hole in the annulus fibrosis;

inflating or allowing the bag to expand within the disc space;

fastening the bag to the inner wall of the annulus fibrosis at one or more points;

filling the expanded bag with one or more biologic or biocompatible materials; and

closing the hole in the annulus fibrosis.

26. The method of claim 25, wherein the bag includes an inflatable bladder or balloon which is filled with a gas or liquid to expand the bag.

27. The method of claim 25, wherein the bag includes a self-expanding frame that assumes a collapsed state for introduction into the disc space and an expanded state once inserted through the hole in the annulus.

28. The method of claim 27, wherein the self-expanding frame is composed of a shape-memory material.

29. The method of claim 25, wherein the bag features a wall which is porous to allow for the diffusion of body fluids therethrough.

30. The method of claim 27, further including the step of fastening the frame to the inner wall of the annulus at one or more points.

31. The method of claim 25, wherein the biologic material includes tissues, cells, or extracellular matrix components.

32. The method of claim 25, wherein the biocompatible material includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis.

33. The method of claim 25, wherein the biocompatible material includes morselized nucleus or annulus from the same disc.

34. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

inserting a collapsed bag into the disc through the hole in the annulus fibrosis, including a self-expanding frame that assumes a collapsed state for introduction into the disc space and an expanded state once inserted through the hole in the annulus;

inflating or allowing the bag to expand within the disc space;

filling the expanded bag with disc tissue or tissues that function like disc tissue; and

closing the hole in the annulus fibrosis.

35. The method of claim 34, wherein the bag includes an inflatable bladder or balloon which is filled with a gas or liquid to expand the bag.

36. The method of claim 34, wherein the bag includes a self-expanding frame that assumes a collapsed state for introduction into the disc space and an expanded state once inserted through the hole in the annulus.

37. The method of claim 34, wherein the self-expanding frame is composed of a shape-memory material.

38. The method of claim 34, wherein the bag features a wall which is porous to allow for the diffusion of body fluids therethrough.

39. The method of claim 34, further including the step of fastening the bag to the inner wall of the annulus at one or more points.

40. The method of claim 34, further including the step of fastening the frame to the inner wall of the annulus at one or more points.

41. The method of claim 34, wherein the tissue includes disc cells or extracellular matrix components.

42. The method of claim 34, wherein the tissue includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis.

43. The method of claim 34, wherein the tissue includes morselized nucleus or annulus from the same disc.

44. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

inserting a collapsed bag into the disc through the hole in the annulus fibrosis;

inflating or allowing the bag to expand within the disc space;

filling the expanded bag with disc tissue or tissues that function like disc tissue; and

fastening the bag to the inner wall of the annulus at one or more points;

closing the hole in the annulus fibrosis.

45. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

providing an implant in the form of a covered frame having a collapsed state and an expanded state;

inserting the implant in the collapsed state into the disc through the hole in the annulus fibrosis;

inflating or allowing the covered frame to expand within the disc space;

filling the expanded implant with one or more biologic or biocompatible materials; and

fastening the frame to the inner wall of the annulus at one or more points;

closing the hole in the annulus fibrosis.

46. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

providing an implant in the form of a covered frame having a collapsed state and an expanded state;

inserting the implant in the collapsed state into the disc through the hole in the annulus fibrosis;

inflating or allowing the covered frame to expand within the disc space;

filling the expanded implant with one or more biologic or biocompatible materials including includes autograft nucleus pulposis, allograft nucleus pulposis or xenograft nucleus pulposis; and

closing the hole in the annulus fibrosis.

47. A method of fortifying an intervertebral disc having an annulus fibrosis with an inner wall, comprising the steps of:

forming a hole through the annulus fibrosis;

providing an implant in the form of a covered frame having a collapsed state and an expanded state;

inserting the implant in the collapsed state into the disc through the hole in the annulus fibrosis;

inflating or allowing the covered frame to expand within the disc space;

filling the expanded implant with one or more biologic or biocompatible materials including morselized nucleus or annulus from the same disc; and

closing the hole in the annulus fibrosis.