Methods for treating a defect in the annulus fibrosis

• US 7,273,497 B2
• Filed: 07/30/2003
• Issued: 09/25/2007
• Est. Priority Date: 05/28/1999
• Status: Expired due to Term

• Current Assignee: Anova Corp.
• Original Assignee: Anova Corp.
• Inventors: Ferree, Bret A.
• Primary Examiner(s): HO, UYEN T
• Application Number:
  US10/630,445
• Publication Number:
  US 20040097980A1
• Time in Patent Office: 1,518 Days
• Field of Search: 623 1711- 1716, 606/61, 606/151, 128/898
• US Class Current: 623/17.16
• 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: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2400/06 : Flowable or injectable implant compositions
• 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, including patches sized to cover the defect, plugs adapted to fill the defect, or a mesh screen 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 may further include one or more anchors to assist in permanently affixing the device with respect to the defect.

Claims

1. A method for treating an annulus fibrosis having an outer layer, at least one inner layer, and a defect extending through the outer and inner layers, comprising the steps of:

inserting a porous mesh into the defect in the annulus fibrosis, the porous mesh being arranged in a structure having a longitudinal axis, a distal end, a proximal end, and a length between the distal and proximal ends;

advancing the porous mesh distally beyond the outer layer of the annulus fibrosis; and

expanding the porous mesh to a diameter larger than the defect to prevent escape of nucleus pulposus through the defect,

wherein the porous mesh expands radially by reducing the length between the distal and proximal ends, and the proximal end of the porous mesh is located distally beyond the outer layer of the annulus fibrosis.

2. The method of claim 1, wherein the step of inserting the porous mesh into the defect further comprises the steps of inserting an elongate tubular sheath into the defect and advancing the porous mesh through the sheath into and distally beyond the outer layer of the annulus fibrosis.

3. The method of claim 2, wherein the step of advancing the porous mesh through the sheath further comprises the step of operating a plunger to push the porous mesh out of the sheath.

4. The method of claim 1, wherein the mesh is a self expanding mesh.

5. The method of claim 4, wherein the porous mesh has a first elongated shape and a memory of a second radially expanded shape, and wherein the method further comprises the step of straightening the porous mesh for introduction into the defect, whereupon it is released and assumes the second radially expanded shape due to the memory effect.

6. The method of claim 1, wherein the porous mesh further comprises a radio-opaque contrast material.

7. The method of claim 1, wherein the porous mesh further comprises one or more anchors, and wherein the method further comprises the step of securing the one or more anchors to at least one of the annulus fibrosis and the vertebra.

8. The method of claim 1, wherein the porous mesh is arranged in the shape of a plug.

9. The method of claim 1, wherein the porous mesh is arranged in a generally conical shape when expanded.

10. The method of claim 9, wherein the conical shape has a convex surface and wherein the convex surface is facing outwardly with respect to the outer layer of the annulus fibrosis.

11. The method of claim 9, wherein the conical shape has a convex surface and wherein the convex surface is facing inwardly with respect to the outer layer of the annulus fibrosis.

12. The method of claim 1, wherein the porous mesh is titanium.

13. The method of claim 1, wherein the porous mesh is expanded within the defect proximal to the nucleus pulposus.

14. A method for treating an annulus fibrosis having an outer layer, at least one inner layer, and a defect extending through the outer and inner layers, comprising the steps of:

inserting an implant into the defect in the annulus fibrosis, the implant being arranged in a structure having a longitudinal axis, a distal end, a proximal end, and a length between the distal and proximal ends;

advancing the implant distally beyond the outer layer of the annulus fibrosis; and

expanding the implant to a diameter larger than the defect to prevent escape of nucleus pulposus through the defect,

wherein the implant expands radially by reducing the length between the distal and proximal ends, and the proximal end of the implant is located distally beyond the outer layer of the annulus fibrosis.

15. The method of claim 14, wherein the step of inserting the implant into the defect further comprises the steps of inserting an elongate tubular sheath into the defect and advancing the implant through the sheath into and distally beyond the outer layer of the annulus fibrosis.

16. The method of claim 15, wherein the step of advancing the implant through the sheath further comprises the step of operating a plunger to push the implant out of the sheath.

17. The method of claim 14, wherein the implant is a porous mesh.

18. The method of claim 14, wherein the implant is a self expanding mesh.

19. The method of claim 18, wherein the mesh has a first elongated shape and a memory of a second radially expanded shape, and wherein the method further comprises the step of straightening the mesh for introduction into the defect, whereupon it is released and assumes the second radially expanded shape due to the memory effect.

20. The method of claim 14, wherein the implant further comprises a radio-opaque contrast material.

21. The method of claim 14, wherein the implant further comprises one or more anchors, and wherein the method further comprises the step of securing the one or more anchors to at least one of the annulus fibrosis and the vertebra.

22. The method of claim 14, wherein the implant is arranged in the shape of a plug.

23. The method of claim 14, wherein the implant is arranged in a generally conical shape when expanded.

24. The method of claim 23, wherein the conical shape has a convex surface and wherein the convex surface is facing outwardly with respect to the outer layer of the annulus fibrosis.

25. The method of claim 23, wherein the conical shape has a convex surface and wherein the convex surface is facing inwardly with respect to the outer layer of the annulus fibrosis.

26. The method of claim 14, wherein the implant is titanium.

27. The method of claim 14, wherein the implant is expanded within the defect proximal to the nucleus pulposus.