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

• US 9,592,062 B2
• Filed: 05/30/2006
• Issued: 03/14/2017
• Est. Priority Date: 05/28/1999
• Status: Expired due to Fees

• Current Assignee: Anova Corp.
• Original Assignee: Anova Corp.
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US11/443,789
• Publication Number:
  US 20060217747A1
• Time in Patent Office: 3,941 Days
• Field of Search: 606/151, 606/246, 606/279, 606/74, 623/17.16, 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: 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 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 device for at least partially preventing intervertebral disc material from exiting a defect in an anulus fibrosus of an intervertebral disc disposed between a first vertebra and a second vertebra, the device comprising:

a flexible element having a distal end, a proximal end and a connecting portion extending between the distal end and the proximal end; and

an anchor for fixedly attaching the proximal end of the flexible element to the first vertebra;

wherein the flexible element is sized and configured so as to be positionable within the nucleus of the intervertebral disc so that the distal end of the flexible element flexingly engages, but is not fixedly attached to, the second vertebra adjacent the intervertebral disc; and

wherein the proximal end of the flexible element is engaged with the anchor and is configured to engage only the first vertebra adjacent the intervertebral disc, and the connecting portion is configured to extend from the first vertebra through the nucleus to the second vertebra so as to at least partially prevent intervertebral disc material from exiting the defect in the anulus fibrosus of the intervertebral disc.

2. A device according to claim 1 wherein the distal end of the flexible element extends substantially parallel to the proximal end of the flexible element.

3. The device according to claim 1 wherein the flexible element is adapted to engage load bearing vertebral body endplate tissue.

4. The device according to claim 1 wherein the distal end of the flexible element and the proximal end of the flexible element are each adapted to present a surface in conformity with an endplate of an adjacent vertebral body.

5. The device according to claim 1 wherein the flexible element has top and bottom edges and first and second side edges, wherein said top and bottom edges are dimensioned to contact the endplates of adjacent vertebral bodies at maximum distraction.

6. A device according to claim 1 wherein the flexible element is of sufficient rigidity to not be extrudable through an anulus defect.

7. The device according to claim 1 wherein the flexible element has a width in a lateral direction and a height in an inferior-superior direction, wherein the height exceeds the distance between an inferior vertebral body and a superior vertebral body when compressed.

8. A device according to claim 1 wherein the flexible element is made from a shape memory material.

9. A device according to claim 1 wherein the flexible element is configured to allow movement between the first vertebra and second vertebra.

10. A device according to claim 1 wherein the flexible element is configured to flex under compression of the intervertebral disc.

11. A device according to claim 1 wherein the flexible element and anchor are configured to be inserted into the intervertebral disc so that the flexible element and the anchor are disposed within the intervertebral disc.