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

• US 10,327,907 B2
• Filed: 07/17/2015
• Issued: 06/25/2019
• Est. Priority Date: 05/28/1999
• Status: Expired due to Fees

• Current Assignee: Suture Concepts Inc.
• Original Assignee: Suture Concepts Inc.
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Harvey, Julianna N
• Application Number:
  US14/802,548
• Publication Number:
  US 20160175104A1
• Time in Patent Office: 1,439 Days
• 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 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• 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 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/00 : Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• 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 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• 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 for treating an annulus fibrosis having a defect include inserting a flexible device into the defect. The flexible device is advanced distally beyond an outer layer of the annulus fibrosus. The flexible device is then expanded such that a width of the flexible device is larger than the defect, where the flexible device prevents escape of nucleus pulposus through the defect. The flexible device may have at least two appendages made from a shape-memory metal. Alternatively, the flexible device may have a U-shaped structure that includes a central portion and two legs. The flexible device may also be anchored to the annulus fibrosis and/or the vertebrae.

Claims

1. A method for treating a defect in an annulus fibrosis surrounding nucleus pulposus of an intervertebral disc, the intervertebral disc located between an upper and a lower vertebra, the method comprising the steps of:

advancing a flexible device into the space between the upper vertebra and the lower vertebra so as to close off the defect in the annulus fibrosis, the flexible device having a first portion, a second portion and a middle portion connecting the first portion to the second portion, wherein the flexible device is advanced so that the first portion is disposed distally of the middle portion and the second portion, with the first portion contacting one of the upper vertebra and the lower vertebra, the middle portion extending from the first portion proximally through the space between the upper vertebra and the lower vertebra to the second portion, and the second portion contacting the other of the upper vertebra and the lower vertebra; and

attaching the second portion to the one of the upper vertebra and the lower vertebra contacted by the second portion,

wherein the flexible device blocks extrusion of nucleus pulposus through the defect in the annulus fibrosis.

2. The method of claim 1, wherein the flexible device is made from a shape memory material.

3. The method of claim 1, wherein the second portion is attached to the upper vertebra.

4. The method of claim 3, wherein the first portion contacts the vertebral endplate of the lower vertebra.

5. The method of claim 4, wherein said first portion of said flexible device slidingly engages the endplate of the lower vertebra.

6. The method of claim 3, wherein said second portion of said flexible device is attached to the endplate of the upper vertebra.

7. The method of claim 6, wherein said second portion of said flexible device is attached to the endplate of the upper vertebra by at least one fastener which extends transverse to the endplate of the upper vertebra.

8. The method of claim 1, wherein the second portion is attached to the lower vertebra.

9. The method of claim 8, wherein said second portion of said flexible device is attached to the endplate of the lower vertebra.

10. The method of claim 9, wherein said second portion of said flexible device is attached to the endplate of the lower vertebra by at least one fastener which extends transverse to the endplate of the lower vertebra.

11. The method of claim 8, wherein said first portion of said flexible device engages the endplate of the upper vertebra.

12. The method of claim 11, wherein said first portion of said flexible device slidingly engages the endplate of the upper vertebra.

13. The method of claim 1, wherein the flexible device allows movement between the upper and lower vertebrae.

14. The method of claim 1, wherein the flexible device flexes under compression of the disc.

15. The method of claim 1, wherein the flexible device returns to an elongated shape under distraction of the disc.

16. The method of claim 1, wherein the first portion maintains contact with the vertebral endplate of the one of the upper or lower vertebra contacted by the first portion under compression of the disc.

17. The method of claim 1, wherein the first portion maintains contact with the vertebral endplate of the one of the upper or lower vertebra contacted by the first portion under distraction of the disc.

18. The method of claim 1, wherein said first portion of said flexible device moves relative to a vertebral endplate of the one of the upper vertebra or lower vertebra contacted by the first portion under compression of the intervertebral disc.

19. The method of claim 1, wherein said first portion of said flexible device moves relative to a vertebral endplate of the one of the upper vertebra or lower vertebra contacted by the first portion under distraction of the intervertebral disc.