Intervertebral disc annulus stent

• US 7,909,879 B2
• Filed: 11/09/2006
• Issued: 03/22/2011
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Cauthen, Joseph C.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/558,034
• Publication Number:
  US 20070156244A1
• Time in Patent Office: 1,594 Days
• Field of Search: 623/16.11, 623/17, 623 11- 1716
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• 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 2/4601 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 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30158 trapezoidal
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4627 : 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 2210/0004 : bioabsorbable
• 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 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 623/902 : Method of implanting

Abstract

A device for repair and reconstruction of the spinal intervertebral disc wall, or annulus fibrosus, after surgical incision or pathologic rupture, which is inserted through an aperture into the disc. The device can be affixed to surrounding tissue employing a variety of means.

Claims

1. A method for treating an intervertebral disc having an annulus fibrosus with a wall, the wall of the annulus fibrosus having an aperture, the method comprising:

passing a device having a body member through the annular aperture in a first configuration;

expanding said body member into a second configuration, in situ, to at least partially span said aperture;

passing at least one anchor device into said intervertebral disc and attaching said anchor device to an adjacent vertebral body, the anchor device attached to an interconnecting member;

securing said body member to said at least one anchor device using the interconnecting member; and

re-approximating the aperture by applying tension to the interconnecting member thereby drawing tissues defining sides of the aperture toward one another.

2. The method of claim 1, wherein the securement of said body member to said at least one anchor device comprises two anchor devices.

3. The method of claim 1, wherein said body member may be additionally affixed to said annulus fibrosus.

4. The method of claim 1, wherein the device further comprises at least one fixation element for attaching the device to the annulus.

5. The method of claim 1, wherein said device is in part configured as a patch, barrier, membrane, scaffold, or stent.

6. The method of claim 1, wherein said device is applied at least in part in said aperture.

7. The method of claim 1, wherein a portion of said device serves as a scaffold for cells across the aperture to enhance natural healing.

8. A method for treating an intervertebral disc having an annulus fibrosus with a wall, the wall of the annulus fibrosus having an aperture, the method comprising:

passing a device having a patch member through the annular aperture in a first configuration and expanding the patch device into a second configuration, in use, within the intervertebral disc and beneath the outer surface of the annulus;

affixing at least one anchor device to a vertebral body adjacent to said intervertebral disc;

securing said patch member to said at least one anchor device with at least one interconnecting member; and

re-approximating the aperture by applying tension to the interconnecting member thereby drawing tissues defining sides of the aperture toward one another.

9. The method of claim 8, wherein at least one of said interconnecting member passes at least partially through the annulus fibrosus.

10. The method of claim 8, wherein said interconnecting member comprises a filament, tether, band, wire, tension band or suture.

11. The method of claim 8, wherein said device is in part configured as a patch, barrier, membrane, scaffold or stent.

12. The method of claim 8, wherein said device is applied at least in part in said aperture.

13. The method of claim 8, wherein said device is a filler.

14. The method of claim 13, wherein said filler is at least in part form-fitting.

15. The method of claim 13, wherein said filler is at least in part non-form-fitting.

16. The method of claim 8, wherein said step of securing further comprises attaching said body member to said vertebral anchor with said interconnecting member.

17. A method for treating an intervertebral disc having an annulus fibrosus with a wall, the wall of the annulus fibrosus having an aperture, the method comprising:

passing a device having a patch member through the annular aperture and placing said patch member, in use, within the intervertebral disc and beneath the outer surface of the annulus;

affixing at least one threaded anchor device at least partially into a vertebral body adjacent to said intervertebral disc;

securing said patch member to said at least one threaded anchor device with at least one interconnecting member coupled to the at least one threaded anchor device; and

re-approximating the aperture by applying tension to the interconnecting member thereby drawing tissues defining sides of the aperture toward one another.

18. A method for treating an intervertebral disc having an annulus fibrosus with a wall, the wall of the annulus fibrosus having an aperture, the method comprising:

passing a device having a foldable patch member through the annular aperture in a first configuration;

unfolding said patch member into a second configuration within the intervertebral disc;

passing at least one anchor device into said intervertebral disc and affixing said anchor device to an adjacent vertebral body, the at least one anchor device being coupled to an interconnecting member;

securing said patch member to said at least one anchor device; and

re-approximating the aperture by applying tension to the interconnecting member thereby drawing tissues defining sides of the aperture toward one another.

19. A method of treating an intervetebral disc having an annulus fibrosus with a wall, said wall of the annulus fibrosus having an aperture, said method comprising the steps of:

(a) providing at least one fastener;

(b) providing at least one patch member;

(c) inserting said at least one fastener into a vertebra adjacent to said aperture in a subanular location;

(d) placing said at least one patch member in a position in proximity to said aperture;

(e) stabilizing said patch in said position using said at least one fastener; and

(f) re-approximating the aperture by applying tension to the at least one fastener thereby drawing tissues defining sides of the aperture toward one another.

20. The method of claim 19, further comprising the step of inserting a fastener into a second vertebra adjacent to said aperture in a subanular location, said second vertebra being opposite to said first vertebra adjacent to said aperture.

21. The method of claim 19, wherein said at least one fastener comprises suture material.

22. The method of claim 19, wherein said at least one fasteners comprises a bone anchor.