Spinal disc annulus reconstruction method and spinal disc annulus stent

• US 7,189,235 B2
• Filed: 03/19/2003
• Issued: 03/13/2007
• 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): Isabella; David J
• Application Number:
  US10/392,739
• Publication Number:
  US 20030187508A1
• Time in Patent Office: 1,455 Days
• Field of Search: 623/11.11, 623 1711- 1716, 623/902, 606/60, 606/61, 606151-156, 606/191, 606/192, 600/37, 128/898
• US Class Current: 606/279
• 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 surgical method of repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, incorporating suture closure, or stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. The design of the spinal disc annulus stent allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Claims

1. A method for treating an intervertebral disc having an aperture in the annulus fibrosus, wherein the aperture provides a pathway for the migration of intradiscal material from the subannular space, the method comprising the steps of:

providing a device having a first folded configuration and second unfolded configuration, wherein said unfolded configuration has a width dimension, a depth dimension, and a height dimension, wherein, in use, said height dimension lies substantially parallel to the axis of a patient'"'"'s spine, the depth dimension lies substantially perpendicular to the axis of the spine, and the width dimension lies substantially parallel to the circumference of the patient'"'"'s disc annulus, and wherein said width dimension is greater than said height dimension and said height dimension is greater than said depth dimension;

wherein the first folded configuration comprises dimensions permitting said device to pass through the aperture and the second unfolded configuration comprises at least one dimension larger than a dimension of the aperture;

inserting the device through the aperture in the first configuration; and

causing or allowing the device to obtain said second configuration whereby said width or height dimension at least partially spans said aperture, thereby providing a barrier restricting the migration of intradiscal material through the aperture.

2. The method of claim 1 wherein the device is comprised at least in part of a shape memory material.

3. The method of claim 1, wherein the device is comprised at least in part of biocompatible fabric.

4. The method of claim 1, wherein the device is at least in part bioabsorbable.

5. The method of claim 1, further comprising the step of treating the annulus tissue surrounding the aperture to reduce the relative motion thereof.

6. The method of claim 5, further comprising the step of reapproximating the aperture.

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

8. The method of claim 6 wherein the device further comprises at least one element for reapproximating the aperture.

9. The method of claim 1, wherein the aperture is pathologic.

10. The method of claim 1, wherein the aperture is formed at least in part by a surgical incision.

11. A method for treating an intervertebral disc having an aperture in the annulus fibrosus, wherein the method of claim 1 is performed following discectomy.

12. The method of claim 1, further comprising the step of applying sutures to acutely stabilize said device.

13. The method of claim 1, wherein said device is comprised at least in part from autograft.

14. The method of claim 13, wherein said autograft is muscle fascia.

15. The method of claim 1, wherein said device is comprised at least in part from allograft.

16. The method of claim 1, wherein said device is comprised at least in part from a biocompatible membrane.

17. The method of claim 16, wherein said biocompatible membrane is a medical grade biocompatible fabric.

18. The method of claim 16, wherein said biocompatible membrane is a medical grade polymeric sheet.

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

20. The method of claim 19, wherein said device comprises a filler material.

21. The method of claim 20, wherein said filler is at least in part form-fitting.

22. The method of claim 20, wherein said filler is at least in part non-form-fitting.

23. The method of claim 1, further comprising the step of placing sutures at about equal distances along the sides of the aperture.

24. The method of claim 1, wherein at least a portion of the device comprises a biodegradable or bioresorbable material.

25. The method of claim 24, wherein the biodegradable or bioresorbable material comprises a fibrous mesh.

26. The method of claim 24, wherein the biodegradable material comprises a medical grade polymeric sheet.

27. The method of claim 1, wherein the device is comprised at least in part of biocompatible fibrous mesh.

28. The method of claim 1, wherein the device is comprised of a material selected from the group consisting of expandable polytetrafluoroethylene (ePTFE), a material to facilitate regeneration of disc tissue, and a hygroscopic material.

29. The method of claim 28, wherein the material to facilitate tissue growth comprises a bioactive silica based material.

30. The method of claim 28, wherein the material to facilitate tissue growth comprises a tissue growth factor.

31. The method of claim 1, wherein the device is comprised at least in part of polymer fibers.

32. The method of claim 1, wherein at least a portion of the device is porous.

33. The method of claim 1, wherein at least a portion of the device is non-porous.

34. The device of claim 1, wherein at least a portion of the device is formed at least in part of xenograft.