Spinal disc annulus reconstruction method and deformable spinal disc annulus stent

• US 8,088,165 B2
• Filed: 03/23/2006
• Issued: 01/03/2012
• 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. III, Burns, Matthew M., Hektner, Thomas R., Burmeister, Paul, Wales, Lawrence W., Adams, Daniel O., Houfburg, Rodney L.
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US11/386,642
• Publication Number:
  US 20060167553A1
• Time in Patent Office: 2,112 Days
• Field of Search: 623 1711- 1716, 606139-148
• 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 623/902 : Method of implanting

Abstract

A spinal disc annulus repair stent for repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, which may incorporate suture closure or other means of stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. In an illustrative embodiment, the design of the spinal disc annulus stent advantageously allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Claims

1. A method of repairing a defect in an intervertebral disc, comprising:

providing an apparatus comprising at least an outer portion having a tissue anchor element, an inner portion, and an interconnecting portion, said interconnecting portion connecting the inner and outer portions to one another;

inserting the inner portion of the apparatus through the defect in the intervertebral disc so that said inner portion spans said defect within the intervertebral disc;

positioning the outer portion of the apparatus at least in part on an outer surface of the intervertebral disc, wherein said positioning comprises placing the tissue anchor element of the outer portion into intervertebral disc tissue;

adjusting the interconnecting portion so as to apply tension between the inner portion and the outer portion.

2. The method of claim 1, wherein placing the tissue anchor element includes anchoring the tissue anchor element into an annulus fibrosus of the intervertebral disc.

3. The method of claim 1, wherein placing the tissue anchor element includes anchoring the tissue anchor to a vertebral body.

4. The method of claim 1, wherein the tissue anchor element is configured as a barb, bone, or T-anchor.

5. The method of claim 4, wherein placing the tissue anchor element within the intervertebral disc includes passing the tissue anchor element through a part of the inner portion of the apparatus.

6. The method of claim 1, wherein adjusting the interconnecting portion includes shortening the interconnecting portion.

7. The method of claim 6, wherein applying tension between the inner portion and the outer portion includes drawing the inner and outer portions toward one another.

8. The method of claim 6, wherein the interconnecting portion includes at least one suture and wherein shortening the interconnecting portion includes tightening the at least one suture.

9. The method of claim 1, wherein said inner portion includes a patch and wherein inserting said inner portion of the apparatus through the defect includes positioning the patch to at least partially span the defect.

10. The method of claim 1, wherein the interconnecting portion includes at least one tension band, and wherein adjusting said interconnecting portion includes tensioning the at least one tension band.

11. The method of claim 1, further comprising providing a locking element, wherein adjusting the interconnecting portion includes locking together said inner portion and said outer portion.

12. The method of claim 11, wherein providing a locking element includes providing a locking element comprising a gasket and a threading mechanism, and wherein locking together said inner portion and said outer portion comprises tightening the gasket around the threading mechanism to secure a first part of the interconnecting portion to a second part of the interconnecting portion.

13. The method of claim 11, wherein the interconnecting portion includes teeth, and wherein providing a locking element further includes providing a locking element comprising a substantially one-way engagement element configured to engage the teeth of the interconnecting portion, and wherein locking together said inner portion and said outer portion includes passing at least a portion of the interconnecting portion through the substantially one-way engagement element.

14. The method of claim 1, further comprising locking said inner portion and said outer portion together by tying a knot in said interconnecting portion.

15. The method of claim 14, wherein tying a knot creates a cinch line portion in the interconnecting portion, and wherein locking said inner portion to said outer portion further includes cinching the cinch line portion.

16. The method of claim 1, wherein inserting the inner portion includes inserting the inner portion through a defect in an annulus fibrosus of the intervertebral disc.

17. The method of claim 16, wherein inserting the inner portion further includes passing the inner portion, in a collapsed configuration, through an insertion tube and into the annulus fibrosus.

18. The method of claim 17, further comprising positioning the inner portion to span the defect in the annulus fibrosus.

19. The method of claim 18, wherein positioning the inner portion includes expanding the inner portion from the collapsed configuration to span the defect.

20. The method of claim 1, wherein providing the apparatus includes providing an apparatus in which the apparatus is made from materials configured to promote healing of a defect in an intervertebral disc.

21. The method of claim 20, wherein providing the apparatus includes providing an apparatus made from materials configured to promote healing of a defect in an intervertebral disc, wherein the apparatus is formed at least in part from at least one of autografts, allografts, xenografts, porous matrixes or meshes of biocompatible fibers, porous matrixes or meshes of bioresorbable fibers, networks of inert fibers intermingled with bioresorbable material, networks of inert fibers intermingled with bioabsorbable material, biodegradable substrates, expandable polytetrafluoroethylenes (ePTFE), hygroscopic materials, bioactive silicas, and materials to facilitate regeneration of tissue.

22. The method of claim 20, wherein providing an apparatus further includes providing an apparatus comprising a coating for affecting a healing process.