Spinal disc annulus reconstruction method and spinal disc annulus stent

• US 8,034,112 B2
• Filed: 11/09/2006
• Issued: 10/11/2011
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: Anulex Technologies, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Wales, Lawrence W., Burns, Matthew M., Burmeister, Paul, Hektner, Thomas R., Houfburg, Rodney L., Cauthen, Joseph C. III, Adams, Daniel O.
• Primary Examiner(s): RAMANA, ANURADHA
• Application Number:
  US11/557,997
• Publication Number:
  US 20070073407A1
• Time in Patent Office: 1,797 Days
• Field of Search: 606246-249, 623 1711- 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 or resorptive
• 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 device 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.

Claims

1. A method for treating an aperture, weakened or thinned portion of an annulus fibrosus of an intervertebral disc wherein said disc has an exterior surface and an interior region, said method including the use of an implant and an implant delivery tool,

said implant delivery tool comprising tubular means for delivery of said implant,

said implant comprising an elongate, flexible member having two end portions and an intermediary portion between said end portions, wherein said intermediary portion traverses a helical pathway comprising at least two rotations, and wherein one rotation is positioned closer to the interior of the disc than the other rotation,

positioning said elongate, flexible member at least partially into or through tissue surrounding said aperture, weakened or thinned portion of the annulus fibrosus, and

applying tension to the intermediary portion of the elongate, flexible member so as to at least partially draw together the tissue surrounding said aperture, weakened or thinned portion of the annulus fibrosus.

2. The method of claim 1 wherein said implant further comprises a repair element selected from the group consisting of a patch, stent, membrane, barrier and scaffold.

3. The method of claim 1 wherein the implant further comprises tissue anchors.

4. The method of claim 1 wherein the elongate, flexible member is selected from a group consisting of a filament, suture, band, wire and tension band.

5. The method of claim 1 wherein the implant further comprises material to facilitate regeneration of disc tissue.

6. A method for treating an aperture, weakened or thinned portion of an annulus fibrosus of an intervertebral disc wherein said disc has an exterior surface and an interior region, said method including the use of an implant and an implant delivery tool,

said implant delivery tool comprising tubular means for delivery of said implant,

said implant comprising an elongate, flexible member having two end portions and an intermediary portion between end portions, wherein said intermediary portion traverses a helical pathway comprising at least two rotations along an axis extending along the length of the delivery tool and generally directed toward the interior of the disc,

positioning at least a portion of the elongate flexible member into or through disc tissue in proximity of said aperture, weakened or thinned portion of the annulus fibrosus, and

shortening of the elongate, flexible member between said end portions so as to at least partially draw together the tissue surrounding the aperture, weakened or thinned portion of the annulus fibrosus.

7. The method of claim 6 wherein the implant further comprises a repair element selected from the group consisting of a patch, stent, membrane, barrier and scaffold.

8. The method of claim 6 wherein the implant further comprises tissue anchors.

9. The method of claim 6 wherein the elongate, flexible member is selected from a group consisting of a filament, suture, band, wire and tension band.

10. The method of claim 6 wherein the implant further comprises material to facilitate regeneration of disc tissue.

11. A method for treating a defect of an annulus fibrosus of an intervertebral disc, said method comprising:

providing an implant and an implant delivery tool,

said delivery tool comprising tubular means for delivery of said implant,

said implant comprising a patch member, an elongate, flexible member and an anchor member,

said patch member configured to receive therethrough said elongate, flexible member,

said elongate, flexible member being disposed about the delivery tool, and

rotating of a portion of the delivery tool so as to apply tension to the elongate flexible member and partially enable the securement of the patch in proximity of the annular defect.

12. The method of claim 11 wherein the patch member is selected from the group consisting of a scaffold, barrier, stent and membrane to at least partially span the annular defect.

13. The method of claim 11 wherein the implant further comprises material to facilitate regeneration of disc tissue.

14. The method of claim 11 wherein the elongate, flexible member is selected from the group consisting of a filament, suture, band, wire and tension band.

15. The method of claim 11 wherein the anchor member is configured as a barb or t-anchor.

16. The method of claim 11 wherein the anchor member and the elongate, flexible member are formed from the same material.