WO2007011994A2

WO2007011994A2 - Device and method for fibrous tissue repair

Info

Publication number: WO2007011994A2
Application number: PCT/US2006/027982
Authority: WO
Inventors: Scott E. Greenhalgh; Michael P. Igoe; John Paul Romano
Original assignee: Stout Medical Group, L.P.
Priority date: 2005-07-15
Filing date: 2006-07-17
Publication date: 2007-01-25
Also published as: WO2007011994A3

Abstract

Devices for repairing fibrous biological tissue are disclosed. The devices include an expandable clip, such as for repairing vertebral annuli. The devices include expandable members, where the members have a first end and a second end. The first end and second end can be forced towards each other, resulting in an expansion of the device. These devices can be deployed inside of fissures in vertebral annuli.

Description

TITLE OF THE INVENTION DEVICE AND METHOD FOR FIBROUS TISSUE REPAIR

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application Nos. 60/699,478 filed 15 July 2005, and 60/706,213 filed 5 August 2005, which are herein incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION [0002] This invention relates to devices and methods for repairing fibrous biological tissue, such as for repairing vertebral annuli, such as repair of herniated or punctured intervertebral discs. [0003] The spinal column is formed from a number of vertebrae which, in their normal state, are separated from each other by cartilaginous intervertebral discs. An exemplary disc is shown in Figure 1. The intervertebral disc 2 acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between the vertebral bodies. Without the disc 2, collapse of the intervertebral space occurs in conjunction with abnormal joint mechanics and premature development of arthritic changes. [0004] The normal intervertebral disc 2 has an outer ligamentous ring called the annulus fibrosus 4 surrounding the nucleus pulposus 6. The annulus 4 binds the adjacent vertebrae together anti is constituted of collagen fibers that are attached to the vertebrae and cross each other so that half of the individual fibers will tighten as the vertebrae are rotated in either direction, thus resisting twisting or torsional motion. The nucleus pulposus 6 is constituted of loose tissue, having about 85% water content which moves about during bending from front to back and from side to side. [0005] The aging process contributes to gradual changes in the intervertebral discs 2. The annulus 4 loses much of its flexibility and resilience, becoming more dense and solid in composition. The aging annulus 4 is also marked by the appearance on propagation of cracks or fissures in the annulus 4. Similarly, the nucleus 6 desiccates, increasing viscosity and thus losing its fluidity. In combination, these features of the aged intervertebral discs 2 result hi less dynamic stress distribution because of the more viscous nucleus pulposus 6, and less ability to withstand localized stresses by the annulus 4 due to its desiccation, loss of flexibility and the presence of fissures. [0006] As shown in Figure 2, occasionally fissures can form rents, conduits, holes or otherwise damaged areas through the annulus 4. In these instances, the nucleus pulposus 6 is urged outwardly from the subannular space through a fissure, rent or other hole 8 or damage often into the spinal column. Extruded nucleus pulposus 6 can mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc. [0007] In the event of annulus rupture, the fissure 8 can have an internal port 10 and an external port 12 along a fissure length 14. The subannular nucleus pulposus 6 migrates along the path of least resistance forcing the fissure 8 to open further, allowing migration of the nucleus pulposus through the wall of the disc 2, with resultant nerve compression and leakage of chemicals of inflammation into the space around the adjacent nerve roots supplying the extremities, bladder, bowel and genitalia. The usual effect of nerve compression and inflammation is intolerable back or neck pain, radiating into the extremities, with accompanying numbness, weakness and, in late stages, paralysis and muscle atrophy and/or bladder and bowel incontinence. Additionally, injury, disease or other degenerative disorders may cause one or more of the intervertebral discs to shrink, collapse, deteriorate or become displaced, herniated or otherwise damaged and compromised. [0008] The surgical standard of care for treatment of herniated, displaced or ruptured intervertebral discs 2 is fragment removal and nerve decompression without a requirement to reconstruct the annular wall. Results are not optimal. Various authors report 3.1 -21 % recurrent disc herniation, representing a failure of the primary procedure and requiring re-operation for the same condition. An estimated 10% recurrence rate results in 39,000 re-operations in the U.S. each year. An additional method of relieving the symptoms is thermal annuloplasty, involving the heating of subannular zones in the non-herniated painful disc, seeking pain relief but making no claim of reconstruction of the ruptured, discontinuous annulus wall.

BRIEF SUMMARY OF THE INVENTION [0009] An intervertebral annulus repair device is disclosed. The repair device can have a first elongated member and a second elongated member. The second elongated member is attached to the first elongated member. The first elongated member has an expanded configuration, and the first elongated member has a contracted configuration. The second elongated member has an expanded configuration, and the second elongated member has a contracted configuration. [0010] The first elongated member can be resilient. The first elongated member can be biased in the expanded configuration. The second elongated member can be resilient. The second elongated member can be biased in the expanded configuration. The first elongated member can be deformable. The second elongated member can be deformable. [0011] The repair device can have a head attached to the first elongated member and the second elongated member. The head can be integral with the first elongated member and the second elongated member. The first elongated member can have a first radius, and the first radius can be less than about 0.6 mm. The second elongated member can have a second radius, and the second radius can be less than about 0.6 mm. [0012] The first elongated member can have a first wire. The second elongated member can have a second wire. The device can have a fabric cover. [0013] Another intervertebral annulus repair device is disclosed. The repair device has a first end, a second end and a brace. The first end is attached to the second end. The brace is between the first end and the second end. The device is configured such that when the first end is moved toward the second end, the device expands. [0014] The repair device can also have a first connector attached to the first end and the second end. The first connector can have a rotating area. The repair device can have a second connector attached to the first end and the second end. [0015] Further disclosed is a delivery device for an intervertebral annulus repair device. The repair device can have an elongated member, a delivery mechanism and a stop proximal to the delivery mechanism. The stop can be an expandable member. The stop can be a buttress. The stop can be a first expandable balloon. The delivery mechanism can include a second expandable balloon. The delivery mechanism can have a first interference fit member and a second interference fit member (e-g., first and second pinching grips). The first interference fit member can be configured to move towards the second interference fit member. [0016] Further disclosed is a device for repair and support of an intervertebral annulus. The device can have a base and a pair of flexible, resilient legs extending from the base. The legs can be arranged in spaced apart relation to one another. The base and the legs can be insertable into the annulus. Motion of the base in an opposite direction outwardly from the annulus can cause the legs to splay outwardly and engage and support the annulus on opposite sides adjacent to the base. [0017] The base can have or be made from a hollow tube. Barbs can be positioned on each of the legs. The barbs can be oriented to allow the legs to penetrate into the annulus, for example, and prevent withdrawal of the legs from the annulus. The device can have a cover surrounding the base member for the base and the legs. The cover can have interlaced filamentary members. The cover can include a coating of a chemical compound for promoting a healing reaction. [0018] Also disclosed is a method of repairing vertebral annulus tissue having a damaged section. The damaged section has a conduit (i.e., fissure) having a conduit inner wall. The method includes inserting an expandable device into the annulus and releasing the device so that the device expands. The expandable device is resiliency expandable. The device has an expandable elongated element. [0019] The method of repairing can include closing the conduit. Closing the conduit can include forcing the conduit inner wall closed. Closing the conduit can include the device applying force from outside the tissue but inside the conduit. Applying force can include the elongated member expanding against the conduit inner wall. [0020] Closing the conduit can include the device applying force from inside the tissue. The method can include inserting the elongated member into the tissue of the annulus. Applying force can include the elongated member pressing toward the conduit from inside the tissue. Forcing the inner wall closed can include applying force from outside of the tissue of the annulus and the conduit. Applying force can include pressing an abutment against the tissue. [0021] The method of repairing can include impairing flow through the damaged section. The device can have a fabric element. The fabric element can impair flow through the damaged section. The fabric element can have a fabric cover. The fabric element can have a wall support. [0022] A method of repairing a vertebral annulus tissue having a damaged section is also disclosed. The damaged section has a conduit having an conduit inner wall. The method includes inserting an expandable device into the annulus and deforming the device so that the device expands. The expandable device is deformably expandable. The device has an expandable elongated element.

BRIEF DESCRIPTION OF THE DRAWINGS [0023] Figure 1 illustrates an intervertebral disc. [0024] Figure 2 illustrates an intervertebral disc with annular damage. [0025] Figure 3 illustrates a side view of a variation of an annulus repair device in a contracted configuration. [0026] Figure 4 illustrates a front view of the annulus repair device of Figure 3 in a contracted configuration. [0027] Figure 5 illustrates a top view of the annulus repair device of Figure 3 in a contracted configuration. [0028] Figure 6 illustrates a front view of the annulus repair device of Figure 3 in an expanded configuration. [0029] Figures 7 through 10 illustrate variations of the endoannular repair device. [0030] Figure 11, 13 and 14 illustrate variations of another annulus repair device in an expanded configuration. [0031] Figure 12 illustrates the annulus repair device of Figure 11 in a contracted configuration. [0032] Figure 15 illustrates a side view of another variation of an annulus repair device in a contracted configuration. [0033] Figure 16 illustrates a front view of the annulus repair device of Figure 15 in a contracted configuration. [0034] Figure 17 illustrates a side view of the annulus repair device of Figure 15 in an expanded configuration. [0035] Figure 18 illustrates a front view of the annulus repair device of Figure 15 in an expanded configuration. [0036] Figure 19 illustrates a side view of another variation of an annulus repair device in a contracted configuration. [0037] Figure 20 illustrates a front view of the annulus repair device of Figure 19 in a contracted configuration. [0038] Figure 21 illustrates a side view of the annulus repair device of Figure 19 in an expanded configuration. [0039] Figure 22 illustrates a front view of the annulus repair device of Figure 19 in an expanded configuration. [0040] Figure 23 illustrates a side view of a variation of the annulus repair device. [0041] Figure 24 illustrates a top view of a variation of the annulus repair device of Figure 23. [0042] Figure 25 illustrates a perspective view of a variation of the annulus repair device. [0043] Figure 26 illustrates a top view of the annulus repair device of Figure 25. [0044] Figures 27 through 29 illustrate perspective views of various variations of the annulus repair device. [0045] Figures 30 and 31 illustrate various views of a variation of the annulus repair device in a disassembled configuration. [0046] Figure 32 illustrates a side view of a variation of the annulus repair device. [0047] Figure 33 illustrates a perspective view of a variation of the annulus repair device of Figure 32. [0048] Figure 34 illustrates a perspective view of a variation of a deployment device loaded with a variation of the annulus repair device. [0049] Figure 35 illustrates a top view of the deployment device of Figure 34 loaded with a variation of the annulus repair device. [0050] Figures 36 and 37 illustrate top views of various variations of a deployment device loaded with a variation of the annulus repair device. [0051] Figures 38 and 39 illustrate sectional views of various variations of the deployment device loaded with a variation of the annulus repair device. [0052] Figure 40 illustrates a side view of an apparatus for deploying the endoannular repair device. [0053] Figures 41 through 56 illustrate a variation of a method for using an annulus repair device. [0054] Figures 57 and 58 illustrate a variation of a method for using an annulus repair device near a vertebra. [0055] Figures 59 through 61 illustrate a variation of a method for using an annulus repair device with a wall support. [0056] Figures 62 through 74 illustrate variations of a method for using a resilient annulus repair device. [0057] Figures 75 through 78 illustrate a top cross-sectional view of a variation of a method for insertion of the endoannular repair device. [0058] Figure 79 illustrates a variation of a method for using an annulus repair device. [0059] Figures 80 through 82 illustrate a variation of a method for using an annulus repair device. [0060] Figures 83 through 86 illustrate posterior views of various deployed configurations for variations of the annulus repair device in an annulus. [0061] Figure 87 illustrates a top cross-sectional view of a deployed configuration for a variation of the annulus repair device in an annulus.

DETAILED DESCRIPTION [0062] Figure 3 illustrates a tissue (e.g., collagen) repair device, for example, a vertebral disc annulus repair device 16 that can have a body 18 and a fabric cover 20. The body 18 can have a head portion 22 and a leg portion 24. The head portion 22 can be integral with the leg portion 24. The fabric cover 20 can cover part or all of the body, for example, the head portion 22 and/or the leg portion 24. The leg portion 24 can have hooks and/or barbs 26. The leg portion 24 can have a leg tip 28. The leg tip 28 can be sharpened. The annulus repair device 16 can have a longitudinal axis 30. The leg portion 24 can be in a contracted configuration. [0063] Figure 4 illustrates that the annulus repair device 16 can be a clip. The leg portion 24 can have a first leg 24a and a second leg 24b. The legs 24a and 24b can be elongated members. The legs 24a and 24b can have attached and/or integral hooks and/or barbs 26. The legs 24a and 24b can be in a contracted configuration. [0064] The annulus repair device 16 can have a device length 32. The device length 32 can be from about 6 mm (0.2 in.) to about 20 mm (0.79 in.), for example, about 13 mm (0.51 in). The leg portion 24 and/or the legs 24a and 24b can have a leg length 34. The leg length 34 can be from about 2 mm (0.08 in.) to about 18 mm (0.71 in.), for example, about 10 mm (0.39 in.). The leg length 34 can be from about 50% of the device length 32 to about 95% of the device length 32, for example, about 80% of the device length 32. [0065] The head portion 22 and/or the head 36 can have a head length 38. The head length 38 can be from about 0.3 mm (0.01 in.) to about 10 mm (0.39 in.), for example, about 3 mm (0.1 in.). The head length 38 can be from about 5% of the device length 32 to about 50% of the device length 32, for example, about 20% of the device length 32. [0066] Figure 5 illustrates the annulus repair device 16 that can have a circular section. The annulus repair device 16 can have a device diameter 40. The device diameter 40 can be from about 1 mm (0.04 in.) to about 2 mm (0.08 in.), for example, about 1.5 mm (0.059 in.). [0067] Figure 6 illustrates the annulus repair device 16 that can have a first leg 24a and a second leg 24b in an expanded configuration. The legs 24a and 24b can radially expand away from the longitudinal axis 30. The device diameter 40 in an expanded configuration can be from about 4 mm (0.2 in.) to about 35 mm (1.4 in.), for example, about 15 mm (0.59 in.). [0068] The legs 24a and 24b can form an expansion angle 42 with respect to the longitudinal axis 30. The expansion angle 42 can be from about 30° to about 150°, for example, about 90°. [0069] The leg portion 24 and/or the head portion 22 can be made from a resilient material (e.g., a shape memory metal, such as Nitinol or ELGILO Y®) or deformable material (e.g., stainless steel, MP35n® Chromium steel). The leg portion 24 can be biased to an expanded or a contracted configuration. [0070] Figure 7 illustrates the endoannular repair device 16 that can have the head portion 22 to which a plurality of flexible, resilient legs in the leg portion 24. The legs can be positioned in spaced apart relation. There can be two legs 24 that extend substantially parallel to one another from the head portion 22. The head section 12 can have internal screw threads 23. The screw threads 23 can be configured to engage with an insertion or deployment device, for example as described below. [0071] The barbs 26 can be oriented to prevent the legs 24 from being withdrawn once inserted into tissue such as an intervertebral annulus. [0072] Figures 9 and 10 illustrate that part of, or the entire, device 16 can be surrounded with the cover 20. In Figure 9, the cover 20 can be positioned only on the head portion 22. Figure 10 illustrates that the cover 20 can surround the head portion 22 and leg portion 24. The cover 20 can be formed from interlaced filamentary members 22. The interlaced filamentary members can provide interstices that can increase the surface area of the device 16 and the friction between the device 16 and the annulus during use. The increased surface area and friction can provide better adhesion between the tissue and the device 16 and/or can promote cell growth and healing of the tissue to the device 16. [0073] Materials for the cover 20 can provide a healing response in living tissue. For example, the cover 20 can be made from polypropylene, other polymers, such as polyethylene, polyester, expanded polytetrafluoroethylene and polyimides, and other materials disclosed herein. The cover can be made from bioabsorbable materials, such as polylactic acid and polyglycolic acid, and combinations thereof. The cover 20 can serve as a reservoir for chemical compounds, such as medicaments that facilitate the healing process. [0074] Figures 11 and 13 illustrate annulus repair devices 44 that can have a proximal first leg 46a, a distal first leg 46b, a proximal second leg 48a and a distal second leg 48b. The proximal first leg 46a can be fixedly attached to or integral with the distal first leg 46b. The proximal second leg 48a can be fixedly attached to, or integral with, the distal second leg 48b. The proximal legs 46a and 48a can be longer, shorter, or the same length as the distal legs 46b and 48b. [0075] Prior to insertion into tissue, such as an annulus, all the legs can be biased to assume a predetermined curved shape. The biased curved shape can cause the legs to splay outwardly into neighboring healthy tissue on opposite sides of the weakened tissue region as the device 16 is inserted. [0076] The degree of curvature required can be determined based upon the bending stiffness of the legs and the character of the tissue in which the device will be inserted. The curvature can determine the path of the legs through the tissue upon insertion. For example, less dense tissue can require less curvature and more flexible legs, while dense tissue can require stiffer legs and greater curvature to achieve the desired positioning of the legs to effect repair of the weakened or ruptured region. [0077] The longer legs can bridge the span of the weakened tissue region and join the healthy tissue regions to one another. The shorter legs can prevent the device 16 from backing out under pressure within the tissue or movement of the tissue when, for example, a disc is placed under pressure or moves in response to motion of various vertebrae. [0078] The head portion 50 can have a first collar 52. The head portion 50 can be tubular in cross-section. The first collar 52 can be fixedly attached to and/or integral with a second collar 54. The first collar 52 can be fixedly attached to the proximal first leg 46a and/or the distal first leg 46b. The second collar 54 can be fixedly attached to the proximal second leg 48a and/or the distal second leg 48b. The proximal first leg 46a, distal first leg 46b, proximal second leg 48a and distal second leg 48b, or combinations thereof, can be wires. [0079] The proximal first and second legs 46a and 48 a and the distal first and second legs 46b and 48b can have a leg diameter 56. The leg diameter 56 can be from about 0.05 mm (0.002 in.) to about 1.27 mm (0.050 in.), for example, about 0.51 mm (0.020 in.). The head portion 50 can have a head diameter 58. The head diameter 58 can be from about 0.10 mm (0.004 in.) to about 2.0 mm (0.079 in.), for example, about 1.0 mm (0.039 in.). [0080] In the expanded configuration, the proximal first and second legs 46a and 48a can have a proximal expansion angle 60. In the expanded configuration, the distal first and second legs 46b and 48b can have a distal expansion angle 62. The proximal and distal expansion angles 60 and 62 can be from the same ranges and examples listed supra for the expansion angle 42. [0081] Figure 12 illustrates that the proximal first and second legs 46a and 48a can have a proximal leg length 64. The proximal leg length 64 can be from about 5% of the device length 66 to about 95% of the device length 66, for example, about 75% of the device length 66. [0082] The distal fust and second legs 46b and 48b can have a distal leg length 68. The distal leg length 68 can be from about 5% of the device length 66 to about 95% of the device length 66, for example, about 15% of the device length 66. [0083] Figure 14 illustrates that the repair device 16 can have legs extending in only one direction from the head portion 50: proximal or distal (shown as proximal for illustrative purposes). [0084] Figures 15 and 16 illustrate an annulus repair device 70 in a contracted configuration that can have a first base 72 and a second base 74. A first connector 76 and a second connector 78 can rotatably attach to the first base 72, for example, at a first hinge area 80. The first connector 76 and the second connector 78 can rotatably attach to the second base 74, for example, at a second hinge area 82. The first and second hinge areas 80 and 82 can be thinned or narrowed portions of the connectors 76 or 78. The annulus repair device 70 can be deformable. [0085] The first connector 76 can have a first extension section 84, a brace connector section 86 and a second extension section 88. The first extension section 84 can rotatably attach to the brace connector section 86 at a third hinge area 90. The second extension section 88 can rotatably attach to the brace connector section 86 at a fourth hinge area 92. [0086] The hinge areas 80, 82, 90 and 92 can be narrowed or thinned portions of the connectors 76 and 78. The thinning can be on a single side of the connectors. The side of the thinning 94 can be the side to which the connector naturally rotates when transforming from the contracted configuration to the expanded configuration. The hinge areas can be interlocking mechanical hinges. [0087] A brace first end 96 can be attached to and/or integral with the brace connector section 86, for example, at the third hinge area 90. The brace first end 96 can be cut from the first extension section 84. A brace second end 98 can be attached to and/or integral with the brace connector section 86, for example, at the fourth hinge area 92. The brace second end 98 can be cut from the second extension section 88. [0088] In the contracted configuration, the annulus repair device 70 can have the device length 100 as listed supra, for example, about 15 mm (0.59 in.). In a contracted configuration, the annulus repair device 70 can have the device diameter 102 as listed supra, for example, about 2 mm (0.08 in.). [0089] Figures 17 and 18 illustrate the annulus repair device 70 of Figures 15 and 16 in the expanded configuration. The first connector 76 can form a bend (i.e., a non-zero angle) at the first, second, third and fourth hinge areas 80, 82, 90 and 92. A brace 104 can be substantially straight. The brace 104 can be made of the brace first end 96, brace connector section 86 and brace second end 98. [0090] In the expanded configuration, the annulus repair device 70 can have the device length 106 as listed supra, for example, about 8 mm (0.3 in.) . In an expanded configuration, the annulus repair device 70 can have the device diameter 108 as listed supra, for example, about 11 mm (0.43 in.). [0091] Figures 19 and 20 illustrate the annulus repair device 110 in a contracted configuration that can have a first base 112 and a second base 114. First and second extension sections 116 and 118 extend between the bases 112 and 114 and can have the first, second and third rotating or hinged areas 120, 122 and 124. [0092] The first hinged area 120 can be located near one end of the first extension section 116. The second hinged area 122 can be located near an end of the second extension section 118 opposite from the first hinged area 120. The third hinged area 124 can be located between the first and second extension sections 116 and 118 about half-way between the first base 112 and second base 114. [0093] Figures 21 and 22 illustrate an expanded configuration of the annulus repair device. In the expanded configuration, there can be a brace 126 around the third hinge area 124. [0094] In the expanded configuration, the annulus repair device 110 can have the device length 128 as listed supra, for example, about 8 mm (0.3 in.). In an expanded configuration, the annulus repair device 110 can have the device diameter 130 as listed supra, for example, about 16 mm (0.63 in.). [0095] The annulus repair device 16 can be bioabsorbable (i.e., bioresorbable, biodegradable) or nonbioabsorbable. The body 18 and/or the fabric cover 20 can be bioabsorbable or non-bioabsorbable. [0096] Figure 23 illustrates that the annulus repair device 16 can have a grommet configuration. The annulus repair device can have a head portion 50 that can attach a first flange 201a to a second flange 201b. The flanges 201a and 201b can be resilient. [0097] Figure 24 illustrates that the flanges 201a and 201b can have a star-shaped configuration. The flanges 201a and 201b can have one, two, or more radially extending branches. The flanges 201a and 201b can have round, square, oval, or triangular configurations. The first flange 201a can have a different configuration from the second flange 201b. [0098] Figures 25 and 26 illustrate that the annulus repair device 110 (shown in a radially expanded, post-deployment configuration) can have more than two connectors, such as four connectors 76a, 76b, 78a and 78b. The connectors can radially expand during deployment at different locations longitudinally and radially. [0099] Figure 27 illustrates a radially expanded (i.e., deployed) configuration of the annulus repair device 16 of Figure 14. Figure 27 illustrates a radially expanded configuration of the annulus repair device 16 of Figure 13 with legs of substantially similar lengths. Figure 29 illustrates that the annulus repair device can have eight or more legs 46a, 46b, 48a, 48b, 203a, 203b, 205a, and 205b. The legs can have various and/or the same lengths. [0100] Figures 30 and 31 illustrate that the annulus repair device 16 can have a first portion 207 and a second portion 209. The annulus repair device 16 can have a first interlocking portion 211 on the first portion 207 and a second interlocking portion 213 on the second portion 209. The first interlocking portion 211 can be configured to releasably or fixedly attach to the second interlocking portion 213. The first portion 207 can be attached to the second portion 209 before, during or after either or both of the individual portions 207 and 209 have been deployed on, into or through the fissure 8. The first interlocking portion 207 can have a first head portion 50a and legs 46a and 48a. The second portion 209 can have a second head portion 50b and legs 46b and 48b. [0101] Figures 32 and 33 illustrate that the head portion 50 can have numerous (e.g., one, two, three four or more) legs extending from opposite lateral sides of the head portion 50. The legs can be configured to extend radially from the head portion during deployment into the fissure 8, and/or retract radially into the head portion, for example, to remove or reposition the annulus repair device 16 during use. [0102] Any or all elements of the annulus repair devices 16, 44, 70 and 110 and/or delivery devices and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILO Y® from Elgin Specialty Metals, Elgin, IL; CONICHROME® from Carpenter Metals Corp., Wyomissing, PA), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, CT), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 October 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363 , polymers such as polyethylene teraphathalate (PET), polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, DE), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, NJ, or DYNEEMA® from Royal DSM N. V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, MA), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold. [0103] Any or all elements of the annulus repair devices 16, 44, 70 and 110 and/or delivery devices and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, DE), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof. 82

[0104] The annulus repair devices 16, 44, 70 and 110 and/or delivery devices and/or elements of the annulus repair devices 16, 44, 70 and 110 and/or delivery devices and/or other devices or apparatuses described herein and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements, fillers, glues, and/or an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors. [0105] Examples of such cements and/or fillers includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof. [0106] The agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-I) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, PA; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, NJ; CELEBREX® from Pharmacia Corp., Peapack, NJ; COX- 1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, PA), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostaglandin E₂ Synthesis in Abdominal Aortic Aneurysms, Circulation, July 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu et al, SpI Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties. [0107] The hooks and/or barbs 26 can be made from metal and can be attached to legs 24 made from a polymer. The body 18 can be metal. The fabric (e.g., the fabric cover 20 and/or the wall support infra) can be made from PET, polypropylene, any pother material listed herein or combinations thereof. The fabric can be knitted, woven, braided or combinations thereof. [0108] The device 16 can be laser cut from a thin walled tube. For example, this method of making can produce a head section 22 with a tubular cross section and legs 24a and 24b with an arcuate cross section. The device 16 can be molded or machined from a blank and have a substantially solid head section 22. The legs 14 can be integrally formed or attached to the head section 22 by welding, brazing, adhesives, or combinations thereof.

METHOD OFUSE [0109] Figures 34 and 35 illustrate a delivery device 132 loaded with the annulus repair device 44. The delivery device 132 can have a catheter 134. The catheter 134 can be from a 3 French to a 6 French catheter, for example, a 5 French catheter. The catheter can have an outer diameter from about 1 mm (0.04 in.) to about 2 mm (0.08 in.), for example, about 2 mm (0.08 in.). The catheter 134 can have a retractable and expandable stop or abutment substantially perpendicular to the catheter 134. For example, the catheter 134 can have a first expandable balloon 136. The first expandable balloon 136 can be an insertion depth 138 away from an insertion end 140 of the catheter 134. The insertion depth 138 can be about equal to or less than the expected fissure length 14. [0110] The annulus repair device 44 can be loaded onto a deployment device on the catheter 134. The deployment device can be a second expandable balloon 142. The second expandable balloon 142 can be configured to expand in substantially only a plane aligned with a plane of expansion of the annulus repair device 44. [0111] Figure 36 illustrates that the retractable and expandable abutment can be a retractable buttress 144 that can be flat when in an expanded configuration, and lie flush against or in the catheter 134 when the buttress 144 is in a retracted configuration (not shown). A buttress or other abutment can be part of a different tool (not shown) that is slid over the catheter 134 during use such that the buttress is in substantially the same longitudinal location on the catheter 134 as the buttress 144 shown in Figure 35. [0112] Figure 37 illustrates that the deployment device can be first and/or second retractable pinch grips 146 and/or 148. The first pinch grips 146 can be on the side of the insertion end 140 of the annulus repair device 44. The first or second pinch grips 146 or 148 can be replaced with a longitudinally static, retractable buttress (not shown). [0113] Figure 38 illustrates that the annulus repair device 44 can be contracted and loaded into a catheter 134. The catheter 134 can have a plunger 150 that is releasably attached to an end of the annulus repair device 44. The plunger 150 can have jaws, an adhesive coating, be magnetic, have a screw engagement into a machined receptacle on the annulus repair device or combinations thereof. The insertion depth 138 can be from about 10% of the fissure length 14 to about 90% of the fissure length 14, for example, about 40% of the fissure length 14. The delivery device 132 can have an expandable balloon 136. Figure 39 illustrates the delivery device 44 with a retractable buttress 144. [0114] Figure 40 illustrates that the repair device 70 can have a crosshead 51. The crosshead 51 can have internal screw threads 23 that engage complementary threads 69 on a rod or shaft 71 of the delivery device 132. The proximal end of the repair device 70 can engage a stop 73 on the shaft. When the shaft 71 is rotated relative to the repair device 70, the crosshead 50 can be drawn toward the stop 73, bending the connectors 76 into a radially expanded configuration shown, for example, in Figures 49 and 50. A separate element (not shown), such as a rotational interference-fit sheath, can be used to prevent rotation of device 70 as shaft 71 is turned. [0115] Figures 41 and 42 illustrate positioning the delivery device 132 loaded with the annulus repair device 44 before implanting the annulus repair device in the vertebral disc 2. The insertion end 140 of the delivery device 132 can be positioned adjacent to the external port 12 of the vertebral disc 2. The longitudinal axis of delivery device 44 can be aligned with the longitudinal axis of the fissure 8. The alignment and positioning can be facilitated with imaging techniques (e.g., x-ray, MRI, sonogram) known to those having ordinary skill in the art. [0116] The catheter 134 can have one or more central channels (not shown) that can be used to pass a guidewire therethrough. By methods known to those having ordinary skill in the art, the guidewire (e.g., a steerable guidewire) can be used to position the delivery device 132. [0117] The channels can also be used to feed other tools to the disc 2. For example, an ultrasound and/or RF transducer can be deployed to the fissure 8, and/or the nucleus 6. The transducer can deliver energy to the fissure 8 and/or nucleus 6 to aid healing and minimize flow through the fissure 8. Also, for example, a fiber optic, or other small scale camera or other imaging device can be deployed through the channel to the fissure 8 and/or the nucleus 6. Also, for example, a hollow tube can be deployed through the channel. Also, for example, a brush, such as a small wire brush, can be deployed through the channel. The brush can be used to abrade and/or clean any tissue in or around the fissure and/or nucleus 6. [0118] Small scale implantable diagnostics (e.g., pressure sensors that can relay readings wirelessly to computers outside the patient) and therapeutics (e.g., drug pumps or time release drug-eluting polymer elements) can be implanted through the channel into the fissure 8 and/or the nucleus 6. [0119] The channels can also be used to supply a vacuum, for example, to remove part or all of the nucleus 6 or damaged tissue. The channels can also be used to deliver material to the fissure 8 and/or the nucleus 6. For example, the channel in the delivery device 132 can be used to deliver bone cement, adhesive, hydrogels such as expandable hydrogels, agents (e.g., anesthetics, antibiotics, and/or any others listed herein), or combinations thereof to the fissure 8 and/or nucleus 6. [0120] Figures 43 through 45 illustrate that the first expandable balloon 136 can be expanded, as shown by arrows. The first expandable balloon 136 can be sufficiently expanded to create a surface substantially perpendicular with the catheter 132. The first expandable balloon 136 can be expanded by carbon dioxide or saline solution, for example, carried through a conduit (not shown) in the catheter. [0121] Figures 46 and 47 illustrate inserting, as shown by arrow, the annulus repair device 70 into the fissure 8. The delivery device 132 can be inserted into the fissure 8 until the first expandable balloon 136 abuts the tissue surrounding the external port 12. The abutment of the first expandable balloon 136 against the tissue surrounding the external port 12 can prevent the deployment of the annulus repair device 70 on the side of the external port 12 outside of the annulus 6. [0122] The location of the first expandable balloon 136 on the catheter 134 can prevent the inserting end 140 from passing through the internal port 10 and entering the nucleus 6. The location of the first expandable balloon 136 on the catheter 134 can control the location of the annulus repair device 70 in the fissure 8. [0123] Figure 48 illustrates that the annulus repair device can be transformed from a contracted configuration into an expanded configuration. The first pinch grips 146 can be translated, as shown by arrows 152, away from the insertion end 140 of the catheter 134 and/or the second pinch grips 148 can be translated, as shown by arrows 154, toward the insertion end 140 of the catheter 134. As the first base 72 is forced towards the second base 74 by the pinch grips 146 and/or 148, the brace 104 can be forced to deform radially outward, as shown by arrows 155, from the catheter 134. [0124] Figures 49 and 50 illustrate that the braces 104 can expand against the inner walls of the fissure 8. The expansion of the braces 104 can cause the fissure 8 to tension in a lateral plane, as shown by arrows, and collapse in other directions (i.e., transversely to the tensioning plane, and longitudinally). [0125] Figure 51 illustrates that the first pinch grips 146 can be retracted, as shown by arrows 156, into the catheter 134. The second pinch grips 148 can be retracted, as shown by arrows 158, into the catheter 134. The first expandable balloon 136 can be deflated or otherwise retracted. [0126] Figure 52 illustrates that under lateral tension from the annulus repair device 70, the internal port 10 can have an internal port height 160 that can be reduced by a factor of about 5 after tensioning compared with the internal port height 160 before tensioning. [0127] Figure 53 illustrates the delivery device 132 prepared for removal from the annulus 4. [0128] Figures 54 through 56 illustrate withdrawing, as shown by arrow, the delivery device 132 from the annulus repair device 70. The catheter 134 can slide out from the first and second bases 72 and 74. When the delivery device is removed from the fissure 8, the external port 12 can collapse transversely to the tensioning from the annulus repair device 70. The external port 12 can have an external port height 164 that can be reduced by a factor of about 5 after tensioning compared to the external port height 164 before tensioning. The lateral tensioning in the fissure 8 can substantially stop flow through the fissure 8. [0129] The annulus repair device 70 can be covered with the fabric cover 168. The fabric cover 168 can block flow through the fissure 8. [0130] Figure 57 illustrates that the annulus 4 can have the fissure 8 on the border of the vertebral disc 2 and a vertebra 170. Figure 58 illustrates that the annulus repair device 70 can be implanted in the fissure 8. The lateral tensioning in the fissure 8 can substantially stop flow through the fissure 8 along the vertebra 170. [0131] Figures 59 and 60 illustrate the annulus repair device 70 attached to, or adjacent to, a wall support 172. The wall support 172 can be implanted into the nucleus 6 along the internal port 10. The wall support 172 can cover the internal port 10. The wall support 172 can be made from a fabric. [0132] Figure 61 illustrates that when the repair device 70 is positioned within an opening 8 in tissue 4, the outward extension of the connectors 16 and 78 can elongate or otherwise distend the opening in the plane and bring opposite sides of the opening 8 together to facilitate a repair. [0133] Figures 62 and 63 illustrate a method for inserting the delivery device 44 (e.g., the delivery device shown in Figure 38) into the fissure 8. The delivery device 44 can be pressed, as shown by arrow 174, into the annulus 4 with enough force to cause deformation of the annulus 4 around and into, as shown by arrows 176, the fissure 8. [0134] The fissure 8 can be partially or totally closed by the tissue deformation, shown by arrows 176. The annulus 4 around the external port 12 can dimple inward (shown clearly in Figure 63) around the first expandable balloon 136. The pressure, as shown by arrow 174, can be large enough to force a herniated nucleus 4 substantially out of the fissure 8, and substantially into a natural, healthy position. [0135] Figure 64 illustrates that both sets of legs 46 and 48 can be deformed to be substantially straight when positioned within the catheter 134 prior to delivery into tissue. As the repair device 16 is released from the constraints of the catheter 134, as shown in Figure 65, the stiffness and biasing of the legs 46 and 48 can causes them to take a curved path through the tissue 4 as the device 16 is inserted. [0136] Figures 66 through 68 illustrate pushing, as shown by arrow 178, the plunger 150, in turn forcing part of the proximal legs 46a and 48a out of the catheter 132. The proximal legs 46a and 48a can expand, as shown by arrows 180, and implant into the annulus 4 around the fissure 8. The delivery device 132 can begin to be pressed, or continue to be pressed, as shown by arrow 182, into the annulus 4. The fissure 8 can be partially or totally closed by the tissue deformation resulting from the pressure. [0137] Figures 69 through 71 illustrate that the delivery device 132 can be firmly pressed into the annulus 4 concurrently with continuing deploying the annulus repair device 44. The delivery device 132 can begin to be pressed, or continue to be pressed, as shown by arrow 182, into the annulus 4. [0138] The fissure 8 can be partially or totally closed by the tissue deformation resulting from the pressure. The plunger 150 can be pushed, as shown by arrow 178, further deploying the annulus repair device 44. The proximal legs 46a and 48a can expand, as shown by arrows 186. The proximal legs 46a and 48a can deploy into the deformed (or in other variations, into a non-deformed) fissure 8, for example, substantially fixing the deformation in place. [0139] Figures 72 through 74 illustrate the complete deployment of the annulus repair device 44 from the delivery device 132. The plunger 150 can push, as shown by arrow 178, the annulus repair device 44 until the annulus repair device 44 is completely or substantially outside of the catheter 134. The plunger 150 can release the annulus repair device 44. [0140] Before the plunger releases the annulus repair device 44, and/or the annulus repair device 44 is completely or substantially outside the catheter 134, the plunger 150 can pull the annulus repair device 44 back into the catheter 134 and the annulus repair device 44 can be repositioned and redeployed or removed. The annulus repair device 44 can be repositioned and redeployed numerous times until the surgeon is satisfied with the placement of the annulus repair device 44 in the annulus 4. [0141] The distal legs 46b and 48b can expand, as shown by arrows 188, for example, after being released from the plunger and/or the annulus repair device 44 is completely or substantially outside the catheter 134. [0142] Figures 75 through 78 illustrate insertion of the repair device 16 into an annulus 4. The repair device 16 can be positioned on the end of a rod 71 having external threads engageable with the internal threads 23 of the repair device 16. As shown in Figure 75, the rod 71 can be inserted through a catheter 134 that is positioned percutaneously adjacent to a weakened region 28 of an annulus 4 of an intervertebral disk 2. [0143] Figure 76 illustrates that the catheter 134 and the repair device 16 can be pushed against the weakened region 9, for example to apply a compressive force to deform the annulus 4 inwardly in the weakened region 9 to form a concavity 11 and establish the tissue of the annulus 4 into a desired supported position. [0144] Figure 76 illustrates that the repair device 16 on the rod 71 can then be pushed, as shown by the arrow, out of the catheter 134 and completely into the annulus 4. The nucleus 6 of the disk 2 can be left unpunctured. [0145] Figure 77 illustrates that after insertion of the repair device 16 into the annulus 4, the rod 71 can be partially withdrawn as shown by the arrow. The withdrawal of the rod 71 can cause the legs 24 to splay radially outwardly from the head portion 22 and engage the healthy tissue on either side of the weakened region 9. With the legs 24 in the splayed position engaging the healthy tissue, the device can hold the annulus 4 in a desired supported position established by the compressive force previously applied. [0146] Figure 78 illustrates that the rod 71 can be rotated to unscrew the rod 71 from engagement with the head portion 22 and the rod 71. The catheter 132 can be removed, as shown by arrow. [0147] Insertion of the repair device 16 head portion 22 first into the annulus 4 allows the natural biasing characteristics of the legs to support the annulus 4 in the weakened region 9 and prevent protrusion of the nucleus 6. Biasing forces in the resilient legs 24 caused by their deformation tend to draw the legs 24 back together and thereby close the insertion opening and hold the tissue of the annulus 4 in the desired supported position. Pressure on the repair device 16 from the nucleus 6 can be resisted by the bending stiffness of the legs 24 allowing the repair device 16 to prevent protrusion of the nucleus 6 through the annulus 4. The repair device 16 furthermore can act as a bridge across the weakened region 9, supporting the annulus 4 and drawing the healthy portions on either side of the weakened region 9 together. [0148] The repair device 16 can be inserted leg portion 24 first into an annulus 4 or other tissue and effectively support and repair an opening (e.g., fissure 8) or weakened region 9. [0149] Figure 79 illustrates a method of implanting the annulus repair device 16 of Figures 3 through 6 into a fissure 8. The annulus repair device 16 can be inserted into the fissure 8 with the head 22 positioned adjacent to the nucleus 6. The first leg 24a and the second leg 24b can be deformed into the annulus 4 surrounding the fissure 8. [0150] The hooks and/or barbs 26 can anchor the legs 24a and 24b in the tissue of the annulus 4. The fabric cover 20 can be used on any variation of the annulus repair device. [0151] The fabric cover 20 and/or the wall support 172 can act as a static plug to hold the nucleus 4 and/or other fluids in place. Polymers and/or drugs delivered (e.g., directly, eluted from the fabric cover 20 or body 18, through ingestion or injection into the blood stream) to the disc 2 can stimulate a healing process. A biocompatible adhesive and/or other glue can be delivered to the fissure 8 to hold the fissure 8 closed. [0152] Other tools (e.g., closure devices such as glues, sutures, staples) can be used to supplement the annulus repair device 16. The annulus repair devices 16 described herein can be used in combination with one another and/or with multiple units of the same variation. [0153] The annulus repair device 16 can be used, for example, after a discectomy is performed, and/or when an artificial or other nucleus material (e.g., PDN@ from Raymedica, Inc., Minneapolis, MN, tissues from CryoLife, Inc. , nucleus replacement devices from Replication Medical, Inc., New Brunswick, NJ, Sofamor Danek nucleus replacement devices Erom Medtronic, Inc., Minneapolis, MN, Depuy AcroMed nucleus replacement devices from Johnson & Johnson, Inc., New Brunswick, NJ, Centerpulse Orthopedics Spine-Tech nucleus replacement devices from Zimmer, Inc., Warsaw, IN, and nucleus replacement devices from Disc Dynamics, Inc., Eden Prairie, MN) is used. The annulus repair device 16 can keep the artificial nucleus in place without touching or otherwise coming in contact with the artificial nucleus. [0154] Figure 80 illustrates that a delivery device 132 can have a first separating fork 190 and a second separating fork 192. The delivery device 132 can have a rotatable shaft 194 within, and protruding from the catheter 134. The annulus repair device 196, for example, having a screw or corkscrew shape, can be releasably attached to the rotatable shaft 194. [0155] Figures 81 and 82 illustrate that the first separating fork 190 and the second separating fork 192 can be inserted into the fissure 8. The first separating fork 190 can then be rotated outward with respect to the second separating fork 192, thereby tensioning the fissure 8. With the fissure 8 tensioned, the rotatable shaft 194 can rotatably drive the annulus repair device 196 through the annulus 4. Once the annulus repair device 196 is implanted in the annulus 4, the rotatable shaft 194 can be released from the annulus repair device 196, and the delivery device 132 (i.e., the forks 190 and 192) can be removed from the annulus 4. [0156] Figure 83 illustrates that two or more annulus repair devices 16a and 16b can be inserted in a single fissure 8. The repair devices 16a and 16b can be positioned superior and inferior to each other. Figure 84 illustrates that multiple annulus repair devices 16a and 16b can be deployed lateral to each other in a single fissure 8. The laterally deployed multiple annulus repair devices can attach near the center of the fissure 8 to each other and/or the top and/or bottom of the fissure 8. [0157] Figure 85 illustrates that an annulus repair device can be configured to attach to the walls of the fissure 8 in multiple planes, for example via multiple legs 24a, 24b, 24c and 24d (e.g., the variation of the annulus repair device 16 shown in Figures 25 and 26 can be used for this application). The multiple planes can be at an angle to each other. Figure 86 illustrate that the multiple planes can be parallel to each other. [0158] Figure 87 illustrates that the annulus repair device 16 can have a grommet configuration. The second flange 201b can be radially contracted and or the fissure 8 can be radially expanded to translate the second flange 201b through the fissure 8 and into the nucleus 6. The head portion 50 can be positioned in the fissure 8. The first flange 201a can be positioned substantially or completely radially outside the annulus 4. The annulus repair device 16 can form a substantially fluid-tight seal with the fissure 8. [0159] Endoannular repair devices and methods disclosed herein provide various techniques for effecting repair of weakened or punctured intervertebral annular discs as well as other soft tissue disorders. The techniques include forming a bridging support between healthy tissue surrounding the weakened region as well as distending tissue in the region of a puncture to facilitate repair of the puncture. [0160] It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. For example, each leg portion 24 can have more than two legs, and the legs can be out of plane with each other. Elements shown with any variation are exemplary for the specific variation and can be used on other variations within this disclosure. For example, the fabric cover 20 can be used with the variations shown in Figures 11 through 22, or any other variations. Also, for example, dimensions can be applied where analogous as understood by one having ordinary skill in the art. For example, the leg length 34 can be used as a length for the connectors 76 and 78, and the head length 38 can be used as a length for the first and/or second base 72 and/or 74.

Claims

We claim: 1. An intervertebral annulus repair device comprising: a first elongated member; a second elongated member attached to the first elongated member; and wherein the first elongated member has an expanded configuration, and wherein the first elongated member has a contracted configuration, and wherein the second elongated member has an expanded configuration, and wherein the second elongated member has a contracted configuration.

2. The device of Claim 1, wherein the first elongated member is resilient.

3. The device of Claim 2, wherein the first elongated member is biased in the expanded configuration.

4. The device of Claim 2, wherein the second elongated member is resilient.

5. The device of Claim 4, wherein the second elongated member is biased in the expanded configuration.

6. The device of Claim 1, wherein the first elongated member is deformable.

7. The device of Claim 6, wherein the second elongated member is deformable.

8. The device of Claim 1, further comprising a head attached to the first elongated member and the second elongated member.

9. The device of Claim 8, wherein the head is integral with the first elongated member and the second elongated member.

10. The device of Claim 1 , wherein the first elongated member has a first radius, and wherein the first radius is less than about 0.6 mm.

11. The device of Claim 10, wherein the second elongated member has a second radius, and wherein the second radius is less than about 0.6 mm.

12. The device of Claim 1, wherein the first elongated member comprises a first wire.

13. The device of Claim 12, wherein the second elongated member comprises a second wire.

14. The device of Claim 1, wherein the device comprises a fabric cover.

15. An intervertebral annulus repair device comprising: a first end; a second end; a brace; and wherein the first end is attached to the second end, and wherein the brace is between the first end and the second end, and wherein the device is configured such that when the first end is moved toward the second end, the device expands.

16. The device of Claim 15, further comprising a first connector attached to the first end and the second end.

17. The device of Claim 16, wherein the first connector comprises a rotating area.

18. The device of Claim 16, further comprising a second connector attached to the first end and the second end. 2006/027982

19. A delivery device for an intervertebral annulus repair device comprising an elongated member, a delivery mechanism; and a stop proximal to the delivery mechanism.

20. The device of Claim 19, wherein the stop is an expandable member.

21. The device of Claim 19, wherein the stop is a buttress.

22. The device of Claim 19, wherein the stop is a first expandable balloon.

23. The device of Claim 19, wherein the delivery mechanism comprises a second expandable balloon.

24. The device of Claim 19, wherein the delivery mechanism comprises a first interference fit member and a second interference fit member, and wherein the first interference fit member is configured to move towards the second interference fit member.

25. A method of repairing a vertebral annulus tissue having a damaged section comprising a conduit having a conduit inner wall, the method comprising: inserting an expandable device into the annulus, wherein the expandable device is resiliently expandable, and wherein the device comprises an expandable elongated element; and releasing the device so that the device expands.

26. The method of Claim 25, wherein the method further comprises closing the conduit.

27. The method of Claim 26, wherein closing the conduit comprises forcing the inner conduit wall closed.

28. The method of Claim 27, wherein forcing the inner conduit wall closed comprises applying force from the device from outside the tissue and inside the conduit.

29. The method of Claim 28, wherein applying force comprises expanding the elongated member against the conduit inner wall.

30. The method of Claim 27, wherein forcing the inner conduit wall closed comprises applying force from the device from inside the tissue.

31. The method of Claim 30, further comprising inserting the elongated member into the tissue of the annulus.

32. The method of Claim 31 , wherein applying force comprises pressing the elongated member toward the conduit.

33. The method of Claim 27, wherein forcing the inner conduit wall closed comprises applying force from outside of the tissue and outside the conduit.

34. The method of Claim 33, wherein applying force comprises pressing an abutment against the tissue.

35. The method of Claim 25, further comprising impairing flow through the damaged section.

36. The method of Claim 35, wherein the device comprises a fabric element, and wherein the fabric element impairs flow through the damaged section.

37. The method of Claim 36, wherein the fabric element comprises a fabric cover.

38. The method of Claim 36, wherein the fabric element comprises a wall support.

39. A method of repairing a vertebral annulus tissue having a damaged section comprising a conduit having an conduit inner wall, the method comprising: inserting an expandable device into the annulus, wherein the expandable device is deformably expandable, and. wherein the device comprises an expandable elongated element; and deforming the device so that the device expands.

40. The method of Claim 39, wherein the method further comprises closing the conduit.

41. The method of Claim 40, wherein closing the conduit comprises forcing the inner conduit wall closed.

42. The method of Claim 41 , wherein forcing the inner conduit wall closed comprises applying force from the device from outside the tissue and inside the conduit.

43. The method of Claim 42, wherein applying force comprises expanding the elongated member against the conduit inner wall.

44. The method of Claim 41 , wherein forcing the inner conduit wall closed comprises applying force from the device from inside the tissue.

45. The method of Claim 44, further comprising inserting the elongated member into the tissue of the annulus.

46. The method of Claim 45, wherein applying force comprises pressing the elongated member toward the conduit.

47. The method of Claim 45, wherein forcing the inner wall closed comprises applying force from outside of a tissue of the annulus and the conduit.

48. The method of Claim 47, wherein applying force comprises pressing an abutment against the tissue.

49. The method of Claim 39, further comprising impairing flow through the damaged section.

50. The method of Claim 49, wherein the device comprises a fabric element, and wherein the fabric element impairs flow through the damaged section.

51. The method of Claim 50, wherein the fabric element comprises a fabric cover.

52. The method of Claim 50, wherein the fabric element comprises a wall support.

53. A device for repair of an intervertebral annulus, said device comprising: a base member; a plurality of flexible, resilient legs extending from said base member in spaced apart relation to one another, said base member and said legs being insertable into said annulus, motion of said base member in an opposite direction outwardly from the annulus causing said legs to splay outwardly and engage and support said annulus on opposite sides adjacent to said base member.

54. A device according to Claim 53, wherein said base member comprises a hollow tube.

55. A device according to Claim 53, comprising a pair of said legs.

56. A device according to Claim 53, further comprising a barb positioned on each of said legs, said barbs being oriented to allow said legs to penetrate into said annulus and preventing withdrawal of said legs from said annulus.

57. A device according to Claim 53, further comprising a cover surrounding said base member.

58. A device according to Claim 53, further comprising a cover surrounding said base member and said legs.

59. A device according to Claim 58, wherein said cover comprises interlaced filamentary members.

60. A device according to Claim 58, wherein said cover includes a coating of a chemical compound for facilitating a healing reaction.