Patent Publication Number: US-2018035999-A1

Title: Tissue repair and fixation system and methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. application Ser. No. 14/182,112 filed Feb. 17, 2014, now U.S. Pat. No. 9,795,372, which is a continuation of application Ser. No. 12/853,897 filed Aug. 10, 2010, now U.S. Pat. No. 8,652,153, which claims the benefit of U.S. Provisional Application Nos. 61/293,939, Filed Jan. 11, 2010, and 61/323,679 filed Apr. 13, 2010, the disclosures of which are incorporated herein by reference in their entireties. 
    
    
     TECHNICAL FIELD 
     The invention generally relates to methods and devices for the closure, sealing, repair and/or reconstruction of an intervertebral disc annulus, and accompanying delivery devices and tools, and their methods of use. 
     BACKGROUND 
     The spinal column is formed from a number of bony vertebrae, which in their normal state are separated from each other by intervertebral discs. These discs are comprised of the annulus fibrosus, and the nucleus pulposus, both of which are soft tissue. The intervertebral disc acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between adjacent vertebral bodies. Without a competent disc, collapse of the intervertebral disc may occur, contributing to abnormal joint mechanics and premature development of degenerative and/or arthritic changes. 
     The normal intervertebral disc has an outer ligamentous ring called the annulus surrounding the nucleus pulposus. The annulus binds the adjacent vertebrae together and 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 is constituted of soft tissue, having about 85% water content, which moves about during bending from front to back and from side to side. 
     The aging process contributes to gradual changes in the intervertebral discs. Fissures in the annulus fibrosus can occur due to various causes, including disease or other pathological conditions, or the natural aging process. Occasionally fissures may form rents through the annular wall. In these instances, the nucleus pulposus is urged outwardly from the subannular space through a rent, often into the spinal column. Extruded nucleus pulposus can, and often does, mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc. 
     In the event of annulus rupture, the subannular nucleus pulposus migrates along the path of least resistance forcing the fissure to open further, allowing migration of the nucleus pulposus through the wall of the disc, 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. 
     SUMMARY 
     The various embodiments of the present invention relate to system for intervertebral disc annulus repair. Accordingly, Example 1 of the present invention is a device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising an implant delivery tool and an implant releasably coupled to the implant delivery tool. The implant delivery tool includes a substantially rigid outer tube having a proximal section and a sharpened distal tip, a body coupled to the proximal section of the outer tube, and a plunger assembly movable axially relative to the body and including a plunger member and a pusher tube coupled thereto and disposed within the outer tube. The implant includes first and second tissue anchors serially disposed within the distal section of the outer tube, and a flexible connecting element coupling the first and second tissue anchors, the connecting element at least partially formed from a braided tubular suture material. The braided suture material includes a distal segment attached to the first tissue anchor, an intermediate segment extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop, and a proximal segment of the braided suture material extending proximally from the intermediate segment and releasably coupled to the implant delivery tool. 
     In Example 2, the device of Example 1 wherein the pusher tube is displaceable within the outer tube from a first position to a second position to eject the first tissue anchor from the outer tube. 
     In Example 3, the device of Example 1 or 2 wherein the pusher tube is further displaceable within the outer tube from the second position to a third position to eject the second tissue anchor from the outer tube. 
     In Example 4, the device of any of Examples 1 through 3 wherein the implant delivery tool includes a releasable tab releasably coupled to the plunger assembly. 
     In Example 5, the device of Example 4 wherein the connecting element is partially disposed within the outer tube and the proximal segment of the flexible connecting element is coupled to the releasable tab of the implant delivery tool. 
     The present invention, according to Example 6, is an implant for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient. The implant comprises first and second tissue anchors sized and shaped to be disposed in a tubular member of a delivery tool and to be inserted into or through a portion of the annulus fibrosus, and a flexible connecting element coupling the first and second tissue anchors. The connecting element is at least partially formed from a tubular braided suture material and includes a distal segment of the braided suture material attached to the first tissue anchor, an intermediate segment of the braided suture material extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop, and a proximal segment of the braided material extending proximally from the intermediate segment and operable by a user to be placed in tension to reduce the length of the adjustable loop. 
     The present invention, in Example 7, is a device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising an implant delivery tool and an implant releasably coupled to the implant delivery tool. The implant delivery tool includes a substantially rigid outer tube having a proximal section, an intermediate section, and a distal section terminating in a sharpened tissue-piercing distal tip having an open end. The intermediate section has a first length, wherein the proximal and distal sections are laterally offset from one another by the intermediate section. The implant delivery tool further includes a body coupled to the proximal section of the outer tube, a plunger assembly including a plunger member slidably disposed within the body, and a pusher tube slidably disposed within the body and the outer tube and coupled to the plunger member. The pusher tube includes a distal end and a flexible segment proximal to the distal end axially coincident with the intermediate portion of the outer tube. The flexible segment has a second length greater than the first length of the intermediate portion of the outer tube. The implant includes a pair of tissue anchors serially disposed within the distal section of the outer tube, and an adjustable flexible connecting element connecting the tissue anchors. The plunger assembly is operable by a user to selectively displace the pusher tube distally within the outer tube so as to serially eject the first tissue anchor and then the second tissue anchor from the open end of the outer tube. 
     In Example 8, the device of Example 7 wherein the pusher tube is displaceable within the outer tube from a first position to a second position to eject the first tissue anchor from the outer tube. 
     In Example 9, the device of Example 8 wherein the pusher tube is further displaceable within the outer tube from the second position to a third position to eject the second tissue anchor from the outer tube. 
     In Example 10, the device of Examples 8 or 9 wherein the intermediate section of the outer tube is axially coincident with at least a portion of the flexible segment of the pusher tube when the pusher tube is in the first, the second and the third positions. 
     In Example 11, the device of any of Examples 7 through 10 wherein the implant delivery tool includes a releasable tab coupled to the plunger assembly. 
     In Example 12, the device of Example 11 wherein a first portion of the connecting element is disposed within the outer tube and a second portion of the flexible connecting element is coupled to the releasable tab of the implant delivery tool. 
     In Example 13, the device of any of Examples 7 through 12 wherein the flexible connecting element has an adjustable length so as to allow separation between the tissue anchors to be reduced after deployment. 
     In Example 14, the device of any of Examples 7 through 13 wherein the flexible connecting element is a knotless suture arrangement including a locking element substantially preventing elongation of the flexible connecting element between the tissue anchors after deployment. 
     In Example 15, the device of any of Examples 7 through 14 wherein the flexible segment of the pusher tube includes a series of slots extending circumferentially about the pusher tube in a helical pattern, the slots imparting lateral flexibility to the flexible segment. 
     In Example 16, the device of Example 15 wherein the slots have an undulating shape. 
     In Example 17, the device of any of Examples 7 through 14 wherein the flexible segment of the pusher tube is heat treated to impart lateral flexibility to the flexible segment. 
     In Example 18, the device of any of Examples 7 through 14 wherein the flexible segment of the pusher tube is in the form of a helical spring. 
     In Example 19, the device of any of Examples 7 through 18 wherein the proximal and distal sections of the outer tube are substantially parallel to one another. 
     In Example 20, the device of any of Examples 7 through 19 wherein the intermediate section of the outer tube has a first curved portion extending from the proximal section and a second curved portion extending proximally from the distal section having an opposite curvature to that of the first curved portion. 
     The present invention, according to Example 21, is a device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising an implant delivery tool and an implant releasably coupled to the implant delivery tool. The implant delivery tool includes a substantially rigid outer tube having a proximal section, a distal section, and an intermediate section having a non-linear shape laterally offsetting the proximal and distal sections from one another. The implant delivery tool further includes a body coupled to the proximal section of the outer tube, a plunger assembly movable axially relative to the body and including a plunger member and a pusher tube coupled thereto and disposed within the outer tube. The pusher tube has a substantially rigid proximal segment, a substantially rigid distal segment including a distal end, and a flexible segment between the proximal and distal segments. The pusher tube is slidably displaceable within the outer tube to assume a plurality of positions, and the flexible segment is configured to conform to the nonlinear shape of the intermediate section of the outer tube in each of the plurality of positions of the pusher tube. The implant includes a pair of tissue anchors serially disposed within the distal section of the outer tube, and an adjustable flexible connecting element connecting the tissue anchors. 
     In Example 22, the device of Example 21 wherein the flexible segment of the pusher tube is dimensioned such that the intermediate section of the outer tube is axially coincident with at least a portion of the flexible segment in each of the plurality of positions of the pusher tube. 
     In Example 23, the device of Example 21 or 22 wherein the proximal and distal sections of the outer tube are substantially parallel to one another. 
     In Example 24, the device of any of Examples 21 through 23 wherein the adjustable flexible connecting element is a knotless suture arrangement including a locking element substantially preventing elongation of the flexible connecting element between the tissue anchors after deployment. 
     In Example 25, the device of any of Examples 21 through 24 wherein the flexible segment of the pusher tube includes a series of slots extending circumferentially about the pusher tube in a helical pattern, the slots imparting lateral flexibility to the flexible segment. 
     The present invention, according to Example 26, is a system for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the system comprising first and second repair devices each including an implant delivery tool and an implant releasably coupled to the implant delivery tool including. The implant delivery tool includes a substantially rigid outer tube having a proximal section and a distal section terminating in a sharpened distal tip, a body coupled to the proximal section of the outer tube, and a plunger assembly movable axially relative to the body and including a pusher tube disposed within the outer tube, wherein the pusher tube is slidably displaceable within the outer tube to assume a plurality of positions. The implant includes first and second tissue anchors serially disposed within the distal section of the outer tube, and a flexible connecting element coupling the first and second tissue anchors. The flexible connecting element is at least partially formed from a braided tubular suture material and includes a distal segment of the braided suture material attached to the first tissue anchor, an intermediate segment of the braided suture material extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop, and a proximal segment of the braided suture material extending proximally from the intermediate segment and releasably coupled to the implant delivery tool. 
     The present invention, according to Example 27, is an instrument for use in implanting a suture assembly. The instrument comprises a body having longitudinal axis, a first end, and a second end. The first end has a canted tip and a first slot therein sized to slidingly receive a portion of the suture assembly. The second end has a tip with a second slot therein sized to receive a portion of the suture assembly. The instrument further comprises a recessed blade with a cutting edge exposed within the second slot. The cutting edge is configured to cut the suture assembly. 
     In Example 28, the instrument of Example 27 wherein the cutting edge of the blade is oriented toward the tip of the second end of the body. 
     In Example 29, the instrument of either of Examples 27 or 28 wherein at least a portion of the blade is oriented at an angle to the longitudinal axis. 
     In Example 30, the instrument of any of Examples 27 through 29 wherein the blade includes a coating. 
     In Example 31, the instrument of Example 30 wherein the coating includes titanium nitride. 
     The present invention, according to Example 32, is an implant for use in an orthopedic repair procedure to repair a tissue defect. The implant comprises first and second tissue anchors and a flexible connecting element. The first and second tissue anchors are sized and shaped to be disposed in a tubular member of a delivery tool and to be inserted into or through tissue proximate the defect. The flexible connecting element couples the first and second tissue anchors and is at least partially formed from a tubular braided suture material. The connecting element includes a distal segment of the braided suture material attached to the first tissue anchor, an intermediate segment of the braided suture material extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop. The connecting element further includes a a proximal segment of the braided material extending proximally from the intermediate segment and operable by a user to be placed in tension to reduce the length of the adjustable loop. 
     The present invention, according to Example 34, is an intervertebral disc repair system comprising an implant and a delivery tool. The implant includes an anchor member and an adjustable suture assembly coupled thereto. The adjustable suture assembly forms an adjustable loop and includes a tension line having a proximal end, and a toggle line coupled to the anchor member for selectively rotating the anchor member during deployment thereof. The delivery tool includes a proximal handle, an outer tubular member, a needle cannula, an inner pusher member, and an actuating mechanism. The outer tubular member extends distally from the handle and has an open distal end. The needle cannula is slidably received within the outer tubular member and has a proximal portion with a proximal end, and an open distal end terminating with a sharpened tip for penetrating tissue. The inner pusher member is slidably received within the needle cannula and has a proximal end and a distal end. The actuating mechanism is coupled to the handle for selectively retracting the needle cannula relative to the outer tubular member and the inner pusher member. The proximal end of the tension line of the implant is operable by the user to reduce at least one dimension of the loop. The anchor member and at least a portion of the adjustable suture assembly of the implant are releasably received within the needle cannula distal to the distal end of the inner pusher member. The delivery tool is configured such that actuation of the actuating mechanism proximally retracts the needle cannula relative to the outer tubular member and the inner pusher member to release the anchor member from the needle cannula, and the toggle line of the adjustable suture assembly of the implant is operable to cause rotation of the anchor member as the anchor member is released from the needle cannula. 
     In Example 35, the system of Example 34 wherein the delivery tool is configured such that the needle cannula and the inner pusher member can be axially advanced together relative to the outer tubular member. 
     In Example 36, the system of Examples 34 or 35 wherein the delivery tool is configured such that the needle cannula is retractable relative to the inner pusher member upon actuation of the actuating member after axially advancing the needle cannula and the inner pusher member relative to the outer tubular member. 
     In Example 37, the system of any of Examples 34 through 36 wherein the delivery tool is configured to prevent proximal movement of the inner pusher member upon retraction of the needle cannula relative to the inner pusher member and the outer tubular member. 
     In Example 38, the system of any of Examples 34 through 37 wherein the adjustable suture assembly includes a knotless locking element configured to prevent elongation of the adjustable loop. 
     In Example 39, the system of any of Examples 34 through 38 wherein the handle of the delivery tool includes a tubular upper portion having a proximal end, and a lower portion extending from the upper portion adapted to be gripped by the user, wherein the outer tubular member extends distally from the tubular upper portion of the handle such that the upper portion of the handle and the outer tubular member define a longitudinal axis of the delivery tool, and wherein the needle cannula and the inner pusher member of the delivery tool are aligned with the longitudinal axis. 
     In Example 40, the system of any of Examples 34 through 39 wherein the proximal end of the inner pusher member further includes an end plate extending radially from the inner pusher member. 
     In Example 41, the system of any of Examples 34 through 40 wherein the delivery tool includes a releasable tab coupled to the proximal end of the second implant tension line, the releasable tab operable by the user to apply tension to the tension line to reduce the at least one dimension of the loop, the releasable tab further releasably coupled to the inner pusher member between the end plate and the proximal end of the upper portion of the handle preventing axial movement of the inner pusher member. 
     In Example 42, the system of any of Examples 34 through 41 wherein the proximal portion of the needle cannula further includes a flange having an aperture therein, and wherein the toggle line has a proximal end portion connected to the flange. 
     In Example 43, the system of any of Examples 34 through 42 wherein the delivery tool is further configured such that actuation of the actuating mechanism proximally retracts the needle cannula thereby applying tension to the toggle line to rotate the anchor member as the anchor member is released from the needle cannula. 
     In Example 44, an intervertebral disc repair system for repairing a defect in an intervertebral disc of a patient, the system comprising a first implant and a first delivery tool, and a second implant and a second delivery tool. The first implant includes first and second tissue anchors, and an adjustable connecting element connecting the first and second tissue anchors, the adjustable connecting element having an adjustable length between the first and second tissue anchors. The first delivery tool includes a tissue penetrating tubular member, the first and second tissue anchors releasably received in the tubular member, the first delivery tool configured to deploy the first and second tissue anchors in the intervertebral disc. The second implant includes an anchor member and an adjustable suture assembly coupled thereto, the adjustable suture assembly forming an adjustable loop and including a tension line having a proximal end operable by a user to reduce at least one dimension of the adjustable loop, and a toggle line coupled to the anchor member for rotating the anchor member during deployment thereof. The second delivery tool includes a proximal handle, an outer tubular member, a needle cannula, an inner pusher member, and an actuating mechanism. The outer tubular member extends distally from the handle and has an open distal end. The needle cannula is slidably received within the outer tubular member and has a proximal portion with a proximal end and an open distal end terminating with a sharpened tip for penetrating tissue. The inner pusher member is slidably received within the needle cannula and has a proximal end and a distal end. The actuating mechanism is coupled to the handle for selectively adjusting an axial position of the needle cannula relative to the outer tubular member and the inner pusher member. The anchor member and at least a portion of the adjustable suture assembly of the second implant are releasably received within the needle cannula of the second delivery tool. The toggle line of the adjustable suture assembly of the second implant is operable to cause rotation of the anchor member during deployment thereof upon actuation of the actuating mechanism by a user. The adjustable suture assembly and the connecting element are configured to be interconnected and placed under tension after deployment of the anchor member and the first and second tissue anchors. 
     In Example 45, the system of Example 44 wherein the second delivery tool is configured such that the needle cannula and the inner pusher member can be axially advanced together relative to the outer tubular member. 
     In Example 46, the system of Examples 44 or 45 wherein the second delivery tool is further configured such that the needle cannula is retractable relative to the inner pusher member upon actuation of the actuating member after axially advancing the needle cannula and the inner pusher member relative to the outer tubular member. 
     In Example 47, the system of any of Examples 44 through 46 wherein the second delivery tool is configured to prevent proximal movement of the inner pusher member during retraction of the needle cannula relative to the inner pusher member and the outer tubular member so as to cause the anchor member to be released from the needle cannula. 
     In Example 48, the system of any of Examples 44 through 47 wherein the second delivery tool includes a releasable tab coupled to the proximal end of the second implant tension line, the releasable tab operable by the user to apply tension to the tension line to reduce the at least one dimension of the loop. 
     In Example 49, the system of any of Examples 44 through 48 wherein the second delivery tool is configured such that actuation of the actuating mechanism proximally retracts the needle cannula relative to the outer tubular member and the inner pusher member to release the anchor member from the needle cannula. 
     In Example 50, the system of any of Examples 44 through 49 wherein the proximal portion of the needle cannula of the second delivery tool further includes a flange having an aperture therein, and wherein the toggle line has a proximal end portion connected to the flange. 
     In Example 51, the system of any of Examples 44 through 50 wherein the second delivery tool is further configured such that actuation of the actuating mechanism proximally retracts the needle cannula thereby applying tension to the toggle line as the anchor member is released from the needle cannula. 
     In Example 51, the system of any of Examples 447 through 51 wherein the handle of the second delivery tool includes a tubular upper portion having a proximal end and a lower portion extending from the upper portion adapted to be gripped by the user, wherein the outer tubular member extends distally from the tubular upper portion of the handle such that the upper portion of the handle and the outer tubular member define a longitudinal axis of the second delivery tool, and wherein the needle cannula and the inner pusher member of the second delivery tool are aligned with the longitudinal axis. 
     In Example 53, the system of any of Examples 44 through 52 wherein the proximal end of the inner pusher member extends proximally from the upper portion of the second delivery tool handle. 
     In Example 54, the system of any of Examples 44 through 53 wherein the proximal end of the inner pusher member further includes an end plate extending radially from the inner pusher member relative to the longitudinal axis. 
     In Example 55, the system of any of Examples 44 through 54 wherein the releasable tab is releasably coupled to the inner pusher member between the end plate and the proximal end of the upper portion of the handle preventing axial movement of the inner pusher member. 
     In Example 56, the system of any of Examples 44 through 55 further comprising a tension guide including a first end having a canted tip and a first slot therein sized to slidingly receive portions of the connecting element of the first implant and the suture assembly of the second implant, and a second end having a tip with a second slot therein, and a recessed blade with a cutting edge exposed within the second slot. The second slot is sized to slidingly receive portions of the connecting element of the first implant and the suture assembly of the second implant. The cutting edge is configured to cut the connecting element and the suture assembly to remove excess portions thereof. 
     In Example 57, the system of Example 56 wherein the cutting edge of the tension guide blade is oriented toward the tip of the second end of the tension guide. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a device for use in repairing an aperture or a defect in an annulus fibrosus of an intervertebral disc according to an embodiment of the present invention. 
         FIGS. 2A, 2B and 2C  are partial cutaway views of an implant delivery tool of the device of  FIG. 1  according to one embodiment of the present invention. 
         FIG. 3  is an elevation view of a plunger assembly of the implant delivery tool shown in  FIG. 2 , including a pusher tube according to one embodiment of the present invention. 
         FIG. 4  is a schematic view illustrating a slot arrangement for imparting flexibility in a flexible segment of the pusher tube of  FIG. 3  according to one embodiment of the present invention. 
         FIGS. 5A-5C  are schematic views of an implant for use in the repair device of  FIG. 1  according to one embodiment of the present invention. 
         FIGS. 6A-6C  are schematic views of an alternative implant for use in the repair device of  FIG. 1  according to one embodiment of the present invention. 
         FIG. 7  is a schematic illustration of an alternative device for use in repairing an aperture or a defect in an annulus fibrosus of an intervertebral disc using the implants of  FIGS. 5A-5C and 6A-6C  according to another embodiment of the present invention. 
         FIGS. 8A-8C  are schematic illustrations showing the annulus fibrosus repair device of  FIG. 1  in use during a repair procedure on an annulus fibrosus. 
         FIGS. 9A-9C  are plan and partial cut-away elevation views of an implant delivery tool with an implant coupled thereto according to one embodiment of the present invention. 
         FIGS. 10A-10C  are plan and cross-sectional elevation views of a handle and outer tubular member of the delivery tool of  FIGS. 9A-9C  according to one embodiment of the present invention. 
         FIGS. 11A-11C  are top, elevation and end views of a needle cannula of the delivery tool of  FIGS. 9A-9C  according to one embodiment of the present invention. 
         FIG. 12  is an elevation view of a pusher tube of the delivery tool of  FIGS. 9A-9C  according to one embodiment of the present invention. 
         FIG. 13  is a schematic illustration of the implant of  FIGS. 9A-9C  according to one embodiment of the present invention. 
         FIGS. 14A-14E  are partial cut-away elevation views of the implant delivery tool of  FIGS. 9A-9C  during use to deploy the implant partially within a vertebra of a patient. 
         FIG. 15A-15F  are schematic illustrations showing the implant of  FIGS. 9A-9C  being deployed in conjunction with a second implant to re-approximate an aperture or defect in a patient&#39;s intervertebral disc according to one embodiment of the present invention. 
         FIGS. 16A-16B  are elevation views of an alternative implant delivery tool with an implant coupled thereto according to another embodiment of the present invention. 
         FIGS. 17A-17D  are elevation, detail perspective and partial cross-sectional views of a tension guide for use in conjunction with the implants of  FIGS. 5A-5B, 6A-6B , and  13  according to one embodiment of the present invention. 
         FIGS. 18A-18B  are schematic illustrations showing the implant of  FIG. 5A-5B or 6A-6B  implanted to repair a defect or tear in a meniscus of the knee according to one embodiment of the present invention. 
     
    
    
     While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION 
       FIG. 1  illustrates a repair device  10  for use in repairing an aperture or a defect in an annulus fibrosus of an intervertebral disc according to an embodiment of the present invention. As shown in  FIG. 1 , the repair device  10  includes an implant delivery tool  20  and an implant  25  coupled thereto for deployment in intervertebral disc tissue. As further shown, the implant delivery tool  20  includes an outer tube  30 , a body  35 , a plunger assembly  40 , and a releasable tab  42 . In the illustrated embodiment, the body  35  is fixedly attached to the outer tube  30 , and the plunger assembly  40  is partially disposed within the body  35 . The tab  42  is releasably coupled to the plunger assembly  40 . The implant delivery tool  20  is configured such that the outer tube  30  can be partially inserted into soft tissues of the intervertebral disc (e.g., the annulus fibrosus) for delivery of the implant  25 , with the plunger assembly  40  being configured to facilitate deployment of the implant. 
     As shown and described in further detail below, the implant  25  is partially disposed within a portion of the implant delivery tool  20  prior to deployment. Additionally, the implant  25  includes a tension line  50  extending external to the outer tube  30  and connected to the tab  42 . The implant  25  is configured to facilitate full or partial closure of an aperture (e.g., a defect resulting from a herniated and ruptured annulus, or an opening from an incision made by a physician in a discectomy procedure) by drawing together the annulus fibrosus tissues defining the aperture under tension (i.e., re-approximating the annulus fibrosus). The tab  42  is positioned, in the undeployed state of  FIG. 1 , so as to prevent spontaneous axial movement of the plunger assembly  40  and, in turn, unintended deployment of the implant  25 . Additionally, the tension line  50  is connected to the tab  42 , which can be manipulated by the user to apply tension to the tension line  50  to facilitate final deployment of the implant  25  (as discussed in further detail below). 
       FIGS. 2A, 2B and 2C  are partial cutaway views of an implant delivery tool  20  of the repair device  10  of  FIG. 1  according to one embodiment of the present invention. As shown in  FIGS. 2A-2C , the outer tube  30  has a proximal section  55 , a distal section  60  and an intermediate section  65  between the proximal and distal sections  55 ,  60 . As further shown, the proximal section  55  is fixedly disposed within the body  35  and extends generally along a line parallel to a longitudinal axis  70  defined by the body  35  and the plunger assembly  40 . 
     In the illustrated embodiment, the intermediate section  65  includes a proximal curved portion  75  and a distal curved portion  80  having an opposite curvature to that of the proximal curved portion  75 . Additionally, as shown, the distal section  60  also extends distally from the distal curved portion  80  along a line generally parallel to the longitudinal axis  70 . Accordingly, as can be seen in  FIGS. 2A and 2B , the proximal and distal sections  55 ,  60  are laterally offset from one another by the intermediate section  65 . In the illustrated embodiment, the proximal and distal sections  55 ,  60  are generally parallel to one another, although in other embodiments these sections may be angularly offset from one another as well. 
     As further shown, distal section  60  of the outer tube  30  terminates in a sharpened, tissue-piercing distal tip  85  and includes a tissue stop  88 . The distal tip  85  is configured to penetrate intervertebral disc tissue, in particular, the annulus fibrosus, for deployment of the implant  25 , with the tissue stop  88  operating to delimit the depth of penetration of the outer tube  30  into the disc tissue. The tissue stop  88  attached to the outer surface of the outer tube  30  and is located proximally a predetermined distance from the distal tip  85 . In the illustrated embodiment, the tissue stop  88  includes a blunt distal face  90  and a sloped proximal face  92 , which is shaped to substantially prevent the proximal face  92  from catching on tissues when retracting the outer tube  30  from the annulus fibrosus. In other embodiments, other structures (e.g., an enlarged diameter segment of the outer tube  30 ) suitable for delimiting the penetration of the outer tube  30 , are provided. 
     As shown and discussed in further detail below, laterally offsetting the proximal and distal sections  55 ,  60  of the outer tube  30  advantageously improves the physician&#39;s visualization of the affected area of the annulus fibrosus to be repaired. That is, it allows the physician to manipulate the implant delivery tool  30 , and in particular, the body  35  and the plunger assembly  40  without having his or her hands interfere with the line of sight to the aperture in the annulus fibrosus. 
     As further shown in  FIGS. 2A-2C , the plunger assembly  40  includes a plunger member  100  and a pusher tube  105 . As illustrated, the plunger member  100  includes a proximal knob  110  and a distal portion  115  extending therefrom. Additionally, the distal portion  115  of the plunger member  100  is slidably and partially rotatably disposed within the body  35 . The pusher tube  105  is fixedly connected to and extends distally from the distal portion  115  of the plunger member  100  within the outer tube  30 , terminating in a distal end  120 . Accordingly, the pusher tube  105  is also slidably and rotatably disposed within the outer tube  30 . 
     The implant delivery tool  20  may, in many respects, have the same general functionality as, for example, the fixation delivery apparatus  400  described above and illustrated in  FIGS. 48A-48E  of co-pending and commonly assigned U.S. Patent Publication No. 2009/0259260, the disclosure of which is incorporated herein by reference in its entirety. Thus, the plunger assembly  40  is slidable relative to the body  35  and the outer tube  30  to effectuate axial movement of the pusher tube  105  for ejecting the implant  25  from the outer tube  30  into the desired implantation location within the disc annulus. In various embodiments, the implant delivery tool  20  further includes additional features that allow the plunger member  100  and, in turn the pusher tube  105 , to assume a plurality of discrete positions relative to outer tube  30  to selectively eject portions of the implant  25  therefrom. 
     For example, in various embodiments, the implant  25  includes two or more soft tissue anchors  125   a ,  125   b  (shown in dashed lines in  FIG. 2C ) disposed in the distal section  60  of the outer tube  30  prior to deployment, with the distal end  120  of the pusher tube  105  positioned just proximal to or abutting the proximal-most tissue anchor  125   a . As will be apparent from  FIGS. 2A and 2C , by selectively advancing the plunger member  100  distally within the body  35  (after removing the tab  42  from the distal portion  115  of the body member  100 ), the pusher tube  105  is advanced a selected distance distally relative to the outer tube  30 , thereby ejecting the distal-most tissue anchor  125   b  from the open distal tip  85  of the outer tube  30 , with the proximal-most tissue anchor  125   a  remaining in the outer tube  30 . Subsequently, e.g., after relocating the distal tip  85  of the outer tube  30  to another location on an opposite side of the aperture in the annulus fibrosus to be repaired, the pusher tube  105  can be advanced distally a second distance to eject the proximal-most tissue anchor  125   a.    
     Thus, as can be seen in  FIGS. 2A and 2B , the implant delivery tool  20  includes additional features for facilitating advancement of the plunger assembly  40  in discrete steps selectively and sequentially eject multiple tissue anchors in series from the outer tube  30 . For example, the implant delivery tool  20  includes an axial spring  150  in the body  35  configured to bias the plunger assembly  40  in the proximal direction, and further includes a pin  155  biased radially inwardly by a lateral spring  160 . The pin  155  is positioned to engage slots in the distal portion  115  of the plunger member  100  (described in further detail below) to control the distal movement of the plunger assembly  40  relative to the body  35  and the outer tube  30 . These features are similar or identical to corresponding features illustrated and described with respect to the fixation delivery apparatus  400  of  FIGS. 48A-48E  of the aforementioned U.S. Patent Publication 2009/0259260, and thus need not be described in further detail here. 
       FIG. 3  is an elevation view of the plunger assembly  40  of the implant delivery tool  20  according to one embodiment of the present invention. As shown in  FIG. 3 , the pusher tube  105  includes a flexible segment  200  disposed between substantially rigid proximal and distal segments  205 ,  210 . As further shown, the proximal segment extends from the distal portion  115  of the plunger member  100 , and the distal segment  210  extends distally from the flexible segment  200  and terminates in the distal end  120  of the pusher tube  105 . In various other embodiments, the flexible segment  200  extends directly from the distal portion  115  of the plunger member  100 , i.e., the rigid proximal segment  205  is omitted. In other embodiments, the relatively rigid proximal segment  205  is present and the relatively rigid distal segment  210  is omitted, and thus the flexible segment  200  extends from the proximal segment  205  to the distal end  120 . In still other embodiments, the entire length of the pusher tube  105  is flexible, and thus the pusher tube  105  includes no rigid proximal or distal segments  205 ,  210 . 
     As further shown, the distal portion  115  of the plunger member  100  includes one or more slots  220  shaped and positioned to be engaged by the pin  155  (see  FIG. 2A ) for controlling the advancement of the plunger assembly  40 , as described above and in the aforementioned U.S. Patent Publication No. 2009/0259260, which is incorporated herein by reference in its entirety. 
     The flexible segment  200  is configured to have a relatively high degree of flexibility in response to laterally-applied forces (i.e., bending forces) without significantly reducing the column strength of the pusher tube  105 . Additionally, the flexible segment  200  is positioned along the pusher tube  105  so that the intermediate section  65  of the pusher tube  30  (see, e.g.,  FIGS. 2A and 2B ) is axially coincident with the flexible segment  200  through the entire range of displacement of the pusher tube  105  relative to the outer tube  30 . That is, in various embodiments, the flexible segment  200  is dimensioned and positioned such that neither the rigid proximal segment  205  (if present) nor the rigid distal segment  210  of the pusher tube  105  will extend into the intermediate section  65  of the outer tube in any of the plurality of positions of pusher tube  105  relative to the outer tube  30 . Accordingly, the flexible segment  200  has a predetermined length L which, in various embodiments, is selected to be greater than the overall length of the intermediate section  65  of the outer tube  30 . Thus, the flexible segment  200  of the pusher tube will substantially conform to the curved or non-linear shape of the intermediate section  65  of the outer tube  30  throughout the entire range of positions of the pusher tube  105 . 
     Overall, the pusher tube  105  has a generally cylindrical tubular structure, with the flexible segment  200  including features to impart the desired degree of flexibility without significantly affecting the column strength (i.e., resistance to buckling) of the pusher tube  200 . In one embodiment, the pusher tube  105  has an outside diameter of about 0.042 inches and an inside diameter of about 0.035 inches. In other embodiments, the pusher tube  105  may have different inside and outside diameters depending on the particular therapeutic needs for the repair device  10 . 
     While not shown in  FIGS. 2A-2C  or  FIG. 3 , in various embodiments, the implant delivery tool  20  may include additional support features within the body  35 , the outer tube  30 , and/or the plunger assembly  40  to support portions of the flexible segment  200  of the pusher tube  105 . For example, in one embodiment, the body  35  or the outer tube  30  can include a sleeve (not shown) which extends proximally into the body  35  and slidably receives the proximal portions of the flexible segment  200 . In one embodiment, the distal portion  115  of the plunger member  100  can include a counterbore (also not shown) to receive the support sleeve on the outer tube  30  and/or the body  35  as the plunger member  100  and the pusher tube  105  are advanced distally relative to the body  35  and the outer tube  30 . 
       FIG. 4  is a schematic drawing illustrating one technique for imparting lateral flexibility to the flexible segment  200  of the pusher tube  105 , according to one embodiment of the present invention. In the illustrated embodiment, the flexible segment  200  includes a slot  230  cut through the wall of the pusher tube  200  in a helical pattern around the circumference of the pusher tube  200 . As shown, the slot  230  has an undulating shape defining a series of keys  235 . The slot  230  is dimensioned to allow a degree of freedom to allow the flexible segment  200  to bend as the pusher tube  105  is advanced distally within the outer tube  30 . In one embodiment, the slot  230  is configured to have an average of about five keys  235  per rotation about the pusher tube  105 . 
     In other embodiments, other techniques can be employed to impart the desired flexibility in the flexible segment  200 . For example, in various embodiments, the slot  230  can have any of a number of shapes providing the desired degree of freedom of movement in response to lateral (i.e., bending) forces. In one embodiment, the slot  230  does not have an undulating shape, and thus takes on the configuration of a helical spring (i.e., without defining any keys  235 ). In still other embodiments, the flexible segment  200  can be heat treated to impart flexibility therein in addition to or in lieu of inclusion of the slot  230 . In short, any technique for imparting bending flexibility to the flexible segment  200  can be employed within the scope of the present invention. 
     While the plunger assembly  100  described above utilizes a tubular pusher tube  105 , in various other embodiments, the pusher tube  105  is replaced by a solid (i.e., non-tubular) pusher member, which may be made of a metallic or polymeric material selected to provide the requisite flexibility and also sufficient column strength to avoid buckling. 
       FIGS. 5A-5C  are schematic views of the implant  25  for use in the repair device  10  of  FIG. 1  according to one embodiment of the present invention. As shown, the implant  25  includes the tissue anchors  125   a ,  125   b  and adjustable flexible connecting element  300  connecting the tissue anchors  125   a ,  125   b . As further shown, the implant  25  includes a retention line  301  coupled to the tissue anchor  125   a . In various embodiments, the retention line  301  is provided to retain the tissue anchor  125   a  within the outer tube  30  of the implant delivery tool  20  during deployment of the distal tissue anchor  125   b , to prevent undesired and premature ejection of the tissue anchor  125   a  from the outer tube  30 . 
     In various embodiments, the retention line  301  extends proximally within the pusher tube  105  of the plunger assembly  40  or within the outer tube  30  and is connected to pusher tube  105 , the plunger member  100 , the body  35 , or some other feature at the proximal end of the implant delivery tool  20 . Once the tissue anchor  125   a  is deployed in the intervertebral disc tissue, the physician can cut and remove the retention line  301  from the implant  25 . In other embodiments, the retention line  301  is configured to be automatically cut by and removed with the delivery tool  20  after deployment of the tissue anchor  125   a , thus eliminating the need for a separate cutting step. In various other embodiments, the retention line  301  is omitted, and a different technique is employed to retain the tissue anchor  125   a  in the outer tube  30  prior to its intended deployment. For example, in one embodiment, the distal end  120  of the pusher tube  105  can include a hook or other feature to engage a knot or similar feature on the implant  25 , and this engagement operates to retain the tissue anchor  125   a  in the outer tube  30 . In still other embodiments, however, the functionality of the retention line  301  is omitted. 
     In the illustrated embodiment, the connecting element  300  is a knotless suture construct formed at least partially or wholly from a tubular, braided suture material and includes a distal segment  302 , an intermediate segment  304  extending proximally from the distal segment  302 , and a proximal segment  306  extending proximally from the intermediate segment  304  to form the tension line  50  (see  FIG. 1 ). 
     As further shown, the intermediate segment  304  includes an adjustable loop  310  and a locking element  315  having a proximal end  317  and a distal end  318 . As shown, the tissue anchor  125   a  is slidably coupled to the adjustable loop  310 , and the tissue anchor  125   b  extends from the locking element  315 , which is interposed between the tissue anchors  125   a  and  125   b . As can be seen in  FIG. 5C , the tissue anchor  125   a  is coupled to the adjustable loop  310  by a suture loop  320  extending through the tissue anchor  125   a  and secured thereto by a knot  325 , thus allowing the tissue anchor  125   a  to slide along the length of the braided suture material of the adjustable loop  310 . Additionally, the distal segment  302  extends through the tissue anchor  125   b  and is secured thereto by a locking arrangement  330 , which in the illustrated embodiment is a knotted loop, and then extends proximally along a fixed length to the locking element  315 . In various embodiments, the distal segment  302  may include only a single strand of suture material, and the locking element  330  is a knot, pledget, or similar structure which prevents the distal segment  302  from being pulled through and detached from the tissue anchor  125   b.    
     In the illustrated embodiment, the connecting element  300  is formed by forming the adjustable loop  310  with the braided suture material of the intermediate segment  304 , and then running the suture material back through an outer wall of a length of the braided suture material to form the locking element  315  in the form of a tubular braided catch. That is, a length of the intermediate segment  304  is inserted through the outer suture wall and into the interior of the braided suture material at the proximal end  317  of the locking element  315 , then exits the braided suture material at the distal end  318  of the locking element  315 , and thereafter extends proximally to form the proximal segment  306  and the tension line  50 . 
     In this configuration, when tension is applied between the tension line  50  and the tissue anchor  125   a  and/or  125   b , the overall length of the adjustable loop  310  is reduced thus reducing the separation between the tissue anchors  125   a  and  125   b . As can be seen from  FIGS. 5A and 5C , as the length of the adjustable loop  310  is reduced, the suture loop  320  allows the tissue anchor  125   a  to slide along the adjustable loop  310 . The braided locking element  315  radially constricts the portion of the intermediate segment  304  extending internally therein, operating to prevent reverse movement of the suture material of the intermediate segment  304  extending within the locking element  315 . Thus, once the adjustable loop  310  is shortened, the locking element  315  will prevent subsequent elongation of the adjustable loop  310 . 
     In the illustrated embodiment, the adjustable connecting element  300  is formed from a single, continuous length of braided suture material. However, in other embodiments, the connecting element  300  is formed from different materials coupled together to form the various components of thereof. For example, in one embodiment, the locking element  315  is a separate braided tube disposed over the suture material forming the other components of the connecting element  300 . 
     Thus, in use, the tissue anchor  125   b  is first ejected from the outer tube  30  of the implant delivery tool  20  and into or through the annulus fibrosus, as discussed above. Subsequently, the outer tube  30  is removed from the annulus fibrosus and re-inserted at a different location (e.g., on an opposite side of the aperture to be repaired) and the tissue anchor  125   a  is then ejected into the annulus fibrosus. As explained above, the retention line  301 , if present, operates to retain the tissue anchor  125   a  in the outer tube  30  during deployment of the tissue anchor  125   b  and subsequent repositioning of the implant delivery tool  20 . After deployment of the tissue anchor  125   a , the retention line  301  can be wholly or partially removed, e.g., by cutting the retention line proximate the tissue anchor  125   a.    
     The physician can then apply tension to the tension line  50 , which will be resisted by the tissue anchor  125   a  and/or  125   b  bearing against the annulus fibrosus tissue. With the tissue anchors  125   a ,  125   b  effectively secured in place against the annulus fibrosus, the tension line  50  can be pulled through the locking element  315  to shorten the length of the adjustable loop  310  between the tissue anchors  125   a ,  125   b . In this way, once both tissue anchors  125   a  and  125   b  bear against the annulus fibrosus tissue, the tissues defining the aperture can be pulled toward one another under tension by further reducing the length of the adjustable loop between the tissue anchors  125   a ,  125   b , thereby at least partially or wholly closing the aperture. The design of the locking element  315 , as discussed above, substantially prevents subsequent reverse movement of the tension line through the locking element  315 , thus maintaining the adjustable loop  310  in tension between the tissue anchors  125   a  and  125   b . Any excess length of the tension line  50  can subsequently be cut away to complete the implantation procedure. 
       FIGS. 6A-6C  are schematic views of an alternative implant  400  for use in the repair device  10  according to one embodiment of the present invention. As shown in  FIGS. 6A-6C , the implant  400  includes a pair of tissue anchors  425   a ,  425   b , an adjustable flexible connecting element  427  connecting the tissue anchors  425   a ,  425   b , and a retention line  428 . In the illustrated embodiment, the connecting element  427  is a knotless suture construct formed at least partially or wholly from a tubular, braided suture material and includes a distal segment  428 , an intermediate segment  430  and a proximal segment  431 . 
     As further shown, the intermediate segment  430  includes an adjustable loop  432 , a locking element  435  having a proximal end  436  and a distal end  437 , and the proximal segment  431  forms a tension line  440 . The retention line  428 , the locking element  435  and the tension line  440  may, in various embodiments, be configured in substantially the same manner as the retention line  301 , the locking element  315  and the tension line  50  described above with respect to the implant  25 , and are thus not described in further detail again here. 
     As shown, the tissue anchor  425   a  is slidably coupled to the adjustable loop  432 , and the tissue anchor  425   b  is fixedly connected to the locking element  435 , which is interposed between the tissue anchors  425   a  and  425   b . As can be seen in  FIG. 6C , the tissue anchor  425   a  is coupled to the adjustable loop  430  by a suture loop  442  extending through the tissue anchor  425   a  and secured thereto by a knot  445 . Additionally, the tissue anchor  425   b  is fixedly attached to the distal segment  428  by a knot  450 , and the distal segment  428  extends proximally along a fixed length to the locking element  435 . 
     In the illustrated embodiment, the connecting element  427  is formed by forming the adjustable loop  432  with the braided suture material of the intermediate segment  430 , and then running the suture material back through an outer wall of the braided suture material to form the locking element  435  in the form of a tubular braided catch. That is, a length of the intermediate segment  430  is inserted through the outer suture wall and into the interior of the braided suture material at the distal end  437  of the locking element  435 , and then exits the braided suture material at the proximal end  436  of the locking element  435 , thereafter extending proximally to form the proximal segment  431  and the tension line  440 . In this configuration, when tension is applied between the tension line  440  and the tissue anchor  425   b , the overall length of the adjustable loop  432  is reduced thus reducing the separation between the tissue anchors  425   a  and  425   b . As can be seen from  FIGS. 6A and 6C , as the length of the adjustable loop  432  is reduced, the suture loop  442  allows the tissue anchor  425   a  to slide along the adjustable loop  432 . However, once the adjustable loop  432  is shortened, the locking element  435  will prevent subsequent elongation of the adjustable loop  432 . 
     Prior to deployment, the tissue anchor  425   a  is disposed within the outer tube  30  of the implant delivery tool  20  proximal to the tissue anchor  425   b . In the illustrated embodiment, the connecting element  427  further includes a resistance feature  460  on the tension line  440  proximal to the locking element  435 , which is positioned inside the outer tube  30  prior to and during deployment of the tissue anchors  425   a ,  425   b  to encourage toggling/rotation of the tissue anchors  425   a ,  425   b  as they are ejected from the outer tube  30 . In the illustrated embodiment, the resistance feature  460  is in the form of a knot dimensioned to contact the inner surface of the outer tube  30 . In various other embodiments, the resistance feature can take on a different form (e.g., a resilient sphere or cylinder disposed over the connecting element  427  suture material), or may be eliminated altogether. 
     In use, the implant  400  operates in much the same manner as the implant  25  described above. That is, the tissue anchor  425   b  is first ejected from the outer tube  30  of the implant delivery tool  20  and into or through the annulus fibrosus, as discussed above. Subsequently, the outer tube  30  is removed from the annulus fibrosus and re-inserted at a different location (e.g., on an opposite side of the aperture to be repaired) and the tissue anchor  425   a  is then ejected into the annulus fibrosus. The retention line  428 , if present, operates to retain the tissue anchor  425   a  in the outer tube  30  during deployment of the tissue anchor  425   b  and repositioning of the implant delivery instrument  20 . The physician can then apply tension to the tension line  440 , which will be resisted by the tissue anchor  425   a  and/or  425   b  bearing against the annulus fibrosus tissue. With the tissue anchors  425   a ,  425   b  effectively secured in place against the annulus fibrosus, the tension line  440  can be pulled through the locking element  435  to shorten the length of the adjustable loop  432  between the tissue anchors  425   a ,  425   b . In this way, once both tissue anchors  425   a  and  425   b  bear against the annulus fibrosus tissue, the tissues defining the aperture can be pulled toward one another under tension by further reducing the length of the adjustable loop between the tissue anchors  425   a ,  425   b , thereby at least partially or wholly closing the aperture. The design of the locking element  435 , as discussed above, substantially prevents subsequent reverse movement of the tension line through the locking element  435 , thus maintaining the adjustable loop  430  in tension between the tissue anchors  425   a  and  425   b . Any excess length of the tension line  440  can subsequently be cut away to complete the implantation procedure. 
     Although the implants  25 ,  400  described above include knotless connecting elements  300 ,  427 , this is not a requirement. Thus, in various embodiments, the knotless locking elements of the respective implants can be replaced by knots, e.g., Roeder knots, Weston knots, or similar constructs, by pledgets, or by other structures allowing for shortening the length of the connecting element portion between the tissue anchors while resisting or preventing subsequent elongation thereof. In sort, any technique for providing the requisite length adjustment capability in the connecting elements  300 ,  427  can be employed within the scope of the present invention. 
     In various embodiments, two repair devices  10  can be provided, e.g., as in an annulus fibrosus repair system, for deployment of two implants  25  or  400  to effectuate re-approximation of an aperture in the annulus fibrosus. In one embodiment, the two implants  25  or  400  can be deployed in a manner such that the portions of the respective adjustable connecting elements spanning across the aperture external to the outside surface of the annulus fibrosus cross each other, in the form of an “X.” This construct advantageously provides multi-location contact between the respective tissue anchors and connecting elements to effectively draw together the tissues defining the aperture in the annulus fibrosus. 
     In still other embodiments, the repair device  10  can be used to secure another implant, e.g., an occlusion device, to an implantation within the annulus fibrosus to occlude an aperture therein. This can be in addition to or in lieu of partially or wholly closing the aperture itself using the repair device  10 . For example, in one embodiment, an expandable occlusion device can be implanted within the intervertebral disc so as to span across the aperture in the annulus fibrosus, and one or more implants  25 ,  400  can then be implanted into or through both the annulus fibrosus tissue and the occlusion device to secure the occlusion device in place. Exemplary occlusion devices that can be used in this manner are described and illustrated in co-pending and commonly assigned U.S. Patent Publication No. 2005/0283246, the disclosure of which is incorporated herein by reference. In other embodiments, a patching element can be positioned on the exterior surface of the annulus fibrosus and secured in place using the implants  25  and/or  400 . 
     While the tissue anchors  125   a/b  and  425   a/b  illustrated above are shown and described as T-anchors, in various embodiments, these tissue anchors can take on any number of forms providing the desired degree of tissue contact and engagement with the annulus fibrosus. In various embodiments, the tissue anchors  125   a/b  and/or  424   a/b  can be constructed to be configured such as the T-anchors  815  shown in  FIG. 69  and/or the T-anchors  951   a/b  in  FIGS. 70, 71A -B,  72  and  73  of the aforementioned co-pending and commonly assigned U.S. Patent Publication 2009/0259260, which is incorporated herein by reference in its entirety. 
     The materials used in the implant delivery tool  20  or the implants  25 ,  400  can include any number of biocompatible materials having suitable mechanical properties. Materials of which to make the outer tube  30  and/or the push tube  105  of the implant delivery tool  20  and also the tissue anchors  125   a/b  and/or  435   a/b  of the implants  25 ,  400  can include, but are not limited to: metals, such as stainless steel, nickel, titanium alloy, and titanium; plastics, such as polytetrafluoroethylene (PTFE), polypropylene, polyether etherketone (PEEK™), polyethylene, polyethylene teraphthalate (PET) and polyurethane, acrylic, polycarbonate, engineering plastics; and/or composites. The adjustable connecting elements  300 ,  427  can likewise be made of any suitable suture material. In various embodiments, the connecting elements  300 ,  427  are made wholly or partially of size 2-0 or 3-0 force fiber suture material. In short, any suitable materials, whether now known or later developed, can be utilized to construct the implant delivery tool  20  and the implants  25 ,  400 , within the scope of the present invention. 
       FIG. 7  illustrates an alternative device  480  for use in repairing an aperture or a defect in an annulus fibrosus of an intervertebral disc utilizing the implants  25 ,  400  according to an embodiment of the present invention. The device  480  includes an implant delivery tool  482  and an implant  25  or  4000  as described above. The implant delivery tool  482  is, except as noted below, substantially the same or identical in structure and function to the implant delivery tool  20  described above. Accordingly, as shown in  FIG. 7 , the implant delivery tool  482  and includes an a substantially rigid outer tube  483  having a proximal section  484  and a sharpened distal tip  485 , a body  486  coupled to the proximal section  484  of the outer tube  483 , and a plunger assembly  488  movable axially relative to the body  486 . The plunger assembly  488  also includes plunger member  489  and a pusher tube (not shown in  FIG. 7  coupled thereto and disposed within the outer tube  483 . The implant delivery tool  482  differs from the implant delivery tool  20  in that the rigid outer tube  483  is generally straight, and does not include the offset intermediate section of the outer tube  30  of the implant delivery tool  20 . Accordingly, in various embodiments, the implant delivery tool  482  is functionally and structurally similar to the fixation delivery apparatus  400  of  FIGS. 48A-48E  of the aforementioned U.S. Patent Publication 2009/0259260, which is incorporated herein by reference in its entirety. 
       FIGS. 8A-8C  are schematic illustrations showing the annulus fibrosus repair device  10  of  FIG. 1  in use during a repair procedure on an annulus fibrosus  500 , and in particular, a procedure to re-approximate tissues defining an aperture  505  in the annulus fibrosus  500 . As shown in  FIG. 8A , in use, the distal section  60  of the outer tube  30  of the implant delivery tool  20  is partially inserted into or through the annulus fibrosus  500  near the aperture  505  for deploying the tissue anchor  125   b  (not shown in  FIG. 8A ) from the distal tip  85  of the outer tube  30 . As further illustrated, because the offset in the outer tube  30  maintains a clear line of site to the implantation location, without visual interference by the body  35  of the implant delivery tool  20 , and consequently, the physician&#39;s own hands. 
     As can be seen in  FIG. 8B , after deployment of the tissue anchor  125   b , the implant delivery tool  20  is subsequently removed and reinserted into or through the tissue of the annulus fibrosus  500  at a second location on the opposite side of the aperture  505 . As shown, a portion of the adjustable connecting element  300  extends across the aperture  505  external to the outer surface of the annulus fibrosus. Again, as can be seen in  FIGS. 8A and 8B , during insertion of the distal tip  85  of the outer tube  30  of the implant delivery tool  20  into the annulus fibrosus  500  proximate the aperture  505 , the offset configuration of the outer tube  30  results in the body  35  of the implant delivery tool  20  being removed from physician&#39;s line of sight to the repair site. 
     Subsequently, as shown in  FIG. 8C , after deployment of the tissue anchor  125   a  and removal of the implant delivery tool  20  from the tissue of the annulus fibrosus  500 , the tension line  50  is pulled to shorten the length of the adjustable connecting element  300  between the tissue anchors  125   a ,  125   b , thereby pulling together and re-approximating the tissues defining the aperture  500 . While not shown in  FIG. 8C , excess length of the tension line  50  can then be removed. 
     In various embodiments, multiple devices  10  each including an implant delivery tool  20  and an implant  25  or  400  can be utilized as a system for intervertebral disc annulus repair. For example, in various embodiments, after deploying the first implant  25  and at least partially re-approximating tissues defining the aperture  500  as shown in  FIG. 8C , a second device  10  can be utilized to deploy a second implant  25  to further re-approximate the defect and/or to augment or reinforce the previously implanted implant  25 . In such embodiments, the second implant  25  may be deployed using the same or similar techniques illustrated in  FIGS. 8A-8C , with each tissue anchor  125   a ,  125   b  of the second implant  25  being inserted into the annulus at different locations such that the adjustable connecting element  300  spans across the defect. The length of the adjustable connecting element  300  of the second implant  25  can then be shortened to complete the re-approximation procedure. Of course, the implant  400  could be utilized in place of the implant  25  in any of the foregoing procedures. 
       FIGS. 9A-9C  are plan and cut-away elevation views of an implant delivery tool  600  with an implant  610  coupled thereto according to another embodiment of the present invention. As shown in  FIGS. 9A-9C , the delivery tool  600  includes a body  612  including a proximal handle  616  and an outer tubular member  620  extending distally from the handle  616  and having an open distal end  624 . As further shown, the delivery tool  600  has a needle cannula  628 , a pusher member  634 , and an actuating mechanism  640 . In the illustrated embodiment, the needle cannula  628  is slidably received within the outer tubular member  620 , and the pusher member  634  is slidably received within the needle cannula  628 . Additionally, the actuating mechanism  640  includes a lever  646  pivotally coupled to the handle  616 , and a releasable safety tab  648  is connected to a portion of the implant  610  and to the inner pusher member  634 . As will be explained and illustrated in further detail below, the lever  646  is configured to engage the needle cannula  628  for selectively adjusting the axial position of the needle cannula  628  relative to the pusher member  634  and the outer tubular member  620 . In addition, the safety tab  648  is coupled to the pusher member  634  and is operable to prevent unintended, spontaneous axial movement of the needle cannula  628  and the pusher member  634  relative to the outer tubular member  620 , as well as to assist the clinician in deploying the implant  610 . 
     As further shown, in the pre-deployed state of  FIGS. 9A-9C , the implant  610  is disposed within the needle cannula  628  and includes an anchor member  650  and an adjustable suture assembly  654 . In the illustrated embodiment, the adjustable suture assembly  654  is connected to the anchor member  650  and also to the delivery tool  600 , as will be explained in further detail below. In various embodiments, the anchor member  650  is configured to be implanted within a vertebra or soft tissue of the patient&#39;s spine, and the adjustable suture assembly  654  is configured to be interconnected to a second implant and placed under tension so as to repair a defect or aperture in the annulus fibrosus. Thus, the implant  610  can, in various embodiments, be used to re-approximate an aperture in the annulus fibrosus in the same manner as the systems disclosed in co-pending and commonly assigned U.S. application Ser. Nos. 12/251,295 and 12/553,583, the entire disclosures of which are incorporated herein by reference in their entireties. 
     The delivery tool  600  is configured to be operated by a clinician to deploy the anchor member  650  into the vertebra and to facilitate tensioning the adjustable suture assembly  654  for repairing the annular defect. In various embodiments, the delivery tool  600  is configured such that, prior to deployment of the anchor member  650 , the needle cannula  628  and the pusher member  634  are disposed within the outer tubular member  620 , as is shown in  FIG. 9A . Additionally, the needle cannula  628  and the pusher member  634  can be advanced distally together relative to the outer tubular member  620 , e.g., to penetrate a vertebral body with the tip of the needle cannula  628  for insertion of the anchor member  650  into the vertebral body, and the needle cannula  628  can subsequently be retracted proximally while the pusher member  634  remains stationary, thereby releasing the anchor member  650  from the needle cannula  628  into the vertebra. The delivery tool  600  advantageously facilitates deployment of the anchor member  650  into the vertebra without requiring first drilling or otherwise forming a hole in the vertebra (e.g., with a bone awl) to receive the anchor member  650 . 
       FIGS. 10A-10C  are plan and cross-sectional elevation views of the body  612  of the delivery tool  600  according to one embodiment of the present invention. As shown in  FIGS. 10A-10C , the handle  616  includes a tubular upper portion  660  having a proximal end  662  and a distal end  663 , and a lower portion  664  extending from the upper portion  660 . As further shown, the outer tubular member  620  extends distally from the distal end  663  of the handle upper portion  660 , and the handle upper portion  660  is generally aligned with the tubular outer member  620  of the delivery tool  600  so as to define a longitudinal axis  666  of the delivery tool  600 . The lower portion  664  of the handle is adapted to be gripped by the clinician during use of the delivery tool  600 . In the illustrated embodiment, the lower portion  664  extends generally orthogonal to the upper portion  660  and the longitudinal axis  666 , although in other embodiments, the lower portion  664  may extend from the upper portion  660  at an oblique angle. 
     As further shown, in  FIG. 10C , the upper portion  660  of the handle  616  includes an upper slot  670  and a lower slot  674  disposed generally 180 degrees from the upper slot  670 . In the illustrated embodiment, the upper and lower slots  670 ,  674  are located between the proximal and distal ends  662 ,  663 . Additionally, the upper slot  670  has a generally constant width along its length. In contrast, in the illustrated embodiment, the lower slot  674  has a rear segment  676  having a first width Wr (see  FIG. 10C ) and a forward segment  678  having second width Wf (see  FIG. 10C ). In the illustrated embodiment, Wf is greater than Wr so as to define a shoulder  182  at the transition between the rear and forward segments  676 ,  678 . Additionally, as further shown, a projection  686  extends distally from the shoulder  682 , forming a recess  688 . 
     As will be explained in further detail below, upper and lower slots  670 ,  674  are dimensioned and configured to slidingly receive and guide structures on the needle cannula  628  and pusher member  634 , respectively. Additionally, the recess  688  is sized to receive a structure (shown in dashed lines in  FIG. 10C ) on the inner pusher member  634  such that the projection  686  operates as a rotation stop preventing unintentional rotation of the pusher member  634 . 
     As further shown, in the illustrated embodiment, the outer tubular member  620  includes a slot  692  extending proximally from the open distal end  624 . The slot  692  provides means by which portions of the adjustable suture assembly  654  can extend from within the needle cannula  628  (see  FIG. 9C ). 
       FIGS. 11A-11C  are plan and elevation views of the needle cannula  628  of the delivery tool  610  according to one embodiment of the present invention. As shown, the needle cannula  628  has a proximal portion  696  with a proximal end  698 , and an open distal end  704  terminating in a sharpened distal tip  708 . In the illustrated embodiment, the proximal portion  696  includes a flange  718  and a pair of diametrically disposed slots  722 ,  726  extending distally from the proximal end  698 . In the illustrated embodiment, the flange  718  includes an aperture  730  for attaching a portion of the adjustable suture assembly  654  of the implant  610 , as explained further below. The needle cannula  628  is dimensioned to be slidingly received within the outer tubular member  620 , and the flange  718  is dimensioned to be slidingly received within the upper slot  670  in the upper portion  660  of the handle  616 . Thus, when assembled, the flange  718  extends from and slides axially within the upper slot  670 , which further operates to prevent rotation of the needle cannula  628 . 
     In the illustrated embodiment the proximal portion  696  of the needle cannula  628  includes sleeve structure fixedly attached to a tubular needle. In various other embodiments, the needle cannula  628  can be configured to include the flange  718  and slots  722 ,  726  as integral features of the tubular needle. 
     As shown, the slots  722 ,  726  are radially offset from the flange  718 . The slots  722 ,  726  have widths selected to slidingly receive structures on the pusher member  634  to allow relative axial movement but prevent relative rotation of the needle cannula  628  and the pusher member  634  when aligned. At the same time, the proximal portion  696  is configured to engage structures on the pusher member  634  when not aligned so as to prevent relative axial movement of the needle cannula  628  and the pusher member  634 . 
     As further shown, the needle cannula  628  further includes a slot  736  adjacent to the open distal end  704 . In the illustrated embodiment, the slot  736  is radially aligned with the flange  718 , and when assembled with the handle  616  and the outer tubular member  620 , with the slot  692  in the outer tubular member  620 . Thus, the slots  692  and  736  both operate to allow portions of the implant adjustable suture assembly  654  to extend from the needle cannula  628 . 
       FIG. 12  is an elevation view of the pusher member  634  of the delivery tool  600  according to one embodiment of the present invention. As shown in  FIG. 12 , the pusher member  634  has a proximal end  740  and a blunt distal end  744 . As further shown, at the proximal end  740  is an end plate  746 . The pusher member  634  further includes a radially extending tab  748 , and a radially extending projection  754  disposed diametrically opposite the tab  748 . When assembled, the pusher member  634  and the needle cannula  628  are configured so that the tab  748  and the projection  754  engage the proximal portion  696  of the needle cannula  628  when not aligned with the slots  722 ,  726 , thereby preventing axial movement of the pusher member  634  relative to the needle cannula  628 . In turn, when the tab  748  and the projection  754  of the pusher member  634  are aligned with the slots  722 ,  726 , the needle cannula  628  can be retracted axially relative to the pusher member  634 , which facilitates deployment of the anchor member  650  into the patient&#39;s vertebra. 
     Additionally, the handle  616 , the needle cannula  628  and the pusher member  634  are further configured such that, when assembled, the tab  748  can be received within the recess  688  in the upper portion  660  of the handle  616  (see  FIG. 10C ), and at the same time aligned with the slot  726  in the needle cannula proximal portion  696 . In this configuration, the projection  686  of the handle upper portion  660  prevents rotation of the pusher member  634  to maintain alignment of the tab  748  and the slot  726  during retraction of the needle cannula  628 . 
     As further shown in  FIG. 12 , the end plate  746  extends radially relative to the pusher member  634 . The end plate  746  facilitates driving the needle cannula  628  and the pusher member  634  disposed therein into the patient&#39;s vertebra (e.g., providing a bearing surface that can be tapped using a mallet). 
     The needle cannula  628  and the pusher member  634  are each dimensioned such that they can extend distally a desired distance (e.g., based on the desired depth of deployment of the anchor member  650  into the vertebra) beyond the distal end  624  of the outer tubular member  620  when fully advanced. Additionally, the pusher member  634  as a whole is longer than the needle cannula  628  (including the proximal portion  696 ), such that the distal end  744  of the pusher member  634  extends distally beyond both the distal end  704  of the needle cannula  628  and the distal end  624  of the outer tubular member  620  when the needle cannula  628  is retracted proximally relative to the pusher member  634 . 
       FIG. 13  is a schematic illustration of the implant  610  showing details of the anchor member  650  and the adjustable suture assembly  654  according to one embodiment of the present invention. As shown in  FIG. 13 , the suture assembly  654  includes a tension line  760  forming a loop  762 , a toggle line  766  and a connecting segment  770 . As further shown, the anchor member  650  has opposed beveled ends  774 ,  776  and a channel  780  extending through the anchor member  650  generally orthogonally to the major length of the anchor member  650 . In the illustrated embodiment, the channel  780  is located nearer to the beveled end  774  than the beveled end  776  which, as explained further below, facilitates toggling of the anchor member  650  during deployment to promote good engagement with the bone (e.g., vertebra) or other tissue in which the anchor member  650  is implanted. 
     As shown in  FIG. 13 , the connecting segment  770  extends through the channel  780  and is fixedly connected to the anchor member  650 . As further shown, the tension line  760  extends from the connecting segment  280  and has a free end  284  and a locking element  288  which itself has first and second ends  294 ,  298 . As shown, the locking element  288  is located between the free end  284  and the adjustable loop  762 . In the illustrated embodiment, the tension line  760  including the locking element  288  is a knotless suture construct formed at least wholly or partially from a tubular, braided suture material to facilitate selective adjustment of the overall dimensions of the loop  762 . Thus, as shown, the suture material of the tension line  262  enters the interior of the tubular suture material at the first end  294  of the locking element  288  and exits the interior of the tubular suture material at the second end  298  of the locking element  288 , thereafter extending to the free end  284 . As explained in further detail below, the free end  284  is connected to the safety tab  648  of the delivery tool  600 , and can be manipulated by the clinician to reduce the dimensions of the loop  762  during an annular repair procedure. 
     In use, when tension is applied to the tension line  760  while the anchor member  650  is embedded in the patient&#39;s vertebra (or other tissue), the overall dimensions of the adjustable loop  762  are reduced. The braided locking element  288  allows the tension line  760  to move within the locking element  288  in the direction of the tensile force, while at the same time radially constricts the portion of the tension line  760  extending internally therein to prevent reverse movement of the tension line  760 . Thus, once the dimensions of the adjustable loop  762  are reduced, the locking element  288  will prevent subsequent enlargement of the adjustable loop  288 . Thus, the tension loop  260  is in many respects similar or identical to the knotless suture construct of the implants  25 ,  400  described above. In other embodiments, however, the tension line  760  with locking element  288  is not a knotless construct, but instead utilizes a knot (e.g., a Roeder knot or a Weston knot) or other means to facilitate one-way adjustment of the dimensions of the loop  762 . 
     As further shown in  FIG. 13 , the toggle line  766  is attached to the connecting segment  770  and has ends  302 ,  304  which, as explained in further detail below, are tied together and connected to the flange  718  of the needle cannula  628  (see  FIG. 9A ). In one embodiment, the toggle line  766  is attached to the connecting segment  770  by one or more knots or other means to prevent sliding movement of the toggle line  766  relative to the connecting segment  770 . Thus, tension applied to the toggle line  766  during operation of the delivery tool  600  is transferred directly to the connecting segment  770 . In this way, because the connecting segment  770  is not centered on the anchor member  650  (due to the fact that the channel  780  is offset from the center of the anchor member), the anchor member  650  will tend to rotate when tension is applied to the toggle line  766 , thus promoting engagement of the anchor member  650  to the bone or tissue in which it is implanted. In one embodiment, the toggle line  766  is configured to have a pre-determined breaking point, e.g., near the location at which it is attached to the connecting segment  770 , such that the toggle line  766  will automatically break during actuation of the delivery tool  600 . In such embodiments, the need to separately cut away the toggle line  766  after deployment of the anchor member  650  is avoided. 
     In other embodiments, however, the toggle line  766  is not designed to automatically break during actuation of the delivery tool  600 . For example, in various embodiments, the toggle line  766  remains attached to the connecting segment  770  (or other component of the suture assembly  654 ) after complete deployment of the anchor member  650 . In such embodiments, the toggle line  766  can be used by the clinician to ensure positive engagement of the anchor member  650  to the bone or other tissue in which it is deployed, e.g., by pulling on the toggle line  766  after deployment of the anchor member  650 . In these embodiments, the toggle line  766  can thereafter be separately be cut away from the suture assembly  654 . 
     Returning to  FIGS. 9A-9C , in the assembled and pre-deployed configuration, the needle cannula  628  is disposed within the outer tubular member  620 , and the proximal portion  696  being disposed within the upper portion  660  of the handle  616  with the flange  718  of the proximal portion  696  disposed in and extending outward from the upper slot  670 . As further shown, the pusher member  634  is partially disposed within the needle cannula  628  and the upper portion  660  of the handle  616 , with the proximal end  740 , including the end plate  746 , of the pusher member  634  extending proximally from the proximal end  662  of the handle upper portion  660 . Additionally, the needle cannula  628  and the pusher member  634  are generally aligned with the longitudinal axis  166 . 
     In the pre-deployed configuration shown, the tab  748  of the pusher member  634  is positioned in the rear segment  676  of the lower slot  674  in the handle upper portion  660 . As explained above, the width Wr of the rear slot segment  676  is selected to substantially prevent rotation of the pusher member  634  relative to the handle  616  when so positioned. As further shown, the tab  748  and the projection  754  of the pusher member  634  are not radially aligned with the slots  722 ,  726  of the needle cannula proximal portion  696 , but rather, abut and bear against the proximal portion  696 . Accordingly, in this configuration, by urging the pusher member  634  axially in the distal direction relative to the handle  616  will also cause the needle cannula  628  to move with the pusher member  634 . In the pre-deployed configuration shown, however, the safety tab  648  is releasably coupled (e.g., clipped or snapped over) the pusher member  634  and abuts the end plate  746  on one end and the proximal end  662  of the handle upper member  660  on the opposing end. Accordingly, the safety tab  648  prevents unintended axial movement of the pusher member  634  relative to the handle  616 . It will be appreciated, however, that removal of the safety tab  648  from the pusher member  634  will allow the pusher member  634  and the needle cannula  628  to be advanced distally relative to the handle  616  and the outer tubular member  620 . 
     As further shown in  FIG. 9B , the lever  646  is pivotally connected to the lower portion  664  of the handle  616  at a pivot point  810 , and itself includes an upper portion  816 , a lower portion  820 , and a resilient member  826  extending from the lower portion  820 . In the illustrated embodiment, the upper portion  816  is disposed within the interior of the handle  616  and is shaped to engage the proximal portion  696  of the needle cannula  628 . Additionally, the lower portion  820  partially extends from the handle lower portion  664 , and the resilient member  826  bears against a wall  830  of the handle  616  interior. Thus, when the lower portion  820  of the lever  646  is urged into the handle lower portion  664 , the upper portion  816 , which is engaged with the proximal portion  696  of the needle cannula  628 , will tend to urge the needle cannula  628  proximally relative to the handle  616 . As will be appreciated, however, in the pre-deployed configuration shown, such proximal movement of the needle cannula  628  is prevented by the tab  748  of the pusher member  634 , which is captured within the rear segment  676  of the lower slot  674  in the handle upper portion  660 . The resilient member  826  operates to bias the lower portion  820  of the lever  646  away from the handle  616 , thereby enhancing the tactile feel and control of the operation of the lever  646  by the clinician. In various embodiments, a spring or other biasing element can be utilized in lieu of or in addition to the resilient member  826 , or alternatively, this biasing function can be eliminated altogether. 
     As can perhaps be best seen in  FIG. 9C , the anchor member  650  is disposed within the needle cannula  628  proximate the open distal end  704 , with the distal end  744  of the pusher member  634  abutting the anchor member  650 . As further shown, the adjustable suture assembly  654  extends outward of the delivery tool  600  through the slots  692  and  736  in the outer tubular member  620  and the needle cannula  628 , respectively. As shown in  FIG. 9B , the toggle line  766  extends external to the delivery tool  600  and is connected to the flange  718  on the needle cannula proximal portion  696 . In the pre-deployed configuration shown, the toggle line  766  operates, at least in part, to prevent the anchor member  650  from unintentionally being ejected from the delivery tool  600 . 
     Additionally, the tension line  760  extends external to the delivery tool  600  and is connected to the safety tab  648 . As further shown in  FIGS. 9A and 9B , the delivery tool  600  also includes a suture management element  836 , which in the illustrated embodiment is an elastic band or sleeve disposed about the outer tubular member  620  near its distal end  624 . The suture management element  836  operates to releasably retain portions of the suture assembly  654  against the outer tubular member  620  prior to and during deployment of the implant  110 , similar or identical to the elastic band ( 473 ) described in co-pending and commonly assigned U.S. application Ser. No. 12/553,583, which is incorporated herein by reference. 
       FIGS. 14A-14E  are partial cut-away elevation views of the implant delivery tool  600  during use to deploy the implant  610  partially within a vertebral body  900  of a patient. As shown in  FIG. 14A , the delivery tool  600  is initially positioned with the distal end  624  of the outer tubular member  620  abutting the surface of the vertebral body  900  at the desired implantation location for the anchor member  650  (not shown in  FIG. 14A ). In this configuration, as explained above, the tab  748  of the pusher member  634  is positioned in the rear segment  676  of the lower slot  674  in the handle upper portion  660 , and the tab  748  and the projection  754  of the pusher member  634  are not radially aligned with the slots  722 ,  726  of the needle cannula proximal portion  696 , but rather, abut and bear against the proximal portion  696 . 
     Then, as shown in  FIG. 14B , the safety tab  648  is removed from the pusher member  634  and set aside, and the needle cannula  628  (with the anchor member  650  disposed therein) and the pusher member  634  are advanced distally so as to drive the sharpened distal tip  708  of the needle cannula into the vertebral body  900 . In various embodiments, for example, a mallet can be used to tap against the end plate  746  of the pusher member  634 . Because the tab  748  and the projection  754  of the pusher member  634  abut and bear against the proximal portion  696  of the needle cannula  628 , distal movement of the pusher member  634  also moves the needle cannula  628  distally relative to the handle  616  and the outer tubular member  620  a desired distance into the vertebral body  900 . 
     The pusher member  634  and other elements of the delivery tool  600  are, in various embodiments, dimensioned to provide a sufficient depth of penetration of the needle cannula  628  into the bone to facilitate deployment of the anchor member  650  and also encourage strong engagement with the bone. For example, in one embodiment, the length of the safety tab  648  is selected to correspond to the desired depth of penetration into the vertebral body  900 , such that the needle cannula  628  will automatically be inserted the desired depth when the end plate  746  abuts the proximal end  662  of the handle upper portion  660 , as shown in  FIG. 14B . 
     With the needle cannula  628  and the pusher member  634  fully advanced distally relative to the handle  616  and the outer tubular member  620 , the tab  748  is positioned in the forward segment  678  of the lower slot  674  in the upper handle portion  660 . As explained above, the width Wf of the forward segment  678  is greater than the width Wr of the rear segment  676 . As shown in  FIG. 14C , the tab  748  (and consequently, the pusher member  634 ) is then rotated to align the tab  748  and the projection  754  with the slots  722 ,  726  in the proximal portion  696  of the needle cannula  628 . Rotation of the tab  748  also aligns the tab  748  with the recess  688  in the forward segment  678  of the lower slot  674  (see  FIG. 10C ). When so aligned, slight proximal movement of the pusher member  634  causes the tab  748  to be received in the recess  688 , so that subsequent rotation of the tab  748  and the pusher member  634  are prevented by the projection  686 . Additionally, the shoulder  682  formed in the lower slot prevents the pusher member  634  from being displaced proximally when in this configuration. 
     With the tab  748  and the projection  754  now aligned with the slots  722 ,  726  in the proximal portion  696  of the needle cannula  628 , as shown in  FIG. 14D , the lower portion  820  of the lever  646  is then urged into the handle lower portion  664 , thereby pivoting the lever  646  and causing the upper portion  816  of the lever  646  to engage the proximal portion  696  of the needle cannula  628  and urge the needle cannula  628  proximally relative to the handle  616 . As such, the needle cannula  628  is retracted relative to the pusher member  634 , which remains stationary and prevents the anchor member  650  from being retracted with the needle cannula  628 . Accordingly, as shown, the anchor member  650  is ejected from the needle cannula  628  and into the vertebral body  900 . 
     As further shown, retraction of the needle cannula  628  applies a tensile force to the toggle line  766  attached to the flange  718  of the needle cannula proximal portion  696 . This in turn tends to cause the anchor member  650  to rotate as it is ejected from the needle cannula  628 , which encourages positive engagement of the anchor member  650  with the vertebral body  900 . In one embodiment, the toggle line  766  is configured to break at a selected location as the needle cannula  628  is retracted and the tension in the toggle line  766  exceeds a predetermined value, thereby allowing the toggle line  766  to be removed without requiring a separate cutting step. As shown in  FIG. 14E , the delivery tool  600  can then be removed, leaving the implant  610  in place with the adjustable suture assembly  654  exposed for use in completing the annular repair procedure. 
       FIG. 15A-15C  are schematic illustrations showing the implant  610  deployed in conjunction with a second implant  1000  to re-approximate an aperture or defect  1018  in a patient&#39;s intervertebral disc  1020  adjacent a vertebral body  1022  according to one embodiment of the present invention. In the illustrated embodiment, the implant  1000  includes a pair of tissue anchors  1025 ,  1030  connected by an adjustable connecting element  1034 . The implant  1000  can, in various embodiments, be substantially similar or identical to the implants  25 ,  400  described above, as well as any of the dual anchor fixation devices disclosed, for example, in co-pending and commonly assigned U.S. patent application Ser. Nos. 12/251,295 and 12/553,583, and commonly assigned U.S. Provisional Application 61/293,939 the entire disclosures of which are incorporated herein by reference in their entireties. Accordingly, the implant  1000  is, in various embodiments, deployed using a delivery tool having a tubular member with a sharp tissue penetrating tip for penetrating the disc annulus, wherein the implant  1000  is received within the tubular member of the aforementioned delivery tool and is deployed in the annulus fibrosus as disclosed in any of the foregoing U.S. patent applications. 
     As shown in  FIG. 15A , in one embodiment, the implant  610  is implanted with the anchor member  650  deployed in the patient&#39;s vertebral body  1022  such that the suture assembly  654  lays across the annular aperture  1018 . The implant  1000  is implanted at a location such that the aperture  1018  is located between the implant  1000  and the vertebral body  1022 . As shown, the tissue anchor  1025  is implanted in the patient&#39;s intervertebral disc  1020  in such a way that the connecting element  1034  extends out of the disc  1020  and through the loop  762  in the implant  610 . As further shown, the tissue anchor  1030  is implanted at a second location in the disc  1020  using a delivery tool such as the delivery tools  20 ,  482  described above or any of the fixation delivery apparatuses disclosed in one of the above-mentioned U.S. patent applications, and is thereafter tightened using a tension guide or other technique. As further shown in  FIG. 15A , a tension guide  1050  is used while tension is applied to the tension line  760  of the implant  610  (e.g., by pulling on the tab  748  attached to the free end  784  of the tension line  760 ) to cinch up the tension line  760  and reduce the dimensions of the loop  762 . Accordingly, both the suture assembly  654  of the implant  610  and the connecting element  1034  of the implant  1000  are placed in tension and, by virtue of their implantation locations, urge the edges of the aperture  1018  together and toward the vertebral body  1022  to re-approximate the aperture  1018 .  FIG. 15B  illustrates the implants  610 ,  1000  in their final implanted configurations, with the aperture  518  at least partially, if not wholly, closed. The implants  610 ,  1000  and the associated delivery tools, e.g., the delivery tool  600  and the delivery tool used to deploy the implant  1000  such as disclosed in any of the above-mentioned U.S. patent applications, as well as the tension guide  1050 , thus form an annular repair system. 
       FIG. 15C  illustrates an alternative use of the system including the implants  610 ,  1000  in their deployed states to repair a defect  1018  in the annulus fibrosus of the patient&#39;s intervertebral disc  1020 . In the illustrated embodiment of  FIG. 15C , the defect  1018  is a rim lesion, i.e., a tear/delamination of the annulus fibrosus from the vertebral body  1022  at the insertion point of the annulus into the vertebral body  1022 . As such, the defect  1018  is located directly adjacent to the vertebral body  1022 , such that there is there is little or no annulus fibrosus tissue between the defect  1018  and the vertebral body  1022 . As shown, the implants  610  and  1000  are used to force the edge of the annulus fibrosus of the intervertebral disc  1020  back into contact with the adjacent surface of the vertebral body  1022  so as to at least partially, if not wholly, close the defect  1018 . 
       FIGS. 15D-15F  illustrate alternative configurations utilizing one or more implants  610  and implants  1000  to repair the defect  1018  in the annulus fibrosus. As can be seen in  FIGS. 15D-15F , any number of configurations of these implants can be employed to accomplish annulus repair, depending on the particular therapeutic needs of the patient. 
     Although in the figures above the anchor member  650  is illustrated and primarily described as being configured for deployment in the patient&#39;s vertebral body for repair of a defect in the adjacent annulus fibrosus, the implant  610 , and the delivery tool  600 , can also advantageously be used for other orthopedic applications. For example, the anchor member  650  can be readily deployed in soft tissue such as the annulus fibrosus itself using the delivery tool  600 . In various embodiments, the anchor member  650  can advantageously be deployed in other soft tissues, and the delivery tool  600  can be used for deploying the anchor member  650  into such tissues. Additionally, the use of the implant  610  and the delivery tool  600  is not limited to use in intervertebral disc repair, but may also be utilized to repair defects in, for example, the joints in the hand or foot, knee, or shoulder. 
       FIGS. 16A and 16B  are plan views of an alternative embodiment of an implant delivery tool  1070  with an implant  1072  coupled thereto according to another embodiment of the present invention. The implant delivery tool  1070  and the implant  1072  are, except as noted below, substantially the same or identical in structure and function to the implant delivery tool  600  and the implant  610 , respectively, described above, and thus need not be described in detail again here. The implant  1072  differs from the implant  600  in that the implant  1072  includes a toggle loop  1074  in lieu of the toggle line  766  of the implant  600 . In the illustrated embodiment, the toggle loop  1074  is releasably retained against the implant delivery tool  1070  by a clip  1076  or other retaining element prior to deployment. In use, after deploying the anchor member (not shown) of the implant  1072  into bone or other tissue, the toggle loop  1074  is freed from the implant delivery tool  1070  and pulled manually by the physician to toggle the anchor member and confirm that the anchor member is positively engaged with the bone or other tissue. Any remaining length of the toggle line can then be cut away using a suture cutter or other cutting device. 
       FIGS. 17A-17D  are elevation, detail perspective and partial cross-sectional views of the tension guide  1050  shown in  FIG. 15A . As shown in  FIGS. 17A-17D , the tension guide  1050  has a body  1090  having opposite first and second ends  1100 ,  1110  and a length therebetween. As further shown, the first end  1100  has a canted tip  1115  with a slot  1120  sized to slidingly receive a suture. The first end  1100  is thus in many respects similar or identical to the corresponding ends of conventional tension guides and/or knot pushers, and thus need not be described in greater detail here. In short, in use, a suture tightened is inserted into the slot  1120  with the canted tip  1115  bearing against the adjustable element (e.g., the locking element  788  of the tension line  760  described above, or alternatively, a knot such as a Roeder or Weston knot) to be tightened. Tension is applied to the suture while the tension guide resists movement of the locking element  788  or similar structure in the direction of the tensile force, so as to cinch up the suture. The foregoing is illustrated, for example, in  FIG. 15A  above in connection with tightening the suture assembly  654  of the implant  610 . 
     As shown in  FIG. 17B , the second end  1110  includes a tip  1130  having a slot  1134  extending axially inward thereof. As further shown, within the slot  1134  is a blade  1140  having a cutting edge  1145  oriented toward the tip  1130 . As shown, the blade  1140  is recessed inward from the periphery of the tip  1130 , and the cutting edge  1145  is further axially recessed from the tip  1130 . Thus, no portion of the blade  1140  extends outward of the body  1090  of the tension guide  1050 . The slot  1134  is dimensioned, e.g., has a width and depth sufficient to freely receive any suture on which the tension guide  1050  is used. The blade  1140  is operable to cut away any excess suture length. 
       FIG. 17C  is a partial cross-sectional elevation view of the second end  1110 . As shown in  FIG. 17C , in one embodiment, the blade  1140  includes a proximal segment  1180  and a distal segment  1184  terminating in the tip  1130 . As further shown, the distal segment  1184  is angled relative to the proximal segment  1180  and the longitudinal axis LA of the tension guide  1050  in general. As further shown, the body  1090  includes an internal post  1190  to which the blade  1140  is secured. In various embodiments, the body  1090  further includes a slotted cap  1194  that is placed over the blade  1140  and the post  1190  and ultrasonically welded or otherwise secured in place to form the second end  1110  of the tension guide  1050 . The cap  1194  operates to both shield the cutting edge  1145  of the blade  1140  as well as secure the blade  1140  to the body  1090 . 
       FIG. 17D  is a partial cross-sectional elevation view of the second end  1110  of an alternative embodiment of the tension guide  1050  utilizing a different blade configuration than that shown in  FIG. 17C . In the embodiment of  FIG. 17D , the blade  1140  does not include a proximal segment. Rather, as shown in  FIG. 17D , the blade  1140  extends only along an angled surface of the post  1190  and is mounted and secured to the post  1190 . Additionally, in the embodiment of  FIG. 17D , the blade  1140  includes a cutout  1205  sized to receive a tab  1210  on the post  1190  to facilitate mounting the blade  1140  to the post  1190 . 
     In both  FIGS. 17C and 17D , the portion of the blade  1140  terminating in the cutting edge  1145  is angled relative to the longitudinal axis of the tension guide  1050 . In various embodiments, the angle α between the active portion of the blade  1140  and the longitudinal axis can be up to 90 degrees. In one embodiment, the angle α is about 45 degrees. The angle α is selected to allow the user to use a straight approach when cutting the suture (e.g., the body  1090  and the tension guide  1050  in general are generally aligned with the suture being cut). This straight approach is advantageously employed in procedures in which access is limited. Using the straight approach allows the user to position the suture in the slot  1134 , and once positioned the user can gently pull the suture straight up and contact the cutting edge  1145  of the blade  1140 , which severs the suture. The tension guide  1050  can also be used at any angle that allows the blade  1140  and the cutting edge  1145  to contact the suture. In various embodiments, the blade  1140  is not angled relative to the longitudinal axis of the tension guide  1050 . 
     The cutting edge  1145  of the blade  1140  is not limited to any particular configuration or profile. In various embodiments, the cutting edge  1145  can have a single or double bevel, or a triple angled bevel. In various embodiments, the cutting edge  1145  can be either single sided or double sided. In various embodiments, the cutting edge  1145  can have a straight, concave or convex profile. 
     Thus, the tension guide  1050  advantageously provides a single tool that can be used by the clinician to both tighten a suture assembly (e.g., the suture assembly  654  of the implant  610 ) and cut away any excess suture material. Thus in use, the clinician uses the first end  1100  to tighten the suture assembly, and then inverts the tension guide  1050  and uses the second end  1110  and the blade  1140  to cut away any excess suture length. Because the cutting edge  1145  is recessed axially from the tip  1130 , it is shielded to avoid unintentionally contacting tissue or portions of the suture assembly to be cut. The small diameter and low profile shape of the tension guide  1050  provide excellent functionality and is well adapted for use within the relatively small diameter access cannulae typically used for annular repair procedures, and eliminates the need to use conventional cutting devices, e.g., surgical scissors and the like, which can be difficult to manipulate within such cannulae. 
     Although primarily described above in connection with an annulus fibrosus repair procedure, it is emphasized that the tension guide  1050  can advantageously be employed in any procedure, including both orthopedic and non-orthopedic procedures, to provide a safe, quick and efficient means to cut and remove excess suture material and, if applicable, tension the suture itself. For example, the tension guide  1050  is readily usable in orthopedic procedures such as meniscal repair procedures as well as shoulder and hip repair procedures. In one embodiment, the tension guide  1050  may be used to both tighten the connecting element  300  and remove excess suture material in the implant  25  when used to repair a tear or other defect in a meniscus of a patient&#39;s knee. Still other applications of the tension guide  1050 , both in sports medicine or other orthopedic repair procedures, will be readily apparent to the skilled artisan based on the foregoing. 
     The tension guide  1050  can be made from a number of suitable biocompatible materials. In various embodiments, the body  1090  can be made from any of a variety of relatively rigid, biocompatible metal or polymeric materials. In various embodiments, the body  1090  is made from a polymer such as, without limitation, polypropylene, polyether etherketone (PEEK™), polyethylene, polyethylene teraphthalate (PET) and polyurethane, acrylic, polycarbonate, engineering plastics; and/or composites. In one embodiment, the body  1090  is made from PEEK™. The blade  1140  can be made from any of a variety of suitable metals or polymers. Suitable metals for use in the blade  1140  include, without limitation, stainless steel, nickel, titanium, and titanium and nickel alloys. In one embodiment, the blade  1140  is formed from stainless steel. In various embodiments, the blade  1140  includes a coating or other treatment to increase the hardness and wear resistance of the blade material. Suitable materials for the aforementioned coatings include, without limitation, titanium nitride, titanium carbide, titanium carbonitride, chromium nitride, diamond-like coatings, zirconium nitride, titanium aluminum nitride, and various non-stick materials such as polytetraflouroethylene (PTFE) and expanded PTFE. In other embodiments, the blade  1140  is not coated. 
       FIGS. 18A-18B  are schematic illustrations of the implant  25  in use to repair a tear or other defect  1300  in a meniscus  1310  of a patient&#39;s knee according to yet another embodiment of the present invention. As shown in  FIGS. 18A and 18B , in one embodiment, the tissue anchors  125   a  and  125   b  can be deployed on the outer surface of the meniscus  1310  with the connecting element  300  extending through the meniscus  1310  and bearing against the inner surface of the meniscus  1310  proximate the tear  1300 . Thus, as shown in  FIG. 18B , the connecting element  300  is irreversibly shortened using the tension guide  1050 , and the meniscal tissue adjacent to the tear  1300  is urged together to effectuate the repair. Any excess suture material of the connecting element  300  is thereafter cut away using the tension guide  1050  as described above. Although  FIGS. 18A and 18B  illustrate the use of only a single implant  25 , in various embodiments, additional implants  25  and/or implants  400  can be used to accomplish the meniscal repair. In still other embodiments, the implants  25 ,  400  can be used for other orthopedic repair procedures in the knee, shoulders, hips, and the like. 
     The materials used in the implants  610 ,  1000 ,  1072 , and the delivery tools  600 ,  1010 ,  1070  can include any number of biocompatible materials having suitable mechanical properties. For example, materials from which to make the anchor member  650  and the tissue anchors  1025 ,  1030  can include, but are not limited to: metals, such as stainless steel, nickel, titanium alloy, and titanium; plastics, such as polytetrafluoroethylene (PTFE), polypropylene, polyether etherketone (PEEK™), polyethylene, polyethylene teraphthalate (PET) and polyurethane, acrylic, polycarbonate, engineering plastics; and/or composites. The adjustable suture assembly  654  and the connecting element  1034  can likewise be made of any suitable suture material. In various embodiments, the anchor member  650 , the tissue anchors  1025 ,  1030  and/or the adjustable suture assembly  654  and the connecting element  1034  can be made of bio-resorbable materials. In various embodiments, the tension line  760 , the toggle line  766  and the connecting segment  770  of the implant  610  are made wholly or partially of size 2-0 or 3-0 ultra high molecular weight polyethylene (UHMWPE) suture material, otherwise known as force fiber suture material. In one embodiment, the anchor member  650  is made from PEEK, the tension line  760  and the connecting segment  770  are made from size 2-0 UHMWPE suture material, and the toggle line  766  is made from size 3-0 UHMWPE suture material. In short, any suitable materials, whether now known or later developed, can be utilized to construct the implant  610  within the scope of the present invention. 
     Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.