Patent Abstract:
An apparatus for tissue repair includes first and second fixation members configured to secure tissue together, a flexible coupling member coupling the first and second fixation members, a first flexible pull member attached to the first fixation member but not the second fixation member, and a second flexible pull member attached to the second fixation member but not the first fixation member. A surgical method for repairing a wound in a rotator cuff includes forming a first and second channel through tissue, advancing a first flexible member and a first fixation member coupled thereto through the first channel, advancing a second flexible member and a second fixation member coupled thereto through the second channel, and pulling a third flexible member coupling the first and second fixation members to shorten a length of the third flexible member between the first and second fixation members. A surgical method includes pulling a first implant through soft tissue of a rotator cuff cross a tear in the tissue to position the first implant on a first side of the tear and a second implant, coupled to the first implant by a flexible coupling member, on a second side of the tear with the flexible coupling member traversing the tear, and pulling the flexible coupling member to shorten a length of the flexible coupling member between the first and second implants to move the implants against the soft tissue to close the tear.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of co-pending U.S. application Ser. No. 11/165,551, filed Jun. 24, 2005, which is incorporated herein by reference. This application relates to U.S. application Ser. No. 09/704,926, which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD  
       [0002]     This invention relates to devices and methods for repairing tissue, and more particularly to devices and methods for repairing tears in rotator cuff tissue.  
       BACKGROUND  
       [0003]     On area in the body where soft tissue is surgically reattached to bone is the attachment of a rotator cuff tendon to the humerus. The rotator cuff tendons have areas of low blood supply. With an increased blood supply, a tissue, such as tendon, can repair and maintain itself better and faster. Thus, areas of poor blood supply in the rotator cuff make these tendons difficult and slow to heal following an injury, such as a tear to the supraspinatus muscle or the subscapularis muscle. In such a tear, part of the tendon is pulled away from the bone. Because of the poor blood supply, rather than attempting to allow an injured rotator cuff to heal on its own, a physician often recommends that the tendon be surgically repaired to better fix the position of the cuff to the bone to prevent further damage and improve the environment for healing. For example, the physician may attempt to fix the tendon to the bone using a fixation member such as a retainer or an anchor. One example of a fixation member is disclosed in U.S. Pat. No. 4,741,330 (the Hayhurst patent), which is incorporated herein by reference.  
         [0004]     Other areas in the body also have tissue that can be surgically reattached to bone when torn from the bone or can be surgically repaired when a tear forms in the tissue. These areas include for example, the biceps tendon, the lateral collateral ligament in the knee, the medial collateral ligament in the knee, the meniscus in the knee, the popliteal ligament in the leg, and the labrum tendon in the knee.  
         [0005]     Fibrous tissue wounds, such as muscle, ligament, and cartilage tears, can be repaired arthroscopically using flexible members such as sutures. Traditionally, to close a fibrous tissue wound, a surgeon would insert two suture needles into the tissue with sutures attached, thread the sutures across the wound, and then tie knots to fix the free ends of the sutures within the tissue.  
         [0006]     To simplify the wound closure procedure and to improve fixation, various types of fixation members have been developed. One example of a fixation member in the form of a retainer is disclosed in the Hayhurst patent. In the Hayhurst patent, one end of a flexible member is fixed to a resiliently-deformable, bar-shaped retainer. The retainer is loaded into the bore of a hollow needle and deployed into or against the fibrous tissue. The surgeon then threads the flexible member across the wound and tensions a free end of the suture to pull the wound closed. When the surgeon tensions the suture, the bar in the retainer becomes oriented transversely to the suture hole, holding the suture in place.  
       SUMMARY  
       [0007]     In one general aspect, a tissue repair device includes a closed loop of multifilament flexible material. The loop is knotless and includes a contact portion in which ends of the multifilament flexible material are interwoven and melted-formed.  
         [0008]     Implementations can include one or more of the following features. For example, the tissue repair device can include a fixation member having a structure that defines a cavity that receives at least a part of the closed loop.  
         [0009]     The tissue repair device can include a flexible member traversing the loop. The flexible member can traverse the loop by being passed through an interior defined by the loop. The flexible member can traverse the loop by being passed through the multifilament flexible material.  
         [0010]     The ends of the multifilament flexible material can be thermally fused together within the contact portion. The flexible member can traverse the loop by being passed through the thermally fused portion of the multifilament flexible material.  
         [0011]     The multifilament flexible material can be made of polymer-based compound.  
         [0012]     The flexible member can traverse the loop by being passed through the interwoven portion of the multifilament flexible material. The multifilament flexible material can be braided or twisted.  
         [0013]     In another general aspect, a tissue repair device is made by forming a closed loop from the multifilament flexible material. The forming includes interweaving ends of the multifilament flexible material together to form a contact portion without tying the ends together in a knot, and causing the ends of the multifilament flexible material to melt in the contact portion.  
         [0014]     Implementations can include one or more of the following features. For example, the method can also include passing at least a part of the multifilament flexible material through a cavity defined by a fixation member.  
         [0015]     The method can include traversing a flexible member through the loop. The traversing can include passing the flexible member through an interior defined by the loop. The traversing can include passing the flexible member through the multifilament flexible material. The traversing can include passing the flexible member through the contact portion of the multifilament flexible material.  
         [0016]     Forming the closed loop can include thermally fusing the ends of the multifilament flexible material in the contact portion. Forming the closed loop from the multifilament flexible material can include forming without applying a filler material to the ends of the flexible element.  
         [0017]     In another general aspect, a tissue repair device includes a closed loop of multifilament flexible material, and a fixation member. The loop is knotless and includes a contact portion in which ends of the multifilament flexible material are interwoven. The fixation member has a structure that defines a cavity that receives at least a part of the closed loop.  
         [0018]     In another general aspect, a tissue repair device includes a fixation member having a structure that defines a cavity, a multifilament flexible element, and a flexible member. The multifilament flexible element includes a part that is within the cavity, and a thermally fused end. The flexible member passes at least partially through the thermally fused end of the multifilament flexible element.  
         [0019]     Implementations can include one or more of the following features. In particular, the multifilament flexible element includes another thermally fused end and the flexible member passes through the other thermally fused end of the multifilament flexible element.  
         [0020]     Aspects of the device and method may include one or more of the following advantages. The ends of the multifilament flexible material are thermally fused together without the use of a filler material. The loop acts as a pulley that reduces pinching of the flexible member between the tissue and the fixation member during deployment. Additionally, the pulley design enables the flexible member to slide relative to the fixation member without being impeded by the edges of the fixation member or by the tissue when the fixation member is deployed in tissue.  
         [0021]     In another general aspect, an apparatus for tissue repair includes first and second fixation members configured to secure tissue together, and a flexible coupling member coupling the first and second fixation members. The apparatus also includes a first flexible pull member attached to the first fixation member but not the second fixation member, and a second flexible pull member attached to the second fixation member but not the first fixation member.  
         [0022]     Implementations can include one or more of the following features. For example, the flexible coupling member includes a slip knot and a first closed loop. Additionally, the first and second fixation members each define at least one opening, and the first closed loop of the flexible coupling member traverses the opening in one of the fixation members, and a second closed loop of flexible material traverses the opening in the other fixation member with the flexible coupling member being slidably received through the second closed loop.  
         [0023]     The first and second pull members include closed loops, and along with the flexible coupling member, can be sutures.  
         [0024]     In another general aspect, a surgical method for repairing a wound in a rotator cuff includes forming a first channel through tissue, advancing a first flexible member and a first fixation member coupled thereto through the first channel, forming a second channel through tissue, and advancing a second flexible member and a second fixation member coupled thereto through the second channel. The method further includes pulling a third flexible member coupling the first and second fixation members to shorten a length of the third flexible member between the first and second fixation members.  
         [0025]     Implementations can include, for example, the first and second channels being formed through rotator cuff tissue and bone tissue.  
         [0026]     In another general aspect, a surgical method includes pulling a first implant through soft tissue of a rotator cuff across a tear in the tissue to position the first implant on a first side of the tear and a second implant, coupled to the first implant by a flexible coupling member, on a second side of the tear with the flexible coupling member traversing the tear. The method further includes pulling the flexible coupling member to shorten a length of the flexible coupling member between the first and second implants to move the implants against the soft tissue to close the tear.  
         [0027]     Implementations can include one or more of the following features. For example, the method includes forming a channel through the soft tissue and across the tear. In addition, pulling the first implant includes pulling a first closed loop of flexible material attached to the first implant through the channel.  
         [0028]     In another general aspect, a method of making a tissue repair device includes passing a flexible material through an opening defined by a first fixation member, forming the flexible material into a first closed loop, traversing a flexible member through the first closed loop, traversing the flexible member through a second fixation member, and forming a second closed loop in the flexible member such that the flexible member is coupled to the second fixation member. The method further includes forming a slip knot in the flexible member.  
         [0029]     Implementations can include, for example, coupling a first flexible pull member to the first fixation member but not the second fixation member, and coupling a second flexible pull member to the second fixation member but not the first fixation member.  
         [0030]     In another general aspect, a tissue repair device includes a closed loop of multifilament flexible material and a fixation member defining a cavity that receives at least a part of the closed loop. The loop is knotless and includes a contact portion in which the ends of the multifilament flexible material are formed together.  
         [0031]     The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.  
     
    
     DESCRIPTION OF DRAWINGS  
       [0032]      FIG. 1A  is a perspective view of a tissue repair device.  
         [0033]      FIG. 1B  is an illustration of the tissue repair device of  FIG. 1A , shown mending a tear in soft tissue.  
         [0034]      FIG. 1C  is a perspective view of the tissue repair device of  FIG. 1A , shown mending a tear in soft tissue.  
         [0035]      FIG. 2  is a side cross-sectional view of a fixation member and a loop of the tissue repair device of  FIG. 1A .  
         [0036]      FIGS. 3A-3C  are side perspective views showing formation of a retaining element that can be formed in the tissue repair device of  FIG. 1A .  
         [0037]      FIG. 4  is a flow chart of a procedure for forming the loop in the tissue repair device of  FIG. 1A .  
         [0038]      FIGS. 5A-5E  show perspective views of the multifilament flexible material that is formed into the loop in the procedure of  FIG. 4 .  
         [0039]      FIG. 6  is a perspective view of another implementation of a tissue repair device.  
         [0040]      FIG. 7  is a perspective view of another implementation of a tissue repair device.  
         [0041]      FIG. 8  illustrates another implementation of a tissue repair apparatus.  
         [0042]      FIGS. 9A-9E  illustrate the placement of the tissue repair apparatus of  FIG. 8  in the shoulder joint to repair a torn rotator cuff.  
         [0043]      FIG. 10  illustrates another implementation of a tissue repair apparatus.  
         [0044]      FIG. 11  illustrates the placement of the tissue repair apparatus of  FIG. 10  in the rotator cuff to repair a tear in the rotator cuff soft tissue. 
     
    
     DETAILED DESCRIPTION  
       [0045]     Referring to  FIGS. 1A-1C  and  2 , a tissue repair device  100  includes a closed loop  105  of multifilament flexible material. The loop  105  is knotless, that is, the loop  105  is formed without tying ends of the multifilament flexible material together in a knot. The multifilament flexible material is a material suitable for implantation into hard or soft human tissue and it may be absorbable or nonabsorbable. The multifilament flexible material has two or more fibers or strands that are twisted, braided, or otherwise interlinked about each other. The multifilament flexible material is capable of being flexed or bent. The loop  105  is closed, with a first end of the multifilament flexible material contacts a second end of the multifilament flexible material to form a contact portion  110 .  
         [0046]     The tissue repair device  100  also includes a fixation member  115  defining a cavity  120  that receives a part  125  of the loop  105 . As shown, the fixation member  115  can also include a second cavity  130  that receives another part  135  of the loop  105 . The fixation member  115  can be made of any rigid material suitable for implantation into hard or soft human tissue. For example, the fixation member  115  can be made of a biocompatible plastic, a biocompatible metal, or a bioabsorbable polymer.  
         [0047]     The fixation member  115  can be formed as a retainer that is transferred through a tear  160  in tissue  165  and held at an outer surface  170  of the tissue  165  after deployment, as shown in  FIGS. 1B and 1C .  
         [0048]     The fixation member  115  can be formed as an anchor or a screw that is drilled or driven into the tissue during deployment, as shown in  FIG. 15  of U.S. application Ser. No. 09/704,926. In an anchor or screw form, the fixation member  115  can include one or more threads on its outer surface to facilitate holding of the fixation member  115  to the tissue. Such anchor or screw forms are particularly adapted for use in hard tissue such as bone. The fixation member  115  can be formed with a generally cylindrical shape for receipt within a delivery device, such as a needle. The fixation member  115  can have a fin extending from its generally cylindrical shape.  
         [0049]     The tissue repair device  100  also includes a flexible member  140 , for example, a suture, that traverses the loop  105 . As shown in  FIGS. 1A and 1B , the flexible member  140  traverses the loop  105  by being passed through an interior  145  of the loop  105  that is bounded by or enclosed by the loop  105  and the fixation member  115 . The flexible member  140  is a material suitable for implantation into hard or soft human tissue and it may be absorbable or nonabsorbable in the tissue after implantation. For example, the flexible member  140  can be made of a natural material, such as, for example, collagen, surgical silk, surgical cotton, or surgical steel. As another example, the flexible member  140  can be made of a synthetic material, such as, for example, a polymer or nylon.  
         [0050]     Referring also to  FIGS. 3A-3C , the tissue repair device  100  can include a second fixation member  150  through which the flexible member  140  is passed, and a retaining element  300 , for example, a slip knot in flexible member  140 . The flexible member  140  is passed through the fixation member  150  by threading the flexible member  140  through a hole within the fixation member  150  and then attaching an end of the flexible member  140  to a region of the flexible member  140  that has not been threaded through the fixation member  150 . The retaining element  300  permits the flexible member  140  to be pulled in the direction of arrow  305  and pass through the retaining element  300 , thus reducing the distance between the fixation member  115  and the fixation member  150  and causing sides of the tear  160  to come into contact with each other. The retaining element  300  prevents an increase in distance between the fixation member  115  and the fixation member  150  to prevent the sides of the tear  160  from coming apart after coming in contact with each other.  
         [0051]     Examples of the fixation members  115 ,  150 , the retaining element  300 , and the flexible member  140  can be found in U.S. application Ser. No. 10/918,445, filed Aug. 16, 2004, which is incorporated herein by reference.  
         [0052]     Referring to  FIGS. 4 and 5 A- 5 E, a procedure  400  is performed to form the loop  105 . Initially, a first end  510  of the multifilament flexible material  500  is inserted or passed through the cavity  120  of the fixation member  115  (step  405 ). If desired, the multifilament flexible material  500  can be inserted through the second cavity  130  of the fixation member fixation member  115 . After insertion, the first end  510  of the material  500  is brought into contact with a second end  505  (step  410 ). To facilitate thermal fusion, the ends  505 ,  510  can be interwoven into each other to make contact, as shown in  FIG. 5B . In this case, the fibers of the end  505  are interwoven with the fibers of the end  510 . For example, the end  505  can be inserted between fibers of the end  510 , as shown in  FIG. 5B . As another example, the end  505  can be inserted through an interior of a Chinese trap formed at the end  510 , as shown in  FIG. 5C .  
         [0053]     Next, energy is supplied to the ends  505 ,  510  until the temperature of the ends  505 ,  510  raises to the point that the material in the ends  505 ,  510  melts or liquefies (step  415 ). At this point, the ends  505 ,  510  blend together to form a blended region, that is, a uniform or homogenous composition. Energy is supplied to the ends  505 ,  510  using, for example, thermal energy, ultrasonic energy, laser light, or electrical arc discharge. The ends  505 ,  510  can be inserted in a suitable energy supplying apparatus, depending on the way in which energy is provided to the ends  505 ,  510 . For example, if the energy supplied is thermal energy, the ends  505 ,  510  can be locally heated using a heater element such as an electrical resistance heater element in the form of a thin film of an alloy. The heater element can create heat by other means, such as by induction, irradiation, or a chemical reaction. The blended region is allowed to cool to form a solid blended composition in the contact portion  110  (step  420 ).  
         [0054]     The multifilament flexible material can be any material that is able to melt or liquefy upon application of an energy that raises its temperature and to solidify upon cooling such that the multifilament flexible material forms a blended region. Examples of materials having these properties include nylon, metals (such as titanium or steel), and polymer-based compounds, such as polyester fiber, polypropylene, polybutester, polyglactin, poliglecaprone, and polydioxanone. Another material that may have these properties is natural silk protein produced by spiders. The multifilament flexible material  500  can be any length and diameter that enables passage through the fixation member  615  and subsequent thermal fusion. For example, in one implementation in which the flexible material  500  is a type 0 size, the material  500  is about 4-12 mm long and has a diameter of about 0.4 mm.  
         [0055]     The procedure  400  produces a contact portion  110  that has a yielding strength that is equivalent to or near to the United States Pharmacopoeia (USP) Standards value for a particular size of suture. For example, for a USP type 0 size suture, the yielding strength of the contact portion is about 12-13 pounds.  
         [0056]     Referring to  FIG. 6 , in another implementation, a tissue repair device  600  includes a closed loop  605  of multifilament flexible material, similar in design to the loop  105  described above. The loop  605  is closed, thus, a first end of the multifilament flexible material contacts a second end of the multifilament flexible material to form a contact portion  610 . One or more of the ends of the multifilament flexible material may include a Chinese trap.  
         [0057]     The tissue repair device  600  also includes a fixation member  615  defining a cavity  620  that receives a part  625  of the loop  605 , as discussed above with respect to  FIG. 2 . The tissue repair device  600  also includes a flexible member  640  that traverses the loop  605 . As shown, the flexible member  640 , in this implementation, traverses the loop  605  by passing through the contact portion  610  of the multifilament flexible material rather than passing through the interior of the loop  605 . In this way, the flexible member  640  freely moves through the contact portion  610 . For example, if the contact portion  610  includes a Chinese trap, then the flexible member  640  would pass directly through the Chinese trap.  
         [0058]     Referring again to  FIGS. 1B and 1C , the loop  105 ,  605  acts like a pulley through which the flexible member  140 ,  640  can freely slide to facilitate deployment of the fixation member  115 ,  615  into tissue  165 . The pulley design reduces pinching of the flexible member  140 ,  640  between the surface  170  of the tissue  165  and the fixation member  115 ,  615  during deployment. Additionally, the loop  105  reduces friction between the flexible member  140 ,  640  and the fixation member  115 ,  615 , thus enabling the flexible member  140 ,  640  to slide without being impeded by the edges of the fixation member  115 ,  615  or by the tissue  165  when the fixation member  115 ,  615  is deployed in tissue  165 . Other pulley designs are shown in U.S. application Ser. No. 09/704,926. The device  100  or  600  can be delivered to the tissue  165  using a delivery device, such as, for example, the delivery devices shown in  FIGS. 3, 5 ,  6 , and  8 - 11  of U.S. application Ser. No. 09/704,926.  
         [0059]     Referring to  FIG. 7 , in another implementation, a tissue repair device  700  includes a multifilament flexible element  705  having a thermally fused end  710  and a part  725  that is within a cavity  720  defined by a fixation member  715 . Unlike the ends  505 ,  510  of the multifilament flexible material of the loop  105 , the end  710  is thermally fused without being contacted to a second end  712  of the element  705 . In this implementation, energy is supplied to the end  710  until the temperature of the end  710  raises to the point that the material in the end  710  melts or liquefies and blends together to form a blended, uniform composition. Energy may be supplied in any one of the manners mentioned above. Next, the blended composition at the end  710  is allowed to cool to form a solid blended composition.  
         [0060]     The multifilament flexible element  705  can be any length and diameter that facilitates passage through the fixation member  715  and subsequent thermal fusion of the end  710 . For example, in one implementation in which the flexible material  705  is a type 0 size, the material  500  is about 4-12 mm long and has a diameter of about 0.4 mm.  
         [0061]     The tissue repair device  700  includes a flexible member  740  that is passed at least partially through the thermally fused end  710  by, for example, threading the flexible member  740  through the end  710  using a needle. After the flexible member  740  is passed through the end  710 , it is free to move relative to the end  710 . Thus, the multifilament flexible element  705  acts like a pulley through which the flexible member  740  can freely slide to facilitate deployment of the fixation member  715  into tissue.  
         [0062]     To improve pullout strength between the flexible member  740  and the flexible element  705 , the second end  712  of the element  705  can also be thermally fused (as discussed above with respect to the end  710 ) and the flexible member  740  can be passed through the thermally fused end  712 , as shown.  
         [0063]     Referring to  FIG. 8 , in another implementation, an apparatus for tissue repair  800  includes a first fixation member  115 , a second fixation member  150 , and a flexible coupling member  140  coupling fixation member  115  to fixation member  150 . Apparatus  800  also includes flexible pull members  810 ,  820  attached to fixation member  115 ,  150 , respectively. Flexible members  140 ,  810 , and  820  are, for example, sutures. Fixation members  115 ,  150  include a plurality of openings, holes, or cavities  120 ,  130 , and  830 , and  152 ,  154 , and  840 , respectively, defined therein.  
         [0064]     A loop  105 , supra, passes through openings  120 ,  130  formed in fixation member  115 . Although loop  105  is illustrated and discussed herein, other loop configurations, for example, loop  605  and element  705  may be used. As shown in  FIG. 8 , flexible coupling member  140  traverses loop  105  by being passed through an interior  145  of loop  105 . Flexible coupling member  140  also traverses fixation member  150  through openings  152 ,  154  and forms a closed loop in the manner described above. Flexible coupling member  140  includes a slip knot  300 . Slip knot  300  permits flexible coupling member  140  to be pulled in the direction of arrow  305  and pass through slip knot  300 , thus reducing the distance between fixation member  115  and fixation member  150 .  
         [0065]     Flexible pull members  810 ,  820  are attached to fixation members  115 ,  150 , respectively, by passing through openings  830 ,  840 , respectively. As illustrated, flexible pull members  810 ,  820  are formed in a closed-loop by, for example, tying the ends of members  810 ,  820  together, though flexible pull members  810 ,  820  need not form closed loops.  
         [0066]     Referring to  FIGS. 9A-9E , the apparatus  800  can be used, for example, under arthroscopic guidance, to repair a torn rotator cuff  910  in the shoulder joint  920 . Referring to  FIG. 9A , the physician initially forms at least two trans-osseous channels,  930 ,  940 , through the humeral bone  950  using a drill (not shown) as described, for example, in U.S. patent application Ser. No. 10/918,445, supra. Referring to  FIG. 9B , the physician pierces the rotator cuff tissue  910  by passing a needle  960 , such as the needles shown in  FIGS. 3, 5 ,  6 , and  8 - 11  of U.S. application Ser. No. 10/918,445, through each of the trans-osseous channels  930 ,  940  and through the tissue  910 . After piercing the tissue, the physician then grasps flexible pull members  810 ,  820 , using, for example, needle  960 , and advances each of the members  810 ,  820  and fixation members  115 ,  150  coupled, respectively, thereto, through the incisions made in the rotator cuff  910  and the trans-osseous channels  930 ,  940 , as illustrated in  FIG. 9C . Once fixation members  115  and  150  have exited channels  930 ,  940 , and because of the way fixation members  115  and  150  are designed and configured, the fixation members  115 ,  150  rotate or toggle as they are pulled retrograde. This orientation helps to reduce the possibility of fixation members  115  and  150  unintentionally being pulled back into channels  930 ,  940 .  
         [0067]     Following placement of fixation members  810 ,  820  against the humeral bone tissue  950 , flexible pull members  810 ,  820  are cut and removed. In addition, the physician pulls the trailing edge  310  of flexible member  140  in the direction of arrow  970  ( FIG. 9D ), reducing the distance between fixation member  115  and fixation member  150  and causing the soft tissue of the rotator cuff  910  to come into contact with the humeral bone tissue  950  thereby closing the wound. The slip knot  300  limits any tendency of the length of the flexible member  140  between fixation member  115  and fixation member  150  to increase. To complete the procedure, the physician cuts the trailing end  310  of flexible member  140  adjacent slip knot  300 . The above-described method may also be used to close a wound in, for example, the soft tissue of the rotator cuff  910 , as illustrated, for example, in  FIGS. 1B and 1C .  
         [0068]     Referring to  FIG. 10 , in another implementation, an apparatus for tissue repair  1000  includes a first fixation member  1010 , a second fixation member  1020 , and a flexible coupling member  1030  coupling fixation member  1010  to fixation member  1020 . Apparatus  1000  also includes a flexible pull member  1040  attached to fixation member  1010 . Flexible members  1030  and  1040  are, for example, sutures. Fixation members  1010 ,  1020  include a plurality of openings, holes, or cavities  1050 ,  1060 , and  1070 , and  1080  and  1090 , respectively, defined therein.  
         [0069]     As shown in  FIG. 10 , flexible coupling member  1030  traverses fixation member  1010  through openings  1060 ,  1070  and traverses fixation member  1020  through openings  1080 ,  1090 . Flexible coupling member  1030  includes a slip knot  300 . Slip knot  300  permits flexible coupling member  1030  to be pulled in the direction of arrow  1095  and pass through slip knot  300 , thus reducing the distance between fixation member  1010  and fixation member  1020 .  
         [0070]     Flexible pull member  1040  is attached to fixation member  1010  by passing through opening  1050 . As illustrated, flexible pull member  1040  is formed in a closed-loop by, for example, tying the ends of member  1040 , though flexible pull member  1040  need not form a closed-loop.  
         [0071]     Referring to  FIG. 11 , the apparatus  1000  can be used, for example, under arthroscopic guidance, to repair a tear  1105  in the soft tissue of a rotator cuff  910 . The physician initially forms a channel (not shown) by passing a needle, such as the needles shown in  FIGS. 3, 5 ,  6 , and  8 - 11  of U.S. application Ser. NO. 10/918,445, through a portion of the rotator cuff tissue  910  on either side of, and through, tear  1105 . As illustrated in  FIG. 11 , the physician then advances fixation member  1010  through the channel formed in tissue  910  and across tear  1105  by pulling flexible pull member  1040  in the direction of arrow  1110 . This also pulls flexible member  1030  across tear  1105  and through the channel. After fixation member  1010  has exited the channel and is positioned on a side  1120  of tear  1105 , because of the manner in which fixation member  1010  is designed and configured, fixation member  1010  rotates or toggles as it is pulled retrograde. This orientation helps to reduce the possibility of fixation member  1010  unintentionally being pulled back into the channel. As illustrated in  FIG. 11 , when fixation member  1010  is positioned proximate side  1120  of tear  1105 , flexible member  1030  traverses tear  1105  and fixation member  1020  is positioned proximate side  1130  of tear  1105 .  
         [0072]     Once fixation members  1010 ,  1020  are in position on either side ( 1120 ,  1130 , respectively) of tear  1105 , the physician cuts and removes flexible pull member  1040 . In addition, the physician pulls the trailing edge  310  of flexible member  1030  in the direction of arrow  1095  to allow the flexible member to pass through slip knot  300 , thus reducing the distance between fixation members  1010  and  1020  and causing the sides ( 1120 ,  1130 ) of tear  1105  to come into contact with each other, thereby closing the wound. The slip knot  300  limits any tendency of the length of the flexible member  1030  between fixation member  1010  and fixation member  1020  to increase. To complete the procedure, the physician cuts the trailing end  310  of flexible member  1030  adjacent slip knot  300 .  
         [0073]     A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. For example, the multifilament flexible material or the contact portion may include a growth factor, such as, for example, an angiogenic factor. The multifilament flexible material or the contact portion may be loaded with a bioactive material, a stimulant, or any substance that promotes healing of the tissue.  
         [0074]     As another example, the contact portion can be formed by stitching the ends of the multifilament flexible material together without raising the temperature at the ends by using an additional element of similar ligature as the thread. For example, if the multifilament flexible material is a type 0 size, then the thread can be a high strength polyethylene suture of 2-0, 4-0, or 8-0 size using the USP standards.  
         [0075]     As another example, in the implementation illustrated in  FIG. 8 , flexible member  140  could traverse fixation member  115  directly through, for example, openings  120 ,  130 , in the case where, for example, loop  105  is not present in the apparatus  800 . Moreover, in the implementation illustrated in  FIGS. 9A-9E , each of the steps of creating a channel, piercing the tissue, and advancing the fixation members  115 ,  150  through the channels may be performed simultaneously or one-at-a-time for each respective fixation member  115 ,  150 . Accordingly, other embodiments are within the scope of the following claims.

Technology Classification (CPC): 0