Abstract:
Methods and apparatuses for repairing a tear in soft tissue are disclosed. A method according to the principles of the present disclosure includes connecting an intermediate member to a bone anchor and placing the intermediate member on the soft tissue. The method further includes inserting a first suture through the intermediate member and the soft tissue to attach the intermediate member to the soft tissue and fixing the bone anchor to bone to secure the soft tissue to the bone.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of: (1.) U.S. patent application Ser. No. 13/288,459 filed on Nov. 3, 2011, and (2.) U.S. patent application Ser. No. 13/288,463 filed on Nov. 3, 2011. The entire disclosures of each of the above applications are incorporated herein by reference. 
     
    
     FIELD 
       [0002]    The present disclosure relates to methods and apparatuses for stitching tendons. 
       BACKGROUND 
       [0003]    This section provides background information related to the present disclosure which is not necessarily prior art. 
         [0004]    Tears caused by trauma or disease in soft tissue, such as cartilage, ligament, or muscle, can be repaired by suturing. A suture construct may be used to secure the soft tissue to bone. One end of the suture construct may be secured to the soft tissue using stitches, and the other end of the suture construct may be secured to the bone using an anchor. The suture construct may include an adjustable loop including strands that may be pulled to reduce the size of the adjustable loop and thereby bring the soft tissue closer to bone. 
         [0005]    Occasionally, the stitches securing the suture construct to the soft tissue may pull through the tissue. In particular, the stitch closest to the end of the tissue tear, adjacent to the anchor, may pull through the tissue, resulting in considerable movement of the soft tissue with respect to its original location in or on the bone. Thus, there is a need in the relevant art for tissue repair techniques and associated devices for facilitating suturing and stitching while preventing stitches from pulling through tissue. 
       SUMMARY 
       [0006]    This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
         [0007]    Methods and apparatuses for repairing a tear in soft tissue are disclosed. A method according to the principles of the present disclosure includes connecting an intermediate member to a bone anchor and placing the intermediate member on the soft tissue. The method further includes inserting a first suture through the intermediate member and the soft tissue to attach the intermediate member to the soft tissue and fixing the bone anchor to bone to secure the soft tissue to the bone. 
         [0008]    Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0009]    The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
           [0010]      FIG. 1  is a perspective view of a first example of an intermediate member routed through a flexible anchor and placed on one side of soft tissue, with stitches extending through the intermediate member and into the soft tissue; 
           [0011]      FIG. 2  is a side view of the intermediate member and soft tissue connected to the flexible anchor using a suture construct including an adjustable loop; 
           [0012]      FIG. 3  is a top view of the intermediate member, soft tissue, flexible anchor, and suture construct of  FIG. 2 ; 
           [0013]      FIG. 4  is a side view of the intermediate member, soft tissue, flexible anchor, and suture construct of  FIG. 2 , with the intermediate member placed around the soft tissue and secured to the soft tissue using stitches; 
           [0014]      FIG. 5  is a side view similar to that shown in  FIG. 4  but with the intermediate member secured to the soft tissue using flexible anchors arranged in an inline configuration; 
           [0015]      FIG. 6  is a side view similar to that shown in  FIG. 4  but with the intermediate member secured to the soft tissue using flexible anchors arranged in a u-shaped configuration; 
           [0016]      FIGS. 7A and 7B  are perspective views of adjustable loops extending through soft tissue and a second example of an intermediate member, with locking members inserted through the adjustable loops; 
           [0017]      FIGS. 8 and 9  are perspective views of a third example of an intermediate member connected to a flexible anchor using an adjustable loop, the intermediate member including needles for additional fixation to soft tissue; 
           [0018]      FIG. 10  is a perspective view of a fourth example of an intermediate member connected to a flexible anchor using an adjustable loop, with stitches extending through the intermediate member and into soft tissue; 
           [0019]      FIGS. 11 and 12  are perspective views of a fifth example of an intermediate member including an adjustable loop that is routed through a flexible anchor to secure the soft tissue to the flexible anchor; and 
           [0020]      FIGS. 13A and 13B  are side views of the intermediate member, soft tissue, flexible anchor, and suture construct of  FIGS. 11 and 12 , with the flexible anchor inserted into bone to secure the soft tissue to the bone. 
       
    
    
       [0021]    Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0022]    Example embodiments will now be described more fully with reference to the accompanying drawings. 
         [0023]    Referring to  FIG. 1 , an intermediate or load-dispersing member  10  is shown routed through a flexible anchor  12 , with stitches  14  extending through the intermediate member  10  and into soft tissue  16  to secure the intermediate member  10  to the soft tissue  16 . The arrangement shown in  FIG. 1  may be used to repair a tear in the soft tissue  16  such as by attaching the soft tissue  16  to another piece of soft tissue or to bone. Instead of applying tension directly to the stitches  14  when attaching the soft tissue  16  to another piece of soft tissue or to bone, tension may be applied to the intermediate member  10 , which in turn applies tension to the stitches  14 . The intermediate member  10  aids in the distribution of load on the stitches  14  to increase the stiffness and maximum failure strength of the repair. In this regard, the intermediate member  10  is configured to increase pull-out forces of the stitches  14  and transfer load from those of the stitches  14  disposed closest to the flexible anchor  12  to those of the stitches  14  disposed further away from the flexible anchor  12 . The intermediate member  10  may be folded over to form first and second segments  18 ,  20 , both of which may be placed on one side of the soft tissue  16 . 
         [0024]    The intermediate member  10  may be a flat, planar ribbon or sheath having a width that is greater than its thickness. The intermediate member  10  may be sufficiently strong to prevent the stitches  14  from being pulled therethrough without tearing the intermediate member  10  but flexible enough to enable manipulation thereof. The intermediate member  10  may be made from polyester, polyethylene, polyurethane urea, and/or bioresorbable material. The intermediate member  10  may be braided, knit, or woven and/or may include a mesh or matrix such as a SportMesh™ Soft Tissue Reinforcement, available from Arthrotek®, a Biomet® company of Warsaw, Ind. 
         [0025]    The flexible anchor  12  defines a passage  22  through which the intermediate member  10  is routed. The flexible anchor  12  may be inserted into a hole drilled into bone, and tension may be applied to first and second segments  18 ,  20  of the intermediate member to set the flexible anchor  12 . In turn, the flexible anchor  12  engages the portion of the bone surrounding the hole and thereby secures the soft tissue  16  to the bone. The flexible anchor  12  may be a JuggerKnot™ Soft Anchor, available from Biomet® of Warsaw, Ind. Further examples of flexible anchors are disclosed in U.S. Patent Application Publication No. 2011/0264141, filed on Jul. 6, 2011, which is incorporated by reference herein in its entirety. 
         [0026]    Referring to  FIGS. 2 and 3 , the intermediate member  10  is shown connected to the flexible anchor  12  using a preformed adjustable self-locking suture construct  24  that includes a tensioning member  26  such as a double-loop configuration having two adjustable loops  28 ,  30 . The tensioning member  26  may incorporate Ziploop™ Technology, available from Biomet of Warsaw, Ind. The tensioning member  26  includes a suture  32  having a first end  34  and a second end  36 . The suture  32  includes a braided body  38  having a first end  40  and a second end  42  and defining a passage  44  therein. 
         [0027]    To form the suture construct  24 , the first end  34  of the suture  32  can be inserted through the passage  22  in the flexible anchor  12  to position the first and second ends  40 ,  42  of the braided body  38  on opposite sides of the passage  22  as shown. The first end  34  of the suture  32  can then be inserted through the first end  40  of the braided body  38 , through the passage  44  in the braided body  38 , and out the second end  42  of the braided body  38  to form the adjustable loop  28 . The second end  36  of the suture  32  can then be inserted through the second end  42  of the braided body  38 , through the passage  44  in the braided body  38 , and out the first end  40  of the braided body  38  to form the adjustable loop  30 . The first and second ends  34 ,  36  can then be tied together to form a knot  46  as shown or left as separate strands. The flexible anchor  12  and the suture construct  24  can be provided together with the suture construct  24  formed as shown. 
         [0028]    To secure the soft tissue  16  to bone, the intermediate member  10  can be inserted partially through the adjustable loops  28 ,  30 , folded, and placed on one side of the soft tissue  16  to form a loop  48 . The stitches  14  can then be formed through the intermediate member  10  and the soft tissue  16  to fix the intermediate member  10  to the soft tissue  16 . The flexible anchor  12  can then be fixed within the bone, and the first and second ends  34 ,  36  of the suture  32  can be pulled to decrease the size of the adjustable loops  28 ,  30 . As the size of the adjustable loops  28 ,  30  decreases, the soft tissue  16  is pulled closer to the location where the flexible anchor  12  is fixed to the bone. 
         [0029]    In various implementations, the suture construct  24  may include multiple adjustable loops and/or multiple braided bodies arranged in various configurations. Further examples of suture constructs are disclosed in U.S. Pat. No. 7,601,165, filed on Sep. 29, 2006, and U.S. Pat. No. 7,959,650, filed on Aug. 22, 2008, which are incorporated by reference herein in their entirety. Further examples of suture constructs incorporating flexible anchors are disclosed in U.S. Pat. No. 7,905,904, filed on Jan. 15, 2008, and U.S. Patent Application Publication No. 2011/0098727 (“the &#39;727 publication”), filed on Oct. 29, 2010, which are incorporated by reference herein in their entirety. An exemplary embodiment of a preformed adjustable self-locking suture construct including a double-loop configuration is disclosed in FIG. 14 of the &#39;727 publication, although other embodiments of the &#39;727 publication may be employed. 
         [0030]    Referring to  FIG. 4 , the first and second segments  18 ,  20  of the intermediate member  10  are shown placed on opposite sides of the soft tissue  16  and secured to the soft tissue  16  using stitches  50 . To form each of the stitches  50 , a suture  52  may be passed through the first segment  18 , the soft tissue  16 , and the second segment  20  in one direction. The suture  52  may then be passed back through the first segment  18 , the soft tissue  16 , and the second segment  20  in the opposite direction to form a loop  54 . Opposite ends of the suture  52  may then be tied together to form a knot  56 . 
         [0031]    Referring to  FIG. 5 , the intermediate member  10  is shown wrapped around the soft tissue  16  with the first and second segments  18 ,  20  placed on opposite sides of the soft tissue  16  and secured to the soft tissue  16  using preformed adjustable self-locking suture constructs  58  arranged in an inline configuration. Each of the suture constructs  58  includes flexible anchors  60 ,  62  positioned on opposite sides of the soft tissue  16  and held together using a tensioning member  64 . Each of the tensioning members  64  can include a suture  65  arranged in a double-loop configuration with two adjustable loops  66 ,  67  and ends  68 . The tensioning members  64  may incorporate Ziploop™ Technology, available from Biomet of Warsaw, Ind. 
         [0032]    Each of the suture constructs  58  may be preformed by passing the ends  68  of the suture  65  through passages in the flexible anchors  60 ,  62  in a manner similar to that described above with respect to the suture construct  24 . One of the flexible anchors  60 ,  62  may then be pushed through the soft tissue  16  to position the flexible anchors  60 ,  62  on opposite sides of the soft tissue  16 . The ends  68  of the suture  65  may then be pulled to decrease the size of the adjustable loops  66 ,  67  and thereby bring the first and second segments  18 ,  20  of the intermediate member  10  closer to each other. The ends  68  of the suture  65  may then be tied together as shown or left as separate strands. An exemplary suture construct including a double-loop configuration passed through two flexible anchors is disclosed in FIG. 14 of the &#39;727 publication. 
         [0033]    Referring to  FIG. 6  the intermediate member  10  is shown wrapped around the soft tissue  16  with the first and second segments  18 ,  20  placed on opposite sides of the soft tissue  16  and secured to the soft tissue  16  using preformed adjustable self-locking suture constructs  69  arranged in a u-shaped configuration. Each of the suture constructs  69  includes flexible anchors  70 ,  72  positioned on the same side of the soft tissue  16  and held together using a tensioning member  74 . Each of the tensioning members  74  includes a suture  75  arranged in a double-loop configuration with adjustable loops  76 ,  77  and ends  78 . The tensioning members  74  may incorporate Ziploop™ Technology, available from Biomet of Warsaw, Ind. 
         [0034]    Each of the suture constructs  69  may be preformed by passing the ends  78  of the suture  75  through passages in the flexible anchors  70 ,  72  in a manner similar to that described above with respect to the suture constructs  58 . One of the flexible anchors  70 ,  72  may then be pushed through the soft tissue  16  in one direction and then pushed through the soft tissue  16  again in the opposite direction to position the flexible anchors  70 ,  72  on the same side of the soft tissue  16 . The ends  78  of the suture  75  may then be pulled to decrease the size of the adjustable loops  76 ,  77  and thereby bring the first and second segments  18 ,  20  of the intermediate member  10  closer to each other. The ends  78  of the suture  75  may then be tied together as shown or left as separate strands. 
         [0035]    Referring to  FIGS. 7A and 7B , an intermediate member  80  is shown wrapped around the soft tissue  16  to form spaced apart segments  80   a ,  80   b  with the soft tissue  16  disposed between the segments  80   a ,  80   b  and suture constructs  82  extending through the segments  80   a ,  80   b  and the soft tissue  16 . Each of the suture constructs  82  includes a suture  84  arranged in a double-loop configuration with two adjustable loops  86 ,  87  and ends  88 . The suture constructs  82  may incorporate Ziploop™ Technology, available from Biomet of Warsaw, Ind. An exemplary suture construct including two adjustable loops is disclosed in FIG. 4A of U.S. Pat. No. 7,601,165. 
         [0036]    Each of the suture constructs  82  may be preformed in a manner similar to that described above with respect to the suture construct  24 . The adjustable loops  86 ,  87  may then be pushed partially through the intermediate member  80  and the soft tissue  16  to position portions of the adjustable loops  86 ,  87  on both opposite sides of the soft tissue  16  as shown. The ends  88  of the suture  84  may then be pulled to decrease the size of the adjustable loops  86 ,  87 . The ends  88  may then be tied together as shown or left as separate strands. 
         [0037]    Locking members  90  may be inserted into the adjustable loops  86  to prevent the adjustable loops  86  from being pulled through the intermediate member  80  when the ends  88  are pulled. The locking members  90  may have sufficient rigidity and size to prevent the adjustable loops  86  from being pulled through the intermediate member  80  but flexible enough to enable manipulation thereof. The locking members  90  may be strips, rods, or sutures, may be made from polyester, polyethylene, and/or polyether ether ketone (PEEK), and may have a thickness or diameter between 0.25 millimeters (mm) and 0.5 mm. Further examples of suture constructs and locking members are disclosed in U.S. Patent Application Publication No. 2011/0208240 (see, e.g., FIGS. 4 through 6), filed on May 2, 2011, which is incorporated by reference herein in its entirety. 
         [0038]    Referring to  FIG. 8 , an intermediate member  100  defines a plurality of bifurcations or openings  102 . The intermediate member  100  may be a flat, planar ribbon or sheath having a width that is greater than its thickness. The intermediate member  100  may be formed (e.g., braided) from polyester, polyethylene, polyurethane urea, and/or bioresorbable material. Each end of the intermediate member  100  has suture ends  104  extending therefrom and converging at a connection  106  between the suture ends  104  and a needle  108 . The suture ends  104  may be incorporated as part of the intermediate member  100  or be separate and passed through passages within the intermediate member  100 . In one example, the intermediate member  100  can be formed by braiding portions of a plurality of strands and the unbraided portions of the strands may form the suture ends  104 . 
         [0039]    The intermediate member  100  is shown connected to the flexible anchor  12  using a preformed adjustable self-locking suture construct  110  that includes a double-loop configuration with two adjustable loops  112 ,  113  and ends  114 . The suture construct  110  may be formed in the manner described above with respect to the suture construct  24 . When the flexible anchor  12  is secured to bone, the ends  114  may be pulled to decrease the size of the adjustable loop  112  and thereby bring the intermediate member  100  closer to the flexible anchor  12 . Further examples of suture constructs including adjustable loops and needles are disclosed in U.S. Patent Application Publication No. 2012/0046693 (see, e.g., FIG. 13), filed on Nov. 3, 2011, which is incorporated by reference herein in its entirety. 
         [0040]    Referring to  FIG. 9 , the intermediate member  100  may be placed around the soft tissue  16  to form spaced-apart segments  100   a ,  100   b  with the soft tissue  16  disposed therebetween, and the needles  108  may be inserted into the soft tissue  16  to secure the intermediate member  100  to the soft tissue  16 . Sutures  116 ,  118  may then be passed through the openings  102  as the sutures  116 ,  118  are stitched in and out of the soft tissue  16 . The sutures  116 ,  118  are stitched in and out of the soft tissue  16  towards a distal end  120  of the soft tissue  16  on one side of the soft tissue  16  and then stitched back in the opposite proximal direction on the opposite side of the soft tissue  16 . The ends of the suture  116  may then be tied to the ends of the suture  118  as shown and the needles  108  may be cut. 
         [0041]    Instead of placing the intermediate member  100  around the soft tissue  16  as shown, both ends of the intermediate member  100  may be placed on one side of the soft tissue  16  in a manner similar to that shown in  FIGS. 1 through 3 . In addition, various stitching methods other than that shown in  FIG. 9  can be utilized to secure the intermediate member  100  to the soft tissue  16 . In any of these variations, the intermediate member  100  transfers load from near the end  120  of the soft tissue  16  to further away from the flexible anchor  12  and the intermediate member  100  reinforces the suture/tendon interfaces. 
         [0042]    Referring to  FIG. 10 , an intermediate member  130  may be a thin, flat, planar ribbon or braid having a width that is greater than its thickness. The intermediate member  130  may be similar to the intermediate member  10  of  FIG. 1 . However, the intermediate member  10  of  FIG. 1  may be sized to cover a larger surface area on the soft tissue  16 , such as between 50 and 60 percent of the soft tissue surface area, to better distribute the load to the stitches  14 . In contrast, the intermediate member  130  may be sized to cover a smaller surface area on the soft tissue  16 , such as about 10 percent of the soft tissue surface area, to maximize the direct contact between the soft tissue  16  and bone and thereby promote integration. 
         [0043]    In various implementations, an orthopedic matrix or mesh  132  may be wrapped around the soft tissue  16  and the intermediate member  130  may be placed over the mesh  132  on opposite sides of the soft tissue  16 . Stitches  134  may be inserted through the intermediate member  130 , through the mesh  132 , and into the soft tissue  16  to secure the intermediate member  130  to the soft tissue  16 . The stitching patterns disclosed above can be incorporated in any of the embodiments disclosed herein. Thus, for example, the stitches  14  shown in  FIGS. 1 through 3  and/or the stitches  134  shown in  FIG. 10  can incorporate one or more of the stitching patterns described with reference to  FIGS. 4 through 6 . 
         [0044]    The mesh  132  may be a SportMesh™ Soft Tissue Reinforcement, available from Arthrotek®, a Biomet® company of Warsaw, Ind. The mesh  132  may improve the distribution of load on the stitches  134  without increasing the amount of surface area on the soft tissue  16  that is completely covered. Further examples of orthopedic meshes are disclosed in U.S. Patent Application No. 2009/0318961 (see, e.g., FIGS. 36A, 36B, and 36C), filed on Jun. 22, 2009, which is incorporated by reference herein in its entirety. 
         [0045]    The intermediate member  130  is shown connected to the flexible anchor  12  using a preformed adjustable self-locking suture construct  136  that includes a double-loop configuration with adjustable loops  138 ,  139  and ends  140 . The adjustable loop  138  may be formed in the manner described above with respect to the suture construct  24 . When the flexible anchor  12  is secured to bone, the ends  140  may be pulled to decrease the size of the adjustable loop  112  and thereby bring the intermediate member  100  closer to the flexible anchor  12 . The intermediate member  130  may then be inserted partially through the adjustable loop  138  and secured to the soft tissue  16 , and the ends  140  may be pulled to bring the soft tissue  16  closer to the flexible anchor  12 . 
         [0046]    Referring to  FIGS. 11 and 12 , a two-piece suture construct  150  is shown connected to the flexible anchor  12 . The suture construct  150  includes a pair of separate sutures  152   a ,  152   b  having ends  154   a ,  154   b  and braided bodies  156   a ,  156   b  that form an intermediate member. Each of the braided bodies  156   a ,  156   b  includes a first portion  158  that defines a passage  160 , a second portion  162 , and a third portion  164 . The first portion  158  may be a generally cylindrical braid, the third portion  164  may be a relatively flat braid such as a braided ribbon, and the second portion  162  may be a transition braid from the cylindrical braid to a flat braid. The first portion  158  may be wider than the second portion  162  and narrower than the third portion  164 . 
         [0047]    To form the suture construct  150 , the suture  152   a  may be passed through the passage  160  in the braided body  156   b , and the suture  152   b  may be passed through the passage  160  in the braided body  156   a . The suture construct  150  may then be passed through the passage  44  in the flexible anchor  12  to position the braided bodies  156   a ,  156   b  on opposite sides of the passage  44  as shown. A suture  166  may then be stitched through the braided bodies  156   a ,  156   b  and the soft tissue  16  as shown in  FIG. 12  to secure the suture construct  150  to the soft tissue  16 . The suture  166  may be stitched using the crisscross pattern shown in  FIG. 12  or other stitching techniques. Further examples of two-piece suture constructs are disclosed in U.S. Patent Application Publication No. 2012/0053630 (see, e.g., FIG. 2), filed on Nov. 3, 2011, which is incorporated by reference herein in its entirety. 
         [0048]    Referring to  FIGS. 13A and 13B , the flexible anchor  12 , the suture construct  150 , and the soft tissue  16  may then be inserted into a hole  168  drilled through cancellous bone  170  and cortical bone  172 . The hole  168  may be a through bore that extends completely through the cancellous bone  170  and the cortical bone  172  as shown. Alternatively, the hole  168  may be a blind bore that extends only partially through the cancellous bone  170  and/or the cortical bone  172 . 
         [0049]    If the hole  168  is a through bore, the flexible anchor  12  may be pushed all of the way through the hole  168  and tension may be applied to the ends  154  of the suture  152  to set the flexible anchor  12  against the cortical bone  172 . If the hole  168  is a blind bore, the flexible anchor  12  may be pushed into the hole  168  and tension may be applied to the ends  154  of the suture  152  to set the flexible anchor  12  against the cancellous bone  170  and/or the cortical bone  172 . Once the flexible anchor  12  is set, applying tension to the ends  154  pulls the soft tissue  16  further into the hole  168 . Although  FIGS. 13A and 13B  illustrating attaching soft tissue to bone using the suture construct  150 , other embodiments of suture constructs and intermediate members disclosed herein may be used in a similar manner to attach soft tissue to bone. 
         [0050]    The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.