Abstract:
The present disclosure relates to a needle for attaching a fixator to a soft tissue graft. The needle includes a pointed distal end and a proximal end, the proximal end including a suture coupler, the suture coupler including a hook and a pocket formed by the hook, wherein the needle is curved along an entire length of the needle. A fixator for use with the needle and method of fixating a soft tissue graft to a bone is also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. patent application Ser. No. 61/388,056, the disclosure of which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND  
       [0002]    1. Field of Technology 
         [0003]    The present disclosure relates generally to tissue graft fixation and, specifically, to components for use in tissue graft fixation. 
         [0004]    2. Related Art 
         [0005]    In ligament reconstruction surgery, if the graft used is harvested from the quad tendon, the choice to use a particular type of fixation device, namely an Endobutton®, requires the use of a suture and a whip type of stitch, which requires the need to tie a knot. The use of knots involves a certain amount of variation in stiffness from knot to knot. The Endobutton® CL uses a continuous loop of suture, which has no knot and has demonstrated superior strength and stiffness. Methods of fixating an Endobutton® CL to a graft, especially a quad tendon, and devices for use therewith are needed. 
       SUMMARY 
       [0006]    In an aspect, the present disclosure relates to a needle for attaching a fixator to a soft tissue graft. The needle includes a pointed distal end and a proximal end, the proximal end including a suture coupler, the suture coupler including a hook and a pocket formed by the hook, wherein the needle is curved along an entire length of the needle. 
         [0007]    In an embodiment, the proximal end further includes a passage and an opening to the passage. In an embodiment, the proximal end further includes a groove on each side of the proximal end. In another embodiment, the needle includes a channel along the length of the needle. In yet another embodiment, the grooves intersect with the pocket. In a further embodiment, the needle further includes a fixator coupled to the needle, the fixator including a flexible member coupled to the fixator, the flexible member coupling the fixator to the needle. 
         [0008]    In yet a further embodiment, a portion of the flexible member is housed within the pocket. In an embodiment, portions of the flexible member extending from the pocket are housed within the grooves. In another embodiment, the flexible member is in the form of a continuous loop, the loop including a first end housed within the pocket and a second end coupled to the fixator. In yet another embodiment, the fixator includes at least one hole, the second end of the suture coupled to the fixator via use of the hole. In a further embodiment, the fixator includes two holes, the second end of the suture coupled to the fixator via use of the two holes. In yet a further embodiment, the fixator includes four holes, the second end of the suture couped to the fixator via use of two of the holes, a trailing suture coupled to the third hole, and a leading suture coupled to the fourth hole. 
         [0009]    In another aspect, the present disclosure relates to a method of fixating a soft tissue graft to bone. The method including coupling a fixator to the soft tissue graft via use of a needle, the needle including a pointed distal end, and a proximal end, the proximal end including a suture coupler, the suture coupler including a hook and a pocket formed by the hook, wherein the needle is curved along an entire length of the needle; and coupling the soft tissue graft to the bone via use of the fixator. 
         [0010]    In an embodiment, the method further includes passing the soft tissue graft through a tunnel within the bone, the bone including a femur. In another embodiment, the fixator includes a flexible member coupled to the fixator, the flexible member coupling the fixator to the needle. In yet another embodiment, a portion of the flexible member is housed within the pocket. In a further embodiment, the flexible member is in the form of a continuous loop, the loop including a first end housed within the pocket and a second end coupled to the fixator. 
         [0011]    In yet a further embodiment, the fixator includes at least one hole, the second end of the suture coupled to the fixator via use of the hole. In an embodiment, the fixator includes two holes, the second end of the suture coupled to the fixator via use of the two holes. In another embodiment, the fixator includes four holes, the second end of the suture coupled to the fixator via use of two of the holes, a trailing suture coupled to a third hole, and a leading suture coupled to a fourth hole. 
         [0012]    Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings: 
           [0014]      FIG. 1  shows a side view of the needle of the present disclosure. 
           [0015]      FIG. 2  shows an isometric view of the needle of  FIG. 1 . 
           [0016]      FIG. 3  shows an isometric view of the needle of  FIG. 1  coupled to a fixator of the present disclosure. 
           [0017]      FIGS. 4-12  show the method of fixating a soft tissue graft to bone of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0018]    The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. 
         [0019]      FIGS. 1 and 2  show the needle  10  of the present disclosure. The needle  10  includes a distal end  11  and a proximal end  12 . For the purposes of this disclosure, the distal end  11  is pointed. However, it is within the scope of this disclosure for the distal end  11  to not be pointed. The proximal end  12  includes a suture coupler  12   a  having a passage  12   b  and an opening  12   b′  to the passage  12   b,  a hook  12   c,  and a pocket  12   d  formed by the hook  12   c . Additionally, the suture coupler  12   a  includes grooves  12   e  on each side of the coupler  12   a , which intersect with the pocket  12   d.  For the purposes of this disclosure, the needle  10  is curved along its entire length. However, it is within the scope of this disclosure for the needle  10  to not be curved. Furthermore, the needle  10  includes channels  13  along a length of the needle  10 . It is within the scope of this disclosure for the needle to have less than two channels  13  or no channels  13 . The purposes of the pocket  12   d  and the grooves  12   e  are for housing of a portion or portions of suture, as will be further described below. The needle  10  is made from a biocompatible metal material and via a process known to one of skill in the art. However, other material that would allow the needle  10  to be strong enough to be used for its intended purpose may be used. 
         [0020]      FIG. 3  shows the needle  10  with a fixator  20  coupled to the needle  10 . The fixator  20  is an Endobutton®CL, manufactured and sold by Smith &amp; Nephew, Inc. The fixator  20  includes a fixation device  21  and a closed loop suture  22  coupled to the fixation device  21 . A first end  22   a  of the suture  22  is coupled to the suture coupler  12   a  by placing the end  22   a  through the opening  12   b ′ of the passage  12   b,  through, the passage  12   b,  and into the pocket  12   d.  The hook  12   c  substantially reduces the possibility of the end  22   a  from escaping the pocket  12   d  and thereby de-coupling from the needle  10 . The fixation device  21  includes four holes  21   a,    21   b  with a second end  22   b  of the suture  22  coupled to two of the holes  21   a.  It is within the scope of this disclosure for the fixation device  21  to include one hole  21   a  and for the end  22   a  of suture  22  to be coupled to the fixation device  21  via the one hole  21   a.  Additionally, the fixation device  21  includes two additional holes  21   b.  These holes  21   b  are for housing of trailing and leading sutures, as is further described in U.S. Pat. Nos. 5,306,301, 5,645,588, 6,533,802, and 7,530,990, the disclosures of which are incorporated herein by reference in their entireties. 
         [0021]      FIGS. 4-12  show a method of coupling a soft tissue graft  30  to bone.  FIG. 4  shows a soft tissue graft  30 . For the purposes of this disclosure, the graft  30  is a quad tendon. However, the graft  30  could be another human or animal soft tissue or a synthetic tissue. The graft  30  includes a first end  31  and a second end  32 . While not shown in  FIGS. 4-12 , the first end  31  includes bone. The second end  32 , which doesn&#39;t include bone, is the end that the fixator  20  is coupled to. As shown in  FIGS. 4 and 5 , the needle  10  is placed through a first location  32   a  of end  32  and pulled through the graft  30 . As shown in  FIGS. 6-8 , the needle  10  is subsequently brought back around the graft  30 , placed through a second location  32   b  of end  32 , and pulled through the graft  30 . As shown in  FIGS. 9-11 , the needle  10  is brought back around the end  32  such that suture end  22   a  is looped around end  32 . The needle  10  may then be removed from the suture  22  by removing needle  10  from end  22   a.  As shown in  FIG. 12 , the final step is to pull on the fixation device  21  to tension suture  22  around end  32 . For the purposes of this disclosure, the needle  10  is placed through the graft  30  twice. However, it is within the scope of this disclosure to place the needle  10  through the graft  30  more or less than two times. 
         [0022]    Once the fixator  20  has been coupled to the graft  30 , the graft  30  can be pulled through bone tunnels located in the tibia and femur and the graft  30  may be affixed to the femur by resting the fixation device  21  on the outer surface of the femur, as more fully explained in the &#39;301, &#39;588, &#39;802, and &#39;990 patents. For the purposes of this disclosure, the method involves the use of the needle  10  and fixator  20  with a soft tissue graft in ligament reconstruction surgery on the knee. However, the needle  10  and fixator  20  may be used with a soft tissue graft in connection with another type of surgery. 
         [0023]    As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.