Abstract:
A surgery using a suture assembly made of a continuous length of braided suture material defining an interior lumen, and forming a loop and a tail, and further comprising a first length and a second length, conceptually divided at a midpoint of the loop. The tail includes first, intermediate and second regions. The first region is formed by the first length breaching the second length and entering the interior lumen of the second length, and extending within the second length. The intermediate region is formed by the first length breaching and exiting the second length, so that the first length and the second length extend in adjacent relation. Finally, the third region is formed by the second length breaching the first length and entering the lumen of the first length and extending within the second length. The transitions between the regions of the tail offer resistance to slippage.

Description:
RELATED APPLICATIONS 
     This application is a continuation of application Ser. No. 14/017,619, filed Sep. 4, 2013, which is incorporated herein by reference as if fully set forth herein, 
    
    
     FIELD 
     This disclosure relates to suture systems and more particularly, to suture loop apparatus and methods for use in surgical techniques. 
     BACKGROUND 
     Various surgical techniques require the use of a suture that engages tissue. Suture loops provide a loop at one end and a single tail at the other end. A known suture loop that is constructed from a braided tube suture passes one of the two tails through the lumen defined by the braided tube. Tension on the loop and the outer tail causes the braided tube to reduce in diameter and frictionally engage the inner tail that is disposed within the lumen. In instances where the tension is relieved, there may be slippage between the inner tail and the outer braid, potentially resulting in eventual disengagement. 
     In view of these and other issues, it would be most desirable to provide an improved suture loop with a positive fixation that does not rely on a constant tension to affect the fixation. 
     SUMMARY 
     In a first separate aspect, the present invention may take the form of a suture assembly made of a continuous length of braided suture material defining an interior lumen, and forming a loop and a tail, and further comprising a first length and a second length, conceptually divided at a point on the loop. The tail includes a first region most proximal to the loop, a second region most distal to the loop and an intermediate region joining the first and second regions. The first region of the tail is formed by the first length of suture material, breaching the second length of suture material and entering the interior lumen of the second length of suture material, thereby closing the loop, and extending within the second length of suture material and the intermediate region of the tail is formed by the first length of suture material breaching and exiting the second length of suture material, so that the first length of suture material and the second length of suture material extend in adjacent relation. Finally, the third region of the tail is formed by the second length of suture material breaching the first length of suture material and entering the lumen of the first length of suture material and extending within the second length of suture material. The transitions between the regions of the tail offer resistance to slippage between the first length of suture material and the second length of suture material. 
     In a second separate aspect, the present invention may take the form of a method of making a suture loop, comprises: providing a length of suture having a suture first end and a suture second end opposite the suture first end, the suture comprises a tubular braid structure comprising strands defining a suture wall having a suture outer surface and a lumen therethrough; defining a first penetration point and a second penetration point a predetermined distance from the first penetration point, the first penetration point and second penetration point are located a predetermined distance from the suture first end and suture second end; disposing the suture first end into the first penetration point, through the lumen and out of the second penetration point forming a loop; defining a third penetration point a predetermined distance from the second penetration point, with the second penetration point between the third penetration point and the first penetration point, and wherein the second penetration point and the third penetration point are adjacent to each other; and disposing the suture second end into the third penetration point and into the lumen, wherein a splice is defined at the second penetration and the third penetration. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  shows a side view of a suture loop, in accordance with an embodiment. 
         FIG. 1A  shows a detail view of circle  1 A, in  FIG. 1 . 
         FIG. 1B  shows the detail view of  FIG. 1A , rotated 90°. 
         FIG. 2  shows a side view of suture. 
         FIG. 3  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 4  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 5  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 6  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 7  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 8  shows a side view of a suture loop construct, in accordance with an embodiment. 
         FIG. 9  shows a side view of the suture loop in accordance with the embodiment of  FIG. 1 . 
         FIG. 10  shows a side view of the needled suture loop, in accordance with an embodiment. 
         FIG. 11A  shows a step in the manufacturing of a suture assembly according to one embodiment of the present invention. 
         FIG. 11B  shows a subsequent and final step in the manufacturing of a suture 
     
    
    
     DETAILED DESCRIPTION 
     References will now be made to embodiments illustrated in the drawings and specific language which will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, as such further applications of the principles of the invention as illustrated therein as being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     In accordance with embodiments, a suture loop is provided that is made entirely of braided biocompatible suture material, such as, but not limited to high strength UHMWPE (ultra-high molecular weight polyethylene), polyester, mixtures thereof, and bio-absorbable compounds and mixtures thereof. It is to be understood that any satisfactory material may be used for the suture loop. It is also understood that the suture loop may comprise a mixture of materials, such as a braid comprising strands of UHMWPE and polyester. 
     In accordance with embodiments, a suture loop is provided that includes a fixed loop size whose fixation is not dependent on maintaining tension on the suture so as to engage an outer braid onto an inner tail. This ensures firm, reliable fixation throughout various physiological conditions, such as, but not limited to, during the healing process and body movement. 
       FIG. 1  is a side view of an embodiment of a suture assembly  1 , comprising a loop  50  and a tail  60 . Assembly  1  is made of a continuous length of braided, lumen-defining suture material  10 , having a first end  11  and a second end  12 . Entirely for ease of description, suture material may be conceptually divided into a first length  24 , extending from end  11  to a midpoint of length  10 , and a second length  26  extending from end  12  to the midpoint of length  10 . 
     Referring to  FIG. 2 , there is shown a length of suture  10  having a suture first end  11  and a suture second end  12  opposite the suture first end  11 . The suture  10  comprises a tubular braid structure comprising strands defining a suture wall  13  having a suture outer surface  14  and a lumen  16  therethrough, as shown in  FIG. 4 . The lumen  16  comprises a first end lumen portion  17  at the suture first end  11  and a second lumen portion  18  near too, but displaced from, the suture second end  12 . 
     In the embodiment of  FIG. 1 , the loop  50  is defined by the entry of first length  24  into second length  26  at penetration point  31 . Referring more specifically to  FIGS. 1A and 1B , first length  24  extends within lumen  18  of length  26  until it reaches a second penetration point  32 , where first length  24  emerges from lumen  18  of second length  26 . First length  24  and second length  26  extend in adjacent relation until a third penetration point  33 , where second length  26  enters lumen  17  of first length  24 . Second length  26  extends within first length  24  until either end  11  or end  12  (as shown in  FIG. 1 ) is reached. 
     As shown in  FIG. 1 , a first tail region  20  is defined as that region where the suture first end  11  is within the second end lumen portion  18 . A second tail region  22  is defined as that region where the suture second end  12  is within the first end lumen portion  17 . The region between the first tail region  20  and the second tail region  22  is defined as a third tail region  36 . Relative motion between the suture first end  11  and the suture second end  12  is prevented by the exit of first length  24  from second length  26  at second penetration point  32 , and the entry of second length  26  into first length  24  at third penetration point  33 . Typically, intermediate region  36  is less than a centimeter in length. 
     An embodiment of a method of making a suture loop  1  comprises providing a length of suture  10  having a suture first end  11  and a suture second end  12  opposite the suture first end  11 . The suture  10  comprises a tubular braid structure comprising strands defining a suture wall  13  having a suture outer surface  14  and a lumen  16  therethrough, as shown in  FIG. 2 . Defining a first penetration point  31  and a second penetration point  32  a predetermined distance from the first penetration point  31 , the first penetration point  31  and second penetration point  32  are located a predetermined distance from the suture first end  11  and suture second end  12 , as shown in  FIG. 3 . Providing a lacing tool  40  comprising an elongated shaft  43  having a shaft first end  41  and a shaft second end  42 , a handle  46  optionally formed in the shaft second end  42 , the shaft first end  41  formed into a hook  45 , the shaft first end  41  further comprising a lever  48  pivotally coupled to the shaft first end  41  adjacent the hook  45  operable to close the hook  45  in a first position and to open the hook  45  in a second position, as shown in  FIG. 4 . Advancing the hook  45  of the lacing tool  40  from the suture outer surface  14  to the lumen  16  at the second penetration point  32  by advancing the hook  45  through the strands of the braid without breaking the strands. Advancing the hook  45  to the first penetration point  31  within the lumen  16 . Advancing the hook  45  from the lumen  16  to the suture outer surface  14  at the first penetration point  31  by advancing the hook  45  through the strands of the braid without breaking the strands, a portion of the shaft  43  extending through the lumen  16  between the second penetration point  32  and the first penetration point  31 , as shown in  FIG. 4 . Placing the suture first end  11  into the hook  45  and closing the lever  48 , as shown in  FIG. 4 . Pulling the hook  45  so as to pull the suture first end  11  into the first penetration point  31 , through the lumen  16  and out of the second penetration point  32  forming a loop  50  and removing the lacing tool  40  from the suture  10 , as shown in  FIG. 5 . 
     The method further comprising defining a third penetration point  33  and a fourth penetration point  34  a predetermined distance from the second penetration point  32 , with the second penetration point  32  between the third penetration point  33  and the first penetration point  31 , and wherein the second penetration point  32  and the third penetration point  33  are adjacent to each other, as shown in  FIG. 6 . Advancing the hook  45  of the lacing tool  40  from the suture outer surface  14  to the lumen  16  at the fourth penetration point  34  by advancing the hook  45  through the strands of the braid without breaking the strands. Advancing the hook  45  to the third penetration point  33  within the lumen  16 . Advancing the hook  45  from the lumen  16  to the suture outer surface  14  at the third penetration point  33  by advancing the hook  45  through the strands of the braid without breaking the strands, a portion of the shaft  43  extending through the lumen  16  between the fourth penetration point  34  and the third penetration point  33 , as shown in  FIG. 7 . Placing the suture second end  12  into the hook  45  and closing the lever  48 , as shown in  FIG. 7 . And, pulling the hook  45  so as to pull the suture second end  12  into the third penetration point  33 , into the lumen  16 , wherein a length of the suture second end  12  is predetermined such that the suture second end  12  does not exit the lumen  16  when the lacing tool  40  is withdrawn from the suture  10  at the fourth penetration point  34 , as shown in  FIG. 8 . 
       FIG. 1  shows the resulting suture loop  1  made in accordance with the embodiment provided above.  FIG. 9  shows a side view of the suture loop  1  of the embodiment of  FIG. 1 . 
       FIG. 10  shows a side view of a suture loop  1  wherein a needle  90  is coupled to the tail  60 .  FIGS. 11A and 11B  show steps in the process of manufacturing a suture assembly having a curved needle  92  at the end of the tail  60 . In accordance with an embodiment, the end  96  of the needle  92  that is opposite the sharp point  94  forms a hollow tube  98  of malleable metal (a “swage” in industry terminology). The end  11  of tail  60  is inserted into hollow tube  98 , to which force  100  is then applied to crimp (“swage,” in industry terminology) needle end  96  about end  11  of tail  60 . 
     A method of making a suture loop, in accordance with an embodiment, comprising providing a length of suture having a suture first end and a suture second end opposite the suture first end, the suture comprising a tubular braid structure comprising strands defining a suture wall having a suture outer surface and a lumen therethrough, defining a first penetration point and a second penetration point a predetermined distance from the first penetration point, the first penetration point and second penetration point are located a predetermined distance from the suture first end and suture second end, disposing the suture first end into the first penetration point, through the lumen and out of the second penetration point forming a loop, defining a third penetration point a predetermined distance from the second penetration point, with the second penetration point between the third penetration point and the first penetration point, and wherein the second penetration point and the third penetration point are adjacent to each other; and disposing the suture second end into the third penetration point and into the lumen. 
     By way of example of the use of embodiments of the suture assembly  1  herein, an anterior cruciate ligament graft may be prepared by arranging loop  50  about the graft, piercing the transverse center of the graft with needle  90 , pulling the tail  60  through the graft until loop  50  is taut about the graft, moving the needle laterally along the graft, and repeating the operation, to form a “baseball stitch.” 
     A method for using a suture assembly  1  comprises advancing the needle  90  and tail  60  into and out of two tissue portions, advancing the tail  60  through the loop  50 , pulling tension on the tail  60  such that the loop  50  and the tail  60  engage the two tissue portions such that the two tissue portions are drawn together, and tying a knot in the tail  60  to retain the suture loop  50  in engagement with the two tissue portions. 
     Another method for using a suture assembly  1  comprises advancing the needle  90  into and out of a first tissue portion, advancing the tail  60  through the loop  50 , pulling tension on the tail  60  such that the loop  50  and the tail  60  engage the first tissue portion such that the suture loop  50  is anchored to the first tissue portion, advancing the tail  60  through a second tissue portion, pulling tension on the tail  60  such that the tail  60  engages the first tissue portion and the second tissue portion such that the first tissue portion and the second tissue portions are drawn together, and tying a knot in the tail  60  to retain the suture loop  50  in engagement with the first tissue portion and the second tissue portion. 
     One type of surgery in which tissue portions are engaged together are surgeries reattaching muscle to ligament, from which it has been torn away. For example, repair of the attachment of calf muscle to the Achilles tendon. 
     While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification, and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth, and as fall within the scope of the invention and the limits of the appended claims.