Abstract:
A suture including a knotted end effector is provided. The suture includes a body portion defining a longitudinal axis and an end effector integrally formed from the body portion. The end effector includes first and second extensions extending outwardly from the longitudinal axis in opposite directions. Each of the first and second extensions includes at least one throw.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims benefit of and priority to U.S. Provisional Application No. 61/104,085, filed Oct. 9, 2008, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to sutures for use in medical procedures. More particularly, the present disclosure relates to a knotted end effector for a suture. 
         [0004]    2. Background of Related Art 
         [0005]    Medical sutures may be formed from a variety of materials and may be configured for use in limitless applications. The proximal end of the suture may have a sharpened tip or may include a needle for penetrating tissue. A distal end of the suture may include an anchor or end effector for maintaining the suture in engagement with the tissue as the suture is pulled through the tissue. End effectors are available in many size and configurations. Typically, an end effector is formed independently of the suture and is later attached to the distal end of the suture. 
         [0006]    In many instances, a clinician may prefer to tie a knot in the suture to anchor the suture within the tissue. Although the clinician may find this practice convenient, the knot formed on the end of the tissue is not always suitable to prevent the suture from being pulled through the tissue, for example, when the knot slips or is too small to engage the tissue. Additionally, the tying of a knot, especially with the fine suture material required for use in many procedures, is tedious and time consuming. 
         [0007]    Therefore, a continuing need exists for a knotted end effector and a method of making a knotted end effector. 
       SUMMARY 
       [0008]    Accordingly, a suture including a knotted end effector is provided. The suture includes a body portion defining a longitudinal axis and an end effector integrally formed from the body portion. The end effector includes first and second extensions extending outwardly from the longitudinal axis in opposite directions. Each of the first and second extensions include at least one throw. The end effector may be substantially perpendicular to the longitudinal axis. The first and second extensions may include a plurality of throws. The first and/or second extension may include three (3) throws. The end effector may include substantially T-shape and may be formed on a distal end of the body portion. 
         [0009]    Also provided is a method of forming an end effector. The method includes the steps of providing a length of suture, crossing a first end of the suture over a second end of a suture to form a first loop, wrapping the first end of the suture around the suture within the first loop “n” number of times, placing the suture about a fixture between the first loop and the first end, wrapping the first end of the suture around the fixture to form a second loop, wrapping the first end of the suture around the suture within the first loop “m” number of times, pulling the first and second ends in opposite directions to tighten the first and second loops about the fixture, threading the first end of the suture through the second loop to form a third loop, threading the second end of the suture through the second loop to form a third loop, removing the suture from the fixture, pulling the third and fourth loops in opposite directions to tighten the first and second loops and pulling the first and second ends of the suture in opposite directions to tighten the third and fourth loops. 
         [0010]    The method may further include the step of trimming the first end of the suture. The fixture may include a channel for receiving first and second ends of the suture. The step of threading the first end of the suture through the second loop may be performed from the top down or from the bottom up. The step of threading the second end of the suture through the second loop may be performed from the top down or from the bottom up. Variables “n” and “m” may be equal or different. In one embodiment, variables “n” and “m” may equal three (3). 
         [0011]    Further provided is a suture including a body portion defining a longitudinal axis and an end effector integrally formed from the body portion. The end effector includes first and second extensions extending perpendicular to the longitudinal axis in opposite directions. Each of the first and second extensions are undulated. The first and second extensions may each include a plurality of throws. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
           [0013]      FIG. 1  is a back view of an end effector according to an embodiment of the present disclosure; 
           [0014]      FIG. 2  is a front view of the end effector of  FIG. 1 ; 
           [0015]      FIGS. 3-15  show sequential steps of a method of forming the end effector of  FIGS. 1 and 2 . 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Referring initially to  FIGS. 1 and 2 , an embodiment of an end effector according to the present disclosure is shown generally as end effector  10 . Although, as shown, end effector  10  is formed on a distal end  12   b  of suture  12 , end effector  10  may be formed anywhere along the length of suture  12 . 
         [0017]    Suture  12  may be formed of degradable materials, non-degradable materials, and combinations thereof. More particularly, suture  12  may be formed of a degradable material selected from the group consisting of polyesters, polyorthoesters, polymer drugs, polydroxybutyrates, lactones, proteins, cat gut, collagens, carbonates, homopolymers thereof, copolymers thereof, and combinations thereof. In other embodiments, suitable degradable materials which may be utilized to form suture  12  include natural collagenous materials or synthetic resins including those derived from alkylene carbonates such as trimethylene carbonate, tetramethylene carbonate, and the like; caprolactone; dioxanone; glycolic acid; lactic acid; homopolymers thereof; copolymers thereof; and combinations thereof. In some embodiments, glycolide and lactide based polyesters, especially copolymers of glycolide and lactide, may be utilized to form suture  12 . 
         [0018]    Suitable non-degradable materials which may be utilized to form suture  12  include polyolefins, such as polyethylene and polypropylene; copolymers of polyethylene and polypropylene, and blends of polyethylene and polypropylene; polyamides (such as nylon); polyamines; polyimines; polyesters such as polyethylene terephthalate; polytetrafluoroethylene; polyether-esters such as polybutester; polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; and combinations thereof. Other suitable non-degradable materials include silk, cotton, linen, carbon fibers, and the like. The polypropylene may be isotactic polypropylene or a mixture of isotactic and syndiotactic or atactic polypropylene. 
         [0019]    Suture  12  may be formed using any technique within the purview of those skilled in the art, such as, for example, extrusion, molding and/or gel spinning. In some embodiments, suture  12  may include a yarn made of more than one filament, which may contain multiple filaments of the same or different materials. Where suture  12  is made of multiple filaments, suture  12  may be made using any known technique such as, for example, braiding, weaving or knitting. Suture  12  may also be combined to produce a non-woven suture. Suture  12  may be drawn, oriented, crinkled, twisted, commingled or air entangled to form yarns as part of the suture forming process. In one embodiment, a multifilament suture may be produced by braiding. The braiding may be done by any method within the purview of those skilled in the art. 
         [0020]    With reference still to  FIGS. 1 and 2 , end effector  10  is configured to prevent complete reception of suture  12  through tissue or other material. End effector  10  fauns a substantially T-shaped knot formed on distal end  12   b  of suture  12 . End effector  10  defines an axis “Y” extending perpendicular to a longitudinal axis “X” of suture  12 . End effector  10  includes first and second extensions  20 ,  30  extending perpendicularly from suture  12  in opposite directions along axis “Y” to form a T-shape. Each of first and second extension  20 ,  30  is formed from a plurality of throws  22   a - c ,  32   a - c , respectively, thereby forming undulated members. As used herein, a throw is defined as an at least three-hundred and sixty degree (360° wrapping or weaving of two limbs and undulated is defined as having a wavelike or rippled form. As shown, first and second extensions  20 ,  30  each include three throws  22   a - c ,  32   a - c , respectively. It is envisioned, however, that first and second extensions  20 ,  30  may include any number of throws  22 ,  32 , respectively. It is further envisioned that the number of throws on first extension  20  does not need to be equal to the number of throws on second extension  30 . A proximal end  12   a  of suture  12  may include one or more needles (not shown) and/or may include one or more barbs. 
         [0021]    The method of forming end effector  10  will now be described with reference to  FIGS. 3-15 . Referring initially to  FIG. 3 , suture  112  is cut to a desired length. The length of the suture may vary depending on the application for which suture  112  is being used. The size of end effector  110  may also affects the length of suture  112 . The more throws  122 ,  132  ( FIG. 15 ) formed in respective extension  120 ,  130  of end effector  110 , the greater the length or size required of suture  112 . The thickness of suture  112  also affects length of suture  112 . Alternatively, suture  112  may be formed on the free end of a spool of thread (not shown) and cut to length following the forming of end effector  10 . A first, short end  114   a  of suture  112  is then crossed over a second, long end  114   b  of suture  112  to form a first loop  113 . First loop  113  should be of sufficient size to permit wrapping of first end  114   a  through first loop  113  multiple times. Although “short” and “long” are used to refer to first and second ends  114   a ,  114   b , respectively, in some embodiments, short end  114   a  may actually be of equal or longer length than long end  114   b.    
         [0022]    Turning to  FIG. 4 , first end  114   a  of suture  112  is then wrapped around suture  112  within loop  113  “n” number of times to form “n” number of throws  122 . As shown, first end  114   a  is wrapped around suture  112  (3) three times to form three (3) throws  122   a - c . As discussed above, first end  114   a  of suture  112  may be wrapped around suture  112  within loop  113  more or less than three (3) times. 
         [0023]    With reference now to  FIG. 5 , first loop  113  is next placed adjacent to a fixture  50 , with fixture  50  being received in the V-shaped notch between first loop  113  and first end  114   a . As will be discussed in further detail below, fixture  50  includes a channel  52  extending along a length thereof. 
         [0024]    Turning to  FIG. 6 , first end  114   a  of suture  112  is next wrapped around fixture  50  to form a second loop  115 . First end  114   a  is then wrapped around suture  112  within loop  113  “m” number of times to form “m” number of throws  132 . As shown, first end  114   a  is wrapped around suture  112  three (3) times to form three (3) throws  132   a - c . As discussed above, first end  114   a  may be wrapped around suture  112  more or less than three (3) times and does not need to be equal to “n” number of throws  122  formed on the opposite side of first loop  113 . 
         [0025]    With reference now to  FIGS. 7 and 8 , first and second ends  114   a ,  114   b  of suture  112  are next pulled in opposing directions, as indicated by arrows “A” and “B” ( FIG. 7 ), thereby tightening first and second loops  113 ,  115  about fixture  50  ( FIG. 8 ). 
         [0026]    As noted above, fixture  50  includes a channel  52  formed along a length thereof to permit the passage of suture ends  114   a ,  114   b  through second loop  115 . With reference now to  FIG. 9 , first end  114   a  of suture  112  is threaded through second loop  115  by passing first end  114   a  through channel  52  of fixture  50 . It is envisioned, however, that the threading of first end  114   a  through second loop  115  may accomplished without the use and/or presence of channel  52 . First end  114   a  is threaded through second loop  115  from the top, as shown, to form a third loop  117 . In an alternative embodiment, first end  114   a  of suture  112  may be threaded through second loop  115  from the bottom. 
         [0027]    Referring now to  FIG. 10 , second end  114   b  of suture  112  is next threaded through second loop  115 , through channel  52 , if present, in a direction opposite to that which first end  114   a  was threaded. As shown, second end  114   b  of suture  112  is threaded through second loop  115  from the bottom up to form a fourth loop  119 . In another embodiment, second end  114   b  may be fed through second loop  115  in the same direction that first end  114   a  was threaded through second loop  115 . In this manner, second end  114   b  is threaded through second loop  115  from the top down. The direction from which short and long ends  114   a ,  114   b  are threaded through second loop  115  determines the final configuration of end effector  110 . In yet another embodiment, second end  114   b  may be threaded through second loop  115  from the top down or the bottom up, and short end  114   b  may be severed adjacent to outer throw  132   c  without short end  112  being threading through second loop  115 . 
         [0028]    With reference to  FIGS. 11 and 12 , suture  112  is next removed from fixture  50  ( FIG. 10 ) and third and fourth loops  117 ,  119  are then pulled in opposite directions ( FIG. 11 ) along an axis perpendicular to the longitudinal axis of suture  112 , as indicated by arrows “C” and “D”, to tighten first and second loops  113 ,  115  about short and long ends  114   a ,  114   b.    
         [0029]    Turning now to  FIG. 13 , next short and long ends  114   a ,  114   b  are pulled in opposite directions, as indicated by arrows “E” and “F,” to tighten third and fourth loops  117 ,  119  about respective throws  122   a - c ,  132   a - c.    
         [0030]    With reference now to  FIGS. 14 and 15 , first end  114   a  may then be cut as close to or as far from end effector  110  as desired. In an alternative embodiment, first end  114   a  may be left uncut, thereby providing a clinician with a means for retracting suture  112 . 
         [0031]    Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure. For example, it is envisioned that suture  12  may include a loop formed a distal of end effector  10  to permit withdrawal of suture  12  from within tissue.