Patent Publication Number: US-2011054523-A1

Title: System And Method For Creating End Effector

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/236,711, filed Aug. 25, 2009, the contents of which are incorporated herein by reference in there entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to end effectors for surgical sutures. More particularly, the present disclosure relates to a knotted end effector and a method for tying a knotted end effector. 
     2. Background of Related Art 
     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. 
     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, the knot may slip or may be 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. 
     Therefore, a continuing need exists for a knotted end effector and a method of making a knotted end effector. 
     SUMMARY 
     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 having first and second sections, each section including at least two throws, the at least two throws of the second section being formed through the at least two throws of the first section. The first and second sections may each include three throws. The number of throws in the first section may be the same or different than the number of throws in the second section. The end effector may be formed on a distal end of the body portion. 
     Also provided is a method of forming an end effector. The method includes the steps of providing a length of suture, wrapping a first end of the suture around a mandrel “n” number of times to form a first section having “n” number of throws, wrapping the first end of the suture through the first section “m” number of times to form a second section having “m” number of throws, removing the suture from the mandrel and pulling the first and second ends of the suture in opposite directions to tighten the first and second sections about one another. The pulling of the first and second ends of the suture in opposite directions forms an end effector. The method may further include the step of trimming the first end of the suture adjacent the end effector. 
     The mandrel used to form the end effector includes at least one channel for receiving the first end of the suture. The mandrel may include a plurality or “m” number of channels. “n” and “m” may or may not be equal. 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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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: 
         FIG. 1  is a perspective view of an end effector according to an embodiment of the present disclosure; 
         FIG. 2-10  show sequential steps of the method of forming an end effector according to the present disclosure; 
         FIG. 11A  is a front view of a system for semi-automated creation of an end effector according to the present disclosure, including a spool, a guide member and a suture winding device; 
         FIG. 11B  is a top view of the suture winding device of  FIG. 11A ; 
         FIG. 12A  is a front view of the suture winding device of  FIGS. 11A and 11B  in operation; 
         FIG. 12B  is a top view of the suture winding device in  FIG. 12A , in operation; 
         FIG. 13A  is a front view of the suture winding device of  FIGS. 11A-12B , wherein the brake assembly has been activated; 
         FIG. 13B  is a top view of the suture winding device in  FIG. 13A ; 
         FIG. 14A  is a front view of the suture winding device of  FIGS. 11A-13B , during manual manipulation of the suture; 
         FIG. 14B  is a top view of the suture winding device in  FIG. 14A ; 
         FIG. 15A  is a front view of the suture winding device of  FIGS. 15A-14B , wherein the brake assembly is deactivated and the suture is removed from the mandrel; 
         FIG. 15B  is a top view of the suture winding device in  FIG. 15A ; 
         FIG. 16  is a side view of an end effector constructed with the assistance of the suture winding device of  FIGS. 11A-15B ; and 
         FIG. 17  is a side view of the end effector of  FIG. 16  with the excess suture material trimmed therefrom. 
     
    
    
     DETAILED DESCRIPTION 
     Referring initially to  FIG. 1 , 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 first or distal end  12   a  of suture  12 , end effector  10  may be formed anywhere along the length of suture  12 . 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 . 
     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, collagen, cotton, linen, carbon fibers, and the like. The polypropylene may be isotactic polypropylene or a mixture of isotactic and syndiotactic or atactic polypropylene. 
     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 solvent casting. 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. 
     With reference still to  FIG. 1 , end effector  10  is configured to prevent complete reception of suture  12  through tissue or other material. End effector  10  forms a knot several times thicker than suture  12  on distal end  12   a  of suture  12 . End effector  10  includes first and second sections  20 ,  30 . Each of first and second sections  20 ,  30  is formed from a plurality of throws  22   a - c,    32   a - c,  respectively. As used herein, a throw is defined as an at least three-hundred and sixty degree (360°) wrapping or weaving of two limbs. As shown, first and second sections  20 ,  30  each include three throws  22   a - c,    32   a - c.  It is envisioned, however, that first and second sections  20 ,  30  may include any number of throws  22   a - c,    32   a - c.  It is further envisioned that the number of throws on first section  20  need not be equal to the number of throws on second section  30 . A proximal end  12   b  of suture  12  may include one or more needles (not shown). In one embodiment, suture  12  includes one or more barbs formed along the length thereof. 
     A method of forming end effector  10  by hand will now be described with reference to  FIGS. 2-8 . Referring initially to  FIG. 2 , suture  112  is first cut to a desired length. The length of suture  112  prior to tying end effector  110  may vary depending on the application for which suture  112  is being used. The desired size of resultant end effector  110  ( FIG. 10 ) also affects the pre-tied length of suture  112 . The more throws  122   a - c,    132   a - c  ( FIG. 10 ) formed in respective first and second sections  120 ,  130  of end effector  110 , the greater the length required of suture  112  prior to forming of end effector  110 . Additional length may be provided to facilitate in the tying of end effector  110 . The additional length may be trimmed once end effector  110  it tied. 
     Turning to  FIGS. 3 and 4 , a first, short end  112   a  of suture  112  is wrapped about a mandrel  50  (shown in phantom) to form a first throw  122   a.  Second and third throws  122   b,    122   c  are similarly formed ( FIGS. 5 and 6 , respectively) to complete first section  120  of end effector  110 . Although disclosed as being formed about mandrel  50 , first section  120  of end effector  110  may be formed about any elongated object having a free end. Alternatively, throws  122   a - c  are formed in a second or free hand of the knot tier. Section  120  may include any number “n” of throws  122 . Although shown including three throws  122   a - c,  it is envisioned that section  120  may include fewer or more than three throws. 
     With reference now to  FIGS. 6-9 , short end  112   a  of suture  112  is next wrapped through first section  120  about throws  122   a - c  to form a first throw  132   a.  Short end  112   a  of suture  112  may be wrapped through first section  120  “m” number of times to form “m” number of throws  132   a - c.  Throws  132   a - c  form second section  130 . As shown, first end  112   a  is wrapped around first section  120  three (3) times to form three (3) throws  132   a - c.  As discussed above, second section  130  may include more or less than three (3) throws  132  and need not be equal to the number “n” of throws  122   a - c  forming first section  120 . Mandrel  50  ( FIG. 3 ) may include any number of channels (not shown) configured to facilitate wrapping of first end  112   a  of suture  112  about first section  120 . 
     Turning now to  FIG. 10 , upon formation of first and second sections  120 ,  130 , suture  112  is removed from mandrel  50  ( FIG. 3 ). First and second ends  112   a,    112   b  of suture  112  may then be grasped and pulled in opposite directions, as indicated by arrows “A” and “B”, to tighten first and second sections  120 ,  130  upon themselves and to form end effector  110 . Short end  112   a  may then be cut as close to or as far from end effector  110  as desired. Although shown and described as being formed using short end  112   a  of suture  112 , end effector  110  may be formed using either end  112   a,    112   b  of suture  112 . In this manner, either end  112   a,    112   b  of suture  112  may be cut as close to or as far from end effector  110  as desired, as represented by dashed lines “y” and “z”. 
     A semi-automated method of forming end effector  210  ( FIG. 16 ) will now be described with reference to  FIGS. 11A-16 . Referring initially to  FIG. 12A , a system for semi-automated creation of end effector  210  is shown generally as system  200 . As shown, system  200  includes a source of thread, i.e., spool  242 , a guide  243  for directing and tensioning suture  112  and a suture winding device  244 . 
     With particular reference now to  FIGS. 11A and 11B , suture winding device  244  includes a base  246 , a motor assembly  248  and a mandrel  250  extending from motor assembly  248 . Mandrel  250  includes a plurality of longitudinal channels  252  extending at least partially along the length thereof As will be discussed in further detail below, channels  252  facilitate the forming of second section  220  of end effector  210  ( FIG. 16 ). Mandrel  250  is configured to be rotated about a central axis “x” thereof by motor assembly  248 . An alai  254  extends transversely from mandrel  250 . Arm  254  includes a clamp member  256  on a distal end  254   b  thereof for securing a first end  212   a  of a suture  212 . Suture winding device  244  further includes a brake assembly  260 . Brake assembly  260  is configured to engage mandrel  250 . Brake assembly  260  includes first and second brake members  262 ,  264 . Each of first and second brake members  262 ,  264  are pivotably secured to base  246  and are configured to selectively engage mandrel  250 . 
     Still referring to  FIGS. 11A and 11B , first end  212   a  of suture  212  is initially secured to clamp member  244 . Turning now to  FIGS. 12A and 12B , activation of motor assembly  248  cause mandrel  250  to rotate about longitudinal axis “x”, in the direction of arrows “C”. Rotation of mandrel  250  causes suture  212  to be wrapped thereabout, forming a first throw  222   a.  Continued rotation of mandrel  250  creates additional throws  222   b,    222   c  and thereby forms first section  220 . As discussed above with regards to end effector  110 , first section  220  of end effector  210  may be any number of throws  222 . 
     With reference now to  FIGS. 13A and 13B , upon formation of first section  220 , including “n” number of throws  222 , brake assembly  260  is activated. Activation of brake assembly  260  cause first and second brake members  262 ,  264  to pivot, in the direction of arrows “D” and “E”, respectively, into engagement with mandrel  250  to thereby lock mandrel  250  and prevent further rotation thereof. Brake members  262 ,  264  may further be configured to engage throws  222   a - c  of first section  220 , thereby preventing first section  220  from becoming unwrapped. 
     With continued reference to  FIGS. 14A and 14B , once brake assembly  260  has been activated, first end  212   a  of suture  212  is removed from clamp  244 . First end  212   a  of suture  212  is then wrapped around throws  222   a - c  of first section  220  using a first channel  252   a  of channels  252  formed in mandrel  250 . Using second and third channels  252   b,    252   c,  first end  212   a  of suture  212  is wrapped around throws  222   a - c  twice more to form second and third throws  222   b,    222   c.  As discussed above, second section  230  may include more or less than three throws  222 , and need not equal first section  220  in number of throws  222 . 
     With reference now to  FIGS. 15A and 15B , upon formation of second section  220 , first and second brake members  262 ,  264  of brake assembly  260  are retracted from engagement with mandrel  250 , in the direction of arrows “F” and “G”. Disengagement of brake assembly  260  permits suture  212  to be slid from mandrel  250 , in the direction of arrows “H”. As suture  212  is slid from mandrel  250 , first and second ends  212   a,    212   b  of suture  212  are pulled in opposite direction, as indicated by arrows “I” and “J”. 
     Turning now to  FIG. 16 , once suture  212  is removed from mandrel  250 , continued pulling of first and second ends  212   a,    212   b  in opposite directions causes first and second section  220 ,  230  to tighten on one another, thereby forming end effector  210 . Suture  212  may be cut to length prior to being removed from mandrel  250  or subsequent to removal therefrom. 
     With reference now to  FIG. 17 , once end effector  210  has been formed from suture  112 , first end  212   a  of suture  212  is cut near end effector  210  to remove any excess material. First end  212   a  of suture  212  may be trimmed as close to or as far from end effector  210  as desired. In one embodiment, first end  212   a  of suture  212  remains long to provide a clinician a means for retracting or otherwise manipulating suture  212  during use. 
     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.