Abstract:
Apparatus for forming a knot, the apparatus comprising:
       a first pathway for receiving a first element, and a second pathway for receiving a second element, wherein the first pathway and the second pathway have configurations which correspond to the paths to be followed by the first element and the second element, respectively, in order to form a knot;   a shuttle for moving the second element; and   a mechanism for moving the shuttle through the second pathway, whereby, when the first element is received in the first pathway and the second element is connected to the shuttle, movement of the shuttle through the second pathway causes the second element to be moved through the second pathway so as to form a knot around the first element.

Description:
REFERENCE TO PENDING PRIOR PATENT APPLICATION 
       [0001]    This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 61/598,450, filed Feb. 14, 2012 by Nathan B. Snyder et al. for SURGICAL SUTURE TYING DEVICE AND SURGICAL TECHNIQUE (Attorney&#39;s Docket No. SNYDER-41A PROV), which patent application is hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to surgical methods and apparatus in general, and more particularly to a method and apparatus for forming a knot in surgical suture. This invention also relates to forming a knot in filaments other than surgical suture. 
       BACKGROUND OF THE INVENTION 
       [0003]    The field of surgery includes both open and arthroscopic procedures. One common technique for most repair or reconstruction procedures is that one or more strands of suture material are used to repair torn soft tissue, or to reattach soft tissue back to bone, so that the anatomy will heal. A critical element of this “suture repair” is the need to tie the ends of the sutures together to form a knot. 
         [0004]    Currently, in some scenarios in which a surgeon ties a knot intra-operatively, a surgeon must develop the skill and dexterity to fashion a knot in the ends of the sutures, pass that knot down to the level of the needed repair, tighten the knot and lock the knot so that the knot will maintain proper tension for holding the tissues together for healing. In many cases, the maneuvers required to tie the desired knot are complex and require considerable practice to learn in order to maintain the requisite level of proficiency. 
         [0005]    In other instances, in order to save a surgeon from having to tie a knot intra-operatively, manufacturers pre-tie a surgical knot in the suture, and provide a device to deploy the suture to the operative site so that a surgeon does not have to tie the suture knot intra-operatively. Currently, in order to manufacture a suture with a pre-tied surgical knot, a person must first be trained to be proficient in knot tying. This raises the possibility of irregularities in the quality of the manufacturing process as a result of fatigue, distraction or human error. 
         [0006]    Accordingly, there is a need for a new and improved method and apparatus for forming a knot in surgical suture which addresses the deficiencies of the prior art. 
         [0007]    In addition, knots are frequently used in non-medical applications (e.g., fishing). The formation of these knots can require substantial skill, can be time-consuming and can be prone to error due to fatigue, distraction or human error. Thus, there is a need for a new and improved method and apparatus for forming a knot in filaments which address the deficiencies of the prior art. 
       SUMMARY OF THE INVENTION 
       [0008]    These and other objects are addressed by the provision and use of a novel apparatus for forming a knot in surgical suture, or for forming a knot in other filaments. 
         [0009]    In one embodiment of the present invention, there is provided a new, hand-held tool designed to facilitate a surgeon&#39;s task of tying a knot using any type of filament or suture material desired. The hand-held tool ensures that perfectly formed knots are developed quickly and easily, with no chance for irregularities. The knots formed with the system of the present invention may include various types of sliding-locking knots and hitches depending on the individual requirement of the surgeon. After a knot is formed by the device of the present invention, the knot may be guided into place, tightened and locked. The efficiency and security provided will save considerable time and ensure consistent, reliable knots in all procedures. 
         [0010]    In another embodiment of the present invention, there is provided a table-top device that may be used by a manufacturer to pre-tie a knot in a filament or suture to be provided to a surgeon, thereby providing a surgeon with a pre-tied knot in a filament or suture using any type of filament or suture material desired. Similar to the hand-held device, the table-top device of the present invention forms a knot in suture with no chance for irregularities and at a rate that is superior to current methods. 
         [0011]    The aforementioned hand-held tool and/or table-top device may also be used to form knots for non-medical applications. 
         [0012]    In one form of the present invention, there is provided apparatus for forming a knot in filament, the apparatus comprising: 
         [0013]    a first assembly comprising a shuttle, and a mechanism for advancing and retracting the shuttle; and 
         [0014]    a second assembly having a first pathway for passing a first strand of filament and a second pathway for passing a second strand of filament; 
         [0015]    wherein the first assembly and the second assembly are connected together so that the shuttle may be passed from the first assembly to the second assembly in order to carry the second strand of filament through the second pathway of the second assembly, thereby forming a knot around the first strand of filament. 
         [0016]    In another form of the present invention, there is provided a method for forming a knot in suture, the method comprising: 
         [0017]    providing a system comprising:
       a first assembly comprising a shuttle, and a mechanism for advancing and retracting the shuttle; and   a second assembly having a first pathway for passing a first strand of filament and a second pathway for passing a second strand of filament;   wherein the first assembly and the second assembly are connected together so that the shuttle may be passed from the first assembly to the second assembly in order to carry the second strand of filament through the second pathway of the second assembly, thereby forming a knot around the first strand of filament;       
 
         [0021]    passing a first strand of filament through the first pathway; 
         [0022]    advancing the shuttle into the second pathway; 
         [0023]    securing a second strand of filament to the shuttle; 
         [0024]    retracting the shuttle, with the second filament of suture attached thereto, through the second pathway so that the second strand of filament is maneuvered around the first strand of filament, thereby forming a knot around the first strand of filament. 
         [0025]    In another form of the present invention, there is provided apparatus for forming a knot, the apparatus comprising: 
         [0026]    a first pathway for receiving a first element, and a second pathway for receiving a second element, wherein the first pathway and the second pathway have configurations which correspond to the paths to be followed by the first element and the second element, respectively, in order to form a knot; 
         [0027]    a shuttle for moving the second element; and 
         [0028]    a mechanism for moving the shuttle through the second pathway, whereby, when the first element is received in the first pathway and the second element is connected to the shuttle, movement of the shuttle through the second pathway causes the second element to be moved through the second pathway so as to form a knot around the first element. 
         [0029]    In another form of the present invention, there is provided a method for forming a knot, the method comprising: 
         [0030]    providing apparatus comprising:
       a first pathway for receiving a first element, and a second pathway for receiving a second element, wherein the first pathway and the second pathway have configurations which correspond to the paths to be followed by the first element and the second element, respectively, in order to form a knot;   a shuttle for moving the second element; and   a mechanism for moving the shuttle through the second pathway, whereby, when the first element is received in the first pathway and the second element is connected to the shuttle, movement of the shuttle through the second pathway causes the second element to be moved through the second pathway so as to form a knot around the first element;       
 
         [0034]    passing the first element through the first pathway; 
         [0035]    advancing the shuttle into the second pathway; 
         [0036]    securing the second element to the shuttle; and 
         [0037]    retracting the shuttle, with the second element attached thereto, through the second pathway so that the second element is maneuvered around the first element, thereby forming a knot around the first element. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0038]    These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: 
           [0039]      FIG. 1  is a right side schematic view of a novel system for forming a knot in suture, wherein the novel system comprises a hand-held shuttle driver assembly and a knot box; 
           [0040]      FIG. 1A  is a right side schematic view of the shuttle driver assembly of  FIG. 1  in which the shuttle driver assembly is transparent; 
           [0041]      FIG. 2  is a left side view of the novel system of  FIG. 1  in which the shuttle driver assembly and knot box are transparent and a shuttle is shown running through a second inner pathway of the knot box; 
           [0042]      FIG. 3  is a view of an exemplary way of securing a loop strand of filament to a shuttle; 
           [0043]      FIG. 4  is a schematic view of a second exemplary way of securing a loop strand of filament to a shuttle; 
           [0044]      FIGS. 5 and 6  are schematic views showing further details of the knot box of the present invention; 
           [0045]      FIG. 7  is a schematic view illustrating the loop strand of filament being pulled through the second pathway of the knot box; 
           [0046]      FIGS. 8-10  are schematic views illustrating the progression of a shuttle carrying the loop strand of filament through the second pathway of the knot box; 
           [0047]      FIG. 11  is a schematic view illustrating the removal of the loop strand of filament through the filament release window of the knot box; 
           [0048]      FIG. 12  is a schematic view illustrating an exemplary path that the loop strand of filament may take over and under a post strand of filament in order to form a knot; and 
           [0049]      FIG. 13  is a view illustrating a table-top version of the system shown in  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0050]    The present invention comprises the provision and use of a novel system for forming a knot in suture or other filament. 
         [0051]    More particularly, the system of the present invention may be used to form a sliding knot or a hitch between two filaments of suture or other filament. 
         [0052]    A sliding knot or a hitch are generally constructed of two strands. One stand is typically referred to as the “post strand” and the other strand is typically referred to as a “loop strand”. The post strand generally maintains a relatively straight form and is typically held under tension so as to enable the loop strand to form a knot around the post strand and eventually slide down the post strand, into the desired position. 
         [0053]    In one preferred form of the present invention, and looking now at  FIGS. 1 ,  1 A and  2 , there is a provided a novel system  5  for forming a knot in suture or other filament. Novel system  5  generally comprises a hand-held shuttle driver assembly  10  and a knot box  15 . 
         [0054]    Shuttle driver assembly  10  comprises a handle portion  20 , which may be held in the palm of a left hand, a shaft  25  extending from the handle portion for receiving knot box  15 , and a shuttle  30  which is configured to pass from handle portion  20  to shaft  25  and into knot box  15 . 
         [0055]    Handle portion  20  of shuttle driver assembly  10  comprises a shuttle reservoir  35  for housing shuttle  30  when shuttle  30  is not extended through knot box  15 , as will be described in further detail below. Handle portion  20  also comprises a rotary dial  40  for advancing shuttle  30  out of handle portion  20  and into knot box  15  and retrieving shuttle  30  out of knot box  15  and into handle portion  20 , and a shuttle travel monitor  45  for controlling how much of shuttle  30  is advanced into, or retrieved from, the knot box  15 . 
         [0056]    Shaft  30  comprises an attachment mechanism  50  for securing knot box  15  to shuttle driver assembly  10 . In one embodiment, attachment mechanism  50  comprises a tongue formed in a top portion of shaft  30  for receipt in a mating groove formed on a bottom portion of knot box  15 . In another embodiment, attachment mechanism  50  comprises a groove formed in a top portion of shaft  30  which may receive a mating projection formed on a bottom portion of knot box  15 . 
         [0057]    Shuttle  30  is configured to be passed from handle portion  20  through shaft  25  and into knot box  15  and then secured to a loop strand of filament so that the loop strand of filament may be towed into, and through, knot box  15 , following a pre-determined path, as will be described in further detail below. In one embodiment, and looking now at  FIG. 3 , shuttle  30  comprises a strand of spheres  52  connected together by a filament  53 , or connected together in some other manner so as to provide a flexible strand of spheres, with a loop or eyelet  55  being formed at one end of shuttle  30 . In this embodiment, a loop strand of filament  57  may be secured to shuttle  30  by passing loop strand of filament  57  through eyelet  55 . 
         [0058]    In another embodiment, and looking now at  FIG. 4 , shuttle  30  comprises a strand of spheres  52  connected together by a filament  53 , or connected together in some other manner so as to provide a flexible strand of spheres, with a three-sided cleat  60  positioned at one end of the shuttle. In this embodiment, three-sided cleat  60  may be used to snag loop strand of filament  57  in order to secure loop strand of filament  57  to shuttle  30 . 
         [0059]    Looking now at  FIGS. 2 ,  5  and  6 , knot box  15  comprises a first pathway  65  for passing a post strand of filament, and a second pathway  70  for passing loop strand of filament  57  through the knot box in a pre-determined path around the post strand of filament in order to form a knot in the filament, as will be discussed in further detail below. 
         [0060]    As stated above, knot box  15  may also comprise an attachment mechanism  50  for connecting knot box  15  to suture driver assembly  10 . In a preferred embodiment, and as shown in  FIG. 5 , attachment mechanism  50  comprises a dovetail slot formed in a bottom portion of knot box  15  for receiving a mating dovetail projection formed on a top portion of shaft  25  of shuttle driver assembly  10 . 
         [0061]    First pathway  65 , which is intended to receive the post strand of filament, may be formed as a straight cutaway through the center of the long access of the knot box, ending approximately halfway into the thickness of the knot box. First pathway  65  may have one or more small filament-engaging elements  80  located along the length of the straight pathway. These filament-engaging elements  80  are designed to secure the post strand of filament in first pathway  65  as the post strand is positioned in the knot box in preparation for forming the knot. 
         [0062]    Second pathway  70 , which is intended to mimic the path that the loop strand of filament must travel in order to form the intended knot, may be formed as an interior pathway in knot box  15 . Second pathway  70  may be formed in a variety of different patterns which correspond to the direction of travel which must be taken by the loop strand of filament in order to generate an intended knot. Accordingly, various knot boxes may be developed, each with a specific set of patterns formed within the knot box, for use in forming a particular knot in accordance with the present invention. 
         [0063]    Second pathway  70  is also formed within knot box  15  so that when loop strand of filament  57  is drawn through the second pathway, as will be described in further detail below, loop strand of filament  57  contacts a specific surface of the second pathway. This specific surface is typically the surface area of the second pathway which, when contacted by loop strand of filament  57 , constitutes the shortest path for loop strand of filament  57  through the second pathway. 
         [0064]    Furthermore, second pathway  70  comprises an opening  85 , also sometimes hereinafter referred to as filament release window  85 , which intersects the second pathway at a different location than where loop strand of filament  57  extends when the loop strand of filament is being pulled through the second pathway by shuttle  30 , as will be discussed in further detail below. The width of filament release window  85  is specifically sized to be smaller than the width of shuttle  30 , but larger than the width of loop strand of filament  57 . Filament release window  85  is configured so as to allow loop strand of filament  57  to exit the second pathway once a user fully advances loop strand of filament  57  through the second pathway and desires to remove the newly formed knot from the knot box. In a preferred embodiment, and looking now at  FIGS. 5 and 6 , first pathway  65  extends through the middle of knot box  15 , and various components of filament release window  85  emanate from either side of first pathway  65 . 
         [0065]    System  5  is preferably used in the following manner to form a knot in filament or suture. 
         [0066]    First, a post strand of filament is secured in first pathway  65  of knot box  15 . Then shuttle  30  is advanced from shuttle reservoir  35 , into and through second pathway  70  via rotation of rotary dial  40  on shuttle driver assembly  10 . Next, an end of loop strand of filament  57  is secured to the end of shuttle  30 , and then the shuttle is pulled back through the second pathway, thereby towing loop strand of filament  57  through second pathway  70  of knot box  15 . As this occurs, loop strand of filament  57  is maneuvered about the post strand of filament in precisely the required pattern in order to form a desired knot on the post strand of suture. 
         [0067]    As can be seen in  FIG. 7 , when tension is applied to the long axis of loop strand of filament  57  as loop strand of filament  57  is pulled through second pathway  70  by shuttle  30 , the loop strand of filament  57  follows the aforementioned shortest path through second pathway  70 . This ensures that loop strand of filament  57  contacts the surface of second pathway  70  which is separate from filament release window  85 , thereby ensuring that loop strand of filament  57  does not inadvertently exit filament release window  85 . 
         [0068]    Looking now at  FIGS. 8-10 , progression of shuttle  30  through an exemplary second pathway  70  is shown in further detail, in which the leading end of shuttle  30  is shown at  90  and the trailing end of shuttle  30  is shown at  95 . The pattern of second pathway  70  shown in  FIGS. 8-10  results in the formation of a sliding, locking knot as loop strand of filament  57  is passed through second pathway  70  (and hence around the post strand of filament). 
         [0069]    Once the knot has been formed on the post strand of filament, the knot may be removed from the knot box by grasping both loop strand of filament  57  and the post strand of filament and gently pulling the two strands out of the knot box, thereby allowing loop strand of filament  57  to exit through filament release window  85 . More particularly, and looking now at  FIG. 11 , once tension is released from the long axis of loop strand of filament  57 , the two ends of the loop strand of filament are drawn so as to cause the loop strand of filament  57  to move toward, and then out, filament release window  85 . This movement allows the newly formed knot to “fall” out of the knot box, thereafter only requiring dressing and positioning to complete the knot. The term “dressing” a knot generally refers to arranging the segments of a finished knot so that the segments of the finished knot lie where the segments are supposed to, and do not cross each other where the segments are not supposed to. Dressing a knot is a normal activity to perform after a knot has been formed and is generally not considered part of knot formation. 
         [0070]    It is important to note that if care is not taken to properly position the filament release window  85  relative to second pathway  70  when the knot box is being manufactured, the loop strand of filament  57  may unintentionally escape from the second pathway before the knot is fully formed, thereby causing the formation of the knot to fail. If, on the other hand, filament release window  85  is not provided in the second pathway at all, the knot has no way to escape from the second pathway after it is has been formed. 
         [0071]    Although the foregoing description describes the formation of a sliding, locking knot, it is important to note that many different kinds of sliding knots may be formed with the system of the present invention. See, for example,  FIG. 12 , which shows an alternative exemplary second pathway  70  that loop strand of filament  57  may take with respect to a post strand of suture in order to form a different knot. 
         [0072]    In the foregoing description, system  5  has been described in the context of a hand-held device. However, it is important to note that the same features of system  5  may be provided in the form of a table-top device for use by a manufacturer in order to form a pre-tied knot in suture or filament. See, for example,  FIG. 13  which shows a table-top version of the system. 
         [0073]    Furthermore, in the foregoing description, a manually-operated rotary dial  40  is provided for moving shuttle  30 . However, it will be appreciated that other advancing and retracting mechanisms, included powered advancing and retracting mechanisms or spring-assisted mechanisms, may be provided for moving shuttle  30 . 
       Modifications of the Preferred Embodiments 
       [0074]    It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.