Patent Publication Number: US-2019167260-A1

Title: Fixation Device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 62/371,907 filed Aug. 8, 2016, which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     A. Field 
     This disclosure relates generally to fixation devices and more particularly to a fixation device or anchor for fastening two ends of a surgical suture. 
     B. Description of Related Art 
     Wide sutures are used to close high-tension wounds such as in hernia or tendon repair, and may be used for soft-tissue to soft tissue fixation, soft tissue to bone fixation, or bone to bone fixation. Two types of wide sutures are tape sutures and mesh sutures. Despite the many advantages of wide sutures, a concern in using these sutures are the size of the large knots needed to anchor or secure the two ends of the suture. Large knots are susceptible to increased palpability, pain, foreign body response, and may increase the risk of infection. Thus, there is a need for an alternative suture fixation or suture anchor device to replace large knots when securing mesh sutures or tape sutures within a patient. 
     SUMMARY 
     The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. 
     In one aspect, a fixation device is disclosed. The fixation device may include a first component and a second component. The first component has a top surface, a base, at least one locking projection, and at least one tapered projection extending from the top surface. The at least one locking projection includes a first locking element. The fixation device further includes a second component having a top surface, a base, at least one locking aperture, and at least one second aperture corresponding to the projections on the first component. The at least one locking apertures includes a second locking element. In some embodiments, the at least one locking projection on the first component is configured to lock together with the at least one locking aperture on the second component to secure together two ends of a mesh suture or a tape suture. 
     In another aspect, the fixation device includes a male component having a top surface, a base, two locking projections, and a tapered projection extending from the top surface. The two locking projections each include a plurality of first locking elements. The fixation device further includes a female component having a top surface, a base, two locking apertures, and a third aperture corresponding to the projections on the male component. The two locking apertures each include a plurality of second locking elements. The two locking projections on the male component are configured to lock together with the two locking apertures on the female component to secure together two ends of a mesh suture or tape suture. 
     In yet another embodiment, a fixation device includes a first component having a top surface, a base, and a plurality of first projections extending from the top surface. The plurality of first projections may be formed as first tines. The fixation device further includes a second component having a top surface, a base, and a plurality of second projections extending from the top surface configured to interlock with the plurality of first projections on the first component to secure together two ends of a mesh suture or tape suture. The fixation device also includes a hinge connecting the first component to the second component. 
     In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Exemplary embodiments are illustrated in the drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. 
         FIG. 1  is a perspective view of a fixation device of the present application; 
         FIG. 2  is a front view of the fixation device shown in  FIG. 1 ; 
         FIG. 3  shows the fixation device of  FIG. 1  in a secured position; 
         FIG. 4A  shows an alternate embodiment of a fixation device of the present application; 
         FIG. 4B  shows the fixation device of  FIG. 4A  in a secured position; and 
         FIG. 4C  shows a side view of the fixation device of  FIG. 4B . 
     
    
    
     DETAILED DESCRIPTION 
     A fixation device for fastening two ends of a surgical mesh suture or tape suture is disclosed. The fixation device may include a first component and a second component which interlock with each other. In some embodiments, the first component may be a male component having one or more projections and the second component may be a female component having one or more apertures or recesses. At least one of the projections may have one or more projection locking elements, and at least one of the apertures may have one or more corresponding aperture locking elements. Moreover, the fixation device may be made of a biocompatible material, such as silicone, PEEK, or any other biocompatible material, for example. 
       FIG. 1  shows an example fixation device  100  of the present application. The fixation device  100  may include two interlocking components: a first, male component  102  and a second, female component  104 . The male component  102  may have a substantially flat top surface  101  and a base portion  103 . The male component  102  may include a plurality of projections extending from the top surface  101 . In one embodiment, the male component  102  includes two lateral locking projections  106 ,  108  and a middle projection  110  located between the lateral locking projections  106 ,  108 . Each of the projections extends outwardly from the top surface  101 . 
     The lateral locking projections  106 ,  108  each include one or more locking elements  112  to enable locking when attached to the female component  104 . In one embodiment, the projection locking elements  112  comprise a plurality of pointed, barbed-shaped projections. However, it should be understood that any suitable locking elements may be used. 
     The middle projection  110  may be tapered distally to enable penetration through a suture. The middle projection  110  provides suture fixation via a cotter pin-like mechanism. Other shapes and structures of the middle projection  110  are possible as well. 
     Referring again to  FIG. 1 , the female component  104  may include corresponding apertures or holes to enable entry and locking of the projections  106 ,  108 , and middle projection  110 . The female component  104  may include a top surface  105  and a base portion  107 . In one embodiment, locking apertures  114 ,  116  are formed in the top surface  105  to correspond to the lateral locking projections  106 ,  108 . The locking apertures  114 ,  116  each include one or more locking elements  118  to enable locking when attached to the male component  102 . In one example, the aperture locking elements  118  comprise a plurality of notches which mate with the locking elements  112  of lateral locking projections  106 ,  108  to lock the male component  102  to the female component  104 . However, in other embodiments, any suitable locking elements may be used. 
     A middle aperture  120  may be located on the female component  104  between the two locking apertures  114 ,  116 . The middle aperture  120  may be shaped and sized to accommodate the middle projection  110  of male component  102 . 
     It should be understood that in alternate embodiments the first component may be the female component having apertures and the second component may be the male component having projections. Additionally, in some embodiments, the first component may include a mix of projections and apertures and the second component may include a corresponding mix of apertures and projections. 
     Moreover, additional or less projections can be formed on the male component  102 , with each having a corresponding aperture formed on the female component  104 . Additionally, although the male component  102  and the female component  104  both have a generally rectangular shape, in alternate embodiments, other suitable shapes are also possible. 
     In one embodiment, the height H of the fixation device  100 , shown in  FIG. 1 , may be about 2 mm. The width W and length L of the assembled fixation device  100  (shown in  FIGS. 1-3 ) may each be about 10 mm. In another embodiment, the height H of the fixation device may be in the range of 0.1 cm to 1 cm, the width W may be in the range of 0.5 cm to 2 cm, and the length L may be in the range of 0.2 cm to 2 cm. Other suitable dimensions are also possible. 
     The fixation device  100  may comprise a biocompatible material, such as silicone, for example. In alternate embodiments, the fixation device  100  may comprise any other suitable biocompatible materials as well, including, but not limited to silicone, Polyether ether ketone (PEEK), Polyethylene, polylactide (PLA), stainless steel, titanium, cobalt chrome, or other biocompatible polymer or metallic alloy or combinations thereof. 
     Referring now to  FIGS. 2 and 3 , the male and female components  102 ,  104  of the fixation device  100  can be assembled and secured together by inserting the projections  106 ,  108 ,  110  into the apertures  114 ,  116 ,  120 . In one embodiment, the male and female components  102 ,  104  of the fixation device  100  are placed around a portion of a surgical mesh (not shown) to secure the mesh within a patient. The male and female components  102 ,  104  may be clamped or closed together around the surgical mesh with a handheld or laparoscopic clip applier (not shown). Once secured together, the locking elements  112  on the locking projections  106 ,  108  engage with the locking elements  118  on the locking apertures  114 ,  116 . 
       FIGS. 4A-4C  show an alternate embodiment of a fixation device  200  of the present application. The fixation device  200  may comprise a button-type structure which secures a mesh extension for a T-line hernia mesh  300 . In one embodiment, the fixation device  200  comprises a first component  202  and second component  204 . The first and second components  202 ,  204  may be formed as discs. In some embodiments, the discs are semi-circular in shape. It should be understood that the first and second components  202 ,  204  may take other suitable shapes as well. In some embodiments, first component  202  may be a different shape than second component  204 . 
     The first and second components  202 ,  204  may be connected by a hinge piece  206 . Thus, the first and second components  202 ,  204  may easily be moved together and apart. The hinge piece  206  may be made of any suitable material. It should be understood that any suitable hinge may be used. 
     The first and second components  202 ,  204  may each include a plurality of projections  208 . In one embodiment, the projections  208  are formed as tines. In some embodiments, the tines include a bishop-shaped or tapered head  210 . When the first and second components  202 ,  204  are secured together, the tines  208  interlock to form a secure connection. 
     In some embodiments, the first and second components  202 ,  204  comprise a biocompatible material, such as silicone. In alternate embodiments, the fixation device  200  may comprise any other suitable biocompatible materials as well. 
     As shown in  FIGS. 4A-4C , the fixation device  200  is placed around a portion of a surgical mesh suture or tape suture  300  to secure the mesh within a patient. In some embodiments, the first and second components  202 ,  204  may be clamped/closed together around the mesh extension  300  with a handheld or laparoscopic clip applier (not shown). 
     While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize that still further modifications, permutations, additions and sub-combinations thereof of the features of the disclosed embodiments are still possible. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.