Patent Publication Number: US-2021186488-A1

Title: Self-locking surgical constructs and methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application Ser. No. 62/953,448, filed on Dec. 24, 2019, U.S. Provisional Application Ser. No. 62/958,767, filed on Jan. 8, 2020, and U.S. Provisional Application Ser. No. 62/968,309 filed on Jan. 31, 2020, each of which is relied upon and incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     This disclosure relates to surgical reconstruction, such as for joint or ligament repair, and associated surgical constructs. Tissue reconstruction surgeries, such as anterior cruciate ligament (ACL) reconstructions and posterior cruciate ligament (PCL) reconstructions, typically involve drilling a tunnel through bone, positioning a substitute graft into the bone tunnel, and fixating the graft within the bone tunnel using a fixation device, such as a button, a screw, or the like. 
     SUMMARY 
     This disclosure provides techniques and reconstruction systems for fixation of soft tissue to bone or bone to bone. The reconstruction system of the disclosure may comprise a surgical construct with at least one fixation device, such as a button, and at least one flexible strand with at least one adjustable loop coupled to the fixation device and connectable to tissue (such as soft tissue, graft, tendon, ligament, synthetic material, biological material, bone, or combinations of such materials, among others), wherein the construct is self-locking with one or more self-locking splices or one or more finger trap mechanisms, or a combination of both. The tissue may be directly looped over the flexible, adjustable loop for insertion and fixation into a bone tunnel or socket. 
     This disclosure may provide, for example, a surgical construct that comprises at least one fixation device; at least one flexible strand that forms at least one adjustable loop, the adjustable loop being coupled to the at least one fixation device; and a self-locking mechanism that includes one or more self-locking splices, one or more finger trap mechanisms, or a combination of one or more self-locking splices and one or more finger trap mechanisms. 
     In some aspects of this disclosure, the construct further comprises another fixation device coupled to the at least one adjustable loop; each fixation device is a button; and/or at least one of the buttons is coupled to the adjustable loop remote from the self-locking mechanism. 
     In other aspects, the flexible strand forms at least two adjustable loops; the at least two adjustable loops are interlocked with one another; the at least one flexible strand is a single strand; the self-locking mechanism is one of the self-locking splices merged with one of the finger trap mechanisms; the self-locking mechanism is one of the finger trap mechanisms and receives two adjustable loops of the flexible strand; the self-locking mechanism is first and second finger trap mechanisms that each receive an adjustable loop of the flexible strand; the construct further comprises one or more splices that receives one or more segments of the flexible strand for strand management of the construct; and/or the construct further comprises another flexible strand forming at least one adjustable loop coupled to the at least one fixation device. 
     The disclosure may also provide, for example, a surgical construct that comprises at least one fixation device; at least one flexible strand that forms at least two adjustable loops, each adjustable loop being coupled to the at least one fixation device; and a self-locking mechanism including one or more self-locking splices, one or more finger trap mechanisms, or a combination of one or more self-locking splices and one or more finger trap mechanisms. And the self-locking mechanism receives portions of the at least two adjustable loops. 
     In some aspects of this disclosure, the at least one fixation device is a button and is coupled to the at least two adjustable loops remote from the self-locking mechanism; the construct further comprises another fixation device coupled to the at least two adjustable loops; and/or the at least one flexible strand is a single strand. 
     This disclosure may further provide a method of tissue repair using a surgical construct that comprises at least one fixation device, at least one flexible strand that forms at least one adjustable loop coupled to the fixation device, and a self-locking mechanism. The method may comprise the steps of: drilling a bone tunnel; looping tissue over the at least one adjustable loop of the construct; advancing the surgical construct with the looped tissue through the bone tunnel; securing the tissue within the bone tunnel by adjusting the length of the adjustable loop; and locking the construct in place via the self-locking mechanism of the construct. 
     In certain aspects of this disclosure, the method further comprises the step of coupling another fixation device to the at least one adjustable loop; the surgical construct forms at least two adjustable loops each coupled to the at least one fixation device, and the length of each of the at least two adjustable loops is adjusted when securing the tissue; and/or the self-locking mechanism receives portions of each of the at least two adjustable loops. 
     This summary is not intended to identify essential features of the claimed subject matter, nor is it intended for use in determining the scope of the claimed subject matter. It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide an overview or framework to understand the nature and character of the disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are incorporated in and constitute a part of this specification. It is to be understood that the drawings illustrate only some examples of the disclosure and other examples or combinations of various examples that are not specifically illustrated in the figures may still fall within the scope of this disclosure. Examples will now be described with additional detail through the use of the drawings, in which: 
         FIGS. 1-21  show exemplary embodiments of this disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     This disclosure generally relates to self-locking surgical constructs and methods of tissue reconstruction using the same. The surgical constructs are designed to simplify reconstructive surgery while also providing a secure repair. The surgical constructs of the disclosure may be used to perform a variety of tissue reconstruction procedures. The tissue reconstruction procedures could include any procedure in which it is desirable to position a replacement graft or filament within a bone tunnel to repair torn tissue. ACL and PCL reconstructions are but two non-limiting examples of reconstruction procedures which could benefit from the use of the surgical fixation system of this disclosure. 
     In a first exemplary embodiment of the disclosure, a surgical construct  100  generally includes a fixation device  110  and a flexible adjustable loop  120  connected to the fixation device  110 , as seen in  FIG. 1 . The loop  120  can carry, for example, a graft for fixating the graft relative to bone and/or a filament (e.g., suture, etc.) for fixating the filament relative to bone. 
     Loop  120  may be an adjustable loop made of a flexible material and/or one or more strands  12 , such as suture, suture tape, or the like, and includes an adjustable length and perimeter. One or more of the opposite free ends  14  and  16  of the strand  12 , which may also be referred to as shortening strands, may be pulled to reduce the size of the loop  120 . For example, the loop  120  may be adjusted in a first direction by pulling on the strand&#39;s free end  14  but is prevented from loosening in the opposite direction due to applied internal tensile forces. For coupling to loop  120 , fixation device  110  may have two openings, for example, similar to the button disclosed in commonly owned U.S. Pat. No. 8,460,379, the subject matter of which is herein incorporated by reference. 
     Surgical construct  100  may be provided with one or more self-locking splices, one or more self-locking finger trap mechanisms, or a combination of any number of self-locking splices with any number of finger trap mechanisms. As seen in  FIG. 1 , for example, construct  100  may have first and second self-locking splices  102   a  and  102   b  and a single finger trap  104  formed in the flexible strand  12  of the loop. The self-locking splices  102   a  and  102   b  are formed by splicing the flexible material or strand  12  that is used to form the loop  120  through itself. The splice may be formed, for example, by two spaced apertures in a length of the strand  12  with a tunnel therein connecting the two apertures. The loop  120  may be connected to the fixation device  110  prior to completely forming the loop  120 . Free end  14  of strand  12  may be threaded through finger trap  104  to form loop  120  and then through the button  110  for tensioning the loop. Once strand  12  is threaded through the openings of button  110 , the strand&#39;s other free end  16  may be threaded through the two self-locking splices  102   a  and  102   b  to lock the repair. In an alternative embodiment, two of the constructs  100  may be wrapped around the button  110  in parallel. 
     As seen in  FIG. 2 , in a second exemplary embodiment of the disclosure, a surgical construct  200  is similar to construct  100 , except that the second self-locking splice  102   b  and finger trap mechanism  104  ( FIG. 1 ) are merged into one self-locking mechanism  202 . As such, both the strand  12  and its free end  16  thread through the merged self-locking mechanism  202 . 
     As seen in  FIG. 3 , in a third exemplary embodiment of the disclosure, a surgical construct  300  is similar to the construct  200  of the second embodiment in that it includes a merged self-locking mechanism  302  (like mechanism  202 ) with a second merged self-locking mechanism  304  that merges the first self-locking splice  102   a  of the first embodiment with a second finger trap mechanism. As such, the strand  12  forming the loop  120  threads through second merged self-locking mechanism  304 . 
     As seen in  FIG. 4 , a fourth embodiment of the disclosure includes a surgical construct  400  that is similar to the construct  300  of the third embodiment with a second loop  122  added. As such, both free ends  14  and  16  of the strand  12  forming the loops  120  and  122  extend through the button  110  for tensioning the loops. Construct  400  may have first and second merged self-locking mechanisms  402  and  404  like the mechanisms  302  and  304  of construct  300 . 
     A surgical construct  500  according to a fifth exemplary embodiment of the disclosure may also include first and second loops  120  and  122 , similar to the construct  400  of the fourth embodiment, where the loops  120  and  122  are interlocked, as seen in  FIG. 5 . Construct  500  may include first and second finger trap mechanisms  502  and  504  to form the loops which forms a 4-strand segment repair. The self-locking splices of the fourth embodiment are not required for construct  500 . 
     As seen in  FIG. 6 , in a sixth exemplary embodiment of the disclosure, a surgical construct  600 , the loops may be threaded through the button  110  twice and threaded through a single finger trap mechanism  604  to form a 6-strand segment repair. In this embodiment, the loops may be separate and not interlocked. 
     As seen in  FIG. 7 , in a seventh exemplary embodiment of the disclosure, a surgical construct  700  is similar to construct  600  of the sixth embodiment, except the loops  120  and  122  are interlocked. Like construct  600 , construct  700  may have a single finger trap mechanism  704  and the interlocked portion of the interlocked loops  120  and  122  may be received in the finger trap mechanism  704 . The second strand segment of the construct  700  goes into and out of the same aperture of the finger trap mechanism  704  as the first strand segment and the third strand segment of the construct  700  also goes into and out of the same aperture as the first strand segment. 
     As seen in  FIG. 8 , a surgical construct  800  according to an eight exemplary embodiment of the disclosure may include multiple strands, multiple loops with multiple self-locking splices  802   a ,  802   b ,  802   c , and  802   d  and multiple finger trap mechanisms  804   a  and  804   b.    
     As seen in  FIG. 9 , a surgical construct  900  according to a ninth exemplary embodiment of the disclosure may be similar to construct  400  of the fourth embodiment, except that the merged self-locking mechanisms  402  and  404  of construct  400  are split. That is first and second self-locking splices  902   a  and  902   b  are provided to interlock the loops  120  and  122  of construct  900  and first and second finger trap mechanisms  904   a  and  904   b  are provided near the button  110 . 
     As seen in  FIG. 10 , in a tenth exemplary embodiment of the disclosure, a surgical construct  1000  is similar to construct  600  of the sixth embodiment, except that construct  1000  has only a single self-locking splice  1002 . 
     As seen in  FIG. 11 , in an eleventh exemplary embodiment of the disclosure, a surgical construct  1100  is similar to construct  600  of the sixth embodiment, except that there are two splices  1102   a  and  1102   b  next to each other and formed such that only three apertures  1106   a ,  1106   b , and  1106   c  for accessing the splices are needed and provided. 
     As seen in  FIG. 12 , in a twelfth exemplary embodiment of the disclosure, a surgical construct  1200  is similar to construct  600  of the sixth embodiment, except that there are two separate finger trap mechanism  1204   a  and  1204   b  (instead of a single finger trap mechanism). Each finger trap mechanism  1204   a  and  1204   b  may receive one of the strand loops  120  and  122 . 
       FIGS. 13 and 14  illustrate thirteenth and fourteenth exemplary embodiments, respectively, of the disclosure, which are both similar to the sixth embodiment. As seen in  FIG. 13 , a surgical construct  1300  is similar to construct  600  of the sixth embodiment and includes first and second self-locking splices  1302   a  and  1302   b  in addition to a single finger trap mechanism  1304  (that receives both strand loops  120  and  122 ), where each splice  1302   a  and  1302   b  receives a strand segment of the construct for strand management thereof. Similarly, as seen in  FIG. 14 , a surgical construct  1400  includes a single self-locking mechanism  1402  in addition to a single finger trap mechanism  1404  (which receives both strand loops  120  and  122 ), where the single self-locking mechanism  1402  receives multiple strand segments for strand management of the construct. 
     As seen in  FIG. 15 , in a fifteenth exemplary embodiment of the disclosure, a surgical construct  1500  is similar to construct  600  of the sixth embodiment and includes a self-locking splice  1502  in addition to a finger trap mechanism  1504  (which receives both of the strand loops  120  and  122 ). The self-locking splice  1502  may receive a strand segment and may have an elongated portion  1503  that is configured to extend through one of the apertures of the button  110  for strand management of the construct. 
     As seen in  FIG. 16 , in a sixteenth exemplary embodiment of the disclosure, a surgical construct  1600  is similar to construct  1300  of the thirteenth embodiment, except that construct  1600  does not include a finger trap mechanism. Instead, the construct  1600  has a third strand loop  124  extending between first and second self-locking splices  1602   a  and  1602   b  and a second fixation device  112 . The second fixation device  112  can be located on the other side of self-locking splices  1602   a  and  1602   b  from fixation device  110 . Two segments of the strand  12  thread through each of the self-locking splices  1602   a  and  1602   b . The second fixation device  112  is coupled to each of the strand loops  120 ,  122 , and  124 . 
     As seen in  FIG. 17 , in a seventeenth exemplary embodiment of the disclosure, a surgical construct  1700  is similar to construct  600  of the sixth embodiment including having a finger trap mechanism  1704  through which the strand loops  120  and  122  may be threaded. The direction of the loops  120  and  122  are different than in construct  600 . In construct  1700 , at least one strand segment of the loops  120  and  122  cross over two other strand segments. 
     As seen in  FIG. 18 , in an eighteenth exemplary embodiment of the disclosure, a surgical construct  1800  is similar to construct  1500  of the fifteenth embodiment, except all of the strand segments converge and splice into one. Like construct  1500 , construct  1800  includes a self-locking splice  1802  in addition to a finger trap mechanism  1804  (which receives both of the strand loops  120  and  122 ). The self-locking splice  1802  receives each strand segment. 
     As seen in  FIG. 19 , in a nineteenth exemplary embodiment of the disclosure, a surgical construct  1900  is similar to construct  600  of the sixth embodiment, except construct  1900  has twice as many tensioning strands, strands  12  and  13 . Two finger trap mechanisms  1904   a  and  1904   b  are provided in this construct to capture and organize the loops of each strand  12  and  13 . 
     As seen in  FIG. 20 , in a twentieth exemplary embodiment of the disclosure, a surgical construct  2000  is similar to construct  1500  of the fifteenth embodiment, except the strand has one loop  120 . Like construct  1500 , construct  2000  includes a self-locking splice  2002  a finger trap mechanism  2004 . The self-locking splice  2002  receives each segment of the strand  12  and the finger trap mechanism  2004  receives the strand loop  120 . Finger trap mechanism  2004  may be elongated to facilitate loading of the fixation device.  110 . 
     As seen in  FIG. 21 , in a twenty-first exemplary embodiment of the disclosure, a surgical construct  2100  is similar to construct  1900  of the nineteenth embodiment, except that that the first strand  12  does not splice back into itself and the second strand  13  does not splice back into itself, leaving strand loops thereof outside of finger trap mechanisms  2104   a  and  2104   b.    
     In an embodiment, each of the fixation devices  110  and  112  can be a button. However, fixation devices having other similar configurations could also be used. The fixation device  110  may be oblong or round and may be made of either metallic or polymeric materials within the scope of this disclosure. 
     The disclosure may also provide methods of fixation of bone to bone, or soft tissue to bone. An exemplary method of the present invention comprises the steps of: (i) providing a bone tunnel; (ii) providing a button/graft construct, such as the surgical constructs of the embodiments discussed above, in the vicinity of the bone tunnel; (iii) looping tissue (graft) over the adjustable loop of the construct; (iv) advancing the button/graft construct with the looped tissue through the bone tunnel; and (v) securing the tissue within the bone tunnel by adjusting the length of the adjustable loop and locking the construct in place via the self-locking splices and/or the finger trap mechanisms of the construct. 
     It should be understood that terms such as “lateral,” “medial,” “distal,” “proximal,” “superior,” and “inferior” are used above consistent with the way those terms are used in the art. Further, these terms have been used herein for purposes of explanation and should not be considered otherwise limiting. Terms such as “generally,” “substantially,” and “about” are not intended to be boundary less terms and should be interpreted consistent with the way one skilled in the art would interpret those terms. 
     Although the different examples have the specific components shown in the illustrations, embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from one of the examples in combination with features or components from another one of the examples. 
     One of ordinary skill in this art would understand that the above-described embodiments are exemplary and non-limiting. That is, modifications of this disclosure would come within the scope of the claims. Accordingly, the following claims should be studied to determine their true scope and content.