Patent Publication Number: US-2019192135-A1

Title: Tensionable constructs with multi-limb locking mechanism through single splice and methods of tissue repair

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a divisional of U.S. application Ser. No. 14/831,511, filed on Aug. 20, 2015, the entire disclosure of which is incorporated by reference herein in its entirety. 
    
    
     BACKGROUND 
     The present invention relates to surgical devices and, in particular, to devices and methods for repair or fixation of soft tissue to bone without the need for knots. 
     SUMMARY 
     Surgical constructs, systems, and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone are disclosed. 
     A surgical construct includes a tensionable construct in the form of a multi-limb locking construct formed through a single splice. A flexible strand is split into a plurality of limbs that are shuttled back through a flexible strand, to create a locking splice construct that is tensionable after insertion in bone. A surgical construct allows attached tissue to be brought proximate to bone and does not require tying of any knots. A flexible strand may be fixed to a fixation device and split into a plurality of limbs that are shuttled back through a flexible strand, to create a locking splice construct that is tensionable after insertion in bone. 
     In an embodiment, a surgical construct includes an anchor, a suture that is attached to the anchor and that splits into two or more limbs, and a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot or similar construct. A suture shuttle is inserted into a center of a single suture with a plurality of suture limbs, to shuttle the suture limbs back through the suture, creating a multi-limb locking mechanism through a single locking splice. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a tensionable knotless construct according to an exemplary embodiment. 
         FIGS. 2 and 3  illustrate an exemplary method of tissue repair with the tensionable knotless construct of  FIG. 1 . 
         FIGS. 4 and 5  illustrate another exemplary method of tissue repair with the tensionable knotless construct of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     Surgical constructs, systems, and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone are disclosed. 
     The surgical constructs comprise tensionable knotless anchors that are inserted into bone and are provided with a multi-limb suture locking mechanism through single splice (tensionable construct). The tensionable knotless anchor may be formed essentially of suture or suture-like material (i.e., a soft anchor without a solid body) or may be attached to a fixation device. 
     The multi-limb suture locking mechanism through single splice is formed of a flexible strand (a suture) and a shuttle/pull device (a suture passing instrument) attached to the flexible strand. A flexible strand includes an unsplit region or end (a single main limb of suture or main strand) and a plurality of limbs attached to the unsplit region (main strand). A shuttle/pull device attached to the unsplit region allows passing of the plurality of limbs through the tissue and then spliced back through the unsplit region. In this manner, multiple locking limbs with variable loop lengths are locked through just one splice. If a fixation device (such as a solid anchor, for example) is employed, a splice may be formed outside the body of the fixation device or inside the body of the fixation device. A multi-limb suture locking mechanism through single splice may be employed for tissue repairs. 
     In an embodiment, a flexible strand (for example, suture) is split into multiple strands or limbs. The strands are passed through the tissue and then spliced back through the single main limb of suture. The individual limbs can slide with variable tension and all could lock within the jacket. 
     In an embodiment, a surgical construct includes an anchor, a suture that is fixed to the anchor and that splits into two or more limbs, and a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot at the end of the suture. A suture shuttle is inserted into a center of the single suture, and is designed to help shuttle the suture limbs back through the suture, creating a single locking splice. A locking splice may be formed outside an anchor body or inside an anchor body. 
     In another embodiment, a surgical construct comprises (i) a suture or suture-like material that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (ii) a suture shuttle with a looped end. A suture shuttle can be pre-assembled to the first region of the suture or suture-like material. A suture shuttle may be inserted into a center of the first region (unsplit region) of the suture or suture-like material. A suture shuttle shuttles the suture limbs back through the suture or suture-like material, creating a single locking splice in the first region (unsplit region) and a plurality of multiple adjustable closed loops. Multiple adjustable closed loops may have adjustable perimeters, and the perimeters may be all similar or different, or at least one perimeter of one loop different than a perimeter of another loop. A surgical construct may consist essentially of (i) a suture or suture-like material that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (ii) a suture shuttle with a looped end. 
     In another embodiment, a surgical construct includes (i) an anchor; (ii) a suture that is fixed to the anchor and that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (iii) a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot at the end of the suture. A suture shuttle can be pre-assembled to the first region of the suture. A suture shuttle may be inserted into a center of the first region (unsplit region) of the suture. A suture shuttle shuttles the suture limbs back through the suture, creating a single locking splice in the first region (unsplit region). 
     In an embodiment, a surgical system for tissue repairs includes a fixation device comprising a body, a longitudinal axis, a proximal end, and a distal end; and a tensionable construct pre-loaded on the fixation device. A tensionable construct may include a flexible strand with a plurality of limbs, and a shuttling device attached to the flexible strand. A flexible strand may have one end which terminates in a knot, and another end which is split into multiple flexible limbs. 
     Methods of soft tissue repair which do not require tying of knots and allow adjustment of both the tension of the suture and the location of the tissue with respect to the bone are also disclosed. An exemplary method of tissue repair comprises (i) installing a fixation device in bone, the fixation device comprising a body, a flexible strand split into a plurality of multiple flexible limbs, the flexible strand extending through at least a portion of the body of the fixation device, and a passing device attached to the flexible strand; and (ii) forming, with the multiple flexible limbs of the flexible strand and with the passing device, multiple knotless closed loops having adjustable perimeters, after the step of installing the fixation device in bone. 
     In one embodiment, two or more suture limbs extending from the split suture are passed through soft tissue. The limbs are then inserted into the suture shuttle loop. The tail of the suture shuttle is pulled, advancing the shuttle loop and two or more suture limbs through the locking splice. The ends of each of the two or more suture limbs are then independently advanced until the desired tension is achieved, creating simple stitches along the soft tissue. 
     In another embodiment, two or more suture limbs, as well as the suture shuttle loop and tail, are all passed through soft tissue. The limbs are then inserted into the suture shuttle loop. The suture shuttle loop and the two or more suture limbs loaded onto it are advanced through the locking splice by pulling the suture shuttle tail. The two or more suture limbs are then independently advanced until the desired tension is achieved, creating a mattress stitch on the soft tissue. 
     Another exemplary method of soft tissue repair comprises inter alia: (i) inserting a fixation device of a surgical construct into bone, the surgical construct comprising a fixation device (for example, an anchor) with a flexible strand (for example, suture) that is attached to the fixation device and that is split into multiple strands/limbs, and with a shuttle/pull device (a suture passing instrument) attached to the flexible strand; (ii) passing the multiple strands/limbs around or through tissue to be fixated (or reattached) to bone, and then through an eyelet/loop of the shuttle/pull device; and (iii) subsequently, pulling on the shuttle/pull device to allow the multiple strands/limbs to pass through the flexible strand and to form a locking splice. In an embodiment, individual multiple strands/limbs are each advanced until desired tension is achieved creating simple stitches along the tissue. In an embodiment, individual multiple strands/limbs may be sequentially advanced through the flexible strand. 
     According to another embodiment, a method of soft tissue repair comprises inter alia: (i) inserting a fixation device of a surgical construct into bone, the surgical construct comprising a fixation device (for example, an anchor) with a flexible strand (for example, suture) that is attached to the fixation device and that is split into multiple strands/limbs, and with a shuttle/pull device (a suture passing instrument) attached to the flexible strand; (ii) passing the multiple strands/limbs together with the shuttle/pull device around or through tissue to be fixated (or reattached) to bone; (iii) subsequently, passing the multiple strands/limbs through an eyelet/loop of the shuttle/pull device; and (iv) subsequently, pulling on the shuttle/pull device to allow the multiple strands/limbs to pass through the flexible strand and to form a locking splice. In an embodiment, individual multiple strands/limbs are each advanced until the desired tension is achieved creating a mattress stitch on the tissue. In an embodiment, individual multiple strands/limbs may be sequentially advanced through the flexible strand. 
     Referring now to the drawings, where like elements are designated by like reference numerals,  FIGS. 1-5  illustrate device  100  (surgical construct, integrated system, surgical system, or assembly  100 ) which includes fixation device  10  assembled with construct  99  (tensionable construct  99 ) formed of flexible strand or flexible material  30  and shuttle/pull device  40  (suture passing instrument  40 ) attached to the flexible strand  30 . Tensionable construct  99  may be pre-loaded on the fixation device  10 . Although the embodiments below will be described with reference to construct  99  (tensionable construct  99 ) attached to at least a part of fixation device  10 , the disclosure is not limited to these exemplary embodiments and contemplates embodiments wherein construct  99  (tensionable construct  99 ) acts as a soft anchor, i.e., without being attached to any fixation device such as fixation device  10 . 
     In an exemplary embodiment, fixation device  10  is a tensionable knotless anchor having a solid anchor body  11  provided with a longitudinal axis  11   a , a proximal end  13 , a distal end  12 , and a plurality of ribs or ridges  15  extending circumferentially around body  11 . Cannulation  11   b  extends along the body  11  to allow passage of flexible strand  30  and of a suture passing device, as detailed below. Proximal end  13  of the anchor  10  may contain a socket  19  ( FIG. 1 ) configured to securely engage a tip of a driver. 
     In an exemplary embodiment, fixation device  10  is an anchor  10  which may be a screw-in anchor or a push-in style anchor. Anchor  10  may be formed of metal, biocompatible plastic such as PEEK, or a bioabsorbable PLLA material. Socket  19  at the distal end  13  of the anchor  10  may have any shape adapted to receive a driver tip for pushing tap-in or screw-in style anchors. Anchor  10  may be made of one or more pieces (a multi-piece construct), or may be provided as an integrated device (a unitary device). Anchor  10  may have various sizes (various diameters and/or lengths) and may be formed of biocompatible materials such as PEEK, biocomposite materials, metals and/or metal alloys, or combination of such materials, among others. 
     In an embodiment, construct  99  (tensionable construct  99 ) may be formed of flexible strand  30  (flexible material, suture, or tie down suture  30 ) and shuttle/pull device  40  (suture passing instrument such as FiberLink™  40 , wire loop  40 , or nitinol loop  40 ) attached to the flexible strand  30 . In an exemplary embodiment, the flexible strand  30  is a suture strand  30  and the shuttle/pull device  40  is a suture passing device  40 . The flexible strand  30  includes an end  32  (unsplit end, unsplit region, or unsplit suture  32 ) which terminates in knot  31 , and another end which is split into multiple limbs  33   a ,  33   b  . . .  33   n  (where “n” may be any number greater than 2). For simplicity,  FIGS. 1-5  illustrate flexible strand  30  split into two limbs  33   a ,  33   b ; however, the constructs detailed below encompass any number of multiple limbs (suture limbs). Knot  31  may be a static knot  31  which prevents suture  30  from passing through distal blind hole  12   a.    
     Suture  30 , which is typically braided or multi-filament or tape, may be preloaded onto the anchor by tying static knot  31  which prevents suture  30  from passing through distal blind hole  12   a . The suture may also be preloaded by insert molding or by any other means known in the art. Suture  30  passes through cannulation  11   b  and terminates in limbs  33   a ,  33   b  exiting proximal end  13  of body  11 . Tensionable knotless anchor  10  is loaded onto a driver (not shown in  FIGS. 1-5 ), and suture  30  is secured to the driver (for example, wrapped around a cleft of the driver) to fasten tensionable knotless anchor  10  securely to the driver. 
     Prior to the fastening of the anchor  10  to the driver, suture passing device  40  (for example, a FiberLink™, a wire loop, or a nitinol loop) is threaded through suture  30  (i.e., attached to a center of the suture  30  through splice region  39  of unsplit end or region  32 ), as shown in  FIG. 1 . Suture passing device  40  includes closed eyelet/loop  44  for passing suture, and tail  42 . Suture passing device  40  passes through an aperture  32   a  of suture  30 , within the body of suture  30  and within the tensionable knotless anchor  10 , and then exits an aperture  32   b  of suture  30 . A distance between apertures  32   a ,  32   b  of suture  30  corresponds to splice or splice region  39 . Tensionable knotless anchor  10  loaded with tensionable construct  99  (formed of suture  30  attached to the suture passing device  40 ) is then secured into bone  80  (for example, into a hole/socket/tunnel formed in bone  80 ) by using a driver. 
       FIGS. 2 and 3  depict exemplary repair  200  with tensionable knotless anchor  10  of construct  100  after it has been inserted into a drilled hole in bone  80 , the suture released from the driver, and the driver removed. Suture limbs  33   a ,  33   b  are passed through (or around) tissue  50  which is to be moved to a desired location (for example, brought into proximity of a drilled hole or socket in bone  80 , to be reattached, for example, to bone  80 ). Suture limbs  33   a ,  33   b  are subsequently passed through eyelet/loop  44  of the suture passing device  40 . Tail  42  of suture passing device  40  is then pulled, thereby pulling suture limbs  33   a ,  33   b  towards tensionable knotless anchor  10 , so that each of the suture limbs  33   a ,  33   b  is passed/advanced through locking splice  39  (splice region  39 ) of suture  30 , i.e., each of the suture limbs  33   a ,  33   b  doubles on itself within suture  30  and inside tensionable knotless anchor  10 , to form multiple adjustable tensionable loops  88   a ,  88   b , . . .  88   n  (where “n” has any value greater than 2). For simplicity,  FIGS. 2 and 3  show only two multiple adjustable loops  88   a ,  88   b  corresponding to respective multiple limbs  33   a ,  33   b ; however, the constructs disclosed herein contemplate any number of multiple adjustable tensionable loops (corresponding to the number of multiple limbs). The suture passing device  40  has also been further pulled through the splice region  39  of suture  30 . 
       FIG. 3  illustrates surgical construct  100  with limbs  33   a ,  33   b  after the limbs have been pulled through themselves, creating locking splice  39  and tensionable loops  88   a ,  88   b . The suture passing device (not visible) helps create single locking splice  39  within tensionable knotless anchor  10  by facilitating suture limbs  33   a ,  33   b  of suture  30  to pass through (shuttle back through) the unsplit end or unslpit suture  32 . Locking splice  39  may be formed within body  11  of fixation device  10 , or outside body  11  of fixation device  10 . In an embodiment, locking splice  39  may be formed outside body  11  of fixation device  10  and within a bone tunnel formed within bone  80  (wherein construct  100  is inserted). 
     Once limbs  33   a ,  33   b  have been fully passed through suture  30 , each of the limbs  33   a ,  33   b  may be pulled to reduce the perimeter of loops  88   a ,  88   b  and until tissue  50  has been moved to the desired location, such as near a drilled hole in bone  80 . Once the desired tension and location is achieved, ends of limbs  33   a ,  33   b  may be clipped off to complete the soft tissue repair or fixation  200 . 
       FIGS. 4 and 5  illustrate another exemplary method of soft tissue repair  300  which does not require tying of knots and allows adjustment of both tension of the suture limbs and the location of the tissue with respect to the bone. According to this embodiment, two or more suture limbs  33   a ,  33   b , as well as the suture shuttle loop  44  and tail  42 , are all passed through tissue  50 . The limbs  33   a ,  33   b  are then inserted into the suture shuttle loop  44 . The suture shuttle loop  44 , together with the two or more suture limbs  33   a ,  33   b  loaded onto the suture shuttle loop  44 , are advanced through the locking splice  39  by pulling the suture shuttle tail  42 , to form adjustable tensionable loops  88   a ,  88   b , as shown in  FIG. 5 . As in the previously-described embodiment, loops  88   a ,  88   b  are multiple adjustable tensionable loops  88   a ,  88   b , each corresponding to a respective one of multiple limbs  33   a ,  33   b . Loops  88   a ,  88   b  have an adjustable perimeter and are self-locking, tensionable constructs formed of a splice (spliced region) and a continuous adjustable closed loop attached to the splice. The two or more suture limbs  33   a ,  33   b  may be then independently advanced until the desired tension is achieved, creating a mattress stitch on the tissue  50  and completing repair  300 . In an embodiment, the two or more suture limbs  33   a ,  33   b  may be sequentially or simultaneously advanced, and then independently tensioned so that desired tension is achieved and final repair completed. 
     Surgical construct  100  with the knotless anchor  10  and tensionable construct  99  may be employed in following exemplary repairs: 
     1) Used in subscapularis repair for simple partial tears: place anchor  10 , pass sutures, shuttle using FiberLoop® (Arthrex, Inc., Naples, Fla.), and tighten. 
     2) Full rotator cuff (RC) tears (subscapularis, supraspinatus, infraspinatus).
         a. Same technique for single row fixation: this will allow for simple repairs passing only one limb of each suture separately through the RC, then shuttle with FiberLink® (Arthrex, Inc., Naples, Fla.), tighten.   b. Single row fixation with horizontal mattress: pass sutures separately, pass FiberLink® through RC as well, shuttle sutures, tighten.   c. Double row fixation with one anchor  10 : pass sutures separately, pass FiberLink® through RC, shuttle sutures, tighten, and bring sutures to lateral row anchor(s).   d. Double row fixation with multiple anchors  10 :
           i. Pass sutures/FiberLink® up through RC either as unit or separately as desired; shuttle sutures into opposing anchor with opposing FiberLink® for interconnection medially.   ii. Since multiple limbs are available, may also shuttle one suture into same anchor for individual anchor fixation. This would be a suture from same anchor/FiberLink® that was passed through RC separately from FiberLink®. This allows for SutureBridge™ fixation without knots.
               1. All passes may be passed through the RC with both anchors done before shuttling sutures.   2. The technique could feature only two sutures per anchor with two anchors medially and two vented SwiveLock® (Arthrex, Inc., Naples, Fla.) anchors laterally.   
               
               

     3) Partial Articular-sided Supraspinatus Tendon Avulsion (PASTA) Repair:
         a. Pass anchor  10  through slit in RC or create a sheath to come through the RC easily, then fixate anchor into bone through tendon   b. Pass sutures separately via Lasso or BirdBeak® (Arthrex, Inc., Naples, Fla.)   c. Shuttle sutures back into FiberLink®, or if hole too big, shuttle FiberLink® through RC as well into a different, smaller hole   d. Tighten       

     4) A tape such as FiberTape® could be incorporated into anchor  10 :
         a. This would allow for SpeedBridge™ plus repairs as above to get better fixation and take away that doctors want to “tie” sutures medially to “help with fixation.” By interconnecting anchors  10  and passing a suture through the medial tissue, fixing it to its same anchor, surgeons get individual anchor fixation and construct fixation together.   b. This would also decrease potential for suture cut-through.       

     5) InternalBrace™—preferably employed with tape. InternalBrace™ may be employed with anchor  10  and interlock anchors across a joint. This would allow a surgeon to “dial in” how much tension to place on the construct. Instead of trying to fix the tension with the initial fixation with the proper length of the FiberTape® (Arthrex, Inc., Naples, Fla.), this technique would allow a surgeon to tighten sequentially. Any external ligament reconstruction or repair like medial collateral ligament (MCL), medial patella-femoral ligament (MPFL), lateral collateral ligament (LCL), anterior cruciate (AC), ankle, etc. would be appropriate. Any internal reconstruction or repair like anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) could potentially be internally braced with this anchor as well. 
     6) Any use of a SwiveLock® would be appropriate usage of anchor  10  in lieu of a free suture and vented SwiveLock® (VSL).
         a. This would include ankle or elbow or hip.   b. SCR would be included in this list as a replacement for VSL.   c. These could replace the VSL anchors In the SpeedBridge™ kit once the tapes were applied.       

     Although tensionable knotless anchor  10  has been depicted above having ridges  15 , and thus designed to be pushed into bone  80 , it could instead be fabricated with threads and thereby designed to be twisted or screwed into bone. 
     Surgical system  100  of  FIGS. 1-5  (with knotless tensionable anchor  10 , suture  30  with suture limbs  33   a ,  33   b , and suture passing device  40  attached to suture  30 ) may be employed in exemplary methods of tissue repair such as a Bankart or SLAP repair, wherein the knotless suture anchor  10  (i.e., a modified knotless SutureTak™ with suture limbs) simplifies arthroscopic glenohumeral joint instability repair by combining a proven and reproducible suture anchor insertion procedure with knotless soft tissue fixation. 
     The knotless suture constructs and systems detailed above may be used in conjunction with any knotless fixation devices which can allow a flexible strand and attached suture passing device to form a single locking splice with attached multiple adjustable loops formed by multiple suture limbs. The knotless suture constructs and systems detailed above may be used in conjunction with any additional fixation devices (which may be similar to or different from construct  100 ) depending on the characteristics of the repair site. 
     A flexible strand may be a suture strand, a tape such as suture tape, or any suture-like material known in the art that could pass through tissue. A flexible strand may include a high-strength suture, such as an ultrahigh molecular weight polyethylene (UHMWPE) suture. High strength suture may be a FiberWire® suture (Arthrex). FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM N.V., Heerlen, the Netherlands), braided with at least one other fiber, natural or synthetic, to form lengths of suture material. 
     A flexible strand may be also formed of TigerWire® suture, or suture chain (such as FiberChain® disclosed in U.S. Pat. No. 7,803,173), or suture tape (such as FiberTape® disclosed in U.S. Pat. No. 7,892,256), the disclosures of which are all incorporated in their entireties herein. 
     At least one of a flexible strand and a shuttle/pull device may be made of any known suture material, such as UHMWPE material or the FiberWire® suture. The UHWMPE suture may be without a core to permit ease of splicing. The shuttle/pull device may be a shuttle/pull suture device such as a FiberLink™ or a Nitinol loop. 
     The limbs may also be formed of a flexible material, a stiff material, or combination of stiff and flexible materials, depending on the intended application. Both the limbs and the splice region may be also coated and/or provided in different colors. The knotless anchors of the present invention can be used with any type of flexible material or suture that forms a splice and a loop.