Adjustable self-locking loop constructs for tissue repairs and reconstructions

Systems and methods for bone to bone, or soft tissue to bone, repairs without knot tying. The repair systems include self-cinching constructs which are tensionable and which include a flexible strand with a knotless, adjustable loop with at least one splice and a shuttle/pull device attached to the flexible strand. A final splice is formed by pulling on the shuttle/pull device subsequent to the knotless, adjustable loop being assembled with or secured to tissue (for example, a soft tissue graft or BTB graft), to allow desired tensioning of the graft to be fixated relative to the bone.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, more particularly, to tissue repairs and reconstruction techniques, and associated fixation and reconstruction devices.

BACKGROUND OF THE INVENTION

Adjustable suture-button constructs and associated techniques for fixation of a tendon or ligament, such as an ACL, are disclosed in U.S. Patent Application Publication Nos. 2010/0256677 and 2010/0268273, the disclosure of which are incorporated by reference herein in their entirety.

Securing a bone block with cortical buttons and loop fixation devices (such as adjustable suture-button constructs) is difficult as a bone-tendon-bone (BTB) graft has two distinct ends and cannot be folded through a loop like a soft tissue graft. It would be desirable to provide adjustable suture-button constructs and techniques for soft tissue repairs (such as BTB ACL reconstruction) that easily secure a bone block to cortical bone, in a way that minimizes material removal from the bone block, minimizes compressive force to the bone block and secures a bone block to cortical bone without the damaging compressive forces, while promoting easy self-locking adjustability.

SUMMARY OF THE INVENTION

The present invention provides methods and reconstruction systems for knotless reconstruction of tissue that securely fixate the tissue to bone. The reconstruction system comprises an adjustable, self-locking knotless tensionable construct attached to tissue, for further insertion into a bone tunnel or socket. The tensionable construct (fixation device) is adjustable in length and allows the surgeon the ability to customize the device to each patient and seat the graft against the wall of the bone tunnel or socket. The adjustments are self-locking and the fixation device minimizes the compressive forces on the bone block.

These and other features and advantages of the present invention will become apparent from the following description of the invention that is provided in connection with the accompanying drawings and illustrated embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides surgical constructs, systems and techniques for knotless tissue repairs and fixations. The surgical constructs comprise a tensionable construct with an adjustable, self-locking knotless flexible closed loop connected to tissue (such as soft tissue, graft, tendon, ligament, synthetic material, biological material, bone, or combinations of such materials, among others). The tissue may be directly looped over the flexible adjustable loop, or the flexible adjustable loop may be passed through tissue, for insertion and fixation into a bone tunnel or socket. The surgical constructs may also comprise a splicing device (a shuttle/pull device) adjacent the flexible, adjustable loop. The splicing device may be a suture passing instrument such as a closed loop, a FiberLink™, a nitinol wire loop, a needle pre-inserted into a splice area, or any splicing device that aids in the formation of a final splice in the adjustable loop). The tensionable construct may optionally include a fixation device (for example, a button) securely attached to the adjustable loop. The splicing device (suture passing instrument or shuttle/pull device) aids in the formation of the final splice of the adjustable, self-locking knotless flexible closed loop. The tensionable construct is adjustable in length and allows the surgeon the ability to customize the device to each patient and seat the graft against the wall of the bone tunnel or socket. The adjustments are self-locking and the fixation device (implant) minimizes the compressive forces on the bone block.

According to an exemplary embodiment, the tensionable construct is provided as a pre-assembled or pre-packaged construct on an assembly board upon which an adjustable flexible closed loop, a shuttle/pull device, a passing suture for fixation device, and a needle are mounted (in a kit, for example) and assembly instructions are provided. The pre-assembled tensionable construct may be assembled with BTB grafts or other tissue grafts (such as a ligament graft like an autograft, allograft or artificial graft), at the time of surgery, to form integrated systems for tissue repairs and reconstructions. During the assembly, the self-locking flexible adjustable closed loop is provided around tissue graft (for example, around a BTB block or a soft tissue strand) or through tissue. If a BTB construct is employed, the self-locking adjustable loop is provided around the BTB bone block without forming any knots or any crossing of the loop strands between the top of the bone block and the button. This minimizes the compressive forces on the bone block which, in turn, leads to a stronger reconstruction. The absence of any knots also limits the chances of the knot tightening down and restricting the adjustability of the implant.

If an exemplary BTB graft is employed, the tensionable construct is assembled with the BTB graft by passing the self-locking adjustable loop of the tensionable construct through a hole in the bone block, and then passing the free strand of the construct through the looped end of the construct and through the loop of the shuttle/pull device (provided in the form of a splice loop of fixed diameter, for example). The flexible strand and the shuttle/pull device attached to it allow the formation of a final splice for the adjustable loop. The shuttle/pull device is provided within the strand (inside of the strand) and forms the final splice subsequent to the insertion of the self-locking adjustable loop through the hole in the bone block. The shuttle/pull device is removed subsequent to the formation of the final splice, and is not part of the final implantable construct (final assembled integrated system).

The integrated systems of the present invention allow formation of the final fixation device with a knotless self-locking mechanism that allows the user (for example, the surgeon) to control the tension of the strand on the tissue to be attached to bone.

At least one of the flexible strand and the splicing device (shuttle/pull device) may be made of any known suture material, such as ultrahigh molecular weight poly ethylene (UHMWPE) or the FiberWire suture (disclosed in U.S. Pat. No. 6,716,234 which is hereby incorporated by reference in its entirety). Typically the suture will be UHWMPE suture without a core to permit ease of splicing. The shuttle/pull device may be a suture passing instrument such as a splicing loop (for example, a loop of a flexible strand, or a FiberLink™ or a Nitinol loop) or a needle pre-inserted into the splice area or any device that allows formation of a final splice in the adjustable closed loop of the tensionable construct.

The present invention also provides 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 including a button and a loop of flexible material having an adjustable length, in the vicinity of the bone tunnel; (iii) attaching tissue to the button/graft construct by looping the tissue (graft) over the adjustable loop or, alternatively, by passing the loop of flexible material through the tissue (graft); (iv) advancing the button/graft construct with the attached tissue through the bone tunnel; and (v) securing the tissue within the bone tunnel by adjusting the length of the adjustable loop.

The present invention also provides methods of 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. An exemplary method of the present invention comprises inter alia the steps of: (i) providing a pre-assembled construct including an adjustable, self-locking knotless flexible closed loop with at least one splice in a flexible strand, the flexible closed loop being adjacent a shuttle/pull device (a splicing device or a suture passing instrument); (ii) assembling the pre-assembled construct with a tissue graft (BTB or other soft tissue graft) by passing the adjustable, self-locking knotless flexible closed loop through or around tissue, and then forming a final splice in the adjustable, self-locking knotless flexible closed loop with the shuttle/pull device to obtain a final implantable construct; (iii) securing the final implantable construct into a bone tunnel/socket; and (iv) pulling on the flexible strand to allow the tissue graft to achieve the desired location relative to the bone, and to allow proper tensioning of the final construct.

Referring now to the drawings, where like elements are designated by like reference numerals,FIG. 1illustrates an exemplary tensionable construct99(ACL TightRope®99) of the present invention employed for the formation of surgical integrated systems100,200,200a(FIGS. 17, 18 and 35, respectively). In the particular exemplary embodiment illustrated inFIG. 1, tensionable construct99is formed of a knotless, closed, adjustable loop50formed of a flexible strand5or flexible material5and a shuttle/pull device40(a suture passing instrument or a splicing device such as a fixed loop40, a FiberLink™40, a nitinol loop40or a needle40, for example) attached to the flexible strand5(i.e., pre-loaded on the flexible strand). Optionally, tensionable construct99may include a fixation device20(for example, a button20). A top view of an exemplary fixation device20is shown inFIG. 1a. Device20has a body25with an oblong configuration (when viewed along a longitudinal axis25aof the device) and a plurality of holes, a tear drop hole21and a round hole22extending along the longitudinal axis25a.

As detailed below, the knotless, closed, adjustable loop50is formed by splicing an end5aof flexible material5(for example, braided high strength (UHMWPE) suture strand5provided in a predetermined color, for example, white) to form splice6. The splice6and loop50are secured to button20by sliding the button over the non-spliced strand5band passing the strand5bthrough both button holes21,22so that the splice6will rest on (abut) the thickness of the button20.

The knotless, closed, adjustable loop50has an adjustable perimeter and length, and is capable of adjusting tension. Details for the formation of adjustable closed loop constructs (similar to the loop50) are set forth, for example, in U.S. Patent Application Publication Nos. 2010/025667 and 2010/0268273, the disclosures of which are incorporated herein in their entirety.

Shuttle/pull device40(splicing device40) of the tensionable construct99may be any suture passing device or splicing device configured to create a final splice in the knotless, closed, adjustable loop50after attachment to tissue to be reconstructed/repaired, and as detailed below. Shuttle/pull device40may be a suture passing instrument in the form of a pre-loaded flexible strand, a loop with a fixed perimeter, a FiberLink™, a nitinol wire loop or a needle pre-attached to the flexible strand forming the knotless, closed, adjustable loop50, for example.

In an exemplary embodiment, shuttle/pull device40is a fixed closed loop with a fixed length and perimeter (i.e., non-adjustable). Fixed loop40may be formed by splicing another flexible strand1(for example, a #2 FiberWire® suture1provided in a predetermined color, for example, blue) through strand5bby first folding the blue strand and then passing both free ends1a,1bof the blue strand through the non-spliced strand5bto form loop40, eyesplice7and loop section1cbelow eyesplice7. Ends1a,1bare tied in a static knot11.

FIG. 1also depicts a passing suture3(for example, a #5 FiberWire® suture) for pulling the button20through a bone tunnel or socket (for example, the femoral tunnel). Like the shuttle/pull device40, the passing suture3is removed at the end of the implantation of the final construct. Also shown inFIG. 1a straight needle4is attached to adjustable, knotless suture loop50for passing the construct (the implant) through a graft, as detailed below. Another illustration of the adjustable, knotless button/loop construct99of the present invention is depicted inFIG. 6.

FIG. 2illustrates the button20, flexible strand5(braid5) and splicing suture1, as starting materials used in configuring the construct99.

FIG. 3(creating eyesplice6and adjustable, closed loop50): Step1: start with a flexible strand5(for example, a white braided suture5such as a UHMWPE braid5of about 40-50 inches); fold the braid at midpoint to create two equal length braid strands5a,5b.

Step2: create an eyesplice6on one of the braid strands (for example, on strand5a) by passing a blunt tip needle4through the center of the braid5and carrying the end5aof the braid5through with it, in the nitinol loop4aof the needle4. The splice6should travel for a distance of about 16-18 mm through the braid, towards the midpoint created in step1to form adjustable, closed loop50. Reduce the eyesplice loop50to about 80 mm.

FIG. 4(positioning the button20): Step3: slide a button20over the non-spliced strand5bpassing the strand through both button holes21,22leading with the full round hole22of the button. Pass the free strand end5athat results from the eyesplice6through the full round hole22and position the button20such that the exit point of the eyesplice6is resting within the thickness of the button20.

FIG. 5(creating the second eyesplice7and the splicing loop40): Step4: prepare an eyesplice7in the same manner as Step2by employing another flexible strand1with two ends1a,1b(for example, a #2 blue suture braid1). Fold the #2 blue braid1at the midpoint and pass both free ends1a,1bof the blue braid through the non-spliced strand5bto form the second eyesplice7.

FIG. 6(construct assembly): Step5: position the blue braid and tie the two free ends1a,1binto a simple overhand knot11above the button20to form splicing loop40(with a fixed perimeter), and loop end1c.

Step6: place a passing suture3(for example, a #5 FiberWire® suture, not shown) through the tear drop button hole21and position the passing suture3so that the strands are about equal length. The passing suture3will pull/pass the button20through the bone (femur or tibia).

Step7: crimp the nitinol wire around a strand section5cof adjustable loop50of the white braid; assemble the end of the nitinol wire into the needle capturing the white braid. The pre-assembled construct (tensionable construct99) is then provided to medical personnel in the OR (for example, surgeon) who then completes the final assembly to create the final implantable construct with the graft. The graft may be a BTB graft or any other soft tissue grafts (for example, a soft tissue graft that cannot be folded over the adjustable, knotless loop) or a ligament, tendon graft or a synthetic graft.

According to additional embodiments, just the loop construct (without fixation device/button20) is provided to the surgeon. This embodiment could be used for soft tissue grafts that cannot be folded over the loop. In this “no button/loop assembly,” the implantation is conducted with an attachable button (as detailed below with reference toFIGS. 31-40).

During the final assembly by the surgeon, the splicing loop40is removed after completing the splice. The passing suture3is also removed after the button20is implanted.

Reference is now made toFIGS. 7-16which illustrate subsequent, exemplary steps of a method of assembling (attaching) the tensionable construct99to tissue (for example, soft tissue or BTB graft) to be repaired and/or reconstructed. Tensionable construct99is provided as a pre-assembled construct that includes a suture passing device40(splicing loop) that aids in creating the final splice for the adjustable loop. As detailed below, the suture passing device may have an exemplary loop configuration and it is not part of the final assembled construct that is implanted; suture passing device40is just an aid for the final assembly and for the formation of the final splice (and spliced loop) of the assembly. The suture passing device40is not limited to a flexible strand or a suture, but it could be a needle pre-inserted into the splice area or a nitinol wire loop, among others.

Details on assembling tissue90with the tensionable construct99to obtain integrated construct100of the present invention are set forth below with reference toFIGS. 7-16. The integrated construct100is a surgical implantable system consisting of tensionable construct99provided with knotless, adjustable loop50with a suture splicing device40attached to the knotless, adjustable loop50and tissue90. During the final assembly by the surgeon, the suture passing device40(splicing loop40) is removed after completing the splice and the formation of final “closed loop”150. The passing suture3is also removed after the button20is implanted.

The embodiments detailed below will be explained, for simplicity, with reference to tissue90as being an exemplary BTB graft90; however, the invention is not limited to this exemplary embodiment and encompasses any tissue and/or tissue graft. BTB grafts and other soft tissue grafts are harvested and provided at the time of surgery so they cannot be assembled by the manufacturer with the fixation device. The partially-assembled construct99(tensionable construct99) is attached to the graft by the surgeon, and during surgery, to complete the assembly of the final construct in the OR. The partially-assembled construct99(tensionable construct99) may be attached to one or both ends of a BTB graft (for the femoral and tibial sides), as desired and depending on the particulars of each surgical repair.

FIGS. 7 and 8: pass the straight needle4of Step7through a drill hole91aformed within the bone block91of BTB graft90so that the loop50extends through the drill hole and a loop portion50cis exposed. Once the implant99is passed, the needle4is cut off.

FIGS. 9 and 10: pass the free strand5bof the implant99through looped portion50cof the knotless, adjustable loop50(implant50) that has been passed through the bone block91.

FIG. 11: pass the free strand5bthrough the pre-loaded passing suture loop40.

FIGS. 12 and 13: pull the tails1aand1bof the pre-loaded passing suture loop40through splice7of the implant99to advance the free strand5bthrough the implant99. The end of the free strand5bis held tightly while pulling it through the implant99.

FIG. 14: the free strand5bpasses through the eyesplice7, forming loop55which is interconnected (interlinked) with adjacent knotless, adjustable loop50through connecting region59. The free strand5bnow becomes the shortening strand of the construct99(TightRope®99).

FIG. 15: even out the implant99by pulling the shortening strands until the implant99is symmetric (i.e., interconnecting region59of the two interconnected loops50,55is within hole91aof the bone block91). Final closed loop150is formed by the two interconnecting loops50,55and two splices6,7.

FIG. 16shows the final construct100(integrated assembly100) with the two shortening strands5a,5bof the TightRope®99and the two strands of #5 FiberWire® suture3for passing button20. Closed loop150is attached to both the graft90and fixation device20(button20).

FIGS. 17 and 18illustrate two exemplary integrated systems100,200. Integrated system100(BTB TightRope®100) includes tensionable construct99and BTB graft90. Integrated system200(ACL TightRope®200) includes tensionable construct99and soft tissue290. Integrated system200(ACL TightRope®200) is formed in a manner similar to that described above for the formation of integrated system100, the difference being that the knotless adjustable loop50is passed not through tunnel91of the bone block90but rather passed around (and secured to) a mid portion290aof folded soft tissue graft290(shown inFIG. 17, with the graft290being folded and looped over the interconnect region59formed by loops50,55).

FIGS. 19-30illustrate steps of an ACL reconstruction with an exemplary BTB TightRope®100(integrated system100) of the present invention. The simplicity and strength of the ACL TightRope® is used with bone-tendon ACL grafts. The BTB TightRope® (tensionable construct99) offers the same adjustable, four-point locking system as the ACL TightRope® but allows placement through a small drill hole in the cortical bone block. The TightRope® button20facilitates dependable, cortical fixation and the adjustable loop50allows the graft to be pulled into the femoral socket as deep as needed for ideal graft tunnel-matching. The BTB TightRope®99also allows fixation of BTB grafts90into anatomic femoral sockets that can be difficult to reach with traditional interference screws.

For graft preparation and implant loading, use the BTB TightRope® for bone blocks of about 10 mm in diameter and about 20 mm in length. Use a 2 mm drill pin to place a hole about 10 mm from the end of the bone block, perpendicular to the cortical bone. The BTB TightRope®99is packaged in a special card to facilitate assembly (as shown inFIG. 41). Step-by-step instructions (FIG. 42) may be also included on the card.

FIG. 19: Use the attached needle4to pass the looped limb50of the TightRope®99through the bone block91in the direction of arrow A. Once passed, cut the wire off the needle4and remove. Take care not to damage implant (loop50) during cutting.

FIG. 20: Pass the straight limb5bof the TightRope®99through the first loop50cin the direction of arrow B.

FIG. 21: Place 1 cm of the tip of the straight limb5binto the blue passing suture loop40and fold over. Pull the tails of the passing suture loop to deliver the straight limb5bthrough the suture splice7and button20. Importantly, as the suture is passed through the splice (by pulling in the direction of arrow C), resistance will be encountered. A hemostat85may be used to pull the passing suture while holding firm counter tension on the straight suture.

FIG. 22: Pull on the newly created shortening strand to even up loop lengths before implantation (by pulling in the direction of arrow D) and to form final construct100. Final integrated construct100includes tensionable construct99a(i.e., without the splicing device40) and BTB graft90attached to it. Closed loop150of tensionable construct99ais attached to both the graft90and the fixation device20. Splices6,7of loops50,55forming closed loop150abut the fixation device20. Final integrated construct100is implanted into a bone tunnel or socket, as detailed below.

FIGS. 23 and 24: FEMORAL SOCKET PREPARATION—The femoral socket81can be prepared in femur80in a retrograde fashion using the FlipCutter® and the RetroConstruction™ Guide System, by a retrograde technique using an Arthrex FlipCutter®, disclosed in U.S. Patent Application Publication No. 2009/0275950. Alternatively, the socket may be drilled transtibially through the medial portal or in an antegrade fashion with a ACL TightRope® Drill Pin and Low Profile Reamers. In a Medial Portal Option, for medial portal and transtibial drilling, an Arthrex RetroButton® Drill Pin may be used. Note the intraosseous length during tunnel preparation and mark that distance on the ACL TightRope® RT implant.FIG. 23shows the FlipCutter® Option employing a FlipCutter®83.FIG. 24shows the Medial Portal Option employing a drill/cutter84.

FIG. 25: Pass the blue passing suture3and white tensioning strands50,55together through the femur80. Pull even tension on both sets of sutures. Clamp sutures together and pull to advance button20. Pull the button20through the femur80. A line on the implant marked at the intraosseous length is helpful to signal that the button has exited the femur. The button20can also be viewed through the medial portal as it exits the femoral cortex. If tunnels are divergent, it may be helpful to use a probe through the lateral portal to facilitate implant and graft passage out of tibia70and into the femoral socket.

FIG. 26: Hold slight tension on the tibial graft sutures during graft advancement. To advance the graft90, pull on the tensioning strands one at a time, alternating approximately 2 cm on each side. Once the graft is fully seated, pull firmly back on the graft to check fixation. Once the graft is seated, do not continue to pull tensioning strands.

FIGS. 27-20: Fix the tibial side of the graft (in tibial tunnel71of tibia70) and cut shortening strands. BTB TightRope®99is also ideal for All-Inside® ACL Reconstruction with RetroScrew® (FIG. 28) or for tibial fixation (FIG. 29). For RetroScrew® fixation, the graft is secured in the tibia70employing interference screw77(FIG. 27) or an interference screw77and a button20a(FIG. 28). Tibial fixation may be also achieved by attaching tensionable construct99to the remaining bone block of the BTB graft90(in a manner similar to the formation of integrated system100for the femoral fixation), to form integrated system100afor tibial fixation of a final reconstruction construct300, as shown inFIG. 29.

FIG. 30: Shows an enlarged view of the final construct300(ACL BTB TightRope®) ofFIG. 29, with two integrated systems100,100afor the fixation of a BTB graft90within femoral socket81and tibial socket71.

FIGS. 31-40show an example of an Open Tightrope ABS199which is passed through a soft tissue graft390that has been stitched together (with stiches322), not allowing loading over a traditional “closed loop” device. This exemplary embodiment employs a tensionable construct199which is similar to the tensionable construct99described above in that it also contains an adjustable knotless loop50and a splicing device40(a suture passing instrument or any shuttle/pull device to form a final splice in the construct); however, tensionable construct199differs from the tensionable construct99in that it does not include a fixation device20(button20). As in the previously-described embodiments, loop50is passed through soft tissue graft390and then the free strand5bof the construct199is passed through looped portion50cof the knotless, adjustable loop50and through the pre-loaded passing suture loop40(splicing device40). A second splice is formed in the flexible strand5and a second loop55is interconnected to loop50(through interconnecting region59) forming close loop150having an adjustable, knotless configuration. Upon fixation of the graft390in a bone tunnel (for example, the tibial tunnel), a slotted button (having a dog bone configuration, for example) may be employed to secure the construct to the tibial cortex.

FIGS. 31 and 32: The looped side50of the tensionable construct199is passed through the graft390with a passing suture33(FIG. 31) to form loop portion50cextending out of the tissue graft (FIG. 32).

FIGS. 33-35: The free end5bis passed through the loop50c(FIG. 33), and then placed in the passing suture40(FIG. 34) where it is pulled through the splice7to create the tightrope “closed loop”150(FIG. 35) of integrated assembly200aincluding tensionable construct199a(without the splicing suture40). In this manner, by pulling the passing suture40, end5bpasses through splice7and forms another closed loop55which is interconnected with loop50by interconnecting region59. The overall construct is an adjustable, knotless, closed loop150formed of two interconnected loops50,55and two splices6,7(all formed from a single, same suture strand5).

FIG. 36: TightRope® loop is assembled and ready to be passed into socket, for example tibial socket71in tibia70. The TightRope®199aand graft290are passed into the tibia70.

FIGS. 37-40: A slotted button120(FIGS. 37-39) is loaded onto the tightrope loop and tensioned against bone which tensions and fixates the graft. The final construct400is shown inFIG. 40with integrated system200aimplanted into tibia and secured to the tibial cortex with button120.

The tensionable constructs of the present invention (which are employed for further attachment to a graft and for subsequent implantation into a surgical site) may be provided in a pre-assembled state, on an assembly board which may be part of a surgical kit. The assembly board may contain the tensionable construct with the flexible closed loop (adjustable, self-locking knotless flexible closed loop), the splicing device (shuttle/pull device), any passing suture for the fixation device (if a fixation device is employed), and a needle, all pre-assembled and ready for use by medical personnel. Instructions may be also provided.

FIG. 41illustrates an exemplary sterilizable assembly board500with an exemplary adjustable tensionable construct99of the invention (pre-assembled tensionable construct99), a needle, and any other necessary components. The assembly board may be folded, and will be supplied with mounted components, as a sterilized product, e.g., a kit. In use, while the suture construct of the invention is maintained in position by a plurality of flexible holding tabs510, the needle4with the threaded loop50are lifted from the board and passed through an opening in the BTB graft block. After the threaded loop50emerges from the bone block opening, the needle4is cut off. A free end5bof the suture is then removed from the board tabs and is passed through the emerged threaded loop section50c. Then the blue splicing loop40is lifted from the board tabs and the free end5bis passed through the lifted loop40. The free suture strand is then pinched against an adjacent section of the free suture strand to form a temporary loop that captures splicing loop section50c. The knotted end11of the splicing loop40is pulled until the temporary loop is in vicinity of the button20. Then the free suture strand end is pulled through the button hole. The BTB graft90is held while the free end is pulled to even out the loops holding the BTB graft90. The assembled BTB graft construct and passing suture are then removed from the assembly board.

FIG. 42shows an exemplary instruction card550that may be part of the kit of the present invention together with the assembly board500.

The tensionable, self-locking adjustable constructs of the present invention are provided around a BTB bone block without forming any knots or any crossing of the loop strands between the top of the bone block and the button. This minimizes the compressive forces on the bone block which, in turn, leads to a stronger reconstruction. The absence of any knots also limits the chances of the knot tightening down and restricting the adjustability of the implant.

The present invention also provides methods of tissue repair/reconstruction by inter alia: (i) providing a surgical reconstruction system comprising an adjustable, self-locking, knotless loop construct including an adjustable loop formed of two interconnected loops and two splices and, optionally, a button attached to the adjustable loop; and (ii) securing tissue (for example, soft tissue or BTB graft) with the reconstruction system.

An exemplary method of BTB ACL reconstruction comprises inter alia the steps of: (i) providing a flexible, adjustable, knotless button/loop construct99with a fixation device (button)20attached to the button/loop construct that is capable of adjusting tension, the button/loop construct99including an adjustable loop50and a non-adjustable, fixed loop40and two corresponding eyesplices6,7; (ii) passing the adjustable loop50through a hole91aformed in a bone block91of a BTB graft90; (iii) passing the free strand5bthrough the looped end50of the construct; (iv) passing the free strand5bthrough the fixed loop40(of the pre-loaded passing suture1); (v) pulling the tails of the pre-loaded passing suture1through the construct to shorten the construct, as desired; and (vi) securing the BTB graft90within a femoral tunnel/socket by pulling on button20. The construct is adjustable in length and allows the surgeon the ability to customize the device to each patient and seat the bone block fully against the back wall of the femoral socket. The adjustments are self-locking and the fixation device (implant) minimizes the compressive forces on the bone block.

Button20of the reconstruction integrated assembly100may be formed, for example, of metal, PEEK or PLLA. As detailed above, the button is provided with openings that allow the passage of the flexible materials to pass thereto. The flexible materials may be a high strength braid construct such as an ultrahigh molecular weight (UHMWPE) braid. As detailed above, the flexible materials may be provided with optional colored strands (for example, white and blue) to assist surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace.

The flexible strands employed for the constructs of the present invention may be formed of a high-strength suture, such as an ultrahigh molecular weight polyethylene (UHMWPE) suture which is the preferred material as this material allows easy splicing. Alternatively, the high strength suture may be a FiberWire® suture, which is disclosed and claimed in U.S. Pat. No. 6,716,234, the entire disclosure of which is incorporated herein by reference. FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra (Honeywell) and Dyneema (DSM), braided with at least one other fiber, natural or synthetic, to form lengths of suture material. The preferred FiberWire® suture includes a core within a hollow braided construct, the core being a twisted yarn of UHMWPE.

The strands may also be formed of a stiff material, or combination of stiff and flexible materials, depending on the intended application. The strands may be also coated and/or provided in different colors. The knotless constructs of the present invention can be used with any type of flexible material or suture that forms a splice and a loop.

The knotless suture constructs also include sutures that are spliced—at least in part—in a manner similar to an Arthrex ACL TightRope®, such as disclosed in U.S. Patent Application Publication Nos. 2010/0256677 and 2010/0268273, the disclosures of which are incorporated by reference herein.

While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments and substitution of equivalents all fall within the scope of the invention. Accordingly, the invention is not to be considered as limited by the foregoing description.