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IPP-0051-US14 cross roads Referring to FIG. 32, a lateral tunnel 400 has been formed into a humerus 402. First and second medial tunnels 404, 406 have been formed into the humerus 402. The medial tunnels 404, 406 are spaced apart at the surface of the bone near the rotator cuff 408 and the medial tunnels 404, 406 intersect the lateral tunnel 400 inside the humerus 402. First and second suture shuttles 410, 412 are inserted into the medial tunnels 404, 406 and exit the bone through the lateral tunnel 400. The sutures are unwound from the suture keeper and the first pair of suture strands 310, 311 is engaged with the first suture shuttle 410 and the second pair of suture strands 320, 321 is engaged with the second suture shuttle 412. By utilizing the suture keeper 300 to manage the sutures, the various strands of sutures may be easily isolated to prevent tangling and to facilitate independent manipulation of a desired suture strand. The tube 370 may be positioned within a surgical portal (not shown) and acts to confine the suture strands to prevent them from entangling one another and/or instruments and other items passed through the portal. 116 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 32-41 illustrate a transosseous surgical repair method using the components illustrated in FIGS. 1-31. The illustrative method of FIGS. 32-41 depicts a rotator cuff repair. However, the implants, instruments, and method illustrated may be used to form transosseous attachments at other locations and for other purposes. 115 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 31 is a side view of the configuration of FIG. 29. 114 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Referring to FIG. 38, the suture threader 280 is pulled out the distal end of the suture anchor 100 to thread the suture strands back through the suture anchor 100 as shown in FIGS. 20-23. The protective tube 370 is split and removed laterally away from the sutures. 122 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Referring to FIG. 29, the suture strands are wrapped around the suture keeper 300 between the proximal and distal notches as many times as necessary to contain the length of the suture strands while keeping the first pair of strands together on the first side and the second pair of strands together on the second side. The ends of the sutures are pulled into the slits 368, 369 to secure the sutures to the suture keeper 300. 112 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Referring to FIG. 28, the suture strands are folded back through the distal notches so that the suture strands and tube 370 lie along the back of the suture keeper 300. The first pair of suture strands 310, 311 is positioned in the first proximal notch 360 and the second pair of suture strands 320, 321 is positioned in the second proximal notch 362. 111 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 27 is a rear view of the configuration of FIG. 26. 110 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Referring to FIG. 26, a tube 370 is placed over the distal ends of the suture strands of the suture anchor 100 of FIG. 24. Optionally, the tube may be a dual lumen tube so that each pair of suture strands passes through a separate lumen in the tube further isolating the first and second pairs from one another. Preferably, the tube 370 is frangible so that it may be torn from the sutures. For example, a thin walled tube 370 may be torn along its length to split the tube and remove it laterally away from the sutures. One or more starter notches may be formed in the sidewall at one or both ends to facilitate tearing the tube. The proximal ends 312, 313, 322, 323 of the first and second suture pairs are passed through the first slot 340. The proximal ends 312, 313 of the first suture pair is passed through the distal most hole 354 of the first pair of holes and then through the proximal most hole 352 of the first pair of holes. The proximal ends 322, 323 of the second suture pair is passed through the distal most hole 356 of the second pair of holes and then through the proximal most hole 358 of the second pair of holes. The proximal ends 312, 313, 322, 323 are all tied together to join them to the suture keeper 300 (FIG. 27). Thus joined, the suture keeper prevents the proximal ends from being pulled back into the suture anchor 100. The suture anchor 100 is mounted on the suture keeper 300 by bending the proximal and distal tabs 342, 348 upwardly and inserting the suture anchor 100 into the first slot 340 between the tabs with the proximal tab 342 pressing against the proximal end 152 of the proximal member 104 and the distal tab 348 pressing against the distal end 110 of the anchor body 102 to releasably hold the suture anchor 100. The first pair of suture strands 310, 311 is positioned in the first distal notch 364 and the second pair of suture strands 320, 321 is positioned in the second distal notch 366. 109 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads Referring to FIG. 25, the suture keeper 300 includes an elongate, generally planar body 330 extending from a proximal end 332 to a distal end 334 and having a length 336 between the proximal and distal ends 332, 334 and a width 338 between first and second sides 326, 328. A first slot 340 formed in the body 330 defines a first, proximal, cantilevered tab 342 free at its distal end 344. Preferably the first slot 340 is narrower than the suture anchor 100 so that the suture anchor can lie in the first slot 340 without passing through the first slot 340. A second slot 346 defines a second, distal, cantilevered tab 348 free at its proximal end 350. Four holes are formed through the body 330 adjacent the first slot 340 with a first pair of holes 352, 354 adjacent a side of the first slot 340 nearer the first side 326 of the body 330 and a second pair of holes 356, 358 adjacent an opposite side of the first slot 340 nearer the second side 328 of the body 330. First and second spaced apart proximal notches 360, 362 are formed into the proximal end 332 of the body 330 with the notches 360, 362 being nearer the first and second sides 326, 328 of the body 330 respectively. First and second spaced apart distal notches 364, 366 are formed into the distal end 334 of the body 330 with the notches 364, 366 being nearer the first and second sides 326, 328 of the body respectively. First and second spaced apart distal slits 368, 369 are formed in the distal end 334 of the body 330 with the slits 368, 369 being nearer the first and second sides 326, 328 of the body respectively. Preferably the distal slits 368, 369 are located between the distal notches 364, 366. In the illustrative example of FIG. 25, the suture keeper is made from a thin, flexible sheet of material. 108 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 24-31 illustrate a suture keeper 300 for managing the suture anchor 100 and sutures in storage and use. Referring to FIG. 24, the suture anchor 100 is prepared as in FIG. 20 with the threader 280 inserted into the suture anchor 100 with the grip portion 286 extending out of the superior distal opening 118 and the loop portion 284 extending out of the superior “U”-shaped opening 158. Four suture strands are loaded in the suture anchor. Preferably each suture strand is uniquely identifiable such as by color, pattern, or otherwise. A first pair of suture strands 310, 311 extends through the longitudinal passageway 114 with proximal ends 312, 313 extending from the inferior “U”-shaped opening 159 and distal ends 314, 315 extending from the first inferior distal opening 120. A second pair of suture strands 320, 321 extends through the longitudinal passageway 114 with proximal ends 322, 323 extending from the inferior “U”-shaped opening 159 and distal ends 324, 325 extending from the second inferior distal opening 122. 107 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 20-23 depict an illustrative example of a suture routing through the suture anchor 100. A suture threader 280 is pre-loaded into the anchor body 102. The suture threader includes a filament 282 forming a distal loop portion 284 and a proximal grip portion 286 joined to the loop portion. The suture threader 280 is inserted through the longitudinal passageway of the anchor body from the superior distal opening 118 to the proximal opening 116 with at least part of the loop portion 284 extending up and out of the superior “U”-shaped opening 158 of the proximal member 104 and the grip portion 286 extending out of the distal opening 118. In the illustrative example of FIGS. 20-23, two sutures 250, 251 are depicted. Any number of sutures may be utilized in accordance with the present disclosure and each of the depicted sutures may represent multiple sutures that are routed together. For simplicity, the suture locking member 160 and retainer 180 have been omitted from FIGS. 20-23 and the routing of only one suture 250 of the illustrated sutures will be described in detail. The suture 250 is threaded through an inferior distal opening 122 of the anchor body 102, with a first portion 252 extending through the longitudinal passageway 114 of the anchor body 102 between the proximal opening 116 and the distal opening. A proximal end 254 of the suture 250 extends out the proximal opening 116 of the anchor body 102 and down through the inferior “U”-shaped slot 188 of the retainer 180 (not shown) and the inferior “U”-shaped opening 159 of the proximal member 104. In FIG. 21, a second portion 256 of the suture 250 contiguous to the first portion 252 extends away from the anchor body 102. A distal end 258 of the suture 250 is inserted through the loop portion 284 of the threader 280. The threader 280 is pulled distally through the anchor body 102 to route the distal end 258 of the suture 250 back through the anchor body 102 so that a third portion 260 of the suture contiguous to the second portion 256 extends within the longitudinal passageway 114 between the proximal opening 116 and the superior distal opening 118. The distal end 258 of the suture is then pulled proximally so that a fourth portion 262 of the suture contiguous to the third portion 260 extends along the exterior surface of the anchor body 102 between the distal opening 118 and the proximal end 108. The suture locking member 160 may then be inserted into the anchor body to secure the first portion 252 of the suture and the third portion 260 of the suture within the longitudinal passageway by compressing the suture portions between the suture locking member 160 and the anchor body 102. For example, the suture may be compressed between the sides of the suture locking member and the interior sidewall of the anchor body as shown in FIGS. 15 and 16. In an example according to the present disclosure, the suture 250, 251 and threader may be provided preloaded to the anchor as shown in the configuration of FIG. 20. 106 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In FIG. 15, the advancement mechanism 214 has been operated to advance the pushrod 208 so that it has pushed the suture locking member 160 out of the proximal member 104 and into the anchor body 102 to secure the suture limbs 220, 222 within the anchor body 102. Preferably, the first portion 210 of the pushrod 208 extends sufficiently far distally from the second portion 212 of the pushrod 208 that the suture locking member 160 is fully inserted into the anchor body 102 before the second portion 212 of the pushrod begins to transmit axial force through the retainer 180 to the proximal end 108 of the anchor body 102. Once the suture locking member 160 is fully inserted, further operation of the advancement mechanism 214 presses the second portion 212 of the pushrod against the retainer 180 which presses against the anchor body 102 causing anchor body 102 to separate from the proximal member 104 at the frangible connection 106 as shown in FIG. 16. Separation of the members transforms the “U”-shaped openings 158, 159 of the proximal member 104 into distally open “U”-shaped slots that will release the suture limbs 220, 222 sideways out of the slots without the need for the ends of the suture limbs to be pulled through the openings 158, 159. In this way, the suture limbs 220, 222 will be released from the proximal member 104 even if the ends of the suture limbs 220, 222 are attached at another location or otherwise inaccessible. 105 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 50 also depicts the anchor 500 of FIGS. 42-48 preloaded with first and second suture threaders 630, 610. In this example, the first threader 630 is extended and a tube 632, like the tube 370 of FIG. 26, is placed over the extended portion of the suture threader 630. The tube may, for example, be used to protect, confine, separate, or otherwise aid in suture management as previously described relative to the example of FIG. 26. In the example of FIG. 50, the proximal end of the tube includes an enlarged cylindrical portion 634 that is sized to press over the distal end of the anchor body to releasably join the tube 632 to the anchor. The distal loop portion 636 of the first threader extends out the distal end of the tube 632. As in the example of FIG. 26, the tube 632 is preferably frangible. For example, the tube is preferably longitudinally splitable. 130 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 52-61, the proximal member 704 is generally cylindrical and has a sidewall 751 (FIG. 61) defining an exterior surface, a proximal end 752, a distal end 754, and a longitudinal axis coaxial with the anchor body longitudinal axis 712 extending between the proximal and distal ends 752, 754. An axial through bore 756 extends through the proximal member 704 from the proximal end 752 to the distal end 754 and communicates with the longitudinal passageway 714 of the anchor body 702. 138 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 52-61, the distal openings include a first, more proximal superior opening 718 and a second, more distal superior opening 720. The first superior opening 718 and second superior opening 720 are formed through the sidewall 750 to communicate with the interior longitudinal passageway 714 and centered over the longitudinal axis of the anchor body 702. The first superior opening 718 and second superior opening 720 are spaced proximally away from the distal end 710 of the anchor body 702 and can be aligned with each other. 137 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In certain embodiments, the anchor body 702 includes a set of internal helical threads 717 near the proximal end 708 of the anchor body 702. In one embodiment, the internal helical threads 717 are in communication with the proximal opening 716. The internal helical threads 717 may serve to engage, partially engage, interface with or communicate with an interference member 770 positioned within the longitudinal passageway 714. 136 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads In the illustrative example of FIGS. 52-61, the anchor body 702 is generally cylindrical and has a sidewall 750 (FIG. 61) defining an exterior surface, a proximal end 708, a distal end 710, and a longitudinal axis 712 extending between the proximal and distal ends 708, 710. An interior longitudinal passageway 714 extends at least partway from the proximal end 708 toward the distal end 710. A proximal opening communicates with the longitudinal passageway nearer the proximal end 708 and a distal opening communicates with the longitudinal passageway nearer the distal end 710. In the illustrative embodiment of FIGS. 52-61, the proximal opening 716 communicates through the proximal end 708 of the anchor body 702 along the axis 712 with the passageway 714. The distal opening comprises a plurality of distal openings that communicate from the exterior surface of the anchor body 702 through the sidewall 750 to the passageway 714. 135 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIGS. 52-61 depict an illustrative example of a suture anchor 700. The suture anchor 700 has an anchor body 702, a proximal member 704 joined to the anchor body 702 by a frangible connection 706 and an interference member 770. The frangible connection may include, for example, a thin wall (as shown), a perforated section, an intermediate material such as an adhesive, and/or other suitable frangible constructions or structures. 134 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads The suture may be threaded through the anchor 500 using the suture threaders. In an example, the first portion of suture 650 is threaded through the distal loop portion 602 of the first suture threader 600. The grip portion 604 of the first suture threader is grasped and pulled to disengage the clip 606 from the anchor body and pull the first portion of suture 650 through the second superior opening 520 in the suture anchor body, proximally along the longitudinal passageway 514, through the proximal opening 516, and out through the inferior “U”-shaped opening 559. The second portion of suture 652 is threaded through the distal loop portion 612 of the second suture threader 610. The grip portion 614 of the second suture threader is grasped and pulled to disengage the clips 616, 618 from the anchor body and pull the second portion of suture 652 through the superior “U”-shaped opening 558, through the proximal opening 516, distally along the longitudinal passageway 514, and out through the first superior opening 518. 133 Added by DJM 9 2021 9/2/21, 12:00 AM
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IPP-0051-US14 cross roads FIG. 51 depicts an example of suture routing through the suture anchor 500 of FIGS. 42-48 such as for example using the threaders of FIGS. 49 or 50. For example, in a transosseous soft tissue fixation procedure, one or more sutures may be extended through a bone tunnel with a first portion of the suture extending from a first opening of the bone tunnel and a second portion of the suture extending from a second opening of the bone tunnel. For example, in a rotator cuff repair procedure a first portion of suture may extend from a lateral opening of a tunnel formed in a humeral bone and a second portion of suture may extend from a medial opening at a desired attachment location for the soft tissue. The second portion may be passed through soft tissue, for example tissue of the rotator cuff, and extended away from the soft tissue. 132 Added by DJM 9 2021 9/2/21, 12:00 AM

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