Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
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View Edit Delete	IPP-0051-US14 cross roads	FIGS. 49 and 50 are examples in which a suture anchor is provided for use without any sutures preloaded with the anchor. This provides maximum flexibility to the user to choose the type and number of sutures to be used and also allows for suture manipulation during the surgical procedure without the anchor potentially interfering with certain suture passing techniques. The threaders are pre-loaded to facilitate threading the sutures through the anchor once the sutures are selected and/or positioned in the bone and soft tissue. The configuration of the example of FIG. 49 is compact and may be more suitable for open or shallow minimally invasive surgical procedures. The configuration of the example of FIG. 50 may be more suitable for arthroscopic or otherwise deep surgical procedures in which suture management is more challenging.	131	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Referring to FIGS. 14-19 one or more sutures are threaded through the anchor body 102 between the proximal and distal openings. In the illustrative example of FIGS. 14-19, separate suture limbs 220, 222 are threaded through each of the inferior distal openings 120, 122 of the anchor body 102, through the longitudinal passageway 114 of the anchor body 102, out the proximal opening 116 of the anchor body 102 and down through the inferior “U”-shaped slot 188 of the retainer 180 and the inferior “U”-shaped opening 159 of the proximal member 104. The suture locking member 160 is retained within the retainer 180 which is received in the proximal member 104. The shaft 206 of the inserter 200 is threadingly engaged with the proximal end of the proximal member 104.	104	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	In the example of FIG. 49 the threaders are labeled to facilitate their use in a procedure to attach, for example, a tendon to a bone. The first suture threader 600 is labeled with a “1” and the message “TUNNEL SUTURES” to indicate that it is used, preferably first, to thread sutures extending from the bone tunnel in which the anchor will be seated through the anchor. The second suture threader 610 is labeled with a “2” and the message “TENDON SUTURES” to indicate that it is used, preferably second, to thread sutures extending from the soft tissue, tendon in this example, through the suture anchor.	129	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIG. 49 depicts the anchor 500 of FIGS. 42-48 preloaded with first and second suture threaders 600, 610. The first threader 600 includes a proximal grip portion 604 and a filament forming a distal loop portion 602 joined to the grip portion. The first threader includes a semi-circular clip 606 sized to snap onto the anchor body to releasably secure the threader to the anchor body. The first suture threader 600 is engaged with the anchor by inserting the distal loop portion 602 through the inferior “U”-shaped opening 559 of the proximal member 504, through the proximal opening 516, along the longitudinal passageway 514, and out through the second superior opening 520. The grip portion is clipped to the anchor body. The second threader 610 includes a proximal grip portion 614 and a filament forming a distal loop portion 612 joined to the grip portion. The second threader includes a pair of semi-circular clips 616, 618 sized to snap onto the anchor body to releasably secure the threader to the anchor body. The second suture threader is engaged with the anchor by inserting the distal loop portion 602 through the first superior opening 518, along the proximally sloping passage 521, along the longitudinal passageway 514, through the proximal opening 516, and out the superior “U”-shaped opening 558 of the proximal member 504. The grip portion is clipped to the anchor body with the second suture threader clips 616, 618 straddling the first suture threader clip 606.	128	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIGS. 42-48 depict a suture anchor 500 according to an example of the present disclosure. The suture anchor 500 is the same as the suture anchor 100 of the example of FIGS. 1-12 except for the configuration of the distal openings. The anchor 500 has an anchor body 502, a proximal member 504 joined to the anchor body 502 by a frangible connection 506 and a suture locking member 560 all configured as in the example of FIGS. 1-12. The anchor body 502 is generally cylindrical and has a sidewall 503 defining an exterior surface, a proximal end 508, a distal end 510, and a longitudinal axis 512 extending between the proximal and distal ends 508, 510. An interior longitudinal passageway 514 extends at least partway from the proximal end 508 toward the distal end 510. A proximal opening 516 communicates through the proximal end 508 of the anchor body 502 along the axis 512 with the interior longitudinal passageway 514. The distal opening comprises a plurality of distal openings that communicate from the exterior surface of the anchor body 502 through the sidewall 503 to the interior longitudinal passageway 514. In the illustrative example of FIGS. 42-48, the distal openings include a first, more proximal superior opening 518 and a second, more distal superior opening 520. The first and second distal openings 518, 520 are formed through the sidewall 503 to communicate with the interior longitudinal passageway 514 and are centered over the longitudinal axis 512 on the same side of the anchor body. The first and second distal openings 518, 520 are spaced proximally away from the distal end 510 of the anchor body. In the example of FIGS. 42-48, the second opening 520 is elongated longitudinally and communicates with a proximally sloping passage 521 that connects it to the interior longitudinal passageway 514.	127	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Referring to FIG. 41, any remaining suture ends are trimmed.	126	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	If desired, the proximal ends 312, 313, 322, 323 of the suture strands may be separated from the suture keeper 300, such as by cutting the sutures, and the ends of the sutures may be passed through the soft tissue to form adjunctive stitches to further anchor the soft tissue. The proximal suture ends are preferably used since any loads carried by the proximal suture ends only act perpendicularly on the proximal end of the anchor and thus they do not exert a significant axial force tending to dislodge the anchor body from the lateral tunnel 400.	125	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Referring to FIG. 40, the distal portions of the suture strands have passed through the anchor body twice and have been pulled back proximally along the outside of the anchor body so that they are compressed between the anchor body and the bone tunnel wall. The proximal portions of the sutures have passed through the anchor body once, exited outwardly through the inferior distal openings, and then been pulled superiorly through the medial tunnels. This suture routing provides sufficiently low friction that the friction may be overcome by a user to independently pull each suture strand through the anchor body 102 to adjust the position and tension of the soft tissue yet sufficiently high friction that when the suture strands are released the imparted position and tension are maintained so the user can evaluate the repair and determine if further adjustments are needed. The inserter 200 may be used to provide an axial counterforce to keep the anchor body 102 in the bone tunnel while adjustments are made. Once the sutures are adjusted as desired, the inserter 200 is actuated to press the suture locking member 160 into the suture anchor 100 and secure the sutures to the suture anchor 100. The inserter 200 is further actuated to press the retainer 180 against the proximal end of the anchor body 102 and separate the proximal member 104 from the anchor body 102. When the proximal end 104 separates from the anchor body 102, the “U”-shaped openings 158, 159 transform into distally opening slots and the sutures release distally from the slots as the proximal end 104 is pulled away from the bone.	124	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Referring to FIG. 39, the inserter 200 is engaged with the proximal member 104 of the suture anchor 100. Any slack in the suture strands may be pulled through the suture anchor 100 by pulling on the proximal ends of the suture strands retained by the suture keeper 300. The suture anchor 100 is inserted into the lateral bone tunnel 400. A mallet 424 may be used to impact the end of the inserter 200 to urge the suture anchor into the lateral bone tunnel 400.	123	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIG. 92 is a perspective exploded view of the system of FIG. 66 according to one embodiment. The suture anchor system 800 can be assembled for use taking the following steps. First, the carriage 1002 can be slid along the shaft 902 from the proximal end 904 toward the distal end 906. The proximal end 904 is passed through the opening 1012 of the carriage 1002. Next, the carriage 1002 can be rotated such that the keyed opening 1020 accepts the second section 920 of the shaft 902. Once the keyed opening 1020 passes into the second section 920 the carriage 1002 may be rotationally fixed relative to the shaft 902.	174	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Next, the puller 1004 is slid along the shaft 902 from the proximal end 904 toward the distal end 906. The puller 1004 is slid until the distal end 1030 contacts the one or more lips 928. Then, the collar 908 is screwed onto the shaft 902 by engaging the external threads 914 within the internal threads of the distal end 932 of the collar 908. At this stage of assembly, the external threads 1032 of the puller 1004 may or may not engage the internal threads 1018 of the carriage 1002. Also at this stage, the inserter 900 / tensioner 1000 is ready for use in a surgical procedure.	175	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	In certain embodiments, a suture anchor 700 may be connected to the distal end 906 of the shaft 902 by way of the internal threads 912 and external helical threads 760 of the proximal member 704. Of course, this step can also be performed during a surgical procedure.	176	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	After the suture anchor system 800 is assembled, a user may insert the interference member 770 through the longitudinal opening 938 at the proximal end 930 of the collar 908 and pass the interference member 770 through the inserter longitudinal passageway 941 until the interference member 770 reaches the longitudinal passageway 714 of the suture anchor 700. In this manner, the interference member 770 can be inserted when needed during a surgical procedure to secure suture within the suture anchor 700.	177	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	In certain embodiments, the driver 910 can be used to move the interference member 770 through the inserter longitudinal passageway 941 and into the longitudinal passageway 714. Alternatively, or in addition, the driver 910 can be used to urge the interference member 770 into the anchor body 702.	178	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIGS. 93-96 are a sequence of perspective views illustrating use of the system of FIG. 66 and the implant of FIG. 52 according to one embodiment. Initially, a user, such as a surgeon, may thread one or more sutures 1034 through a suture anchor 700 having an anchor body 702 and proximal member 704 connected by a frangible connection 706. (See FIG. 93) Next, a user may connect an inserter 900 or tensioner 1000 or combination inserter/tensioner 900/1000 to the proximal member 704 by screwing the external helical threads 760 of the proximal member 704 into the internal threads 912 of the shaft 902. (See FIG. 94) At this stage, the one or more sutures 1034 may be loose and portions or ends of the one or more sutures 1034 may extend proximally towards the suture grip member 1010.	179	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Next, a user may loosen the fastener 1040 such that the superior grip plate 1036 and inferior grip plate 1038 can be readily separated. In certain embodiments, the fastener 1040 can be removed and/or the superior grip plate 1036 removed. Referring now to FIG. 95, next a user inserts the one or more sutures 1034 or portions of the one or more sutures 1034 between the superior grip plate 1036 and inferior grip plate 1038. In certain embodiments, the user may wrap or wind the one or more sutures 1034 around the boss 1046. At this stage, a user may then re-connect or tighten the fastener 1040 to close and/or compress the superior grip plate 1036 against the inferior grip plate 1038 and thereby secure and/or tension the one or more sutures 1034 between the anchor body 702 and the suture grip member 1010. In one embodiment, a user may tighten the one or more sutures 1034 manually between the suture grip member 1010 and the anchor body 702 as the fastener 1040 compresses the superior grip plate 1036 against the inferior grip plate 1038. Next, a user may rotate the puller 1004 in a direction 1070.	180	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	Rotation of the puller 1004 in direction 1070 moves the external threads 1032 into the carriage 1002 by engagement with the internal threads 1018 of the carriage 1002. As the threads 1032, 1018 engage, this translates and moves the carriage 1002 proximally towards the puller 1004 in direction 1072. The translation of the carriage 1002 creates a translation force in direction 1072 which applies tension to the one or more sutures 1034.	181	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	The threads 1032, 1018 of the puller 1004 and carriage 1002 provide a significant mechanical advantage that increases tension in the one or more sutures 1034 secured between the anchor body 702 and the suture grip member 1010. Advantageously, reversing the rotation of the puller 1004 in a direction opposite direction 1070 loosens the one or more sutures 1034 such that a user can remove the one or more sutures 1034 or adjust the position or tension of the one or more sutures 1034.	182	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIG. 96 illustrates the position of the carriage 1002 relative to the puller 1004 after a desired level of tension is placed into the one or more sutures 1034. Note that the carriage 1002 is closer to the proximal end 904 of the shaft 902 than before the one or more sutures 1034 were tightened. This causes more of the planar surface 924 of the second section 920 to be exposed. Next, a user can insert the interference member 770 distally within the inserter longitudinal passageway 941 in the direction indicated by arrow 1074. In one embodiment, the interference member 770 is inserted with the point 780 entering the inserter longitudinal passageway 941 first. The user can then urge the interference member 770 through the inserter longitudinal passageway 941 until the interference member 770 reaches the distal end 906 of the shaft 902 and enters the bore 756 of the proximal member 704. A user can move the interference member 770 through the inserter longitudinal passageway 941 and/or bore 756 using gravity or a tool such as a driver.	183	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	IPP-0051-US14 cross roads	FIG. 97 illustrates one example of a driver 1080 that can be used to move the interference member 770 through the inserter longitudinal passageway 941 and/or bore 756. The driver 1080 may be cylindrical and elongated and may include a drive shaft 1082 having a proximal end 1084 and a distal end 1086. The driver 1080 also includes a drive coupler 1088, external drive threads 1090, and a drive feature 1092.	184	Added by DJM 9 2021	9/2/21, 12:00 AM

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