Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	IPP-0051-US14 cross roads	Referring to FIG. 37, the proximal portions of the sutures may be pulled to move the knots 420, 421 into the patient to a position adjacent to the rotator cuff 408. Since the suture strands have been kept separate by the suture keeper 300 and the surgical technique, the knots 420, 421 may be independently positioned and tensioned to provide precise control over the final position and tension of the rotator cuff 408. The distal ends 314, 315, 324, 325 of the suture pairs are passed through the loop 284 of the suture threader 280.	121	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	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
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	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	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. 41, any remaining suture ends are trimmed.	126	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	In one embodiment, the one or more teeth 220 may have a broad base that tapers to a point to facilitate engagement with the tissue 208. The one or more teeth 220 may have a variety of sizes and shapes, including different sizes between them. The one or more teeth 220 extend from a wall of the opening 214. Referring to Figures 2B and 2D, one or more teeth of the one or more teeth 220 may extend perpendicular to the wall. Alternatively, or in addition, one or more teeth of the one or more teeth 220 may extend from the wall at an angle. For example, in one embodiment, the one or more teeth 220 may extend from the wall and point towards the proximal end 212 at an angle between 0 and 85 degrees.	40	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 4 also illustrates that an angle 422 between the bone engagement feature 406 and the body 402 may be designed or fabricated such that the bone engagement feature 406 maintains a low profile when installed. In certain embodiments, the angle is between 90 degrees and 15 degrees.	51	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	In certain embodiments, the body 402 and/or bone engagement feature 406 may be contoured and/or shaped to have a minimal profile once deployed in the bone tunnel 416. For example, based on an angle of entry for the bone tunnel 416 the parts of the fixation device 400 outside the bone tunnel 416 may be shaped and/or contoured to match a contour of a patient’s body where the fixation device 400 is deployed.	50	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Those of skill in the art will recognize that the bone engagement feature 406 may be embodied in a variety of configurations. For example, rather than a flange that circumscribes the body 402, the bone engagement feature 406 may comprise one or more arms that extend from the body and may be positioned to engage with the cortex or a countersink depression in the tibia 418.	49	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	In certain embodiments, the body 402 may be sized to readily fit within the bone tunnel 416 and the bone engagement feature 406 may abut the cortex of the tibia 418 around the bone tunnel 416. In another embodiment, a surgeon may resect an end of the bone tunnel 416 with a larger diameter than the bone tunnel 416 such that the bone engagement feature 406 becomes countersunk and thus flush with a cortex of the tibia 418.	48	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Once the one-way tissue engagement feature 404 engages the tissue 408 the user has full control of how much tension is placed within the graft. Advantageously, as the tissue 408 pass through the fixation device 400, the fixation device 400 advances along the tissue 408 (e.g., graft) and seats within the bone tunnel 416. This process of moving the fixation device 400 along the tissue 408 may be referred to herein as synching of the fixation device 400. During the steps of synching of the fixation device 400, a surgeon may advantageously check, monitor, and manage tension in the graft with the knee in different positions of flexion. Once sufficient checks of tension are done at one or more flexion positions of the knee, the user may further tighten or synch the fixation device 400. Advantageously, the fixation device 400 secures the tissue 408 with a sufficient force within the bone tunnel 416 to enable the patient to return to regular activities quickly. In one embodiment, the fixation device 400 secures the tissue 408 to retain the tissue 408, such as a graft, when graft experiences 150-500 Newtons (N) of force due to activities of daily living and rehabilitation exercises.	47	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	In one embodiment, the fixation device 400 is deployed within a bone tunnel 416. The bone tunnel 416 may be formed within a tibia 418 as part of an anterior cruciate ligament (ACL) replacement procedure. During such a procedure a distal end of the tissue 408 may be fixed to a femur (not shown) using either embodiments of the disclosed solution or existing fixation devices and/or techniques. With the distal end of the tissue 408 secured, a proximal end of the tissue 408 may be threaded through the opening 414 of the fixation device 400. The tissue 408 may be pulled through the opening 414 such that the one-way tissue engagement feature 404 engages the tissue 408. Next a user (e.g. surgeon) can pull the tissue 408 through the fixation device 400 to tension the graft within the bone tunnel 416.	46	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 4 is a cross-sectional view of a fixation device 400 taken along a longitudinal axis of the fixation device positioned within a bone tunnel of a bone, according to one embodiment. The fixation device 400 may include a body 402, a one-way tissue engagement feature 404, and a bone engagement feature 406. The fixation device 400 secures a tissue 408 and has a distal end 410 and a proximal end 412. The fixation device 400 is illustrated in a deployed state such that part of the body 402 sits within a bone tunnel 416 and secures the tissue 408.	45	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 3 is a cross-sectional view of a fixation device 300 taken along a longitudinal axis of the fixation device, according to one embodiment. The fixation device 300 may include a body 302, a one-way tissue engagement feature 304, and a bone engagement feature 306. For clarity, a tissue is not shown in Figure 3. The fixation device 300 may include a distal end 310, a proximal end 312, and an opening 314. The bone engagement feature 306 may include one or more teeth 316.	44	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 2D is an end view of the fixation device of FIG. 2A from the distal end 210, according to one embodiment. In one embodiment, the bone engagement feature 206 is a stop 222 connected to the body 202 and configured to engage with a bone of a patient. The stop 222 may be configured to prevent the fixation device 200 from moving into a bone tunnel, such as a femoral tunnel or tibial tunnel, in response to tension from a tissue 208 within the opening 214. The stop 222 may be a flange that circumscribes the body 202.	43	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 2C is a perspective view of the fixation device of FIG. 2A from the proximal end 212, according to one embodiment. In the illustrated embodiment, the one-way tissue engagement feature 204 may comprise a single row of one or more teeth 220. Of course, multiple rows of one or more teeth 220 may be used in certain embodiments.	42	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	In the illustrated embodiment, the fixation device 200 includes four sets of one or more teeth 220: a top set, a bottom set, and two side sets. Of course, the number of teeth 220, their position within the opening 214, the configuration of the one or more teeth 220 relative to each other can be different in different embodiments of this disclosed technology.	41	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	Figure 5A is a side perspective view, end perspective view, opposite end perspective view, and a side perspective view of a fixation device 500a having a circular longitudinal cross-section in four different orientations, according to one embodiment. In the illustrated embodiment, the teeth 502 are shaped to come to a point. From left to right, the first orientation is with the fixation device 500a on its side. The next orientation shows the fixation device 500a from the proximal end 212. The next orientation shows the fixation device 500a from the distal end 210. The next orientation shows the fixation device 500a standing on end.	52	Added by DJM 9 2021	9/2/21, 12:00 AM
View Edit Delete	HAR-1	As the tissue 208 is pushed, pulled, placed under tension, or biased in the second direction 118, the one or more teeth 220 may pierce/bite into the tissue 208. The piercing or biting of the one or more teeth 220 may cause the one or more teeth 220 to go into the tissue 208 a relatively small distance initially. But, as the tension increases or more force is applied to move the tissue 208 in the second direction 118, the one or more teeth 220 may sink or seat deeper into the tissue 208 which enhances the engagement and further secures the tissue 208 to prevent the tissue 208 from moving in the second direction 118. In this manner, the one or more teeth 220 may enable the one-way tissue engagement feature 204 to permit the tissue 208 to move in one direction, but not in an opposite direction.	39	Added by DJM 9 2021	9/2/21, 12:00 AM

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