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HAR-1 Figure 3 is a cross-sectional view of a fixation device taken along a longitudinal axis of the fixation device, according to one embodiment. 9 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2D is an end view of the fixation device of FIG. 2A from the first end, according to one embodiment. 8 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2C is a perspective view of the fixation device of FIG. 2A from a second end, according to one embodiment. 7 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2B is a perspective view of the fixation device of FIG. 2A from a first end, according to one embodiment. 6 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2A is a perspective view of a fixation device, according to one embodiment. 5 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 1B is a side view of a fixation device, according to one embodiment. 4 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 1A is a perspective view of a fixation device, according to one embodiment. 3 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 The one or more teeth 220 are connected to the body 202 and are configured, arranged, and/or positioned such that the one or more teeth 220 permit the tissue 208 to slide by the one or more teeth 220 when the tissue 208 moves in first direction 116 and engage and prevent, limit, or interfere with movement of the tissue 208 past the one or more teeth 220 when the tissue 208 is pushed, pulled, or biased in the second direction 118. Thus, the one or more teeth 220 engage the tissue 208 within the opening 214 such that the tissue 208 can move through the opening 214 in the first direction 116 and not move through the opening 214 in the second direction 118 opposite the first direction 116. 38 Added by DJM 9 2021 9/2/21, 12:00 AM
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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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HAR-1 Various surgical procedures in people and animals include a fixation step, procedure, use of a device (also referred to as a fixator), of the like. The fixation feature, or function, may be between two pieces of bone, soft tissue and bone, soft tissue and hard tissue, soft tissue and soft tissue, and/or a combination of these. Unfortunately, many known fixation techniques, steps, procedures, devices, or components are complicated, involve multiple parts, are not easy to revise, become loose over time, are difficult to tension, and have other limitations. 2 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2B is a perspective view of the fixation device of FIG. 2A from the distal end 210, according to one embodiment. In the illustrated embodiment, the bone engagement feature 206 is near the proximal end 212 of the fixation device 200. The one-way tissue engagement feature 204 may include one or more teeth 220 within the opening 214. In certain embodiments, a variety of other, additional, or alternative protrusions, bias members, barbs, bumps, arms, or other interference structures may be used in place of the one or more teeth 220. 37 Added by DJM 9 2021 9/2/21, 12:00 AM

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