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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 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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HAR-1 The bone engagement feature 206 is configured to contact and/or engage bone in response to threading, pulling, or pushing the tissue 208 through the one-way tissue engagement feature 204. In the illustrated embodiment, the bone engagement feature 206 may be a flange (illustrated in red) that circumscribes the body 202. The flange may be a separate part connected to the body 202. Alternatively, or in addition, the flange may be formed as part of and be integrated with the body 202. The bone engagement feature 206 may include a distal end 216 and a proximal end 218. 36 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 The one-way tissue engagement feature 204 is connected to the body 202. The one-way tissue engagement feature 204 may include an opening 214 that extends through the body 202. The one-way tissue engagement feature 204 serves to secure the tissue 208 such that the tissue 208 can only move with respect to the fixation device 200 in one direction. Specifically, the one-way tissue engagement feature 204 may secure the tissue 208 within the opening 214 such that the tissue 208 can move in one direction (longitudinally in the illustrated embodiment) within the opening 214 but not the opposite direction. 35 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 The body 202 has a distal end 210 and a proximal end 212. The body 202 provides structural support for the fixation device 200. The body 202 may have a variety of shapes and sizes. In one embodiment, the body 202 is an elongated body. The body 202 may have a circular longitudinal cross section. The body 202 may be tube shaped. 34 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As explained herein, the tissue 208 may be a manmade tissue or a biological tissue and/or a combination of these. For example, in one embodiment, the tissue 208 is a hamstring graft (i.e., Hamstring tendon autograft (GST)) that includes one or more sutures and/or suture tape secured to one end or extending along the length of the graft. In one embodiment, suture(s) or suture tape may extend along the length of the tissue 208 to add structural strength to the graft and may enhance the engagement of the one-way tissue engagement feature 204 of the tissue 208. 33 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Figure 2A illustrates a side perspective view of an example of a fixation device 200 according to one embodiment of the present disclosure. The fixation device 200 may include a body 202, a one-way tissue engagement feature 204, and a bone engagement feature 206. The fixation device 200 secures a tissue 208. 32 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 In one embodiment, the engagement feature 140 is a surface on the distal end 120 of a structure that includes the engagement feature 140. Alternatively, or in addition, the engagement feature 140 may be on the proximal end 122 of a structure that includes the engagement feature 140, or at any position between the distal end 120 and the proximal end 122. 31 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 The engagement feature 140 connects to the one-way tissue engagement feature 110. Consequently, the one-way tissue engagement feature 110 secures the engagement feature 140 to the tissue 114 and the engagement feature 140 secures the tissue 114 to the body part in contact with the engagement feature 140. 30 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 Next, the surgeon tensions 612 the tissue graft by pulling the tissue graft (e.g., tissue 408) through the opening 112 in the first direction 116 (e.g., toward the proximal end 412 of the fixation device 400) such that one or more teeth 220 retain the tissue graft from moving in the second direction 118. Tension placed in the tissue graft by the surgeon and/or movement, such as flexion of a knee joint, may pull the tissue graft towards a distal end 410 of the fixation device 400. However, the one or more teeth 220 bite and engage with the tissue graft to prevent movement of the tissue graft in the second direction 118. Then, the method 600 ends. 63 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 2.A fixation device for tissue, the device comprising: 81 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 an engagement feature configured to maintain contact between the fixation device and a part of the body in response to tension applied to the tissue in a second direction opposite the first direction. 80 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 a one-way tissue engagement feature having an opening that receives a length of tissue passing through the opening in a first direction; and 79 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 1.A fixation device for tissue within a body of a patient, the device comprising: 78 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, "feature" refers to a distinctive attribute or aspect of something. (Search "feature" on google.com. Oxford Languages, 2021. Web. 20 Apr. 2021.) A feature may include one or more modifiers that identify one or more particular functions, attributes, advantages, or operations and/or particular structures relating to the feature. Examples of such modifiers applied to a feature, include, but are not limited to, "attachment feature," "securing feature," "alignment feature," "adjustment feature," "guide feature," "protruding feature," "engagement feature," "disengagement feature," and the like. 72 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, "flange" refers to a protrusion such as a protruded ridge, lip or rim, either external or internal, designed, configured, engineered, or positioned for engagement with another object and/or for attachment, or transfer of a contact force with another object (e.g., such as a flange on the end of a pipe, steam cylinder, etc., or on the lens mount of a camera); or that serves to increase strength (e.g., the flange of an iron beam such as an I-beam or a T-beam); or for stabilizing and guiding the movements of a machine or its parts (e.g., the inside flange of a rail car or tram wheel, which keep the wheels from running off the rails). (Search "flange" on Wikipedia.com May 24, 2021. CC-BY-SA 3.0 Modified. Accessed July 14, 2021.) 71 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, "implant" refers to a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices. The surface of implants that contact the body may be made of, or include a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Orthopedic implants may be used to alleviate issues with bones and/or joints of a patient's body. Orthopedic implants are used to treat bone fractures, osteoarthritis, scoliosis, spinal stenosis, and chronic pain. Examples of orthopedic implants include, but are not limited to, a wide variety of pins, rods, screws, anchors, and plates used to anchor fractured bones while the bones heal or fuse together. (Search "implant (medicine)" on Wikipedia.com May 26, 2021. CC-BY-SA 3.0 Modified. Accessed June 30, 2021.) 68 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, "tissue" refers to a flexible line or flexible member of natural material, natural biological material, biomaterial, biomimetic materials, manmade material, or a combination of these either in a single structure, a composite structure, or a plurality of tissue structures that extend in parallel and/or may be woven or bonded together. In certain embodiments, a tissue may be long and thin. In certain embodiments, a tissue may be planar. In certain embodiments, a tissue may be elastic or inelastic. In a medical context, due to the flexible nature of a tissue, tissue may be referred to herein as "soft tissue." Examples of a tissue include, but are not limited to, a thread, a suture, suture tape, a woven structure, a fibrous material, a cord, a ligament, cartilage, muscle, a ligament graft, and/or any of these in combination with each other, and the like. 67 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, an “opening” refers to a gap, a hole, an aperture, a space or recess in a structure, a void in a structure, or the like. In certain embodiments, an opening can refer to a structure configured specifically for receiving something and/or for allowing access. In certain embodiments, an opening can pass through a structure. In other embodiments, an opening can exist within a structure but not pass through the structure. An opening can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. 66 Added by DJM 9 2021 9/2/21, 12:00 AM
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HAR-1 As used herein, a "fixation" refers to an apparatus, instrument, structure, device, component, member, system, assembly, step, process, or module structured, organized, configured, designed, arranged, or engineered to connect two structures. The structures may one or the other or both manmade and/or biological tissues, hard tissues such as bones, teeth or the like, soft tissues such as ligament, cartilage, tendon, or the like. Typically, fixation is used as an adjective to describe a device or component or step in securing two structures such that the structures remain connected to each other in a desired position and/or orientation. Fixation devices can also serve to maintain a desired level of tension or redistribute load and stresses experienced by the two structures and can serve to reduce relative motion of one part relative to others. Examples of fixation devices are many and include both those for external fixation as well as those for internal fixation and include, but are not limited to pins, wires, Kirschner wires, screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like. 64 Added by DJM 9 2021 9/2/21, 12:00 AM

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