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IPP-0050-US35 nextremity Various conditions may affect skeletal joints such as the deterioration, elongation, shortening, or rupture of soft tissues, cartilage, and/or bone associated with the joint and consequent laxity, pain, and/or deformity. One may desire to change the angular alignment of a bone or a portion of a bone to restore function and/or reduce pain. One may likewise desire to fuse a joint to fix the bones of the joint in a better angular alignment or reduce pain caused by motion at the joint. One may likewise desire to support a fractured bone to allow healing of the fracture to occur. One may likewise desire to support an implant on a bone. To this end, various osteotomy procedures, joint fusion procedures, fracture fixation procedures, joint resurfacing procedures, implants and instruments have been proposed. Such procedures have been performed throughout the body to make various angular adjustments in, fuse joints associated with, fuse fractures associated with, and/or resurface articular surfaces of tibia, fibula, femur, pelvis, humerus, ulna, radius, carpal, metacarpal, tarsal, metatarsal, phalangeal and other bones. 2 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 11 is a front elevation view of the hole forming guide of FIG. 10; 30 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 10 is a perspective view of an example of a hole forming guide for the bone implant of FIG. 1; 29 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 9 is a detail cross sectional view of the bone implant of FIG. 1 taken along line 9-9 of FIG. 5; 28 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 8 is a detail view of the bone implant of FIG. 1; 27 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 7 is a detail view of the bone implant of FIG. 1; 26 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 6 is a detail view of the bone implant of FIG. 1; 25 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 5 is a cross sectional view of the bone implant of FIG. 1 taken along line 5-5 of FIG. 1A; 24 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 4 is a side elevation view of the bone implant of FIG. 1; 23 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity The fixation member may be inserted into or through the aperture 118 at an included angle between the longitudinal axis of the fixation member and the aperture length axis ranging from 90 degrees to a value corresponding to a projected length of the aperture along the fixation member longitudinal axis equal to or greater than the fixation member transverse dimension. In one embodiment, the angular stops limit the rotation of the guide to be within this range so it is guaranteed that the fixation member will fit through the aperture. In the illustrative example of FIGS. 19-22 the first and second angular positions are limited by abutment of the side surface 416 of the cross guide with the peripheral edge 326 of the inserter 300. 101 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 40 is a side view of a guide 802 according to one embodiment of the present disclosure. In one embodiment, the guide 802 includes a body 814, a guide member 816, and an engagement member 818. The body 814 has a proximal end 820 and a distal end 822. 115 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 39 illustrates one or more of the tools, instruments, fixation members, and/or implants that may be used with the guide 802. For example, the system 800 may include one or more sleeves 808a,b, a driver 810, and/or an exemplary fixation member 812. In certain embodiments, the bone fastener 804 used in the system 800 may be substantially similar to the embodiments of the bone fastener 804 described herein. As used herein, a "driver" refers to a mechanical piece, component, or structure for imparting motion to another piece, component, or structure. ("driver." Merriam-Webster.com. Merriam-Webster, 2021. Web. 6 Jan. 2021. Modified.) In certain embodiments, a driver can be a wheel configured or connected to other parts such that rotation or motion of the driver causes motion of other interconnected or intercoupled parts of a component, system, apparatus, or device. 114 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 39 is a perspective view illustrating a system 800 for deploying a fixation member into a bone fastener, according to one embodiment of the present disclosure. In one embodiment, the system 800 includes a guide 802 and a fastener, such as a bone fastener 804. In certain embodiments, the system 800 may include a separate inserter 806. Alternatively, or in addition, the features, components, and/or functionality of an inserter may be included in the guide 802. 112 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIG. 38, a human foot illustrates various examples of applications for the present disclosure. A phalangeal fusion is indicated at 700. A metatarsophalangeal fusion is indicated at 702. A fusion of a midshaft fracture or osteotomy is indicated at 704. Metatarsocuneiform fusions are indicated at 706 and 708. In this example, joining elements 710, 712 have been attached between separate fasteners to form a construct in a lisfranc procedure. For example, the joining elements 710, 712 may be attached with screws threaded into the sockets in the proximal ends of the fastener legs. The joining elements 710, 712 may be rigid or flexible depending on the amount of constraint desired. Tarsal fusions are indicated at 714 and 716. 111 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity The implants, instruments and methods of examples of the present disclosure may be used at many different locations within a patient to secure bone portions relative to one another and may further be used to form various constructs as shown in the illustrative example of FIG. 38. While illustrative, this example is not comprehensive and it will be apparent to one skilled in the art that these implants, instruments, and methods may be used anywhere two bone portions, or portions of a single bone, are to be secured. The size and proportion of the fastener may be varied to suit a particular anatomical location. 110 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIGS. 35-37, the cross guide 400 is mounted to the inserter 300 which is attached to the fastener 100. The cross guide 400 is pivoted relative to the inserter 300 to direct the cross fixation axis 420 in a desired direction. For example, it may be pivoted to align with a desired entry point on the bone 632. The rotation stops guarantee that the axis 420 is not angled so acutely as to prevent passage of a fixation member through the fastener aperture 118. The sleeve 422 is translated axially to position the sleeve close to the bone entry point 632 to stabilize a guide wire 634 as it is inserted through the sleeve, into the bone, and through the aperture 118. A fixation screw 636 is advanced over the guide wire 634 into the bone and through the aperture 118. The guide wire 634 is then removed. In one embodiment, the screw 636 is sized and positioned for bi-cortical fixation. In one embodiment, the screw passes through both bone portions to further stabilize the interface 604. 109 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIGS. 33 and 34, the inboard gaps 620, 622 diminish as the fastener is advanced until at some point in the fastener's travel, the fastener leg inboard surfaces 128, 130 contact the inboard bone hole walls. Since the inboard surfaces 128, 130 diverge at the same angle as the bone holes 610, 612, the fastener leg inboard surfaces 128, 130 contact the bone all along the length of the portions of the legs that have been inserted. Further advancing the fastener will compress the bone between the fastener legs uniformly along the fastener legs proximally to distally. In other words, as the fastener is further advanced, the bone is compressed between the fastener legs normal to the insertion direction the same amount at every point along the fastener legs proximally to distally. For bones having a longitudinal axis 628 normal to the insertion direction 630, the bone portions will be compressed axially relative to the longitudinal axis 628. The amount of compression can be tailored by setting the spacing of the inboard surfaces of the bone holes 610, 612 relative to the fastener leg inboard surfaces 128, 130. With the inboard bone hole surfaces further apart, the inboard fastener surfaces will contact the bone holes earlier in the fastener's travel and further advancing the fastener to a final resting position will cause relatively more compression. Alternatively, with the inboard bone hole surfaces closer together, the inboard leg surfaces will contact the bone holes later in the fastener's travel and further advancing the fastener to the same final resting position will cause relatively less compression. In one aspect, the fastener 100 is seated with the trailing ends of the fastener legs flush with or below the bone surface to reduce irritation of surrounding tissues. In one embodiment, the fastener 100 is seated with the trailing end 108 of the body below flush and, in one embodiment, below the proximal cortex 607 to allow for cortical healing above the fastener body 104. To remove the fastener, it is pulled proximally. The sharpened trailing edge of the body 104 aids in passing the body through any bone that has grown over the body 104. In one embodiment, the leading end 106 of the body stays inside the bone and, in one embodiment, the leading end 106 is above the distal cortex 609 to preserve bone strength. 108 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIGS. 31 and 32, a fastener 100 is started into the bone holes 610, 612. The inserter 300 has been omitted from the figures to simplify the drawings. The outboard surfaces 148, 150 of the fastener legs are sized to match the proximal spacing of the outboard bone hole walls. Since outboard surfaces 148, 150 are parallel, they stay in contact with the proximal portion of the bone holes 610, 612 as the fastener is advanced into the bone portions. Inboard gaps 620, 622 are present between the fastener legs and the bone holes. Outboard gaps 624, 626 occur between the fastener legs and the bone holes distal of the proximal edge of the bone holes as the fastener is advanced. 107 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIG. 30, a depth gauge 618 is used to probe the bone holes 610, 612 to determine their depth as an aid in selecting a fastener of the appropriate size to provide bi-cortical fixation. Depending on the shape of the bone portions, the holes may have different depths and may receive a fastener having different length legs. 106 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity Referring to FIGS. 28 and 29, a saw blade 614 is guided in the saw slot 216 of the guide 200 to form a bone slot 616 to ease insertion of the fastener body through the proximal cortex. In one embodiment, the saw slot may only extend through the proximal bone cortex since only a proximal slot is needed to insert the fastener body. 105 Added by DJM 12 2021 12/2/21, 12:00 AM

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