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FLO-4 The rotatable structure 112 is coupled to the bone plate 108 such that the rotatable structure 112 is rotatable between a locked orientation and an unlocked orientation. 35 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As used herein, "locked orientation" refers to a position, condition, state, or configuration of a first object, component, part, apparatus, system, or assembly relative to another object, component, part, apparatus, system, or assembly in which the first object, component, part, apparatus, system, or assembly either alone or in combination with others parts or components prevents, limits, impedes, is in a fixed relationship to, or restricts motion and/or operation of the another object, component, part, apparatus, system, or assembly. 34 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As embodied in FIG. 1A, the locking mechanism 110 may include a rotatable structure 112 with an unlocked orientation, in which the bone screws 104 are insertable into and/or withdrawable from the bones 102, and a locked orientation, in which the rotatable structure 112 blocks withdrawal of the bone screws 104 from the bones 102. As used herein, "unlocked orientation" refers to a position, condition, state, or configuration of a first object, component, part, apparatus, system, or assembly relative to another object, component, part, apparatus, system, or assembly in which the first object, component, part, apparatus, system, or assembly either alone or in combination with others parts or components enables, facilitates, opens, and/or permits motion and/or operation of the another object, component, part, apparatus, system, or assembly. 33 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As illustrated in FIG. 1A, a locking mechanism 110 of the present disclosure may be incorporated into an implant assembly 100. However, in alternative embodiments, a locking mechanism 110 according to the present disclosure may be incorporated into any of a wide variety of implants, including but not limited to bone plates, spacers, fusion cages, arthroplasty implants, intramedullary implants, and the like. The locking mechanism 110 may be used to keep the bone screws 104 in their proper positions relative to the bones 102, overcoming the tendency of the bone screws 104 to loosen and withdraw from the bones 102 over time. 32 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As used herein, a “bone plate” refers to a flat structure. In certain embodiments, a bone plate can be configured to support a load (including a tension, compression, shear, torsion, and/or bending load). In certain embodiments, a bone plate may comprise a generally planar structure. A bone plate can be a separate structure connected to, or integrated with, another structure. Alternatively, a bone plate can be connected to part of another structure. A bone plate 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. A bone plate can be made from a variety of materials including, metal, plastic, ceramic, wood, fiberglass, or the like. One bone plate may be distinguished from another based on where the plate is positioned within a structure, component, or apparatus. 31 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 A bone screw 104 is a type of screw adapted for use with implants in, on, or in connection with, parts of the body of a patient. As used herein, a "screw" refers to a type of fastener characterized by a helical ridge, known as a male thread (external thread). Screws may be made from a variety of materials including metal, plastic, composite materials, natural materials, or the like. Screws can be used to fasten materials by the engagement of the screw thread with a similar female thread (internal thread) in the matching part. Screws can also be self-threading (also known as self-tapping) where the thread cuts into the material when the screw is turned, creating an internal thread that helps pull fastened materials together and prevent pull-out. There are many screws for a variety of materials; those materials commonly fastened by screws include wood, sheet metal, and plastic. (Search "screw" on Wikipedia.com Apr. 6, 2021. Modified. Accessed Apr. 20, 2021.) A screw generally includes a head connected to a shank. The helical ridge extends from the shank. 30 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 FIG. 1A illustrates an implant assembly 100. The implant assembly 100 may be secured to one or more adjacent bones 102 via one or more bone screws 104, which are inserted through screw openings 106 in the bone plate 108. In the example of FIG. 1A, the implant assembly 100 may include a bone plate 108 for a cervical spine. 29 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 For example, using an implant assembly with a single rotatable structure that can secure two screws when in a locked orientation can result in a more reliable and effective expandable implant assembly. These and other unique features of the implant assembly are discussed below and illustrated in the accompanying drawings. 28 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 For example, the implant assembly may have a thin profile for minimally invasive spine (MIS) surgery techniques which can reduce the size of the incisions, soft tissue damage, blood loss, less intrusive implants, post-operative pain, recovery time, risk of surgical complications, and the like. Furthermore, the shape, or profile, of an implant assembly can facilitate insertion of the implant during the surgery. A reliable locking mechanism can provide more stable and secure engagement between the implant and bones or vertebral bodies on either side of a space where the implant is positioned. 27 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 In one embodiment, the present disclosure provides an implant assembly that comprises a cervical plate that is affixed to multiple vertebrae of the spine of a patient using a plurality of screws. Thus, one or more levels of the spine are immobilized. In use, it is advantageous that these screws are prevented from backing out of the cervical plate over time. The present disclosure provides a locking mechanism for this purpose. 26 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 The head 210 may be designed to work with a bone plate 108 by interfacing with the screw opening 106. For example, the head 210 may have a semispherical rim 222 that can engage a semispherical seat 140 of the screw opening 106. The semispherical rim 222 and the semispherical seat 140 may have similar or the same radii of curvature so that the semispherical rim 222 can reside in the semispherical seat 140 in any of a variety of relative orientations, about all three orthogonal axes. 58 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As shown, the raised ridges 216 may be more spaced apart than the radial grooves 116. Thus, the rotatable structure 112, in the locked orientation, may interlock with the head 210 of the screw 302 reliably, despite minor variations in the exact orientation of the head 210. There may be, for example, two of the radial grooves 116 for each of the raised ridges 216 overlied by the radial grooves 116. 68 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 In one embodiment, the screw opening 106 includes a semispherical seat 140 (FIG. 1) that can engage a semispherical rim 222 of the head 210. The semispherical rim 222 and the semispherical seat 140 may have similar or the same radii of curvature so that the semispherical rim 222 can reside in the semispherical seat 140 in any of a variety of relative orientations, about all three orthogonal axes. 67 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 FIG. 3A also illustrates a way the radial grooves 116 of the rotatable structures 112 interlock with the raised ridges 216 on the heads 210 of the screws 104. In the locked orientation, the radial grooves 116 may be oriented generally parallel to the raised ridges 216 that they overlie, as more clearly shown in FIG. 1A. 66 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 FIG. 3A illustrates details of a recess 120 of the bone plate 108. In one embodiment, the recess 120 includes a rim 304 that may partially surround the recess 120. In certain embodiments, the rim 304 may include a feature for a detent mechanism that includes a structure on the rim 304 and a structure of the rotatable structure 112. For example, as illustrated in FIG. 1, the rim 304 can include a niche 130 and the rotatable structure 112 can include an ear 132 configured to seat within the niche 130. 65 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 FIG. 3A depicts the implant assembly 100 of FIG. 1A, in use with a screw 302 according to an alternative configuration. The screw 302 has only a single thread start and may be more suitable than the screw 104 for use in healthy bone than the screw 104. The screw 302 is otherwise configured similarly to the screw 104. 64 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 The radial grooves 116 of each arm 114 may be similarly shaped to mate with the raised ridges 216 on the head 210 of the corresponding screw 104 such that the clockwise rotation of the screw 104 (corresponding to tightening of the screw 104 within the bone 102) is permitted, while counterclockwise rotation of the screw 104 (corresponding to loosening of the screw 104 within the bone 102) is not permitted while the rotatable structure 112 is in the locked orientation. Thus, the engagement of the arms 114 with the heads 210 of the screws 104 may prevent the screws 104 from rotating in a manner that would loosen them relative to the bones 102 in which they reside. 63 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 FIG. 2D illustrates details of a head feature 107 of the screw 104. The raised ridges 216 on the head 210 of each of the screws 104 may have sloping faces 218 that slope toward the distal end 204 of the screw 104, along the clockwise direction. The sloping faces 218 may be connected by engagement faces 220 that are parallel to or more nearly parallel to the axis of the screw 104. Thus, the raised ridges 216 may be readily driven clockwise into the bone with a driver (not shown) with mating engagement ridges that engage the engagement faces 220. Such a mating interface may not generally be suitable for rotating the screw 104 counterclockwise, as the engagement ridges may slide along the sloping faces rather than transmitting counterclockwise torque. Thus, the raised ridges 216 may present an interface that facilitates driving the screws 104 into the bones 102 and keeping them in place, but not withdrawal of the screws 104 from the bones. 62 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 As further shown in FIGS. 2B and 2C, the first screw thread 240 and the second screw thread 242 may each have a substantially constant major diameter and pitch. Where it is present, the second screw thread 242 may be spaced such that its threads bisect the space between adjacent threads of the first screw thread 240. In some embodiments, the first screw thread 240 and the second screw thread 242 may have tapered minor diameter 250 that is smaller at the intermediate portion 202 than near the head 210. This tapered minor diameter may compress the cortical portion of the bone 102 for maximum purchase in the cortical bone as the screw 104 is inserted. The first screw thread 240, distally of the second screw thread 242, may have a constant minor diameter 252 that preserves and reduces stress on the cancellous portion of the bone 102. 61 Added by DJM 5 2021 5/1/21, 12:00 AM
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FLO-4 The first screw thread 240 and the second screw thread 242 may each have any known thread form. For example, the first screw thread 240 and the second screw thread 242 may be buttress threads, standard threads, square threads, and/or ACME threads, or may have any other thread shape known in the orthopedic field. 60 Added by DJM 5 2021 5/1/21, 12:00 AM

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