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Dave's PCF WIP: Paragraphs
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PER-12 In a step 130, the manufactured cutting guide may be used in surgery to facilitate treatment of the condition. Specifically, the bone apposition surface of the cutting guide may be placed against the corresponding contours of the first cuneiform and the first metatarsal. The resection features (for example, slots) may then be positioned on either side of the joint between the first cuneiform and the first metatarsal to guide resection of the first metatarsal and the first cuneiform to remove the intervening joint. The cutting guide may then be removed, and the remaining portions of the first cuneiform and the first metatarsal may be placed to abut each other. The cutting guide may have been shaped such that the cuts made to the first cuneiform and the first metatarsal are properly oriented to bring the first metatarsal back into its proper orientation relative to the rest of the foot. The first cuneiform and the first metatarsal may be secured together using a bone plate or the like. The surgical wound may be closed to allow the foot to heal, and to allow the first cuneiform and the first metatarsal to fuse together. 71 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The method 100 and the method 120 are merely exemplary. Those of skill in the art will recognize that various steps of the method 100 and the method 120 may be reordered, omitted, and/or supplemented with additional steps not specifically shown or described herein. 72 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 As mentioned previously, the method 120 is one species of the method 100; the present disclosure encompasses many different procedures, performed with respect to many different bones and/or joints of the body. Exemplary steps and instrumentation for the method 120 will further be shown and described in connection with Figures 2 through 7D. Those of skill in the art will recognize that the method 120 may be used in connection with different instruments; likewise, the instruments of Figures 2 through 7D may be used in connection with methods different from the method 100 and the method 120. 73 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 2A is a perspective dorsal view of a foot 200. The foot 200 may have a medial cuneiform 202, an intermediate cuneiform 204, lateral cuneiform 206, a first metatarsal 208, a second metatarsal 210, third metatarsal 212, fourth metatarsal 214, fifth metatarsal 216, navicular 218, cuboid 220, talus 222, and calcaneus 224, among others. The medial cuneiform 202 and the intermediate cuneiform 204 may be joined together at a first metatarsocuneiform joint, and the first metatarsal 208 and the second metatarsal 210 may be joined together at a second metatarsocuneiform joint. The foot 200 includes a set of proximal phalanges numbered first through fifth (230, 232, 234, 236, 238) and a set of distal phalanges numbered first through fifth (240, 242, 244, 246, 248) and a set of middle phalanges numbered second through fifth (250, 252, 254, 256). 74 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 2B is a perspective lateral view of a foot 200, with bones of the foot labeled. 75 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 2C is a perspective medial view of a foot illustrating a dorsal side 280 and a plantar side 282. The foot 200, as illustrated, may have a tibia 226 and a fibula 228, among others. Dorsal refers to the top of the foot. Plantar refers to the bottom of the foot. Proximal 284 is defined as “closer to the primary attachment point”. Distal 286 is defined as “further away from the attachment point”. Plantarflex or plantarflexion 288 means movement toward the plantar side 282 of a foot or hand, toward the sole or palm. Dorsiflex or dorsiflexion means movement toward the dorsal side 278 of a foot or hand, toward the top. Figure 2D is a perspective dorsal view of the foot 200. A transverse plane is the plane that shows the top of the foot. A lateral side 292 means a side furthest away from the midline of a body, or away from a plane of bilateral symmetry of the body. A medial side 294 means a side closest to the midline of a body, or toward a plane of bilateral symmetry of the body. For a Lapidus procedure, the intermetatarsal (IM) angle 296 is the angle to be corrected to remove the hallux valgus (bunion) deformity. 76 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 2E is a view of a foot illustrating common planes 260 of reference for a human foot. Figure 2E illustrates a sagittal plane 262 that divides the foot into a right section and a left section half. The sagittal plane 262 is perpendicular to frontal or coronal plane 264 and the transverse plane 266. In the foot, the frontal plane 264 generally runs vertically through the ankle and the transverse plane 266 generally runs horizontally through the midfoot and toes of the foot. 77 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 2F is a perspective view of a portion of a foot 200 with a bunion deformity to be treated through use of the method 100 (and more specifically, the method 120) described above. The foot 200 may have a medial cuneiform 202, a intermediate cuneiform 202, a first metatarsal 208, and a second metatarsal 210. The medial cuneiform 202 and the first metatarsal 208 may be joined together at a first metatarsocuneiform joint, and the intermediate cuneiform 202 and the second metatarsal 210 may be joined together at a second metatarsocuneiform joint. 78 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The first metatarsal 208 may be excessively angled in a medial direction 270 (i.e., toward the lower left-hand corner of the page), causing a painful protrusion at a distal end 272 of the first metatarsal 208, and further causing the phalanges (not shown) attached to the distal end 272 to be angled excessively in a lateral direction 274 (i.e., pointing toward the other phalanges of the foot, rather than pointing directly forward). The excessive medial angulation of the first metatarsal 208 may also result in an excessive gap between the first metatarsal 208 and the second metatarsal 210. 79 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The first metatarsal 208 may further be offset in a plantar direction 276 or in a dorsal direction 290, relative to the remainder of the foot 200. Accordingly, the orientation of the first metatarsal 208 may need to be adjusted to move the distal end 272 in the lateral direction 274 and in the plantar direction 276 and/or in the dorsal direction 278. 80 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Every deformity is different; accordingly, the degree of angular adjustment needed in each direction may be different for every patient. Use of a patient-specific cutting guide may help the surgeon obtain the optimal realignment in the lateral direction 274 and in the plantar direction 276 or the dorsal direction 278. Conversely, use of one of several differently-sized cutting guides may provide only approximate correction, as the surgeon may not have a guide that precisely matches the correction needed for the foot 200, and must thus choose the cutting guide that most closely provides the desired correction. Such differently sized cutting guides would not be contoured to fit the medial cuneiform 202 or the first metatarsal 208, thus introducing additional potential for error as the surgeon must properly align the selected cutting guide. 81 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Thus, providing a patient-specific cutting guide may provide unique benefits. Specifically, the patient-specific cutting guide may provide precise correction of the deformity present in the foot 200 and may also reduce the likelihood of improper correction due to misalignment of the cutting guide on the foot 200. The optimal cut provided by such a cutting guide may further reduce the likelihood that additional procedures, such as attachment of the first metatarsal 208 to the second metatarsal 210 to each other with screws or the like, will be needed to provide the desired correction. Any such additional procedure carries its own added surgical burden and risk of failure. Thus, the use of patient-specific instrumentation may shorten surgery, accelerate recovery, and reduce the risk of complications. 82 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figures 3A-19H are top perspective, top perspective, bottom, front elevation, rear elevation, right, left, and alternative top perspective, respectively, of a patient-specific cutting guide, or cutting guide 300, according to one alternative embodiment. 83 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The cutting guide 300 may be designed to facilitate resection of a first cuneiform near a distal end and a first metatarsal near a proximal end with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsal relative to the first cuneiform, thereby providing correction in a lateral direction, in a plantar direction, and/or a dorsal direction. 84 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 As shown, the cutting guide 300 may have a body 310 with a monolithic construction and the general shape of a rectangular prism. As used herein, a "body" refers to a main or central part of a structure. The body may serve as a structural component to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A body may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. A body may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. A body may include a modifier that identifies a particular function, location, orientation, operation, and/or a particular structure relating to the body. Examples of such modifiers applied to a body, include, but are not limited to, "inferior body," "superior body," "lateral body," "medial body," and the like. 85 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The body 310 includes a proximal side 312, a distal side 314, a medial side 316, a lateral side 318, a superior side 320, and an inferior side 322. In the illustrated embodiment, the body 310 may also include a proximal arm 330 that extends from the body 310 and a distal arm 340 that extends from the body 310. The proximal side 312 is the side closest to the core of the patient when the cutting guide 300 is in use. The distal side 314 is the side furthest from the core of the patient when the cutting guide 300 is in use. The medial side 316 is the side facing medially when the cutting guide 300 is in use. The lateral side 318 is the side facing laterally when the cutting guide 300 is in use. The superior side 320 is the side facing up away from the bone(s) when the cutting guide 300 is in use. The inferior side 322 is the side facing down, facing, and/or contacting the bone(s) (e.g., contacting a surface of one or more bones) when the cutting guide 300 is in use. 86 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 The inferior side 322 may be custom contoured to match the shapes of one or more of the surfaces of the first cuneiform and/or the first metatarsal. In one embodiment, the inferior side 322 may include a bone engagement surface 324. The bone engagement surface 324 can be shaped to match a first surface of a first bone and a second surface of a second bone of a joint. 87 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 "Bone engagement surface" refers to a surface or other feature of an object, instrument, or apparatus, such as an implant that is oriented toward, faces, or contacts one or more bones of a patient. In one aspect, the bone engagement surface may abut, touch, or contact a surface of a bone. In another aspect, the bone engagement surface, or parts of the bone engagement surface, may be close to, but not abut, touch, or contact a surface of the bone. In certain aspects, the bone engagement surface can be configured to engage with a surface of one or more bones. Such a bone engagement surface may include projections and recesses that correspond to and match projections and recesses of the one or more bone surfaces. As used herein, matching projections and recesses means that a projection on one structure is of the substantially same size and shape as a corresponding recess of the other structure such that when the two structures are brought into contact or close proximity each projection of one structure seats/sits/fits within the recess of the other structure. A bone engagement surface may include flat parts of a side or surface, contoured parts of a side or surface, projections and/or recesses of a side or surface, or any combination of these. Such variations in the make-up and configuration of a bone engagement surface can exist within a single embodiment or separate embodiments. Said another way, a bone engagement surface is a surface that is the mirror inverse of a surface of the bone that the bone engagement surface abuts, touches, and/or contacts. 88 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 "Joint" or "Articulation" refers to the connection made between bones in a human or animal body which link the skeletal system to form a functional whole. Joints may be biomechanically classified as a simple joint, a compound joint, or a complex joint. Joints may be classified anatomically into groups such as joints of hand, elbow joints, wrist joints, axillary joints, sternoclavicular joints, vertebral articulations, temporomandibular joints, sacroiliac joints, hip joints, knee joints, articulations of foot, and the like. (Search "joint" on Wikipedia.com Dec. 19, 2021. CC-BY-SA 3.0 Modified. Accessed Jan 20, 2022.) 89 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In one example, the bone engagement surface 324 can be shaped such that the bone engagement surface 324 matches a surface of a cuneiform bone and a surface of a metatarsal bone of a tarsometatarsal (“TMT”) joint. The bone engagement surface 324 can be so shaped because it is fabricated from a bone model of the patient’s bones. The body 310 is configured, designed, and/or fabricated to seat transverse to a joint (e.g., a TMT joint) with the bone engagement surface 324 engaging a first surface of a first bone and a second surface of a second bone. 90 Added by DJM Jan 2024 1/6/24, 10:03 PM

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