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Dave's PCF WIP: Paragraphs
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PER-10 In certain embodiments, the topography of the articular surfaces of a joint may not factor into the form and/or shape of the cuneiform apposition portion 742 and/or the metatarsal apposition portion 744 because those parts of the bones will be resected during the procedure. Alternatively, or in addition, the topography of the articular surfaces of a joint may be factored into the form and/or shape of the cuneiform apposition portion 742 and/or the metatarsal apposition portion 744 even though those parts of the bones will be resected during the procedure. 111 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Like the cuneiform apposition portion 342 and the metatarsal apposition portion 344 of the cutting guide 300, generation of the contours of the cuneiform apposition portion 742 and the metatarsal apposition portion 744 may be performed relative easily in various CAD programs through surface copy operations, Boolean operations, and/or the like. 112 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 The body 710 may further have guide features that guide a cutter to resect the first cuneiform 210 and the first metatarsal 230 in the manner needed to make the desired correction. For example, the guide features may be used to guide a planar cutting blade, an arcuate cutting blade, a drill or mill, and/or the like. 113 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In the embodiment of Figures 7A through 7D, the guide features may guide a reciprocating planar blade, such as that of a surgical bone saw, that forms planar cuts in the first cuneiform 210 and the first metatarsal 230. Thus, the guide features may take the form of a first slot 750 and a second slot 752, which may be positioned toward the center of the body 710, on opposite sides of the joint probe 720. Thus, upon proper positioning of the cutting guide 700, the first slot 750 may be positioned over the first cuneiform 210 to facilitate resection of the first cuneiform 210, while the second slot 752 may be positioned over the first metatarsal 230 to facilitate resection of the first metatarsal 230. 114 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In operation, the cutting guide 700 may be used in a manner similar to that of the cutting guide 300. However, the cutting guide 700 may only be secured to each of the first cuneiform 210 and the first metatarsal 230 with a single pin or K-wire (not shown), as mentioned previously. Further, the cutting guide 700 is smaller than the cutting guide 300. Thus, the cutting guide 700 may be placed through a smaller, less invasive incision. One advantage to patient-specific instrumentation may be that instruments may be made smaller, since they are not limited to certain sizes. Many known instruments come in discrete sizes, each of which is designed to accommodate a range of patient anatomic dimensions. Thus, for given patient anatomy, the instrument must be large enough to treat the anatomy at either end of its range. This typically requires the instrument to be oversized for many anatomic dimensions it is designed to treat. Notably, the cutting guide 700 is merely one compact example; other cutting guides may be made even smaller; in some embodiments, cutting guides may be made that have a smaller width between holes (e.g., holes 740 on the cutting guide 700). As long as the holes are sufficiently far apart to avoid interference of the pins 500 with the operation of the cutting blade, the cutting guide may function appropriately. Thus, Lapidus and other procedures may be accomplished through a very narrow incision through the use of patient-specific instrumentation. 115 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Those of skill in the art will recognize that a wide variety of differently configured cutting guides may be used in conjunction with the method 120 set forth above. Further, a wide variety of patient-specific instruments may be used in connection with the method 100, including but not limited to cutting guides, gages, implant positioning guides, joint distractors, joint compressors, soft tissue retractors, and the like. "Patient specific cutting guide" refers to a cutting guide designed, engineered, and/or fabricated for use with a specific patient. In one aspect, a patient specific cutting guide is unique to a single patient and may include features unique to the patient such as a surface contour or other features. 116 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In some embodiments, one or more articulating surfaces of a joint may be replaced and/or resurfaced. For example, for the MTP joint, a patient-specific cutting guide may be used to determine the angles of cuts on the distal metatarsal or the proximal phalanx in preparation for replacement or resurfacing of the metatarsal head and/or the proximal phalangeal base. Implants for either the metatarsal or the phalanx may be customized to match the patient’s original anatomy, such as the curvature of the MTP joint. In other embodiments, an MTP joint may be fused through the use of patient-specific cutting guides. Patient-specific cutting guides may be used to treat (for example, via fusion, resurfacing, and/or arthroplasty) any joint in the body, using methods similar to the method 100. 118 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 As used herein, "osteotomy procedure" or "surgical osteotomy" refers to a surgical operation in which one or more bones are cut to shorten or lengthen them or to change their alignment. The procedure can include removing one or more portions of bone and/or adding one or more portions of bone or bone substitutes. (Search "osteotomy" on Wikipedia.com Feb. 3, 22, 2021. CC-BY-SA 3.0 Modified. Accessed Feb. 15, 2022.) As used herein, "patient specific osteotomy procedure" refers to an osteotomy procedure that has been adjusted, tailored, modified, or configured to specifically address the anatomy, physiology, condition, abnormalities, needs, or desires of a particular patient. In certain aspects, one patient specific osteotomy procedure may be useable in connection with only one patient. In other aspects, one patient specific osteotomy procedure may be useable with a number of patients having a particular class of characteristics. 120 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 After the cut has been made to split the calcaneus 1000 into the first bone segment 1040 and the second bone segment 1042, the surgeon may angle the second bone segment 1042 relative to the first bone segment 1040 in the predetermined (previously modeled) relative orientation. This reorientation between the first bone segment 1040 and the second bone segment 1042 may leave a wedge-shaped gap between the first bone segment 1040 and the second bone segment 1042. In order to maintain the desired relative orientation, an implant 1060 with a wedge shape may be inserted into the gap and secured to the first bone segment 1040 and the second bone segment 1042. The implant 1060 may be fabricated specifically for the patient, since the precise angulation and position of the realignment may also be patient specific. As shown, the implant 1060 may have exterior surfaces that are contoured to match the contours of the adjoining portions of the first bone segment 1040 and the second bone segment 1042. Thus, the implant 1060 may provide secure fixation, while not protrude beyond the adjoining surfaces of the first bone segment 1040 and the second bone segment 1042. Thus, the implant 1060 may be devoid of proud edges or other protrusions that could otherwise interfere with motion between the calcaneus 1000 and the talus 1010, or with surrounding soft tissues, thus interfering with the patient’s post-operative gait. "Soft tissue" refers to tissue of a patient (i.e., human or animal). Examples of soft tissue include but are not limited to skin, ligament, tendon, fascia, fat muscle, fibrous tissue, blood vessels, lymph vessels, brain tissue, and/or nerves. 126 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In some embodiments, one or more additional procedures may be carried out, in addition to or in the alternative to those of Figure 9. For example, in addition to or in the alternative to the Evans calcaneal osteotomy and the medializing calcaneal osteotomy, a cotton osteotomy (medial cuneiform opening wedge osteotomy) and/or a first metatarsal midfoot osteotomy may be performed. Patient-specific cutting guides may be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of bone engagement surfaces that are shaped to rest on the particular bony surfaces adjacent to the osteotomy. 130 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Those of skill in the art will appreciate that in various embodiments certain aspects may interface with one or more dorsal surfaces of each or both of the bones of a joint. The illustrated embodiments provide at least one example. In other embodiments, at least one of a cutting guide body, a proximal arm, a distal arm, and a bone engagement surface of a inferior surface of the body is configured to engage a dorsal surface of one or more of a first bone and a second bone. 273 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Those of skill in the art will appreciate that the position and orientation of the first slot 2260 and second slot 2270 and the corresponding cut surface a surgeon can form using these guide features can vary depending on the anatomical structures of the patient, the osteotomy procedure being performed, preferences of the surgeon, the nature of the condition, and the like. 261 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Referring to FIGS. 22H and 23, in one embodiment, the body 2210, or one or more arms, may include one or more bone attachment features that facilitate attachment of the body 2210 to the first cuneiform 210 and/or first metatarsal 230. Such bone attachment features may include any of a wide variety of fasteners including, but not limited to, holes, spikes, fastening devices, and/or the like. Effective connection of the cutting guide 2200 to one or more bones across a joint can ensure that cut surfaces are formed in desired locations and orientation and mitigate removal of hard tissue and/or soft tissue outside in undesired locations. 262 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Accordingly, the cutting guide 2200 includes one or more bone attachment features. As embodied in Figures 22A through 22H, the bone attachment features may take the form of one or more holes 2250 that extend from the inferior side 2222 to the superior side 2220 and/or one or more fixation devices. The holes 2250 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the first cuneiform 210 and/or the first metatarsal 230 to keep the cutting guide 2200 in place. 263 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 FIG. 23 illustrates one example of a cutting guide 2200 coupled to the bones using a proximal bone attachment feature 2252 and a distal bone attachment feature 2254. In the illustrated embodiment, the proximal bone attachment feature 2252 includes at least one hole 2250 and a fastener and the distal bone attachment feature 2254 includes at least one hole 2250 and a fastener. In FIG. 23 the fasteners are K-wires. Advantageously, the proximal bone attachment feature 2252 and the distal bone attachment feature 2254 each include at least two holes 2250, each with a K-wire passing through the hole 2250 and into bone facing the inferior side 2222. Using two holes 2250 and two fasteners ensures a stable coupling between the cutting guide 2200 and the bone(s). Advantageously, in certain embodiments, the two holes 2250 of the proximal bone attachment feature 2252 and distal bone attachment feature 2254 are align such that inserted K-wires are parallel to each other. Among other benefits, parallel K-wires of each of the proximal bone attachment feature 2252 and distal bone attachment feature 2254 prevent the cutting guide 2200 from pivoting around one of the K-wires of a proximal bone attachment feature 2252 or a distal bone attachment feature 2254. 264 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In the illustrated embodiment, the proximal arm 2230 includes the proximal bone attachment feature 2252 and the distal arm 2240 includes the distal bone attachment feature 2254. In one embodiment, the holes 2250 of the proximal bone attachment feature 2252 are aligned with each other and aligned perpendicular to a guide feature such as the second slot 2270 (see reference line 1992). The holes 2250 of the distal bone attachment feature 2254 may also be aligned with each other and aligned perpendicular to another guide feature such as the first slot 2260 (see reference line 1994). This means that the aligned holes 2250 (and K-wires secured within them) of the distal bone attachment feature 2254 will also be perpendicular to the cut surface formed using the first slot 2260. This also means that the aligned holes 2250 (and K-wires secured within them) of the proximal bone attachment feature 2252 will also be perpendicular to the cut surface formed using the second slot 2270. Consequently, at least one of the proximal bone attachment feature 2252 and the distal bone attachment feature 2254 can be used to position and orient a cut surface of the first metatarsal 230 and a cut surface of the first cuneiform 210. In certain embodiments, the proximal bone attachment feature 2252 and distal bone attachment feature 2254 may not be aligned with each other, the offset in the alignment may be the change in orientation of the bones of the joint desired to address the condition. It should be noted that the distal bone attachment feature 2254 may be parallel to the longitudinal axis 2276. In this manner, the distal bone attachment feature 2254 can be used as a reference for positioning a distal alignment feature 2290 on the first metatarsal 230. 265 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Returning to Figures 22A through 20, the body 2210 may further have features that facilitate desired translation and orientation of the first metatarsal 230 and/or first cuneiform 210 in order to fuse or join the two bones to complete the procedure. For example, in the illustrated embodiment, the cutting guide 2200 may include at least one alignment feature. A second alignment feature may be integrated into the cutting guide 2200 or the second alignment feature may be a separate feature from the cutting guide 2200. 266 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 In the illustrated embodiment, the proximal bone attachment feature 2252 serves as both a bone attachment feature and as an alignment feature, e.g., proximal alignment feature 2280. In this manner, the proximal bone attachment feature 2252 can provide both a bone attachment feature and an alignment feature in a single feature. In situations where a second bone of a joint, such as a first metatarsal 230, does not need to be rotated, translated, and/or re-oriented to mitigate a patient’s condition, the distal bone attachment feature 2254 may also serve as both a bone attachment feature and as an alignment feature, e.g., distal alignment feature 2290. 267 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 Typically, in an osteotomy for a condition such as a hallux valgus, it is desirable to rotate the first metatarsal 230 to address the condition. The first metatarsal 230 may be rotated for example to re-position distal plantar sesamoids from a lateral orientation to a more plantar orientation. Research has shown that performing such re-orientation mitigates recurrence of a hallux valgus condition. In such situations, the distal bone attachment feature 2254 may serve as a bone attachment feature and as a reference for the positioning of a distal alignment feature 2290 that is separate from the cutting guide 2200. 268 Added by DJM 2 2022 2/25/22, 12:00 AM
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PER-10 For example, in such instances, the distal bone attachment feature 2254 may serve as a reference for placement of a distal alignment feature 2290 (See FIG. 24A) that is parallel to the distal bone attachment feature 2254 as measured along the longitudinal axis 2276 of the first metatarsal 230. Subsequent to formation of a cut surface on the first metatarsal 230, the distal alignment feature 2290 can be coupled to the first metatarsal 230 in parallel to the distal bone attachment feature 2254 (e.g., by way of a pin guide). In certain embodiments, the distal alignment feature 2290 can include two or more aligned holes and/or a pair of K-wires that enter the bone in parallel to each other. In addition, in such a situation, the proximal alignment feature 2280 and the distal alignment feature 2290 may not be aligned initially. Instead, the proximal alignment feature 2280 and distal alignment feature 2290 may be configured to align when the bone coupled to the distal alignment feature 2290 is rotated. 269 Added by DJM 2 2022 2/25/22, 12:00 AM

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