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PER-8 PROV As shown, the method 120 may begin with a step 122 in which a CT scan (or another three-dimensional image) of the patient’s foot is obtained. The step 122 may entail capturing a scan of only the first cuneiform and first metatarsus, or may entail capture of additional anatomic information, such as the entire foot. Additionally or alternatively, the step 122 may entail receipt of previously captured image data. Capture of the entire foot in the step 122 may facilitate proper alignment of the first metatarsus with the rest of the foot (for example, with the second metatarsus). Performance of the step 122 may result in generation of a three-dimensional model of the patient’s foot, or three-dimensional surface points that can be used to construct such a three-dimensional model. 55 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV Figure 1B is a flowchart diagram depicting a method 120 for correcting bunion deformity of the human foot, according to one embodiment. The method 120 may be used to carry out an arthrodesis procedure by which the first metatarsocuneiform joint is removed and the first cuneiform and first metatarsus are secured together in a manner that properly aligns the first metatarsus, providing correction of the deformity. 54 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV As mentioned previously, the method 100 may be used to correct a wide variety of bone conditions. One particular example of the method 100 will be shown and described in connection with Figure 1B, for correction of a bunion deformity of the foot. 53 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV In a step 110, the manufactured instrumentation may be used in surgery to facilitate treatment of the condition. In some embodiments, this may entail placing the modelled bone apposition surface against the corresponding contour of the bone used to obtain its shape, and then using the guide feature(s) to guide resection of one or more bones. Then the bone(s) may be further treated, for example, by attaching one or more joint replacement implants (in the case of joint arthroplasty), or by attaching bone segments together (in the case of arthrodesis or fracture repair). Prior to completion of the step 110, the instrumentation may be removed from the patient, and the surgical wound may be closed. 52 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The surgical osteotomy may be the Evans calcaneal osteotomy or the medializing calcaneal osteotomy. The first bone may be the calcaneus. The cutting guide may further have a second bone engagement surface shaped to match a second contour of the calcaneus such that, with the first bone engagement surface overlying the first contour and the second bone engagement surface overlying the second contour, the first guide feature is positioned to guide a cutter to resect the calcaneus to perform the Evans calcaneal osteotomy or the medializing calcaneal osteotomy. 21 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV In addition to or in the alternative to the step 108, the model(s) may be used to select from available sizes of implants and/or instruments and advise the surgeon accordingly. For example, where a range of cutting guides are available for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal cutting guide and/or optimal placement of the cutting guide on the bone. Similarly, if a range of implants may be used for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal implant(s). More particularly, properly-sized spacers, screws, bone plates, and/or other hardware may be pre-operatively selected. 50 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV In a step 108, the model(s) may be used to manufacture patient-specific instrumentation and/or implants. This may be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, and/or the like. Additive manufacturing may provide unique benefits, as the model may be directly used to manufacture the necessary instrumentation and/or implants (without the need to generate molds, tool paths, and/or the like beforehand). Such instrumentation may optionally include a cutting guide with the bone apposition surface and one or more guide features as described above. 49 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV In a step 106, the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the condition, as it exists in the patient’s anatomy. In some embodiments, any known CAD program may be used to view and/or manipulate the CAD model and/or CT scan, and generate one or more instruments that are matched specifically to the size and/or shape of the patient’s bone(s). In some embodiments, such instrumentation may include a cutting guide that is attachable to one or more bones, with one or more guide features that facilitate resection of the one or more bones pursuant to a procedure such as arthroplasty or arthrodesis. In some embodiments, performance of the step 106 may include modelling an instrument with a bone apposition surface that is shaped to match the contour of a surface of the bone, such that the bone apposition surface can lie directly on the corresponding contour. 48 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV After the step 102 has been carried out, the method 100 may proceed to a step 104 in which a CAD model of the patient’s anatomy is generated. The CAD model may be of any known format, including but not limited to SolidWorks, Catia, AutoCAD, or DXF. In some embodiments, customized software may be used to generate the CAD model from the CT scan. The CAD model may only include the bone(s) to be treated or may include surrounding tissues. In alternative embodiments, the step 104 may be omitted, as the CT scan may capture data that can directly be used in future steps without the need for conversion. 47 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV As shown, the method 100 may begin with a step 102 in which a CT scan (or another three-dimensional image) of the patient’s anatomy is obtained. The step 102 may entail capturing a scan of only the particular bone(s) to be treated, or may entail capture of additional anatomic information, such as the surrounding tissues. Additionally or alternatively, the step 102 may entail receiving a previously captured image, for example, at a design and/or fabrication facility. Performance of the step 102 may result in possession of a three-dimensional model of the patient’s anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model. 46 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV Figure 1A is a flowchart diagram depicting a method 100 for correcting a bone condition, according to one embodiment. The method 100 may be used for any of a wide variety of bone conditions, including but not limited to deformities, fractures, joint failure, and/or the like. Further, the method 100 may provide correction with a wide variety of treatments, including but not limited to arthroplasty, arthrodesis, fracture repair, and/or the like. 45 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The present disclosure discloses surgical systems and methods by which a bone condition, such as a deformity, may be corrected through the use of patient-specific instrumentation. Known methods of correcting bone conditions are often limited to a finite range of discretely sized instruments. A patient with an unusual condition, or anatomy that falls between instrument sizes, may not be readily treated with such systems. One example is correction of a bunion, in particular, via adjustment of the angulation between a cuneiform and a metatarsus. 44 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV FIG. 16 illustrates an exemplary embodiment of a parallel distractor that can be used with certain embodiments. 41 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The cutting guide may further have a first end having the first bone engagement surface, a second end having the second bone engagement surface, a first bone attachment feature positioned to secure the first end to the cuneiform, and a second bone attachment feature positioned to secure the second end to the metatarsus. 20 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV Various bone conditions may be corrected through the use of an osteotomy, in which one or more bones are cut, replaced, and/or reoriented. Cutting guides are often used to help the surgeon properly locate the cut. Unfortunately, many known cutting guides are not patient-specific, and can be difficult to properly position to perform the osteotomy on a specific patient. Even if properly positioned, many known cutting guides are difficult to secure at the desired position, without moving away from the desired position prior to performance of the osteotomy. As a result, many known osteotomy procedures carry risk of an improper cut that fails to correct the underlying condition, or even endangers surrounding tissues. 2 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The various systems and methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available osteotomy systems and methods. 3 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV In some embodiments, a method may be used to correct a condition present in a patient. The method may include obtaining a first bone model of a first bone of one or more bones of the patient’s foot and using at least the first bone model to generate a cutting guide model. The cutting guide model may define a first bone engagement surface shaped to match a first contour on the first bone, and a first guide feature that, with the first bone engagement surface overlying the first contour, is positioned to guide resection of the one or more bones as part of a surgical osteotomy for correcting the condition. The surgical procedure may be selected from a first group consisting of a bunion correction osteotomy, an Evans calcaneal osteotomy, and a medializing calcaneal osteotomy. The first bone may be selected from a second group consisting of a metatarsus, a cuneiform, and a calcaneus. 4 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The one or more bones may include the cuneiform and the metatarsus. The surgical osteotomy may be the bunion correction osteotomy. The condition may be a bunion, and the first guide feature may be positioned to guide resection of one of the cuneiform and the metatarsus. 5 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The first bone may be the cuneiform. The first guide feature may be positioned to guide resection of the cuneiform. The cutting guide model may further define a second bone engagement surface shaped to match a second contour of the metatarsus, and a second guide feature that, with the second bone engagement surface overlying the second contour, is positioned to guide resection of the metatarsus. 6 Added by DJM 7 2021 7/2/21, 12:00 AM
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PER-8 PROV The method may further includeobtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion. 7 Added by DJM 7 2021 7/2/21, 12:00 AM

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