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Delete 		PER-4 DIV1 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. 65 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 As shown, the cutting guide 1043 may have a first end 1044 and a second end 1045, each of which has a bone attachment feature 1046. The bone attachment features 1046 may be used to secure the first end 1044 and the second end 1045 to the first bone segment 1040 and the second bone segment 1042, respectively. The first end 1044 may have a first bone engagement surface 1047 that is shaped to match a corresponding contour on the first bone segment 1040, and the second end 1045 may have a second bone engagement surface 1048 that is shaped to match a corresponding contour on the second bone segment 1042. Thus, the cutting guide 1043 may naturally lie flush with the surface of the calcaneus 1000, in the optimal position on the calcaneus 1000 to facilitate resection of the calcaneus 1000 to divide the first bone segment 1040 from the second bone segment 1042. The cutting guide 1043 may have a guide feature 1049, such as a slot, that can be used to guide a cutter to form a single cut between the first bone segment 1040 and the second bone segment 1042. 64 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 13 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Figure 2 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 first cuneiform 210, a second cuneiform 220, a first metatarsus 230, and a second metatarsus 240. The first cuneiform 210 and the second cuneiform 220 may be joined together at a first metatarsocuneiform joint, and the first metatarsus 230 and the second metatarsus 240 may be joined together at a second metatarsocuneiform joint. 22 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 As mentioned previously, the method 120 is only 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. 21 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 20 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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 metatarsus. The guide features (for example, slots) may then be positioned on either side of the joint between the first cuneiform and the first metatarsus to guide resection of the first metatarsus 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 metatarsus 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 metatarsus are properly oriented to bring the first metatarsus back into its proper orientation relative to the rest of the foot. The first cuneiform and the first metatarsus may be secured together through the use of 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 metatarsus to fuse together. 19 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 In a step 128, the model(s) may be used to manufacture patient-specific instrumentation and/or instruments. This may include manufacturing the cutting guide with the bone apposition surface and the guide features as described above. As in the step 108, the step 128 may additionally or alternatively involve provision of one or more instruments and/or implants from among a plurality of predetermined configurations or sizes. Further, the step 128 may additionally or alternatively involve provision of instructions for placement and/or anchorage of one or more instruments and/or instruments to carry out the procedure. 18 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 In a step 126, the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the bunion deformity. Such instrumentation may include a cutting guide that is attachable to the first cuneiform and the first metatarsus, with two guide features that facilitate resection of the cuneiform and the metatarsus in preparation for arthrodesis. In some embodiments, performance of the step 126 may include modelling the cutting guide with a bone apposition surface that is shaped to match contours of the surfaces of the cuneiform and the metatarsus, such that the bone apposition surface can lie directly on the corresponding contours of the first cuneiform and the first metatarsus. 17 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 After the step 122 has been carried out, the method 120 may proceed to a step 124 in which a CAD model of the relevant portion of the patient’s anatomy is generated. The CAD model may optionally include the bones of the entire foot, like the CT scan obtained in the step 122. In alternative embodiments, the step 124 may be omitted in favor of direct utilization of the CT scan data, as described in connection with the step 104. 16 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 15 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 14 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The resulting bleeding and/or prepared bone may readily grow together and fuse, upon abutment of the distal end of the first cuneiform 210 to the proximal end of the first metatarsus 230, particularly with application of some compression across the juncture of the two bones. Since the positions and orientations of the first slot 350 and the second slot 352 were carefully selected to provide the proper correction, the first metatarsus 230 may be positioned to abut the first cuneiform 210, resulting in reorientation of the first metatarsus 230 to a desired orientation, relative to the lateral direction 260 and the plantar direction 280 and/or the dorsal direction 290. Further, the surgeon may optionally rotate the first metatarsus 230, relative to the first cuneiform 210, about an axis perpendicular to the cutting planes, if desired. 41 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 12 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Thus, the result of the step 108 may be provision, to the surgeon, of one or more of the following: (1) one or more patient-specific instruments; (2) one or more patient-specific implants; (3) an instrument, selected from one or more available instrument sizes and/or configurations; (4) an implant, selected from one or more available implant sizes and/or configurations; (5) instructions for which instrument(s) to select from available instrument sizes and/or configurations; (6) instructions for which implant(s) to select from available implant sizes and/or configurations; (7) instructions for proper positioning or anchorage of one or more instruments to be used in the procedure; and (8) instructions for proper positioning or anchorage of one or more implants to be used in the procedure. These items may be provided to the surgeon directly, or to a medical device company or representative, for subsequent delivery to the surgeon. 11 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 10 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 9 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 8 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 7 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 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. 6 Added by DJM Jan 2024 1/6/24, 9:54 PM

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