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Delete 		PER-16 In the illustrated embodiment, the first angle 1150 and the second angle 1152 are right angles. Of course, in certain embodiments, the first angle 1150 may not be at a right angle with respect to the distal side 1114 of the first bone attachment feature 1006 and the second angle 1152 may not be at a right angle with respect to the proximal side 1142 of the second bone attachment feature 1008. Alternatively, or in addition, the first height 1120 and/or second height 1122 may be defined such that the trajectory 1124 of the cutter guide 1010 extends at an angle that is not perpendicular to the longitudinal axis 1154 of at least one of the bones that is to be resected/dissected using the pivoting resection guide 1002. Accordingly, in this manner, the angle of the trajectory 1124 can be predetermined and/or can be patient-specific to meet the needs of the patient, the angle needed for a correction, the preferences of a surgeon, or the like. 279 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 FIGs 11A-11H, illustrate an embodiment of an osteotomy system 1000 that includes both a first bone attachment feature 1006 and a second bone attachment feature 1008 with a cutter guide 1010 between them. However, certain embodiments of an osteotomy system may have substantially the same constructs, components, and aspects as those described with respect to embodiments in FIGs 11A-11H with the exception that these embodiments may include either the first bone attachment feature 1006 or the second bone attachment feature 1008. Thus, the present disclosure supports embodiments of a pivoting resection guide that includes one of the first bone attachment feature 1006 or the second bone attachment feature 1008 but not both. Such an embodiment can also include a first bone engagement surface 1022 or second bone engagement surface 1024 depending on which bone attachment feature is included. The first bone engagement surface 1022 or second bone engagement surface 1024 may be determined at least in part based on a model of a bone of a patient’s foot. In certain embodiments, the bone is the bone that the first bone attachment feature 1006 or the second bone attachment feature 1008 will contact during the surgical procedure. 280 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 For example, suppose in one embodiment, the osteotomy system includes a first bone attachment feature 1006, at least one fastener 1012, a cutting tool 1026, and the cutter guide 1010. Accordingly, the first bone attachment feature 1006 includes a first bone engagement surface 1022 that is configured to engage with a bone surface to position the first bone attachment feature 1006 for the surgical procedure. Alternatively, in another embodiment, the osteotomy system includes a second bone attachment feature 1008, at least one fastener 1012, a cutting tool 1026, and the cutter guide 1010. Accordingly, the second bone attachment feature 1008 includes a second bone engagement surface 1024 that is configured to engage with a bone surface to position the second bone attachment feature 1008 for the surgical procedure. 281 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 FIG. 12A is an exploded view of a pivoting resection guide 1002, according to one embodiment, including a handle 1004. The osteotomy system 1000 includes a cutting tool 1026, first bone attachment feature 1006, second bone attachment feature 1008, cutter guide 1010 and the first coupler 1118 and second coupler 1148 describe earlier. 282 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The cutter guide 1010 is configured to receive a cutting tool 1026 such as a burr, a drill bit, or the like. The cutting tool 1026 can also be referred to as a cutter. The cutting tool 1026 includes a proximal end 1202 and a distal end 1204. The cutting tool 1026 is configured to be deployed within an opening 1206 in the cutter guide 1010. In one embodiment, the opening 1206 in the cutter guide 1010 extends from one end to the other. The opening 1206 extends from a proximal end of the cutter guide 1010 to a distal end of the cutter guide 1010. The opening 1206 of the cutter guide is sized and shaped to accept at least the cutting section 1222 of the cutting tool cutting tool 1026. 283 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The handle 1004 provides precise and accurate control of the cutting tool 1026 as the pivoting resection guide 1002 is used to guide the cutting tool 1026 is performing an osteotomy. The handle 1004 enables a surgeon to pivot the cutter guide 1010 with fine control within a plane between the first bone attachment feature 1006 and the second bone attachment feature 1008 and without interference from the cutting tool 1026. 284 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The handle 1004 includes a distal handle end 1208 and a proximal handle end 1210 opposite the distal handle end 1208. The distal handle end 1208 includes a handle coupler 1212. The handle coupler 1212 is configured to couple the handle 1004 to the cutter guide 1010, at least temporarily. The handle 1004 also includes an opening 1214 that extends from the proximal handle end 1210 to the distal handle end 1208. In certain embodiments, the opening 1214 is coaxial with a longitudinal axis 1216 of the handle 1004. The opening 1214 is sized to accept the cutting tool 1026. In particular, the handle 1004 is configured to pass the cutting tool 1026 through the handle 1004. The handle coupler 1212 couples the handle 1004 to the cutter guide 1010. Coupling the handle 1004 to the cutter guide 1010 forms a first-class lever. The first-class lever magnifies a load force applied to a bone in contact with the cutting tool 1026 near the distal end 1204 of the cutting tool 1026 based on an effort force applied by a user toward the proximal handle end 1210. 285 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The cutting tool 1026 includes a body 1218 that includes a drive section 1220, a cutting section 1222, and a guide section 1224 between the drive section 1220 and the cutting section 1222. In one embodiment, the body 1218 is an elongate body with a round cross section. The drive section 1220 is near the proximal end 1202 and is configured to couple to a driver that rotates the cutting tool 1026. The guide section 1224 engages with the pivoting resection guide 1002 and guides the cutting tool 1026 during the creation of an osteotomy. The cutting section 1222 is near the distal end 1204. The cutting section 1222 is the part that resects/dissects the bone to form an osteotomy. In one embodiment, the cutting section 1222 includes a set of flutes or grooves that include sharp edges configured to cut and resect hard tissue and/or soft tissue. 286 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 In certain embodiments, the cutting section 1222 has a predetermined length. This predetermined length may be patient-specific. Alternatively, or in addition, the predetermined length is configured based on a diameter of the tissue the cutting tool 1026 will resect/dissect. In certain embodiments, the predetermined length is configured to extend from one cortex of a bone to an opposite cortex of the bone when the cutting tool 1026 is used to resect the bone. Alternatively, or in addition, the cutting tool 1026 can be used to form a channel or bone tunnel or recess, in such cases the predetermined length may be set to accommodate that use. 287 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 In the illustrated embodiment, the cutter guide 1010 includes two arms that each extend into an opening 1226, 1228 in each of the first bone attachment feature 1006 and the second bone attachment feature 1008. The arms may be secured in the openings using one or more fasteners 1016 (e.g., set screws, thumbscrews, pins, dowels, or the like). Together the arms, openings, and/or fasteners 1016 may operate as one example of a first coupler 1118 and/or second coupler 1148. 288 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 In one embodiment, the determination module 410 may use advanced computer analysis system such as image segmentation to determine the anatomic data. The determination module 410 may determine anatomic data from one or more sources of medical imaging data, images, files, or the like. The determination module 410 may perform the image segmentation using 3D modeling systems and/or artificial intelligence (AI) segmentation tools. In certain embodiments, the determination module 410 is configured to identify and classify portions of bone based on a condition of the bone, based on the bone condition. Such classifications may include identifying bone stability, bone density, bone structure, bone deformity, bone structure, bone structure integrity, and the like. Accordingly, the determination module 410 may identify portions or sections or one or more bones based on a quality metric for the bone. Advantageously, that determination module 410 can identify high quality bone having a viable structure, integrity, and/or density versus lower quality bone having a nonviable structure, integrity, and/or density and a plurality of bone quality levels in between. 183 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 Accordingly, the determination module 410 can guide a surgeon to determine which areas of one or more bones of a patient are within a “soft tissue envelope” (bone of undesirable quality) as that bone relates to a particular deformity or pathology. Identifying the quality of one or more bones of the patient can aid a surgeon in determining what type of correction or adjustment is needed. For example, an ulceration that occurs due to a boney deformity can be mapped using the determination module 410 in a way that a correction can be performed to correct the deformity and reduce pressure to an area and address the structures that were causing the pressure ulceration/ skin breakdown. 184 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 In addition, the determination module 410 and/or another component of the apparatus 402 can be used to perform anatomic mapping which may include advanced medical imaging, such as the use of CT scan, ultrasound, MRI, and bone density scans can be combined to effectively create an anatomic map that determines the structural integrity of the underlying bone. 185 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 Identifying the structural integrity of the underlying bone can help in determining where bone resections can be performed to preserve the densest bone in relation to conditions such as Charcot neuropathic, arthropathy where lesser dense bone can fail and collapse. It is well documented in the literature that failure to address and remove such lesser dense bone can ultimately lead to failure of a reconstruction and associated hardware. 186 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The present disclosure provides, by way of at least the exemplary system 400, an anatomic map that can be part of anatomic data. The anatomic map can combine structural, deformity, and bone density information and can be utilized to determine the effective density of bone and help to determine where bone should be resected in order to remove the lesser dense bone while maintaining more viable bone to aid in the planning of the osteotomy / bone resection placement. 187 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The location module 420 determines or identifies one or more recommended locations and/or trajectory angles for deployment of an instrument, graft, and/or soft tissue based on the anatomic data 412 and/or the bone model 404. In one embodiment, the location module 420 may compare the anatomic data 412 to a general model that is representative of most patient’s anatomies and may be free from deformities or anomalies. The location module 420 can operate autonomously and/or may facilitate input and/or revisions from a user. The location module 420 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the determining of the location and/or trajectory angles is. 188 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The provision module 430 is configured to provide a preliminary guide model 438. The preliminary guide model 438 may serve as a model for an instrument to be used in a surgical procedure. The provision module 430 may use a variety of methods to provide the preliminary guide model. In one embodiment, the provision module 430 may generate a preliminary guide model. In the same, or an alternative embodiment, the provision module 430 may select a template guide model for a surgical procedure configured to enable locating the position and/or providing the trajectory provided by the location module 420. In one embodiment, the provision module 430 may select a template guide model from a set of template guide models (e.g., a library, set, or repository of template guide models). 189 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The registration module 440 registers the preliminary guide model with one or more bones or other anatomical structures of the bone model 404. As explained above, registration is a process of combining medical imaging data, patient imaging data, and/or one or more models such that the preliminary guide model can be used with the bone model 404. 190 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The design module 450 designs a patient-specific guide (or patient-specific guide model) based on the preliminary guide model. The design operation of the design module 450 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the designing of the patient-specific guide (or patient-specific guide model) is. 191 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The manufacturing module 460 may manufacture a patient-specific guide 406 using the preliminary guide model. The manufacturing module 460 may use a patient-specific guide model generated from the preliminary guide model. The manufacturing module 460 may provide the patient-specific guide model to one or more manufacturing tools and/or fabrication tool. The patient-specific guide model may be sent to the tools in any format such as an STL file or any other CAD modeling or CAM file or method for data exchange. In one embodiment, a user can adjust default parameters for the patient-specific guide such as types and/or thicknesses of materials, dimensions, and the like before the manufacturing module 460 provides the patient-specific guide model to a manufacturing tool. 192 Added by DJM Jan 2024 1/3/24, 4:26 AM

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