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Delete 		PER-17 The exports (404, 412, 462, 506, and 508) may be inputs for a variety of 3rd party tools 510 including a manufacturing tool, a simulation tool, a virtual reality tool, an augmented reality tool, an operative procedure simulation tool, a robotic assistance tool, and the like. A surgeon can then use these tools when performing a procedure or for rehearsals and preparation for the procedure. For example, a physical model of the bones, patient-specific instrument 406, and/or fixators can be fabricated, and these can be used for a rehearsal operative procedure. Alternatively, a surgeon can use the bone model 404, preliminary instrument model 438, and/or a fixator model to perform a simulated procedure using an operative procedure simulation tool. 222 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Referring now to FIGS. 3-5, certain methods, systems, and/or apparatuses a disclosed herein for preparing for, planning, outlining, one or more surgical procedures. Alternatively, or in addition, the methods, systems, and/or apparatuses a disclosed herein can be used for preoperative development and design of patient-specific devices or instrumentation and/or for preoperative rehearsal and/or instruction of a surgeon before the surgical procedure is initiated. For example, a surgeon can use the method 300, bone model(s) 404, patient instrument(s) 406, system 400, and/or apparatus 402 to perform a mock surgical procedure virtually before an actual surgical procedure. 223 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 These techniques and/or technologies can greatly advance the medical field and provide valuable instruction and experience to a surgeon prior to an actual surgical procedure. Furthermore, these techniques and/or technologies are made effective owing to the accuracy and precision of the models because of the fidelity of the medical imaging of the patient anatomy. This virtual modeling of patient anatomy has become very accurate and helpful, particularly for hard tissue such as bones and the surfaces of these bones. 224 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Unfortunately, the fidelity and accuracy of these models is not as advanced with respect to the modeling of soft tissue of a patient such as sinews, skin, tendons, ligaments, muscles, fat, and the like. Thus, rehearsal of a surgical procedure, particularly one that includes translating and/or reorienting one or more bone fragments has limited benefit. In such cases, because the surgeon cannot predict or know beforehand how much movement and reorientation the soft tissue of a patient will permit, the surgeon needs to be able to revise or adapt a surgical procedure intraoperatively to achieve optimal outcomes. The system, apparatus, and methods of the present disclosure enable a surgeon to make intraoperative adjustments to surgical plan based on what the surgeon learns during the surgery. 225 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The present disclosure leverages the use of models, such as computer models, and particularly models of a specific patient to provide and/or generate instrumentation, implants, and/or surgical plans that advanced patient care. Advantageously, these models are unique and customized for a particular patient. Thus, the models reflect the actual anatomical features and aspects of the patient. 226 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 However, the utility and helpfulness of the models, methods, systems, and/or apparatuses of FIGS 3-5, is dependent on how effectively a surgeon can navigate within, on, or in relation to one or more anatomical references or anatomical features of a patient such that the steps of the surgical procedure can be performed on a patient in the same manner as those modeled using models of the anatomy of the patient. This process of navigation is referred to as a mapping or translation between the virtual or model environment to a physical or real world environment that includes the patient anatomy and the operating field. 227 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Advantageously, the models, methods, systems, and/or apparatuses of the present disclosure facilitate mapping or translating between a virtual or model environment and/or instrumentation to a physical or real world environment for a surgical procedure. The present disclosure provides this feature or benefit by providing an apparatus, system, and method, that enables a surgeon to identify, create, form, and/or use a reference feature for a surgical procedure. The reference feature provides a reference and/or starting point on, in, or associated with anatomy of a patient such that steps, stages, features, or aspects planned and configured within the model can be accurately performed on, with, or to the anatomy of the patient. In certain embodiments, one or more steps of a surgical procedure can be done in connection with or in relation to the reference feature. 228 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The reference feature facilitates moving from one coordinate system or frame of reference in a virtual environment to a position, location, frame of reference, environment, or orientation on, or in, an actual object, structure, device, apparatus, anatomical structure, or the like. Advantageously, the reference feature can coordinate objects, models, or structures in a digital or virtual model or representation with corresponding objects or structures (e.g., anatomical structures) of actual physical objects or structures. Said another way, the reference feature can serve to map from a virtual or modeled object to an actual or physical object. 229 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Advantageously, the embodiment of the present disclosure include features and aspects that assist a surgeon in locating at least one reference feature, which can then be used in one or more stages of a surgical procedure. In certain embodiments, the actual instruments fabricated using the present disclosure may include one or more references (e.g., a model references). The one or more model instruments may use the one or more references to position and/or orient the one or more model instruments such that other steps of a surgical procedure can be performed in relation to those one or more model instruments and/or model references. Certain model references may key off or related to anatomical references of modeled anatomical body parts. The reference feature(s) correspond to the model references and together enable a surgeon to identify reference features on actual anatomy of a patient for a surgical procedure. In one embodiment, the reference feature may comprise a pin placed within a hole of an instrument. Alternatively, or in addition, the reference feature may comprise a bone engagement surface of an instrument or device, such as a patient-specific device. 230 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 6 illustrates an exemplary apparatus configured to determine a deformity, according to one embodiment. In one embodiment, the apparatus 402 may include a deformity detection module 422. The deformity detection module 422 determines or identifies one or more deformities or other anomalies based on the anatomic data 412. The deformity may include a deformity between two bones of a patient’s foot as represented in the bone model 404. In one embodiment, the deformity detection module 422 may compare the anatomic data 412 to a general model that is representative of most patient’s anatomies and that does not have a deformity or anomaly. In one embodiment, if the anatomic data 412 does not match the general model a deformity is determined. Various deformities may be detected including those that have well-known names for the condition and those that are unnamed. 231 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 6 illustrates an exemplary deformity detection module 422 configured to determine a deformity, according to one embodiment. The deformity detection module 422 may detect one or more deformities and/or anomalies of a patient’s anatomy by analyzing anatomic data 412 and other inputs, such as a certain type or class of deformities to search for. 232 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The deformity detection module 422 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the detection of the deformity is. The user may provide instructions to the deformity detection module 422 to facilitate automatic or partially automated detection or determination of one or more deformities. 233 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The deformity detection module 422 may be configured for automated determination of a deformity. For example, in one embodiment, the deformity detection module 422 includes an artificial intelligence or machine learning module 424 (e.g., ANN, GAN, or the like). The artificial intelligence or machine learning module 424 is configured to implement one or more of a variety of artificial intelligence modules that may be trained for detecting an anomaly or deformity based on anatomic data 412. In another embodiment, the deformity detection module 422 may receive patient imaging data, a bone model, a CAD model or the like and use these inputs to determine deformities in the bones of a patient. 234 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In one embodiment, the artificial intelligence or machine learning module 424 may be trained using a large data set of anatomic data 412 for healthy non-deformed bones and a large data set of anatomic data 412 for deformed bones in which the deformity has been previously identified and labeled in the dataset. The artificial intelligence or machine learning module 424 may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module 424 accepts the anatomic data 412 for a particular patient, the artificial intelligence or machine learning module 424 is able to determine what deformity 426 exists in the patient’s bones, when such a deformity 426 exists. In one embodiment, the artificial intelligence or machine learning module 424 comprises a Generative Adversarial Networks (GAN). 235 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIGs. 7A and 7B illustrate one example of a method for determining a deformity 426 and a correction for the deformity, according to one embodiment. The deformity detection module 422 may use a particular method for determining whether or not two or more bones have a deformity 426. The deformity detection module 422 may use one or more advanced computing techniques for determining the deformity 426. 236 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Referring now to FIG. 7A, in one embodiment, the deformity detection module 422 starts by identifying a center longitudinal axis 428a, 1228b (Fig. 7A shows two of the plurality of axes, rather than each for clarity) for each bone in the bone model 404. For example, the deformity detection module 422 may identify the center longitudinal axis 428a for a first metatarsal and the center longitudinal axis 428b for the second metatarsal. 237 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Next, the deformity detection module 422 may identify a reference axis 429 perpendicular with one of the center longitudinal axes 428a,b, such as center longitudinal axis 428b. The reference axis 429 may be at, or near, a joint between bones of the bone model 404. The deformity detection module 422 may determine that a deformity 426 exists if the center longitudinal axes 428a,b are not parallel or are not parallel when measured with a predefined margin for error. FIG. 7A illustrates a bone model 404 with a deformity 426. The deformity 426 is that the first metatarsal is not parallel, or not sufficiently parallel, to the second metatarsal at the joint between the first metatarsal and the medial cuneiform bones. Once the deformity 426 is determined, the deformity detection module 422 or apparatus 402 may determine what steps, procedures, devices, or instrumentation can be used to correct the deformity 426. The deformity detection module 422 may use a name, label, tag, or other identifier for a particular deformity 426. 238 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 7B illustrates the bone model 404 of FIG. 7A after a corrective procedure and/or application of corrective implants may be performed. The center longitudinal axes 428a,b are parallel, or sufficiently parallel, such that the deformity 426 is no longer a problem for a patient. 239 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 8 illustrates an exemplary provision module 430 configured to provide a preliminary instrument model, according to one embodiment. The provision module 430 may accept anatomic data 412 and a designation, identifier, label, or name of a deformity 426. In the illustrated embodiment, the provision module 430 may generate a preliminary instrument model 438 (e.g., generate from ‘scratch’) or the provision module 430 may select a template instrument model 436 automatically from a set of template instrument models 436 stored in a repository 802. The provision module 430 may incorporate a variety of parameters in order to provision, generate, determine, or select a template instrument model 436. For example, in addition to the anatomic data 412, the provision module 430 may include patient imaging data, deformity parameters for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used, patient preferences, and/or surgeon input parameters. 240 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In one embodiment, the provision module 430 may include a generator 432 and/or a selection module 434. In one embodiment, the generator 432 is configured to generate a preliminary instrument model 438. In certain embodiments, the generator 432 may generate or create the preliminary instrument model based on anatomic data and/or a bone model or a combination of these and no other inputs. (e.g. no model or predesigned structure, template, or prototype). Alternatively, or in addition, the generator 432 may generate or create the preliminary instrument model using a standard set of features or components that can be combined to form the preliminary instrument model. The generated preliminary instrument model may subsequently be modified or revised by an automated process, and/or manual process, to generate the preliminary instrument model used in this disclosure. 241 Added by DJM Jan 2024 1/6/24, 10:05 PM

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