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Delete 		PER-17 The fabrication module 1080 may include and/or communicate with machines and/or equipment that is configured to interpret the one or more STL files and fabricate a physical patient-specific device 1090 that matches the design and/or specifications of the patient-specific device model 1072. Alternatively, or in addition, the fabrication module 1080 may prepare the one or more STL files that are then provided to a third party manufacturer that uses manufacturing tools to fabricate the patient-specific device 1090 from the patient-specific device model 1072. In one embodiment, the fabrication module 1080 may send the one or more STL files for the patient-specific device 1090 to a third-party directly over a communications network. 288 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In one embodiment, once the fabrication module 1080 generates the patient-specific device 1090 the patient-specific device 1090 may be ready for use in a surgical procedure. Alternatively, or in addition, one or more post fabrication steps may be performed on the patient-specific device 1090 before it is ready for use. 289 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In certain embodiments, the fabrication module 1080 is configured to not only generate the patient-specific device 1090 or instructions for a manufacturing tool to generate the patient-specific device 1090, but the fabrication module 1080 may also generate one or more other materials and/or devices that can be used for a surgical procedure to remediate a condition present in a patient’s foot. 290 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 For example, in one embodiment, the fabrication module 1080 may generate a preoperative plan 1092 and/or other complementary devices 1094. The preoperative plan 1092 may be configured and/or customized for a surgical procedure that uses the patient-specific device 1090. The preoperative plan 1092 may be generated in a digital and/or a hardcopy format and may include images of the bone model 404 and/or the patient-specific device 1090 at one or more stages of a surgical technique for a surgical procedure. The preoperative plan 1092 may include specific measurements for angles, lengths, widths, and/or orientations of the bones of the bone model 404 and/or the patient-specific device 1090. Alternatively, or in addition, the preoperative plan 1092 may include recommendations for consideration by a surgeon for the surgical procedure. The preoperative plan 1092 may be provided in the form of a report or a document. 291 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The complementary devices 1094 may include a positioner, an alignment device, a targeter, a jig, a guide, other instrumentation, and/or a physical model of one or more bones of the bone model 404. These complementary devices 1094 may be needed for a surgical procedure that uses the patient-specific device 1090 and/or may be optional and may be useful to certain surgeons but not as useful to others. The physical model of one or more bones of the bone model 404 may be useful to a surgeon to enable them to handle a representation of the bones of the patient and study or review different angles, perspectives, and/or options for the surgical procedure. 292 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Referring to FIGs 10 and 11, the system 1000 can be used for a variety of surgical procedures to generate a variety of patient-specific device 1090 depending on the needs of the patient and/or the preferences of the surgeon. In one embodiment, the system 1000 can be used to generate a resection guide for use by a surgeon to perform one or more osteotomies on bones of a patient’s foot to remediate a hallux valgus deformity (Bunion). A resection guide is an instrument configured to be placed on, against, or near one or more bones of a patient and guide a cutting tool in performing one or more osteotomies of the bone(s). 293 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Initially, a medical imager 1010 may be used to generate medical imaging of a patient’s foot having the condition. The medical imager 1010 may generate medical imaging 1030 using a CT scanner and the medical imaging 1030 may be recorded in a storage device in a file having a DICOM format. In one embodiment, the patient-specific device design apparatus 450 may include executable code configured to direct a segmentor 1020 such as an autosegmentor to segment the medical imaging 1030 DICOM files into a format suitable for use, reading, and/or importation by the patient-specific device design apparatus 450 (e.g., STL file(s)). In one embodiment, the segmented medical imaging 1030 may serve as input to the patient-specific device design apparatus 450 and/or may be included in a set of work instructions 1040. 294 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Next, the patient-specific device design apparatus 450 can receive a set of work instructions 1040 by way of the receiver module 1060. In one embodiment, the set of work instructions 1040 includes a workflow 1050 and a prescription 1100. Alternatively, the set of work instructions 1040 may not include a workflow 1050 or a prescription 1100. Instead, the workflow 1050 may be incorporated into executable code executed by the patient-specific device design apparatus 450. The set of work instructions 1040 may identify the patient and/or the surgical procedure. 295 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In one embodiment, the user 1002 can change over the course of initiating generation of a patient-specific device 1090 to its final fabrication. For example, the user 1002 may initially be a surgeon and the surgeon may operate the patient-specific device design apparatus 450 to initiate generation of a patient-specific device 1090, such input from a surgeon may be considered a prescription 1100 sufficient to satisfy regulatory requirements for a jurisdiction that recognizes the surgeon as one qualified to perform the surgical procedure. Later, an operator may interact with the patient-specific device design apparatus 450 to generate the patient-specific device 1090. 296 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Once the receiver module 1060 has the set of work instructions 1040, the navigation module 1070 may navigate a workflow together with a user 1002 to with a user to generate a bone model 404 of a first metatarsal and a medial cuneiform of a patient's foot based on medical imaging 1030 of the patient’s foot. The bone model 404 is configured to include a deformity (e.g., hallux valgus) of the first metatarsal of the patient's foot. In one embodiment, the bone model 404 of a first metatarsal and a medial cuneiform of a patient's foot may be generated first because the bone model 404 may be used for specific angles and/or orientations of osteotomies in one, two or three planes of the foot to provide a desired level of correction. Bones of the bone model 404 can be repositioned, reoriented, and/or virtually resected or cut to make a correction to the bones of the bone model 404. This change and/or repositioning and virtual cutting can be used as a reference to define aspects or features of the patient-specific device 1090. 297 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The navigation module 1070 may navigate the workflow together with a user to generate a resection guide model 1072 that includes a proximal resection feature (e.g., cut guide, cut channel) configured to enable an osteotomy of the medial cuneiform and a distal resection feature (e.g., cut guide, cut channel) configured to enable an osteotomy of the first metatarsal. Advantageously, the resected medial cuneiform and first metatarsal can be fuses by a surgeon to remediate a condition of the patient’s foot. 298 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The fabrication module 1080 fabricates the resection guide 1090 from the resection guide model 1072. Alternatively, or in addition, the fabrication module 1080 may provide instructions for a manufacturing tool to fabricate the resection guide model 1072. The fabrication module 1080 can also generate a preoperative plan 1092 and/or complementary devices 1094 for use in a surgical procedure to address a hallux valgus condition. 299 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Referring now to FIG. 11, the prescription 1100 can provide a convenient tool for defining and/or initiating a set of work instructions 1040. FIG. 11 illustrates one representative example of a prescription 1100. The prescription 1100 may be specifically configured for generating a patient-specific device 1090. 300 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 Those of skill in the art appreciate that the prescription 1100 may take a variety of forms and/or formats, each of which is within the scope of the present disclosure. The prescription 1100 may be available in printed paper format, in a digital format, in the form of a form presented on a webpage, integrated into a form or series of questions of a desktop or mobile device software application, or the like. In one embodiment, the prescription 1100 may be a fillable pdf file. 301 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The prescription 1100 can include instructions to a surgeon for a procedure and/or for completing the prescription 1100. The prescription 1100 can include specific instructions, requirements, considerations, preferences, or the like from a surgeon regarding the desired outputs of the system 1000. In a prescription 1100, a surgeon can indicate what angles and/or anatomical data 412 is desired and/or required. The prescription 1100 can indicate a type of patient-specific device 1090 (e.g., medial or dorsal). The prescription 1100 can indicate a material for use in fabrication of the patient-specific device 1090. 302 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In the illustrated example embodiment, the prescription 1100 includes instructions 1102 for a surgeon in completing the prescription 1100. The prescription 1100 includes contact information 1104 for the surgeon. The prescription 1100 includes patient information 1106 that identifies the patient. The prescription 1100 includes procedure details 1108 that identify the foot involved, the status of collecting the medical imaging 1030, when the procedure is to be done, the medical facility for the procedure, and the like. The prescription 1100 includes patient-specific device and/or implant hardware details 1110 that may identify fixation hardware by name, model, type, brand and/or vendor and/or may include a style or type of patient-specific device 1090 desired (e.g., standard (generally placed between medial side of metatarsal phalangeal (“MTP”) joint and dorsal side of MTP joint), dorsal (generally placed on dorsal side of MTP joint), sizes for the patient-specific device 1090, or whether to defer those preferences to a vendor generating the patient-specific device 1090. The prescription 1100 may also include a signature block 1112 for collecting a surgeon’s signature to authorize the prescription and production of the patient-specific device 1090. The signature may be a manual signature or a digital / electronic signature. 303 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 12 illustrates an exemplary workflow 1050 for providing a patient-specific device 1090, according to one embodiment. In the illustrated embodiment, the workflow 1050 includes a sequence of steps 1202 that are to be completed in numerical order starting from step 1 and proceeding to the last step, step 24, in this example. Each step 1202 may include a corresponding description 1204. The description1204 may provide a brief indication of what the step 1202 accomplishes. 304 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 In certain embodiments, the system 1000 may present the sequence of steps 1202 to a user 1002 by way of a user interface. The system 1000 may also present the descriptions 1204 to the user 1002 in the user interface. 305 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 FIG. 13A illustrates an exemplary user interface 1300 for one step of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. The user interface 1300 may be one implementation of an I/O interface 910. The user interface 1300 may be a user interface developed specifically for use with the system 1000. Alternatively, or in addition, the user interface 1300 may be a user interface for a modeling computer program product and the patient-specific device design apparatus 450 may comprise an add-in or plugin that operates with the modeling computer program product. Examples of a suitable modeling computer program product include Solidworks, AutoCAD, and the like. 306 Added by DJM Jan 2024 1/6/24, 10:05 PM
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Delete 		PER-17 The user interface 1300 may include one or more control panes 1302, a canvas 1304, and a workflow pane 1306. The one or more control panes 1302 include a set of buttons, icons, text information, menu items, and/or other controls to enable a user 1002 to access, modify, store, update, retrieve and/or work with one or more models. Using controls in the one or more control panes 1302 a user can load a model, store a model, change model, delete a model, and/or initiate fabrication of a physical device based on the model. 307 Added by DJM Jan 2024 1/6/24, 10:05 PM

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