Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	The manufacturing module 460 may manufacture a patient-specific instrument 406 using the preliminary instrument model. The manufacturing module 460 may use a patient-specific instrument model generated from the preliminary instrument model. The manufacturing module 460 may provide the patient-specific instrument model to one or more manufacturing tools and/or fabrication tool (e.g., additive and/or subtractive). The patient-specific instrument 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 instrument such as types and/or thicknesses of materials, dimensions, and the like before the manufacturing module 460 provides the patient-specific instrument model to a manufacturing tool.	216	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Effective connection of the guide to one or more bones can ensure that surgical steps are performed in desired locations and/or with desired orientations and mitigate undesired surgical outcomes.	217	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 5 illustrates an exemplary system 500 configured to generate one or more patient-specific instruments configured to correct a bone condition, according to one embodiment. The system 500 may include similar components or modules to those described in relation to FIG. 4. In addition, the system 500 may include a fixator selector 502 and/or an export module 504.	218	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The fixator selector 502 enables a user to determine which fixator(s) to use for a patient-specific osteotomy procedure planned for a patient. In one embodiment, the fixator selector 502 may recommend one or more fixators based on the bone model 404, the location, the trajectory, or input from a user or a history of prior osteotomy procedures performed. The fixator selector 502 may select a fixator model from a set of predefined fixator models or select a physical fixator from a set of fixators. The fixators may include a plate and associated accessories such as screws, anchors, and the like.	219	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the fixator selector 502 includes an artificial intelligence or machine learning module. The artificial intelligence or machine learning module is configured to implement one or more of a variety of artificial intelligence modules (e.g., ANN, GAN, or the like) that may be trained for selecting fixator(s) based on anatomic data 412 and/or other input parameters. In one embodiment, the artificial intelligence or machine learning module may be trained using a large data set of anatomic data 412 for suitable fixator(s) identified and labeled in the dataset by professionals for use to treat a particular condition. The artificial intelligence or machine learning module may implement, or use, a neural network configured according to the training such that the artificial intelligence or machine learning module is able to select or recommend suitable fixator(s).	220	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The export module 504 is configured to enable exporting of a patient-specific instrument model 462 for a variety of purposes including, but not limited to, fabrication/manufacture of a patient-specific instrument 406 and/or fixator(s), generation of a preoperative plan, generation of a physical bone model matching the bone model 404, and the like. In one embodiment, the export module 504 is configured to export the bone model 404, anatomic data 412, a patient-specific instrument model 462, a preoperative plan 506, a fixator model 508, or the like. In this manner the custom instrumentation and/or procedural steps for a procedure (e.g., a graft harvesting procedure, minimally invasive surgical (MIS) procedure, or the like) can be used in other tools. The preoperative plan 506 may include a set of step by step instructions or recommendations for a surgeon or other staff in performing a procedure (e.g., a graft harvesting procedure, minimally invasive surgical (MIS) procedure, or the like). The preoperative plan 506 may include images and text instructions and may include identification of instrumentation to be used for different steps of the procedure (e.g., a graft harvesting procedure, minimally invasive surgical (MIS) procedure, or the like). The instrumentation may include the patient-specific instrument 406 and/or one or more fixators/fasteners. In one embodiment, the export module 504 may provide a fixator model which can be used to fabricate a fixator for the procedure.	221	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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
View Edit 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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