Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-20	Those of skill in the art will appreciate that the resection guides 820 of the present disclosure can be designed and/or fabricated with a variety of features and/or aspects. For example, in one embodiment, the one or more openings 1106 and/or one or more openings 1116 may extend through the body 1102 and/or body 1112 at a right angle to a surface of the body 1102 and/or body 1112. Alternatively, or in addition, the resection feature 1104 and/or resection feature 1114 may extend through the body 1102 and/or body 1112 at a right angle to a surface of the body 1102 and/or body 1112. Or, one of the proximal resection guide 820a and the distal resection guide 820b may include openings perpendicular to a surface of the body and the other may have openings that are angled at a non-perpendicular angle relative to the surface of the body. Or, one of the proximal resection guide 820a and the distal resection guide 820b may include a resection feature perpendicular to a surface of the body and the other may have a resection feature that is angled at a non-perpendicular angle relative to the surface of the body. Those of skill in the art will appreciate that any permutation of angled orientations between the openings and the a resection features of the proximal resection guide 820a and/or the distal resection guide 820b can be used since these guides are fabricated to satisfy a preoperative plan for a correction for the patient.	283	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The resection guide provides an accurate and precise guide for performing one or more osteotomies on a bone of a patient. In particular, the resection guide is specifically designed and engineered for one or more osteotomies at or near an end of a metatarsal bone and/or a cuneiform bone of the patient. Advantageously, the variability and flexibility provided for the design of the resection guide enable an innumerable set of resection guides that can be fabricated.	284	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	154	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The location module 420 determines or identifies one or more recommended locations and/or trajectory angles for deployment of an instrument 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.	155	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The provision module 430 is configured to provide a preliminary instrument model 438. The provision module 430 may use a variety of methods to provide the preliminary instrument model. In one embodiment, the provision module 430 may generate a preliminary instrument model. In the same, or an alternative embodiment, the provision module 430 may select a template instrument model for a tendon (or tendon substitute) deployment 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 instrument model for a minimally invasive surgical (MIS) bunion correction procedure configured to enable locating the position and/or providing the trajectory for the fixation deployment. In one embodiment, the provision module 430 may select a template instrument model from a set of template instrument models (e.g., a library, set, or repository of template instrument models).	156	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The registration module 440 registers the preliminary instrument 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 instrument model can be used with the bone model 404.	157	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The design module 450 designs a patient-specific instrument (or patient-specific instrument model) based on the preliminary instrument 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 instrument (or patient-specific instrument model) is.	158	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	159	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	160	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	161	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The fixator selector 502 enables a user to determine which fixator(s) to use for a MIS bunion correction 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 MIS bunion correction 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.	162	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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 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).	163	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	164	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	165	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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 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.	166	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	167	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	168	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	169	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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.	170	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	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 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.	171	Added by DJM Jan 2024	1/6/24, 10:06 PM

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