Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	TMC-PAT-4	In certain embodiments, the design tool 414 may be tools or models used by a user with the apparatus 402 to perform a step in a design and/or planning process for a surgical procedure and/or for fabrication of one or more patient-specific instruments 406. These design tools 414 may be configured to operate like a physical counterpart and may thus have similar, look, feel, behavior features, characteristics, and the like. Alternatively, or in addition, the design tools 414 may have features and/or functionality that differs from a physical counterpart and may be useful in a virtual environment.	201	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Alternatively, or in addition, the design tools 414 may not resemble a physical device and/or tool. Instead, the design tools 414 may include a set of computer executable code that implements a process and/or an algorithm to accomplish a particular feature and/or task for a user. For example, one or more of the bone models of a bone model 404 may include certain attributes, reference features, anatomical feature, anatomical landmark, and/or attributes that can be used to facilitate the design and/or planning process. Examples of these reference features may include an axis, a plane, a surface, a pivot point, a manipulation point, or the like.	202	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In one embodiment, rather than use a design tool 414, a user may access a feature or function of the apparatus 402 to perform a particular operation during the planning and design stages. For example, one feature may refer to one or more reference features to maintain a certain offset, orientation, position, or other characteristic of one bone model versus another bone model. This feature may be configured to maintain a particular relationship between two bone models, particularly where one bone model is manipulated using the user interface 408.	203	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	For example, in one embodiment, a user of the user interface 408 may activate a relationship feature that maintains a particular offset, orientation, and/or position of a bone model of a second metatarsal 210 with respect to a bone model of a first metatarsal 208. This relationship can be a relationship derived based on anatomic data, defined by a technician, defined by a process, or defined by a user. Such a relationship feature may be used in place of a design tool 414 such as a digital fulcrum design tool 414.	204	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The relationship feature may be activated by a user once the bone model of a second metatarsal 210 and the bone model of a first metatarsal 208 have a desired relationship to each other. The relationship feature may be configured to maintain the desired relationship (e.g., offset, orientation, etc.) even if a user manipulates one or the other of the bone model of a second metatarsal 210 and the bone model of a first metatarsal 208. In this manner, a relationship feature can be used by a user in a similar manner to how a design tool 414 such as a digital fulcrum design tool 414 could be used. Once a user makes final adjustments to positions and/or orientations of the bone model of a second metatarsal 210 and the bone model of a first metatarsal 208, the user may proceed with a design and/or planning process to complete the design and/or configuration of one or more instruments, one or more patient-specific instruments 406, one or more surgical technique, and the like.	205	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	206	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	207	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	208	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	209	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	210	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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).	211	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	212	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	213	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Referring now to FIGS. 3-5, certain methods, systems, and/or apparatuses are disclosed herein for preparing for, planning, outlining, and/or instrumenting, 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 systems, instrumentation, and/or implants and/or for preoperative rehearsal and/or instruction of a surgeon before the surgical procedure. 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.	214	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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 accurate and helpful, particularly for hard tissue such as bones and the surfaces of these bones.	215	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The fidelity and accuracy of soft tissue models is not as advanced as hard tissue models. Models soft tissue of a patient such as sinews, skin, tendons, ligaments, muscles, fat, and the like may be of limited help preoperatively. Thus, rehearsal of a surgical procedure, particularly one that includes translating and/or reorienting one or more bone fragments may have limited benefits. 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 may need 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.	216	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	However, the present disclosure can provide a very accurate representation because bone models of the bone model 404 can originate from medical imaging taken with soft tissue in place, the bone model 404 initially reflects bone orientation and/or relationships based on the current soft tissue arrangement. A surgeon, recognizing the role soft tissue may play during the surgical procedure, the surgeon may arrange for two or more preoperative plans and/or one or more patient-specific instruments to accommodate what is found during the surgical procedure.	217	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	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.	218	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	However, the utility and helpfulness of the models, methods, systems, and/or apparatuses of FIGS 3-5, may be 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.	219	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	"Bone fragment" refers to a part of a bone that is normally part of another bone of a patient. A bone fragment may be separate from another bone of a patient due to a deformity or trauma. In one aspect, the bone the bone fragment is normally connected or joined with is referred to as a parent bone.	123	Added by DJM Jan 2024	1/3/24, 4:24 AM

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