Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-20	In certain embodiments, a navigation guide 900 may include a registration key 938. The registration key 938 serves to further guide a surgeon to position the navigation guide 900 in a desired location with respect to anatomy of a patient. In certain embodiments, the registration key 938 may include one or more structures of the inferior side 918 that extend down into, or on, one or more of the adjacent joints and/or between the bones. The registration key 938 facilitates a desired alignment and placement of a navigation guide 900 on one or more joints and/or between bones. In one embodiment, the registration key 938 includes a protrusion that engages an opening between two bones of a joint. The registration key 938 may be on an inferior side 918 of the body 906. The registration key 938 can be formed by a variety of structures, including recesses, planar parts of an inferior side 918, angled parts of an inferior side 918, one or more projections added to an inferior side 918, openings in guide features, and the like.	239	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Referring to FIGs. 9A and 9B, the navigation guide 900 includes a longitudinal axis 940 and a coupler 942 between the proximal end 902 and the distal end 904. The coupler 942 is configured to hold or keep the proximal end 902 and the distal end 904 together until a user operates the coupler 942 to separate the proximal end 902 and the distal end 904. Thus, the coupler 942 can temporarily hold the proximal end 902 and the distal end 904 and also release the proximal end 902 and the distal end 904 when needed. Those of skill in the art will appreciate that the coupler 942 can be implemented in a variety of ways using a variety of structures. In the illustrated embodiment, the coupler 942 implemented using a threaded shaft with a head and a driver and a set of holes in the body 906. At least one of the holes of the set of holes has internal threads configured to engage the external threads of the shaft.	240	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	As explained herein, the present disclosure enables fabrication of patient-specific instrumentation. FIGS. 9A-9C illustrate a patient-specific navigation guide 900 configured to guide a surgeon for an arthrodesis procedure on a tarsometatarsal (“TMT”) joint of a patient. Specifically, the navigation guide 900 may be configured with a body 906 that spans a TMT joint between a metatarsal bone (e.g., a first metatarsal 208) and a cuneiform (e.g., a medial cuneiform 202). Accordingly, the inferior side 918 is configured to interface with the cuneiform bone and the metatarsal bone of the patient. In particular, the bone engagement surface 922 and/or bone engagement opening 936 are configured to interface with surfaces the cuneiform and metatarsal (e.g., a dorsal surface of each bone). In the illustrated embodiment, the reference feature is the set of proximal guide pins 928 deployed in the cuneiform and the set of distal guide pins 930 deployed in the metatarsal.	241	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The reference feature can serve as a guide to a surgeon for a number of steps in a surgical procedure. In one embodiment, the reference feature includes a first reference feature and second reference feature. The first reference feature may include the set of proximal guide pins 928 deployed in a bone such as a cuneiform and the second reference feature may include the set of distal guide pins 930 deployed in a bone such as a metatarsal. Having two or more reference features can be advantageous because if a condition of a patient prevents deployment of one reference feature or the other, the second reference feature can serve as a backup. Furthermore, where a surgical procedure involves more than one bone, one reference feature can be established in a first bone and a second reference feature can be established in a second bone. Further, different stages of a surgical procedure may use one reference feature and not the other. Thus, having two reference features can facilitate certain stages of the surgical procedure.	242	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Advantageously, providing two or more reference features can facilitate stages of a surgical procedure such as when bone fragments are to be aligned and/or reduced and/or when resections or osteotomies are to be performed on different bones of the patient. In one embodiment, a first reference feature may include a proximal alignment feature 944 and a second reference feature may include a distal alignment feature 946.	243	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The proximal alignment feature 944 and the distal alignment feature 946 may be engaged in later steps of a surgical procedure by an instrument such as a positioning guide 880 to translate and/or rotate the one or more bones into a desired final position for reduction.	244	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Typically, in an osteotomy for a condition such as a hallux valgus, it is desirable to rotate the first metatarsal 208 to address the condition. The first metatarsal 208 may be rotated for example to re-position distal plantar sesamoids from a lateral orientation to a more plantar orientation. Research has shown that performing such re-orientation mitigates recurrence of a hallux valgus condition. In such situations, the distal alignment feature 946 may serve as a reference and/or anchor for a positioning guide 880 that may cause the first metatarsal 208 to rotate and/or translate as the positioning guide 880 is deployed.	245	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

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