Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-16	FIGs 11E and 11F illustrate an embodiment of the osteotomy system 1000 in which the first coupler 1118, second coupler 1148, first height 1120, and second height 1122 are each configured to define a trajectory 1124 for the cutter guide 1010 relative to one or more bones that receive the osteotomy. The trajectory 1124 for the cutter guide 1010 defines the trajectory of a cutting tool used with the cutter guide 1010 to resect or dissect one or more bones.	274	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In the illustrated embodiment, the first coupler 1118, second coupler 1148, first height 1120, and second height 1122 are configured such that the trajectory 1124 is parallel to the longitudinal axes of the fasteners 1012. Those of skill in the art will appreciate that one or more of the first height 1120 and/or second height 1122 and/or how the first coupler 1118 and/or second coupler 1148 engage with the cutter guide 1010 can be changed to provide a different angle for the trajectory 1124 relative to the first bone attachment feature 1006 and/or second bone attachment feature 1008 and/or to the longitudinal axes of the fasteners 1012. Said another way, the first coupler 118, second coupler 1148, first height 120, and second height 122 can be related and/or correlated to define the trajectory 1124 for the cutter guide 1010 towards one or more bones.	275	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Alternatively, or in addition, the angle of the opening 1116 through the body 1102 of the first bone attachment feature 1006 and/or the angle of the opening 1146 through the body 1132 of the second bone attachment feature 1008 can be used to define a trajectory 1124 for the cutter guide 1010. The angle of the openings 1116, 1146 alone or together with one or more of the first coupler 1118, second coupler 1148, first height 1120, and/or second height 1122 can be used separately and/or together in different combinations to define the trajectory 1124. Each of these permutations and/or combinations are within the scope of the present disclosure. In the illustrated embodiment, the angle of the opening 1116 through the body 1102 of the first bone attachment feature 1006 and/or the angle of the opening 1146 through the body 1132 of the second bone attachment feature 1008 are each perpendicular to the pivot axis 1014.	276	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	FIG. 11E illustrates that the first coupler 1118 engages the cutter guide 1010 at a first angle 1150 that is perpendicular to the distal side 1114 of the first bone attachment feature 1006 and that the second coupler 1148 engages the cutter guide 1010 at a second angle 1152 that is perpendicular to the proximal side 1142 of the second bone attachment feature 1008. FIG. 11E illustrates a longitudinal axis 1154 that represents the longitudinal axis of a bone that is to be resected (e.g., first metatarsal 208).	277	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In one embodiment, the determination module 410 may use advanced computer analysis system such as image segmentation to determine the anatomic data. The determination module 410 may determine anatomic data from one or more sources of medical imaging data, images, files, or the like. The determination module 410 may perform the image segmentation using 3D modeling systems and/or artificial intelligence (AI) segmentation tools. In certain embodiments, the determination module 410 is configured to identify and classify portions of bone based on a condition of the bone, based on the bone condition. Such classifications may include identifying bone stability, bone density, bone structure, bone deformity, bone structure, bone structure integrity, and the like. Accordingly, the determination module 410 may identify portions or sections or one or more bones based on a quality metric for the bone. Advantageously, that determination module 410 can identify high quality bone having a viable structure, integrity, and/or density versus lower quality bone having a nonviable structure, integrity, and/or density and a plurality of bone quality levels in between.	183	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Accordingly, the determination module 410 can guide a surgeon to determine which areas of one or more bones of a patient are within a “soft tissue envelope” (bone of undesirable quality) as that bone relates to a particular deformity or pathology. Identifying the quality of one or more bones of the patient can aid a surgeon in determining what type of correction or adjustment is needed. For example, an ulceration that occurs due to a boney deformity can be mapped using the determination module 410 in a way that a correction can be performed to correct the deformity and reduce pressure to an area and address the structures that were causing the pressure ulceration/ skin breakdown.	184	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In addition, the determination module 410 and/or another component of the apparatus 402 can be used to perform anatomic mapping which may include advanced medical imaging, such as the use of CT scan, ultrasound, MRI, and bone density scans can be combined to effectively create an anatomic map that determines the structural integrity of the underlying bone.	185	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Identifying the structural integrity of the underlying bone can help in determining where bone resections can be performed to preserve the densest bone in relation to conditions such as Charcot neuropathic, arthropathy where lesser dense bone can fail and collapse. It is well documented in the literature that failure to address and remove such lesser dense bone can ultimately lead to failure of a reconstruction and associated hardware.	186	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	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.	187	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The location module 420 determines or identifies one or more recommended locations and/or trajectory angles for deployment of an instrument, graft, 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.	188	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The provision module 430 is configured to provide a preliminary guide model 438. The preliminary guide model 438 may serve as a model for an instrument to be used in a surgical procedure. The provision module 430 may use a variety of methods to provide the preliminary guide model. In one embodiment, the provision module 430 may generate a preliminary guide model. In the same, or an alternative embodiment, the provision module 430 may select a template guide model for a surgical 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 guide model from a set of template guide models (e.g., a library, set, or repository of template guide models).	189	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The registration module 440 registers the preliminary guide 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 guide model can be used with the bone model 404.	190	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The design module 450 designs a patient-specific guide (or patient-specific guide model) based on the preliminary guide 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 guide (or patient-specific guide model) is.	191	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The manufacturing module 460 may manufacture a patient-specific guide 406 using the preliminary guide model. The manufacturing module 460 may use a patient-specific guide model generated from the preliminary guide model. The manufacturing module 460 may provide the patient-specific guide model to one or more manufacturing tools and/or fabrication tool. The patient-specific guide 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 guide such as types and/or thicknesses of materials, dimensions, and the like before the manufacturing module 460 provides the patient-specific guide model to a manufacturing tool.	192	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	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.	193	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Figure 5 illustrates an exemplary location module 420 configured to determine a location and/or trajectory for an instrument (patient-specific or patient-matched), according to one embodiment. The location module 420 may factor in one or more landmarks on one or more surfaces of one or more bones of a patient of the bone model 404. The location module 420 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the determination of the location is. The user may provide instructions to the location module 420 to facilitate automatic or partially automated determination of one or more locations.	194	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The location module 420 may include a location module 422. The location module 422 may be configured for automated determination of a location for use of an instrument. For example, in one embodiment, the location module 422 includes an artificial intelligence or machine learning module 424. 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 identifying bones in the bone model 404, determining surfaces and/or sides of one or more bones, determining landmarks (both natural and/or abnormalities), determining axes of a bone, such as a longitudinal axis and/or a horizontal axis of a bone based on anatomic data 412 and/or a bone model 404. In another embodiment, the location module 420 may receive patient imaging data, a bone model, a CAD model or the like and use these inputs to determine a location and/or trajectory in relation to one or more bones of a patient.	195	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	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 bones and a large data set of anatomic data 412 for bones with abnormalities and/or landmarks in which the abnormalities and/or landmarks have 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 one or more locations (e.g., a recommended location and one or more alternative locations for the guide.	196	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	The location module 422 may interact with a patient specific feature module 426. The patient specific feature module 426 may take one or more locations provided by the location module 422 and the bone model 404 and/or anatomic data 412 and determine suitable patient specific features. In certain embodiments, the patient specific features provided by the patient specific feature module 426 may include a number of resection features, an angle or trajectory for one or more resection features, a number, size, and/or position of bone attachment features, a number, size, or position of alignment guides or a combination of these. In certain embodiments, the patient specific feature module 426 may focus on resection features.	197	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	As with the location module 420, the patient specific feature module 426 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the determination of the trajectory is. The user may provide instructions to the patient specific feature module 426 to facilitate automatic or partially automated determination of one or more trajectories. In one embodiment, the location module 422 includes an artificial intelligence or machine learning module 424 that facilitates determining one or more trajectories.	198	Added by DJM Jan 2024	1/3/24, 4:26 AM

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