Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-12	The deformity module 1220 may include a deformity detection module 1222. The deformity detection module 1222 may be configured for automated determination of a deformity. For example, in one embodiment, the deformity detection module 1222 includes an artificial intelligence or machine learning module 1224. The artificial intelligence or machine learning module 1224 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 1212. In another embodiment, the deformity module 1220 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.	235	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one embodiment, the artificial intelligence or machine learning module 1224 may be trained using a large data set of anatomic data 1212 for healthy non-deformed bones and a large data set of anatomic data 1212 for deformed bones in which the deformity has been previously identified and labeled in the dataset. The artificial intelligence or machine learning module 1224 may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module 1224 accepts the anatomic data 1212 for a particular patient, the artificial intelligence or machine learning module 1224 is able to determine what deformity 1226 exists in the patient’s bones, when such a deformity 1226 exists.	236	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 14A and 14B illustrates one example of a method for determining a deformity and a correction for the deformity, according to one embodiment. The deformity module 1220 may use a particular method for determining whether or not two or more bones have a deformity 1226. The deformity module 1220 may use one or more advanced computing techniques for determining the deformity 1226.	237	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Referring now to Figure 14A, in one embodiment, the deformity module 1220 starts by identifying a center longitudinal axis 1228a, 1228b (Fig. 14A shows two of the plurality of axes for clarity) for each bone in the bone model 1204. For example, the deformity module 1220 may identify the center longitudinal axis 1228a for a first metatarsal and the center longitudinal axis 1228b for the second metatarsal.	238	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Next, the deformity module 1220 may identify a reference axis 1229 perpendicular with one of the center longitudinal axes 1228a,b, such as center longitudinal axis 1228b. The reference axis 1229 may be at or near a joint between bones of the bone model 1204. The deformity module 1220 may determine that a deformity 1226 exists if the center longitudinal axes 1228a,b are not parallel or are not parallel when measured with a predefined margin for error. Figure 13A illustrates a bone model 1204 with a deformity 1226. The deformity 1226 is that the first metatarsal is not parallel or not sufficiently parallel to the second metatarsal at the joint between the first metatarsal and the medial cuneiform bones. Once the deformity 1226 is determined, the deformity module 1220 or apparatus 1202 may determine what steps, procedures, or instrumentation can be used to correct the deformity 1226. The deformity module 1220 may use a name, label, tag, or other identifier for a particular deformity 1226.	239	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 14B illustrates the bone model 1204 of Figure 14A after a corrective procedure and/or application of corrective implants may be performed. The center longitudinal axes 1228a,b are parallel, or sufficiently parallel, such that the deformity 1226 is not a problem for a patient.	240	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 15 illustrates an exemplary provision module 1230 configured to provide a preliminary cutting guide model, according to one embodiment. The provision module 1230 may accept anatomic data 1212 and a designation, identifier, label, or name of a deformity 1226. In the illustrated embodiment, the provision module 1230 may generate a preliminary cutting guide model 1238 (e.g., generate from ‘scratch’) or the provision module 1230 may select a template cutting guide model 1236 automatically from a set of template cutting guide models 1236 stored in a repository 1502. The provision module 1230 may incorporate a variety of parameters in order to provision, generate, determine, or select a template cutting guide model 1236. For example, in addition to the anatomic data 1212, the provision module 1230 may include patient imaging data, deformity parameters for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used, patient preferences, and/or surgeon input parameters.	241	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one embodiment, the provision module 1230 may include a generator 1232 and/or a selection module 1234. In one embodiment, the generator 1232 is configured to generate a preliminary cutting guide model 1238. In certain embodiments, the generator 1232 may generate or create the preliminary cutting guide model based on anatomic data and/or a bone model or a combination of these and no other inputs. (e.g. no model or predesigned structure, template, or prototype). Alternatively, or in addition, the generator 1232 may generate or create the preliminary cutting guide model using a standard set of features or components that can be combined to form the preliminary cutting guide model. The generated preliminary cutting guide model may subsequently be modified or revised by an automated process, and/or manual process, to generate the preliminary cutting guide model used in this disclosure.	242	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The selection module 1234 may be configured to select a template cutting guide model 1236 for an osteotomy procedure configured to correct the deformity identified by the deformity module 1220. In one embodiment, the provision module 1230 may select a template cutting guide model 1236 from a set of template cutting guide models 1236 (e.g., a library, set, or repository of template cutting guide models 1236). In one embodiment, the template cutting guide model 1236 may include digital models. In another embodiment, the template cutting guide model 1236 may include physical models. In such an embodiment, the repository 1502 may be a warehouse or other inventory repository. Where the template cutting guide model 1236 are physical models, the systems, modules, and methods of this disclosure can be used and the physical model may be milled or machined (e.g., a CNC machine) to form a patient specific cutting guide that conforms to the bone surfaces of the patient.	243	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Selection of a suitable template cutting guide model 1236 may be completely automated and/or may be partially automated and/or may depend on confirmation from a user before a generated preliminary cutting guide model or a proposed template cutting guide model 1236 becomes the preliminary cutting guide model 1238. In another embodiment, the selection module 1234 may facilitate a manual selection by a user of a template cutting guide model 1236 that would become the preliminary cutting guide model 1238. The selection module 1234 may use the anatomic data 1212 or the bone model 1204 or a combination of these to select a suitable template cutting guide model that would become the preliminary cutting guide model 1238.	244	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In another embodiment, the generator 1232 may facilitate revisions or edits by a user of a generated cutting guide model that will become the preliminary cutting guide model 1238. The selection module 1234 may use the anatomic data 1212 or the bone model 1204 or a combination of these to select a suitable template cutting guide model that would become the preliminary cutting guide model 1238.	245	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The repository 1502 may include any number of, and/or a variety of template cutting guide models 1236. The template cutting guide models 1236 may be distinguished based on a gender or age of the patient, which joint of a midfoot, hind foot, or ankle will be cut, which material will be used for the template cutting guide, and the like. The template cutting guide model 1236 may differ from each other in what degree of deformity correction the template cutting guide model 1236 is designed to provide. In addition, the template cutting guide models 1236 may be distinguished based how one or more features of the template cutting guide model 1236 are positioned, arranged, and/or configured relative to each other. For example in certain template cutting guide models 1236, the number, position, and/or configuration of alignment features and/or bone attachment features (e.g., holes) may vary based on needs or preferences of patients, the nature of the deformity, and/or surgeon preferences.	246	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In certain embodiments, the template cutting guide models 1236 may vary in how the slots (e.g., resection features, See Figure 6) for the cuts are positioned, angled, and oriented relative to each other and/or to a longitudinal axis of respective bones at a joint for use with the template cutting guide model 1236. For example in one template cutting guide model 1236 the slot 1352 for a resection of a metatarsal bone may be perpendicular to a longitudinal axis of the metatarsal bone and the slot 1350 may be angled relative to a longitudinal axis of the cuneiform or cuboid bone such that once the two bones are brought together the deformity is corrected. Alternatively, in another template cutting guide model 1236 the slot for a resection of a metatarsal bone may be angled relative to a longitudinal axis of the metatarsal bone and the slot 1350 may be perpendicular to a longitudinal axis of the cuneiform or cuboid bone such that once the two bones are brought together the deformity is corrected.	247	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The selection module 1234 may be configured to automatically select a template cutting guide model 1236 and/or provide an automatic template cutting guide model 1236 recommendation that can be changed by a user, such as a surgeon. For example, in one embodiment, the provision module 1230 and/or selection module 1234 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 a template cutting guide model 1236 based on anatomic data 1212 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 1212 for suitable template cutting guide models 1236 identified and labeled in the dataset by professionals for use to treat a particular deformity 1226. The artificial intelligence or machine learning module may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module is able to select a suitable template cutting guide model 1236. The template cutting guide model 1236 selected by the selection module 1234 can become the preliminary cutting guide model 1238.	248	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 16 illustrates an exemplary design module 1250 configured to design a patient specific cutting guide model, according to one embodiment. The design module 1250 may accept a preliminary cutting guide model 1238 and generate a patient specific cutting guide model 1602. In one embodiment, the design module 1250 includes a contour module 1604, an application module 1606, and/or an optional modification module 1608.	249	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Referring now to FIG 16, the design module 1250 may modify the preliminary cutting guide model 1238 such that the bone-facing and/or bone-contacting surfaces of the preliminary cutting guide model 1238 match a contour of the surfaces and/or joint of bones of a joint that is to be resected using the preliminary cutting guide model 1238.	250	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The contour module 1604 may determine a contour of the bones that will contact the preliminary cutting guide model 1238. The contour module 1604 may use a bone model 1204 and/or anatomic data 1212 to determine the contour. For example, the contour module 1604 may determine the shapes of the medial cuneiform 202 and/or the first metatarsal 208.	251	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The application module 1606 may apply the contour to the provided preliminary cutting guide model 1238 to custom contour a bone apposition surface of the preliminary cutting guide model 1238 to match the shapes of the medial cuneiform 202 and/or the first metatarsal 208. Applying the contour to the preliminary cutting guide model 1238 may convert the preliminary cutting guide model 1238 to a patient specific cutting guide model 1602.	252	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Generation of the contours of the cuneiform apposition portion 326 and the metatarsal apposition portion 328 of the preliminary cutting guide model 1238 may be performed relative easily in various CAD programs. In some embodiments, the shapes of the corresponding surfaces of the medial cuneiform 202 and the first metatarsal 208 may be obtained directly from the bone model 1204, anatomic data 1212, CAD models and/or CT scan data, and simply copied onto the preliminary cutting guide model 1238. Various operations may be used to copy surfaces from one object to another. Additionally or alternatively, various Boolean operations, such as a Boolean subtraction operation, may be used to remove material from a model for the body 310 of the preliminary cutting guide model 1238 with a shape that matches the surfaces of the medial cuneiform 202 and the first metatarsal 208.	253	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In certain embodiments, the design module 1250 may include an optional module, such as a modification module 1608. The modification module 1608 may enable a user such as a technician or surgeon to make additional modifications to the design and configuration of the preliminary cutting guide model 1238. In one embodiment, the user can change any of the features, angles, configurations, or parameters of the preliminary cutting guide model 1238. For example, a surgeon may be aware of other concerns or anatomic deformities of a patient, for example on an opposite foot or in connection with a hip or other orthopedic joint which motivate the surgeon to adjust an angle of one of more resection features of the preliminary cutting guide model 1238.	254	Added by DJM Jan 2024	1/6/24, 10:03 PM

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