Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-8 PROV	Like the cuneiform apposition portion 342 and the metatarsus apposition portion 344 of the cutting guide 300, generation of the contours of the cuneiform apposition portion 742 and the metatarsus apposition portion 744 may be performed relative easily in various CAD programs through surface copy operations, Boolean operations, and/or the like.	92	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 22 illustrates an exemplary design module 1850 configured to design a patient specific cutting guide model, according to one embodiment. The design module 1850 may accept a selected template cutting guide model 1834 and generate a patient specific cutting guide model 2202. In one embodiment, the design module 1850 includes a contour module 2204, an application module 2206, and/or an optional modification module 2208.	177	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The design module 1850 designs a patient specific cutting guide (or patient specific cutting guide model) based on the selected template cutting guide model. The design operation of the design module 1850 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the designing of the patient specific cutting guide (or patient specific cutting guide model) is.	163	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The manufacturing module 1860 may manufacture a patient specific cutting guide 1806 using the selected template cutting guide model 1834. The manufacturing module 1860 may use a patient specific cutting guide model generated from the selected template cutting guide model 1834. The manufacturing module 1860 may provide the patient specific cutting guide model to one or more manufacturing tools and/or fabrication tool. The patient specific cutting 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 cutting guide such as types and/or thicknesses of materials, dimensions, and the like before the manufacturing module 1860 provides the patient specific cutting guide model to a manufacturing tool.	164	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 19 illustrates an exemplary deformity module 1820 configured to determine a deformity, according to one embodiment. The deformity module 1820 may detect one or more deformities and/or anomalies of a patient’s anatomy by analyzing anatomic data 1812 and other inputs, such as a certain type or class of deformities to search for.	165	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The deformity module 1820 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the detection of the deformity is. The user may provide instructions to the deformity module 1820 to facilitate automatic or partially automated detection or determination of one or more deformities.	166	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The deformity module 1820 may include a deformity detection module 1822. The deformity detection module 1822 may be configured for automated determination of a deformity. For example, in one embodiment, the deformity detection module 1822 includes an artificial intelligence or machine learning module 1824. The artificial intelligence or machine learning module 1824 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 1812. In another embodiment, the deformity module 1820 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.	167	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, the artificial intelligence or machine learning module 1824 may be trained using a large data set of anatomic data 1812 for healthy non-deformed bones and a large data set of anatomic data 1812 for deformed bones in which the deformity has been previously identified and labeled in the dataset. The artificial intelligence or machine learning module 1824 may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module 1824 accepts the anatomic data 1812 for a particular patient, the artificial intelligence or machine learning module 1824 is able to determine what deformity 1826 exists in the patient’s bones, when such a deformity 1826 exists.	168	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figures 20A and 20B illustrates one example of a method for determining a deformity and a correction for the deformity, according to one embodiment. The deformity module 1820 may use a particular method for determining whether or not two or more bones have a deformity 1826. The deformity module 1820 may use one or more advanced computing techniques for determining the deformity 1826.	169	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Referring now to FIG. 20A, in one embodiment, the deformity module 1820 starts by identifying a center longitudinal axis 1828a, 1828b (Fig. 20A shows two of the plurality of axes for clarity) for each bone in the bone model 1804. For example, the deformity module 1820 may identify the center longitudinal axis 1828a for a first metatarsal and the center longitudinal axis 1828b for the second metatarsal.	170	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, the deformity module 1820 may identify a reference axis 1829 perpendicular with one of the center longitudinal axes 1828a,b, such as center longitudinal axis 1828b. The reference axis 1829 may be at or near a joint between bones of the bone model 1804. The deformity module 1820 may determine that a deformity 1826 exists if the center longitudinal axes 1828a,b are not parallel or are not parallel when measured with a predefined margin for error. FIG. 20A illustrates a bone model 1804 with a deformity 1826. The deformity 1826 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 1826 is determined, the deformity module 1820 or apparatus 1802 may determine what steps, procedures, or instrumentation can be used to correct the deformity 1826. The deformity module 1820 may use a name, label, tag, or other identifier for a particular deformity 1826.	171	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	FIG. 20B illustrates the bone model 1804 of FIG. 20A after a corrective procedure and/or application of corrective implants may be performed. The center longitudinal axes 1828a,b are parallel, or sufficiently parallel, such that the deformity 1826 is not a problem for a patient.	172	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 21 illustrates an exemplary selection module 1830 configured to select a template cutting guide model, according to one embodiment. The selection module 1830 may accept anatomic data 1812 and a designation, identifier, label, or name of a deformity 1826. In the illustrated embodiment, the selection module 1830 may select a template cutting guide model 1832 automatically from a set of template cutting guide models 1832 stored in a repository 2102. The selection module 1830 may incorporate a variety of parameters in order to determine or select a template cutting guide model 1832. For example, in addition to the anatomic data 1812, the selection module 1830 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.	173	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The repository 2102 may include any number of, and/or a variety of template cutting guide models 1832. The template cutting guide models 1832 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 1832 may differ from each other in what degree of deformity correction the template cutting guide model 1832 is designed to provide. In addition, the template cutting guide models 1832 may be distinguished based how one or more features of the template cutting guide model 1832 are positioned, arranged, and/or configured relative to each other. For example in certain template cutting guide models 1832, the number, position, and/or configuration of alignment features 1260a,b and/or bone attachment features (e.g., holes 1240) may vary based on needs or preferences of patients, the nature of the deformity, and/or surgeon preferences.	174	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In certain embodiments, the template cutting guide models 1832 may vary in how the slots 1350,1352 (e.g., guide features, See FIG. 13) 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 1832. For example in one template cutting guide model 1832 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 1832 the slot 1352 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.	175	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The selection module 1830 may be configured to automatically select a template cutting guide model 1832 and/or provide an automatic template cutting guide model 1832 recommendation that can be changed by a user such as a surgeon. For example, in one embodiment, the selection module 1830 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 1832 based on anatomic data 1812 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 1812 for suitable template cutting guide models 1832 identified and labeled in the dataset by professionals for use to treat a particular deformity 1826. 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 1832. The template cutting guide model 1832 selected by the selection module 1830 is referred to as a selected template cutting guide model 1834.	176	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The registration module 1840 registers the selected template cutting guide model 1834 with one or more bones or other anatomical structures of the bone model 1804. As explained above, registration is a process of combining medical imaging data, patient imaging data, and/or one or more models such that the selected template cutting guide model 1834 can be used with the bone model 1804.	162	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Referring now to FIGS. 3A-3D, and 22, the design module 1850 may modify the selected template cutting guide model 1834 such that the bone-facing and/or bone-contacting surfaces of the selected template cutting guide model 1834 match a contour of the surfaces and/or joint of bones of a joint that is to be resected using the selected template cutting guide model 1834.	178	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The contour module 2204 may determine a contour of the bones that will contact the selected template cutting guide model 1834. The contour module 2204 may use a bone model 1804 and/or anatomic data 1812 to determine the contour. For example, the contour module 2204 may determine the shapes of the first cuneiform 210 and/or the first metatarsus 230.	179	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The application module 2206 may apply the contour to the selected template cutting guide model 1834 to custom contour a bone apposition side 330 of the selected template cutting guide model 1834 to match the shapes of the first cuneiform 210 and/or the first metatarsus 230. Applying the contour to the selected template cutting guide model 1834 may convert the selected template cutting guide model 1834 to a patient specific cutting guide model 2202.	180	Added by DJM 7 2021	7/2/21, 12:00 AM

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