Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
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	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	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
View Edit Delete	PER-8 PROV	Generation of the contours of the cuneiform apposition portion 342 and the metatarsus apposition portion 344 of the selected template cutting guide model 1834 may be performed relative easily in various CAD programs. In some embodiments, the shapes of the corresponding surfaces of the first cuneiform 210 and the first metatarsus 230 may be obtained directly from the bone model 1804, anatomic data 1812, CAD models and/or CT scan data, and simply copied onto the selected template cutting guide model 1834. 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 selected template cutting guide model 1834 with a shape that matches the surfaces of the first cuneiform 210 and the first metatarsus 230.	181	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In certain embodiments, the design module 1850 may include an optional module, such as a modification module 2208. The modification module 2208 may enable a user such as a technician or surgeon to make additional modifications to the design and configuration of the selected template cutting guide model 1834. In one embodiment, the user can change any of the features, angles, configurations, or parameters of the selected template cutting guide model 1834. 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 guide features of the selected template cutting guide model 1834.	182	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Image registration is a process of correctly aligning images; Shape-Based Segmentation: Many methods parametrize a template shape for a given structure, often relying on control points along the boundary. The entire shape is then deformed to match a new image. Two of the most common shape-based techniques are Active Shape Models and Active Appearance Models; Image-Based Segmentation: Some methods initiate a template and refine its shape according to the image data while minimizing integral error measures, like the Active contour model and its variations; Interactive Segmentation: Interactive methods are useful when clinicians can provide some information, such as a seed region or rough outline of the region to segment. An algorithm can then iteratively refine such a segmentation, with or without guidance from the clinician. Manual segmentation, using tools such as a paint brush to explicitly define the tissue class of each pixel, remains the gold standard for many imaging applications. Recently, principles from feedback control theory have been incorporated into segmentation, which give the user much greater flexibility and allow for the automatic correction of errors; Subjective surface Segmentation: This method is based on the idea of evolution of segmentation function which is governed by an advection-diffusion model. To segment an object, a segmentation seed is needed (that is the starting point that determines the approximate position of the object in the image). Consequently, an initial segmentation function is constructed. With the subjective surface method, the position of the seed is the main factor determining the form of this segmentation function; and Hybrid segmentation which is based on combination of methods. (Search "medical image computing" on Wikipedia.com June 24, 2021. CC-BY-SA 3.0 Modified. Accessed June 24, 2021.)	143	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In a step 130, the manufactured cutting guide may be used in surgery to facilitate treatment of the condition. Specifically, the bone apposition surface of the cutting guide may be placed against the corresponding contours of the first cuneiform and the first metatarsus. The guide features (for example, slots) may then be positioned on either side of the joint between the first cuneiform and the first metatarsus to guide resection of the first metatarsus and the first cuneiform to remove the intervening joint. The cutting guide may then be removed, and the remaining portions of the first cuneiform and the first metatarsus may be placed to abut each other. The cutting guide may have been shaped such that the cuts made to the first cuneiform and the first metatarsus are properly oriented to bring the first metatarsus back into its proper orientation relative to the rest of the foot. The first cuneiform and the first metatarsus may be secured together using a bone plate or the like. The surgical wound may be closed to allow the foot to heal, and to allow the first cuneiform and the first metatarsus to fuse together.	53	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As mentioned previously, the method 120 is one species of the method 100; the present disclosure encompasses many different procedures, performed with respect to many different bones and/or joints of the body. Exemplary steps and instrumentation for the method 120 will further be shown and described in connection with Figures 2 through 7D. Those of skill in the art will recognize that the method 120 may be used in connection with different instruments; likewise, the instruments of Figures 2 through 7D may be used in connection with methods different from the method 100 and the method 120.	55	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Every deformity is different; accordingly, the degree of angular adjustment needed in each direction may be different for every patient. Use of a patient-specific cutting guide may help the surgeon obtain the optimal realignment in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290. Conversely, use of one of several differently-sized cutting guides may provide only approximate correction, as the surgeon may not have a guide that precisely matches the correction needed for the foot 200, and must thus choose the cutting guide that most closely provides the desired correction. Such differently sized cutting guides would not be contoured to fit the first cuneiform 210 or the first metatarsus 230, thus introducing additional potential for error as the surgeon must properly align the selected cutting guide.	59	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 4 is a perspective view of the foot 200 of Figure 2, with the cutting guide 300 of Figures 3A, 3B, 3C and 3D properly positioned on the first cuneiform 210 and the first metatarsus 230, but as yet not attached to the first cuneiform 210 and the first metatarsus 230. The surgeon has made the incision(s) to expose the dorsal surfaces of the first cuneiform 210 and the first metatarsus 230, and has inserted the cutting guide 300 such that the cuneiform apposition portion 342 (identified by the first bone indicator 360 on the outward-facing side 332 of the body 310) is resting on the corresponding dorsal surface of the first cuneiform 210, and the metatarsus apposition portion 344 (identified by the second bone indicator 362 on the outward-facing side 332 of the body 310) is resting on the corresponding dorsal surface of the first metatarsus 230. Since the cuneiform apposition portion 342 and the metatarsus apposition portion 344 are contoured to match the bone surfaces on which they rest, the body 310 may readily slide into its proper position on the first cuneiform 210 and the first metatarsus 230.	70	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As shown, the body 310 may have two holes 340 positioned over the first cuneiform 210, and two holes 340 positioned over the first metatarsus 230. This is merely exemplary; in some embodiments, a cutting guide may be secured to one of the first cuneiform 210 and the first metatarsus 230 or may be secured to either of the first cuneiform 210 and the first metatarsus 230 with one pin 500, or with more than two pins 500. Further, in some alternative embodiments, different fasteners may be used, such as screws, clamps, clips, and/or the like.	73	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As indicated previously, the cutting guide 300 is one of many patient-specific instruments that may be used in connection with the method 100 and/or the method 120. An alternative cutting guide suitable for use with the method 120 will be shown and described in connection with Figures 7A, 7B, 7C, and 7D.	81	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, a breaker tool 1271 can be used to separate the alignment feature 1260a from the body 1210. In one embodiment, a breaker tool 1271 can be a “T” shaped tool with a crosswise proximal handle, a shaft, and a distal end. A user may operate the breaker tool 1271 by placing the distal end in a receiver 1276 of one or more detachable connectors 1270. Pressing and/or twisting the distal end into the receiver 1276 breaks one or more bridges 1274 and thus separates the alignment feature 1260a. A user may insert the distal end into one or more receivers 1276 to separate the alignment feature 1260a from the body 1210.	133	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 17 illustrates a flowchart diagram depicting a method 1700 for generating one or more patient specific instruments configured to correct a bone condition, according to one embodiment. Prior to steps of the method 1700, a bone model (also referred to as CAD model above) is generated. The bone model may be generated using medical imaging of a patient’s foot and may also be referred to as an anatomic model. The medical imaging image(s) may be used by computing devices to generate patient imaging data. The patient imaging data may be used to measure and account for orientation of one or more structures of a patient’s anatomy. In certain embodiments, the patient imaging data may serve or be a part of anatomic data for a patient.	138	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As used herein, "anatomic data" refers to data identified, used, collected, gathered, and/or generated in connection with an anatomy of a human or animal. Examples of anatomic data may include location data for structures, both independent, and those connected to other structures within a coordinate system. Anatomic data may also include data that labels or identifies one or more anatomical structures. Anatomic data can include volumetric data, material composition data, and/or the like. Anatomic data can be generated based on medical imaging data or measurements using a variety of instruments including monitors and/or sensors. Anatomic data can be gathered, measured, or collected from anatomical models and/or can be used to generate, manipulate, or modify anatomical models.	139	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	A bone model or anatomic model of a patient’s body or body part(s) may be generated by computing devices that analyze medical imaging images. Structures of a patient’s body can be determined using a process called segmentation.	140	Added by DJM 7 2021	7/2/21, 12:00 AM

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