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	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	Alternatively, or in addition, a user may use the modification module 2208 to modify a predefined osteotomy procedure. The user may add, remove, or modify steps and the instrumentation used in the osteotomy procedure to create a patient specific osteotomy procedure. In this manner, a user may configure features of a selected template cutting guide model 1834 or modified template cutting guide model and/or osteotomy procedure specific to a patient specific osteotomy procedure the surgeon is planning for the patient. As used herein, "patient specific osteotomy procedure" refers to an osteotomy procedure that has been adjusted, tailored, modified, or configured to specifically address the needs or desires or a particular patient. In certain aspects, one patient specific osteotomy procedure may be useable in connection with only one patient. In other aspects, one patient specific osteotomy procedure may be useable with a number of patients having a particular class of characteristics.	183	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The user may review the selected template cutting guide model 1834 and may adjustments or revisions or make no adjustments or revisions. The output of the modification module 2208 and/or the application module 2206 is a patient specific cutting guide model 2202.	184	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 23 illustrates an exemplary system 2300 configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment. The system 2300 may include similar components or modules to those described in relation to FIG. 18. In addition, the system 2300 may include a fixator selector 2302 and/or an export module 2304.	185	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The fixator selector 2302 enables a user to determine which fixator(s) to use for an osteotomy procedure planned for a patient. In one embodiment, the fixator selector 2302 may recommend one or more fixators based on the bone model 1804, the deformity 1826 or input from a user or a history of prior osteotomy procedures performed to correct a particular deformity 1826. In one embodiment, the fixator selector 2302 selects a bone plate for fixation of two bones of the patient during an osteotomy procedure. The fixator selector 2302 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.	186	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As used herein, a "fixator" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or engineered to connect two bones or bone fragments or a single bone or bone fragment and another fixator to position and retain the bone or bone fragments in a desired position and/or orientation. Examples of fixators include both those for external fixation as well as those for internal fixation and include, but are not limited to pins, wires, Kirschner wires, screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like.	187	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, the fixator selector 2302 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 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 fixator(s) 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 or recommend suitable fixator(s).	188	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The export module 2304 is configured to enable exporting of a patient specific cutting guide model 2202 for a variety of purposes including, but not limited to, fabrication/manufacture of a patient specific cutting guide 1806 and/or fixator(s), generation of a preoperative plan, generation of a physical bone model matching the bone model 1804, and the like. In one embodiment, the export module 2304 is configured to export the bone model 1804, anatomic data 1812, a patient specific cutting guide model 2202, a preoperative plan 2306, a fixator model 2308, or the like. In this manner the custom instrumentation and/or procedural steps for an osteotomy procedure can be used in other tools. The preoperative plan 2306 may include a set of step by step instructions or recommendation for a surgeon or other staff in performing an osteotomy procedure such as patient specific osteotomy procedure. The preoperative plan 2306 may include images and text instructions and may include identification of instrumentation to be used for different steps of the osteotomy procedure. The instrumentation may include the patient specific cutting guide 1806 and/or one or more fixators. In one embodiment, the export module 2304 may provide a fixator model which can be used to fabricate a fixator for the osteotomy procedure.	189	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The exports (1804, 1812, 2202, 2306, and 2308) may be inputs for a variety of 3rd party tools 2310 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 an osteotomy procedure or for rehearsals and preparation for the osteotomy procedure. For example, a physical model of the bones, patient specific cutting guide 1806, and/or fixators can be fabricated, and these can be used for a rehearsal operative procedure. Alternatively, a surgeon can use the bone model 1804, selected template cutting guide model 1834, and/or a fixator model to perform a simulated osteotomy procedure using an operative procedure simulation tool.	190	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	"Repository" refers to any data source or dataset that includes data or content. In one embodiment, a repository resides on a computing device. In another embodiment, a repository resides on a remote computing or remote storage device. A repository may comprise a file, a folder, a directory, a set of files, a set of folders, a set of directories, a database, an application, a software application, content of a text, content of an email, content of a calendar entry, and the like. A repository, in one embodiment, comprises unstructured data. A repository, in one embodiment, comprises structured data such as a table, an array, a queue, a look up table, a hash table, a heap, a stack, or the like. A repository may store data in any format including binary, text, encrypted, unencrypted, a proprietary format, or the like.	148	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
View Edit Delete	PER-8 PROV	As used herein, "segmentation" or "image segmentation" refers the process of partitioning an image into different meaningful segments. These segments may correspond to different tissue classes, organs, pathologies, bones, or other biologically relevant structures. Medical image segmentation accommodates imaging ambiguities such as by low contrast, noise, and other imaging ambiguities.	141	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Certain computer vision techniques can be used or adapted for image segmentation. For example, the techniques and or algorithms for segmentation may include, but are not limited to: Atlas-Based Segmentation: For many applications, a clinical expert can manually label several images; segmenting unseen images is a matter of extrapolating from these manually labeled training images. Methods of this style are typically referred to as atlas-based segmentation methods. Parametric atlas methods typically combine these training images into a single atlas image, while nonparametric atlas methods typically use all of the training images separately. Atlas-based methods usually require the use of image registration in order to align the atlas image or images to a new, unseen image.	142	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

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