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	In one embodiment, the method 1700 begins after a bone model of a patient’s body or body part(s) is generated. In a first step 1702, the method 1700 may review the bone model and data associated with the bone model to determine anatomic data of a patient’s foot.	144	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	After step 1702, the method 1700 determine 1704 a deformity in the patient’s anatomy using the anatomic data. In certain embodiments, the detection and/or identification of a deformity may employ advanced computer analysis, expert systems, machine learning, and/or automated/artificial intelligence. As used herein, "artificial intelligence" refers to intelligence demonstrated by machines, unlike the natural intelligence displayed by humans and animals, which involves consciousness and emotionality. The distinction between artificial intelligence and natural intelligence categories is often revealed by the acronym chosen. 'Strong' AI is usually labelled as artificial general intelligence (AGI) while attempts to emulate 'natural' intelligence have been called artificial biological intelligence (ABI). Leading AI textbooks define the field as the study of "intelligent agents": any device that perceives its environment and takes actions that maximize its chance of achieving its goals. The term "artificial intelligence" can also be used to describe machines that mimic "cognitive" functions that humans associate with the human mind, such as "learning" and "problem solving". (Search "artificial intelligence" on Wikipedia.com June 25, 2021. CC-BY-SA 3.0 Modified. Accessed June 25, 2021.) Various kinds of deformities may be identified, such as a bunion. The deformities determined may include congenital as well as those caused by injury or trauma.	145	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, the method 1700 proceeds and a template cutting guide model is selected 1706 from a repository of template cutting guide models. A template cutting guide model is a model of a template cutting guide.	146	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As used herein, "template cutting guide" refers to a guide configured, designed, and/or engineered to serve as a template for creating, generating, or fabricating a patient specific cutting guide. In one aspect, the template cutting guide may be used, as-is, without any further changes, modifications, or adjustments and thus become a patient specific cutting guide. In another aspect, the template cutting guide may be modified, adjusted, or configured to more specifically address the goals, objectives, or needs of a patient or a surgeon and by way of the modifications become a patient specific cutting guide. The patient specific cutting guide can be used by a user, such as a surgeon, to guide making one or more resections of a structure, such as a bone for a procedure. Accordingly, a template cutting guide model can be used to generate a patient specific cutting guide model. The patient specific cutting guide model may be used in a surgical procedure to address, correct, or mitigate effects of the identified deformity and may be used to generate a patient specific cutting guide that can be used in a surgical procedure for the patient.	147	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	Next, the method 1700 may register 1708 the template cutting guide model with one or more bones of the bone model. This step 1708 facilitates customization and modification of the template cutting guide model to generate a patient specific cutting guide model from which a patient specific cutting guide can be generated. The registration step 1708 combines two models and/or patient imaging data and positioned both models for use in one system and/or in one model.	149	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As used herein, "registration" or " image registration" refers to a method, process, module, component, apparatus, and/or system that seeks to achieve precision in the alignment of two images. As used here, "image" may refer to either or both an image of a structure or object and another image or a model (e.g., a computer based model or a physical model, in either two dimensions or three dimensions). In the simplest case of image registration, two images are aligned. One image may serve as the target image and the other as a source image; the source image is transformed, positioned, realigned, and/or modified to match the target image. An optimization procedure may be applied that updates the transformation of the source image based on a similarity value that evaluates the current quality of the alignment. An iterative procedure of optimization may be repeated until a (local) optimum is found. An example is the registration of CT and PET images to combine structural and metabolic information. Image registration can be used in a variety of medical applications: Studying temporal changes; Longitudinal studies may acquire images over several months or years to study long-term processes, such as disease progression. Time series correspond to images acquired within the same session (seconds or minutes). Time series images can be used to study cognitive processes, heart deformations and respiration; Combining complementary information from different imaging modalities. One example may be the fusion of anatomical and functional information.	150	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Since the size and shape of structures vary across modalities, evaluating the alignment quality can be more challenging. Thus, similarity measures such as mutual information may be used; Characterizing a population of subjects. In contrast to intra-subject registration, a one-to-one mapping may not exist between subjects, depending on the structural variability of the organ of interest. Inter-subject registration may be used for atlas construction in computational anatomy. Here, the objective may be to statistically model the anatomy of organs across subjects; Computer-assisted surgery: in computer-assisted surgery pre-operative images such as CT or MRI may be registered to intra-operative images or tracking systems to facilitate image guidance or navigation. There may be several considerations made when performing image registration: The transformation model. Common choices are rigid, affine, and deformable transformation models. B-spline and thin plate spline models are commonly used for parameterized transformation fields. Non-parametric or dense deformation fields carry a displacement vector at every grid location; this may use additional regularization constraints. A specific class of deformation fields are diffeomorphisms, which are invertible transformations with a smooth inverse; The similarity metric. A distance or similarity function is used to quantify the registration quality. This similarity can be calculated either on the original images or on features extracted from the images. Common similarity measures are sum of squared distances (SSD), correlation coefficient, and mutual information. The choice of similarity measure depends on whether the images are from the same modality; the acquisition noise can also play a role in this decision. For example, SSD may be the optimal similarity measure for images of the same modality with Gaussian noise. However, the image statistics in ultrasound may be significantly different from Gaussian noise, leading to the introduction of ultrasound specific similarity measures.	151	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Multi-modal registration may use a more sophisticated similarity measure; alternatively, a different image representation can be used, such as structural representations or registering adjacent anatomy; The optimization procedure. Either continuous or discrete optimization is performed. For continuous optimization, gradient-based optimization techniques are applied to improve the convergence speed.(Search "medical image computing" on Wikipedia.com June 24, 2021. CC-BY-SA 3.0 Modified. Accessed June 25, 2021.)	152	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, the method 1700 may design 1710 a patient specific cutting guide model based on the template cutting guide model. The design step 1710 may be completely automated or may optionally permit a user to make changes to a template cutting guide model or partially completed patient specific cutting guide model before the patient specific cutting guide model is complete. A template cutting guide model and patient specific cutting guide model are two examples of an instrument model. As used herein, "instrument model" refers to a model, either physical or digital, that represents an instrument, tool, apparatus, or device. Examples, of an instrument model can include a cutting guide model, a patient specific cutting guide model, and the like. In one embodiment, a patient specific cutting guide and a patient specific cutting guide model may be unique to a particular patient and that patient’s anatomy and/or condition.	153	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The method 1700 may conclude by a step 1712 in which patient specific cutting guide may be manufactured based on the patient specific cutting guide model. Various manufacturing tools, devices, systems, and/or techniques can be used to manufacture the patient specific cutting guide. As used herein, “manufacturing tool” or "fabrication tool" refers to a manufacturing or fabrication process, tool, system, or apparatus which creates an object, device, apparatus, feature, or component using one or more source materials. A manufacturing tool or fabrication tool can use a variety of manufacturing processes, including but not limited to additive manufacturing, subtractive manufacturing, forging, casting, and the like. The manufacturing tool can use a variety of materials including polymers, thermoplastics, metals, biocompatible materials, biodegradable materials, ceramics, biochemicals, and the like. A manufacturing tool may be operated manually by an operator, automatically using a computer numerical controller (CNC), or a combination of these techniques.	154	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 18 illustrates an exemplary system 1800 configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment. The system 1800 may include an apparatus 1802 configured to accept, review, receive or reference a bone model 1804 and provide a patient specific cutting guide 1806. In one embodiment, the apparatus 1802 is a computing device. In another embodiment, the apparatus 1802 may be a combination of computing devices and/or software components or a single software component such as a software application.	155	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The apparatus 1802 may include a determination module 1810, a deformity module 1820, a selection module 1830, a registration module 1840, a design module 1850, and a manufacturing module 1860. Each of which may be implemented in one or more of software, hardware, or a combination of hardware and software.	156	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The determination module 1810 determines anatomic data 1812 from a bone model 1804. In certain embodiments, the system 1800 may not include a determination module 1810 if the anatomic data is available directly from the bone model 1804. In certain embodiments, the anatomic data for a bone model 1804 may include data that identifies each anatomic structure within the bone model 1804 and attributes about the anatomic structure. For example, the anatomic data may include measurements of the length, width, height, and density of each bone in the bone model. Furthermore, the anatomic data may include position information that identifies where each structure, such as a bone is in the bone model 1804 relative to other structures, including bones. The anatomic data may be in any suitable format and may be stored separately or together with data that defines the bone model 1804.	157	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, the determination module 1810 may use advanced computer analysis such as image segmentation to determine the anatomic data. Alternatively, or in addition the determination module 1810 may use software and/or systems that implement one or more artificial intelligence methods (e.g., machine learning and/or neural networks) for deriving, determining, or extrapolating, anatomic data from the bone model. In one embodiment, the determination module 1810 may perform an anatomic mapping of the bone model 1804 to determine each unique aspect of the intended osteotomy procedure and/or bone resection and/or bone translation. The anatomic mapping may be used to determine coordinates to be used for an osteotomy procedure, position and manner of resections to be performed either manually or automatically or using robotic surgical assistance, a width for bone cuts, an angle for bone cuts, a predetermined depth for bone cuts, dimensions and configurations for resection instruments such as saw blades, milling bit size and/or speed, saw blade depth markers, and/or instructions for automatic or robotic resection operations.	158	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The deformity module 1820 determines or identifies one or more deformities or other anomalies based on the anatomic data 1812. The deformity may include a deformity between two bones of a patient’s foot as represented in the bone model 1804. In one embodiment, the deformity module 1820 may compare the anatomic data 1812 to a general model that is representative of most patient’s anatomies and that does not have a deformity or anomaly. In one embodiment, if the anatomic data 1812 does not match the general model a deformity is determined. Various deformities may be detected including those that have well-known names for the condition and those that are unnamed.	159	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The selection module 1830 is configured to select a template cutting guide model 1832 for an osteotomy procedure configured to correct the deformity identified by the deformity module 1820. In one embodiment, the selection module 1830 may select a template cutting guide model 1832 from a set of template cutting guide models 1832 (e.g., a library, set, or repository of template cutting guide models 1832). In one embodiment, the template cutting guide model 1832 may include digital models. In another embodiment, the template cutting guide model 1832 may include physical models. In such an embodiment, the repository 2102 may be a warehouse or other inventory repository. Where the template cutting guide model 1832 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.	160	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Selection of a suitable template cutting guide model 1832 may be completely automated and/or may be partially automated and/or may depend on confirmation from a user before a proposed template cutting guide model 1832 becomes the selected template cutting guide model 1834. In another embodiment, the selection module 1830 may facilitate a manual selection by a user of the template cutting guide model 1832. The selection module 1830 may use the anatomic data 1812 or the bone model 1804 or a combination of these to select a suitable template cutting guide model (also referred to as a selected template cutting guide model 1834).	161	Added by DJM 7 2021	7/2/21, 12:00 AM

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