Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-12	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.	215	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	"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.	216	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Next, the method 1100 may register 1108 the preliminary cutting guide model with one or more bones of the bone model. This step 1108 facilitates customization and modification of the preliminary cutting guide model to generate a patient-specific cutting guide model from which a patient-specific cutting guide can be generated. The registration step 1108 combines two models and/or patient imaging data and positions both models for use in one system and/or in one model (e.g., model registration).	217	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As used herein, "model 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.	218	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	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.	219	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	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.)	220	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Next, a surgeon can resect a distal articular surface of the medial cuneiform 202 and a proximal articular surface of the first metatarsal 208 by way of the second slot 370 and the first slot 360. After resection, the distal end of the medial cuneiform 202 includes a planar cut surface and the proximal end of the first metatarsal 208 includes a planar cut surface. Figure 4 illustrates that the bone engagement surface 324 conforms to the surface of the two bones (e.g., medial cuneiform 202 and first metatarsal 208).	125	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 5A, 5B illustrate a perspective view of a first cuneiform and a first metatarsal with one embodiment of a patient-specific cutting guide. Prior to resection completed in the illustrated stage of Figure 4, a surgeon may desire to check or confirm that the desired cutting guide is being used and that a selected cutting guide will provide a desired alignment between the bones of the foot after the resection and fixation steps.	126	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Accordingly, in the illustrated embodiment, the cutting guide 300 may include one member of a coupler 410 configured to engage a corresponding member of the coupler coupled to an alignment guide 420. Those of skill in the art appreciate that various designs of a coupler may be used. In the illustrated embodiment, the coupler 410 includes an opening 412 (See Figure 20) that may extend from the superior side 320 into the body 310 through to the inferior side 322 and a post 414. In one embodiment, the opening 412 may include one of the slots, such as second slot 370. The post 414 may include an engagement member 416.	127	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one embodiment, the opening 412 and the post 414 engage each other in a friction fit. For example, the post 414 may slide into the second slot 370 and the engagement member 416 may slide into the opening 412. In one embodiment, the engagement member 416 may include tabs that are biased outward and greater than a diameter of the opening 412 such that the tabs engage the opening 412 when inserted and release the opening when the tabs are pressed together.	128	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The alignment guide 420 includes a body 422, an inferior end 424, and superior end 426 and one or more openings 428 near the superior end 426. The openings 428 may be aligned. A surgeon may use the alignment guide 420 by engaging the coupler 410 to couple the alignment guide 420 to the cutting guide 300. Next, a surgeon may insert one or more K-wires through the openings. The openings 428 and alignment guide 420 may be configured such that K-wires within the openings extend along an anterior-posterior axis and indicate the orientation and alignment of the medial cuneiform 202 and first metatarsal 208 once the osteotomy procedure is completed. A surgeon may compare this alignment with the orientation and alignment of other bones of the patient. In this manner, a surgeon can confirm that osteotomy procedure will accomplish the desired outcome once completed.	129	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 6A-6C are top perspective, top, bottom, respectively, of a patient-specific cutting guide 600 according to one embodiment. The cutting guide 600 may be designed to facilitate resection of a first cuneiform near a distal end and a first metatarsal near a proximal end with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsal relative to the first cuneiform, thereby providing correction in a lateral direction, in a plantar direction, and/or a dorsal direction.	130	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As shown, the cutting guide 600 may have a body 610 with a monolithic construction and the general shape of a rectangular shape. The body 610 includes a proximal side 612, a distal side 614, a medial side 616, a lateral side 618, a superior side 620, and an inferior side 622. In the illustrated embodiment, the body 610 may also include a proximal arm 630 that extends from the body 610 and a distal arm 640 that extends from the body 610. The proximal side 612 is the side closest to the core of the patient when the cutting guide 600 is in use. The distal side 614 is the side furthest from the core of the patient when the cutting guide 600 is in use. The medial side 616 is the side facing medially when the cutting guide 600 is in use. The lateral side 618 is the side facing laterally when the cutting guide 600 is in use. The superior side 620 is the side facing up away from the bone(s) when the cutting guide 600 is in use. The inferior side 622 is the side facing down, facing, and/or contacting the bone(s) (e.g., contacting a surface of one or more bones) when the cutting guide 600 is in use.	131	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The inferior side 622 may be custom contoured to match the shapes of one or more of the surfaces of the first cuneiform and/or the first metatarsal. In one embodiment, the inferior side 622 may include a bone engagement surface 624. The bone engagement surface 624 can be shaped to match a first surface of a first bone and a second surface of a second bone of a joint.	132	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one example, the bone engagement surface 624 can be shaped such that the bone engagement surface 624 matches a surface of a cuneiform bone and a surface of a metatarsal bone of a tarsometatarsal (“TMT”) joint. The bone engagement surface 624 can be so shaped because it is fabricated from a bone model of the patient’s bones. The body 610 is configured, designed, and/or fabricated to seat transverse to a joint (e.g., a TMT joint) with the bone engagement surface 624 engaging a first surface of a first bone and a second surface of a second bone.	133	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 6A-6C includes similar components, parts, devices, apparatus, features, and aspects as those disclosed and described in relation to Figures 3A-19H, however the difference in Figures 6A-6C is that body 610, bone engagement surface 624, and/or one or more arms (e.g., proximal arm 630 and/or distal arm 640) are configured to couple to the bones and extend transverse to the joint, at least partially, if not completely, on the dorsal sides of the bones. Accordingly, the cutting guide 600 may be referred to as a dorsal cutting guide.	134	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In addition, the cutting guide 600 may be configured to avoid contact with soft tissue such as nerves, tendons, blood vessels, and the like that may run along a medial and/or a lateral side of the first metatarsal 208. Accordingly, the cutting guide 600 may be fabricated to seat transverse to the TMT joint such that the bone engagement surface contacts a dorsal surface of the a first bone (e.g., medial cuneiform 202) and/or a second bone (e.g., first metatarsal 208). For example, the proximal arm 630 and/or distal arm 640 may be positioned more laterally than in other embodiments.	135	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In the illustrated embodiment, the body 610 is configured to reside on the dorsal surfaces of the first cuneiform and the first metatarsal to provide proper alignment of the body 610 with the metatarsocuneiform joint (e.g., the joint between the first metatarsal and the medial cuneiform bone, aka a TMT joint). In another embodiment, the body 610 is configured to reside or sit between the medial surfaces and the dorsal surfaces for an osteotomy.	136	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In certain embodiments, the bone engagement surface 624 may include a cuneiform apposition portion 626 and a metatarsal apposition portion 628. As shown, the cuneiform apposition portion 626 may be contoured to match the contour of the surface of the first cuneiform on which it is to rest, and the metatarsal apposition portion 628 may similarly be contoured to match the contour of the surface of the first metatarsal on which it is to rest. (See Figure 6C) Thus, the body 610 may have only one stable position and orientation relative to the first cuneiform and the first metatarsal during a surgical osteotomy for correcting the condition.	137	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Advantageously, the fidelity of the patient imaging data enables the bone model, preliminary cutting guide model, and patient specific instrument (e.g., patient specific cutting guide, patient specific pin guide, patient specific alignment guide, etc.) to uniquely match a particular patient. Consequently, the bone engagement surface 624 can engage the surfaces of the bones of a joint in a single configuration. Such a close matching fit facilitates the surgical osteotomy.	138	Added by DJM Jan 2024	1/6/24, 10:03 PM

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