Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-12	Those of skill in the art will appreciate that the one or more bone attachment features 2024 may be implemented in a variety of ways and/or with a variety of structures. For example, in one embodiment that a bone attachment features 2024 may be embodied as one or more prongs, pins, or spikes extending from the medial side 2032 of the resection guide 2020a. The pins, prongs or spikes may be driven into the bone by way of a mallet. Of course, other embodiments for the bone attachment feature 2024 may have a different configuration and still fall within the scope of the present disclosure.	307	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In certain embodiments, the resection guide 2020a can include one or more handles 2026. The handle 2026 can facilitate positioning and/or placement of the resection guide 2020a. In certain embodiments, the resection guide 2020a may not include handles 2026. Instead, a user may grasp the body 2028 for positioning. Alternatively, or in addition, the handle 2026 may be relatively straight and may be aligned with a longitudinal axis of the resection guide 2020a such that handle 2026 can be used as a visual guide for a surgeon to confirm the positioning, placement, and/or orientation of the resection guide 2020a on a bone of the patient. Of course, other aspects of the resection guide 2020a may serve the same or similar functions as a handle 2026, such that a dedicated handle 2026 may not be needed.	308	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Furthermore, handle 2026 may serve more than one function or purpose. In certain embodiments, one or more of the handles 2026 can serve as both a handle used by a user to position/orient the resection guide 2020a and/or as a landmark registration feature.	309	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	A landmark registration feature serves to assist a surgeon in mapping or converting from a position of a model of a resection guide 2020 one a model of one or more bones of a patient in a virtual environment and/or in a preoperative plan to an actual physical position on one or more bones of a patient during a procedure. In the illustrated embodiment, the resection guide 2020a includes at least one landmark registration feature.	310	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In particular, the resection guide 2020 may include a plantar landmark registration feature 2041a. In another embodiment, the resection guide 2020 may include a dorsal landmark registration feature 2041b. See for example, Figure 21E. Alternatively, or in addition, the resection guide 2020 can include a landmark registration feature 2041 that extends from any side of the resection guide 2020.	311	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The landmark registration feature 2041 is configured to engage with landmarks on the bone of the patient. Advantageously, the landmark registration feature 2041 can provide a surgeon with confidence and assurance in the placement and positioning of the resection guide 2020a on the bone because the landmark registration feature 2041 engages with one or more particular landmarks on the bone (e.g., a projection or a depression or cavity). The landmark registration features 2041 is one feature that assists a surgeon in transferring a position of an instrument model relative to a bone model of the patient to an instrument positioned on the actual bone of the patient during a surgical procedure.	312	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Next, the method 1100 may design 1110 a patient-specific cutting guide model based on the preliminary cutting guide model. The design step 1110 may be completely automated or may optionally permit a user to make changes to a preliminary cutting guide model or partially completed patient-specific cutting guide model before the patient-specific cutting guide model is complete. A preliminary 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.	221	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The method 1100 may conclude by a step 1112 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.	222	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 12 illustrates an exemplary system 1200 configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment. "Bone condition" refers to any of a variety of conditions of bones of a patient. Bone conditions may be caused by or result from deformities, misalignment, malrotation, fractures, joint failure, and/or the like. A bone condition includes, but is not limited to, any angular deformities of one or more bone segments in either the lower or upper extremities (for example, tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). "Malrotation" refers to a condition in which a part, typically a part of a patient's body has rotated from a normal position to an unnormal or uncommon position. The system 1200 may include an apparatus 1202 configured to accept, review, receive or reference a bone model 1204 and provide a patient-specific cutting guide 1206. In one embodiment, the apparatus 1202 is a computing device. In another embodiment, the apparatus 1202 may be a combination of computing devices and/or software components or a single software component such as a software application.	223	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The apparatus 1202 may include a determination module 1210, a deformity module 1220, a provision module 1230, a registration module 1240, a design module 1250, and a manufacturing module 1260. Each of which may be implemented in one or more of software, hardware, or a combination of hardware and software.	224	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The determination module 1210 determines anatomic data 1212 from a bone model 1204. In certain embodiments, the system 1200 may not include a determination module 1210 if the anatomic data is available directly from the bone model 1204. In certain embodiments, the anatomic data for a bone model 1204 may include data that identifies each anatomic structure within the bone model 1204 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 1204 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 1204.	225	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one embodiment, the determination module 1210 may use advanced computer analysis system such as image segmentation to determine the anatomic data. Alternatively, or in addition the determination module 1210 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 1210 may perform an anatomic mapping of the bone model 1204 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.	226	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The deformity module 1220 determines or identifies one or more deformities or other anomalies based on the anatomic data 1212. The deformity may include a deformity between two bones of a patient’s foot as represented in the bone model 1204. In one embodiment, the deformity module 1220 may compare the anatomic data 1212 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 1212 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.	227	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The provision module 1230 is configured to provide a preliminary cutting guide model 1238. The provision module 1230 may use a variety of methods to provide the preliminary cutting guide model. In one embodiment, the provision module 1230 may generate preliminary cutting guide model. In the same or an alternative embodiment, the provision module 1230 may select a template cutting guide model for an osteotomy procedure configured to correct the deformity identified by the deformity module 1220. In one embodiment, the provision module 1230 may select a template cutting guide model from a set of template cutting guide models (e.g., a library, set, or repository of template cutting guide models).	228	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The registration module 1240 registers the preliminary cutting guide model with one or more bones or other anatomical structures of the bone model 1204. As explained above, registration is a process of combining medical imaging data, patient imaging data, and/or one or more models such that the preliminary cutting guide model can be used with the bone model 1204.	229	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The design module 1250 designs a patient-specific cutting guide (or patient-specific cutting guide model) based on the preliminary cutting guide model. The design operation of the design module 1250 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.	230	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The manufacturing module 1260 may manufacture a patient-specific cutting guide 1206 using the preliminary cutting guide model. The manufacturing module 1260 may use a patient-specific cutting guide model generated from the preliminary cutting guide model. The manufacturing module 1260 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 1260 provides the patient-specific cutting guide model to a manufacturing tool.	231	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Effective connection of the cutting guide to one or more bones across a joint can ensure that cut surfaces are formed in desired locations and orientation and mitigate removal of hard tissue and/or soft tissue outside in undesired locations.	232	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 13 illustrates an exemplary deformity module 1220 configured to determine a deformity, according to one embodiment. The deformity module 1220 may detect one or more deformities and/or anomalies of a patient’s anatomy by analyzing anatomic data 1212 and other inputs, such as a certain type or class of deformities to search for.	233	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The deformity module 1220 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 1220 to facilitate automatic or partially automated detection or determination of one or more deformities.	234	Added by DJM Jan 2024	1/6/24, 10:03 PM

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