Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	Advantageously, because the present disclosure uses a bone model of the patient’s bones the sizes, dimensions, lengths and configurations of the components of the example systems can each be changed, adapted, revised, and/or customized to meet the needs and/or preferences of the patient and/or surgeon. Advantageously, using the apparatus, systems, and/or methods of the present disclosure the surgeon may have a preoperative plan that identifies which specific bone screw (length, width, diameter, thread, pitch, etc.) to use for the fasteners.	381	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Advantageously, the present disclosure provides an apparatus, system, and/or method that can remediate a condition in a patient's foot. Those of skill in the art will appreciate that the methods, processes, apparatuses, systems, devices, and/or instruments of the present disclosure can be used to address a variety of conditions in a variety of procedures and/or parts of the body of the patient.	382	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Conventionally, correction methods, systems, and/or instrumentation for a condition such as, for example, a bunion and/or a hallux valgus, face several challenges. One example is how to cut the bone such that the cut faces have a desired angle in relation to each other. Advantageously, the present disclosure can address many, if not all, of these challenges to assist a surgeon in performing the surgical procedure and improve the quality of patient care and outcomes.	383	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.	384	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.	385	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.	386	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Recitation in the claims of the term "first" with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. §112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein.	387	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of this disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure set forth herein without departing from it spirit and scope.	388	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17		389	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The navigation module 1070 may also navigate the workflow 1050 together with a user 1002 to generate a patient-specific device model 1072 configured specifically to the patient. The patient-specific device model 1072 may be used for a variety of purposes. For example, the patient-specific device model 1072 may be used to generate a prosthetic. Alternatively, or in addition, the patient-specific can be configured for use in a surgical procedure to remediate a condition of the patient’s foot. Advantageously, generation of the patient-specific device model 1072 can be used to generate a physical version of the patient-specific device model 1072.	286	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The fabrication module 1080 serves to either fabricate a patient-specific device 1090 from the patient-specific device model 1072 or generate instructions that enable a manufacturing tool (e.g., an additive manufacturing tool) to fabricate a patient-specific device 1090 from the patient-specific device model 1072. For example, in one embodiment, the fabrication module 1080 communicates with the navigation module 1070 to obtain a definition of the patient-specific device model 1072. The definition may be represented by one or more STL files used for conventional modeling computer program product, software programs and/or computer aided manufacturing (CAM) programs, devices, systems, and/or platforms.	287	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The fabrication module 1080 may include and/or communicate with machines and/or equipment that is configured to interpret the one or more STL files and fabricate a physical patient-specific device 1090 that matches the design and/or specifications of the patient-specific device model 1072. Alternatively, or in addition, the fabrication module 1080 may prepare the one or more STL files that are then provided to a third party manufacturer that uses manufacturing tools to fabricate the patient-specific device 1090 from the patient-specific device model 1072. In one embodiment, the fabrication module 1080 may send the one or more STL files for the patient-specific device 1090 to a third-party directly over a communications network.	288	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, once the fabrication module 1080 generates the patient-specific device 1090 the patient-specific device 1090 may be ready for use in a surgical procedure. Alternatively, or in addition, one or more post fabrication steps may be performed on the patient-specific device 1090 before it is ready for use.	289	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the fabrication module 1080 is configured to not only generate the patient-specific device 1090 or instructions for a manufacturing tool to generate the patient-specific device 1090, but the fabrication module 1080 may also generate one or more other materials and/or devices that can be used for a surgical procedure to remediate a condition present in a patient’s foot.	290	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	For example, in one embodiment, the fabrication module 1080 may generate a preoperative plan 1092 and/or other complementary devices 1094. The preoperative plan 1092 may be configured and/or customized for a surgical procedure that uses the patient-specific device 1090. The preoperative plan 1092 may be generated in a digital and/or a hardcopy format and may include images of the bone model 404 and/or the patient-specific device 1090 at one or more stages of a surgical technique for a surgical procedure. The preoperative plan 1092 may include specific measurements for angles, lengths, widths, and/or orientations of the bones of the bone model 404 and/or the patient-specific device 1090. Alternatively, or in addition, the preoperative plan 1092 may include recommendations for consideration by a surgeon for the surgical procedure. The preoperative plan 1092 may be provided in the form of a report or a document.	291	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The complementary devices 1094 may include a positioner, an alignment device, a targeter, a jig, a guide, other instrumentation, and/or a physical model of one or more bones of the bone model 404. These complementary devices 1094 may be needed for a surgical procedure that uses the patient-specific device 1090 and/or may be optional and may be useful to certain surgeons but not as useful to others. The physical model of one or more bones of the bone model 404 may be useful to a surgeon to enable them to handle a representation of the bones of the patient and study or review different angles, perspectives, and/or options for the surgical procedure.	292	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Referring to FIGs 10 and 11, the system 1000 can be used for a variety of surgical procedures to generate a variety of patient-specific device 1090 depending on the needs of the patient and/or the preferences of the surgeon. In one embodiment, the system 1000 can be used to generate a resection guide for use by a surgeon to perform one or more osteotomies on bones of a patient’s foot to remediate a hallux valgus deformity (Bunion). A resection guide is an instrument configured to be placed on, against, or near one or more bones of a patient and guide a cutting tool in performing one or more osteotomies of the bone(s).	293	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Initially, a medical imager 1010 may be used to generate medical imaging of a patient’s foot having the condition. The medical imager 1010 may generate medical imaging 1030 using a CT scanner and the medical imaging 1030 may be recorded in a storage device in a file having a DICOM format. In one embodiment, the patient-specific device design apparatus 450 may include executable code configured to direct a segmentor 1020 such as an autosegmentor to segment the medical imaging 1030 DICOM files into a format suitable for use, reading, and/or importation by the patient-specific device design apparatus 450 (e.g., STL file(s)). In one embodiment, the segmented medical imaging 1030 may serve as input to the patient-specific device design apparatus 450 and/or may be included in a set of work instructions 1040.	294	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Next, the patient-specific device design apparatus 450 can receive a set of work instructions 1040 by way of the receiver module 1060. In one embodiment, the set of work instructions 1040 includes a workflow 1050 and a prescription 1100. Alternatively, the set of work instructions 1040 may not include a workflow 1050 or a prescription 1100. Instead, the workflow 1050 may be incorporated into executable code executed by the patient-specific device design apparatus 450. The set of work instructions 1040 may identify the patient and/or the surgical procedure.	295	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the user 1002 can change over the course of initiating generation of a patient-specific device 1090 to its final fabrication. For example, the user 1002 may initially be a surgeon and the surgeon may operate the patient-specific device design apparatus 450 to initiate generation of a patient-specific device 1090, such input from a surgeon may be considered a prescription 1100 sufficient to satisfy regulatory requirements for a jurisdiction that recognizes the surgeon as one qualified to perform the surgical procedure. Later, an operator may interact with the patient-specific device design apparatus 450 to generate the patient-specific device 1090.	296	Added by DJM Jan 2024	1/6/24, 10:05 PM

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