Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	Once the receiver module 1060 has the set of work instructions 1040, the navigation module 1070 may navigate a workflow together with a user 1002 to with a user to generate a bone model 404 of a first metatarsal and a medial cuneiform of a patient's foot based on medical imaging 1030 of the patient’s foot. The bone model 404 is configured to include a deformity (e.g., hallux valgus) of the first metatarsal of the patient's foot. In one embodiment, the bone model 404 of a first metatarsal and a medial cuneiform of a patient's foot may be generated first because the bone model 404 may be used for specific angles and/or orientations of osteotomies in one, two or three planes of the foot to provide a desired level of correction. Bones of the bone model 404 can be repositioned, reoriented, and/or virtually resected or cut to make a correction to the bones of the bone model 404. This change and/or repositioning and virtual cutting can be used as a reference to define aspects or features of the patient-specific device 1090.	297	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The navigation module 1070 may navigate the workflow together with a user to generate a resection guide model 1072 that includes a proximal resection feature (e.g., cut guide, cut channel) configured to enable an osteotomy of the medial cuneiform and a distal resection feature (e.g., cut guide, cut channel) configured to enable an osteotomy of the first metatarsal. Advantageously, the resected medial cuneiform and first metatarsal can be fuses by a surgeon to remediate a condition of the patient’s foot.	298	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The fabrication module 1080 fabricates the resection guide 1090 from the resection guide model 1072. Alternatively, or in addition, the fabrication module 1080 may provide instructions for a manufacturing tool to fabricate the resection guide model 1072. The fabrication module 1080 can also generate a preoperative plan 1092 and/or complementary devices 1094 for use in a surgical procedure to address a hallux valgus condition.	299	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Referring now to FIG. 11, the prescription 1100 can provide a convenient tool for defining and/or initiating a set of work instructions 1040. FIG. 11 illustrates one representative example of a prescription 1100. The prescription 1100 may be specifically configured for generating a patient-specific device 1090.	300	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Those of skill in the art appreciate that the prescription 1100 may take a variety of forms and/or formats, each of which is within the scope of the present disclosure. The prescription 1100 may be available in printed paper format, in a digital format, in the form of a form presented on a webpage, integrated into a form or series of questions of a desktop or mobile device software application, or the like. In one embodiment, the prescription 1100 may be a fillable pdf file.	301	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The prescription 1100 can include instructions to a surgeon for a procedure and/or for completing the prescription 1100. The prescription 1100 can include specific instructions, requirements, considerations, preferences, or the like from a surgeon regarding the desired outputs of the system 1000. In a prescription 1100, a surgeon can indicate what angles and/or anatomical data 412 is desired and/or required. The prescription 1100 can indicate a type of patient-specific device 1090 (e.g., medial or dorsal). The prescription 1100 can indicate a material for use in fabrication of the patient-specific device 1090.	302	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated example embodiment, the prescription 1100 includes instructions 1102 for a surgeon in completing the prescription 1100. The prescription 1100 includes contact information 1104 for the surgeon. The prescription 1100 includes patient information 1106 that identifies the patient. The prescription 1100 includes procedure details 1108 that identify the foot involved, the status of collecting the medical imaging 1030, when the procedure is to be done, the medical facility for the procedure, and the like. The prescription 1100 includes patient-specific device and/or implant hardware details 1110 that may identify fixation hardware by name, model, type, brand and/or vendor and/or may include a style or type of patient-specific device 1090 desired (e.g., standard (generally placed between medial side of metatarsal phalangeal (“MTP”) joint and dorsal side of MTP joint), dorsal (generally placed on dorsal side of MTP joint), sizes for the patient-specific device 1090, or whether to defer those preferences to a vendor generating the patient-specific device 1090. The prescription 1100 may also include a signature block 1112 for collecting a surgeon’s signature to authorize the prescription and production of the patient-specific device 1090. The signature may be a manual signature or a digital / electronic signature.	303	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 12 illustrates an exemplary workflow 1050 for providing a patient-specific device 1090, according to one embodiment. In the illustrated embodiment, the workflow 1050 includes a sequence of steps 1202 that are to be completed in numerical order starting from step 1 and proceeding to the last step, step 24, in this example. Each step 1202 may include a corresponding description 1204. The description1204 may provide a brief indication of what the step 1202 accomplishes.	304	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the system 1000 may present the sequence of steps 1202 to a user 1002 by way of a user interface. The system 1000 may also present the descriptions 1204 to the user 1002 in the user interface.	305	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13A illustrates an exemplary user interface 1300 for one step of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. The user interface 1300 may be one implementation of an I/O interface 910. The user interface 1300 may be a user interface developed specifically for use with the system 1000. Alternatively, or in addition, the user interface 1300 may be a user interface for a modeling computer program product and the patient-specific device design apparatus 450 may comprise an add-in or plugin that operates with the modeling computer program product. Examples of a suitable modeling computer program product include Solidworks, AutoCAD, and the like.	306	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The user interface 1300 may include one or more control panes 1302, a canvas 1304, and a workflow pane 1306. The one or more control panes 1302 include a set of buttons, icons, text information, menu items, and/or other controls to enable a user 1002 to access, modify, store, update, retrieve and/or work with one or more models. Using controls in the one or more control panes 1302 a user can load a model, store a model, change model, delete a model, and/or initiate fabrication of a physical device based on the model.	307	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The canvas 1304 presents a model to the user and enables a user to interact with the model including changing the view and/or perspective, the coordinate system, the color of the model or parts of the model, use and/or apply tools to the model to take measurements, identify vertices, identify planes, implement cuts or resections on the model, define longitudinal axes, and the like. In FIG. 13A, the canvas 1304 displays a bone model 404 of first metatarsal 208 with the base or proximal end of the first metatarsal 208 on the left hand side and the head of the first metatarsal 208 on the right hand side.	308	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The workflow pane 1306 illustrates and/or presents a sequence of steps 1202 of the workflow 1050 to the user 1002 in the user interface 1300. The canvas 1304 presents one or more models to a user 1002 in the user interface 1300. The workflow pane 1306 may present the sequence of steps 1202 in order from top to bottom, with the first step shown at the top of the workflow pane 1306 and the last step shown at the bottom of the workflow pane 1306. Of course, not all the steps of the workflow 1050 may be visible at once and the workflow pane 1306 may include a scroll bar to enable the user 1002 to see a subset of the sequence of steps 1202.	309	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Advantageously, embodiments of the present disclosure enable both a user 1002 and the system 1000 to interact with, and manipulate, and/or modify one or more models either each alone and independently and/or together in a joint effort. In this manner, the efficiencies of using the system 1000 and the expertise of the user 1002 are leveraged together in generating a patient-specific device 1090.	310	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the workflow 1050 may include steps that are performed exclusively by the system 1000 and others that are performed exclusively by the user 1002. In the one embodiment, steps that are to be performed exclusively by the system 1000 may be indicated by a particular icon, such a robot head icon 1308 while steps that are to be performed exclusively by a user 1002 may be indicated by a particular icon, such a person head icon 1310. In another embodiment, certain steps may be performed by the system 1000 or patient-specific device design apparatus 450 and subsequently may be modified, revised, and/or adapted by a user 1002.	311	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the patient-specific device design apparatus 450 manipulates a model 1312. Those of skill in the art will appreciate that the model 1312 may be any model including a bone model 404 of one or more bones of a patient and/or a patient-specific device model 1072, either alone and separate or together presented at once within the canvas 1304. The illustrated embodiment includes bone model 404 of a first metatarsal 208.	312	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the patient-specific device design apparatus 450 may include computer program code, executable code, that includes a set of instructions in the code to manipulate the model 1312 according to a particular step in the sequence of steps 1202. After the code completes the particular step, a subsequent step may be performed by the user 1002.	313	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the patient-specific device design apparatus 450 does not manipulate the model 1312 until after receiving an instruction from the user 1002. Of course, the instruction from the user 1002 can take a variety of forms. For example, in one embodiment, the instruction from the user 1002 may be an explicit instruction for the patient-specific device design apparatus 450 to implement a step of the sequence of steps 1202 in response to a user 1002 activating a control of the user interface 1300. For example, a “continue” button 1313 may be displayed to a user that the user can use to provide instruction for the patient-specific device design apparatus 450 to implement a current step in the sequence of steps 1202. Alternatively, or in addition, the user interface 1300 may include a “start” control button 1315 associated with a step (e.g., (presented near the step on the workflow pane 1306) and the patient-specific device design apparatus 450 may not initiate that particular step until the user activates that “start” control.	314	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the system 1000 has completed the first step, step 1 and the workflow 1050 has advanced to the second step. In the first step, the system 1000 may perform some initialization and/or setup functions for using the model 1312. In one example, the system 1000 may load one or more STL files as a solid 3D object(s) and present this object as the model 1312 to a user, with a desired orientation, view, perspective, and/or coloring. Advantageously, the system 1000 may perform certain steps faster and more efficiently than a user 1002. Alternatively, or in addition, steps the system 1000 may perform may be more routine, repetitive, or mundane. Other steps of the sequence of steps 1202 may be reserved or designated for the user 1002 and may require a higher degree of skill, precision, experience, and/or expertise.	315	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The system 1000 may highlight 1314 the step of the workflow 1050 currently being performed. Those of skill in the art will appreciate that the highlight 1314 may take a variety of forms including a bounding box, a background coloring, animations, and the like.	316	Added by DJM Jan 2024	1/6/24, 10:05 PM

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