Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
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 patient-specific device design apparatus 450 is configured to generate, or facilitate generation, of a patient-specific device configured to facilitate remediating a condition present in a patient’s foot. The patient-specific device design apparatus 450 includes a receiver module 1060, a navigation module 1070, and a fabrication module 1080.	271	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The receiver module 1060 receives a set of work instructions 1040 for a patient-specific device. The set of work instructions 1040 may include a workflow 1050. In another embodiment, the receiver module 1060 may retrieve the set of work instructions 1040 from a location on a storage device 914 and/or from a remote location over a network. In certain embodiments, a user 1002 may identify or define the set of work instructions 1040 for the patient-specific device design apparatus 450 to use.	272	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The workflow 1050 defines a sequence of steps to be performed in order to generate the patient-specific device. Alternatively, the workflow 1050 defines a sequence of steps to be performed in order to generate instructions that can be used by a manufacturing tool to generate the patient-specific device. In certain embodiments, the sequence of steps can be completed in any order. In another embodiment, the sequence of steps indicates a predefined sequence that must be completed successfully in order to generate the patient-specific device. In the illustrated embodiment, the workflow 1050 is identified by and/or included in the set of work instructions 1040. Alternatively, the workflow 1050 may be defined in memory 906. The workflow 1050 may be stored and/or defined in a variety of formats including in a file in binary format, in XML format, in text format, or the like.	273	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, a workflow 1050 may be referred to as a recipe or a checklist, a set of steps that are known to lead to a desired result once followed by and completed. In certain embodiments, a workflow 1050 is to be followed and each step completed in an exact order such that the goal of the workflow 1050, the outcome is accomplished. The workflow 1050 ensures that a desired patient-specific device is generated or instructions for generating a patient-specific device is generated in a consistent and reliable manner. Advantageously, by using implementations of the present disclosure a single workflow 1050 that could be performed manually is scaled to produce a high number of patient-specific devices in a very consistent, reliable, and dependable manner.	274	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The receiver module 1060 provides the workflow 1050 to the navigation module 1070. The navigation module 1070 navigates the workflow 1050 to generate one or more models for use in generating the patient-specific device. Said another way, the navigation module 1070 traverses the steps of the workflow 1050 in an appropriate order. If the workflow 1050 requires that the steps be done in a specific order, the navigation module 1070 progresses through the steps according to that specified order. If the workflow 1050 does not require that the steps be done in a specific order, the navigation module 1070 may use any of a variety of algorithms to determine which step to implement first and which step to implement next until all the steps of the workflow 1050 are completed.	275	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the navigation module 1070 is configured to navigate and/or traverse through the steps of the workflow 1050 together with the user 1002. In one embodiment, the navigation module 1070 may communicate or interact with the I/O interface 910 to present (e.g., display device 916) the workflow 1050 to a user, receive instructions (e.g., input device 918) from a user 1002, and interact with a user 1002, as the user 1002 and navigation module 1070 navigate the workflow 1050 together. Navigating the workflow 1050 together with a user 1002 can mean different things depending on the embodiment.	276	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the workflow 1050 can include an ordered sequence of steps from a first step to a last/final step. Each of these steps may be required to be done in order to successfully generate the patient-specific device 1090. In such an embodiment, certain steps of the workflow 1050 may be performed independently by the patient-specific device design apparatus 450 while other steps of the workflow 1050 are performed by the user 1002. For example, in one embodiment, an initial step of the workflow 1050 may be performed by the patient-specific device design apparatus 450 and the next step may be performed by the user 1002. In such an example, the order of steps may alternate between one done by the patient-specific device design apparatus 450 and one done by the user 1002 until all the steps are completed. In this manner, this is one example of the navigation module 1070 navigating the workflow 1050 together with the user 1002.	277	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In another embodiment, a user 1002 may direct the navigation module 1070 regarding which steps to perform and in which order. Alternatively, or in addition, the user 1002 may perform certain steps of the workflow 1050 and direct the navigation module 1070 to perform other steps of the workflow 1050. For certain steps of the workflow 1050, one step may depend on another being completed prior to that step. In such circumstances, the navigation module 1070 may alert the user 1002 to this requirement and ensure that such order between these two steps is enforced. Alternatively, or in addition, the navigation module 1070 may alert the user 1002 to the requirement but permit the user 1002 to override the requirement.	278	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In still another embodiment, certain steps can be performed by either the user 1002 or the patient-specific device design apparatus 450, in such circumstances, a user 1002 may designate whether the patient-specific device design apparatus 450 should perform one or more steps or whether the user 1002 will perform the one or more steps. In certain cases, where the patient-specific device design apparatus 450 performs the one or more steps, the user 1002 may review the work performed by the patient-specific device design apparatus 450 and revise the work performed, as needed.	279	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, one or more steps in a workflow 1050 may require a high degree of accuracy and/or expertise consequently such steps may be designated and/or reserved for a user 1002 to perform. For example, certain steps may set or define one or more reference features that may be relied upon in other steps. One example of a reference feature may be a specific cut plane/face or a specific longitudinal axis for a bone or a position, location, and/or depth of a guide pin such as a K-wire. Each or any combination of these reference features may serve as markers or guides for other components or steps in a surgical technique and/or in the design and/or fabrication of a patient-specific device. Accordingly, steps that identify, locate, and/or define such reference features may be reserved for a trained operator and/or user 1002 to perform. In certain embodiments, such steps of a workflow 1050 may be referred to as “key steps.” In one embodiment, only the user 1002 may perform key steps. In another embodiment, the patient-specific device design apparatus 450 may perform a key step initially and the outcome of such a step may be checked, verified, confirmed, revised, reworked, and/or, redone based on the user 1002 assessment of the outcome of the performance by the patient-specific device design apparatus 450.	280	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	A workflow 1050 that includes key steps can provide valuable safeguards and benefits for applications of the embodiments of the present disclosure. For example, in the medical industry where the goal is high quality outcomes and mitigation of any, many, all, or substantially all risks and/or complications, including key steps in the workflow 1050 provides assurances that patient-specific devices generated using the embodiments of the present disclosure will have the highest of standards in quality and performance. Such benefits can increase confidence and trust in the patient-specific device generated and the surgical procedures that use them.	281	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, generation of the patient-specific device 1090 may be dependent on one or more anatomical structures of the patient. Consequently, certain steps of the workflow 1050 may relate to preparing and/or positioning and/or orienting models of those anatomical structures for use in designing/defining the patient-specific device 1090. Said another way, the preparing, positioning, orienting, or the like of models of anatomical structures and/or the defining or identification of reference features relative to those anatomical structures may serve as one or more key steps in a workflow 1050.	282	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Accordingly, in certain embodiments, the navigation module 1070 may navigate the workflow 1050 together with a user 1002 both to generate a bone model 404 and to generate a patient-specific device model 1072 configured specifically to a patient. Alternatively, or in addition, the navigation module 1070 may navigate the workflow 1050 together with a user 1002 to generate one or the other of a bone model 404 and a patient-specific device model 1072 configured specifically to a patient. In still another embodiment, the navigation module 1070 may navigate the workflow 1050 together with a user 1002 to generate one or the other of a bone model 404 and a patient-specific device model 1072 configured specifically to a patient and the other model may be generated exclusively by the navigation module 1070 navigating the workflow 1050 without the user 1002.	283	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the navigation module 1070 navigates the workflow 1050 together with a user 1002 to generate a bone model 404 of a patient’s foot based on medical imaging of the patient’s foot. In one embodiment, the medical imaging takes the form of STL files generated by a segmentor 1020 or autosegmentor. Alternatively, or in addition, the medical imaging may be provided in the form of DICOM files or any other suitable form of medical imaging that the patient-specific device design apparatus 450 is configured to recognize.	284	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The bone model 404 is configured to match the anatomy of the patient’s foot. This means that whatever abnormality, condition, and/or indication present in the patient’s foot is modeled and/or represented and/or reflected in the bone model 404. Thus, an abnormality or deformity in the orientation and/or configuration of bones of the patient’s foot is included in the bone model 404. Advantageously, modeling anatomy that includes an abnormality or a deformity that may be caused by trauma, disease, or natural processes, enables the abnormality or deformity to be addressed in the bone model 404 and remediation steps for the abnormality or deformity to be used for generation of a patient-specific device.	285	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

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