Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	The segmentor 1020 may be configured to accept one or more DICOM files as input and generate models of one or more internal structures, such as bones, captured and/or represented in the DICOM files. In one embodiment, the segmentor 1020 is configured to generate output files in a common or standard format that other systems, software, programs, or devices can interpret and/or understand. For example, the segmentor 1020 may generate Stereolithography (STL) files.	265	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the segmentor 1020 may be a module and/or subsystem within the system 1000. Alternatively, or in addition, the segmentor 1020 may be an independent system and/or apparatus specifically configured to accept DICOM files (medical imaging 1030) as input and generated STL files that define models of anatomical structures represented in the DICOM files. Alternatively, or in addition, the segmentor 1020 may be specifically configured to distinguish certain types of anatomy in the DICOM files such as bones as opposed to other anatomy such as soft tissue. In certain embodiments, the segmentor 1020 may be operated by a user/operator that interacts with the segmentor 1020 using a user interface to manually review and complete an image segmentation process.	266	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the segmentor 1020 may comprise an advanced computer analysis system such as software, a software add-in, and/or systems that implement one or more artificial intelligence methods (e.g., machine learning and/or neural networks (e.g., ANN, GAN, or the like)) for deriving, determining, or extrapolating, anatomic structures from medical imaging 1030. For example, in one embodiment, neural network may be trained to examine DICOM file(s) of a patient’s foot and identify each of the boundaries for each of the bones of the foot captured in the DICOM files. Once identified, the segmentor 1020 may present the identified bones in the form of a bone model that includes at least one bone of a patient’s foot. Additionally, the medical imaging 1030 may be configured to output an STL that defines the bone model such that a modeling computer program product can interpret, display, modify, and/or manipulate the bone model.	267	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the segmentor 1020 is configured to automatically import DICOM files, segment the medical imaging 1030 to identify one or more bone model(s) and automatically export the bone model to a form of medical imaging 1030 referred to herein as STL files. A segmentor 1020 configured to automatically segment medical imaging 1030 and convert the medical imaging 1030 into another form of medical imaging 1030, such as STL files for models of the structures is referred to herein as an autosegmentor. In one embodiment, the segmentor 1020 is an autosegmentor.	268	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Referring to FIG. 10, the system 1000 may include a set of work instructions 1040. The set of work instructions 1040 may include the medical imaging 1030. In one embodiment, the medical imaging 1030 may be provided in the form of STL files that describe models of bones that a modeling computer program product can interpret, display, modify, and/or manipulate. In one embodiment, the set of work instructions 1040 is provided to the patient-specific device design apparatus 450. Alternatively, or in addition, medical imaging 1030 can be provided directly to the patient-specific device design apparatus 450.	269	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, the set of work instructions 1040 provides at least the minimal amount of information, data, files, metadata, and/or resources needed for the patient-specific device design apparatus 450 to generate, or facilitate generation of, a patient-specific device. In the illustrated embodiment, the set of work instructions 1040 includes the medical imaging 1030 in the form of STL files generated by a segmentor 1020. The set of work instructions 1040 may also include a workflow 1050. The set of work instructions 1040 can include a variety of information such as patient identification information, information about the type of surgical procedure to be performed, the surgeon who will do the procedure, a prescription for the procedure and/or the patient-specific device, location information (i.e. file system location, server location, online service credentials, 3rd party facility access credentials, etc.) for the medical imaging 1030, the workflow 1050, and/or a repository of template patient-specific device models for use by the patient-specific device design apparatus 450, and the like.	270	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

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