Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	As explained herein, the system 1000 may be configured to generate a patient-specific device 1090 and/or a complementary devices 1094 such as a 1 to 1 three dimensional model of the bones of a patient’s foot. In such an embodiment, the workflow 1050 or another workflow 1050 of the set of work instructions 1040 may include a step for interconnecting the bone models of the model 1312. Those of skill in the art will appreciate that the bones of a patient are generally naturally interconnected by soft tissue. Such soft tissue is generally a challenge to represent and model in a modeling computer program product and information about such soft tissue may not be captured in medical imaging 1030. Consequently, the bone models in the user interface 1300 may be in the correct position and orientation relative to each other, however there may be no physical connections between each of the bone models.	352	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the medical imager 1010 is configured to communicate with the segmentor 1020 and can provide medical imaging 1030 for one or more patients to the segmentor 1020 for processing. Similarly, the segmentor 1020 may communicate with the medical imaging 1030 and report on the progress of this processing of medical imaging 1030. Alternatively, or in addition, both the medical imager 1010 and the segmentor 1020 are configured to communicate with the computing device 902.	364	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	As in the system 1000, the segmentor 1020 of the system 1400 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 1404 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.	363	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 may be configured and/or may include code executable by the processor 904 to coordinate operations between the computing device 902, the medical imager 1010, and/or the segmentor 1020. In the illustrated embodiment, the segmentor 1020 is an autosegmentor meaning the segmentor 1020 is configured to segment medical imaging 1030 without any operator or user assistance and/or intervention.	362	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the system 1400 and certain of its components are distributed and may communicate with each other over a communication network 1402, such a computer network. The communication network 1402 may include the Internet, a wide area network ("WAN"), a metropolitan area network ("MAN"), a local area network ("LAN"), a token ring, a wireless network, a fiber channel network, a SAN, network attached storage ("NAS"), ESCON, or the like, or any combination of networks. The communication network 1402 may also include a network from the IEEE 802 family of network technologies, such Ethernet, token ring, Wi-Fi, WiMax, and the like. The communication network 1402 may include servers, switches, routers, cabling, radios, and other equipment used to facilitate networking computing device 902 and clients such as a medical imager 1010 and/or a segmentor 1020. In one embodiment, the system 1400 includes multiple computing devices 902 that communicate as peers over a communication network 1402. One of skill in the art will recognize other communication network 1402 comprising one or more communication network 1402 and related equipment with single or redundant connections between one or more clients.	361	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 14 illustrates an exemplary system 1400 configured to design a patient-specific device 1090, according to one embodiment. The system 1400 may have many structures, features, and functions, operations, and configuration similar or identical to those of the system 1000 described in relation to FIG. 10 and the system 900 and the computing device 902 described in relation to FIG. 9, like parts are identified with the same reference numerals. Accordingly, the system 1400 may include a medical imager 1010, a segmentor 1020, and a computing device 902. The computing device 902 may include a processor 904, a memory 906 that stores executable code for a patient-specific device design apparatus 450, and a storage device 914.	360	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Once the user 1002 completes step 2, the user 1002 may advance the second workflow 1350 by activating a control such as control 1317, indicating that this step is completed. The second workflow 1350 may continue until all steps are completed in the design and/or generation of the patient-specific device model 1072 which can then be used to fabricate a patient-specific device 1090 that matches the patient-specific device model 1072.	359	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The workflow 1350 in step 2 is indicated by highlight 1314. In this step a user 1002 or operator may position the patient-specific device model 1072 in relation to the bone model of the medial cuneiform 202, the first metatarsal 208 in a deformed condition 1330, and the MTP joint between these bones. In certain embodiments, such a step may require the experience, skill, and expertise of the user 1002 to ensure desired outcomes, meet the requirements of a prescription 1100 and/or meet the preferences of a surgeon. One goal in this step may be to ensure that the inferior side of the patient-specific device model 1072 seats well on the surface of the model of the first metatarsal 208 and the medial cuneiform 202 and at least part of the patient-specific device model 1072 extends down into a space of the MTP joint. Such positioning, especially with such small devices such as the patient-specific device model 1072 can be of great assistance to a surgeon during a surgical procedure in positioning a patient-specific device 1090, fabricated to match the patient-specific device model 1072, into the same position on the patient as positioned in the model 1312.	358	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Also note, that the patient-specific device model 1072 includes an initial resection feature 1352 (e.g., cut channel, or cut slot) but does not yet have a resection feature for an osteotomy of the medial cuneiform. In one embodiment, the patient-specific device model 1072 may be, or may be based on, a template patient-specific device model available from a repository 802. In certain embodiments, the initial resection feature 1352 is already designed into the patient-specific device model 1072 and configured to be perpendicular to the longitudinal axis of the first metatarsal 208 in a deformed condition 1330. Those of skill in the art will appreciate that the initial resection feature 1352 may have more or fewer features predesigned and positioned to facilitate the development of a final patient-specific device model 1072. In the illustrated embodiment, the patient-specific device model 1072 may also initially include a set of distal holes sized and positioned to receive pins such as K-wires and/or a distal hole for a distal K-wire during a surgical procedure.	357	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	At this stage, the workflow 1350 has progressed to step 2. In step 1, the system 1000 has loaded a bone model 404 that includes a set of active models 1316 and a set of context models 1318. The set of active models 1316 includes a first metatarsal 208 in a deformed condition 1330, a first proximal phalange in a deformed condition 1332, and a first distal phalange in a deformed condition 1334. In addition, the system 1000 has added a patient-specific device model 1072 to the assembly that includes the bone model 404. Note that the system 1000 has positioned the patient-specific device model 1072 at an initial position across a MTP joint of the first metatarsal bone model in a deformed condition 1330.	356	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13E illustrates an embodiment that includes a single set of work instructions 1040 that includes two workflows 1050. A first workflow 1050 may be for preparing and/or working with a bone model 404, as described above, and the second workflow 1050 may be for preparing, working with, and/or generating a patient-specific device 1090. The first workflow 1050 has been completed and a user 1002 has initiated the second workflow 1350. FIG. 13E illustrates an exemplary user interface 1300 for one step, one stage, of a second workflow 1350 for generating a patient-specific device 1090, according to one embodiment.	355	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Those of skill in the art will appreciate that the set of work instructions 1040 may include a single workflow 1050 for generating a bone model 404, for generating a bone model 404 and a patient-specific device model 1072, for generating a bone model 404, a patient-specific device model 1072, and a patient-specific device 1090, for generating a bone model 404, a patient-specific device model 1072, a patient-specific device 1090, and a preoperative plan 1092, and/or for generating a bone model 404, a patient-specific device model 1072, a patient-specific device 1090, a preoperative plan 1092, and one or more complementary devices 1094. Alternatively, or in addition, the variety of models, patient-specific devices 1090, preoperative plans 1092, and/or complementary devices 1094 can be generated using a plurality of workflows 1050 and/or using separate sets of work instructions 1040.	354	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In one embodiment, particularly, where a surgeon has requested a three dimensional model of the bones of the patient (e.g., a complementary devices 1094), the workflow 1050 of the system 1000 may include a step in which a user 1002 and/or the patient-specific device design apparatus 450 adds one or more connectors between two bone models of the model 1312 (e.g., a bone model 404). In one embodiment, each proximal end of a bone model may be interconnected to an adjacent bone model where a joint exists. The connector may be any connector. In one embodiment, the connector may be a structure created by a user 1002 in the user interface 1300 that joins two bones across one or more joints and is made of the same material that is used to fabricate the 1 to 1 three dimensional model of the bones of a patient’s foot, by the fabrication module 1080.	353	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	The medical imaging 1030 of the bones of a patient are represented in the same position and orientation to each other as in the foot of the patient. In certain embodiments of the present disclosure, same position and/or orientation of the bones of the patient in the medical imaging 1030 is maintained as the medical imaging 1030 is used to generate the active models 1316 and the context models 1318 presented to a user 1002 in the canvas 1304.	346	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the model 1312 may include a bone model 404 that includes bone models for bones as those bones existed when the medical imaging 1030 was generated. In addition, where one or more osteotomies are to be performed, the model 1312 may also include a bone model for each bone that is to receive an osteotomy. For example, where a Lapidus procedure is to be performed on a patient, the model 1312 may include a bone model 404 that includes an active model 1316 of a first metatarsal 208 and an active model 1316 of a medial cuneiform 202 in the same condition as these bones are when the medical imaging 1030 was generated. In addition, the model 1312 may include in the set of active models 1316, a cut first metatarsal 208 model and a cut medial cuneiform 202 model. The cut versions of these models may be used in the workflow 1050 to design a patient-specific device 1090 based on where those cuts are in the respective models.	341	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13D illustrates an exemplary user interface 1300 for one step, one stage, of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. At this stage, the workflow 1050 has progressed to step 22. In the highlighted 1314 step 22, a user, different from a first user that may have completed a plurality of prior steps in the sequence of steps 1202, may complete step 22. Having another user do one or more steps in the sequence of steps 1202 can provide a safeguard against inadvertent errors and/or mistakes in completing the workflow 1050.	342	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the other user that performs step 22 may be quality control user who reviews the model 1312 of the bone model 404. A quality control user is a user who may have more experience and/or possess more skill and/or expertise than a primary user executing steps of the workflow 1050. Alternatively, or in addition, the quality control user may possess additional training, certifications, and/or licenses than the primary user. The quality control user may review the model 1312, one or more bone model 404, a set of active model 1316, a set of context model 1318, a patient-specific device model 1072, a set of work instructions 1040, a prescription 1100, as well as any logs or notes the primary user is expected to maintain in order to confirm that the steps of the workflow 1050 have been performed to a desired level of quality and excellence. If the quality control user identifies something that can or should be corrected, the quality control user may instruct a user 1002 to make the correction and/or the quality control user may interact with the model 1312 to make the correction.	343	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	After completing step 22, a quality control user or a primary user 1002 may signal that the workflow 1050 can continue and the system 1000 can start step 23 by activating a control labeled “I’m done.”	344	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13D illustrates the set of active models 1316 and the context models 1318 together in the canvas 1304. Advantageously, the bone models shown on the canvas 1304 are in a three dimensional space and oriented in the same position and/or configuration as the bones of a patient when the medical imaging 1030 was captured. Those of skill in the art will appreciate that a medical imager 1010 may user a coordinate system to provide a main point of reference for the anatomical structures captured in the medical imaging 1030.	345	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Similarly, if there is no abnormality and/or deformity present in the bones of the patient, the model 1312 reflects that no abnormality and/or deformity is present. In certain cases, a patient may coordinate with a surgeon to perform a surgical procedure for more cosmetic and/or aesthetic reasons rather than to correct or address a deformity. Those of skill in the art will appreciate that the present disclosure can be used for those cases as well.	349	Added by DJM Jan 2024	1/6/24, 10:05 PM

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