Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	TMC-PAT-4	In one embodiment, the determination module 410 may use advanced computer analysis system such as image segmentation to determine the anatomic data. The determination module 410 may determine anatomic data from one or more sources of medical imaging data, images, files, or the like. The determination module 410 may perform the image segmentation using 3D modeling systems and/or artificial intelligence (AI) segmentation tools. In certain embodiments, the determination module 410 is configured to identify and classify portions of bone based on a condition of the bone, based on the bone condition. Such classifications may include identifying bone stability, bone density, bone structure, bone deformity, bone structure, bone structure integrity, and the like. Accordingly, the determination module 410 may identify portions or sections or one or more bones based on a quality metric for the bone. Advantageously, that determination module 410 can identify high quality bone having a viable structure, integrity, and/or density versus lower quality bone having a nonviable structure, integrity, and/or density and a plurality of bone quality levels in between.	181	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Accordingly, the determination module 410 can guide a surgeon to determine which areas of one or more bones of a patient are within a “soft tissue envelope” (bone of undesirable quality) as that bone relates to a particular deformity or pathology. Identifying the quality of one or more bones of the patient can aid a surgeon in determining what type of correction or adjustment is needed. For example, an ulceration that occurs due to a boney deformity can be mapped using the determination module 410 in a way that a correction can be performed to correct the deformity and reduce pressure to an area and address the structures that were causing the pressure ulceration/ skin breakdown.	182	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In addition, the determination module 410 and/or another component of the apparatus 402 can be used to perform anatomic mapping which may include advanced medical imaging, such as the use of CT scan, ultrasound, MRI, X-ray, and bone density scans can be combined to effectively create an anatomic map that determines the structural integrity of the underlying bone.	183	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Identifying the structural integrity of the underlying bone can help in determining where bone resections (e.g., osteotomies) can be performed to preserve the densest bone in relation to conditions such as Charcot neuropathic, arthropathy where lesser dense bone can fail and collapse. It is well documented in the literature that failure to address and remove such lesser dense bone can ultimately lead to failure of a reconstruction and associated hardware.	184	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The present disclosure provides, by way of at least the exemplary system 400, an anatomic map that can be part of anatomic data. The anatomic map can combine structural, deformity, and bone density information and can be utilized to determine the effective density of bone and help to determine where bone should be resected in order to remove the lesser dense bone while maintaining more viable bone to aid in the planning of the osteotomy / bone resection placement.	185	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The location module 420 determines or identifies one or more recommended locations and/or trajectory angles for deployment of an instrument and/or soft tissue based on the anatomic data 412 and/or the bone model 404. In one embodiment, the location module 420 may compare the anatomic data 412 to a general model that is representative of most patient’s anatomies and may be free from deformities or anomalies. The location module 420 can operate autonomously and/or may facilitate input and/or revisions from a user. The location module 420 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the determining of the location and/or trajectory angles is.	186	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The provision module 430 is configured to provide a preliminary instrument model 438. The provision module 430 may use a variety of methods to provide the preliminary instrument model. In one embodiment, the provision module 430 may generate a preliminary instrument model. In the same, or an alternative embodiment, the provision module 430 may select a template instrument model for surgical procedure configured to enable locating the position and/or providing the trajectory/trajectories provided by the location module 420. In one embodiment, the provision module 430 may select a template instrument model for a minimally invasive surgical (MIS) bunion correction procedure configured to enable locating the position and/or providing the trajectory for the fixation deployment. In one embodiment, the provision module 430 may select a template instrument model from a set of template instrument models (e.g., a library, set, or repository of template instrument models).	187	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The registration module 440 registers the preliminary instrument model 438 with one or more bones or other anatomical structures of the bone model 404. As explained above, registration is a process of combining medical imaging data, patient imaging data, and/or one or more models such that the preliminary instrument model can be used with the bone model 404.	188	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In certain embodiments, the location module 420, provision module 430, and/or registration module 440 may be used together or one or more of these may be used individually to plan and design instrumentation for a surgical procedure. In one embodiment, the instrumentation designed may be used by a user for the procedure. In another embodiment, the apparatus 402 may include one or more instruments and/or tools that are used together within the apparatus 402 to design, validate, and/or fabricate one or more instruments for a surgical procedure. In one embodiment, the apparatus 402 may design, validate, and/or fabricate one or more patient-specific instruments for a surgical procedure.	189	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	For example, in one embodiment, the bone model 404 may include a plurality of models for a plurality of bones of a patient. The plurality of bones of the patient may be organized and associated with each other in a manner that substantially corresponds to how those same plurality of bones of the patient are organized and associated with each other. Advantageously, this means that any deformity or any patient-specific characteristic or attribute of the patient’s bones is included in the bone model 404. Alternatively, or in addition, the bone model 404 may include one or more soft tissue models or other representations for soft tissue of a patient and include those soft tissue models in substantially the same location and configuration in relation to the plurality of bone models.	190	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In one embodiment, the apparatus 402 includes a user interface 408. The user interface 408 can include software, hardware, and/or a combination of hardware and software that enable a user such as a surgeon and/or a technician to interact with the apparatus 402 and/or one or more modules of the apparatus 402. Accordingly, the user interface 408 may include a display, a keyboard, a mouse, a touch screen, a stylus, a microphone, a speaker, and/or one or more other peripherals that accept input from a user and/or provide output to the user as the user interacts with the apparatus 402.	191	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The user interface 408 may be used to control, operate, and/or interact with any one of the determination module 410, location module 420, provision module 430, registration module 440, design module 450, and manufacturing module 460 either alone and independently and/or in combination of any of them together. Those of skill in the art will appreciate that the user interface 408 may be part of or coupled directly to the apparatus 402. Alternatively, or in addition, the user interface 408 may interface with the apparatus 402 from a remote location over a computer network.	192	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	The user interface 408 can include an operating system, a graphical user interface, and/or one or more other software applications that enable the user to interact with and guide the development of one or more patient-specific instruments 406. In the illustrated embodiment, the user interface 408 may include a plurality of design tools 414. The design tools 414 can be any tool that a user may use to prepare, refine, adjust, plan, design, and/or organize the bone model 404 and/or instruments that are going to be used in a surgical procedure. Examples of design tools 414 include but are not limited to rulers, protractors, alignment guides, model translation and/or rotation tools, spaces, sizers, trial guide models, clamps, forceps, spreaders, distractors, compressors, and the like. In certain embodiments, the design tools 414 may be specific to the apparatus 402. In another embodiment, the design tools 414 may be modeled to represent and/or behave just like actual tools that a user might use.	193	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In one embodiment, the design tools 414 can include a set of digital instruments or digital tools that are configured for use within the apparatus 402 but are not going to be fabricated. For example, in one embodiment, one of the design tools may be a digital fulcrum. The digital fulcrum may operate like a spacer or positioner and may be designed to be positioned between two model bones. Once positioned between two model bones, the digital fulcrum may serve as a fulcrum as a user translates and/or rotates one model bone in relation to another.	194	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	A digital fulcrum design tool 414 can be useful in planning for a particular surgical procedure, such as a Lapidus procedure. In a Lapidus procedure, a user may seek to move a first metatarsal 208 until the longitudinal axis of the first metatarsal 208 is parallel or near parallel to a longitudinal axis of a second metatarsal 210. A digital fulcrum design tool 414 may include a body connected to a handle. The body may be sized, shaped, and/or configured to fit between a base of a bone model of the first metatarsal 208 and the base of a bone model of the second metatarsal 210. The handle facilitates positioning and manipulating the digital fulcrum design tool 414.	195	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Once a digital fulcrum design tool 414 is positioned, the body maintains a desired spacing between the bone model of the first metatarsal 208 and the bone model of the second metatarsal 210 as a user manipulates the bone model of the first metatarsal 208. A user may manipulate the bone model of the first metatarsal 208 to put the bone model of the first metatarsal 208 in a corrected position for planning the Lapidus surgical procedure.	196	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	With the digital fulcrum design tool 414 in position and the bone model of the first metatarsal 208 and the bone model of the second metatarsal 210 in a desired position and/or orientation relative to each other. A user can now proceed with the planning and design of one or more instruments for use in the surgical procedure. In particular, a user can plan and design positions and orientations for one or more fasteners, for a resection guide (which can be patient-specific), for one or more resection features, and for one or more other instruments the user plans to use in the surgical procedure.	197	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	Advantageously, the digital fulcrum design tool 414 enables a user to do in a virtual environment the same steps that the user might do in an actual environment during a surgical procedure. For example, in certain surgical procedures, a user may manipulate the position of the first metatarsal 208 in relation to the second metatarsal 210 and use a physical fulcrum instrument or positioner to guide this positioning and/or manipulation. In such a technique, the physical fulcrum instrument or positioner may remain in place as a surgeon determines position and/or trajectories for one or more fasteners and/or guides such as a resection guide. Using the system 400, a user can determine the positions and/or trajectories for fasteners (e.g., K-wires or pins), a resection guide, patient-specific aspects of the resection guide or other instrumentation, in the virtual environment. Those determinations can be preserved by the features created in a patient-specific instrument 406 fabricated using the apparatus 402. For example, holes formed in a resection guide may be positioned and oriented based on a configuration done using the apparatus 402. Fasteners or pins deployed into one or more bones of a patient through the holes may be used to secure a resection guide and then subsequently used to translate and/or rotate the one or more bones during a reduction and/or subsequent fusion of the one or more bones (e.g., a compressor may slide over the fasteners to assist in a reduction).	198	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In one embodiment, the digital fulcrum design tool 414 has a standard size and/or one of a plurality of standard sizes. Alternatively, or in addition, the digital fulcrum design tool 414 is patient-specific and may be generated virtually using the methods and/or apparatuses described herein.	199	Added by DJM Jan 2024	1/3/24, 4:24 AM
View Edit Delete	TMC-PAT-4	In certain embodiments, the digital fulcrum design tool 414 enables a user to work with models of bones of a patient using the apparatus 402 in a similar manner to how the user would work with the actual bones of the patient during a surgical procedure. In this manner, the digital fulcrum design tool 414 can assist a user in planning a surgical procedure such that adjustments can be made as needed to ensure a successful outcome.	200	Added by DJM Jan 2024	1/3/24, 4:24 AM

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