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Delete 		PER-16 As used herein, "medical imaging" refers to a technique and process of imaging the interior of a body for clinical analysis and medical intervention, as well as visual representation of the function of some organs or tissues (physiology). Medical imaging seeks to reveal internal structures hidden by the skin and bones, as well as to diagnose and treat disease. Medical imaging may be used to establish a database of normal anatomy and physiology to make possible identification of abnormalities. Medical imaging in its widest sense, is part of biological imaging and incorporates radiology, which uses the imaging technologies of X-ray radiography, magnetic resonance imaging, ultrasound, endoscopy, elastography, tactile imaging, thermography, medical photography, nuclear medicine functional imaging techniques as positron emission tomography (PET) and single-photon emission computed tomography (SPECT). Another form of X-ray radiography includes computerized tomography (CT) scans in which a computer controls the position of the X-ray sources and detectors. Magnetic Resonance Imaging (MRI) is another medical imaging technology. Measurement and recording techniques that are not primarily designed to produce images, such as electroencephalography (EEG), magnetoencephalography (MEG), electrocardiography (ECG), and others, represent other technologies that produce data susceptible to representation as a parameter graph vs. time or maps that contain data about the measurement locations. In certain embodiments bone imaging includes devices that scan and gather bone density anatomic data. These technologies may be considered forms of medical imaging in certain disciplines. (Search "medical imaging" on Wikipedia.com June 16, 2021. CC-BY-SA 3.0 Modified. Accessed June 23, 2021.) Data, including images, text, and other data associated with medical imaging is referred to as patient imaging data. As used herein, "patient imaging data" refers to data identified, used, collected, gathered, and/or generated in connection with medical imaging and/or medical imaging data. Patient imaging data can be shared between users, systems, patients, and professionals using a common data format referred to as Digital Imaging and Communications in Medicine (DICOM) data. DICOM data is a standard format for storing, viewing, retrieving, and sharing medical images. 82 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 As used herein, "medical image computing" or "medical image processing" refers to systems, software, hardware, components, and/or apparatus that involve and combine the fields of computer science, information engineering, electrical engineering, physics, mathematics and medicine. Medical image computing develops computational and mathematical methods for working with medical images and their use for biomedical research and clinical care. One goal for medical image computing is to extract clinically relevant information or knowledge from medical images. While closely related to the field of medical imaging, medical image computing focuses on the computational analysis of the images, not their acquisition. The methods can be grouped into several broad categories: image segmentation, image registration, image-based physiological modeling, and others. (Search "medical image computing" on Wikipedia.com June 24, 2021. CC-BY-SA 3.0 Modified. Accessed June 24, 2021.) Medical image computing may include one or more processors or controllers on one or more computing devices. Such processors or controllers may be referred to herein as medical image processors. Medical imaging and medical image computing together can provide systems and methods to image, quantify and fuse both structural and functional information about a patient in vivo. These two technologies include the transformation of computational models to represent specific subjects/patients, thus paving the way for personalized computational models. Individualization of generic computational models through imaging can be realized in three complementary directions: definition of the subject-specific computational domain (anatomy) and related subdomains (tissue types); definition of boundary and initial conditions from (dynamic and/or functional) imaging; and characterization of structural and functional tissue properties. Medical imaging and medical image computing enable the translation of models to the clinical setting with both diagnostic and therapeutic applications. (Id.) In certain embodiments, medical image computing can be used to generate a bone model, a patient-specific model, and/or a patent specific instrument from medical imaging and/or medical imaging data. 83 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 As used herein, "model" refers to an informative representation of an object, person or system. Representational models can be broadly divided into the concrete (e.g., physical form) and the abstract (e.g. behavioral patterns, especially as expressed in mathematical form). In abstract form, certain models may be based on data used in a computer system or software program to represent the model. Such models can be referred to as computer models. Computer models can be used to display the model, modify the model, print the model (either on a 2D medium or using a 3D printer or additive manufacturing technology). Computer models can also be used in environments with models of other objects, people, or systems. Computer models can also be used to generate simulations, display in virtual environment systems, display in augmented reality systems, or the like. Computer models can be used in Computer Aided Design (CAD) and/or Computer Aided Manufacturing (CAM) systems. Certain models may be identified with an adjective that identifies the object, person, or system the model represents. For example, a "bone" model is a model of a bone, and a "heart" model is a model of a heart. (Search "model" on Wikipedia.com June 13, 2021. CC-BY-SA 3.0 Modified. Accessed June 23, 2021.) As used herein, “additive manufacturing” refers to a manufacturing process in which materials are joined together in a process that repeatedly builds one layer on top of another to generate a three-dimensional structure or object. Additive manufacturing may also be referred to using different terms including: additive processes, additive fabrication, additive techniques, additive layer manufacturing, layer manufacturing, freeform fabrication, ASTM F2792 (American Society for Testing and Materials), and 3D printing. Additive manufacturing can build the three-dimensional structure or object using computer-controlled equipment that applies successive layers of the material(s) based on a three-dimensional model that may be defined using Computer Aided Design (CAD) software. Additive manufacturing can use a variety of materials including polymers, thermoplastics, metals, ceramics, biochemicals, and the like. Additive manufacturing may provide unique benefits, as an implant together with the pores and/or lattices can be directly manufactured (without the need to generate molds, tool paths, perform any milling, and/or other manufacturing steps). 84 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 "Repository" refers to any data source or dataset that includes data or content. In one embodiment, a repository resides on a computing device. In another embodiment, a repository resides on a remote computing or remote storage device. A repository may comprise a file, a folder, a directory, a set of files, a set of folders, a set of directories, a database, an application, a software application, content of a text, content of an email, content of a calendar entry, and the like. A repository, in one embodiment, comprises unstructured data. A repository, in one embodiment, comprises structured data such as a table, an array, a queue, a look up table, a hash table, a heap, a stack, or the like. A repository may store data in any format including binary, text, encrypted, unencrypted, a proprietary format, or the like. 85 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 "Reference” refers to any apparatus, structure, device, system, component, marking, and/or indicator organized, configured, designed, engineered, and/or arranged to serve as a source of information or a point of comparison used to support or establish knowledge, truth, or quality. (© ChatGPT Jan. 9 Version, Modified, accessed chat.openai.com/chat Jan. 28, 2023). In certain embodiments, a reference can serve as a starting point or initial position for one or more steps in a surgical procedure. A reference may be a type of fiducial. In certain embodiments, “reference” can be with an adjective describing the reference. For example, a “model reference” is a reference within a model such as a computer model. A model reference refers to any feature, aspect, and/or component within a model. Examples of a model reference include, but are not limited to, a point, a plane, a line, a plurality of points, a surface, an anatomical structure, a shape, or the like. An “anatomical reference” is a reference within, on, near, or otherwise associated with an anatomical structure such as a bone. A reference (e.g., model, actual, virtual, and/or real) may also be referred to as a reference feature. 86 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 “Reference feature” refers to a feature configured for use as a point, plane, axis, or line of reference (aka a reference). A reference or reference feature can be used to position, measure, orient, fixation, couple, engage, and/or align one object or structure with another object or structure. In certain embodiments, a reference or reference feature can serve as a baseline, a ground truth, a waypoint, a control point, a landmark, and/or the like. A reference feature can facilitate moving from one coordinate system or frame of reference in a virtual environment to a position, location, frame of reference, environment, or orientation on, or in, an actual object, structure, device, apparatus, anatomical structure, or the like. Advantageously, a reference feature can coordinate objects, models, or structures in a digital or virtual model or representation with corresponding objects or structures (e.g., anatomical structures) of actual physical objects or structures. Said another way, a reference feature can serve to map from a virtual or modeled object to an actual or physical object. 87 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 As used herein, "feature" refers to a distinctive attribute or aspect of something. (Search "feature" on google.com. Oxford Languages, 2021. Web. 20 Apr. 2021.) A feature may include one or more apparatuses, structures, objects, systems, sub-systems, devices, or the like. A feature may include a modifier that identifies a particular function or operation and/or a particular structure relating to the feature. Examples of such modifiers applied to a feature, include, but are not limited to, "attachment feature," "alignment feature," "securing feature," "placement feature," "protruding feature," "engagement feature," "disengagement feature," “resection feature”, “guide feature”, "alignment feature," and the like. 88 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 As used herein, a "marking" or "marker" refers to a symbol, letter, lettering, word, phrase, icon, design, color, diagram, indicator, figure, structure, device, apparatus, surface, component, system, or combination of these designed, intended, structured, organized, configured, programmed, arranged, or engineered to communication information and/or a message to a user receiving, viewing, or encountering the marking. The marking or "marker" can include one or more of a tactile signal, a visual signal or indication, an audible signal, and the like. In one embodiment, a marking may comprise a number or set letters, symbols, or words positioned on a surface, structure, color, color scheme, or device to convey a desired message or set of information. 89 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 As used herein, a "protrusion" refers to a structure or portion of a structure that protrudes or extends from at least one other structure such as a surface of the at least one other structure. Generally, the other structure is connected to, or in contact with, the protrusion. 90 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 "Set" refers to a collection of objects. A set can have zero or more objects in the collection. Generally, a set includes one or more objects in the collection. 91 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 Exemplary embodiments of the disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the disclosure but is merely representative of exemplary embodiments. 1 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		PER-16 The phrases "connected to," "coupled to" and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase "fluid communication" refers to two features that are connected such that a fluid within one feature can pass into the other feature. 2 Added by DJM Jan 2024 1/3/24, 4:26 AM
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Delete 		TMC-PAT-4 In another example, the anatomical data about a patient available from the medical imaging and/or a model of patient anatomy (e.g., bone model) can be used to define other instruments for a surgical procedure. For example, when a Lapidus procedure is performed it can be helpful to have a positioner that can be placed between the first metatarsal 208 and the second metatarsal 210 to position the first metatarsal 208 for the surgical procedure. The positioner can be patient-specific and/or can be patient-matched (patient-matched refers to an instrument or device that is selected from a set of pre-fabricated instruments or devices to satisfactorily service a user based on a set of characteristics, such as size of the foot, size of the deformity, angles for certain landmarks, angles for a deformity, type of deformity, size of the bone, and the like). Alternatively, or in addition, a positioner can be used with the bone model 404 to assist in positioning one or more models of bones of a patient in order to define, determine, and/or design one or more other instruments of a system (e.g., resection guide 820a, resection guide 820b, resection guide 820c, or the like). 432 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 FIG. 14 illustrates a page from a preoperative plan 506 and a medical image 1400 of a patient-specific guide positioned on a patient according to one embodiment. FIG. 14 illustrates two steps in an example preoperative plan 506. The example preoperative plan 506 shown may be similar to the preoperative plans 506 described in relation to FIG. 5. The preoperative plan 506 can include a plurality of steps. The preoperative plan 506 can exist in a variety of formats including data on a computer storage device or memory, a printed format, a set of physical models, or the like. FIG. 14 illustrates one page of a preoperative plan 506 showing two steps 512, 514. 433 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 One step 512 includes a drawing or illustration of bones of a foot. The illustration can include accurate drawings, prints, and/or representations of the bones of a foot of a particular patient. For example, the illustration can be generated based on the medical imaging referred to in the present disclosure. In one embodiment, the illustration shows the bones of the foot of a patient prior to completing a surgical procedure. In the example illustration, the bones of the foot are configured to represent bones of a patient foot that includes a deformity. The illustration shows the first metatarsal 208 extends medially rather than parallel to the second metatarsal 210. The illustration also shows a representation of a resection guide 820 (e.g., resection guide 820c) positioned on a dorsal surface of a medial cuneiform 202, extending over a first TMT joint, and on a dorsal surface of a first metatarsal 208. 434 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 In the illustrated embodiment, step 514 includes the same drawing or illustration of bones of the same foot as in step 512. Similarly, step 514 illustrates the same example resection guide 820 (e.g., resection guide 820c) in the same position as in step 512. Step 514 also illustrates a fastener 710 deployed in an anchor feature 942 of the resection guide 820c. Step 514 illustrates the medial cuneiform 202 in a transparent state so a user can visualize a trajectory for the fastener 710 deployed in the anchor feature 942. 435 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 The preoperative plan 506 assists the user, a surgeon, in performing the surgical procedure according to a recommended operative technique. Of course, the surgeon can revise, change, adjust, or not follow each step of the preoperative plan 506 as the surgeon decides in their own discretion. 436 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 In the illustrated embodiment, the medical image is a dorsoplantar projection/view using an X-ray or a fluoroscopy device. In one embodiment, the medical image 1400 shows bones of a patient and a resection guide 820c positioned on a dorsal side of the bones at a stage of a surgical procedure. At this stage, a surgeon has created an incision and taken steps to permit an inferior side 916 of the resection guide 820c to rest on a dorsal surface of the medial cuneiform 202 and the first metatarsal 208. The surgeon appears to have deployed a fastener 710 in a distal hole 940 of the bone attachment feature 910 and deployed a fastener 710 in a proximal hole 940 of the bone attachment feature 908. 437 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 Medical image 1400 shows a number of advantages of the present disclosure available to a surgeon. First, different parts of the resection guide 820c described herein can be seen in the medical image 1400. For example, the resection guide 820c includes and the medical image 1400 shows a proximal resection feature 902, a distal resection feature 904, a window 906, a bone attachment feature 908, a bone attachment feature 910, an anchor feature 942, and one or more markings 970. 438 Added by DJM Jan 2024 1/3/24, 4:24 AM
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Delete 		TMC-PAT-4 Medical image 1400 shows clearly where the proximal resection feature 902 and distal resection feature 904 are in relation to each other and in relation to the bones of the patient. Advantageously, a surgeon can see the distal end of the medial cuneiform 202 and the proximal end of the first metatarsal 208 by way of the window 906. This visual indicator for the surgeon can provide clarity that osteotomies formed using the resection features are in the desired positions and/or angles relative to the bones in a preoperative condition. If a surgeon determines that something is not as planned or as needed, the surgeon can alter the surgical procedure to account for this. 439 Added by DJM Jan 2024 1/3/24, 4:24 AM

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