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TMC-PAT-4
FIG. 9B is a superior side view of one example resection guide 820b. FIG. 9B illustrates the window 906 and its relationship to the proximal resection feature 902 and/or distal resection feature 904, in one embodiment. In the illustrated embodiment, the window 906 is positioned between the proximal resection feature 902 and the distal resection feature 904. In addition, the window 906, in this embodiment, is an opening that extends from the superior side 914 to the inferior side 916.
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Added by DJM Jan 2024
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TMC-PAT-4
The window 906 serves to enable a surgeon to visualize anatomy below the resection guide 820b when the resection guide 820b is positioned on one or more bones of a patient (e.g., on a dorsal side). In the illustrated embodiment, the window 906 is an opening. Alternatively, or in addition, the window 906 can be a solid structure that is opaque to light but radiolucent to electromagnetic waves (e.g., X-rays, both still x-rays and fluoroscopy).
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TMC-PAT-4
The window 906 can have a variety of sizes and/or shapes and can be patient-specific or patient-matched. Alternatively, or in addition, the size and/or shape of the window 906 can be determined at least in part by the surgeon which plans to use the resection guide 820b. In certain embodiments, the window 906 is sized and/or shaped to enable visualization of as much of the anatomy of the patient, while maintaining the structural integrity of the body 900, proximal resection feature 902, and/or distal resection feature 904. Advantageously, the window 906 is sized to enable visualization of one or more articular surfaces of one or more bones facing the inferior side 916 of the resection guide 820b. In one embodiment, the window 906 is configured to enable observation of an articular surface and/or an end of both a cuneiform and a metatarsal of a TMT joint.
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TMC-PAT-4
Due to the small size of the cuneiform and a metatarsal of a TMT joint and potential for significant improvement in quality of life for patients undergoing an arthrodesis of the TMT joint, a surgeon may appreciate the opportunity to view the anatomy of the bones in relation to the resection guide 820b and/or the trajectories of resections to be made using the proximal resection feature 902 and/or distal resection feature 904. Thus, having a resection guide 820b with a window 906 can provide a significant level of confidence and relief of stress prior to making any resections of the bones. For example, a surgeon can position and secure the resection guide 820b to one or more bones of the foot of the patient and then use fluoroscopy to visualize where the ends of the bones in relation to the proximal resection feature 902 and/or distal resection feature 904 that will be used to resect the bones. Having the ability to see where the bones end can provide certainty and/or clarity to a surgeon prior to performing any of the osteotomies. In certain embodiments, because the window 906 facilitates resection or performance of osteotomies, the window 906 may be referred to as a resection window.
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TMC-PAT-4
In the illustrated embodiment, the window 906 has a lateral end that begins towards the lateral side 924 of the body 900 and a medial end that is near the medial side 922. Furthermore, the window 906 has a proximal side 932 that extends into and/or connects with the proximal resection feature 902. In one embodiment, the window 906 may also include a distal side 934 that extends into and/or connects with the distal resection feature 904. The extension of the proximal side 932 and the distal side 934 may form a pair of lateral fingers 936 that extend towards the medial side 922 and a pair of medial fingers 938 that extend towards the lateral side 924. In certain embodiments, the lateral fingers 936 and/or medial fingers 938 are configured to have sufficient structural integrity to retain a cutting tool within the proximal resection feature 902 and/or distal resection feature 904 and may be as short as possible to maximize the size of the window 906 while still enabling the proximal resection feature 902 and/or distal resection feature 904 to guide a cutting tool for the resection(s). Advantageously, the space between the proximal side 932 and distal side 934 enables visualization of the ends of one or more bones that the surgeon will resect using the resection guide 820b.
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Added by DJM Jan 2024
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TMC-PAT-4
The window 906 may be configured to show one or more bones on an inferior side of the resection guide 820b when the resection guide 820b is in use. In the illustrated embodiment, the window 906 is positioned between the resection features 902, 904. The window 906 can be made up of a single opening, a pair of openings, or a plurality of openings. In one embodiment, the window 906 includes a plurality of openings that extend from the superior side 914 to the inferior side 916. The single opening and/or plurality of openings may have a variety of forms, shapes, sizes, and/or configurations. In one embodiment, the window 906 may be a rectangular or other polygonal opening. The window 906 enables a surgeon to view past the resection guide 820b to visualize progress before, during or after one or more dissection or resection steps.
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TMC-PAT-4
FIG. 9B also illustrates the first bone attachment feature 908 and second bone attachment feature 910. The bone attachment features 908, 910 are configured to engage one or more bones of the patient to couple the body 900 to one or more bones of the patient. As embodied in FIGs. 9A through 9G, the bone attachment features 908, 910 may take the form of one or more holes 940 that extend from the superior side 914 to the inferior side 916 and/or one or more fixation devices (e.g., fasteners 710, a first fastener and a second fastener). The holes 940 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in a cuneiform and/or a metatarsal to keep the resection guide 820b in place. In one embodiment, a first bone attachment feature 908 can include a single hole 940 and a second bone attachment feature 910 can include a single hole 940.
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TMC-PAT-4
In one embodiment, the first bone attachment feature 908 and the second bone attachment feature 910 may each include a set of two holes 940 each hole configured to accept a fastener 710. Two holes 940 may be used to prevent rotation or pivoting of the resection guide 820b about a single fastener 710 in one hole. The holes 940 may be referred to as a set of openings, such that the resection guide 820b may include a set of proximal openings configured to accept a first pair of fasteners and a set of distal openings configured to accept a second pair of fasteners.
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TMC-PAT-4
Alternatively, or in addition, in certain embodiments, the holes may have a non-circular geometric shaped cross section (e.g., triangle, square, oval, etc.) and the fastener 710 may have a similar and corresponding non-circular geometric shaped cross section such that a single hole and a single fastener 710 can be used for one or more of the first bone attachment feature 908 and the second bone attachment feature 910.
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TMC-PAT-4
In the illustrated embodiment, the first bone attachment feature 908 is near the proximal end 824 and the second bone attachment feature 910 is near the distal end 826. In such an embodiment, the first bone attachment feature 908 may be referred to as a proximal bone attachment feature and the second bone attachment feature 910 may be referred to as a distal bone attachment feature. In one embodiment, the holes 940 of the first bone attachment feature 908 may be aligned, or may be substantially aligned, with the holes 940 of the second bone attachment feature 910. Alternatively, or in addition, the first bone attachment feature 908 and second bone attachment feature 910 are not aligned, longitudinally along the body 900, with each other.
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TMC-PAT-4
Advantageously, the models, methods, systems, and/or apparatuses of the present disclosure facilitate mapping or translating between a virtual or model environment and/or instrumentation to a physical or real-world environment for a surgical procedure. The present disclosure provides this feature or benefit by providing an apparatus, system, and method, that enables a surgeon to identify, create, form, and/or use reference features for a surgical procedure. The reference feature provides a reference and/or starting point on, in, or associated with anatomy of a patient such that steps, stages, features, or aspects planned and configured within the model can be accurately performed on, with, or to the anatomy of the patient. In certain embodiments, one or more steps of a surgical procedure can be done in connection with or in relation to the reference feature.
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TMC-PAT-4
The reference feature facilitates 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, the 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, the reference feature can serve to map from a virtual or modeled object to an actual or physical object.
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TMC-PAT-4
Advantageously, the embodiment of the present disclosure includes features and aspects that assist a surgeon in locating at least one reference feature, which can then be used in one or more stages of a surgical procedure. In certain embodiments, the actual instruments fabricated using the present disclosure may include one or more references (e.g., a model references). The one or more model instruments may use the one or more references to position and/or orient the one or more model instruments such that other steps of a surgical procedure can be performed in relation to those one or more model instruments and/or model references. Certain model references may key off or related to anatomical references of modeled anatomical body parts. The reference feature(s) correspond to the model references and together enable a surgeon to identify reference features on actual anatomy of a patient for a surgical procedure.
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TMC-PAT-4
In certain embodiments, one or more fasteners deployed in an instrument such as a resection guide can serve as reference features, for an initial stage of the surgical procedure and/or for subsequent stages of the surgical procedure. In certain embodiments, a bone engagement feature can serve as a reference feature for an osteotomy system and/or surgical procedure.
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TMC-PAT-4
Advantageously, the embodiments of the present disclosure leverage patient-specific models of patient anatomy and the use of these models to generate patient-specific instruments as well as input from users of the osteotomy (e.g., surgeons). In one embodiment, this input is provided in the form of user directions. Combining patient-specific medical imaging, patient-specific anatomical models, and user directions enable the present disclosure to provide a customized or patient-specific osteotomy that serves the patient’s needs as well as aides the surgeon in performing the surgical procedure. In this manner, a surgeon can perform the surgical procedure with higher confidence and assurance that the procedure performed on the patient will coincide with the plan set forth using models in a virtual environment. Consequently, the present disclosure improves the level of patient care and positive outcomes.
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TMC-PAT-4
FIG. 6 illustrates an exemplary system 600 configured to design, generate, develop, and/or produce an osteotomy system, according to one embodiment. In certain embodiments, the osteotomy system can be patient-specific. One advantage of the present disclosed embodiments is that an end user of an osteotomy system (e.g., instruments, preoperative plan, implants, etc.) can have as much, or as little control or input, over one or more or all of the aspects of the osteotomy system. Furthermore, this osteotomy system can be customized both to the needs and specific aspects of the patient as well as to the needs and/or preferences and/or desires of the user (e.g., surgeon).
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TMC-PAT-4
The system 600 may include similar components or modules to those described in relation to FIG. 4. The structures, features, and functions, operations, and configurations of the system 600 may be similar or identical to components or modules of system 400, like parts identified with similar reference numerals. Accordingly, the system 600 may include an apparatus 602 configured to accept, review, receive or reference a bone model 404 and user instructions 604 and provide a patient-specific osteotomy system 606. In one embodiment, the apparatus 602 is a computing device. In another embodiment, the apparatus 602 may be a combination of computing devices, systems, apparatuses, software components, single software component such as a software application, one or more third party manufacturers, or the like.
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TMC-PAT-4
The apparatus 602 may include a determination module 610, a location module 620, a provision module 630, an optional registration module 640, a design module 650, a selection module 660, and an export/fabrication module 670. Each of which may be implemented in one or more of, software, hardware, or a combination of hardware and software. In certain embodiments, one or more parts of the system 600 may be operated by a user (e.g., a technician), a plurality of users, and may include input, involvement, and/or feedback from an end user of the osteotomy system developed. Generally, the end user of the osteotomy system will be a surgeon. Those of skill in the art will appreciate that depending on the surgical procedure being performed, one or more of the modules of the apparatus 602 may or may not be used.
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TMC-PAT-4
The determination module 610 may operate in a similar manner to the determination module 410. The location module 620 may operate in a similar manner to the location module 420. The provision module 630 may operate in a similar manner to the provision module 430. The registration module 640 may operate in a similar manner to the registration module 440.
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TMC-PAT-4
The design module 650 enables one or more users to design an osteotomy system 606 and in particular a patient-specific osteotomy system 606. A patient-specific osteotomy system 606 can include a number of different instruments, components, and/or systems, including but not limited to one or more cutting tools, one or more resection guides, one or more provisional fasteners, one or more fixation systems and/or instruments, a preoperative plan, one or more kits of implants and/or trial components, one or more alignment guides, one or more positioning guides, one or more reduction guides, one or more, one or more navigation guides, one or more fixation guides, one or more, one or more compression guides, one or more rotation guides, and the like. In addition, one or more of these components can be patient-specific. For example, the patient-specific osteotomy system 606 can include a patient-specific instrument, patient-specific trajectory guide, a patient-specific resection guide, a patient-specific cutting guide, a patient-specific positioning guide or positioner, another patient-specific instrument, or the like.
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