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TMC-PAT-4
In certain embodiments, the components of system 700 may be made as small as possible to minimize the amount of soft tissue that is opened in the patient for the osteotomy procedure. Alternatively, or in addition, walls and/or sides of the components may be beveled and/or angled to avoid contact with other hard tissue or soft tissues in the operating field for the osteotomy procedure.
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TMC-PAT-4
Those of skill in the art will appreciate that for certain osteotomy procedures a complementary component 730 may not be needed or a given complementary component 730 may be optional for use in the osteotomy procedure. Similarly, those of skill in the art will appreciate that certain features of the fasteners 710, resection guides 720, and/or complementary components 730 can be combined into one or more of apparatus or devices or may be provided using a plurality of separate devices.
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TMC-PAT-4
FIG. 8 illustrates an exemplary system 800, according to one embodiment. The system 800 may include one or more fasteners 810, such as fasteners 710, a resection guide 820, such as resection guide 820a or resection guide 820b or resection guide 820c and may include one or more other complementary components 830. The resection guides 820a, 820b, 820c facilitate resection of one or more bones of a patient for a surgical procedure.
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TMC-PAT-4
In one embodiment, the resection guides 820a, 820b, 820c include a body that includes a proximal side, a distal side, a medial side, a lateral side, a superior side, and an inferior side. The body includes a bone engagement feature, a resection feature, and a bone attachment feature. In certain embodiments, the body may also include a window and/or one or more landmark registration features. In another embodiment, a resection guide 820a, 820b, 820c may include one member of a coupler configured to engage a corresponding member of the coupler coupled to an alignment guide.
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TMC-PAT-4
The resection features 822 guide a surgeon in performing a resection by facilitating keeping a cutting tool in line with and/or within an opening of the resection features 822 (at a desired trajectory relative to one or more bones of the patient). In the illustrated embodiments, the resection features 822 are shaped like slots or channels and include two closed ends. In another embodiment, a resection feature 822 may include an open end and a closed end.
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TMC-PAT-4
One difference between embodiments of the resection guides 820a, 820b, 820c may be the number of resection features 822. In the illustrated embodiments, resection guide 820a includes a single resection feature 822a. Resection guides 820b, 820c illustrate alternative embodiments that include two resection features 822a, 822b. In other embodiments, the resection guides 820, 820b, 820c may include one resection feature 822, two resection features 822, three resection features 822, four resection features 822, or the like.
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TMC-PAT-4
In the illustrated embodiments, resection guides 820 include a proximal end 824 and a distal end 826. The resection guide 820a includes a single resection feature 822a. The single resection feature 822a may extend through the body from a superior side of the body to an inferior side. The resection feature 822a may be configured to guide a cutting tool to form a first osteotomy in a first bone along a first trajectory and a second osteotomy in a second bone along a second trajectory. The first trajectory and second trajectory may be determined based on an angle of at least of portion of the single resection feature 822a through the body. In certain embodiments, one or more of the first trajectory and the second trajectory may be at least partially determined based on a bone model of a patient’s foot. The bone model may be defined at least in part based on medical imaging of the patient’s foot. The first trajectory and the second trajectory determined at least in part based on the bone model may determine final trajectory or a proposed trajectory that a surgeon can then alter or revise as needed to accomplish a desired outcome.
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TMC-PAT-4
Advantageously, the angle of each resection feature (e.g., slot or part of a slot), and thus the first trajectory and/or the second trajectory relative to: another resection feature, to one or more bones, to one or more bone surfaces, to one or more reference points, to one or more reference lines, and/or to one or more reference planes can be determined, selected, or indicated by a surgeon before the resection guide 820 is fabricated. In addition, a surgeon can designate which sides of the resection features 822 are open end or closed end.
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TMC-PAT-4
The single resection feature 822a may be implemented in the form of a single slot and/or a plurality of connected slots. For example, the single resection feature 822a may include a proximal slot 828 closer to a proximal end 824 and a distal slot 832 closer to the distal end 826 and a connector 834 that connects the proximal slot 828 to the distal slot 832.
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TMC-PAT-4
In the illustrated embodiments, resection guides 820b, 820c include a two resection features 822 (e.g., resection feature 822a and resection feature 822b). Resection feature 822a may be similar to, or may be, a proximal slot 828 and may be near the proximal end 824. Resection feature 822b may be similar to, or may be, a distal slot 832 and may be near the distal end 826. Thus, as with a proximal slot 828 and/or a distal slot 832, the resection feature 822a and resection feature 822b can guide a cutting tool to form a first osteotomy in a first bone and a second osteotomy in a second bone, respectively. The first osteotomy in the first bone along the first trajectory and the second osteotomy in the second bone along the second trajectory may have a first trajectory and a second trajectory determined based on an angle of at least of portion of the respective resection feature 822a, 822b through the body. In certain embodiments, one or more of the first trajectory and the second trajectory may be at least partially determined based on a bone model of a patient’s foot. The bone model may be defined at least in part based on medical imaging of the patient’s foot. The first trajectory and the second trajectory determined at least in part based on the bone model may determine final trajectory or a proposed trajectory that a surgeon can then alter or revise as needed to accomplish a desired outcome. The bone model may be a model of both the first bone and the second bone or of one of the first bone and the second bone. In one embodiment, the first bone is a cuneiform, and the second bone is a metatarsal. In certain embodiments, the cuneiform and the metatarsal may be of a patient and may be a cuneiform and a metatarsal that are both part of a particular joint such as a TMT joint.
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TMC-PAT-4
Those of skill in the art will appreciate that the resection guide 820 may have a variety of shapes, sizes and configurations. In one embodiment, these attributes can each be customized and adapted to meet needs or preferences of patients, a patient’s anatomy, the nature of the deformity, and/or surgeon preferences. Advantageously, the features of the resection guides 820 can facilitate one or more osteotomies as well as other steps in a surgical procedure.
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TMC-PAT-4
In the illustrated embodiment, each of the resection guides 820a, 820b, 820c may be configured for use on a medial side of a midfoot of a patient, with the side visible in FIG. 8 facing away from the bone(s). The parts of the resection feature 822a or resection features 822a, 822b may be positioned and oriented relative to each other to facilitate an arthrodesis surgical procedure that remediates a deformity with a goal of correcting a deformity.
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TMC-PAT-4
In certain embodiments, the resection guides 820a, 820b, 820c include a patient-specific bone engagement feature configured to engage at least a portion of at least one foot bone to assist in positioning the resection guide, a first bone attachment feature configured to accept a first fastener that engages the first bone, and a second bone attachment feature configured to accept a second fastener that engages the second bone. The resection guides 820a, 820b, 820c also include a window 836. In one embodiment, the window 836 is positioned in the body between a proximal slot 828 and a distal slot 832. In one embodiment, the window 836 extends from a superior side of the body to an inferior side of the body. In another embodiment, the window 836 is radiolucent such that the window 836 provides visibility of at least one anatomical structure inferior to the resection guide, when the resection guide is in use. In one embodiment, the window 836 is an opening or hole. In another embodiment, the window 836 may be a structure that includes a plurality of openings or holes. In yet another embodiment, the window 836 may be a structure that is opaque to light but is radiolucent when used with an imaging device such as an X-ray machine fluoroscopy machine, or other imaging device. These aspects, as well as others, will be described in further detail in subsequent paragraphs.
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TMC-PAT-4
Alternatively, or in addition, the resection guide 820a and resection guide 820b in the illustrated embodiments include a member of a coupler configured to engage a corresponding member of the coupler coupled to an alignment guide. Those of skill in the art appreciate that various designs of a coupler may be used. In the illustrated embodiment, the coupler may include an opening 838 that may extend from the superior side into the body through to the inferior side. The opening 838 may be configured to accept a post or extension from part of the alignment guide, when the post or extension is inserted into the opening 838.
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TMC-PAT-4
FIGS. 9A-9F illustrate views of an example resection guide 820b of the system 800 of FIG. 8, according to one embodiment. The resection guide 820b includes a proximal end 824 and a distal end 826. The resection guide 820b includes a body 900, resection features embodied as a proximal resection feature 902 and a distal resection feature 904, a window 906, and a bone attachment feature. In the illustrated embodiment, the bone attachment feature is embodied as a first bone attachment feature 908, a second bone attachment feature 910. In addition, the resection guide 820b includes a patient-specific bone engagement feature 912. In certain embodiments, the resection guide 820b may include one or more landmark registration features 960. Other embodiments may not include landmark registration features 960.
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TMC-PAT-4
The body 900 connects and/or supports the structures and/or features and/or aspects of the resection guide 820b. The resection guide 820b includes a superior side 914, an inferior side 916, a proximal side 918, a distal side 920, a medial side 922, and a lateral side 924. In one embodiment, the resection guide 820b is configured for use on a dorsal side of a midfoot of a patient. The surgical procedure may include a medial approach and/or a dorsal approach or an approach between the medial and the dorsal sides of the midfoot. The names of the sides of the resection guide 820b refer to the position of the sides when the resection guide 820b is in use on one or more bones of a midfoot of a patient.
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TMC-PAT-4
After the step 102 has been carried out, the method 100 may proceed to a step 104 in which a CAD model of the patient’s anatomy (including one or more bones) is generated. The CAD model may be one example of a bone model. The CAD model may be of any known format, including but not limited to SolidWorks, Catia, AutoCAD, or DXF. In some embodiments, customized software may be used to generate the CAD model from the CT scan. The CAD model may only include the bone(s) to be treated and/or may include surrounding tissues. In alternative embodiments, the step 104 may be omitted, as the CT scan may capture data that can directly be used in future steps without the need for conversion.
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TMC-PAT-4
In one embodiment, the CAD model generated and/or patient-specific instrumentation, implants, and/or plan for conducting an operative procedure, may be enhanced by the use of advanced computer analysis system, machine learning, and/or automated/artificial intelligence. For example, these technologies may be used to revise a set of steps for a procedure such that a more desirable outcome is achieved.
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TMC-PAT-4
In a step 106, the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the condition, as it exists in the patient’s anatomy. In some embodiments, any known CAD program may be used to view and/or manipulate the CAD model and/or CT scan, and generate one or more instruments that are matched specifically to the size and/or shape of the patient’s bone(s). In some embodiments, such instrumentation may include a targeting guide, trajectory guide, drill guide, cutting guide, tendon trajectory guide, capital fragment positioning guide, or similar guide that can be attached to one or more bones, with one or more features that facilitate work on the one or more bones pursuant to a procedure such as arthroplasty or arthrodesis. In some embodiments, performance of the step 106 may include modelling an instrument with a bone engagement surface that is shaped to match the contour of a surface of the bone, such that the bone engagement surface can lie directly on the corresponding contour.
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TMC-PAT-4
In a step 108, the model(s) may be used to manufacture patient-specific instrumentation and/or implants. This may be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, and/or the like. Additive manufacturing may provide unique benefits, as the model may be directly used to manufacture the instrumentation and/or implants (without the need to generate molds, tool paths, and/or the like beforehand). Such instrumentation may optionally include a targeting guide, trajectory guide, drill guide, cutting guide, positioner, positioning guide, tendon trajectory guide, or the like.
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Added by DJM Jan 2024
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