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The selection module 434 may be configured to select a template instrument model 436 for an osteotomy procedure configured to correct the deformity identified by the deformity module 420. In one embodiment, the provision module 430 may select a template instrument model 436 from a set of template instrument models 436 (e.g., a library, set, or repository of template instrument models 436). In one embodiment, the template instrument model 436 may include digital models. In another embodiment, the template instrument model 436 may include physical models. In such an embodiment, the repository 802 may be a warehouse or other inventory repository. Where the template instrument model 436 are physical models, the systems, modules, and methods of this disclosure can be used and the physical model may be milled or machined (e.g., a CNC machine) to form a patient specific cutting guide that conforms to the bone surfaces of the patient. |
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Selection of a suitable template instrument model 436 may be completely automated and/or may be partially automated and/or may depend on confirmation from a user before a generated preliminary instrument model or a proposed template instrument model 436 becomes the preliminary instrument model 438. In another embodiment, the selection module 434 may facilitate a manual selection by a user of a template instrument model 436 that would become the preliminary instrument model 438. The selection module 434 may use the anatomic data 412 or the bone model 404 or a combination of these to select a suitable template instrument model that would become the preliminary instrument model 438. |
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In another embodiment, the generator 432 may facilitate revisions or edits by a user of a generated instrument model that will become the preliminary instrument model 438. The selection module 434 may use the anatomic data 412 or the bone model 404 or a combination of these to select a suitable template instrument model that would become the preliminary instrument model 438. |
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The repository 802 may include any number of, and/or a variety of template instrument models 436. The template instrument models 436 may be distinguished based on a gender or age of the patient, which joint of a midfoot, hind foot, or ankle will be cut, which material will be used for the template cutting guide, and the like. The template instrument model 436 may differ from each other in what degree of deformity correction the template instrument model 436 is designed to provide. In addition, the template instrument models 436 may be distinguished based on how one or more features of the template instrument model 436 are positioned, arranged, and/or configured relative to each other. For example in certain template instrument models 436, the number, position, and/or configuration of alignment features and/or bone attachment features (e.g., holes) may vary based on needs or preferences of patients, the nature of the deformity, and/or surgeon preferences. |
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In certain embodiments, the template instrument models 436 may vary in how the slots (e.g., guide features, See FIG. 6) for the cuts are positioned, angled, and oriented relative to each other and/or to a longitudinal axis of respective bones at a joint for use with the template instrument model 436. For example in one template instrument model 436 the slot for a resection of a metatarsal bone may be perpendicular to a longitudinal axis of the metatarsal bone and the slot may be angled relative to a longitudinal axis of the cuneiform or cuboid bone such that once the two bones are brought together the deformity is corrected. Alternatively, in another template instrument model 436 the slot for a resection of a metatarsal bone may be angled relative to a longitudinal axis of the metatarsal bone and the slot may be perpendicular to a longitudinal axis of the cuneiform or cuboid bone such that once the two bones are brought together the deformity is corrected. |
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The selection module 434 may be configured to automatically select a template instrument model 436 and/or provide an automatic template instrument model 436 recommendation that can be changed by a user, such as a surgeon. For example, in one embodiment, the provision module 430 and/or selection module 434 includes an artificial intelligence (e.g., ANN, GAN, or the like) or machine learning module. The artificial intelligence or machine learning module is configured to implement one or more of a variety of artificial intelligence modules that may be trained for selecting a template instrument model 436 based on anatomic data 412 and/or other input parameters. In one embodiment, the artificial intelligence or machine learning module may be trained using a large data set of anatomic data 412 for suitable template instrument models 436 identified and labeled in the dataset by professionals for use to treat a particular deformity 426. The artificial intelligence or machine learning module may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module is able to select a suitable template instrument model 436. The template instrument model 436 selected by the selection module 434 can become the preliminary instrument model 438. |
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FIG. 9 illustrates an exemplary system 900 configured to design a patient-specific device, according to one embodiment. In various examples, the system 900 includes one or more instances of a computing device 902, such as for example, a computing device such as a server, a desktop, a laptop, a tablet, smartphone, or the like. The computing device 902 may include any computing device that capable or configured to support generating a patient-specific device model that can be used to also generate a patient-specific device, each based on medical imaging of the anatomy of a patient. |
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As used herein, a "guide" refers to a part, component, member, or structure designed, adapted, configured, or engineered to guide or direct one or more other parts, components, or structures. A guide may be part of, integrated with, connected to, attachable to, or coupled to, another structure, device, or instrument. In one embodiment, a guide may include a modifier that identifies a particular function, location, orientation, operation, type, and/or a particular structure of the guide. Examples of such modifiers applied to a guide, include, but are not limited to, "pin guide" that guides or directs one or more pins, a "cutting guide" that guides or directs the making or one or more cuts, a placement, deployment, or insertion guide that guides or directs the placement, positioning, orientation, deployment, installation, or insertion of a fastener and/or implant, a "cross fixation guide" that guides deployment of a fastener or fixation member, an "alignment guide" that guides the alignment of two or more objects or structures, a "navigation guide" that guides a user in navigating a course or process or procedure such as a surgical procedure, a "resection guide" that serves to guide resection of soft or hard tissue, such as in an osteotomy, a "reduction guide" can serve to guide reduction of one or more bone segments or fragments, an "placement guide" that serves to identify how an object can be placed in relation to another object or structure, and the like. Furthermore, guides may include modifiers applied due to the procedure or location within a patient for which the guide is to be used. For example, where a guide is used at a joint, the guide may be referred to herein as an “arthrodesis guide.” |
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Those of skill in the art will appreciate that a resection feature may take a variety of forms and may include a single feature or one or more features that together form the resection feature. In certain embodiments, the resection feature may take the form of one or more slots or cut channels. Alternatively, or in addition, a resection feature may be referenced using other names including, but not limited to, channel, cut channels, and the like. |
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"Cut channel" refers to a channel, slot, hole, or opening, configured to facilitate making a cut. In certain embodiments, a cut channel is one example of a resection feature, resection member, and/or resection guide. "Rotation slot" refers to a channel, slot, hole, or opening, configured to facilitate rotating one structure in relation to another structure. |
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As used herein, “slot” refers to a narrow opening or groove. (search "slot" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 04 Aug. 2021. Modified.) |
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“Hole” refers to a gap, an opening, an aperture, a port, a portal, a space or recess in a structure, a void in a structure, or the like. In certain embodiments, a hole can refer to a structure configured specifically for receiving something and/or for allowing access. In certain embodiments, a hole can pass through a structure. In other embodiments, an opening can exist within a structure but not pass through the structure. A hole can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. As used herein, the term “hole” can include one or more modifiers that define specific types of “holes” based on the purpose, function, operation, position, or location of the “hole.” As one example, a “fastener hole” refers to an “hole” adapted, configured, designed, or engineered to accept or accommodate a “fastener.” |
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As used herein, an “opening” refers to a gap, a hole, an aperture, a port, a portal, a slit, a space or recess in a structure, a void in a structure, or the like. In certain embodiments, an opening can refer to a structure configured specifically for receiving something and/or for allowing access. In certain embodiments, an opening can pass through a structure. In such embodiments, the opening can be referred to as a window. In other embodiments, an opening can exist within a structure but not pass through the structure. In other embodiments, an opening can initiate on a surface or at an edge or at a side of a structure and extend into the structure for a distance, but not pass through or extend to another side or edge of the structure. In other embodiments, an opening can initiate on a surface or at an edge or at a side of a structure and extend into the structure until the opening extends through or extends to another side or edge of the structure. An opening can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. As used herein, the term “opening” can include one or more modifiers that define specific types of “openings” based on the purpose, function, operation, position, or location of the “opening.” As one example, a “fastener opening” refers to an “opening” adapted, configured, designed, or engineered to accept or accommodate a “fastener.” |
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As used herein, an "interface," or "engagement interface" refers to an area, a boundary, or a place at which two separate and/or independent structures, members, apparatus, assemblies, components, and/or systems join, connect, are coupled, or meet and act on, or communicate, mechanically and/or electronically, with each other. In certain embodiments, "interface" may refer to a surface forming a common boundary of two bodies, spaces, structures, members, apparatus, assemblies, components, or phases. (search "interface" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 15 Nov. 2021. Modified.) In certain embodiments, the term interface may be used with an adjective that identifies a type or function for the interface. For example, an engagement or coupling interface may refer to one or more structures that interact, connect, or couple to mechanically join or connect two separate structures, each connected to a side of the interface. |
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"User" refers to any person that operates a computing device and/or a user interface.” |
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"User interface" refers to component, module, device, system, software, hardware, or apparatus that enables one or more people to provide user input, communicate, and/or interact with an electronic or computing device using mechanical, electronical, manual, audio, visual, or tactile input. In one example, a user interface may refer to one or more mechanical, electrical, or electromechanical structures that interact with, or enable, a user to provide user input, instructions, input signals, data, or data values and receive output, output data, or feedback. |
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"User input" refers to a form of input data that is provided directly or indirectly by a user, operator, or beneficiary of an apparatus, module, system, method, or process. User input can be provided by a variety of input devices and can include any indicator or indication of input data from the user. A variety of signals, indicators, indications, gestures, movements, touches, keystrokes, or the like can serve as user input. "Input data" refers to data identified, used, collected, gathered, and/or generated to serve as input to another component, circuit, driver, device, manager, control circuit, storage media, storage device, or controller. The input data can be in analog or digital format and can represent a data signal and/or one or more data values. As used herein, an "indicator" refers to an apparatus, device, component, system, assembly, mechanism, hardware, software, firmware, circuit, module, set of data, or logic structured, organized, configured, programmed, designed, arranged, or engineered to convey information or indicate a state, condition, context, location, or position to a user of a module, device or apparatus that includes, or is associated with the indicator. The indicator can include one or more of an audible signal, a tactile signal, a visual signal or indication, a visual marker, a visual icon, and the like. |
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"Display device" and/or "display" refers to any apparatus, device, component, module, circuit, sub-circuit, structure, electronic component, hardware, or logic configured, programmed, designed, arranged, or engineered to display, show, or present one or more visual images and/or videos to a user. A display device can use analog or digital technologies. Examples of a display device include one or more LEDs, a seven segment display, an LCD display, an LED display, and the like. |
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"Cortical bone" refers to a type of bone tissue. Cortical bone is a type of bone tissue typically found between an external surface of a bone and an interior area of the bone. Cortical bone is more dense and typically stronger structurally than other types of bone tissue. “Cortical surface” refers to a surface of cortical bone. |
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“Cortex” refers to an area of bone that extends from an external surface of the bone towards a center part of the bone. The cortex is typically comprised of cortical bone. |
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