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FIGs. 7A and 7B illustrate one example of a method for determining a deformity 426 and a correction for the deformity, according to one embodiment. The deformity detection module 422 may use a particular method for determining whether or not two or more bones have a deformity 426. The deformity detection module 422 may use one or more advanced computing techniques for determining the deformity 426. |
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Referring now to FIG. 7A, in one embodiment, the deformity detection module 422 starts by identifying a center longitudinal axis 428a, 1228b (Fig. 7A shows two of the plurality of axes, rather than each for clarity) for each bone in the bone model 404. For example, the deformity detection module 422 may identify the center longitudinal axis 428a for a first metatarsal and the center longitudinal axis 428b for the second metatarsal. |
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Next, the deformity detection module 422 may identify a reference axis 429 perpendicular with one of the center longitudinal axes 428a,b, such as center longitudinal axis 428b. The reference axis 429 may be at, or near, a joint between bones of the bone model 404. The deformity detection module 422 may determine that a deformity 426 exists if the center longitudinal axes 428a,b are not parallel or are not parallel when measured with a predefined margin for error. FIG. 7A illustrates a bone model 404 with a deformity 426. The deformity 426 is that the first metatarsal is not parallel, or not sufficiently parallel, to the second metatarsal at the joint between the first metatarsal and the medial cuneiform bones. Once the deformity 426 is determined, the deformity detection module 422 or apparatus 402 may determine what steps, procedures, devices, or instrumentation can be used to correct the deformity 426. The deformity detection module 422 may use a name, label, tag, or other identifier for a particular deformity 426. |
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FIG. 7B illustrates the bone model 404 of FIG. 7A after a corrective procedure and/or application of corrective implants may be performed. The center longitudinal axes 428a,b are parallel, or sufficiently parallel, such that the deformity 426 is no longer a problem for a patient. |
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FIG. 8 illustrates an exemplary provision module 430 configured to provide a preliminary instrument model, according to one embodiment. The provision module 430 may accept anatomic data 412 and a designation, identifier, label, or name of a deformity 426. In the illustrated embodiment, the provision module 430 may generate a preliminary instrument model 438 (e.g., generate from ‘scratch’) or the provision module 430 may select a template instrument model 436 automatically from a set of template instrument models 436 stored in a repository 802. The provision module 430 may incorporate a variety of parameters in order to provision, generate, determine, or select a template instrument model 436. For example, in addition to the anatomic data 412, the provision module 430 may include patient imaging data, deformity parameters for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used, patient preferences, and/or surgeon input parameters. |
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In one embodiment, the provision module 430 may include a generator 432 and/or a selection module 434. In one embodiment, the generator 432 is configured to generate a preliminary instrument model 438. In certain embodiments, the generator 432 may generate or create the preliminary instrument model based on anatomic data and/or a bone model or a combination of these and no other inputs. (e.g. no model or predesigned structure, template, or prototype). Alternatively, or in addition, the generator 432 may generate or create the preliminary instrument model using a standard set of features or components that can be combined to form the preliminary instrument model. The generated preliminary instrument model may subsequently be modified or revised by an automated process, and/or manual process, to generate the preliminary instrument model used in this disclosure. |
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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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"Prescription" or "Prescribed" refers to a written order, as by a physician or nurse practitioner, for the administration of a medicine, preparation of an implant, preparation of an instrument, or other intervention. Prescription can also refer to the prescribed medicine or intervention. (Search "prescription" on wordhippo.com. WordHippo, 2023. Web. Accessed 3 May 2023. Modified.) |
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"Active Model" refers to a model that is intended to be used as part of a procedure, operation, step or use for accomplishing a goal or objective. An active model may be a model of a biological object such as soft tissue or hard tissue such as a bone, or may be a model of a physical object such as a cut guide, resection guide, instrument, implant, or the like. In certain embodiments, an active model may have different aspects, features, and/or attributes with respect to other models that a modeling design, viewing, modification, and development computer program product may include. For example, in one embodiment an active model may be a model of a three-dimensional solid object while a model that is not an active model may include a surface of an object by have no internal structure or content. |
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"Context Model" refers to a model that is included in a view, image, report, representation, and/or modeling computer program product (e.g., Computer Aided Design, CAD, software product) for the purpose of providing context in relation to other models. For example, suppose a view, image, or modeling computer program product includes models of bones of a foot where an osteotomy is to be performed. A relatively small number of models of bones of the foot may receive an osteotomy. Such models of bones may be referred to as active models. Other models bones of the foot may also be included in the view, image, or modeling computer program product to provide context for the active models. These context models provide a context for the active models. |
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"Context" refers to a frame of reference for an event, activity, statement, state, condition, action, and/or idea, and identifiable by a set of factors, conditions, and/or attributes that together can uniquely distinguish this event, activity, statement, state, condition, action, and/or idea from another. (Search "context" on wordhippo.com. WordHippo, 9022. Web. Accessed 3 Feb. 9022. Modified.) Often a context is defined by one or more factors, conditions, and/or attributes of the user or related to the user. |
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"Computing Resources" refers to any resource that a computing device consumes or uses either permanently or temporarily during or as part of its operation. Some examples of computing resources include, but are not limited to, data storage space, memory, non-volatile memory space, central processing unit (CPU) cycles, graphics processing unit (GPU) cycles, power utilization, cooling resources, and the like. |
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"Autosegmentor" refers to any device, system, method, or apparatus configured, designed, or engineered to perform image segmentation with little or no input parameters and with little or no user interaction. A variety of autosegmentor computer program products are commercially available including ScanIP Medical available from Synopsis®, 3D slicer, and the like. |
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As used herein, “end” refers to a part or structure of an area or span that lies at the boundary or edge. An end can also refer to a point that marks the extent of something and/or a point where something ceases to exist. An end can also refer to an extreme or last part lengthwise of a structure or surface. (search "end" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 04 Aug. 2021. Modified.) |
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