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PER-32 The body 1032 may include a resection feature 1022 that guides a cutting tool to resect one or more bones, such as a distal tibia in the manner needed to make the desired resection. For example, the resection features 1022 may be used to guide a planar cutting blade, an arcuate cutting blade, a drill or mill, a burr, and/or the like. The resection features 1022 may guide a reciprocating planar blade, such as that of a surgical bone saw, which forms planar cuts in a distal tibia. Various manual or powered tools may be used to form the planar cuts. In one embodiment, a sagittal bone saw can be used. In one example, the resection feature 1022 may take the form of a single slot 1052 in a “V” shape. 171 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 The body 1032 may include a pattern 1033 of openings that extend from one surface or side to an opposite surface or side. In the illustrated embodiment, the pattern 1033 is a honeycomb pattern of holes in the shape of hexagons. The pattern 1033 serves to enhance visualization by a surgeon of bone contacting the resection guide 1020. In addition, the pattern 1033 reduces the amount of material needed to fabricate the resection guide 1020. In certain embodiments, the resection guide 1020 may be fabricated from metal using additive manufacturing. Furthermore, the pattern 1033 provides an aesthetic benefit for the resection guide 1020. 172 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 The resection guide 1020 includes an anterior side 1034, a posterior side 1036, a medial side 1038, a lateral side 1040, a superior side 1042, and an inferior side 1044. FIG. 11A is an inferior perspective view. FIG. 11B is a superior perspective view. FIG. 11C is lateral side perspective view. FIG. 11D is a medial side perspective view. 173 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 In one embodiment, the resection guide 1020 may include an alignment guide 1046. The alignment guide 1046 may be a part of, connected to, or extend from the body 1032 or may be a separate component. The alignment guide 1046 serves as a guide to orient the resection guide 1020 relative to a longitudinal axis of a bone. In the illustrated embodiment, the alignment guide 1046 includes a structure that extends from the medial side 1038 and includes a hole sized to accept and retain a fastener 1010 such as a K-wire. The hole is positioned such that with a K-wire in the hole, a surgeon can align the K-wire with a longitudinal axis of a bone, such as a tibia to ensure that the features of the resection guide 1020 are aligned relative to the longitudinal axis of the bone.. The alignment guide 1046 assists a surgeon in desired placement and orientation of the resection guide 1020 during a surgical procedure. 174 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 In one embodiment, the single slot 1052 extends from the medial side 1038 to the lateral side 1040. In certain embodiments, the single slot 1052 may extend from near the anterior side 1034 to near the posterior side 1036 and then back to near the anterior side 1034 to form a “V” shape with an apex of the “V” being near the posterior side 1036. 175 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 As used herein, "registration" or " image registration" refers to a method, process, module, component, apparatus, and/or system that seeks to achieve precision in the alignment of two images. As used here, "image" may refer to either or both an image of a structure or object and another image or a model (e.g., a computer based model or a physical model, in either two dimensions or three dimensions). In the simplest case of image registration, two images are aligned. One image may serve as the target image and the other as a source image; the source image is transformed, positioned, realigned, and/or modified to match the target image. An optimization procedure may be applied that updates the transformation of the source image based on a similarity value that evaluates the current quality of the alignment. An iterative procedure of optimization may be repeated until a (local) optimum is found. An example is the registration of CT and PET images to combine structural and metabolic information. Image registration can be used in a variety of medical applications: Studying temporal changes; Longitudinal studies may acquire images over several months or years to study long-term processes, such as disease progression. Time series correspond to images acquired within the same session (seconds or minutes). Time series images can be used to study cognitive processes, heart deformations and respiration; Combining complementary information from different imaging modalities. One example may be the fusion of anatomical and functional information. 43 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 Since the size and shape of structures vary across modalities, evaluating the alignment quality can be more challenging. Thus, similarity measures such as mutual information may be used; Characterizing a population of subjects. In contrast to intra-subject registration, a one-to-one mapping may not exist between subjects, depending on the structural variability of the organ of interest. Inter-subject registration may be used for atlas construction in computational anatomy. Here, the objective may be to statistically model the anatomy of organs across subjects; Computer-assisted surgery: in computer-assisted surgery pre-operative images such as CT or MRI may be registered to intra-operative images or tracking systems to facilitate image guidance or navigation. There may be several considerations made when performing image registration: The transformation model. Common choices are rigid, affine, and deformable transformation models. B-spline and thin plate spline models are commonly used for parameterized transformation fields. Non-parametric or dense deformation fields carry a displacement vector at every grid location; this may use additional regularization constraints. A specific class of deformation fields are diffeomorphisms, which are invertible transformations with a smooth inverse; The similarity metric. A distance or similarity function is used to quantify the registration quality. This similarity can be calculated either on the original images or on features extracted from the images. Common similarity measures are sum of squared distances (SSD), correlation coefficient, and mutual information. The choice of similarity measure depends on whether the images are from the same modality; the acquisition noise can also play a role in this decision. For example, SSD may be the optimal similarity measure for images of the same modality with Gaussian noise. However, the image statistics in ultrasound may be significantly different from Gaussian noise, leading to the introduction of ultrasound specific similarity measures. 44 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 Multi-modal registration may use a more sophisticated similarity measure; alternatively, a different image representation can be used, such as structural representations or registering adjacent anatomy; The optimization procedure. Either continuous or discrete optimization is performed. For continuous optimization, gradient-based optimization techniques are applied to improve the convergence speed.(Search "medical image computing" on Wikipedia.com June 24, 2021. CC-BY-SA 3.0 Modified. Accessed June 25, 2021.) 45 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 As used herein, a "resection" refers to a method, procedure, or step that removes tissue from another anatomical structure or body. A resection is typically performed by a surgeon on a part of a body of a patient. (Search "surgery" on Wikipedia.com May 26, 2021. CC-BY-SA 3.0 Modified. Accessed May 26, 2021.) Resection may be used as a noun or a verb. In the verb form, the term is "resect" and refers to an act of performing, or doing, a resection. Past tense of the verb resect is resected. 46 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Bone condition" refers to any of a variety of conditions of bones of a patient. Generally, a bone condition refers to an orientation, position, and/or alignment of one or more bones of the patient relative to other anatomical structures of the body of the patient. Bone conditions may be caused by or result from deformities, misalignment, malrotation, fractures, joint failure, and/or the like. A bone condition includes, but is not limited to, any angular deformities of one or more bone segments in either the lower or upper extremities (for example, tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). Alternatively, or in addition, “bone condition” can refer to the structural makeup and configuration of one or more bones of a patient. Thus bone condition may refer to a state or condition of regions, a thickness of a cortex, bone density, a thickness and/or porosity of internal regions (e.g. whether it is calcaneus or solid) of the bone or parts of the bone such as a head, a base, a shaft, a protuberance, a process, a lamina, a foramen, and the like of a bone, along the metaphyseal region, epiphysis region, and/or a diaphyseal region. "Malrotation" refers to a condition in which a part, typically a part of a patient's body has rotated from a normal position to an unnormal or uncommon position. 47 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 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 "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”. 48 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 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," "securing feature," "placement feature," "protruding feature," "engagement feature," "disengagement feature," “resection feature”, “guide feature”, and the like. 49 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "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. 50 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Transosseous placement feature" refers to a placement feature that extends through one or more bones and that enables, or facilitates, placement of another device, apparatus, or instrument. 51 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Patient specific feature" refers to a feature, function, structure, device, guide, tool, instrument, apparatus, member, component, system, assembly, module, or subsystem that is adjusted, tailored, modified, organized, configured, designed, arranged, engineered, and/or fabricated to specifically address the anatomy, physiology, condition, abnormalities, needs, or desires of a particular patient or surgeon serving the particular patient. In one aspect, a patient specific feature is unique to a single patient and may include features unique to the patient such as a number of cut channels, a number of bone attachment features, a number of bone engagement surfaces, a number of resection features, a depth of one or more cutting channels, an angle for one or more resection channels, a surface contour, component position, component orientation, and/or other features. "Distal tibia resection guide" refers to a resection guide designed, engineered, fabricated, or intended for use with, one, in, or about a medial part, section, surface, portion, or aspect of an anatomical structure such as a bone, digit, limb, or other anatomical structure for one or more steps of a resection procedure. "Distal fibula resection guide" refers to a resection guide designed, engineered, fabricated, or intended for use with, one, in, or about a lateral part, section, surface, portion, or aspect of an anatomical structure such as a bone, digit, limb, or other anatomical structure for one or more steps of a resection procedure. 52 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Bone fragment" refers to a part of a bone that is normally part of another bone of a patient. A bone fragment may be separate from another bone of a patient due to a deformity or trauma. In one aspect, the bone the bone fragment is normally connected or joined with is referred to as a parent bone. 53 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Cut surface" refers to a surface of an object that is created or formed by the removal of one or more parts of the object that includes the original surface. Cut surfaces can be created using a variety of methods, tools, or apparatuses and may be formed using a variety of removal actions, including, but not limited to, fenestrating, drilling, abrading, cutting, sawing, chiseling, digging, scrapping, and the like. Tools and/or methods used for forming a cut surface can include manual, mechanical, motorized, hydraulic, automated, robotic, and the like. In certain embodiments, the cut surface(s) are planar. 54 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Orientation" refers to a direction, angle, position, condition, state, or configuration of a first object, component, part, apparatus, system, or assembly relative to another object, component, part, apparatus, system, assembly, reference point, reference axis, or reference plane. 55 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 "Longitudinal axis" refers to an axis of a structure, device, object, apparatus, or part thereof that extends from one end of a longest dimension to an opposite end. Typically, a longitudinal axis passes through a center of the structure, device, object, apparatus, or part thereof along the longitudinal axis. The center point used for the longitudinal axis may be a geometric center point and/or a mass center point. 56 Added by DJM Jan 2024 1/6/24, 9:48 PM
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PER-32 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. Alternatively, or in addition, a resection feature may be referenced using other names including, but not limited to, channel, cut channels, and the like. 57 Added by DJM Jan 2024 1/6/24, 9:48 PM

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