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Delete 		PER-12 "Repository" refers to any data source or dataset that includes data or content. In one embodiment, a repository resides on a computing device. In another embodiment, a repository resides on a remote computing or remote storage device. A repository may comprise a file, a folder, a directory, a set of files, a set of folders, a set of directories, a database, an application, a software application, content of a text, content of an email, content of a calendar entry, and the like. A repository, in one embodiment, comprises unstructured data. A repository, in one embodiment, comprises structured data such as a table, an array, a queue, a look up table, a hash table, a heap, a stack, or the like. A repository may store data in any format including binary, text, encrypted, unencrypted, a proprietary format, or the like. 216 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Next, the method 1100 may register 1108 the preliminary cutting guide model with one or more bones of the bone model. This step 1108 facilitates customization and modification of the preliminary cutting guide model to generate a patient-specific cutting guide model from which a patient-specific cutting guide can be generated. The registration step 1108 combines two models and/or patient imaging data and positions both models for use in one system and/or in one model (e.g., model registration). 217 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 As used herein, "model 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. 218 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 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. 219 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 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.) 220 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Referring to Figure 3D, in one embodiment, anatomical data about the patient can be used to define other structures of the cutting guide 300 or other patient specific instruments. For example, anatomical data about the patient that can be captured in the patient imaging data (e.g., due to the fidelity of the technology providing the patient imaging data) can be used to define how deep a first resection feature and/or second resection feature is. Controlling the depth of the first resection feature and/or second resection feature can be used to manage how deep a surgeon’s cutting instruments can reach within the first resection feature and/or second resection feature. Managing a depth for one or more resection features may be referred to as defining a patient specific height for the cutting guide 300. 109 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 For example, in one embodiment, patient imaging data can be used to define a distance between at a first top edge 366 of the first resection feature (e.g., first slot 360) and the first surface (e.g., a surface of a first bone such as a first metatarsal 208). Alternatively, or in addition, patient imaging data can be used to define a distance between at a second top edge 368 of the second resection feature (e.g., second slot 370) and the second surface (e.g., a surface of a second bone such as a medial cuneiform 202). Managing the distance between a first top edge 366 and/or second top edge 368 and a bone surface is one way to provide a stop within the cutting guide 300. The stop can serve to limit how deep a surgeon will resect hard tissue/soft tissue when using the cutting guide 300 for a procedure. If a surgeon resects until the resection instruments engages the stop, the surgeon can be assured that the resection extends to a desired depth (not too far and not too short). 110 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 As used herein, a “stop” refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to prevent, limit, impede, stop, or restrict motion or movement and/or operation of the another object, member, structure, component, part, apparatus, system, or assembly. 111 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Referring to Figures 3H and 4, in one embodiment, the body 310, or one or more arms, may include one or more bone attachment features that facilitate attachment of the body 310 to the medial cuneiform 202 and/or first metatarsal 208. Such bone attachment features may include any of a wide variety of fasteners including, but not limited to, holes, spikes, fastening devices, and/or the like. 112 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Effective connection of the cutting guide 300 to one or more bones across a joint can ensure that cut surfaces are formed in desired locations and orientation and mitigate removal of hard tissue and/or soft tissue outside in undesired locations. 113 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Accordingly, the cutting guide 300 includes one or more bone attachment features. As embodied in Figures 3A through 3H, the bone attachment features may take the form of one or more holes 350 that extend from the inferior side 322 to the superior side 320 and/or one or more fixation devices. The holes 350 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the medial cuneiform 202 and/or the first metatarsal 208 to keep the cutting guide 300 in place. 114 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Figure 4 illustrates one example of a cutting guide 300 coupled to the bones using a proximal bone attachment feature 352 and a distal bone attachment feature 354. In the illustrated embodiment, the proximal bone attachment feature 352 includes at least hole 350 and a fastener and the distal bone attachment feature 354 includes at least hole 350 and a fastener. In Figure 4 the fasteners are K-wires. Advantageously, the proximal bone attachment feature 352 and the distal bone attachment feature 354 each include at least two holes 350, each with a K-wire passing through the hole 350 and into bone facing the inferior side 322. Using two holes 350 and two fasteners ensures a stable coupling between the cutting guide 300 and the bone(s). Advantageously, in certain embodiments, the two holes 350 of the proximal bone attachment feature 352 and distal bone attachment feature 354 are align such that inserted K-wires are parallel to each other. Among other benefits, parallel K-wires of each of the proximal bone attachment feature 352 and distal bone attachment feature 354 prevent the cutting guide 300 from pivoting around one of the K-wires of a proximal bone attachment feature 352 or a distal bone attachment feature 354. 115 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 In the illustrated embodiment, the proximal arm 330 includes the proximal bone attachment feature 352 and the distal arm 340 includes the distal bone attachment feature 354. In one embodiment, the holes 350 of the proximal bone attachment feature 352 are aligned with each other and aligned perpendicular to a resection feature such as the second slot 370. The holes 350 of the distal bone attachment feature 354 may also be aligned with each other and aligned perpendicular to another resection feature such as the first slot 360. This means that the aligned holes 350 (and K-wires secured within them) of the distal bone attachment feature 354 will also be perpendicular to the cut surface formed using the first slot 360. This also means that the aligned holes 350 (and K-wires secured within them) of the proximal bone attachment feature 352 will also be perpendicular to the cut surface formed using the second slot 370. Consequently, at least one of the proximal bone attachment feature 352 and the distal bone attachment feature 354 can be used to position and orient a cut surface of the first metatarsal 208 and a cut surface of the medial cuneiform 202. 116 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Returning to Figures 3A through 4, the body 310 may further have features that facilitate desired translation and orientation of the first metatarsal 208 and/or medial cuneiform 202 in order to fuse or join the two bones to complete the procedure. For example, in the illustrated embodiment, the cutting guide 300 may include at least one alignment feature. A second alignment feature may be integrated into the cutting guide 300 or the second alignment feature may be a separate feature from the cutting guide 300. 117 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 In the illustrated embodiment, the proximal bone attachment feature 352 serves as both a bone attachment feature and as an alignment feature, e.g., proximal alignment feature 380. In this manner, the proximal bone attachment feature 352 can provide both a bone attachment feature and an alignment feature in a single feature. In situations where a second bone of a joint, such as a first metatarsal 208, does not need to be rotated, translated, and/or re-oriented to mitigate a patient’s condition, the distal bone attachment feature 354 may also serve as both a bone attachment feature and as an alignment feature, e.g., distal alignment feature 390. 118 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Typically, in an osteotomy for a condition such as a hallux valgus, it is desirable to rotate the first metatarsal 208 to address the condition. The first metatarsal 208 may be rotated for example to re-position distal plantar sesamoids from a lateral orientation to a more plantar orientation. Research has shown that performing such re-orientation mitigates recurrence of a hallux valgus condition. In such situations, the distal bone attachment feature 354 may serve as a bone attachment feature and as a reference for the positioning of a distal alignment feature 390 that is separate from the cutting guide 300. 119 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 For example, in such instances, the distal bone attachment feature 354 may serve as a reference for placement of a distal alignment feature 390 (See Figure 4A) that is parallel to the distal bone attachment feature 354 as measured along the longitudinal axis 376 of the first metatarsal 208. Subsequent to formation of a cut surface on the first metatarsal 208, the distal alignment feature 390 can be coupled to the first metatarsal 208 in parallel to the distal bone attachment feature 354 (e.g., by way of a pin guide). In certain embodiments, the distal alignment feature 390 can include two or more aligned holes and/or a pair of K-wires that enter the bone in parallel to each other. In addition, in such a situation, the proximal alignment feature 380 and the distal alignment feature 390 may not be aligned initially. Instead, the proximal alignment feature 380 and distal alignment feature 390 may be configured to align when the bone coupled to the distal alignment feature 390 is rotated. Fasteners 356 of the distal bone attachment feature 354 may be aligned with longitudinal axis 376 and perpendicular to first slot 360 by way of holes 350. Fasteners 356 of the proximal bone attachment feature 352 may be aligned with reference line 392 and perpendicular to second slot 370 by way of holes 350. The reference line 392 may not be aligned with the longitudinal axis 376. 120 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Figure 4 illustrates an example cutting guide 300 seated transverse to a tarsometatarsal (“TMT”) joint 400. The TMT joint 400 includes a lateral end 402 and a medial end 404. In certain embodiments, such as the illustrated embodiment, the body 310 is configured to extend between the lateral end 402 and the medial end 404. In addition, the proximal arm 330 and the distal arm 340 may be aligned with each other. 121 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Furthermore, in certain embodiments, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 near the lateral end 402 (See Figure 6). Said another way, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 such that the arms extend over a dorsal surface of the medial cuneiform 202 and a dorsal surface of the first metatarsal 208. In another embodiment, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 near the medial end 404. 122 Added by DJM Jan 2024 1/6/24, 10:03 PM
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Delete 		PER-12 Figure 4 illustrates an example cutting guide 300 at a particular stage in an osteotomy procedure. In one embodiment, a surgeon has formed an incision transverse to a TMT joint 400 with a dorsal approach. In the illustrated embodiment, the cutting guide 300 may be configured (e.g., the bone engagement surface 324) to seat between the dorsal surface and medial surface of both the medial cuneiform 202 and the first metatarsal 208. The surgeon has also formed the incision down to the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208. Further, the surgeon has cut, or moved to the side, soft tissue covering the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208 sufficient to seat the bone engagement surface 324 onto the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208. 123 Added by DJM Jan 2024 1/6/24, 10:03 PM

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