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Delete 		PER-4 DIV1 Figure 1A is a flowchart diagram depicting a method 100 for correcting a bone condition, according to one embodiment. The method 100 may be used for any of a wide variety of bone conditions, including but not limited to deformities, fractures, joint failure, and/or the like. Further, the method 100 may provide correction with a wide variety of treatments, including but not limited to arthroplasty, arthrodesis, fracture repair, and/or the like. 5 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The present disclosure discloses surgical systems and methods by which a bone condition, such as a deformity, may be corrected through the use of patient-specific instrumentation. Known methods of correcting bone conditions are often limited to a finite range of discretely sized instruments. A patient with an unusual condition, or anatomy that falls between instrument sizes, may not be readily treated with such systems. One example is correction of a bunion, in particular, via adjustment of the angulation between a cuneiform and a metatarsus. 4 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The first metatarsus 230 may further be offset in a plantar direction 280 or in a dorsal direction 290, relative to the remainder of the foot 200. Accordingly, the orientation of the first metatarsus 230 may need to be adjusted to move the distal end 250 in the lateral direction 260 and in the plantar direction 280 and/or in the dorsal direction 290. 24 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Once the cutting guide 300 has been secured relative to the first cuneiform 210 and the first metatarsus 230, the first cuneiform 210 and the first metatarsus 230 may be resected. In some embodiments, a reciprocating blade may be inserted into the first slot 350 and moved medially and laterally, between opposite ends of the first slot 350, to make a planar cut that removes the distal end of the first cuneiform 210. Similarly, the reciprocating blade (or a different reciprocating blade) may be inserted into the second slot 352 and moved medially and laterally, between opposite ends of the second slot 352, to make a planar cut that removes the proximal end of the first metatarsus 230. The cuts in the first cuneiform 210 and the first metatarsus 230 may be made in either order. In either case, once both cuts are made, the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsus 230 may be removed, resulting in exposure of “bleeding” bone at the distal end of the first cuneiform 210 and the proximal end of the first metatarsus 230. The cutting guide 300 may be removed, along with some or all of the pins 500. If desired, at least two of the pins 500 may remain in place and used to attach a distractor (not shown) to the first cuneiform 210 and the first metatarsus 230, such that the distractor can temporarily widen the space between the first cuneiform 210 and the first metatarsus 230 to allow for fenestration and/or other preparation of the cut surfaces of the first cuneiform 210 and the first metatarsus 230. Once such preparation has been carried out, the remaining pins 500 may also be removed. 40 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 As shown, the body 310 may have two holes 340 positioned over the first cuneiform 210, and two holes 340 positioned over the first metatarsus 230. This is merely exemplary; in some embodiments, a cutting guide may be secured to only one of the first cuneiform 210 and the first metatarsus 230, or may be secured to either of the first cuneiform 210 and the first metatarsus 230 with only one pin 500, or with more than two pins 500. Further, in some alternative embodiments, different fasteners may be used, such as screws, clamps, clips, and/or the like. 39 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Figure 5 is a perspective view of the foot 200 of Figure 2, with the cutting guide 300 of Figures 3A, 3B, 3C, and 3D properly positioned on the first cuneiform 210 and the first metatarsus 230, and attached to the first cuneiform 210 and the first metatarsus 230 in preparation for resection of the first cuneiform 210 and the first metatarsus 230. Specifically, pins 500 may be inserted through the holes 340 in the body 310 and anchored in the first cuneiform 210 and the first metatarsus 230. Each of the pins 500 may have a sharp and/or threaded distal end that can penetrate and/or readily be retained in the bone of the first cuneiform 210 or the first metatarsus 230. Additionally or alternatively, a drill or other hole-forming instrument may be used to pre-form holes in the first cuneiform 210 and/or the first metatarsus 230 to receive the distal ends of the pins 500. 38 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Notably, the joint probe 320 (not visible) may reside between the first cuneiform 210 and the first metatarsus 230 (i.e., distal to the first cuneiform 210 and proximal to the first metatarsus 230). The surgeon may need to cut the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsus 230 to form a space between the first cuneiform 210 and the first metatarsus 230 to receive the joint probe 320. Positioning the joint probe 320 in this space may further help to ensure that the cutting guide 300 is properly aligned relative to the first cuneiform 210 and the first metatarsus 230. 37 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Figure 4 is a perspective view of the foot 200 of Figure 2, with the cutting guide 300 of Figures 3A, 3B, 3C and 3D properly positioned on the first cuneiform 210 and the first metatarsus 230, but as yet not attached to the first cuneiform 210 and the first metatarsus 230. The surgeon has made the necessary incision(s) to expose the dorsal surfaces of the first cuneiform 210 and the first metatarsus 230, and has inserted the cutting guide 300 such that the cuneiform apposition portion 342 (identified by the first bone indicator 360 on the outward-facing side 332 of the body 310) is resting on the corresponding dorsal surface of the first cuneiform 210, and the metatarsus apposition portion 344 (identified by the second bone indicator 362 on the outward-facing side 332 of the body 310) is resting on the corresponding dorsal surface of the first metatarsus 230. Since the cuneiform apposition portion 342 and the metatarsus apposition portion 344 are contoured to match the bone surfaces on which they rest, the body 310 may readily slide into its proper position on the first cuneiform 210 and the first metatarsus 230. 36 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Returning to Figures 3A through 3D, the body 310 may further have features that facilitate proper positioning of the cutting guide 300 on the first cuneiform 210 and the first metatarsus 230. More specifically, the body 310 may have a first bone indicator 360 with the text “CUN,” indicating that the end of the body 310 with the first bone indicator 360 is to be positioned over the first cuneiform 210. Similarly, the body 310 may have a second bone indicator 362 with the text “MET,” indicating that the end of the body 310 with the second bone indicator 362 is to be positioned over the first metatarsus 230. In addition, the body 310 may have a side indicator 370 with the text “LEFT,” indicating that the cutting guide 300 is to be used in connection with the patient’s left foot. The side indicator 370 may be particularly helpful when bunion corrections are to be provided on both of the patient’s feet. In such a case, the surgeon may manufacture or receive two separate cutting guides: one for the left foot (the foot 200 of Figure 2) and another for the right foot (not shown). 35 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 In alternative embodiments, a guide feature may be designed to guide a different type cutter, such as a drill, mill, or side-cutting burr. In such embodiments, the guide feature may not be a slot, but may instead be a translatable or rotatable cutter retainer that guides translation and/or rotation of the cutter relative to the bone. 34 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 In the embodiment of Figures 3A through 3D, the guide features may guide a reciprocating planar blade, such as that of a surgical bone saw, that forms planar cuts in the first cuneiform 210 and the first metatarsus 230. Thus, the guide features may take the form of a first slot 350 and a second slot 352, which may be positioned toward the center of the body 310, on opposite sides of the joint probe 320. Thus, upon proper positioning of the cutting guide 300, the first slot 350 may be positioned over the first cuneiform 210 to facilitate resection of the first cuneiform 210, while the second slot 352 may be positioned over the first metatarsus 230 to facilitate resection of the first metatarsus 230. 33 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The body 310 may further have guide features that guide a cutter to resect the first cuneiform 210 and the first metatarsus 230 in the manner needed to make the desired correction. For example, the guide features may be used to guide a planar cutting blade, an arcuate cutting blade, a drill or mill, a burr, and/or the like. 32 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Generation of the contours of the cuneiform apposition portion 342 and the metatarsus apposition portion 344 may be performed relative easily in various CAD programs. In some embodiments, the shapes of the corresponding dorsal surfaces of the first cuneiform 210 and the first metatarsus 230 may be obtained directly from the CAD models and/or CT scan data, and simply copied onto the model for the body 310 of the cutting guide 300. Various operations may be used to copy surfaces from one object to another. Additionally or alternatively, various Boolean operations, such as a Boolean subtraction operation, may be used to remove material from a model for the body 310 with a shape that matches the dorsal surfaces of the first cuneiform 210 and the first metatarsus 230. 31 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The bone apposition side 330 may be custom contoured to match the shapes of the first cuneiform 210 and/or the first metatarsus 230. As embodied in Figures 3A through 3D, the bone apposition side 330 may have a cuneiform apposition portion 342 shaped to lie against the dorsal surface of the first cuneiform 210, and a metatarsus apposition portion 344 shaped to lie against the dorsal surface of the first metatarsus 230. As shown, the cuneiform apposition portion 342 may be contoured to match the contour of the dorsal surface of the first cuneiform 210 on which it is to rest, and the metatarsus apposition portion 344 may similarly be contoured to match the contour of the dorsal surface of the first metatarsus 230 on which it is to rest. Thus, the body 310 may have only one stable position and orientation relative to the first cuneiform 210 and the first metatarsus 230. 30 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The body 310 may have a bone apposition side 330 that, upon attachment of the body 310 to the first cuneiform 210 and the first metatarsus 230, is to face toward the first cuneiform 210 and the first metatarsus 230. The body 310 may also have an outward-facing side 332 that, upon attachment of the body 310 to the first cuneiform 210 and the first metatarsus 230, faces outward, away from the first cuneiform 210 and the first metatarsus 230. Further, the body 310 may have one or more bone attachment features that facilitate attachment of the body 310 to the first cuneiform 210 and/or the first metatarsus 230. Such bone attachment features may comprise any of a wide variety of holes, spikes, fastening devices, and/or the like. As embodied in Figures 3A through 3D, the bone attachment features may take the form of holes 340 that extend from the bone apposition side 330 to the outward-facing side 332. The holes 340 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the first cuneiform 210 and/or the first metatarsus 230 to keep the cutting guide 300 in place. 29 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 As shown, the cutting guide 300 may have a body 310 with a monolithic construction and the general shape of a rectangular prism. The cutting guide 300 may further have a joint alignment feature that helps align the body 310 with the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsus 230. The joint alignment feature may consist of a joint probe 320 that extends from the body 310 and has a blade-like shape. The body 310 may reside on the dorsal surfaces of the first cuneiform 210 and the first metatarsus 230, while the joint probe 320 may protrude into the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsus 230 to provide proper alignment of the body 310 with the metatarsocuneiform joint. 28 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Figures 3A, 3B, 3C, and 3D are top perspective, alternative top perspective, front elevation, and bottom perspective views, respectively, of a patient-specific cutting guide, or cutting guide 300, according to one embodiment. The cutting guide 300 may be designed to facilitate resection of the first cuneiform 210 and the first metatarsus 230 with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsus 230, thereby providing correction in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290. 27 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Thus, providing a patient-specific cutting guide may provide unique benefits. Specifically, the patient-specific cutting guide may provide precise correction of the deformity present in the foot 200 and may also reduce the likelihood of improper correction due to misalignment of the cutting guide on the foot 200. The optimal cut provided by such a cutting guide may further reduce the likelihood that additional procedures, such as attachment of the first metatarsus 230 to the second metatarsus 240 to each other with screws or the like, will be needed to provide the desired correction. Any such additional procedure carries its own added surgical burden and risk of failure. Thus, the use of patient-specific instrumentation may shorten surgery, accelerate recovery, and reduce the risk of complications. 26 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 Every deformity is different; accordingly, the degree of angular adjustment needed in each direction may be different for every patient. Use of a patient-specific cutting guide may help the surgeon obtain the optimal realignment in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290. Conversely, use of one of a number of differently-sized cutting guides may provide only approximate correction, as the surgeon may not have a guide that precisely matches the correction needed for the foot 200, and must thus choose the cutting guide that most closely provides the desired correction. Such differently sized cutting guides would not be contoured to fit the first cuneiform 210 or the first metatarsus 230, thus introducing additional potential for error as the surgeon must properly align the selected cutting guide. 25 Added by DJM Jan 2024 1/6/24, 9:54 PM
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Delete 		PER-4 DIV1 The first metatarsus 230 may be excessively angled in a medial direction 270 (i.e., toward the lower left-hand corner of the page), causing a painful protrusion at a distal end 250 of the first metatarsus 230, and further causing the phalanges (not shown) attached to the distal end 250 to be angled excessively in a lateral direction 260 (i.e., pointing toward the other phalanges of the foot, rather than pointing directly forward). The excessive medial angulation of the first metatarsus 230 may also result in an excessive gap between the first metatarsus 230 and the second metatarsus 240. 23 Added by DJM Jan 2024 1/6/24, 9:54 PM

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