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Dave's PCF WIP: Paragraphs
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PER-12 In certain embodiments, fasteners 3310 can be configured to facilitate resection using the resection features 3322. For example, the bone attachment features 3324 can be configured such that fastener 3310a enters at substantially the same angle as the posterior resection feature 3322a. In addition, fastener 3310b may be shorter such that the fastener 3310b does not interfere with resection using the anterior resection feature 3322b. Alternatively, or in addition, the bone attachment feature 3324 that receives the fastener 3310b can be angled to extend at substantially the same angle as the anterior resection feature 3322b. 460 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 35C is a plantar view of the bones and resection guide 3320. Figure 35C illustrates a closer view of the stage in the surgical osteotomy procedure (e.g., an Akin osteotomy) of Figure 35A with the resection guide 3320 secured and positioned on the first proximal phalanx 3406. Figure 35C illustrates a stage in the surgical osteotomy procedure (e.g., an Akin osteotomy) in which a wedge resection has been performed. Fasteners 3310 serve to engage the proximal and distal parts of the first proximal phalanx 3406 after the resection and/or for subsequent repositioning of the proximal and distal parts of the first proximal phalanx 3406. Figure 35B illustrates a cutting tool such as an oscillating saw 3414 inserted into one of the resection features 3322. 461 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Cutting a wedge shape for an Akin procedure while leaving a desired amount of bone (cortical bone) on the opposite side can be a challenge to do without the solutions of the present disclosure. Advantageously, the resection features 3322 of the resection guide 3320 are configured to make this resection straightforward once the resection guide 3320 is positioned on the bone in the desired location. The bone engagement surface 3330 facilitates proper placement of the resection guide 3320. 462 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Note that Figure 35C illustrates a wedge cut that does not extend to the opposite side of the bone, instead approximately a 1-3 mm section, portion 3410, of bone may be left on the other side (lateral side) of the bone. This section 3410 can facilitate handling of the parts of the first proximal phalanx 3406 during the surgical osteotomy procedure (e.g., an Akin osteotomy). In certain embodiments, the remaining portion 3410 can be used as a living hinge to keep the two parts of the bone together during a fixation step or during one or more steps of the surgical osteotomy procedure. Advantageously, using the methods of this disclosure one can define how thick to make the section 3410 as well as what angles to cut in the bone for the wedge. 463 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 35D illustrates a dorsal view of a first proximal phalanx 3406 after the resection cuts are made. Figure 35D illustrates how one embodiment of a fixation guide 3390c can use the same fasteners 3310 used to form the osteotomy to position a fixation guide 3390 for deploying a K-wire that can be used to deploy a cannulated compression screw. The fixation guide 3390 is positioned for deployment of a K-wire along line 3416. 464 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 35E illustrates the first proximal phalanx 3406 after one embodiment of a resection guide 3320 is removed and the osteotomy is closed. In the illustrated embodiment, the osteotomy may be an oblique osteotomy preplanned by a surgeon to assist in providing a correction. Note that the bone attachment features 3324 and/or resection features 3322 can be configured in the resection guide 3320 such that once the resection guide 3320 is removed the fasteners 3310 can be used to align, reorient, and/or correct positioning of the proximal part 3406a relative to the distal part 3406b of the first proximal phalanx 3406. Advantageously, each of the aspects and/or attributes of a resection guide 3320 and/or a one or more bone attachment features 3324 and/or resection features 3322 and/or position and/or orientation of fasteners 3310 can be patient-specific and/or can be predetermined before the surgical procedure. 465 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 35F illustrates the first proximal phalanx 3406 after a resection guide 3320, such as the example of Figure 35E, is removed, the osteotomy is closed, and a fixation guide 3390a is deployed. In the illustrated embodiment of Figure 35F, the osteotomy may be an oblique osteotomy. The fixation guide 3390a can be used to direct or guide a temporary fastener 3310 that can hold a proximal part 3406a in contact with a distal part 3406b until permanent fixation is deployed. The fixation guide 3390 may include positioning features (such as holes or openings in a body of the fixation guide 3390). These positioning feature may engage fasteners 3310 originally deployed with the resection guide 3320. The positioning features can ensure that a fixation guide 3390a guides a fastener 3310 in a desired orientation. 466 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In certain embodiments, the positioning feature 3620, 3622 may include additional aides to ensure a surgeon has properly positioned the fixation guide 3390a. For example, in one embodiment, the positioning feature 3620 may include tabs or nubs configured to pliably deform as a fastener 3310 is slid into the positioning feature 3620. Once the fastener 3310 slides past the tabs or nubs into the positioning feature 3620, an audible snap or click may be produced and/or a tactile feedback snap may signal to a surgeon that the fastener 3310 is properly positioned in the positioning feature 3620. Alternatively, or in addition, the positioning feature 3620 may be shaped such that at an open end the opening is smaller than an interior part of the opening. With such a shape, the smaller opening can provide interference as a fastener 3310 is pressed into the positioning feature 3620. With added pressure, the fastener 3310 may then “pop” into the wider part of the opening of the positioning feature 3620 to seat the fastener 3310 so that the fixation guide 3390a is “locked” into position relative to the two fasteners 3310. 467 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Alternatively, or in addition, the resection guide 3320 may also function as a fixation guide 3390, fixation guide 3390b. For example, holes for the bone attachment features 3324 of the resection guide 3320 may be angled and positioned such at once the fasteners 3310 are removed, the holes in the bone can serve as openings for deployment of a permanent fastener such as a bone staple and/or bone screws of a bone plate. In such an embodiment, the fixation guide 3390b serves both as a resection guide 3320 and as a fixation guide 3390. 468 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figures 36A-36E illustrate views of fixation guide 3390a of an osteotomy system, according to one embodiment. The fixation guide 3390a may include a body 3602, an alignment guide 3604, and one or more of a positioning feature 3620 and/or a positioning feature 3622. The fixation guide 3390a also includes a lateral side, a medial side, a proximal side, a distal side, a superior side, and an inferior side. 469 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In certain embodiments, the size, shape, and configuration of the fixation guide 3390a may be patient-specific and/or may be designed preoperatively to guide placement of a fastener 3310 during an Akin procedure. In such embodiments, the size, position, angle and/or orientation of the alignment guide 3604 may be such that a fastener 3310 guided by the alignment guide 3604 will engage both the proximal part 3406a and the distal part 3406b of the first proximal phalanx 3406. In certain embodiments, the alignment guide 3604 is a hole in the body 3602. 470 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 A surgeon may engage the positioning feature 3620 with a fastener 3310 (e.g., a proximal fastener) and the positioning feature 3622 with a fastener 3310 (e.g., a distal fastener) in such an engagement, the body 3602 is configured to position the alignment guide 3604 for a desired entry point for a fastener 3310. A surgeon may then deploy the fastener 3310 through the proximal part 3406a and the distal part 3406b of the first proximal phalanx 3406 and then remove the fixation guide 3390a. In one embodiment, the positioning feature 3620 is implemented as a hole in the body 3602. The positioning feature 3622 may also be a hole. In the illustrated embodiment, the positioning feature 3620 is implemented as an elongated opening in the body 3602. 471 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figures 37A-37B illustrate views of a fixation guide of an osteotomy system, according to another embodiment. Figure 37A is a cross section view of the resection guide 3320 taken from a posterior side 3333 to an anterior side 3334 between the dorsal side 3335 and the plantar side 3336. Note that the bone attachment feature 3324b is angled. In certain embodiments, the bone attachment feature 3324b may be angled based on what kind of permanent fixation will be used to complete the procedure and based on where the bones will be once the bones are reoriented and/or repositioned after the osteotomy. 472 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In the illustrated embodiment, the bone attachment feature 3324b may be angled such that the same hole in the bone that the fastener 3310 created while being used to secure the resection guide 3320 to the bone, may be reused together with a hole made by the bone attachment feature 3324a. These holes may be used for deployment of a bone stable that may permanently secure the proximal part 3406a to the distal part 3406b of the first proximal phalanx 3406 after the resection. In this manner, the resection guide 3320 can serve as both a resection guide and a fixation guide 3390b. Figure 37B is a similar cross section view, with the fasteners 3310 in place to show the angles more clearly. 473 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In one embodiment, the fasteners 3310 may be deployed parallel to cut faces that are formed when resection is done using the resection features 3322, by way of an angle of the holes in the resection guide 3320. After resection using each of the resection features 3322, the fasteners 3310 may be at an angle relative to each other (as illustrated in Figure 37B). Next, a surgeon may remove the resection guide 3320. A surgeon may also remove a fastener 3310, such as distal fastener 3310a. The resection guide 3320 can then be removed. Next, the surgeon may redeploy distal fastener 3310a into its original hole in the bone. The distal fastener 3310a can then be used to position a fixation guide 3390 such as fixation guide 3390a. In certain embodiments, engaging the fasteners 3310 with a fixation guide 3390a may close a resected wedge and/or rotate the fasteners 3310 so that they are aligned with each other, which in turn moves the bones to a desired orientation. Alternatively, or in addition, closing a resected wedge may move the fasteners 3310 into alignment with each other such that using the fixation guide 3390a places an alignment guide 3604 in a desired position. 474 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Following closure of an osteotomy (closing the resected wedge), the osteotomy is fixated to facilitate fusion of the bone. Two methods may be used, staples and crossing-the-cut fully threaded compression screws. For surgeons that prefer staples, the present disclosure includes two pin holes (e.g., attachment feature 3324a and attachment feature 3324b having a diameter of about 2 mm but could be any diameter). Advantageously in one embodiment, these pin holes can be positioned and/or oriented in the resection guide 3320 relative to the desired cut angle for one or more cuts in the bone (which is patient specific) such that following closure of the resected wedge, the holes in the bone left by the pins are parallel to each other and set approx. 10 mm apart (which is a common spanning distance for conventional closing wedge staples). 475 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 For example, in one embodiment, a first bone attachment feature 3324a (which may include fastener 3310b and an opening through a resection guide 3320) is configured to form a first guide hole 3422a in the phalanx. The second bone attachment feature 3324b is configured to form a second guide hole 3422b in the phalanx. Advantageously, in the illustrated embodiment, a surgeon decides to use a bone staple, such as bone staple 3424. The bone staple 3424 may include a bridge 3426 that connects a first leg 3428 and a second leg 3430. 476 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 In one embodiment, the first guide hole 3422a has a depth, diameter, and/or orientation configured to receive a first leg 3428 of the bone staple 3424. Similarly, the second guide hole 3422b has a depth, diameter, and/or orientation configured to receive a second leg 3430 of the bone staple 3424. In this manner, the holes formed for the resection guide 3320 can be reused for fixation. Minimizing the number of holes in a bone, especially, a small bone such as those in the foot of a patient can significantly improve the outcomes for the patient and/or the recovery. 477 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Should surgeons prefer to use a crossing screw, the resection guide 3320 can include saw/cut channels configured to allow for a crossing cut compression screw. The compression screws may be cannulated. To deploy the compression screws, a K-wire may be placed across the resected section at a desired location (which may be predefined) to target a middle of the osteotomy where sufficient bone stock may exist so as to prevent bone fracture and provide the greatest bone stock for fixation. Advantageously, the present disclosure enables a surgeon to preoperatively identify a desired targeting angle for a crossing resection k-wires for installation of a compression screw. The targeting angle can be used to configure a fixation guide 3390 such as fixation guide 3390a. 478 Added by DJM Jan 2024 1/6/24, 10:03 PM
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PER-12 Figure 37A and Figure 37B illustrate the idea of designing and/or fabricating a resection guide 3320 that includes one or more patient-specific aspects. In particular, the resection guide 3320 can include bone attachment features 3324 that accommodate fasteners used later in a surgical procedure. Those of skill in the art will appreciate that while this concept is explained and/or applied in relation to the example resection guide 3320, the same concept can be applied and falls within the scope of the present disclosure for other example instrumentation and/or implants including but not limited to an example resection guide 2020 such as resection guide 2020a or any other instrument described herein. 479 Added by DJM Jan 2024 1/6/24, 10:03 PM

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