Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
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View Edit Delete	PER-12	Returning to Figures 3A through 4, the body 610 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 600 may include at least one alignment feature. A second alignment feature may be integrated into the cutting guide 600 or the second alignment feature may be a separate feature from the cutting guide 600.	155	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In the illustrated embodiment, the proximal bone attachment feature 652 serves as both a bone attachment feature and as an alignment feature, e.g., proximal alignment feature 680. In this manner, the proximal bone attachment feature 652 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 654 may also serve as both a bone attachment feature and as an alignment feature, e.g., distal alignment feature 690.	156	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit 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 654 may serve as a bone attachment feature and as a reference for the positioning of a distal alignment feature 690 that is separate from the cutting guide 600.	157	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	For example, in such instances, the distal bone attachment feature 654 may serve as a reference for placement of a distal alignment feature 690 that is parallel to the distal bone attachment feature 654 as measured along the longitudinal axis 676 of the first metatarsal 208. Subsequent to formation of a cut surface on the first metatarsal 208, the distal alignment feature 690 can be coupled to the first metatarsal 208 in parallel to the distal bone attachment feature 654 (e.g., by way of a pin guide). In certain embodiments, the distal alignment feature 690 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 680 and the distal alignment feature 690 may not be aligned initially. Instead, the proximal alignment feature 680 and distal alignment feature 690 may be configured to align when the bone coupled to the distal alignment feature 690 is rotated.	158	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 7 illustrates an example cutting guide 600 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 610 is configured to extend between the lateral end 402 and the medial end 404. In this manner, the first slot 660 and second slot 670 extend along the TMT joint 400 in a lateral medial direction and are long enough that a surgeon can readily resect the respective ends of the respective bones of the joint. In addition, the proximal arm 630 and the distal arm 640 may be aligned with each other. In one embodiment, the proximal arm 630 and distal arm 640 may extend proximal to the lateral side 618 and/or proximal to the lateral end 402 of the joint (e.g., TMT joint 400).	159	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Advantageously, the cutting guide 600 can be used with patients that have smaller bones and joints such as children or female patients. The cutting guide 600 fits directly on the dorsal surfaces of the bones of the joint. This placement can avoid contact with soft tissues that may run along the medial and/or lateral surfaces of the bones of the joint.	160	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 7 illustrates that the cutting guide 600 can be secured to the bones using the proximal bone attachment feature 652 and/or distal bone attachment feature 654 each of which may include two or more fasteners 356. In certain embodiments, the fasteners 356 of the proximal bone attachment feature 652 are aligned with each other and perpendicular to the second slot 670. The fasteners 356 of the distal bone attachment feature 654 are aligned with each other and perpendicular to the first slot 660. The fit of the bone engagement surface 624 to the surfaces (dorsal in this embodiment) of the bones helps to secure the cutting guide 600 in place and ensure that resection of the bones using the first slot 660 and second slot 670 forms the desired cut surfaces for the procedure.	161	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Those of skill in the art will appreciate that in various embodiments certain aspects may interface with one or more dorsal surfaces of each or both of the bones of a joint. The illustrated embodiments provide at least one example. In other embodiments, at least one of a cutting guide body, a proximal arm, a distal arm, and a bone engagement surface of a inferior surface of the body is configured to engage a dorsal surface of one or more of a first bone and a second bone.	162	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	It should be noted that the cutting guide 300 and/or cutting guide 600 may be configured to engage with a dorsal surface of one bone (e.g., a medial cuneiform 202) and a lateral surface of a second bone (e.g., a first metatarsal 208) of a joint (e.g., TMT joint 400). For example, where the patient has a hallux valgus condition, the first metatarsal 208 may have rotated about its longitudinal axis 376/676 such that the lateral surface of the first metatarsal 208 faces dorsal. Advantageously, the present disclosure accounts for this and the cutting guide 300/600 is configured to contact a dorsal surface on one bone and a lateral surface of the second bone (or proximal surface if the bone is rotated in the other direction). Furthermore, the proximal alignment feature 380/680 may engage with a dorsal surface of a proximal bone and the distal alignment feature 390/690 may engage with a dorsal surface of a distal bone, even though the distal bone has rotated.	163	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Referring to Figures 4 and 7, in the illustrated embodiments, the proximal alignment feature 380/680 and distal alignment feature 390/690 may be in separate devices rather than being combined in a single device. Figures 4 and 7 show the proximal alignment feature 380/680 as part of the cutting guide 300/600.	164	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 8A is a perspective view of a foot, after resection of the medial cuneiform 202 and the first metatarsal 208, removal of the cutting guide 300, and placement of the first metatarsal 208 to abut the medial cuneiform 202. As shown, the distal end 272 of the first metatarsal 208 may now be positioned much closer to the second metatarsal 210, in a more natural position. Further, Figure 8A depicts a first proximal phalanx 230, which may now be properly oriented generally parallel to the other phalanges (not shown), rather than pointing in the lateral direction 274. If desired, further steps may be performed relative to the joint between the first metatarsal 208 and the first proximal phalanx 230 in order to place them in the proper relative orientation. The distal end 272 may also have been shifted in the plantar direction 276 or in the dorsal direction 278 from the position of Figure 2. Thus, the desired dual-plane correction of the orientation of the first metatarsal 208 may be complete.	165	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The first metatarsal 208 may be secured to the medial cuneiform 202, at least until proper bone in-growth has occurred between the medial cuneiform 202 and the first metatarsal 208. In some embodiments, a bone plate (not shown) or other fastener (not shown) may be used to secure the medial cuneiform 202 and the first metatarsal 208 together. Additional hardware (not shown) may be used to stabilize the position and/or orientation of the first proximal phalanx 230 relative to the first metatarsal 208, if desired. The surgical wound may be closed, and the foot 200 may be allowed to heal with the bunion deformity corrected.	166	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 8B and 8C are dorsal views of the foot 200, before and after correction, respectively. Figures 8B and 8C illustrate the correction of the angulation of the first metatarsal 208, by which the distal end 272 of the first metatarsal 208 is moved in the lateral direction 274. In some embodiments, an implant 810 may be inserted in the space between the first metatarsal 208 and the medial cuneiform 202 in order hold the first metatarsal 208 and the medial cuneiform 202 together and/or facilitate bony fusion between the first metatarsal 208 and the medial cuneiform 202.	167	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In some embodiments, an implant 810 may be patient-specific. For example, the implant 810 may have a cuneiform-facing side 820 that is shaped and/or sized to be secured to the adjoining, resected surface of the medial cuneiform 202, and a metatarsal-facing side 830 that is shaped and/or sized to be secured to the adjoining, resected surface of the first metatarsal 208. As the resections made to the first metatarsal 208 and the medial cuneiform 202 may both planar, the cuneiform-facing side 820 and/or the metatarsal-facing side 830 may also be planar. However, the cuneiform-facing side 820 and/or the metatarsal-facing side 830 may advantageously each be shaped to match the profile of the resected surface of the medial cuneiform 202 and the first metatarsal 208, respectively.	168	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	This shaping may be accomplished by custom-designing the implant 810 for the patient, using the same models (for example, from CT scans) of the first metatarsal 208 and the medial cuneiform 202 that were used to generate the cutting guide 300. Thus, the implant 810 may have a shape that provides secure attachment and/or fusion between the first metatarsal 208 and the medial cuneiform 202 while avoiding proud edges or other protruding features that could otherwise interfere with surrounding tissues.	169	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figures 9A, 9B, and 9C are dorsal pre-operative, dorsal post-operative, and lateral post-operative views, respectively, of a foot treated with an Evans calcaneal osteotomy, according to one embodiment. Outward rotation of the foot may occur in patients with flatfoot. An Evans or lateral column lengthening procedure is sometimes performed for these patients. An incision is made on the outside of the foot, and the front half of the heel bone is cut. A bone wedge (typically either titanium or a bone-based graft) is then placed into the cut area of the heel bone. This wedge helps to “lengthen” the heel bone and rotate the foot back into its correct position. The wedge is usually kept in place using screws or a surgical staple.	170	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 10 illustrates an exemplary embodiment of a compressor/distractor 1000 that can be used with certain embodiments. The compressor/distractor 1000 can be used for one or both of distraction and compression. For example, the compressor/distractor 1000 can be used to distract the first metatarsal 208 relative to the medial cuneiform 202.	171	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	A user may slide holes 1002a,b over pins in one or both bones. This can cause a desired rotation and translation of the first metatarsal 208 relative to the medial cuneiform 202. When a user places the parallel compressor/distractor 1000 on over the pins this can force the cut faces of the two bones to become parallel. Advantageously, the cut faces of the two bones can be forced to become parallel because the position, orientation, and angles of the holes of alignment feature(s) can be predefined and customized for each patient when the cutting guide 600 is fabricated.	172	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	This alignment enables parallel compression of the two bones together using the parallel compressor/distractor 1000. Parallel compression enables more effective compression of the two bones together. Next, the space between the resected surfaces of the medial cuneiform 202 and the first metatarsal 208 is prepared for fusion. Then, the parallel compressor/distractor 1000 can be activated such that the medial cuneiform 202 and the first metatarsal 208 are fused together. The parallel compressor/distractor 1000 may include a first leg 1004 and a second leg 1006. At one end of each leg 1004/1006, the leg may include a toe 1008/1010 at its distal end. In one embodiment, the toes 1008/1010 are angled to point towards each other. The angled configuration of the legs 1004/1006 by way of the toes 1008/1010 may apply a torque force at the toes 1008/1010 which may further assist in pressing two bones connected to the parallel compressor/distractor 1000 together.	173	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The present disclosure is not limited to cutting guides or extremity procedures. In some embodiments, patient-specific instrumentation may be used to correct a wide variety of bone conditions. Such conditions include, but are not limited to, any angular deformities from within one bone segment in either the lower or upper extremities (for example, tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). The present disclosure may also be used to treat an interface between two bone segments (for example, the ankle joint, metatarsal cuneiform joint, lisfranc's joint, complex charcot deformity, wrist joint, knee joint, etc.). As one example, an angular deformity or segmental malalignment in the forefoot may be treated, such as is found at the metatarsal cuneiform level, the midfoot level such as the navicular cuneiform junction, hindfoot at the calcaneal cubiod or subtalar joint or at the ankle between the tibia and talar junction. Additionally, patient-specific instruments could be used in the proximal leg between two bone segments or in the upper extremity such as found at the wrist or metacarpal levels.	174	Added by DJM Jan 2024	1/6/24, 10:03 PM

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