Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-10	Advantageously, with pins 1280a,b in place and pins 1280e,f in place the cutting guide 1400 has been fabricated and custom engineered such that bringing pins 1280a,b and pins 1280e,f in parallel alignment with each other will align the resected surfaces of the first cuneiform 210 and first metatarsal 230 to accomplish a desired translation, rotation, and/or orientation of the first metatarsal 230 relative to the first cuneiform 210 for the procedure. In other words, the alignment features 1260a,b are placed and configured in the cutting guide 1400 such that bringing pins 1280a,b and pins 1280e,f in parallel alignment provides a desired frontal plane correction required to bring sesamoids into proper alignment, based on an evaluation of a pre-operative CAD model. Because the cutting guide 1400 is custom fabricated for a particular patient, the alignment features 1260a,b are positioned such that aligning these alignment features 1260a after the resection will provide a desired frontal plane rotation that is unique to each patient and built into, designed into, the cutting guide 1400. The detachable connector 1270 connecting the alignment feature 1260a to the body 1210 is what enables a single cutting guide 1200 to become two during a procedure and provide a custom translation and rotation of a first metatarsal 230 that can be unique for each patient.	158	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Furthermore, fabricating a cutting guide that is customized to a particular patient and a specific desired correction/adjustment enables correction of a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used. The alignment features 1260 disclosed in this solution and the corresponding pins formed within a cutting guide that may also include a detachable connector 1270 enable correction procedures for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used. For example, embodiments of the procedures and devices herein disclosed can be used to address cavus, and mid foot dislocations, fracture malunion, metatarsal adductus, etc. They can also be used in preparation for joint resurfacing procedures of the foot and ankle to optimize placement of an arthroplasty implant.	159	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, with the alignment feature 1260a separated from the body 1210, and pins 1280c,d removed, a user can remove the two parts of the cutting guide 1400 separately. Pins 1280a,b remain in the first cuneiform 210 and pins 1280e,f remain in the first metatarsal 230.	161	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, a parallel compressor/distractor 1500 such as the exemplary parallel compressor/distractor 1500 illustrated in FIG. 15 is used to distract the first metatarsal 230 relative to the first cuneiform 210. The user slides holes 1502a,b over pins 1280a,b and holes 1502c,d over pins 1280e,f. This causes a desired rotation and translation of the first metatarsal 230 relative to the first cuneiform 210. When a user places the parallel compressor/distractor 1500 on over these pins 1280a,b,e,f this forces 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 1278 and/or holes of either or both of the alignment feature 1260a and alignment feature 1260b can be predefined and customized for each patient when the cutting guide 1300 is fabricated. This alignment enables parallel compression of the two bones together using the parallel compressor/distractor 1500. Parallel compression enables more effective compression of the two bones together. Next, the space between the resected surfaces of the first cuneiform 210 and the first metatarsal 230 is prepared for fusion. Then, the parallel compressor/distractor 1500 is activated such that the first cuneiform 210 and the first metatarsal 230 are fused together. The parallel compressor/distractor 1500 may include a first leg 1504 and a second leg 1506. At one end of each leg 1504/1506, the leg may include a toe 1508/1510 at its distal end. In one embodiment, the toes 1508/1510 are angled to point towards each other. The angled configuration of the legs 1504/1506 by way of the toes 1508/1510 may apply a torque force at the toes 1508/1510 which may further assist in pressing two bones connected to the parallel compressor/distractor 1500 together.	162	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Referring to FIG. 16, in certain embodiments, a parallel compressor/distractor 1600 such as the exemplary parallel compressor/distractor 1600 having holes 1602 illustrated in FIG. 16 can be used to distract the first metatarsal 230 relative to the first cuneiform 210. The parallel compressor/distractor 1600 may also include a cross joint guide 1604. The user may slide holes 1602a,b over pins 1280a,b and holes 1602c,d (not visible, obscured by holes 1606a,b which are aligned with holes 1602c,d) over pins 1280e,f.	163	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The cross joint guide 1604 may serve as a guide for cross joint fasteners or other kinds of implants or fixation devices that can be installed across a joint between the first cuneiform 210 and the first metatarsal 230. In one embodiment, the cross joint guide 1604 may include one or more bone attachment features that may take the form of holes 1608 that extend from one side of the cross joint guide 1604 to the other side and/or one or more fixation devices. The holes 1608 may be used to connect a holding across the joint between the first cuneiform 210 and the first metatarsal 230 after compression.	164	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, the method 1700 proceeds and a preliminary cutting guide model is provided 1706 from a repository of template cutting guide models. A preliminary cutting guide model is a model of a preliminary cutting guide.	173	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	As used herein, "preliminary cutting guide" refers to a guide configured, designed, and/or engineered to serve as a template, prototype, archetype, or starting point for creating, generating, or fabricating a patient specific cutting guide. In one aspect, the preliminary cutting guide may be used, as-is, without any further changes, modifications, or adjustments and thus become a patient specific cutting guide. In another aspect, the preliminary cutting guide may be modified, adjusted, or configured to more specifically address the goals, objectives, or needs of a patient or a surgeon and by way of the modifications become a patient specific cutting guide. The patient specific cutting guide can be used by a user, such as a surgeon, to guide making one or more resections of a structure, such as a bone for a procedure. Accordingly, a preliminary cutting guide model can be used to generate a patient specific cutting guide model. The patient specific cutting guide model may be used in a surgical procedure to address, correct, or mitigate effects of the identified deformity and may be used to generate a patient specific cutting guide that can be used in a surgical procedure for the patient.	174	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The bone facing side 730 may be custom contoured to match the shapes of the first cuneiform 210 and/or the first metatarsal 230. As embodied in Figures 7A through 7D, the bone facing side 730 may have a cuneiform apposition portion 742 shaped to lie against the dorsal surface of the first cuneiform 210, and a metatarsal apposition portion 744 shaped to lie against the dorsal surface of the first metatarsal 230. As shown, the cuneiform apposition portion 742 may be contoured to match the contour of the dorsal surface of the first cuneiform 210 on which it is to rest, and the metatarsal apposition portion 744 may similarly be contoured to match the contour of the dorsal surface of the first metatarsal 230 on which it is to rest. Thus, the body 710 may have only one stable position and orientation relative to the first cuneiform 210 and the first metatarsal 230. Alternatively, or in addition, the cuneiform apposition portion 742 may be contoured to match the contour of a surface that is between the dorsal surface and a medial or lateral surface and/or the surface includes at least a portion of the dorsal surface of the first cuneiform 210 on which it is to rest, and the metatarsal apposition portion 744 may similarly be contoured to match the contour of a surface that is between the dorsal surface and a medial or lateral surface and/or the surface includes at least a portion of the dorsal surface of the dorsal surface of the first metatarsal 230.	110	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Once the cutting guide 300 has been secured relative to the first cuneiform 210 and the first metatarsal 230, the first cuneiform 210 and the first metatarsal 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 metatarsal 230. The cuts in the first cuneiform 210 and the first metatarsal 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 metatarsal 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 metatarsal 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 metatarsal 230, such that the distractor can temporarily widen the space between the first cuneiform 210 and the first metatarsal 230 to allow for fenestration and/or other preparation of the cut surfaces of the first cuneiform 210 and the first metatarsal 230. Once such preparation has been carried out, the remaining pins 500 may also be removed.	99	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The resulting bleeding and/or prepared bone may readily grow together and fuse, upon abutment of the distal end of the first cuneiform 210 to the proximal end of the first metatarsal 230, particularly with application of some compression across the juncture of the two bones. Since the positions and orientations of the first slot 350 and the second slot 352 were carefully selected to provide the proper correction, the first metatarsal 230 may be positioned to abut the first cuneiform 210, resulting in reorientation of the first metatarsal 230 to a desired orientation, relative to the lateral direction 260 and the plantar direction 280 and/or the dorsal direction 290. Further, the surgeon may optionally rotate the first metatarsal 230, relative to the first cuneiform 210, about an axis perpendicular to the cutting planes, if desired.	100	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Figure 6A is a perspective view of the foot 200 of Figure 2, after resection of the first cuneiform 210 and the first metatarsal 230, removal of the cutting guide 300, and placement of the first metatarsal 230 to abut the first cuneiform 210. As shown, the distal end 250 of the first metatarsal 230 may now be positioned much closer to the second metatarsal 240, in a more natural position. Further, Figure 6A depicts a first proximal phalanx 600, which may now be properly oriented generally parallel to the other phalanges (not shown), rather than pointing in the lateral direction 260. If desired, further steps may be performed relative to the joint between the first metatarsal 230 and the first proximal phalanx 600 in order to keep them in the proper relative orientation. The distal end 250 may also have been shifted in the plantar direction 280 or in the dorsal direction 290 from the position of Figure 2. Thus, the desired dual-plane correction of the orientation of the first metatarsal 230 may be complete.	101	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The first metatarsal 230 may be secured to the first cuneiform 210, at least until proper bone in-growth has occurred between the first cuneiform 210 and the first metatarsal 230. In some embodiments, a bone plate (not shown) or other fastener (not shown) may be used to secure the first cuneiform 210 and the first metatarsal 230 together. Additional hardware (not shown) may be used to stabilize the position and/or orientation of the first proximal phalanx 600 relative to the first metatarsal 230, if desired. The surgical wound may be closed, and the foot 200 may be allowed to heal with the bunion deformity corrected.	102	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Figures 6B and 6C are dorsal views of the foot 200, before and after correction, respectively. Figures 6B and 6C illustrate the correction of the angulation of the first metatarsal 230, by which the distal end 250 of the first metatarsal 230 is moved in the lateral direction 260. In some embodiments, an implant 610 may be inserted in the space between the first metatarsal 230 and the first cuneiform 210 in order hold the first metatarsal 230 and the first cuneiform 210 together and/or facilitate bony fusion between the first metatarsal 230 and the first cuneiform 210.	103	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In some embodiments, the implant 610 may be patient-specific. For example, the implant 610 may have a cuneiform-facing side 620 that is shaped and/or sized to be secured to the adjoining, resected surface of the first cuneiform 210, and a metatarsal-facing side 630 that is shaped and/or sized to be secured to the adjoining, resected surface of the first metatarsal 230. As the resections made to the first metatarsal 230 and the first cuneiform 210 may both planar, the cuneiform-facing side 620 and/or the metatarsal-facing side 630 may also be planar. However, the cuneiform-facing side 620 and/or the metatarsal-facing side 630 may advantageously each be shaped to match the profile of the resected surface of the first cuneiform 210 and the first metatarsal 230, respectively.	104	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	This shaping may be accomplished by custom-designing the implant 610 for the patient, using the same models (for example, from CT scans) of the first metatarsal 230 and the first cuneiform 210 that were used to generate the cutting guide 300. Thus, the implant 610 may have a shape that provides secure attachment and/or fusion between the first metatarsal 230 and the first cuneiform 210 while avoiding proud edges or other protruding features that could otherwise interfere with surrounding tissues.	105	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Figures 7A, 7B, 7C, and 7D are top perspective, alternative top perspective, front elevation, and bottom perspective views, respectively, of a patient-specific cutting guide, or cutting guide 700, according to one alternative embodiment. The cutting guide 700 may be used to correct a bunion deformity, such as that of the foot 200 of Figure 2. Thus, the cutting guide 700 may also be designed to facilitate resection of the first cuneiform 210 and the first metatarsal 230 with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsal 230, thereby providing correction in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290.	107	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	As shown, the cutting guide 700 may have a body 710 with a monolithic construction and the general shape of a rectangular prism. The cutting guide 700 may further have a joint alignment feature that helps align the body 710 with the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsal 230. The joint alignment feature may consist of a joint probe 720 that extends from the body 710 and has a blade-like shape. The body 710 may reside on the dorsal surfaces of the first cuneiform 210 and the first metatarsal 230, while the joint probe 720 may protrude into the metatarsocuneiform joint between the first cuneiform 210 and the first metatarsal 230 to provide proper alignment of the body 710 with the metatarsocuneiform joint. Notably, the joint probe 720 may have surfaces that are not simply planar, but rather have some contouring by which the shape of the joint probe 720 is matched to the adjoining surfaces of the first cuneiform 210 and/or the first metatarsal 230. Such contouring of the joint probe 720 may enable more precise alignment of the body 710 with the metatarsocuneiform joint.	108	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The body 710 may have a bone facing side 730 that, upon attachment of the body 710 to the first cuneiform 210 and the first metatarsal 230, is to face toward the first cuneiform 210 and the first metatarsal 230. The body 710 may also have an outward-facing side 732 that, upon attachment of the body 710 to the first cuneiform 210 and the first metatarsal 230, faces outward, away from the first cuneiform 210 and the first metatarsal 230. Further, the body 710 may have one or more bone attachment features that facilitate attachment of the body 710 to the first cuneiform 210 and/or the first metatarsal 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 7A through 7D, the bone attachment features may take the form of holes 740 that extend from the bone facing side 330 to the outward-facing side 332 and/or one or more fixation devices. 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 metatarsal 230 to keep the cutting guide 700 in place. As embodied in Figures 7A through 7D, only one hole 340 may be present on each side of the body 710. Thus, the body 710 may be secured to the first cuneiform 210 with only a single pin or K-wire (not shown) and to the first metatarsal 230 with only another single pin or K-wire (not shown).	109	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	As shown, the body 310 may have two holes 340 positioned over the first cuneiform 210, and two holes 340 positioned over the first metatarsal 230. This is merely exemplary; in some embodiments, a cutting guide may be secured to one of the first cuneiform 210 and the first metatarsal 230 or may be secured to either of the first cuneiform 210 and the first metatarsal 230 with 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.	98	Added by DJM 2 2022	2/25/22, 12:00 AM

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