Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-8 PROV	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.	117	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	A threaded hole 1130 may optionally be provided in the contoured surface 1120. The threaded hole 1130 may be used to secure the implant 1060 to an insertion instrument, a positioning instrument, and/or a removal instrument. The threaded hole 1130 may be formed in a recess 1140 in the contoured surface 1120 so that the threaded hole 1130 can have the desired orientation, without affecting the shape of the contoured surface 1120 more than necessary. Of course, many other features may be used to secure an instrument to the implant 1060, including various clips, clamps, fasteners, and interfacing features, as known in the art.	116	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The edges of the first bone-facing surface 1100 and the second bone-facing surface 1110 may be shaped to line up with the edges of the cut surfaces of the first bone segment 1040 and the second bone segment 1042, respectively. The implant 1060 may also have a contoured surface 1120 that extends between the edges of the first bone-facing surface 1100 and the second bone-facing surface 1110. The contoured surface 1120 may also be contoured to match the contours of the adjoining portions of the first bone segment 1040 and the second bone segment 1042. Thus, the contoured surface 1120 may provide a continuous surface, devoid of protrusions, that extends between the adjoining surfaces of the first bone segment 1040 and the second bone segment 1042.	115	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 11 is a perspective view of the implant 1060, in isolation. As shown, the implant 1060 may have a first bone-facing surface 1100 that is generally flat and shaped to match the cut surface of the first bone segment 1040. The first bone-facing surface 1100 is shown in Figure 11 with a smooth shape; however, in alternative embodiments, the first bone-facing surface 1100 may be roughened and/or may have teeth, spikes, ridges, and/or other features intended to penetrate the first bone segment 1040 in order to provide for more secure engagement of the implant 1060 with the first bone segment 1040. Similarly, the implant 1060 may have a second bone-facing surface 1110 (not visible) that is also generally flat and shaped to match the cut surface of the second bone segment 1042. Like the first bone-facing surface 1100, the second bone-facing surface 1110 may be roughened or have protruding features that strengthen engagement of the implant 1060 with the second bone segment 1042. If desired, the implant 1060 may be further held in place through the use of bone screws, cement, one or more bone plates, and/or other features known in the art to secure an implant to bone.	114	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Like the implant 1060, the bone plate 1070 may be made of any known biocompatible material, through the use of any manufacturing process known in the art. In some embodiments, the bone plate 1070 may also be fabricated specifically for the foot 200, enabling the bone plate 1070 to maintain precisely the desired level of correction. When made specifically for the foot 200 in combination with each other, the implant 1060 and the bone plate 1070 may provide a highly predictable, precise, and customizable level of correction of the flat foot deformity.	113	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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, metatarsus 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.	138	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	a one or more alignment features positioned to move one or more of the first bone and a second bone as part of a surgical osteotomy for correcting the condition;	149	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	securing a cutting guide to a first bone and a second bone of a patient’s foot the cutting guide fabricated based on a cutting guide model defining:	148	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	1.A method for correcting a condition present in a patient’s foot, the method comprising:	147	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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 metatarsus 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. The holes 1608 may be used to connect a holding across the joint between the first cuneiform 210 and the first metatarsus 230 after compression.	143	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Referring to FIG. 16, in certain embodiments, a parallel distractor 1600 such as the exemplary parallel distractor 1600 having holes 1602 illustrated in FIG. 16 can be used to distract the first metatarsus 230 relative to the first cuneiform 210. The parallel 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.	142	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, a parallel distractor 1500 such as the exemplary parallel distractor 1500 illustrated in FIG. 15 is used to distract the first metatarsus 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 metatarsus 230 relative to the first cuneiform 210. When a user places the parallel 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 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 metatarsus 230 is prepared for fusion. Then, the parallel distractor 1500 is activated such that the first cuneiform 210 and the first metatarsus 230 are fused together.	141	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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 metatarsus 230.	140	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, a breaker tool 1271 can be used to separate the alignment feature 1260a from the body 1210. In one embodiment, a breaker tool 1271 can be a “T” shaped tool with a crosswise proximal handle, a shaft and a distal end. A user may operate the breaker tool 1271 by placing the distal end in a receiver 1276 of one or more detachable connectors 1270. Pressing and/or twisting the distal end into the receiver 1276 breaks one or more bridges 1274 and thus separates the alignment feature 1260a. A user may insert the distal end into one or more receivers 1276 to separate the alignment feature 1260a from the body 1210.	139	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In order to maintain the heel 1050 in the proper position relative to the remainder of the second bone segment 1042, a bone plate 1070 may be secured to the heel 1050 and to the remainder of the second bone segment 1042. The bone plate 1070 may include a first end 1080 secured to the remainder of the second bone segment 1042, a second end 1082 secured to the heel 1050, and an intermediate portion 1084 that extends from the first end 1080 to the second end 1082, and provides the desired medial shift between the first end 1080 and the second end 1082. The first end 1080 and the second end 1082 may be secured to the remainder of the second bone segment 1042 and to the heel 1050, respectively, through the use of screws 1090.	112	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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 metatarsus 230 to accomplish a desired translation, rotation, and/or orientation of the first metatarsus 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 metatarsus 230 that can be unique for each patient.	137	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, a surgeon may next remove the pins 1280c,d. Alternatively, a surgeon may remove the pins 1280c,d after breaking the alignment feature 1260a away from the body 1210, as described below.	136	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	At this stage in a surgical procedure, the cutting guide 1400 is placed on the first cuneiform 210 and the first metatarsus 230 and pins 1280a-d are connected to the bones through the respective holes 1240. Next, a surgeon uses the guide features of the cutting guide 1400 to reset the first cuneiform 210 and the first metatarsus 230. Then, a surgeon may insert pins 1280e,f into holes 1278 of the alignment feature 1260a. Alternatively, in another embodiment, a surgeon may insert pins 1280e,f into holes 1278 of the alignment feature 1260a before resecting the first cuneiform 210 and/or first metatarsus 230.	135	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	FIG. 14 illustrates a 3D color perspective view of a first cuneiform 210 and first metatarsus 230 with one embodiment of a cutting guide 1400 secured to the two bones. The cutting guide 1400 includes pins 1280a-f in the holes 1240 of bone attachment features and the holes 1278 of the alignment features 1260, such as alignment feature 1260a.	134	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	FIG. 13 illustrates that in one embodiment, the holes 1240 of each bone attachment feature can be parallel to each other such that pins 1280 in the holes 1240 are parallel to each other. Red line A illustrates that the holes 1240a, 1240b are aligned perpendicular to a resection cut that has been made on the first cuneiform 210 through slot 1350. Pins 1280 in holes 1240a,b may be referred to as cuneiform pins and these parallel cuneiform pins form a line (red line A) perpendicular to a cut plane in the first cuneiform 210. Red line B illustrates that the holes and corresponding parallel pins 1281 (which may be referred to as metatarsus pins) may form a line perpendicular to a cut plane in the first metatarsus 230. The metatarsus pins 1281 are aligned perpendicular to a resection cut (also referred to as a MET cut) that has been made on the first metatarsus 230 through slot 1352.	133	Added by DJM 7 2021	7/2/21, 12:00 AM

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