Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-10	Generally, an osteotomy procedure is not done while a patient places their weight on one or more feet involved in the procedure. Thus, a surgeon can not intraoperatively determine how much correction of bone positioning and/or rotation may be desired to correct a condition such as a hallux valgus. However, because the present disclosure can be used to generate patient specific instrumentation from weight-bearing patient imaging data, the present disclosure can provide instruments such as cut guide, pin guide, bone engagement surface 1924/2224, parallel compressor/distractor, or the like that account for positions and configurations of the patient’s bones while bearing the weight of the patient. Advantageously, using weight-bearing patient imaging data can provide for more successful procedures and more long term and lasting correction of conditions for the patient.	300	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Accordingly, referring to FIG. 30B, a second guide feature 3070 in the form of a second slot may be defined in the preliminary cutting guide model 3000 and configured to guide formation of a second cut surface of a second bone of the patient corresponding to the second modeled bone. The first guide feature 3060 and second guide feature 3070 are positioned in the preliminary cutting guide model 3000 such that fixing the first cut surface of the first bone to the second cut surface of the second bone mitigates the condition. Note that the preliminary cutting guide model 3000 includes both the first guide feature 3060 and the second guide feature 3070. In the illustrated embodiment, the second guide feature 3070 is oriented and positioned for formation of the second cut surface. In addition, a second hole 3050 is defined in the proximal arm 3030. The second hole 3050 aligns with a first hole 3050 of the proximal alignment feature 3080 in addition the holes of the proximal alignment feature 3080 are perpendicular to the second guide feature 3070.	311	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	FIG. 29 is a flow chart diagram of one example method 2900 for making a patient specific cutting guide according to one embodiment. Prior to steps of the method 2900, a bone model (also referred to as CAD model above) or one or more bones of a patient is generated. The bone model may be generated using medical imaging of a patient’s foot and may also be referred to as an anatomic model. The medical imaging image(s) may be used by computing devices to generate patient imaging data. The patient imaging data may be used to measure and account for orientation of one or more structures of a patient’s anatomy. In certain embodiments, the patient imaging data may serve or be a part of anatomic data for a patient.	298	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In certain embodiments, the compressor/distractor 2830 includes legs that are closer to each other at distal end of each leg than at a proximal end of each leg. The legs 1504/1506 and toes 1508/1510 of the compressor/distractor 1500/2830 are one example of such an embodiment. Advantageously, the cut guide 2810 can be customized for a specific patient. In certain embodiments, this means that the position and orientation of one or more of the first guide feature, second guide feature, bone engagement surface, first bone attachment feature, second bone attachment feature, first alignment feature, and/or second alignment feature, can be determined based on patient imaging data and can be engineered and fabricated to address a specific condition for a particular patient. For example, the position and orientation of one or more of the first guide feature, second guide feature may be such that a planter edge of a first cut surface of a first metatarsal 230 contacts a corresponding planter edge of a second cut surface of a first metatarsal 230 as the two cut surfaces are brought together to fuse the joint. The compressor/distractor 1500/2830 may translate and/or rotate one or the other or both of the first metatarsal 230 and first cuneiform 210 such that the two cut surfaces. In this manner, the cut guide 2810 and/or the system 2800 avoids a plantar gap between the two bones. Avoiding a plantar gap can be a factor in a successful fusion that also avoids non-union.	297	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The compressor/distractor 2830 may include the parallel compressor/distractor 1500 and/or the parallel compressor/distractor 1600. The compressor/distractor 2830 can engage the medial cuneiform alignment feature and the first metatarsal alignment feature and compress a first cut surface of the first metatarsal against a second cut surface of the medial cuneiform. The medial cuneiform alignment feature and the first metatarsal alignment feature may be substantially aligned prior to connecting the compressor/distractor 2830. Connecting the compressor/distractor 2830 may provide final alignment of the medial cuneiform alignment feature and the first metatarsal alignment feature. In certain embodiments, the medial cuneiform alignment feature and the first metatarsal alignment feature may not be aligned with each other. Instead, legs of the compressor/distractor 2830 may be configured to engage the unaligned medial cuneiform alignment feature and first metatarsal alignment feature. The compressor/distractor 2830 may also include a compression feature but not a distractor feature. In certain embodiments, different sizes of compressor/distractor 2830 may be included to different sizes of patients.	296	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The system 2800 may include a plurality of pin guides 2400 each of a different size, such as different degrees of offset angle (angle C), different sizes based on gender, and different sizes or configurations based on which extremity is involved. Advantageously, the first metatarsal alignment feature 2820 may be independent of the cut guide 2810. The independence provides flexibility relating to de-rotation of the first metatarsal.	295	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The first metatarsal alignment feature 2820 may take the form of various devices. In one embodiment, the first metatarsal alignment feature 2820 may include the distal alignment feature 1990 and/or the distal alignment feature 2290 of a pin guide 2400 or one or more fasteners 1956 placed by a surgeon or placed using one or more of a de-rotation handle 2500 and/or alignment handle 2510. The pin guide 2400 may position a plurality of alignment pins such that the first metatarsal 230 can be rotated to align the pins and rotate the first metatarsal 230 through a desired rotation angle about the first metatarsal 230 longitudinal axis.	294	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In certain embodiments, the cut guide 2810 may be a patient specific instrument, a patient specific cut guide. In certain embodiments, the cut guide 2810 is fabricated for a particular joint, of a particular patient, and/or to address a particular condition. Various example cut guides such as cut guide 300, cut guide 700, cut guide 1043, cut guide 1200, cutting guide 1900, cut guide 2200, or the like may serve as the cut guide 2810 of the system 2800. The cut guide 2810 may include a first guide feature configured to define a first cut surface configured for resection of a first metatarsal of a patient. First slot 1960 and/or first slot 2260 may serve as one example of the first guide feature. The cut guide 2810 may include a second guide feature configured to define a second cut surface configured for resection of a medial cuneiform of a patient. Second slot 1970 and/or second slot 2270 may serve as one example of the second guide feature. The cut guide 2810 may include an inferior side comprising a bone engagement surface shaped to match a first surface of the first metatarsal and a second surface of the medial cuneiform. Inferior side 1922 and/or bone engagement surface 1924 or inferior side 2222 and/or bone engagement surface 2224 may serve as one example of the inferior side and bone engagement surface. In one embodiment, the cut guide 2810 may include a medial cuneiform alignment feature coupled to the medial cuneiform. The proximal alignment feature 1980 and/or the proximal alignment feature 2280 may serve as the medial cuneiform alignment feature. The first guide feature and/or the second guide feature of the cut guide 2810 may be configured based on patient imaging data such that fusion of the first metatarsal at the first cut surface to the medial cuneiform at the second cut surface mitigates the condition. In certain embodiments, the cut guide 2810 is fabricated for single use with a single patient and on a left or a right extremity of the patient.	293	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	FIG. 28 illustrates a perspective view of an exemplary system 2800 for correcting a condition in accordance with one embodiment. The system 2800 includes a cut guide 2810, a first metatarsal alignment feature 2820, and a compressor/distractor 2830.	292	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Alternatively, or in addition, the surgeon may leave the parallel compressor/distractor 1500 connected and actively applying a compressive force to press the bones together while another kind of fastener 2710, such as a bone plate. The fastener 2710 may be deployed with one or more bone screws into the bones to connect the first metatarsal 230 to the first cuneiform 210. Advantageously, the fastener 2710 can be deployed which the bones are under active compression. This can promote osteointegration and fusion of the bones to close the joint. With the fastener 2710 deployed a surgeon may release, and remove, the parallel compressor/distractor 1500. This may complete the osteotomy procedure with the remains steps being closing the incision(s) and preparing the patient for recovery.	291	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, various forms of fixation may be used to complete the fusion of the two bones. FIG. 27 illustrates a perspective view of the first cuneiform and the first metatarsal of FIGS. 24A, 25A with a parallel compressor/distractor 1500 and fastener(s). In one embodiment, a surgeon may slide the cross joint guide 1604 over the fasteners 1956 of the distal alignment feature 1990/2290 and use the holes 1608 to deploy fasteners such as K-wires or bone screws across the joint to respectively, temporarily or permanently fuse the joint.	290	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, the surgeon may use the parallel compressor/distractor 1500 to compress the two bones together at the newly formed cut surfaces. This causes a desired rotation and translation of the first metatarsal 230 relative to the first cuneiform 210. This forces the cut surfaces (or faces) of the two bones to become parallel. Advantageously, the cut surfaces of the two bones can be forced to become parallel because the position, orientation, and angles of the fasteners 1956 of either, or both, of the proximal alignment feature 1980/2280 and distal alignment feature 1990/2290 can be predefined and customized for each patient when the cutting guide 1900/2200 is fabricated. This alignment enables parallel compression of the two bones together using the parallel compressor/distractor 1500 to provide active compression. Parallel active compression enables more effective compression of the two bones together. The parallel compressor/distractor 1500 is activated such that the first cuneiform 210 and the first metatarsal 230 are pressed together against each other.	289	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	According to certain methods, a surgeon may next distract the joint in order to prepare surfaces for fusion. The surgeon may slide holes 1502a,b over fasteners 1956 and holes 1502c,d over fasteners 1956. The surgeon activates the parallel compressor/distractor 1500 to distract the first metatarsal 230 relative to the first cuneiform 210. Connecting the parallel compressor/distractor 1500 may perform final alignment of the first cuneiform 210 and first metatarsal 230. Once distracted, the surgeon may remove intruding soft tissue and may fenestrate and/or abrade the cut surfaces of the two bones to encourage fusion and/or osteointegration.	288	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	the first guide feature is configured to define a first cut surface formed by resection of the first bone;	326	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	5. The patient specific instrument of claim 4, wherein the second bone attachment feature and the second alignment feature comprise a single feature.	338	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	wherein the first alignment feature and first bone attachment feature are not aligned and the first alignment feature and the second alignment feature are configured to align when the first bone is rotated.	337	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	the proximal arm comprises a second bone attachment feature and a second alignment feature each positioned perpendicular to the second guide feature; and	336	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	the distal arm comprises a first bone attachment feature positioned perpendicular to the first guide feature and parallel with a first alignment feature configured to be coupled to the first bone;	335	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	a distal arm extending from the body and away from the proximal arm; and	333	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	a proximal arm extending from the body; and	332	Added by DJM 2 2022	2/25/22, 12:00 AM

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