Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-10	wherein the first slot and second slot are positioned such that fixing the first cut surface of the first bone to the second cut surface of the second bone mitigates the condition.	364	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	defining a second slot configured to guide formation of a second cut surface of a second bone of the patient corresponding to a second modeled bone; and	363	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	defining a first slot configured to guide formation of a first cut surface of a first bone of the patient corresponding to a first modeled bone;	362	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	15. The method of claim 12, wherein defining one or more guide features of the preliminary cutting guide model further comprises:	361	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	wherein the one or more guide features of a preliminary cutting guide model are configured to enable a surgeon to form the first cut surface and the second cut surface.	360	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	modifying the bone model of the first modeled bone to include the first cut surface and the second modeled bone to include the second cut surface; and	359	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	Next, a first cut surface in the first modeled bone is defined that is perpendicular to the longitudinal axis of the first modeled bone. The first cut surface may be defined using a first guide feature 3060 and may be predefined in a preliminary cutting guide model 3000. In certain embodiments, the first cut surface may be formed during the procedure on a patient’s bone by a surgeon cutting using a first guide feature 3060. The first guide feature 3060 may be defined in the preliminary cutting guide model 3000 such that cutting using the first guide feature 3060 will form the first cut surface. The first guide feature 3060 may include a slot formed in the preliminary cutting guide model 3000 that is configured to guide formation of the first cut surface.	307	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	For example, accessing 2910 a bone model of one or more bones of a patient based on the condition and/or the bone model may include additional steps. For example, the bone model may include a first modeled bone (not shown in FIG. 30A) and a second modeled bone (not shown in FIG. 30A) of a joint of the patient and the bone model may be modified such that the first modeled bone (e.g., a first metatarsal 230) is rotated about a longitudinal axis of the first modeled bone from a first position to a second position. FIG. 30A illustrates one example of a preliminary cutting guide model 3000.	306	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	FIGS. 30A-30C illustrates perspective views of an exemplary preliminary cutting guide model modified in accordance with one embodiment for use as a patient-specific cutting guide. In certain embodiments, steps of the method 2900 may include additional steps that add to or expand upon steps of the method 2900.	305	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	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.	304	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	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.	303	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	“Topographical” refers to the physical distribution of parts, structures, or features on the surface of, or within, an organ or other anatomical structure, or organism. (Search “define topographical” on google.com. Oxford Languages, Copyright 2022. Oxford University Press. Web., Modified. Accessed 15 Feb. 2022.)	302	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In one embodiment, the method 2900 begins after a bone model of a patient’s body or body part(s) is generated. In a first step 2910, bone model of one or more bones of a patient based on the condition and/or the bone model is accessed. Next, the method 2900 defines 2920 one or more guide features of a preliminary cutting guide model for an osteotomy procedure, the preliminary cutting guide model comprising a superior surface and an inferior surface. Next, the method 2900 proceeds by defining 2930 at least a portion of the inferior surface of the preliminary cutting guide model according to a topographical surface of at least one bone of the bone model such that the inferior surface substantially matches a contour of the topographical surface. In certain embodiments, the method 2900 may also include a step of defining one or more alignment features of the preliminary cutting guide model for the osteotomy procedure. After step 2930, the preliminary cutting guide model is configured for fabrication of a patient specific cutting guide corresponding to the preliminary cutting guide model. After step 2930, the method 2900 may end.	301	Added by DJM 2 2022	2/25/22, 12:00 AM
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	A bone model or anatomic model of a patient’s body or body part(s) may be generated by computing devices that analyze medical imaging images. Structures of a patient’s body can be determined using a process called segmentation. In certain embodiments, the patient imaging data maybe gathered from the patient as the patient is not placing their weight on one or more feet. Alternatively, or in addition, in certain embodiments, the patient imaging data maybe gathered from the patient as the patient is placing their weight on one or more feet. Such imaging may be referred to as weight-bearing patient imaging data. For example in one embodiment, the bone model is derived from patient imaging data generated while the patient placed their weight on at least one joint involved in the osteotomy procedure.	299	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	In one embodiment, the preliminary cutting guide model 3000 may originally include a predefined first guide feature 3060 that is aligned perpendicular to two or more holes 3050 of a distal bone attachment feature 3054. It should be noted that the preliminary cutting guide model 3000 of FIG. 30A does not include a second guide feature and/or a second hole 3050 because the orientation and position of the second guide feature and/or a second hole 3050 has not yet been determined or defined. In certain embodiments, the preliminary cutting guide model 3000 may be selected from a repository of template cutting guide models. Each template cutting guide model may be configured for an osteotomy procedure configured to correct one of a plurality of conditions.	308	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

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