Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-32	In one embodiment, a surgeon may use the placement feature 1510 during a surgical procedure. For example, a surgeon may secure a distal tibia resection guide 1420a in a desired location and with a desired orientation using one or more of the alignment guide 1046 and/or the bone engagement surface 1026 and/or the landmark registration features 1028. Next, a surgeon may deploy a fastener 1010 / connector 1530 through a first anchor 1520 / hole of a bone attachment feature 1024. The fastener 1010 / connector 1530 may pass through a tibia 224 and through a fibula 226. The distal end 1534 of the connector 1530 now extends from the fibula 226. Next, a surgeon may pass the distal end 1534 through a hole of the second anchor 1540 to identify a desired height for the distal fibula resection guide 1410a. In the illustrated embodiment, the second anchor 1540 is aligned with a longitudinal axis of the distal fibula resection guide 1410a. However, this does not need to be the case. With the distal end 1534 in the second anchor 1540, the surgeon may next deploy one or more fasteners 1010 to secure the distal fibula resection guide 1410a to the fibula 226. In this manner, the distal fibula resection guide 1410a is properly positioned in spite of few landmarks on the fibula 226 to use for reference.	236	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Those of skill in the art will appreciate that the exemplary system 900 may include a resection guide 920 designed for a particular patient and their specific bone condition. For example, event of significant loss of bone or the lack of bone with a desirable level of density and/or structural integrity, the fasteners 910, resection guides 920, and/or complementary components 930 can be strategically designed and placed on a patient’s foot to remove pathological bone and also be used to strategically place bone void fillers such allograft, 3D printed constructs (metallic, synthetic bone or biological), and the like. In this manner, a very patient-specific solution can be realized that may involve aspects of various surgical procedures but can be done with high precision and accuracy because the patient-specific instrumentation has been developed, designed, manufactured beforehand and is used to facilitate that realization of the planned correction during the procedure.	237	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Those of skill in the art will appreciate that for certain patients with certain pathologies, the form and/or shape of the resection guide 1020 can be different. For example, suppose a surgeon desires to remove a larger wedge from a medial side of a distal tibia of a patient. In such an embodiment, the body 1032 of the resection guide 1020b may be shorter than an example resection guide 1020a.	238	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16 illustrates an exemplary system 1600 that includes resection guide 1020a, according to one embodiment. The system 1600 may include one or more fasteners 910, such as fasteners 1010, a resection guide 920, such as resection guide 1020a, and may include one or more other complementary components 930, such as a reduction guide 960, such as reduction guide 1660a. Alternatively, or in addition, the complementary components 930 may include a rotation guide 950, a compression guide 970, a positioning guide 980 and/or a fixation guide 990. Of course, one or more of the complementary components 930 can be configured to serve more than one function. For example, a rotation guide 950 may also serve as a reduction guide 960 or a reduction guide 960 may also serve as a compression guide 970, and the like.	239	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Advantageously, because the system 1600 is customizable and/or patient-specific one or more of the members of the system may include various features or aspects as needed for a particular surgical procedure and or desired by a surgeon. For example, one or more of a distal tibia resection guide, a distal fibula resection guide, alignment guide, rotation guide, compression guide, reduction guide, positioning guide, and/or fixation guide may include one or more patient-specific features. Alternatively, or in addition, at least one of the distal tibia resection guide, the distal fibula resection guide, alignment guide, rotation guide, compression guide, reduction guide, positioning guide, and/or fixation guide comprise a bone engagement surface. in addition, at least one of the distal tibia resection guide, the distal fibula resection guide, alignment guide, rotation guide, compression guide, reduction guide, positioning guide, and/or fixation guide comprise a landmark registration feature. Furthermore, one or more of a distal tibia resection guide, a distal fibula resection guide, alignment guide, rotation guide, compression guide, reduction guide, positioning guide, and/or fixation guide are combined into a single guide. Those of skill in the art will appreciate that a variety of systems 1600 can be fabricated across a range between very generic members of the system 1600 to very patient-specific members of the system 1600.	240	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16 illustrates stages of performing a surgical procedure using a media approach to form a closing wedge. FIG. 16A illustrates a medial perspective view of a foot and ankle including a calcaneus 222, a tibia 224, talus 228, and a navicular 218. Certain patients may present with foot or ankle bones having a variety of conditions. Due to age, disease, deformity, or different pathologies, the bones of the midfoot may be deteriorated to the point that individual bones may be challenging to distinguish from each other. FIG. 16 illustrates one such example. The division between the tibia 224 and the talus 228 may be challenging to distinguish.	241	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16A illustrates one example of a resection guide 1020b coupled to the bones using bone attachment features 1024 that include fasteners 1010, e.g., K-wires. In one embodiment, a surgeon has formed an incision down to the cortical bone surface with a medial approach. In the illustrated embodiment, the resection guide 1020b may be configured (e.g., using the bone engagement surface 1026) to seat on the tibia 224. The surgeon has deployed two or more fasteners 1010 (e.g., K-wires) through the holes of the bone attachment features 1024. The alignment guide 1046 is shown with a vertical K-wire to confirm alignment with the longitudinal axis of the tibia 224.	242	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16B is a close up view of the same stage illustrated in FIG. 16A. A surgeon may then continue to by performing an osteotomy using the resection feature 1022a and the resection feature 1022b. It should be noted that that fastener 1010 of the distal bone attachment feature 1060 is angled in a superior/cephalad direction. In certain embodiments, the angle of the fastener 1010 may match the angle of the resection feature 1022b. In this manner, the fastener 1010 of the distal bone attachment feature 1060 can serve as a stop to assist a surgeon in keeping a resection along a desired angle. Those of skill in the art will appreciate that the fastener 1010 can be inserted at any angle. In addition, the holes 1056 that receive the fastener 1010 can be angled at a desired angle for a particular surgical procedure.	243	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	In certain embodiments, the resection guide 1020b can be designed for a specific patient and/or to address a specific condition. Referring now to FIG. 16B, a technician may begin designing a resection guide 1020b by accessing a model of a patient’s bones based on medical imaging data. Firs, the technician may place or position the model such that the longitudinal axis 1412 (aka the load bearing axis) of the tibia 224 is vertical. Generally, a goal for a correction is to place the talus 228 in line with the longitudinal axis 1412 of the tibia 224. Next, a technician may locate a transition point along a lateral surface the tibia 224 (where the surface transitions to the lateral face). A first resection feature 1022a, or a first side 1108 of a single slot 1052 may be positioned at this location. Next, the technician may measure an angle in the caudal direction or cephalad direction (depending on the preferences of surgeon or needs of the patient. The angle measured is the angle determined from the model to bring the talus 228 in line with the longitudinal axis 1412 of the bone (e.g., tibia 224). The first line of the angle is the first resection feature 1022a that second line of the angle is a second resection feature 1022b. The two resection features 1022 are then positioned in the body 1032 of the resection guide 1020. In certain embodiments, the technician may design an angled hole for a distal bone attachment feature 1060 to direct a fastener 1010 into the bone at the same angle as the angle between the two resection features 1022. In this manner, a surgeon can deploy a K-wire in the hole(s) of the distal bone attachment feature 1060 and visually check the angles in the patient’s bone with medical imaging equipment before resection is started.	244	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	In certain embodiments, the technician may determine/measure, using a model, a suitable depth within each of the resection features 1022 for the cuts. These depths can be included in a preoperative plan provided to the surgeon who can use them and account for them using a markings on a cutting tool (e.g. laser depth markings on a saw blade).	245	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16C illustrates the tibia 224 after the osteotomies. The resection guide 1020b is not shown for clarity. The medial wedge opening is visible. The surgeon has resected the bone to remove a wedge shape that converge laterally. In the illustrated embodiment, the wedge shape extends to the lateral surface of the tibia 224. Alternatively, or in addition, the wedge shape may extend into the bone and stop short of the lateral surface of the tibia 224 and in this manner preserve a living hinge on the lateral side. The living hinge can facilitate reduction of the bone fragments. With the resection completed, the resection guide 1020b can be removed.	246	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	FIG. 16D illustrates the tibia 224 after reduction. The resection guide 1020b has been removed. Advantageously, in certain embodiments, one or more fasteners 1010 used for the resection guide 1020b can also be used with one or more of the complementary components 930. For example, the two fasteners 1010 used for the proximal bone attachment feature 1058 can also be used to position and orient the reduction guide 1660a.	247	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	In the illustrated embodiment, the one or more fasteners 1010 of the proximal bone attachment feature 1058 may initially extend into the bone perpendicular to the body 1032 and the fastener 1010 of the distal bone attachment feature 1060 may initially extend into the bone at an angle. See FIG. 16B. Consequently, in certain embodiments, the fastener 1010 of the distal bone attachment feature 1060 may need to be removed so that the resection guide 1020b can be slid off of the fasteners 1010 of the proximal bone attachment feature 1058 since the angle of the fastener 1010 of the distal bone attachment feature 1060 may prevent sliding off of the resection guide 1020b from the proximal bone attachment feature 1058 and the distal bone attachment feature 1060 with the fastener 1010 of both bone attachment features in place. With the resection guide 1020b removed, in accordance with certain procedures, the fastener 1010 of the distal bone attachment feature 1060 may be reinserted into the same hole in the bone fragment 224 it was in before removal.	248	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Next, a surgeon may slide a reduction guide 1660a over the fasteners 1010 of the proximal bone attachment feature 1058 and the reinserted fastener 1010 of the distal bone attachment feature 1060. As the reduction guide 1660a slides towards the tibia 224 the bone fragments are reduced. In certain embodiments, the reduction guide 1660a includes a plurality of holes that extend from one side of the reduction guide 1660a to the other side and configured to receive fasteners 1010. In the illustrated embodiment, the reduction guide 1660a includes a first hole 1694, a second hole 1696, and a third hole 1698. In the illustrated embodiment, the first hole 1694 and the second hole 1696 are horizontally aligned with each other and extend perpendicular to the longitudinal axis 1412 of the tibia 224. In other embodiments, the first hole 1694 and the second hole 1696 are horizontally aligned with each other and one or more may extend at an angle not perpendicular to the longitudinal axis 1412 of the tibia 224.	249	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	When a lateral side of the reduction guide 1660a contacts the tibia 224, the bone fragments are fully reduced. In certain embodiments, the lateral side of the reduction guide 1660a may include a bone engagement surface that registers to the medial surface of the tibia 224. Advantageously, the bone engagement surface can be configured to account for any offset of variation in bone fragment positions as a result of the resections and the subsequent reduction.	250	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	The reduction guide 1660a can hold and maintain the reduction for a surgeon at this stage in a surgical procedure. Having a reliable and stable device to maintain and hold a reduction for a surgeon can relieve stress that could be brought on by the execution of the surgical procedure. The reduction guide 1660a can hold the reduction for an extended period of time while a surgeon plans a next stage and/or otherwise prepares for a next stage such as deployment of permanent fixation. During this intervening time, a surgeon is assured that the reduced osteotomy will remain in place. Once permanent fixation is in place, the reduction guide 1660a can be removed and the fasteners 1010 removed and the incision(s) closed.	251	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	As explained above, the resection guide 1020b can be positioned, sized, configured, and oriented and/or trajectories set for the resection guide 1020b preoperatively using bone models. Additionally, a surgeon can provide a prescription for the location of guide features (e.g., resection features 1022) to account for other conditions of a particular patient.	252	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Those of skill in the art will appreciate that the resection guide 1020b can be used for a variety of procedures in an ankle, hindfoot, midfoot, forefoot, hand, wrist, elbow, shoulder, distal or proximal end of a long bone, and/or the like. One skilled in the art can appreciate that the presented embodiments may be modified, revised, or repositioned to address a surgeon’s particular angles, approach, entry locations and/or preferences.	253	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Those of skill in the art will appreciate that for certain patients with certain pathologies, the form and/or shape of the resection guide 1020b can be different. For example, suppose midfoot bones of a patient have deteriorated such that a larger wedge is to be resected than the example shown in FIG. 16. In such an embodiment, the body 1032 of the resection guide 1020b may be longer.	254	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	Advantageously, the present disclosure provides a system 900, 1000 for remediating a condition present in a patient. In the examples disclosed, the system 900,1000 can be used for forming closing wedges in a distal end of the leg near the ankle. Advantageously, the system 900,1000 includes both resection guides 920, 1020 and complementary components 930. Depending on the needs of a patient, one or more components of the system 900,1000 may be unique for the procedure on this patient. Consequently, the composition of the components in the complementary components 930 can vary from patient to patient.	255	Added by DJM Jan 2024	1/6/24, 9:49 PM

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