Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-20	In one embodiment, the body 906 is configured to reside on the dorsal surfaces of the first cuneiform and the first metatarsal to provide proper alignment of the body 906 with the metatarsocuneiform joint (e.g., the joint between the first metatarsal and the medial cuneiform bone, aka a TMT joint). In another embodiment, the body 906 is configured to reside or sit between the medial surfaces and the dorsal surfaces, or on the medial surfaces of the first cuneiform and the first metatarsal to provide proper alignment of the body 906 with the metatarsocuneiform joint (e.g., the joint between the first metatarsal and the medial cuneiform bone) for an osteotomy.	232	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	In certain embodiments, the bone engagement surface 922 may include a cuneiform apposition portion 932 and a metatarsal apposition portion 934. As shown, the cuneiform apposition portion 932 may be contoured to match the contour of the surface of the first cuneiform on which it is to rest, and the metatarsal apposition portion 934 may similarly be contoured to match the contour of the surface of the first metatarsal on which it is to rest. Thus, the body 906 may have only one stable position and orientation relative to the first cuneiform and the first metatarsal during a surgical osteotomy for correcting the condition.	233	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Advantageously, the fidelity of the patient imaging data enables the bone model, preliminary cutting guide model, and patient specific instrument (e.g., patient-specific cutting guide, patient specific pin guide, patient specific alignment guide, navigation guide, resection guides, etc.) to uniquely match a particular patient. Consequently, the bone engagement surface 922 can engage the surfaces of the bones of a joint in a single configuration. Such a close matching fit facilitates the surgical osteotomy.	234	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	FIG. 9C illustrates an inferior view towards the inferior side 918 of the navigation guide 900. In the illustrated embodiment, the navigation guide 900 includes a bone engagement opening 936 formed on the inferior side 918 of the body 906. The bone engagement opening 936 is an opening in a side of the body 906 configured to match a size, contour, and/or configuration of a bone. Advantageously, the length, width, and/or depth of the bone engagement opening 936 are configured to match the shape of the bone that fills the bone engagement opening 936 when the navigation guide 900 is deployed and used.	235	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	In the illustrated embodiment, the bone engagement opening 936 is on the inferior side 918 of the body 906. The bone engagement opening 936 is configured to receive at least a portion of a bone when the navigation guide 900 is deployed for use. In one embodiment, the bone engagement opening 936 is the opening near, or on, the inferior side 918 and may be bordered by a part of the inferior side 918 opposite the superior side 916, part of the inferior side 918 opposite the lateral side 914, and/or part of the inferior side 918 opposite the medial side 912. In certain embodiments, the medial side 912 and/or lateral side 914 may extend in an inferior direction as shown.	236	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	In certain embodiments, the bone engagement opening 936 includes the bone engagement surface 922. Where the bone engagement opening 936 includes the bone engagement surface 922 the matching of the bone engagement surface 922 to one or more surfaces of one or more bones can provide a further assurance to a surgeon that the navigation guide 900 is precisely positioned in a position desired. As illustrated in FIG. 9C, the bone engagement opening(s) 936, bone engagement surface 922, and/or a registration key can cooperate such that the navigation guide 900 fits like a puzzle piece onto and/or within anatomy of a patient. Consequently, a surgeon can have high assurance that the navigation guide 900 has been positioned in the location desired and/or designed and/or preplanned. In another embodiment, the bone engagement opening 936 may not include a bone engagement surface 922 and instead the bone engagement opening 936 may include a recess, cavity, depression, or the like and a smooth surface on an inferior side 918 of the body 906.	237	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	FIG. 9C illustrates that the bone engagement opening 936 may be in two parts bone engagement opening 936a and bone engagement opening 936b. Each respective bone engagement opening 936a and bone engagement opening 936b may be configured to receive a different bone. The bone engagement opening 936a may be configured to receive a cuneiform and the bone engagement opening 936b may be configured to receive a metatarsal.	238	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	In certain embodiments, a navigation guide 900 may include a registration key 938. The registration key 938 serves to further guide a surgeon to position the navigation guide 900 in a desired location with respect to anatomy of a patient. In certain embodiments, the registration key 938 may include one or more structures of the inferior side 918 that extend down into, or on, one or more of the adjacent joints and/or between the bones. The registration key 938 facilitates a desired alignment and placement of a navigation guide 900 on one or more joints and/or between bones. In one embodiment, the registration key 938 includes a protrusion that engages an opening between two bones of a joint. The registration key 938 may be on an inferior side 918 of the body 906. The registration key 938 can be formed by a variety of structures, including recesses, planar parts of an inferior side 918, angled parts of an inferior side 918, one or more projections added to an inferior side 918, openings in guide features, and the like.	239	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Referring to FIGs. 9A and 9B, the navigation guide 900 includes a longitudinal axis 940 and a coupler 942 between the proximal end 902 and the distal end 904. The coupler 942 is configured to hold or keep the proximal end 902 and the distal end 904 together until a user operates the coupler 942 to separate the proximal end 902 and the distal end 904. Thus, the coupler 942 can temporarily hold the proximal end 902 and the distal end 904 and also release the proximal end 902 and the distal end 904 when needed. Those of skill in the art will appreciate that the coupler 942 can be implemented in a variety of ways using a variety of structures. In the illustrated embodiment, the coupler 942 implemented using a threaded shaft with a head and a driver and a set of holes in the body 906. At least one of the holes of the set of holes has internal threads configured to engage the external threads of the shaft.	240	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	As explained herein, the present disclosure enables fabrication of patient-specific instrumentation. FIGS. 9A-9C illustrate a patient-specific navigation guide 900 configured to guide a surgeon for an arthrodesis procedure on a tarsometatarsal (“TMT”) joint of a patient. Specifically, the navigation guide 900 may be configured with a body 906 that spans a TMT joint between a metatarsal bone (e.g., a first metatarsal 208) and a cuneiform (e.g., a medial cuneiform 202). Accordingly, the inferior side 918 is configured to interface with the cuneiform bone and the metatarsal bone of the patient. In particular, the bone engagement surface 922 and/or bone engagement opening 936 are configured to interface with surfaces the cuneiform and metatarsal (e.g., a dorsal surface of each bone). In the illustrated embodiment, the reference feature is the set of proximal guide pins 928 deployed in the cuneiform and the set of distal guide pins 930 deployed in the metatarsal.	241	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The reference feature can serve as a guide to a surgeon for a number of steps in a surgical procedure. In one embodiment, the reference feature includes a first reference feature and second reference feature. The first reference feature may include the set of proximal guide pins 928 deployed in a bone such as a cuneiform and the second reference feature may include the set of distal guide pins 930 deployed in a bone such as a metatarsal. Having two or more reference features can be advantageous because if a condition of a patient prevents deployment of one reference feature or the other, the second reference feature can serve as a backup. Furthermore, where a surgical procedure involves more than one bone, one reference feature can be established in a first bone and a second reference feature can be established in a second bone. Further, different stages of a surgical procedure may use one reference feature and not the other. Thus, having two reference features can facilitate certain stages of the surgical procedure.	242	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Advantageously, providing two or more reference features can facilitate stages of a surgical procedure such as when bone fragments are to be aligned and/or reduced and/or when resections or osteotomies are to be performed on different bones of the patient. In one embodiment, a first reference feature may include a proximal alignment feature 944 and a second reference feature may include a distal alignment feature 946.	243	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The proximal alignment feature 944 and the distal alignment feature 946 may be engaged in later steps of a surgical procedure by an instrument such as a positioning guide 880 to translate and/or rotate the one or more bones into a desired final position for reduction.	244	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Typically, in an osteotomy for a condition such as a hallux valgus, it is desirable to rotate the first metatarsal 208 to address the condition. The first metatarsal 208 may be rotated for example to re-position distal plantar sesamoids from a lateral orientation to a more plantar orientation. Research has shown that performing such re-orientation mitigates recurrence of a hallux valgus condition. In such situations, the distal alignment feature 946 may serve as a reference and/or anchor for a positioning guide 880 that may cause the first metatarsal 208 to rotate and/or translate as the positioning guide 880 is deployed.	245	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	In certain embodiments, the preliminary instrument model may be generated based on anatomic data and/or a bone model or a combination of these, and no model or predesigned structure, template, or prototype. Alternatively, or in addition, the preliminary instrument model may be, or may originate from, a template instrument model selected from a set of template instrument models. Each model in the set of template instrument models may be configured to fit an average patient’s foot. The template instrument model may subsequently be modified or revised by an automated process or manual process to generate the preliminary instrument model used in this disclosure.	141	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	As used herein, “template instrument” refers to an instrument configured, designed, and/or engineered to serve as a template for creating, generating, or fabricating a patient-specific instrument. In one aspect, the template instrument may be used, as-is, without any further changes, modifications, or adjustments and thus become a patient-specific instrument. In another aspect, the template instrument 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 instrument. The patient-specific instrument 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 template instrument model can be used to generate a patient-specific instrument model. The patient-specific instrument 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 instrument that can be used in a surgical procedure for the patient.	142	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Next, the method 300 may register 308 the preliminary instrument model with one or more bones of the bone model. This step 308 facilitates customization and modification of the preliminary instrument model to generate a patient-specific instrument model from which a patient-specific instrument can be generated. The registration step 308 may combine two models and/or patient imaging data and position both models for use in one system and/or in one model.	143	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	Next, the method 300 may design 310 a patient-specific instrument and/or procedure model based on the preliminary instrument model. The design step 310 may be completely automated or may optionally permit a user to make changes to a preliminary instrument model or partially completed patient-specific instrument model before the patient-specific instrument model is complete. A preliminary instrument model and patient-specific instrument model are two examples of an instrument model. As used herein, “instrument model” refers to a model, either physical or digital, that represents an instrument, tool, apparatus, or device. Examples, of an instrument model can include a cutting instrument model, a resection instrument model, an alignment instrument model, a reduction instrument model, a patient-specific tendon trajectory instrument model, graft harvesting instrument model, minimally invasive surgical (MIS) positioner model, or the like. In one embodiment, a patient-specific instrument and a patient-specific instrument model may be unique to a particular patient and that patient’s anatomy and/or condition.	144	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	The method 300 may conclude by a step 312 in which a patient-specific instrument may be manufactured based on the patient-specific instrument model. Various manufacturing tools, devices, systems, and/or techniques can be used to manufacture the patient-specific instrument.	145	Added by DJM Jan 2024	1/6/24, 10:06 PM
View Edit Delete	PER-20	FIG. 4 illustrates an exemplary system 400 configured to generate one or more patient-specific instruments configured to facilitate surgical procedures, according to one embodiment. The system 400 may include an apparatus 402 configured to accept, review, receive or reference a bone model 404 and provide a patient-specific instrument 406. In one embodiment, the apparatus 402 is a computing device. In another embodiment, the apparatus 402 may be a combination of computing devices and/or software components or a single software component such as a software application.	146	Added by DJM Jan 2024	1/6/24, 10:06 PM

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