Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-10	FIG. 19H illustrates second angle B. In one embodiment, a second cut surface formed by resection using second slot 1970 extends posteriorly away from a first cut surface formed by resection using first slot 1960. Described another way, in the illustrated embodiment, angle B is an angle between the first plane 1978 that includes the first slot 1960 and a first cut surface formed by resection using first slot 1960 and a third plane 1981 that includes the second slot 1970 and a second cut surface formed by resection using second slot 1970, the third plane 1981 extending from the first plane toward the proximal side 1912 of the body 1910. In certain embodiments, angle B can range between about 0 degrees to about 35 degrees. In certain embodiments, angle B may start at 0 degrees and then increase to a positive number of degrees as illustrated or decrease to a negative number of degrees depending on how a surgeon may prescribe adjustments for a correction.	217	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Those of skill in the art will appreciate that the position and orientation of the first slot 1960 and second slot 1970 and the corresponding cut surface a surgeon can form using these guide features can vary depending on the anatomical structures of the patient, the osteotomy procedure being performed, preferences of the surgeon, the nature of the condition, and the like. For example in the illustrated embodiment, the medial end 1964 of the first slot 1960 is closer to the medial end 1974 of the second slot 1970 than the lateral end 1962 is in relation to the lateral end 1972. In another embodiment, the lateral end 1962 of the first slot 1960 may be closer to the lateral end 1972 of the second slot 1970 than the medial end 1964 is in relation to the medial end 1974. Of course in another embodiment, the first slot 1960 and second slot 1970 may be configured such that a first distance between lateral end 1962 and lateral end 1972 and a second distance between medial end 1964 and medial end 1974 are substantially the same.	218	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Referring to FIG. 19D, in one embodiment, anatomical data about the patient can be used to define other structures of the cutting guide 1900 or other patient specific instruments. For example, anatomical data about the patient that can be captured in the patient imaging data (e.g., due to the fidelity of the technology providing the patient imaging data) can be used to define how deep a first guide feature and/or second guide feature is. Controlling the depth of the first guide feature and/or second guide feature can be used to manage how deep a surgeon’s cutting instruments can reach within the first guide feature and/or second guide feature. Managing a depth for one or more guide features may be referred to as defining a patient specific height for the cutting guide 1900.	219	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	For example, in one embodiment, patient imaging data can be used to define a distance between at a first top edge 1966 of the first guide feature (e.g., first slot 1960) and the first surface (e.g., a surface of a first bone such as a first metatarsal 230). Alternatively, or in addition, patient imaging data can be used to define a distance between at a second top edge 1968 of the second guide feature (e.g., second slot 1970) and the second surface (e.g., a surface of a second bone such as a first cuneiform 210). Managing the distance between a first top edge 1966 and/or second top edge 1968 and a bone surface is one way to provide a stop within the cutting guide 1900. The stop can serve to limit how deep a surgeon will resect hard tissue/soft tissue when using the cutting guide 1900 for a procedure. If a surgeon resects until the resection instruments engages the stop, the surgeon can be assured that the resection extends to a desired depth (not too far and not too short).	220	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	As used herein, a “stop” refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to prevent, limit, impede, stop, or restrict motion or movement and/or operation of the another object, member, structure, component, part, apparatus, system, or assembly.	221	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Thus, upon desired positioning of the cutting guide 1900, the second slot 1970 may be positioned over at least a portion of the first cuneiform to facilitate resection of the first cuneiform, while the first slot 1960 may be positioned over at least a portion of the first metatarsal to facilitate resection of the first metatarsal. In one embodiment, the second slot 1970 is positioned near the distal end of the first cuneiform and the first slot 1960 is positioned near the proximal end of the first metatarsal. The first slot 1960 and second slot 1970 together, with the bone engagement surface 1924 overlying the first cuneiform and the first metatarsal, are positioned to guide resection of the first cuneiform and the first metatarsal during a surgical osteotomy for correcting a condition.	209	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	As used herein, a "fastener", "fixation device", or "fastener system" refers to any structure configured, designed, or engineered to join two structures. Fasteners may be made of a variety of materials including metal, plastic, composite materials, metal alloys, plastic composites, and the like. Examples of fasteners include, but are not limited to screws, rivets, bolts, nails, snaps, hook and loop, set screws, bone screws, nuts, posts, pins, thumb screws, and the like. Other examples of fasteners include, but are not limited to wires, Kirschner wires (K-wire), anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, sutures, soft sutures, soft anchors, tethers, interbody cages, fusion cages, and the like. In certain embodiments, the term fastener may refer to a fastener system that includes two or more structures configured to combine to serve as a fastener. An example of a fastener system is a rod or shaft having external threads and an opening or bore within another structure having corresponding internal threads configured to engage the external threads of the rod or shaft. In certain embodiments, the term fastener may be used with an adjective that identifies an object or structure that the fastener may be particularly configured, designed, or engineered to engage, connect to, join, contact, or couple together with one or more other structures of the same or different types. For example, a "bone fastener" may refer to an apparatus for joining or connecting one or more bones, one or more bone portions, soft tissue and a bone or bone portion, hard tissue and a bone or bone portion, an apparatus and a bone or portion of bone, or the like.	223	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Effective connection of the cutting guide 1900 to one or more bones across a joint can ensure that cut surfaces are formed in desired locations and orientation and mitigate removal of hard tissue and/or soft tissue outside in undesired locations.	224	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Accordingly, the cutting guide 1900 includes one or more bone attachment features. As embodied in Figures 19A through 19H, the bone attachment features may take the form of one or more holes 1950 that extend from the inferior side 1922 to the superior side 1920 and/or one or more fixation devices. The holes 1950 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the first cuneiform 210 and/or the first metatarsal 230 to keep the cutting guide 1900 in place.	225	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	FIG. 20 illustrates one example of a cutting guide 1900 coupled to the bones using a proximal bone attachment feature 1952 and a distal bone attachment feature 1954. In the illustrated embodiment, the proximal bone attachment feature 1952 includes at least one hole 1950 and a fastener and the distal bone attachment feature 1954 includes at least one hole 1950 and a fastener. In FIG. 20 the fasteners are K-wires. Advantageously, the proximal bone attachment feature 1952 and the distal bone attachment feature 1954 each include at least two holes 1950, each with a K-wire passing through the hole 1950 and into bone facing the inferior side 1922. Using two holes 1950 and two fasteners ensures a stable coupling between the cutting guide 1900 and the bone(s). Advantageously, in certain embodiments, the two holes 1950 of the proximal bone attachment feature 1952 and distal bone attachment feature 1954 are align such that inserted K-wires are parallel to each other. Among other benefits, parallel K-wires of each of the proximal bone attachment feature 1952 and distal bone attachment feature 1954 prevent the cutting guide 1900 from pivoting around one of the K-wires of a proximal bone attachment feature 1952 or a distal bone attachment feature 1954.	226	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In the illustrated embodiment, the proximal arm 1930 includes the proximal bone attachment feature 1952 and the distal arm 1940 includes the distal bone attachment feature 1954. In one embodiment, the holes 1950 of the proximal bone attachment feature 1952 are aligned with each other and aligned perpendicular to a guide feature such as the second slot 1970. The holes 1950 of the distal bone attachment feature 1954 may also be aligned with each other and aligned perpendicular to another guide feature such as the first slot 1960. This means that the aligned holes 1950 (and K-wires secured within them) of the distal bone attachment feature 1954 will also be perpendicular to the cut surface formed using the first slot 1960. This also means that the aligned holes 1950 (and K-wires secured within them) of the proximal bone attachment feature 1952 will also be perpendicular to the cut surface formed using the second slot 1970. Consequently, at least one of the proximal bone attachment feature 1952 and the distal bone attachment feature 1954 can be used to position and orient a cut surface of the first metatarsal 230 and a cut surface of the first cuneiform 210.	227	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Returning to Figures 19A through 20, the body 1910 may further have features that facilitate desired translation and orientation of the first metatarsal 230 and/or first cuneiform 210 in order to fuse or join the two bones to complete the procedure. For example, in the illustrated embodiment, the cutting guide 1900 may include at least one alignment feature. A second alignment feature may be integrated into the cutting guide 1900 or the second alignment feature may be a separate feature from the cutting guide 1900.	228	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	In the illustrated embodiment, the proximal bone attachment feature 1952 serves as both a bone attachment feature and as an alignment feature, e.g., proximal alignment feature 1980. In this manner, the proximal bone attachment feature 1952 can provide both a bone attachment feature and an alignment feature in a single feature. In situations where a second bone of a joint, such as a first metatarsal 230, does not need to be rotated, translated, and/or re-oriented to mitigate a patient’s condition, the distal bone attachment feature 1954 may also serve as both a bone attachment feature and as an alignment feature, e.g., distal alignment feature 1990.	229	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Typically, in an osteotomy for a condition such as a hallux valgus, it is desirable to rotate the first metatarsal 230 to address the condition. The first metatarsal 230 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 bone attachment feature 1954 may serve as a bone attachment feature and as a reference for the positioning of a distal alignment feature 1990 that is separate from the cutting guide 1900.	230	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	For example, in such instances, the distal bone attachment feature 1954 may serve as a reference for placement of a distal alignment feature 1990 (See FIG. 24A) that is parallel to the distal bone attachment feature 1954 as measured along the longitudinal axis 1976 of the first metatarsal 230. Subsequent to formation of a cut surface on the first metatarsal 230, the distal alignment feature 1990 can be coupled to the first metatarsal 230 in parallel to the distal bone attachment feature 1954 (e.g., by way of a pin guide). In certain embodiments, the distal alignment feature 1990 can include two or more aligned holes and/or a pair of K-wires that enter the bone in parallel to each other. In addition, in such a situation, the proximal alignment feature 1980 and the distal alignment feature 1990 may not be aligned initially. Instead, the proximal alignment feature 1980 and distal alignment feature 1990 may be configured to align when the bone coupled to the distal alignment feature 1990 is rotated. Fasteners 1956 of the distal bone attachment feature 1954 may be aligned with longitudinal axis 1976 and perpendicular to first slot 1960 by way of holes 1950. Fasteners 1956 of the proximal bone attachment feature 1952 may be aligned with reference line 1992 and perpendicular to second slot 1970 by way of holes 1950. The reference line 1992 may not be aligned with the longitudinal axis 1976.	231	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	FIG. 20 illustrates an example cutting guide 1900 seated transverse to a tarsometatarsal (“TMT”) joint 2000. The TMT joint 2000 includes a lateral end 2002 and a medial end 2004. In certain embodiments, such as the illustrated embodiment, the body 1910 is configured to extend between the lateral end 2002 and the medial end 2004. In addition, the proximal arm 1930 and the distal arm 1940 may be aligned with each other.	232	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Furthermore, in certain embodiments, the proximal arm 1930 and the distal arm 1940 may be positioned extending from the body 1910 near the lateral end 2002 (See FIG. 23). Said another way, the proximal arm 1930 and the distal arm 1940 may be positioned extending from the body 1910 such that the arms extend over a dorsal surface of the first cuneiform 210 and a dorsal surface of the first metatarsal 230. In another embodiment, the proximal arm 1930 and the distal arm 1940 may be positioned extending from the body 1910 near the medial end 2004.	233	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	The inferior side 1922 may be custom contoured to match the shapes of one or more of the surfaces of the first cuneiform and/or the first metatarsal. In one embodiment, the inferior side 1922 may include a bone engagement surface 1924. The bone engagement surface 1924 can be shaped to match a first surface of a first bone and a second surface of a second bone of a joint.	197	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, the method 1700 may register 1708 the preliminary cutting guide model with one or more bones of the bone model. This step 1708 facilitates customization and modification of the preliminary cutting guide model to generate a patient specific cutting guide model from which a patient specific cutting guide can be generated. The registration step 1708 combines two models and/or patient imaging data and positions both models for use in one system and/or in one model.	178	Added by DJM 2 2022	2/25/22, 12:00 AM
View Edit Delete	PER-10	Next, the method 1700 may design 1710 a patient specific cutting guide model based on the preliminary cutting guide model. The design step 1710 may be completely automated or may optionally permit a user to make changes to a preliminary cutting guide model or partially completed patient specific cutting guide model before the patient specific cutting guide model is complete. A preliminary cutting guide model and patient specific cutting guide 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 guide model, a patient specific cutting guide model, and the like. In one embodiment, a patient specific cutting guide and a patient specific cutting guide model may be unique to a particular patient and that patient’s anatomy and/or condition.	182	Added by DJM 2 2022	2/25/22, 12:00 AM

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