Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-12	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.	111	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Referring to Figures 3H and 4, in one embodiment, the body 310, or one or more arms, may include one or more bone attachment features that facilitate attachment of the body 310 to the medial cuneiform 202 and/or first metatarsal 208. Such bone attachment features may include any of a wide variety of fasteners including, but not limited to, holes, spikes, fastening devices, and/or the like.	112	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Effective connection of the cutting guide 300 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.	113	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Accordingly, the cutting guide 300 includes one or more bone attachment features. As embodied in Figures 3A through 3H, the bone attachment features may take the form of one or more holes 350 that extend from the inferior side 322 to the superior side 320 and/or one or more fixation devices. The holes 350 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the medial cuneiform 202 and/or the first metatarsal 208 to keep the cutting guide 300 in place.	114	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 4 illustrates one example of a cutting guide 300 coupled to the bones using a proximal bone attachment feature 352 and a distal bone attachment feature 354. In the illustrated embodiment, the proximal bone attachment feature 352 includes at least hole 350 and a fastener and the distal bone attachment feature 354 includes at least hole 350 and a fastener. In Figure 4 the fasteners are K-wires. Advantageously, the proximal bone attachment feature 352 and the distal bone attachment feature 354 each include at least two holes 350, each with a K-wire passing through the hole 350 and into bone facing the inferior side 322. Using two holes 350 and two fasteners ensures a stable coupling between the cutting guide 300 and the bone(s). Advantageously, in certain embodiments, the two holes 350 of the proximal bone attachment feature 352 and distal bone attachment feature 354 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 352 and distal bone attachment feature 354 prevent the cutting guide 300 from pivoting around one of the K-wires of a proximal bone attachment feature 352 or a distal bone attachment feature 354.	115	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In the illustrated embodiment, the proximal arm 330 includes the proximal bone attachment feature 352 and the distal arm 340 includes the distal bone attachment feature 354. In one embodiment, the holes 350 of the proximal bone attachment feature 352 are aligned with each other and aligned perpendicular to a resection feature such as the second slot 370. The holes 350 of the distal bone attachment feature 354 may also be aligned with each other and aligned perpendicular to another resection feature such as the first slot 360. This means that the aligned holes 350 (and K-wires secured within them) of the distal bone attachment feature 354 will also be perpendicular to the cut surface formed using the first slot 360. This also means that the aligned holes 350 (and K-wires secured within them) of the proximal bone attachment feature 352 will also be perpendicular to the cut surface formed using the second slot 370. Consequently, at least one of the proximal bone attachment feature 352 and the distal bone attachment feature 354 can be used to position and orient a cut surface of the first metatarsal 208 and a cut surface of the medial cuneiform 202.	116	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Returning to Figures 3A through 4, the body 310 may further have features that facilitate desired translation and orientation of the first metatarsal 208 and/or medial cuneiform 202 in order to fuse or join the two bones to complete the procedure. For example, in the illustrated embodiment, the cutting guide 300 may include at least one alignment feature. A second alignment feature may be integrated into the cutting guide 300 or the second alignment feature may be a separate feature from the cutting guide 300.	117	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In the illustrated embodiment, the proximal bone attachment feature 352 serves as both a bone attachment feature and as an alignment feature, e.g., proximal alignment feature 380. In this manner, the proximal bone attachment feature 352 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 208, does not need to be rotated, translated, and/or re-oriented to mitigate a patient’s condition, the distal bone attachment feature 354 may also serve as both a bone attachment feature and as an alignment feature, e.g., distal alignment feature 390.	118	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	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 bone attachment feature 354 may serve as a bone attachment feature and as a reference for the positioning of a distal alignment feature 390 that is separate from the cutting guide 300.	119	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	For example, in such instances, the distal bone attachment feature 354 may serve as a reference for placement of a distal alignment feature 390 (See Figure 4A) that is parallel to the distal bone attachment feature 354 as measured along the longitudinal axis 376 of the first metatarsal 208. Subsequent to formation of a cut surface on the first metatarsal 208, the distal alignment feature 390 can be coupled to the first metatarsal 208 in parallel to the distal bone attachment feature 354 (e.g., by way of a pin guide). In certain embodiments, the distal alignment feature 390 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 380 and the distal alignment feature 390 may not be aligned initially. Instead, the proximal alignment feature 380 and distal alignment feature 390 may be configured to align when the bone coupled to the distal alignment feature 390 is rotated. Fasteners 356 of the distal bone attachment feature 354 may be aligned with longitudinal axis 376 and perpendicular to first slot 360 by way of holes 350. Fasteners 356 of the proximal bone attachment feature 352 may be aligned with reference line 392 and perpendicular to second slot 370 by way of holes 350. The reference line 392 may not be aligned with the longitudinal axis 376.	120	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 4 illustrates an example cutting guide 300 seated transverse to a tarsometatarsal (“TMT”) joint 400. The TMT joint 400 includes a lateral end 402 and a medial end 404. In certain embodiments, such as the illustrated embodiment, the body 310 is configured to extend between the lateral end 402 and the medial end 404. In addition, the proximal arm 330 and the distal arm 340 may be aligned with each other.	121	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Furthermore, in certain embodiments, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 near the lateral end 402 (See Figure 6). Said another way, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 such that the arms extend over a dorsal surface of the medial cuneiform 202 and a dorsal surface of the first metatarsal 208. In another embodiment, the proximal arm 330 and the distal arm 340 may be positioned extending from the body 310 near the medial end 404.	122	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 4 illustrates an example cutting guide 300 at a particular stage in an osteotomy procedure. In one embodiment, a surgeon has formed an incision transverse to a TMT joint 400 with a dorsal approach. In the illustrated embodiment, the cutting guide 300 may be configured (e.g., the bone engagement surface 324) to seat between the dorsal surface and medial surface of both the medial cuneiform 202 and the first metatarsal 208. The surgeon has also formed the incision down to the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208. Further, the surgeon has cut, or moved to the side, soft tissue covering the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208 sufficient to seat the bone engagement surface 324 onto the cortical bone surface of the medial cuneiform 202 and the first metatarsal 208.	123	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	A surgeon has deployed two or more fasteners 356 (e.g., K-wires) through the holes 350 of the proximal bone attachment feature 352 and the distal bone attachment feature 354. In certain embodiments, the distal bone attachment feature 354 and/or the proximal bone attachment feature 352 can include an additional hole 358 for another fastener 356. The additional hole 358 and fastener 356 can help keep the cutting guide 300 in place during resection and alignment operations. In certain embodiments, the additional hole 358 is aligned with two holes 350 of the distal arm 340, but need not be aligned.	124	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Exemplary embodiments of the disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the disclosure but is merely representative of exemplary embodiments.	1	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The phrases "connected to," "coupled to" and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase "fluid communication" refers to two features that are connected such that a fluid within one feature can pass into the other feature.	2	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.	3	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Standard medical planes of reference and descriptive terminology are employed in this disclosure. While these terms are commonly used to refer to the human body, certain terms are applicable to physical objects in general. A standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. A mid-sagittal, mid-coronal, or mid-transverse plane divides a body into equal portions, which may be bilaterally symmetric. The intersection of the sagittal and coronal planes defines a superior-inferior or cephalad-caudal axis. The intersection of the sagittal and transverse planes defines an anterior-posterior axis. The intersection of the coronal and transverse planes defines a medial-lateral axis. The superior-inferior or cephalad-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular.	4	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Anterior means toward the front of a body. Posterior means toward the back of a body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of a body, particularly toward a plane of bilateral symmetry of the body. Lateral means away from the midline of a body or away from a plane of bilateral symmetry of the body. Axial means toward a central axis of a body. Abaxial means away from a central axis of a body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body from the side which has a particular condition or structure. Proximal means toward the trunk of the body. Proximal may also mean toward a user, viewer, or operator. Distal means away from the trunk. Distal may also mean away from a user, viewer, or operator. Dorsal means toward the top of the foot or other body structure. Plantar means toward the sole of the foot or toward the bottom of the body structure.	5	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Antegrade means forward moving from a proximal location/position to a distal location/position or moving in a forward direction. Retrograde means backward moving from a distal location/position to a proximal location/position or moving in a backwards direction. Sagittal refers to a midline of a patient’s anatomy, which divides the body into left or right halves. The sagittal plane may be in the center of the body, splitting it into two halves. Prone means a body of a person lying face down. Supine means a body of a person lying face up.	6	Added by DJM Jan 2024	1/6/24, 10:03 PM

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