Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-33	In certain embodiments, a user, or end user, may review the bone model, and a model of the bone tunnel guide 920 and based on these models determine, at least in part, where to position and/or orient a trajectory port 924 within a bone tunnel guide 920. Advantageously, determining a position and/or orientation for the trajectory port 924 in a model of an instrument can be directly reflected in a fabricated instrument based on the model. In one embodiment, the position and/or orientation for the trajectory port 924 can be based on user instructions 604. Alternatively, or in addition, other features of a trajectory port 924 can be based, at least partially, on user instructions 604. Alternatively, or in addition, in one embodiment, features of a bone tunnel guide 920 can be based on accepted practice aspects for a particular surgical procedure.	268	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	FIGs. 9A-9I illustrate views of a bone tunnel guide 920 of the system of FIG. 8, according to one embodiment. The bone tunnel guide 920 includes at least one trajectory port 924. In the illustrated embodiment, the bone tunnel guide 920 includes a bone engagement feature 928. Other embodiments may not include a bone engagement feature 928. In certain embodiments, one or more of the bone engagement features 928 may include a bone engagement surface 946. Alternatively, or in addition, the bone tunnel guide 920 may include a bone engagement surface 946. Alternatively, or in addition, the bone tunnel guide 920 may also include one or more bone attachment features 930 (not shown), and a handle coupler 950.	269	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The trajectory port 924 extends from the body 932. In one embodiment, the trajectory port 924 includes an opening 948 that extends from a top surface of the trajectory port 924 through to the bottom surface. The trajectory port 924 serves to guide a surgeon and indicates a desired trajectory for a temporary fastener, a cutting tool, or other instrumentation a surgeon may use for deploying a tendon, tendon substitute, tendon anchor, soft tissue, a graft, or the like.	270	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	For example, in a tendon transfer, a surgeon may insert a temporary fastener such as a K-wire into the opening 948 and deploy the K-wire into bone that contacts the inferior surface (inferior side 936) of the bone tunnel guide 920. Alternatively, or in addition, a surgeon may deploy fastener 910 into the opening 948 and into bone contacting an inferior surface of the bone tunnel guide 920. In certain embodiments, the opening 948 has a circular cross-section and has a diameter sized to accept the fastener 910 or a cutting tool that a surgeon wants to use for the procedure.	271	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Advantageously, the trajectory port 924 and/or opening 948 may extend from the body 932 at any angle needed to provide a desired trajectory angle. In one embodiment, the opening 948 extends perpendicular to the body 932. In another embodiment, the opening 948 extends at an angle between about 5 degrees and about 85 degrees relative to the body 932.	272	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, the length of the opening 948 is sufficient to assist a surgeon in maintaining a trajectory along a longitudinal axis of the opening 948 through the bone tunnel guide 920 and into a bone of a patient. Alternatively, or in addition, the length of the opening 948 may extend away from the body 932 such that the trajectory port include a port body that extends away from the body 932. The port body may have a length that enables a user to grasp the port body to secure the bone tunnel guide 920 in place for formation of a bone tunnel by way of the trajectory port 924.	273	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The bone tunnel guide 920 includes a superior side 934, an inferior side 936, a medial side 938, a lateral side 940, a posterior side 942, and an anterior side 944. FIG. 9A is a perspective view. FIG. 9B is a perspective view. FIG. 9C is a medial side perspective view. FIG. 9D is a lateral side perspective view. FIG. 9E is an inferior side perspective view. FIG. 9F is an inferior side view. FIG. 9G is a superior side view. FIG. 9H is a posterior side view. FIG. 9I is an anterior side view.	274	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The bone engagement feature 928 serves to facilitate registration of the bone tunnel guide 920 to a surface of a bone and/or to one or more landmarks of the bone. The bone tunnel guide 920 can include one, two, or more bone engagement features 928. In the illustrated embodiment, the bone tunnel guide 920 includes two bone engagement features 928a,928b. A bone engagement feature 928, may be sized, shaped, positioned, and/or oriented to engage at least a portion of a bone of a patient such that the bone engagement feature 928 positions the bone tunnel guide 920 in a position that corresponds to a modeled position of a bone tunnel guide model engaging a bone model. The bone model may be a model of at least a portion of a bone of a patient. In the bone tunnel guide model, the bone engagement feature 928 are also models. The modeled bone engagement feature(s) 928 can be created when the bone tunnel guide 920 is fabricated.	275	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Advantageously, the present disclosure includes embodiments that may include one or more aspects that are patient-specific. Since the bone tunnel guide 920 is configured, designed, and fabricated based on and for a particular patient as well as the needs, instructions, expertise, experience, and/or preferences of that patient’s surgeon, a variety of aspects of the bone tunnel guide 920 can be patient-specific. Alternatively, or in addition, certain features of the soft tissue rearrangement system 800 such as the bone engagement feature 928 can include at least one patient-specific aspect that is unique to the patient.	276	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	For example, in one embodiment, a bone engagement feature 928 can include a bone engagement surface 946 on a bone-facing surface (e.g., inferior side 936) of the bone engagement feature 928. FIG. 9E and FIG. 9F illustrate examples of the bone engagement features 928 that include a bone engagement surface 946. In one embodiment, a bone engagement surface 946 is on a single bone engagement feature 928. In another embodiment, a bone engagement surface 946 may span a bone engagement feature 928 and include an inferior side 936 of the body 932 and/or an inferior side of one or more other bone engagement features 928.	277	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Alternatively, or in addition, the bone engagement surface 946 can be configured to engage at least one landmark of the bone of the patient. For example, when in a desired position, a bone engagement feature 928 may cover a bone spur that extends from a surface of the bone. Accordingly, the bone engagement feature 928 and/or bone engagement surface 946 can be configured to include an indentation or void shaped to accept and engage with the bone spur, when the bone tunnel guide 920 is in the planned/desired position.	278	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, the bone engagement surface(s) 946 is configured such that the bone engagement surface 946 forms substantially a mirror image of a bone surface. For example, the bone engagement surface 946 may correspond to a surface of a bone such that bone tunnel guide 920 provides haptic feedback to a user when the bone tunnel guide 920 translates to the position corresponding to the modeled position of the bone tunnel guide model engaging the bone model. This means a surgeon can position a bone tunnel guide 920 in an approximate position to the modeled position and then translate the bone tunnel guide 920 medially, laterally, anteriorly, posteriorly, or the like until the bone engagement surface 946 and/or the the bone engagement feature(s) 928, alone or together with the bone engagement surface 946, provide that haptic feedback to a surgeon confirming that the bone tunnel guide 920 has now assumed the substantially same position on the bone as the modeled position used to design the bone tunnel guide 920.	279	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Alternatively, a bone engagement feature 928 may be included in the bone tunnel guide 920 to specifically engage with a particular landmark at, or near, a planned position for the bone tunnel guide 920 on the bone. For example, suppose a bone spur extends from a patient’s bone just posterior to a planned position for the bone tunnel guide 920. A user may request (e.g., by way of user instructions 604) that another bone engagement feature 928 be added to the design, a bone engagement feature 928 that extends posteriorly to cover/include/engage with that bone spur. In this manner, certain landmarks and/or landmark configurations can be accounted for and/or used to facilitate the accurate and precise positioning of the bone tunnel guide 920 during a planned surgical procedure. Consequently, a number of bone engagement features 928 included in the bone tunnel guide 920, as well as the size, shape, configuration, position, and/or orientation of each bone engagement feature 928 can be determined at least partially by user instructions 604. For example, a surgeon may request that one bone engagement feature 928 be made wider to provide greater registration with bone surface in that area of the bone during the surgical procedure.	280	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Advantageously, a user may define and/or determine how many bone engagement features 928 are included in a bone tunnel guide 920. Alternatively, or in addition, a number of different bone tunnel guides 920 may be included in a soft tissue rearrangement system 800 which can be used intraoperatively as decided by a surgeon. A user may provide initial user instructions 604 for a certain number of bone engagement features 928 of a certain configuration and then later revise that user instructions 604 to modify, add, or remove bone engagement features 928.	281	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Advantageously, because the design and configuration of the bone tunnel guide 920 is being determined before the bone tunnel guide 920 is fabricated, changes and revisions can be readily made to a model of the bone tunnel guide 920 that is later used for fabricating the bone tunnel guide 920. In one embodiment, at least one aspect of the bone tunnel guide 920 is configured based at least partially on user directions 604 provided before the bone tunnel guide 920 is fabricated. For example, a user may provide user instructions 604 that each bone engagement feature 928 include a bone engagement surface 946 that matches a contour of a bone surface of a patient when the bone tunnel guide 920 is in a desired position during a surgical procedure.	282	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The bone tunnel guide 920 can be fabricated using additive manufacturing, subtractive manufacturing, molding, casting, or the like. The bone tunnel guide 920 can be made from a variety of materials such as, but not limited to, polymers (e.g., polyimide (nylon) polymers, Nylene®), metal (e.g., titanium, titanium alloys, stainless-steel, stainless-steel alloys, nickel-titanium alloys), ceramic, biocompatible materials, or the like. In certain embodiments, a material is selected that will reduce the cost for the bone tunnel guide 920.	283	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, a number of bone engagement features 928 (e.g., 928a, 928b, 928c?) of the plurality of bone engagement features 928 may be directly proportional to a number of landmark configurations near, or at, a modeled position of a bone tunnel guide model engaging a bone model of a bone, or a portion of a bone, of a patient. For example, suppose a user provides medical imaging that is used to generate a model of one or more bones of a patient and a model of a bone tunnel guide 920 that could be used.	284	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	A user may review an initial design of the bone tunnel guide 920 and a model of the bone that will receive the bone tunnel for a surgical procedure. The user may identify four distinct landmark configurations on, at, or near where a bone tunnel is planned for the surgical procedure. Accordingly, the surgeon/user may provide user instructions 604 that four bone engagement features 928 be included in a bone tunnel guide 920 for the surgical procedure. Each of the four-bone engagement features 928 may be specifically designed and/or engineered to engage with each of the four landmark configurations. In one embodiment, one of the landmark configurations may be a bony surface; another landmark configuration may be a joint; landmark configurations may be a bone distal to a joint; another landmark configurations may be a different part of a bone surface. In this example, the number of landmark configurations (four) is directly proportional to the number of bone engagement features 928 (four).	285	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Once a technician or engineer designs a model of the bone tunnel guide 920 together with one or more models of bones of a patient, the technician may send the designed model to the user or otherwise make the design available for review by the user/surgeon. A surgeon can review the model and/or the one or more modeled bones, and/or manipulate them in an interface to visualize where the model of the bone tunnel guide 920 will register to one or more bones and thus where a resulting bone tunnel can be formed in one or more bones.	286	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Based on this review, the surgeon may have further changes and/or adjustments to the model of the bone tunnel guide 920 based on patient anatomy, steps for a planned surgical procedure, and/or surgeon preferences. With this feedback from the surgeon, the technician may make further adjustments and/or changes to the designed model of the bone tunnel guide. This process of review and revision can be repeated multiple times until the surgeon approves the design. At this point the technician can arrange for the model of the bone tunnel guide to be fabricated to create the bone tunnel guide 920. The bone tunnel guide 920 is then provided to the user for use in a surgical procedure.	287	Added by DJM Jan 2024	1/6/24, 9:58 PM

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