Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-16	Referring now to FIG. 11E, the first bone attachment feature 1006 includes a first height 1120 that extends from a highest point on the surface of the superior side 1104 to a lowest point on the surface of the inferior side 1106. Similarly, the second bone attachment feature 1008 includes a second height 1122 that extends from a highest point on the surface of the superior side 1134 to a lowest point on the surface of the inferior side 1136.	273	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	FIGs 11E and 11F illustrate an embodiment of the osteotomy system 1000 in which the first coupler 1118, second coupler 1148, first height 1120, and second height 1122 are each configured to define a trajectory 1124 for the cutter guide 1010 relative to one or more bones that receive the osteotomy. The trajectory 1124 for the cutter guide 1010 defines the trajectory of a cutting tool used with the cutter guide 1010 to resect or dissect one or more bones.	274	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In the illustrated embodiment, the first coupler 1118, second coupler 1148, first height 1120, and second height 1122 are configured such that the trajectory 1124 is parallel to the longitudinal axes of the fasteners 1012. Those of skill in the art will appreciate that one or more of the first height 1120 and/or second height 1122 and/or how the first coupler 1118 and/or second coupler 1148 engage with the cutter guide 1010 can be changed to provide a different angle for the trajectory 1124 relative to the first bone attachment feature 1006 and/or second bone attachment feature 1008 and/or to the longitudinal axes of the fasteners 1012. Said another way, the first coupler 118, second coupler 1148, first height 120, and second height 122 can be related and/or correlated to define the trajectory 1124 for the cutter guide 1010 towards one or more bones.	275	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Alternatively, or in addition, the angle of the opening 1116 through the body 1102 of the first bone attachment feature 1006 and/or the angle of the opening 1146 through the body 1132 of the second bone attachment feature 1008 can be used to define a trajectory 1124 for the cutter guide 1010. The angle of the openings 1116, 1146 alone or together with one or more of the first coupler 1118, second coupler 1148, first height 1120, and/or second height 1122 can be used separately and/or together in different combinations to define the trajectory 1124. Each of these permutations and/or combinations are within the scope of the present disclosure. In the illustrated embodiment, the angle of the opening 1116 through the body 1102 of the first bone attachment feature 1006 and/or the angle of the opening 1146 through the body 1132 of the second bone attachment feature 1008 are each perpendicular to the pivot axis 1014.	276	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	FIG. 11E illustrates that the first coupler 1118 engages the cutter guide 1010 at a first angle 1150 that is perpendicular to the distal side 1114 of the first bone attachment feature 1006 and that the second coupler 1148 engages the cutter guide 1010 at a second angle 1152 that is perpendicular to the proximal side 1142 of the second bone attachment feature 1008. FIG. 11E illustrates a longitudinal axis 1154 that represents the longitudinal axis of a bone that is to be resected (e.g., first metatarsal 208).	277	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Furthermore, patient-specific instruments may be used for various other procedures on the foot, or on other bones of the musculoskeletal system. For example, patient-specific instruments and/or other instruments may be used for various procedures including resection and translation of a head of a long bone, determining where to perform an osteotomy on one or more joints or part of one or more bones, determining ligament or tendon attachment or anchoring points, determining where to form bone tunnels or position anchors, tendon or graft deployment, and the like.	141	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	FIG. 1A is a flowchart diagram depicting a method 100 for correcting a bone condition, according to one embodiment. The method 100 may be used for any of a wide variety of bone conditions, including but not limited to deformities, fractures, joint failure, and/or the like. Further, the method 100 may provide correction with a wide variety of treatments, including but not limited to arthroplasty, arthrodesis, fracture repair, and/or the like.	142	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	As shown, the method 100 may begin with a step 102 in which a CT scan (or another three-dimensional image, also referred to as medical imaging) of the patient’s anatomy is obtained. The step 102 may include capturing a scan of only the particular bone(s) to be treated, or may include capture of additional anatomic information, such as the surrounding tissues. Additionally, or alternatively, the step 102 may include receiving a previously captured image, for example, at a design and/or fabrication facility. Performance of the step 102 may result in possession of a three-dimensional model of the patient’s anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model.	143	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	After the step 102 has been carried out, the method 100 may proceed to a step 104 in which a CAD model of the patient’s anatomy (including one or more bones) is generated. The CAD model may be one example of a bone model. The CAD model may be of any known format, including but not limited to SolidWorks, Catia, AutoCAD, or DXF. In some embodiments, customized software may be used to generate the CAD model from the CT scan. The CAD model may only include the bone(s) to be treated and/or may include surrounding tissues. In alternative embodiments, the step 104 may be omitted, as the CT scan may capture data that can directly be used in future steps without the need for conversion.	144	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In one embodiment, the CAD model generated and/or patient-specific instrumentation, implants, and/or plan for conducting an operative procedure, may be enhanced by the use of advanced computer analysis system, machine learning, and/or automated/artificial intelligence. For example, these technologies may be used to revise a set of steps for a procedure such that a more desirable outcome is achieved.	145	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In a step 106, the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the condition, as it exists in the patient’s anatomy. In some embodiments, any known CAD program may be used to view and/or manipulate the CAD model and/or CT scan and generate one or more instruments that are matched specifically to the size and/or shape of the patient’s bone(s). In some embodiments, such instrumentation may include a targeting guide, trajectory guide, drill guide, resection guide, cutting guide, tendon trajectory guide, capital fragment positioning guide, or similar guide that can be attached to one or more bones, with one or more features that facilitate work on the one or more bones pursuant to a procedure such as arthroplasty or arthrodesis. In some embodiments, performance of the step 106 may include modelling an instrument with a bone engagement surface that is shaped to match the contour of a surface of the bone, such that the bone engagement surface can lie directly on the corresponding contour.	146	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In a step 108, the model(s) may be used to manufacture patient-specific instrumentation and/or implants. This may be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, and/or the like. Additive manufacturing may provide unique benefits, as the model may be directly used to manufacture the instrumentation and/or implants (without the need to generate molds, tool paths, and/or the like beforehand). Such instrumentation may optionally include a targeting guide, trajectory guide, drill guide, resection guide, dissection guide, cutting guide, positioner, positioning guide, tendon trajectory guide, or the like.	147	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In addition to, or in the alternative to the step 108, the model(s) may be used to select from available sizes of implants and/or instruments or instruments having various attributes and advise the surgeon accordingly. For example, where a range of guides are available for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal guide and/or optimal placement of the guide on the bone. Similarly, if a range of implants and/or instruments may be used for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal implant(s). More particularly, properly-sized spacers, screws, bone plates, and/or other hardware may be pre-operatively selected.	148	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	Thus, the result of the step 108 may provision, to the surgeon, of one or more of the following: (1) one or more patient-specific instruments; (2) one or more patient-specific implants; (3) an instrument, selected from one or more available instrument sizes and/or configurations; (4) an implant, selected from one or more available implant sizes and/or configurations; (5) instructions for which instrument(s) to select from available instrument sizes and/or configurations; (6) instructions for which implant(s) to select from available implant sizes and/or configurations; (7) instructions for proper positioning or anchorage of one or more instruments to be used in the procedure; and (8) instructions for proper positioning or anchorage of one or more implants to be used in the procedure. These items may be provided to the surgeon directly, or to a medical device company or representative, for subsequent delivery to the surgeon.	149	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In a step 110, the manufactured instrumentation may be used in surgery to facilitate treatment of the condition. In some embodiments, this may include placing the modelled bone engagement surface against the corresponding contour of the bone used to obtain its shape, and then using the resection feature(s) to guide resection of one or more bones. Then the bone(s) may be further treated, for example, by attaching one or more joint replacement implants (in the case of joint arthroplasty), or by attaching bone segments together (in the case of arthrodesis or fracture repair). Prior to completion of the step 110, the instrumentation may be removed from the patient, and the surgical wound may be closed.	150	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	As mentioned previously, the method 100 may be used to correct a wide variety of bone conditions. One example of the method 100 will be shown and described in connection with FIG. 1B, for correction of a bunion deformity of the foot.	151	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In certain embodiments, one or more of a method, apparatus, and/or system of the disclosed solution can be used for training a surgeon to perform a patient-specific procedure or technique. In one embodiment, the CAD model generated and/or patient-specific instrumentation, implants, and/or plan for conducting an operative procedure can be used to train a surgeon to perform a patient-specific procedure or technique.	152	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In one example embodiment, a surgeon may submit a CT scan of a patient’s foot to an apparatus or system that implements the disclosed solution. Next, a manual or automated process may be used to generate a CAD model and for making the measurements and correction desired for the patient. In the automated process, an advanced computer analysis system, machine learning and automated/artificial intelligence may be used to generate a CAD model and/or one or more patient-specific instruments and/or operation plans. For example, a patient-specific instrument may be fabricated that is registered to the patient’s anatomy using a computer-aided machine (CAM) tool. In addition, a CAM tool may be used to fabricate a 3D structure representative of the patient’s anatomy, referred to herein as a patient-specific synthetic cadaver. (e.g., one or more bones of a patient’s foot). Next, the patient-specific instrument and the patient-specific synthetic cadaver can be provided to a surgeon who can then rehearse an operation procedure in part or in full before going into an operating room with the patient.	153	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	In certain embodiments, the patient-specific instrument or instrument can be used to preposition and/or facilitate pre-drilling holes for a plate system for fixation purposes. Such plate systems may be optimally placed, per a CT scan, after a correction procedure for optimal fixation outcome. In another embodiment, the CAD model and/or automated process such as advanced computer analysis, machine learning and automated/artificial intelligence may be used to measure a depth of through a patient-specific resection guide for use with robotics apparatus and/or systems which would control the depth of each cut within the guide to protect vital structures below or adjacent to a bone being cut. In another embodiment, the CAD model and/or automated process such as advanced computer analysis, machine learning and automated/artificial intelligence may be used to define desired fastener (e.g. bone screw) length and/or trajectories through a patient-specific instrument and/or implant. The details for such lengths, trajectories, and components can be detailed in a report provided to the surgeon preparing to perform a procedure.	154	Added by DJM Jan 2024	1/3/24, 4:26 AM
View Edit Delete	PER-16	FIG. 1B is a flowchart diagram depicting a method 120 for correcting or remediating a bone condition, according to one embodiment. The method 120 may be used to prepare for an orthopedic procedure which corrects or remediates a bone, muscle, deformity, and/or tendon condition of a patient.	155	Added by DJM Jan 2024	1/3/24, 4:26 AM

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