Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-33	For example, suppose a surgeon would like a patient-specific system 606 for an osteotomy procedure. One goal of the procedure may be to relieve pain of the patient and to remove a minimal amount of bone in the process of completing the procedure. In such an example, the bone model 404 may be of one or more bones of a foot and/or ankle of the patient. The surgeon may provide a request and/or a set of user instructions 604 for a patient-specific system 606 for this osteotomy procedure.	227	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	Those of skill in the art will appreciate that the user instructions 604 may be of a variety of different types, lengths, number of details and may be provided in a variety of different formats including oral, written, or the like. In one embodiment, the user instructions 604 may be a request for a patient-specific system 606 that includes a set of default instruments, preoperative plan, implants, or the like. For example, the user instructions 604 may as short and simple as “Please provide an osteotomy system for a bone of the left foot for patient <<identifying information (e.g., name, dob, etc.)>> with medial approach.” The user instructions 604 may be provided in the form of a product order, a purchase order, a prescription, or the like. The user instructions 604 may be provided in written manual / analog form, include a manual signature, digital form, include an e-signature, or the like. In addition, the user instructions 604 may include security and/or authorization features that enable the receiver to confirm that the user instructions 604 are valid and are authorized by a particular surgeon or doctor. The user instructions 604 may indicate the approach to the surgical site (e.g., an ankle or foot joint or bone) the surgeon wants to take, anterior, posterior, medial, lateral, or the like.	228	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In another embodiment, the user instructions 604 may include specific instructions for the number and/or kind or type of components in the patient-specific system 606 and/or the configuration of one or more of these components. For example, the user instructions 604 may identify a specific fixation product or fixation system the surgeon will be using for permanent fixation of the osteotom(ies). Alternatively, or in addition, the user instructions 604 may include designation of one or more complementary components and/or configurations for these components to be included in the patient-specific system 606.	229	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, the user instructions 604 may designate a particular material and/or mass for fabricating one or more guides to be included in the patient-specific system 606. Some surgeons may find that patient-specific instruments, such as a patient-specific resection guide may more readily register to one or more bone surfaces if the instrument has a greater mass and/or weight. With the greater mass and a sufficient fidelity bone engagement surface, a patient-specific instrument may seem to find its own way or seek out a desired position on a bone that matches or substantially matches a position planned when the patient-specific system 606 was developed. Consequently, a surgeon may request in the user instructions 604 that the instrument be made from a metal such as titanium.	230	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	With the bone model 404 and user instructions 604 a user such as a technician may operate the design module 650 alone or together with other modules of the apparatus 602 to develop a patient-specific system 606. In certain embodiments, a single user operates the apparatus 602. Alternatively, or in addition, a plurality of users, which may include an end user, such as surgeon can operate or interact with one or more modules of the apparatus 602 as the patient-specific system 606 is designed or developed.	231	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, a technician may provide a patient-specific system 606 that includes one or more complementary components and one or more resection guides, which may be patient-specific. The technician may also provide a preoperative plan. These may be provided to an end user (e.g., surgeon) either directly or by accessing the apparatus 602 remotely. The end user may review the preoperative plan and/or the components of the patient-specific system 606 (e.g., resection guides) and may approve of the patient-specific system 606 or may request changes. In certain embodiments, these changes may include the addition of one or more added bone engagement features, one or more resection guides, a change in a trajectory for a bone attachment feature, a change in trajectory for an osteotomy, an addition of openings in a guide to coincide with openings needed for a fixation system, as well as a plurality of other possible changes to the patient-specific system 606. The technician may then make the requested changes and present a revised patient-specific system 606 for the surgeon to review again. Next, the surgeon may approve of the revised patient-specific system 606 and/or request additional changes.	232	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In the illustrated embodiment, the design module 650 may include a plurality of resection features 652 and/or a plurality of bone engagement features 654. A technician may select one or more resection features 652 and/or one or more bone engagement features 654 and include them in the patient-specific system 606. Alternatively, or in addition, a surgeon may designate which resection features 652 and/or bone engagement features 654 to include in the patient-specific system 606.	233	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, the surgeon and technician may collaborate and/or consult with each other regarding the design and/or configuration of the patient-specific system 606 and its components. The technician may share with the surgeon information about the technological features and/or limitations of the components of the patient-specific system 606 and use the technician’s experience and know-how to make recommendations to the surgeon. The surgeon can present ideas and/or requests regarding what the surgeon would like for components of the patient-specific system 606 and the technician can determine whether those ideas/requests can be satisfied using a patient-specific system 606.	234	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The apparatus 602 uses both the bone model 404 and user instructions 604 to provide a patient-specific system 606. Advantageously, the apparatus 602 enables a surgeon to be involved in the design and development of a patient-specific system 606 that is suited not just for the patient, but also for the needs, skills and/or preferences of the surgeon. In this manner, a patient-specific system 606 can be provided that improves patient care and accomplishing desired outcomes.	235	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, the operation of the design module 650 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the designing of the patient-specific system 606 is, including any patient-specific instrument models, patient-specific instruments, and/or other components of the patient-specific system 606.	236	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The apparatus 602 may include a selection module 660 and an export / fabrication module 670. The selection module 660 facilitates the selection and/or customization of one or more complementary components for a patient-specific system 606. Complementary components are described herein, but can include certain guides or other aids to facilitate completing a surgical procedure as planned. In one embodiment, the operation of the selection module 660 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the selection module 660 is.	237	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The export / fabrication module 670 is configured to enable exporting of a patient-specific system 606 for a variety of purposes including, but not limited to, fabrication/manufacture of one or more patient-specific instruments and/or fixator(s), ordering or fabricating one or more members of the patient-specific system 606, generation of a preoperative plan, generation of a physical bone model matching the bone model 404, and the like.	238	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In one embodiment, the export / fabrication module 670 is configured to export the bone model 404, anatomic data 412, one or more patient-specific instrument models 462, a preoperative plan 506, a fixator model 508, or the like. In this manner the custom instrumentation and/or procedural steps for a procedure can be used in other tools. The preoperative plan 506 may include a set of step-by-step instructions or recommendations for a surgeon or other staff in performing a procedure (e.g., a graft harvesting procedure, minimally invasive surgical (MIS) procedure, or the like). The preoperative plan 506 may include images and text instructions and may include identification of instrumentation to be used for different steps of the procedure (e.g., a graft harvesting procedure, minimally invasive surgical (MIS) procedure, or the like). The instrumentation may include a patient-specific instrument, bone engagement features, and/or one or more fixators/fasteners.	239	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	FIG. 7 illustrates an exemplary system 700 for remediating a condition present in a patient’s foot, according to one embodiment. The system 700 can include one or more fasteners 710, one or more soft tissue rearrangement guides (STRGs) 720, and one or more complementary components 730. While a system 700 can be used for a variety of procedures, one or more features, components, and/or aspects of the system 700 may be particularly suited for one or more osteotomies on one or more bones of a structure such as a patient’s foot, ankle, wrist, hand, shoulder, or the like.	240	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, the one or more fasteners 710 can include one or more permanent fasteners and/or one or more temporary fasteners. Typically, the fasteners 710 may be used during a variety of different steps of a procedure. Temporary fasteners are often used because they can securely hold bone or parts/fragments of bones while steps of the procedure are conducted. A common temporary fastener that can be used with system 700 is a K-wire, also referred to as a pin, guide pin, and/or anchor pin. Permanent fasteners 710 such as bone screws, bone staples, sutures, tethers or the like may also be used in a surgical procedure.	241	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The one or more STRGs 720 assist a surgeon in performing different steps for a soft tissue rearrangement procedure or other procedure. The one or more STRGs 720 assist a surgeon in positioning and aligning instrumentation and/or bone tunnels for a soft tissue rearrangement procedure. Those of skill in the art will appreciate that a STRG 720 may be referred to by different names in different embodiments and/or contexts. For example, a STRG 720 may also be referred to as a tendon transfer system, a tendon trajectory guide, bone tunnel guide, a tendon transfer anchor guide, a patient-specific tendon transfer anchor guide, or the like.	242	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, a STRG 720 includes one or more trajectory ports 722, one or more landmark registration features 724 and a bone engagement feature 726. The trajectory port 722 can take a variety of forms and/or embodiments. Similarly, the landmark registration feature 724 can take a variety of forms and/or embodiments. The bone engagement feature 726 is a feature of the STRG 720 that contacts and/or engages with one or more bones of a patient. In certain embodiments, the STRG 720 can include one or more optional bone attachment features 728.	243	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	The trajectory port 722 guides placement of a temporary fastener and/or forming an opening or tunnel in the bone of a patient. The landmark registration feature 724 can serve to ensure the STRG 720 is placed in a desired location on one or more bones. The bone engagement feature 726 can also serve to ensure the STRG 720 is placed in a desired location on one or more bones. In certain embodiments, the bone attachment feature 728 can include a hole in the STRG 720 that operates together with a temporary fastener such as a K-wire or pin to secure the STRG 720 to bone.	244	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, a STRG 720 may include one or more bone engagement features 726 and/or one or more landmark registration features 724. In certain embodiments, a landmark registration feature 724 may extend from one or more sides or ends of a STRG 720 and engage with one or more landmarks of a bone or joint or anatomical structure of a patient. Registration of the landmark registration feature 724 to a landmark of a bone or joint can serve to confirm and/or ensure that a surgeon has located a desired placement and/or orientation for a STRG 720.	245	Added by DJM Jan 2024	1/6/24, 9:58 PM
View Edit Delete	PER-33	In certain embodiments, the bone engagement features 726 are patient-specific: designed and/or contoured to match anatomy such as a surface of: one or more bones and/or bone surfaces the STRG 720 contacts during the procedure or one or more joints proximal to the STRG 720 during the procedure. Alternatively, or in addition, the bone engagement feature 726 may not be patient-specific, and may, or may not, contact a bone surface during use of the STRG 720. In one embodiment, a skin contact surface may be used in addition to, or in place of, a bone engagement surface. Those of skill in the art appreciate that one or more sides of any of the members of the system 700 may include one or more bone engagement features 726. Consequently, one or more sides of the fasteners 710, the resection guide(s) 720, the complementary components 730, navigation guides 792, and/or the implants 794 may include one or more bone engagement features 726.	246	Added by DJM Jan 2024	1/6/24, 9:58 PM

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