Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-4 DIV1	While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of this disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure set forth herein without departing from it spirit and scope.	82	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1		83	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	The present disclosure discloses surgical systems and methods by which a bone condition, such as a deformity, may be corrected through the use of patient-specific instrumentation. Known methods of correcting bone conditions are often limited to a finite range of discretely sized instruments. A patient with an unusual condition, or anatomy that falls between instrument sizes, may not be readily treated with such systems. One example is correction of a bunion, in particular, via adjustment of the angulation between a cuneiform and a metatarsus.	4	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	Figure 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.	5	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	As shown, the method 100 may begin with a step 102 in which a CT scan (or another three-dimensional image) of the patient’s anatomy is obtained. The step 102 may entail capturing a scan of only the particular bone(s) to be treated, or may entail capture of additional anatomic information, such as the surrounding tissues. Additionally or alternatively, the step 102 may entail 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.	6	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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 is generated. 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 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.	7	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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 cutting guide that is attachable to one or more bones, with one or more guide features that facilitate resection of 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 apposition surface that is shaped to match the contour of a surface of the bone, such that the bone apposition surface can lie directly on the corresponding contour.	8	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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 necessary instrumentation and/or implants (without the need to generate molds, tool paths, and/or the like beforehand). Such instrumentation may optionally include a cutting guide with the bone apposition surface and one or more guide features as described above.	9	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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 and advise the surgeon accordingly. For example, where a range of cutting guides are available for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal cutting guide and/or optimal placement of the cutting guide on the bone. Similarly, if a range of implants 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.	10	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	Thus, the result of the step 108 may be 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.	11	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	In a step 110, the manufactured instrumentation may be used in surgery to facilitate treatment of the condition. In some embodiments, this may entail placing the modelled bone apposition surface against the corresponding contour of the bone used to obtain its shape, and then using the guide 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.	12	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	As mentioned previously, the method 100 may be used to correct a wide variety of bone conditions. One particular example of the method 100 will be shown and described in connection with Figure 1B, for correction of a bunion deformity of the foot.	13	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	Figure 1B is a flowchart diagram depicting a method 120 for correcting bunion deformity of the human foot, according to one embodiment. The method 120 may be used to carry out an arthrodesis procedure by which the first metatarsocuneiform joint is removed and the first cuneiform and first metatarsus are secured together in a manner that properly aligns the first metatarsus, providing correction of the deformity.	14	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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, as represented in Figures 1A through 11, is not intended to limit the scope of the disclosure but is merely representative exemplary of exemplary embodiments.	1	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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 is able to pass into the other feature.	2	Added by DJM Jan 2024	1/6/24, 9:54 PM
View Edit Delete	PER-4 DIV1	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, 9:54 PM
View Edit Delete	PER-32	The reduction anchor 1630 also includes a front surface 1638, a back surface 1640 (See FIG. 16G), an anterior surface 1642, a posterior surface 1644, a proximal surface 1646, and a distal surface 1648. The reduction anchor 1630 may be made of a variety of materials such as plastic, PEEK, metal, or the like and may be fabricated using additive manufacturing.	270	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	The reduction stabilizer 1650 serves to hold, maintain, and/or retain a reduction in place so that a surgeon can prepare and/or plan for subsequent steps in a surgical procedure. The reduction stabilizer 1650 can be embodied in any structure that accomplishes and/or maintains the stabilized reduction. In the illustrated embodiment, the reduction stabilizer 1650 engages one or more fasteners of a first bone fragment, such as proximal bone fragment 224b and one or more fasteners of a second bone fragment, such as distal bone fragment 224a.	271	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	In the illustrated embodiment, the reduction stabilizer 1650 includes a first hole 1662 and a second hole 1664 each configured to engage the first fastener 1602 and the second fastener 1606. The reduction stabilizer 1650 may also include a fastener lock 1666 configured to engage and retain a bone fragment such as distal bone fragment 224a. In the illustrated embodiment, the fastener lock 1666 is embodied as a hole in the reduction stabilizer 1650 that is configured to engage the third fastener 1610. In certain embodiments, the fastener lock 1666 is configured to retain a bone fragment. In the illustrated embodiment, the fastener lock 1666 retains a bone fragment by way of the third fastener 1610 that engages the bone fragment.	272	Added by DJM Jan 2024	1/6/24, 9:49 PM
View Edit Delete	PER-32	The reduction stabilizer 1650 also includes a front surface 1668, a back surface 1670 (See FIG. 16G), an anterior surface 1642, a posterior surface 1644, a proximal surface 1646, and a distal surface 1648. The reduction anchor 1630 may be made of a variety of materials such as plastic, PEEK, metal, or the like and may be fabricated using additive manufacturing.	273	Added by DJM Jan 2024	1/6/24, 9:49 PM

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