Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	PER-8 PROV	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.	35	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As used herein, "medical imaging" refers to a technique and process of imaging the interior of a body for clinical analysis and medical intervention, as well as visual representation of the function of some organs or tissues (physiology). Medical imaging seeks to reveal internal structures hidden by the skin and bones, as well as to diagnose and treat disease. Medical imaging may be used to establish a database of normal anatomy and physiology to make possible identification of abnormalities. Medical imaging in its widest sense, is part of biological imaging and incorporates radiology, which uses the imaging technologies of X-ray radiography, magnetic resonance imaging, ultrasound, endoscopy, elastography, tactile imaging, thermography, medical photography, nuclear medicine functional imaging techniques as positron emission tomography (PET) and single-photon emission computed tomography (SPECT). Another form of X-ray radiography includes computerized tomography (CT) scans in which a computer controls the position of the X-ray sources and detectors. Magnetic Resonance Imaging (MRI) is another medical imaging technology. Measurement and recording techniques that are not primarily designed to produce images, such as electroencephalography (EEG), magnetoencephalography (MEG), electrocardiography (ECG), and others, represent other technologies that produce data susceptible to representation as a parameter graph vs. time or maps that contain data about the measurement locations. These technologies may be considered forms of medical imaging in certain disciplines. (Search "medical imaging" on Wikipedia.com June 16, 2021. CC-BY-SA 3.0 Modified. Accessed June 23, 2021.) Data, including images, text, and other data associated with medical imaging is referred to as patient imaging data. As used herein, "patient imaging data" refers to data identified, used, collected, gathered, and/or generated in connection with medical imaging. Patient imaging data can be shared between users, systems, patients, and professionals using a common data format referred to as Digital Imaging and Communications in Medicine (DICOM) data. DICOM data is a standard format for storing, viewing, retrieving, and sharing medical images.	34	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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 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.	33	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The present disclosure discloses surgical systems and methods by which a bone condition, such as a deformity, may be corrected using 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.	31	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	29	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 24 illustrates an exemplary system configured to generate patient specific footwear configured to a specific patient’s feet, according to one embodiment.	28	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figure 23 illustrates an exemplary system configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment.	27	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Further, the body 1210 may have one or more bone attachment features that facilitate attachment of the body 1210 to the first cuneiform and/or the first metatarsus. Such bone attachment features may comprise any of a wide variety of holes, spikes, fastening devices, and/or the like. As embodied in Figures 12A through 12H, the bone attachment features may take the form of holes 1240 that extend from a bone apposition side 1230 to the outward-facing side 1232. The holes 1240 may be shaped to accommodate pins, K-wires, and/or other elongated bone fixation elements that can be anchored in the first cuneiform and/or the first metatarsus to keep the cutting guide 1200 in place.	121	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, the detachable connector 1270 may include one or more grooves 1272 between an alignment feature 1260a and the body 1210. The groove 1272 is an opening between the alignment feature 1260 and the body 1210. Within a groove 1272 one or more bridges 1274 connect the alignment feature 1260 with the body 1210. In one embodiment, the size, position, number, and configuration of one or more grooves 1272 and the corresponding one or more bridges 1274 is determined such that the alignment feature 1260 remains securely connected to the body 1210 for one part of the procedure and can be readily separated using a breaker tool 1271 for another part of the procedure.	129	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Referring to FIG. 12H, in certain embodiments, the cutting guide 1200 may include a detachable connector 1270 that couples an alignment feature 1260a, 1260b to the body 1210. The detachable connector 1270 may connect or couple the alignment feature 1260a to the body 1210 and/or the alignment feature 1260b to the body 1210. In one embodiment, the detachable connector 1270 may comprise a breakaway structure designed, engineered, and fabricated to securely connect an alignment feature 1260a, 1260b to the body 1210 for one part of a procedure and to readily separate or breakaway from the body 1210 when a breaker tool 1271 (See FIG. 14) is used to activate the breakaway function or feature.	128	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In the embodiment of FIG. 12A, one alignment feature 1260a is in the lower right-hand side of the metatarsus apposition portion 1244 and the other alignment feature 1260b is on the left-hand side of the cuneiform apposition portion 1242. The two alignment features 1260a and 1260b may be separate features, or certain features such as one or more attachment features may serve a dual purpose as both an attachment feature and as an alignment feature. For example, in the embodiment of FIG. 12A, alignment feature 1260b may use the same structure as the bone attachment features and may take the form of holes 1240 that extend from a bone apposition side 1230 to the outward-facing side 1232.	127	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Returning to Figures 12A through 12H, the body 1210 may further have features that facilitate desired translation and orientation of the first metatarsus in order to fuse or join the first cuneiform and the first metatarsus to complete the procedure. For example, in the illustrated embodiment, the cutting guide 1200 may include two alignment features 1260a and 1260b.	126	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In alternative embodiments, a guide feature may be designed to guide a different type cutter, such as a drill, mill, or side-cutting burr. In such embodiments, the guide feature may not be a slot, but may instead be a translatable or rotatable cutter retainer that guides translation and/or rotation of the cutter relative to the bone.	125	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In the embodiment of Figures 12A through 12F, the guide features may guide a reciprocating planar blade, such as that of a surgical bone saw, that forms planar cuts in the first cuneiform and the first metatarsus. Thus, the guide features may take the form of a first slot 1250 and a second slot 1252, which may be positioned toward the center of the body 1210. Thus, upon proper positioning of the cutting guide 1200, the first slot 1250 may be positioned over the first cuneiform to facilitate resection of the first cuneiform, while the second slot 1252 may be positioned over the first metatarsus to facilitate resection of the first metatarsus.	124	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The body 1210 may further have guide features that guide a cutter to resect the first cuneiform and the first metatarsus in the manner needed to make the desired correction. For example, the guide features may be used to guide a planar cutting blade, an arcuate cutting blade, a drill or mill, a burr, and/or the like.	123	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The bone apposition side 1230 may be custom contoured to match the shapes of the first cuneiform and/or the first metatarsus. As embodied in Figures 12A through 12F, the bone apposition side 1230 may have a cuneiform apposition portion 1242 shaped to lie against the surface of the first cuneiform, and a metatarsus apposition portion 1244 shaped to lie against the surface of the first metatarsus. As shown, the cuneiform apposition portion 1242 may be contoured to match the contour of the surface of the first cuneiform on which it is to rest, and the metatarsus apposition portion 1244 may similarly be contoured to match the contour of the surface of the first metatarsus on which it is to rest. Thus, the body 1210 may have only one stable position and orientation relative to the first cuneiform and the first metatarsus.	122	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In certain embodiments, the detachable connector 1270 may include one or more receivers 1276. The receiver 1276 is sized, configured, and positioned to accept an end of the breaker tool 1271 such that insertion of the end of the breaker tool 1271 breaks one or more bridges 1274 and thus separates the alignment feature 1260 from the body 1210. The receiver 1276 may have any cross-section shape including circular, elliptical, square, rectangular, or the like.	130	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	As shown, the cutting guide 1200 may have a body 1210 with a monolithic construction and the general shape of a rectangular prism. The body 1210 may reside on the dorsal surfaces of the first cuneiform and the first metatarsus to provide proper alignment of the body 1210 with the metatarsocuneiform joint.	120	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	The cutting guide 1200 may be designed to facilitate resection of a first cuneiform and a first metatarsus with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsus, thereby providing correction in a lateral direction and in a plantar direction or a dorsal direction.	119	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Figures 12A, 12B, 12C, 12D, 12E, 12F, 12G, and 12H are top perspective, top, bottom, front elevation, rear elevation, right, left, and alternative top perspective, respectively, of a patient-specific cutting guide, or cutting guide 1200, according to one alternative embodiment.	118	Added by DJM 7 2021	7/2/21, 12:00 AM

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