Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-8 PROV	The present disclosure is not limited to cutting guides or extremity procedures. In some embodiments, patient-specific instrumentation may be used to correct a wide variety of bone conditions. Such conditions include, but are not limited to, any angular deformities from within one bone segment in either the lower or upper extremities (for example, tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). The present disclosure may also be used to treat an interface between two bone segments (for example, the ankle joint, metatarsal cuneiform joint, lisfranc's joint, complex charcot deformity, wrist joint, knee joint, etc.). As one example, an angular deformity or segmental malalignment in the forefoot may be treated, such as is found at the metatarsal cuneiform level, the midfoot level such as the navicular cuneiform junction, hindfoot at the calcaneal cubiod or subtalar joint or at the ankle between the tibia and talar junction. Additionally, patient-specific instruments could be used in the proximal leg between two bone segments or in the upper extremity such as found at the wrist or metacarpal levels.	117	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, a parallel distractor 1500 such as the exemplary parallel distractor 1500 illustrated in FIG. 15 is used to distract the first metatarsus 230 relative to the first cuneiform 210. The user slides holes 1502a,b over pins 1280a,b and holes 1502c,d over pins 1280e,f. This causes a desired rotation and translation of the first metatarsus 230 relative to the first cuneiform 210. When a user places the parallel distractor 1500 on over these pins 1280a,b,e,f this forces the cut faces of the two bones to become parallel. Advantageously, the cut faces of the two bones can be forced to become parallel because the position, orientation, and angles of the holes 1278 and/or holes of either or both of the alignment feature 1260a and alignment feature 1260b can be predefined and customized for each patient when the cutting guide 1300 is fabricated. This alignment enables parallel compression of the two bones together using the parallel distractor 1500. Parallel compression enables more effective compression of the two bones together. Next, the space between the resected surfaces of the first cuneiform 210 and the first metatarsus 230 is prepared for fusion. Then, the parallel distractor 1500 is activated such that the first cuneiform 210 and the first metatarsus 230 are fused together.	141	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, with the alignment feature 1260a separated from the body 1210, and pins 1280c,d removed, a user can remove the two parts of the cutting guide 1400 separately. Pins 1280a,b remain in the first cuneiform 210 and pins 1280e,f remain in the first metatarsus 230.	140	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Next, a breaker tool 1271 can be used to separate the alignment feature 1260a from the body 1210. In one embodiment, a breaker tool 1271 can be a “T” shaped tool with a crosswise proximal handle, a shaft and a distal end. A user may operate the breaker tool 1271 by placing the distal end in a receiver 1276 of one or more detachable connectors 1270. Pressing and/or twisting the distal end into the receiver 1276 breaks one or more bridges 1274 and thus separates the alignment feature 1260a. A user may insert the distal end into one or more receivers 1276 to separate the alignment feature 1260a from the body 1210.	139	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Furthermore, fabricating a cutting guide that is customized to a particular patient and a specific desired correction/adjustment enables correction of a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used. The alignment features 1260 disclosed in this solution and the corresponding pins formed within a cutting guide that may also include a detachable connector 1270 enable correction procedures for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used. For example, embodiments of the procedures and devices herein disclosed can be used to address cavus, and mid foot dislocations, fracture malunion, metatarsus adductus, etc. They can also be used in preparation for joint resurfacing procedures of the foot and ankle to optimize placement of an arthroplasty implant.	138	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	Advantageously, with pins 1280a,b in place and pins 1280e,f in place the cutting guide 1400 has been fabricated and custom engineered such that bringing pins 1280a,b and pins 1280e,f in parallel alignment with each other will align the resected surfaces of the first cuneiform 210 and first metatarsus 230 to accomplish a desired translation, rotation, and/or orientation of the first metatarsus 230 relative to the first cuneiform 210 for the procedure. In other words, the alignment features 1260a,b are placed and configured in the cutting guide 1400 such that bringing pins 1280a,b and pins 1280e,f in parallel alignment provides a desired frontal plane correction required to bring sesamoids into proper alignment, based on an evaluation of a pre-operative CAD model. Because the cutting guide 1400 is custom fabricated for a particular patient, the alignment features 1260a,b are positioned such that aligning these alignment features 1260a after the resection will provide a desired frontal plane rotation that is unique to each patient and built into, designed into, the cutting guide 1400. The detachable connector 1270 connecting the alignment feature 1260a to the body 1210 is what enables a single cutting guide 1200 to become two during a procedure and provide a custom translation and rotation of a first metatarsus 230 that can be unique for each patient.	137	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	In one embodiment, a surgeon may next remove the pins 1280c,d. Alternatively, a surgeon may remove the pins 1280c,d after breaking the alignment feature 1260a away from the body 1210, as described below.	136	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	At this stage in a surgical procedure, the cutting guide 1400 is placed on the first cuneiform 210 and the first metatarsus 230 and pins 1280a-d are connected to the bones through the respective holes 1240. Next, a surgeon uses the guide features of the cutting guide 1400 to reset the first cuneiform 210 and the first metatarsus 230. Then, a surgeon may insert pins 1280e,f into holes 1278 of the alignment feature 1260a. Alternatively, in another embodiment, a surgeon may insert pins 1280e,f into holes 1278 of the alignment feature 1260a before resecting the first cuneiform 210 and/or first metatarsus 230.	135	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 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.	44	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	52	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	51	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	50	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	49	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	48	Added by DJM 7 2021	7/2/21, 12:00 AM
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 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.	47	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) 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.	46	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	45	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	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.	53	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	FIG. 16 illustrates an exemplary embodiment of a parallel distractor that can be used with certain embodiments.	41	Added by DJM 7 2021	7/2/21, 12:00 AM
View Edit Delete	PER-8 PROV	FIG. 15 illustrates an exemplary embodiment of a parallel distractor that can be used with certain embodiments.	40	Added by DJM 7 2021	7/2/21, 12:00 AM

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