Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-12	Alternatively, or in addition, a user may use the modification module 1608 to modify a predefined osteotomy procedure. The user may add, remove, or modify steps and the instrumentation used in the osteotomy procedure to create a patient specific osteotomy procedure. In this manner, a user may configure features of a preliminary cutting guide model 1238 or modified preliminary cutting guide model and/or osteotomy procedure specific to a patient specific osteotomy procedure the surgeon is planning for the patient. As used herein, "patient specific osteotomy procedure" refers to an osteotomy procedure that has been adjusted, tailored, modified, or configured to specifically address the needs or desires or a particular patient. In certain aspects, one patient specific osteotomy procedure may be useable in connection with only one patient. In other aspects, one patient specific osteotomy procedure may be useable with a number of patients having a particular class of characteristics.	255	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The user may review the preliminary cutting guide model 1238 and may adjustments or revisions or make no adjustments or revisions. The output of the modification module 1608 and/or the application module 1606 is a patient specific cutting guide model 1602.	256	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 17 illustrates an exemplary system 1700 configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment. The system 1700 may include similar components or modules to those described in relation to Figure 12. In addition, the system 1700 may include a fixator selector 1702 and/or an export module 1704.	257	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The fixator selector 1702 enables a user to determine which fixator(s) to use for an osteotomy procedure planned for a patient. In one embodiment, the fixator selector 1702 may recommend one or more fixators based on the bone model 1204, the deformity 1226 or input from a user or a history of prior osteotomy procedures performed to correct a particular deformity 1226. In one embodiment, the fixator selector 1702 selects a bone plate for fixation of two bones of the patient during an osteotomy procedure. The fixator selector 1702 may select a fixator model from a set of predefined fixator models or select a physical fixator from a set of fixators. The fixators may include a plate and associated accessories such as screws, anchors, and the like.	258	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As used herein, a "fixator" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or engineered to connect two bones or bone fragments or a single bone or bone fragment and another fixator to position and retain the bone or bone fragments in a desired position and/or orientation. Examples of fixators include both those for external fixation as well as those for internal fixation and include, but are not limited to pins, wires, Kirschner wires, screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like.	259	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In one embodiment, the fixator selector 1702 includes an artificial intelligence or machine learning module. The artificial intelligence or machine learning module is configured to implement one or more of a variety of artificial intelligence modules that may be trained for selecting fixator(s) based on anatomic data 1212 and/or other input parameters. In one embodiment, the artificial intelligence or machine learning module may be trained using a large data set of anatomic data 1212 for suitable fixator(s) identified and labeled in the dataset by professionals for use to treat a particular deformity 1226. The artificial intelligence or machine learning module may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module is able to select or recommend suitable fixator(s).	260	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The export module 1704 is configured to enable exporting of a patient specific cutting guide model 1602 for a variety of purposes including, but not limited to, fabrication/manufacture of a patient specific cutting guide 1206 and/or fixator(s), generation of a preoperative plan, generation of a physical bone model matching the bone model 1204, and the like. In one embodiment, the export module 1704 is configured to export the bone model 1204, anatomic data 1212, a patient specific cutting guide model 1602, a preoperative plan 1706, a fixator model 1708, or the like. In this manner the custom instrumentation and/or procedural steps for an osteotomy procedure can be used in other tools. The preoperative plan 1706 may include a set of step by step instructions and/or recommendations for a surgeon or other staff in performing an osteotomy procedure such as patient specific osteotomy procedure. The preoperative plan 1706 may include images and text instructions and may include identification of instrumentation to be used for different steps of the osteotomy procedure. The instrumentation may include the patient specific cutting guide 1206 and/or one or more fixators. In one embodiment, the export module 1704 may provide a fixator model which can be used to fabricate a fixator for the osteotomy procedure.	261	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The exports (1204, 1212, 1602, 1706, and 1708) may be inputs for a variety of 3rd party tools 1710 including a manufacturing tool, a simulation tool, a virtual reality tool, an augmented reality tool, an operative procedure simulation tool, a robotic assistance tool, and the like. A surgeon can then use these tools when performing an osteotomy procedure or for rehearsals and preparation for the osteotomy procedure. For example, a physical model of the bones, patient specific cutting guide 1206, and/or fixators can be fabricated, and these can be used for a rehearsal operative procedure. Alternatively, a surgeon can use the bone model 1204, preliminary cutting guide model 1238, and/or a fixator model to perform a simulated osteotomy procedure using an operative procedure simulation tool.	262	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Figure 18 is a rear, perspective view of a foot 1800, after performance of an Evans calcaneal osteotomy and a medializing calcaneal osteotomy with patient-specific instruments and/or implants, according to one embodiment. The foot 1800 may have a calcaneus 1806 and a talus 1810, in addition to the metacarpals 1820 and cuneiforms 1830. Pursuant to the Evans calcaneal osteotomy, an anterior portion of the calcaneus 1806 may be cut along the medial-lateral direction to separate a first bone segment 1840 of the calcaneus 1806 from a second bone segment 1842 of the calcaneus 1806. The second bone segment 1842 may be reoriented medially, relative to the first bone segment 1840, such that a heel 1850 of the calcaneus 1806 is moved medially, simulating a natural, healthy arch in the foot 200.	263	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The cut between the first bone segment 1840 and the second bone segment 1842 may be carried out virtually (for example, in CAD) on a model of the calcaneus 1806 obtained from a CT scan or other imaging of the patient’s foot. Thus, the optimal realignment of the posterior end of the calcaneus 1806 can be obtained. If desired, a patient-specific cutting guide, or cutting guide 1843, may be generated in order to facilitate resection of the calcaneus 1806.	264	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As shown, the cutting guide 1843 may have a first end 1844 and a second end 1845, each of which has a bone attachment feature 1846. The bone attachment features 1846 may be used to secure the first end 1844 and the second end 1845 to the first bone segment 1840 and the second bone segment 1842, respectively. The first end 1844 may have a first bone engagement surface 1847 that is shaped to match a corresponding contour on the first bone segment 1840, and the second end 1845 may have a second bone engagement surface 1848 that is shaped to match a corresponding contour on the second bone segment 1842. Thus, the cutting guide 1843 may naturally lie flush with the surface of the calcaneus 1806, in the optimal position on the calcaneus 1806 to facilitate resection of the calcaneus 1806 to divide the first bone segment 1840 from the second bone segment 1842. The cutting guide 1843 may have a resection feature 1849, such as a slot, that can be used to guide a cutter to form a single cut between the first bone segment 1840 and the second bone segment 1842.	265	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	After the cut has been made to split the calcaneus 1806 into the first bone segment 1840 and the second bone segment 1842, the surgeon may angle the second bone segment 1842 relative to the first bone segment 1840 in the predetermined (previously modeled) relative orientation. This reorientation between the first bone segment 1840 and the second bone segment 1842 may leave a wedge-shaped gap between the first bone segment 1840 and the second bone segment 1842. In order to maintain the desired relative orientation, an implant 1860 with a wedge shape may be inserted into the gap and secured to the first bone segment 1840 and the second bone segment 1842. The implant 1860 may be fabricated specifically for the patient, since the precise angulation and position of the realignment may also be patient specific. As shown, the implant 1860 may have exterior surfaces that are contoured to match the contours of the adjoining portions of the first bone segment 1840 and the second bone segment 1842. Thus, the implant 1860 may provide secure fixation, while not protruding beyond the adjoining surfaces of the first bone segment 1840 and the second bone segment 1842. Thus, the implant 1860 may be devoid of proud edges or other protrusions that could otherwise interfere with motion between the calcaneus 1806 and the talus 1810, or with surrounding soft tissues, thus interfering with the patient’s post-operative gait. "Soft tissue" refers to tissue of a patient (i.e., human or animal). Examples of soft tissue include but are not limited to skin, ligament, tendon, fascia, fat muscle, fibrous tissue, blood vessels, lymph vessels, brain tissue, and/or nerves.	266	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	The implant 1860 may be made of any biocompatible material, including but not limited to Titanium and alloys thereof, stainless steel, PEEK, and/or the like. The implant 1860 may be formed by any method known in the art, including but not limited to forging, casting, milling, additive manufacturing, and/or the like. In some embodiments, the implant 1860 may have an interior void that can be filled with bone graft or other material designed to promote boney in-growth between the cut surfaces of the first bone segment 1840 and the second bone segment 1842. In alternative embodiments, the implant 1860 may have a mesh and/or lattice structure that facilitates such boney in-growth, which structure may be formed via additive manufacturing.	267	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As mentioned previously, a medializing calcaneal osteotomy may optionally be performed in addition to or in place of the Evans calcaneal osteotomy. As shown, the heel 1850 may be cut from the remainder of the second bone segment 1842 and may be displaced medially. This displacement may also help to restore normal gait and tendon function in the foot 200, particularly when coupled with the Evans calcaneal osteotomy. The proper displacement of the heel 1850 relative to the remainder of the second bone segment 1842 may be determined based on analysis of the CAD models from scans of the foot 200. If desired, the model of the calcaneus 1806 may be divided and manipulated in CAD to simulate the repositioning of the heel 1850 pursuant to the medializing calcaneal osteotomy. Thus, the alignment of the heel 1850 relative to the remainder of the foot 200 can easily be assessed and optimized prior to surgery.	268	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Such preoperative alignment and planning may be particularly useful where multiple procedures, such as the Evans calcaneal osteotomy and the medializing calcaneal osteotomy, are combined for a single patient. Without such planning, it may be difficult to properly assess the effect of the combined procedures on the patient’s anatomy. For example, the effect of the Evans calcaneal osteotomy, and that of the medializing calcaneal osteotomy, is to shift the heel 1850 medially. The combined shift may be difficult to assess in the operating room but may be much more easily and accurately gauged via manipulation of the modeled anatomy.	269	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In some embodiments, one or more additional procedures may be carried out, in addition to or in the alternative to those of Figure 9. For example, in addition to or in the alternative to the Evans calcaneal osteotomy and the medializing calcaneal osteotomy, a cotton osteotomy (medial cuneiform opening wedge osteotomy) and/or a first metatarsal midfoot osteotomy may be performed. Patient-specific cutting guides may be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of bone engagement surfaces that are shaped to rest on the particular bony surfaces adjacent to the osteotomy.	270	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	As in the case of the Evans calcaneal osteotomy, a custom cutting guide, or cutting guide 1853, may be generated to help the surgeon obtain the correction that was previously modeled and/or planned using the computer models of the patient’s foot. The cutting guide 1853 may have a structure and function similar to that of the cutting guide 1843 used for the Evans calcaneal osteotomy. Such a cutting guide may have contoured surfaces that match the contours of the adjoining boney surfaces of the remainder of the second bone segment 1842 and/or the heel 1850.	271	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	More specifically, the cutting guide 1853 may have a first end 1854 and a second end 1855, each of which has a bone attachment feature 1856. The bone attachment features 1856 may be used to secure the first end 1854 and the second end 1855 to the second bone segment 1842 and the heel 1850, respectively. The first end 1854 may have a first bone engagement surface 1857 that is shaped to match a corresponding contour on the second bone segment 1842, and the second end 1855 may have a second bone engagement surface 1858 that is shaped to match a corresponding contour on the heel 1850. Thus, the cutting guide 1853 may naturally lie flush with the surface of the calcaneus 1806, in the optimal position on the calcaneus 1806 to facilitate resection of the calcaneus 1806 to divide the second bone segment 1842 from the heel 1850. The cutting guide 1853 may have a resection feature 1859, such as a slot, that can be used to guide a cutter to form a single cut between the second bone segment 1842 and the heel 1850.	272	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	In order to maintain the heel 1850 in the proper position relative to the remainder of the second bone segment 1842, a bone plate 1870 may be secured to the heel 1850 and to the remainder of the second bone segment 1842. The bone plate 1870 may include a first end 1880 secured to the remainder of the second bone segment 1842, a second end 1882 secured to the heel 1850, and an intermediate portion 1884 that extends from the first end 1880 to the second end 1882, and provides the desired medial shift between the first end 1880 and the second end 1882. The first end 1880 and the second end 1882 may be secured to the remainder of the second bone segment 1842 and to the heel 1850, respectively, through the use of screws 1890.	273	Added by DJM Jan 2024	1/6/24, 10:03 PM
View Edit Delete	PER-12	Like the implant 1860, the bone plate 1870 may be made of any known biocompatible material, through the use of any manufacturing process known in the art. In some embodiments, the bone plate 1870 may also be fabricated specifically for the foot, enabling the bone plate 1870 to precisely maintain the desired level of correction. When made specifically for the foot in combination with each other, the implant 1860 and the bone plate 1870 may provide a highly predictable, precise, and customizable level of correction of the flat foot deformity.	274	Added by DJM Jan 2024	1/6/24, 10:03 PM

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