Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	IPP-0050-US35 nextremity	FIG. 54 is a perspective view of an inserter and one embodiment of an engagement member according to one embodiment;	61	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 43 is a front elevation view of an example of an inserter for the bone implant of FIG. 1;	50	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 42 includes examples of implants, fasteners, tools, and/or instruments that may be used with the guide;	49	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 41 is an exploded view of a guide according to one embodiment of the present disclosure;	48	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 40 is a side view of a guide according to one embodiment of the present disclosure;	47	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 39 is a perspective view of one embodiment of a guide;	46	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIGS. 38 illustrates an example surgical applications for the implant of FIG. 1;	45	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIGS. 26-37 illustrate an example of a surgical method utilizing the implant of FIG. 1;	44	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 25 is a detail view of the bone implant of FIG. 25;	43	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 24 is a front elevation view of the bone implant of FIG. 23;	42	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As used herein, a "fixation" refers to an apparatus, instrument, structure, device, component, member, system, assembly, step, process, or module structured, organized, configured, designed, arranged, or engineered to connect two structures either permanently or temporarily. The two structures may one or the other or both of manmade and/or biological tissues, hard tissues such as bones, teeth or the like, soft tissues such as ligament, cartilage, tendon, or the like. In certain embodiments, fixation is used as an adjective to describe a device or component or step in securing two structures such that the structures remain connected to each other in a desired position and/or orientation. Fixation devices can also serve to maintain a desired level of tension, compression, or redistribute load and stresses experienced by the two structures and can serve to reduce relative motion of one part relative to others. Examples of fixation devices are many and include both those for external fixation as well as those for internal fixation and include, but are not limited to pins, wires, Kirschner wires (K-wires), screws, anchors, bone anchors, plates, bone plates, intramedullary nails or rods or pins, implants, interbody cages, fusion cages, and the like.	77	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The fastener 100 may be provided as a plurality of fasteners that have different sizes to accommodate different anatomy. In one example, the fastener is provided as a plurality of fasteners of varying leg length 127 with the leg width 121, depth 123, outboard wall 148, 150 spacing, and divergence angle being the same for each fastener. In this way differing bone thicknesses may be accommodated while using the same instruments described below.	86	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The aperture 118, if present, is sized to receive an appropriate cross fixation fastener. In one embodiment, its length 120 is as long as possible, and corresponds to an angular variation, that gives maximum flexibility for cross fixation placement without colliding with the legs.	85	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The leg length 127 may be close to the bone thickness along the insertion axis 102. The legs may be the same length or different lengths and they may be staggered at one or both ends. In the illustrative example of FIGS. 1-9, the leg lengths are different and the legs are level at the proximal end but staggered at the distal end. For use in foot surgery, the leg lengths may be in the range of 10-50 mm and, in one embodiment, in the range of 14-32 mm. For use at other locations, the leg length may be outside of these ranges and can be, for example, quite long in large implants for applications such as tibial osteotomies.	84	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As stated above, the body leading and trailing end recess distances 170, 172 may be equal to or greater than the local bone cortex thickness. The distances 170, 172 may be in the range of 1-8 mm and may vary for different size implants and different applications.	83	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrative example of FIGS. 1-9, the leg width is constant and equal to the leg depth at the proximal end of the leg.	82	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The various sizes and proportions for the fastener will vary based on the application. For example, in one embodiment, depending on the application, leg depth ranges from 2 mm to 7 mm and the body thickness may range from 0.5-5 mm. Further for example, in many applications, such as for use in the mid and fore regions of the hands and feet, a fastener may advantageously have a leg depth of 2.5-4.5 mm and a body thickness of 0.5-1.5 mm. The ratio of leg depth to body thickness may range from 14:1 to 1.5:1. In one embodiment, the ratio ranges from 5:1 to 3:1.	81	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrative example of FIGS. 1-9, the fastener legs 124, 126 have a generally elliptical cross section. Near the trailing end the cross section is approximately circular. Near the distal end, the legs are non-circular having a major diameter 129 greater than a minor diameter 131 (FIG. 8). In the illustrative example of FIGS. 1-9, the leg shape can be describes as being a pair of cylinders that diverge toward the leading end with material removed on the outboard surfaces so that the outboard surfaces are rendered parallel. The resulting legs are circular at the trailing end as seen in FIG. 7 and transition into the shape of intersecting circles as the material is removed, becoming narrower, i.e. tapering, in the minor axis toward the leading end as seen in FIG. 8. The front 152 and back 154 of each leg are parallel as seen in FIG. 4. The trailing end of each leg includes barbs 156 as seen in FIG. 6. The barbs 156 are generally in the form of upwardly swept circular projections 158 on the front, back and inboard surfaces of the trailing portion of the leg such as would result if the barbs were circular projections surrounding divergent cylindrical legs and material was removed on the outboard surfaces so that the outboard surfaces were rendered parallel and consequently removing progressively more of the circular projections in the leading direction. Alternatively, the barbs may extend completely around the circumference of the leg. The trailing ends of the legs include a cavity 160 (FIG. 9) operable to couple with an inserter as described below. In one embodiment, the cavity is threaded to receive a threaded connector. In the illustrative example of FIGS. 1-9, the cavity 160 is a stepped cylindrical cavity with a larger diameter trailing portion 162 and a smaller diameter, threaded leading portion 164. The leading end of each leg includes a radius 161, 163 to ease insertion of the fastener 100 into holes formed in bone. The inboard surfaces 128, 130 of the legs have an inboard surface trailing end spacing 165 at the trailing end of the legs. The trailing end of the body 108 is recessed toward the leading end of the legs by a trailing end recess distance 170. The leading end of the body 106 is recessed toward the trailing end of the legs by a leading end recess distance 172. The recess distances 170, 172 may be equal to or greater than a bone cortex thickness at a location at which the fastener is to be used so that the body 104 is located inward of the cortical bone when the fastener is installed.	80	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrative example of FIGS. 1-9, each leg 124, 126 further includes an elongate outboard surface 148, 150 facing away from the insertion axis 102 and extending from the leading end to the trailing end. In the illustrative example of FIGS. 1-9, the elongate outboard surfaces 148, 150 are parallel to one another and the insertion axis 102.	79	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The fastener 100 includes first and second legs 124, 126 connected to the body. The legs have a width 121, a depth 123 (FIG. 7), and a length 127 (FIG. 1A). The first and second legs may be the same size or they may be different sizes to accommodate particular anatomy. For example, the legs may have the same width and depth but have different lengths so that they can accommodate bi-cortical fixation in bone portions of varying thickness. Each leg has an elongate inboard surface 128, 130 facing the insertion axis 102 and extending from a leading end 132, 134 to a trailing end 136, 138. The elongate inboard surface 128, 130 is spaced from the insertion axis 102 a leading distance 140, 142 near the leading end and the elongate inboard surface is spaced from the insertion axis 102 a trailing distance 144, 146 near the trailing end. The leading distance 140, 142 and trailing distance 144, 146 for each leg may be equal such that the inboard surface is parallel to the insertion axis 102. The leading distance 140, 142 and trailing distance 144, 146 for each leg may be unequal such that, for example, one or both of the leg inboard surfaces may converge or diverge distally from the insertion axis 102. In one embodiment, at least one of the leading distances 140, 142 is greater than the corresponding trailing distance 144, 146 and the other leading distance 140, 142 is equal to or greater than the corresponding trailing distance 144, 146 such that the inboard surfaces 128, 130 diverge relative to one another distally or in other words in the leading direction defined by the leading ends and at least one diverges from the insertion axis 102. In the illustrative example of FIGS. 1-9, each leg diverges from the insertion axis 102 in the leading direction. The inboard surfaces 128, 130 may each diverge from the insertion axis 102 by a divergence angle. The included angle between the inboard surfaces 128, 130 is the sum of the individual divergence angles. As described above, the legs may diverge symmetrically or asymmetrically. The individual divergence angles may be in the range of 1-5 degrees. In the illustrative example of FIGS. 1-9, the divergence angles are each 3 degrees yielding an included angle of 6 degrees. When the legs are positioned in bone, the projected area of each leg perpendicular to the insertion axis affects the resistance of the leg to pulling through the bone. The larger the projected area the greater the pull through strength. For a given leg length, the area is determined by the leg depth, or for a cylindrical leg by its diameter. The body is inserted into a slot formed in the bone between the legs. As the slot width increases relative to the leg projected area, the resistance of the leg to being pulled into the slot decreases. Thus, a thinner body and consequently thinner slot increases pull through strength. This can be expressed in terms of the difference between the leg depth and body thickness or in terms of a ratio of leg depth to body thickness.	78	Added by DJM 12 2021	12/2/21, 12:00 AM

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