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	wherein the shoulder pinches the body as the shaft advances distally within the socket to secure the guide member at one of the plurality of relative orientations about the engagement axis.	199	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	a shaft connected to the handle, the shaft configured to engage a socket; and	198	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The engagement member 818 may be configured to rotationally couple to an inserter 806. In the illustrative example of FIG. 41, the engagement member 818 includes a pin 836 extending distally from the distal end 822 of the guide body 814 and aligned with the engagement axis 412. In one embodiment, the pin 836 extends distally from an inferior surface 838 of body 814 or the engagement member 818. In one embodiment, the pin 836 is configured to engage a cavity or socket of an inserter 806 connected to the bone fastener 804. In one embodiment, the pin 836 may engage a stepped cavity or a stepped socket of an inserter 806. As described above, the stepped cavity or stepped socket may include a smooth portion and a threaded portion.	131	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 40-47, a guide 802 is engageable with the inserter 806 to guide placement of an elongate member (e.g., fixation member 812) into, or through, the aperture 118 of the fastener 804. The guide 802 is coupled to the inserter 806 by inserting the pin 836 into the socket 880 until the inferior surface 838 abuts the superior surface 882 of the inserter handle portion 860 as shown in FIG. 47. Thus assembled, the cross fixation insertion axis 420 is aligned with the center of the fastener aperture 118. Insertion of a fixation member allow fixation axis 420 will enter the aperture 118. In addition, in an exemplary embodiment, the inserter 806 is positioned between the engagement member 818 and the fastener 804.	144	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The inserter 806 is joined to the fastener 804 by sliding the locking bolts 868 proximally until the knobs 870 abut the proximal margin 872 of the window 866 as shown in FIG. 45. The threaded portion 322 may then be inserted into the cavity 160 of the fastener 804. Each knob 870 is then rotated to thread the locking bolt 868 into the cavity 160 and secure the fastener 804 to the inserter 806 as shown in FIG. 46.	143	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrated embodiment, the inserter 806 includes four stop members 892a,b,c,d positioned about the peripheral edge 884. Alternatively, or in addition, the inserter 806 may include a single stop member 892a, a pair of stop members 892a,b on one long side, a pair of stop members 892a,c on one short side. In the illustrated embodiment, the stop member 892 may include a projection 894 and a recess 896. As used herein, a “recess” refers to hollow, void, opening, or depression formed in a surface. In certain embodiments, the recess does not pass through the structure having the surface. A recess can have a variety of cross-section shapes (e.g., ovoid, oval, round, circular, rectangular, square, or the like) and have a variety of configurations for one or more walls that define the recess. In one example, a recess can have one or more walls that connect in rounded corners. In certain embodiments, a recess is sized and shaped to receive or accept another structure.	142	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The coupling member may also include one or more rotational stop members 892 arranged about a longitudinal axis of the body 854. The one or more stop members 892 may cooperate with a stop of the engagement member 818 (e.g., side surface 840) to define a set of relative orientations for the guide 802 relative to the fastener 804 and/or inserter 806.	141	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The proximal end 858 of the inserter 806 includes a coupling member configured to rotationally couple to a guide 802 described herein. In the illustrative example of FIGS. 43-46, the coupling member includes a socket 880 extending distally into a superior surface 882 of the coupling member and a peripheral edge 884. In certain embodiments, the socket 880 may include internal threads 886. Alternatively, or in addition, the socket 880 may be a stepped cylindrical socket or cavity with a larger diameter proximal portion 888 and a smaller diameter, distal portion 890 that includes the internal threads 886. In one embodiment, the threads 834 of the lock mechanism 824 are configured to engage the internal threads 886 of the socket 880 and the socket 880 has a depth that permits distal advancement of the shaft 828 until the shoulder 830 presses against the superior surface 832 of the engagement member 818.	140	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Side cuts or windows 866 communicate with the passages. Each passage receives a locking bolt 868 in axial sliding and rotating relationship. Each bolt 868 traverses one of the windows 866 exposing the portion of the bolt 868 within the window for manipulation. A knob 870 may be connected to each bolt 868, such as by pinning, to allow a user to rotate the bolt 868 about the passage axis 862 and to serve as a limit to axial travel of the bolt 868 as the knob abuts the proximal or distal margins 872, 874 of the window 866. Each bolt 868 includes a smooth cylindrical portion 876 sized to fit into a trailing portion of a stepped cylindrical cavity in one of the fastener legs. Each bolt 868 may include a threaded portion 878, distal to the smooth portion 876, sized to screw into a threaded leading portion of a stepped cavity in one of the fastener legs.	139	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 43-46, in one embodiment, an inserter 806 is configured for use with the fastener 804 of FIG. 39, or other FIGS. of this disclosure. The inserter 806 includes a body 854 having a distal end 856 and a proximal end 858 including a handle portion 860. The body 854 includes a pair of laterally spaced passages extending from the distal end 856 toward the proximal end 858 and each defining a passage axis 862. The passage axes 862 are angled 864 to align with cavities in the fastener 804.	138	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In one embodiment, one or more of the sleeves 808a,b,c may include a handle or knob on a proximal end 844a,b,c. Alternatively, or in addition, the sleeves 808a,b,c may include a tapered and/or pointed end near, or at, the distal end 846a,b,c. The axial through passage, passage 842, may be sized to guide a guide wire or pin 852 (e.g., a “K-wire”) along the cross fixation insertion axis 420. Each of the one or more sleeve 808a,b,c may be translated along the axis 420 relative to the body 814 to position the distal end 846a,b,c at a desired spacing from a bone.	137	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In certain embodiments, each of the sleeves 808a,b,c may include a passage that extends from a proximal end 844a,b,c to a distal end 846a,b,c. The passages within the sleeves 808a,b,c may be sized and configured to accept one or more implants, fasteners, tools, and/or instruments for use in deploying a fixation member. Examples of these implants, fasteners, tools, and/or instruments include but are not limited to a driver 810 coupled to a fixation member 812, a fixation member 812, a drill bit 848, depth gauge 850, a pin 852 which is one example of a temporary fastener 852 (e.g., a K-wire), or the like. FIG. 42 includes examples of implants, fasteners, tools, and/or instruments that may be used with the guide 802. Each of these example implants, fasteners, tools, and/or instruments may be canulated, in certain embodiments.	136	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The guide member 816 may include a passage 842 through the guide member 816 that aligns with the cross fixation insertion axis 420. The guide member 816 may also include one or more of a first sleeve 808a, a second sleeve 808b, and a third sleeve 808c. The first sleeve 808a may be coaxial with the cross fixation insertion axis 420 and have a cross sectional diameter less than a cross sectional diameter of the passage 842. The second sleeve 808b may be coaxial with the cross fixation insertion axis 420 and have a cross sectional diameter less than a cross sectional diameter of the first sleeve 808a. The third sleeve 808c may be coaxial with the cross fixation insertion axis 420 and have a cross sectional diameter less than a cross sectional diameter of the second sleeve 808b. In certain embodiments, the sleeves 808a,b,c may include external threads configured to engage with internal threads of a sleeve and/or the passage 842 that has a larger cross sectional diameter. In one embodiment, the first sleeve 808a fits axially within the passage 842 and either the second sleeve 808b or the third sleeve 808c fit axially within the first sleeve 808a. Alternatively, or in addition, the first sleeve 808a fits axially within the passage 842, the second sleeve 808b fits axially within the first sleeve 808a, and the third sleeve 808c fit axially within the second sleeve 808b.	135	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In one embodiment, the guide member 816 defines a fixation axis 420 transverse to the engagement axis 412 and along which a fixation member may be guided to pass into or through a fastener aperture. The fixation axis 420 may also be referred to as a cross fixation insertion axis 420. The guide member 816 may be coupled to, connected to, and/or integrated with the guide 802 near the proximal end 820 of the guide 802.	134	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The side surface 840 is one example of a stop that is configured to limit the plurality of relative orientations about the engagement axis to a range of angles such that deployment of the fixation member 812 will enter an aperture of the bone fastener 804. Those of skill in the art will recognize that a stop may be implemented in a variety of ways connection with, separate from, or in addition to the side surface 840 illustrated in FIG. 41. For example, the engagement member 818 may include a single stop having two ends or the engagement member 818 may include two or more stops.	133	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The engagement member 818 may include an axial stop and a rotational stop to aid in positioning the guide 814 relative to the bone fastener 804 (and/or inserter 806). In the illustrative example of FIG. 41, the inferior surface 838 of the engagement member 818 serves as the axial stop and, in one embodiment, a side surface 840 transverse to the inferior surface 838 and formed on the guide body 814 may serve as a rotational stop.	132	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As used herein, a "body" refers to a main or central part of a structure. The body may serve as a structural component to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A body may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. A body may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. A body may include a modifier that identifies a particular function, location, orientation, operation, and/or a particular structure relating to the body. Examples of such modifiers applied to a body, include, but are not limited to, "inferior body," "superior body," "lateral body," "medial body," and the like. In one embodiment, the body 814 has an arc or acuate shape and may resemble an “arm” that extends between the proximal end 820 and the distal end 822.	116	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In certain embodiments, the pinching of the body between the shoulder 830 and the bone fastener 804 (and/or inserter 806) abuts one or more surfaces of the body 814 (e.g., superior surface 832) against one or more surfaces of the lock mechanism 824 to create a press fit (also referred to as a friction fit or press fit) between the surfaces. In certain embodiments, this press fit is sufficient to retain the guide member 816 at one of the plurality of relative orientations about the engagement axis 412.	130	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In embodiments in which the socket is in the inserter 806, the shaft 828 may pass through the opening in the body 814 and engage the socket which positions at least a portion of the body between the threads 834 and the shoulder 830. In one embodiment, to operate the lock mechanism 824 a user rotates the handle 826 such that the threads 834 advance distally into the socket. As the shaft 828 advances distally within the socket, the shoulder 830 of the handle 826 pinches the body 814 towards the bone fastener 804 (and/or inserter 806).	129	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As used herein, a “thread” or "screw thread" refers to a helical structure used to convert between rotational and linear movement or force and/or to connect or engage two structures. A screw thread can be a ridge that wraps around a cylinder in the form of a helix, referred to as a straight thread. A screw thread can also be a ridge that wraps around a cone shape, referred to as a tapered thread. A screw thread is a feature of a screw as a simple machine and also in use as a threaded fastener. A screw thread can provide one or both of the following functions: conversion of rotary motion or force into linear motion or force, and preventing or mitigating linear motion or force without corresponding rotation motion or force. In certain implementations of screw threads that convert a rotation force or torque into linear motion, or vice versa, the screw threads may be referred to as drive threads because of the drive function rotating the threads serves to extend or retract a structure linearly. External screw threads are those formed on an external surface of a structure, such as a cylinder or cone shaped structure. Internal screw threads are those formed on an internal wall or surface of a nut, substrate, or opening. The cross-sectional shape of a thread is often called its form or threadform (also spelled thread form). The thread form may be square, triangular, trapezoidal, or other shapes. The terms form and threadform can refer to other design aspects taken together (cross-sectional shape, pitch, and diameters) in addition to cross-sectional shape, but commonly refer to the standardized geometry used by the screw. Major categories of threads include machine threads, material threads, and power threads. Generally, triangular threadforms are based on an isosceles triangle. These threadforms are usually called V-threads or vee-threads because of the shape of the letter V. For 60° V-threads, the isosceles triangle is, more specifically, equilateral. For buttress threads, the triangle is scalene. The theoretical triangle shape for the thread form can be truncated to varying degrees (that is, the tip of the triangle is cut short). A V-thread in which there is no truncation (or a minuscule amount considered negligible) is called a sharp V-thread. Truncation occurs (and is codified in standards) for practical reasons. The mechanical advantage of a screw thread depends on its lead, which is the linear distance the screw travels in one revolution. In general, the lead of a screw thread may be selected so that friction is sufficient to prevent linear motion or force from being converted to rotary, that is so the screw does not slip or disengage even when linear force is applied, as long as no external rotational force is present. A “length of thread engagement” refers to a distance that one set of threads (external or internal) engages another set of one or more threads (external or internal). The tightening of a fastener's screw thread is comparable to driving a wedge into a gap until the wedge sticks fast through friction and slight elastic deformation. (Search 'screw thread' on Wikipedia.com July 16, 2021. Modified. Accessed Aug. 17, 2021.)	128	Added by DJM 12 2021	12/2/21, 12:00 AM

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