Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	IPP-0050-US35 nextremity	Implementations may include one or more of the following features. The system may include the bone fastener, where the bone fastener may include: a first leg having a leading end and a trailing end; a second leg having a leading end and a trailing end; and a body connected to the first leg and to the second leg, the body defining the aperture. The engagement member may include a lock mechanism that may include: a handle having a shoulder; a shaft connected to the handle, the shaft configured to engage a socket; and where 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.	5	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The shaft may include threads near a distal end of the shaft and the socket may include a threaded socket configured to engage threads of the shaft, the guide may include: an inserter positioned between the engagement member and the bone fastener, the inserter may include the threaded socket; and where the shoulder pinches the body against the inserter. The body may include an arcuate body. The engagement member may include: a shaft having a proximal end and a distal end that engages the bone fastener; a collar connected to the body, the collar having an aperture through the collar, the aperture sized to receive the shaft; a protrusion coupled to the shaft towards the proximal end; and where the protrusion presses against at least a portion of the collar when the shaft engages the bone fastener.	6	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The engagement member may include: an inserter configured to couple to the bone fastener, the inserter having a proximal end having a coupling member may include a socket that extends distally into a superior surface of the coupling member; and where the shaft may include external threads near the distal end of the shaft configured to engage internal threads of the socket, the socket having a depth that accepts distal advancement of the shaft until the protrusion presses against the collar.	7	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIG. 27, a drill 608 is guided in the guide holes 208, 210 to form corresponding holes 610, 612 in the bone. In one embodiment, these holes pass through the bones so that the legs of the fastener 100 will engage the bone portions bi-cortically at the proximal and distal cortices 607, 609.	104	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In one embodiment, the engagement member 818 couples the guide 802 to the bone fastener 804. For example, in one embodiment the engagement member 818 engages the bone fastener 804 such that the guide member 816 is rotatable relative to the bone fastener 804 about an engagement axis 412 to a plurality of relative orientations. In another example, the engagement member 818 engages the bone fastener 804 such that the guide 802 is rotatable relative to the bone fastener 804 about an engagement axis 412 to a plurality of relative orientations.	120	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In one embodiment, a passage of the guide member 816 is sized to accept one or more sleeves 808. Each sleeve 808 may include an axial through passage having a cross-sectional diameter sized to permit the sleeve 808 to slide axially within the passage. In the illustrated embodiment, the sleeves 808a,b may each have different cross-sectional diameters that permit certain ones of the one or more sleeves 808a,b to fit within each other in a nested configuration such that a longitudinal axis of the sleeves 808a,b aligns with the fixation insertion axis 420.	119	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 includes a passage through the guide member 816 defining the cross fixation insertion axis 420 and one or more sleeves 808a,b received in the passage in axial sliding relationship. As used herein, "passage" refers to a duct, a vessel, an opening, a void, or other channel in a body of a an apparatus, instrument, structure, member, device, component, system, or assembly. In certain embodiments, a passage is narrow and longer than the passage is wide. (Search "passage" on wordhippo.com. WordHippo, 2021. Web. Accessed 15 Nov. 2021. Modified.)	118	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The guide member 816 may facilitate or enable preparation of a site for deployment of a fixation member 812. Alternatively, or in addition, the guide member 816 may serve to guide deployment of a fixation member 812 to secure a bone fastener 804. In one embodiment, the guide member 816 may be coupled to the body 814 near the proximal end 820. In the illustrated embodiment, the guide member 816 is coupled to the body 814 at the proximal end 820.	117	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	FIG. 40 is a side view of a guide 802 according to one embodiment of the present disclosure. In one embodiment, the guide 802 includes a body 814, a guide member 816, and an engagement member 818. The body 814 has a proximal end 820 and a distal end 822.	115	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 39 illustrates one or more of the tools, instruments, fixation members, and/or implants that may be used with the guide 802. For example, the system 800 may include one or more sleeves 808a,b, a driver 810, and/or an exemplary fixation member 812. In certain embodiments, the bone fastener 804 used in the system 800 may be substantially similar to the embodiments of the bone fastener 804 described herein. As used herein, a "driver" refers to a mechanical piece, component, or structure for imparting motion to another piece, component, or structure. ("driver." Merriam-Webster.com. Merriam-Webster, 2021. Web. 6 Jan. 2021. Modified.) In certain embodiments, a driver can be a wheel configured or connected to other parts such that rotation or motion of the driver causes motion of other interconnected or intercoupled parts of a component, system, apparatus, or device.	114	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 39 is a perspective view illustrating a system 800 for deploying a fixation member into a bone fastener, according to one embodiment of the present disclosure. In one embodiment, the system 800 includes a guide 802 and a fastener, such as a bone fastener 804. In certain embodiments, the system 800 may include a separate inserter 806. Alternatively, or in addition, the features, components, and/or functionality of an inserter may be included in the guide 802.	112	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIG. 38, a human foot illustrates various examples of applications for the present disclosure. A phalangeal fusion is indicated at 700. A metatarsophalangeal fusion is indicated at 702. A fusion of a midshaft fracture or osteotomy is indicated at 704. Metatarsocuneiform fusions are indicated at 706 and 708. In this example, joining elements 710, 712 have been attached between separate fasteners to form a construct in a lisfranc procedure. For example, the joining elements 710, 712 may be attached with screws threaded into the sockets in the proximal ends of the fastener legs. The joining elements 710, 712 may be rigid or flexible depending on the amount of constraint desired. Tarsal fusions are indicated at 714 and 716.	111	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The implants, instruments and methods of examples of the present disclosure may be used at many different locations within a patient to secure bone portions relative to one another and may further be used to form various constructs as shown in the illustrative example of FIG. 38. While illustrative, this example is not comprehensive and it will be apparent to one skilled in the art that these implants, instruments, and methods may be used anywhere two bone portions, or portions of a single bone, are to be secured. The size and proportion of the fastener may be varied to suit a particular anatomical location.	110	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 35-37, the cross guide 400 is mounted to the inserter 300 which is attached to the fastener 100. The cross guide 400 is pivoted relative to the inserter 300 to direct the cross fixation axis 420 in a desired direction. For example, it may be pivoted to align with a desired entry point on the bone 632. The rotation stops guarantee that the axis 420 is not angled so acutely as to prevent passage of a fixation member through the fastener aperture 118. The sleeve 422 is translated axially to position the sleeve close to the bone entry point 632 to stabilize a guide wire 634 as it is inserted through the sleeve, into the bone, and through the aperture 118. A fixation screw 636 is advanced over the guide wire 634 into the bone and through the aperture 118. The guide wire 634 is then removed. In one embodiment, the screw 636 is sized and positioned for bi-cortical fixation. In one embodiment, the screw passes through both bone portions to further stabilize the interface 604.	109	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 33 and 34, the inboard gaps 620, 622 diminish as the fastener is advanced until at some point in the fastener's travel, the fastener leg inboard surfaces 128, 130 contact the inboard bone hole walls. Since the inboard surfaces 128, 130 diverge at the same angle as the bone holes 610, 612, the fastener leg inboard surfaces 128, 130 contact the bone all along the length of the portions of the legs that have been inserted. Further advancing the fastener will compress the bone between the fastener legs uniformly along the fastener legs proximally to distally. In other words, as the fastener is further advanced, the bone is compressed between the fastener legs normal to the insertion direction the same amount at every point along the fastener legs proximally to distally. For bones having a longitudinal axis 628 normal to the insertion direction 630, the bone portions will be compressed axially relative to the longitudinal axis 628. The amount of compression can be tailored by setting the spacing of the inboard surfaces of the bone holes 610, 612 relative to the fastener leg inboard surfaces 128, 130. With the inboard bone hole surfaces further apart, the inboard fastener surfaces will contact the bone holes earlier in the fastener's travel and further advancing the fastener to a final resting position will cause relatively more compression. Alternatively, with the inboard bone hole surfaces closer together, the inboard leg surfaces will contact the bone holes later in the fastener's travel and further advancing the fastener to the same final resting position will cause relatively less compression. In one aspect, the fastener 100 is seated with the trailing ends of the fastener legs flush with or below the bone surface to reduce irritation of surrounding tissues. In one embodiment, the fastener 100 is seated with the trailing end 108 of the body below flush and, in one embodiment, below the proximal cortex 607 to allow for cortical healing above the fastener body 104. To remove the fastener, it is pulled proximally. The sharpened trailing edge of the body 104 aids in passing the body through any bone that has grown over the body 104. In one embodiment, the leading end 106 of the body stays inside the bone and, in one embodiment, the leading end 106 is above the distal cortex 609 to preserve bone strength.	108	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 31 and 32, a fastener 100 is started into the bone holes 610, 612. The inserter 300 has been omitted from the figures to simplify the drawings. The outboard surfaces 148, 150 of the fastener legs are sized to match the proximal spacing of the outboard bone hole walls. Since outboard surfaces 148, 150 are parallel, they stay in contact with the proximal portion of the bone holes 610, 612 as the fastener is advanced into the bone portions. Inboard gaps 620, 622 are present between the fastener legs and the bone holes. Outboard gaps 624, 626 occur between the fastener legs and the bone holes distal of the proximal edge of the bone holes as the fastener is advanced.	107	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIG. 30, a depth gauge 618 is used to probe the bone holes 610, 612 to determine their depth as an aid in selecting a fastener of the appropriate size to provide bi-cortical fixation. Depending on the shape of the bone portions, the holes may have different depths and may receive a fastener having different length legs.	106	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 28 and 29, a saw blade 614 is guided in the saw slot 216 of the guide 200 to form a bone slot 616 to ease insertion of the fastener body through the proximal cortex. In one embodiment, the saw slot may only extend through the proximal bone cortex since only a proximal slot is needed to insert the fastener body.	105	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 15-18, an inserter 300 is configured for use with the fastener 100 of FIGS. 1-9. The inserter 300 includes a body 302 having a distal end 304 and a proximal end 306 including a handle portion 308. The body includes a pair of laterally spaced passages extending from the distal end 304 toward the proximal end 306 and each defining a passage axis 307. The passage axes 307 are angled 309 to align with the cavities 160 in the fastener 100. Side cuts or windows 310 communicate with the passages. Each passage receives a locking bolt 312 in axial sliding and rotating relationship. Each bolt 312 traverses one of the windows 310 exposing the portion of the bolt 312 within the window for manipulation. A knob 314 is fixed to each bolt 312, such as by pinning, to allow a user to rotate the bolt 312 about the passage axis 307 and to serve as a limit to axial travel of the bolt 312 as the knob abuts the proximal or distal margins 316, 318 of the window 310. Each bolt 312 includes a smooth cylindrical portion 320 sized to fit into the trailing portion 162 of the stepped cylindrical cavity 160 in one of the fastener legs. Each bolt 312 includes a threaded portion 322, distal to the smooth portion 320, sized to screw into the threaded leading portion 164 of the stepped cavity 160. The proximal end 306 of the inserter 300 includes a coupling member configured to rotationally couple to a cross guide discussed further below. As used herein, “coupling”, “coupling member”, or "coupler" refers to a mechanical device, apparatus, member, component, or structure, that is organized, configured, designed, arranged, or engineered to connect the ends of adjacent parts or objects. In certain embodiments, a coupling can be used to connect two shafts together at their ends for the purpose of transmitting power. In other embodiments, a coupling can be used to join two pieces of rotating equipment while permitting some degree of misalignment or end movement or both. In certain embodiments, couplings may not allow disconnection of the two parts, such as shafts during operation. (Search "coupling" on Wikipedia.com July 26, 2021. CC-BY-SA 3.0 Modified. Accessed July 27, 2021.) In the illustrative example of FIGS. 15-18, the coupling member includes a socket 324 extending distally into a top surface 325 of the handle portion 308 and a peripheral edge 326.	88	Added by DJM 12 2021	12/2/21, 12:00 AM

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