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	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	FIGS. 26-37 illustrate a method of using the fastener and instruments of FIGS. 1-22. Referring to FIG. 26, first and second bone portions 600, 602 abut at an interface 604 such as a joint articular surface, fracture, osteotomy cut plane, or other interface. The hole forming guide 200 is positioned over the bone portions with the alignment notches 218 aligned with the interface 604 to center the guide 200 over the interface 604. Fixation pins 606 may be placed in holes 220 in the guide 200 to secure the guide 200 to the bone portions.	103	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIGS. 23-25 depict another illustrative example of a fastener 500 according to one example of the present disclosure in which the rigid body 104 of fastener 100 has been replaced with a flexible member 502. The fastener includes first and second legs 504, 506. The flexible member 502 connects to axially spaced first and second connectors on the first leg 504 and passes through a receiver on the second leg 506 in sliding relationship to permit the angle between the fastener legs to be varied between arbitrary angles and to facilitate equal tensioning of the flexible member 502. In the illustrative example of FIGS. 23-25, the flexible member 502 is attached at a first location 508 on the first leg 504, extends to the second leg 506, passes through a first passage 510 in the second leg, extends axially along a portion of the second leg, passes through a second passage 512 in the second leg, and returns to the first leg 504 where it is attached at a second location 516. The flexible member 502 is able to slide freely within the passages 510, 512 in the second leg to allow the fastener legs 504, 506 to be variably angled relative to one another and so that tension in the flexible member is distributed equally throughout the flexible member 502. The fastener 500 may include a tensioning device operable to shorten the portion of the flexible member 502 that extends outwardly from the first leg 504. In the illustrative example of FIGS. 23-25, the first leg 504 includes a tensioning member operable to shorten the flexible member, such as for example by pressing the flexible member into the socket 524. For example, a tensioning screw 520 may be engaged with the threaded portion 522 of the socket 524. The flexible member 502 is attached to the first leg 504 so that it passes through the threaded portion 522 distal to the tensioning screw 520. Advancing the tensioning screw 520 presses the flexible member distally into the socket causing a portion of the flexible member 502 to be pulled into the first leg 504 and thus shortening the portion of the flexible member 502 that extends outwardly from the first leg 504. In use, for example, holes may be formed in the bone using a hole guide as in the preceding examples. The legs 504, 506 may be attached to a driver, for example like that of FIG. 15, and inserted into the bone holes. Tensioning screw 520 may then be inserted and advanced to shorten the flexible member and compress the bone.	102	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 10-14, a hole forming guide 200 includes a body 202 defining hole axes 204, 206 along which a hole forming tool may be guided. In the illustrative example of FIGS. 10-14, the axes 204, 206 are defined by cylindrical guide holes 208, 210. The guide holes 208, 210 are operable to receive a hole forming tool such as a punch or drill and constrain the hole forming tool to longitudinal motion along the axes 204, 206 to form holes in an underlying bone. The axes 204, 206 are angled to correspond to the divergent legs of the fastener of FIGS. 1-9. The inboard surfaces of the guide holes 208, 210 have a guide hole inboard surface leading end spacing 212 at the leading end 214 of the guide 200 that is equal to or greater than the inboard surface trailing end spacing 165 of the fastener. If the guide hole inboard surface leading end spacing 212 is equal to the fastener leg inboard surface trailing end spacing 165, the inboard surfaces 128, 130 of the fastener legs will just touch the inboard surfaces of the bone holes when the fastener leg trailing ends are inserted flush with the bone surface. Further seating of the fastener legs below the surface of the bone will result in compression of the bone between the fastener legs. Likewise, if the guide hole inboard surface leading end spacing 212 is greater than the fastener leg inboard surface trailing end spacing 165, the inboard surfaces 128, 130 of the fastener legs will just touch the inboard surfaces of the bone holes when the fastener leg trailing ends are proud of the bone surface. Further insertion of the fastener until the trailing ends of the legs are flush with the bone surface will result in compression of the bone. The amount of compression for a given insertion depth of the fastener may be determined by selecting the relationship of guide hole inboard surface leading end spacing 212 to fastener leg inboard surface trailing end spacing 165. With the included angle between the leg inboard surfaces matching the included angle between the hole inboard surfaces, the compression of the bone between the fastener legs is uniform at all positions between the legs normal to the insertion axis and inserting the bone fastener does not create a relative bending moment between the first and second bone portions. An insertion axis is an axis along which an object is inserted. An insertion axis may also be the same axis used to extract an object. The guide 200 further includes a guide slot 216 connecting the holes 208, 210. The slot 216 may be used to guide a chisel, broach, saw or other cutting tool to remove bone and form a connecting slot between bone holes formed using the guide holes 208, 210 for receiving the fastener body 104. Alignment notches 218 are provided to indicate the center of the guide 200. Fixation holes 220 are provided to receive fixation pins or screws to fix the guide in position on a bone.	87	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The cross guide 400 is coupled to the inserter 300 by inserting the pin 407 into the socket 324 until the shoulder 414 abuts the top surface 325 of the inserter handle 308 as shown in FIG. 20. Thus assembled, the cross fixation insertion axis 420 is aligned with the center of the fastener aperture 118. The cross guide 400 may be rotated relative to the inserter 300 about the engagement axis 412 through an infinite number of angular positions between a first angular position shown in solid line in FIGS. 21 and 22 and a second angular position shown in dashed lines. In one embodiment, the guide and inserter define stops between them limiting the angular positions. For example, a fixation member to be inserted through the fastener aperture 118, such as screw 636 in FIG. 36, has a longitudinal axis and a transverse dimension normal to the longitudinal axis.	100	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The sleeve 422 includes an axial through passage, proximal handle portion 424 and a distal leading end 426 forming a tapered tip. The axial through passage is sized to guide a guide wire (e.g., a “K-wire”) along the cross fixation insertion axis 420. The sleeve may be translated along the axis 420 relative to the guide body 402 to position the leading end 426 at a desired spacing from a bone.	99	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrative example of FIGS. 19-22, the guide member includes a passage through the guide body 402 defining the cross fixation insertion axis 420 and a sleeve 422 received in the passage in axial sliding relationship. As used herein, a “sleeve” refers to structure that is narrow and longer longitudinally than the structure is wide. In certain embodiments, a sleeve serves to surround, enclose, wrap, and/or contain something else. In certain embodiments, a sleeve may surround, enclose, wrap, and/or contain a passage or void. (Search "sleeve" on wordhippo.com. WordHippo, 2021. Web. Accessed 15 Nov. 2021. Modified.) In certain embodiments, the term sleeve may be preceded by and adjective that identifies the structure, implement, component or instrument that may be used with, inserted into or associated with the sleeve. For example, a “pin sleeve” may be configured to accept a pin or wire such as a K-wire, a “drive sleeve” may be configured to accept a drill or drill bit, a “fixation member sleeve” may be configured to accept a fastener or fixation member.	98	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrative example of FIGS. 19-22, a shoulder 414 formed near the proximal end 408 of the pin 407 serves as the axial stop and a side surface 416 transverse to the shoulder 414 and formed on the guide body 402 serves as the rotational stop. The guide member 406 defines a cross fixation insertion axis 420 transverse to the engagement axis 412 and along which a fixation member may be guided to pass through or into the fastener aperture 118.	97	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The guide 400 includes a stop such as an axial stop and a rotational stop to aid in positioning the guide 400 relative to the inserter 300. As used herein, a “stop” refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to prevent, limit, impede, stop, or restrict motion or movement and/or operation of the another object, member, structure, component, part, apparatus, system, or assembly.	96	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	A pin can have a variety of geometric cross-sectional shapes, including, but not limited to a circle, an ellipse, an ovoid, or other circular or semi-circular shape, as well as a rectangle, a square, or other polygon. A pin has two ends one end can be blunt and the other end may come to a point. A pin can be made from a variety of materials including, metal, plastic, ceramic, wood, fiberglass, or the like. A pin may also 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.	95	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As used herein, an “pin” refers to an elongated structure. In certain embodiments, a pin can be used to connect two structures or serve as a bearing between two structures. In certain embodiments, a pin can be configured to support a load (including a tension, compression, shear, torsion, and/or bending load). In certain embodiments, a pin may be a cylindrical structure that is thinner that connected structures. A pin can serve a variety of functions and may include a modifier identifying a particular function for example certain solutions may use alignment pins, attachment pins, securement pins, or the like. Pins may serve a temporary or permanent structural purpose. Pins can be used in a variety of devices, components, apparatus, and systems, including but not limited to, fixation plates, measurement instruments, pin guides, cutting guides, surgical instrumentation, and the like. A pin can serve as a fastener either temporarily or permanently. One example of a pin is a Kirschner wire ("K-wire").	94	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In one embodiment, the cross guide 400 includes an arcuate guide body 402 having at one end an engagement member 404 and at an opposite end a guide member 406. The engagement member 404 is configured to rotationally couple to the inserter 300. In the illustrative example of FIGS. 19-22, the engagement member 404 includes a pin 407 extending distally from the guide body 402 from a proximal end 408 to a distal end 410 and defining an engagement axis 412. As used herein, an "engagement axis" refers to an axis about which one apparatus, instrument, structure, device, component, member, system, assembly or module engages with another apparatus, instrument, structure, device, component, member, system, assembly or module either permanently or temporarily.	93	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In certain embodiments, the guide may be referred to as a cross guide or cross fixation guide as the elongate member may be deployed transverse to the fastener 100. The elongate member may be a pin, screw, drill, wire or other member. In one embodiment, the elongate member may be a fixation member. For example, the guide 400 may be used to place a guide wire through the aperture and the guide wire may be used to insert a cannulated screw.	92	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	Referring to FIGS. 19-22, a guide 400 is engageable with the inserter to guide placement of an elongate member into or through the aperture 118 of the fastener 100. As used herein, a "guide" refers to a part, component, member, or structure designed, adapted, configured, or engineered to guide or direct one or more other parts, components, or structures. A guide may be part of, integrated with, connected to, attachable to, or coupled to, another structure, device, or instrument. In one embodiment, a guide may include a modifier that identifies a particular function, location, orientation, operation, type, and/or a particular structure of the guide. Examples of such modifiers applied to a guide, include, but are not limited to, "pin guide" that guides or directs one or more pins, a "cutting guide" that guides or directs the making or one or more cuts, a "deployment or insertion guide" that guides or directs the deployment, installation, or insertion of a fastener and/or implant, a "cross fixation guide" that guides deployment of a fastener or fixation member, and the like.	91	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	The inserter 300 is joined to the fastener 100 by first sliding the locking bolts 312 proximally until the knobs 314 abut the proximal margin 316 of the window 310 as shown in FIG. 17. The threaded portion 322 may then be inserted into the cavity 160 of the fastener 100. Each knob 314 is then rotated to thread the locking bolt 312 into the cavity 160 and secure the fastener 100 to the inserter 300 as shown in FIG. 18.	90	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	As used herein, a “socket” refers to a hollow, void, opening, or depression formed in or defined within a surface of an object or structure. In certain embodiments, the socket does not pass through the object or structure having the surface. A socket 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 socket. In one example, a socket can have one or more walls that connect in rounded corners. In certain embodiments, a socket is sized and shaped to receive or accept another structure. In certain embodiments, a socket may comprise a stepped socket having a proximal portion and a distal portion and the two portions have different diameters or different widths or lengths that define a step between the two portions.	89	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
View Edit Delete	IPP-0050-US35 nextremity	Those of skill in the art will appreciate that the socket 1030 may have a variety of different forms, features, and configurations within the scope of the present disclosure. In one embodiment, the socket 1030 has a depth that accepts distal advancement of the shaft 1002 until the protrusion 1006 presses against the collar 1004. Alternatively, or in addition, the socket 1030 has a depth that accepts distal advancement of the shaft 1002 until the protrusion 1006 presses against the collar 1004 with a sufficient press fit to restrain rotation of the collar 1004 about the inserter 1008 and/or bone fastener.	159	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In the illustrated embodiment, the guide 2002 includes a guide member 2016 that may include a pivot member 2024. The pivot member 2024 may be connected or coupled to the guide body 2014 near the proximal end 2020. The pivot member 2024 enables a user to adjust an orientation of the fixation axis 420 (also referred to as a cross fixation insertion axis). In certain embodiments, the pivot member 2024 connects to a passage that accepts sleeves 2008. The pivot member 2024 may pivot or rotate about an axis which is transvers to a cross fixation insertion axis and an engagement axis.	173	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	In certain embodiments, the engagement member 2018 is configured to secure the guide member 2016 and/or the guide 2002 at any of the plurality of relative orientations. In one embodiment, the engagement member 2018 may secure the guide member 2016 at a desired relative orientation temporarily. For example, while a fixation member 812 is being deployed. In another embodiment, the engagement member 2018 may secure the guide member 2016 at a desired relative orientation permanently.	172	Added by DJM 12 2021	12/2/21, 12:00 AM

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