Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
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	The fixation member may be inserted into or through the aperture 118 at an included angle between the longitudinal axis of the fixation member and the aperture length axis ranging from 90 degrees to a value corresponding to a projected length of the aperture along the fixation member longitudinal axis equal to or greater than the fixation member transverse dimension. In one embodiment, the angular stops limit the rotation of the guide to be within this range so it is guaranteed that the fixation member will fit through the aperture. In the illustrative example of FIGS. 19-22 the first and second angular positions are limited by abutment of the side surface 416 of the cross guide with the peripheral edge 326 of the inserter 300.	101	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	FIG. 48A illustrates one example angle or orientation in a range of motion for the system according to one embodiment of the present disclosure;	54	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 56 is a diagram of an example of an engagement interface according to one embodiment of the present disclosure;	63	Added by DJM 12 2021	12/2/21, 12:00 AM
View Edit Delete	IPP-0050-US35 nextremity	FIG. 55 is a cross section view of one embodiment of an engagement member;	62	Added by DJM 12 2021	12/2/21, 12:00 AM
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. 53 is a top view of an inserter;	60	Added by DJM 12 2021	12/2/21, 12:00 AM

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