Alignment-indicating devices for stylets

Abstract

Alignment-indicating devices which obviate any kinking or bending of stylets as currently done by clinicians for indicating misalignment of the distal ends of stylets and catheters. For example, an alignment-indicating device (100) includes an elastomeric device body (102) and a contacting surface (104) thereof. The device body is configured to at least partially encircle a stylet body (18) and the contacting surface thereof is configured to contact an external surface of the stylet body. The contacting surface of the device body has sufficient friction to maintain the alignment-indicating device in position about a proximal portion of the stylet (12) upon placement there by a clinician after aligning distal ends of the stylet and a catheter. The alignment-indicating device thereby obviates any kinking or bending of the proximal portion of the stylet by the clinician for indicating misalignment of the distal ends of the stylet and catheter.

Description

Docket No. 101672.0640PCTALIGNMENT-INDICATING DEVICES FOR STYLETS AND METHODS THEREOFPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 762,532, filed February 24, 2025, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Stylets are utilized during placement of peripherally inserted central catheters (“PICCs”) or the like for stiffening such catheters, thereby facilitating their placement in patients. During such a placement, a catheter 10 such as a PICC is trimmed to length, a stylet 12 is inserted into a lumen of the catheter 10, and a distal end of the stylet 12 is aligned with a distal end of the catheter 10 as shown in FIG. 15, thereby stiffening the catheter 10 along an entirety of at least its catheter tube 14 during such a placement. Subsequent to aligning the distal end of the stylet 12 with the distal end of the catheter 10, a clinician will kink or bend a proximal portion of the stylet 12 against a fluid fitting 16 (e.g., Luer connector) of the catheter 10 from which the stylet 12 extends. This bend or kink provides an important alignment indicator on the stylet 12 that visually or tactilely indicates to the clinician whether the distal end of the stylet 12 remains aligned with the distal end of the catheter 10 during the placement of the catheter 10.

[0003] Indeed, without such an alignment indicator, the distal end of the stylet 12 might inconspicuously extend past the distal end of the catheter 10, which can injure a patient, damage the distal end of the stylet 12, or both during the placement of the catheter 10. Alternatively, the distal end of the stylet 12 might inconspicuously fail to extend to the distal end of the catheter 10, which can result in the catheter 10 being malpositioned upon the placement thereof due to the flexibility of the catheter tube 14. However, a non-traditional or advanced technology stylet including one or more technological components (e.g., one or more optical fibers) might become damaged if a proximal portion of such a stylet is kinked or bent for an alignment indicator. Accordingly, alignment-indicating devices are needed for at least non-traditional or advanced technology stylets to indicate to clinicians whether such stylets are properly disposed in their corresponding catheters during and aligned therewith during placement.Docket No. 101672.0640PCT

[0004] Disclosed herein are alignment-indicating devices for stylets and methods thereof that address the foregoing.SUMMARY

[0005] Disclosed herein is an alignment-indicating device for a stylet including, in some embodiments, an elastomeric device body and a contacting surface thereof. The device body is configured to at least partially encircle a stylet body of the stylet. The contacting surface of the device body is configured to contact an external surface of the stylet body. The contacting surface of the device body has sufficient friction to maintain the alignment-indicating device in position about a proximal portion of the stylet upon placement there by a clinician after aligning distal ends of the stylet and a catheter. The alignment-indicating device obviates any kinking or bending of the proximal portion of the stylet by the clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter.

[0006] In some embodiments, the contacting surface of the device body has sufficient lubricity to allow the clinician to adjust the position of the alignment-indicating device about the proximal portion of the stylet until the distal ends of the stylet and the catheter are aligned.

[0007] In some embodiments, the device body consists of a biocompatible silicone.

[0008] In some embodiments, the device body approximates a torus having an inner diameter commensurate with or greater than an outer diameter of the stylet body.

[0009] In some embodiments, the device body approximates a frustum. A longitudinal through hole through the device body has an inner diameter commensurate with an outer diameter of the stylet body.

[0010] In some embodiments, the device body approximates a cylinder. A longitudinal through hole through the device body has an inner diameter commensurate with an outer diameter of the stylet body.

[0011] In some embodiments, the through hole includes a curvilinear flare extending from the contacting surface of the device body through a proximal end of the device body, a distal end of the device body, or each of the proximal end and the distal end of the device body. The curvilinear flare is configured to provide strain relief to the stylet when the stylet extends through the curvilinear flare.Docket No. 101672.0640PCT

[0012] In some embodiments, the device body includes one or more grasp tabs extending from the device body. The grasp tab(s) allow the clinician to grasp the grasp tab(s) when adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

[0013] In some embodiments, the device body includes one or more recesses in the device body. The recess(es) allow the clinician to hold the alignment-indicating device by way of the recess(es) when adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

[0014] In some embodiments, the alignment-indicating device further includes an active friction-adjusting means for actively adjusting friction between the contacting surface of the device body and the proximal portion of the stylet before adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

[0015] In some embodiments, the active friction-adjusting means includes a friction hitch around the device body. The friction hitch reduces friction between the contacting surface of the device body and the proximal portion of the stylet when loosened. The friction hitch increases friction between the contacting surface of the device body and the proximal portion of the stylet when tightened.

[0016] In some embodiments, the active friction-adjusting means includes a beaded-tie fastening device around the device body. The beaded-tie fastening device reduces friction between the contacting surface of the device body and the proximal portion of the stylet when loosened. The beaded-tie fastening device increases friction between the contacting surface of the device body and the proximal portion of the stylet when tightened.

[0017] In some embodiments, the alignment-indicating device further includes a strainreliefboot extending from a proximal portion of the device body, a distal portion of the device body, or each of the proximal portion and the distal portion of the device body. The strainrelief boot is configured to provide strain relief to the stylet when the stylet extends through the strain-relief boot.

[0018] In some embodiments, the alignment-indicating device further includes a rigid housing in which the device body is disposed.Docket No. 101672.0640PCT

[0019] In some embodiments, the rigid housing includes a cavity in a distal portion of the rigid housing. The cavity is configured to accommodate therein a fluid fitting of the catheter.

[0020] In some embodiments, the cavity of the rigid housing has an inner diameter commensurate with or greater than an outer diameter of the fluid fitting of the catheter. The cavity thereby provides sufficient friction to maintain the fluid fitting of the catheter in the cavity of the rigid housing upon insertion by the clinician after aligning distal ends of the stylet and a catheter.

[0021] In some embodiments, the rigid housing includes one or more threads lining the cavity. The thread(s) are complementary to that of the fluid fitting of the catheter such that the alignment-indicating device screws onto the fluid fitting of the catheter, thereby axially compressing the device body in the rigid housing and radially compressing the device body around the proximal portion of the stylet.

[0022] Also disclosed herein is an alignment-indicating device for a stylet including, in some embodiments, a pair of flexible jaws and a closure mechanism. The pair of jaws are joined together at a hinged end of the pair of jaws by a living hinge. Each jaw of the pair of jaws includes a contacting surface facing the other jaw of the pair of jaws, wherein the contacting surface is configured to contact an external surface of a stylet body of the stylet. Each jaw of the pair of jaws also has a length sufficient to flexibly surround at least half the stylet body of the stylet. The closure mechanism is at an open-ended end of the pair of jaws opposite the hinged end. The contacting surfaces of the pair of jaws have sufficient friction to maintain the alignment-indicating device in position about a proximal portion of the stylet upon placement there and subsequent closure of the closure mechanism by a clinician after aligning distal ends of the stylet and a catheter. The alignment-indicating device obviates any kinking or bending of the proximal portion of the stylet by the clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter in a patient.

[0023] In some embodiments, the pair of jaws consist of a biocompatible polypropylene or polyethylene, optionally, lined with an elastomer for the contacting surfaces.

[0024] Also disclosed herein is a method of using an alignment-indicating device for a stylet. In some embodiments, the method includes obtaining the alignment-indicating device. The alignment-indicating device includes an elastomeric device body and a contacting surfaceDocket No. 101672.0640PCTthereof. The device body is configured to at least partially encircle a stylet body of the stylet. The contacting surface of the device body is configured to contact an external surface of the stylet body. The method also includes inserting the stylet into the alignment-indicating device. The method also includes temporarily positioning the alignment-indicating device about a proximal portion of the stylet. The method also includes inserting a distal portion of the stylet into a lumen of a catheter. The method also includes aligning distal ends of the stylet and the catheter. The method also includes repositioning the alignment-indicating device about the proximal portion of the stylet with the distal ends of the stylet and the catheter aligned. The contacting surface of the device body has sufficient friction to maintain the alignmentindicating device in position about the proximal portion of the stylet while placing the catheter in a patient. The alignment-indicating device obviates any kinking or bending of the proximal portion of the stylet by a clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter the patient. The method also includes placing the catheter in the patient.

[0025] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0026] FIG. 1 illustrates an alignment-indicating device approximating a torus in accordance with some embodiments.

[0027] FIG. 2 illustrates the alignment-indicating device of FIG. 1 with one or more grasp tabs in accordance with some embodiments.

[0028] FIG. 3 illustrates the alignment-indicating device approximating a frustum in accordance with some embodiments.

[0029] FIG. 4 illustrates the alignment-indicating device of FIG. 3 with a curvilinear flare extending from a contacting surface of a device body through a proximal end of the device body in accordance with some embodiments.

[0030] FIG. 5 illustrates the alignment-indicating device of FIG. 3 with a strain-relief boot extending from a distal portion of the device body in accordance with some embodiments.Docket No. 101672.0640PCT

[0031] FIG. 6 illustrates the alignment-indicating device approximating a cylinder in accordance with some embodiments.

[0032] FIG. 7 illustrates the alignment-indicating device of FIG. 6 with a friction hitch around the device body for actively adjusting friction of the contacting surface of the device body and a stylet in accordance with some embodiments.

[0033] FIG. 8 illustrates the alignment-indicating device of FIG. 6 with a beaded-tie fastening device around the device body for actively adjusting friction of the contacting surface of the device body and the stylet in accordance with some embodiments.

[0034] FIG. 9 illustrates the alignment-indicating device including the device body disposed in a rigid housing having a cavity configured to accommodate a fluid fitting of a catheter in accordance with some embodiments.

[0035] FIG. 10 illustrates the alignment-indicating device of FIG. 9 with one or more threads lining the cavity for screwing onto the fluid fitting of the catheter in accordance with some embodiments.

[0036] FIG. 11 illustrates the alignment-indicating device of FIG. 9 with a viewing window in the rigid housing in accordance with some embodiments.

[0037] FIG. 12 illustrates the alignment-indicating device approximating a waisted cylinder in accordance with some embodiments.

[0038] FIG. 13 illustrates the alignment-indicating device including a pair of flexible jaws and a closure mechanism in accordance with some embodiments.

[0039] FIG. 14 illustrates a method of using the alignment-indicating device in accordance with some embodiments.

[0040] FIG. 15 illustrates an existing method of kinking orbending a stylet to indicates misalignment of distal ends of the stylet and the catheter.DESCRIPTION

[0041] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of theDocket No. 101672.0640PCTconcepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0042] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0043] “Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient. For example, a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device includes the proximal end of the medical device, or if it is deemed expedient in the followingDocket No. 101672.0640PCTdescription, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.

[0044] “Distal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient. For example, a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. Likewise, a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. A “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. The distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medical device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device. Should context not suggest the distal portion, the distal section, or the distal length of the medical device includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.

[0045] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.Alignment-indicating devices

[0046] FIGS. 1-12 illustrate an alignment-indicating device 100 for the stylet 12 in accordance with some embodiments.

[0047] As shown, the alignment-indicating device 100 can include an elastomeric device body 102 and a contacting surface 104 thereof configured to contact an external surface of a stylet body 18 of the stylet 12. As will become more apparent in view of the followingDocket No. 101672.0640PCTdescription, such an alignment-indicating device 100 obviates any intentional kinking or bending of the proximal portion of the stylet 12 by a clinician for indicating misalignment of the distal ends of the stylet 12 and the catheter 10 while placing the catheter 10.

[0048] FIGS. 1, 3, 6, and 12 illustrate the device body 102 approximating various solid figures in accordance with some embodiments.

[0049] The device body 102 can approximate any solid figure, solid of revolution, or finite solid of a geometric surface including a polyhedron, particularly, a convex polyhedron, a prism, an antiprism, a cylinder, an ellipsoid, a hyperboloid, a torus, or any portion of the foregoing such as the lemon or apple portion of a spindle torus. For example, the device body 102 can approximate a solid torus, frustum, or cylinder. Such a device body 102 is configured to at least partially encircle the stylet body 18 of the stylet 12 with a fit allowing the contacting surface 104 of the device body 102 to be in contact with the external surface of the stylet body 18.

[0050] When the device body 102 approximates the solid torus of FIG. 1, the device body 102 has an inner diameter commensurate with or greater than an outer diameter of the stylet body 18 such as that associated with a close-running, sliding, or location clearance fit per the International Organization for Standardization (“ISO”) on engineering fits. When the device body 102 approximates the frustum of FIG. 3, the device body 102 has a longitudinal through hole 106 through the device body 102 having an inner diameter commensurate with or greater than the outer diameter of the stylet body 18. When the device body 102 approximates the cylinder of FIG. 6, the device body 102 also has the longitudinal through hole 106 through the device body 102 having the inner diameter commensurate with or greater than the outer diameter of the stylet body 18. Instead of the device body 102 being a right cylinder as shown in FIG. 6, the device body 102 can alternatively be an elliptical cylinder or even a waisted cylinder (i.e., a cylinder having a waist) as shown in FIG. 12. Like the device body 102 shown in FIG. 6, the device body 102 shown in FIG. 12 also has the longitudinal through hole 106 through the device body 102 having the inner diameter commensurate with or greater than the outer diameter of the stylet body 18.

[0051] The device body 102 can consist of any biocompatible elastomer that provides the contacting surface 104 of the device body 102 with suitable friction against the external surface of the stylet body 18 when the device body 102 and the stylet 12 have an engineeringDocket No. 101672.0640PCTfit like that set forth above. Such an elastomer includes, but is not limited to, a silicone. The contacting surface 104 of the device body 102 accordingly has sufficient friction, notably, without being sticky or transferring an adhesive residue, to maintain the alignment-indicating device 100 in position about the proximal portion of the stylet 12 upon placement there by a clinician after aligning the distal ends of the stylet 12 and the catheter 10. Such friction is sufficient friction even in the presence of saline or bodily fluid, which is advantageous over, for example, adhesive tape, which becomes ineffective when inevitably wetted with saline or bodily fluid. Notwithstanding the foregoing, the biocompatible elastomer should also provide the contacting surface 104 of the device body 102 with sufficient lubricity to allow the clinician to adjust the position of the alignment-indicating device 100 about the proximal portion of the stylet 12 until the distal ends of the stylet 12 and the catheter 10 are aligned.

[0052] Having described some general features of the alignment-indicating device 100, some additional, but optional, features are of the alignment-indicating device 100 are set forth below. While some of these optional features are shown with respect to the device body 102 approximating the foregoing solid torus, frustum, or cylinder, it should be understood that these optional features are not limited to the device bodies with which they are shown. In an example, the grasp tab 108 shown in FIG. 2 for the alignment-indicating device 100 having the solidtorus device body 102 can be added to the alignment-indicating device 100 of FIG. 3 in which the device body 102 is the foregoing frustum.

[0053] FIG. 2 illustrates the alignment-indicating device 100 of FIG. 1 with one or more grasp tabs 108 in accordance with some embodiments.

[0054] As shown, the device body 102 can include one or more grasp tabs 108 extending from the device body 102. When the device body 102 includes a single grasp tab 108, the grasp tab 108 can extend from any portion of the device body 102 such as a proximal portion of the device body 102, a distal portion of the device body 102, or a medial portion of the device body 102 between the proximal and distal portions. When the device body 102 includes a pair of grasp tabs 108, the pair of grasp tabs 108 can likewise extend from any portion of the device body 102; however, the pair of grasp tabs 108 are optimally positioned opposite each other on a perimeter (e.g., circumference) of a transverse cross-section of the device body 102, wherein the cross-section of the device body 102 is perpendicular to a central axis of the device body 102 that aligns with the stylet body 18. When the device body 102 includes a trio of grasp tabs 108 (or more), the trio of grasp tabs 108 (or more) can likewiseDocket No. 101672.0640PCTextend from any portion of the device body 102; however, the trio of grasp tabs 108 (or more) are optimally positioned equidistant from each other on the foregoing perimeter (e.g., circumference) of the cross-section of the device body 102. The grasp tab(s) 108 allow the clinician to grasp the grasp tab(s) 108 when adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12.

[0055] The device body 102 can alternatively or additionally include one or more recesses 110 in the device body 102. When the device body 102 includes a single recess 110, the recess 110 can extend into any portion of the device body 102 such as the proximal portion of the device body 102, the distal portion of the device body 102, or the medial portion of the device body 102 between the proximal and distal portions. Notably, the recess 110 can extend into the medial portion of the device body 102 around an entirety of the foregoing perimeter (e.g., circumference) of the cross-section of the device body 102. When the device body 102 is a right cylinder like that shown in FIG. 6, such a recess 110 around the device body 102 results in the device body 102 of FIG. 12, which approximates a waisted cylinder. When the device body 102 includes a pair of recesses 110, the pair of recesses 110 can likewise extend into any portion of the device body 102; however, the pair of recesses 110 are optimally positioned opposite each other on the foregoing perimeter (e.g., circumference) of the cross-section of the device body 102. When the device body 102 includes a trio of recesses 110 (or more), the trio of recesses 110 (or more) can likewise extend into any portion of the device body 102; however, the trio of recesses 110 (or more) are optimally positioned equidistant from each other on the foregoing perimeter (e.g., circumference) of the cross-section of the device body 102. The recess(es) 110 allow the clinician to hold the alignment-indicating device 100 by way of the recess(es) 110 when adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12.

[0056] FIGS. 4 and 11 illustrates the alignment-indicating device 100 with a strainrelieving curvilinear flare 112 extending from the contacting surface 104 of the device body 102 in accordance with some embodiments.

[0057] As shown, the device body 102 can include the curvilinear flare 112 extending from the contacting surface 104 of the through hole 106 through a proximal end of the device body 102, a distal end of the device body 102, or each of the proximal end and the distal end of the device body 102. Such a curvilinear flare 112 is configured to provide strain relief to the stylet 12 when the stylet 12 extends through the curvilinear flare 112 or lies against theDocket No. 101672.0640PCTcurvilinear flare 112. Indeed, the curvilinear flare 112 reduces a curvature and, thus, strain, on the stylet 12 extending from the device body 102.

[0058] FIG. 5 illustrates the alignment-indicating device 100 with a strain-relief boot 114 extending from the device body 102 in accordance with some embodiments.

[0059] As shown, strain relief can alternatively or additionally be provided to the stylet 12 by way of the strain-relief boot 114 extending from the proximal portion of the device body 102, the distal portion of the device body 102, or each of the proximal portion and the distal portion of the device body 102. The strain-relief boot 114 can be molded together with the device body 102, the strain-relief boot 114 can be molded separately and overmolded into the device body 102, or the strain-relief boot 114 can be molded separately and inserted into the device body 102 after it is molded. Such a strain-relief boot 114 is configured to provide strain relief to the stylet 12 when the stylet 12 extends through the strain-relief boot 114. Like the curvilinear flare 112, the strain-relief boot 114 reduces the curvature and, thus, the strain, on the stylet 12 extending from the device body 102.

[0060] FIGS. 7 and 8 illustrate the alignment-indicating device 100 with an active friction-adjusting means for actively adjusting friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 in accordance with some embodiments. Indeed, FIG. 7 illustrates the alignment-indicating device 100 with a friction hitch 116 around the device body 102 for actively adjusting friction of the contacting surface 104 of the device body 102 and the stylet 12, and FIG. 8 illustrates the alignment-indicating device 100 with a beaded-tie fastening device 118 around the device body 102 for actively adjusting friction of the contacting surface 104 of the device body 102 and the stylet 12.

[0061] As shown in FIG. 7, the active friction-adjusting means can include the friction hitch 116 such as a Prusik hitch around the device body 102. Such a friction hitch 116 reduces friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 when loosened. The friction hitch 116 increases friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 when tightened. Accordingly, via the friction hitch 116, a clinician can actively reduce friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 before adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12. Also, the clinician can actively increase friction between the contacting surface 104Docket No. 101672.0640PCTof the device body 102 and the proximal portion of the stylet 12 after adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12.

[0062] As shown in FIG. 8, the active friction-adjusting means can include the beaded-tie fastening device 118 around the device body 102. Such a beaded-tie fastening device 118 reduces friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 when loosened. The beaded-tie fastening device 118 increases friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 when tightened. Accordingly, via the beaded-tie fastening device 118, a clinician can actively reduce friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 before adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12. Also, the clinician can actively increase friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 after adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12.

[0063] It should be understood that the active friction-adjusting means for actively adjusting friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 is not limited to the foregoing Prusik hitch or the beaded-tie fastening device 118. Indeed, other friction hitches 116 other than the Prusik hitch are possible, and webbing or some other tie together with a clip, cam buckle, or the like can be used instead of the beaded-tie fastening device 118 to actively reduce or increase friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12.

[0064] FIGS. 9-11 illustrate the alignment-indicating device 100 including the device body 102 disposed in a rigid housing 120 in accordance with some embodiments.

[0065] As shown, the alignment-indicating device 100 can include the rigid housing 120 and the device body 102 disposed in the rigid housing 120. Such a rigid housing 120 can be molded over the device body 102 and, if present, the strain-relief boot(s) 114, or the device body 102 together with any strain-relief boot(s) 114 can be inserted into the rigid housing 120 after it is molded.

[0066] As shown in FIGS. 9 and 10, the rigid housing 120 can advantageously include a cavity 122 in a distal portion of the rigid housing 120 configured to accommodate therein a fluid fitting 16 of the catheter 10. The cavity 122 of the rigid housing 120 has an inner diameterDocket No. 101672.0640PCTcommensurate with or greater than an outer diameter of the fluid fitting 16 of the catheter 10 such as that associated with a close-running, sliding, or location clearance fit per the ISO on engineering fits. The cavity 122 thereby provides sufficient friction to maintain the fluid fitting 16 of the catheter 10 in the cavity 122 of the rigid housing 120 upon insertion of the fluid fitting 16 therein by the clinician after aligning the distal ends of the stylet 12 and the catheter 10. To ensure the fluid fitting 16 of the catheter 10 remains properly seated in the cavity 122 of the rigid housing 120 after insertion, the rigid housing 120 can include a viewing window 124 as shown in FIG. 9. Such a viewing window 124 allows the clinician to visually check to see if the fluid fitting 16 remains properly seated in the cavity 122 of the rigid housing 120.

[0067] As shown in FIG. 10, the rigid housing 120 can include one or more threads 125 lining the cavity 122. The thread(s) 125 are complementary to that of the fluid fitting 16 of the catheter 10 such that the alignment-indicating device 100 screws onto the fluid fitting 16 of the catheter 10. Not only does such a threaded cavity 122 ensure the fluid fitting 16 remains properly seated in the cavity 122 of the rigid housing 120 (without proximal or distal movement) and, thereby, obviate visually checking to see if the fluid fitting 16 remains properly seated in the cavity 122, but, being that the device body 102 is disposed in the rigid housing 120 proximal of the cavity 122, screwing the alignment-indicating device 100 onto the fluid fitting 16 of the catheter 10 axially compresses the device body 102 in the rigid housing 120 and, simultaneously, radially compresses the device body 102 around the proximal portion of the stylet 12. As such, the rigid housing 120 shown in FIG. 10 provides yet another active friction-adjusting means for actively adjusting friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 when the alignment-indicating device 100 is screwed onto or off of the fluid fitting 16 of the catheter 10. Indeed, when the alignment-indicating device 100 is tightened such as by screwing it onto the fluid fitting 16 of the catheter 10, friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 is increased. Conversely, when the alignment-indicating device 100 is loosened such as by screwing it off of the fluid fitting 16 of the catheter 10, friction between the contacting surface 104 of the device body 102 and the proximal portion of the stylet 12 is reduced.

[0068] FIG. 13 illustrates the alignment-indicating device 100 in accordance with some other embodiments.Docket No. 101672.0640PCT

[0069] As shown, the alignment-indicating device 100 can include a pair of flexible jaws 126 and a closure mechanism, which, like any embodiment of the alignment-indicating device 100 set forth herein obviates any intentional kinking or bending of the proximal portion of the stylet 12 by a clinician for indicating misalignment of the distal ends of the stylet 12 and the catheter 10 while placing the catheter 10.

[0070] Beginning with the closure mechanism, which is shown as, but not limited to, a latch mechanism including a latch 128 and a complementary jaw recess 130 upon which the latch 128 latches, the closure mechanism can be at an open-ended end of the pair of jaws 126 into which the stylet body 18 is inserted. Opposite the open-ended end of the pair of jaws 126, the pair of jaws 126 can be joined together at a hinged end of the pair of jaws 126 by a living hinge 132.

[0071] Each jaw of the pair of jaws 126 can have a length sufficient to flexibly surround at least half the stylet body 18 of the stylet 12. Such a pair of jaws 126 can consist of a biocompatible polypropylene or polyethylene imparting some flexibility to the pair of jaws 126. Further, each jaw of the pair of jaws 126 can include a contacting surface 134 facing the other jaw of the pair of jaws 126, wherein the contacting surface 134 is configured to contact the external surface of the stylet body 18 of the stylet 12. Such contacting surfaces 134 can be textured portions of their corresponding jaws 126, or the contacting surfaces 134 can be elastomer-lined portions of their corresponding jaws 126. The contacting surfaces 134 of the pair of jaws 126 thereby have sufficient friction to maintain the alignment-indicating device 100 in position about the proximal portion of the stylet 12 upon placement there and subsequent closure of the closure mechanism by a clinician after aligning the distal ends of the stylet 12 and the catheter 10.

[0072] Notably, the alignment-indicating device 100 of FIG. 13 also provides an active friction-adjusting means for actively adjusting friction between the contacting surfaces 134 of the pair of jaws 126 and the proximal portion of the stylet 12 before adjusting the position of the alignment-indicating device 100 about the proximal portion of the stylet 12.Methods

[0073] Methods include making and using the alignment-indicating device 100. In an example of making the alignment-indicating device 100, the alignment-indicating device 100Docket No. 101672.0640PCTcan be molded, assembled, or some combination thereof in view of disclosure set forth above. An example of using the alignment-indicating device 100 in set forth below.

[0074] FIG. 14 illustrates a method of using the alignment-indicating device 100 for the stylet 12 in accordance with some embodiments.

[0075] The method can include obtaining the alignment-indicating device 100 set forth above; inserting the stylet 12 into the alignment-indicating device 100; temporarily positioning the alignment-indicating device 100 about the proximal portion of the stylet 12; and inserting a distal portion of the stylet 12 into a lumen of the catheter 10. As shown, the method also includes aligning the distal ends of the stylet 12 and the catheter 10; and repositioning the alignment-indicating device 100 about the proximal portion of the stylet 12 with the distal ends of the stylet 12 and the catheter 10 aligned. Again, the contacting surface 104 of the device body 102 has sufficient friction to maintain the alignment-indicating device 100 in position about the proximal portion of the stylet 12 while placing the catheter 10 in a patient, thereby obviating any kinking or bending of the proximal portion of the stylet 12 by a clinician for indicating misalignment of the distal ends of the stylet 12 and the catheter 10 while placing the catheter 10 the patient. Lastly, the method also includes placing the catheter 10 in the patient with the alignment-indicating device 100 in position about the proximal portion of the stylet 12.

[0076] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

Docket No. 101672.0640PCTCLAIMSWhat is claimed is:

1. An alignment-indicating device for a stylet, comprising:an elastomeric device body configured to at least partially encircle a stylet body of the stylet; anda contacting surface of the device body configured to contact an external surface of the stylet body, the contacting surface of the device body having sufficient friction to maintain the alignment-indicating device in position about a proximal portion of the stylet upon placement there by a clinician after aligning distal ends of the stylet and a catheter, the alignmentindicating device obviating any kinking or bending of the proximal portion of the stylet by the clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter.

2. The alignment-indicating device according to claim 1, wherein the contacting surface of the device body has sufficient lubricity to allow the clinician to adjust the position of the alignment-indicating device about the proximal portion of the stylet until the distal ends of the stylet and the catheter are aligned.

3. The alignment-indicating device according to either claim 1 or 2, wherein the device body consists of a biocompatible silicone.

4. The alignment-indicating device according to any of the preceding claims, wherein the device body approximates a torus having an inner diameter commensurate with or greater than an outer diameter of the stylet body.

5. The alignment-indicating device according to any of claims 1-3, wherein the device body approximates a frustum, a longitudinal through hole through the device body having an inner diameter commensurate with an outer diameter of the stylet body.

6. The alignment-indicating device according to any of claims 1-3, wherein the device body approximates a cylinder, a longitudinal through hole through the device body having an inner diameter commensurate with an outer diameter of the stylet body.Docket No. 101672.0640PCT7. The alignment-indicating device according to either claim 5 or 6, wherein the through hole includes a curvilinear flare extending from the contacting surface of the device body through a proximal end of the device body, a distal end of the device body, or each of the proximal end and the distal end of the device body, the curvilinear flare configured to provide strain relief to the stylet when the stylet extends through the curvilinear flare.

8. The alignment-indicating device according to any of the preceding claims, wherein the device body includes one or more grasp tabs extending from the device body, thereby allowing the clinician to grasp the grasp tab(s) when adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

9. The alignment-indicating device according to any of the preceding claims, wherein the device body includes one or more recesses in the device body, thereby allowing the clinician to hold the alignment-indicating device by way of the recess(es) when adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

10. The alignment-indicating device according to any of the preceding claims, wherein the alignment-indicating device further includes an active friction-adjusting means for actively adjusting friction between the contacting surface of the device body and the proximal portion of the stylet before adjusting the position of the alignment-indicating device about the proximal portion of the stylet.

11. The alignment-indicating device according to claim 10, wherein the active friction-adjusting means includes a friction hitch around the device body, the friction hitch reducing friction between the contacting surface of the device body and the proximal portion of the stylet when loosened, and the friction hitch increasing friction between the contacting surface of the device body and the proximal portion of the stylet when tightened.

12. The alignment-indicating device according to claim 10, wherein the active friction-adjusting means includes a beaded-tie fastening device around the device body, the beaded-tie fastening device reducing friction between the contacting surface of the device body and the proximal portion of the stylet when loosened, and the beaded-tie fastening device increasing friction between the contacting surface of the device body and the proximal portion of the stylet when tightened.Docket No. 101672.0640PCT13. The alignment-indicating device according to any of the preceding claims, wherein the alignment-indicating device further includes a strain-relief boot extending from a proximal portion of the device body, a distal portion of the device body, or each of the proximal portion and the distal portion of the device body, the strain-relief boot configured to provide strain relief to the stylet when the stylet extends through the strain-relief boot.

14. The alignment-indicating device according to any of claims 1-3 and 5-7, wherein the alignment-indicating device further includes a rigid housing in which the device body is disposed.

15. The alignment-indicating device according to claim 14, wherein the rigid housing includes a cavity in a distal portion of the rigid housing, the cavity configured to accommodate therein a fluid fitting of the catheter.

16. The alignment-indicating device according to claim 15, wherein the cavity of the rigid housing has an inner diameter commensurate with or greater than an outer diameter of the fluid fitting of the catheter, thereby providing sufficient friction to maintain the fluid fitting of the catheter in the cavity of the rigid housing upon insertion by the clinician after aligning distal ends of the stylet and a catheter.

17. The alignment-indicating device according to claim 15, wherein the rigid housing includes one or more threads lining the cavity, the one or more threads complementary to that of the fluid fitting of the catheter such that the alignment-indicating device screws onto the fluid fitting of the catheter, thereby axially compressing the device body in the rigid housing and radially compressing the device body around the proximal portion of the stylet.

18. An alignment-indicating device for a stylet, comprising:a pair of flexible jaws joined together at a hinged end of the pair of jaws by a living hinge, each jaw of the pair of jaws including:a contacting surface facing the other jaw of the pair of jaws, the contacting surface configured to contact an external surface of a stylet body of the stylet; anda length sufficient to flexibly surround at least half the stylet body of the stylet; anda closure mechanism at an open-ended end of the pair of jaws opposite the hinged end, the contacting surfaces of the pair of jaws having sufficientDocket No. 101672.0640PCTfriction to maintain the alignment-indicating device in position about a proximal portion of the stylet upon placement there and subsequent closure of the closure mechanism by a clinician after aligning distal ends of the stylet and a catheter, the alignment-indicating device obviating any kinking or bending of the proximal portion of the stylet by the clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter in a patient.

19. The alignment-indicating device according to claim 18, wherein the pair of j aws consist of a biocompatible polypropylene or polyethylene, optionally, lined with an elastomer for the contacting surfaces.

20. A method of using an alignment-indicating device for a stylet, comprising: obtaining the alignment-indicating device, the alignment-indicating device including:an elastomeric device body configured to at least partially encircle a stylet body of the stylet; anda contacting surface of the device body configured to contact an external surface of the stylet body;inserting the stylet into the alignment-indicating device;temporarily positioning the alignment-indicating device about a proximal portion of the stylet;inserting a distal portion of the stylet into a lumen of a catheter;aligning distal ends of the stylet and the catheter;repositioning the alignment-indicating device about the proximal portion of the stylet with the distal ends of the stylet and the catheter aligned, the contacting surface of the device body having sufficient friction to maintain the alignment-indicating device in position about the proximal portion of the stylet while placing the catheter in a patient, and the alignmentindicating device obviating any kinking or bending of the proximal portion of the stylet by a clinician for indicating misalignment of the distal ends of the stylet and the catheter while placing the catheter the patient; and placing the catheter in the patient.

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