System and method for vibrating standing fluid in an iv catheter assembly

Abstract

Provided herein is a system including an IV catheter assembly with a catheter having a distal end positionable intravenously within a patient and a port providing fluid access to the catheter, wherein a lumen of the catheter may retain a fluid therein. The system also includes a device connected to the IV catheter assembly and configured to cause vibration of the fluid. The device includes a connector configured to couple the device to the port of the IV catheter assembly and an actuating element configured to cause oscillations or vibrations within the fluid, wherein the oscillations or vibrations within the fluid prevent attachment of occlusions and / or a biofilm within the lumen of the catheter.

Description

SYSTEM AND METHOD FOR VIBRATING STANDING FLUID IN AN IVCATHETER ASSEMBLYCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 584,302 entitled “System and Method for Vibrating Standing Fluid in an IV Catheter Assembly” filed September 21, 2023, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to intravenous (IV) catheters and, more specifically, to devices for use with IV catheters that prevent the adherence of blood clots and / or biofilms within the catheter.Description of Related Art

[0003] Vascular access devices (VADs) are used in the medical field to access peripheral and / or central vasculature of a patient for purposes of infusion therapy and / or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. The VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years).

[0004] Some of the most common complications associated with indwelling intravenous (IV) catheters are the issues of catheter occlusion / blockage and the risk of contamination of the IV catheter that may lead to transmitting of a catheter related bloodstream infection (CRBSI) to a patient.

[0005] With regard to the occlusion of the IV catheter, it is recognized that blood clots or other thrombotic occlusions may attach to the inner wall or surface of the IV catheter, either along a length of the catheter or at the tip of the catheter. As a result of such catheter occlusions, the IV catheter may need to be removed from the patient, with it being recognized that such catheter removal is time consuming, uncomfortable for the patient, and expensive due to increased length of stay and therapy interruptions.

[0006] With regard to contamination of the IV catheter, it is common for microbial biofilms to develop on the inner wall or surface of the IV catheter. In the development of such biofilms,bacteria may aggregate and proliferate on the inner wall or surface of the IV catheter, with the bacteria excreting an encasing exopolysaccharide ‘slime’ that consolidates their attachment to IV catheter wall and the microaggregates differentiating into characteristic biofilms.

[0007] Several methods exist for preventing the formation of blood clots and biofilms within an IV catheter. As a first example, regular flushing of the IV catheter with saline or heparin may be employed to prevent the build-up of blood clots and bacterial microorganisms that can lead to biofilm formation. However, such flushing of the IV catheter is labor intensive for healthcare providers (as they must continuously monitor the saline levels and reinstall new saline bags when required), and the patient must be connected to the line at all times. As a second example, antimicrobial catheters may be used that are designed to release agents that prevent the growth of bacteria and other microorganisms, which can help to prevent biofilm formation. However, the antimicrobial effects of catheters may wear off with time. As a third example, antibiotic lock therapy may be used with the IV catheter, which involves instilling an antibiotic solution into the IV catheter lumen and leaving it in place for a specific duration in order to prevent the growth of bacteria and other microorganisms. However, overexposure to antibiotics may lead to an increase in antibiotic resistant microorganisms, i.e., bacterial spores.

[0008] Accordingly, a need exists in the art for an apparatus that provides for treatment / prevention of occlusions and biofilms within an indwelling IV catheter.SUMMARY OF THE INVENTION

[0009] Provided herein is a system including an IV catheter assembly with a catheter having a distal end positionable intravenously within a patient and a port providing fluid access to the catheter, wherein a lumen of the catheter may retain a fluid therein. The system also includes a device connected to the IV catheter assembly and configured to cause vibration of the fluid. The device includes a connector configured to couple the device to the port of the IV catheter assembly and an actuating element configured to cause oscillations or vibrations within the fluid, wherein the oscillations or vibrations within the fluid prevent attachment of occlusions and / or a biofilm within the lumen of the catheter.

[0010] In some embodiments, the device comprises a wearable device including an attachment member configured to retain the wearable device on a user.

[0011] In some embodiments, the attachment member comprises one of an adhesive pad and an armband.

[0012] In some embodiments, the device further includes a housing enclosing the actuating element and secured to the attachment member, a printed circuit board positioned within thehousing and configured to control operation of the actuating element, and a power source positioned within the housing and configured to provide power to both the printed circuit board and the actuating element.

[0013] In some embodiments, the connector includes a connecting tube comprising a distal end and a proximal end, with the proximal end positioned within the housing and the distal end positioned outside of the housing, and a luer connection comprising a distal connector and a proximal connector, the distal connector attached to the port and the proximal connector attached to the distal end of the connecting tube.

[0014] In some embodiments, the actuating element includes an electric motor and a cam module operably connected to the electric motor, wherein operation of the electric motor causes the cam module to repeatedly pinch and release the proximal end of the connecting tube, thereby causing a pressure differential within the connecting tube that, in turn, causes the oscillations or vibrations of the fluid.

[0015] In some embodiments, the device comprises a cap connected to the port of the IV catheter assembly.

[0016] In some embodiments, the cap includes a cap body comprising an outer body and a tapered protrusion positioned within the outer body, the cap body comprising the connector, a printed circuit board secured to a proximal end of the cap body and configured to control operation of the actuating element, and a power source positioned on the printed circuit board and configured to provide power to both the printed circuit board and the actuating element.

[0017] In some embodiments, the actuating element includes a pair of leads extending out from the printed circuit board and through a cavity within the tapered protrusion, a piezoelectric actuator positioned at a distal end of the tapered protrusion and electrically connected to the pair of leads, the piezoelectric actuator configured to vibrate when power is provided thereto via the pair of leads, and a diaphragm coupled with the piezoelectric actuator and affixed to the distal end of the tapered protrusion, the diaphragm configured to expand and contract responsive to vibration of the piezoelectric actuator, thereby causing the oscillations or vibrations of the fluid.

[0018] In some embodiments, the cap further comprises a disinfecting member disposed within the outer body and positioned about the tapered protrusion, the absorbent disinfecting member including a disinfecting solution therein.

[0019] In some embodiments, the actuating element is controllable to tune an amplitude and frequency of the oscillations or vibrations of the fluid.

[0020] In some embodiments, the oscillations or vibrations of the fluid can be continuous or pulsed.

[0021] Also provided herein is a method for preventing adhesion of a biofilm and / or thrombus within a lumen of an indwelling IV catheter. The method includes providing an IV catheter assembly including a catheter having a distal end positionable intravenously within a patient and a port providing fluid access to the catheter, wherein a lumen of the catheter may retain a fluid therein. The method also includes coupling a vibrational device to the IV catheter assembly, the device comprising a connector configured to couple the device to IV catheter assembly and an actuating element configured to cause oscillations or vibrations within the fluid. The method also includes powering-on the vibrational device, so as to cause the actuating element to directly introduce oscillations or vibrations into the fluid, with the oscillations or vibrations within the fluid preventing an attachment of occlusions and / or a biofilm within the lumen of the catheter.

[0022] In some embodiments, the fluid comprises saline, heparin, blood, or a mixture thereof, and wherein the method further comprises injecting the saline and / or heparin into the IV catheter assembly, prior to coupling of the vibrational device to the IV catheter assembly.

[0023] In some embodiments, coupling the vibrational device to the IV catheter assembly includes coupling a cap to the port, the cap comprising a cap body comprising an outer body and a tapered protrusion positioned within the outer body, a printed circuit board secured to a proximal end of the cap body and configured to control operation of the actuating element, and a power source positioned on the printed circuit board and configured to provide power to both the printed circuit board and the actuating element, wherein the cap includes the actuating element therein, with the actuator element comprising a pair of leads extending out from the printed circuit board and through a cavity within the tapered protrusion, a piezoelectric actuator positioned at a distal end of the tapered protrusion and electrically connected to the pair of leads, the piezoelectric actuator configured to vibrate when power is provided thereto via the pair of leads, and a diaphragm coupled with the piezoelectric actuator and affixed to the distal end of the tapered protrusion, the diaphragm configured to expand and contract responsive to vibration of the piezoelectric actuator, thereby causing the oscillations or vibrations of the fluid.

[0024] In some embodiments, coupling the vibrational device to the IV catheter assembly includes coupling a wearable device to the port, the wearable device comprising a housing enclosing the actuating element and secured to the attachment member, a printed circuit board positioned within the housing and configured to control operation of the actuating element, and a power source positioned within the housing and configured to provide power to both theprinted circuit board and the actuating element, wherein the wearable device also includes the connector, the connector comprising a connecting tube comprising a distal end and a proximal end, with the proximal end positioned within the housing and the distal end positioned outside of the housing, and a luer connection comprising a distal connector and a proximal connector, the distal connector attached to the port and the proximal connector attached to the distal end of the connecting tube, and wherein the wearable device also includes the actuating element, the actuating element comprising an electric motor and a cam module operably connected to the electric motor, wherein operation of the electric motor causes the cam module to repeatedly pinch and release the proximal end of the connecting tube, thereby causing a pressure differential within the connecting tube that, in turn, causes the oscillations or vibrations of the fluid.

[0025] In some embodiments, the method further includes controlling the actuating element to tune an amplitude and / or frequency of the oscillations or vibrations of the fluid, so as to prevent an attachment of occlusions and / or biofilm within the lumen of the catheter.

[0026] In some embodiments, the method further includes controlling the actuating element such that the oscillations or vibrations of the fluid are continuous or pulsed.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 is a perspective view of an IV catheter assembly, with which embodiments of the present disclosure may be employed;

[0028] FIG. 2 is a perspective view of a device for vibrating a fluid within the IV catheter assembly of FIG. 1, according to an aspect of the present disclosure;

[0029] FIG. 3 shows an exploded view of the device of FIG. 2;

[0030] FIG. 4 shows a top view of the device of FIG. 2;

[0031] FIG. 5 is a perspective view of a device for vibrating a fluid within the IV catheter assembly of FIG. 1, according to another aspect of the present disclosure;

[0032] FIG. 6 is a perspective view of a cap for vibrating a catheter lock solution within the IV catheter assembly of FIG. 1, according to another aspect of the present disclosure;

[0033] FIG. 7 is a cross-sectional view of the cap and the IV catheter assembly of FIG. 6, according to an aspect of the present disclosure;

[0034] FIG. 8 is an exploded view of the cap of FIG. 7;

[0035] FIG. 9 is a cross-sectional view of the cap and the IV catheter assembly of FIG. 6, according to another aspect of the present disclosure;

[0036] FIG. 10 is an exploded view of the cap of FIG. 9;

[0037] FIG. 11 is a perspective view of a cap for vibrating a catheter lock solution within an IV catheter assembly, according to another aspect of the present disclosure; and

[0038] FIG. 12 is a cross-sectional view of the cap and the IV catheter assembly of FIG. 11.DESCRIPTION OF THE INVENTION

[0039] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, equivalents, variations, and alternatives are intended to fall within the spirit and scope of the present invention.

[0040] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0041] As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device being manipulated by the user would be the proximal end of the device.

[0042] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0043] As used herein, “at least one of’ is synonymous with “one or more of.” For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0044] Provided herein are devices for maintaining patency of an indwelling IV catheter, such as a peripherally inserted central catheter (PICC) or central venous catheter (CVC) as nonlimiting examples, with the devices operating to vibrate catheter lock solution within the IVcatheter, so as to prevent the adherence of blood clots / biofilms within the catheter. While certain vascular access devices (VADs) or catheter assemblies are discussed below and exemplified in the attached drawings with which such devices may be implemented, those of skill will appreciate that any number of different VADs and / or catheter assemblies may be used within the scope of the present disclosure.

[0045] Reference is first made to FIG. 1, which depicts an intravenous (IV) catheter assembly 10 with which aspects of the disclosure may be implemented, according to a nonlimiting embodiment. The IV catheter assembly 10 includes a catheter tube 12 having a distal end 14 that may be inserted transcutaneously through the skin of a patient at an insertion site. The IV catheter assembly 10 also includes a hub 16 coupled to a proximal end 18 of the catheter tube 12. In the illustrated embodiment, the hub 16 is configured as a bifurcation hub 16, with the catheter assembly 10 further including a plurality of extension legs 20 that operably connect, via the bifurcation hub 16, to a corresponding number of lumens defined by the catheter tube 12. In some embodiments, a clamp 21 may be provided on each extension leg 20 to control a flow of fluid therethrough by selectively sealing off the extension leg 20.

[0046] Each of the extension legs 20 includes a luer hub 22 positioned at a proximal end 24 thereof, with the luer hub providing a (input) port to the IV catheter assembly 10. As used herein, a “luer” hub refers to a connector that includes a tapered portion (i.e., a luer taper) for creating a friction engagement between a tapered stem or elongated member of a male luer connector and a tapered cavity. Each luer hub 22 is configured as a female luer connection having a tapered cavity 26 configured to receive and engage a tapered stem or elongated member of a male luer connector, as well as a threaded outer surface 28 configured to engage threads on the inner surface of an annular shield of the male luer connector.

[0047] While hub 16 is shown in FIG. 1 as a bifurcation hub 16, in other embodiments, the hub may be a singular hub 16 having a luer hub 22 formed directly thereon at its proximal end. As described above, such a luer hub 22 is configured as a female luer connection having a tapered cavity 26 configured to receive and engage a tapered stem or elongated member of a male luer connector.

[0048] In still other embodiments, the IV catheter assembly 10 may include a catheter adapter (e.g., a y-adapter) rather than a hub 16. Such a catheter adapter may include one or more extension legs extending proximally therefrom, with such extension legs 20 including a luer hub 22 at the proximal end thereof, as previously described.

[0049] It is recognized that embodiments of the disclosure, as described here below, may be incorporated in and / or used with any of the catheter assemblies as described above, or with stillother catheter assemblies not described herein. Thus, it is understood that aspects of the disclosure are not meant to be limited to use only with the specific catheter assemblies described here below.

[0050] Referring now to FIG. 2, shown is a non-limiting embodiment of a system 30 that includes the catheter assembly 10 of FIG. 1, along with a vibrational device 32 that may be used with the catheter assembly 10 to prevent the buildup of occlusions and / or biofilms within the catheter tube 12 and / or extension legs 20. That is, the device 32 may operate to introduce oscillations or vibrations into a standing column of fluid contained or locked within the catheter assembly 10, with the oscillations or vibrations introduced into the fluid acting to prevent attachment of occlusions and / or a biofilm within the catheter tube 12 and / or extension leg 20. The fluid may be in the form of a saline solution or other catheter lock solution (e.g., heparin) injected into the catheter assembly 10 via a fluid introducing device (i.e., syringe), with it recognized that blood retained in the catheter tube 12 may also mix with the saline / heparin to provide an overall standing column of fluid within the catheter assembly 10. The fluid may be introduced into the catheter assembly 10 following a blood draw procedure or injection of a medicament into a patient, with the fluid flushing the luer hub 22 (or a needle-free connector coupled thereto) and being received within with fluid lumens in the catheter assembly 10 (i.e., fluid lumens in the extension leg 20 and catheter tube 12).

[0051] As shown in FIG. 2 and also in FIGS. 3-5, device 32 is configured as a small, wearable device that may be connected to the IV catheter assembly via a connector 34 that, in the illustrated embodiment, is a double-sided male luer connection. The connector 34 may include a distal male luer connection 36 that mates with luer hub 22 and a proximal male luer connection 38 that mates with the device 32. The wearable device 32 includes an attachment member 40 that may be secured to the body of a patient. In one embodiment, the attachment member 40 is provided as an adhesive pad 40a (FIGS. 2 and 3) that is applied to the skin of the patient, while in another embodiment the attachment member 40 is provided as an arm band 40b (FIG. 5) that is secured onto an arm of the patient.

[0052] In addition to attachment member 40, wearable device includes a housing 42 secured to the attachment member 40, with the housing 42 containing therein a printed circuit board (PCB) 44, a power source (e.g., battery) 46, and an actuating element 48. A connecting tube 50 extends out from the housing 42, with a proximal end 52 of the connecting tube 50 positioned within housing 42 and positioned adjacent to the actuating element 48 and a distal end 54 positioned outside of the housing 42 and secured to the proximal male luer connection

[0053] According to aspects of the disclosure, the actuating element 48 of device 32 includes an electric motor 56 and an associated cam module 58 that is operably connected to the electric motor 56. The electric motor 56 receives power from power source 46 and may be operatively controlled via signals received from PCB 44, which may include one or more processors or control modules, input devices, and electrical connections thereon, as known in the art. When powered-on and activated, the electric motor 56 causes the cam module 58 to actuate, such as by rotating the cam module 58. Rotation of the cam module 58 causes the cam module 58 to repeatedly come into contact with the proximal end 52 of the connecting tub 50, which is secured to housing 42 and positioned so as to be immediately adjacent the cam module 58. In particular, rotation of the cam module 58 causes the cam module 58 to repeatedly pinch and release the proximal end 52 of the connecting tube 50. This pinching and releasing of the connecting tube 50 generates a pressure differential within the connecting tube 50 that, in turn, introduces oscillations or vibrations into the standing column of fluid in the catheter assembly 10, which was previously introduced into (and is contained within) the catheter assembly 10 - i.e., within the extension leg 20 and catheter tube 12. The actuating element 48 thus functions to oscillate / vibrate the intraluminal fluid with respect to the stationary tubing of the extension leg 20 and catheter tube 12, with the effect being that the adherence of biofilm or blood clots within the fluid lumens of the catheter assembly 10 is prevented, so as assist in maintaining the patency of the IV catheter assembly 10.

[0054] Referring now to FIG. 6, shown is another non-limiting embodiment of a system 60 that includes the catheter assembly 10 of FIG. 1, along with a device 62 that may be used with the catheter assembly 10 to prevent the buildup of occlusions and / or biofilms within the catheter tube 12 and / or extension legs 20. As previously described, the device 62 may operate to introduce oscillations or vibrations into a fluid contained or locked within the catheter assembly 10, with the oscillations or vibrations introduced into the fluid acting to prevent attachment of occlusions and / or a biofilm within the catheter tube 12 and / or extension leg 20.

[0055] As shown in FIG. 6 and also in FIGS. 7 and 8, device 62 is configured as a vibrational cap (hereafter “cap 62”) that may be connected to the IV catheter assembly 10 when not in use. As shown in FIG. 6, the cap 62 may mate with a luer hub 22 of the IV catheter assembly 10 of FIG. 1. The cap 62 includes a cap body 64 that may be formed as a generally cylindrical member that includes a top wall 66, a sidewall 68, a protrusion 70 extending down from the top wall 66, and an open bottom end 72 formed by the sidewall 68. According to embodiments, the protrusion 70 is integrally formed with the top wall 66 and sidewall 68, so as to provide a single, unitary cap body 64 that may be easily manufactured. For example, the cap body 64can be formed from a thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene, such that the cap body 64 may be formed via an injection molding process, according to some embodiments.

[0056] The protrusion 70 of cap body 64 may be configured as a tapered member (i.e., a luer taper) configured to interfit with a tapered cavity of a female luer connection, such as a tapered cavity of luer hub 22. The protrusion 70 may further be configured as a hollow member through which components of the cap may be routed, as explained in further detail below. Additionally, the protrusion 70 may have a height that is greater than that of the sidewall 68, such that the protrusion 70 extends out past the open bottom end 72 of cap body 64. In other embodiments, the protrusion 70 could extend down so as to be flush with the open bottom end 72.

[0057] The cap body 64 is configured such that the top wall 66, sidewall 68, and protrusion 70 collectively define or form an inner cavity 74 of the cap body 64, with the open bottom end 72 of the cap body 64 presenting an opening 46 to the cavity 74 that provides for positioning of the luer hub 22 within the cavity 74. The shape of the top wall 66 and sidewall 68, along with the extending of protrusion 70 down from the top wall 66 at a location aligned with a central axis of the cap 62, results in the cavity 74 having a generally annular shape. The cap 62 is thus recognized as being structured as a male luer connection, with the protrusion 70 providing a tapered stem of the connection and the sidewall 68 (that is spaced apart from protrusion 70) providing an annular shield extending about the tapered protrusion 70.

[0058] According to some aspects of the disclosure, the sidewall 68 of the cap body 64 may have a threaded inner surface that engages and interlocks with a threaded outer surface (or segment) 28 of the luer hub 22. In order to secure the cap 62 to the luer hub 22, the cap 62 is twisted relative to the luer hub 22, so as to cause the corresponding threaded surfaces to engage and draw the luer hub 22 together with the cap 62.

[0059] As shown in FIGS. 7 and 8, cap 62 also includes a PCB 76, a power source 78 (e.g., battery), and an actuating element 80 incorporated therein. According to aspects of the disclosure, the actuating element 80 includes a piezoelectric actuator 82 that is connected to the power source and PCB 76 via a pair of leads 84, with the piezoelectric actuator 82 connected to a diaphragm 86 (of actuating element 80) that is selectively expanded and contracted responsive to vibration of the piezoelectric actuator 82, as explained in further detail below.

[0060] Cap 62 is constructed such that the PCB 76 is secured to the top wall 66 of cap body 64. In some embodiments, a cover 88 may be positioned over the PCB 76 (and secured to top wall 66) in order to provide environmental protection thereto. The PCB 76 may include oneor more processors or control modules, input devices, and electrical connections thereon, as known in the art, with the power source 78 positioned on the PCB 76 to provide power thereto. The leads 84 of actuating element 80 are connected to the PCB 76, with the leads 84 extending outwardly therefrom and being routed through a hollow interior 90 of protrusion 70, such that they may extend generally extend from the top wall 66 of cap 62 down to the open bottom end 72 of cap 62. The pair of leads 84 is connected at the far end thereof to terminals of the piezoelectric actuator 82, which is also positioned within the hollow interior 90 of protrusion 70. The diaphragm 86 is secured to an opposing surface of the piezoelectric actuator 82 (from leads 84), with the diaphragm 86 further affixed / sealed to the end of protrusion 70 so as to close off the hollow interior of the protrusion 70 and provide a fluid-tight connection between the cap 62 and the luer hub 22.

[0061] In order to operate the cap 62 to introduce vibrations into the standing column of fluid in catheter assembly 10, the cap 62 is first powered-on and activated such that the PCB 76 drives a signal waveform to actuate the piezoelectric actuator 82. The signal waveform is transmitted to the piezoelectric actuator 82 via leads 84, with the signal waveform causing the piezoelectric actuator 82 to expand and contract (i.e., vibrate), which in turn pushes the diaphragm 86 back and forth. The back and forth movement of the diaphragm 86 causes a corresponding push and pull over the fluid in the IV catheter assembly 10 (in extension leg 20 and catheter tube 12), therefore causing the fluid to vibrate (i.e., a microliter vibration). The actuating element 80 thus functions to oscillate / vibrate the intraluminal fluid with respect to stationary tubing of the extension leg 20 and catheter tube 12, with the effect being that the adherence of biofilm or thrombus (blood clots) within the fluid lumens of the catheter assembly 10 is prevented, so as assist in maintaining the patency of the IV catheter assembly 10.

[0062] According to some embodiments, the operation of the actuating element 80 module may be selectively controlled to create different modes of vibrational movement of the fluid. For example, via actuation signals provided to the piezoelectric actuator 82 (from PCB 76), the piezoelectric actuator 82 may be controlled to tune an amplitude and frequency of the vibrations generated in the fluid. In some embodiments, the piezoelectric actuator 82 may be controlled to generate continuous or pulsed vibrations in the fluid, as determined to best prevent formation of biofilm or blood clots within the fluid lumens of the catheter assembly 10.

[0063] In some embodiments, the cap 62 described above may be configured as a disinfecting cap that that contains an amount of cleaning or disinfecting solution for sterilizing portions of the luer hub 22 (or other port or valve) to which it is connected. Referring now to FIGS. 9 and 10, a disinfecting cap 92 is illustrated according to another embodiment. Thedisinfecting cap 92 is almost identical to the cap 62 shown and described in FIGS. 7 and 8 (i.e., the disinfecting cap 92 is also a vibrational cap), except that a disinfecting member 94 is also included in the disinfecting cap 92. The disinfecting member 94 includes a disinfecting solution contained therein that is configured to disinfect portions of the luer hub 22 upon mating of the disinfecting cap 92 therewith.

[0064] As shown in FIGS. 9 and 10, the disinfecting member 94 is an annular structure positioned within the cavity 74 of the cap body 64. The disinfecting member 94 is positioned about the protrusion 70 of cap body 64, with the protrusion 70 inserted through an opening 96 in the disinfecting member 94. The disinfecting member 94 is held in an upper portion of the cavity 74, such that the disinfecting member 94 may be positioned adjacent the top wall 66 of the cap body 64, with the disinfecting member 94 extending down to fill a portion of the cavity 74.

[0065] The disinfecting member 94 can be formed from an absorbent material capable of absorbing a cleaning or disinfecting solution for cleaning and / or disinfecting portions of the luer hub 22. In some examples, the disinfecting member 94 can comprise a porous foam (e.g., an open cell foam) or sponge capable of absorbing the cleaning or disinfecting solution. In other examples, the foam material can be a polyurethane foam, as known in the art, including an open cell structure capable of absorbing a disinfectant or cleaning solution. In other embodiments, the material of the disinfecting member 94 can be abrasive with sufficient texture, friction, and / or anti-slip properties to scrub surfaces of the luer hub 22 to mechanically remove microbes, debris, and other contaminants from surfaces of the luer hub 22. For example, the disinfecting member 94 can comprise a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0066] The disinfecting member 94 can be provided (i.e., presoaked) with the cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antimicrobial, anti-fungal, antibacterial, or antiviral solution that sterilizes surfaces of the luer hub 22. In some examples, the cleaning solution can be isopropyl alcohol (IPA), such as about 70% IPA. In other examples, the cleaning solution can be about 0.5% to about 3.5% chlorhexidine gluconate in combination with about 70% IPA. A chlorohexidine composition may be beneficial because it has a slower evaporation rate than IPA and, therefore, provides a more persistent disinfectant activity after the disinfecting cap 92 is removed from the luer hub 22 and before an additional connector (e.g., needleless connector) and associated component of a vascular access device (VAD) is connected to the luer hub 22.

[0067] As the disinfecting member 94 is formed from a porous foam, sponge, or other elastomeric material, the disinfecting member 94 is configured as compressive member. Accordingly, when the disinfecting cap 92 is mated with the female connection of luer hub 22, the luer hub 22 may compress the disinfecting member 94 when drawn into the cavity 74 via mating of the threaded outer surface 28 of luer hub 22 with the threaded inner surface of cap body 64. Compression of the disinfecting member 94 releases cleaning or disinfecting solution from the disinfecting member 94, with it being recognized that the amount of disinfecting solution released from the disinfecting member 94 may be controlled based on how much the disinfecting member 94 is compressed (based on an initial height / thickness of the disinfecting member 94) and the amount of cleaning or disinfecting solution contained therein.

[0068] Disinfecting cap 92 also includes a PCB 76, a power source 78 (e.g., battery), and an actuating element 80 incorporated therein, as previously described with cap. Disinfecting cap 92 is constructed such that the PCB 76 is secured to the top wall 66 of cap body 64 and may include one or more processors or control modules, input devices, and electrical connections thereon, as known in the art, with the power source 78 positioned on the PCB 76 to provide power thereto. The leads 84 of actuating element 80 are connected to the PCB 76, with the leads 84 extending outwardly therefrom and being routed through the hollow interior 90 of protrusion 70, such that they may extend generally extend from the top wall 66 of cap down to the open bottom end 72 of the disinfecting cap 92. The pair of leads 84 is connected at the far end thereof to terminals of the piezoelectric actuator 82, which is also positioned within the hollow interior 90 of protrusion 70. The diaphragm 86 is secured to an opposing surface of the piezoelectric actuator 82 (from leads 84), with the diaphragm 86 further affixed / sealed to the end of protrusion 70 so as to close off the hollow interior of the protrusion 70 and provide a fluid-tight connection between the disinfecting cap 92 and the luer hub 22.

[0069] In order to operate the disinfecting cap 92 to introduce vibrations into the standing column of fluid, the disinfecting cap 92 is first powered-on and activated such that the PCB 76 drives a signal waveform to actuate the piezoelectric actuator 82. The signal waveform is transmitted to the piezoelectric actuator 82 via leads 84, with the signal waveform causing the piezoelectric actuator 82 to expand and contract (i.e., vibrate), which in turn pushes the diaphragm 86 back and forth. The back and forth movement of the diaphragm 86 causes a corresponding push and pull over the fluid in the IV catheter assembly 10 (in extension leg 20 and catheter tube 12), therefore causing the fluid to vibrate (i.e., a microliter vibration). The actuating element 80 thus functions to oscillate / vibrate the intraluminal fluid with respect to stationary tubing of the extension leg 20 and catheter tube 12, with the effect being that theadherence of biofilm or thrombus (blood clots) within the fluid lumens of the catheter assembly 10 is prevented, so as assist in maintaining the patency of the IV catheter assembly 10.

[0070] While embodiments of the caps 62, 92 in FIGS. 6-8 and FIGS. 9 and 10 are shown and described as being coupled directly to a luer hub 22 of IV catheter assembly 10, it is recognized that the caps 62, 92 may be secured to other ports or connectors of the IV catheter assembly 10. As shown in FIGS. 11 and 12, in some embodiments, either of caps 62, 92 may be mated with a needle-free connector 100. The needle-free connector 100 may generally include a male luer connection 102, a female luer connection 104, and a septum 106 (including a slit), with the septum 106 configured to receive and engage a corresponding tapered stem or elongated member of a male luer connection (such as that on cap 62, 92). The male luer connection 102 of needle-free connector 100 may be connected to the luer hub 22, while the female luer connection 104 may be connectable to a device or component useable with the IV catheter assembly 10, such as a syringe or other fluid transfer device (e.g., blood draw device).

[0071] The cap 62, 92 may be coupled to the female luer connection 104 of the needle-free connector 100. As described in detail above, the cap 62, 92 is operable to introduce vibrations into the standing column of fluid, with it recognized that some fluid may be present within the needle-free connector 100 (and retained therein by the septum 106 when closed). The cap 62, 92 may be operated to introduce vibrations into the standing column of fluid, as described in detail above, with the vibrations preventing a buildup and adherence of biofilm or thrombus (blood clots) within the fluid lumens of the catheter assembly 10, so as assist in maintaining the patency of the IV catheter assembly 10.

[0072] Beneficially, embodiments of the disclosure described herein provide systems and methods for maintaining patency of an indwelling IV catheter, such as a peripherally inserted central catheter (PICC) or central venous catheter (CVC) as non-limiting examples, with the systems / methods operating to vibrate a catheter lock solution within the IV catheter, so as to prevent the adherence of blood clots / biofilms within the catheter.

[0073] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS1. A system comprising: an intravenous (IV) catheter assembly including a catheter having a distal end positionable intravenously within a patient and a port providing fluid access to the catheter, wherein a lumen of the catheter may retain a fluid therein; and a device connected to the IV catheter assembly and configured to cause vibration of the fluid, the device comprising: a connector configured to couple the device to the port of the IV catheter assembly; and an actuating element configured to cause oscillations or vibrations within the fluid; wherein the oscillations or vibrations within the fluid prevent attachment of occlusions and / or a biofilm within the lumen of the catheter.

2. The system of claim 1, wherein the device comprises a wearable device including an attachment member configured to retain the wearable device on a user.

3. The system of claim 2, wherein the attachment member comprises one of an adhesive pad and an armband.

4. The system of claim 2, wherein the device further comprises: a housing enclosing the actuating element, the housing secured to the attachment member; a printed circuit board positioned within the housing and configured to control operation of the actuating element; and a power source positioned within the housing and configured to provide power to both the printed circuit board and the actuating element.

5. The system of claim 4, wherein the connector comprises: a connecting tube comprising a distal end and a proximal end, with the proximal end positioned within the housing and the distal end positioned outside of the housing; and a luer connection comprising a distal connector and a proximal connector, the distal connector attached to the port and the proximal connector attached to the distal end of the connecting tube.

6. The system of claim 5, wherein the actuating element comprises: an electric motor; and a cam module operably connected to the electric motor; wherein operation of the electric motor causes the cam module to repeatedly pinch and release the proximal end of the connecting tube, thereby causing a pressure differential within the connecting tube that, in turn, causes the oscillations or vibrations of the fluid.

7. The system of claim 1, wherein the device comprises a cap connected to the port of the IV catheter assembly.

8. The system of claim 7, wherein the cap comprises: a cap body comprising an outer body and a tapered protrusion positioned within the outer body, the cap body comprising the connector; a printed circuit board secured to a proximal end of the cap body and configured to control operation of the actuating element; and a power source positioned on the printed circuit board and configured to provide power to both the printed circuit board and the actuating element.

9. The system of claim 8, wherein the actuating element comprises: a pair of leads extending out from the printed circuit board and through a cavity within the tapered protrusion; a piezoelectric actuator positioned at a distal end of the tapered protrusion and electrically connected to the pair of leads, the piezoelectric actuator configured to vibrate when power is provided thereto via the pair of leads; anda diaphragm coupled with the piezoelectric actuator and affixed to the distal end of the tapered protrusion, the diaphragm configured to expand and contract responsive to vibration of the piezoelectric actuator, thereby causing the oscillations or vibrations of the fluid.

10. The system of claim 1, wherein the cap further comprises a disinfecting member disposed within the outer body and positioned about the tapered protrusion, the absorbent disinfecting member including a disinfecting solution therein.

11. The system of claim 1, wherein the actuating element is controllable to tune an amplitude and frequency of the oscillations or vibrations of the fluid.

12. The system of claim 11, wherein the oscillations or vibrations of the fluid can be continuous or pulsed.

13. The system of claim 1, wherein the IV catheter assembly comprises: a catheter hub comprising a distal end and a proximal end, the catheter coupled to the distal end of the catheter hub and extending out distally therefrom; an extension line coupled to the proximal end of the catheter hub; and a luer hub positioned at a proximal end of the extension line, the luer hub in fluid communication with the catheter through the extension line and the catheter hub.

14. The system of claim 13, wherein the port comprises one of: the luer hub; or a proximal port of a connector connected to the luer hub, the connector comprising a needle-free connector or a double-ended male luer connector.

15. A method for preventing adhesion of a biofilm and / or thrombus within a lumen of an indwelling IV catheter, the method comprising: providing an intravenous (IV) catheter assembly including a catheter having a distal end positionable intravenously within a patient and a port providing fluid access to the catheter, wherein a lumen of the catheter may retain a fluid therein; coupling a vibrational device to the IV catheter assembly, the device comprising: a connector configured to couple the device to IV catheter assembly; andan actuating element configured to cause oscillations or vibrations within the fluid; and powering-on the vibrational device, so as to cause the actuating element to directly introduce oscillations or vibrations into the fluid, with the oscillations or vibrations within the fluid preventing an attachment of occlusions and / or a biofilm within the lumen of the catheter.

16. The method of claim 15, wherein the fluid comprises saline, heparin, blood, or a mixture thereof, and wherein the method further comprises injecting the saline and / or heparin into the IV catheter assembly, prior to coupling of the vibrational device to the IV catheter assembly.

17. The method of claim 15, wherein coupling the vibrational device to the IV catheter assembly comprises coupling a cap to the port, the cap comprising: a cap body comprising an outer body and a tapered protrusion positioned within the outer body, the cap body comprising the connector; a printed circuit board secured to a proximal end of the cap body and configured to control operation of the actuating element; and a power source positioned on the printed circuit board and configured to provide power to both the printed circuit board and the actuating element; wherein the cap includes the actuating element therein, with the actuator element comprising: a pair of leads extending out from the printed circuit board and through a cavity within the tapered protrusion; a piezoelectric actuator positioned at a distal end of the tapered protrusion and electrically connected to the pair of leads, the piezoelectric actuator configured to vibrate when power is provided thereto via the pair of leads; and a diaphragm coupled with the piezoelectric actuator and affixed to the distal end of the tapered protrusion, the diaphragm configured to expand and contract responsive to vibration of the piezoelectric actuator, thereby causing the oscillations or vibrations of the fluid.

18. The method of claim 15, wherein coupling the vibrational device to theIV catheter assembly comprises coupling a wearable device to the port, the wearable device comprising: a housing enclosing the actuating element, the housing secured to the attachment member; a printed circuit board positioned within the housing and configured to control operation of the actuating element; and a power source positioned within the housing and configured to provide power to both the printed circuit board and the actuating element; wherein the wearable device also includes the connector, the connector comprising: a connecting tube comprising a distal end and a proximal end, with the proximal end positioned within the housing and the distal end positioned outside of the housing; and a luer connection comprising a distal connector and a proximal connector, the distal connector attached to the port and the proximal connector attached to the distal end of the connecting tube; and wherein the wearable device also includes the actuating element, the actuating element comprising: an electric motor; and a cam module operably connected to the electric motor; wherein operation of the electric motor causes the cam module to repeatedly pinch and release the proximal end of the connecting tube, thereby causing a pressure differential within the connecting tube that, in turn, causes the oscillations or vibrations of the fluid.

19. The method of claim 15, further comprising controlling the actuating element to tune an amplitude and / or frequency of the oscillations or vibrations of the fluid, so as to prevent an attachment of occlusions and / or biofilm within the lumen of the catheter.

20. The method of claim 15, further comprising controlling the actuating element such that the oscillations or vibrations of the fluid are continuous or pulsed.

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