Ultraviolet disinfection probe for indwelling catheters

Abstract

Provided herein is a catheter system including an intravenous catheter assembly including a catheter defining a lumen extending between a distal end and a proximal end of the catheter, and an access connector configured to provide access to the lumen of the catheter. The catheter system also includes a disinfection probe connectable to the access connector, the disinfection probe including a housing having a proximal end and a distal end, an illumination system disposed at least partially within the housing and configured to emit disinfecting ultraviolet light, and an advancement member configured to advance a portion of the illumination system into the catheter beyond the distal end of the housing in response to movement of the advancement member relative to the housing, such that when advanced therein by the advancement member, the disinfecting ultraviolet light disinfects the lumen of the catheter.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 400,241, filed August 23, 2022, entitled "Ultraviolet Disinfection Probe for Indwelling Catheters," the entire disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION Provided herein are devices and systems for use in vascular access, particularly for use in blood sampling via an indwelling catheter. [Background technology]

[0002] 2. Description of Related Art Vascular access devices (VADs) can access a patient's peripheral blood vessels. VADs can be placed for short-term (days), medium-term (weeks), or long-term (months to years). VADs can be used for infusion therapy and / or blood collection.

[0003] Common types of VADs include over-the-needle peripheral venous catheters (PIVCs), peripherally inserted central venous catheters (PICCs), central venous catheters (CVCs), and midline catheters. Currently, there are several limitations to the use of such VADs for fluid infusion and blood collection, including the introduction of blood collection devices through the VAD, which can lead to microbial introduction and catheter-related bloodstream infections (CRBSIs).

[0004] Some existing VADs employ antimicrobial barrier caps to reduce the incidence of CRBSI. These barrier caps are cleaning devices designed to keep the VAD's catheter hub / connector clean, for example by encapsulating the needleless luer valve in an antimicrobial solution. However, while barrier caps are often effective at disinfecting the catheter hub, they do not address the concern of bacteria entering the VAD's fluid pathway (catheter) outside / downstream of the catheter hub. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need in the art for devices and systems that provide for disinfection of multiple components of a VAD, including the fluid pathways outside the catheter hub, to reduce the risk of CRBSI when introducing instruments into the VAD to perform blood draws. [Means for solving the problem]

[0006] Summary of the Invention Provided herein is a catheter system including an intravenous catheter assembly including a catheter having a distal end and a proximal end and defining a lumen extending between the distal and proximal ends, and an access connector configured to provide access to the lumen of the catheter. The catheter system also includes a disinfection probe connectable to the access connector, the disinfection probe including a housing having a proximal end and a distal end, an illumination system disposed at least partially within the housing and configured to emit disinfecting ultraviolet light, and an advancement member configured to advance a portion of the illumination system into the catheter beyond the distal end of the housing in response to movement of the advancement member relative to the housing, wherein the disinfecting ultraviolet light disinfects the lumen of the catheter when advanced by the advancement member into the lumen of the catheter.

[0007] In some embodiments, the access connector includes a needleless access connector, and the disinfection probe includes a blunt cannula at a distal end of the housing that is reversibly coupleable to the needleless access connector, and the advancement member is configured to advance a portion of the illumination system through the blunt cannula and the needleless access connector and into the lumen of the catheter.

[0008] In some embodiments, the illumination system includes an ultraviolet light source disposed adjacent the proximal end of the housing and configured to emit disinfecting ultraviolet light; and an optical fiber extending distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber, wherein the advancement member is configured to advance a portion of the optical fiber beyond the distal end of the housing.

[0009] In some embodiments, the illumination system includes a coating layer covering a portion of the optical fiber, the coating layer configured to block transmission of the disinfecting ultraviolet light.

[0010] In some embodiments, the coating layer covers the entire length of the optical fiber except for the tip at the distal end of the optical fiber, and the sterilizing ultraviolet light is emitted only from the tip.

[0011] In some embodiments, the coating layer covers the length of the optical fiber and includes openings formed therein at spaced locations along the length of the optical fiber, such that the sterilizing ultraviolet light is emitted from the optical fiber only at those locations.

[0012] In some embodiments, the illumination system includes a guidewire and a light strip mounted on the guidewire, the light strip having a plurality of ultraviolet light emitting diodes (LEDs) configured to emit disinfecting ultraviolet light, and an advancement member configured to advance a portion of the guidewire and the light strip beyond the distal end of the housing.

[0013] In some embodiments, multiple ultraviolet LEDs are evenly spaced along the length of the light strip.

[0014] In some embodiments, the advancement member is configured to move along an exterior surface of the housing, the advancement member engaging the illumination system to advance portions of the illumination system beyond the distal end of the housing and into the catheter.

[0015] In some embodiments, the irradiation system includes a control system configured to selectively control the emission of the disinfecting ultraviolet light, the control system having one or more of an on / off switch, a timer, and a communication device.

[0016] In some embodiments, the illumination system is configured to emit UV-C light.

[0017] Also provided herein is a disinfection probe for disinfecting a catheter of an intravenous catheter assembly, the disinfection probe including a housing having a proximal end and a distal end, an illumination system disposed at least partially within the housing and configured to emit disinfecting ultraviolet light, and an advancing member configured to advance a portion of the illumination system beyond the distal end of the housing and into the catheter in response to movement of the advancing member relative to the housing, wherein the disinfecting ultraviolet light disinfects a lumen of the catheter when advanced into the catheter by the advancing member.

[0018] In some embodiments, the disinfection probe further includes a blunt cannula disposed at the distal end of the housing and reversibly connectable to a needleless access connector of the intravenous catheter assembly, and the advancement member is configured to advance a portion of the illumination system through the blunt cannula and the needleless access connector and into the lumen of the catheter.

[0019] In some embodiments, the illumination system includes an ultraviolet light source disposed adjacent the proximal end of the housing and configured to emit disinfecting ultraviolet light, an optical fiber extending distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber, and an advancement member configured to advance a portion of the optical fiber beyond the distal end of the housing.

[0020] In some embodiments, the illumination system includes a coating layer over a portion of the optical fiber configured to block the transmission of disinfecting ultraviolet light.

[0021] In some embodiments, the coating layer covers the entire length of the optical fiber except for the tip at the distal end of the optical fiber, and the disinfecting ultraviolet light is emitted only from the tip.

[0022] In some embodiments, the coating layer covers the length of the optical fiber and includes openings formed therein at spaced locations along the length of the optical fiber, and the sterilizing ultraviolet light is emitted from the optical fiber only at the locations of the openings.

[0023] In some embodiments, the illumination system includes a guidewire and a light strip mounted on the guidewire, the light strip having a plurality of ultraviolet light emitting diodes (LEDs) configured to emit disinfecting ultraviolet light, and an advancement member configured to advance a portion of the guidewire and the light strip beyond the distal end of the housing.

[0024] In some embodiments, multiple ultraviolet LEDs are evenly spaced along the length of the light strip.

[0025] In some embodiments, the advancement member is configured to move along an exterior surface of the housing, the advancement member engaging the illumination system to advance a portion of the illumination system beyond the distal end of the housing and into the catheter. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 is a perspective view of a non-limiting embodiment of a conventional catheter assembly useful with the disinfection probes described herein. [Figure 2] FIG. 1 is a perspective view of a sterilization probe according to one aspect or embodiment of the present disclosure. [Figure 3] FIG. 3 is an exploded view of the disinfection probe of FIG. 2. [Figure 4] FIG. 3 is a side view of an optical fiber included in the disinfection probe of FIG. 2 according to one aspect or embodiment of the present disclosure. [Figure 5]FIG. 3 is a side view of an optical fiber included in the disinfection probe of FIG. 2 according to another aspect or embodiment of the present disclosure. [Figure 6] FIG. 3 is a side view of the disinfection probe of FIG. 2 in a retracted position. [Figure 7] FIG. 3 is a side view of the disinfection probe of FIG. 2 in an extended position. [Figure 8] FIG. 10 is a perspective view of a sterilization probe according to another aspect or embodiment of the present disclosure. [Figure 9] FIG. 9 is an exploded view of the disinfection probe of FIG. 8. [Figure 10] FIG. 9 is a side view of an illumination element included in the disinfection probe of FIG. 8 according to one aspect or embodiment of the present disclosure. [Figure 11] FIG. 9 is a side view of the disinfection probe of FIG. 8 in a retracted position. [Figure 12] FIG. 9 is a side view of the disinfection probe of FIG. 8 in an extended position. [Figure 13] FIG. 10 is a perspective view of a sterilization probe according to another aspect or embodiment of the present disclosure. [Figure 14] FIG. 14 is a side cross-sectional view of a portion of the sterilization probe of FIG. 13 taken along line 14-14, illustrating a wheel member thereof, according to one aspect or embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] Description of the Invention The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0028] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "lower," "lateral," "longitudinal," and derivatives thereof will refer to the present invention as oriented in the drawings. However, unless expressly specified to the contrary, it should be understood that the present invention contemplates various alternative modifications. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0029] As used herein, the terms "proximal" and "distal" refer to directions closer to and away from a user who brings the device into contact with a patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device that is manipulated by the user would be the proximal end of the device.

[0030] It should be understood that any numerical range recited herein is intended to include all values ​​and subranges subsumed therein. For example, a range of "1-10" is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., having a minimum value of 1 or greater and a maximum value of 10 or less.

[0031] Provided herein are devices and systems for introducing instruments through indwelling catheters, such as peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. While particular catheter assemblies are shown in the accompanying figures and described below, those skilled in the art will understand that the disinfection probes described herein may be useful with any number of different catheter assembly configurations.

[0032] Referring to FIG. 1 , a non-limiting embodiment of a catheter assembly 10 useful in a blood collection device is shown. The catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 may include an additional port 18, which may be disposed between the distal end 14 and the proximal end 16 or at the proximal end 16. The first catheter adapter 12 includes a first lumen 20 extending through the distal end 14 and the proximal end 16, which may be sealed at the proximal end 16 of the catheter adapter 12. The catheter assembly 10 may include a catheter 22 extending from the distal end 14, such as a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as known to those skilled in the art.

[0033] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 (or “secondary catheter”) extending from the port 18. The first fluid conduit 24 may be formed from any suitable material known to those skilled in the art and may have a distal end 26 and a proximal end 28. The distal end 26 of the first fluid conduit 24 may be coupled to the port 18, and the proximal end 28 of the first fluid conduit 24 may be coupled to a connector 30. The connector 30 may be a T-connector (e.g., one side port positioned at a 90-degree angle relative to the longitudinal axis of the connector 30), a Y-connector (e.g., one side port positioned at a 25-degree, 60-degree, or 75-degree angle relative to the longitudinal axis of the connector 30), or any other type of connector known in the art. Connector 30 includes a second lumen 32 therethrough and has any number of branches appropriate to the type of connector, such as branches extending between distal end 36 and proximal end 40 of connector 30 and branches provided at port 34 of connector 30.

[0034] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a needleless access connector 38 coupled to the proximal end 40 of the connector 30 and / or an extension set 42 coupled to the port 34 of the connector 30. The extension set 42 includes a second fluid conduit 44 coupled at its end 46 to the port 34 and a luer connection 48 at its opposite end 50, with the second fluid conduit 44 provided with a clamp 52 to enable occlusion thereof. Suitable needleless access connectors 38 include, for example, split septum connectors or self-healing septum connectors; for example, FIG. 1 shows a septum 54 provided on the needleless access connector 38. While the non-limiting embodiments of FIGS. 1 and 3 show the needleless access connector 38 disposed on the connector 30, one skilled in the art will understand that a suitable needleless access connector may be disposed on the luer 48.

[0035] As noted above, it is recognized that during use of the catheter assembly 10, bacteria or other pathogens may enter the fluid pathway of the catheter assembly 10, i.e., the catheter 22, the lumen 20 of the catheter adapter 12, and / or the first fluid conduit 24, which may potentially cause a CRBSI during subsequent use. To provide a solution for disinfecting the fluid pathway, thereby reducing or preventing the occurrence of a CRBSI, a disinfection probe is provided for use with the catheter assembly 10.

[0036] 2 and 3, a non-limiting embodiment of a disinfection probe 60 for use with the catheter assembly 10 of FIG. 1 is shown. The disinfection probe 60 includes at least a housing 62, a coupling device 64, an illumination system 66, and an advancement member 68. As described in more detail below, at least a portion of the illumination system 66 is movable within the housing 62, and a portion of the illumination system 66 can be advanced from inside the housing 62 (i.e., a first position) to outside the housing 62 (i.e., a second position), with its distal end routed within the catheter assembly 10. Once a portion of the illumination system 66 is routed within the catheter assembly 10, the illumination system 66 can be controlled to emit disinfecting ultraviolet light that disinfects one or more components of a fluid pathway within the catheter assembly 10, such as, by way of non-limiting example, the catheter 22, the lumen 20 of the catheter adapter 12, and / or the first fluid conduit 24.

[0037] 2 and 3, the illumination system 66 of the disinfection probe 60 includes an ultraviolet light source 70 and an optical fiber 72 connected thereto that functions to transmit light emitted from the ultraviolet light source 70 along its length. The ultraviolet light source 70 may be provided as an ultraviolet lamp configured to emit ultraviolet light of a wavelength suitable for killing or damaging microorganisms (bacteria), thereby providing sterilization of the surface of the tool or component upon which the ultraviolet light impinges. In some embodiments, the ultraviolet light source 70 is thus provided as a UV-C light source that emits ultraviolet light of a wavelength of 200-280 nm (preferably 250-270 nm), although it is recognized that the ultraviolet light source 70 could emit ultraviolet light of other wavelengths that are capable of providing sterilization.

[0038] The optical fiber 72 is composed of one or more glass fibers of a composition and thickness that allows the fiber to bend while also providing light transmission along the length 72 of the optical fiber. In some embodiments, the optical fiber 72 is surrounded by a coating layer 74 composed of one or more layers of a material having a refractive index lower than that of the glass fibers of the optical fiber 72, which causes light to be confined to the core of the optical fiber 72 by total internal reflection at the interface between the two. The coating layer 74 may have one of several suitable configurations depending on various embodiments. In the embodiment of FIG. 4, the coating layer 74 may cover the entire length of the optical fiber 72 except for its tip at the tip portion 76, such that the sterilizing ultraviolet light is emitted only from the tip of the optical fiber 72. In the embodiment of FIG. 5, the coating layer 74 covers the length of the optical fiber 72 but includes openings 75 formed therein at spaced locations along the length of the optical fiber 72, where the sterilizing ultraviolet light is emitted from the optical fiber 72. Other embodiments may provide the optical fiber 72 without any coating layer 74 applied thereto, and in such embodiments, the disinfecting ultraviolet light would be emitted from the optical fiber 72 along the entire length of the optical fiber 72.

[0039] The optical fiber 72 is sized to permit its introduction into and advancement through the fluid pathway of the catheter assembly 10 (i.e., the lumen of the catheter 22, the lumen 20 of the catheter adapter 12, and the first fluid conduit 24) and provide for disinfection of the fluid pathway. Thus, the optical fiber 72 may have an outer diameter (e.g., between 10 gauge and 30 gauge) smaller than the smallest lumen of the fluid pathway of the catheter assembly. The optical fiber 72 may have a length sufficient to position the distal end 76 of the optical fiber 72 at a desired location within the fluid pathway of the catheter assembly 10. Thus, in one embodiment, the optical fiber 72 may have a length sufficient to provide for advancement of its distal end 76 from the housing 62, through the catheter assembly 10, the catheter adapter 12, and all the way to the distal end of the catheter 22.

[0040] 2 and 3 , the housing 62 of the disinfection probe 60 may be an elongated member having a proximal end 78 and a distal end 80 and defining an interior volume 82. In some embodiments, the housing 62 may be formed from a pair of housing portions 62 a, 62 b joined together to define the interior volume 82. The housing 62 may include one or more features or surface finishes on its exterior surface that may be positioned to improve the ergonomics of the disinfection probe 60, which may in some cases allow a user to operate the disinfection probe 60 with one hand (i.e., one-handed use). Additionally, the proximal end 78 of the housing 62 may include an opening or port 84 configured to receive a portion of the optical fiber 72 (i.e., the portion of the optical fiber 72 extending from the ultraviolet light source 70) and provide for advancement and retraction of the optical fiber 72 through the port 84.

[0041] A coupling device 64 of the sterilization probe 60 is provided at the distal end 80 of the housing 62, and the coupling device 64 provides reversible coupling of the sterilization probe 60 to the catheter assembly 10, for example, via the needleless access connector 38 shown in FIG. 1. In some embodiments, the coupling device 64 is configured as a lock 86 including a blunt cannula 88 and a locking arm 90 for mating with the needleless access connector 38 of the catheter assembly 10, with the blunt cannula 88 and locking arm 90 forming three points of contact therewith. However, one skilled in the art will understand that any connection or coupling, such as a luer, can be used so long as the distal end 76 of the optical fiber 72 can pass through the coupling device 64 to access the catheter assembly 10.

[0042] The advancement member 68 of the sterilization probe 60 includes a first portion 92 and a second portion 94. The first portion 92 is movably disposed along a top surface 96 of the housing 62, and the second portion 94 is movably disposed within the interior volume 82 of the housing 62. The advancement member 68 and the housing 62 are arranged such that a connecting portion (not shown) of the advancement member 68 that couples the first portion 92 and the second portion 94 is positioned within a slot 98 formed in the top surface 96 of the housing 62, the slot 98 extending generally between the proximal end 78 and the distal end 80 of the housing 62. When the first portion 92 and the second portion 94 are coupled together, movement of the first portion 92 along the top surface 96 of the housing 62 results in corresponding movement of the second portion 94 within the interior volume 82.

[0043] 2 and 3 , the first portion 92 of the advancement member 68 may be configured as a tab or protrusion having a contact surface 100a engageable by a user and a lower portion 100b that contacts the outer surface 96 of the housing 62. In such an embodiment, the upper surface 96 of the housing 62 may include a track 101, such as a set of ribs, ridges, bumps, grooves, etc., along which the lower portion 100b of the tab or protrusion advances when the advancement member 68 is engaged by a user. In this manner, a user may engage the first portion 92 of the advancement member 68 and move the advancement member 68 relative to the housing 62.

[0044] 3 , the second portion 94 includes an opening 102 extending therethrough configured to grip or retain a portion of the optical fiber 72. Because the portion of the optical fiber 72 is retained within the opening 102 of the second portion 94, movement of the advancement member 68 relative to the housing 62 results in corresponding movement of the optical fiber 72 relative to the housing 62. In this manner, the distal end 76 of the optical fiber 72 can be selectively moved out of or back into the interior volume 82 of the housing 62 as needed, such as to advance the distal end 76 of the optical fiber 72 from the housing 62 when the disinfection probe 60 is coupled to the catheter assembly 10 and a disinfection procedure is to be performed.

[0045] 6 and 7 illustrate operation of the disinfection probe 60 in which the optical fiber 72 is moved between a first position and a second position. More specifically, when the optical fiber 72 is in the first position (FIG. 6), at least a distal end 76 of the optical fiber is disposed within the interior volume 82, and when the optical fiber 72 is in the second position (FIG. 7), at least a portion of the optical fiber 72 extends out the distal end of the housing 62, through the coupling device 64 (and into the catheter assembly 10 of FIG. 1). The configuration of the disinfection probe 60, specifically, the length of the optical fiber 72 that may extend beyond the housing 62 and the coupling device 64, including the length of the fluid path through which the optical fiber 72 is advanced, can be determined based on the structure of the catheter assembly 10 with which the length of the optical fiber 72 is used.

[0046] Operation of the disinfection probe 60 will now be described in further detail in accordance with an embodiment of the present disclosure. In the first step in operating the disinfection probe 60, the disinfection probe 60 is first connected to the catheter assembly 10 by inserting the blunt cannula 88 into the needleless access connector 38 and locking the locking arm 90 into place. The next operational step involves powering on the illumination system 66 (either via the battery 104 or via supplied line power) and advancing the optical fiber 72 through the fluid path of the catheter assembly 10, it being recognized that the order of these steps may vary depending on the configuration of the illumination system 66.

[0047] When the illumination system 66 is comprised of an optical fiber 72 having a coating layer 74 applied along its entire length except for a tip 76 at its distal end (FIG. 4), the ultraviolet light source 70 is first turned on, and disinfecting ultraviolet light is emitted from the ultraviolet light source 70, transmitted through the optical fiber 72, and emitted from the tip. The optical fiber 72 is then continued to be advanced (via actuation of the advancement member 68, as described above) through a portion of the fluid pathway of the catheter assembly 10, and as the tip of the optical fiber 72 passes nearby, the disinfecting ultraviolet light emitted into that area disinfects that region of the fluid pathway (i.e., disinfects the space around the tip). In one embodiment, the advancement of the optical fiber 72 can continue until the tip of the optical fiber 72 reaches the desired region of the catheter 22.

[0048] When the illumination system 66 is configured with a coating layer 74 having openings 75 formed therein spaced along the length of the optical fiber 72 (FIG. 5), the optical fiber 72 is first advanced through those portions of the fluid path of the catheter assembly 10 that are to be disinfected (again, via actuation of the advancement member 68, as previously described). In one embodiment, advancement of the optical fiber 72 may continue until the tip of the optical fiber 72 reaches the desired region of the catheter 22. Following the desired advancement of the optical fiber 72 into the fluid path of the catheter assembly 10, the ultraviolet light source 70 is then turned on, and disinfecting ultraviolet light is emitted from the ultraviolet light source 70, transmitted through the optical fiber 72, and emitted through the openings 75 in the coating layer. It will be appreciated that the optical fiber 72 may be held in place for a predetermined time while the disinfecting ultraviolet light is emitted from the optical fiber 72, the openings 75 being spaced to allow all regions of the fluid path of the catheter assembly to be exposed to the disinfecting ultraviolet light when the optical fiber 72 is advanced into place.

[0049] It will be appreciated that operation of the irradiation system 66 may be provided via a control system 106 provided therewith. According to an embodiment, the control system 106 may include a plurality of control-related components 108, such as, by way of example, one or more of an on / off switch, a timer, a communication device (e.g., a Wi-Fi or Bluetooth transmitter / receiver, or a USB port), that allow an operator to selectively control operation of the irradiation system 66, including the duration and / or intensity of the disinfecting ultraviolet light radiation provided therefrom. Such selective control of the disinfection probe 60 may ensure proper disinfection of the fluid pathways of the catheter assembly.

[0050] 8-12, a sterilization probe 110 according to another embodiment is shown. The structure of the sterilization probe 110 may closely match the structure of the sterilization probe 60 of FIGS. 2-7, and therefore common numbers are used herein to identify identical components within the sterilization probe 110; however, the sterilization probe 110 includes an illumination system 112 that is different from that of the illumination system 66. Specifically, the illumination system 112 includes an illumination element 114 formed from a guidewire 116 and a light strip 118, which includes a plurality of ultraviolet light-emitting diodes (LEDs) 120 configured to emit sterilizing ultraviolet light.

[0051] As best shown in FIG. 10 , the guidewire 116 and light strip 118 of the illumination element 114 are coupled to one another to provide a semi-rigid yet flexible structure that can be advanced outside the housing 62 of the disinfection probe 110 and into the connected catheter assembly. The guidewire 116 is constructed of a suitable material (e.g., stainless steel or nitinol) and is configured as a solid wire or a coiled / braided wire that provides significant flexibility, pushability, and kink resistance. Additionally, the guidewire 116 may be coated with a polymeric and / or hydrophilic coating to increase lubricity and reduce friction during deployment. The light strip 118 is coupled to the guidewire 116 and is formed from multiple ultraviolet LEDs 120 mounted on a flexible substrate 122. The flexible substrate 122 may be formed as a thin-film integrated circuit (IC) substrate 122 containing wiring therein configured to provide power and control connections to the ultraviolet LEDs 120 mounted thereon. The ultraviolet LEDs 120 are spaced evenly apart at regular intervals on the substrate 122 so that the germicidal ultraviolet light emitted therefrom during use provides complete and consistent coverage along the length of the light strip 118. In the illustrated embodiment, the ultraviolet LEDs 120 are positioned on opposite sides of the substrate 122 to allow for a wider range of germicidal ultraviolet light emission, although it will be appreciated that in other embodiments the ultraviolet LEDs 120 could be provided only on the top or bottom of the substrate 122, or as a cylindrical element surrounding the substrate 122.

[0052] Similar to the arrangement of the optical fiber 72 in the disinfection probe 60 described above in the embodiment of Figures 2-7, a portion of the illumination element 114 is retained within the second portion 94 of the advancement member 68 (i.e., within the opening 102 thereof), and movement of the advancement member 68 relative to the housing 62 results in corresponding movement of the illumination element 114 relative to the housing 62. In this manner, the distal end 124 of the illumination element 114 can be selectively moved out of or back into the interior volume 82 of the housing 62 as needed, such as to advance the distal end 124 of the illumination element 114 from the housing 62 when the disinfection probe 60 is coupled to the catheter assembly 10 and a disinfection procedure is to be performed.

[0053] 11 and 12 illustrate operation of the disinfection probe 110, in which the lighting element 114 is moved between a first position and a second position. More specifically, when the lighting element 114 is in the first position (FIG. 11), at least the distal end 124 of the lighting element 114 is disposed within the interior volume 82, and when the lighting element 114 is in the second position (FIG. 12), at least a portion of the lighting element 114 extends from the distal end 80 of the housing 62 and through the coupling device 64 (into the catheter assembly 10 of FIG. 1). The configuration of the disinfection probe 110, specifically, the length of the lighting element 114 that may extend beyond the housing 62 and the coupling device 64, can be determined based on the structure of the catheter assembly 10, including the length of the fluid path through which the lighting element 114 is advanced and the length of the optical fiber 72 used.

[0054] Operation of the sterilization probe 110 will now be described in further detail, in accordance with an embodiment of the present disclosure. In the first step of activating the sterilization probe 110, the sterilization probe 110 is first connected to the catheter assembly 10 by inserting the blunt cannula 88 into the needleless access connector 38 and securing the locking arm 90 in place. The illumination element 114 is then advanced (again, via actuation of the advancement member 68, as previously described) through those portions of the fluid path of the catheter assembly 10 to be disinfected. In one embodiment, advancement of the illumination element 114 may continue until the tip of the illumination element 114 reaches the desired region of the catheter 22. Following the desired advancement of the illumination element 114 into the fluid path of the catheter assembly 10, the ultraviolet LEDs 120 are powered on, such as via the battery 104 or supplied line power, and sterilizing ultraviolet light is emitted from the ultraviolet LEDs 120 of the illumination element 114. It will be appreciated that the lighting element 114 is held in place for a predetermined time while the ultraviolet LEDs 120 emit disinfecting ultraviolet light, and that when the lighting element 114 is advanced into place, the ultraviolet LEDs 120 are spaced to allow all areas of the fluid path of the catheter assembly to be exposed to the disinfecting ultraviolet light.

[0055] It is recognized that operation of the lighting elements 114 may be provided via a control system 106 included in the illumination system 112. According to an embodiment, the control system 106 may include a plurality of control-related components 108, including, by way of example, one or more of an on / off switch, a timer, and a communication device (e.g., a Wi-Fi or Bluetooth transmitter / receiver, or a USB port), that allow an operator to selectively control the operation of the lighting elements 114, including the duration and / or intensity of the sterilizing ultrasonic light emissions provided by the lighting elements 114. Such selective control of the disinfection probe 110 may ensure proper disinfection of the fluid pathways of the catheter assembly.

[0056] 13 and 14 , another embodiment of a disinfection probe 130 is shown that can be advantageously used to disinfect the internal fluid pathways of long catheters, such as PICCs or CVCs. In the disinfection probe 130, a wheel member 132 is provided on the housing 62 at the distal end 80 thereof and functions as the probe's advancement member. The wheel member 132 replaces the advancement member 68 included in the previously shown and described disinfection probes 60, 110 and is configured to provide advancement and retraction of the illumination components within the disinfection probe 130. While the wheel member 132 is described here as advancing / retracting the optical fiber 72 (and coating layer 74), it will be appreciated that, according to other embodiments, the wheel member could also interact with the illumination element 114 (guidewire 116 and light strip 118). In actuation of the disinfection probe 130, an operator actuates (e.g., rotates) the wheel member 132, which, in turn, causes linear advancement or retraction of the optical fiber 72, depending on the direction of rotation of the wheel member 132.

[0057] As shown in FIG. 14 , the wheel member 132 is disposed within a compartment 134 formed within the housing 62. The wheel member 132 includes a spool 136 and an advance wheel 138. The spool 136 includes an axle 136a that holds the spool 136 within the compartment 134 and allows the spool 136 to rotate. The spool 136 also includes a spool drum 136b on which the optical fiber 72 is wound. The advance wheel 138 extends upward from the compartment 134 to be engaged by an operator. The operator can directly rotate the advance wheel 138 by applying a force to the advance wheel 138, which can rotate in a forward or backward direction.

[0058] During operation of the disinfection probe 130, rotation of the advancement wheel 138 in a forward direction (i.e., toward the distal end 80 of the housing 62) causes the optical fiber 72 to advance toward the distal end 80 of the housing 62, and the distal end 76 of the optical fiber 72 may be extended from the housing 62 and the blunt cannula 88 into the catheter assembly. Conversely, rotating the advancement wheel 138 in the opposite direction (i.e., toward the proximal end 78 of the housing 62) causes the optical fiber 72 to retract toward the proximal end 78 of the housing 62, and the distal end 76 of the optical fiber 72 may be retracted into the housing 62.

[0059] Advantageously, embodiments of the present disclosure therefore provide a disinfection probe usable with a catheter assembly to disinfect the internal fluid pathways of an indwelling catheter of the catheter assembly. A distal end of the disinfection probe can be advanced into the catheter assembly from which disinfecting ultraviolet (UV-C) light is emitted to disinfect and sterilize the fluid pathways, thereby reducing the likelihood of CRBSI.

[0060] While the present disclosure has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A catheter system, comprising:

1. An intravenous catheter assembly, the intravenous catheter assembly comprising: a catheter having a distal end and a proximal end, the catheter defining a lumen extending between the distal end and the proximal end; an access connector configured to provide access to the lumen of the catheter; and a disinfection probe connectable to the access connector, the disinfection probe comprising: a housing having a proximal end and a distal end; an illumination system disposed at least partially within the housing and configured to emit disinfecting ultraviolet light; an advancement member configured to advance a portion of the illumination system beyond the distal end of the housing and into the catheter in response to movement of the advancement member relative to the housing; the disinfecting probe into which the disinfecting ultraviolet light is advanced by the advancement member to disinfect the lumen of the catheter.

2. 2. The catheter system of claim 1, wherein the access connector comprises a needleless access connector, the disinfection probe comprises a blunt cannula at the distal end of the housing reversibly coupleable to the needleless access connector, and the advancement member is configured to advance a portion of the illumination system through the blunt cannula and the needleless access connector and into the lumen of the catheter.

3. 10. The catheter system of claim 1, wherein the illumination system comprises: an ultraviolet light source disposed adjacent the proximal end of the housing and configured to emit the disinfecting ultraviolet light; an optical fiber extending distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber; The catheter system, wherein the advancement member is configured to advance a portion of the optical fiber beyond the distal end of the housing.

4. 4. The catheter system according to claim 3, wherein the illumination system includes a coating layer covering a portion of the optical fiber, the coating layer being configured to block transmission of the disinfecting ultraviolet light.

5. 5. The catheter system according to claim 4, wherein the coating layer covers the entire length of the optical fiber except for a tip at the distal end of the optical fiber, and the disinfecting ultraviolet light is emitted only from the tip.

6. 5. The catheter system of claim 4, wherein the coating layer covers a length of the optical fiber and includes openings formed therein at spaced locations along the length of the optical fiber, and wherein the disinfecting ultraviolet light is emitted from the optical fiber only at those locations.

7. 10. The catheter system of claim 1, wherein the illumination system comprises: A guide wire; a light strip attached to the guidewire, the light strip comprising a plurality of ultraviolet light emitting diodes (LEDs) configured to emit the sterilizing ultraviolet light; The catheter system, wherein the advancement member is configured to advance the guidewire and a portion of the light strip beyond the distal end of the housing.

8. 8. The catheter system of claim 7, wherein the plurality of ultraviolet LEDs are equally spaced along the length of the light strip.

9. 10. The catheter system of claim 1, wherein the advancement member is configured to move along an outer surface of the housing, the advancement member engaging the illumination system to advance a portion of the illumination system into the catheter beyond the distal end of the housing.

10. 10. The catheter system of claim 1, wherein the irradiation system comprises a control system configured to selectively control the emission of the disinfecting ultraviolet light, the control system comprising one or more of an on / off switch, a timer, and a communication device.

11. 10. The catheter system of claim 1, wherein the illumination system is configured to emit UV-C light.

12. 2. The catheter system according to claim 1, wherein the advancement member comprises a wheel member disposed on the housing and rotatable relative to the housing, the wheel member being operably coupled to an illumination component of the illumination system, and wherein, when the wheel member is rotated, the illumination component is advanced from the housing and retracted into the housing.

13. 1. A disinfection probe for disinfecting a catheter of an intravenous catheter assembly, said disinfection probe comprising: a housing having a proximal end and a distal end; an illumination system disposed at least partially within the housing and configured to emit disinfecting ultraviolet light; an advancement member configured to advance a portion of the illumination system beyond the distal end of the housing and into the catheter in response to movement of the advancement member relative to the housing; a disinfection probe, wherein the disinfecting ultraviolet light disinfects the lumen of the catheter when advanced therein by the advancement member.

14. 14. The disinfection probe of claim 13, further comprising a blunt cannula disposed at the distal end of the housing, the blunt cannula being reversibly coupleable to a needleless access connector of the intravenous catheter assembly; The disinfection probe, wherein the advancement member is configured to advance a portion of the irradiation system through the blunt cannula and the needleless access connector and into the lumen of the catheter.

15. 14. The disinfection probe of claim 13, wherein the illumination system comprises: an ultraviolet light source disposed adjacent the proximal end of the housing and configured to emit the disinfecting ultraviolet light; an optical fiber extending distally from the ultraviolet light source and configured to transmit the disinfecting ultraviolet light along a length of the optical fiber; The disinfection probe, wherein the advancement member is configured to advance a portion of the optical fiber beyond the distal end of the housing.

16. 16. The disinfection probe of claim 15, wherein the illumination system comprises a coating layer covering a portion of the optical fiber, the coating layer configured to block transmission of the disinfecting ultraviolet light.

17. 17. The disinfection probe of claim 16, wherein the coating layer covers the entire length of the optical fiber except for a tip at the distal end of the optical fiber, and the disinfecting ultraviolet light is emitted only from the tip.

18. 17. The disinfection probe of claim 16, wherein the coating layer covers a length of the optical fiber and includes openings formed therein at spaced locations along the length of the optical fiber, and wherein the disinfecting ultraviolet light is emitted from the optical fiber only at those locations.

19. 14. The disinfection probe of claim 13, wherein the illumination system comprises: A guide wire; a light strip attached to the guidewire, the light strip comprising a plurality of ultraviolet light emitting diodes (LEDs) configured to emit disinfecting ultraviolet light; The disinfection probe, wherein the advancement member is configured to advance the guidewire and a portion of the light strip beyond the distal end of the housing.

20. 20. The disinfection probe of claim 19, wherein the ultraviolet LEDs are evenly spaced along the length of the light strip.

21. 14. The disinfection probe of claim 13, wherein the advancement member is configured to move along an outer surface of the housing, and the advancement member engages the illumination system to advance a portion of the illumination system beyond the distal end of the housing and into the catheter.

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