Intravenous line component with integral interval timer

Abstract

An intravenous line component having a body adapted to function as a component (such as a needleless connector) of an intravenous line configured for providing intravenous access, and an interval timer integrated into the body. The interval timer is configured to provide a change in state, such as a visible change in color, after a defined period of time. The defined period of time is selected to correspond to a duration of time after a start time matched to a prescribed time for replacement of the intravenous line component to mitigate a bacterial infection risk, e.g., at 72, 96 and / or 168 hours after use in an active IV line. The interval timer may be configured to change state as a function of a photosensitive, vapor-sensitive, thermosensitive, or other reaction upon exposure to the environment, by mixing of substances, or by contact with fluid passing through the intravenous line.

Description

ATTORNEY DOCKET NO. 09674.029WO1-GSBINTRAVENOUS LINE COMPONENT WITH INTEGRAL INTERVAL TIMERCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority, under 35 U.S.C. §119(e), of U.S. Provisional Patent Application No. 63 / 699,989, filed September 27, 2024, the entire disclosure of which is hereby incorporated herein by reference.FIELD OF THE INVENTION

[0002] The present invention relates generally to intravenous lines providing venous access, and more particularly, to an intravenous line component, having an integrated interval timer serving as an expiration notification feature prompting intravenous line component removal and / or replacement to avoid bloodstream bacterial infections, such as central line associated bloodstream infections (CLABSIs).DISCUSSION OF RELATED ART

[0003] Various medical treatments require prolonged venous access necessitating placement of an intravenous line. Examples of such intravenous lines include central venous catheters (CVC), such as a peripherally inserted central catheter (PICC) or other venous access port inserted through the skin and into a vein, for a variety of purposes. Most such intravenous lines include a needleless connector component, many of which have split-septum design configured to receive a blunt tip of a syringe for introducing or withdrawing fluids via the needleless connector and associated venous access line.

[0004] By way of example, a CVC is a catheter device inserted into a large, central vein (e.g., internal jugular, subclavian, or femoral). In the case of the CVC, the device is typically advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium, in a procedure generally referred to as providing a "central line" or "central venous access." The CVC can then be used to administer medications or fluids into the bloodstream and / or to obtain blood samples.ATTORNEY DOCKET NO. 09674.029WO1-GSB

[0005] The CVC and other intravenous devices typically terminate externally in a catheter tail with a needleless connector, such as a luer lock. This needleless connector is typically attached to the external lumen of the CVC or other tubing, allowing for catheter access for aspiration and / or infusion. They are also attached to peripheral intravenous lines and intraosseous access lines.

[0006] A common problem associated with CVCs providing direct access / fluid communication with the bloodstream is the possible introduction of bacteria into the bloodstream via the CVC. By way of example, in the context of a CVC, the introduction of bacteria may lead to a central line-associated bloodstream infection (CLABSI), which can be fatal. Even without a fatality, significant additional costs and harm are incurred in the case of a CLABSI, e.g., to mitigate the infection. Accordingly, avoidance of introduction of bacteria into the bloodstream is desirable.

[0007] In many instances, proper preparation and aseptic techniques can be used to avoid introduction of bacteria via the CVC during insertion, access, and line access. However, there are additional inherent infection risks with increased indwell time and repeated or frequent line access. These risks are typically addressed by monitoring the patient for signs of infection, aseptic techniques for line access, daily chlorhexidine gluconate (CHG) line care, and prompt removal of an unneeded CVC. At this point, however, CLABSIs have generally been unavoidable, and risk can only be mitigated.

[0008] Current evidence-based practice dictates that infection risks can be mitigated by regularly removing / changing / replacing bacteria-prone portions of the intravenous lines (such as detachable needleless connectors on the central line tubing of CVCs or an entire needle, line, hub, connector of a 1 -piece port) at regular intervals, which in the example of CVC lines, is typically every 72 to 96 hours (3 to 4 days, respectively), but no more frequently than every 72 hours (3 days). Accordingly, a prescribed “expiration date” at which / by which a CVC needleless connector or other intravenous line portion should be removed and replaced (to prevent / manage bacterial infection) could be considered to be 3 days, by way of example. Generally, needleless connectors or other bacteria-prone portions of intravenous lines should not be left unchanged for greater than 7 days. Accordingly, a prescribed “expiration date” at which / by which a CVC needleless connector or other intravenous line portion should be removed and replaced (to prevent / manageATTORNEY DOCKET NO. 09674.029WO1-GSB bacterial infection)) could be considered to be 7 days, by way of alternative example. Relevant expiration / replacement guidelines apply to all CVCs and other intravenous access lines, except those being used for lipid or blood infusions, which may require more frequent replacement. This shorter dwell time / interval is necessary because while use of these needleless connectors has been shown to decrease the incidence of microbial colonization, microbial buildup still occurs on the connector and the structural integrity of the needleless connector begins to degrade over time, allowing microbes to potentially enter the catheter.

[0009] Somewhat similarly, and analogously, an entire external port structure may have a similar expiration date by which some or all of the external port structure may need to be changed to avoid / mitigate infection risk according to applicable practices.

[0010] However, consistency of this appropriate expiration date / dwell time interval tends to be poorly managed in clinical settings. By way of example, current standards of practice for identifying the 72-hour / 3-day minimum (or 96-hour / 4-day, or 168-hour / 7-day maximum) time period for CVC needleless connector replacement include using a manual timer, labeling / using stickers, and recording notes in the patient's chart. Documentation related to CVC needleless connectors and the most recent date of change is traditionally electronic medical record (EMR)-based, but it is inconsistently completed / updated, often after delay / asynchronously, making EMR- based notation of the need for cap changes less likely to be successfully and consistently completed. Labels and / or stickers cannot be used safely directly on the cap due to an increased risk of infection secondary to an adhesive surface on the cap where additional dirt / bacteria could unintentionally build up. Further, labels and / or stickers would not be feasible on the CVC site dressing either due to the likelihood of label removal every 72-168 hours causing the dressing to become nonocclusive, which would then require an additional CVC dressing change and expose the patient to additional potential for infection. Accordingly, the expiration date / dwell time interval is typically managed on an ad hoc basis, and in a manner that is not plainly visible to caregivers while treating a patient, and that is highly dependent upon clinician notes and recordkeeping, diligent reference to and monitoring of the same, avoidance of human error in recording relevant time-of-insertion / interval data,ATTORNEY DOCKET NO. 09674.029WO1-GSB regularly monitoring the dwell time, records, etc. all of which is prone to human error, and easily overlooked.

[0011] What is needed is an improved approach for managing the timelines for replacement of intravenous line components, such as needleless connectors, to help to ensure timely replacement and mitigation and / or avoidance of bloodstream infections associated with such intravenous line components.SUMMARY

[0012] The present invention provides an improved approach for managing the timelines for removal / replacement (collectively referred to herein as “replacement’) of intravenous line components, such as needleless connectors, to help to ensure timely replacement and mitigation of bloodstream infection risk associated with such intravenous line components. More particularly, the provides intravenous lines providing venous access and / or components thereof (e.g., a needleless connector of an IV or CVC line) that have a body including an integrated interval timer that is configured to provide a change in state (e.g., a visible change in color) upon / after a prescribed time interval corresponding to a time interval for replacement of a relevant portion of the intravenous line , e.g., 72-168 hours for a CVC line to mitigate bacterial infection risk for a needleless connector.

[0013] The state-changing portion thereby serves as an expiration notification feature (preferably a visible expiration notification feature) indicating that the intravenous line, or a relevant thereof, is due for removal and / or replacement according to common indwell time limits designed to avoid or mitigate CLABSIs or other bacterial infections. In certain embodiments, the portion of the intravenous line configured to change state is provided directly on or in close association with the intravenous line, so that it provides a visible indication / notification to a clinician that will be readily seen by a clinician during normal clinical activities without a need to reference separate notes, charts, an EMR record, etc., thereby increasing the likelihood that the expiration date will be noted by the clinician and remove / replacement guidelines will be complied with.BRIEF DESCRIPTION OF THE FIGURESATTORNEY DOCKET NO. 09674.029WO1-GSB

[0014] An understanding of the following description will be facilitated by reference to the attached drawings, in which:

[0015] Fig. 1 is a plan view of an exemplary intravenous line in the nature of a central venous catheter showing a lumen terminating in a needleless connector with visible expiration notification feature in accordance with an exemplary embodiment of the present invention;

[0016] Figs. 2A-2C are perspective views of an exemplary needleless connector in accordance with an exemplary embodiment of the present invention;

[0017] Fig. 3A is a plan view of an exemplary protective package containing an exemplary needleless connection in accordance with an exemplary embodiment of the present invention, shown closed;

[0018] Fig. 3B is a perspective view of the exemplary protective package of Fig. 3A, shown partially open;

[0019] Fig. 4A shows an exemplary needleless connector and an exemplary protective package for the needleless connector bearing exemplary legends usable to interpret states of the interval timer of the needleless connector, in accordance with an exemplary embodiment of the present invention, shown in the interval timer in an exemplary first state;

[0020] Fig. 4B shows an exemplary needleless connector and an exemplary protective package for the needleless connector bearing exemplary legends usable to interpret states of the interval timer of the needleless connector, in accordance with an exemplary embodiment of the present invention, shown in the interval timer in an exemplary second state; and

[0021] Fig. 4C shows an exemplary needleless connector and an exemplary protective package for the needleless connector bearing exemplary legends usable to interpret states of the interval timer of the needleless connector, in accordance with an exemplary embodiment of the present invention, shown in the interval timer in an exemplary third state.DETAILED DESCRIPTION

[0022] The present invention provides intravenous lines providing venous access that include a body / member (e.g., a needleless connector of a CVC line) adapted to function as a component of an intravenous line (an integral part or a partATTORNEY DOCKET NO. 09674.029WO1-GSB attached to or otherwise directly associated therewith) that has an integrated interval timer configured to provide a visible change in state (e.g., change in color) over a defined time interval corresponding to (e.g., matched to) a time interval for replacement of a relevant portion of the intravenous line , e.g., 72 hours for a CVC line to mitigate bacterial infection risk needleless connector. The state-changing portion thereby serves as a visible expiration notification feature indicating that the intravenous line, or a relevant portion of the intravenous line (e.g., a needleless connector), is due for removal and / or replacement according to common indwell time limits designed to avoid or mitigate CLABSIs or other bacterial infections. The portion of the intravenous line configured to change state is provided directly on or in close association with the intravenous line, so that it provides a visible indication / notification to a clinician that will be readily seen by a clinician during normal clinical activities without a need to reference separate notes, charts, an EMR record, etc., thereby increasing the likelihood that the expiration date will be noted by the clinician and remove / replacement guidelines will be complied with.

[0023] More particularly, the present invention provides a component of an intravenous access line assembly with a visible notification feature for indicating expiration time limit information. The present invention may be implemented in various embodiments, and is discussed below for non-limiting illustrative purposes with reference to Figs. 1-2C. Fig. 1 is a plan view of an exemplary intravenous access line 100 in accordance with the present invention. The exemplary intravenous line 100 is shown for illustrative purposes as a central venous catheter having a largely conventional structure. Accordingly, the exemplary intravenous line 100 includes a catheter body / lumen 110 terminating in hub 120 supporting a detachable needleless connector 150. In this exemplary embodiment, a conventional slide clamp 130 is associated with the intravenous line, and part of the intravenous line assembly 100. The slide clamp 130 is supported on the lumen 110 for selectively pinching closed the lumen (e.g., during change of the needleless connector).

[0024] As is well known in the art, in such an arrangement, applicable guidelines / best practices require regular replacement of the needleless connector and / or other portions after a certain period of indwell time (e.g., 72-168 hours after insertion into a vein) to limit bacterial infection risk. The end of the relevant period ofATTORNEY DOCKET NO. 09674.029WO1-GSB indwell time is referred to herein as the “expiration date.” Accordingly, in accordance with the present invention, a portion of the intravenous line assembly is provided with a visible expiration notification indicator 160 in accordance with the present invention. The visible expiration notification indicator changes state in visible fashion in a manner that corresponds to the relevant indwell period of time and the expiration date. Accordingly, the visible expiration notification indicator 160 acts as an interval timer configured to provide a visible change in state (e.g., appearance) at a time corresponding to a recommended expiration date for a relevant portion of an intravenous line (e.g., an entire port assembly, or a needleless connector or a CVC).Any portion / body of an intravenous line assembly (i.e., intravenous line and anything physically interconnected thereto) may be configured as a body adapted to function as a component of an intravenous line configured for providing intravenous access, and having an interval timer integrated into the body, the interval timer being configured to provide a change in state after a defined period of time. In this manner, the interval timer serves as the expiration notification indicator to change its state (e.g., visible state) in accordance with the present invention.

[0025] For example, in one embodiment the particular portion of the intravenous line that needs to be removed / replaced at the expiration date may be configured to change state (e.g., color) and thereby serve as the visible expiration notification indicator. For example, the detachable needleless connector body of a CVC line may be so configured, or all or a portion of a one-piece port may be so configured. By way of further example, the tubing of an IV line, the fluids / packaging of an IV line, a Foley / urinary catheter, a feeding tube, a sterile dressing or portion thereof, or a needle of an intravenous line, all or a portion of a port (needle , line / tubing, clamp, hub and / or needleless connector), or a lumen or hub of a CVC, PICC or other intravenous line, etc. could be configured in accordance with the present invention to change state and thereby served as the visible expiration notification indicator indicating an expiration date, etc. to change / replace the item changing state to mitigate a bacterial infection risk, in accordance with applicable medical practices / guidelines.

[0026] In another embodiment, gel commonly included inside the needleless connector (typically for sealing purposes) is configured to change state over time, to serve at the visible expiration notification indicator.ATTORNEY DOCKET NO. 09674.029WO1-GSB

[0027] In one exemplary embodiment, a needleless connector (e.g., a needleless connector including a luer lock) is configured to change its visible appearance state, and thereby to serve as the interval timer 160 providing a visible expiration notification indicator. For example, all or a portion of the needleless connector body 150 may be made to change color predictably over time to indicate expiration of a predetermined period of time corresponding to a time period for change of the needleless connector. Figs. 2A-2C illustrate an exemplary needleless connector body 150 in accordance with the present invention, showing an interval timer 160 changing color(s) over time, e.g., from clear to indicate no change / replacement currently needed (Fig. 2A) (e.g., at 0-72 hours after start / insertion / blood contact), to yellow (or another different color) to indicate a warning that it is currently within a time window for change / replacement at this time (Fig. 2B) (e.g., from 72-168 hours after start / insertion / blood contact), to red (or another different color) to indicate that the expiration date has arrived or passed and that it is time for an immediate change / replacement (Fig. 2C), (e.g., at 168 hours after start / insertion / blood contact).

[0028] In another exemplary embodiment, a portion of the intravenous line assembly that does not itself need to be removed / replaced to mitigate bacterial infection risk may be configured as the visible expiration notification indicator. For example, a detachable slide clamp body 130 may be so configured in accordance with the present invention. After the change in state of the slide clamp 130 is completed, the relevant portion of the intravenous line would be removed and replaced. Additionally, the slide clamp 130 could be removed, and a new slide clamp 130 configured in accordance with the present invention would be attached to serve as the visible expiration notification indicator for the newly-placed relevant portion of the intravenous line, effectively “restarting the clock” for an expiration notification indicator for the new intravenous line portion.

[0029] In one example, the visible expiration notification indicator may be made of a material that is configured to change state (e.g., color) predictably over time to indicate one or more predetermined periods of time (e.g., expiration of a predetermined period of time). By way of alternative example, the visible expiration notification indicator may be provided as a coating of a material that is configured to change state (e.g., color) predictably over time to indicate one or moreATTORNEY DOCKET NO. 09674.029WO1-GSB predetermined periods of time (e.g., expiration of a predetermined period of time). By way of example, the state changing material may be selected to be driven by a duration of exposure to room air, light / ambient light or other environmental conditions, such as room temperature or humidity. Accordingly, in certain embodiments, the state-changing material may be a photosensitive / photochromism material that changes state over time due to a prolonged period of exposure to ambient light, such that the period corresponds to a period of time after which the needleless connector should be changed to avoid / mitigate infection risk.

[0030] In some embodiments, the beginning of the time period and any reaction or process driving the state change may be driven by removal from a protective package, removal of a coversheet, exposure to a light source or chemical or other substance, etc. so that an affirmative act is required to begin the timer / state / color change process, and to allow for synchronization of the time period with a time of insertion / replacement of the IV line component, etc. By way of illustrative example, Figs. 3A and 3B show an exemplary protective package 200 including a package body 210 and a coversheet 220. The package body is constructed of a material configured to prevent, delay or otherwise avoid initiation of the relevant change-of-state process / reaction for the interval timer (e.g., 160) of the body (e.g., needleless connector 150) contained in the protective package 200. For example, if the interval timer’s state change process is driven by exposure to light or a particular wavelength of light, the protective package may block the light or particular wavelength of light to avoid initiation of the state change process / reaction. By way of further example, if the interval timer’s state change process is driven by exposure to room / ambient air or a component thereof, the protective package may be sealed to block the room / ambient air or component thereof from reaching the interval timer to avoid initiation of the state change process / reaction. Fig. 3A shows the protective package 200 in a closed position. Fig. 3B shows the protective package 200 in a partially-open position in which the interval timer / needleless connector 160 begins to be exposed to the ambient light, air, etc.. The package could / would be opened at / near a time of incorporation into an intravenous line, and thus the predictable time of the relevant change-of-state process can serve as an accurate measure of dwell time, and an accurate measure of time interval supportingATTORNEY DOCKET NO. 09674.029WO1-GSB replacement / expiration, beginning at the time of opening of the protective package 200.

[0031] By way of alternative example, the visible expiration notification indicator may be provided in an internal chamber of a relevant component of the intravenous line, such as a needleless connector. For example, the needleless connector or an associated component may be configured in accordance with the present invention to contain one or more chemical substances that react over time to produce the state / color change. By way of example, the beginning of the time period and any reaction or process driving the state / color change may be driven by removal from a package (as discussed above), removal of a coversheet, exposure to a light source or chemical or other substance, pinching / crushing / twisting a sealed multichambered structure to cause two discrete substances stored separately to mix, e.g., by twisting two portions of the needleless connector, etc., to trigger a chemiluminescent reaction, by heat-activating thermochromic substances, e.g. by hand warmth or hand rubbing, etc. so that an affirmative act is required to begin the timer / state / color change process, and to allow for synchronization of the time period with a time of insertion / replacement of the intravenous line component, etc.

[0032] In certain embodiments, the state-changing material may involve the activation of vapor-chromic or chemical sensors that change state / color over / after a period of time corresponding to a period of time after which the needleless connector should be changed to avoid / mitigate infection risk.

[0033] In certain embodiments, the state-changing material held in fluid communication with saline, blood or other IV fluids passing through the statechanging visible expiration notification indicator and may change state / color due to exposure as the visible expiration notification indicator is used as part of an active intravenous line, or in use to temporarily flush the line with normal saline or another substance, such that the state / color change occurs or is completed over a period that corresponds to a period of time after which the needleless connector should be changed to avoid / mitigate infection risk.

[0034] In certain embodiments, the interval timer and / or state-changing material may include an electrically-powered digital timer that displays numbers / symbols / text or color to indicate time intervals / dwell times and / or expiration such that the state / color / numbers / text / symbols change occurs or is completed over aATTORNEY DOCKET NO. 09674.029WO1-GSB period that corresponds to a period of time after which the needleless connector should be changed to avoid / mitigate infection risk.

[0035] In certain embodiments, the interval timer may include statechanging material that may involve a digital timer in the form of a pull tag clamp or device that is affixed to the needleless connector or lumen. When the clamp / device is pulled, a time is displayed that could not exceed the maximum hours appropriate (168 for a central line component, 96 hours for continuous intravenous external tubing) and begin counting down to indicate the number of hours remaining before expiration, after which the needleless connector or tubing should be changed to avoid / mitigate infection risk.

[0036] It should be noted that the present invention is applicable to other intravenous devices, such as peripheral IVs (PIV) and intraosseous lines for improved blood stream infection prevention, especially for those patients with PIVs in addition to central lines. For example, PIV devices generally use the same connector pieces as CVCs and may be constructed of a color-changing material, etc. that is configured to change color after: exposure to light or normal saline; activation of vapor-chromic sensors or chemical sensors within the needleless connector; using thermochromic pigments (activated by vigorous warming between the palms); twisting the cap and triggering chemiluminescence to indicate that replacement of the PIV device should be made at the time of the color change to comply with best practices. While there is no established best practice for line or connector replacement for PIVs, routine replacement has shown to decrease incidences of infiltration and catheter failure.

[0037] Additionally, the present invention is applicable to other devices, such as IV tubing to indicate when it requires changing to circumvent the current labeling process, which is often fraught with confusion and errors due to miscounting, confusing labels, and accidental removal / displacement of labels. For example, IV tubing may be constructed of a color-changing material that is configured to change color after exposure to light or normal saline; activation of vapor-chromic sensors or chemical sensors within the needleless connector; using thermochromic pigments (activated by vigorous warming between the palms); twisting the cap and triggering chemiluminescence to indicate that replacement of the IV tubing should be made at the time of the color change completes to complyATTORNEY DOCKET NO. 09674.029WO1-GSB with best practices requiring continuous tubing to be changed after a predetermined period of time (e.g., 96 hours for continuous infusion tubing). Tubing color may begin to change after initial exposure and may continue to change on a spectrum ending with a “complete” color change (for example, the material may begin clear and change to yellow at / by 84 hours, and continue to red at / by 96 hours).

[0038] In certain embodiments, the intravenous access line assembly component with a visible notification feature for indicating expiration time limit information (such as a needleless connector or line clamp) may be packaged in lightblocking (or air / oxygen-blocking) material or other material, or be constructed, so as to prevent commencement of a reaction or process that will begin the “timer” and initiate the change in color or other state such that an affirmative act of a clinician, etc. (e.g., by opening the package to expose the device to light or air / oxygen at a time of placement of the device in an active IV line) is required to start the “timer” and / or process such that a completion of the state / color change will be visible to a clinician to readily indicate expiration of the period of time to prompt changing / replacement of the needleless connector in a timely fashion to follow infection prevent practices based on changing the port at a prescribed (e.g., 24- and / or 48-hour) interval. Notably, this state change will occur without any careful documentation subject to human error, etc., and thus is more reliable than conventional approaches to managing needleless connector or other IV-line assembly component replacement at regular prescribed intervals to avoid / mitigate infection risk.

[0039] In certain embodiments, the gel inside a needleless connector, or any portion of material making up the body of the intravenous line and in contact with the fluids passing through the intravenous line, or a coating on any such portion, may be configured to change state (e.g., color) in response to presence of one or more types of bacteria, rather than to time. Accordingly, body or any such component may be configured to provide a bacteria presence indicator that is not based on time, but is merely based on the observed presence of bacteria (or a sufficient quantity thereof). Accordingly, a color or other state change of in such an embodiment could indicate that an immediate change / removal / replacement is needed to mitigate problematic bloodborne infection risk, due to the current presence of bacteria. This could provide for an early change / removal / replacement of an intravenous line orATTORNEY DOCKET NO. 09674.029WO1-GSB component thereof on the basis of time alone if, for example, sufficient bacteria to cause a state / color change was found to be present and to provide a visible indication prior to a prescribed time window for change of the intravenous line component.

[0040] In use, a relevant intravenous line assembly component (e.g., an entire IV line or needleless connector or other component) having an expiration notification feature may be placed into service (e.g., in contact with blood or other fluids) with a patient in conventional fashion. At this time (e.g., before or after but close in time, such as during a single patient visit), the clinician may initiate the timer in any suitable fashion according to the structure and / or construction of the intravenous line assembly component having an expiration notification feature being used. For example, this may be passive (simply placing the item into service as part of an active intravenous line, or may be active, requiring a separate act by the clinician (e.g., opening a package, removing a protective cover sheet, exposing to light / liquid / other substance, pinching chambers to cause mixing of substances, etc.). Due to the construction of the intravenous line assembly component having an expiration notification feature in accordance with the present invention, this starts a reaction or other process that acts as a timer, accumulating elapsed time since the start until a change of state (such as a color change) is caused at / upon / after a predefined interval of time, to indicate expiration of a relevant period of time associated with a need to change / replace the relevant intravenous line component. This change of state, directly on or directly associated with / in contact with, the intravenous line assembly component, indicates passage of one or more time intervals related to a time for prescribed removal / replacement of the relevant intravenous line assembly component, according to applicable medical guidelines and / or best practices, e.g. to mitigate bacterial infection risk. In this manner, the change of state will be readily directly discernible (e.g., visible) by a clinician and patient during interaction with the patient.

[0041] In certain embodiments, a color-key or other legend may be provided as reference materials on the body and / or its packaging, e.g., to act as a guide in interpreting the changes in state of the interval timer. For example, the legend may include a clear field indicating 0-72 hours of dwell / exposure time, a yellow field adjacent text indicating a 72-168 hour dwell / exposure time, and a redATTORNEY DOCKET NO. 09674.029WO1-GSB field adjacent text indicated a >168 hour dwell / exposure time and / or expired state. In this manner, a state of the interval timer may be compared to the legend on the body and / or it’s packaging and a comparison may be made to interpret the state change and associate it with an actual dwell / exposure time.

[0042] Figs. 4A-4C show an exemplary needleless connector 150 and an exemplary protective package for the needleless connector. In this embodiment, each of the needleless connector / body 150 and the package 200 includes a legend 170, 250 configured to act as a guide in interpreting the changes in state of the interval timer. For example, each legend 170, 250 includes at least one field 172 / 172a / 172b / 172c / 252 / 252a / 252b / 252c indication a state of the interval timer 160, along with text and / or graphics indicating a meaning of the particular state indicated by the associated field. For example, the legends 170, 250 of Figs. 4A-4C include a first field 172a / 252a showing an initial state of the interval timer (e.g., clear / initial color at 0 hours / before a change of state). Additionally, in this example, the legends 170, 250 include text and / or graphs adjacent that field 172a / 252a indicating the meaning of the associated state of the internal timer, namely in this example, 0-72 hours of dwell time, and that the needleless connector is in an OK state and not in need of being change / replaced in accordance with applicable guidelines for mitigation of bacterial infection risk. The current state can be determined by a visual comparison of a current state of the interval timer to the fields of the legend 170 / 250. Accordingly, it can be visually observed, by direct observation of the needleless connector 150 / interval timer 160 and / or its packaging, that the interval timer 160 is in the initial stage (0-72 hours) in Fig. 4A, and not currently in need of being replaced.

[0043] By way of further example, the legends 170, 250 of Figs. 4A-4C include a second field 172b / 252b showing an additional (changed) state of the interval timer (e.g., yellow color at 72 hours / after a first change of state). Additionally, in this example, the legends 170, 250 include text and / or graphs adjacent that field 172b / 252b indicating the meaning of the associated state of the internal timer, namely in this example, 72 or more hours of dwell time (but not yet 168 hours of dwell time), and that the needleless connector is in an OK state, in a window of time in which it could be changed / replaced, but not yet expired / in need of being change / replaced in accordance with applicable guidelines for mitigation of bacterial infection risk. Again, the current state can be determined by a visualATTORNEY DOCKET NO. 09674.029WO1-GSB comparison of a current state of the interval timer to the fields of the legend 170 / 250. Accordingly, it can be visually observed, by direct observation of the needleless connector 150 and / or its packaging, that the interval timer 160 is in a changed stage (72-168 hours of dwell time) in Fig. 4B, and not currently in need of being replaced.

[0044] By way of further example, the legends 170, 250 of Figs. 4A-4C include a third field 172c / 252c showing another (changed) state of the interval timer (e.g., red color at 168 hours / after a second change of state). Additionally, in this example, the legends 170, 250 include text and / or graphs adjacent that field 172c / 252c indicating the meaning of the associated state of the internal timer, namely in this example, 168 or more hours of dwell time (and an expired state), such that the needleless connector is in now expired and in need of being change / replaced in accordance with applicable guidelines for mitigation of bacterial infection risk. Again, the current state can be determined by a visual comparison of a current state of the interval timer to the fields of the legend 170 / 250. Accordingly, it can be visually observed, by direct observation of the needleless connector 150 and / or its packaging, that the interval timer 160 is in a second changed stage (>168 hours of dwell time) in Fig. 4C, and currently in need of being replaced.

[0045] Accordingly, the present invention provides intravenous lines providing venous access that include a portion (e.g., a needleless connector) that is configured to provide a visible change in state (e.g., change in color) over a time interval corresponding to a time interval for replacement of a relevant portion of the intravenous line,. In this manner, the state-changing portion thereby serves as a plainly-visible expiration notification feature indicating that the intravenous line, or relevant portion thereof, is due (or progressing toward being due) for removal and / or replacement according to common indwell time limits designed to avoid or mitigate CLABSIs or other bacterial infections. The portion of the intravenous line configured to change state is provided directly on or in close association with the intravenous line, so that it provides a visible indication / notification to a clinician that will be readily seen by a clinician during normal clinical activities without a need to reference separate notes, charts, an EMR record, etc., thereby increasing the likelihood that the expiration date will be noted by the clinician and remove / replacement guidelines will be complied with.ATTORNEY DOCKET NO. 09674.029WO1-GSB

[0046] While there have been described herein the principles of the invention, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation to the scope of the invention. Accordingly, it is intended by the appended claims, to cover all modifications of the invention which fall within the true spirit and scope of the invention.

Claims

ATTORNEY DOCKET NO. 09674.029WO1-GSBWhat is claimed is:1 . An intravenous line component comprising: a body adapted to function as a component of an intravenous line configured for providing intravenous access; and an interval timer integrated with the body, the interval timer being configured to provide a change in state after a defined period of time.

2. The intravenous line component of claim 1 , wherein the defined period of time is configured to correspond to an expiration time for a portion of an intravenous line assembly.

3. The intravenous line component of claim 1 , wherein the defined period of time is configured to correspond to a duration of time after a start time matched to a prescribed time for replacement for the intravenous line component to mitigate a bacterial infection risk.

4. The intravenous line component of claim 1 , wherein the defined period of time is one of 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after a start time.

5. The intravenous line component of claim 1 , wherein the body is configured as a needleless connector.

6. The intravenous line component of claim 1 , wherein the body is configured as a component of at least one of a central venous catheter, a peripherally inserted central catheter, a port and an intraosseous line.

7. The intravenous line component of claim 1 , wherein the body is configured as a component of at least one of an intravenous line slide clamp, intravenous line tubing, intravenous line hub, an intravenous line fluid, and an intravenous line dressing.ATTORNEY DOCKET NO. 09674.029WO1-GSB8. The intravenous line component of claim 1 , wherein the interval timer is configured to provide the change in state as a visible change in state.

9. The intravenous line component of claim 8, wherein the interval timer is configured to provide the change in state as a change in color.

10. The intravenous line component of claim 1 , wherein the interval timer is configured to provide a first change in state after a first defined period of time and a second change in state after a second defined period of time different from the first defined period of time.11 . The intravenous line component of claim 10, wherein the interval timer is configured to provide the first change in state as a first change in color to a first color, and to provide the second change in state as a second change in color to a second color different from the first color.

12. The intravenous line component of claim 10, wherein the first defined period of time is selected to correspond to a beginning of a time interval for recommended replacement of a portion of the intravenous line, and the second defined period of time is selected to correspond to an end of the time interval for recommended replacement of the intravenous line component.

13. The intravenous line component of claim 1 , wherein the body is adapted to function as a component of an intravenous line that requires periodic replacement to mitigate bacterial infection risk.

14. The intravenous line component of claim 1 , wherein the body is adapted to function as a component of an intravenous line that does not require periodic replacement to mitigate bacterial infection risk.

15. The intravenous line component of claim 1 , wherein the body is adapted to be selectively detachable from another portion of the intravenous line.ATTORNEY DOCKET NO. 09674.029WO1-GSB16. The intravenous line component of claim 1 , wherein the interval timer is integrated into the body by construction of the body of a material configured to change state predictably relative to the defined period of time.

17. The intravenous line component of claim 1 , wherein the interval timer is integrated into the body by coating at least a portion of the body with a material configured to change state predictably relative to the defined period of time.

18. The intravenous line component of claim 1 , wherein the interval timer is configured to provide the change in state after the defined period of time as a function of a duration of exposure to one of room air, ambient light, and another environmental condition.

19. The intravenous line component of claim 1 , wherein the interval timer is configured to provide the change in state as a function of at least one of a photosensitive, a photochromic, a vapor-sensitive, a vapor-chromic, a thermosensitive, a thermochromic and a chemical reaction.

20. The intravenous line component of claim 1 , wherein the interval timer is configured to provide the change in state as a function of a chemical reaction of substances contained within a sealed chamber of the body.21 . The intravenous line component of claim 1 , wherein the interval timer is configured to provide the change in state as a function of a chemical reaction of a substance contained within a chamber of the body that is in fluid communication with a fluid passed through the intravenous line.

22. The intravenous line component of claim 1 , wherein the interval timer is started by one of removal of the body from a package, removal of a protective coversheet from the interval timer, exposure of the interval timer to a light source, and exposure of the interval timer to a chemical substance, and exposure of the interval timer to a fluid passing through the interval timer.ATTORNEY DOCKET NO. 09674.029WO1-GSB23. The intravenous line component of claim 1 , further comprising a bacteria presence indicator comprising a state-changing material configured to change state when in contact with bacteria, the state-changing material of the bacteria presence indicator being disposed on the body in a position to be in contact with a fluid passing through the body.

24. The intravenous line component of claim 1 , further comprising a legend configured to act as a guide for interpreting a current state of the interval timer, the legend comprising at least one field indicating a state of the interval timer, along with at least one of text and graphics indicating a meaning of the state indicated by the at least one field.

25. An intravenous line component comprising: a body adapted to function as a needleless connector of an intravenous line configured for providing intravenous access; and an interval timer integrated with the body, the interval timer being configured to provide a change in state after a defined period of time configured to correspond to a duration of time after a start time matched to a prescribed time for replacement of the intravenous line component to mitigate a bacterial infection risk.

26. The intravenous line component of claim 25, wherein the defined period of time is one of 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after a start time.

27. The intravenous line component of claim 25, wherein the interval timer is configured to provide the change in state as a visible change in state.

28. The intravenous line component of claim 27, wherein the interval timer is configured to provide the change in state as a change in color.

29. The intravenous line component of claim 25, wherein the interval timer is configured to provide a first change in state after a first defined period of time and a second change in state after a second defined period of time different from the first defined period of time.ATTORNEY DOCKET NO. 09674.029WO1-GSB30. The intravenous line component of claim 29, wherein the interval timer is configured to provide the first change in state as a first change in color to a first color, and to provide the second change in state as a second change in color to a second color different from the first color.31 . An intravenous line component comprising: a body adapted to function as a needleless connector of an intravenous line configured for providing intravenous access; and an interval timer integrated with the body, the interval timer being configured to provide a visible change in color after a defined period of time configured to correspond to a duration of time after a start time matched to a prescribed time for replacement of the intravenous line component to mitigate a bacterial infection risk.

32. The intravenous line component of claim 31 , wherein the defined period of time is one of 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after a start time.

33. The intravenous line component of claim 31 , wherein the interval timer is configured to provide a first change in state after a first defined period of time and a second change in state after a second defined period of time different from the first defined period of time.

34. The intravenous line component of claim 33, wherein the interval timer is configured to provide the first change in state as a first change in color to a first color, and to provide the second change in state as a second change in color to a second color different from the first color.

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