BRPI0711757B1 - MEDICAL DEVICE COMPRISING VASCULAR ACCESS DEVICE WITH TIME-SENSITIVE STATUS INDICATOR AND METHOD FOR USING THE MEDICAL DEVICE - Google Patents

Abstract

MEDICAL DEVICE A vascular access device for communicating with a patient's vascular system is described, which may include a status indicator. The status indicator may detect and signal that a period of time has elapsed in relation to use of the vascular access device.

Description

BACKGROUND OF THE INVENTION

The present disclosure relates to an infusion therapy with vascular access devices. Infusion therapy is one of the most common health care procedures. Hospitalized patients as well as patients under home care receive fluids, pharmaceuticals, and blood products through a vascular access device (VAD) that can be inserted at least partially into the vascular system. Infusion therapy can be used to treat an infection, to deliver anesthetics or pain medications, to provide nutritional support, to treat cancerous growths, to maintain blood pressure and heart rhythm, or for many other significant clinical uses. Infusion therapy is facilitated by a vascular access device. The vascular access device can access a patient's peripheral or central vasculature. The vascular access device can be indwelling for short term (days), moderate term (weeks), or long term (months or years). The vascular access device can be used for continuous infusion therapy or intermittent therapy. A vascular access device is most commonly a plastic catheter that is inserted into a patient's vein, but may include any device used to access the vasculature, such as a catheter, syringe, Luer adapter, attached intravenous (IV) set, bag, or device, needle, or other related device. The catheter may be a few centimeters long for peripheral access to several centimeters long for central access. A vascular access device may be inserted transcutaneously or may be surgically implanted beneath the patient's skin. A vascular access device may have a single lumen or multiple lumens for infusion of multiple fluids simultaneously.

Commonly, the proximal end of the vascular access device includes a Luer adapter to which other vascular access devices can be attached to form an extravascular system. For example, an administration set of one or more vascular access devices can be attached to a vascular access device at one end and to an intravenous bag at the other. The administration set is a fluid conduit for the continuous infusion of fluids and pharmaceuticals. Commonly, an intravenous access device is a vascular access device that can be attached to another vascular access device. The IV access device closes the vascular access device and allows for the intermittent infusion or injection of fluids and pharmaceuticals. An IV access device may comprise a housing and a septum to close the system. The septum can be opened with a blunt cannula or a male Luer of a medical device.

Complications associated with infusion therapy can result in significant morbidity and even mortality. One significant complication is catheter-related blood stream infection (CRBSI). An estimated 250,000–400,000 cases of central intravenous catheter (CVC)-associated BSIs occur annually in US hospitals. The attributable mortality is estimated at 12%–25% for each infection and the cost to the healthcare system is $25,000–$56,000 per episode.

Vascular access device infection resulting in CRBSIs can be caused by a sterile insertion technique or by pathogens entering the fluid flow path subsequent to catheter insertion. Studies have shown that the risk of CRBSI increases with the length of catheter indwelling. This is due to a risk of contamination with each access of the vascular access device through an upstream port or IV access device. When contaminated, pathogens adhere to the vascular access device or IV access device, colonize, and form a biofilm. The biofilm is resistant to most biocidal agents and provides a replenishment source for pathogens to enter a patient's bloodstream and cause a BSI.

Recent studies have shown a potential correlation between IV access device use and CRBSI rates. An IV access device is designed to close the lumen of another vascular access device between uses. Closing the vascular access device is thought to prevent pathogens from infecting the vascular access device and causing CRBSI. Contamination of an IV access device during use can originate from a variety of sources, including an uncleaned septum, a contaminated male Luer, or contaminated infusion fluid. Contamination can result in pathogen colonization and biofilm formation, which can cause CRBSI if pathogens enter the bloodstream. The risk of IV device contamination increases over time and with each use of the device.

Before accessing an IV access device, the top surface of the septum or valve should be swabbed with an alcohol pad or other pad containing an antimicrobial agent. The swab cleans the surface of the external material and disinfects the surface. If the top surface is not swabbed and allowed to air dry completely before use, external substances and pathogens can be introduced into the device. The pathogens can colonize the device and catheter, leading to the formation of a biofilm. The pathogens in the biofilm can divide and enter the patient's bloodstream, resulting in CRBSI. To ensure that the highest rate of external substances and pathogens are killed, the alcohol or antimicrobial agent should be applied first and then air dried completely. Unfortunately, a large percentage of IV access device accesses are completed without swabbing and drying the top surface of the septum or valve. Therefore, what is needed are indicators to remind the operator to clean or replace the vascular access device to reduce the risk and occurrence of CRBSI.

SUMMARY OF THE INVENTION

The present invention was developed in response to technology problems and needs that have not yet been completely solved by currently available vascular access devices and IV access devices. Accordingly, these developed systems and methods provide a vascular access device, or IV access device, with a status indicator that can communicate a passage of time from when the vascular access device was first placed in service, an amount of use of the vascular access device during service, and/or disinfection of the vascular access device.

A vascular access device for introducing a substance into a patient's blood vessel includes a body with a lumen, a septum with a lumen, and a status indicator. The vascular access device may also include a second vascular access device with a proximal end and a distal end. The distal end of the second vascular access device is introduced into the blood vessel, and the vascular access device is a connector attached to the proximal end of the second vascular access device. The status indicator provides an indication of elapsed time using a time-sensitive adhesive, an insulated color-changing substrate with a variably transmissible or variably permeable layer, a fluid-absorbing material in contact with a separate dye series, colored liquid, and a material through which the liquid is transferred, a photochromic material including an oxidizable material, and/or a septum including a slit and an adhesive to seal the slit. The status indicator additionally, or alternatively, provides an indication of use of the vascular access device that includes a ratchet, a septum that includes an outer surface and at least one removable layer of colored material on the outer surface of the septum, a bar code, a radio frequency identification chip, and/or a piezoelectric crystal. The status indicator additionally, or alternatively, provides an indication of disinfection of the vascular access device that includes a thermochromatic material, a pH sensor, an alcohol sensor, a moisture-sensitive compound, a colored substrate beneath a textured surface, a colored liquid reservoir, a piezochromatic material, a polymer that changes color in the presence of intense ultraviolet light, and/or a pathogen dye solution.

These and other features and advantages of the present invention will become more fully apparent from the following description and appended claims, or may be learned by practice of the invention set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the foregoing and other features and advantages of the invention are obtained may be readily understood, a more particular description of the invention briefly described above will be provided by reference to the specific embodiments thereof which are illustrated in the accompanying drawings. These drawings represent only typical embodiments of the invention and are therefore not to be construed as limiting the scope of the invention. Figure 1 is a perspective view of a vascular access device with a status indicator. Figure 2 is a cross-sectional view of a status indicator with a time-sensitive adhesive. Figure 3 is a cross-sectional view of a status indicator with snap-fit arms. Figure 4 is a cross-sectional view of a status indicator with a clamp. Figure 5 is a cross-sectional view of a status indicator with adhesive assembled and disassembled. Figure 6 is a cross-sectional view of a spring-anchored status indicator assembled and disassembled. Figure 7 is a cross-sectional view of a status indicator with a compression spring. Figure 8 is a cross-sectional view of a status indicator with a wick and pigment. Figure 9 is a cross-sectional view of the wick and pigment of Figure 8. Figure 10 is a side view of the status indicator of Figure 8 on the surface of a vascular access device. Figure 11 is a side view of a status indicator with a colored liquid reservoir in a vascular access device. Figure 12 is a cross-sectional view of the reservoir of Figure 11. Figure 13 is a side view of a strip status indicator in a vascular access device. Figure 14 is a close-up side view of the strip status indicator of Figure 13. Figure 15 is a cross-sectional view of the strip of Figure 14 taken along lines 146-146 of Figure 14. Figure 16 is a perspective view of a photochromatic vascular access device illuminated as a status indicator. Figure 17 is a perspective view of a darkened photochromic vascular access device as a status indicator. Figure 18 is a perspective view of a brightened photochromic disk as a status indicator attached to a vascular access device. Figure 19 is a perspective view of a darkened photochromic disk as a status indicator attached to a vascular access device. Figure 20 is a perspective view of a label as a status indicator attached to a vascular access device. Figure 21 is a side view of a label with multiple chemical reservoirs as a status indicator. Figure 22 is a timeline of the visual change of a status indicator. Figure 23 is a cross-sectional view of a status indicator in a septal slit. Figure 24 is a side view of a ratchet-type status indicator of a vascular access device. Figure 25 is a top view of the ratchet status indicator of Figure 24. Figure 26 is a cross-sectional view of a multilayer status indicator. Figure 27 is a close-up cross-sectional view of the multilayer status indicator of Figure 26. Figure 28 is a perspective view of the top of a septum with a multilayer status indicator. Figure 29 is a perspective view of the top of a septum with a multilayer status indicator after use. Figure 30 is a side view of a bar code status indicator of a vascular access device. Figure 31 is a side view of a radio frequency identification chip status indicator of a vascular access device. Figure 32 is a side view of a piezoelectric crystal status indicator of a vascular access device. Figure 33 is a perspective view of a thermochromatic status indicator layer on top of a septum. Figure 34 is a perspective view of a pH sensor status indicator layer on top of a septum. Figure 35 is a perspective view of an alcohol sensor status indicator layer on top of a septum. Figure 36 is a perspective view of a textured surface status indicator layer on top of a septum. Figure 37 is a perspective view of a moisture-sensitive status indicator layer on top of a septum. Figure 38 is a top cross-sectional view of a pigment transport reservoir status indicator before and after use. Figure 39 is a perspective view of a piezochrome status indicator layer on top of a septum. Figure 40 is a cross-sectional view of a loaded dual chamber syringe status indicator. Figure 41 is a cross-sectional view of a partially ejected dual chamber syringe status indicator. Figure 42 is a cross-sectional view and a close-up cross-sectional view of a status indicator of the inner surface of a vascular access device. Figure 43 is a front view of various status indicators in the initial and final condition. Figure 44 is a schematic diagram of various vascular access devices.

DETAILED DESCRIPTION OF THE INVENTION

The presently disclosed embodiments of the present invention will be better understood by reference to the drawings, in which like reference numerals indicate identical or functionally similar elements. It is readily understood that the components of the present invention, generally described and illustrated herein in the figures, may be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed description, depicted in the figures, is not intended to limit the scope of the claimed invention, but is merely representative of the presently preferred embodiments of the invention. Now, referring to Figure 1, an intravenous (IV) access device and/or a vascular access device 10 is used to introduce a substance into a patient's blood vessel. As used herein, a vascular access device includes any device employed to access the vasculature, such as a catheter, a syringe, a Luer adapter, an attached IV set, bag or device, a needle, or other related devices. The vascular access device 10 includes a body 12 with a lumen 14 and a septum 16 disposed in the lumen 14. The septum 16 may have a slit 18 through which a device may introduce a substance into the lumen 14 of the vascular access device 10. The device 10 also includes a status indicator 20 which will be described in further detail in the following figures. Now, referring to FIG. 2, a status indicator 22 includes a time-sensitive adhesive 24 attached to a movable member 26 and the body 12 of a vascular access device 10. The movable member 26 is attached to the first end of a spring 28, and the second end of the spring 28 is attached to the body 12 of a vascular access device 10. The vascular access device 10 includes a window 30 through which the movable member 26 may be viewed by an operator of the device 10 when the device 10 is in use. An operator of status indicator 22 may use status indicator 22 to find out how long device 10 has been in use. When device 10 is first attached to another vascular access device, such as a catheter or other structure that is placed in a patient's blood vessel or vein, an operator, such as a patient, physician, clinician, nurse, or other healthcare professional, may allow movable member 26 to be moved away from stationary member 32 in the direction of spring 28. Eventually, time-sensitive adhesive 24 will allow movable member 26 to disengage from stationary member 32, causing movable member 26 to shift its position in the direction of spring 28. When movable member 26 is moved from a first position to a second position, a red label 34 will be placed in the viewing area of window 30, through which the operator can see red indicator 34. By viewing red indicator 34, an operator will know that device 10 has been in use for a specific period of elapsed time. Now, referring to Figure 3, a status indicator 36 has one or more snap-fit arms 38 attached to the head 40 of a movable member 42. In turn, the movable member 42 is attached as its rear to a first end of a spring 44, and the second end of the spring 44 is attached to a body 12 of a vascular access device 10. The plastic snap-fit arms 38 engage the head 40 in such a manner that the movable member 42 is held by the snap-fit arms 38 for a predetermined amount of time. After a predetermined amount of time, tension from the extended spring 44 causes the movable member 42 to pull on the snap-fit arms 38, which in turn causes the snap-fit arms 38 to drag in a direction 46 away from the head 40 of the movable member 42. Ultimately, the snap-fit arms 38 will pull far enough that the movable member 42 is released from the snap-fit arms 38 and moves from a first position on the snap-fit arms 38 to a second position toward the spring 44 and away from the snap-fit arms 38. In the second position, the movable member exposes a colored indicator 48 through a window 50 of the body 12. When an operator of the vascular access device 10 observes that the indicator 48 is exposed in the window 50, the operator will know that a given amount of time has elapsed, indicating that the device 10 may need to be cleaned or replaced.

Now, referring to Figure 4, a status indicator 52 includes a clamp 54 that can be removed by an operator to initiate the sequence of steps illustrated in Figure 2. Once the clamp 54 is removed from the status indicator 52, a spring 56, which is connected to the body 12 of the vascular access device 10, can pull a movable element 58 away from a stationary element 60 for a period of time. After a predetermined amount of time has elapsed, an adhesive 62 securing the movable member 58 to the stationary member 60 will be released, and the movable member 58 will move from a first position to a second position in the direction of a spring 56. When the movable member 58 moves to the second position, an indicator 64, or other visible colored structure, will be exposed through a window 66. When the indicator 64 is exposed through the window 66 of the device 10, an operator will know that a given amount of time has elapsed, indicating that the device 10 may need to be cleaned or replaced.

The clamp 54 shown in FIG. 4 allows an operator to initiate the synchronization sequence of the status indicator 52 at any point in time. By allowing the operator control over when the status indicator is engaged by removing the clamp 54, an operator may choose to either engage the status indicator 52 upon first removing the device 10 from its sterile packaging, upon first attaching the device 10 to another vascular access device, or upon first using the attached device 10 by inserting a needle or other device to introduce a substance through the device 10 into a patient's blood vessel.

Now, referring to FIG. 5, a status indicator 68 may be delivered to an operator in its packaging in such a manner that an adhesive 74 is not already attached to a stationary member 72. At any point after removal of the device 10 from its packaging, an operator may engage or install the status indicator by pressing, or otherwise placing, a movable member 74 containing the time-sensitive adhesive 70 against the surface of the stationary member 72. When the status indicator 68 is installed by the operator, the operator initiates a timing sequence whereby the movable member 74 is pulled with a spring 76 in a direction opposite the boundary surfaces of the movable member 74 and the stationary member 72.

Now, with respect to Figure 6, a status indicator 78 may come unattached from a vascular access device 10 when the device 10 is still in its sterile packaging. Similar to the status indicator 68 of FIG. 5, a user may engage the status indicator 78 of FIG. 6 at any desired point in the operation of the device 10. A spring 80 is compressed to a state where no tension or force is placed on the spring 80. The spring 80 is attached to a first end of a movable member 82 and to a second end of an anchor 84. The movable member 82 is attached to a stationary member 86 by means of a time-sensitive adhesive 88. The anchor 84 may be installed by an operator by moving the anchor 84 in a direction 90 opposite to the direction of the movable member 82. By moving the anchor 84 a certain distance in the direction 90, the anchor 84 is engaged in the notch 92. When the anchor 84 is fully engaged in the notch 92, an appropriate amount of tension and force is placed on the spring 80 such that the movable member 82 disengages from the stationary member 86. stationary 86 after an appropriate predetermined amount of time, which indicates that the device 10 has been in operation for an appropriate amount of time.

Now, referring to Figure 7, a status indicator 94 includes a compression spring 94 attached at a first end of the body 12 of the device 10 and at a second end to a movable member 98. The movable member 98 is attached at a base surface 102 to a top surface 104 of the body 12 of the device 10. The compression spring 96 is compressed while the movable member 98 is adhered to the body 12. After a predetermined amount of time, the adhesive 100 will release the movable member 98 from the body 12 under the pressure and force of the compression spring 96. When moved, the movable member 98 will expose an indicator 106 in a window 108, through which an operator can view the indicator 106. When the operator observes the indicator 106 through the window 108, the operator will know that the device 10 has been in use for the predetermined amount of time. time. Any of the status indicators of FIGS. 2 through 7 may be initiated by an operator in a number of ways when the device 10 is placed in service. In one embodiment, the elements may be initiated together with a clamp that takes the charge from the adhesive. The clamp is then removed at the start of service. In another embodiment, the elements are initiated together, but a spring is not charged until the start of service. In another embodiment, an operator presses the two elements together at the start of service. Any of these actions that initiate the start of service for any of the status indicators discussed above may be coupled with other actions that are commonly performed with a vascular access device. For example, a dust cover that protects certain structures on the vascular access device 10 may be removed after the device 10 is removed from its sterile packaging or after the vascular access device 10 is attached to another device. The dust cover may be removed by pulling the dust cover from a surface of the body 12 of the vascular access device 10 or by twisting and pulling the dust cover from the device 10. The device 10 may also be removed from the packaging, and a portion of the packaging may cause the status indicator to begin the timing sequence that places it in service. Additionally, as the dust cover is removed, a clamp may be removed with the dust cover, a spring may be loaded with the dust cover, or a movable element may be brought into contact with a stationary element. Any other action performed by an operator of the device 10 may be combined to engage or disengage a status indicator. The status indicators of FIGS. 2 through 7 may include any form of visual or mechanical indication shown, for example, with the red indicator 34 of FIGS. 2. The indicator 34, or other form of visual or mechanical indication, may be of any size, shape, or color, and may include any mechanical structure that can indicate any elapsed period of time to an operator. Furthermore, multiple status indicators or multiple indicators may be used on a single device 10. In one embodiment, a device 10 includes a mobile element with multiple indicators that indicate that multiple time periods have elapsed.

In another embodiment, multiple movable elements are attached to one or more stationary elements using multiple time-sensitive adhesives of varying strengths and/or quantities. The multiple adhesives release at different time intervals, causing each of the multiple movable elements to release in sequence and thus illustrating to the operator that certain periods of time have elapsed. For example, a first movable element with a weak adhesive or a small amount of adhesive may first disengage from a stationary element to show an operator that 12 hours have elapsed since the device 10 was placed in service. A second movable element attached to a stationary element with a stronger adhesive than the first movable element or attached to a stationary element with a larger amount of adhesive may later disengage from the stationary element, indicating to an operator that 24 hours have elapsed since the device 10 was placed in service.

This sequence may occur for a third and subsequent moving elements to indicate to an operator that several time periods have elapsed.

8 through 10, a status indicator 110 includes a fluid-absorbing material or wick 112 and a series of separate pigments 114. The wick 112 is in contact with the pigment 114 as shown in the cross-sectional view of the status indicator 110 that is disposed in the body 12 of the vascular access device 10. The status indicator 110 also includes an open port 116 to which a catheter or other fluid delivery system or device is attached. For example, a catheter attached to an IV bag delivers water or saline into the open port 116, delivering a constant supply of saline or water to the wick 112. Alternatively, the device may include an external fluid reservoir that is activated upon use of the device. As time passes, the capillary forces of the wick 112 draw additional water along the length of the wick 112. As water is drawn along the wick 112, the center of the pigment 114 is wetted, and the color of the water-soluble pigment 114 is infiltrated through the wall of the wick 112 such that it is visible on the outer surface of the wick 112. The wetted pigment is visible to an operator through a viewing window 118. As used above, and as mentioned throughout this description and in the claims, “use” includes any use of a vascular access device or any structure in communication with the device, including any use of or interaction with the device, including disinfection by a health care provider or other individual, or with the environment after the vascular access device is removed from its manufacturer's packaging. Now, referring to FIG. 9, there is shown a cross-sectional view of the wick 112 and the water-soluble pigment 114. As the wick material or wick 112 is moistened, the pigment 114 is dissolved and the color migrates into the wick material in a direction 120. Now, referring to FIG. 10, the status indicator 110 of FIG. 8 is shown embedded in the surface of a vascular access device 10. The status indicator 10 shows the orifice 116 that is open to receive a supply of fluid. The status indicator 110 also shows a serpentine path 122 through which the wick material 112 and the pigment 114 travel. The entire length, or any portion, of the path 112 may be viewable by an operator through the body 12 of the device 10. The viewing window 118 of the status indicator 110 shown in FIG. 10 allows the operator to see when the pigment 114 at the end of the path 122 has dissolved and migrated to the wick 112 in the viewing window 118. When the pigment 114 is seen in the viewing window 118, an operator will know that a predetermined amount of time has elapsed. Then, the operator will know that the operator should clean and/or replace the device 10.

In one embodiment, the material used to make the wick 112 is a fabric yarn or a paper wick with a water-soluble pigment center. In another embodiment, the path 122 of the wick 112 and the pigment 114 is not serpentine. Instead, the path 122 is a straight line. Preferably, the serpentine path 122 is spaced and has a length suitable to cover the entire predetermined time period for the status indicator 110. The path may also be wound around the entire device 10 in multiple revolutions. In another embodiment, the wick 112 is visible along the entire length of its path. In another embodiment, the wick 112 is visible at discrete points along the length of the path. In the foregoing two embodiments, preferably, the status indicator includes markings on the surface of the body 12 of the device 10 that indicate that various amounts of time have elapsed since the device 10 was placed in service. As the pigment dissolves along the path, the various time indicator points are reached and become visible to an operator. In another embodiment, the pigment 114 comes in various shapes, sizes, and colors. For example, along the path 122, a first series of pigment 114 is colored green to indicate a first 12-hour period, a second series of pigment 114 is colored yellow to indicate a second 12-hour period from hour 12 to hour 24, and a third series of pigment may be colored red to indicate a third 12-hour period from hour 24 to hour 36. When the path turns red, an operator will know that the device should be cleaned or replaced soon or immediately. The thickness and width of the wick and pigment material and the size and spacing of the channel or path in which the wick and pigment are placed can be varied in order to adjust the rate and visibility at which the pigment is dissolved and displayed to an operator along the path.

Now, referring to Figure 11, a status indicator 124 of a vascular access device 10 includes a colored liquid 126 and a material 128 placed in a channel 130 through which the colored liquid 126 is transferred.

Now, referring to FIG. 12, a cross-section of the colored liquid reservoir 126 of FIG. 11 is shown located on the exterior surface of the body 12 of the device 10. A seal 132 prevents the colored liquid 126 from being absorbed by the material 128 until an operator exerts pressure on the liquid reservoir 126. When an operator places pressure on the colored liquid 126, the seal 132 is broken and the colored liquid 126 is allowed to travel in a direction 134 along the material 128 until the colored liquid 126 is visible to an operator in a window 136.

As shown in FIG. 12, the status indicator 124 is integrated into the device 10. In another embodiment, the status indicator 124 is a label with a colored ink or colored oil as the colored liquid 126, and the label is attached to the device 10. In this embodiment, the colored ink or oil 15 is initially contained in a reservoir that is obscured from view by means of a mask of the label. The ink or oil is then exposed to a porous or absorbent material. The material is designed to drain the ink or oil at a specified rate. Activation of the draining may be accomplished by an operator squeezing the reservoir, as shown. However, the squeezing may not be accomplished by the operator's fingers. Instead, squeezing of the reservoir may be initiated in conjunction with use of the device 10 as it is placed into service or upon any other event capable of acting upon the reservoir. For example, compression is caused by removing a dust cover from device 10. As another example, compression is caused when device 10 is attached to another vascular access device that provides access to the patient's blood vessel. By twisting device 10 onto another device, the force required to twist and attach the two devices together can also simultaneously compress the reservoir to initiate displacement of the colored ink or oil along the absorbent material. At at least one point equivalent to a desired elapsed drain time, the colored material is exposed for viewing by an operator in at least one viewing window. In this manner, the material changes color and the operator can view the time based on the change in relevance count.

Now, referring to Figure 20, a label 162 discussed above is attached to a vascular access device 10. The label 162 shows an elapsed time period in number of days by advancing a colored strip across the label 162. In one embodiment, the label may be integrated into the device 10.

Now, referring to Figure 13, a status indicator 138 is a label adhered to the outer surface of the device 10.

Now, referring to FIG. 14, the status indicator 138 is shown in additional detail. The label, or strip, of the status indicator 138 indicates various time periods 140 along its length. The time periods 140 are divided as follows: 12 hours, 24 hours, 36 hours, and 72 hours. When any of these given time periods have elapsed, as displayed by the status indicator 138 to an operator, the operator may either clean or remove and replace the device 10, depending on the specific needs of the patient and the environment in which the device 10 is used. The strip 142 is a multilayer strip that is light sensitive. When exposed to light, the strip 142 slowly begins to change color initially at a first end and then the color change progresses to a second end of the strip 142 in a direction 144. The rate at which the color shifts in direction 144 can be modulated or adjusted or tuned by superimposing a semi-transparent layer over a color-changing substrate as shown in FIG. 15.

Now, referring to FIG. 15, a cross section of the strip 142 of FIG. 14 is shown along lines 146-146. The cross section of the strip 142 reveals a color-changing substrate 148 and a variably transmissive insulation layer 150 on top of the color-changing substrate 148. The variably transmissive layer 150 has a greater degree of light transmissivity at its first end 152, and a lesser amount of light transmissivity at its second end 154. Between end 152 and end 154, the degree of light transmissivity of the layer 150 is graduated from a greater to a lesser amount of transmissivity. Thus, the transmissive layer 150 allows light to communicate with the color change layer 148 at a greater rate at end 152 than light would communicate at end 154. This allows the status indicator 148 to show an anticipated color change at end 152 relative to the color change at end 154. The anticipated color change is shown in FIG. 14 as a colored band starting at end 152 and moving through the 12 o'clock, 24 o'clock, and 36 o'clock marks. However, because end 154 of FIG. 14 has a lower level of light transmissivity, light has still not been allowed to communicate with the color change substrate 148, and the strip 142 still does not show a color change at end 154.

In one embodiment, as shown in connection with FIGS. 13 through 15, supra, the status indicator 138 is sensitive to light. In another embodiment, the status indicator is sensitive to oxygen. When exposed to oxygen, the status indicator strip begins to slowly change color. In this embodiment, instead of having a semitransparent layer 150, the strip includes a semipermeable layer over the color-changing substrate 148. The semipermeable layer is permeable to oxygen. The semipermeable layer is variably permeable such that the first end of the strip changes color before the second end of the strip changes color, indicating a change in time during use of the device 10. The color change will begin at one end of the strip, and will continue along the length of the strip over the elapsed period of time. In this manner, the position of the contour between the colored and uncolored portions of the strip becomes an indicator of how long the strip has been exposed to oxygen.

In one embodiment, a light or oxygen sensitive strip is mounted on an adhesive backing and is applied to any time sensitive device 10. The device is stored in a light or oxygen tight package to ensure that the strip does not begin its timing sequence until after the package is opened. Many of the embodiments discussed in connection with FIGS. 13 through 15 appear very much like a temperature sensitive strip used in a fish tank. However, the colored strip or band indicates the passage of time rather than a change in temperature. The principles discussed in these embodiments can be applied to indicate the passage of time, an amount of use of the device 10, or the disinfection of the device 10.

The oxygen-sensitive material discussed above may be an oxidizable compound that is coated onto a substrate. The oxidizable compound may be a metal, such as aluminum, silver, or magnesium. When oxidized, the metal may change color or exhibit some other visual change. In one embodiment, a layer that is semipermeable to oxygen may coat the oxidizable compound. In another embodiment, the compound is coated directly onto the layer. The layer is designed to have a rate of oxygen permeability controlling the timing of oxidation of the metal. The layer and/or oxidizable compound may contain an antioxidant to control the timing of oxidation. The antioxidant will delay the oxidation reaction until the antioxidant is consumed. The oxidative compound and layer may be incorporated directly into the device 10. Alternatively, the oxidative compound and layer may be adhesively attached to the device 10. Alternatively, the oxidative compound and layer may be incorporated into a disk or other structure that may be attached to the exterior surface of the device 10. Multiple labels, disks and/or stripes of varying lengths may be used together on a single device 10 to indicate the passage of multiple time periods. Now, referring to FIG. 16, a status indicator 156 includes a photochromic material that forms the body 12 of a device 10. The photochromic material 156 is a visual status indicator that shows a distinct change in color from when the device 10 is first placed in service in initial use to a specific time lapse, as set forth. For example, the photochromic material 156 starts out as a light or white color upon initial use of the device 10. After the device 10 has been attached to a vascular access device, or otherwise placed in service, for 24 hours, the photochromic material 156 changes to a dark color 158, as shown in FIG. 17. Now, referring to FIG. 17, the dark photochromic material 158 of the device 10 indicates to an operator that the device 10 has been placed in service for at least 24 hours and has reached an infection risk threshold. The operator may then clean or replace the device 10. The color change of the photochromic material 156 and 158 of FIGS. 16 and 17 may be accomplished in a variety of embodiments. In one embodiment, a photochromic pigment is incorporated directly into the device 10, into any portion thereof, or any structure attached thereto. Photochromic materials can be used, for example, to indicate a passage of time during which a photochromic material has been exposed to light or lack thereof, to indicate whether, and to what extent, a photochromic material has been disinfected, and/or to indicate whether, and to what extent, a photochromic material has been properly cleaned. Commonly, photochromic pigments are compounds used for non-medical device applications, such as eyeglasses and printing. When sunlight or ultraviolet (UV) radiation is applied, the pigment becomes activated and the molecular structure changes, allowing a color to appear.

Photochromic materials include a colorless isomer that contains a spirocarbon atom. This carbon atom is sp3 hybridized and serves to separate the molecule into two halves. Because of the highly localized pi systems that are separated by an sp3 hybridized carbon, all of the absorption is in the UV part of the spectrum with no absorption in the visible part of the spectrum, and therefore the molecule appears colorless. When the molecule absorbs UV light, the spirocarbon atom opens. The molecular structure then changes to one of extended conjugation and the molecule absorbs light in the visible region. Many colors are possible by mixing four basic colors: blue, yellow, violet, and orange/red. UV-absorbing compounds can be used in conjunction with photochromic pigments to extend the time of the color change.

The sensitivity of the ultraviolet material 158 may be modified and/or modulated to provide a material that only changes color during the presence of very high intensity ultraviolet light. Thus, an ultraviolet light rod or other light source may be applied to the high intensity UV sensitive material 158 to change its color. After its color is changed and the intense light source is removed, it may return to an original color after a predetermined amount of time. The intense ultraviolet light source may be applied to the material just before, during or after disinfection of the material.

A light source may be provided not only to change the color or to provide some other visual change to a vascular access device, but a UV light source may additionally or alternatively be used to sterilize or disinfect the device. UV rays of various intensities and wavelengths may be used to kill or damage bacteria or pathogens on the device in order to disinfect the device. In such an embodiment, a UV wand or other device may be placed by a healthcare provider in communication with at least a portion of a vascular access device in order to disinfect the device. The wand may remain in communication with the vascular access device until the device is disinfected. After disinfection occurs, the healthcare provider may remove the UV wand.

The light source may also be used to confirm that all or a significant number of pathogens have been killed. For example, a photochromic material may require a color change to be completed in order to indicate that all or a significant number of bacteria and pathogens have been completely killed on the light-sensitive material. An operator may then be able to confirm that the operator remembered to sterilize or disinfect the device 10. For example, the absence of a glow or other color on the material indicates that the operator forgot the vital sterilization or disinfection step.

As shown in Figure 17, the color change may also occur in another embodiment in which the photochromic pigment is incorporated into the device 10 by adding the pigment to the polymer making up the body 12 and/or the septum 16. The preferred housing polymer is polycarbonate, but other clear or translucent polymers such as acrylic, polyvinyl chloride, polypropylene, and polyurethane may be used. The addition of the pigment may occur at the time the polymer is polymerized or during a subsequent compounding operation. The pigment may also be added at the time of injection molding of the body 12 or the septum 16.

In another embodiment, the photochromic pigment may also be applied as a coating to the body 12 or septum 16. The pigment may be mixed with a solvent, and the mixture may be sprayed, poured, atomized, printed or dipped onto the appropriate surface. The solvent will evaporate leaving the pigment on the surface. The photochromic pigment may also be printed onto a label, and the label may be attached to the device 10.

Now, with respect to Figure 18, a disk 160 discussed above is attached to the outer surface of device 10. Now, with respect to Figure 19, disk 160 has changed from a light color to a dark color, consistent with the principles discussed herein.

In another embodiment, a status indicator may communicate an elapsed period of time to an operator via a change in the refractive transparency index of a material forming the body 12 of the device 10. The change in the transparency of the substrate material may be initiated by oxidation, moisture absorption, or crystallization of the polymer. In this embodiment, the substrate includes a compound that is sensitive to oxidation and, when oxidized, changes the refractive index of the substrate. In another embodiment, the substrate is a material that absorbs moisture. When the moisture content of the substrate reaches a specified amount, the substrate swells, causing a change in the optical properties of the material. In another embodiment, a polymer of the substrate may crystallize, causing an optical change, such as a change in the clarity of the material. In the disclosed embodiments, the substrate may form the body 12 of the device 10, may be a separate disk shown in FIGS. 18 and 19, or may be a label shown in FIGS. 20.

Now, referring to FIG. 21, a status indicator 164 is a label that may be attached to a device 10. The label includes a first chemical 166 and a second chemical 168. The chemicals 166 and 168 are contained in separate reservoirs that are obscured from an operator's view by a mask of the multilayer label 164. The status indicator 164 is activated by compression of the reservoirs using either an operator's fingers or by action that is performed in conjunction with installation, cleaning, attachment of the device 10 or another device, or other use of the device 10. Upon activation, the two chemicals 166 and 168 are mixed in a chamber 170. Upon mixing, the chemicals react with each other and change color. The chamber 170 is viewable by an operator. When the operator observes a color change in the window of chamber 170, the operator will know that a predetermined amount of time has elapsed. The two chemicals 166 and 168 may move from their separate reservoirs into the interior of chamber 170 by means of a porous or absorbent material or by means of microfluidic channels 172 and 174. In another embodiment, a change in pH when the two chemicals 166 and 168 are mixed results in a color change in chamber 170. In another embodiment, the reservoirs containing chemicals 166 and 168 are separated from each other and/or form chamber 170 using a breakable seal similar to seal 132 described above in connection with FIG. 12.

In another embodiment, the device package 10 is resistant to environmental factors that initiate a timing sequence of all of the status indicators discussed herein. Depending on the particular status indicator, the package includes a barrier to light, oxygen and/or other gases, and moisture, as appropriate. The package may also include a mechanism for initiating the timing sequence of the particular status indicator upon removal of the package.

The above-discussed time-sensitive status indicator signals, which are communicated to an operator, correlate with a risk level that has been shown to result in catheter-related blood stream infections (CRBSIs) if exceeded. The activation time for the signal may differ depending on the application of the device 10. As stated, the risk of contamination and pathogen colonization increases with use of the device 10. For devices used in a high-use application, such as an intensive care unit (ICU), a short-term (24-hour) time-sensitive status indicator will be used. For medium-use applications, the activation time may be 48 hours. And, for minimal-use applications, the signal activation time may be 72 hours to 96 hours, or longer.

Now, with respect to FIG. 22, as set forth, a status indicator may be a color change or it may be a change in other visual properties, such as transparency. In one embodiment, the timing of the visual change will follow an s-shaped curve 176. As shown in FIG. 22, there will be no change, or minimal change, for a specified period of time 178, and then the visual change will be rapid, intense, and non-reversible for a separate period of time 180. Activation of the visual change 182 may be delayed until the desired time periods discussed herein. Initiation of the time-sensitive status indicator may occur by exposing the status indicator to environmental factors, such as light, air, and moisture, as discussed herein. Initiation may also occur upon removal of the device 10 from its sterile packaging, upon initial use, or upon actuation of the device 10 through normal or deliberate use, or by manual or other actuation by the operator.

Now, referring to Figure 23, there is shown the septum 16 of the vascular access device 10 of Figure 1. The septum 16 includes a slot 18 through which a needle, catheter, or male Luer can be inserted into the device 10. The surface of the slot 18 may be coated with a lubricant or an adhesive 184. The lubricant or adhesive 184 shown in Figure 23 is a cross-linking silicone lubricant that seals by gluing, or otherwise adhering, the slot 18 after a given amount of time. Silicone crosslinking of the silicone material forming the body of the septum 16 may be initiated, initiated or catalyzed by enzymes produced by a bacterium or other pathogen, and the gap 18 is sealed by adhesive lubricant 184, thereby blocking access of a needle, catheter, male Luer or other device that an operator may wish to insert through the septum 16. Thus, in the embodiment of FIG. 23 , a status indicator 186 is a mechanical indicator that prevents an operator from further accessing the septum 16 after a predetermined amount of time. The type and amount of adhesive or lubricant 184 that is used, and the location at which the lubricant or adhesive 184 is applied along the length of the gap 18 may be varied to adjust the speed or rate at which the gap is sealed.

Alternatively, the adhesive may be time-sensitive in that it is sensitive to moisture. The adhesive gradually absorbs moisture over a predetermined period of time. Once moisture is absorbed to a specific level, the gap 18 may be closed by glue in the manner discussed above.

In addition to the embodiments discussed above with respect to FIGS. 1-23, a status indicator may indicate an amount of usage by an operator in addition to or in place of an elapsed period of time. Embodiments of the status indicator that may communicate usage of a device 10 to an operator are discussed with respect to the following FIGS. 24, a status indicator 188 provides an indication of the use of a vascular access device 10. The status indicator 188 includes a ratchet mechanism 190 that includes a ratchet 92 that communicates with multiple sequential teeth 194 of the ratchet mechanism 190. As the ratchet 192 articulates between the multiple sequential teeth 194, the ratchet 192 advances from a first position to a second position in a direction 196 along the device 10. Now, referring to FIG. 25, a top view of the status indicator 188 is shown. The device 10 is frequently accessed by another device from a direction shown in the view of FIG. 25. When another device, such as a needle, catheter, or male Luer, accesses the device 10, the ratchet 192, which is spring loaded, moves from a first elevation to a second elevation in a direction 196 along the device 10. for a second elevation, and is pivoted from a first tooth 194 to a second tooth 194, causing the ratchet mechanism 190 to rotate the pointer 198 of the ratchet 192 to move along a direction 196 shown in FIG. 24. Thus, the ratchet mechanism 190 may be used to sense a usage amount of the device 10 as it is matched, combined, or otherwise accessed by other devices. Each time a device accesses the device 10, the pointer 198 of the ratchet 192 will advance in a direction 196 to indicate that the device 10 has again been accessed. As shown in FIG. 24, a counter 200 illustrates to an operator the number of times the device 10 has been accessed by an operator. By viewing the counter 200 and the location of the pointer 198 relative to the counter 200, any operator viewing the device 10 can understand the usage history of the device 10 without ever having seen the device or interacted with the patient during the life of the device. The status indicator 188 and ratchet mechanism 190 of FIGS. 24 and 25 function in much the same way as the click mechanism of a pen. Any similar mechanism that can indicate usage of the device 10, including the ratchet mechanism of a pen, can fall within the scope of the status indicator 188 described herein. The ratchet 192 and/or the pointer 198 may be of any size, shape or color, and may be visible in any window or series of windows, or may be visible throughout the body 12 of the device 10. Now, referring to FIG. 26, a septum 16 of a vascular access device 10 includes a status indicator 204 on the top outer surface 202 of the septum 16. The status indicator 204 includes at least one removable layer of colored material on the outer surface 202 of the septum 16. Now, referring to FIG. 27, there is shown an exploded cross-sectional view of the status indicator 204 of the septum 16 of FIG. 26. The status indicator 204 includes multiple layers 206 of different colored materials. A first layer 208 is colored green, a second layer 210 is colored yellow, and a third layer 212 is colored red. Now, referring to FIG. 28, initially, the surface 202 of the septum 16 is coated with all three layers of the soft, easily scratched colored material. The material may also be slightly soluble in alcohol. Thus, the status indicator 204 of FIG. 28 shows a green top layer 208 of the material on its outermost surface. Now, referring to FIG. 29, after an operator scratches, works on, rubs, or otherwise disturbs the top surface 202 of the septum 16, the green top layer 208 will be removed, and the yellow middle layer 210 will be exposed. After further access and use of the device 10, the yellow layer 210 will be removed, exposing the red base layer 212. When part or all of the top surface 202 is displayed as a red color 212 to the operator, the operator will know that the device 10 has received a certain amount of use. The operator may then choose to clean and/or replace the device 10.

In one embodiment, the status indicator 203 of FIGS. 26 through 29 includes a material that is soluble in alcohol. Operators often swab alcohol on the exterior surface 202 of the septum 16 in order to clean the device 10 and kill any bacteria or other pathogens that are on the surface 202 of the septum 16 or in the crevice 18 of the septum 16. By allowing the layered material to be slightly soluble in alcohol, the material may change color, texture, and/or shape in order to visually communicate to an operator that the identifier 10 has been swabbed one or more times. In another embodiment, the material may be a colored, easily scratched material that, when touched, rubbed, or otherwise accessed or disturbed, changes color or shape. In another embodiment, multiple layers 206 with multiple characteristics, including alcohol solubility, saline solubility, water solubility, and abrasion, may be stacked on top of each other to achieve a variety of applications to adapt septum 16 and status indicator 204 to a particular use in a hospital. Now, referring to FIG. 30, a status indicator 214 includes a bar code label 216 attached to a vascular access device 10. When device 10 is placed in service, and each time device 10 is accessed, an operator scans bar code 216 with a bar code reader to keep track of the time device 10 has been in use and the number of times device 10 has been accessed. A database on the bar code reader or other device capable of receiving data from the bar code reader provides an alarm when time or access limits are reached. For example, after 24 hours after device 10 was initially scanned for the first time, a device may provide an alarm to the operator indicating that device 10 has been in use for at least 24 hours. Alternatively or additionally, an alarm indicating that the maximum number of accesses has been reached may also be communicated to an operator. The bar code 216 may be in the form of a tag or pendant label or other structure that is attached, affixed, or otherwise secured or connected to the device 10. Now, referring to FIG. 31, a status indicator 218 includes a radio frequency identification (RFID) chip 220. The RFID chip 220 is placed on the outer surface of a vascular access device 10. The RFID chip 220 enables the device 10 to store information regarding the amount of time the device 10 has been in service and/or the number and frequency of accesses or uses of the device 10. A reader is used to signal the chip 220 when the device 10 is placed in service, and each time the chip 220 is accessed, so that the chip 220 can record the data. The reader may also read the start time and number of accesses from the chip 220. Thus, the embodiment of FIG. 31 of a status indicator 218 provides an advantage over the status indicator 214 of FIG. 30 in that the information is stored on the chip 220 of the device 10 rather than in the remote database of a bar code reader or other device. Numerous different readers may access and manipulate the information on the device 10 without requiring a single reader to track the device 10 or without requiring a connection to a central remote database. Thus, each of the numerous different operators that come into contact with the device 10 has its own separate reader and may learn about the history of the device 10 independently. Now, referring to FIG. 32, a status indicator 222 includes a piezoelectric crystal 224 in series with an RFID chip 220. The piezoelectric crystal 224 senses when the device 10 is activated and produces a small amount of electrical charge when the crystal is compressed by use of the device 10. The charge produced by the crystal 224 is detected by the RFID chip 220, and the RFID chip increments the counter based on the number of accesses or uses. Thus, the embodiment of the status indicator 222 of FIG. 32 does not require a separate reader to indicate whether or not the device 10 has been used. Instead, the RFID chip 220 senses each use of the device 10 upon compression of the device by the handling of an operator. A reader is only required to be used in order to retrieve the information collected on the RFID chip 220. Various other electrical circuits and components, in addition to those illustrated in FIGS. 30 through 32, are possible.

In addition to the multiple embodiments discussed herein directed to detecting the time and usage of a device 10, other embodiments of the status indicators described herein may provide an indication of disinfection, sterility, cleanliness, or the presence or absence of a bacteria or other pathogen on a device 10.

Now, referring to FIG. 33, a status indicator 226 includes a thermochromatic material 228 on a wipeable outer surface 230 of a septum 16 of a vascular access device 10. The thermochromatic material 228 is a status indicator 226 that provides a reversible indication of cleaning and disinfection. Upon wiping the surface 230 with alcohol or another rapidly evaporating liquid, the surface 230 temporarily changes color to another color indicating that the device 10 has been cleaned. After accessing the device 10, and after the alcohol or other liquid has completely evaporated, the color of the thermochromatic material 228 will change to its original color.

Color change can be achieved by means of thermochromatism, which is the ability of a substance to change color as a function of a change in temperature. Two thermochromatic approaches are based on liquid crystals and leucopigments. Liquid crystals can exhibit different colors at different temperatures. The crystal structure of the material changes as the temperature changes, resulting in selective reflection of certain wavelengths. The crystals will then return to their original structure upon return to the starting temperature. Therefore, the color of thermochromatic liquid crystals is changeable and reversible. Liquid crystals can be encapsulated in microcapsules.

A leucopigment is a pigment whose molecules can take two forms, one of which is colorless. For example, the spiro form of an oxazine moiety of the molecule is separated by a carbon hybridized to SP3 or spirocarbon. An illustrative example includes microcapsules with crystal violet lactone, a weak acid, and a dissociable salt dissolved in dodecanol are encapsulated. When the solvent melts, the salt dissociates, the pH inside the microcapsules drops, the pigment becomes protonated, its lactone ring opens, and its absorption spectrum shifts dramatically causing the pigment to turn dark violet.

Another thermochromatic material is polythiophene. Chains of a polyacrylamide derivative are attached to a polythiophene backbone. At lower temperatures, the chains are irregular and elongated. As the temperature increases, the chains and backbone are brought into a compact spherical structure. This conformational change causes a color change from orange-red to yellow.

As shown in Figure 33, in use, an operator prepares to access device 10 by wiping the top surface of septum 16 with an alcohol swab or similar disinfecting tool. After wiping, the alcohol applied to surface 230 begins to evaporate. As the alcohol evaporates, the surface temperature decreases, causing thermochromatic material 228 to change color. The color change may be a status indicator 226 to the operator that septum 16 is disinfected and device 10 is ready for access. As the surface temperature of the septum returns to room temperature, the color change reverses, returning to the original color or to no relevance count. 70% isopropyl alcohol evaporating from a stainless steel surface can cause a temperature shift of 20 degrees F (11.1 degrees C). The septum 16 and the coating may be made of a polymer. However, polymers do not have good thermal conductivity. Therefore, the temperature change caused by the evaporation of alcohol from the surface of a polymer may not be as great as that of stainless steel. Thus, metal nanoparticles may be added to the material or coating of the septum 16 to improve thermal conductivity. Now, referring to FIG. 34, a status indicator 232 includes at least one pH sensor 234. The pH sensor 234 is located on the outer surface 230 of the septum 16 of a device 10. The pH shift may indicate whether the septum 16 has been swabbed with a substance having a pH in a specific range or not. The pH of 70% isopropyl alcohol in water is between five and six. A reversible pH sensor 234 sensitive to a pH range of five to six is integrated into the scrubbing surface 230 by a coating or by compounding the sensor 234 into the septum material 16. Upon scrubbing of the surface 230, the alcohol solution causes the pH sensor 234 to change color, indicating that the device 10 has been disinfected and is ready for access. After evaporation of the alcohol solution, the pH of the scrubbing surface 230 will shift out of the sensor's range of five to six, and the sensor 234 will return to a reference color. Now, referring to FIG. 35, a status indicator 236 includes an alcohol sensor 238 on the surface 230 of a septum 16 of a vascular access device 10. The alcohol sensor 238 initiates a color change caused by a chemical reaction between a chemochromatic compound and alcohol solution or other disinfecting agent. The chemochromatic compound of the alcohol sensor 238 may be integrated into the rubbing surface 230 by means of a coating or may be compounded into the septum material 16 itself. Upon rubbing the surface 230 with alcohol, the alcohol solution reacts with the chemochromatic compound causing a color change and indicating that the device 10 has been disinfected and is ready for access. Upon evaporation of the alcohol solution, the reaction will reverse and the chemochromatic compound of the sensor 238 will return to a reference color. An alcohol indicator, consisting of a carrier matrix with an alcohol oxidase enzyme that catalyzes a reaction that converts alcohol to an oxidizing agent, and a hydrogen donor indicator, which changes color when oxidized, may be used. Examples of hydrogen donors include 2,2'-azinodi-(3-ethylbenzothiazoline sulfonic acid); 3-methyl-2-benzothiazolinone hydrazone and 3-dimethylaminobenzoic acid; 3,4-dichlorophenol and 4-aminophenazone, o-tolidine; and o-tolidine and dianisidine.

Several additional or alternative chemicals may be identified or developed that exhibit a reversible or irreversible color change when exposed to alcohol, chlorhexidine gluconate (CHG), or other common disinfectants. Several companies currently produce test strips that react with the alcohol that is present in saliva after alcohol has been consumed. One such strip is produced by Chematics and is called the ALCO-SCREENTM test strip. The ALCO-SCREENTM test strip will turn green or blue when exposed to saliva containing alcohol. At higher concentrations of alcohol than that found in saliva, the strip will turn dark brown or black through a chemical reaction. Such a strip in another embodiment may be applied to the surface of the septum 16 or to any portion of the device 10. Now, referring to FIG. 36, a status indicator 240 includes a textured surface 242 on the surface 230 of a septum 16. Beneath the textured surface 242 is a colored substrate 244. When the textured surface 242 is wiped with alcohol, water, or another disinfectant or liquid, the liquid is absorbed by the textured surface 242 and the contact surface 242 becomes nearly transparent. In its transparent state, the surface 242 provides a window through which an operator can view the colored substrate 244. In this manner, a surface that is nearly matte, opaque, or otherwise obscured when a final surface is applied becomes a transparent window to a more visible colored substrate when the surface is wetted. Thus, when surface 242 is wetted, it will appear to take on the color of the submerged surface or colored substrate 244. After the liquid has completely evaporated, again, surface 242 will appear matte, opaque, or otherwise obscured. Now, referring to FIG. 37, a status indicator 246 includes a moisture-sensitive layer 248 on the surface 230 of a septum 16. Moisture-sensitive layer 248 may also be a moisture-sensitive compound fully integrated with the material of septum 16. Upon rubbing of the surface of moisture-sensitive layer 248, water from an alcohol solution may be absorbed by moisture-sensitive layer 248, causing a color change and indicating that device 10 has been disinfected and is ready for access. After evaporation of the water from any liquid, moisture-sensitive layer 248 returns to a reference color. Desiccants are an example of moisture-sensitive layers or compounds. Many desiccants change to a blue color upon absorption of water and then return to a reference color when the moisture is removed. Now, referring to FIG. 38, a status indicator 250 includes a colored liquid reservoir 252 with an elastomeric septum 16 of a vascular access device 10. The reservoir contains both an opaque white liquid and a colored pigment. When properly designed, the reservoir is partially or completely evacuated when exposed to pressure on a surface 230 of the septum 16 during normal cleaning and use. Then, the fluid 252 is displaced into a pressurized storage reservoir. When the pressure is released, the fluid 252 will slowly flow back from the holding reservoir 254 into the original reservoir 256. FIG. 38 shows a top view 258 of the original reservoir 256 prior to use of the septum 16. The original reservoir 256 is shown in a dark color. After cleaning or use of septum 16, a top view 260 shows the original reservoir 256 evacuated of the colored pigment 252, thus leaving the original reservoir 256 a lighter color than the original reservoir 256 of top view 258. As shown in FIG. 38, device 10 has a surface 230 that changes color when exposed to a change in temperature, alcohol, or other disinfectant. Then, device 10 changes color back to the original color after an appropriate amount of time that will correspond to the time required for the disinfectant to evaporate and completely kill a bacteria or other pathogen. This will impose two important behaviors on operators: first, proper and thorough disinfection, and second, waiting an appropriate amount of time before inserting a device into the septum 16. The rate at which the surface 230 changes from a dark color to a light color can be adjusted by varying the type of liquid or other material placed in the reservoir, the size of the reservoir, the color of the material, and/or the dimensions and materials of the body of the septum 16. Now, referring to FIG. 39, a status indicator 262 includes a piezochrome material 264. The piezochrome material 264 is a material that will change color when exposed to pressure. The material 264 can be coated as a layer onto a surface 230 of a septum 16. In another embodiment, the material 264 can be embedded in the surface of the septum. In yet another embodiment, the material 264 can be integrated into the material of the septum 16 as a composite. When appropriate disinfectant rubbing occurs on surface 230, the pressure caused by the rubbing action will cause surface 230 to change color. As the pressure is removed, surface 230 will return to its original color. This approach, like many other surface contact approaches described herein, encourages an operator to disinfect the entire surface of the corresponding status indicator. Now, referring to FIG. 40, a status indicator 263 includes a pathogen staining solution 265 or other reagent. Solution 265 is placed in a dual chamber syringe 266 that contains both solution 265 and saline cleaning solution 268 divided by a movable stop 270. Syringe 266 includes a plunger 272 and at least one notch 274 within which the movable stop will collide as plunger 272 advances through the lumen of syringe 266. Now, referring to FIG. 41 , plunger 272 of FIG. 40 is shown advanced through syringe 266 such that movable stop 270 has advanced and collided with notches 274. In this advanced state, plunger 272 has expelled solution 265 into a vascular access device 10, and leakage 276 caused by collision of movable stop 270 with notches 274 has allowed saline solution 264 to leak out. past the movable stop 270 and into the device 10. An operator may attach the syringe 266 of FIGS. 40 and 41 to a device 10 and flow the syringe 266 as the operator would any normal syringe. A head cap 278 attached to the end of the plunger 272 pushes the saline solution 268, which pushes the movable stop 270, which in turn pushes the pathogen-staining solution 265 into the device 10. The pathogen-staining solution 265 stains all microorganisms and pathogens as it passes through them. When the staining solution 265 has completely flowed into the device 10, the movable stop 270 reaches the notches 274 in the syringe tube 266, allowing the saline solution 268 to flow past the movable stop 270 and into the device 10. The saline solution 268 then flows the staining solution 265 out of the device 10, leaving the device 10 clean. All microorganisms on the device 10 will now be stained and visible to an operator. In this manner, the device 10, and any other device to which the device 10 is attached, can be checked for disinfection and the absence of pathogens each time the status indicator 263 is employed. As another embodiment, notches 274 may be supplemented or replaced by grooves or other recesses in the material of the syringe tube 266. Fluid, such as saline solution 268, may flow through the grooves or recesses when the movable stop 270 is in communication with the grooves or recesses. Now, referring to FIG. 42, an enlarged view shows a status indicator 280 disposed on the inner surface 282 of the body 12 of a vascular access device 10. The status indicator 280 includes a fluid-activated pigment substrate 284 beneath a degradable membrane 286. The chamber 288 in the device 10 fills with the fluid 290 when the device 10 is placed in service. Fluid 290 in chamber 288 contacts interior surface 282, causing degradable membrane 286 to dissolve or degrade over a controlled period of time, thereby exposing fluid-activated pigment 284 to fluid 290. When fluid-activated pigment 284 changes color, or otherwise causes fluid 290 to change color, an operator will know that device 10 has been exposed to fluid 290 and placed in service for a given period of time. The rate at which degradable membrane 286 degrades or dissolves can be adjusted to produce the desired synchronization effect by varying the properties, thicknesses, and application location of membrane material 286 in device 10.

In one embodiment, the status indicator 280 of FIG. 42 includes a color or other mechanism to alert an operator that the device 10 has expired. In another embodiment, the status indicator 280 of FIG. 42 includes a moisture-sensitive layer or other fluid-activated indicator in place of the fluid-activated pigment 284. When the moisture-sensitive layer is exposed to fluid 290, the layer will indicate to an operator that a given period of time has elapsed. In another embodiment, the status indicator 280 includes a lubricant or adhesive similar or identical to the lubricant or adhesive 184 discussed in connection with FIG. 23. In this embodiment, the lubricant or adhesive and the degradable membrane 286 are placed on the exposed surface of the slit 18 of the septum 16. After the degradable membrane 286 is removed, the lubricant or adhesive will cause the slit 18 to seal, thereby further blocking use of and access to the device 10 by an operator.

In combination with any of the elements discussed herein, additional examples of status indicators may be provided. For example, a status indicator related to a label or other indicator capable of displaying a visual change over time may be provided in addition to, for example, the status indicator discussed with reference to Figures 13-22. Some of these examples of status indicators are discussed below.

Referring now to Figure 43, a device 10 may include at least one status indicator 292, 294, 296, 298, 300, 302, 304 and/or 306 in any combination. Upon occurrence of an environmental, physical, temporal, or other change, such as a change in light (using dyes or photochromic materials), oxygen level, temperature, usage, cleanliness, or time discussed previously (e.g., using dye migration that becomes visible over time), status indicators 292, 294, 296, 298, 300, 302, 304, and/or 306 change from an initial condition 308 to a final condition 310. At an initial condition 308, status indicators 292, 294, 296, 298, 300, 302, 304, and/or 306 indicate that no significant change in environment, physical usage, time, or other event has occurred.

For example, a temporal change (i.e., a change in time) may be recorded and displayed for a 24-hour period shown by status indicators 292 and 294, a 48-hour period shown by status indicator 296, a 72-hour period shown by status indicators 298 and 306, or a 96-hour period shown by status indicator 300. Any combination of multiple time periods may be recorded and displayed. For example, status indicators 302 and 304 each record and display multiple sequential time periods of 24, 48, 72, and 96 hours. For a temporal change, any time period may be measured as desired by the particular use, treatment regimen, facility policy, industry guideline or recommendation, or as required by law. For example, 24 hours may be recorded and displayed on a label attached to the catheter or other tubing used for lipid infusion. Such labels may be identified to measure “lipids” or “TPN” (i.e., total parenteral nutrition), as shown by status indicator 292. 48 hours may be recorded and displayed on a label attached to any portion of an IV set if directed by the policy of the particular facility in which the label is being used. 72 hours may be recorded and displayed on a label attached to any portion of an IV set or other vascular access device in accordance with the Infusion Nurses Society infusion safety standards and recommendations. And, 96 hours may be recorded and displayed on a label attached to any portion of an IV set or other vascular access device in accordance with Center for Disease Control guidelines. Upon a change in environment, physical use, or time, the status indicators will exhibit a visible change, e.g., by dimming or coloring at least a portion of the status indicators 292, 294, 296, 298, 300, 302, 304, and/or 306 until such change is finally displayed as depicted in final condition 310 for each status indicator 292, 294, 296, 298, 300, 302, 304, and/or 306. Such a visual change may occur as a rapid change from one color to another, as shown by comparing initial condition 308 with final condition 310 of status indicators 292, 294, 296, 298, and 300 and as depicted in the graph of FIG. The visual change may occur as a darkened word 312 such as “REPLACE,” as shown by comparing the initial condition 308 with the final condition 310 of the status indicator 304. Such a visual change may occur as a gradual, gradient, color change indicating a gradual change in environment, physical use, or time, as shown by comparing the initial condition 308 with the final condition 310 of the status indicator 302. As shown in the final condition 310 of the status indicator 302, a portion representing a 24-hour period is completely darkened, indicating that the passage of 24 hours has indeed occurred, and a portion representing the 96-hour period has darkened to no degree, indicating that a 96-hour period has indeed not occurred. Most of the portion representing a 48-hour period is darkened, indicating that a 48-hour period probably occurred, and most of a portion representing a 72-hour period is darkened, indicating that a 72-hour period certainly did not occur. The status indicator 302, as shown in the final condition, is not necessarily in the final condition. That is, after a 96-hour period has elapsed, the status indicator 302 should be completely darkened in its final condition.

A healthcare professional may attach or replace one or more labels or status indicators to any vascular access device and/or the labels or status indicators may already be attached to or integral with the devices prior to access by the healthcare professional.

As discussed herein, a vascular access device, such as device 10, may include any device that can deliver therapy to a patient's vascular system. Several examples of vascular access devices are provided herein. By way of further example, and with reference to Figure 44 , a vascular access device may include any one or more of the following structures, taken alone or in combination, and any other structure in communication with any of the following structures: an IV and/or drip chamber assembly 320 including a tip 322, a tip cap 324, an opening, such as a tip opening 326, a cannula or catheter 328, a clamp, including a sliding clamp 330, a quick-fit clamp 332, or a rolling clamp 334, a burette 335, a burette opening 338, a burette fill port 340, a medicament leak barrier 342, a drip chamber 344, a filter 346, a safety strip 348, an IV port 350, a valve, such as a check valve 352, an injection site, and/or connector Luer 354, a Y-port 356, an access port including a needle access port 358, a blunt canister access port 360, a Luer access port 362, a T-site manifold 364, a stopcock 366, or a stopcock manifold 368, a pump including a pump cartridge 370, an air or particulate filter 372 including an aperture 374, a flow regulator 376 such as a precision flow regulator, a glow bulb 378, a vent 380, a sliding Luer 382, a cap such as a dust cap 384, a Luer lock 386, an aperture cap 388, a universal Luer 390, a needle tip cannula 392 or catheter tip cannula, a needle tip protector or shield 394, or protector or catheter tip shield 396, and/or a needle assembly, such as a butterfly needle assembly 398.

Hundreds, if not thousands, of vascular access devices exist or may be developed in the future. The vascular access devices described herein are merely an abbreviated list of some vascular access devices to which the principal

The principles and elements of the claimed invention may be applied. The principles and elements of the claimed invention may be applied in any of the above-discussed embodiments, their equivalents, or similar later technologies. Specifically, a status indicator may be placed in communication with any vascular access device to detect and/or communicate an event or passage of time useful to a healthcare professional, such as the passage of time during which the device has been in use, an amount of use of the device, whether or not the device has been cleaned, disinfected, or sterilized, and/or whether and to what degree one or more pathogens are resident on or near the device.

Many of the embodiments discussed above have been described including both reversible and non-reversible changes of the state indicators. For example, a color change from a first color to a second color may be reversed from the second color to the first color after a period of time or the occurrence of a certain event. Although not all examples of reversible state indicators have been provided herein, every claimed embodiment, whether described as reversible or non-reversible, or described without regard to reversibility, may be capable of reversing from a second state back to a first state, or from a second state to an additional third state, and is intended to fall within the scope of the claimed invention.

The present invention may be embodied in other specific forms without departing from its structures, methods or other essential features amply described herein and claimed below. For example, the elements discussed above may be combined in any number and orientation in an enabling manner with any number and orientation of any of the other elements discussed above to produce a status indicator for a vascular access device. The embodiments described are to be considered in all respects only as illustrative and not restrictive. Accordingly, the scope of the invention is indicated by the appended claims rather than by the foregoing description. All changes falling within the meaning and range of equivalence of the claims are to be embraced within their scope.

Claims (7)

1. A medical device comprising: a vascular access device for communicating with a patient's vascular system, the vascular access device comprising: a body (12) having a lumen (14), a portion of the lumen including a septum (16) having a slit (18); and CHARACTERIZED by the fact that a status indicator (22) is coupled to the body (12), the status indicator (22) including a movable member (26) having a first end and a second end, the first end being reversibly coupled to a first portion of the body and the second end being coupled to a second portion of the body by means of a spring member (28), wherein the status indicator provides an elapsed time indication. 2. The medical device of claim 1 further comprising: a second vascular access device having a proximal end and a distal end, wherein the distal end of the second vascular access device is introduced into the vascular system, and wherein the vascular access device is a connector fixed directly or indirectly to the proximal end of the second vascular access device. 3. The medical device of claim 1, further comprising a time-sensitive adhesive (24) positioned interposed between the first end of the movable element and the first body portion. 4. The medical device of claim 1, wherein the movable element of the status indicator includes a colored label (162). 5. A method for using a medical device as defined in claim 1, comprising: a. attaching the device having a status indicator (22) to a vascular access device, said status indicator including a movable element (26) having a first end and a second end, the first end being reversibly coupled to a surface of the device and the second end being coupled to a portion of the device via a spring (28), the status indicator being activated upon commencement of use; b. observing the change of the status indicator; and c. cleaning or removing the device having the status indicator by observing a physical movement of the movable element from a first position to a second position. 6. The medical device of claim 5, wherein observing the change of the status indicator includes observing that the status indicator has changed color. 7. The medical device of claim 6, wherein the status indicator changes color in response to light.