Disinfection confirmation device

Abstract

The invention relates to a device for obtaining confirmation of the completion of disinfection, comprising an electrically activated light source. The device also includes at least one housing having a wall formed by a diffusion control film and encapsulating a salt that is soluble in a sanitizer for disinfection. The at least one housing and the light source are electrically connected in series.

Description

Technical Field

[0001] The present disclosure generally relates to components for medical infusion devices, and more particularly, to an apparatus capable of confirming the disinfection of components for medical infusion devices. Background Art

[0002] When connecting or replacing infusion tubing during patient treatment, various components (such as connectors) exposed to air need to be disinfected to avoid bloodstream infections. The Infusion Nurses Society (INS) has established standard operating procedures for disinfecting these components, which require disinfecting these components for a certain amount of time. However, studies have shown that healthcare providers do not always disinfect components for the required amount of time. This may be because providers do not have an accurate way to measure whether the components have been disinfected. Summary of the Invention

[0003] In view of the above challenges, there is a need for a means to provide visual confirmation that a component has been properly disinfected. Aspects of the present technology relate to apparatuses and methods capable of visually confirming that a component, such as a connector, has been properly disinfected. The apparatus and method can be suitably configured to provide confirmation for a variety of disinfectants and can be used with various types of components, including, for example, needleless connectors for connecting medical infusion tubing. The apparatus described herein can be used as a stand-alone device that can be coupled to different components or integrated into a component during the manufacture of the component.

[0004] Advantages of the present technology include improved patient safety and workflow efficiency for healthcare providers by providing a simple and built-in method for obtaining confirmation of adequate disinfection of components used in medical infusion devices prior to using the components. For example, in one aspect of the present disclosure, an apparatus for obtaining confirmation of disinfection completion includes an electrically activated light source and at least one housing having a wall formed by a diffusion control membrane and encapsulating a salt. The salt is selected to be soluble in a disinfectant used for disinfection. The at least one housing, a power source, and the light source are electrically connected in series. The apparatus can additionally include a power source for providing electrical energy to the at least one light source. Advantageously, by appropriately selecting the salt, the apparatus can be modified to obtain disinfection confirmation when using various different disinfectants. Additionally, the apparatus can provide a visual indication that the disinfectant has volatilized and that the component is ready for use.

[0005] Another example includes a needleless connector having a power source, an electrically activated light source, and at least one housing having a wall formed of a diffusion control membrane and encapsulating a salt. The salt is selected to be soluble in a disinfectant used for disinfection. The at least one housing, the power source, and the light source are electrically connected in series. By selecting a suitable salt that is soluble in the particular disinfectant used, the needleless connector can be appropriately modified to provide a visual indication of disinfection completion using a variety of disinfectants.

[0006] Embodiments include one or more of the following features, either alone or in combination. For example, the diffusion control membrane is configured to control the penetration of the disinfectant through the diffusion control membrane such that the ionic mobility of the salt dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has penetrated through the diffusion control membrane for a predetermined amount of time. Such a diffusion control membrane can include materials such as polyethersulfone (PES), polystyrene, molybdenum disulfide, or graphene.

[0007] From the following detailed description, other advantages of the subject technology will become apparent to those of ordinary skill in the art, in which certain aspects of the subject technology are shown and described by way of example only. As will be recognized, the subject technology is capable of other and different configurations, and several details thereof can be modified in various other respects, all without departing from the subject technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings are included to provide a further understanding and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the disclosure and, together with the description, serve to explain the principles of the embodiments of the disclosure. In the drawings:

[0009] Figure 1A There is shown an apparatus for providing confirmation of disinfection completion according to aspects of the present disclosure.

[0010] Figure 1B is a schematic view of a housing encapsulating a salt according to aspects of the present disclosure.

[0011] Figure 2 There is shown a needleless connector according to aspects of the present disclosure, which can provide confirmation of disinfection completion. DETAILED DESCRIPTION

[0012] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided for some aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0013] It should be understood that this disclosure includes examples of the subject technology and does not limit the scope of the appended claims. The various aspects of the subject technology will be illustrated below according to specific but non-limiting examples. The various embodiments described in this disclosure may be implemented in different ways and variations and according to the intended application and implementation.

[0014] Aspects of the subject technology relate to components of a medical infusion device that need to be disinfected prior to use to avoid the risk of bloodstream infection. The Infusion Nurses Society (INS) provides standard operating procedures for disinfecting these components. The procedure includes swabbing the component with a disinfectant for a certain amount of time prior to using the component. The amount of time the component is swabbed can vary depending on the specific disinfectant. The specified amount of time is based on empirical data collected during research to determine the amount of time required to obtain a certain level (e.g., 99.99%) of disinfection of the component by swabbing the component with the specified method using the specific disinfectant. For example, the INS recommends swabbing a needleless connector with an isopropyl alcohol swab (70% solution) for at least 15 seconds.

[0015] However, during use, it is often difficult for healthcare providers (e.g., infusion nurses) to keep track of the time, and thus, the provider may not know if the component has been properly disinfected. In fact, studies have shown that providers often fail to swab the component for the specified amount of time. Additionally, it is difficult for the provider to determine when the component is ready for use, i.e., when the disinfectant has evaporated or is no longer present on the surface of the component.

[0016] Aspects of the subject technology relate to devices and methods for facilitating proper disinfection of components of an infusion tubing by providing a visual confirmation that disinfection has been completed according to a specified procedure. Additionally, the devices and methods disclosed herein provide a visual indication that the disinfectant has evaporated from the component and the component is ready for use. Advantageously, the device can be attached to an existing component or can be integrated into the component during manufacture to eliminate additional steps during the workflow. Various aspects of the present disclosure provide a medical-grade needleless connector having a built-in mechanism for providing a visual confirmation that the needleless connector has been properly disinfected and a further visual confirmation that the disinfectant used for disinfection has evaporated and the connector is ready for use.

[0017] Figure 1A FIG. shows a schematic view of an apparatus for providing a visual confirmation of disinfection completion in accordance with aspects of the present disclosure.

[0018] In some embodiments, apparatus 100 may include a power source 105, an electrically activated light source 110, and at least one housing 115. The power source 105, the light source 110, and the at least one housing 115 are connected in series via conductive leads 120.

[0019] As Figure 1A shown, apparatus 100 may be designed to be mounted closely on the outer edge of a needleless connector for connecting a medical infusion device. However, there are no particular limitations on the shape and size of the apparatus.

[0020] The power source 105 may be any suitable power source sufficient to provide power to a circuit formed by the light source 110, the at least one housing 115, and the wire 120. Thus, the power source 105 may be a commercially available battery. Although there are no particular limitations on the battery capacity, in some embodiments, depending on the design of the apparatus, it may be necessary to limit the battery size, thereby limiting the battery capacity. However, those of ordinary skill in the art will be able to easily select a suitable battery for the apparatus after understanding the present disclosure.

[0021] The light source 110 may be any suitable light source. However, in some embodiments, based on the specific application of apparatus 100, a light-emitting diode (LED) may be used as the light source 110. Although any suitable commercially available LED capable of adapting to the physical design parameters of the apparatus may be used, those of ordinary skill in the art will recognize that the selected LED should have sufficient luminous intensity to distinguish between the on and off states of the LED at least in indoor diffused lighting. Thus, for example, a suitable LED may have a luminous intensity of at least about 10 mcd. The suitable form factor of the LED may depend on the design parameters of apparatus 100.

[0022] The conductive leads 120 may be standard insulated (or laminated) copper wires for connecting electronic components. However, there are no particular limitations on the type of conductive leads 120 that may be used in the apparatus, as long as the wire allows apparatus 100 to be formed within the desired design parameters.

[0023] Figure 1B FIG. shows a schematic view of the housing 115. At least one wall 1150 of the housing 115 includes a diffusion control membrane. The housing 115 encapsulates an ionic salt 1155. The ionic salt 1155 is selected to be soluble in a disinfectant. The diffusion control membrane is selected to allow the disinfectant (such as isopropyl alcohol) to diffuse through the wall, but to prevent the diffusion of the ionic salt 1155 and / or the ions of the salt once the salt is dissolved in the disinfectant.

[0024] The size and shape of the outer housing 115 are selected to permit the disinfectant to diffuse through the wall 1150 at a rate such that the ionic mobility of the salt gradually increases to permit sufficient current flow through the circuit to activate the light source 110 only after a prescribed amount of time. Thus, the outer housing 115 functions as a variable resistor in the circuit, and the resistance provided by the outer housing 115 decreases as more disinfectant diffuses through the wall 1150. When the resistance provided by the outer housing 115 drops to a threshold, sufficient current flows through the circuit to activate the light source 110, providing a visual confirmation that disinfection is complete.

[0025] Accordingly, in some embodiments, the volume of the outer housing 115 may range from about 1 nl to about 1 μl. For example, the outer housing 115 may have a volume of about 1 nl, about 5 nl, about 10 nl, about 15 nl, about 20 nl, about 25 nl, about 30 nl, about 35 nl, about 40 nl, about 45 nl, about 50 nl, about 55 nl, about 60 nl, about 65 nl, about 70 nl, about 75 nl, about 80 nl, about 85 nl, about 90 nl, about 100 nl, about 110 nl, about 120 nl, about 130 nl, about 140 nl, about 150 nl, about 160 nl, about 170 nl, about 180 nl, about 190 nl, about 200 nl, about 220 nl, about 240 nl, about 260 nl, about 280 nl, about 300 nl, about 325 nl, about 350 nl, about 375 nl, about 400 nl, about 450 nl, about 500 nl, about 550 nl, about 600 nl, about 650 nl, about 700 nl, about 750 nl, about 800 nl, about 850 nl, about 900 nl, about 950 nl, about 1000 nl, or any volume between any two of these volumes.

[0026] The diffusion control membrane is selected not only to control the materials that can diffuse through the membrane, but also to control the rate of diffusion. The diffusion control membrane controls the rate of diffusion of the disinfectant such that the resistance provided by the outer housing 115 drops to the threshold only after a prescribed amount of time. Thus, the light source 110 is activated only after a prescribed amount of time that the disinfectant has been applied to the device, providing a visual confirmation that the device has been exposed to the disinfectant for a prescribed amount of time and that the disinfection process has been properly carried out.

[0027] In some embodiments, a quantity of salt 1155 may be encapsulated within a housing 115, and the housing is sealed with a diffusion control membrane 1150. The salt 1155 is selected to be soluble in the disinfectant that will be used to disinfect the component. Examples of salts that may be used include, but are not limited to, inorganic salts (such as potassium chloride, sodium chloride, and magnesium chloride), or organic salts (such as octanoic acid and cetyltrimethylammonium bromide (CTAB)).

[0028] In some embodiments, the housing 115 and the salt 1155 therein are designed and configured to reduce the resistance to a threshold after a period ranging from about 1 second to about 1 minute. In other words, the housing and the salt therein are designed and configured such that the light source is only activated after the disinfectant has diffused through the wall 1150 for a time ranging from about 1 second to about 1 minute. Thus, in some embodiments, the device 100 is designed and configured such that the light source is activated after being exposed to the disinfectant for about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 11 seconds, about 12 seconds, about 13 seconds, about 14 seconds, about 15 seconds, about 16 seconds, about 17 seconds, about 18 seconds, about 19 seconds, about 20 seconds, about 21 seconds, about 22 seconds, about 23 seconds, about 24 seconds, about 25 seconds, about 26 seconds, about 27 seconds, about 28 seconds, about 29 seconds, about 30 seconds, about 31 seconds, about 32 seconds, about 33 seconds, about 34 seconds, about 35 seconds, about 36 seconds, about 37 seconds, about 38 seconds, about 39 seconds, about 40 seconds, about 41 seconds, about 42 seconds, about 43 seconds, about 44 seconds, about 45 seconds, about 46 seconds, about 47 seconds, about 48 seconds, about 49 seconds, about 50 seconds, about 51 seconds, about 52 seconds, about 53 seconds, about 54 seconds, about 55 seconds, about 56 seconds, about 57 seconds, about 58 seconds, about 59 seconds, about 60 seconds or even longer.

[0029] In addition, when the disinfectant evaporates, the ionic mobility of the salt decreases, thereby increasing the resistance of the salt above the threshold, deactivating the light source 110 and providing an indication that the disinfectant has evaporated and the component is ready for use.

[0030] Thus, the resistance range provided by the outer casing can range from several kiloohms in the dry state to a few ohms when the outer casing is filled with a disinfectant solution and the salt encapsulated therein dissolves in the disinfectant solution. In some embodiments, the threshold resistance when the light source is activated can be in the range from about 10 Ω to about 500 Ω. For example, the threshold resistance can be about 10 Ω, about 15 Ω, about 20 Ω, about 25 Ω, about 30 Ω, about 35 Ω, about 40 Ω, about 45 Ω, about 50 Ω, about 55 Ω, about 60 Ω, about 65 Ω, about 70 Ω, about 75 Ω, about 80 Ω, about 85 Ω, about 90 Ω, about 95 Ω, about 100 Ω, about 110 Ω, about 120 Ω, about 130 Ω, about 140 Ω, about 150 Ω, about 160 Ω, about 170 Ω, about 180 Ω, about 190 Ω, about 200 Ω, about 220 Ω, about 240 Ω, about 260 Ω, about 280 Ω, about 300 Ω, about 325 Ω, about 350 Ω, about 375 Ω, about 400 Ω, about 450 Ω, about 500 Ω, about or any value between any two of these values.

[0031] In some embodiments, the diffusion control membrane is formed of materials such as, for example, polyethersulfone (PES), polystyrene, molybdenum disulfide, graphene, or combinations thereof. The specific material used for the diffusion control membrane can be selected according to the specific disinfectant used in the device. Thus, any material having adjustable pore size, pore structure, and pore density can be used to form the diffusion control membrane.

[0032] For example, an aqueous solution of isopropyl alcohol (IPA) is the most commonly used disinfectant. The molecular size of the disinfectant is approximately 0.4 nm. Thus, in order to allow IPA to diffuse through the diffusion control membrane, the diffusion control membrane should have a pore size greater than 0.4 nm. On the other hand, the pore size should be less than the molecular size of the undissolved salt to prevent the undissolved salt from diffusing out of the outer casing 115. Thus, the specific pore size for the diffusion control membrane depends on the specific salt encapsulated within the outer casing 115. However, those of ordinary skill in the art will readily understand, upon understanding the present disclosure, that the devices and methods disclosed herein are not limited to using an IPA solution as the disinfectant and can be appropriately modified for any selected disinfectant. Some disinfectants commonly used to disinfect components of medical infusion devices include, but are not limited to, IPA solutions, chlorhexidine gluconate, povidone iodine, iodophor, or combinations thereof.

[0033] In some embodiments, in the case where the selected disinfectant is a solution of two solvents (e.g., IPA and water), the type and amount of salt are selected to ensure that the salt dissolves in the disinfectant solution without disrupting the azeotropic properties of the disinfectant solution. Thus, if the disinfectant is, for example, an IPA solution, any salt that is miscible with IPA and water can be selected.

[0034] Without wishing to be bound by theory, in the case where the disinfectant is a solution of two solvents, the selected salt should be soluble in both of the two solvents that form the disinfectant solution, because if the salt is only soluble in one of the two solvents that form the disinfectant solution, the solvents may separate, resulting in the evaporation of only one of the solvents, leaving the other solvent remaining. The remaining solvent can continue to dissolve the salt, such that although one of the disinfectant solvents evaporates, the conductivity does not decrease. This situation may lead to the continuous activation of the light source 110 and no indication that the disinfectant has evaporated can be obtained.

[0035] Figure 2 A schematic diagram of a needleless connector according to an exemplary embodiment of the present disclosure is shown, in which a device 100 is embedded. The needleless connector 200 includes four (4) housings 215 symmetrically disposed around its opening. The housings 215 are connected by wires 220.

[0036] The design parameters of the housing 215, the battery 105, and the light source 110 are based on the assumption that the connector 200 has a service life of approximately 200 uses. Thus, for example, if it is assumed that the disinfectant solution evaporates in approximately 10 seconds, then each time it is used, the light source 110 should remain activated (i.e., in the on state) for approximately 10 seconds. This results in a total activation time of approximately 35 - 40 minutes over the service life of the connector.

[0037] Such needleless connectors are typically used in hospital environments with indoor diffused lighting. Thus, in order for the provider to properly distinguish between the on and off states of the light source 110, the minimum luminous intensity of the light source is desirably approximately 10 - 20 mcd. For a typical light-emitting diode (LED) capable of emitting light at an intensity in the range of approximately 10 - 20 mcd, the current consumption during the on state is in the range of approximately 50 - 100 mA.

[0038] In addition, in order to properly embed the battery in the needleless connector, the size of the battery is restricted. Some commercially available batteries having a form factor suitable for embedding in the needleless connector have a battery capacity in the range of approximately 400 mAh. Such batteries, at a discharge current of approximately 50 - 100 mA per activation, should last for approximately 4 - 8 hours. In other words, when embedded in a component such as the needleless connector 200, commercially available small form factor batteries will be sufficient to power the device 100.

[0039] Using these battery and light source parameters, in order to provide a suitable resistance value, each housing 215 should have an “activation” resistance in the range of approximately 10 Ω to approximately 100 Ω. In other words, when the salt is dissolved in the disinfectant solution, the resistance of the housing 215 should be in the range of approximately 10 to approximately 100 Ω. To obtain such a resistance, within the design constraints of being able to embed the device 100 into a component such as the needleless connector 200, in one example, the housing can have a total volume of approximately 4 nl (about 400 μm × 100 μm × 100 μm) and encapsulate approximately 2 nl volume of CTAB / octanoic acid, leaving approximately 2 nl (about 15 ng by weight) of the disinfectant solution (70% v / v aqueous isopropanol solution). Such a housing, after being filled with the disinfectant solution, is estimated to have a resistance of approximately 50 Ω (based on a CTAB conductivity of approximately 700 μS / cm).

[0040] In another aspect of the present disclosure, a method for disinfecting components used in medical infusion tubing is provided. The method can include applying a disinfectant to the component until the light source is activated, and using the component when the light source is deactivated. Components that are externally coupled or embedded therein include means for providing confirmation of disinfection completion, such as the device 100. Thus, in some embodiments, the method can further include coupling a confirmation device, such as the device 100, to the component before applying the disinfectant.

[0041] In some embodiments, applying the disinfectant can include wiping the component with a swab containing the disinfectant. The swab containing the disinfectant can be, for example, a swab soaked in the disinfectant solution. In some embodiments, the disinfectant can be an aqueous solution of isopropanol or chlorhexidine.

[0042] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0043] The illustrative articles of the subject technology

[0044] For convenience, multiple examples of the various aspects of the present disclosure are described in numbered articles (1, 2, 3, etc.). These are provided only as examples and do not limit the subject technology. The reference numerals and identification of the drawings are shown herein only as examples and for illustrative purposes, and the articles are not limited by these identifications.

[0045] Item 1. A device for obtaining confirmation of disinfection completion, the device comprising: an electrically activated light source; and at least one housing having at least one wall including a diffusion control membrane and encapsulating a salt that is soluble in a disinfectant for disinfection, wherein the at least one housing and the light source are electrically connected in series.

[0046] Item 2. The device according to Item 1, wherein the diffusion control membrane is configured to be permeable to the disinfectant and impermeable to the undissolved salt.

[0047] Item 3. The device according to any one of Items 1-2, wherein the diffusion control membrane is configured to control the penetration of the disinfectant through the diffusion control membrane such that the ionic mobility of the salt dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has penetrated through the diffusion control membrane for a predetermined amount of time.

[0048] Item 4. The device according to Item 3, wherein the predetermined amount of time is in the range of about 1 second to about 1 minute.

[0049] Item 5. The device according to Item 3, wherein after the disinfectant has penetrated through the diffusion control membrane for a predetermined amount of time, the resistance of the housing is reduced to a range of about 10 to about 100 Ω.

[0050] Item 6. The device according to any one of Items 1-5, further comprising a power source.

[0051] Item 7. The device according to any one of Items 1-6, wherein the salt comprises an inorganic salt.

[0052] Item 8. The device according to any one of Items 1-7, wherein the light source is a light-emitting diode.

[0053] Item 9. The device according to any one of Items 1-8, wherein the diffusion control membrane comprises a material selected from the group consisting of polyethersulfone (PES), polystyrene, molybdenum disulfide, and graphene.

[0054] Item 10. A needleless connector, comprising: a power source; an electrically activated light source; and at least one housing having at least one wall including a diffusion control membrane and encapsulating a salt that is soluble in a disinfectant for disinfecting the surface of the needleless connector to be disinfected, the at least one housing being disposed along the surface of the needleless connector to be disinfected, wherein the at least one housing, the power source, and the light source are electrically connected in series.

[0055] Item 11. The needleless connector according to Item 10, wherein the diffusion control membrane is configured to control the penetration of the disinfectant through the diffusion control membrane such that the ionic mobility of the salt dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has penetrated through the diffusion control membrane for a predetermined amount of time.

[0056] Item 12. The needleless connector according to Item 11, wherein the predetermined amount of time is in the range of about 1 second to about 1 minute.

[0057] Item 13. The needleless connector according to any one of Items 11-12, wherein after the disinfectant has penetrated through the diffusion control membrane for the predetermined amount of time, the resistance of the housing is reduced to a range of about 10 to about 100 Ω.

[0058] Item 14. The needleless connector according to any one of Items 10-13, wherein the diffusion control membrane is configured to be permeable to the disinfectant and impermeable to undissolved salts.

[0059] Item 15. The needleless connector according to any one of Items 10-14, wherein the diffusion control membrane comprises a material selected from the group consisting of polyethersulfone (PES), polystyrene, molybdenum disulfide, and graphene.

[0060] Item 16. The needleless connector according to any one of Items 10-15, wherein the salt comprises an inorganic salt selected from the group consisting of potassium chloride, sodium chloride, and magnesium chloride, or an organic salt selected from the group consisting of cetyltrimethylammonium bromide or octanoic acid.

[0061] Item 17. The needleless connector according to any one of Items 10-16, wherein the volume of the at least one housing is in the range of about 1 nl to about 1 μl.

[0062] Item 18. A method for disinfecting a needleless connector, the method comprising: applying a disinfectant to the needleless connector, the needleless connector having an authentication device coupled thereto, the authentication device comprising: a power source, an electrically activated light source, and at least one housing having at least one wall including a diffusion control membrane and encapsulating a salt that is soluble in the disinfectant for disinfection, wherein the at least one housing, the power source, and the light source are electrically connected in series, wherein the disinfectant is applied until the light source is activated; and using the needleless connector when the light source is deactivated.

[0063] Item 19. The method according to Item 18, wherein the diffusion control membrane is configured to control the penetration of the disinfectant through the diffusion control membrane such that the ionic mobility of the salt dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has penetrated through the diffusion control membrane for a predetermined amount of time.

[0064] Item 20. The method according to Item 19, wherein the predetermined amount of time is in the range of about 1 second to about 1 minute.

[0065] Additional Considerations

[0066] In some embodiments, any one of the items herein can depend on any one of the independent items or any one of the dependent items. In one aspect, any one of the items (e.g., a dependent item or an independent item) can be combined with any other one or more items (e.g., a dependent item or an independent item). In one aspect, the claims can include some or all of the words (e.g., steps, operations, means, or components) recited in an item, sentence, phrase, or paragraph. In one aspect, the claims can include some or all of the words recited in one or more items, sentences, phrases, or paragraphs. In one aspect, some of the words in each of the items, sentences, phrases, or paragraphs can be removed. In one aspect, additional words or elements can be added to the items, sentences, phrases, or paragraphs. In one aspect, the subject technology can be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject technology can be implemented using additional components, elements, functions, or operations.

[0067] The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. Although the subject technology has been specifically described with reference to various drawings and configurations, it should be understood that these are for illustrative purposes only and should not be considered as limiting the scope of the subject technology.

[0068] There can be many other ways to implement the subject technology. The various functions and elements described herein can be divided differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be apparent to those skilled in the art, and the general principles defined herein can be applied to other configurations. Thus, many changes and modifications can be made to the subject technology by those of ordinary skill in the art without departing from the scope of the subject technology.

[0069] Unless otherwise specified, the use of the singular form of an element is not intended to mean "one and only one" but "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (e.g., "his") include feminine and neuter genders (e.g., "her" and "its"), and vice versa. The use of headings and subheadings (if any) is for convenience only and does not limit the disclosure.

[0070] The term "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" should not be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0071] As used herein, the phrase "at least one" before a series of items (separated by the term "or" in any item) modifies the listed items as a whole rather than each member of the list. The phrase "at least one" does not require the selection of at least one of the items; rather, the phrase allows for the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each item. By way of example, the phrase "at least one of A, B, or C" can mean: only A, only B, or only C; or any combination of A, B, and C.

[0072] Phrases such as "an aspect" do not mean that such an aspect is essential to the subject technology or that such an aspect applies to all configurations of the subject technology. The disclosure related to an aspect can apply to all configurations or one or more configurations. An aspect can provide one or more examples. The phrase "an aspect" can refer to one or more aspects, and vice versa. Phrases such as "an embodiment" do not mean that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. The disclosure related to an embodiment can apply to all embodiments or one or more embodiments. An embodiment can provide one or more examples. The phrase "an embodiment" can refer to one or more embodiments, and vice versa. Phrases such as "a configuration" do not mean that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. The disclosure related to a configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. The phrase "such a configuration" can refer to one or more configurations, and vice versa.

[0073] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions they relate to and the customs of the field to which they belong.

[0074] It should be understood that the particular order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary methods. It is understood that based on design preferences, the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can be performed simultaneously. Some or all of the steps, operations, or processes can be performed automatically without user intervention. The appended method claims (if any) present the elements of the various steps, operations, or processes in an exemplary order and are not meant to be limited to the specific order or hierarchy presented.

[0075] All structural and functional equivalents of the elements of the various aspects described throughout this disclosure are known to those of ordinary skill in the art or will later be known to those of ordinary skill in the art, and are hereby expressly incorporated by reference herein and are intended to be covered by the claims. In addition, nothing disclosed herein is dedicated to the public, whether or not such disclosure is explicitly recited in the claims. Further, with respect to the scope of the terms "comprising", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "comprising" as interpreted when used as a transitional word in the claims.

[0076] The title, background, summary, brief description of the drawings, and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than as restrictive descriptions. The filing of this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. Further, in the detailed description, it can be seen that the description provides illustrative examples and, to simplify the present disclosure, various features are combined in various embodiments. The disclosed method should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as reflected in the following claims, the inventive subject matter lies in less than all the features of a single disclosed construction or operation. The following claims are thus incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.

[0077] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language of the claims and to include all legal equivalents.

Claims

1. A device for obtaining confirmation that disinfection is complete, the device comprising: electrically activated light sources; as well as at least one housing having at least one wall comprising a diffusion controlling membrane and enclosing a salt soluble in a disinfectant for disinfection, Wherein, the at least one housing and the light source are electrically connected in series.

2. The device according to claim 1, wherein: The diffusion control membrane is configured to be permeable to the disinfectant and impermeable to undissolved salts.

3. The device according to any one of claims 1 to 2, wherein: The diffusion control membrane is configured to control permeation of the disinfectant through the diffusion control membrane such that ionic mobility of salts dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has permeated through the diffusion control membrane for a predetermined amount of time.

4. The device according to claim 3, wherein: The predetermined amount of time is in the range of about 1 second to about 1 minute.

5. The device according to claim 3, wherein: After the sterilant has permeated through the diffusion control membrane for the predetermined amount of time, the electrical resistance of the housing decreases to within a range of about 10 to about 100 Ω.

6. The device according to any one of claims 1 to 5, further comprising a power supply.

7. The device according to any one of claims 1 to 6, wherein: The salts include inorganic salts.

8. The device according to any one of claims 1 to 7, wherein: The light source is a light emitting diode.

9. The device according to any one of claims 1 to 8, wherein: The diffusion control membrane includes a material selected from the group consisting of polyethersulfone (PES), polystyrene, molybdenum disulfide and graphene.

10. A needleless connector, comprising: power supply; electrically activated light sources; as well as at least one housing having at least one wall including a diffusion controlling membrane and enclosing a salt soluble in a disinfectant used to disinfect a surface of the needleless connector to be disinfected, the at least one housing being disposed along a surface of the needleless connector to be disinfected, Wherein, the at least one housing, the power supply and the light source are electrically connected in series.

11. The needleless connector according to claim 10, wherein: The diffusion control membrane is configured to control permeation of the disinfectant through the diffusion control membrane such that ionic mobility of salts dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has permeated through the diffusion control membrane for a predetermined amount of time.

12. The needleless connector according to claim 11, wherein: The predetermined amount of time is in the range of about 1 second to about 1 minute.

13. The needleless connector according to claim 11, wherein: After the sterilant has permeated through the diffusion control membrane for the predetermined amount of time, the electrical resistance of the housing decreases to within a range of about 10 to about 100 Ω.

14. The needleless connector according to any one of claims 10 to 13, wherein: The diffusion control membrane is configured to be permeable to the disinfectant and impermeable to undissolved salts.

15. The needleless connector according to any one of claims 10 to 14, wherein: The diffusion control membrane includes a material selected from the group consisting of polyethersulfone (PES), polystyrene, molybdenum disulfide and graphene.

16. The needleless connector according to any one of claims 10 to 15, wherein: The salt includes an inorganic salt selected from the group consisting of potassium chloride, sodium chloride and magnesium chloride, or an organic salt selected from the group consisting of hexadecyltrimethylammonium bromide or octanoic acid.

17. The needleless connector according to any one of claims 10 to 16, wherein: The at least one housing has a volume in the range of about 1 nl to about 1 μl.

18. A method for sterilizing a needleless connector, the method comprising: applying a disinfectant to the needleless connector, the needleless connector having a confirmation device coupled thereto, the confirmation device comprising: power supply, an electrically activated light source, and at least one housing having at least one wall including a diffusion control membrane and enclosing a salt, the salt being soluble in a disinfectant for disinfection, wherein the at least one housing, the power source, and the light source are electrically connected in series, wherein the disinfectant is applied until the light source is activated; and The needleless connector is used when the light source is deactivated.

19. The method according to claim 18, wherein: The diffusion control membrane is configured to control permeation of the disinfectant through the diffusion control membrane such that ionic mobility of salts dissolved in the disinfectant is sufficient to activate the light source only after the disinfectant has permeated through the diffusion control membrane for a predetermined amount of time.

20. The method according to claim 19, wherein: The predetermined amount of time is in the range of about 1 second to about 1 minute.

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