Integrated time display device for topical skin application

Abstract

The applicator includes a body configured to contain a fluid, an application member in selective fluid communication with the body, and a time display device, the time display device including a capillary component having a fluid path, the time display device configured to provide at least a first observable signal directly or indirectly based on progression of the fluid along the fluid path, the first observable signal indicating a first particular application period.

Description

Technical Field

[0001] The present disclosure relates to a time display device configured to be used with a fluid applicator, particularly a fluid applicator for applying a disinfectant solution.

Background Art

[0002] In the technical field of disinfectant solutions, the application time can significantly affect the logarithmic reduction of the microbial load. Efficacy studies conducted with specific disinfectant products follow specific application times, and it is extremely important for medical personnel to reproduce this application time in order to achieve the desired microbial kill.

[0003] It can be difficult to comply with the marked application time. In practice, when medical personnel do not use a timing device, the application time is often significantly shorter than the application time indicated on the product label. However, using an external timing device (e.g., a watch) requires additional procedural steps, and particularly when performing procedures that inherently require a large number of steps, such as preparing a patient's skin before surgery and / or preparing for needle insertion, there is an increased risk that medical personnel will inadvertently miss a step. Furthermore, when using an external timing device, there is also a possibility of leading to an application failure mode where medical personnel omit to check the start or end time of the application without noticing. Also, when using an external timing device, medical personnel may need to divert their attention from the treatment surface, such as the skin of a surgical patient.

[0004] Therefore, in this technical field, there is a need for a time display device that does not have the drawbacks of an external timing device and ensures compliance with the marked application time.

Summary of the Invention

Problems to be Solved by the Invention

[0005] The present disclosure relates to a time display device configured to be used with a fluid applicator, particularly a fluid applicator for applying a disinfectant solution.

Means for Solving the Problems

[0006] According to some embodiments, the time display device includes a capillary component having at least one fluid path through which a fluid can travel by capillary action. The time display device of the present disclosure may be configured to provide at least a first observable signal indicating the end of a first particular coating period in response to a particular physical and / or chemical event. [Brief explanation of the drawing]

[0007] [Figure 1] An exemplary applicator including a time display device according to an aspect of this disclosure is shown. [Figure 2A] An exemplary applicator including a time display device according to an aspect of this disclosure is shown. [Figure 2B] An exemplary top view of an applicator including a time display device according to an aspect of this disclosure is shown. [Figure 2C] A three-dimensional diagram of an exemplary applicator including a time display device according to an aspect of this disclosure is shown. [Figure 2D] A three-dimensional diagram of an exemplary applicator including a time display device according to an aspect of this disclosure is shown. [Figure 2E] An exemplary side view of an applicator including a time display device according to an aspect of this disclosure is shown. [Modes for carrying out the invention]

[0008] This disclosure relates to a time display device configured for use with a fluid applicator, particularly a fluid applicator for dispensing disinfectants. In some embodiments, the time display device includes a capillary component having at least one fluid path through which a fluid can travel by capillary action. The time display device of the Disclosure may be configured to provide at least a first observable signal indicating the end of a first particular application period in response to a particular physical and / or chemical event. In some embodiments, the time display device of the Disclosure may provide a second, third, or more observable signal to indicate the end of a second, third, or more application periods, respectively.

[0009] As used herein, the terms “fluid applicator” and “applicator” refer to a device having at least a body and an applicator, the body being configured to contain a fluid (e.g., disinfectant) and selectively fluid-communicating with the applicator so that the fluid is selectively delivered from the body to the applicator. In some embodiments, the applicator is a component that applies the fluid to a surface, such as a foam sponge material or any suitable material that can apply the fluid to the external surface of the applicator.

[0010] In some embodiments, the body of the applicator may house one or more ampoules and / or similar containers into which a fluid, such as a disinfectant, can be placed before being applied to a surface. The applicator may further include a fluid metering device, such as a cotton spool, configured to at least partially control and / or guide the flow of fluid from the body to the application member when the applicator is in use. The applicator may optionally include an actuator configured to actuate the applicator, the actuation of which corresponds to the body being provided in fluid communication with the application member, as described herein.

[0011] Non-limiting and exemplary applicators that may be used in accordance with this disclosure are, for example, the concurrently pending U.S. Patent Application No. 15 / 163,500 of the present applicant, and U.S. Patents Nos. 5,690,958, 6,536,975, 8,708,983, 8,899,859, 9,119,946, 9,572,967, 9,757,551, 9,968,764, 10,076,648 and 10,549,078, all of which are incorporated herein by reference.

[0012] In some embodiments, the fluids described herein may include a disinfectant solution containing at least one disinfectant and a solvent. In some embodiments, the disinfectant solution is an aqueous solution. As used herein, “aqueous solution” means a solution in which water makes up at least half of the solvent. In some embodiments, the disinfectant solution is an alcohol solution. As used herein, “alcohol solution” means a solution in which alcohol makes up at least half of the solvent.

[0013] As used herein, the term “disinfectant” refers to a chemical component that inactivates, inhibits or otherwise destroys the unacceptable action of microorganisms. In some embodiments, the disinfectant may contain cationic molecules (i.e., positively charged molecules), such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanides). In some embodiments, the disinfectant may contain bis-(dihydropyridinyl)-decane derivatives (i.e., compounds derived from bis-(dihydropyridinyl)-decane). In some embodiments, the disinfectant may contain octenidine salts and / or chlorhexidine salts. Non-limiting examples of disinfectants used in accordance with this disclosure include octenidine dihydrochloride, chlorhexidine gluconate, alexidine, and any combination thereof.

[0014] Additionally or alternatively, the disinfectant may contain iodine. According to some embodiments, iodine may be provided as an iodine complex such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethyleneoxypolypropyleneoxy-iodine, undecoinium-chloride-iodine, iodine povacrilex, and combinations thereof.

[0015] According to some embodiments, the concentration of one disinfectant in the disinfectant solution or the cumulative concentration of two or more disinfectants may be about 0.0001% to about 2.0% w / v, optionally about 0.01% to about 1.0% w / v, or optionally about 0.1% to about 0.4% w / v. According to some embodiments, the concentration of one disinfectant in the disinfectant solution or the cumulative concentration of two or more disinfectants may be about 0.0001% to about 0.4% w / v, or optionally about 0.1% to about 0.2% w / v. According to some embodiments, the concentration of one disinfectant in the disinfectant solution or the cumulative concentration of two or more disinfectants may be about 0.1% to about 2.0% w / v, optionally about 0.5% to about 2.0% w / v, or optionally about 2.0% w / v. According to some embodiments, the concentration of one disinfectant in the disinfectant solution or the cumulative concentration of two or more disinfectants may be approximately 0.1% to approximately 15.0% w / v, arbitrarily approximately 0.1% to approximately 10.0% w / v, arbitrarily approximately 5.0% to approximately 10.0% w / v, arbitrarily approximately 10.0% to approximately 15.0% w / v, arbitrarily approximately 13% w / v, or arbitrarily approximately 8.5% w / v.

[0016] It should be understood that the concentrations disclosed herein may correspond to the concentrations of one or more disinfectants having one or more active ingredients. For example, a disinfectant containing povidone-iodine has an active ingredient containing iodine. In this example, the concentration of the active ingredient in the disinfectant may be lower than the concentration of the disinfectant.

[0017] According to some embodiments, the concentration of the active ingredient of one disinfectant or the cumulative concentration of the active ingredients of two or more disinfectants in the disinfectant solution may be approximately 0.01% to approximately 5.0% w / v, optionally approximately 0.01% to approximately 2.5% w / v, optionally approximately 0.01% to approximately 2.0% w / v, optionally approximately 0.5% to approximately 1.5% w / v, or optionally approximately 1.0% w / v.

[0018] According to some embodiments, the solvent may include alcohol. Non-limiting examples of alcohol include ethanol, propanol, isopropyl alcohol, and combinations thereof. According to some embodiments, the concentration of alcohol in the disinfecting solution may be from about 50% to about 90% v / v, optionally from about 70% to about 80% v / v, and optionally about 70% v / v. According to some embodiments, the concentration of alcohol in the disinfecting solution may be from about 10% to about 50% v / v, optionally from about 20% to about 30% v / v. According to some embodiments, the solvent may be composed of alcohol.

[0019] Additionally or alternatively, the solvent may include water. According to some embodiments, the concentration of water in the disinfecting solution may be from about 10% to about 50% v / v, optionally from about 20% to about 30% v / v. According to some embodiments, the concentration of water in the disinfecting solution may be from about 50% to about 90% v / v, optionally from about 70% to about 80% v / v. According to some embodiments, the solvent may be composed of water.

[0020] According to some embodiments, the disinfecting solution may further include a film-forming polymer. Non-limiting examples of the film-forming polymer include, for example, ethyl cellulose, hydroxypropyl methyl cellulose, iodine povidone, and acrylate polymers such as acrylamide polymers, octyl acrylamide polymers, methacrylate polymers, carboxyacrylate polymers, and polymers having dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate side groups. The concentration of the film-forming polymer may vary depending on the specific solvent and disinfectant present in the disinfecting solution.

[0021] According to some embodiments, the concentration of the film-forming polymer in the disinfecting solution may be from about 0.1% to about 5% w / v, optionally from about 0.2% to about 3.0% w / v, optionally from about 0.5% to about 2.0% w / v, and optionally from about 0.75% to about 2.5% w / v.

[0022] Examples of acrylate polymers include, but are not limited to, DERMACRYL® AQF (a polymer containing 2-propenoic acid, 2-methylic acid, butyl 2-propenate, and methyl-2-propenate) and DERMACRYL® 79P (a polymer containing 2-propenoic acid, 2-methylic acid, 2-methylpropyl ester, 2-propenoic acid, and N-(1,1,3,3-tetramethylbutyl)-2-propenamide) manufactured by Akzo Nobel Coatings Inc., and EUDRAGIT® EPO (poly(butyl metasylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) manufactured by Evonik Industries). DERMACRYL® 79P is a hydrophobic, high molecular weight carboxylated acrylic copolymer. EUDRAGIT® EPO is a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.

[0023] According to some embodiments, the disinfecting solution may further contain a colorant. In some non-limiting examples, the colorant may include an anionic colorant such as an anionic dye. The anionic dye may be any dye suitable for medical use, such as a dye approved by the Food and Drug Administration for use in food, pharmaceuticals, and / or cosmetics (i.e., a "D&C" or "FD&C" dye). Exemplary anionic dyes include FD&C Blue No.1 (Brilliant Blue FCF), FD&C Blue No.2 (Indigocarmine), FD&C Green No.3 (Fast Green FCF), FD&C Red No.3 (Erythrosine), FD&C Red No.40 (Allura Red), FD&C Yellow No.5 (Tartrazine), FD&C Yellow No.6 (Sunset Yellow FCF), D&C Yellow No.8 (Fluorescein), D&C Orange No.4, and combinations thereof, but are not limited thereto. They may be combined to achieve a specific color. For example, the orange hue may include both FD&C Red No.40 and D&C Yellow No.8.

[0024] According to some embodiments, the concentration of the colorant in the disinfecting solution may be from about 0.01% to about 0.15% w / v, optionally from about 0.03% to about 0.12% w / v, and optionally from about 0.05% to about 0.09% w / v.

[0025] According to some embodiments, the disinfecting solution may contain one or more plasticizers. The plasticizer may be an ester of an organic acid, such as triethyl citrate and dibutyl sebacate. The concentration of the plasticizer in the disinfecting solution may be from about 0.05% to about 2.0% w / v, optionally from about 0.75% to about 1.5%, and optionally from about 0.1% to about 1.0% w / v.

[0026] According to some embodiments, the disinfecting solution may be a solution used in a ChloraPrep® applicator, which contains about 2% w / v chlorhexidine gluconate in a solvent containing about 70% v / v isopropyl alcohol and water.

[0027] It should be understood that, in some embodiments, one or more components contained in a disinfectant solution can provide two or more functions as described herein. For example, a disinfectant solution may contain an alcohol as described herein, which can function as both a solvent and a disinfectant as described herein. In another example, a disinfectant solution may contain iodine povacrilex as described herein, which can function as both a disinfectant and a film-forming polymer as described herein.

[0028] As described herein, a time display device includes a capillary component having at least one fluid path through which a fluid can travel by capillary action. As used herein, “capillary action” means the action of a fluid flowing into and passing through space without the assistance of an external force such as gravity, and / or without resistance to an external force.

[0029] A capillary component may be configured to provide at least one observable signal in response to a specific physical and / or chemical event. Examples of observable signals include, but are not limited to, changes in the size of the capillary component, changes in the position of the capillary component, changes in the color of the capillary component, changes in the color intensity of the capillary component, and combinations thereof.

[0030] In some embodiments, the time display device may further include one or more signal-transmitting components that function in combination with a capillary component. If the time display device includes one or more signal-transmitting components, the observable signals may additionally or alternatively include changes in the color of the signal-transmitting component, changes in the color intensity of the signal-transmitting component, changes in the relative position of the signal-transmitting component with respect to the capillary component, visibility of the signal-transmitting component to the user, and combinations thereof.

[0031] In one non-limiting example, the capillary component may include an adsorbent. As used herein, “adsorbent” means a material configured to absorb and / or adsorb fluids. Examples of adsorbents useful in accordance with this disclosure include, but are not limited to, silica gel, aluminum oxide, cellulose, paper, titanium oxide, polyurethane foam, natural fibers, synthetic fibers, and combinations thereof. In some embodiments, the capillary component may include a substrate on which the adsorbent is provided. For example, the capillary component may include a sheet of a substrate coated with an adsorbent, as described herein. In some embodiments, the substrate may be non-adsorbent, i.e., a material that does not absorb and / or adsorb fluids, as described herein. Examples of substrates useful in accordance with this disclosure include, but are not limited to, glass, plastics, metals (e.g., aluminum foil), alloys, and combinations thereof.

[0032] In some embodiments, the adsorbent is provided in fluid communication with the applicator's coating member such that, when the applicator is operated, some of the disinfectant is absorbed and / or adsorbed by the adsorbent. Figure 1 shows an exemplary applicator 100 having a body 101, a coating member 102, and an actuator 103 as described herein. In this example, the applicator 100 includes a capillary component 104 provided near the surface 105 of the coating member 102, where the surface 105 of the coating member 102 is near the point of fluid delivery from the body 101 to the coating member 102 (e.g., the surface near the inlet of a fluid conduit, not shown).

[0033] In the example shown in Figure 1, when a fluid (e.g., disinfectant) is delivered from the main body 101 to the coating member 102 during the operation of the applicator, a portion of the delivered fluid is absorbed and / or adsorbed by the capillary component 104 along the fluid path of the adsorbent via capillary action.

[0034] In some embodiments, the progression of fluid along the fluid pathway of a capillary component may, indirectly or directly, provide at least a first observable signal, as described herein. For example, the progression of fluid along the fluid pathway may correspond to a change in the color and / or color intensity of the capillary component, for example, through physical wetting of an adsorbent in contact with the fluid and / or a chemical reaction between the adsorbent and components of the fluid (e.g., a solvent or disinfectant as described herein). In this example, the observable signal may include a change in the color and / or color intensity of the capillary component indicating a certain degree of fluid progression along the fluid pathway of the capillary component.

[0035] In one non-limiting example, as described herein, the capillary component 104 in Figure 1 may include a sheet of substrate with an adsorbent coating. As shown in Figure 1, the capillary component 104 may be provided on and / or as part of a flange component 109 of a body 101, the flange component 109 configured to connect to a coating member 102. In this example, the adsorbent coating may be in fluid communication with the coating member 102 at least at its first end 107 such that a portion of the fluid delivered to the coating member 102 when the applicator is operated is absorbed and / or adsorbed by the adsorbent. The progression of the fluid along the length 106 of the capillary component 104 may be observed as a color change of the adsorbent. In this example, the observable signal may be a complete color change of the adsorbent, thus indicating that the fluid has progressed approximately 100% along the fluid path, i.e., that the fluid has progressed substantially over the entire length 106 of the capillary component 104.

[0036] However, it should be understood that the arrangement and operation of the above time display device are not particularly limited. For example, as shown in Figure 1, the capillary component 104 may include an adsorbent without a substrate. In this example, the fluid path may extend from the surface of the capillary component 104 connected to the coating member 102 (i.e., the surface facing the top surface 110) to the top surface 110, i.e., along the height of the capillary component 104. In this example, the observable signal may be a change in color visible on the top surface 110 of the capillary component 104, indicating that the fluid has traveled approximately 100% along the fluid path, i.e., that the fluid has traveled across the entire height of the capillary component 104.

[0037] Additionally or alternatively, the observable signal may include changes in the color and / or color intensity of the signal-transmitting components contained in the time display device. For example, the signal-transmitting components may include one or more components configured to chemically react and / or physically interact with components of the fluid (e.g., through physical dissolution) to provide changes in color and / or color intensity. In this example, the signal-transmitting components may be provided at positions along the fluid path of the capillary component such that changes in color and / or color intensity occur when the fluid reaches the signal-transmitting components, thereby providing an observable signal. Additionally or alternatively, the observable signal may include changes in the translucency, volume, and / or position of the signal-transmitting components.

[0038] For example, the signal-transmitting component may include a hydrogel having a first opaque (i.e., non-transparent) state. In this example, the hydrogel may have a second state, such as a transparent state, upon contact with the fluid component. In this example, the observable signal may be a change in the transparency of the signal-transmitting component from the first state to the second state.

[0039] In another non-limiting example, the signal-transfer component may include a hydrogel having a first state corresponding to a first volume. In this example, the hydrogel may expand to a second state corresponding to a second volume larger than the first volume upon contact with the fluid component. In this example, the observable signal may be the change in volume of the signal-transfer component from the first state to the second state.

[0040] In another non-limiting example, the signal-transmitting component may include a soluble component having an observable color. The signal-transmitting component may be provided at a position along the fluid path of the capillary component such that when the fluid reaches the signal-transmitting component, the soluble component dissolves in the fluid and moves along the fluid path with the fluid. In this example, the observable signal may be a change in the relative position of the signal-transmitting component with respect to the fluid path.

[0041] In one non-limiting example, as described herein, the capillary component 104 may include a sheet of a substrate having an adsorbent coating. In this example, as described herein, the adsorbent coating is in fluid communication with the coating member 102 at least at its first end 107. The adsorbent may further include a signal-transmitting component at its second end 108. This provides an observable signal, resulting in a change in color and / or color intensity when the fluid reaches the signal-transmitting component after traveling along the length 106 of the capillary component 104.

[0042] In another non-limiting example, as described herein, the capillary component 104 may include an adsorbent without a substrate. In this example, the upper surface 110 of the capillary component 104 may include a signal-transmitting component. This provides an observable signal by causing a change in color and / or color intensity on the upper surface 110 of the capillary component 104 when the fluid reaches the signal-transmitting component after traveling from the coating member 102.

[0043] Examples of materials useful for signal transmission components include, but are not limited to, materials having a first state and a second state different from the first state when in contact with a fluid (e.g., disinfectant). For example, as described herein, the first state may be a first color or color intensity, and the second state may be a second color or color intensity different from the first color or color intensity. Additionally or alternatively, as described herein, the first state may be a first transparency (i.e., translucent, transparent, opaque, also referred to herein), and the second state may be a second transparency different from the first transparency. Additionally or alternatively, as described herein, the first state may be a first volume, and the second state may be a second volume different from the first volume. Additionally or alternatively, as described herein, the first state may be a first position, and the second state may be a second position different from the first position.

[0044] Examples of signal-transmission components useful in accordance with this disclosure include, but are not limited to, the colorants described herein. In one non-limiting example, the signal-transmission component may include a colorant. In this example, as described herein, the colorant has a first color that is not easily observable in small amounts and a second color that is easily observable, the second color appearing when the colorant is dissolved in an aqueous solution or an alcohol solution. In this example, it should be understood that the observable signal includes the presence of the second color.

[0045] As described herein, the adsorbent may be directly fixed, bonded and / or integrated with the coating member and / or body (e.g., its flange component). In some non-limiting examples, the adsorbent may be bonded, melted, welded, molded, attached by an adhesion mechanism or thermal sprayed to the coating member and / or body, or a combination thereof. Exemplary adhesion mechanisms include, but are not limited to, pins, tacks and combinations thereof. Additionally or alternatively, as described herein, the adsorbent may be provided on the substrate as a coating, and as described herein, the substrate may be fixed, bonded and / or integrated with the coating member and / or body (e.g., its flange component). According to some embodiments, the adsorbent and / or substrate may have a shape that conforms to the shape of the coating member, for example, a shape having at least one dimension less than or equal to the corresponding dimension of the coating member, and / or a shape substantially identical to the shape of the coating member. The capillary component may be positioned relative to the coating member so that the adsorbent does not come into contact with the surface to which the fluid (e.g., disinfectant) is applied by the coating member during use of the applicator.

[0046] In the example shown in Figure 1, it should be understood that the time display device is an "open system." As used herein, the term "open system" refers to a display device system in which the fluid traveling along the fluid path is open to the surrounding environment, such as a time display device.

[0047] In some embodiments, the time display device may be provided as a closed system. As used herein, the term “closed system” refers to a display device system in which a fluid traveling along a fluid path is isolated from the surrounding environment, such as a time display device.

[0048] For example, Figure 2A shows an example of a closed system as described herein. Similar to the example shown in Figure 1, Figure 2A shows an exemplary applicator 200 having a body 201, a coating member 202, and an actuator 203 as described herein. In this example, as described herein, the time display device may include a capillary conduit 204 that forms a fluid path. Specifically, the capillary conduit 204 is a conduit having a length-to-diameter ratio sufficient to achieve capillary action. In this example, it should be understood that the fluid traveling along the fluid path (flowing through the conduit) forms a closed system by being isolated from the external environment at least by the material of the capillary conduit.

[0049] Examples of materials useful for capillary conduits include, but are not limited to, glass, plastics, paper (including paper with or without lining and / or coating), foil (e.g., metallic foil), plasticizers and / or nonplasticizers (e.g., acrylics), and combinations thereof.

[0050] The exemplary time display device shown in Figure 2A may further include a fluid signaling component provided within an actuated container. As used herein, “actuated container” means a container containing a substance (e.g., a fluid signaling component) and configured to release the substance upon activation. According to some embodiments, the actuated container may be direction-sensitive, such that it releases its contents in a controllable manner when positioned in a particular direction (e.g., vertically). Additionally or alternatively, the actuated container may be a fragile pressure-sensitive container that releases its contents in a controllable manner when a certain level of pressure is applied.

[0051] For example, Figure 2A shows an example of an actuated container 205 positioned relative to the actuator 203 such that when the actuator 203 is activated (in this example, when the lever is pushed down), the actuator 203 provides the actuated container 205 with sufficient force to break it. This causes the material contained in the actuated container 205 (e.g., fluid signaling components) to be released.

[0052] Examples of functional containers useful in accordance with this disclosure include, but are not limited to, ampoules (e.g., glass ampoules) and blister packs.

[0053] Examples of materials useful for workable containers include, but are not limited to, glass and polymers such as polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin copolymers (COC) or cyclic olefin polymers (COP), polypropylene (PP), polyethylene (PE), polyamides (e.g., nylon), methacrylate-modified acrylonitrile butadiene styrene (ABS) and glycol-modified polyethylene terephthalate (PET), metals such as aluminum, foils thereof, laminates thereof, and combinations thereof.

[0054] In some embodiments, the operable container may be configured, as described herein, to deliver a fluid (e.g., disinfectant) from the main body to the coating member and to release a fluid signal transmission component from the operable container in conjunction with the operation of the applicator. For example, as shown in Figure 2A, the operable container 205 is positioned relative to the actuator 203 so as to deliver a fluid (e.g., disinfectant) from the main body 201 to the coating member 202 in conjunction with the operation of the applicator, as described herein, and to release a fluid signal transmission component from the operable container 205 simultaneously or substantially simultaneously, as described herein.

[0055] Examples of exemplary materials useful for fluid signaling components include, but are not limited to, water, glycerin, glycol, alcohol solutions, aqueous solutions, and combinations thereof. In some embodiments, as described herein, the fluid signaling component may be colored, for example, with a coloring agent. Alternatively, the fluid signaling component may be uncolored.

[0056] In some embodiments, as described herein, the operable vessel may be in direct or indirect fluid communication with the capillary component in a selective manner.

[0057] For example, Figure 2A shows an example in which the operable vessel 205 is indirectly fluid-communicated with the capillary conduit 204 via a fluid reservoir 206 and a fluid channel 207. This can be visualized, for example, in Figure 2B, which shows a top view of the time display device in Figure 2A. As shown in Figure 2B, when the actuator is operated, the fluid signal transmission component is released from the operable vessel 205 into the fluid channel 207 and can reach the fluid reservoir 206 along the fluid channel 207. The fluid reservoir 206 can be fluid-communicated with the capillary conduit 204 via a restricting opening 208. The restricting opening 208 may have a size and / or direction through which the fluid contained in the fluid reservoir 206 can pass when the applicator is operating. As described herein, the fluid that has passed through the restricting opening 208 can enter the capillary conduit 204 and travel along the fluid path (i.e., through the conduit) by capillary action.

[0058] It should be understood that, as described herein, an observable signal can be provided indirectly or directly by the progression of fluid along the fluid path of the capillary conduit 204. For example, as described herein, the observable signal may include the progression of a fluid signal transmission component toward a selected point along the length of the capillary conduit 204, such as substantially the entire length of the fluid path (e.g., substantially the entire length of the capillary conduit 204). As shown in Figures 2A and 2B, the capillary conduit 204 may be configured so that the fluid progressing through it is visible to the user.

[0059] Figures 2A and 2B show components of a time display device (e.g., an operable container 205, a capillary conduit 204, a reservoir 206, and a fluid channel 207) located near the outer surface of the main body 201, but it should be understood that one or more of these components may be located inside the main body 201. In the example where at least the capillary conduit 204 is located inside the main body 201, the observable signal may indicate the progression of a fluid signal transmission component toward a selected point along the length of the capillary conduit 204 at a dispensing indicator location such as a window, level sensor, or other gauge observable to the user.

[0060] In some embodiments, as shown in Figure 2B, the time display device may include one or more reference marks 209. The reference marks 209 may indicate the progression of a particular fluid along a fluid path and may correspond to one or more coating periods, as will be described later. In this example, the observable signal may indicate the end of a particular coating period by corresponding to the fluid progressing to the position marked by the reference marks. The example shown in Figure 2B shows reference marks 209 corresponding to 0 seconds, 10 seconds, 20 seconds, and 30 seconds, but it should be understood that the time display device may include enough additional or alternative marks to indicate appropriate coating periods.

[0061] Figure 2C is a stereoscopic view of the example shown in Figures 2A and 2B. In particular, Figure 2C shows the fluid passage 207 and the fluid reservoir 206 as described herein. As shown in Figure 2C, the fluid reservoir 206 is in fluid communication with the capillary conduit 204 via a regulating opening 208 as described herein.

[0062] Figure 2D is another stereoscopic view of the example shown in Figures 2A to 2C. In particular, Figure 2D shows the fluid channel 207, the fluid reservoir 206, the regulating opening 208, and the capillary conduit 204 as described herein.

[0063] Figure 2E is a side view of an example shown in Figures 2A-2D, which includes a main body 201, a coating member 202, an actuator 203, an operable container 205, a fluid channel 207, and a fluid reservoir 206, as described herein.

[0064] Additionally or alternatively, the observable signals may include changes in the color, color intensity, transmittance, volume, and / or position of the second signal-transmitting component.

[0065] In one non-limiting example, the second signal-transmitting component may comprise one or more components that chemically react and / or physically interact with the first fluid signal-transmitting component (e.g., by physical dissolution) to provide a change in color and / or color intensity. In this example, the second signal-transmitting component may comprise a colorant, such as a powder in the first colorless state. As described herein, the second signal-transmitting component may be provided at a location along the fluid path of the capillary component such that when the first fluid signal-transmitting component reaches the second signal-transmitting component, the second signal-transmitting component provides an observable signal by sufficiently dissolving in the first fluid signal-transmitting component and providing it with a change in color and / or color intensity.

[0066] In another non-limiting example, the second signal-transmitting component may include a fiber having a first state, such as a first color. In this example, the first fluid signal-transmitting component may provide a wet mark having a different color from the first color upon contact with the fiber. In this example, the observable signal may be the appearance of the wet mark.

[0067] In another non-limiting example, the second signal-transmitting component may include a hydrogel having a first opaque (i.e., non-transparent) state. In this example, the hydrogel may have a second state, such as a transparent state, upon contact with the first fluid signal-transmitting component. In this example, the observable signal may be a change in the transparency of the second signal-transmitting component from the first state to the second state.

[0068] In another non-limiting example, the second signal-transfer component may include a hydrogel having a first state corresponding to a first volume. In this example, the hydrogel may expand to a second state corresponding to a second volume larger than the first volume upon contact with the first fluid signal-transfer component. In this example, the observable signal may be the change in volume of the second signal-transfer component from the first state to the second state.

[0069] In another non-limiting example, the second signal-transmitting component may include a soluble component having an observable color. The second signal-transmitting component may be provided at a position along the fluid path of the capillary component such that when the first fluid signal-transmitting component reaches the second signal-transmitting component, the soluble component dissolves into the first signal-transmitting component and moves along the fluid path together with the first fluid signal-transmitting component. In this example, the observable signal may be a change in the relative position of the second signal-transmitting component with respect to the fluid path.

[0070] Examples of materials useful for the second signal transmission component include, but are not limited to, materials having a first state and a second state different from the first state when in contact with the first fluid signal transmission component. For example, as described herein, the first state may be a first color, and the second state may be a second color different from the first color. Additionally or alternatively, as described herein, the first state may be a first transparency (i.e., translucent, transparent, opaque, also referred to herein as opaque), and the second state may be a second transparency different from the first transparency. Additionally or alternatively, as described herein, the first state may be a first volume, and the second state may be a second volume different from the first volume. Additionally or alternatively, as described herein, the first state may be a first position, and the second state may be a second position different from the first position.

[0071] As described herein, a time display device of the present disclosure may be configured to provide at least a first observable signal for specific physical and / or chemical events indicating a particular coating period. As used herein, “coating period” refers to the period during which a fluid contained in an applicator (e.g., disinfectant) is applied to a surface by the coating member. To apply the fluid to a surface, it is necessary to deliver the fluid from the body to the coating member, which can be achieved by operating an actuator and / or by positioning the applicator in a specific direction, for example, vertically, as described herein.

[0072] In some embodiments, a time display device of the present disclosure may be configured to provide a second, third, or more observable signal to indicate the end of a second, third, or more specific coating period, respectively. The second, third, or more observable signals may be the same as and / or different from at least one other observable signal that can be provided by the time display device. In one non-limiting example, as described herein, the first observable signal may correspond to a first degree of fluid progression along the fluid path. In this example, as described herein, the second observable signal may correspond to a second degree of fluid progression along the fluid path that is greater than the first degree. Thus, as described herein, the time display device may be configured to indicate two, three, or more different coating periods.

[0073] In some embodiments, a particular application period may be the period required for the disinfectant described herein to provide an acceptable antimicrobial effect. In one non-limiting example, the application period may correspond to the time required for the disinfectant described herein to provide an acceptable logarithmic reduction of the microbial load when applied to the surface of a medical device or the surface of an animal or human body, etc.

[0074] In some non-limiting examples, a particular application period may be approximately 30 seconds, optionally approximately 45 seconds, optionally approximately 60 seconds, optionally approximately 75 seconds, optionally approximately 90 seconds, optionally approximately 105 seconds, optionally approximately 120 seconds, optionally approximately 135 seconds, optionally approximately 150 seconds, optionally approximately 165 seconds, optionally approximately 180 seconds, optionally approximately 195 seconds, or optionally approximately 210 seconds. According to some embodiments, a particular application period may be approximately 30 seconds to 3 minutes.

[0075] Additionally or alternatively, the specific application period may be the time required for the disinfectant to provide a 1-logarithmic reduction of the microbial load, optionally a roughly 2-logarithmic reduction, optionally a roughly 3-logarithmic reduction, or optionally a roughly 4-logarithmic reduction.

[0076] It should be understood that, as described herein, specific application periods may depend at least in part on the identity of the disinfectant, including its effectiveness against microorganisms.

[0077] In some embodiments, a time display device may be configured such that the rate of fluid movement along the fluid path of a capillary component is sufficient to reliably measure a specific coating period. The rate of fluid movement along the fluid path of a capillary component may depend at least in part on one or more physical and / or chemical properties of the capillary component and / or the fluid. Exemplary physical and / or chemical properties include, but are not limited to, the porosity of the adsorbent, the polarity of the fluid (e.g., the polarity of the solvent and / or the fluid signaling component contained in the disinfectant), the polarity of the adsorbent, one or more dimensions of the fluid path, the shape of the fluid path, the chemical composition of the fluid path, and combinations thereof.

[0078] In one non-limiting example, the velocity of fluid along the fluid path of a capillary component can be selected by choosing a combination of an adsorbent with a specific polarity (including a non-polar adsorbent) and a fluid with a specific polarity. In this example, the fluid velocity may be highest when the polarity of the adsorbent is closest to the polarity of the fluid, while the fluid velocity may be lowest when the polarity of the adsorbent is most different from the polarity of the fluid.

[0079] Additionally or alternatively, the velocity of fluid along the fluid path of a capillary component can be selected by selecting specific dimensions of the fluid path, such as the width and / or length of the fluid path. Additionally or alternatively, the velocity of fluid along the fluid path of a capillary component can be selected by selecting specific shapes of the fluid path, such as a linear fluid path and / or a meandering fluid path.

[0080] Additionally or alternatively, the rate of fluid movement along the fluid path of a capillary component can be selected by selecting a specific chemical composition of the fluid path. For example, the fluid contact surface of the fluid path may be provided with one or more chemical additives having properties that assist or inhibit the fluid movement along the fluid path. In one non-limiting example, as described herein, the chemical additives affect the polarity of the fluid contact surface of the fluid path and thus affect the rate of fluid movement along the fluid path.

[0081] In some embodiments, the time display device may be provided as an integrated component of the applicator, for example, as shown in Figures 1 and 2A to 2E. In some non-limiting examples, the time display device may be molded as part of the applicator. Additionally or alternatively, the time display device may be provided as a separate device configured to be adjacent to the applicator, at least in part, via a connector. For example, as described herein, the time display device may include a substrate and / or adsorbent distinct from the applicator. The substrate and / or adsorbent layer may be configured to be fixed and / or bonded to the applicator via a connector before use. Exemplary connectors include, but are not limited to, adhesives, snaps, fasteners (e.g., male fasteners, female fasteners), wraps (e.g., hook wraps, loop wraps), straps, applicator housings, and combinations thereof.

[0082] In some embodiments, the time display device may be located within the user's field of view while the user is operating the applicator as intended. For example, as shown in Figure 1, the substrate and / or adsorbent may be located near the surface of the coating member, where the user can observe it when applying the fluid to the surface. In another example, as shown in Figures 2A to 2E, the capillary conduit may be located at a position on the body where the user can observe it when applying the fluid to the surface.

[0083] In some embodiments, the time display device, as described herein, may not contain any components that are incompatible with the disinfectant solution. For example, the time display device may not contain any electrical components and / or energy sources that provide an ignition source for the flammable solution. In some embodiments, the time display device may not contain any flammable materials.

[0084] Furthermore, this disclosure relates to an applicator including a time display device, as described herein.

[0085] Furthermore, this disclosure relates to a method using a time display device and / or applicator as described herein. In some embodiments, the method includes the steps of providing an applicator having a time display device as described herein, operating the applicator to apply a fluid to a surface, and observing the time display device for an observable signal. The method may further include the step of stopping the application of the fluid when an observable signal is observed, or after an observable signal has been observed.

[0086] While the embodiments described herein are described in conjunction with the exemplary embodiments outlined above, various substitutes, variations, modifications, improvements, and / or substantial equivalents, whether known or currently unpredictable, will become apparent to those skilled in the art. Therefore, as stated above, the exemplary embodiments are illustrative and not limiting. Various modifications can be made without departing from the spirit and scope of this disclosure. Accordingly, this disclosure is intended to encompass all known or future-developed substitutes, variations, modifications, improvements, and / or substantial equivalents.

[0087] Accordingly, the claims are not intended to be limited to the embodiments shown herein, but to give the full scope consistent with the language of the claims, and references to singular elements are intended to mean "one or more" and not "one and only" unless otherwise specified. All structural and functional equivalents to elements of various embodiments described throughout this disclosure, whether known to those skilled in the art or to become known thereafter, are expressly incorporated by reference herein and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly stated in the claims or not. Elements of the claims should not be construed as means plus function unless they are expressly referred to using the phrase "means for".

[0088] The word “exemplary” is used herein to mean “serving as an example, illustration, or representation.” Any embodiment described herein as “exemplary” should not necessarily be construed as being preferable or more advantageous than other embodiments. Unless otherwise specified, the term “some” means one or more. Combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” may include any combination of A, B, and / or C, and may include multiples of A, multiples of B, and multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any of these combinations may include one or more of A, B, or C. Nothing disclosed herein, whether such disclosure is expressly stated in the claims or not, is intended to be made available to the public.

[0089] The word "approximately" is used to mean within ±5% of a specified value, arbitrarily within ±4%, arbitrarily within ±3%, arbitrarily within ±2%, arbitrarily within ±1%, arbitrarily within ±0.5%, arbitrarily within ±0.1%, and arbitrarily within ±0.01%.

Claims

1. A body configured to contain a fluid, A coating member that selectively communicates with the main body via fluid, A time display device, including, The time display device includes a capillary conduit having a fluid path, The time display device is configured to provide a first observable signal indicating at least a first specific coating period based on the progression of the fluid along the fluid path. The time display device further includes a fluid signal transmission component provided in an operable container, wherein the operable container is configured differently from the configuration of the main body that houses the fluid, the fluid signal transmission component is different from the fluid housed in the main body, and the operable container, when operated, is an applicator that selectively communicates with the capillary conduit, directly or indirectly, to transfer the fluid signal transmission component to the capillary conduit.

2. The present invention further includes an actuator configured to operate the applicator such that the main body is provided in fluid communication with the coating member, The applicator according to claim 1, wherein the operable container is positioned relative to the actuator such that the operation of the applicator corresponds to the operation of the operable container.

3. The applicator according to claim 1, wherein the operable container is direction sensitive to controllably release the fluid signal transmission component from the operable container when the applicator is provided in a first direction.

4. The aforementioned time display device is A fluid channel that selectively communicates with the operable container, The applicator according to claim 1, further comprising a fluid reservoir that is in fluid communication with the fluid passage through a regulating opening and is in fluid communication with the capillary conduit.

5. The applicator according to claim 1, wherein the fluid is a disinfectant solution containing at least one disinfectant and a solvent.

6. The applicator according to claim 5, wherein the first specific application period is the period required for the disinfectant to provide an acceptable antimicrobial effect, and the period is 30 seconds to 3 minutes.

7. A step of providing an applicator comprising a body configured to contain a fluid, a coating member selectively in fluid communication with the body, and a time display device, wherein the time display device includes a capillary conduit having a fluid path, the time display device is configured to provide a first observable signal indicating at least a first specific coating period by the progression of the fluid along the fluid path, the time display device further includes a fluid signal transmission component provided in an operable container, the operable container being configured differently from the body in which the fluid contains the fluid, and the fluid signal transmission component being configured differently from the fluid contained in the body, and the operable container being selectively in fluid communication with the capillary conduit, directly or indirectly, so that when the operable container is operated, it transfers the fluid signal transmission component to the capillary conduit. The steps include: operating the applicator to apply a fluid to the surface of a medical device; A method for applying a fluid to the surface of a medical device, comprising the step of observing the time display device for the first observable signal.

8. The applicator further includes an actuator configured to operate the applicator such that the main body is provided in fluid communication with the coating member, The method according to claim 7, wherein the operable container is positioned relative to the actuator such that the operation of the applicator corresponds to the operation of the operable container.

9. The method according to claim 7, wherein the operable container is direction sensitive to controllably release the fluid signal transmission component from the operable container when the applicator is provided in a first direction.

10. The aforementioned time display device is A fluid channel that selectively communicates with the operable container, The method according to claim 7, further comprising a fluid reservoir that is in fluid communication with the fluid passage through a regulating opening and is in fluid communication with the capillary conduit.

11. The method according to claim 7, wherein the fluid is a disinfectant solution containing at least one disinfectant and a solvent.

12. The method according to claim 11, wherein the first specific application period is the period required for the disinfectant to provide an acceptable antimicrobial effect, and the period is 30 seconds to 3 minutes.

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