Integrated time indicating device during topical skin application

Abstract

An applicator having a body configured to contain a fluid, an applicator member in selective fluid communication with the body, and a time indicating device, wherein the time indicating device comprises a capillary component having a fluid path, wherein the time indicating device is configured such that fluid progression along the fluid path directly or indirectly provides at least a first observable signal, and wherein the first observable signal is indicative of a first particular application period.

Description

Technical Field

[0001] This disclosure relates to a time indication device configured for use with a fluid applicator (particularly a fluid applicator for applying a disinfectant solution). Background Technology

[0002] In the field of disinfectant solutions, application time has a significant impact on the logarithmic reduction of microbial load. Efficacy studies using specific disinfectant products that follow a specific application time, and that are repeated by healthcare practitioners, are crucial for achieving the desired microbial kill.

[0003] Adhering to the indicated application time is challenging. In practice, when healthcare practitioners do not use timing devices, the application time is often much shorter than the product label indicates. However, using an external timing device (e.g., a clock) introduces additional procedural steps, increasing the risk of healthcare practitioners unintentionally missing steps, especially when performing procedures that inherently require multiple steps, such as preparing the patient's skin prior to surgery and / or acupuncture. Furthermore, using an external timing device can also lead to application failure modes, in which healthcare practitioners unintentionally neglect to check the start or end time of the application. Additionally, using an external timing device may require healthcare practitioners to divert their attention from the surgical surface (e.g., the surgical patient's skin).

[0004] Therefore, there is a need in the art for a time indication device that ensures adherence to the application time of the markings without the disadvantages of an external timing device. Summary of the Invention

[0005] This disclosure relates to a time indication device configured for use with a fluid applicator (particularly a fluid applicator for applying a disinfectant solution). According to some aspects, the time indication device includes a capillary element having at least one fluid path along which fluid can proceed via capillary action. The time indication device of this disclosure can be configured to provide at least a first observable signal upon the occurrence of a specific physical and / or chemical event, wherein the first observable signal indicates the end of a first specific application cycle. Attached Figure Description

[0006] Figure 1 An exemplary applicator including a time indication device is shown according to aspects of this disclosure.

[0007] Figure 2A An exemplary applicator including a time indication device is shown according to aspects of this disclosure.

[0008] Figure 2B A top view of an exemplary applicator including a time indication device according to aspects of this disclosure is shown.

[0009] Figure 2C A three-dimensional view of an exemplary applicator including a time indication device according to aspects of this disclosure is shown.

[0010] Figure 2D A three-dimensional view of an exemplary applicator including a time indication device according to aspects of this disclosure is shown.

[0011] Figure 2E A side view of an exemplary applicator, including a time-indicating device, is shown according to aspects of this disclosure. Detailed Implementation

[0012] This disclosure relates to a time indication device configured for use with a fluid applicator (particularly a fluid applicator for applying a disinfectant solution). According to some aspects, the time indication device includes a capillary component having at least one fluid path along which fluid can proceed via capillary action. The time indication device of this disclosure can be configured to provide at least a first observable signal after a specific physical and / or chemical event has occurred, wherein the first observable signal indicates the end of a first specific application cycle. According to some aspects, the time indication device of this disclosure can be configured to provide second, third, or more observable signals to indicate the end of a second, third, or more application cycles, respectively.

[0013] As used herein, the terms "fluid applicator" and "applicator" refer to a device having at least a body and an applicator component, wherein the body is configured to contain a fluid (e.g., a disinfectant solution) and is in selective fluid communication with the applicator component, such that the fluid can be selectively delivered from the body to the applicator component. According to some aspects, the applicator component is a part configured to apply fluid to a surface, such as a foam sponge material or any suitable material that allows fluid to be applied to a surface outside the applicator.

[0014] According to some aspects, the body of the applicator may contain one or more ampoules and / or similar containers in which fluid (such as a disinfectant solution) may be contained before application to a surface. The applicator may also include a fluid dispensing device (such as a pledget) configured to at least partially control and / or direct 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, wherein actuation of the applicator corresponds to the body being configured in fluid communication with the application member, as described herein.

[0015] Non-limiting exemplary applicators that can be used under this disclosure can be found, for example, in the applicant’s co-pending U.S. Application No. 15 / 163,500 and in U.S. Patent 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, the disclosure of which is incorporated herein by reference in its entirety.

[0016] According to some aspects, the fluid described herein may include a disinfectant solution, wherein the disinfectant solution comprises at least one disinfectant and a solvent. According to some aspects, the disinfectant solution is an aqueous solution. As used herein, the term "aqueous solution" means a solution in which the solvent comprises at least a majority of water. According to some aspects, the disinfectant solution is an alcoholic solution. As used herein, the term "alcoholic solution" means a solution in which the solvent comprises at least a majority of alcohol.

[0017] As used herein, the term "disinfectant" refers to a chemical component that inactivates, inhibits, or otherwise destroys the unacceptable behavior of microorganisms. According to some aspects, disinfectants may include cationic molecules (i.e., molecules with a positive charge), such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanides). According to some aspects, disinfectants may include bis-(dihydropyridinyl)-decane derivatives (i.e., compounds derived from bis-(dihydropyridinyl)-decane). According to some aspects, disinfectants may include octenidine salts and / or chlorhexidine salts. Non-limiting examples of disinfectants useful according to this disclosure include octenidine hydrochloride, chlorhexidine gluconate, alixidine, and any combination thereof.

[0018] Additionally or alternatively, disinfectants may include iodine. Depending on some aspects, iodine may be provided as iodine complexes, such as povidone-iodine (PVPI), nonylphenoxy-(vinyloxy)-iodine, polyethyleneoxy-polypropyleneoxy-iodine, endychloride iodine, iodinepovacrylex (iodinepovacrylex), and combinations thereof.

[0019] According to some aspects, the concentration of a single disinfectant or the cumulative concentration of two or more disinfectants in the disinfection solution may be from about 0.0001% to about 2.0% w / v, optionally from about 0.01% to about 1.0% w / v, optionally from about 0.1% to about 0.4% w / v. According to some aspects, the concentration of a single disinfectant or the cumulative concentration of two or more disinfectants in the disinfection solution may be from about 0.0001% to about 0.4% w / v, and optionally from about 0.1% to about 0.2% w / v. According to some aspects, the concentration of a single disinfectant or the cumulative concentration of two or more disinfectants in the disinfection solution may be from about 0.1% to about 2.0% w / v, optionally from about 0.5% to about 2.0% w / v, and optionally from about 2.0% w / v. According to some aspects, the concentration of a single disinfectant or the cumulative concentration of two or more disinfectants in the disinfection solution may be from about 0.1% to about 15.0% w / v, optionally from about 0.1% to about 10.0% w / v, optionally from about 5.0% to about 10.0% w / v, optionally from about 10.0% to about 15.0% w / v, optionally about 13% w / v, optionally about 8.5% w / v.

[0020] 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 less than the concentration of the disinfectant itself.

[0021] According to some aspects, the concentration of a single disinfectant active component or the cumulative concentration of two or more disinfectant active components in the disinfectant solution may be from about 0.01% to about 5.0% w / v, optionally from about 0.01% to about 2.5% w / v, optionally from about 0.01% to about 2.0% w / v, optionally from about 0.5% to about 1.5% w / v, and optionally about 1.0% w / v.

[0022] According to some aspects, the solvent may include alcohols. Non-limiting examples of alcohols include ethanol, propanol, isopropanol, and combinations thereof. According to some aspects, the alcohol concentration in the disinfectant solution may be from about 50% to about 90% v / v, optionally from about 70% to about 80% v / v, and optionally from about 70% v / v. According to some aspects, the alcohol concentration in the disinfectant solution may be from about 10% to about 50% v / v, and optionally from about 20% to about 30% v / v. According to some aspects, the solvent may consist of alcohols.

[0023] Additionally or alternatively, the solvent may include water. According to some aspects, the concentration of water in the disinfectant solution may be from about 10% to about 50% v / v, and optionally from about 20% to about 30% v / v. According to some aspects, the concentration of water in the disinfectant solution may be from about 50% to about 90% v / v, and optionally from about 70% to about 80% v / v. According to some aspects, the solvent may consist of water.

[0024] Depending on some aspects, the disinfectant solution may also contain a film-forming polymer. Non-limiting examples of film-forming polymers include ethyl cellulose, hydroxypropyl methylcellulose, polyiodine, and acrylate polymers (such as acrylamide polymers, octylacrylamide polymers, methacrylate polymers, carboxyacrylate polymers, and polymers having dimethylamine ethyl methacrylate, butyl methacrylate, and methyl methacrylate side groups). The concentration of the film-forming polymer can vary depending on the specific solvent and disinfectant present in the disinfectant solution.

[0025] According to some aspects, the concentration of the film-forming polymer in the disinfectant 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.

[0026] Exemplary acrylate polymers include, but are not limited to: AQF (a polymer of 2-acrylic acid, 2-methyl-2-acrylate and butyl 2-acrylate and methyl 2-methyl-2-acrylate), 79P (a polymer of 2-acrylic acid, 2-methyl, 2-methylpropyl ester with 2-acrylic acid and N-(1,1,3,3-tetramethylbutyl)-2-acrylamide) (all manufactured by Akzo Nobel Coatings Inc.), and E PO (poly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate) (manufactured by Evonik Industries). 79P is a hydrophobic, high-molecular-weight carboxylated acrylic copolymer. EPO is a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.

[0027] Depending on some aspects, the disinfectant solution may also include a colorant. In some non-limiting examples, the colorant may include anionic colorants, such as anionic dyes. Anionic dyes may be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, pharmaceuticals, and / or cosmetics (i.e., "D&C" or "FD&C" dyes). Exemplary anionic dyes include, but are not limited to: FD&C Blue 1 (Brilliant Blue FCF), FD&C Blue 2 (Edible Indigo), FD&C Green 3 (Firm Green FCF), FD&C Red 3 (Erysipelothrix), FD&C Red 40 (Allura Red), FD&C Yellow 5 (Tartrazine), FD&C Yellow 6 (Sunset Yellow FCF), D&C Yellow 8 (Fluorescence), D&C Orange 4, and combinations thereof. Combinations may be implemented to achieve a specific color. For example, an orange hue may include both FD&C Red 40 and D&C Yellow 8.

[0028] According to some aspects, the concentration of the colorant in the disinfectant 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.

[0029] Depending on some aspects, the disinfectant solution may include 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 disinfectant 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.

[0030] According to some sources, the disinfectant solution can be found in ChloraPrep. TM The solution used in the applicator contains approximately 2% w / v chlorhexidine gluconate in a solvent that contains approximately 70% v / v isopropanol and water.

[0031] It should be understood that, depending on some aspects, the disinfectant solution may contain one or more components that can provide two or more functions as described herein. For example, the disinfectant solution may include alcohols as described herein, which, as described herein, can be used both as a solvent and as a disinfectant. In another embodiment, the disinfectant solution contains polymeric iodine as described herein, which, as described herein, can be used both as a disinfectant and as a film-forming polymer.

[0032] As described herein, the time indication device includes a capillary element having at least one fluid path along which fluid can proceed via capillary action. As used herein, the term "capillary action" refers to the action of fluid flowing into and through space without the assistance of external forces (such as gravity) and / or the opposite.

[0033] Capillary components can 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.

[0034] Depending on some aspects, the time indication device may also include one or more signaling components that work in conjunction with the capillary components. If the time indication device includes one or more signaling components, the observable signals may additionally or alternatively include changes in the color of the signaling components, changes in the color intensity of the signaling components, changes in the position of the signaling components relative to the capillary components, the visibility of the signaling components to the user, and combinations thereof.

[0035] In a non-limiting example, the capillary component may include an adsorbent. As used herein, the term "adsorbent" refers to a material configured to absorb and / or adsorb fluids. Examples of adsorbents useful according to this disclosure include, but are not limited to, silica gel, alumina, cellulose, paper, titanium dioxide, polyurethane foam, natural fabrics, synthetic fabrics, and combinations thereof. According to some aspects, the capillary component may include a substrate on which the adsorbent is disposed. For example, the capillary component may include a substrate sheet having an adsorbent coating as described herein. According to some aspects, the substrate may be a non-adsorbent, i.e., a material that does not absorb and / or adsorb fluids, as described herein. Examples of substrates useful according to this disclosure include, but are not limited to, glass, plastics, metals (such as aluminum foil), alloys, and combinations thereof.

[0036] According to some aspects, the adsorbent can be provided in fluid communication with the coating component of the applicator, such that when the applicator is actuated, a portion of the disinfectant solution is absorbed and / or adsorbed by the adsorbent. Figure 1 An exemplary applicator 100 is shown, having a body 101, an applicator 102, and an actuator 103, as described herein. In this example, the applicator 100 includes a capillary member 104 disposed adjacent to a surface 105 of the applicator 102 near the point where fluid is delivered from the body 101 to the applicator 102 (e.g., near a fluid inlet (not shown)).

[0037] exist Figure 1 In the example shown, when a fluid (such as a disinfectant solution) is delivered from the body 101 to the coating member 102 when the applicator is actuated, a portion of the delivered fluid is absorbed and / or adsorbed by the capillary member 104 via capillary action along the fluid path of the adsorbent.

[0038] According to some aspects, fluid advance along the fluid path of a capillary component can indirectly or directly provide at least a first observable signal, as described herein. For example, fluid advance along the fluid path can correspond to a change in the color and / or color intensity of the capillary component, such as through physical wetting of the fluid after contact with the adsorbent and / or through chemical reactions between the adsorbent and components of the fluid (e.g., solvents or disinfectants as described herein). In this example, the observable signal may include a change in the color and / or color intensity of the capillary component, which represents a certain degree of fluid advance along the fluid path of the capillary component.

[0039] In a non-restrictive example, Figure 1 The capillary component 104 may include a substrate sheet having an adsorbent coating, as described herein. Figure 1 As shown, the capillary element 104 may be disposed on and / or as part of the flange element 109 of the body 101, the flange element 109 being configured to interface with the 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 is absorbed and / or adsorbed by the adsorbent when the applicator is actuated. Fluid advance along the length 106 of the capillary element 104 can be observed as a color change of the adsorbent. In this example, the observable signal may be a complete color change of the adsorbent, indicating approximately 100% fluid advance along the fluid path, i.e., indicating that the fluid has advanced the entire length 106 of the capillary element 104.

[0040] However, it should be understood that the arrangement and operation of the aforementioned time indication device are not particularly restricted. For example, as Figure 1 The capillary component 104 shown may include an adsorbent without a substrate. In this example, the fluid path can extend from the surface of the capillary component 104 that interfaces with the coating member 102 (i.e., the surface opposite the top surface 110) to the top surface 110, that is, along the height of the capillary component 104. In this example, the observable signal may be a color change visible on the top surface 110 of the capillary component 104, indicating that approximately 100% of the fluid has progressed along the fluid path, that is, indicating that the fluid has traveled the entire height of the capillary component 104.

[0041] Additionally or alternatively, the observable signal may include changes in the color and / or color intensity of a signaling element included in the time indication device. For example, the signaling element may include one or more components configured to chemically react and / or physically interact with the components of the fluid (e.g., via physical dissolution) to provide a change in color and / or color intensity. In this example, the signaling element may be positioned along the fluid path of the capillary component such that a change in color and / or color intensity occurs when the fluid reaches the signaling element, thereby providing an observable signal. Additionally or alternatively, the observable signal may include changes in the translucency, volume, and / or position of the signaling element.

[0042] For example, the signaling component may include a hydrogel having a first state that is not translucent (i.e., opaque). In this example, the hydrogel may have a second state, such as a transparent state, when in contact with a component of the fluid. In this example, the observable signal may be the change in translucency of the signaling component from the first state to the second state.

[0043] In another non-limiting example, the signaling component may include a hydrogel having a first state corresponding to a first volume. In this example, upon contact with a component of the fluid, the hydrogel may expand to a second state corresponding to a second volume larger than the first volume. In this example, the observable signal may be the volume change of the signaling component from the first state to the second state.

[0044] In another non-limiting example, the signaling component may include a soluble component with an observable color. The signaling component may be positioned along the fluid path of the capillary component such that when fluid reaches the signaling component, the soluble component dissolves therein, thus traveling along the fluid path with the fluid. In this example, the observable signal may be a change in position of the signaling component relative to the fluid path.

[0045] In a non-limiting example, capillary 104 may include a substrate sheet having an adsorbent coating, as described herein. In this example, as described herein, the adsorbent coating is in fluid communication with the coating member 102 at least at a first end 107. The adsorbent may also include a signaling element at a second end 108, such that a change in color and / or color intensity occurs as the fluid travels along the length 106 of capillary 104 and reaches the signaling element, thereby providing an observable signal.

[0046] In another non-limiting example, capillary 104 may include an adsorbent without a substrate as described herein. In this example, the top surface 110 of capillary 104 may include a signaling element such that a change in color and / or color intensity occurs on the top surface 110 of capillary 104 as the fluid travels from coating member 102 to the signaling element, thereby providing an observable signal.

[0047] Exemplary materials for signaling components include, but are not limited to, materials having a first state and a second state upon contact with a fluid (such as a disinfectant solution), wherein the first state differs from the second state. For example, 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, as described herein. Additionally or alternatively, the first state may be a first translucency (i.e., translucent, transparent, or non-translucent (also referred to herein as opaque)), and the second state may be a second translucency different from the first translucency, as described herein. Additionally or alternatively, the first state may be a first volume, and the second state may be a second volume different from the first volume, as described herein. Additionally or alternatively, the first state may be a first position, and the second state may be a second position different from the first position, as described herein.

[0048] Examples of signaling components useful according to this disclosure include, but are not limited to, colorants, as described herein. In one non-limiting example, the signaling component may include a colorant. In this example, the colorant may have a first color that is not easily observed at low amounts and a second color that is easily observed, wherein the second color appears when the colorant is dissolved in an aqueous or alcoholic solution, as described herein. It should be understood that, in this example, the observable signal includes the presence of the second color.

[0049] As described herein, the adsorbent can be directly fixed to, adhered to, and / or integrated into the coating member and / or body (e.g., its flange portion). In some non-limiting examples, the adsorbent can be glued, melted, welded, molded, attached with an attachment mechanism, or sprayed onto the coating member and / or body, or combinations thereof. Exemplary attachment mechanisms include, but are not limited to, pins, tacks, and combinations thereof. Additionally or alternatively, the adsorbent can be provided as a coating on a substrate described herein, wherein the substrate is fixed, adhered to, and / or integrated into the coating member and / or body described herein (e.g., its flange portion). According to some aspects, the adsorbent and / or substrate can have a shape consistent with the shape of the coating member, such as a shape having at least one dimension equal to or smaller than the corresponding dimension of the coating member and / or a shape substantially the same as the shape of the coating member. Capillary components can be positioned relative to the coating member such that, when the applicator is in use, the adsorbent does not contact the surface of the fluid (e.g., disinfectant solution) applied by the coating member.

[0050] It should be understood that, Figure 1 In the illustrated embodiment, the time indication device is an "open system." As used herein, the term "open system" refers to a system such as a time indication device in which the fluid traveling along the fluid path is open to the surrounding environment.

[0051] Depending on some aspects, time indication devices can be provided as closed systems. As used herein, the term "closed system" refers to a system such as a time indication device in which the fluid traveling along the fluid path is separated from the surrounding environment.

[0052] For example, Figure 2A An example of a closed system as described in this article is shown. Similar to... Figure 1 The example shown, Figure 2A An exemplary applicator 200 is shown, having a body 201, an applicator member 202, and an actuator 203 as described herein. In this example, the time indication device may include a capillary 204 that forms a fluid path as described herein. Specifically, the capillary 204 is a tube having a length-to-diameter ratio sufficient to achieve capillary action. It should be understood that in this example, the fluid advancing along the fluid path (i.e., flowing through the tube) is separated from the external environment at least by the material of the capillary, thereby forming a closed system.

[0053] Exemplary materials for use in capillaries include, but are not limited to, glass, plastics, paper (including paper with and without lining and / or coating), foil (such as metal foil), plasticized and / or non-plasticized polymeric materials (such as acrylic resins), and combinations thereof.

[0054] Figure 2A The exemplary time indication device shown may also include a fluid signaling element disposed in an actuable container. As used herein, the term "actuable container" refers to a container configured to contain a substance (e.g., the fluid signaling element) and configured to release the substance upon actuation. According to some aspects, the actuable container may be orientation-sensitive, such that when positioned in a particular orientation (e.g., vertical orientation), the actuable container controllably releases its contents. Additionally or alternatively, the actuable container may be a fragile pressure-sensitive container configured to controllably release its contents when a certain level of pressure is applied.

[0055] For example, Figure 2AAn example of an actuable container 205 positioned relative to actuator 203 is shown, such that when actuator 203 is actuated (i.e., in this example, when the lever is pressed down), actuator 203 provides a force on the actuable container 205 sufficient to cause the actuable container 205 to rupture. Thus, the substance contained in the actuable container 205 (e.g., a fluid signaling component) is released.

[0056] Containers with useful examples of performance actuation according to this disclosure include, but are not limited to, ampoules (such as glass ampoules) and blister packs.

[0057] Exemplary materials for actuable containers include, but are not limited to: glass; polymers such as polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polytrifluoroethylene (PCTFE), cyclic olefin copolymers (COC) or 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 of the above materials; laminates of the above materials; and combinations thereof.

[0058] According to some aspects, the actuable container can be configured such that actuation of the applicator concurrently delivers fluid (e.g., a disinfectant solution) from the body to the applicator member as described herein, and releases fluid from the actuable container via a signaling element. For example, as Figure 2A As shown, the actuable container 205 is positioned relative to the actuator 203 such that actuation of the applicator delivers fluid (such as a disinfectant solution) from the body 201 to the applicator member 202 as described herein, while simultaneously or almost simultaneously releasing a fluid signaling element from the actuable container 205 as described herein.

[0059] Exemplary materials for fluid signaling components include, but are not limited to, water, glycerol, ethylene glycol, alcohol solutions, aqueous solutions, and combinations thereof. According to some aspects, the fluid signaling component may be colored, for example, via a colorant as described herein. Optionally, the fluid signaling component may be uncolored.

[0060] According to some aspects, as described herein, an actuable container can be in direct or indirect selective fluid communication with capillary components.

[0061] For example, Figure 2A An embodiment is shown in which an actuable container 205 is indirectly fluidly connected to a capillary 204 via a fluid storage section 206 and a fluid channel 207. This can be, for example, in... Figure 2B As seen in the image, this diagram illustrates... Figure 2A A top-view perspective view of the time indicator device. (See image below.) Figure 2BAs shown, when the actuator is actuated, the fluid signaling component can be released from the actuable container 205 into the fluid channel 207 and along the fluid channel until it reaches the fluid reservoir 206. The fluid reservoir 206 can be in fluid communication with the capillary 204 via a limiting orifice 208. The limiting orifice 208 can be sized and / or oriented such that the fluid contained in the fluid reservoir 206 can pass through the limiting orifice 208 during applicator movement. The fluid passing through the limiting orifice 208 can enter the capillary 204 and proceed along the fluid path (i.e., through the tube) via capillary action, as described herein.

[0062] It should be understood that the fluid advance along the fluid path of capillary 204 can provide observable signals, either indirectly or directly, as described herein. For example, observable signals may include fluid signaling components that advance along the length of capillary 204 (such as approximately the entire length of the fluid path, e.g., approximately the entire length of capillary 204) to a selected point, as described herein. Figure 2A and Figure 2B As shown, capillary 204 can be configured such that the fluid flowing through it can be seen by the user.

[0063] It should also be understood that, although Figure 2A and Figure 2B Components of a time indication device (e.g., an actuable container 205, capillary 204, reservoir 206, and fluid channel 207) are shown located near the outer surface of the body 201; however, one or more of these components may be located inside the body 201. In embodiments where at least the capillary 204 is located inside the body 201, an observable signal can indicate that the fluid signaling component advances along the length of the capillary 204 to a selected point at the application indicator location (such as a window, level sensor, or other metering device observable by the user).

[0064] According to some aspects, the time indicating device may include one or more reference markers 209, such as Figure 2B As shown. Reference mark 209 can indicate the progress of a specific fluid along the fluid path and can correspond to one or more coating cycles, as described herein. In this example, the observable signal can correspond to the fluid progressing to a position marked by the reference mark, thus indicating the end of a specific coating cycle. It should be understood that, although Figure 2B The example shown illustrates reference marker 209 corresponding to 0, 10, 20, and 30 seconds, but the time indicator may include additional or alternative markers sufficient to indicate the appropriate application cycle.

[0065] Figure 2C It shows Figure 2A and Figure 2B The example shown is a 3D view. Specifically, Figure 2C The fluid passage 207 and fluid storage section 206, as described herein, are shown. Figure 2C As shown, the fluid storage unit 206 is in fluid communication with the capillary 204 via the limiting hole 208, as described herein.

[0066] Figure 2D It shows Figures 2A-2C Another 3D view of the example shown. Specifically, Figure 2D Fluid channel 207, fluid storage section 206, limiting orifice 208 and capillary 204 are shown as described herein.

[0067] Figure 2E It shows Figures 2A-2D The side view of the example shown includes a body 201, a coating member 202, an actuator 203, an actuable container 205, a fluid channel 207, and a fluid storage section 206, as described herein.

[0068] Additionally or alternatively, the observable signal may include changes in the color, color intensity, translucency, volume, and / or position of the second signaling component.

[0069] In a non-limiting example, the second signaling component may include one or more components configured to chemically react and / or physically interact (e.g., via physical dissolution) with the first fluid signaling component to provide a change in color and / or color intensity. In this example, the second signaling component may include a colorant, such as a powder having a colorless first state. The second signaling component may be positioned along the fluid path of the capillary component such that when the first fluid signaling component reaches the second signaling component, the second signaling component dissolves therein sufficiently to provide a change in color and / or color intensity to the first fluid signaling component, thereby providing an observable signal as described herein.

[0070] In another non-limiting example, the second signaling component may include a fabric having a first state (such as a first color). In this example, the first fluid signaling component may provide a wetting mark to the fabric upon contact, the wetting mark having a color different from the first color. In this example, the observable signal may be the appearance of the wetting mark.

[0071] In another non-limiting example, the second signaling component may include a hydrogel having a non-transparent (i.e., opaque) first state. In this example, the hydrogel may have a second state (such as a transparent state) when in contact with the first fluid signaling component. In this example, the observable signal may be the change in translucency of the second signaling component from the first state to the second state.

[0072] In another non-limiting example, the second signaling component may include a hydrogel having a first state corresponding to a first volume. In this example, upon contact with the first fluid signaling component, the hydrogel may expand to a second state corresponding to a second volume, which is larger than the first volume. In this example, the observable signal may be the volumetric change of the second signaling component from the first state to the second state.

[0073] In another non-limiting example, the second signaling component may include a soluble component with an observable color. The second signaling component may be positioned along the fluid path of the capillary component such that when the first fluid signaling component reaches the second signaling component, the soluble component dissolves therein and thus travels along the fluid path with the first fluid signaling component. In this example, the observable signal may be a change in position of the second signaling component relative to the fluid path.

[0074] Exemplary materials for the second signaling component include, but are not limited to, materials having a first state and a second state when in contact with the first fluid signaling component, wherein the first state differs from the second state. 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, the first state may be a first semi-transparency (i.e., semi-transparent, transparent, or non-semi-transparent (also referred to herein as opaque)), and the second state may be a second semi-transparency different from the first semi-transparency, as described herein. 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.

[0075] The timing indication device of this disclosure can be configured to provide at least a first observable signal upon the occurrence of a specific physical and / or chemical event as described herein, wherein the physical and / or chemical event represents a specific coating cycle. As used herein, the term "coating cycle" refers to the time period during which a fluid (e.g., a disinfectant solution) contained in the applicator is applied to a surface via a coating member. It should be understood that applying fluid to a surface will require the fluid to be delivered from the body to the coating member, which can be achieved by actuating an actuator as described herein and / or by positioning the applicator in a specific orientation (e.g., in a vertical position).

[0076] According to some aspects, the time indication device of this disclosure can be configured to provide second, third, or more observable signals to indicate the end of a second, third, or more specific coating cycle, respectively. The second, third, or more observable signals may be the same as and / or different from at least one other observable signal provided by the time indication device. In a non-limiting example, the first observable signal may correspond to a first degree of fluid progression along the fluid path as described herein. In this example, the second observable signal may correspond to a second degree of fluid progression along the fluid path as described herein, the second degree being greater than the first degree. In this way, the time indication device can be configured to indicate two, three, or more different coating cycles, as described herein.

[0077] According to some aspects, this particular application cycle can be the time period required for the disinfectant solution described herein to provide an acceptable bactericidal effect. In a non-limiting example, the application cycle can correspond to the time required for the disinfectant solution described herein to provide an acceptable logarithmic reduction in the total amount of microorganisms when applied to a surface (such as the surface of a medical device or the surface of an animal or human body).

[0078] In some non-limiting examples, a particular application cycle 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, and optionally approximately 210 seconds. Depending on some aspects, a particular application cycle may be between approximately 30 seconds and 3 minutes.

[0079] Additionally or alternatively, a specific application cycle may be the time required for the disinfectant solution to reduce the total amount of microorganisms by 1 log (1 log unit), optionally by about 2 log (2 log units), optionally by about 3 log (3 log units), and optionally by about 4 log (4 log units).

[0080] It should be understood that a particular application cycle can depend at least in part on the properties of the disinfectant solution (such as its efficacy against microorganisms), as described herein.

[0081] According to some aspects, the time indication device can be configured such that the fluid advance rate along the fluid path of the capillary component is sufficient to reliably measure a particular application cycle. The fluid advance rate along the fluid path of the capillary component can 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 contained in the disinfectant solution and / or the polarity of the fluid signaling component), 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.

[0082] In a non-limiting example, the fluid advance rate along the fluid path of the capillary can be selected by choosing a combination of an adsorbent (including a non-polar adsorbent) with a specific polarity and a fluid with a specific polarity. In this example, the fluid advance rate is highest when the polarity of the adsorbent most closely matches the polarity of the fluid, and lowest when the polarity of the adsorbent is least similar to that of the fluid.

[0083] Additionally or alternatively, the fluid advance rate along the capillary component can be selected by choosing a specific dimension of the fluid path (such as the width and / or length of the fluid path). Additionally or alternatively, the fluid advance rate along the capillary component can be selected by choosing a specific shape of the fluid path (such as a straight fluid path and / or a tortuous fluid path).

[0084] Additionally or alternatively, the fluid advance rate along the capillary component can be selected by choosing specific chemical components of the fluid path. For example, the fluid contact surface of the fluid path can be provided with one or more chemical additives that have properties that either aid or hinder fluid advance along the fluid path. In a non-limiting example, the chemical additives can affect the polarity of the fluid contact surface of the fluid path, which can affect the fluid advance rate along the fluid path, as described herein.

[0085] Depending on some aspects, the time indication device can be provided as an integrated component of the applicator, for example, such as Figure 1 and Figures 2A-2EAs shown. In some non-limiting embodiments, the time indicator may be molded as part of the applicator. Additionally or alternatively, at least a portion of the time indicator may be provided as a different device configured to abut the applicator via a connector. For example, the time indicator may include a substrate and / or absorbent different from those of the applicator, as described herein. The substrate and / or absorbent layers may be configured such that they can be secured and / or adhered to the applicator via the connector prior to use. Exemplary connectors include, but are not limited to, adhesives, snaps, fasteners (e.g., male and female fasteners), wraps (e.g., hook and loop wraps), straps, applicator housings, and combinations thereof.

[0086] In some respects, the time indicator can be positioned within the user's field of vision when the user operates the applicator as intended. For example, such as... Figure 1 As shown, the substrate and / or adsorbent can be disposed close to the surface of the coated component, allowing the user to observe the coated component as the fluid is applied to the surface. In another embodiment, as... Figures 2A-2E As shown, the capillary can be positioned at the location of the body, which the user can observe when applying fluid to the surface.

[0087] According to some aspects, the time indicator may not contain any components incompatible with the disinfectant solution described herein. For example, the time indicator may not contain any electrical components and / or power sources that could provide an ignition source for the flammable solution. According to some aspects, the time indicator may not contain any combustible materials.

[0088] This disclosure also relates to applicators that include time indication devices as described herein.

[0089] This disclosure also relates to methods of using a time-indicating device and / or applicator as described herein. According to some aspects, the method includes: providing an applicator having a time-indicating device as described herein; actuating the applicator to apply a fluid to a surface; and observing the time-indicating device in response to an observable signal. The method may further include interrupting the application of fluid when an observable signal has been observed or after an observable signal has been observed.

[0090] While the aspects described herein have been described in conjunction with the foregoing exemplary aspects, various alternatives, modifications, variations, improvements, and / or substantial equivalents (whether known or currently unforeseen (or possibly unforeseen at present)) will be apparent to those skilled in the art. Therefore, the exemplary aspects described above are intended to be illustrative and not restrictive. Various changes may be made without departing from the spirit and scope of this disclosure. Thus, this disclosure is intended to encompass all known or subsequently developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0091] Therefore, the claims are not intended to be limited to the aspects shown herein, but are to be consistent with the full scope of the language of the claims, wherein, unless specifically stated otherwise, elements referred to in the singular are not intended to mean “one and only one”, but rather “one or more”. All structural and functional equivalents of elements of the various aspects described in this disclosure that are known to or will be known thereafter by those skilled in the art are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims. Unless a claim element is expressly stated using the phrase “means for”, it should not be construed as means plus function.

[0092] Furthermore, the term “example” as used herein means “serving as an example, illustration, or explanation.” Any aspect described herein as an “example” is not necessarily to be construed as being more preferred or advantageous than other aspects. 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” include any combination of A, B, and / or C, and may include multiple A, multiple B, or multiple 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 only A, only B, only C, A and B, A and C, B and C, or A and B and C, wherein any such combination may contain one or more components of A, B, or C.

[0093] As used in this document, the term “about” means within ±5%, optionally within ±4%, optionally within ±3%, optionally within ±2%, optionally within ±1%, optionally within ±0.5%, optionally within ±0.1%, and optionally within ±0.01% of the stated value.

Claims

1. An applicator, comprising: The body is configured to contain fluid; The coating component is in selective fluid communication with the body. as well as Time indication device, wherein: The time indication device includes a capillary tube with a fluid path. The time indication device is configured such that the advance of fluid along the fluid path provides at least a first observable signal representing a first specific coating cycle, and The time indication device further includes a fluid signaling component disposed in an actuable container, wherein the actuable container is in direct or indirect selective fluid communication with the capillary, such that when the actuable container is actuated, the fluid signaling component is delivered to the capillary. The actuation of the applicator delivers the fluid from the body to the applicator member, while simultaneously releasing the fluid signaling element from the actuable container.

2. The applicator according to claim 1, The applicator further includes an actuator configured to actuate the applicator such that the body is positioned in fluid communication with the applicating member, and The actuable container is positioned relative to the actuator such that actuation of the applicator corresponds to actuation of the actuable container.

3. The applicator of claim 1, wherein the actuable container is orientation-sensitive such that when the applicator is positioned in a first orientation, the actuable container can controllably release the fluid signaling element therefrom.

4. The applicator according to claim 1, wherein the time indication device further comprises: A fluid channel, in selective fluid communication with the actuable container; as well as The fluid storage section is in fluid communication with the fluid channel and with the capillary via a limiting orifice.

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

6. The applicator of claim 5, wherein the first specific application cycle is the time period required for the disinfectant solution to provide an acceptable bactericidal effect, wherein the time period is between 30 seconds and 3 minutes.

7. A method for applying a fluid to the surface of a medical device, the method comprising: Provide an applicator, the applicator comprising: The body is configured to contain fluid; The coating component is in selective fluid communication with the body; and Time indication device, wherein: The time indication device includes a capillary tube with a fluid path. The time indication device is configured such that the advance of fluid along the fluid path provides at least a first observable signal representing a first specific coating cycle, and The time indication device further includes a fluid signaling component disposed in an actuable container, wherein the actuable container is in direct or indirect selective fluid communication with the capillary, such that when the actuable container is actuated, the fluid signaling component is delivered to the capillary. Actuating the applicator to apply the fluid to the surface of the medical device, wherein actuation of the applicator delivers the fluid from the body to the application member, while simultaneously releasing the fluid signaling element from the actuable container; and The time indication device is observed in relation to the first observable signal.

8. The method according to claim 7, The applicator further includes an actuator configured to actuate the applicator such that the body is positioned in fluid communication with the applicating member, and The actuable container is positioned relative to the actuator such that actuation of the applicator corresponds to actuation of the actuable container.

9. The method of claim 7, wherein the actuable container is orientation-sensitive such that when the applicator is positioned in a first orientation, the actuable container can controllably release the fluid signaling component therefrom.

10. The method of claim 7, wherein the time indicating device further comprises: A fluid channel, in selective fluid communication with the actuable container, and The fluid storage section is in fluid communication with the fluid channel and with the capillary via a limiting orifice.

11. The method of claim 7, wherein the fluid is a disinfectant solution comprising at least one disinfectant and a solvent.

12. The method of claim 11, wherein the first specific application cycle is the time period required for the disinfectant solution to provide an acceptable bactericidal effect, wherein the time period is between 30 seconds and 3 minutes.

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