Applicator with colorant

Abstract

The present specification discloses an applicator having a body portion for containing a fluid and an application member having a colorant releasably secured thereto and / or on a surface thereof, the colorant not being contained within the body portion. The present specification also discloses a method for manufacturing the applicator.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63,383,826, filed November 15, 2022, the entire contents of which are expressly incorporated herein. [Technical Field]

[0002] SUMMARY The present disclosure relates to an applicator configured to provide a colored cleaning fluid. [Background technology]

[0003] Applicators are frequently used in medical settings, for example, to provide irrigation fluid to patients and / or equipment prior to medical procedures, and in such cases, it is often beneficial to color the irrigation fluid so that the user can easily visualize the application of the irrigation fluid.

[0004] Conventionally, components such as pledgets are provided within the body of the applicator, and the pledgets contain dyes that can color the irrigation fluid as it passes through them. However, these pledgets have several drawbacks. For example, the use of such pledgets often results in the dye being accidentally released into the applicator during assembly.

[0005] Additionally, known processes for providing dye to applicator components (e.g., pledgets) have several drawbacks. For example, a process known as a "dip-and-dry" process, in which a material is dipped in dye and allowed to dry, typically results in inconsistent dye output on the applicator components. Furthermore, such processes are time consuming and often consume excess dye (i.e., an amount of dye beyond that needed to color the wash solution).

[0006] Therefore, there remains a need for an applicator that avoids the problems associated with current applicators known in the art. Summary of the Invention [Means for solving the problem]

[0007] The present disclosure relates to an applicator having a body portion containing a fluid and an application member having a colorant releasably secured thereto and / or on a surface thereof, the colorant not being contained within the body portion.

[0008] The present disclosure further relates to a method for manufacturing an application member as described herein, comprising the steps of providing an application member material and applying a colorant to the application member material sufficient to releasably fix the colorant to the surface and / or interior of the application member material by a controllable coloring process. [Brief explanation of the drawings]

[0009] [Figure 1] 1 illustrates an example of an applicator according to aspects of the present disclosure. [Figure 2A] 1 illustrates an example of an applicator member according to an aspect of the present disclosure. [Figure 2B] 1 illustrates an example of an applicator member according to an aspect of the present disclosure. [Figure 2C] 1 illustrates an example of an applicator member according to an aspect of the present disclosure. [Figure 2D] 1 illustrates an example of an applicator member according to an aspect of the present disclosure. [Figure 2E] 1 illustrates an example of an applicator member according to an aspect of the present disclosure. [Figure 3] 1 illustrates an example of an applicator according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present disclosure relates to an applicator having a body portion and an application member configured to releasably secure a colorant. The colorant according to the present disclosure may be configured to color a fluid before and / or during application of the fluid to a surface by the application member. According to some aspects, the body portion of the applicator of the present disclosure may not include a colorant.

[0011] The present disclosure further relates to a method for manufacturing an applicator or a portion thereof, such as an application member. According to some aspects, the method may include providing an application member material and applying a first amount of colorant to the application member material by a controllable coloring process.

[0012] FIG. 1 illustrates an example of an applicator as described herein. As shown in FIG. 1 , applicator 100 includes a body portion 101 and an application member 102. According to some embodiments, body portion 101 may be configured to contain a fluid to be applied to a surface by applicator 100. For example, body portion 101 may be configured to contain one or more ampoules and / or similar containers (not shown) that can contain the fluid prior to application of the fluid to the surface. Additionally or alternatively, the body portion itself may contain the fluid prior to application of the fluid to the surface (not shown). Applicator 100 may optionally include an actuator 103 configured to actuate applicator 100, where actuation of applicator 100 corresponds to placing body portion 101 in fluid communication with application member 102 via a fluid path (not shown). In some non-limiting examples, actuation of actuator 103 may include crushing, puncturing, shattering, and / or otherwise disrupting the ampoule to release the fluid contained therein.

[0013] Although not shown, the applicator 100 may further include a fluid metering device, such as a pledget. According to some embodiments, a fluid metering device may be provided within the body portion 101 to control and / or direct the flow of fluid from the body portion 101 to the application member 102, as described herein.

[0014] Non-limiting exemplary applicators that may be used in accordance with the present disclosure can be found, for example, in U.S. Patent Nos. 5,690,958, 6,536,975, 7,993,066, 8,708,983, 8,899,859, 9,119,946, 9,572,967, 9,757,551, 9,968,764, 10,076,648, and 10,813,892, the disclosures of which are incorporated herein by reference in their entirety. According to some embodiments, the applicator may be configured to contain and / or apply a selected amount of fluid, also referred to herein as the "applicator size." In some non-limiting examples, applicator sizes may be about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, about 4 mL, about 4.5 mL, about 5 mL, about 5.5 mL, about 6 mL, about 6.5 mL, about 7 mL, about 7.5 mL, about 8 mL, about 8.5 mL, about 9 mL, about 9.5 mL, about 10 mL, about 10.5 mL, about 11 mL, about 11.5 mL, about 12 mL, about 12.5 mL, or about 13. mL, about 13mL, about 13.5mL, about 14mL, about 14.5mL, about 15mL, about 15.5mL, about 16mL, about 16.5mL, about 17mL, about 17.5mL, about 18mL, about 18.5mL, about 19mL, about 19.5 mL, about 20 mL, about 20.5 mL, about 21 mL, about 21.5 mL, about 22 mL, about 22.5 mL, about 23 mL, about 23.5 mL, about 24 mL, about 24.5 mL, about 25 mL, about 25.5 mL, or about 26 mL.

[0015] In some non-limiting examples, fluids as described herein may include cleaning fluids, such as biocides, biostats, or combinations thereof. As used herein, the term "biocide" refers to a chemical agent that inactivates microorganisms. As used herein, the term "biostat" refers to a chemical agent that reduces and / or prevents the growth of microorganisms. It should be understood that in some cases, a chemical agent may function as both a biocide and a biostat.

[0016] Exemplary biocides and / or biostats according to the present disclosure include antibiotics, disinfectants, and sanitizers. As used herein, an "antibiotic" is a natural or synthetic organic substance that selectively inhibits or destroys bacteria or other microorganisms, generally at low concentrations. As used herein, a "disinfectant" is a biocide and / or biostat that destroys or inhibits the growth of microorganisms in or on living tissue. As used herein, a "sanitizer" is a biocide and / or biostat that destroys or inhibits the growth of microorganisms in or on inanimate surfaces.

[0017] Non-limiting examples of biocides and / or biostats according to the present disclosure include alcohols, aldehydes, anilides, biguanides, diamidines, halogen releasers, silver compounds, peroxygen, phenols, bisphenols, halophenols, quaternary ammonium compounds, combinations thereof, and solutions thereof.

[0018] According to some embodiments, the cleaning liquid may be a cleaning solution comprising one or more biocides and / or biostats and a solvent. For example, the cleaning liquid may be a disinfectant solution comprising a disinfectant and a solvent. According to some embodiments, the cleaning solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution comprising water as at least a majority of the solvent. According to some embodiments, the cleaning solution is an organic solution. As used herein, the term "organic solution" refers to a solution comprising an organic component, such as alcohol, as at least a majority of the solvent.

[0019] According to some embodiments, the antiseptic may include a cationic molecule (i.e., a molecule having a positive charge), such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from a biguanide). According to some embodiments, the antiseptic may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some embodiments, the antiseptic may include an octenidine salt and / or a chlorhexidine salt. Non-limiting examples of antiseptics for use in accordance with the present disclosure include octenidine dihydrochloride, chlorhexidine gluconate, povidone-iodine, alcohol, and combinations thereof.

[0020] According to some embodiments, the concentration of each biocide and / or biostat in the cleaning solution, alternatively the total concentration of biocides and / or biostats in the cleaning solution, may be from about 0.0001% to about 2.0% w / v, optionally from about 0.01% to about 1% w / v, and optionally from about 0.1% to about 0.4% w / v. According to some embodiments, the concentration of each biocide and / or biostat in the cleaning solution, alternatively the total concentration of biocides and / or biostats in the cleaning 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 embodiments, the concentration of each biocide and / or biostat in the cleaning solution, alternatively the total concentration of biocides and / or biostats in the cleaning solution, may be from about 0.5% to about 3.5% w / v, optionally from about 0.5% to about 2.0% w / v, optionally about 2.0% w / v.

[0021] According to some embodiments, the solvent may include an organic solvent such as an alcohol, an organosulfur compound, a ketone, or a combination thereof. Non-limiting examples of alcohols include methanol, ethanol, propanols such as n-propanol and / or isopropanol, and combinations thereof. A non-limiting example of a ketone is acetone. A non-limiting example of an organosulfur compound is dimethyl sulfoxide (DMSO). According to some embodiments, the concentration of the organic solvent in the cleaning solution may be about 50% to about 90% v / v, optionally about 70% to about 80% v / v, or optionally about 70% v / v. According to some embodiments, the concentration of the alcohol in the cleaning solution may be about 10% to about 50% v / v, or optionally about 20% to about 30% v / v.

[0022] In some embodiments, the solvent may comprise water. In some embodiments, the concentration of water in the cleaning solution may be about 10% to about 50% v / v, optionally about 20% to about 30% v / v. In some embodiments, the concentration of water in the cleaning solution may be about 50% to about 90% v / v, optionally about 70% to about 80% v / v.

[0023] According to some embodiments, the cleaning solution may further comprise one or more film-forming polymers. Non-limiting examples of film-forming polymers include acrylate polymers (e.g., acrylamide polymers, octylacrylamide polymers, methacrylate polymers), carboxyacrylate polymers, carboxylated acrylic copolymers, acrylate copolymers, polymethacrylate-based copolymers, hydroxypropyl cellulose, and polymers with dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate side groups. The concentration of the film-forming polymer may vary depending on the particular solvent and biocide and / or biostat present in the cleaning solution.

[0024] According to some embodiments, the concentration of the film-forming polymer in the wash solution may be from about 0.1% to about 5% w / v, optionally from about 0.2% to about 3% 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.

[0025] Exemplary acrylate polymers include, but are not limited to, DERMACRYL® AQF (methacrylic acid alkyl ester-acrylic acid alkyl ester-methacrylic acid copolymer) and DERMACRYL® 79P (acrylic acid octylamide-acrylic acid ester copolymer) manufactured by Akzo Nobel Coatings Inc., and EUDRAGIT® EPO (poly(butyl methacylate-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.

[0026] According to some embodiments, the application member 102 of the present disclosure may include a material sufficient to releasably immobilize a colorant. As used herein, a colorant is "releasably immobilized" if at least a portion of the colorant molecules are immobilized by the application member 102 prior to one or more events and at least a portion of the colorant molecules are released in response to one or more events.

[0027] In one non-limiting example, the event may be contact of the colorant with one or more components of a cleaning fluid as described herein. In this example, the colorant may be releasably immobilized by the application member 102 until a cleaning fluid is provided to the application member 102, for example, by actuation of the applicator 100 as described herein. In this example, at least a portion of the colorant molecules provided by the colorant may be released by the application member 102 in an amount sufficient to color the cleaning fluid passing through the application member 102.

[0028] In another non-limiting example, the event may be a selected cumulative scrubbing action provided to the application member 102. In this example, the colorant may be releasably immobilized by the application member 102 until the selected cumulative scrubbing action is provided to the application member 102, for example, by a surface to which the application member 102 applies cleaning fluid. In this example, when the selected cumulative scrubbing action is achieved, at least a portion of the colorant molecules provided by the colorant may be released by the application member 102 in an amount sufficient to color cleaning fluid passing through the application member 102.

[0029] In another non-limiting example, the event may be a specific temperature. In this example, the colorant may be releasably immobilized by the application member 102 until the application member 102 reaches a selected temperature. The selected temperature may be achieved by providing heat to the application member 102, such as heat provided by a surface (e.g., the subject's skin), heat provided by friction (e.g., friction between the application member 102 and a surface), or a combination thereof. In some non-limiting examples, the selected temperature may be about 25-40°C, optionally about 25-35°C, optionally about 35-40°C, optionally about 33-37°C, optionally about 30°C, optionally about 31°C, optionally about 32°C, optionally about 33°C, optionally about 34°C, optionally about 35°C, optionally about 36°C, optionally about 37°C, optionally about 38°C, optionally about 39°C, or optionally about 40°C.

[0030] According to some embodiments, the colorant may be releasably immobilized by the application member 102 via any chemical and / or physical interaction sufficient to releasably immobilize the colorant as described herein. Non-limiting examples of interactions include adsorption, absorption, and combinations thereof. According to some embodiments, all or a portion of the colorant may be releasably immobilized on the surface of the application member 102, within the application member 102 (e.g., by entrapment in pores, pockets, etc.), or a combination thereof.

[0031] In some non-limiting examples, the colorant can include one or more anionic colorants, such as one or more anionic dyes. The anionic dyes can be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, drugs, and / or cosmetics (i.e., "D&C" or "FD&C" dyes). Exemplary anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigo Carmine), 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. They can be combined to achieve specific colors. For example, an orange hue may include both FD&C Red No. 40 and D&C Yellow No. 8. According to some embodiments, the colorant may be provided as part of the signaling element, for example, as described in Applicant's Patent No. 10,982,980, the entire contents of which are expressly incorporated herein by reference.

[0032] According to some embodiments, the application member 102 may include an application member material sufficient to releasably immobilize a colorant as described herein. Non-limiting examples of application member materials include foam, felt, nonwoven materials, and combinations thereof. In some examples, all or a portion of the application member material may be hydrophobic or hydrophilic. Non-limiting examples of materials useful for application member materials include those described in U.S. Patent No. 7,993,066, the contents of which are incorporated herein by reference. For example, the application member material may include an open-cell foam material, such as a hydrophilic or hydrophobic polyester-polyurethane foam. Additionally or alternatively, the application member material may include a nonwoven material.

[0033] According to some embodiments, the application member 102 may have one, two, three, four, or more individual layers, each of which individually includes an application member material that is the same as or different from the application member material included in another individual layer. According to some embodiments, all of the individual layers can releasably immobilize a colorant as described herein, and each individual layer releasably immobilizes a colorant that is the same as or different from the colorant releasably immobilized by at least one other individual layer. Alternatively, one or more individual layers may not include a colorant as described herein.

[0034] 1 shows one non-limiting example of an application member 102 having a first layer 102a proximal to the body portion 101 and a second layer 102b distal to the body portion 101. In one example, both layers 102a, 102b are capable of releasably immobilizing a colorant. Alternatively, only one of layers 102a, 102b is capable of releasably immobilizing a colorant. For example, layer 102a may include a nonwoven material that does not releasably immobilize (or does not contain) a colorant, and layer 102b may include a foam, at least a portion of which releasably immobilizes a colorant as described herein.

[0035] It should be understood that the applicator as described herein is not limited to the example shown in Figure 1. For example, the application member 102 may have only one layer. Alternatively, the application member 102 may have three, four, or more layers as described herein.

[0036] According to some embodiments, at least one layer of the applicator member 102 may have a colored portion to which a colorant is releasably fixed. According to some embodiments, one layer of the applicator member 102 may have a colored portion to which a colorant is releasably fixed, and another layer of the applicator member 102 may be free of a colorant. According to some embodiments, the applicator member 102 may have a non-colored portion that does not include a colorant.

[0037] 2A shows a photograph of an applicator member 200 having a colored portion 201 and a non-colored portion 202. According to some embodiments, the colored portion 201 may be defined by one or more interior boundaries 203 spaced a distance 204 from an outer edge 205 of the applicator member 200. According to some embodiments, the distance 204 may be sufficient to reduce or eliminate leaching of colorant from the applicator member 200 during manufacturing and / or storage of the applicator member. For example, the distance 204 may be sufficient to reduce or eliminate leaching of colorant from the applicator member 200 during a terminal sterilization process. Additionally or alternatively, the distance 204 may be sufficient to reduce or eliminate leaching of colorant from the applicator member 200 when the applicator is provided in packaging, as is known in the art.

[0038] According to some embodiments, the colored portion 201 may be defined by one or more interior boundaries 203, each approximately 0 to 0.3 inches from the nearest outer edge 205 of the applicator member 200. In some non-limiting examples, one or more outer edges of the applicator member may be free of colorant. In some examples, all outer edges of the applicator member are free of colorant.

[0039] According to some embodiments, the colored portion 201 may have a certain depth, i.e., colorant molecules can penetrate the application member 200 a certain distance from the surface 206 of the application member 200, where this certain distance is relative to the thickness 208 of the application member 200. As used herein, the "thickness" of the application member is the dimension of the application member extending from the distal end to the proximal end relative to the body of the applicator in which it is mounted.

[0040] According to some embodiments, the depth of the colored portion 201 may be about 0.01 to 100%, optionally about 0.01 to 90%, optionally about 0.01 to 80%, optionally about 0.01 to 70%, optionally about 0.01 to 60%, optionally about 0.01 to 50%, optionally about 0.01 to 40%, optionally about 0.01 to 30%, optionally about 0.01 to 20%, or optionally about 0.01 to 10% of the total thickness of the applicator member.

[0041] While FIG. 2A illustrates the colored portion 201 extending a particular distance from the surface 206 of the application member 200 (the surface 206 being distal to the body 207 of the applicator to which it is attached), it should be understood that the application members of the present disclosure are not necessarily limited in this regard. For example, the surface may be a surface proximal to the applicator body, a surface between one or more layers of the application member, or any combination thereof. Also, while FIG. 2A illustrates a generally square application member 200 having a generally square colored portion 201, it should be understood that the present disclosure is not limited in this regard. For example, the application member 200 and / or colored portion 201 may have any other shape that may be useful in the art, such as a polygonal, circular, and / or elliptical shape. For example, FIG. 2B illustrates a generally square application member 200a having a generally circular colored portion 201a. FIG. 2B also illustrates a generally circular application member 200b having a generally circular colored portion 201b. In some non-limiting examples, the application member and / or colored portion may have an irregular shape, such as the irregularly shaped colored portion 201c shown in FIG. 2C. In another example, FIG. 2D shows a “flower-shaped” colored portion 201d. Furthermore, the colored portion may include a continuous region, multiple discrete regions, or may be configured in shapes such as stripes, dots, triangles, etc. It should be understood that application members and colored portions of any shape as described herein, and any combination thereof, are encompassed by the present disclosure. Furthermore, it should be understood that one or more boundaries of a colored portion may extend to the nearest outer edge of the application member, eliminating any distance between them. For example, FIG. 2E shows application member 200e, where colored portion 201e covers the entire surface of application member 200, such that there is no distance between the boundary of colored portion 201e and outer edge 205e of application member 200e.

[0042] According to some aspects, the body of the applicator of the present disclosure may not include a colorant, for example, the fluid metering device of the applicator may not include a colorant as described herein.

[0043] According to some embodiments, colored portion 201 may be provided by a controllable coloring process. As used herein, a "controllable coloring process" refers to a process of providing a colorant to a material (e.g., an application member material) that allows for releasably immobilizing a selectable amount of colorant and / or allows for a selectable configuration (e.g., shape and / or depth) of the resulting colored portion as described herein.

[0044] In some non-limiting examples, the application members of the present disclosure can releasably immobilize about 0.001-50 mg, optionally about 0.001-30 mg, and optionally about 2-30 mg of colorant. In some non-limiting examples, the application members can releasably immobilize about 0.001-10 mg, optionally about 0.001-1 mg, and optionally about 0.01-0.15 mg of colorant. It should be understood that the amount of colorant immobilized by the application member can depend on the type of colorant and / or application member material. For example, the application member can contain about 1-50 mg, optionally about 6-50 mg, and optionally about 2-30 mg of FD&C Yellow 6 and / or about 0.01-0.45 mg, optionally about 3-0.45 mg, and optionally about 0.01-0.15 mg of FD&C Green 3. The amount of colorant may depend on the particular properties of the colorant, such as the visibility of the colorant on a desired surface (e.g., skin). Thus, the controllable coloring process of the present disclosure may be adjustable to vary the selected amount of colorant and / or the selected configuration of the resulting colored portion.

[0045] According to some aspects, the controllable coloring process may include a spraying step in which a colorant is sprayed onto the application member material as described herein. As used herein, the term "spraying" refers to the deposition of an aerosolized material (e.g., an aerosolized colorant). In some non-limiting examples, the spraying step may include an electrostatic spraying step. According to some aspects, the aerosolized material may include a colorant as described herein and, optionally, a solvent. For example, the solvent may include water, alcohol, or a combination thereof. Additionally or alternatively, the controllable coloring process may include a pouring step, a coating step (including a roll-on coating step), a dipping step, or a combination thereof, in which the colorant is applied to the application member material by pouring, coating, and / or dipping, respectively. In these examples, the colorant may optionally be provided as a solution including a solvent as described herein. For example, the solvent may include water, alcohol, or a combination thereof.

[0046] According to some embodiments, the controllable coloring process may further include a drying step after the spraying, pouring, coating, and / or immersion steps. The drying step may include drying the application member material simultaneously and / or sequentially by air, forced convection, heated forced convection, an external heat source, or a combination thereof. According to some embodiments, the drying step may include drying the application member material to room temperature. As used herein, room temperature refers to a temperature between about 20 and 22°C.

[0047] In some non-limiting examples, a colorant may be provided to an application member material via a controllable coloring process before, during, or after manufacturing of an application member using the application member material. For example, the application member material may be provided with a colorant and then processed to form an application member (e.g., by cutting or otherwise dividing the application member material and / or attaching portions of the application member material to the body of an applicator as described herein). Additionally or alternatively, the colorant may be provided to the application member material after it has been cut or otherwise divided and / or attached to the body of an applicator.

[0048] FIG. 3 illustrates another example of an applicator according to the present disclosure. As shown in FIG. 3, applicator 300 may include a body portion 301 and an applicator member 302, similar to those described in connection with FIG. 1. Application member 302 may include a first layer 302a proximal to body portion 301 and a second layer 302b distal to body portion 301, similar to those described in connection with FIG. 1. FIG. 3 also illustrates actuator 303 having first and second actuating portions 303a, 303b, which can be compressed toward one another to actuate applicator 300 as described herein.

[0049] The present disclosure further relates to methods of using the applicators as described herein. For example, the methods may include applying a fluid to a surface with the applicator to perform one or more cleaning operations. In one non-limiting example, one or more cleaning operations according to the present disclosure may include one or more sterilization steps. As used herein, the term "sterilization" means destroying, inactivating, or significantly reducing the concentration of at least a portion of microorganisms present on an inanimate surface, and / or reducing or preventing the growth of microorganisms on the inanimate surface. Exemplary inanimate surfaces include, but are not limited to, work surfaces in medical settings, surfaces of medical equipment, and combinations thereof. Additionally or alternatively, one or more cleaning operations according to the present disclosure may include one or more disinfection steps. As used herein, providing a "disinfecting action" means destroying, inactivating, or significantly reducing the concentration of at least a portion of microorganisms present on a human or animal surface, and / or reducing or preventing the growth of microorganisms on a human or animal surface. Exemplary human and animal surfaces include, but are not limited to, skin, wounds, hair follicles, mucous membranes, and combinations thereof.

[0050] While the embodiments described herein are described in conjunction with the exemplary embodiments outlined above, various alternatives, variations, modifications, improvements, and / or substantial equivalents, whether known or currently unforeseen or potentially currently unforeseeable, will become apparent to those skilled in the art. Accordingly, the exemplary embodiments as set forth above are intended to be illustrative rather than limiting. Various changes can be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to embrace all known or later-developed alternatives, variations, modifications, improvements, and / or substantial equivalents.

[0051] Accordingly, the claims are not intended to be limited to the embodiments set forth herein but are to be accorded full scope consistent with the language of the claims, and reference to an element in the singular is intended to mean "one or more," and not "one and only one," unless expressly stated otherwise. All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed as a means-plus-function unless the element is expressly recited using the phrase "means for."

[0052] As used herein, the recitation of numerical ranges by endpoints (e.g., about 50:1 to 1:1, about 100 to 500°C, about 1 minute to 60 minutes) includes all values ​​within that range; for example, about 1 minute to 60 minutes includes 21 minutes, 22 minutes, 23 minutes, and 24 minutes as endpoints within the specified range. Thus, for example, ranges such as 22 to 36, 25 to 32, and 23 to 29 are also ranges with endpoints included within the range 1 to 60, depending on, for example, starting materials, temperature, a particular application, a particular embodiment, or claim limitations, as needed. The examples and methods disclosed herein demonstrate that the recited ranges encompass every point within that range, since different results or products may be derived after varying one or more reaction parameters. Furthermore, the methods and examples disclosed herein illustrate various aspects of the disclosed ranges and the effects of varying ranges individually or in combination with other recited ranges.

[0053] Furthermore, the word "example" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "example" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise specified, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof" can include any combination of A, B, and / or C, and can 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," "A, B, C, or any combination thereof" can be A only, B only, C only, A and B, A and C, B and C, or A, B, and C, and any of these combinations can include one or more of A, B, or C. Nothing disclosed herein is intended to be made available to the public, whether or not such disclosure is expressly recited in the claims.

[0054] As used herein, the terms "about" and "approximately" are defined as close as understood by one of ordinary skill in the art. In one non-limiting embodiment, the terms "about" and "approximately" are defined as within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

Claims

1. a body portion for containing a fluid; an application member including a colorant releasably secured thereto and / or on its surface; The applicator does not contain a colorant within the body portion.

2. The application member is a coloring portion containing the colorant; The applicator of claim 1 , further comprising: a non-colored portion that does not contain a colorant.

3. The applicator of claim 2 , wherein the colored portion is defined by an interior boundary spaced from an outer edge of the applicator member.

4. The applicator of claim 3 , wherein the colored portion is a continuous area.

5. The applicator of claim 3 , wherein the colored portion includes a plurality of distinct regions.

6. 10. The applicator of claim 1, wherein the fluid is contained within an ampoule housed in the body portion, and the applicator further includes a fluid metering device within the body portion.

7. The applicator of claim 1 , wherein the application member comprises an open-cell foam material.

8. 2. The applicator of claim 1, wherein the application member includes a first layer positioned away from the body portion and a second layer positioned toward the body portion, the first layer including the colorant and the second layer not including the colorant.

9. The applicator of claim 8 , wherein the first layer comprises an open-cell foam material and the second layer comprises a nonwoven material.

10. The applicator of claim 1 , wherein the fluid is a cleaning fluid.

11. 11. The applicator of claim 10, wherein the cleaning solution comprises an antiseptic selected from the group consisting of octenidine dihydrochloride, chlorhexidine gluconate, and combinations thereof.

12. The applicator of claim 1 , wherein the entire outer edge of the applicator member is free of colorant.

13. providing an application member material; applying a colorant to a colored portion of the application member material sufficient to releasably fix the colorant to a surface and / or interior of the application member material by a controllable coloring process.

14. 14. The method of claim 13, wherein the colorant is contained in a colored portion of the applicator member, the colored portion being defined by an interior boundary spaced from an outer edge of the applicator member.

15. The method of claim 14 , wherein the applicator member includes a non-colored portion that does not contain a colorant.

16. The method of claim 13 , wherein the controllable coloring process includes a spraying step.

17. The method of claim 13 , wherein the applicator material comprises an open-cell foam material.

18. The method of claim 13 further comprising forming a first layer of the applicator member using the applicator member material and providing a second layer of the applicator member.

19. The method of claim 18 , wherein the second layer is free of colorants.

20. 1. An applicator member comprising an applicator member material and a colorant releasably secured therein and / or to a surface thereof, the colorant is contained in a colored portion of the application member; The applicator member wherein the colored portion is defined by an interior boundary spaced from an outer edge of the applicator member.

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