Fluid application device and method

The present invention provides a device and a method for application of topical antiseptics. The device comprises a handle; a base coupled to the handle; and a substantially hydrophilic foam coupled to the base. The substantially hydrophilic foam is configured to receive the topical antiseptic.

FIELD

The present application relates to an apparatus and method for fluid application.

INTRODUCTION

Preparation of patients for various medical procedures, e.g., surgery, typically includes application of a topical solution (or fluid), e.g., an antiseptic solution, to sanitize the area targeted for medical procedures. Topical solutions may be applied to the targeted area by saturating a sponge-like material with the solution and using a handheld device, for example a pair of forceps or a hemostat, to direct the saturated sponge to the targeted area. The sponges or foam materials are typically soaked in a fluid contained within an open pan or other container.

In certain instances, existing devices used to apply solutions exhibit various disadvantages. For example, typical applicators utilize sponges that do not retain fluid efficiently, resulting in leakage. As a result, preparation of targeted areas for antiseptic cleaning becomes a messy procedure. In addition, leakage of various fluids onto areas outside of the targeted areas can lead to pooling of the various fluids which may cause irritation or discomfort.

Another example of a disadvantage involves the difficulty of dispensing a desired dose of fluid at the targeted area. During fluid application, in certain instances, it may be desirable to control the amount of fluid, e.g., antiseptic solution, that is dispensed from the applicator. However, because existing applicators dispense fluid inefficiently, the precise amount of solution delivered to the targeted area may be difficult to determine. This may result in either more or less solution applied to the targeted area than is desired. In addition, typical applicators utilize foams and/or fluid delivery systems that fail to timely dispense a precise amount of fluid. For example, certain applicators with internal ampoules that store fluid take time for the fluid to saturate the sponge and thus be available for application to the patient. This can result in unpredictable and imprecise dispensing of the desired solution.

SUMMARY

According to certain embodiments, an applicator device for applying a fluid comprises a handle comprising a proximate end and a distal end, a base coupled to the proximate end of the handle, and a substantially hydrophilic foam coupled to the base, wherein the substantially hydrophilic foam is configured to receive the fluid.

According to certain embodiments, an applicator device can be supplied ready to use, i.e., without the need for additional manipulation beyond removing the device from its packaging, if any.

According to certain embodiments, an applicator system comprises an applicator device for applying a fluid comprising a handle that comprises a proximate end and a distal end, a base coupled to the proximate end of the handle, a substantially hydrophilic foam coupled to the base, wherein the substantially hydrophilic foam is configured to receive the fluid, and a storage device configured to receive the applicator device.

According to certain embodiments, a method of applying a fluid comprises introducing a fluid to a substantially hydrophilic foam and depositing a desired portion of the fluid onto a targeted area.

DESCRIPTION OF VARIOUS EMBODIMENTS

In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of “or” means “and/or” unless otherwise stated. Furthermore, the use of the term “including,” as well as other forms, such as “includes” or “included,” is not limiting. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components that comprise more than one subunit unless specifically stated otherwise. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

The section headings used herein are for organizational purposes only, and are not to be construed as limiting the subject matter described. All documents cited in this application, including, but not limited to patents, patent applications, articles, books, and treatises, are expressly incorporated by reference in their entirety for any purpose.

The term “fluid” as used herein refers to a liquid that in certain embodiments may be used to sanitize a region in preparation for various medical procedures. The liquid may be an antiseptic solution containing an active ingredient. Various antiseptic solution active ingredients are known in the art, including, but not limited to, ethanol, isopropyl alcohol, other alcohols, and combinations thereof; benzalkonium chloride; benzethonium chloride; chlorhexidine gluconate; chlorhexidine gluconate with alcohol; chloroxylenol; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinols; iodine-containing compounds; povidone iodine; povidone iodine with alcohol, ethanol, isopropyl alcohol and other alcohols, and combinations thereof.

In certain embodiments, the antiseptic solution may include a biguanide derivative and/or salts thereof, e.g., olanexidine [1-(3,4-dichlorobenzyl)-5-octylbiguanide] and salts thereof, as the active ingredient, as disclosed, for example in U.S. Pat. No. 5,376,686. The antiseptic solution may also incorporate certain surfactants, for example, polyoxyethylene-based nonionic surfactants, and/or alcohols, for example, ethanol, isopropyl alcohol and other alcohols, and/or water, in varying amounts. Useful surfactants are known to one skilled in the art, for example, Poloxamer 124 (a/k/a Polyoxypropylene-polyoxyethylene Block Copolymer 124), which is available as Polyoxyethylene(20) polyoxypropylene(20) glycol from Asahi Denka Co., Ltd., Japan, POE (9) lauryl ether (available as ‘BL-9EX’ from Nikko Chemicals Co., Ltd., Tokyo, Japan), POE (10) lauryl ether, also known as nonoxynol-10, or NP-10, (available as ‘Emulin NL-100’ from Sanyo Chemical Industries, Ltd., Kyoto Japan).

In certain embodiments, the antiseptic solution may include an active ingredient and a polyoxyethylene-based nonionic surfactant in various concentrations. For example, in certain embodiments, the biguanide derivative and/or salts thereof may be present at a concentration of about 0.05 to about 5.0% (w/v of biguanide base) and the polyoxyethylene-based nonionic surfactant may be present at a concentration of about 0.05 to about 16% (w/v).

The term “substantially hydrophilic foam” as used herein refers to a polymer-based foam that has an affinity for water. For example, certain embodiments of the invention can utilize a polyurethane foam with an open-cell pore structure. In certain instances, the substantially hydrophilic foam can be designed for a high rate of fluid absorption such as, for example, absorption of around 20 times the weight of the foam. While not wishing to be bound by theory, a substantially hydrophilic foam can demonstrate an affinity for water through one or more mechanisms including, but not limited to, the presence of polar groups in the polymer chains that can form hydrogen bonds with water or liquids containing active protons and/or hydroxyl groups, a fine open-cell pore structure that channels liquid into the body of the foam structure by capillary forces, and/or the addition of absorbing materials, such as super absorbers and/or surfactants, to the foam matrix. Substantially hydrophilic foams that can be utilized in certain embodiments of the invention are available from organizations including the following: Rynel, Inc. (Boothbay, Me.), Avitar, Inc. (Canton, Mass., USA), Lendell Manufacturing, Inc. (Charles, Mich., USA), and Copura (Denmark). In addition, certain patents, including U.S. Pat. No. 5,135,472 to Hermann, et al., disclose substantially hydrophilic foams that may be utilized in certain embodiments of the invention.

According to certain embodiments, as illustrated inFIG. 1Aor4A, an applicator device10may comprise a handle100, a base102, and a substantially hydrophilic foam112. Handle100may comprise various cross-sectional geometries, including, but not limited to, circular, oval, rectangular, triangular, polygonal, and/or complex shapes that include combinations thereof. In certain embodiments, handle100may be generally smooth along its length. As illustrated byFIG. 4A, in certain embodiments, handle100may include various indentations and/or protrusions106along its length to facilitate, for example, a user's manipulation of applicator device10. Indentations and/or protrusions106may exist at various locations around the circumference of handle100. In certain embodiments, at least a portion of handle100may include a surface coating, for example rubber, to facilitate the use of applicator device10. In certain embodiments, at least a portion of handle100may include a texture applied to the surface of handle100to, e.g., help transport any unwanted liquid away from handle100and allow the user to obtain a secure grip.

In certain embodiments, as illustrated inFIGS. 1A-1B, handle100may define an opening107. In certain embodiments, opening107may comprise various shapes including, but not limited to, elliptical, circular, rectangular, polygonal, and the like. In certain embodiments, opening107may allow for a number of different gripping positions.

According to certain embodiments, illustrated inFIG. 4A, handle100may include a distal end12that can define an endpiece108. Endpiece108may, in certain embodiments, be an integral part of handle100such as, for example, an end to a solid rod or tube. In certain embodiments, endpiece108may be a separate piece from handle100that attaches to handle100. As illustrated inFIG. 5A, in certain embodiments endpiece108may comprise a larger cross-sectional size than handle100to, for example, allow for endpiece108to sealably interface with a storage device52. In certain embodiments, endpiece108may have a smaller cross-sectional size than handle100to, for example, allow for endpiece108to slide at least partially within handle100. Non-limiting exemplary embodiments of certain attachments of endpiece108to handle100include press-fits, interference-fits, mechanical interlocks, hinges, keyways, threaded passages, and the like, or combinations thereof.

In certain embodiments, as illustrated inFIG. 6A, a second handle101can couple to endpiece108. In certain embodiments, second handle101and endpiece108can form one contiguous piece. In certain embodiments, second handle101can incorporate certain ergonomic considerations. For example, second handle101can be shaped in a manner to facilitate a user's grip of applicator device10. AlthoughFIG. 6Aillustrates one possible shape to accomplish such considerations, one skilled in the art can vary this shape in a number of ways to accomplish the same result.

In certain embodiments, as illustrated inFIG. 1A, handle100may include one or more deviations, such as, for example, curves, bends, angles, and the like, at various positions along the length of handle100. In certain embodiments, these deviations may exist along multiple axes or along a single axis, and may facilitate, e.g., ergonomic considerations. For example, in certain embodiments, handle100may include a first bend109generally along the vertical axis. In certain embodiments, as discussed in more detail below, first bend109may define an angle110with the horizontal axis. In certain embodiments, handle100may define a second bend111. In certain embodiments, second bend111may align handle100with the horizontal axis. In certain embodiments, an extended handle (not shown) may be attached to handle100to allow for various considerations, including, but not limited to, greater leverage and/or reach. In certain embodiments, as illustrated inFIG. 4A, handle100may not comprise any deviations. In other words, handle100may be generally straight.

In certain embodiments, handle100may comprise a solid piece, such as, for example, a solid rod. In certain embodiments, as illustrated inFIG. 4A, at least a portion of handle100may include a hollow region104. Hollow region104may be configured to receive fluid directly or indirectly. In certain embodiments, directly receiving fluid can be directly received by, for example, pouring and/or injecting fluid into hollow region104. In certain embodiments, fluid can be injected into hollow region104through, for example, a substantially sealable membrane located along the length of handle100and/or at distal end12. In certain embodiments, fluid can be indirectly received by, for example, inserting a fluid-containing device such as, for example, a cartridge or other container, at least partially within hollow region104. In certain embodiments, such cartridge or container may form part of endpiece108.

According to certain embodiments, handle100and/or base102may be made of numerous materials including, but not limited to, metals, metal-alloys, plastics and other polymers, including, for example, nylon, composite materials, or any combination thereof. Handle100may be made by various manufacturing processes known in the art including, but not limited to, molding, injection molding, machining, casting, extruding, and/or combinations thereof.

According to certain embodiments, handle100may couple to base102. In certain embodiments, base102may be an integral part of handle100. An integral base/handle combination may be manufactured by various processes known in the art, including, but not limited to, molding, injection molding, casting, machining, or combinations thereof. In certain embodiments, handle100may couple to base102in a variety of ways known in the mechanical arts, including, but not limited to, attachments by hinges, adhesives, mechanical interlocks, threaded portions, press-fits, friction-fits, interference fits, slide-fits, and/or combinations thereof.

In certain embodiments, applicator device10may include an interchangeable attachment between handle100and base102. An interchangeable attachment may, for example, facilitate the use of variously sized bases102on the same handle100, and vice versa. This may facilitate, e.g., the use of differently-sized substantially hydrophilic foams112with the same handle100.

In certain embodiments, base102may comprise a variety of shapes. For example, as illustrated in certain embodiments inFIGS. 1B and 4B, the shape of base102may be generally triangular with rounded edges. Other examples of shapes for base102include, but are not limited to, rectangular, circular, oval, various polygonal shapes, and/or complex shapes comprising a combination thereof.

According to certain embodiments, handle100and base102may define an angle110. AlthoughFIGS. 1A and 4Aillustrate angle110at approximately 45 degrees, certain embodiments comprise angles within the range of 0 to 180 degrees. Allowing angle110to vary over a wide range gives flexibility to the design of applicator100to accommodate various factors such as, for example, ergonomic factors. In certain embodiments, the attachment of handle100to base102through hinge-like connections may facilitate a plurality of angles110. In certain embodiments, the hinge-like connections may comprise lockable positions, allowing for applicator device10to be used at an intermediate angle.

In certain embodiments, a user may dispense fluid contained in substantially hydrophilic foam112by pressing on, and thereby compressing, the substantially hydrophilic foam. As a result, compression of substantially hydrophilic foam112, in certain embodiments, may facilitate the dispensing of fluid retained by substantially hydrophilic foam112. In certain embodiments, the volume of substantially hydrophilic foam112can determine the amount of fluid (i.e., to dispense a desired amount of fluid) that can be dispensed from substantially hydrophilic foam112. That is, if one desires an applicator that dispenses a larger amount of fluid, the volume of substantially hydrophilic foam112can be increased (i.e., increase the desired amount). Also, if one desires an applicator that dispenses a smaller amount of fluid, the volume of substantially hydrophilic foam112can be decreased (i.e., decrease the desired amount). For example, as illustrated in certain embodiments inFIGS. 1C-1Dand4C-4D, the thickness of substantially hydrophilic foam112may vary, while the cross sectional area of substantially hydrophilic foam112remains constant, to facilitate dispensing a varied amount of fluid that generally corresponds to the thickness variation of substantially hydrophilic foam112. Alternatively, both the thickness and the cross sectional area of substantially hydrophilic foam112may be varied in order to vary the amount of liquid dispensed.

According to certain embodiments, an abrasion layer114may be coupled to substantially hydrophilic foam112. In certain embodiments, abrasion layer114may abrade an area targeted for treatment, for example the epidermis. Abrasion may occur before, during, and/or after dispensing the fluid. In certain embodiments, abrasion may cause a loosening of certain biologic materials, for example body oils, body soils, and/or bacteria, to facilitate treatment of the targeted area. For example, before application of an antiseptic solution, a user may abrade the epidermis of a patient to loosen bacteria in order to improve the efficacy of the antiseptic process. In certain embodiments, abrasion layer114may comprise more than one layer of material, which may facilitate a greater amount of abrasion and/or abrasion of harder to clean areas. In certain embodiments, abrasion layer114may comprise various textures and/or weaves, for example, a gauze-like material. In certain embodiments, abrasion layer114may be made from various materials that facilitate abrasion, including, but not limited to, cotton, rayon, nylon, and/or combinations thereof. In certain embodiments, the material that abrasion layer114is made from can be chosen from a number of materials that exhibit varying degrees of abrasiveness. For example, the skin of a premature baby can be thin and fragile, thus an applicator device that comprises an abrasion layer made from nylon or rayon may be preferable to an abrasion layer made from cotton. In certain embodiments, abrasion layer114may comprise a plurality of layers of different materials.

As illustrated in certain embodiments inFIGS. 1A-1Cand4A-4C, abrasion layer114may have a shape that generally corresponds to the shape of substantially hydrophilic foam112. However, in certain embodiments, abrasion layer114may have various other shapes including, but not limited to, circular, oval, rectangular, triangular, polygonal, and the like, or complex shapes including one or more of the same. In certain embodiments, abrasion layer114may couple to substantially hydrophilic foam112by various attachment mechanisms including, but not limited to, adhesive bonding, fusion bonding, mechanical interlocks, hook-and-loop mechanisms (e.g., Velcro®), threaded pieces, and the like. In certain embodiments, abrasion layer114may be laminated to substantially hydrophilic foam112. Lamination and/or attachment of various materials to foams is known in the art. For example, U.S. patent application Ser. No. 10/829,919, U.S. Provisional Application No. 60/464,306, and PCT Serial No. US04/012474 all disclose methods and apparatuses for attaching materials to polyurethane foam.

In certain embodiments, as illustrated inFIGS. 2A and 2B, an applicator system20may comprise applicator device10, a sealable container200, and a storage device30. In certain embodiments, sealable container200may be configured to receive applicator device10. In certain embodiments, sealable container200may comprise a seal202that may define a sealed region204wherein applicator device10may be kept. In certain embodiments, sealable container200may be a removable cover and/or a container, either of which can be flexible and/or rigid. For example,FIG. 2Billustrates a rigid, sealable container200with a bottom and side walls that can be made from high-density polyethylene and other polymers, or combinations thereof and a top made from laminated aluminum foil or other appropriate lidding materials, Tyvek, plastics and the like. In certain embodiments, sealable container200may be made from any material that can prevent outside contaminants from entering sealed region204including, but not limited to, one or more polymer-based materials (e.g., plastic trays), Tyvek, metallic constructs, laminated constructs, paper, and/or any combinations thereof.

In certain embodiments, an applicator system can be provided to the user in ready-to-use form. For example, as illustrated inFIGS. 2A and 2B, an applicator device10can reside within a sealable container200with a pre-measured amount of fluid retained by a substantially hydrophilic foam112and/or an abrasion layer114. Thus, a user can simply open the sealable container to gain access to the applicator device and begin using the applicator device, without the need for any additional manipulation of the applicator device. Similarly, as illustrated in exemplary embodiments inFIGS. 5A-8B, the applicator device10can reside within a storage device52that comprises a wall500. The storage device52can contain a pre-measured amount of fluid506for retention by substantially hydrophilic foam112and/or an abrasion layer114. As is discussed in more detail below, the wall500can form a seal516(see, e.g.,FIG. 5B) with an endpiece108of the applicator device10. Thus, a user can simply remove the applicator device10from the storage device52, thereby unsealing the endpiece108from the wall500. As a consequence, these configurations can promote the efficient use of the applicator device in a wide variety of operating conditions.

In certain embodiments, as illustrated inFIGS. 2A,2B,3A and3B, storage device30may be configured to receive base102, substantially hydrophilic foam112, and/or abrasion layer114. In certain embodiments, storage device30may be made from a rigid material that generally prevents substantially hydrophilic foam112and/or abrasion layer114from being substantially compressed. Rigid materials consistent with certain embodiments of storage device30include, but are not limited to, metals, plastics and other polymers, glass, composite materials, and combinations thereof. In certain embodiments, storage device30may comprise a body300and a closure302. In certain embodiments, storage device30may define an inner portion304within which at least a portion of applicator device10can reside. In certain embodiments, body300may be shaped in a manner so as to facilitate the placement of base102, substantially hydrophilic foam112, and/or abrasion layer114within inner portion304. In certain embodiments, closure302may open and/or close at a hinge303to facilitate enclosure of base102, substantially hydrophilic foam112, and/or abrasion layer114within inner portion304. In certain embodiments, closure302may define a recess306to allow for handle100to pass through storage device30.

In certain embodiments, recess306can incorporate a seal (not shown) to substantially contain fluid within inner portion304and/or to substantially prevent entry of certain microbes into inner portion304. In certain embodiments, the seal can be generally compliant so as to conform around handle100. In certain embodiments, closure302can define a tab305. In certain embodiments, as illustrated inFIG. 3B, tab305can extend beyond a top surface301of body300. In certain embodiments, tab305can facilitate a user's opening and/or closing of closure302. For example, tab305can allow for a user to open closure302even when the user is wearing gloves.

FIG. 5Aillustrates certain embodiments of an applicator system50comprising a storage device52configured to receive applicator device10. Storage device52may comprise a wall500and a bottom502that define a chamber504. In certain embodiments, wall500and/or bottom502may be transparent. In certain embodiments, wall500and/or bottom502may be translucent. In certain embodiments, wall500and/or bottom502may be opaque. Storage device52may comprise various cross-sectional geometries including, but not limited to, circular, oval, rectangular, triangular, polygonal, or complex shapes comprising a combination thereof.

In certain embodiments, applicator device10may be inserted into and/or removed from chamber504of storage device52, thereby exposing substantially hydrophilic foam112and/or abrasion layer114to a fluid506. In certain embodiments, storage device52may comprise a seat508. Seat508may include one or more angled regions510that may define a well512to at least partially contain fluid506. As illustrated byFIG. 5B, in certain embodiments, angled regions510may generally correspond to certain surfaces of substantially hydrophilic foam112and/or abrasion layer114, so as to facilitate contact between substantially hydrophilic foam112and/or abrasion layer114and fluid506. As a result, fluid506may be more efficiently transported between substantially hydrophilic foam112and/or abrasion layer114and well512for later dispensing. AlthoughFIGS. 5A-8Billustrate substantially hydrophilic foam112and/or abrasion layer114mating to the respective angled regions (e.g.,510), one skilled in the art would realize that possible aberrations in mating can occur due to, e.g., various manufacturing tolerances.

Still referring to certain embodiments as illustrated byFIG. 5B, endpiece108may attach to storage device52to form an interface514. Endpiece108and wall500may form a seal516generally located at interface514. Seal516may substantially prevent various contaminants from entering chamber504and/or fluid506. As a result, the sterility of certain components within chamber504(e.g., handle104, base102, substantially hydrophilic foam112and/or abrasion layer114, seat508and/or fluid506) may be ensured. In certain embodiments, seal516may be formed by placing a compliant material (e.g., rubber) between endpiece108and wall500. In certain embodiments, seal516may be formed by various mechanisms known in the mechanical arts, including, but not limited to, threaded screw-type mechanisms, press-fit and/or slip-fit mechanisms, friction-fit mechanisms, and the like, or combinations thereof.

According to certain embodiments, as illustrated inFIGS. 6A-6C, handle100may extend or retract to allow for a larger or smaller applicator system50. In this manner, in certain embodiments, applicator device10and/or applicator system50can facilitate certain space-saving design considerations. In certain embodiments, endpiece108and wall500may form a seal, as described in more detail above. As illustrated inFIG. 6B, handle100may be comprised of an upper portion600and a lower portion602. In certain embodiments, lower portion602may slide within upper portion600in a telescoping manner. In certain embodiments, upper portion600may slide within lower portion602. Other ways exist in which handle100may extend and/or retract including, but not limited to, an accordion-style collapsing of either or both upper portion600and lower portion602, a threaded mechanism that allows for extension and/or retraction by twisting upper portion600relative to lower portion602, and/or a folding of upper portion600onto lower portion602through the use of, e.g., a hinge located between upper portion600and lower portion602. Interconnect604may define a transition between upper portion600and lower portion602. In certain embodiments, interconnect604may be located at approximately the center of handle100. In certain embodiments, interconnect604may be located away from the center of handle100. In certain embodiments, interconnect604may incorporate a locking mechanism to hold handle100in an extended state. Locking mechanisms are well known in the art and include, but are not limited to, spring-loaded mechanical stops.

According to certain embodiments, as illustrated inFIGS. 7A-7C, applicator system50may comprise an intermediate endpiece700. Intermediate endpiece700may allow handle100to extend and/or retract while intermediate endpiece700retains contact with wall500. As a result, any seal formed between intermediate endpiece700and wall500continues to prevent certain unwanted contaminants from entering chamber504, even while handle100is extended or retracted.

According to certain embodiments, as illustrated inFIGS. 8A-8B, endpiece108may be removed from handle100. Endpiece108may be attached to handle100in a variety of ways known in the art including, but not limited to, press-fits, friction-fits, threaded attachments, screws, adhesives, and the like. In certain embodiments, endpiece108can comprise a cavity. In certain embodiments, the cavity can be conical in shape. For example, the cross-section of the cavity can comprise an angled portion109and a flat portion110wherein angled portion109can direct handle100toward flat portion110as endpiece108is attached to storage device52. That is, in certain embodiments, the cavity can locate handle100in the center of storage device52as endpiece108is connected to storage device52.

According to certain embodiments, the applicator device and/or the applicator system may be sterilized in various ways known in the art including, but not limited to, exposure to ethylene oxide (“(Et)2O”), gamma radiation, electron beam, and/or steam. According to various embodiments, the fluid may be sterilized in various ways known in the art including, but not limited to, filtration, exposure to gamma radiation, electron beam, and/or steam. For example, U.S. Pat. No. 6,682,695 discloses a method for sterilizing a fluid that can be consistent with certain embodiments of the invention.

According to certain embodiments, as illustrated byFIGS. 5A-5B, applicator device10may be inserted into storage device52to place substantially hydrophilic foam112and/or abrasion layer114(see, e.g.,FIG. 4A) in contact with fluid506. After insertion, endpiece108may form a seal with wall500of storage device52through, for example, a screw mechanism. As substantially hydrophilic foam112and/or abrasion layer114contacts fluid506, fluid506may transfer to substantially hydrophilic foam112and/or abrasion layer114. While applicator system50is sealed, applicator system50may be sterilized by exposure to, for example, (Et)2O, gamma radiation, electron beam, and/or steam. Once an area for treatment has been targeted, a user may unseal endpiece108from wall500by, for example, unscrewing endpiece108. Thereafter, applicator device10may be removed from storage device52, including substantially hydrophilic foam112and/or abrasion layer114, which may contain fluid506. The user may then abrade the epidermis of the area selected for treatment using abrasion layer114(see, e.g.,FIG. 4A), in a rubbing or scraping manner. When desired, the user may apply pressure to applicator device10, thereby compressing substantially hydrophilic foam112and/or abrasion layer114to release a desired amount of fluid506into the targeted area.

Example 1: The effectiveness of the applicators was evaluated using a Pig Skin Model conducted under controlled laboratory conditions. This controlled laboratory model was devised to simulate clinical dermal use of the applicators to deliver and apply antimicrobial solutions to the skin. The use of this controlled laboratory model allowed the determination of the effectiveness of the applicator and an antimicrobial solution in reducing bacterial counts on the skin.

Olanexidine [1-(3,4-dichlorobenzyl)-5-octylbiguanide] was the active ingredient of an antiseptic solution tested with four different embodiments of the applicator invention described herein. The reduction in the colony counts of the bacteria on the surface of the Pig Skin was determined; the Log10units were used for the expression of the counts. This method of expressing the number of colony forming units is recommended in the requirements in the Tentative Final Monograph for Health-Care Antiseptic Drug Products; Proposed Rule, dated Jun. 17, 1994. In the Pig Skin study, the number of colony forming units was determined.

In in vitro studies designed to determine the olanexidine minimum inhibitory concentration (“MIC”) of a wide range of bacteria, olanexidine was shown to inhibit >95% of 1050 organisms with ≦32 μg/ml of olanexidine solution. The bacteria included in the MIC testing study included clinical isolates from a number of bacterial and fungal species. The MIC method is a widely accepted methodology that is useful for determining and comparing in vitro antimicrobial activity, while the Pig Skin Model is useful for determining activity under simulated conditions of use. The following chart summarizes the results obtained with the Pig Skin Model: