HK1166617B - Fluid application device and method - Google Patents

Description

Fluid application device and method

This application claims benefit of U.S. provisional application No. 61/141,544 filed on 30/12/2008.

Technical Field

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

Background

Preparation of a patient for various medical procedures (e.g., surgery) typically includes applying a topical solution (or fluid), such as an antimicrobial solution, to disinfect a target area for the medical procedure. The topical solution can be applied to the target area by soaking the sponge-like material with the solution and directing the soaked sponge to the target area using a handheld device, such as a pair of forceps or a pair of hemostats. The sponge or foam material is typically soaked in a fluid contained in an open pan or other container.

In some cases, existing devices for applying solutions suffer from various drawbacks. For example, typical applicators use a sponge that does not effectively hold the fluid and results in leakage. As a result, the preparation of the target area for antimicrobial cleaning becomes a cumbersome procedure. In addition, leakage of various fluids onto areas outside of the target area can result in pooling of the various fluids, which can cause irritation, discomfort, and/or other undesirable conditions.

Another example of a drawback includes the difficulty of dispensing a desired dose of fluid at a target area. During fluid application, it may be desirable in some instances to control the amount of fluid (e.g., antimicrobial solution) dispensed from the applicator. However, because existing applicators dispense fluids inefficiently, the exact amount of solution delivered to the target area may be difficult to determine. This may result in more or less solution being applied to the target area than desired. In addition, typical applicators use foam and/or fluid delivery systems that cannot dispense precise amounts of fluid in real time. For example, some applicators with internal ampoules that store fluid take time for the fluid to soak into the sponge and thus be applied to the patient. This can lead to unpredictable and inaccurate dispensing of the desired solution.

Disclosure of Invention

In certain aspects, the present disclosure relates to applicator devices for applying a fluid. The applicator device may include a handle. The handle may include an elongated hollow body having a proximal end and a distal end and at least one longitudinal internal rib disposed on an inner surface of an outer wall of the hollow body, wherein the at least one longitudinal internal rib is configured to orient and direct the container containing the fluid when the container is disposed within the hollow body. In addition, the applicator device may include a base at the distal end of the hollow body. Also, the applicator device may include an applicator pad coupled to the base.

In some aspects, the present disclosure relates to applicator devices for applying a fluid. The applicator device may include a handle. The handle may include an elongated hollow body having a proximal end and a distal end. The applicator device may further include a base at the distal end of the hollow body and an applicator pad coupled to the base. Additionally, the applicator device may include an actuator sleeve having a proximal end, a distal end, and an outer wall having an outer surface, the actuator sleeve configured to be inserted into the hollow body such that the outer surface of the outer wall of the actuator sleeve is disposed within the inner surface of the outer wall of the hollow body. The actuator sleeve may be configured to be actuated to release fluid from a reservoir configured to be inserted into the hollow body to the applicator pad. The actuator sleeve may include at least one notch extending from a distal end of the actuator sleeve to a proximal end of the actuator sleeve. The recess may be configured to interact with a corresponding outward protrusion on the container.

In various aspects, the present disclosure is directed to a system for applying a fluid. The system may include a container configured to contain a fluid. Additionally, the system may include an applicator device for applying the fluid. The applicator device may include an elongated hollow body having a proximal end and a distal end, which hollow body may be configured to have a container inserted therein. The applicator device may further include a base at the distal end of the elongated hollow body and an applicator pad configured to be coupled to the base. Further, the applicator pad may include an annular actuator sleeve having a proximal end and a distal end, the annular actuator sleeve configured to fit within the hollow body between the inner surface of the outer wall of the hollow body and the outer wall of the container such that longitudinal translation of the actuator sleeve releases the fluid in the container, allowing the fluid to flow to the applicator pad. The actuator sleeve may include one or more longitudinal protrusions projecting distally and configured to interact with a cap on the distal end of the container to remove the cap from the container to release the fluid in the container.

In some aspects, the present invention relates to methods for applying a fluid to a surface. The method may include releasing fluid in a container disposed within the hollow body to an applicator pad coupled to a base of the hollow body at the distal end of the hollow body by longitudinally translating within the hollow body an actuator sleeve having a proximal end, a distal end, and an outer wall having an outer surface. Upon longitudinal translation, the outer surface of the outer wall of the actuator sleeve may be disposed within the inner surface of the outer wall of the hollow body, and the actuator may interact with the cap portion on the distal end of the container to remove the cap portion from the container to release the fluid in the container.

In some aspects, the present disclosure is directed to a system for applying a fluid that includes a container configured to contain the fluid and an applicator device for applying the fluid. The applicator device may include an elongated hollow body having a proximal end and a distal end, the hollow body configured to have the container inserted therein. The applicator device may also include a base at the distal end of the elongated hollow body. In addition, the applicator device may include an annular actuator sleeve having a proximal end and a distal end, the annular actuator sleeve configured to fit within the hollow body between the inner surface of the outer wall of the hollow body and the outer wall of the container such that longitudinal translation of the actuator sleeve within the hollow body releases the fluid in the container, allowing the fluid to flow to the applicator pad. In some embodiments, the container may include a flat side and the actuator sleeve may include a thicker reinforcement corresponding to the insertion side of the container.

In some aspects, the present disclosure is directed to a system for applying a fluid that includes a container configured to contain the fluid and an applicator device for applying the fluid. The applicator device may include an elongated hollow body having a proximal end and a distal end, the hollow body being configured to have the container inserted therein. The applicator device may further include a base and an annular actuator sleeve at the distal end of the elongated hollow body. The actuator sleeve may have a proximal end and a distal end and be configured to be inserted within the hollow body between the inner surface of the outer wall of the hollow body and the outer wall of the container such that longitudinal translation of the actuator sleeve within the hollow body causes the actuator sleeve to act on the container, thereby releasing the fluid in the container, allowing the fluid to flow to the applicator pad. In addition, the container may include a body portion, a cap portion, and a neck portion between the body portion and the cap portion. The neck may comprise a frangible portion and a hinge element arranged relative to the frangible portion. The hinge element may be configured to maintain the connection between the body portion and the lid portion after the frangible portion is broken, thus allowing the lid portion to pop open.

Drawings

1A-1C show perspective views of an exemplary embodiment of an applicator system for applying a fluid at various stages of assembly;

fig. 2A shows a side cross-sectional view of an applicator system according to an exemplary disclosed embodiment;

FIG. 2B shows a close-up view of a portion of the applicator system shown in FIG. 2A;

fig. 3A illustrates a front view of a handle and base of a fluid applicator device, according to an exemplary disclosed embodiment;

FIG. 3B shows a side cross-sectional view of the handle and base shown in FIG. 3A;

fig. 3C shows a side cross-sectional view of the assembled applicator system, including the handle and base shown in fig. 3B, with the actuator sleeve actuated;

fig. 3D illustrates a close-up view of a portion of fig. 2A showing a sealing feature of an applicator device according to an exemplary disclosed embodiment;

4A-4H illustrate several exemplary disclosed embodiments of the base of the applicator device;

5A-5D illustrate several exemplary disclosed embodiments of applicator pads;

6A-6D illustrate several exemplary disclosed embodiments of actuator sleeves;

FIG. 7 illustrates a front cross-sectional view of a system for applying a fluid, according to an exemplary disclosed embodiment;

FIGS. 8A-8C show side cross-sectional views of a system for applying fluid in combination with different sized fluid containers;

FIG. 9 is a cross-sectional view of an alternative embodiment of a system for applying a fluid;

FIG. 10 is a container configured for use with the system shown in FIG. 9;

11A-11C show perspective views of another exemplary embodiment of an applicator system for applying a fluid at various stages of assembly;

fig. 12A shows a side cross-sectional view of an applicator system according to an exemplary disclosed embodiment;

fig. 12B shows a close-up view of a portion of the applicator system shown in fig. 12A;

fig. 13A shows a front view of a handle and base of a fluid applicator device, according to an exemplary disclosed embodiment;

FIG. 13B shows a side cross-sectional view of the handle and base shown in FIG. 13A;

FIG. 13C shows a rear view of the handle and base shown in FIG. 13A;

fig. 14A shows a side cross-sectional view of an exemplary assembled applicator system in a pre-activated state;

fig. 14B shows a close-up view of a portion of the applicator system shown in fig. 14A in a pre-activated state;

fig. 15A shows a side cross-sectional view of an exemplary assembled applicator system in an activated state;

fig. 15B illustrates a close-up view of a portion of the applicator system illustrated in fig. 15B, showing the sealing feature and the retention feature;

FIGS. 16A-16D illustrate several exemplary disclosed embodiments of an actuator sleeve;

FIG. 17A shows a front cross-sectional view of a system for applying a fluid, according to an exemplary disclosed embodiment; and

fig. 17B illustrates a front cross-sectional view of a fluid container for use with the system shown in fig. 17A.

Description of various embodiments

In this application, the use of the singular also includes the plural unless specifically stated otherwise. In this application, the use of "or" means "and/or" unless stated otherwise. Furthermore, the use of the term "including" as well as other forms thereof, 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 comprising more than one unit unless explicitly stated otherwise.

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 disclosed applicators may be configured to dispense/apply any fluid having a viscosity suitable to allow passage and dispensed by the disclosed devices. In some embodiments, the disclosed applicators may be used to dispense/apply an antimicrobial solution. The term "antimicrobial liquid" as used herein refers to a liquid that may be used, in certain embodiments, to disinfect an area that is to be subjected to various medical procedures.

Reference will now be made in detail to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

Fig. 1A-1C illustrate a system 10 for applying a fluid at various stages of assembly. Fig. 1A shows the system 10 assembled. As shown in fig. 1B and 1C, the system 10 may include a container 12 configured to contain a fluid. Additionally, the system 10 may include an applicator device 14 configured to apply a fluid to a surface. Applicator device 14 may include a handle, which may include an elongated hollow body 16. The hollow body 16 may also include a proximal end 18 and a distal end 20. The hollow body 16 may be configured to have the container 12 inserted therein (see, e.g., fig. 2A). Applicator device 14 may include a base 22 at distal end 20 of hollow body 16 and an applicator pad 24 coupled to base 22. In addition, applicator device 14 may include an annular actuator sleeve 26, annular actuator sleeve 26 having a proximal end 28 and a distal end 30, and may be configured to fit within hollow body 16 between an inner surface 32 (see, e.g., fig. 2A) of an outer wall 34 of hollow body 16 and an outer wall 36 of container 12, such that actuation of actuator sleeve 26 may release fluid in container 12, thereby allowing fluid to flow to applicator pad 24.

Container with a lid

As shown in fig. 2A and 2B, the container 12 may include a body portion 38 and a cap portion 40 at a distal end 42 of the body portion 38. As shown in fig. 2A, the container 12 may be configured for insertion into the hollow body 16 with the distal end 42 of the container 12 oriented toward the distal end 20 of the hollow body 16. In some embodiments, the cover portion 40 is removable from the body portion 38. For example, the cover portion 40 may be press-fit, snap-fit, threaded, etc. onto the body portion 38 or into the body portion 38. In certain embodiments, the cover portion 40 may be integrally formed with the body portion 38. As shown in fig. 2B, in certain embodiments, the container 12 may include a frangible portion 46 between the body portion 38 and the cap portion 40, wherein the frangible portion 46 is configured to break when the actuator sleeve 26 displaces the cap portion 40. That is, in some embodiments, pushing the lid 40 away from the container 12 includes breaking the frangible portion 46 of the container 12. The opening created at the distal end 42 of the container 12 is sized and shaped to allow the container 12 to self-vent and drain once the cover 40 is removed from the container 12. Additionally, in some embodiments, the distal end of the container 12 may be penetrated to allow fluid to exit.

In certain embodiments, the cap portion 40 may be configured to be pushed longitudinally away from the container 12 within the hollow body 16 as the actuator sleeve 26 is longitudinally translated. In some embodiments, it may be configured to twist the cap portion 40 to remove the cap portion 40 from the container 12. In certain embodiments, the cap 40 may be configured to be removed from the container 12 using both a pushing and twisting action. In some alternative embodiments, the lid portion 40 may be pulled. In these embodiments, the actuator sleeve 26 may include an annular element (not shown) configured to be pulled over a portion of the container 12.

The container 12 may be constructed of any type of material suitable for constructing a fluid-containing container with a frangible or removable cap. In some embodiments, the container 12 may be a blow-fill-seal (blow-fill-seal) container. Exemplary materials from which the container 12 may be made include polyethylene, polypropylene, nylon, and mixtures of such materials.

In certain embodiments, the liquid contained in the container 12 may be an antimicrobial solution containing an active ingredient. The active ingredients of various antimicrobial solutions are well known in the art, including, but not limited to, ethanol, isopropanol, other alcohols, and combinations thereof; benzalkonium chloride; benzethonium chloride; chlorhexidine gluconate; chlorhexidine gluconate with alcohol; chloroxylenol; chloro-fluorophenylurea; a ofloxacin compound; hexachlorophene; hexylresorcinol; an iodine-containing compound; povidone iodine; povidone-iodine with alcohols and combinations thereof.

In certain embodiments, the antimicrobial solution may include a biguanide derivative and/or a salt thereof as an active ingredient, such as for example, olanexidine [1- (3, 4-dichlorobenzyl) -5-octylbiguanide ] and salts thereof, for example as disclosed in U.S. patent No. 5,376,686. The antimicrobial solution may also incorporate certain surfactants, such as varying amounts of polyoxyethylene based nonionic surfactants and/or alcohols, such as ethanol, isopropanol, and other alcohols, and/or water. Useful surfactants are well known to those skilled in the art, such as poloxamer 124(a/k/a polyoxypropylene-polyoxyethylene Block Copolymer 124), polyoxyethylene (20) polyoxypropylene (20) glycol available from Asahi denkaco, ltd, Japan (Asahi electro Chemical co., ltd), PEO (9) lauryl ether ("BL-9" available from Nikko Chemicals co., ltd, tokyo, Japan), and EX PEO (10) lauryl ether also known as nonoxynol-10 or NP-10 (E mulin NL-100' available from Sanyo Chemical Industries, ltd, tokyo, Japan).

In certain embodiments, the antimicrobial solution may include various concentrations of active ingredient and polyoxyethylene-based nonionic surfactant. In some embodiments, the polyoxyethylene-based nonionic surfactant may be present at a concentration of about 0.05% (w/v) to about 16% (w/v).

In certain embodiments, the topical antimicrobial agent may include a biguanide derivative and/or a salt thereof, which may be present at a concentration of about 0.05% (w/v of biguanide base) to about 5% (w/v of biguanide base). In some embodiments, the biguanide derivative and/or salt thereof may be olanexidine [1- (3, 4-dichlorobenzyl) -5-octylbiguanide ] or a salt thereof. In some embodiments, the salt may be a gluconate.

In some embodiments of the system 10, the applicator device 14 may be provided in a ready-to-use form. For example, the applicator device 14 may be stored, packaged, and/or shipped, etc., as shown in fig. 2A, with the applicator pad 24 attached to the base 22, and the container 12 and actuator sleeve 26 inserted within the hollow body 16. In these embodiments, the container 12 may be prefilled with a fluid, such as an antimicrobial fluid.

Hollow body

As shown in fig. 3A, the hollow body 16 may include various shapes, sizes, and/or one or more external gripping features to assist a user in handling the applicator device 10. For example, the hollow body 16 may include indentations, protrusions, texturing, rubberized materials, etc. to enhance secure gripping of the hollow body 16. For example, as shown in FIG. 3A, the hollow body 16 may include one or more protruding gripping members 48 and/or textured gripping bands 50. In some embodiments, more than one textured grip strip 50 may be provided. Likewise, in some embodiments, the hollow body 16 may include an ergonomically curved (not shown) and/or widened exterior configured to conform to the contour of the palm of a hand.

The hollow body 16 and/or the base 22 may be made of any suitable material, including, but not limited to, metals, metal alloys, plastics, and other polymers, including, for example, polycarbonate, nylon, modacrylic, methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), thermoplastic alloys, various composites, or combinations thereof. The hollow body 16 may be formed by various manufacturing processes known in the art including, but not limited to, molding, injection molding, machining, casting, extruding, and/or combinations thereof.

In some embodiments, one or more components of the applicator 12 may be constructed of a transparent or translucent material. For example, one or more portions of the hollow body 16 and/or the actuator sleeve 26 may be constructed of a transparent or translucent material. The transparency and/or translucency of certain components may enable viewing of the amount of fluid remaining in container 12 and/or facilitate monitoring of the flow of fluid through applicator device 14 during dispensing.

The hollow body 16 may include one or more internal guide elements configured to orient and guide the containers 12 when the containers 12 are disposed within the hollow body 16. For example, as shown in fig. 3B, the hollow body 16 may include one or more longitudinal inner guide ribs 52 disposed on the inner surface 32 of the hollow body 16. The internal guide ribs 52 may be configured to limit rotation of the container 12 within the hollow body 16. For example, in some embodiments, the hollow body 16 may include two substantially parallel guide ribs 52 spaced apart from one another. In these embodiments, the container 12 may include corresponding outward protrusions 54, as shown in fig. 3C, the corresponding outward protrusions 54 being sized and shaped to fit into the guide ribs 52 and be guided by the guide ribs 52. Alternatively or additionally, the hollow body 16 may include one or more grooves (not shown) for orienting and guiding the containers 12. For example, in certain embodiments, the ribs 52 may instead be grooves on the inner surface 32 of the hollow body 16.

As also shown in fig. 3B, the hollow body 16 may include one or more longitudinal stop ribs 56 substantially parallel to the guide ribs 52 and disposed between the guide ribs 52. Each guide rib 52 may include a proximal end 58 and a distal end 60, and each stop rib 56 may have a proximal end 62 and a distal end 64. In some embodiments, the proximal end 62 of each stop rib 56 may be located distally from the proximal end 58 of the guide rib 52 and may be configured to interact with the distal end 65 (see fig. 3C) of the outward protrusion 54 on the container 12 to stop the longitudinal translation of the container 12 in the distal direction within the hollow body 16. Applicator device 14 may be configured such that when longitudinal translation of container 12 in the distal direction is prevented by stop rib 56 and rotational translation is prevented by guide rib 52, longitudinal translation of actuator sleeve 26 pushes and/or twists cap portion 40 of the container to remove cap portion 40 from container 12, as shown in fig. 3C.

The hollow body 16 may also include one or more inwardly projecting protrusions 66. As shown in fig. 3C, the inwardly projecting protrusions 66 may be further configured to reorient the cap portion 40 of the container 12 after the container 12 is ruptured by actuation of the actuator sleeve 26, for example, by tilting the cap portion 40 to prevent the cap portion 40 from becoming lodged within the hollow body 16, which may result in a retardation or reduction of fluid flow down to the applicator pad 24. As shown in fig. 3C, the inwardly projecting protrusion 66 may be configured to stop longitudinal translation of the actuator sleeve 26. That is, the inwardly projecting protrusions 66 may act as stops, limiting the range of longitudinal translation of the actuator sleeve 26.

The hollow body 16 may include one or more internal restraining and/or sealing features at the proximal end 18 of the hollow body 16. For example, as shown in fig. 3B and 3D, in some embodiments, the hollow body 16 may include circumferential constraining ribs 68 configured to secure the actuator sleeve 26 within the hollow body 16. The binding ribs 68 may be configured to interact with corresponding features on the actuator sleeve 26. For example, as shown in fig. 3B and 3D, the actuator sleeve 26 may include a circumferential sealing rib 69 configured to not only seal the interface between the actuator sleeve 26 and the hollow body 16 against leakage, but also to interact with the constraining rib 68, whereby the constraining rib 68 acts as a stop preventing the actuator sleeve 26 from moving proximally past the point where the sealing rib 69 contacts the constraining rib 68 (see fig. 3D).

The constraining rib 68 and the sealing rib 69 may have the same or different profiles. While the figures show the constraining ribs 68 on the hollow body 16 and the sealing ribs on the actuator sleeve 26, in certain embodiments, the constraining ribs and sealing ribs may be reversed such that the sealing ribs may be on the hollow body 16 and the constraining ribs may be on the actuator sleeve 26. Additionally, although the figures illustrate the confinement and sealing features as including ribs, in some embodiments, the confinement and sealing features may include bosses, recesses, detents, etc. (not shown).

Base seat

According to certain embodiments, the hollow body 16 and the base 22 may define an angle 70, for example as shown in fig. 3C. Although the figures illustrate embodiments in which the angle 70 is about 45 °, the hollow body 16 and the base 22 may define any angle in the range of 0 ° to 180 °.

As shown in fig. 3B, base 22 may include an inner surface 72 and an outer surface 74, with applicator pad 24 being configured to be affixed to outer surface 74. As shown in fig. 4A-4H, the base 22 may include one or more perforations 76. Applicator pad 24 may be configured to attach to base 22 over perforations 76. Perforations 76 may allow fluid to flow from hollow body 16 to applicator pad 24.

In some embodiments, as shown in fig. 4G, the outer surface 74 may include one or more channels 78. Channels 78 may be configured to distribute fluid to different portions of applicator pad 24. Likewise, as shown in fig. 4H, in some embodiments, the outer surface 74 of the base 22 may be textured. The texture may facilitate not only the attachment of the applicator pad 24 to the base 22, but also the distribution of the fluid to different portions of the applicator pad 24. Additionally, the outer surface 74 of the base 22 may be textured and/or otherwise surface treated to reduce surface energy and/or promote fluid distribution. For example, other possible surface treatments may include hydrophilic coatings, plasma or flame treatments, and other surface treatments known in the art.

According to certain embodiments, the base 22 may be coupled to the hollow body 16. The base 22 may be coupled to the hollow body 16 in a variety of ways known in the mechanical art, including, but not limited to, attachment by hinges, adhesives, mechanical interlocks, threaded portions, press fits, friction fits, interference fits, slip fits, and/or combinations thereof. According to other embodiments, the base 22 may be integrally formed with the hollow body 16. The integrated 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, the applicator device 10 may include an interchangeable attachment between the hollow body 16 and the base 22. Interchangeable attachments may, for example, facilitate the use of different sized pedestals on the same hollow body 16, or vice versa. This may facilitate, for example, the use of applicator pads of different sizes with the same hollow body 16.

The base 22 may be constructed in a number of shapes and sizes. In some embodiments, the shape and/or size of base 22 may generally correspond to the shape and/or size of applicator pad 24. In other embodiments, base 22 and applicator pad 24 may have different shapes and/or sizes. As shown in the figures, in certain embodiments, base 22 and/or applicator pad 24 may be substantially triangular with rounded edges. As shown, this substantially triangular shape may approximate a teardrop shape. Other exemplary shapes for the base 22 may include, but are not limited to, rectangular, circular, oval, various polygonal shapes, and/or complex shapes including combinations thereof. As shown in the figures, in some embodiments, the sides of the polygonal shape may be curved, including embodiments in which the base 22 has a substantially triangular shape.

Applicator pad

Applicator pad 24 may be coupled to base 22 using a variety of attachment mechanisms. For example, applicator pad 24 may be attached to base 22 using any suitable method, including, for example, adhesive bonding, such as using medical grade cyanoacrylate, UV curable adhesive, PSA film, and the like. In some embodiments, applicator pad 24 may use RF welding, heat staking, ultrasonic welding, laser welding, mechanical interlocking, hook and loop (e.g., hook-and-loop) mechanisms) Screws, etc., and combinations of these mechanisms, are attached to the base 22. Thus, base 22 and applicator pad 24 may each be configured to attach to one another using any of these mechanisms, and thus may include appropriate features (e.g., texture, adhesive, mechanical latching/clamping elements, etc.) to enable such attachment.

As noted above, like base 22, applicator pad 24 may have any suitable shape and/or size. For example, as shown in the figures, in some embodiments, applicator pad 24 may have a substantially triangular shape with rounded sides (e.g., a teardrop shape). This substantially triangular shape allows the applicator device 14 to be used on surfaces having a variety of contours. For example, the smaller tips at the rounded corners of the triangle, particularly the distal-most tip 80, may be able to access crevices and smaller surface features, while the wide proximal end of applicator pad 24 may provide a large pad surface that enables fluid to be applied to a larger, more gently contoured surface.

In some embodiments, applicator pad 24 may comprise a substantially hydrophobic foam. In other embodiments, applicator pad 24 may comprise a substantially hydrophilic foam. The disclosed applicator pad may include a substantially hydrophobic or substantially hydrophilic foam. The term "substantially hydrophobic foam" as used herein refers to a polymer-based foam that does not absorb significant amounts of water. In contrast, the following provides a definition of a substantially hydrophilic foam. For purposes of the present invention, a substantially hydrophobic foam shall refer to any foam that is not substantially hydrophilic (as defined below).

The term "substantially hydrophilic foam" as used herein refers to a polymer-based foam having an affinity for water. For example, certain embodiments of the present invention can utilize polyurethane foams with open cell, fine cell structures. In some cases, substantially hydrophilic foams can be designed to absorb fluids at high rates, such as, for example, about 20 times the weight of the absorbent foam. While not wishing to be bound by theory, substantially hydrophilic foams can demonstrate water affinity 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, the finely open porous structure directing fluid into the bulk of the foam structure through capillary forces, and/or the incorporation of absorbent materials such as superabsorbents and/or surfactants into the foam matrix. Substantially hydrophilic foams that can be used in certain embodiments of the present invention can be obtained from tissues including: foamx Innovations (Media, PA, a.k.a. fxi), Crest Foam Industries, inc. (moonochie, NJ), Rynel, inc. (bootbay, Maine), Avitar, inc. (Canton, MA, USA), Lendell Manufacturing, inc. (Charles, Ml, USA), copura (denomark), and Foamtec International co. Additionally, certain patents, including U.S. patent No. 5,135,472 to Hermann et al, disclose substantially hydrophilic foams that may be used in certain embodiments of the present invention.

Applicator pad 24 may or may not include felt. In addition, applicator pad 24 may or may not include a mesh. In some embodiments, applicator pad 24 may include a variety of pad materials. In these embodiments, combinations of any of the above characteristics may be used. For example, in one example, one of the plurality of material pads may be hydrophobic and the second pad material may be hydrophilic.

Applicator pad 24 may be composed of a single material or multiple materials, and applicator pad 24 may include a single layer or multiple layers, and/or may include slits to facilitate distribution of fluid and flow through the applicator pad, or may not include slits. Fig. 5A-5D illustrate several exemplary embodiments of applicator pad 24 having various combinations of the features listed above. For example, in some embodiments, applicator pad 24 may comprise a single layer and no slits, as shown in fig. 5A. In other embodiments, applicator pad 24 may comprise a single layer, which may include slits 82, as shown in fig. 5B. As shown in fig. 5B, applicator pad 24 may include a plurality of slits. Further, the slits 82 may be arranged in a pattern. For example, FIG. 5B shows a pattern of angularly oriented substantially parallel slits 82.

In certain embodiments, applicator pad 24 may comprise multiple layers. As shown in fig. 5C and 5D, applicator pad 24 may include a base layer 84 and a laminate 86. The slit 82 may be provided in the base layer 84 and/or the laminate 86. Fig. 5C and 5D illustrate embodiments in which slits 82 are provided at least in a stack 86. Fig. 5C shows a pattern of substantially parallel slits 82 similar to fig. 5B. Fig. 5C shows a version in which the slits 82 are oriented in a generally transverse direction, as opposed to those oriented at an angle in fig. 5B. The slits 82 may be arranged at any angle. The slits 82 may be provided in any of a variety of shapes, such as generally circular slits 82 in FIG. 5D. The slits 82 may also be formed in various other shapes including, but not limited to, circles, ellipses, polygons, and the like. The slits 82 may be formed by any suitable process, such as by die/kiss cutting.

In some embodiments, each layer may be composed of a different mat material. In certain embodiments, applicator pad 24 may include at least one abrasion layer (abrasion layer). In some applications, a rubbing layer may be used to rub a target area of treatment, such as the epidermis. Rubbing may be performed before, during, and/or after dispensing the fluid. In certain embodiments, friction may cause certain biological materials to relax, such as body oils, body soils, and/or bacteria, to facilitate treatment of the target area. For example, prior to application of the antimicrobial solution, the user may rub the patient's epidermis to loosen bacteria in order to improve the efficacy of the antimicrobial application process. In certain embodiments, the frictional layer may include more than one layer of material, which may facilitate greater amounts of friction and/or more forceful friction to clean the area.

In certain embodiments, the frictional layer may include various textures and/or fabrics, such as gauze-like or foam materials. In certain embodiments, the exemplary gauze-like material may be made of a variety of materials that facilitate friction, including, but not limited to, cotton, rayon, nylon, and/or combinations thereof. The friction layer material may be selected from a number of materials that exhibit different degrees of friction. For foam materials, the degree of friction may vary depending on, among other things, the size of the pores/pores. The skin of the premature infant is thin and fragile, so an applicator device comprising an abrasive layer made of nylon or rayon may preferably be an abrasive layer made of cotton. In certain embodiments, the friction layer may comprise multiple layers of different materials. In some embodiments, such as a foam abrasion layer, the abrasion layer may be flame laminated to the base 22 and/or the applicator pad 24.

As shown in fig. 5C and 5D, the shape of the laminate 86 (which may include a rubbing layer) may generally correspond to the shape of the base layer 84 of the applicator pad 24. However, in certain embodiments, the stack 86 may have various other shapes, including, but not limited to, circular, oval, rectangular, triangular, polygonal, etc., or complex shapes including one or more of the above. The layers of applicator pad 24 may be attached to one another by various attachment mechanisms, including, but not limited to, adhesive bonding (e.g., using a pressure sensitive adhesive), welding, flame lamination, hot melt, ultrasonic welding, and the like. Certain methods of laminating and/or attaching various materials to an applicator pad material (e.g., foam) are known in the art. For example, U.S. patent application No. 10/829,919, U.S. provisional patent application No. 60/464,306, and PCT No. US04/012474 all disclose methods and apparatus for attaching materials to polyurethane foam.

Actuator sleeve

Actuator sleeve 26 may be configured to be actuated to release fluid in container 12 to applicator pad 24. Fig. 6A-6D illustrate various exemplary embodiments of the actuator sleeve 26. The actuator sleeve 26 may have an outer wall 88 with an outer surface 90. The actuator sleeve 26 may be configured to be inserted into the hollow body 16 such that the outer surface 90 of the outer wall 88 of the actuator sleeve 26 is disposed within the inner surface 32 of the outer wall 34 of the hollow body 16. Actuator sleeve 26 may be configured to be actuated to release fluid from container 12 to applicator pad 24. The actuator sleeve 26 may be configured to translate longitudinally within the hollow body 16 in order to release fluid from the container 12. The actuator sleeve 26 may be translated longitudinally within the hollow body 16 by applying a force to the proximal end 28 of the actuator sleeve 26. In some embodiments, the proximal end 28 of the actuator sleeve 26 may be shaped to provide a substantially uniform distribution of force across the proximal end 28. For example, as shown in fig. 6D, in certain embodiments, the proximal end 28 of the actuator 26 can have a rounded convex surface. Such a convex surface may distribute the force across the proximal end, thereby reducing the pressure experienced by the user. For example, a rounded convex surface may distribute the force across the palm of the user's hand. In other embodiments, the proximal end 28 of the actuator sleeve 26 may have a concave surface (see corresponding actuator sleeve 1026 in fig. 16D) that evenly distributes the force across, for example, a user's thumb or finger.

In some embodiments, the actuator sleeve 26 may include one or more notches 92 extending from the distal end 30 of the actuator sleeve 26 to the proximal end 28 of the actuator sleeve 26. In these embodiments, the container 12 may include a restraining feature, such as an outward protrusion 54, to orient and position the container 12 within the hollow body 16. Such a restraining feature may be configured to fit within the recess 92 of the actuator sleeve 26.

In some embodiments, the actuator sleeve 26 may include one or more longitudinal tabs 94 extending distally and configured to interact with the cap 40 of the container 12 to remove the cap 40 from the container 12 to release the fluid in the container 12. For example, as shown in fig. 6D, the actuator sleeve 26 may include two longitudinal projections 94 that may define two notches 92. An actuator sleeve having two recesses 92 is compatible with a container 12 having two outward projections 54 (see fig. 7).

As shown in fig. 6A, 6C, and 6D, in some embodiments, the one or more longitudinal protrusions 94 may include an angled surface 96 (some embodiments may include a multi-angled surface 98), the angled surface 96 configured to rotate the cap portion 40 of the container 12 as the actuator sleeve 26 is longitudinally translated. In these embodiments, actuation of the actuator sleeve 26 by longitudinal translation may cause the cap 40 to rotate as a result of interaction between the angled surface 96 and the cap 40. For example, the cap portion 40 may include a protruding element 100 (see fig. 1C) that may interact with the angled surface 96 of the actuator sleeve 26 to rotate the cap portion 40 to remove the cap portion 40 from the container 12, thereby releasing the fluid in the container 12.

As shown in fig. 6B, in some embodiments, the longitudinal projection 94 may include a substantially non-angled distal end 101. The non-angled distal end 101 may be configured to push the at-body element 100 distally when the actuator sleeve 26 is longitudinally translated in a distal direction. As also shown in fig. 6B, in some embodiments, the longitudinal projection 94 may include an inwardly projecting longitudinal rib 102 that terminates at the distal end 30 of the longitudinal projection 94. In these embodiments, the ribs 102 may interact with similar features of the raised elements 100 or the cover portion 40 to push open the cover portion 40 of the container 12.

As shown in fig. 6D, in some embodiments, the one or more longitudinal projections 94 may include teeth 103, the teeth 103 configured to interact with the cap portion 40 (see, e.g., fig. 1B, with the protrusion elements 100) to prevent counter-rotation of the cap portion 40 on at least one side of the container 12 during longitudinal translation of the actuator sleeve 26, while allowing the cap portion 40 to be rotated by the angled surface 96 of the actuator sleeve 26 on the other side of the container 12 to release the fluid in the container 12. The effect of preventing the reverse rotation of the cover part 40 on one side and producing the rotation of the cover part 40 on the other side is to rotate the cover part 40 with the connection between the teeth 103 and the protrusion element 100 as the center of rotation, rather than with the center of the cover part 40 as the center of rotation. Additionally, the teeth 103 may function to push the cap portion 40 longitudinally away from the container 12. Thus, in these embodiments, the lid 40 may be removed from the container 12 using a push and twist motion.

Additionally, the actuator sleeve 26 may include a venting feature configured to allow air to enter the hollow body 16 to displace the fluid as the fluid exits the hollow body 16 into the applicator pad 24, thereby maintaining atmospheric pressure within the applicator device 14. For example, in some embodiments, the actuator sleeve 26 may include a hole 106 (or passage), the hole 106 in a location that helps to allow air to easily enter the applicator device 14 while limiting the possibility that fluid can escape via a tortuous path and/or small orifice size. As shown in fig. 6D, in some embodiments, the aperture 106 may be located at the proximal end 28 of the actuator 26.

The components of the applicator system 10, including the applicator device 14 and/or the container 12, may be configured to be sterilized in a variety of ways known in the art, including, but not limited to, exposure to ethylene oxide ("(Et) 2O"), gamma radiation, electron beam, and/or steam. Additionally, the system 10 may be configured for use with sterile fluids. In some embodiments, the fluid may be sterilized prior to filling the container 1012. In other embodiments, the fluid may be sterilized when contained within the vessel 1012. In certain embodiments, the fluid and the container 1012 may be sterilized when assembled as a unitary body with the hollow body 1016 or the applicator device 1014. According to various embodiments, fluids may be sterilized by various methods known in the art, including, but not limited to, filtration, exposure to gamma rays, electron beam, and/or steam. For example, U.S. Pat. No. 6,682,695 discloses a method of sterilizing fluids compatible with certain embodiments of the present invention.

In some embodiments, the system 10 may be configured to coat fluids in different sized fluid containers. For example, as shown in fig. 8A-8C, because the actuator sleeve 26 applies a force to the container 12 at the distal end 42 of the container 12, the applicator device 14 may be used with containers having many lengths.

Fig. 9 is a cross-sectional view of a system 110 for applying a fluid, showing the system assembled and in a pre-actuated state. As shown in fig. 9, the system 110 may include a container 112, and the container 112 may have flat sides 115 (see also fig. 10). The system 110 may include an actuator sleeve 126, with the actuator sleeve 126 having a thicker and thus reinforced portion 117 that corresponds to the flat side 115 of the receptacle 112. For example, as shown in FIG. 9, when the system 110 is assembled, the thicker portion 117 of the actuator sleeve 126 may abut the flat side 115 of the receptacle 112. In other embodiments, the container 12 and the hollow body 16 are similar but replaceable, for example with corresponding tongues and grooves, insertion projections, etc.

As shown in fig. 9, the container 12 may include a body portion 138 and a lid portion 140. The container 112 may include a neck portion 119 between a body portion 138 and a cap portion 140. The neck 119 may include a frangible portion 146. The frangible portion 146 can be configured to break when the actuator sleeve 126 is longitudinally translated in a distal direction, acting on the receptacle 112 by pressing the distal end 130 of the actuator sleeve 126 against the cap portion 140 of the receptacle 112. The cover portion 140 may include a protruding element 121 that may be acted upon by the distal end 130 of the actuator sleeve 126.

In some embodiments, the receptacle 112 may include a hinge element 123 between the body portion 138 and the cover portion 140. For example, the receptacle 112 may include a frangible portion 146 on the side of the receptacle 112 where the actuator sleeve 126 contacts the cover 140. The hinge element 123 may be disposed relative to the frangible portion 146 such that upon longitudinal translation of the actuator sleeve 126, the frangible portion 146 breaks, separating the lid portion 140 from the body portion 138 except for the hinge element 119, and the hinge element 119 may maintain the connection between the body portion 138 and the lid portion 140 of the container 112, thus allowing the lid portion 140 to spring open.

Fig. 11A-17B illustrate various alternative embodiments of hollow bodies, containers, and actuator sleeves, which may be as shown or combined with other embodiments, including those described above, and will be understood by those skilled in the art. 11A-11C illustrate the system 101 at various stages of assembly. Fig. 11A shows the assembled system 1010. As shown in fig. 11B and 11C, the system 1010 may include a vessel 1012 configured to contain a fluid. Additionally, the system 1010 may include an applicator device 1014 configured to apply a fluid to a surface. The applicator device 1014 can include a handle that includes an elongated hollow body 1016. The hollow body 1016 may also include a proximal end 1018 and a distal end 1020.

The hollow body 1016 may be configured to have a container 1012 inserted therein (see, e.g., fig. 12A). The applicator device 1014 may include a base 1022 at the distal end 1020 of the hollow body 1016 and an applicator pad 1024 coupled to the base 1022. In addition, the applicator device 1014 may include an annular actuator sleeve 1026, the annular actuator sleeve 1026 having a proximal end 1028 and a distal end 1030, and may be configured to fit within the hollow body 1016 between an inner surface 1032 of an outer wall 1034 of the hollow body 1016 (see, e.g., fig. 12A) and an outer wall 1036 of the container 1012, such that actuation of the actuator sleeve 1026 may release fluid in the container 12, allowing the fluid to flow to the applicator pad 1024.

Container with a lid

As shown in fig. 12A and 12B, the receptacle 1012 can include a body portion 1038 and a cover portion 1040 at a distal end 1042 of the body portion 1038. The container 1012 can be configured to be inserted within the hollow body 1016 with the distal end 1042 of the container 1012 oriented toward the distal end 1020 of the hollow body 1016, as shown in fig. 12A. In some embodiments, the cover portion 1040 is removable from the body portion 1038. For example, the cover portion 1040 can be press-fit, snap-fit, threaded, etc. onto or into the body portion 1038. In certain embodiments, the cover portion 1040 can be integrally formed with the body portion 1038.

As shown in fig. 12B, in some embodiments, the receptacle 1012 can include a frangible portion 1046 between the body portion 1038 and the cover portion 1040, wherein the frangible portion 1046 is configured to break when the cover portion 1040 is displaced by the actuator sleeve 1026. That is, in some embodiments, pushing the cover 1040 away from the receptacle 1012 includes rupturing the frangible portion 1046 of the receptacle 1012. Once the cover 1040 is removed from the receptacle 1012, the opening created at the distal end 1042 of the receptacle 1012 is sized and shaped to allow the receptacle 1012 to self-vent and drain. In certain embodiments, the cover 1040 can be configured to be pushed longitudinally within the hollow body 1016 away from the vessel 1012 as the actuator sleeve 1026 longitudinally translates. In some embodiments, the container 1012 can be opened by piercing a distal end of the container 1012.

As shown in fig. 17A and 17B, in some embodiments, the container 1012 may include a venting feature 1096. The venting feature 1096 may be located at the proximal end of the container 1012 and may comprise, for example, a thinner material portion that is easily pierced by a corresponding piercing element (e.g., spike 1098 on the actuator sleeve 1026), as shown in fig. 16D and 17A. As the actuator sleeve 1026 moves longitudinally, the spike 1098 may pierce the container 1012, allowing air to enter the container 1012 to displace the fluid as the fluid is expelled from the container 1012 once the cover 1012 has been removed from the container 1012. Such venting of the vessel 1012 may facilitate faster and/or predictable fluid flow out of the vessel 1012.

The container 1012 may be constructed of any type of material suitable for constructing a fluid-containing container with a frangible or removable cover. Exemplary such materials are discussed above with respect to container 12.

The liquid contained in the container 1012 may be an antimicrobial solution containing an active ingredient. The active ingredients of exemplary such antimicrobial solutions are discussed above.

In some embodiments of the system 1010, the applicator device 1014 may be provided in a ready-to-use form. For example, the applicator device 1014 can be stored, packaged, and/or shipped, etc., with the applicator pad 1024 attached to the base 1022, and the container 1012 and actuator sleeve 1026 inserted into the hollow body 1016, as shown in fig. 12A. In these embodiments, the container 1012 may be pre-filled with a fluid, such as an antimicrobial fluid.

The container 1012 may include a neck 2014 as shown in FIG. 17B. In some embodiments, the neck 2014 may be configured to help measure fluid flow. For example, the neck 2014 may be somewhat narrow in size, thereby limiting the flow rate of fluid exiting the container 1012.

For system 10, in some embodiments, system 1010 may be configured to paint fluids in different sized fluid containers (see fig. 8A-8C). Additionally, the system 1010 may also be configured to include a container having at least one flat side, similar to that shown in fig. 9 and 10.

Hollow body

As shown in fig. 13A, the hollow body 1016 may include various shapes, sizes, and/or one or more external gripping features to assist a user in handling the applicator device 1014. For example, the hollow body 1016 may include indentations, protrusions, texturing, rubberized materials, etc. to help securely grip the hollow body 1016. For example, as shown in FIG. 13A, the hollow body 1016 may include one or more protruding gripping members 1048 and/or a textured gripping strip 1050. In some embodiments, more than one textured gripping strip 1050 may be provided. Likewise, in some embodiments, the hollow body 1016 may include an ergonomically curved (not shown) and/or widened exterior configured to conform to the contour of a palm of a hand.

The hollow body 1016 and/or the base 1022 may be made of any suitable material. Exemplary materials are discussed above with respect to the hollow body 16 and the base 22. The hollow body 1016 may be formed by various manufacturing processes known in the art including, but not limited to, molding, injection molding, machining, casting, extruding, and/or combinations thereof.

In some embodiments, one or more components of the applicator 1012 may be constructed of a transparent or translucent material. For example, one or more portions of the hollow body 1016 and/or the actuator sleeve 1026 may be made of a transparent or translucent material. The transparency and/or translucency of certain components can enable viewing of the amount of fluid remaining in the container 1012 and/or help monitor the fluid flowing through the applicator device 1014 as it is dispensed.

The hollow body may include one or more internal guide elements configured to orient and guide the containers 1012 when the containers 1012 are disposed in the hollow body 1016. For example, as shown in fig. 13B, the hollow body 1016 may include one or more longitudinal inner guide ribs 1052 disposed on an inner surface 1032 of the hollow body 1016. The inner guide ribs 1052 may be configured to limit rotation of the vessel 1012 within the hollow body 1016. For example, in some embodiments, the hollow body 1016 may include two substantially parallel guide ribs 1052 spaced apart from one another. In these embodiments, the receptacle 1012 can include a corresponding outward protrusion 1054, such as shown in FIG. 12A, the corresponding outward protrusion 1054 being sized and shaped to fit over the guide rib 52 and be guided by the guide rib 1052. Alternatively or additionally, the hollow body 1016 may include one or more grooves (not shown) for orienting and guiding the containers 1012. For example, in certain embodiments, the guide ribs 1052 may instead be slots in the inner surface 1032 of the hollow body 1016.

As also shown in fig. 13B, the hollow body 1016 may include one or more longitudinal stop ribs 1056 that are substantially parallel and disposed between the guide ribs 1052. Each guide rib 1052 may include a proximal end 1058 and a distal end 1060, and each stop rib 1056 may have a proximal end 1062 and a distal end 1064. In some embodiments, the proximal end 1062 of each stop rib 1056 may be located distally from the proximal end 1058 of the guide rib 1052 and may be configured to interact with the distal end 1065 (see fig. 14A) of the outward protrusion 1054 on the receptacle 1012 to stop the longitudinal translation of the receptacle 1012 in the distal direction within the hollow body 1016. As shown in fig. 14A, the applicator device 1014 may be configured such that when longitudinal translation of the container 1012 in the distal direction is prevented by the stop ribs 1056 and rotational translation is prevented by the guide ribs 1052, longitudinal translation of the actuator sleeve 1026 pushes the cap portion 1040 of the container to remove the cap portion 1040 from the container 1012.

The hollow body 1016 may also include one or more inwardly projecting protrusions 1066. As shown in fig. 15A, the inwardly projecting protrusions 1066 may be further configured to reorient the cap portion 1040 of the receptacle 1012 after being disconnected from the receptacle 1012 by actuation of the actuator sleeve 1026, such as tilting the cap portion 1040 to prevent the cap portion 1040 from becoming lodged within the hollow body 1016, which may result in a retardation or reduction of fluid flow down to the applicator pad 1024. As also shown in fig. 15A, the inwardly projecting tabs 1066 may be configured to stop longitudinal translation of the actuator sleeve 1026. That is, the inwardly projecting tabs 1066 may act as stops, limiting the range of longitudinal translation of the actuator sleeve 1026.

The hollow body 1016 may also include one or more internal restraining and/or sealing features at the proximal end 1018 of the hollow body 1016. For example, as shown in fig. 13B and 15B, in some embodiments, the hollow body 1016 can include circumferential constraining ribs 1068 configured to secure the actuator sleeve 1026 within the hollow body 16. The constraining ribs 1068 may be configured to interact with corresponding features on the actuator sleeve 1026. For example, as shown in fig. 11B and 15B, the actuator sleeve 1026 may include a circumferential sealing rib 1069 configured to not only seal the interface between the actuator sleeve 1026 and the hollow body 1016 from leakage, but also to interact with the constraining rib 1068, whereby the constraining rib 1068 acts as a stop preventing the actuator sleeve 1026 from moving proximally past the point where the sealing rib 1069 contacts the constraining rib 1068.

The constraining rib 1068 and the sealing rib 1069 may have the same or different profiles. While the figures show the constraining ribs 1068 on the hollow body 16 and the sealing ribs on the actuator sleeve 1026, in certain embodiments, the constraining ribs and sealing ribs can be reversed such that the sealing ribs can be located on the hollow body 1016 and the constraining ribs can be located on the actuator sleeve 1026. Additionally, although the figures illustrate the confinement and sealing features as including ribs, in some embodiments, the confinement and sealing features may include bosses, recesses, detents, etc. (not shown).

The applicator device 1014 may include a label 2002, such as shown in fig. 11A-C, the label 2002 configured to adhere to an outer wall 1034 of the hollow body 1016. In addition to providing a writable/printable/etc. information surface, the label 2002 may interact with one or more features of the hollow body 1016. In some embodiments, the label is removable.

For example, in some embodiments, the hollow body 1016 may include one or more vent channels 2004, the one or more vent channels 2004 in communication with one or more apertures 2006 and one or more slits 2007, each aperture 2006 and each slit 2007 passing through an outer wall 1034 of the hollow body 1016 (see fig. 11C, 13A, and 13B). When covered by the label 2002, the vent channel 2004 may constitute a serpentine path through which air may vent from one area of the hollow body 1016 to another when in an upright ("in use") position (e.g., the proximal end of the applicator device 1014 is higher than the distal end of the applicator device 1014) and inhibit fluid outflow when the applicator device 1014 is placed on a flat surface (i.e., the hollow body 1016 is oriented substantially parallel to the ground) or held upside down (i.e., the applicator pad 2024 is held higher than the proximal end of the applicator device 1014). For example, when the applicator device 1014 is held upright, the channels 2004, holes 2006, and slits 2007 may allow air to flow between the proximal region (communicating holes 2006) and a more distal region (communicating slits 2007). This may facilitate self-draining of the container 1012. Additionally, the serpentine path of the channels 2004 may prevent fluid leakage when the applicator device is oriented horizontally or upside down. To prevent fluid from leaking in an upside down orientation, one or more slits 2007 may be located away from the highest liquid level that will occur within the fluid hollow body 1016 in the release vessel 1012. Alternatively or additionally, the channel 2004 may include a distally projecting ring 2009 that extends distally to the highest liquid level that will occur within the hollow body 1016.

The label 2002 may be attached to the outer wall 1034 of the hollow body 1016 via any suitable method. For example, the label 2002 may be attached to the outer wall 1034 of the hollow body 1016 via a pressure sensitive adhesive, RF welding, hot melt, or the like.

Likewise, in some embodiments, the hollow body 1016 may include one or more container holding sheets 2008. As shown in fig. 11C and 13A, the slit 2007 may include a U-shaped opening around the retention sheet 2008. In some embodiments, the retention sheet 2008 may be locked in place when the label 2002 is attached to the outer wall 1034 of the hollow body 1016 over the retention sheet 2008 (see fig. 11C, 12B, and 17A). As shown in fig. 12B, once the containers 1012 are pushed far enough into the hollow body 1016, the retention tabs 2008 may project inwardly over the proximal ends of the outward projections 1054 of the containers 1012 to prevent the containers 1012 from translating proximally. In some embodiments, the retention sheet 2008 may be flexible such that the containers 1012 may be removed from the hollow bodies 1016. However, application of the label 2002 to the outer wall 1034 of the hollow body 1016 may lock the retention tabs 2008 in an inwardly protruding position, thus preventing removal of the container 1012 from the hollow body 1016. In certain embodiments, the retention sheet 2008 may be substantially rigid. In these embodiments, the container may be locked into position, for example, by rotating the container, whereby the outer protrusion of the container is positioned below the retaining sheet 2008. In some embodiments, rotation of the container can be performed automatically, for example, as the actuator sleeve is inserted into the hollow body 1016 as the container is inserted into the hollow body 1016.

Although the retention tabs 2008 are shown as tabs, other container retention features may be utilized, such as rings, bosses, or recesses that may be capable of collapsing outward and/or inward to allow assembly (i.e., insertion of the container 1012 into the hollow body 1016).

Base seat

According to certain embodiments, the hollow body 1016 and the base 1022 may define a corner 1070, such as shown in fig. 15A. Although the figures illustrate embodiments in which the angle 1070 is about 45 °, the hollow body 1016 and the base 1022 may define any angle in the range of 0 ° to 180 °.

As shown in fig. 13B, the base 1022 may include an inner surface 1072 and an outer surface 1074, the applicator pad 1024 being configured to be affixed to the outer surface 1074. Similar to the base 22 discussed above and shown in fig. 4A-4H, the base 1022 can include one or more perforations 1076 (see also fig. 13C). The applicator pad 1024 may be configured to attach to the base 1022 over the perforation 1076. Perforations 1076 may allow fluid to flow from hollow body 1016 to applicator pad 1024.

In some embodiments, the outer surface 1074 may include one or more channels, such as the channel 78 shown in fig. 4G. Likewise, in some embodiments, the outer surface 1074 of the base 1022 may be textured and/or may have other surface treatments, as shown in the figures and discussed above with respect to the outer surface 74 of the base 22 in fig. 4H.

According to certain embodiments, the base 1022 may be coupled to the hollow body 1016. The base 1022 may be coupled to the hollow body 1016 in any number of ways known in the mechanical arts including, but not limited to, by hinges, adhesives, mechanical interlocks, threaded portions, press fits, friction fits, interference fits, slip fits, and/or combinations thereof. According to other embodiments, the pedestal 1022 may be integrally formed with the hollow body 1016. The integrated 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, the applicator device 1040 may include an interchangeable attachment between the hollow body 1016 and the base 1022.

The base 1022 may be formed in many shapes and sizes. The discussion above regarding the shape and size of the base 22 and the applicator pad 24 (and corresponding figures) also applies to the shape and size of the base 1022 and the applicator pad 1024.

Applicator pad

The above description of the applicator pad 24 (and shown in the figures) illustrates features of the applicator pad 1024.

Actuator sleeve

The actuator sleeve 1026 may be configured to actuate to release fluid from the reservoir 1012 to the applicator pad 1024. Fig. 6A-6D illustrate various embodiments of an actuator sleeve 1026. Actuator sleeve 1026 may have an outer wall 1088, with outer wall 1088 having an outer surface 1090. The actuator sleeve 1026 may be configured to be inserted into the hollow body 1016 such that the outer surface 1090 of the outer wall 1088 of the actuator sleeve 1026 is disposed within the inner surface 1032 of the outer wall 1034 of the hollow body 1016. The actuator sleeve 1026 may be configured to actuate to release fluid in the reservoir 1012 to the applicator pad 1024. The actuator sleeve 1026 may be configured to translate longitudinally within the hollow body 1016 in order to release fluid from the reservoir 1012. The actuator sleeve 1026 may be translated longitudinally within the hollow body 1016 by applying a force to the proximal end 28 of the actuator sleeve 1026. In some embodiments, the proximal end 1028 of the actuator sleeve 1026 may be shaped to provide a substantially uniform force distribution across the proximal end 1028. For example, in certain embodiments, the proximal end 1028 of the actuator 1026 may have a rounded convex surface (see the proximal end 28 of the actuator sleeve 26 shown in fig. 6D). Such a convex surface may distribute forces across the proximal end 1028, thereby reducing the pressure experienced by the user. For example, a rounded convex surface may distribute forces across the palm of a user's hand. In other embodiments, the proximal end 1028 of the actuator sleeve 1026 may have a concave surface, as shown in fig. 11A and 14A, that evenly distributes the force across, for example, the thumb or fingers of the user.

In some embodiments, the actuator sleeve 1026 can include one or more notches 1092 extending from the distal end 1030 of the actuator sleeve 1026 to the proximal end 1028 of the actuator sleeve 1026. In these embodiments, the container 1012 can include a restraining feature, such as an outward protrusion 1054, to orient and position the container 1012 within the hollow body 1016. Such a restraining feature may be configured to fit within the recess 1092 of the actuator sleeve 1026.

In some embodiments, the actuator sleeve 1026 may include one or more longitudinal projections 1094 that project distally and are configured to interact with the cap 1040 of the receptacle 1012 to remove the cap 1040 from the receptacle 1012 to release the fluid in the receptacle 1012. For example, as shown in fig. 6C, the actuator sleeve 1026 may include two longitudinal projections 94, which may define two recesses 1092. An actuator sleeve having two recesses 1092 may be compatible with a container 1210 having two outward projections 1054 (see fig. 17A).

As shown in fig. 16A-16D, in some embodiments, the longitudinal projections 1094 may not be equal in length (see length difference 1020 in fig. 16B). In these embodiments, the cover 1040 may be pushed away from one side of the vessel 1012 each time the actuator sleeve 1026 is actuated by longitudinal translation. For example, the cover 1040 may include a protruding element 1100 (see fig. 11C) that may interact with the longitudinal protrusion 1094 of the actuator sleeve 1026 to remove the cover 1040 from the receptacle 1012, thereby releasing the fluid in the receptacle 1012.

In some embodiments, the longitudinal protrusion 1094 can comprise a distal end 1101, and the distal end 1101 can be configured to push the tab member 1100 distally when the actuator sleeve 1026 is longitudinally translated in a distal direction. As shown in fig. 16A, in some embodiments, the distal end 1101 of one or more longitudinal projections 1094 may include a recess 1103 that may be configured to interact with the cap 1040 (e.g., with the tab member 1100, see fig. 11B) to prevent rotation of the cap 1040 during longitudinal translation of the actuator sleeve 1026. In addition, each recess 1103 may serve as a cradle to retain a corresponding protruding element 1100 on the cover 1040 as the distal end 1101 of the longitudinal projection 1094 pushes the cover 1040 longitudinally away from the receptacle 1012.

The components of the applicator system 1010, including the applicator device 1014 and/or the container 1012, may be configured to be sterilized in a variety of ways known in the art, including, but not limited to, exposure to ethylene oxide ("(Et) 2O"), gamma rays, electron beams, and/or steam. Additional information regarding sterilization is discussed above.

In addition to the sealing ribs 1069, the actuator sleeve 1026 may also include constraining features, such as ribs or partial ribs 2000. The partial ribs 2000 may provide a constraining actuator sleeve 1026 to prevent unintended longitudinal translation of the actuator sleeve 1026, such as during shipping/transportation. For example, the constraining ribs 1068 of the hollow body 1016 may be left between the sealing ribs 1069 and the partial ribs 2000 of the actuator sleeve 1026 during shipping. Although the figures illustrate the confinement and sealing features (e.g., partial ribs 2000) as including ribs, in some embodiments, the confinement and sealing features may include bosses, recesses, detents, etc. (not shown).

As shown in fig. 16A and 16C, in some embodiments, the actuator sleeve 1026 may further include one or more flow features, such as cutouts 2012. The cutouts 2012 may allow free flow of fluid outside of the container 1012 to reduce the likelihood that fluid will become trapped between the container 1012 and the proximal interior of the actuator sleeve 1026 after actuation of the device.

Additionally, the longitudinal protrusion 1094 may include one or more knobs 2016 at the distal end. The ball 2016 may prevent the distal end of the longitudinal protrusion 1094 from deflecting radially outward during actuation. This ensures that the longitudinal projections 1094 do not miss the cover 1040 of the container 1012. Additionally, the ball 2016 may provide reinforcement to the distal tip of the longitudinal protrusion 1094.

As described above, the actuator sleeve 1026 may include spikes 1098 thereon to pierce the proximal end of the container 1012.

Various other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (35)

1. An applicator device for applying a fluid, comprising:

an elongated hollow body having a proximal end and a distal end and comprising at least one longitudinal inner guide rib and at least one longitudinal stop rib located on an inner surface of an outer wall of the hollow body;

an applicator pad coupled to a base at a distal end of the hollow body; and

an actuator sleeve inserted within the hollow body and including at least one distally projecting longitudinal protrusion;

wherein the at least one longitudinal protrusion acts distally on a cap portion of a container containing a fluid to open the cap portion when the actuator sleeve is translated distally within the hollow body, thereby releasing the fluid from the container to the applicator pad,

the fluid containing vessel is positioned within the hollow body such that the cap is distally positioned and, in addition, circumferential translation of the fluid containing vessel is inhibited by the at least one longitudinal inner guide rib and distal translation of the fluid containing vessel is inhibited by the at least one longitudinal stop rib.

2. The applicator device of claim 1, wherein the cap portion includes at least one protruding element that bulges toward an inner wall of the hollow body, the at least one longitudinal projection of the actuator sleeve acting on the at least one protruding element to open the cap portion.

3. The applicator device of claim 2, wherein the at least one longitudinal projection of the actuator sleeve pushes the at least one protruding element of the cap distally, thereby opening the cap.

4. The applicator device of claim 3, wherein the actuator sleeve includes two longitudinal projections of unequal length, such that upon longitudinal translation of the actuator sleeve, the longitudinal projections push the cap portion off of the container on one side at a time.

5. The applicator device of claim 4, wherein the longitudinal projection has a recess that interacts with the protruding element of the cap portion.

6. The applicator device of claim 3, wherein the actuator sleeve includes two longitudinal projections of equal length, such that upon longitudinal translation of the actuator sleeve, each of the longitudinal projections pushes the cap portion away from the container.

7. The applicator device of claim 6, wherein the longitudinal projection has a recess that interacts with the protruding element of the cap portion.

8. The applicator device of claim 2, wherein the actuator sleeve includes two longitudinal projections of unequal length such that the end of the longer of the longitudinal projections interacts with one protruding element.

9. The applicator device of claim 2, wherein the actuator sleeve includes two longitudinal projections of unequal length, such that a longer one of the longitudinal projections of the actuator sleeve includes an inwardly projecting longitudinal rib that interacts with one of the raised elements.

10. The applicator device of any one of claims 2-9, wherein the body portion and the cap portion of the fluid-containing reservoir are integrally formed with one another via a neck portion having a frangible portion that breaks when the longitudinal projections of the actuator sleeve push the protruding elements of the cap portion.

11. The applicator device of claim 10, wherein the frangible portion is formed over the entire circumference of the neck.

12. An applicator device according to any one of claims 4, 5, 8 and 9, wherein the body portion of the fluid-containing reservoir and the cap portion are integrally formed with one another via a neck portion having a frangible portion formed on a portion thereof, the frangible portion breaking when the longitudinal projection of the actuator sleeve pushes the protruding element of the cap portion.

13. The applicator device of claim 10, wherein the fluid-containing reservoir includes a hinge element disposed relative to the frangible portion and configured to maintain a connection between the body portion and the cap portion after the frangible portion is broken, thereby allowing the cap portion to pop open.

14. The applicator device of claim 2, wherein the at least one longitudinal projection of the actuator sleeve includes an angled surface that exerts a circumferential force on the at least one raised element of the cap to rotate the cap to open the cap.

15. The applicator device of claim 14, wherein the actuator sleeve includes two longitudinal projections, one of the longitudinal projections having an angled surface and the other of the longitudinal projections having teeth that interact with the protruding elements of the cap to prevent reverse rotation of the cap.

16. The applicator device of claim 1, wherein the hollow body includes one or more internal restraining features at a proximal end of the hollow body, the one or more internal restraining features including one or more ribs, bosses, or depressions configured to secure the actuator sleeve within the hollow body.

17. The applicator device of claim 16, wherein the at least one longitudinal interior guide rib on the interior surface of the outer wall of the hollow body is configured to orient and guide the container when the container is located within the hollow body.

18. The applicator device of claim 17, wherein the at least one longitudinal inner guide rib includes two substantially parallel guide ribs spaced apart from one another;

wherein the container includes an outward projection sized and shaped to fit into and be guided by the spaced apart substantially parallel guide ribs.

19. The applicator device of claim 18, wherein the hollow body includes the at least one longitudinal stop rib that is substantially parallel to and disposed between the guide ribs;

wherein each of the guide ribs has a proximal end and a distal end, and each of the stop ribs has a proximal end and a distal end, the proximal end of each of the stop ribs being located distal to the proximal end of the guide rib and being configured to interact with the distal end of the outward protrusion on the container so as to stop longitudinal translation of the container in a distal direction within the hollow body.

20. The applicator device of claim 16, wherein the hollow body comprises one or more container holding tabs;

wherein the retaining flap projects inwardly over the proximal end of the container once the container is pushed distally into the hollow body so as to prevent proximal translation of the container.

21. The applicator device of claim 1, wherein the hollow body includes an inwardly projecting protrusion configured to stop longitudinal translation of the actuator sleeve;

wherein the inwardly projecting protrusion is configured to reorient the cap portion of the container after being broken from the container by actuation of the actuator sleeve.

22. The applicator device of claim 1, wherein the proximal end of the actuator sleeve includes a sealing feature configured to interact with an inner surface of an outer wall of the hollow body to prevent fluid from leaking from the hollow body.

23. The applicator device of claim 1, wherein the actuator sleeve includes a partial rib disposed circumferentially around a proximal end of the actuator sleeve;

wherein the partial ribs are configured to interact with corresponding constraining ribs on the inner surface of the hollow body.

24. The applicator device of claim 1, wherein the actuator sleeve includes at least one notch extending from a distal end of the actuator sleeve to a proximal end of the actuator sleeve;

wherein the container includes an outward protrusion sized and shaped to fit within the recess of the actuator sleeve, the recess configured to interact with a corresponding outward protrusion on the container.

25. The applicator device of claim 1, wherein the at least one longitudinal projection includes one or more features at a distal end of the at least one longitudinal projection to prevent the distal end of the at least one longitudinal projection from deflecting radially outward during actuation.

26. The applicator device of claim 1, wherein the actuator sleeve has a proximal end and a distal end, the actuator sleeve configured to fit between an inner surface of an outer wall of the hollow body and an outer wall of the container, longitudinal translation of the actuator sleeve within the hollow body releasing fluid in the container, thereby allowing fluid to flow to the applicator device;

wherein the container comprises a flat side; and

wherein the actuator sleeve comprises a thicker reinforcement corresponding to the flat side of the container.

27. The applicator device of claim 1, further comprising a label configured to be affixed to an outer wall of the hollow body, wherein the vent channel, when covered by the label, constitutes one or more serpentine paths through which air may be vented to and/or from the interior of the hollow body when in the upright use position, and inhibits fluid outflow when the applicator device is placed on a flat surface and the hollow body is oriented substantially parallel to the ground.

28. An applicator system for applying a fluid, comprising:

an applicator device, the applicator device comprising:

an elongated hollow body having a proximal end and a distal end and comprising at least one longitudinal inner guide rib and at least one longitudinal stop rib located on an inner surface of an outer wall of the hollow body;

an applicator pad coupled to a base at a distal end of the hollow body;

an actuator sleeve inserted within the hollow body and including at least one distally projecting longitudinal protrusion; and

a fluid-containing vessel located within the hollow body such that a cap is distally positioned and further wherein circumferential translation of the vessel is inhibited by the at least one longitudinal inner guide rib and distal translation of the vessel is inhibited by the at least one longitudinal stop rib;

wherein when the actuator sleeve is translated distally within the hollow body, the at least one longitudinal protrusion acts distally on a cap portion of the fluid-containing reservoir to open the cap portion, thereby releasing the fluid from the reservoir to the applicator device.

29. The applicator system of claim 28, wherein the at least one longitudinal projection of the actuator sleeve pushes the at least one protruding element of the cap distally, thereby opening the cap.

30. The applicator system of claim 29, wherein the actuator sleeve includes two longitudinal projections of unequal length, such that upon longitudinal translation of the actuator sleeve, the longitudinal projections push the cap away from the container on one side at a time.

31. The applicator system of claim 29, wherein the actuator sleeve includes two longitudinal projections of equal length, such that upon longitudinal translation of the actuator sleeve, each of the longitudinal projections pushes the cap away from the container.

32. The applicator system of claim 29, wherein the actuator sleeve includes two longitudinal projections of unequal length such that the end of the longer of the longitudinal projections interacts with one protruding element.

33. The applicator system of claim 28, wherein the actuator sleeve includes two longitudinal projections of unequal length, such that the longer of the longitudinal projections of the actuator sleeve includes an inwardly projecting longitudinal rib that interacts with a protruding element located on the cap portion.

34. The applicator system of claim 28, wherein the at least one longitudinal projection of the actuator sleeve includes an angled surface that exerts a circumferential force on at least one protruding element of the cap to rotate the cap to open the cap.

35. The applicator system of claim 34, wherein the actuator sleeve includes two longitudinal projections, one of the longitudinal projections having an angled surface and the other of the longitudinal projections having teeth that interact with the protruding elements of the cap to prevent reverse rotation of the cap.