Fluid application device

ES 2 575 007 T3

DESCRIPTION

Fluid application device and method

Countryside

The present application relates to a fluid application apparatus and method.

Introduction

Preparing patients for various medical interventions, for example surgery, typically includes the application of a topical solution (or fluid), for example an antiseptic solution, to disinfect the area targeted for medical interventions. Topical solutions can be applied to the targeted area by saturating a sponge-like material with the solution and using a portable device, for example a pair of forceps or a hemostat, to direct the saturated sponge to the targeted area. Sponges or foam materials are typically soaked with a fluid contained within an open bowl or other container.

In certain cases, existing devices used to apply solutions exhibit various disadvantages. For example, typical applicators use sponges that do not hold fluid efficiently, resulting in leakage. As a result, preparing targeted areas for antiseptic cleansing becomes an unpleasant intervention. In addition, the leakage of various fluids into areas outside of the targeted areas can lead to accumulation of various fluids that can cause irritation, discomfort, and / or other undesirable conditions.

Another example of a disadvantage involves the difficulty of dispensing a desired dose of fluid to the targeted area. During fluid application, in certain cases, it may be desirable to control the amount of fluid, eg, 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 can be difficult to determine. This can result in more or less solution applied to the targeted area than is desired. Additionally, typical applicators utilize foams and / or fluid delivery systems that fail to timely dispense a precise amount of fluid. For example, certain internal blister applicators 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 inaccurate dispensing of the desired solution.

Document WO 03/076000 pertains to a fluid product applicator.

US 6,371,675 relates to a skin disinfectant applicator.

US 2007/0020029 refers to a surgical preparatory solution application system and methods.

Document WO 02/46089 pertains to a liquid applicator with diametrically opposite wings.

Document WO 2006/055397 pertains to a fluid application device and method.

US 5,791,801 relates to a liquid applicator.

Summary

In some aspects, the present description is directed to an applicator device for applying a fluid as defined in the claims.

In certain aspects, the present invention is directed to a method of applying a fluid to a surface as defined in the claims.

Brief description of the drawings

Figure 1 illustrates an exploded view of an applicator according to an embodiment described as an example;

Figure 2A illustrates a cross-sectional side view of a fluid-containing package;

Figure 2B illustrates a cross-sectional side view of an assembled applicator including the package of Figure 2A;

Figure 2C illustrates a cross-sectional side view of the package of Figure 2A in a collapsed state;

Figure 2D illustrates a cross-sectional side view of an assembled applicator including a collapsed package;

Figure 3A is a perspective view of a handle with a receptacle of an applicator device according to a

ES 2 575 007 T3 embodiment described as an example;

Figure 3B is a perspective view of a lid corresponding to the receptacle shown in Figure 3A;

Figure 3C is a cross-sectional view of an assembled applicator according to certain embodiments;

Figure 4A illustrates a front perspective view of an assembled applicator according to certain embodiments;

Figure 4B illustrates a rear perspective view of an applicator assembled according to certain embodiments;

Figure 5A illustrates a front view of a handle for an applicator device according to certain embodiments;

Figure 5B illustrates a bottom view of a handle for the applicator device shown in Figure 5A;

Figure 6A illustrates a front view of a handle for an applicator device according to certain embodiments;

Figure 6B illustrates a bottom view of a handle for the applicator device shown in Figure 6A;

Figure 7A illustrates a front view of an assembled applicator;

Figure 7B illustrates a bottom view of the applicator shown in Figure 7A;

Figure 8 illustrates a cross-sectional side view of a portion of an applicator device;

Figures 9A-9H illustrate various examples of a base of an applicator device;

Figures 10A-10F depict a series of steps for creating a rounded applicator pad from a flat disk of absorbent pad material;

Figure 11 illustrates an edge weld between an applicator pad and a base of an applicator device; ^Y

Figures 12A-12D illustrate various applicator pads as examples.

Description of various embodiments

In this application, the use of the singular includes the plural, unless otherwise specifically indicated. In this application, the use of "or" means "and / or", unless otherwise indicated. 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 that constitute a unit and elements and components that constitute more than one unit, unless specifically indicated otherwise.

The described applicator can be configured to dispense / apply any liquid with a suitable viscosity to allow its passage through and dispensing into the described device. In some embodiments, the described applicator can be used to dispense / apply an antiseptic fluid. The term "antiseptic fluid", as used herein, refers to a liquid that, in certain embodiments, can be used to disinfect a region in preparation for various medical procedures.

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

Figure 1 illustrates an exploded view of a system 10 for applying a fluid. As shown in Figure 1, the system 10 may include a package 12 configured to contain a fluid. Additionally, system 10 may include an applicator device 14 configured to apply a fluid to a surface. The applicator device 14 may include a handle 16. The handle 16 may comprise a socket 18 at a proximal end 20 and a base 22 at a distal end 24. Applicator device 14 may also include an applicator pad 26 coupled to base 22. Applicator device 14 may include a cap 28 configured to confine package 12 within receptacle 18.

Package

Package 12 may include proximal end 30 and distal end 32 and may be configured to insert into receptacle 18 with distal end 32 of package 12 facing distal end 24 of handle 16, as shown in Figure 1. Fluid within package 12 can be expelled by applying an external force to package 12, which can cause package 12 to burst (e.g., in a frangible area), allowing (or forcing) the fluid to flow distally through the base 22 and toward applicator pad 26.

Package 12 can be configured in any suitable way. In some embodiments, package 12 may

ES 2 575 007 T3 have a substantially round shape, as shown in the accompanying drawings. Package 12 may be configured to fit within, and generally correspond to, the shape of receptacle 18, which may also be substantially round, as shown. In some embodiments, the package 12 may contain orientation features to simplify the assembly of the components of the fluid application system 10. For example, package 12 may have a shape that corresponds to a mating shape of receptacle 18. Mating shapes may be asymmetric to orient package 12 relative to receptacle 18.

In certain embodiments where package 12 and receptacle 18 have substantially matching mating shapes (for example, as shown in Figure 1), the orientation features may include structure in receptacle 18 that substantially deviates from the shape. round receptacle 18 and a corresponding structure in package 12 that deviates from the substantially round shape of package 12. For example, orientation features can include asymmetric shapes, such as corresponding projections on receptacle 18 and package 12 (in a teardrop shape), as shown in Figure 1. That is, applicator device 14 can include a package boss 36 on package 12 that is configured to orient with a corresponding receptacle feature 34 on receptacle 18.

Asymmetric mating shapes, such as teardrops, can not only facilitate assembly by making it readily apparent how package 12 and receptacle 18 should align with each other, but can also ensure that the frangible area of ​​package 12 faces toward the distal end of applicator device 14 so that fluid released from packet 12 can easily flow into applicator pad 26. For example, in certain embodiments, receptacle 18 may be configured to orient package 12 with package boss 36 positioned toward base 22. In such embodiments, package boss 36 may include the frangible area of ​​package 12. This positioning of the frangible area (i.e., toward the base 22) may allow fluid to flow easily from the package 12 into (and through) the base 22 and into the applicator pad 26 upon rupture of the frangible area. example due to gravity and / or due to squeezing of package 12 to expel fluid from package 12 and receptacle 18.

As shown in Figure 2A, package 12 may include opposing sides 38 defining between them a sealed space 40 that can be filled with fluid. One or the other or both opposite sides 38 can be deformable. Fluid within package 12 can be expelled by applying an external force to opposite sides 38 of package 12, which can cause package 12 to rupture, allowing (or forcing) fluid to flow distally through base 22 and toward applicator pad 26.

The frangible area of ​​package 12 can be configured to break open upon application of reasonable activating force (eg, squeezing / compressing package 12). Although the frangible area can be configured to break open upon application of force by a user, the package 12, including the frangible area, can be configured to maintain structural integrity during handling, storage, etc., in order to prevent accidental leaks or openings.

The package 12 can be formed of any type of material that is suitable for forming a fluid containment package with a frangible area. For the purposes of this description, the term "frangible" will mean breakable, burst (as in the case of a flexible package), or otherwise configured to break. In some embodiments, the frangible area can be a part of the package that has been prepared to have less strength than other portions of the package. For example, in certain embodiments, a frangible seal can be created by sealing the desired area as frangible at a temperature lower than that required for maximum seal strength. In other embodiments, a frangible seal may be created by forming the frangible area by using a specially formulated "peelable" film having inherently lower adhesion.

Package 12 may be self-draining by means of a two-sided configuration that allows one side to be gently reversed into the other when package 12 is compressed. For example, as shown in Figures 2A and 2B, package 12 can include a first package side 42 and a second package side 44. The first package side 42 and the second package side 44 can be sealed to each other in a sealed portion 46 around the perimeter of package 12. Package 12 can be configured so that, upon compression, the first side 42 of the package is inverted into the second side 44 of the package, thereby collapsing the sealed space 40, as shown in Figures 2C and 2D. Package 12 can be configured to fully collapse (and, in some examples, remain collapsed) in order to evacuate substantially all of the fluid from package 12.

Package 12 may include a collapsible feature that allows first side 42 of package 12 to invert from a convex position, as shown in Figures 2A and 2B, to a concave position, as shown in Figures 2C and 2D. , after compressing the package 12, so that the previously sealed space 40 is substantially completely collapsed. In some examples, the first side 42 and the second side 44 of the package 12 can be formed from films of different thicknesses. For example, in some embodiments, the first side 42 of the package may be formed of a thinner film than the second side 44 of the package to allow deformation of the first side 42 of the package to reverse the first side 42 of the package and,

ES 2 575 007 T3 therefore, the collapse of packet 12.

Alternatively or additionally, the first side 42 of the package may be sized and / or configured differently than the second side 44 of the package to provide collapsibility of the package 12. For example, the first side 42 of the package may include a first central portion 48 and first peripheral portions 50, and the second side 44 of the package may include a second central portion 52 and second peripheral portions 54. The first side 42 of the package and the second side 44 of the package can be sealed to each other at a junction between the first peripheral portions 50 and the second peripheral portions 54. In certain examples, the first central portion 48 may have a smaller diameter (eg, on the order of tenths or hundredths of an inch) than the second central portion 52, thus forming a collapsible feature that allows the first side 42 of the package to fits within the second side 44 of the package, as shown in Figures 2C and 2D.

In certain embodiments, the liquid contained in package 12 can be an antiseptic solution that contains an active ingredient. Various active ingredients of an antiseptic solution 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; fluorosalane; hexachlorophene; hexylresorcinols; compounds containing iodine; povidone iodine; povidone iodine with alcohol, ethanol, isopropyl alcohol, and other alcohols and combinations thereof.

In some embodiments, the antiseptic solution may include a biagunide derivative and / or salts thereof, for example olanexidine [1- (3,4-dichlorobenzyl) -5-octylbiguanide] and salts thereof, as an active ingredient, as described described, for example in US Patent No. 5,376,686. In certain embodiments, the typical antiseptic can include olanexidine gluconate.

The antiseptic solution may also incorporate certain surfactants, for example nonionic surfactants based on polyoxyethylene and / or alcohols, for example ethanol, isopropyl alcohol and other alcohols, and / or water, in varying amounts. Useful surfactants are known to those skilled in the art, for example Poloxamer 124 (also known as 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 can include an active ingredient and a polyoxyethylene-based nonionic surfactant in various concentrations. In some embodiments, the polyoxyethylene-based nonionic surfactant may be present in a concentration of from about 0.05 to about 16% (weight / volume).

In certain embodiments, the topical antiseptic may include a biguanide derivative and / or salts thereof, in a concentration of from about 0.05 to about 5.0% (weight / volume of biguanide base). In some embodiments, the biguanide derivative or the salt thereof may be olanexidine [1- (3,4-dichlorobenzyl) -5octylbiguanide] or a salt thereof.

In some examples of system 10, applicator device 14 may be provided in ready-to-use form. For example, the applicator device 14 can be stored, packaged and / or transported, etc. with applicator pad 26 attached to base 22 and with package 12 confined within receptacle 18 by lid 28, as shown in Figure 2B. (See also FIG. 4A.) In such examples, the packet 12 may be pre-filled with a fluid, such as an antiseptic fluid, for example.

Receptacle

The receptacle 18 may be configured to receive the pack 12 and facilitate the expulsion of fluid from the pack 12. The handle 16 may have features that facilitate the delivery of fluid to the absorbent pad 26, such as a smooth and tapered neck 56 between the receptacle 18 and base 22, which may include a distal opening 57 through which fluid can flow from receptacle 18 to applicator pad 26, as shown in Figures 2B and 2D. The receptacle 18 may comprise a bowl-like housing 58 defining a recess 60 and having a rim 62. (See Figure 1.) The lid 28 may be sealed to the rim 62, for example using a heat seal, radio frequency (RF) welding, adhesive bonding, laser welding or any other suitable type of fixation. In some examples, the receptacle 18 may include energy directors or textured surfaces for ultrasonic welding or other manner of attachment of the lid 28 to the receptacle 18.

In addition to package orientation features such as asymmetric shapes, as described above, receptacle 18 may include one or more different package orientation features such as, but not limited to, a depression, a well, ribs, an embossing. , a de-embossing or a series of such elements, to accept and / or secure the package 12. For example, as shown in Figures 2B and 2D, receptacle 18 can include various steps and / or contours that can be shaped to match

ES 2 575 007 T3 corresponding features on package 12 and / or retain them. (See also figure 1.)

Figures 3A-3C illustrate one embodiment of applicator device 14 that includes examples of package orientation features. For example, as shown in Figure 3A, the receptacle 18 may include one or more interior ribs 63, an embossed ridge 64, and an embossed area that forms a well 65. As shown in Figure 3B, the lid 28 can be configured to be used with the receptacle shown in Figure 3A. In some embodiments, cap 28 may include an indented face 66 that may allow a dome 67 of cap 28 to have a lower profile, as shown in Figure 3B. Figure 3C is a cross-sectional view of an assembled applicator device 14 that includes the components shown in Figures 3A and 3B.

In addition to the orientation features, the handle 16 may also include one or more exterior gripping features to facilitate manipulation of the applicator device 14 by a user. For example, receptacle 18 may include gripping features such as ergonomic shaping and / or sizing, as well as indentations, protruding gripping members, strips and / or textured areas, rubberized material, etc., to promote a secure grip on receptacle 18 . In some embodiments, handle 16 may include one or more gripping ribs 68 (eg, on socket 18), as shown in Figure 4B.

In some embodiments, applicator device 14 may include a purge feature configured to allow air to flow into or out of receptacle 18. Such purge feature may be configured to limit leakage of fluid out of handle 16 at undesirable locations, while a controlled fluid supply to the absorbent pad is still allowed. For example, in some embodiments, a purge feature can be located at the proximal end 20 of the handle 16, where air can pass into and out of the handle 16, while fluid resides at a distal end of the handle 16 when the applicator device 14 is held in a vertical position. In some embodiments, the bleed feature may include an area that is left unsealed at a junction between lid 28 and rim 62 of receptacle 18. For example, in certain embodiments, the rim 62 of the receptacle 18 may include a groove (not shown) on which the lid 28 may be left unsealed.

In some embodiments, one or more portions / components of applicator device 14 may be formed of a transparent or translucent material. For example, one or more portions of the receptacle 18 may be formed of a transparent or translucent material. In some embodiments, one or more cap portions 28, package 12, and / or base 22 may be formed of transparent or translucent materials. The transparency and / or translucency of certain portions / components of applicator device 14 may allow observation of the amount of fluid remaining in package 12 and / or may facilitate monitoring of fluid flow through applicator device 14 while it is in use. being dispensed.

As shown in Figures 5A and 5B, in some examples, receptacle 18 may include a three-sided channel 69 configured to direct fluid flow to distal opening 57 in base 22, which may be slotted to incorporate the channel. 69. Also, as shown in Figures 6A and 6B, the handle 16 may have a wider base 22 with a widened distal opening 57. Such a wider base 22 may be compatible with a wider applicator pad 26. For example, as shown in Figures 7A and 7B, applicator device 14 may include a wider base 22 and a corresponding wider applicator pad 26. Features such as channel 69, a widened-type distal opening 57, and a wider base 22 can facilitate increased flow and / or distribution of fluid to applicator pad 26.

Handle 16, ie, socket 18 and base 22, can be formed using any suitable process, such as injection molding, machining, and / or any other suitable manufacturing method. Features such as open channel 69 and / or widened-type distal opening 57 can facilitate molding of handle 16. Handle 16 can be formed of any suitable material, including, for example, thermoplastic such as polyester, SB block copolymer, polyolefins, etc.

Top

Lid 28 may be configured to seal package 12 within receptacle 18. Lid 28 may also be flexible and thus be configured to deflect in response to application of exterior pressure, allowing application of external pressure to package 12 when it is disposed within the receptacle 18 to thereby compress the package 12 to release fluid from the package 12. In some embodiments, the lid 28 may be configured to distribute the force applied to the lid 28. For example, in some embodiments, the lid 28 may have a dome shape, as illustrated by the lid dome 67. (See Figures 1, 2B, and 3B.)

Cap 28 may be formed by any suitable method, including thermoforming and die cutting for semi-rigid embodiments of cap 28. For embodiments where cap 28 may be of a stretchable material, cap 28 may be die cut tapered. Examples of materials from which lid 28 may be formed include any suitable materials for sealing to receptacle 18. Such materials can include, for example, polyesters, polyolefins, SB block copolymers, etc.

ES 2 575 007 T3

Lid 28 may be sealed to receptacle 18 using any suitable method. For example, cap 28 can be attached to receptacle 18 using heat sealing, adhesive / glue, laser welding, ultrasonic welding, etc.

Base

The base 22 is to be located at the distal end 24 of the handle 16 and is to be configured to direct the flow of fluid released from the pack 12 to the applicator pad 26. As shown in Figure 2B, the distal opening 57 allows fluid flows into applicator pad 26 after release from package 12. As described in more detail below, distal opening 57 is to be configured to receive a portion of applicator pad 26.

Base 22 can be formed in a variety of shapes and sizes. In some embodiments, the shape and / or size of the base 22 may correspond generally to that of the applicator pad 26, as shown in Figures 6A and 6B. (See also Figure 1.) In other embodiments, applicator pad 26 may have a shape and / or size that differs from base 22.

Base 22 is to be oriented at an angle relative to receptacle 18. For example, certain embodiments of receptacle 18, for example embodiments having a substantially round shape, as in Figure 1, may be formed around a central receptacle axis 70 through, for example, the substantially round shape of the receptacle 18. The central socket axis 70 may be oriented at an angle 71 relative to an axis 72 perpendicular to a plane 74 (see Figure 2B) that includes the base 22. In some embodiments, the angle 71 may be approximately 90 degrees, such as shown in Figures 1 and 2B, for example. In other embodiments, angle 71 can be any angle within the range of 0 to 180 degrees. For example, in Figure 8, angle 71 is shown at approximately 45 degrees.

As shown in Figure 8, the base 22 may include an inner surface 76 and an outer surface 78, to be attached to which the applicator pad 26 may be configured. In some examples, as shown in Figures 9A-9H, base 22 may include one or more perforations 80, to be attached to which applicator pad 26 may be configured. perforations 80 may allow fluid flow from receptacle 18 to applicator pad 26.

In some examples, outer surface 78 may include one or more channels 82, as shown in Figure 9G. Channels 82 may be configured to distribute fluid to different portions of applicator pad 26. Also, in some embodiments, outer surface 78 of base 22 may be textured, as shown in Figure 9H. The texture can promote not only the attachment of the applicator pad 26 to the base 22, but can also facilitate the distribution of the fluid to different parts of the applicator pad 26.

According to certain examples, the base 22 can be coupled to the receptacle 18. The base 22 can be coupled to the receptacle 18 in a variety of ways known in the mechanical arts, including, but not limited to, hinge fastening, adhesives, mechanical interlocks, portions threaded, press fit, friction fit, interference fit, slip fit and / or combinations thereof. According to other examples, base 22 may be integrally formed with receptacle 18. An integral base / handle combination can be manufactured by various processes known in the art, including, but not limited to, molding, injection molding, casting, machining or combinations thereof.

In certain examples, the applicator device 10 may include an interchangeable grip between the socket 18 and the base 22. An interchangeable clamp may facilitate, for example, the use of bases having various shapes and sizes in the same socket 18, and vice versa. This can facilitate, for example, the use of differently sized applicator pads with the same receptacle 18.

Applicator pad

Applicator pad 26 is configured to engage base 22, in fluid communication with an interior portion of receptacle 18. In the claimed embodiment, as shown in Figure 2B, a portion of applicator pad 26 is to be inserted into distal opening 57 of base 22 and is to wrap around an outer portion 84 of distal opening 57. Applicator pad 26 may be attached to base 22 (eg, through ultrasonic welding, adhesive, etc.) at outer portion 84 of distal opening 57. In some wrapping embodiments of applicator pad 26 (eg, As shown in Figure 2B), the applicator pad 26 may be at least partially preformed, for example in a shape such as that shown in Figure 1. For example, applicator pad 26 can be molded, cut or shaped and / or compressed to such a configuration.

Some wrapping embodiments of the applicator pad 26 can be formed from a disc-shaped pad by inserting a portion of the disc into the distal opening 57 of the base 22 and then wrapping another portion of the disc around the outer portion 84 of the distal opening 57. Figures 10A-10F depict

ES 2 575 007 T3 a series of steps to create a rounded applicator pad from a flat disk of absorbent pad material. Figure 10A shows an applicator pad 26 as a flat disk in position on the applicator device 14. As shown in Figure 10B, the disk-shaped applicator pad 26 can be compressed and pressed into the distal opening 57 of the base. 16. Figure 10C shows the disc unrestricted at distal opening 57. As shown in Figure 10D, a tool 85 can then be moved downward on the disc. Figure 10E shows that the applicator pad 26 has been pushed around the outer portion 84 of the distal opening 57, where the applicator pad 26 can be attached to the base 16. Figure 10F shows that the tool 85 is removed, leaving the finished rounded applicator pad 26.

As noted above, like base 22, applicator pad 26 can be of any suitable size and / or shape. In certain embodiments, the applicator pad 26 may have a rounded or substantially spherical or hemispherical shape, as shown in Figures 1 and 2B, for example. In some examples, the applicator pad 26 may have alternate shapes, as shown in Figures 7A and 7B, as well as Figures 8, 9A-9H and 12A-12D. In certain examples, base 22 and / or applicator pad 26 may be generally triangular with rounded edges, as shown in Figures 9A-9H and 12A-12D. This generally triangular shape can approximate a teardrop shape, as shown. Other examples of shapes for base 22 may include, without limitation, rectangular, circular, oval, rhombic shapes, various polygonal shapes (see, for example, Figures 7A and 7B), and / or complex shapes comprising combinations thereof.

A generally triangular / teardrop shape or a rhombus shape can allow applicator device 14 to be used on surfaces that have a variety of contours. For example, the smaller tips at the vertices of the triangle or, for example, a rhombus shape (see, for example, Figures 7A and 7B), particularly the most distal tip 86, can allow access to cracks and features of smaller surface, while the broad proximal end of applicator pad 26 can provide a large pad surface to allow fluid application to larger, more smoothly contoured surfaces.

Applicator pad 26 can be attached to base 22 using any of a variety of clamping mechanisms. For example, applicator pad 26 can be attached to base 22 using any suitable method, including, for example, adhesive bonding using, for example, medical grade cyanoacrylate, UV curing adhesive, and the like. In some embodiments, applicator pad 26 can be attached to base 22 using RF welding, thermal upsetting, ultrasonic welding, laser welding, mechanical interlocks, hook and loop mechanisms (eg, Velcro®), threaded pieces, etc. , as well as combinations of these mechanisms. Accordingly, base 22 and applicator pad 26 can each be configured for attachment to one another using any of these mechanisms and thus can include appropriate features (e.g., texture, adhesive, latches / mechanical clamping, coatings, etc.) to allow such clamping.

In some examples, applicator pad 22 can be attached to base 22 using edge weld 87, as shown in Figure 11. Edge weld 87 can be created by holding handle 16 in a mount with base 22 facing up. , placing applicator pad 26 on top of base 22 and bringing the ultrasonic horn down onto applicator pad 26 and base 22. In this way, the applicator pad 26 can be wrapped substantially evenly around the base 22. During this process, the ultrasonic energy welds the surface of the applicator pad 26 to the edge of the base 22 and, when the ultrasonic horn is removed, the main body of the foam snaps back to an uncompressed state.

In some embodiments, applicator pad 26 may include a substantially hydrophobic foam. Alternatively or additionally, the applicator pad 26 may include a substantially hydrophilic foam. The term "substantially hydrophobic foam", as used herein, refers to a polymer-based foam that does not absorb a substantial amount of water. Rather, a definition of a substantially hydrophilic foam is provided below. For purposes of this description, a "substantially hydrophobic foam" will 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 that has an affinity for water. For example, certain embodiments of the invention may utilize a polyurethane foam with an open cell pore structure. In certain cases, the substantially hydrophilic foam can be designed for a high rate of fluid absorption such as, for example, absorption of about 20 times the weight of the foam. Although not wishing to be bound by any 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 polymer chains that can form bonds. hydrogen 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 absorbent materials, such as superabsorbents and / or surfactants, to the foam matrix. Substantially hydrophilic foams that can be used in certain embodiments of the invention are available from

ES 2 575 007 T3 organizations including the following: Foamex International Inc. (Media, PA), Crest Foam Industries, Inc. (Moonachie, NJ), Rynel, Inc. (Boothbay, Maine), Avitar, Inc. (Canton, MA, USA), Lendell Manufacturing, Inc. (Charles, MI, USA) and Copura (Denmark). In addition, certain patents, including US Patent No. 5,135,472 to Hermann et al., Describe substantially hydrophilic foams that can be used in certain embodiments of the invention. In some embodiments, applicator pad 26 may be formed from a hydrophobic, cross-linked polyurethane foam from Foamex.

The applicator pad 26 may include felting or may not be felted. In addition, the applicator pad 26 may include cross-linking or it may not be cross-linked. In some embodiments, applicator pad 26 can include multiple pad materials. In such embodiments, combinations of any of the above features may be employed. For example, in an exemplary multi-material pad, one pad material can be hydrophobic and a second pad material can be hydrophilic.

The applicator pad 26 can include a single layer or multiple layers. In addition, applicator pad 26 may include grooves to facilitate distribution and / or flow of fluid through applicator pad 26. Figures 12A-12D illustrate various examples of applicator pad 26 having various combinations of the features listed above. . For example, applicator pad 26 may comprise a single layer and no indentations, as shown in FIG. 12A. In various examples, applicator pad 26 may comprise a single layer, which may include indentations 88, as shown in Figure 12B. As illustrated in Figure 12B, applicator pad 26 can include multiple indentations. Furthermore, the grooves 88 can be arranged in a pattern. For example, Figure 12B shows a pattern of substantially parallel grooves 88 oriented at an angle.

In other examples, the applicator pad 26 may include multiple layers. As shown in Figures 12C and 12D, the applicator pad 26 may comprise a base layer 90 and a laminated layer 92. The grooves 88 may be provided in the base layer 90 and / or laminated layer 92. Figures 12C and 12D illustrate examples in which slits 88 are provided in at least one laminate layer 90. Figure 12C shows a substantially parallel groove pattern 88 similar to that of Figure 12B. Figure 12C illustrates a pattern in which the grooves 88 are oriented in a generally lateral direction, as opposed to those in Figure 12B, which are oriented at an angle. The grooves 88 can be arranged at any angle. In addition, the grooves 88 may be arranged in any of a plurality of shapes, such as the groove 88 in FIG. 12D, which is generally circular. The grooves 88 can also be formed in various other shapes including, but not limited to, ovals, polygons, etc. The grooves 88 can be formed in any suitable manner, for example, by die cutting / osculation.

In some examples, each layer can be formed from a different pad material. In various examples, applicator pad 26 may include at least one abrasion layer. In certain applications, an abrasion layer can be used to erode an area targeted for treatment, for example the epidermis. Abrasion can be done before, during and / or after dispensing the fluid. In certain examples, abrasion can cause a release of certain biological materials, for example body oils, body earths, and / or bacteria, to facilitate treatment of the targeted area. For example, prior to application of an antiseptic solution, a user may erode a patient's epidermis to release bacteria to improve the effectiveness of the antiseptic application process. In certain examples, an abrasion layer may comprise more than one layer of material, which can facilitate a greater amount of abrasion and / or abrasion of more difficult to clean areas.

In certain examples, an abrasion layer may comprise various textures and / or ligaments, for example a gauze or foam-like material. In certain examples, an exemplary gauze-like material can be made of various materials that facilitate abrasion, including, but not limited to, cotton, rayon, nylon, and / or combinations thereof. The material of the abrasion layer can be chosen from a plurality of materials that exhibit varying degrees of abrasiveness. For foam materials, the level of abrasiveness may differ depending, among other things, on the size of the cells / pores. The skin of a premature baby can be thin and fragile, and thus an applicator device comprising an abrasion layer made of nylon or rayon may be preferable to an abrasion layer made of cotton. In certain examples, an abrasion layer can comprise a plurality of layers of different materials. In some examples, for example foam abrasion layers, the abrasion layer may be flame laminated to base 22 and / or applicator pad 24.

As illustrated in Figures 12C and 12D, the laminated layer 92 (which may comprise an abrasion layer) may have a shape that generally corresponds to the shape of the base layer 90 of the applicator pad 26. However, in certain For examples, the laminated layer 92 may have various other shapes, including, but not limited to, circular, oval, rectangular, triangular, polygonal, and the like, or complex shapes that include one or more thereof. The layers of applicator pad 26 can be attached to one another by a variety of clamping mechanisms, including, but not limited to, adhesive bonding (eg, using pressure sensitive adhesives), fusion bonding, flame lamination, thermal upsetting. , ultrasonic welding,

ES 2 575 007 T3 etc. Methods for laminating and / or attaching various materials to applicator pad materials, such as foams, are known in the art. For example, US Patent Application No. 10 / 829,919, US Provisional Application No. 60 / 464,306, and PCT Application Serial No. US04 / 012474 all describe methods and apparatus for attaching materials to polyurethane foam.

The components of the applicator system 10, including the applicator device 14 and / or the package 12, can be configured to 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 vapor. According to various examples, the fluid can also 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, US Patent No.

6,682,695 describes a method for sterilizing a fluid that may be compatible with certain embodiments of the invention.