WO2001085073A1

WO2001085073A1 - Applicator for a urine collection bag

Info

Publication number: WO2001085073A1
Application number: PCT/US2000/007582
Authority: WO
Inventors: Fabio Cinelli; Peter Coles; Alessandro Guglielmi; Gregor Hoffman; Maurizio Marchesini; Kevin Oliver; Gianfranco Palumbo; Manuela Scholz; Udo Friedel Schonborn; Ann Marie Sullivan; Thomas Sutton; Eva Susanne Dominique Thurnay; Sabrina Turacchio
Original assignee: The Procter & Gamble Company
Priority date: 2000-03-22
Filing date: 2000-03-22
Publication date: 2001-11-15
Also published as: EP1265569A1; AU2000237686A1; CA2400549A1; JP2003532493A

Abstract

The present invention relates to a urine collection bag (10). More particularly, the invention relates to an applicator (40) for the placement of such a urine collection bag (10) to the uro-genital area of a wearer and the use thereof. According to the present invention the applicator (40) comprises a means for releasable attachment to the urine collection bag (10).

Description

Applicator for a urine collection bag

Field of the invention

The present invention relates to urine collection bags for babies, children or adults, to be adhesively attached in a releasable manner to the uro-genital area of the wearer. More particularly it relates to an applicator for such a device, which can be used to place the device in the uro-genital area of a wearer.

Background

Urine collection bags are known articles of manufacture that are designed to be worn principally by incontinence sufferers and infants. Such urine collection bags are attached to the uro-genital region of the wearer and are intended to entrap and immediately contain urine and other bodily discharges. As a consequence, these devices are functionally effective in lessening epidermal irritation; in preventing contamination of articles such as clothing and bedding; and even in preventing the soiling of the carers themselves. A problem naturally associated with these devices is their attachment to the human body. The approach which is mostly used in the field is to provide the device with an adhesive flange, which will stick to the uro-genital area.

Representative prior art in the field of urine collection bags includes the following: GB 2,268,882 discloses a urostomy bag of plastic material provided with a circular stomal orifice which is surrounded by a first coupling member, by which the pouch can be affixed to a counterpart coupling member, which can be attached to a wearer. US 4,804,377 discloses a collector for urine specimens from children. The collector comprises a rectangular flange for adhesive attachment. EP 140 478 discloses a disposable diaper having a water proof barrier preferably polypropylene or polyethylene formed as a flattened bag having a single opening. US 1 ,092,274, US 3,292,626 and Chinese patent application CN 1079381 all disclose urine collection bags for female infants.

Besides and in connection with optimum adherence, the correct placement of the device is also a key issue in the field of urine collection bags. Total or substantial misplacement of the device will lead to a severe misfunctioning, in particular incomplete collection of urine and leakage.

If the misplacement of the device is recognised before use, the placement of the device is normally corrected, typically by the carer. The necessary detachment and reattachment of the device causes an additional stress on the affected areas of skin of the wearer. Many wearers, who make use of urine collection bags have sensitive skin due to their age, whether very old or very young, and furthermore sometimes also suffer from skin irritations. Proper placement of the device in the first place is therefore highly desirable.

In an attempt to improve the correct placement of the device GB 1 ,092,274 discloses a pediatric urine collection bag for female use, which is provided with a wedge like projection adapted to engage the lower perineal area of an infant. Another device has been disclosed in the field of faecal collectors: In Kokai Patent Application No. HEI8 (1996) 117 261 , an external accessory is described to assist in the placement of the adhesive part of the disclosed faecal management device onto the wearer. Such a tool may help in the placement of such a faecal management device when compared to the placement without any aide. However, the successful use of such a tool will require training, in particular if the tool is not specifically designed for its purpose. A further problem with the disclosed tool is that a caretaker, for example, when dealing with a bedridden patient, may have only one hand available for the application of the device. For the field of urine collection bag the use of such a tool seems not appropriate, as the uro-genital area is considerably more sensitive to pressure than the perianal area and further requires higher hygienic standards. Preferred embodiments of the present invention address all of the above described needs.

The urine collection bags which are disclosed in the mentioned prior art are normally handled and placed onto the skin of the wearer by using the flange itself. Typically, one of the first necessary handling steps is the removal of the release means from the adhesive surface of the flange. When then placing the device, the caretaker will normally touch the adhesive area of the flange with the fingers and leave finger marks. Such marks will reduce the adhesive force of the affected areas of the adhesive surface, if dirt is deposited from the fingers or if an adhesive is used, which tends to adhere less on second contact with a surface.

Furthermore, during application of the urine collection bag to the wearer by holding the flange, pressure typically needs to be exercised upon the flange. However, as a result of such pressure the flange may suffer deformation, leading to a poorer performance of the device, in particular to a poorer adhesion, discomfort or possibly leaking of the device. Hence, there still exists a need for urine collection bags which can be easily and correctly positioned onto the desired area of the wearer by the caretaker or wearer themselves without causing discomfort to the wearer or damage to the device.

In attempting to overcome all the aforementioned problems relating to the prior art, it has now been found that the use of an applicator with an adhesive urine collection bag greatly facilitates the correct placement of the device. Furthermore such an applicator maintains the bag of the device in a folded configuration prior to the use of the device and supports the hygienic and protective packaging of the device.

Brief summary of the invention

The present invention relates to a urine collection bag (10). More particularly, the invention relates to an applicator (40) for the placement of such a urine collection bag (10) to the uro-genital area of a wearer and the use thereof. Claimed and described is an applicator (40) comprising a means for releasable attachment to the urine collection bag (10) and the use of an applicator (40) for the placement of a urine collection bag on a wearer.

Brief description of the drawings

Figure 1 is a perspective view of one preferred urine collection bag. L denotes a longitudinal axis, T denotes a transversal axis.

Figure 2 is a perspective view of a preferred V-shaped applicator for a urine collection bag according to the present invention.

Figure 3 is a perspective view of a preferred ring shaped applicator and a urine collection bag according to the present invention.

Figure 4 is a perspective view of a preferred applicator comprising a raised portion shown together with a urine collection bag. Figure 5 is a schematic view of a preferred folding pattern (pattern A) for a urine collection bag.

Figure 6 is a schematic view of another preferred folding pattern (pattern B) for a urine collection bag.

Figure 7 is a perspective view of a preferred combination of a preferred U- shaped applicator and a urine collection bag.

Detailed description of the invention

The invention relates to a urine collection bag (10) as shown in Figure 1. The urine collection bag (10) comprises a bag (11 ) and a flange (12).

Description of the urine collection bag as a whole The present invention relates to urine collection bag for male and for female wearers. Preferably the urine collection bags are disposable.

The term "disposable" as used herein describes devices which generally are not intended to be laundered or otherwise restored or reused (i.e., they are intended to be discarded after a single use and, preferably, to be recycled, composted or otherwise disposed of in an environmentally compatible manner).

Referring now to Figure 1 , there is shown a urine collection bag (10). Typically disposable urine collection bags (10) comprise a bag (11 ) having an aperture (21 ) and a flange (12) surrounding the aperture (21 ) preferably for adhesive attachment to the uro-genital area of a wearer. Any urine collection bag (10) known in the art can be provided with an applicator (40) according to the present invention. The bag (11 ) as used herein is a flexible receptacle for the containment of discharged urine. The bag (11 ) can be provided in any shape or size depending on the intended use thereof, i.e. whether the device is intended for bedridden patients or active patients suffering from incontinence or for infants. For example, elongated bags which are principally tubular or rectangular are typically utilised by bedridden patients and elderly incontinence sufferers. For more active wearers whether infants or adults, the urine collection bag should preferably be anatomically shaped such that the device follows the contours of the body and can be worn inconspicuously by the wearer under normal garments.

Particularly, preferred shapes are flat circular and flat T shaped type bags, cone shaped bags, truncated cone shaped bags and pyramidal or truncated pyramidal shaped bags. In a most preferred embodiment of the present invention, the bag (11 ) has a substantially flat T shape.

In addition, the bag (11 ) is preferably shaped to fit the uro-genital region of the wearer and ensure good contact between the flange (12) and the skin of the wearer. For example the bag (11) may be provided with a neck portion or conduit.

The bag (11 ) is preferably designed to provide sufficient volume for urine under a variety of wearing conditions, also when worn by a freely moving, i.e. not bedridden wearer.

The bag (11 ) is designed to safely contain any entrapped material, typically it will be liquid impermeable, yet it may be breathable. The bag (11 ) is designed of sufficient strength to withstand rupture in use, also when pressure on the bag (11 ) is exerted.

According to the present invention, depending on the shape of the bag (11 ) required, the bag (11 ) may be provided from a unitary piece of material or from a number of separate pieces of material, which may be identical or different and which are sealed at their respective peripheries.

According to the present invention the bag (11) can comprise one or multiple layers, preferably two or three layers. The layer on the inside of the bag, which will typically at least partially come in contact with urine and or other bodily excretions is called the inner layer. The outermost layer of the bag, which will typically at least partially come in contact with the skin to the wearer and the garments of the wearer, is called the outer layer.

The additional layers of the bag material may be provided from any material, preferably so that the bag is liquid impervious. The layers may in particular comprise any material such as nonwovens or films. In a preferred embodiment of the present invention a laminate may be formed from a nonwoven layer and a film. The laminate can be formed by means known to the man skilled in the art.

Any nonwoven layer can comprise felt fabrics, spunlaced fabrics, fluid jet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laid fabrics, melt-blown fabrics, staple fibre carding fabrics, spunbonded fabrics, stitch-bonded fabrics, apertured fabrics, combinations of the above or the like. _v

Suitable film materials for any of said layers preferably comprise a thermoplastic material. The thermoplastic material can be selected from among all types of hot-melt adhesives, polyolefins especially polyethylene, polypropylene, amorphous polyolefins, and the like; material containing meltable components comprising fibres or polymeric binders including natural fibres such as cellulose - wood pulp, cotton, jute, hemp; synthetic fibres such as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene metal, polyimide; binders such as bicomponent high melt/low melt polymer, copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloride copolymer, copolymer polyamide, materials comprising blends wherein some of the constituent materials are not meltable; air and vapour permeable materials including microporous films such as those supplied by EXXON Chemical Co., Ill, US under the designation EXXAIRE or those supplied by Mitsui Toatsu Co., Japan under the designation ESPOIR NO; and monolithic breathable materials such as Hytrel™ available from DuPont and Pebax™ available from ELF Atochem, France.

In a preferred embodiment a film, which is comprised in any layer, is preferably permeable to gases such as air and to vapour such as water vapour in order to avoid the problem of entrapment and condensation of moisture vapour given off by the body of the wearer and thus, the hot, clammy and uncomfortable conditions after a short period of use.

The outer layer of the bag is preferably provided with a hydrophobic fibrous nonwoven layer. Such material layers present an uneven surface to the skin of the wearer and thus reduce significantly the problem of occlusion and greatly improve skin healthiness.

In one preferred embodiment of the present invention the bag comprises two layers. Preferably the outer layer comprises said fibrous hydrophobic nonwoven layer and the inner layer comprises a film.

In yet another preferred embodiment of the present invention, the bag (11 ) comprises three layers, preferably one film and two nonwoven layers. In an even more preferable embodiment the film is interposed between the two nonwoven layers. This sequence of layers results in a closed fibrous structure, which has a particularly pleasing sensation on contact with the skin of the wearer. In yet another preferred embodiment the inner layer comprises a film and the other two layers comprise nonwovens.

Typically, the nonwoven layer is treated with a surface active material, such as a fluorchemical or other hydrophobic finishings, to provide the requisite hydrophobicity. The nonwoven layer, however, may equally be treated with coatings of liquid impervious materials such as hot-melt adhesives or coatir.gs of silicone or other hydrophobic compounds such as rubbers and vegetable and mineral waxes or it may be physically treated using nano-particulates or plasma coating techniques, for example.

The nonwoven layer can also be treated with agents to improve the tactile perceivable softness of the bag. The agents include but are not limited to vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents are known to impart a silky or flannel-like feel to the nonwoven layer without rendering it greasy or oily to the tactile sense of the wearer. Additionally, surfactant material, including anionic, cationic, non-ionic and amphoteric surfactants, may be added to further enhance softness and surface smoothness.

Furthermore, the nonwoven layer may be impregnated with a lotion to provide desirable therapeutic or protective coating lotion benefits. The lotion is transferable to the skin of the wearer by normal contact and wearer motion and/or body heat. Generally, mineral oil in the form of a lotion is recognised as being effective in imparting a soothing, protective coating to the skin of the wearer. It is also possible to impregnate the nonwoven layer with a solid oil phase of cream formulation or to incorporate into the nonwoven layer an array of pressure- or thermal- or hydrorupturable capsules containing for example, baby oil.

In one embodiment of the present invention the bag (11 ) may contain absorbent material . The absorbent material may comprise any absorbent material which is capable of absorbing and retaining liquids. The absorbent material may comprise a wide variety of liquid-absorbent materials commonly used in disposable diapers and other absorbent articles such as comminuted wood pulp, which is generally referred to as airfelt. Examples of other suitable absorbent materials include creped cellulose wadding; meltblown polymers, including coform; chemically stiffened, modified or cross-linked cellulosic fibers; tissue, including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any other known absorbent material or combinations of materials.

The absorbent material may be positioned in the bag (11 ) in any suitable manner. For example, the absorbent material may be loosely arranged within the bag (11 ) or may be secured to the inner layer of the bag (11). Any known techniques for securing absorbent material to nonwoven and film substrates may be used to secure the absorbent material to the inner layer of the bag ( 1). The absorbent material may also be arranged to have any desired shape or configuration (e.g., rectangular, oval, circular, etc.).

Optionally the outer surface of bag (11 ) may be provided with patches of adhesive for securing the bag (11 ) to the body of the wearer. Preferably, the patches of adhesive are positioned on the outer surface of bag (11 ) such that they are secured to the abdomen of the wearer in use. Any number, size and shape of adhesive patches may be used depending on the intended use of the device. The adhesive may be any medically approved water resistant pressure sensitive adhesive such as hydrpcolloid adhesives and hydrogel adhesives. Particularly effective adhesives in providing the desired adhesive properties to secure the flange to the skin of the wearer whilst allowing for relatively painless application and removal are hydrophillic hydrogels formed from crosslinking polymers with a plastisicer to form a 3-dimensional matrix.

The bag (11 ) may comprise various folds, which can ensure better wearing comfort for a moving wearer and which in use can provide extra storage capacity if needed. Z-folds are preferred. Preferably the wearer facing portion (16) of the bag (11 ) comprises two parallel z-folds oriented in the longitudinal direction as shown in Figure 1.

The flange (12) is attached to the bag (11 ) according to any means known to the man skilled in the art which may provide permanent or releasable attachment. Preferably however, the flange is attached to the bag by adhesive. Typically, the bag will be attached to the flange, towards the outer periphery of flange so as not to cause any obstruction for the entering liquids.

The flange (12) may be provided in any size depending on the wearer group for which the device is intended. Similarly the flange (12) may be provided in any shape and preferably has a symmetrical shape preferably at least one lobe (14).

The flange comprises a garment facing portion (22) and a wearer facing portion (23). In an preferred embodiment these are two large, substantially flat surfaces. In a preferred embodiment the wearer facing portion (23) of the flange (12), however, comprises a raised, curved bulge (32) positioned beneath the aperture (21 ) and extending across the flange (12) for approximately the width of the aperture (21 ). The bulge (32) is shaped to span the perineum of a wearer. Typically urine collection bags (10) for female wearer's comprise such a bulge (32), while urine collection bags (10) for male wearer's do not need to comprise such a bulge (32).

The flange (12) should be made of soft, flexible and malleable material to allow easy placement of the flange to the uro-genital area. In addition it is preferred that the flange (12) be made of a hydrophobic material such that if urine does come into contact with the perimeter surrounding the aperture (21 ) it is repelled and does not wick to the outer edge of the flange (12). Typical materials include nonwoven materials, wovens, open celled thermoplastic foams, closed-cell thermoplastic foams, composites of open celled foams and stretch nonwoven, and films. A closed-cell foam of polyethylene has been found effective, but more preferably an open celled polyurethane foam is used. Preferably, such foams have a thickness within the general range of 0.1 to 5 millimetres and a density of

5 to 250 g/m³, more preferably 50 g/m³. Other thermoplastic foam materials, or other suitable plastics sheet materials having the described properties of such foams (i.e., softness, pliability, stretchability, and contractability) might also be used. Preferably, the material of garment facing surface (21 ) of the flange (12) may extend into the defined aperture area so as to form a skirt or flap of material which prevents unintentional adhesion of the surface edges of the flange (12) defining the aperture (21 ) to one another during use.

According to the present invention the urine collection bag further comprises an attachment means to secure the device to the wearer. Such means include straps and more preferably comprises a body-compatible pressure sensitive adhesive (20) applied to the wearer facing portion (23) of the flange (12).

According to the present invention any medically approved water resistant pressure sensitive adhesive may be used to attach the device to the uro-genital area of the wearer, such as hydrocolloid adhesives and hydrogel adhesives. Particularly effective adhesives in providing the desired adhesive properties to secure the flange to the skin of the wearer at the sensitive uro-genital area, whilst allowing for relatively painless application and removal, are formed from crosslinking polymers with a plastisicer to form a 3-dimensional matrix.

Suitable adhesives for use herein are hydrogel adhesives available from 3M and Promeon.

The adhesive (20) can be applied to the wearer facing surface (22) of the flange (12) by any means known in the art such as slot coating, spiral, or bead application or printing. Typically the adhesive (20) is applied at a basis weight of from 20g/m² to 2500g/m², more preferably from 500g/m² to 2000g/m² most preferably from 700g/m² to 1500g/m² depending on the end use envisioned. For example for urine collection bags (10) to be used for babies the amount of adhesive (20) may be less than for urine collection bags designed for active adult incontinence sufferers.

According to another aspect of the present invention, the urine collection bag (10) has been found particularly useful and beneficial when utilized in conjunction with a garment or a disposable diaper or a faecal collection bag. Typically the urine collection bag (10) will be positioned to the uro-genital area of the wearer positioned and secured to the wearer by the adhesive flanges and patches of adhesives. Subsequently, the diaper is positioned over the urine collection bag and fastened in a conventional manner around the body of the wearer. It has been found that in addition to providing excellent separation between urine and faecal matter, the combined urine collection bag (10) and diaper system reduce skin irritation, which may at time occur, especially as the wearer group includes the very old, young and unhealthy wearers.

Detailed description of the applicator

To allow a more detailed and clear description of the urine collection bag (10) and the applicator (40), in the following paragraphs firstly the terms, as used herein, will be defined.

Regarding in particular the flange (12) the longitudinal axis is to be understood as follows: The direction which is substantially defined by a line connecting the coccyx, the perineum and the genital area for a wearer with the urine collection bag (10) in the intended wearing position defines the longitudinal direction. The longitudinal axis is an axis in the longitudinal direction, which crosses the centre of the aperture (21 ). The longitudinal axis is typically also an axis of symmetry.

Longitudinal, when used for the applicator (40), shall denote the direction which is substantially parallel to the longitudinal direction of the urine collection bag (10) when the applicator (40) is used for placing the urine collection bag (10). Typically the pressure areas (42) are aligned parallel with a longitudinal axis.

The transversal axis is an axis perpendicular to said longitudinal axis of the urine collection bag (10), which crosses the centre of the aperture (21). The transversal direction is generally aligned with the wearer's hips when the urine collection bag (10) is in the intended wearing position. Centre is used to describe a point of an object or a part of an object, which coincides with the centre of mass, if said object or part were of uniform density.

The garment facing portion (17) is the portion of the bag (11 ), which is generally oriented away from the wearer, when the urine collection bag (10) is worn, and towards a garment, if a garment is worn. The garment facing portion (17) does not comprise the aperture (21 ). The size and the shape of the garment facing portion (17), in particular its length and width, are defined by the bag peripheral rim (18).

The wearer facing portion (16) is the portion of the bag (11), which comprises the aperture (21 ) and is generally oriented towards the wearer, when the urine collection bag (10) is worn. The size and the shape of the wearer facing portion (16) are defined by the bag peripheral rim (18).

Above as used herein with regard to the urine collection bag (10) generally denotes the direction towards the head of an upright standing wearer wearing the urine collection bag (10) in the intended wearing position and top portion denotes the portion of the urine collection bag (10) which is above the centre the urine collection bag. Below generally denotes the direction opposite to the above direction. Bottom portion denotes the portion of the urine collection bag which is below the centre of the urine collection bag (10).

Inwards, as used herein, with regard to the folding of the bag (11) denotes any direction which is more oriented towards the centre of the bag (11 ) than away from the centre of the bag (11 ).

The invention relates an applicator (40) for the placing of a urine collection bag (10) to the uro-genital area of a wearer and the use thereof. Preferred applicators (40) are shown in Figures 2 to 4. According to the present invention the applicator (40) is provided with a releasable attachment means. Releasable attachment, as used herein, refers to an attachment which involves enough force to be maintained during unpacking, handling and applying the urine collection bag (10) and yet is easily removable after application of the urine collection bag (10), even by an elderly user. Preferably the releasable attachment means are reuseable or refastenable if the applicator is to be reused. The releasable attachment means will typically also ensure the correct positioning of the applicator (40) relative to the urine collection bag (10) and help to maintain the folded configuration of the bag (11 ), if the bag is folded.

Preferred attachment means comprise any adhesive means, mechanical means, including clamps, clips, strings, rubber bands, and mechanical means relying on a design where one part fits snugly into another without comprising a^' separate and dedicated attachment means, and all means disclosed hereinafter.

Preferably the urine collection bag (10), which is to be used in combination with the applicator (40), is provided with pressure sensitive adhesive (20) on the flange (12) for adhesive attachment to the skin in the uro-genital area of a wearer. For secure attachment of the urine collection bag (10) pressure thus needs to be exerted onto the device and the skin of the wearer to ensure adhesion. While this can be done, for example through the bare hands and fingers, it has now been found that the use of an applicator allows the caretaker or wearer to exert more pressure and is of great help in ensuring that pressure is exerted in a controlled manner and onto the correct areas.

In addition the utilisation of the applicator (40) also greatly assists in assuring that the bag (11 ), which is preferably provided in a folded configuration prior to the placing of the urine collection bag (10), remains in that folded configuration during application. The applicator (40) was also found to provide hygienic and mechanical protection for the urine collection bag (10). Furthermore the applicator (40) was found to assist in the economic, aesthetically pleasing and protective packaging of the urine collection bag (10). The portion of the applicator (40) which is generally used to handle the applicator (40), typically by holding the applicator (40) with fingers, is herein referred to as handling portion (44). Some applicators (40) may not have a dedicated handling portion (44), others may have a multitude of handling portions (44). Any portion of the applicator (40) which is used to exert pressure onto the urine collection bag (10) are herein referred to as pressure area (42).

An applicator (40) according to a present invention can be made in a variety of shapes and from a variety of materials. The applicator (40) for the urine collection bag (10) can be made of any suitable material or combination of materials. The material should allow the transfer of the required forces from the handling portion (44) of the applicator (40) to the pressure areas (42). Preferably the material is inexpensive and suitable for a mass manufacturing process. Preferably the material is environmentally friendly for disposal, in particular for flushing in a toilet.

Preferred materials are wood, metal, plastic and cardboard. Cardboard maybe be provided with a coating, e.g. a wax coating to improve the hygienic handling of the applicator (40) and to prevent any dirt from easily sticking to or otherwise soiling the applicator (40). Preferably the cardboard has a thickness from 0.01 to 5 mm, more preferably from 0.1 to 1 mm, most preferably from 0.3 to 0.7 mm.

Preferred materials also include those used for tampon applicators, which are typically provided from plastics, polymers or flushable smooth surfaced cardboard. Materials such as paper or wood pulp which are also used for tampon applicators are hence also within the scope of the present invention. More preferred materials are disclosed in EP 613672 A1 , where a commercially effective, aesthetically pleasing, rapidly disintegrating, water-soluble disposable tampon applicator and a method for making it are disclosed. The materials disclosed in EP 613672 A1 such as water-soluble polymers having a coating comprising a water-insoluble polymeric material selected from the group consisting of wax (comprising natural wax and synthetic wax), hydrogenated vegetable oil, and food grade shellac, may also be utilised for the application herein. Among the preferred water-soluble polymers is polyvinyl alcohol and thermoplastic starch.

The applicator (40) is typically used by a person, whether the wearer or a caretaker, and typically handled by that person using the hands. Thus, to be held and to be used to exert pressure by the caretaker or wearer, the applicator (40) typically comprises a handling portion (44). This handling portion (44) may comprise separate pieces of material or may be an integral part of the applicator (40).

The applicator (40) may further comprise various labels, e.g. colour labels. One such label can be used to indicate which portion of the applicator is to be brought in registry with a particular portion of the urine collection bag (10). For example, a colour label may indicate which portion of the applicator (40) is to be brought in registry with the centre of the aperture (21 ).

Similarly colour labels on the applicator (40) can be also used to indicate how the applicator in combination with the urine collection bag (10) is to be oriented for placement, e.g. with regard to the perineal and the coccygeal areas of a wearer. Furthermore the applicator (40) can be labelled to provide usage instructions or any other written instructions.

In one preferred embodiment of the applicator (40) is an essentially flat piece of cardboard, which is preferably of oval form. A portion of the edge of the piece of cardboard is brought in contact with the garment facing portion (17) of the bag (11 ) so as to exert pressure. Of course, the applicator may also be provided from a different material, preferably a material as listed above or alternatively may have another shape, preferably a round, rectangular, square or half-moon shape. The applicator (40) may also comprise two notches to hold a rubber band in place, which may be used as a releasable attachment means. In another preferred embodiment one cross section of the applicator (40) comprises essentially a V- or a U-shape. The term "V-shape", as used herein, refers to an applicator (40) comprising one cross section comprising one folding line between two straight portions. The term "U-shape", as used herein, refers to an applicator (40) comprising one cross section comprising three straight portions and two folding lines disposed there-between. Preferably the two folding lines have a perpendicular distance of 10 cm to 0.1 cm, more preferably 5 cm to 1 cm, most preferably 2 cm to 3 cm.

A U-shape embodiment of this kind is shown in Figure 2. The edges of the V- or U-shape applicator (40) are highly advantageous in exerting pressure on essentially two areas, referred to as pressure areas (42) which lie to the left and to the right of the sensitive uro-genital area of a wearer. Preferred applicators (40) according to the present invention comprise at least two pressure areas (42) and more preferably two, three or four pressure areas (42). At the same time the V- or U- shape applicator (40) ensures easy gripping by providing one central handling portion (44). Moreover, the central handling portion ensures that pressure is applied onto both pressure areas (42). Yet a further benefit of this embodiment is that the U- or V-shape embraces portions of the urine collection bag and thereby helps to maintain a folded configuration of the urine collection bag (10) and particularly of its bag (11 ).

It has been found that the above described embodiments work well when provided from cardboard. When provided for a urine collection bag (10) for an adult user the pressure areas (42) of the applicator have a length (measured in the longitudinal direction) from 5 cm to 20 cm preferably from 8 cm to 15 cm.

The transversal distance of the pressure area (42) when provided for a urine collection bag (10) for adults, is preferably from 1 cm to 10 cm, more preferably 3 cm to 5 cm, most preferably 1 cm to 2 cm. Yet another preferred embodiment of the present invention is shown in Figure 3 together with a folded urine collection bag (10). In this embodiment the applicator has essentially a ring shape. This embodiment of an applicator is highly efficient in keeping the urine collection bag (10) in a folded configuration, which can be chosen for application. Further the applicator allows safe gripping of the urine collection bag (10) by its handling portion (44). This ensures hygienic handling and is a particular benefit for an elderly user who wants to apply the collector (10) without the help of the caretaker.

The pressure exerted by the applicator (40) of Figure 3 is transmitted from the handling portion (44) of the applicator (40) via the folded bag towards the flange (12) of the urine collection bag (10). The elasticity of the folded bag ensures that not too much pressure is exerted onto the sensitive uro-genital area of a wearer.

The inner circumference of the ring is to be selected so, that the ring fits snugly around the folded bag (11 ), whilst also allowing separation of ring and urine collection bag (10) after attachment of the urine collection bag (10). When used for a urine collection bag (10) for an adult wearer, the ring preferably has an inner circumference from 10 cm to 50 cm, more preferably from 15 cm to 40 cm, yet more preferably from 20 cm to 30 cm and a width of 0.5 mm to 100 mm, preferably 2 mm to 50 mm, more preferably 5 mm to 30 mm. Preferred materials for the present embodiments include cardboard, rubber and adhesive materials, such as adhesive tapes. When an adhesive material such as an adhesive tape, is chosen for the applicator (40) in an alternative embodiment the applicator (40) can be provided in other forms than a ring form, for example U-shape, which is in contact with only three sides of the folded bag (11 ).

Yet another preferred embodiment of the present invention is shown in Figure 4. In this preferred embodiment an applicator (40) is provided which comprises a positioning means in the form of a raised portion (46). This raised portion (46) is designed for insertion into the vagina of a female user. Preferably the raised portion (46) is surrounded by an oval base plate.

Preferably this applicator (40) is positioned so that the raised portion (46) protrudes through the aperture (21 ) of the urine collection bag (10) and the base plate remains on the garment facing portion (22) of the flange (12). This applicator (40) largely supports the correct positioning of the urine collection bag (10), since the applicator (40) assumes a very defined position with regard to the uro-genital area, when the raised portion (46) is inserted into the vagina, preferably the labiae minora of the vagina, and the flange (12) assumes thereby an ideal position as to surround the uro-genital area for optimal sealing.

This embodiment can be provided from any material or combination of materials, preferably a plastic material is used. The raised portion (46) may also be provided from a foam material. The material should allow to transfer the required pressure and satisfy hygienic requirements. Preferred materials are polyolefine, polyethylene, polypropylene and polystyrene. One particularly preferred embodiment provided for an adult female wearer, has an elliptical base plate with a major axis of preferably from 5 cm to 15 cm, more preferably from 7 cm to 10 cm and a minor axis of preferably 1 cm to 10 cm, more preferably 2 cm to 4 cm and the raised portion has a height of preferably 1 cm to 5 cm, more preferably 2 cm to 3 cm over the base plate. The form and the material of the base plate should be chosen so that pressure can be exerted onto the garment facing portion (22) of the flange (12). If the urine collection bag (10) comprises a bulge (32), preferred applicators (40) will allow to exert the required pressure onto the garment facing portion (22) of the flange (12) adjacent to the bulge (32).

According to the present invention the base plate should exceed the inner periphery of the flange (12) in at least one direction, more preferably two or more opposed or perpendicular directions, as to ensure releasable attachment of the applicator (40) to the urine collection bag (10), preferably by positioning the base plate on the garment facing portion (22) of the flange (12) prior to use of the urine collection bag (10). The flexibility of the flange (12) and optionally also the applicator (40) ensures that the applicator (40) can be separated from the urine collection bag (10) after the applicator (40) has been used.

Most preferably the base plate comprises an orifice, which allows for insertion of a finger. Optionally the garment facing side of the raised portion (46) comprises a loop for insertion of a finger, which allows for easy removal of the applicator (40).

According the present invention an applicator (40) may be provided with alternative or additional positioning means. Those positioning means may be adapted to allow alignment with the labia majora, the labia minora, the perineum, the anus or other parts of the human body. The form of those positioning means is to be ^"chosen in view of the anatomy of the particular parts of the body. The positioning means will preferably comprise a raised portion (46) of suitable form, namely height and width, as to fit the body.

If the flange (12) of the urine collection bag (10) is provided with an adhesive (20) and a release means such as a release sheet to cover the adhesive (20) before use, in one preferred embodiment of the invention, the applicator (40) is joined to the release sheet, so that the removal of the applicator (40) induces the removal of the release sheet in one handling step.

An applicator (40) according to the present invention may be used repeatedly to apply the same or a different urine collection bag. Therefore, if the applicator (40) is joined to the release sheet, the means of joining may be selected to allow separation of the release sheet and the applicator (40), while allowing to exert enough force as to remove the release sheet.

Further, may the raised portion (46) be provided with several layers of adhesive foils which can be peeled off one after the other as to expose a clean and hygienic foil service for each use of the applicator (40). Preferred materials for such foils include latex and artificial silk, a non-woven layer may also be considered.

Preferably the urine collection bag (10) is provided in a particular configuration prior to use. In that configuration, the flange (12) is folded along the longitudinal axis to allow easier placement of the flange (12) in the uro-gential area of a wearer. Furthermore the bag (11) is preferably folded, which provides numerous advantages. For example, folding of the bag (11 ) allows a smaller packaging format of the urine collection bag (10), thus reducing the costs for transport and packaging material. Moreover, the handling of the urine collection bag (10) is more convenient if the bag (11 ) is folded. The bag (11 ), when not folded, may also cover parts of the body of the wearer, so that the person placing the urine collection bag (10) cannot sufficiently visually control the placing.

Numerous patterns for the folding of the bag (11 ) are within the scope of the present invention. The folding should result in a sufficiently small size of the bag

(11 ) in its folded state to provide the benefits described above, should not cause damage to the bag and should allow an uncomplicated unfolding of the bag after placement. Highly preferred folding patterns are self-supporting, in that the urine collection bag (10) remains in the folded configuration without the help of any supporting means such as adhesive.

Preferred ways of folding the bags (11 ) include the following:

Pattern A (cf. Figure 5): As a first step the bag (11 ) is folded about one transversal line (Line 1), so that the garment facing portion (17) of the bag (11 ) is folded upon itself. Preferably this transversal axis is positioned above the flange

(12) close to the centre of the bag (11 ). In a second step the bag (11 ) is folded inwards along a central longitudinal line (Line 2), preferably the longitudinal axis. In a third step the portions of the bag (11 ) extending outboard the flange (12) in transversal direction are folded inwards about two longitudinal lines (Line 3 and Line 3'). Pattern B (cf. Figure 6): As a first step the bag (11 ) is folded about two longitudinal lines (Line 1 and line 1 '). Thereby the inward folded portions preferably overlay each other and thus provide a pocket (open to the top end of the collector (10)). In a second step the bag (11 ) is folded about one transversal line (Line 2), so that the garment facing portion (17) of the bag (11 ) is folded upon itself. Preferably this transversal axis is positioned above the flange (12) close to the upper end of the flange (12). In a third step the bottom portion of the collector (10) is folded inwards along a transversal line (Line 3). Most preferably the bottom portion of the collector is tucked into the above described pocket provided by the bag (11 ), whereby the pattern is rendered self-supporting.

Other preferred folding patterns are any of those comprising any of the above described folding lines.

Most preferably the applicator (40) and the urine collection bag (10) in combination are provided in a particular configuration prior to use. This allows ready application of the urine collection bag (10) with only a few handling steps, since there is no need to have separate items at hand (the applicator (40) and the urine collection bag (10)) and to position the applicator on the appropriate areas of the urine collection bag (10) for application. Such a prior to use configuration for the bag (11 ) and the applicator (40) in combination preferably comprises the bag (11) in one of the folded patterns described above. If the applicator (40) is provided with pressure areas (42), these areas (42) preferably have contact with the garment facing portion (22) of the flange (12).

Figure 6 shows a preferred prior to use configuration for a U-shaped applicator (40) in combination with a urine collection bag (10) for an adult female wearer. The urine collection bag (10) is provided in a preferred folding pattern comprising one fold along the longitudinal axis. The pressure areas (42) of the applicator (40) are in contact with the z-folds (35) of the bag (11 ), which ensures reliable contact between urine collection bag (10) and applicator (40) as to exert pressure.

Preferably the applicator (40) or the urine collection bag (10) are provided with a means to maintain the folded configuration of the bag (11 ), if the bag is folded. Such a means can be identical to or separate from the releasable attachment means holding applicator (40) and urine collection bag (10) together. A means to maintain the folded configuration of the bag (11 ) may be provided in the form of any string or band, which may be provided in form of a closed loop, such as a rubber band. Such a means may also be provided in form of a clamp or a clip, made from any suitable material such as plastic or metal. Namely a U- or V- shaped applicator (40) may be provided from an elastic material so as to exert forces onto the portions of the bag (11 ) embraced by the applicator (40) and thereby supporting the folded configuration of the bag (11 ) and further ensuring that that applicator (40) and the urine collection bag (10) are held together.

Placing a urine collection bag (10) which is provided in combination with an applicator (40) by using the applicator (40) by a person preferably comprises the following handling steps: a) removing the urine collection bag (10) and the applicator (40) from packaging material, which may be provided; b) holding the urine collection bag (10), preferably by using the handling portion (44) of the applicator (40); c) removing the release means from the adhesive (20) provided on said flange (12), preferably using one hand for the removal of the release means while holding the urine collection bag (10) and the applicator (40) with the other hand; d) supporting the placement body position of the wearer, preferably using one or two hands. When for example applying the urine collection bag to a baby, most preferably one hand is used to hold up the babies legs whilst the urine collection bag (10) and the applicator (40) are held with the other hand; £3

e) placing said urine collection bag (10) in the uro-genital area of the wearer by using the handling portion (44) of the applicator (40) and/or using the placement lobes (14) on the flange (12) (if present) or a portion of the bag

(11 ); f) letting said adhesive (20) on said flange (12) attach to the body of the wearer; g) exerting pressure towards the uro-genital area or other areas of the wearer to be in contact with the adhesive (20 by using the applicator (40); h) releasing the grasp of the urine collection bag (10); i) separating the applicator (40) from the urine collection bag (10) while holding it using the handling portion (44), e.g. by pulling in a direction substantially away from the uro-genital area of the wearer; j) unfolding the bag (11 ),

Depending on the used embodiment of the present invention and conditions of the placement, numerous other handling steps in placing the urine collection bag (10) using an applicator (40) may also be undertaken, different handling steps may be undertaken or certain of the mentions handling steps may not be involved.

For example, when the urine collection bag is used by a female adult who applies the urine collection bag (10) without the help of a caretaker, a urine collection bag (10) preferably comprising a bulge (32) is used and application steps d) to g) preferably comprise the following steps: The top portion of the flange (12) is brought in registry with the upper end of the labia majora. Then the flange (12) is adhesively attached first in the upper area of the pudential region and subsequently in the lower area of the pudential region ensuring proper adhesive of the urine collection bag (10) by exerting pressure with the applicator (40). Normally, this application ensures that the bulge (32) is in registry with the perineum. If necessary the placement is to be corrected as to achieve that. According to the present invention an applicator (40) may be provided for single use or for multiple use. Urine collection bags (10) are often used as a precaution and hence are re-applied, e.g. after a toilet has been used. Therefore, one urine collection bag (10) may be applied several times and an applicator (40) may find multiple uses. An applicator (40) may also be used to apply a number of different urine collection bags (10). Therefore, according to the present invention, an applicator (40) may be provided separately from a urine collection bag (10) or may be provided as one component of a kit with a multitude of urine collection bags (10). If provided as a kit, the applicator (40) and the multitude of urine collection bags (10) are preferably provided in one package.

Claims

What is claimed is :

1. An applicator (40) for the placement of a urine collection bag (10) on a wearer comprising a means for releasable attachment to said urine collection bag (10).

2. An applicator (40) according to Claim 1 , said applicator (40) comprising a longitudinal axis, characterised in that said applicator (40) is symmetrical to said longitudinal axis.

3. An applicator (40) according to any one of the preceding claims, characterised in that said applicator (40) comprises two pressure areas (42).

4. An applicator (40) according to any one of the preceding claims, characterised in that said applicator (40) comprises a positioning means.

5. A urine collection bag (10) characterised in that said urine collection bag (10) comprises an applicator (40) according to anyone of the proceeding claims.

6. A urine collection bag (10) according to Claim 5 characterised in that said urine collection bag (10) is folded in a folding pattern comprising at least one folding line.

7. A urine collection bag (10) according to Claim 6 characterised in that said folding pattern is selected from the group comprising pattern A and pattern B as defined herein.

8. A urine collection bag (10) according to Claim 6 wherein said applicator (40) is further characterised in that said applicator (40) comprises a means to maintain said folding pattern.

9. An applicator (40) according to Claim 8, characterised in that said means to maintain said folding pattern comprises an adhesive.

10. Use of an applicator (40) for the placement of the urine collection bag (10) on a wearer.