CA2369171A1 - Faecal collector with a reliable, comfortable flange - Google Patents

Abstract

The present invention relates to human waste management devices for babies, children or adults. The invention resides principally in providing such devices with a flange (12) which is comfortable to wear and ensures safe attachment to the body. The overall caliper of the flange (12) and the adhesive layer (20) according to the present invention is less than 1.3 mm while the transversal diameter of the aperture (21) is less than 80 mm.</SDO AB>

Description

FAECAL COLLECTOR WITH A RELIABLE, COMFORTABLE FLANGE

Field of the invention The present invention relates to human waste management devices for babies, children or adults. Said devices are provided with a flange to allow for safe attachment, comfortable wearing and low skin exposure.
Back4round of the invention Human waste management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and in particular by bedridden patients. Such human waste management devices are attached to the perianal or uro-genital region of the wearer and are intended to entrap and immediately contain faecal material, urine and other bodily discharges. Such devices, as they are mostly known today are constituted of a bag at one extremity of which is positioned the aperture and the attachment device, which typically is adhesive.
Faecal management devices are disclosed in for example the following documents: US 3,577,989, which details a disposable plastic bag for incontinence sufferers. US 4,784,656, which describes a receptacle for collecting faecal matter. The receptacle is formed from two sheets of thermoplastic film that are heat sealed along their side edges. GB 2 152 387, which teaches a faecal collector for incontinence sufferers comprising a collection bag consisting of a pair of panels of thermoplastic sheet material joined at their margins. EP 245 discloses bags substantially consisting of a front and a rear wall, which are made of a synthetic plastic material, such as PVC. GB 2 215 605 discloses an ostonomy bag comprising panels of synthetic plastic material, the rear bag wall further comprising a needled film.
Urine management devices are, for instance, disclosed in the following documents: GB 1 092 274 discloses a pediatric urine collector for female use comprising a collector bag of plastic material opening. The collector is secured to the body of the wear by adhesive material. GB 2 268 882 discloses a urostomy pouch/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 and US 3,292,626 disclose a urine collector for female infants. Chinese patent application CN 1079381 discloses urine bags for infants with circular and elliptical apertures.
A problem naturally associated with these devices is their secure attachment to the human body whilst allowing for the faecal matter or urine to be safely contained within the bag. The approach which is mostly used in the field and described in most of the above cited documents is to provide the device with a flange which surrounds an aperture and provide adhesive on the flange, which will stick to the perianal or uro-genital area. Further considerations regarding the selection of the flange and the adhesive are disclosed in the following documents:
US 3,734,096 teaches to provide the flange from a compressable and flexible material, such as a plastic sheet of about 0.4 mm thickness. The flexibility is portrayed as to contribute to allow the flange to follow the movement of the sphincter muscle during defaecation. The thickness of the adhesive means is said to be of little consequence.
EP 0 753 290 A2 teaches to provide the flange from a heat-sealable, stretchable material, such as a film or a non-woven fabric. For attachment of the flange to the human body a hydrocolloid adhesive is disclosed. As known in the art, such hydrocolloid layers are typically thick, having a caliper of about 1 mm or above.
Specified in one example is a non-woven material with a caliper of 0.33 mm and a hydrocolloid layer with a caliper of 1.02 mm.
WO 99/00089 discloses numerous materials for the flange, the preferable choice being an open celled polyurethane foam. The thickness of the adhesive layer to be used for attachement is not disclosed.
Despite the above considerations in selecting the flange and adhesive, the problem of unintentional detachment of faecal management devices is a problem known in the art, as disclosed for example in GB 2 116 849.
Thus, considering the possible unintended detachment and the handling after use, a small aperture is desirable. Moreover, a small aperture prevents faecal matter from coming into contact with large areas of the wearer's skin. This reduces skin irritation problems, which may occur due to the age of typical wearers of such devices, whether very old or very young. On the other hand, the aperture should be large enough as to allow complete collection of faecal material, even in case of non ideal placement. This is, for example, addressed in WO 99/00089.
Hence, there still exists a need for a human waste management device which ensures reliable adhesive attachment, which can be easily be placed and ensures low skin exposure.

In attempting to overcome all the aforementioned problems relating to the prior art, it has now been found that adhesive human waste management devices can be provided with particularly selected flange characteristics.
Summary of the invention The present invention relates to human waste management devices for babies, children or adults. The invention resides principally in providing such devices with a flange (12) which is comfortable to wear and ensures safe attachment to the body. The overall caliper of the flange (12) and the adhesive layer (20) according to the present invention is less than 1.3 mm while the transversal diameter of the aperture (21 ) is less than 80 mm.
Brief descrietion of the drawinas It is believed that the invention will be better understood from the foregoing description in conjunction with the accompanying drawings in which:
Figure 1 is a perspective view of a preferred embodiment of a faecal management device according to the present invention.
Figure 2 is a cross sectional view along line T-T of the preferred embodiment depicted in Figure 1. c denotes the overall caliper of the flange (12) and the adhesive layer (20).
Figure 3 is an on top view onto the flange of a faecal management device according to the present invention. d denotes the transversal diameter of the aperture (21 ).
Figure 4 is a schematic representation of a cast of the anal region.

Detailed description of the invention The invention relates to human waste management devices. Such a human waste management device may be a faecal management device (10), which is designed for attachment to the anal area and mainly used for collecting faeces, 5 or it may be a urine management device, which is attached to the urinary duct and mainly used for collecting urine. A human waste management device may also be a device to collect both urine and faeces and thus be attached to both of the above areas. All of the above human waste management devices are preferably designed for single use and disposal thereafter.
A faecal management device (10) is shown in Figure 1.
Description of the human waste management device as a whole Typically human waste management devices comprise a bag (11 ) having an aperture (21 ) and a flange (12) surrounding the aperture for preferably adhesive attachment to the perianal area of a wearer as visible from Figure 1. Any human waste management device known in the art can be provided according to the present invention.
The bag (11 ) as used herein is a flexible receptacle for the containment of excreted faecal matter or urine. 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 in typical wearing conditions, such as sitting.
According to the present invention the bag material can comprise one or multiple layers, preferably two or three layers. The layer on the inside of the bag (11 ), which will typically at least partially come in contact with faecal material or urine 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 layers of the bag material may comprise any material, preferably so that the bag is liquid impervious. The layers may in particular comprise any material such as non-wovens or films. In a preferred embodiment of the present invention a laminate may be formed from a non-woven layer and a film. The laminate can be formed by means known to the man skilled in the art.
Any non-woven 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.
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., III, US
under the designation EXXAIRE or those supplied by Mitsui Toatsu Co., Japan under the designation ESPOIR NO; and monolithic breathable materials such as HytreIT"" available from DuPont and PebaxT"' 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 material may comprise a non-woven 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 material comprises two layers. Preferably the outer layer comprises a non-woven layer and the inner layer comprises a film.
In yet another preferred embodiment of the present invention, the bag material comprises three layers, preferably one film and two non-woven layers. In an even more preferable embodiment the film is interposed between the two non-woven 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 non-wovens.
Any non-woven layer or the non-woven layers comprised by the bag material may be hydrophobic or hydrophilic. If the bag material does not comprise a film layer, preferably at least one non-woven layer is hydrophobic. As a consequence, fluid penetration is resisted through the bag (11 ) of the human waste management device (10). If the bag material comprises a film or a hydrophobic non-woven layer, further non-woven layers may be hydrophilic.
Typically, the non-woven layer is treated with a surface active material, such as a fluorchemical or other hydrophobic finishings, to provide the requisite hydrophobicity. The non-woven layer, however, may equally be treated with coatings of liquid impervious materials such as hot-melt adhesives or coatings 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.
Any non-woven layer can also be treated with agents to improve the tactile perceivable softness of the bag (11 ). 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 non-woven layer without rendering it greasy or oily to the tactile sense of the wearer.
Additionally, surfactant material, including anionic, nonionic, cationic and amphoteric surfactants, may be added to further enhance softness and surface smoothness.
Furthermore, the non-woven layer may be impregnated with a lotion to provide desirable therapeutic or protective coating lotion benefits. The lotion coating on the bag (11 ) 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 non-woven layer with a solid oil phase of cream formulation or to incorporate into the non-woven layer an array of pressure- or thermal- or hydrorupturable capsules containing for example, baby oil.
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 a number of separate pieces of material, which may be identical or different and which are sealed at their respective peripheries. The preferred shape of the bag depends in particular on the intended use thereof, i.e. whether the device is intended for bedridden patients or active patients suffering from incontinence or requiring an artificial bowel or for infants.
The bags described herein preferably have a wearer facing portion (16) and a garment facing portion (17), which both comprise separate pieces of material.

The wearer facing portion (16) and the garment facing portion (17) are sealed at the periphery of the bag (11 ), thus creating a bag peripheral rim (18). The wearer facing portion (16) and the garment facing portion (17) may each independently comprise more than one section of material. Preferably the garment facing portion (17) comprises only one section of material; most preferably also the wearer facing portion (16) comprises only one section of material.
The wearer facing portion (16), the garment facing portion (17) and the pieces of material comprised by either of these portions are secured to each other by means known to the man skilled in the art, such as adhesive, thermobonding or pressure bonding in order to provide the desired bag configuration. The rim (18), at which the wearer facing portion (16) and the garment facing portion (17) are sealed together, may be provided inside the bag (11 ) rather than outside the bag (11 ), thus being coextensive with the inner surface (15) of the bag (11 ) rather than with the outer surface (30) of the bag (11 ).
Hence a variety of shapes of the bag is within the scope of the present invention.
Particularly, preferred shapes are flat circular type bags, cone shaped bags, truncated cone shaped bags and pyramidal or truncated pyramidal shaped bags and flat T shaped bags.
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 or may be secured to the inner surface (15) of the bag (11 ). Any known 5 techniques for securing absorbent material to nonwoven and film substrates may be used to secure the absorbent material to the inner surface (15) of the bag.
The absorbent material may also be arranged to have any desired shape or configuration (e.g., rectangular, oval, circular, etc.).

10 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 faecal matter or urine.
The flange may be provided in any size depending on the wearer group for which the device is intended. Similarly the flange may be provided in any shape and preferably has a symmetrical shape preferably comprising a plurality of lobes (13).
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, however, the flange (12) may also comprise projections, a front projection (28) and/or a rear projection (29), in case of a faecal management device (10) designed to fit the perineal and/or coccygeal area of the wearer and in case of a urine management device (10) designed to fit the genital and/or perineal area.
If a human waste management device is to be used by a female wearer the presence of a projection to fit the perineum has been found very beneficial.
According to the present invention the human waste management device (10) further comprises an attachment means to secure the device to the wearer.
Such means comprise a body-compatible pressure sensitive adhesive provided as an adhesive layer (20) applied to the wearer facing portion (23) of the flange (12) and may also comprise straps.
According to the present invention any medically approved water resistant pressure sensitive adhesive may be used to attach the device to the perianal or 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 perianal area, whilst allowing for relatively painless application and removal, are formed from crosslinking polymers with a plastisicer to form a 3-dimensional matrix.
The adhesive layer (20) can be applied to the wearer facing portion (23) of the flange (12) by any means known in the art such as slot coating, spiral, or bead application or printing. Typically the adhesive layer (20) is applied at a basis weight of from 20g/m2 to 2500g/mz, more preferably from 100 g/m2 to 1000g/m2 depending on the end use envisioned and the adhesive caliper desired. For example, for human waste management devices (10) to be used for babies the amount of adhesive may be less than for human waste management devices (10) designed for active adult incontinence sufferers.
The adhesive layer (20) is preferably covered with a release means (not shown) in order to protect the adhesive layer (20), such as siliconized paper. The adhesive (20) can cover the entire wearer facing portion (23) of the flange (12), more preferably the flange (12) has at least one, preferably two to six non-adhesive portions. These portions may be adhesive free or may contain inactivated or covered adhesives. As is evident from Figure 1, the adhesive is in one preferred embodiment not applied to the entire wearer facing portion (23) of the flange (12), so as to provide lobes (13) on either side of the flange (12) which are non-adhesive and can thereby serve to facilitate placement and removal of the device whilst avoiding contact with the adhesive. These lobes (13) are however preferably also covered by the release means. Before application of the human waste management device (10) to the skin of the wearer, the release means if present is removed.
The human waste management device (10) of the present invention has been found to be particularly useful and beneficial when used in conjunction with a garment, or diaper, preferably a disposable diaper.
To allow a more detailed and clear description of the device (10), in the following paragraphs firstly a few terms will be defined, as used herein.
Regarding in particular the flange (12) the longitudinal axis for a faecal management device (10) is to be understood as follows: The direction which is substantially defined by the anal groove in the intended wearing position shall define the longitudinal direction. The longitudinal axis is an axis in the longitudinal direction, which crosses the centre of the aperture (21 ). The most preferred indication of the intended wearing position is the presence of one or two projections (28) and/or (29) designed to fit the perineal and/or coccygeal area of the wearer, a less preferred indication of the intended wearing position is a fold in said flange (12) prior to use intended to be placed in parallel to the anal groove when placing the product. The longitudinal axis is typically also an axis of symmetry. Regarding in particular the flange (12) the longitudinal axis for a urine management device 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 management device (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.
The transversal axis is an axis perpendicular to said longitudinal axis, which crosses the centre of the aperture (21 ). The transversal direction, which is defined by the transversal axis, is generally aligned with the wearer's hips.

Unbent is used with regard to the flange (12). The flange (12) is typically bent along a longitudinal axis to place it onto the perianal area of the wearer. In an unbent state the flange (12) is typically flattest.
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.
Thus for the aperture (21 ), the centre is to be determined when the area within the contour of the aperture (21 ) is considered to be filled with a material of uniform thickness and density, when the flange (12) is unbent.
A diameter of the aperture (21 ) is the length of a line through the centre of the aperture (21 ), whose ends lie on the inner periphery (25) of the aperture (21 ), when the flange is unbent. The diameter of a flexible aperture (21 ) has to be measured when no outer forces are present which could affect the shape of the aperture (21 ) (apart from normally unavoidable forces such as gravity). The longitudinal diameter of the aperture (21 ) is measured along the longitudinal axis. The transversal diameter of the aperture (21 ) is measured along the transversal axis.
While the present invention comprises urine management devices as well as faecal management devices the following description focuses on faecal management devices. However, the person skilled in the art has no difficulties to adapt a urine management device to the teachings of the present invention.
It has been found that certain flanges greatly improve wearing comfort and safe attachment while minimising skin exposure.
Flanges (12) according to the present invention can be provided from numerous materials which are soft, flexible, pliable and malleable. Moreover, the material is preferably elastic (inter alia to follow movements of the sphincter muscle), stretchable, contractible and breathable. Even more preferred materials allow to WO 00/61039 PCT/iJS99/07908 securely embed a hydrogel adhesive, for example by having a three-dimensional microstructure in the surface region. A suitable material is a plastic film.
Such a plastic film may be provided with a layer of pressure sensitive adhesive to which a hydrogel adhesive will more firmly bond. Another preferred material is a laminate of a plastic film and a non-woven. Other preferred materials include wovens, open celled thermoplastic foams, closed-cell thermoplastic foams, composites of open celled foams and stretch nonwoven, and films. Preferably, such foams have a basis weight of 5 to 250 g/m2, more preferably 50 g/m2.
Other thermoplastic foam materials, or other suitable plastics sheet materials having the described properties might also be used. Highly preferred materials are non-woven materials, e.g. spun-bonded or melt-blown non-wovens. The materials preferably have a basis weight from 15g/m2 to 30g/mz.
The caliper of such material providing the flange (12) is preferably from 0.01 mm to 1.25 mm, more preferably from 0.05 mm to 0.5 mm, yet more preferably from 0.1 mm to 0.3 mm.
Flanges according to the present invention comprises an adhesive for attachment to the human body. The adhesive is deposited on the wearer facing portion (23) of the flange (12) as to form an adhesive layer (20). Preferably the adhesive layer (20) is a continuous layer. In an alternative embodiment the adhesive layer (20) is deposited in a discontinuous pattern, e.g. in a dotted pattern. Preferably the caliper of the adhesive layer (20) is uniform. If the caliper of the adhesive layer (20) is non uniform, the average caliper of the adhesive layer (20) is herein referred to as the caliper of the adhesive layer (20).
The adhesive layer (20) should also be thin, preferably having a caliper from 0.01 mm to 1.25 mm, more preferably from 0.5 mm to 1.1 mm, most preferably from 0.8 mm to 1.0 mm.
According to the present invention the overall caliper of the flange (12) is not more than 1.3 mm, preferably from 0.1 mm to 1.3 mm , more preferably from 0.9 mm to 1.25 mm, yet more preferably from 1.0 mm to 1.2 mm. The term overall caliper, as used herein, denotes the caliper of the flange (12) and the adhesive layer. If the caliper is not uniform, the term overall caliper, as used herein, denotes the average overall caliper. For the particular embodiment of a faecal management device (10) of Figure 2 the overall caliper is marked as c.

The bag (11 ) is provided with an aperture (21 ) whereby faecal matter or urine is received from the body prior to storage within the bag cavity. The aperture (21 ) is surrounded by a flange (12) and may be provided in any shape or size, such as circular, oblong, heart shaped and may be symmetrical or asymmetrical, 10 preferably the aperture has an oblong configuration either in the longitudinal or in the transversal direction. However, the transversal diameter of the aperture (21 ) must be less than 80 mm. Preferably, a flange (12) according to the present invention should have a transversal diameter from 5 to 60 mm, more preferably from 30 mm to 55 mm, yet more preferably from 40 mm to 50 mm. For the 15 particular embodiment of a faecal management device (10) of Figure 3 the transversal diameter is marked as d.
The thin overall caliper of the flange (12) in combination with a small transversal diameter of the aperture (21 ) ensures that the faecal material is transferred into the human waste management device close to the anal opening. The anal groove tightly surrounds the anal opening towards the buttocks essentially in a V-shape. In order to collect faecal material close to the anal opening, only a thin flange can be positioned close to the anal opening, since the buttocks would otherwise need to be spread apart in a way, which is both inconvenient for the wearer and difficult to achieve for a caretaker placing such a device.
This interdependence of flange (12) caliper, aperture (21 ) transversal diameter and close to source human waste collection is further illustrated by the following experimental data relating to a faecal management device (10) for a male or female baby. The data can be best understood from the schematic representation of the experiments given in Figure 4: Represented is a cast (220) of the anal region taken from a sitting baby boy, adjacent to the anal opening (210). Faecal matter excreted by a wearer will have a typical diameter, represented as d, of about 2 cm for example for a baby.
Attachment of the flange of a faecal management device (10) can only be so close to the anal opening (210) so as not to obstruct faecal matter which is to be entrapped in the bag (11 ) of the faecal management device (10). The flange caliper contributes to the obstruction of faecal matter. Hence, an ideal theoretical flange having an overall caliper of 0 mm could be closest to the anal opening (210). The ideal distance is represented in Figure 4 as x, corresponding to a transversal flange diameter of about 2x. A thin flange (230) in accordance with the present invention, due to its non-vanishing caliper cannot be worn so close to the anal opening (210), the distance to the anal opening (210) being y > x, corresponding to a transversal flange diameter of about 2y. A conventional thick flange (240) can be worn only at a distance to the anal opening of z > y, corresponding to an also greater transversal flange diameter of about 2z.
Typically for a baby x has a value of approximately 25 mm, y of 28 mm and z of 33 mm.
Conventional flanges have an overall caliper which does not allow for positioning close to the anal opening and hence require a larger aperture. This leads to an unnecessary and undesirable area of exposes skin, i.e. all the skin within the area of the aperture. Such skin exposure favours skin irritations. Moreover, it has been found that less skin exposure reduces the need for frequent changes of human waste management devices, thus giving a considerable convenience, economical and ecological benefit. It has further been found that less skin cleaning is required after the detachment of the device, which largely improves the convenience of such devices for the caretaker, such as a baby's mother.
In another aspect, the present invention allows the safer attachment by providing a larger flange (12) surface area. The flange (12) surface area available for adhesive attachment of the device (10) is determined by the area within the aperture (21 ) and the area within the outer periphery of the flange (12).
With regard to the outer periphery, the flange (12) can have only a limited size as determined by the anatomy of the intended wearers and comfort considerations.
Namely for babies only small flanges (12) are suitable. For a given outer periphery of the flange (12) the most surface area is available for an adhesive (20), when the area within the aperture (21 ) is small. A small transversal diameter of the aperture (21 ) contributes to such a small area within the aperture (21 ).
In yet another aspect, a small transversal diameter of the aperture (21 ) lessens the risk of leakage after the detachment of the device and allows for easier closing and sealing of the aperture (21 ).
Moreover, in the defaecation process pressure onto builds up at the inner periphery (25) of the flange (12), namely at the edges of the flange. The edge area of the flange (12) which is subjected to such pressure depends on the overall caliper of the flange (12) as visible from Figure 4. Hence, a thin flange (12) reduces the risk of detachment in comparison with a thick flange (12).

Claims (7)

1. A human waste management device comprising an aperture (21) and a flange (12) surrounding said aperture (21), said flange (12) having a transversal diameter, said flange (12) being provided with an adhesive layer (20), characterised in that said flange (12) and said adhesive layer (20) have an overall caliper of no more than 1.3 mm and in that said transversal diameter of the aperture (21) is less than 80 mm.

2. A human waste management device according to Claim 1, characterised in that said flange (12) and said adhesive layer (20) have an overall caliper of less than 1.2 mm.

3. A human waste management device according to any one of the preceding claims, characterised in that said transversal diameter of the aperture (21) is less than 50 mm.

4. A human waste management device according to any one of the preceding claims, characterised in that said flange comprises a non-woven material.

5. A human waste management device according to any one of the preceding claims, characterised in that said non-woven material is a spun-bonded non-woven material.

6. A human waste management device according to any one of the preceding claims, characterised in that said non-woven material has a basis weight from 15g/m2 to 30g/m2.

7. A human waste management device according to any one of the preceding claims, characterised in that said adhesive layer (20) comprises a hydrogel.