CA2369190A1 - Faecal collector with a convenient release sheet - Google Patents

Abstract

The present invention relates to human waste management devices and absorbent articles for babies, children or adults. The invention resides principally in providing the device with a release sheet (36) for the adhesive (20) provided on the flange (12) for the attachment to the body of a wearer, the release sheet (36) comprising at least one adhesive contacting portion (41) and at least one non adhesive contacting portion (42), which at least partially overlays said adhesive contacting portion.

Description

FAECAL COLLECTOR WITH A CONVENIENT RELEASE SHEET
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Field of the invention The present invention relates to human waste management devices for babies, 15 children or adults and further to hygienic absorbent articles, such as diapers, incontinence articles and feminine protection articles. Said devices are provided with a convenient release sheet to cover adhesive portions of the flange prior to use.
20 Background 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 25 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.
30 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 0 140 478 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.
Mainly in order to protect the adhesive before use, faecal management devices for adhesive attachment are known which are provided with a release sheet.
Such devices are disclosed for example in the following documents: Japanese Kokai Application HEI 8[1996]-117261 discloses the adhesive covered with paper. GB 2 152 387 discloses a release sheet provided by a paper to which a silicone coating is applied. GB 2 116 849 discloses a release sheet comprising a plurality of individually removable sections. While the force required to remove each section may be less than the force fequired to remove a single release J
sheet covering the whole area of the body contact adhesive, this solution requires disposal of such a plurality of sections, which is inconvenient. EP 0 290 discloses a release sheet comprising a tab to facilitate the removal of the release sheet. The tab projects outward the layer of body contact adhesive and is of a size appropriate for gripping with thumb and forefinger.
Similarly, the use of release sheets for urine management devices is also known and disclosed in the following documents: US 3,292,626 discloses a peel patch.
GB 1,092,274 discloses a backing paper to cover adhesive material. US
4,804,377 discloses a semi-rigid carrier member to protect the adhesive face of the device.
All human waste management devices disclosed in the documents, which are referred to above, are typically used for bedridden patients. Thus, they are typically applied by a nurse or another person having training and experience regarding the application of such a device. However, in a recent patent application (EPO application 97110603.4; "Shaped faecal management device") and co-pending applications, faecal management devices are disclosed which are optimised for use on babies. Such use requires that the human waste management device is carried and applied in a large variety of circumstances, for example, by a mother carrying such device in her handbag.
By contact with a multitude of other items not uncommonly carried in a handbag, the body contact adhesive of a human waste management device may suffer mechanical damage, or, not less likely, dirt, dust or other substances may be deposited thereon. This is highly undesirable since it will typically lead to a reduced sticking forces of the adhesive and therefore may induce leakage or even unintentional detachment of the human waste management device.
Unintentional detachment is known in the art, as mentioned in GB 2,116,849. Of course, reliable protection of the adhesive is also desirable while the device is shipped, packaged or stored, be it in a warehouse, a hospital or a private household.

In particular when the device is used by a mother as described above, it is important that the release paper can be easily removed, preferably with one movement. For example a tab, as disclosed in EP 0 753 290, may not allow for safe gripping and convenient removal of the release sheet, particularly if it is attached to a strong adhesive. Moreover, there is a need to not only conveniently grip the release sheet for removal, but to also safely and conveniently hold the other parts of the device, namely in order to avoid deformation of the flange and of other parts of the device.
Moreover, it is desirable that the method of removal of the release sheet be intuitive to the user and requires minimal instructions or experience. While this appears most important when the device is applied by a mother, or for example a grandmother, who only infrequently applies the device, intuitive handling is also important for all human waste management device used in a hospital environment, where the training of staff induces considerable costs.
European patent application 99100119.9 ("A human waste management device with an anatomically shaped flange") discloses devices with non-planar flanges.
The flange of a human waste management device may for example comprise humps, e.g. to fit the perineum, and may have a three dimensional shape. As disclosed in the same application the device may also be provided in a folded prior to use configuration. A conventional release sheet may be even harder to remove if it follows a three dimensional shape or a fold of the prior to use configuration.
Patent application No. PCT/US98/13298 ("Applicator for a faecal management device") discloses devices which are prior to use provided in combination with an applicator. The correct positioning of the device on such an applicator is important for the correct and secure placement of the device onto a wearer.
When a conventional release sheet is removed, in particular if being removed by peeling from various ends, the flange is normally subject to unequal forces from various directions. This leads easily to a mispositioning of the device on the applicator and thus to a misplacement on the wearer. Such misplacement results in a low wearing comfort and possibly even in leakage or unintentional detachment.

Hence, there still exists a need for a human waste management device which ensures reliable adhesive attachment and which can be easily be handled and placed, namely allowing for easy and convenient removal and later disposal of a release sheet covering the adhesive for attachment.
In attempting to overcome all the aforementioned problems relating to the prior art, it has now been found that for adhesive human waste management devices a release sheet can be provided which is folded upon itself.
Summary of the invention The present invention relates to human waste management devices for babies, children or adults and further to hygienic absorbent articles, such as diapers, incontinence articles and feminine protection articles. The invention resides principally in providing the device with a release sheet (36) for the adhesive (20) provided on the flange (12) for the attachment to the body of a wearer, the release sheet (36) comprising at least one adhesive contacting portion (41 ) and at least one non adhesive contacting portion (42), which at least partially overlays said adhesive contacting portion.
Brief description of the drawings 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 which can be used in combination with the present invention. .

Figure 2 is a top plan view of a preferred embodiment of the present invention for a faecal management device.
Figure 3 is a cross sectional view along line 3-3 of the preferred embodiment depicted in Figure 2.
Figure 4 is a cross sectional view of the faecal management device shown in Figures 2 and 3, showing the device in an intermediate state of the release sheet removal.
Figure 5 is a top plan view of another preferred embodiment of a faecal management device according to the present invention.
Figure fi is a cross sectional view along line 6-6 of the preferred embodiment of a faecal management device depicted in Figure 5.
Detailed description of the invention The invention relates to human waste management devices and further to hygienic absorbent articles, such as diapers, incontinence articles and feminine protection articles. 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, 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.
While a release sheet (36) in accordance with the present invention has been found to be particularly useful for a flange (12) of a human waste management device, such a release sheet (36) is also useful to cover adhesive portions, in particular flanges covered with an adhesive, of other absorbent articles, such as diapers, incontinence articles and feminine protection articles.
A recent patent application (attorney's docket number 7321 Q) discloses, for example, absorbent articles having a first waist region, a second waist region and a crotch region located between the first waist region and the second waist region, the absorbent article comprising: a topsheet including a primary aperture surrounded by a flange for receiving faecal waste, and a backsheet joined with at least a portion of the topsheet, and an absorbent core disposed between at least a portion of the topsheet and the backsheet, and a spacing member disposed between the topsheet and the backsheet, the spacing member providing a void space into which faeces can be directed; and a body adhering composition disposed about at least a portion of the primary aperture surrounded by a flange for adhering the topsheet of the absorbent article to the wearer during use.
The term "flange", as used herein, denotes the portion of the absorbent article of human waste management device which is adjacent to the aperture and hence defines the form of the aperture, irrespective if the flange is a distinguishable separate piece of material or is comprised by another piece of material, such as the topsheet of the absorbent article.
The release sheets (36) of the present invention also seem highly suitable to be applied to human waste management device as described hereinafter.

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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, in which a faecal management device (10) is shown. 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 5 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, t~ 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; meltbloVvn 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 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.).
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, preferably the aperture has an oblong configuration either in the longitudinal or in the transversal direction.

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.
The flange (12) should be made of soft, flexible and malleable material to allow easy placement of the flange (12) to the perianal or uro-genital area. 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/m2, more preferably 50 g/m2. 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.

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 (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 (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 (20) is applied at a basis weight of from 20g/m2 to 2500g/mZ, more preferably from 500g/m2 to 2000g/mz most preferably from 700g/m2 to 1500g/mz depending on the end use envisioned. For example, for human waste management devices (10) to be used for babies the amount of adhesive (20) may be less than for human waste management devices (10) designed for active adult incontinence sufferers.
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 conta~~t with the adhesive.

WO 00/61041 PCT/iJS00/09781 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.

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.
According to the present invention the adhesive (20), which is provided on the wearer facing portion (23) of the flange (12), is covered with a release sheet (36), which comprises at least one adhesive contacting portion (41 ) and at least one non adhesive contacting portion (42), which at least partially overlays the adhesive contacting portion (41 ). In one preferred embodiment a release sheet (36) comprising both portions is provided by the same piece of material, for example, a thin plastic foil, which is folded onto itself, so that the non adhesive contacting portion (42) essentially overlays the entire adhesive contacting portion (41 ). Such an embodiment is depicted in Figure 2.
An adhesive contacting portion (41 ) is a portion of the release sheet (36) which is in contact with the adhesive (20) of the flange (12). An adhesive contacting portion (41 ) may also comprise material with extends over the adhesive (40) and which is in one plane with the adhesive contacting portion (41 ) of the release sheet (36). A non adhesive contacting portion (42) of the release sheet (36) is not in contact with the adhesive (20).
It has now been found that providing the release sheet (36) with a adhesive contacting portion (41 ) and a non adhesive contacting portion (42), which at least partially overlays the adhesive contacting portion (41 ), facilitates the removal of the release sheet (36), since this allows removal of the release sheet (36) at an advantageous angle. This allows the forces applied for the removal of the release sheet (36) to be substantially parallel with the adhesive (20).
Without wishing to be bound by theory, it is believed that the removal of the release sheet (36) by applying forces substantially parallel to the adhesive (20) which is covered by the release sheet (36) requires less forces than the removal by applying forces substantially vertical to the adhesive (20). Since reliable adhesive attachment of a human waste management device is important and an adhesive providing the desired reliable attachment to the skin in use is likely to also engage in strong attachment to a release sheet (36), easy removal is very desirable, but is not readily achieved by conventional release papers, which exercise forces substantially vertical to the adhesive (20) when being removed.
The adhesive contacting portions (41 ) and the non adhesive contacting portions (42) of the release sheet (36) are typically separated by a fold (37) in the release sheet (36), by which the release sheet (36) is folded onto itself, or by a line of juncture. Such a line of junction joins the adhesive contacting portion (41 ) and the non adhesive contacting portion (42) to one another and can be provided by any means known in the art such as adhesive, thermobonding and hot or cold crimping.
The term fold (37), as used herein, refers to a fold in the release sheet (36) by which the release sheet is provided with a folding line by which it is folded onto itself. Thus, a fold in the release sheet (36) resulting from folding the flange (12), e.g in a prior to use configuration, comprising a release sheet (36) is not encompassed by the term fold (37) as used herein. A prior to use configuration is a configuration preferred for the provision of the device, which is chosen in view of the packaging of the device or in view of its application and which may be different from the configuration of the device in use. Figures 2, 3 ,5 and depict devices in preferred prior to use configurations, in which the flange (12) is folded along one fold.

A release sheet (36) in accordance with the present invention may comprise any number of folds (37) or lines of juncture, preferably it comprises one to five folds (37) or lines of juncture, more preferably two to four folds (37) or lines of juncture, most preferably two folds or lines of juncture. While each fold (37) or line of juncture may be oriented in any direction, preferably all folds (37) or lines of juncture have parallel orientation to each other. Preferably the folds (37) or lines of juncture are either oriented in the longitudinal direction or in the transversal direction.
Longitudinal, as used herein, with reference to a human waste management device in a prior to use configuration, in which the flange (12) is provided with one fold, refers to the direction of the fold in the flange. Transversal, as used herein, with reference to a human waste management device in its prior to use configuration in which the flange (12) is folded, refers to the direction defined by a line which is perpendicular to the folding line of the flange (12) and which comprises the centre of mass of the device (10).
The release sheet (36) may be provided from any suitable material, may it be a single material or a combination of several different materials. Suitable materials are, for example, paper and all plastic materials, in particular polyethylene.
The material is preferably thin, preferably having a caliper of 1 to 1000 Nm, more preferably 10 to 300 Nm, most preferably 40 to 160 pm. In addition, the release sheet (36) may further comprise a coating. One preferred coating for the adhesive contacting side of the adhesive contacting portion (41 ) a silicone coating.
The release sheet (36) may be provided from a single piece of material or several pieces of material which are joined together. For example, the adhesive contacting portions (41 ) and the non adhesive contacting portions (42) may each comprise separate pieces of material and may be joined by a line of juncture, such that these portions can overlay each-other without being folded onto each other. In a preferred embodiment the release sheet (36) is provided from a single ply material, however, a release sheet (36) provided from two or multiple ply material have also been found to work well.
Moreover, the release sheet (36) may comprise excess material so as to provide a gripping portion (39). The gripping portion (39) is preferably formed by material of each of the non adhesive contacting portions (42) which is joined together.
Such a gripping portion (39) preferably has a surface area from 1 cm2 to 50 cm2, more preferably from 5 cm2 to 20 cmz, most preferably from 8 cm2 to 15 cmz.
The gripping portion (39) according to the present invention is provided so that it can be gripped with two or more, for example, three fingers,'depending on individual habits and physiological disposition of the user.
Preferably a human waste management device according to the present invention is provided in a certain prior to use configuration, which preferably comprises one fold. The configuration is preferably chosen for easy application and easy removal of the release sheet (36). In a preferred prior to use configuration the flange (12) comprises at least one fold. For a faecal management device (10) this fold is preferably later to be brought in registry with the anal groove. More preferably the device (10) is prior to use provided with an applicator (40), for example as depicted in Figure 2 and further described in patent application No. PCT/US98/13298 ("Applicator for a faecal management device"). When an applicator (40) is used the fold in the prior to use configuration of the flange (12) may be maintained by any means such as a rubber band.
Figures 1 and 2 show a preferred embodiment of the present invention in top view and cross sectional view. In Figure 2, the device (10) is shown in its prior to use configuration in which it is folded about an applicator (40). The release sheet (36) comprises a polyethylene sheet which comprises two folds (37) oriented in the longitudinal direction. The two folds (37) allow folding of the release sheet (36) onto itself on either side of the flange (12) thereby providing one adhesive contacting portion (41 ) and two non adhesive contacting portions (42). The two non adhesive contacting portion (42) overlay the adhesive contacting portion (41 ). These folds (37) are so positioned that the lobes (13) on the flange (12) (which may serve as a help in placing the device (10)) are not covered by the release sheet (36). Moreover, the release sheet (36) comprises excess material so as to provide a gripping portion (39). The gripping portion (39) is formed by material of each of the non adhesive contacting portions (42) which is joined together. The gripping portion (39) is provided on the opposite side of the longitudinal folds (37) than the lobes (13). In this prior to use configuration the release sheet (36) comprising two folds (37) and following the fold in the flange (12) essentially has the form of the letter "M" when seen in a cross sectional view - as apparent from Figure 2.
This embodiment of the present invention has been found to allow a particularly easy removal of the release sheet (36), which can be done as follows: the user of the human waste management device will hold the device (10) with one hand typically putting thumb and forefinger each on one lobe (13) on each side of the applicator (40). Using the other hand, and typically again thumb and forefinger, the user will grip the release sheet (36) at the gripping portion (39). To remove the release sheet (36) the user will pull the release sheet (36) away from the flange (12) while still holding the device with the other hand. The force applied in pulling will be transmitted by the non adhesive contacting portion (42) of the release sheet (36) towards the folds (37) which are adjacent to the lobes (13).
These forces are further transmitted via the two folds (37) and cause portions of the release sheet (36) which are adjacent to the two folds (37) and which form part of the adhesive contacting portion (41 ) to be removed. As a result folds (37) provided by adjacent portions of the release sheet (36) are formed at a position closer to the fold in the flange (12). In the process of the removal of the release sheet (36) the folds (37) will move towards the aperture (21 ). An intermediate removal state is depicted in Figure 4.

This process of removal ensures low force removal of the release sheet (36).
Moreover, in the process an even distribution of forces with regard to the applicator (40) is ensured. Hence the device (10) will maintain its position on the 5 applicator (40) and can be securely placed onto the wearer.
The device (10) can be held so, that the user pulls the release sheet (36) towards his body, which was found a preferred way of removal for many users.
10 Upon completion of the removal the release sheet (36) is easily handled, typically for disposal, by still holding it at the gripping portion (39).
Moreover, upon completion of the removal the device is held in an ideal way for the subsequent application to a wearer by use of the applicator (40).
15 In this preferred embodiment, the device further comprises markers (38) to guide the user, as shown in Figure 3. For example, a marker (38) on the release sheet (36) may indicate where to grip the release sheet (36) for removal and in which direction to pull. Such markers (38) may, for example, be provided by adhesive paper labels or by direct application of ink to the release sheet (36).
Figures 5 and 6 show another preferred embodiment of the present invention, a faecal management device (10) in its prior to use configuration, which is provided with an applicator (40).
For this embodiment of a faecal management device (10) the release sheet (36) is provided with two folds (37) in the transversal direction. The release sheet (36) comprises two adhesive contacting portions (41 ) and two non adhesive contacting portions (42). Each non adhesive contacting portion (42) overlays one adhesive contacting portion (41 ). The two non adhesive contacting portions (42) are each provided with excess material at one transparent side of the device (10) as to provide a gripping portion (39).

The device (10) is further provided with lobes (13) comprising a non-woven material which is comprised by the flange (12). These lobes (13) are useful to hold the device (10) when the release sheet (36) is peeled off by use of the gripping portion (39). They may later be used as a help for the detachment of the device (10).
The release sheet (36) is so designed that it comprises one further fold (37) in the longitudinal direction. As opposed to the folds (37) in the transversal direction the fold (37) in the longitudinal direction does not primarily serve a function in the removal of the release sheet (36), but is beneficial for the protection of the device (10) prior to use.
In another preferred embodiment of the present invention the release sheet (36) also covers any lobes (13), which may be comprised by the flange (12), for example as a help in placement.
In yet another preferred embodiment of the present invention the non adhesive contacting portions (42) serve to wrap the device (10) prior to use. They can be joined (e.g. by adhesive, crimping, thermobonding, a perforation line and other means known in the art) so as to provide a pocket, which can contain the bag (11 ) and other parts of the device (10) and also the applicator (40). In preparing for the placement of the device (10) the non adhesive contacting portions (42) are detached to overlap the adhesive contacting portions (41 ) and may further be joined so as to provide a gripping portion (39).
In another preferred embodiment of the present invention the release sheet (36) comprises two adhesive contacting portions (41 ) and two non adhesive contacting portions (42). The adhesive contacting portions (41 ) preferably comprise a coating such as a silicone coating. The non adhesive contacting portions (42) do not comprise a coating and may be provided from a different material then the adhesive contacting port~6ns (41 ). Such different material can offer the advantage of being a cheaper material than the material of the adhesive contacting portions (41 ). The non adhesive contacting portion (42) may also be smaller in size then the adhesive contacting portion (41 ), for example may be provided as a tab sized as to allow gripping with two fingers.
If a human waste management device is provided with a flange (12) in an essentially flat prior to use configuration, which may, however, also comprise at least one hump, preferably the release sheet (36) comprises one adhesive contacting portion (41 ) and one non adhesive contacting portion (42). If the flange (12) comprises one or more humps these humps may be covered with separate release sheets (36), preferably comprising at least one adhesive contacting portion (41 ) and at least one non adhesive contacting portion (42).

Claims (9)

What is claimed is:

1. A human waste management device or absorbent article comprising an aperture (21) and a flange (12) surrounding said aperture (21), said flange (12) being provided with adhesive (20) for attachment to the body of a wearer, said adhesive (20) being provided with a release sheet (36), said release sheet (36) comprising at least one adhesive contacting portion (41) and at least one non adhesive contacting portion (42) characterised in that said non adhesive contacting portion at least partially overlays said adhesive contacting portion.

2. A human waste management device or absorbent article according to Claim 1, characterised in that said release sheet (36) comprises at least one fold (37) or line of juncture.

3. A human waste management device or absorbent article according to Claim 2, characterised in that said release sheet (36) comprises at least two folds (37) or lines of juncture.

4. A human waste management device or absorbent article according to Claim 3, characterised in that said folds (37) or said lines of juncture have parallel orientation.

5. A human waste management device or absorbent article according to any one of the preceding claims, characterised in that said release sheet (36) comprises a gripping portion (39).

6. A human waste management device or absorbent article according to any one of the preceding claims, characterised in that said release sheet (36) comprises at least one marker (38).

7. A human waste management device or absorbent article according to any one of the preceding claims characterised in that said flange (12) prior to use is provided with one fold.

8. A human waste management device or absorbent article according to Claims 3 and 7, characterised in that said folds (37) or said lines of juncture of the release sheet (36) are oriented in the longitudinal direction.

9. A human waste management device or absorbent article according to Claims 3 and 7, characterised in that said folds (37) or said lines of juncture of the release sheet (36) are oriented in the transversal direction.