MXPA00000044A - Shaped skin attachment means for a faecal collector - Google Patents

Abstract

The present invention relates to a faecal management device (10) designed to provide improved body fit between the flange and the skin of the wearer and thereby prevent leakage. The faecal management device (10) comprises a bag (11) having an aperture (21), and an anatomically-shaped flange (12), which surrounds the aperture (21). The flange (12) provides for adhesive attachment to the perianal area of the wearer. In particular, the front portion (26) of the flange comprises a projection (28), which provides an effective seal between the flange (12) and the skin of the wearer and prevent leakage to the urinary tract. In particular the device (10) fits snugly into the folds at the margin of the vulva of the wearer and thereby improves sealing. In another aspect of the present invention, the faecal management device comprising such a flange is used in combination with a disposable diaper.

Description

MEANS OF FIXING THE PI THE FORMED FOR A COLLECTOR OF FECAL FECES FIELD OF THE INVENTION The present invention relates to a stool management device that adjusts the body. In particular, the present invention is directed toward stool handling devices with improved skin attachment means such that improved fit to the body and tight seal is provided between the user's body and the skin, thereby preventing the contact between the fecal material and the urinary tract. The devices find a particular utility in the female users of said devices.

BACKGROUND OF THE INVENTION Fecal management devices are known manufacturing items that are designed to be worn primarily by those who suffer from incontinence and infants. Said stool handling devices are fixed to the user's anal region and are intended to entrap and immediately contain fecal matter and other bodily discharges. As a consequence, these devices are functionally effective in eliminating the problem of the user's skin getting dirty; in reducing epidermal irritation; in preventing contamination of items such as clothing and bedding; and even in preventing staining of the same caregivers. However, a problem that frequently occurs during the use of said stool management devices is that the fecal material may flow into the urinary tract of the user, in particular of the users within the sensitive urethra of the user. Typically, the presence of said fecal material can cause detestable infections in this area. Such a condition is very undesirable, painful and distressing for the user bedridden or for the infant. There are many items on the market that claim entrampe and immediate containment of fecal material in an effective manner. The prior art is rich in such samples. For example, WO 96/19167 describes an absorbent article adapted to contain fecal material and highly fluidic material that is ejected at a high velocity. The absorbent article comprises stool container members positioned transversely to the outside of the absorbent assembly, which functions by interrupting the lateral movement of the fecal material. The stool container members are formed of elastic and porous materials to maintain and provide sufficient void volume to collect fecal material, respectively. WO 94/14395 discloses a disposable absorbent article comprising a transverse partition positioned on the surface facing the body of the topsheet and extending outward therefrom, to be straightened and spread away from the plane of the disposable absorbent article. The transverse partition divides the absorbent article into a front portion and a rear portion, and presents an abrupt discontinuity between the two portions. The fecal material deposited in the rear position is obstructed from the migration longitudinally towards the frontal portion by the transverse partition. WO 97/01 316 details a diaper with a bag for collecting fecal material and a urine collector for storing urine. The bag is formed by folding the diaper backwards along an imaginary center line (perpendicular to the longitudinal sides of the diaper) and stretching the edges (spaced from the central imaginary line) parallel to the imaginary line simultaneously. In this way, the fecal material is isolated from the user's skin. Japanese application JP 08-1 17 261 A discloses a diaper having a bag-like structure, which is designed for those suffering from incontinence. The bag comprises a slit or a hole in a position facing the anus with the slit or the hole, being surrounded by a surface coated with an adhesive. The bag is made of water repellent material. United States Patent No. 3, 577,989 details a disposable plastic retention-disposal bag for those suffering from incontinence. The flange is specifically designed and shaped such that it is generally convex at its curved rear end while it is generally concave at its front end. In particular, for a patient, the convex portion of the flange is adapted to closely follow the curved contour of the body and to fit between the cheeks of the buttocks and below and around the anus while the front end portion of the The eyelash is designed to closely follow the curved contour of the patient's body above the vulva. Between the end portions of the flange are elongated side portions sized to closely follow the contour of the curved body between the anus, the cheeks and the upper part of the patient's legs. European Patent EP 0 245 064 describes a fecal incontinence bag having flexible front and rear walls secured together around its periphery. The front wall has a hole for the entry of matter discharged by the user. The hole is surrounded by an adhesive pad of water-resistant material compatible with the skin secured to the external surface of the front wall. The pad is generally heart-shaped such that when in place the concave portion of the heart-shaped pad is facing the front of the user. For all cases of the prior art, the fecal matter is not entirely contained in the bag of the stool management device. It is known that some fecal matter leaks from the anal region and creeps towards the urethra. However, for a stool management device there is a need that is extremely effective in completely isolating fecal material from the user's sensitive urinary tract. The present invention addresses this need by providing a projection on the front portion of the flange. It has been found that the presence of such a projection is only advantageous and prevents the fecal material from flowing out of the frontal portion of the flange into the urinary tract. In addition, the presence of such a projection in the stool management device does not cause discomfort to the user, leads to a great reduction in infections and epidermal irritations derived from fecal material and causes a high level of satisfaction in the user and carer in relation to the patient. to the health of the skin.

In another aspect of the present invention, the fecal handling device with this projection can be advantageously used with a disposable diaper. The prior art is omitted in said combination. As described above, none of the prior art documents disclose two separate entities that function synergistically to isolate the fecal material from the sensitive organs of the user and further isolate the wearer's skin from the absorbent material of the diaper.

BRIEF DESCRIPTION OF THE INVENTION The fecal handling device constructed in accordance with the present invention comprises a bag having an opening and an anatomically formed flange surrounding the opening for adhesive attachment to the perianal area of the user. The anatomically formed flange is fixed to the bag and comprises an outer periphery, an inner periphery adjacent to the opening, a longitudinal center line and a transverse center line, wherein the transverse center line divides the flange into a front portion and a portion thereof. later. In particular, the flange comprises a projection on the front portion. The projection is disposed between the outer periphery and the inner periphery of the flange in a direction parallel to the longitudinal direction. Preferably, the projection extends from the outer periphery to the inner periphery and is arranged in a symmetrical manner. The projection has an effective height ranging from 0.5 millimeters to 15 millimeters, preferably from 2 millimeters to 10 millimeters, more preferably an effective height of approximately 3 to 7 millimeters. The projection is particularly beneficial for female users where the projection is adapted to fit comfortably between the vulva and the anus, that is, the female user's perineum. In another aspect of the present invention, the present stool management device is used in combination with a disposable diaper.

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 the stool handling device according to the present invention. Figure 2 shows a perspective view of the stool handling device in conjunction with a disposable diaper; and Figure 3 is a partially cut away perspective view of a disposable diaper embodying the present invention.

DETAILED DESCRIPTION OF THE INVENTION According to Figure 1, the typical fecal handling device (10) comprises a bag (11) having an opening (21) and an anatomically formed flange (12) surrounding the opening (21) for adhesive fixation to the user's skin in the user's anus area between the user's buttocks and the gluteal groove. From Figure 1, it is evident that the anatomically formed flange (12) comprises an outer periphery (24), and an internal periphery (25) adjacent to and defining an opening (21), a longitudinal centerline L and a line transverse central T orthogonal to this one. The transverse center line T segments the anatomically formed flange (12) into a front portion (26) and a back portion (27). The tab (1 2) further comprises a surface that gives the user (23) and a surface that gives the garment (22). In accordance with the present invention, it has been surprisingly found that the presence of a projection placed on the user-facing surface of the anatomically shaped flange (12) is particularly effective in reducing and preventing any fecal material from escaping from the device (10). ) between the skin and the eyelash. It is believed that the position of said projection (28) on the front portion (26) of the user-facing surface of the flange (23) not only provides a flange that more readily conforms to the contours of the body anatomy, but also provides an improved seal in the flange positions, where the output of stool more easily occurs and thus prevents any unnecessary contact between the skin and the excreted matter. In addition, a further surprising advantage of the present invention is that the presence of the front projection (28) also assists in the placement of the device on the desired skin location of the user of the device, further enhancing the sealing benefit. This is particularly useful for female users where the projection can be inserted into the urethra. According to the present invention the projection is placed between the outer periphery (24) and the internal periphery (25) of the anatomically formed flange (12) in a direction parallel to the longitudinal direction L. In addition, the projection also extends in a transverse direction between the longitudinal side edges on either side of the longitudinal center line L. More preferably, the flange (12) extends from the outer periphery (24) to the inner periphery (25). In the transverse direction, the projection (28) preferably does not extend to the other side of the total transverse width of the flange but only up to 50% of the width, more preferably up to 30% of the width of the flange measured through the center of the projection The front projection (28) can be positioned symmetrically or asymmetrically around the longitudinal center line. L. In a more preferred embodiment, the projection (28) is positioned in a substantially symmetric manner. According to the present invention, the projection extends perpendicular to the plane of the flange. It is important that the projection (28) be straightened and lifted above the plane of the flange (12) to an effective height H sufficient to present an abrupt discontinuity to obstruct the movement of the fecal material. As used herein, the term "effective height" refers to the maximum distance in the Z direction of the garment portion (23) of the flange (12) in its extended orientation of the projection, including the adhesives if they are present on the projection surface. The projection (28) has an effective height that varies from 0.5 millimeters to 15 millimeters.

Preferably, the projection (28) has an effective height ranging from 2 millimeters to 10 millimeters, more preferably an effective height of about 3 to 7 millimeters. The measurements of the effective height are carried out without the aid of a micrometer so that no pressure is exerted on the adhesive of the material. Typically, the projection (28) is orthogonal to the plane of the flange (12). It should be recognized however that if the flange (12) has wrinkles, roughness, ripples or other deviation of the plan, these should be taken into consideration in the projection position (28), when its effective height is determined. According to the present invention, the projection (28) can have any shape. Typically the projection (28) has a substantially convex longitudinal and / or transverse cross section. The front projection (28) is typically convex in shape and provides a longitudinal cross-section of hump type or mount type and / or cross cross section or provides a tubular cross section. The projection may also have a double hump-type cross section, to provide a projection (28) having two or more different heights. Preferably, the hump exhibiting the maximum or effective height of the projection will be placed towards the outer periphery (24) of the flange (12). The projection (28) is preferably hollow or partially hollow to improve the elasticity and flexibility of the projection but can also be completely filled. For embodiments wherein the projection (28) is hollow or partially hollow, the projection may require additional support means to maintain the desired elastic configuration of the projection (28). The support means include adhesives or the provision of an elastic material that connects the longitudinal sides of the projection (28) to one or the other at least the base of the projection (28) on the surface that gives the user (23) of the tab (12). According to the present invention, the projection (28) should preferably be laterally compressible such that the projection will move inward when compressed by lateral forces instead of reclining. The projection (28) must also be elastically deformable such that, for example, the longitudinal sides are compressed the top or top of the projection will be reinforced upwards and will thus provide a vertical extension of the projection during use, and will increase the total effective height of the device. In this way, the sealing effect provided by the protection (28) and more preferably in combination with the flange (12) and the adhesive (20) is always maintained, even when the user of the device is active during use and with that provide increased pressures on the device. The configuration of the projection (28) can be selected to provide the additional enhanced setting, for example, if it is attempted for a particular group of female users. For example, the front projection (28) for a device intended for female users should typically have a higher effective height, than the front projection (28) for a device intended for male users. However, the design and the exact dimension can be easily selected by the experts in the field.

The projection (28) can be formed as an integral part of the tab or can be provided as separate entities, whereby a material that can be different or identical to the material of the tab, is attached to the tab (12) using the means known in the art, typically adhesive. However, preferably the projection (28) is formed as an integral part of the flange. The projection (28) can be made by forming an individual fold in the constituent material of the flange (12) or by thermally joining the material of the flange. Alternatively, the projection (28) can be provided by a compatible adhesive material to the body. In a preferred embodiment of the present invention, however, the projection, (28) is formed from the same material of the flange and uses a support adhesive means. The projection (28) can be either coated with adhesive or substantially free of adhesive. According to a preferred embodiment of the present invention, the projection (28) is also coated with a body compatible adhesive. For embodiments wherein the projection (28) comprises a longitudinal cross-section of dual hump for example, it has been found particularly beneficial to provide only one of the surfaces of the hump, preferably the hump that provides "effective height" with an adhesive compatible to the body. The surface of the remaining hump can be provided with an anti-skid material, such as rubber. As shown in Figure 1, the opening (21) is surrounded by a flange (12) and can be provided in any shape or size, such as circular, oblong, heart-shaped and can be symmetrical or asymmetric, preferably the The opening has an oblong configuration in either the longitudinal or transverse direction, more preferably the contours of the opening are in the form of two ellipses with the respective main axes being substantially perpendicular. The flange (12) is attached to the bag (11) according to any means known to the man skilled in the art, which can provide a permanent or removable bond. Preferably, however, the flange is attached to the bag by adhesives. Typically, the bag will be attached to the flange, towards the outer periphery of the flange so as not to cause any obstruction to the entrance of the fecal material. The tab can be provided in any size depending on the group of users for whom the device is directed. Similarly, the flange can be provided in any shape and preferably has a symmetrical shape preferably comprising a plurality of lobes (13). The tab comprises a portion that gives the garment (22) and a portion that gives the user (23). The tab (12) should be made of soft, flexible and moldable materials to allow easy placement of the tab in the perianal area. Typical materials include non-woven materials, fabrics, open cell thermoplastic foams, closed cell thermoplastic foams, open cell foam composites and stretch nonwovens, and films, materials placed with air including natural and synthetic fibers, thermally bonded air laid materials, felt fabrics, needle punched fabrics, glued spun fabrics, fluid entangled fabrics, wet laid fabrics, dry laid fabrics, melt blown fabrics, carded fabrics, fiber cut, knitted yarn fabrics, knit knits, knits with openings, combinations of the above or the like. A closed cell polyethylene foam has been found effective, but more preferably an open cell polyurethane foam is used. Preferably, said foams have a thickness in the general range of 0.1 to 5 millimeters and a density of 5 to 250 g / m3, more preferably 50 g / m3. Other thermoplastic foam materials, or other suitable plastic sheet materials having the described properties of said foams (eg softness, flexibility, stretchability, and contractibility) could also be used. Preferably, the material of the garment-facing surface (23) of the flange (12) may extend in a defined opening area to form a skirt or fin of a material that prevents unintentional adhesion of the edges of the surface of the tab (12) that define the opening (21) to each other during use. In accordance with the present invention, the stool management device (1 0]) further comprises joining means for securing the device to the user. Said means include belts and more preferably comprises a pressure sensitive adhesive compatible to the body (20) applied to the user-facing portion (23) of the flange (12). The adhesive (20) is preferably covered with release means (not shown) to protect the adhesive (20) such as paper with silicone. The adhesive (20) can completely cover the surface that gives the user of the flange or more preferably have at least one, preferably two to six portions without adhesive. These portions may be free of adhesive or may contain inactive or coated adhesives. As is evident from Figure 1, the adhesive is not a preferred embodiment applied to the total area of the surface that it gives to the user of the flange (12), as well as to provide lobes (13) on either side of the flange ( 12), which are not adhesive and can thus serve to facilitate the placement and separation of the device, while avoiding contact with the adhesive. These lobes are, however, preferably also covered by the detachment means. Before the application of the stool management device (10) to the user's skin, the release means are removed if present. In accordance with the present invention, any medically-approved, water-resistant pressure-sensitive adhesive may be used to attach the device to the user's perianal area, such as hydrocolloid adhesives and hydrogel adhesives. The adhesives particularly effective in providing the desired adhesive properties to secure the flange to the wearer's skin in the sensitive perianal area, while permitting a relatively painless application and separation, are formed of crosslinking polymers with a plasticizer to form a three-dimensional matrix. The adhesive (20) may be applied to the surface that gives the user of the flange (12) by any means known in the art such as a slot coating, application or spiral or bead printing. Typically, the adhesive (20) is applied at a basis weight of 20g / m2 to 2500g / m2, more preferably 500g / m2 to 2000g / m2, most preferably 700g / m2 to 1 500g / m2 depending on the end use contemplated. For example, for handling devices, stool (10) that is used by infants, the amount of adhesive (20) may be less than for stool management devices designed for active adults who suffer from incontinence. The bag (11) as used herein is a flexible receptacle for containing excreted fecal matter. The bag (11) can be provided in any shape or size depending on the intended use, ie, if the device is intended to be used for patients bedridden or for active patients suffering from incontinence or requiring of an artificial intestine or for infants. For example. Elongated pouches that are mainly tubular or rectangular can typically be used by bedridden patients and elderly people suffering from incontinence. For more active users, whether they are infants or adults, the stool management device should preferably be anatomically shaped, so that the device follows the contours of the body and can be discreetly worn by the user under normal garments. Particularly, the preferred shapes are flat circular type bags, cone shaped bags, truncated cone shaped bags and truncated pyramidal or pyramid shaped bags. In the most preferred embodiment of the present invention, the bag (11) has a substantially truncated cone shape. Typically, the bags will have a portion that gives the user (16) and a portion that gives the garment (17). The portion that gives the user (16) of the stool management device (10) is disposed adjacent to the gluteus of the user. Thus, the portion that gives the user (16) widely covers the buttocks of the user and does not hang between the user's thighs.

In addition, the bag (11) is preferably formed to allow at least the insertion and partial retention of the bag in the middle of the gluteus of the user and thus ensure good contact between the flange and the skin of the user. For example, the bag (11) can be provided with a neck portion or a conduit. The bag (11) is preferably designed to provide sufficient volume for the fecal material under a variety of conditions of use, also when it is used for a free movement, i.e., a user who is not bedridden. Sitting on the bag, for example, will result in a very small volume in some areas of the bag. In this way, the bag is preferably formed to give sufficient volume in the areas that are not subject to much pressure under conditions of use such as when sitting. The bag (11) is designed to securely contain any trapped material, this will typically be impervious to liquid, it can still be breathable. The bag (11) is designed with sufficient strength to withstand rupture when in use, also when pressure is exerted on the bag (11) under typical conditions of use, such as when sitting. According to the present invention, depending on the shape of the bag (11) required, the bag (11) can be provided from a piece of unitary material or a number of pieces of separated material, which can be identical or different and which are sealed in their respective peripheries. In a preferred embodiment, the bags here have a portion that gives the user (16) and a portion that gives the garment (1 7), which comprise separate pieces of material. The portion that it gives to the user (16) and the portion that gives the garment (17) are sealed at the periphery of the bag (1 1), thus creating a peripheral edge (18) in the bag. As seen in Figure 1, the portion that gives the user (16) of the bag (1 1) can comprise two more sections (1 9), which are secured together by means known to the man skilled in the art. , such as adhesives, thermal bonding or pressure bonding to provide the desired configuration to the bag. Said edge (18) can also be inside the bag (1 1), thus being coextensive with the inner surface (15) of the bag (1 1) instead of with the external surface (30) of the bag (eleven ). Preferably, the bag is asymmetric to the transverse axis, such that the distance measured in the longitudinal direction from the center of the opening (21) to the front end of the bag (11) is shorter than the distance (12). measured towards the back end of the bag (1 1). According to the present invention, the bag (1 1) can comprise one or multiple layers, preferably two or three layers. The layer on the inside of the bag, which typically, at least partially, will come into contact with the fecal material is called the inner layer (1 5). The outermost layer of the bag, which typically, at least partially, may be in contact with the user's skin and the user's garments, is called the outer layer. The layers of the bag material can be provided from any material, preferably in such a way that the bag is impermeable to the liquid. The layers may, in particular, comprise any material such as nonwovens or films. In a preferred embodiment of the present invention, a sheet can be formed of a non-woven layer and a film. The laminate can be formed by means known to man skilled in the art. Any nonwoven layer may comprise felt fabrics, glued spun fabrics, fluid entangled fabrics, air laid fabrics, wet laid fabrics, dry laid fabrics, melt blown fabrics, cut fiber woven fabrics, knitted yarn fabrics, knit knits, knits with openings, combinations of the above or the like. Suitable film film materials for any of said layers preferably comprise a thermoplastic material. The thermoplastic material can be chosen from among all types of thermal fusion adhesives, polyolefins especially polyethylene, polypropylene, amorphous polyolefins, and the like; materials containing melt-comprising components comprising polymeric binders or fibers, including natural fibers such as cellulose, wood pulp, cotton, jute, hemp; synthetic fibers such as glass fiber, rayon, polyester, polyolefin, acrylic, polyamide, aramid, polytetrafluoroethylene metal, polyimide, binder such as high melting / low melting two component polymer, polyester copolymer, polyvinyl chloride, copolymer acetate / polyvinyl chloride, polyamide copolymer, materials comprising mixtures wherein some of the constituent materials are not meltable; air and vapor permeable materials including micro porous films such as those supplied by EXXON Chemical Co., 11, EU under the designation EXXAIRE or those supplied by Mitsui Toatsu Co, Japan, under the designation ESPOI R NO; and breathable monolithic materials, such as Hytrel® available from DuPont and Pebax ® available from ELF Atochem, France. In a preferred embodiment, a film, which is composed of any layer, is preferably permeable to gases such as air and to vapors such as water vapor to avoid the problem of entrapment and condensation of the moist vapor released by the body. of the user and in this way, of the heat, viscous and discomfort conditions after a short period of use. The outer layer of the bag is preferably provided with a non-woven layer. These layers of the material present an uneven surface to the wearer's skin and thus significantly reduce the problem of occlusion and profoundly improve the health of the skin. In a preferred embodiment of the present invention, the bag comprises two layers. Preferably, the outer layer comprises a nonwoven layer and the inner layer comprises a film. In yet another preferred embodiment of the present invention, the bag (1 1) comprises three layers, preferably one film and two non-woven layers. In an even more preferred embodiment, the film is interposed between the two non-woven layers. This sequence of layers results in a closed fibrous structure, which has a particular pleasant sensation upon contact with the wearer's skin. In still another preferred embodiment, the inner layer comprises a film and the other two layers comprise nonwoven materials.

The non-woven layer or the layers of the non-woven layers comprised by the bag (11) may be hydrophobic or hydrophilic. If the bag (11) does not comprise a film layer, preferably at least one nonwoven layer is hydrophobic. As a consequence, the penetration of fluids is resisted through the portion that gives the user (16) and the portion that gives the garment (17) of the stool management device (10). If the bag comprises a hydrophobic film or nonwoven layer, the additional nonwoven layers can be hydrophilic Typically, the non-woven layer is treated with an active surface material, such as a fluorochemical or other hydrophobic finishes, to provide the requisite hydrophobic capacity. The nonwoven layer, however, can also be treated with coatings of liquid impervious materials, such as thermal fusion adhesives or with silicone coatings or other hydrophobic compounds such as vegetable and mineral waxes and waxes, or can be physically treated using nanoparticle techniques or plasma layer techniques, for example. The non-woven layer can also be treated with agents to improve the softness perceptible to the touch of the portion that it gives to the user (16) and the portion that gives the garment (17). The agents include but are not limited to vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents is known to impart a silky or similar feel to the flannel to the non-woven layer without making it oily or oily to the user's feel. Additionally, surfactant materials, including anionic, non-anionic, cationic and non-cationic surfactants, can be added to further enhance smoothness and surface smoothness. In addition, the non-woven layer may be impregnated with a lotion to provide the desirable therapeutic or protective lotion coating benefits. The lotion coating in the portion that gives the user (16) and in the portion that gives the garment (17) is able to transfer to the user's skin by normal contact and by the movement of the user and / or by the heat of the body. Generally, mineral oil in the form of a lotion is recognized as being effective in imparting a comforting, protective coating to the wearer's skin. It is also possible to impregnate the nonwoven layer with a solid oil phase of cream formulation or to incorporate in the nonwoven layer an array of capsules capable of breaking by pressure, with heat or with water, containing for example, baby oil. In one embodiment of the present invention, the bag may contain absorbent material. The absorbent material can comprise any absorbent material that 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 crushed wood pulp, which is generally referred to as an air filter. Examples of other suitable absorbent materials include creped cellulose wadding, meltblown polymers, including coform; chemically hardened, modified or cross-linked cellulosic fibers; tissue, including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; gelling absorbent materials; or any other known absorbent material or combinations of materials. The absorbent material can be placed in the bag (11) in any appropriate way. For example, the absorbent material can be freely arranged in the bag or can be secured in the inner layer of the bag (11). Any known technique for securing the absorbent material to the nonwoven substrates or to the film can be used to secure the absorbent material in the inner layer of the bag. The absorbent material can also be arranged to have the desired shape or configuration (eg, rectangular, oval, circular, etc.).

Detailed description of a diaper to be used in combination with the stool management device The stool management device (10) of the present invention has been found particularly useful and beneficial when used in conjunction with a garment, or diaper (50), preferably a disposable diaper - referred to in Figure 2. The device Fecal management device (10) is preferably first placed in the perianal area of the user before the disposable diaper (50) is applied. In particular, the diaper (50) is placed on the stool management device (10) and fastened in a conventional manner around the body of the user. It has been found that, in addition, to provide an excellent separation between urine and fecal matter, the system of the fecal handling device (10) and the currently combined diaper (50) reduces skin irritation, which can occur sometimes, especially since the typical user group includes very old users, the very young and the sick. Indeed, the presence of the stool management device (10) allows the formation of a separation layer between the user's skin and the diaper (50), that is, a part of the absorbent core (58) of the diaper (10). ). The diaper (50) may be of the conventional type (a modality of which is described below, but by no means as a limiting example) or it may be adapted to effectively and comfortably contain the stool handling device (10). ) in accordance with teachings of the present invention. As used herein, the term "disposable diaper" refers to articles that absorb and contain expulsions from the body; and more specifically, it relates to articles that are placed against or close to the user's body to absorb and contain the various expulsions discharged from the body and that are intended to be discarded after a single use (i.e., they are not intended to be washed). or otherwise restored or reused) and, preferably, to be recycled, composted or otherwise disposed in an environmentally compatible manner. The term "diaper", as used herein, refers to a garment generally worn by infants or by those suffering from incontinence and which is placed between the legs and secured around the wearer's waist. Figure 3 is a partially cutaway perspective view of the diaper (50) embodying the present invention before being placed on the wearer on the stool management device (10). As seen in Figure 3, a preferred diaper (50) comprises a body portion (52) and a restrainable mechanical fastening device (54). A preferred body portion (51) comprises a liquid permeable top sheet (56), and absorbent core (58), a liquid impermeable backsheet (60), elastically contractible leg cuffs (62); each leg fold (62) preferably comprises a side flap (64) and one or more elastic members (66). For purposes of simplification, only one elastic member (66) is shown on the side flap (64). While the top sheet (56), the absorbent core (58), the backsheet (60), the side flaps (64), and the elastic members (66) can be assembled in a variety of well-known configurations. A preferred disposable diaper configuration is shown and generally described in U.S. Patent No. 3,860,003, an even more preferred disposable diaper configuration is shown and generally described in international publication WO 93/16669. In this preferred diaper configuration, the back sheet (60) is joined to the top sheet (56); the absorbent core (58) is placed between the upper sheet (56) and the back sheet (60); the side flaps (64) extend outward from and along each side edge of the absorbent core (58); and the elastic member (66) is operatively associated with each side flap (64). Figure 3 shows the portion of the body (52) wherein the top sheet (56) and the back sheet (60) are coextensive and have length and width dimensions generally greater than those of the absorbent core (58). The upper sheet (56) is superimposed on the back sheet (60) thus forming the periphery (68) of the body portion (52). The body portion (52) has an inner surface (74) and an outer surface (76). When the backsheet (60) is used, it typically forms the outer surface (76) of the body portion (52). The internal surface (74) is that surface of the diaper (50) opposite the outer surface (76) and in the embodiment shown is typically formed by the upper sheet (56). In general, the internal surface (74) of the diaper (50) is that surface coextensive with the external surface (76) and which is for the larger part in contact with the user when the diaper (50) is used. The absorbent core (58) of the body portion (52) can be any absorbent means that is generally compressible, capable of shaping, non-irritating to the wearer's skin, and capable of absorbing and retaining liquids such as urine and other certain body discharges. The absorbent core (58) can be manufactured in a variety of sizes and shapes (eg, rectangular, hourglass, "T" -shaped, asymmetric, etc.) and a wide variety of commonly used absorbent liquid materials in disposable diapers and other absorbent articles such as crushed wood pulp which is generally referred to as an air filter. Examples of other suitable absorbent materials include creped cellulose wadding, meltblown polymers including coform, crosslinked cellulose fibers, tissue including tissue wraps, absorbent foams, absorbent sponges, superabsorbent polymers, gelling absorbent materials, or any equivalent materials or combinations of materials. The configuration and construction of the absorbent core 58 can also be varied (e.g., the absorbent core 58 can have zones of varying gauge, hydrophilic gradients, superabsorbent gradients, or acquisition zones with lower average density and lower average basis weight, or may comprise one or more layers or structures). In addition, the size and absorbent capacity of the absorbent core (58) can be varied to encompass users ranging from infants to adults. The backsheet (60) is impervious to liquids (eg, urine) and is preferably manufactured from a thin plastic film, preferably a thermoplastic film, although other flexible liquid impervious materials may also be used. The term "flexible", as used herein, refers to materials that are docile and that will easily take on the shape and general outline of the human body. The backsheet (60) prevents the exudates absorbed and contained in the absorbent core (58) from staining items that are in contact with the diaper (50), such as undergarments and bedding. The backsheet (60) can thus comprise polymeric films such as polyethylene or polypropylene thermoplastic films, or composite materials such as a film-coated nonwoven material. Exemplary films are manufactured by Tredegar Industries, Inc. of Terre Haute, Ind., USA, or BP Chemical PlasTec, Rotbuchenstrasse 1, D-8000 Munich, Germany. The backsheet (60) is preferably textured to provide a more fabric-like appearance. In addition, the backsheet (60) can also allow the vapors to escape from the absorbent core (58) while still preventing the exudates from passing through the backsheet (60), for example, being supplied with micro-openings. The size of the backsheet (60) is dictated by the size of the absorbent core (58) and the exact design of the selected diaper.

The upper sheet (56) of the diaper is docile, soft to the touch and non-irritating to the wearer's skin. In addition, the topsheet (56) is permeable to liquids, allowing liquids (eg, urine) to easily penetrate through its thickness. An appropriate top sheet (56) can be manufactured from a wide range of materials, such as porous foams, cross-linked foams, apertured films; or woven or nonwoven webs of natural fibers (e.g., wood or cotton fibers) or from a combination of natural or synthetic fibers. Preferably, it is made of a material that isolates the wearer's skin from liquids retained in the absorbent core (58). There are a number of manufacturing techniques that can be used to manufacture the top sheet (56). For example, the topsheet (56) can be a non-woven web of fibers. An exemplary top sheet (56) is carded and thermally bonded by means well known to those skilled in the art of fabrics. A suitable top sheet (56) is manufactured by, for example, Veratec Inc., a division of International Paper Company, of Walpole, Mass., USA. A particularly preferred top sheet (56) for incontinence garments comprises a formed thermoplastic film.

Claims (10)

1. A stool management device (10) comprising a bag (11), said bag (11) having an opening and an anatomically formed flange (12) surrounding said opening for adhesive attachment to the perianal area of the user, said anatomically formed flange (12) being fixed to said bag (11), wherein said anatomically formed flange comprises an outer periphery (24), and an internal periphery (25) adjacent to said opening, a longitudinal centerline (L) and an transverse center line (T) orthogonal thereto, said transverse center line (T) segmenting said anatomically formed flange (12) into a front portion (26) and a back portion (27), said flange having a surface that gives the user (23) and a surface that gives the garment (22), characterized in that the surface that gives the user (23) of said anatomically formed flange (12) comprises a projection (28) on said front portion (26).

A stool management device (10) according to claim 1, wherein said projection (28) is disposed between said outer periphery (24) and said internal periphery (25) of said anatomically formed flange (12). ) in a direction parallel to said longitudinal direction (L).

3. A stool management device (10) according to claim 2, wherein said projection (28) extends from said outer periphery (24) to said internal periphery (25).

4. A stool management device (10) according to any of the preceding claims, wherein said projection (28) is symmetrical in relation to said longitudinal axis.

5. A stool management device (10) according to any of the preceding claims, wherein said projection (28) has an effective height ranging from 0.5 millimeters to 15 millimeters.

6. A stool management device (10) according to claim 5, wherein said projection (28) has an effective height ranging from 2 millimeters to 10 millimeters, preferably from about 3 millimeters to 7 millimeters.

7. A stool management device (10) according to any of the preceding claims, wherein said protection (28) is adapted to fit between the vulva and the anus of a female user.

8. The use of the stool management device (10) according to any of the preceding claims in combination with a disposable diaper (50).

9. The use of a stool management device (10) according to claim 8, wherein the stool management device (10) is first placed in the perianal area of the female user, said projection (28) which is fitted between the vulva and the anus and then said disposable diaper (50) is placed on said fecal device (10) and fastened in a conventional manner around the body of said female user.

10. The use of a stool management device (10) according to claim 8, wherein said stool management device (10) provides a separation layer between the skin of said user and said disposable diaper. (fifty). eleven . The use of a stool management device (10) according to claim 9, wherein said projection (28) prevents the fecal material from flowing into the urethra of the female user.