MXPA01000329A - Faecal collector with improved adhesive flange attachment means - Google Patents

Abstract

The present invention relates to a human waste management device such as a urine management device or a faecal management device (10) for babies, children or adults to be attached to the wearer. The device (10) has an improved adhesive means to the skin of the wearer so as to facilitate easy application and removal of the device from the wearer, whilst ensuring maintenance of the device in the desired position, particularly on wet skin, for the entire period of wear, including circumstances or periods of wear during which the wearer is active, i.e. not bedridden.

Description

FECAL COLLECTOR THAT HAS IMPROVED MEANS OF TISSUE LINKING FIELD OF I-, INVENTION The present invention relates to a fecal management device for infants, children or adults, which is attached to the user's skin. The device has improved user skin attachment means in order to facilitate the application and easy removal of the user's device in a painless manner, while ensuring that the device remains in the desired position, particularly in wet skin and wet during the total period of use, including those circumstances of periods of use during which the user is active, that is, ambulatory.

BACKGROUND OF THE INVENTION Fecal management devices are items that are known to be manufactured and are designed to be used primarily by people suffering from incontinence and, in particular, non-ambulatory patients. These fecal management devices are attached to the perianal area, natural or artificial, and / or in the urogenital region of the user and have, the intention to catch and immediately contain fecal matter and other bodily fluid discharges. These devices, in the manner known today, are constituted by a relatively long and narrow tube which has an opening and a skin attachment device, which can be an adhesive, provided by one of its extremities. . Due to their typical elongated shape and their dimensions, such devices can easily be wound around the thighs of users and / or cause the formation of bends and kinks in the devices themselves, the events naturally affect the storage capacity of the device and may have as a result, the unintentional separation of the user's device during its use, which has undesirable and anguishing consequences for both the user and the person in charge of the patient. Said bags are disclosed, for example, in the following documents: U.S. Patent 3,577,989, which discloses a disposable containment and disposal bag for incontinence sufferers that includes a containment member having a top opening portion and a tab secured to the containment member around the upper opening portion. The flange may include a layer of adhesive on its surface as a means of attaching the bag to the user, or alternatively it exposes the use of elastic bands to attach the bag to the wearer. U.S. Patent 4,784,656 describes a receptacle for collecting fecal material from those suffering from incontinence. The fecal material collector comprises a gasket, driving means or a cylinder and a receptacle; the receptacle and the driving means are each formed of two canvases of thermoplastic film with odor barrier which are heat sealed along their side ends, respectively, and a side surface of the gasket is covered with a layer of pressure sensitive adhesive, water resistant and medically approved; UK Patent 2 152 387, teaches a fecal collector for those suffering from incontinence comprising a collection bag and a ring, which is provided with a pressure sensitive adhesive and water resistant. The fecal collector comprises a pair of panels of thermoplastic canvas material joined at their margins to define an elongated bag with an opening at one of its ends; SE 8 104 934, which exposes an oblong bag made of a thin, flexible and impermeable material. The collecting bag comprises an inner portion and a lower portion at an angle of 120 degrees in the longitudinal direction to the inner portion. The bag is designed in, this shape to allow you to assume a convenient position along the thigh of the person when in use. United Kingdom Patent 1 078 588 discloses a urine collector comprising a liquid-proof bag with a tube-like configuration having an opening surrounded by attachment means in the form of a material having an adhesive. Other types of bags for the handling of fecal material having a flatter shape are known from patent EP 245 064. Patent EP 245 064 discloses bags having an anterior and a posterior wall, the anterior wall contains the opening and the means of attachment to the body. The attachment means is a skin-compatible, water-resistant material, such as a water-insoluble viscose hydrocolloid binding point. The general shape of the front and rear walls is rectangular, the width of the bag is relatively short compared to the length thereof. The conditions of use of the devices will naturally depend on the nature of the user; when the user is active, such as a baby or a child, or an ambulatory adult suffering from incontinence, the conditions of use of the bag become much more distressing and the risk of detachment will increase greatly, due to the user's movement and the pressure of the user's body, if the containment properties are not optimal; that is, there is a likelihood that the material, once excreted and contained in the bag, exerts pressure that can result in the involuntary detachment of the bag, as well as undesirable consequences for both the user and the person in charge of the bag. sick. Therefore, it is essential that the devices join safely to the user and not unintentionally detach during use. On the other hand, the adhesive must have a composition compatible with the skin and not be rough or aggressive to the skin or cause irritation or inflammation. Also, preferably the adhesive will be compatible with the user's skin since a maximum of skin contact is achieved between the adhesive and the surface of the skin. In addition, it is also desirable to provide an adhesive such that the device can be easily removed from the user, without the user experiencing any level of unacceptable pain. This is particularly important in circumstances such as when the device is misplaced, and the device is required to be detached and re-applied once or several times. However, on the other hand, the desired level of adhesion, although painless, must of course also be maintained during multiple applications of the device. The problem to achieve the desired level of adhesion is also aggravated in those conditions where the P1213 skin moistens. Normally, before the device is placed, the skin is cleaned and as a result it becomes moist. However, currently available adhesives, such as hydrocolloids, often do not adhere in a resistant manner immediately to the skin and may need to be held in place until sufficient minimum adhesion occurs. In addition, the adhesive's total adhesion ability tends to be significantly reduced on the surfaces of wet skin by itself, so that the device will not normally remain attached to the wearer's skin if any pressure is exerted on the device , for example due to the movement of the user or during the defecation process. However, moist and wet skin is not only a prevailing problem in the device application stage, since a significant amount of humidity is generated during the use of the device by the user due to the perspiration and the material contained inside. of the bag. The resulting moist environment increases more naturally when the device is used in combination with a diaper. Under the circumstances, current adhesives can not normally absorb this moisture and again, the strength of the adhesive is reduced to such an extent that the device will frequently come off P1213 under pressure exerted during use. Therefore, it is extremely important to provide an adhesive that maintains its adhesive strength on moist skin. However, none of the bags in the prior art regarding the field of fecal management even recognizes or addresses the problem of providing these devices with the means of attachment that meet these criteria. However, prior art in the general field of adhesives for attachment to the skin is more developed in the field of articles such as plasters, patches and bandages. However, these items are normally applied in an emergency situation where, for example, a cut in the user's skin occurs and the absorption of body fluids emanating from a wound is desirable. In this context, the aspects of the performance of the article such as its easy application and the use of the product, the comfortable use as well as the painless removal, and the discretion, are subordinated to criteria such as sterility, support in healing and mechanical protection of the wound. The use of adhesives for absorbent articles for the absorption of body fluids emanating naturally from the body in the absence of any wound, such as, for example, sanitary napkins and diapers have also been disclosed, for example, in the P-213 registration of the approved invention of the United States H1602 or WO 96/33683 and WO 95/16424. The latter exhibits sanitary articles having a topical adhesive that is applied on the user-oriented side of a sanitary napkin along the entire periphery. WO 96/13238 discloses a topical adhesive which is described in terms of dependence frequency. -The European patent application EP-638 303 discloses the use of a topical adhesive in the lateral folds of sanitary napkins in order to maintain the folds in vertical position. Swiss publication CH-643730 discloses the use of a very long sanitary napkin having fluted outer edges with a topical adhesive on the four corners of the outer edges in order to provide a topical adhesive area well outside the growth region of the pubic hair. However, all these disclosures typically describe the adhesive only in general terms or are concentrated in the area of application of the adhesive to the article. The nature of the adhesive by itself in addition to the basic physical requirements such as pressure sensitivity are not analyzed, particularly with reference to the chemical composition. It is known, with respect to the field of devices for the urinary management, for example, of the WO Patent PL213 92/11825, that a urinary incontinence pad having an elastic body is provided, to which outer surface an adhesive layer such as a hydrophilic hydrogel adhesive is applied. However, urinary absorption devices have to comply with totally different functional criteria than those devices of the present invention. In particular, fecal handling devices contain solid or semi-solid waste that can easily move within the confines of the bag and exert pressure on the orifice and thereby cause detachment of the user's device. In comparison, the urinary pads can easily absorb the liquid in such a way that it will not flow out of the absorbent and therefore the devices are not designed to be able to withstand the pressures commonly exerted within a fecal management device. In the same way, U.S. Patent 4,699,146 discloses pressure sensitive elastomeric hydrophilic adhesives for use with a return electrosurgical electrode and a support network of substrates such as ostomy devices. Therefore, there is still a need to provide a device for handling human waste for the collection of excreted matter from the P1213 natural anal orifice and / or urogenital area having an adhesive to securely attach the device and painlessly remove it from the user's skin and therefore an object of the present invention is to provide the device. Another object of the present invention is to provide an adhesive that exhibits the ability to adhere to the skin after a new application, particularly in multiple subsequent applications, for example, when the device is misplaced, while allowing painless detachment. Another additional object is to provide an adhesive that leaves no residue on the skin after removal. Still another object of the present invention is that the adhesive adheres to wet or damp skin, regardless of whether the direct application of the device to wet skin, or the moisture that is generated on the surface of the skin during the period of use of the skin. device. It has now been discovered that the drawbacks will be alleviated essentially by providing the flange of the device with an adhesive as defined below. In a particularly preferred embodiment of the present invention, the total performance of the devices is further improved if a P-2-3 bags are provided with a particular configuration, thus allowing the use of devices for several groups of users, such as infants, children and active adults suffering from incontinence, as well as non-ambulatory incontinent adults. In another aspect of the present invention, the fecal management device with its specific adhesive can be used with advantage in combination with an undergarment that can be used again or preferably with a disposable diaper.

SUMMARY OF THE NINE The present invention relates to a human waste management device such as a device for handling urine or a device for fecal management (10) for the collection of matter excreted from the natural anal orifice and / or the urogenital region; the device comprises a bag (11), the bag (11) has an opening (21) defined by a flange (12) surrounding the opening (21); the tab (12) has a garment garment surface (22) and a user garment surface (23), where the user garniture surface (23) of the flange (12) comprises an adhesive (20) where the adhesive (20) is an adhesive essentially insoluble to water and sensitive to pressure that P-2-3 comprises a polymer that forms a three-dimensional matrix, and comprises less than 10% of hydrocolloids, for the adhesive bonding of the device to the perianal area of the user.

BRIEF DESCRIPTION OF THE DRAWINGS It is considered that the invention will be better understood from the following description together with the following drawings: Figure 1 is a perspective view of a fecal management device according to the present invention. Figure 2 is a perspective view of a fecal management device in combination with a disposable diaper; and Figure 3 is a perspective view and partially cut away of a disposable diaper embodying the present invention. Figure 4 is a plan view of a urine handling device of the present invention.

DETAILED DESCRIPTION OF THE INVENTION In accordance with the present invention, any disposable device for human waste such as a urine handling device or fecal management device known in the art for collecting fecal material excreted from an anal hole that occurs naturally or urine can be provided in accordance with the present invention. Typically fecal management devices comprise a bag (11) having an opening (21) and a flange (12) surrounding the opening, preferably for an adhesive bond to the perianal area of a user, as seen in the figure 1. The bag (11) that is used here is a flexible receptacle for containing the excreted fecal matter. The bag (11) can have any shape or size depending on the use that it will have, that is, if the device is designed for non-ambulatory patients or for active patients suffering from incontinence or requiring an artificial intestine or for infants. For example, for non-ambulatory patients or geriatric patients suffering from incontinence, elongated pouches are used that are mainly tubular or rectangular in shape. For more active users, whether infants or adults, the fecal management device should preferably have an anatomical shape, so that the device follows the contour of the body and can be used without noticing under normal clothing.

Particularly, the preferred shapes are flat circular type bags, cone shaped bags, truncated cone shaped bags and truncated or pyramidal pyramidal bags. In one embodiment of this invention with superlative preference, the bag (11) has an essentially truncated cone shape. Typically the bags will have a user-facing portion (16) and a garment-oriented portion (17). The user-facing portion (16) of the fecal management device (10) is positioned adjacent to the user's back. In this form, the user-facing portion (16) broadly covers the user's butt and does not hang between the user's thighs. In addition, the bag (11) preferably has a shape that allows at least the partial insertion and retention of the bag between the wearer's back and, therefore, ensures good contact between the flange and the wearer's skin. For example, the bag (11) can be provided with a duct or neck portion. The bag (11) is preferably designed to provide a sufficient volume for the fecal matter according to various conditions of use, and also when it is used by a user who has free movement, ie ambulatory, When sitting on the bag ( 11), for example, will cause the volume of some areas of the bag to be greatly reduced. Therefore, it is preferred that the bag (11) has a shape that provides sufficient volume in areas that are not subject to too much pressure under conditions of use, such as when sitting. The bag (11) is designed to securely hold any trapped material, it will typically be impervious to liquids, although it can let air through. The bag is designed with sufficient strength to withstand rupture during use, also when pressure is exerted on the bag (11) under typical conditions of use, for example, when sitting. According to the present invention, depending on the shape of the bag (11) that is required, the bag (11) can be provided from a single piece of material or from several separate pieces of material, which can be identical or different and that are sealed in their respective peripheries. In a preferred embodiment the bags of the present have a portion (16) facing the user and a portion (17) facing the undergarment, comprising separate pieces of material. The portion (16) facing the user and the portion (17) oriented towards the garment are sealed at the periphery of the bag (11) thus creating a peripheral ring (18) of the Pl-13 bag. As can be seen in Figure 1, the portion (16) facing the user, in the bag (11) can comprise two additional sections (19), which are secured together by means known to the person skilled in the art, for example adhesives, thermal bonding adhesives or pressure adhesives, in order to provide the desired configuration of the bag. The ring (18) can also be inside the bag, and has the same extension as the inner surface (15) of the bag (11) but not the same extension as the outer surface (30) of the bag (eleven) . Preferably the bag (11) is asymmetric to the transverse axis, so that the distance measured in the longitudinal direction from the center of the aperture (21) towards the front end of the bag (11) is shorter than the distance measured towards the rear end of the bag (11). According to the present invention, the bag (11) can comprise one or several layers, preferably two or three layers. The layer inside the bag, which will typically be at least partially in contact with the fecal material, is called the inner layer. The outermost layer of the bag, which will typically be brought into contact, at least partially, with the wearer's skin and with the wearer's garment, is called the outer layer.

P1213 The layers of the bag material can be made of any material, preferably so that the bag is impermeable to liquids. The particular layer may comprise any material, for example non-woven fabrics or films. In a preferred embodiment of this invention, a laminate can be formed from a nonwoven fabric layer and a film. The laminate can be formed by means known to the person skilled in the art. Any non-woven layer may comprise plush fabrics, spin-woven fabrics, fluid-entangled matting fabrics, air-laid fabrics, wet deposited fabrics, dry-deposited fabrics, melt-blow fabrics, carded fabrics of short fibers , fabrics joined by spinning, fabrics joined by stitches, fabrics with openings, combinations of the above or similar. Suitable film materials for any type of layer preferably comprise a thermoplastic material. The thermoplastic material may be selected from all types of hot melt adhesives, polyolefins, especially polyethylene, polypropylene, amorphous polyolefins and the like, materials containing melt-forming components and comprising polymeric fibers or binders including fibers. natural, for example, cellulose-wood pulp, cotton, jute, hemp, fibers P1213 synthetic fibers such as glass, rayon, polyester, polyolefin, acrylic, polyamide, aramid, polytetrafluoroethylene metal, polyimide; binders such as high / low melting bicomponent polymers, polyester copolymers, polyvinyl chloride, polyvinyl chloride / acetate copolymers, polyamide copolymer, materials comprising blends where some of the constituents can not be melted; vapor permeable and air-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 materials with breathing properties for example Hytrel "1 * from DuPont and Pebax" 11 from ELF Atochem, France. In a preferred embodiment, a film is used, which is comprised of any type of layer, preferably permeable to gases such as air and steam as water vapor, in order to avoid the problem of moisture vapor emitted by the body of the user and , therefore, hot and uncomfortable conditions are avoided after a short period of use. The outer layer of the bag is preferably provided with a non-woven layer. These layers of material present a non-uniform surface for the skin of the P1213 user and, therefore, significantly reduce the problem of occlusion and greatly improve the health of the skin. In a preferred embodiment of this invention, the bags comprise two layers. Preferably the outer layer comprises a nonwoven layer and the inner layer comprises a film. In yet another preferred embodiment of this invention, the bag (11) comprises three layers, preferably one film and two nonwoven layers. In yet another more preferred embodiment, the film is interposed between two non-woven layers. This sequence of layers originates from a closed fibrous structure that imparts a particularly pleasurable sensation upon contact with the wearer's skin. In yet another preferred embodiment, the inner layer comprises one film and the other two layers comprise nonwoven materials. The non-woven layer or the non-woven layers comprised by the bag (11) can be hydrophobic or hydrophilic. If the bag (11) does not comprise a film layer, preferably at least one nonwoven layer is hydrophobic. As a result, the penetration of the fluid through the portion (16) facing the user and the portion (17) facing the garment in the fecal management device (10) is resisted. Yes P1213 the bag comprises a film or a hydrophobic nonwoven layer, the other nonwoven layers can be hydrophilic. Typically, the non-woven layer is treated with a surfactant material, for example a fluorochemical or any other hydrophobic finish, to provide the required hydrophobicity. The non-woven layer can also be treated with coatings of liquid impervious materials, for example silicone hot melt coatings or hot melt adhesives or other hydrophobic compounds, for example vegetable and animal waxes and waxes, or can be physically treated using nanoparticles or plasma coating techniques, for example. The non-woven layer can also be treated with agents to improve the softness perceived by the touch of the portion (16) facing the user and the portion (17) oriented towards the garment. 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 perception to the flannel in the non-woven layer, without making it oily or oily to the user's touch. Additionally, surfactant material may also be added, including anionic, non-anionic, cationic and non-cationic surfactants, in order to improve smoothness and surface smoothness. In addition, the non-woven layer can be impregnated with a lotion to provide the desirable benefits of the therapeutic or protective coating lotion. The coating lotion in the portion (16) facing the user and the portion (17) facing the garment can be transferred to the wearer's skin by the normal contact and movement of the wearer and / or body heat. In general, it is recognized as effective to impart a softening action, and a protective coating to the wearer's skin mineral oil in the form of a lotion. It is also possible to impregnate the non-woven layer with a solid oily phase of cream formulation or to incorporate into the non-woven layer an arrangement of hydro-breakable or rupturing capsules by pressure or heat, 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 that are commonly used in de-oiled diapers and other absorbent articles, for example shredded pulp, to which in general P1213 is called airfelt (aerated felt). Examples of other suitable absorbent materials include creped cellulose wadding; melt blow polymers among which are included coform; crosslinked, modified or chemically stiffened cellulosic fibers; fabrics including woven envelopes and woven laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials, or any other absorbent material or combinations thereof. The absorbent material can be placed in the bag (11) in any suitable manner. For example, the absorbent material can be loosely placed inside the bag or can be secured to the inner surface of the bag (11). Any known technique for securing the absorbent material to film substrates and non-woven fabrics may be used to secure the absorbent material to the inner surface (15) of the bag. The absorbent material can also be placed so that it has the desired configuration or shape (for example rectangular, oval, circular, etc.). As shown in Figure 4, the outer surface of the bag (11) is provided with patches of adhesive (40) to secure the bag (11) to the wearer's body. Preferably, the adhesive patches (40) are placed on the outer surface of the bag (11) so that they are secured to the user's abdomen in use. Any number, size and shape of adhesive patches (40) can be used, depending on the intended use of the device. The device for handling human waste, in particular the urine handling devices according to the present invention, preferably also comprises an additional acquisition layer. The acquisition layer is normally secured to the inner surface of the bag. However, the acquisition layer can also be secured to the flange, or both to the flange and to the inner surface of the bag. The acquisition layer is preferably placed so that it separates the genitals of the user from direct contact with the absorbent material. The acquisition layer is permeable to fluids which allows urine to pass easily through it so that it can be absorbed by the absorbent material. The acquisition layer can be manufactured in a wide range of materials, such as porous foams, cross-linked foams, plastic films with openings, or strips of woven or nonwoven material of natural fibers (for example cotton or wood fibers), synthetic fibers (for example, poly, ester or polypropylene fibers), or a combination of natural and synthetic fibers. If the layer of P1213 barrier acquisition includes fibers, the fibers may be nonwoven but fused together, wet-weave, melt-blown, matted with fluid jet or processed in some other manner as is known in the art. The acquisition layer is designed to have a pore size such that the absorbent material is not allowed to pass through and come in contact with the wearer's skin. While designed to not have a large pore size that allows the passage of absorbent material, the acquisition layer preferably has a pore size greater than the pore size of the absorbent material. Preferably, the acquisition layer is less hydrophilic than the absorbent material. The acquisition layer can be treated with a surfactant to increase its initial wettability. However, when treated with a surfactant, the acquisition layer should be even less hydrophilic than the absorbent material. Suitable methods for treating the acquisition layer with a surfactant include spraying the acquisition layer with the surfactant and immersing the material in the surfactant. Alternatively, a surfactant can be incorporated into the acquisition layer. As shown in Figure 1, the bag (11) is provided with an opening (21) by means of which the P1213 fecal matter is received from the body, before being stored inside the pocket of the bag. The opening (21) is surrounded by a flange (12) and can be provided in any size or shape, for example circular, oval, heart-shaped and can be symmetrical or asymmetric, preferably the opening has an oval configuration, either in the longitudinal direction transverse or in both directions, for example, the contour of the opening is in the form of two ellipses with their respective main axes essentially perpendicular. The flange (12) is attached to the bag (11) according to the means known to the experts, which provide permanent or releasable union. However, the tab of preference is attached to the bag by an adhesive. Typically, the bag will be attached to the flange, toward the outer periphery of the flange so as not to cause any obstruction to the fecal matter that enters. The tab can be provided in any size depending on the group of users for whom it is intended. Similarly, the flange can be provided in any shape and preferably has a symmetrical shape preferably comprising a plurality of lobes (13). The flange comprises a portion (22) oriented Pl_13 to the garment and a portion (23) oriented towards the user. In a preferred embodiment, these two portions are large and have essentially planar surfaces, however, the flange may also comprise projections (28, 29), designed to adapt to the perianal or coccyx area of the user. The flange (12) should be made of a soft, flexible and malleable material to allow easy placement of the flange (12) in the perianal area. Typical materials include nonwovens, fabrics, open cell thermoplastic foams, closed cell thermoplastic foams, open cell foam composites and films and non-woven materials with stretchable characteristics. A polyethylene closed-cell foam has proved effective, but more preferably an open-cell polyurethane foam is used. Preferably, these foams have a thickness in the general range of 0.1 to 5 millimeters and a density of 5 to 250 g / m2, more preferably 50 g / m2. Other thermoplastic foam materials or other suitable plastic sheet materials having the described properties of these foams (ie softness, collapsibility, stretchability and shrinkability) can also be used. Preferably, the material of the garment-oriented portion (22) in the tab P1213 (12) may extend towards the defined opening area, so as to form a skirt or flap of material that prevents unintentional adhesion of the edges of the flange surface that define the opening therebetween during use. According to the present invention, the faecal management device further comprises a joining means for securing the device to the user. This means comprises a pressure sensitive adhesive (20) compatible with the body, which is applied to the portion (23) facing the user, in the flange (12). According to the present invention, it has now been discovered that any medically suitable adhesives essentially insoluble to water and sensitive to pressure comprise a polymer forming a three-dimensional matrix and comprising less than 10%, preferably less than 5% of the The weight of the hydrocolloid adhesive is particularly effective in providing the desirable adhesive properties to secure the flange to the wearer's skin in the sensitive perianal area, even in conditions where the skin is moist, while allowing relatively painless peeling after use. The term "hydrocolloidal" used herein refers to absorbent colloidal materials, and mixtures of P1213 absorbent colloidal materials selected from starch, modified starches such as dextrin, cellulose ester such as carboxymethicellulose, and natural gums such as karaya pectin, gelatin, guar gum, gum arabic, locust bean gum and carboxypolymethylene. According to the present invention, the three-dimensional matrix referred to herein as a gel or hydrogel comprises as an essential component a polymer that can be physically or chemically crosslinked. The polymer can be natural or synthetic. The non-crosslinked polymer includes repeating units derived from vinyl alcohols, vinyl ethers and their copolymers, carboxyvinyl monomers, vinyl ester monomers, carboxy vinyl ester monomers, vinylamide monomers, hydroxyvinyl monomers, cationic vinyl monomers containing amino groups or groups quaternaries, N-vinyl lactam monomer, polyethylene oxides, polyvinylpyrrolidone (PVP), acrylics such as hydroxyethyl methacrylate, methoxydiethoxyethyl methacrylate and hydroxydiethoxyethyl methacrylate and sulphonated polymers such as sulfonated acrylamide polymers and mixtures thereof. Alternatively, the non-crosslinked polymer can be a homopolymer or a copolymer of a polyvinyl ether, or a copolymer derived from maleic ester ester medium. In the same way, any other units of P1213 monomers of compatible polymers such as copolymers, for example: polyvinyl alcohol and polyacrylic acid or ethylene and vinyl acetate. As another alternative, the polymers may be elastomers of block copolymer thermoplastics, such as ABA block copolymers such as styrene-olefin-styrene block copolymers or ethylene-propylene block copolymers. More preferably, such polymers include styrene / isoprene / styrene (SIS), styrene / ethylene-propylene / styrene (SEPS) and styrene / ethylene-butylene / styrene (SEBS) hydrogenated grade. Particularly preferred polymers are acrylics, sulfonated polymers such as sulfonated acrylamide polymers, vinyl alcohols, vinyl pyrrolidine, polyethylene oxide and mixtures thereof. According to the present invention, the three-dimensional adhesive matrix also essentially comprises a plasticizer, which preferably is liquid at room temperature. This material is selected so that the polymer can be solubilized or dispersed within the plasticizer. For embodiments where the crosslinking will be carried out by irradiation, the plasticizer must be compatible with the crosslinking by irradiation, so that it does not inhibit the crosslinking process of the polymer by irradiation. The plasticizer can be hydrophilic or Hydrophobic P1213. Suitable plasticizers include water, alcohols, polyhydric alcohols such as glycerol and sorbitol, and glycols and ether glycols such as polyalkylene glycol mono or dieters, polyalkylene glycol mono or diester, polyethylene glycols (typically up to a molecular weight of about 600), glycolate , glyceryl esters, sorbitan esters, esters of citric and tartaric acid, amphoteric surfactants derived from imidazoline, lactams, amides, polyamides, quaternary ammonium compounds, condensation products of polyethyleneimine and epichlorohydrin, liquid polybutenes, esters such as phthalates, adipates, stearates , palmitates, sebacates or myristates, natural or synthetic oils such as vegetable oils, minerals and their combinations. Particularly preferred are polyhydric alcohols, polyethylene glycol (with a molecular weight of up to about 600), glycerol, sorbitol, water and mixtures thereof. Typically the adhesive comprises a polymer to plasticizer ratio by a weight of from 1: 100 to 100: 1, more preferably from 50: 1 to 1:50. However, the exact amounts and proportions of the polymer and plasticizer will depend to a large extent on the exact nature of the polymer and plasticizers used and can P1213 to be easily selected by an expert in the field. For example, a polymeric material with higher molecular weight will require a higher amount of plasticizer than a low molecular weight polymer. In addition to the polymer and plasticizer components of the adhesive, the adhesive may comprise several additional optional components, for example, the composition may comprise from 0% to 50% of the weight of the composition, of an adherent resin. Adherent resins are particularly useful in combination with the ABA block copolymer adhesive compositions. Suitable tackifying resins include, for example, resin derivatives of rosin, terpene, terpene-phenolic resins, hydrocarbon resins, such as Cs and Cs / Cg resins, aromatic resins and hydrogenated resins. Other optional suitable ingredients include from 0% to 10% or more, preferably from 0% to 5% by weight of substances that further facilitate and stabilize the three-dimensional matrix and matrix forming process. For example, for hydrophobic adhesive compositions, these could be Cß to C22 ácidos fatty acids, their metal salts and their polyoxie derivatives; lanolin derivatives, silica, bentonite, montmorillonite and its derivatives; waxes or their mixtures. Other common additives known in the art, P1213 as preservatives, antioxidants, agents against ultraviolet rays, metallic fillers and their mixtures can also be included in the composition of the adhesive in amounts of up to 10% each, respectively. According to the present invention, the polymer component of the adhesive can be physically or chemically crosslinked in order to form the three-dimensional matrix. Physical crosslinking refers to the polymers having grids that are not chemically covalent bonds but are physical in nature such that there are areas in the three-dimensional matrix that have high crystallinity or areas that have a high glass transition temperature. Chemical crosslinking refers to polymers that are bound by chemical bonds. Preferably, the polymer is chemically crosslinked by radiation techniques such as thermal radiation, E-beam radiation, UV light radiation, gamma or microwave radiation. In addition to the chemical crosslinks being formed in the system, a polyfunctional crosslinker and / or free radical initiator may be present in the premix to initiate crosslinking at the time of irradiation. The components can preferably be present in amounts of up to 5% by weight. The resulting adhesive compositions can Pl-213 be divided into three types of families: hydrophilic, hydrophobic and combined phase compositions, depending on the nature of the adhesive components. Hydrophilic adhesives are compositions where the plasticizer is usually water or glycol and / or mixtures thereof and the polymer phase is synthetic (for example, polyacrylics). Optionally, the compositions may comprise up to 10% by weight of natural colloidal gums. Hydrophobic adhesives are compositions in which the plasticizer is typically an oil or a mixture of oils of vegetable or mineral origin and the polymer is generally a synthetic polymer, preferably an elastomer, which is soluble or dispersible in the oils. Mixed phase adhesives are compositions in which both hydrophobic and hydrophilic components, possibly in both plasticizers and polymers, form two or more separate phases. In such cases of preference an emulsifier is present at a suitable level to form stable emulsions between the incompatible phases. Preferred adhesive compositions for use in the present invention are hydrophilic, which provide particularly satisfactory adhesion to moist skin.

P1213 Suitable adhesives for use herein include Promeon, available from Promeon Division of Medtronic Inc., Minneapolis, Minnesota, USA, and a hydrogel adhesive available in 3M.The adhesive (20) can be applied to the portion ( 23) facing the user in the tab (12), by any means known in this field, for example slot coating, spiral or flange application, or printing Typically, the adhesive (20) is applied at a basis weight between 20g / m2 and 2500g / m2, more preferably between 500g / m2 and 2000g / m2, and most preferably between 700g / m2 and 1500g / m2, depending on the intended end use, for example, fecal management devices (10) which are to be used for babies, use an amount of adhesive (20) less than that used for the devices (10) designed for active adults suffering from incontinence.The adhesive (20) is preferably covered with a release means (not shown) in order to pro glue the adhesive (20), for example siliconized paper. The adhesive (20) can cover the entire portion (23) facing the user in the flange (12) or, more preferably, has at least a non-adhesive portion, and preferably from two to six. These portions may be without adhesive or may contain coated or inactivated adhesives. How is it P-213 of Figure 1, the adhesive, in one of the preferred embodiments, does not apply to the entire user-facing region in the flange (12), so as to provide lobes (13) on both sides of the tab (12), which are non-adhesive and therefore can serve to facilitate the placement and removal of the device, while avoiding contact with the adhesive. These lobes of preference are covered by release means. Before the application of the fecal management device (10) to the user's skin, the release means, if present, are removed.

DETAILED DESCRIPTION OF A DIAPER TO BE USED IN COMBINATION WITH THE FAUCET MANUSION DEVICE The devices for handling human waste, in particular the faecal management device 10 of this invention have proved particularly useful and beneficial when used together with a garment or diaper (50), preferably a disposable diaper, see Figure 2. The fecal management device (10) is preferably first co-located in the perianal area of the user, before the disposable diaper (50) is applied. In particular, the diaper (50) is placed on the fecal management device (10) and fastened, conventionally around the body of the user. It has been discovered that, in addition, for P1213 provide excellent separation between fecal matter and urine, the fecal management device system (10) combined with the diaper (50) effectively reduces skin irritation, which usually occurs, especially since the typical user group includes elderly and very young people as well as users who suffer from a disease. In fact, the presence of the fecal 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) can be of the conventional type (a modality of which is described below, although in no way considered a limiting example) or can be adapted to effectively and comfortably contain the fecal management device (10) according to the teachings of the present invention. In the sense used herein the term "disposable diapers" refers to articles that absorb and contain body exudates and, specifically, refers to articles that are placed against the body of the user or in proximity to it, in order to absorb and contain the various exudates discharged from the body and intended to be discarded after a single use (ie, they are not intended to be washed or re-established or reused) and, preferably, to be discarded Pl_13 to recycle, they will compost or they will be disposed of in a way compatible with environmental issues. In the sense used herein, the term "diaper" refers to a garment that is generally worn by infants or incontinent persons, which is placed between the legs and fastened around the wearer's waist. Figure 3 is a perspective view and partially cut away of a diaper (50) incorporating the present invention, before the user is placed on the fecal management device (10). As can be seen in Figure 3, a preferred diaper (50) comprises a body portion (52) and a resilient mechanical fastening device (54). A preferred body portion (52) comprises a liquid permeable upper sheet (56), an absorbent core (58), a backing sheet (60) impervious to liquid and leg cuffs (62) elastically contractible; each leg cuff (62) preferably comprises a lateral flap (64) and one or more elastic members (66). For purposes of clarity, only one elastic member (66) is shown on the side flap (64). While the top sheet (56), the absorbent core (58) and the back sheet (60), the side flaps (64) and the elastic members (66) can be assembled in a variety of known configurations. A preferred configuration of disposable diaper is shown P1213 and describes in general in the document the Patent of the US 3,860,003, and a more preferred configuration is shown and described generally in WO 93/16669. In this preferred diaper configuration, the backsheet (60) is attached to the top sheet (56); the absorbent core (58) is placed between the top sheet (56) and the back sheet (60), the side flaps (64) extend outwardly from the sides of the absorbent core (58) and along each of them, and the elastic member (66) is operatively associated with each side flap (64). Figure 3 shows the body portion (52) where the top sheet (56) and the back sheet (60) are of the same length and have length and width dimensions generally greater than those of the absorbent core (58). The upper sheet (56) is superimposed on the backing sheet (60), thereby forming the periphery (68) of the body portion (52). The body portion (52) has an inner surface (74) and an outer surface (76). When a backing sheet (60) is used, it typically forms the outer surface (76) of the body portion (52). The inner surface (74) is the surface of the diaper (50) that is opposite the outer surface (76) and in the embodiment shown is typically formed by the top sheet P12-.3 (56). In general, the inner surface (74) of the diaper (50) is the surface of the same extension as the outer surface (76) and that, for the most part, is in contact with the user when he wears the diaper (50). ). The absorbent core (58) of the body portion (52) can be any absorbent means which is generally compressible, comfortable and non-irritating to the wearer's skin and capable of absorbing and retaining liquids, for example urine and any other body discharge. The absorbent core (58) can be manufactured in a variety of sizes and shapes (e.g., rectangular, hourglass shaped, "T" shaped, asymmetrical, etc.) and from a variety of liquid absorbent materials that are commonly used in disposable diapers and other absorbent articles, for example pulp shredded wood that is generally called airfelt (aerated felt). Examples of other suitable absorbent materials include creped cellulose wadding, melt blending polymers including coform, crosslinked cellulosic fibers, fabrics that include tissue wrappers, foams, absorbers, absorbent sponges, superabsorbent polymers, absorbent gelling materials or any other material or combinations and equivalents of them. The configuration and Pl-213 construction of the absorbent core (58) may also vary (e.g., the absorbent core (58) may have zones of various gauges, hydrophilic gradients, superabsorbent gradients or areas of weight acquisition of lower average density or lower average base , or may comprise one or more layers or structures). In addition, the size and absorbent capacity of the absorbent core (58) may vary to suit a wide range of users, from infants to adults. The bottom sheet 60 is impervious to liquids (eg, urine) and is preferably made of a thin plastic film, preferably a thermoplastic film, although other flexible and liquid impervious materials may also be used. In the sense used herein the term "flexible" refers to materials that yield and that easily conform to the general outline and shape of the human body. The backing sheet (60) prevents the exudates absorbed and contained in the absorbent core (58) from soiling articles that are in contact with the diaper (50), for example underwear and bedding. The backing sheet (60) can then comprise polymeric films, for example polyethylene or polypropylene thermoplastic films, or composite materials, for example non-woven and film-coated materials. The P1213 exemplary films are manufactured by Tredegar Industries, Inc. of Terre Haute, Ind., USA or BP-Chemical PlasTec, Rotbuchenstrasse 1, D-8000 München, Germany. The lower canvas (60) is preferably textured to provide an appearance similar to that of a garment. In addition, the backsheet (60) can also allow the vapors to escape from the absorbent core (58), still preventing the exudates from passing the backing sheet (60), for example, because micro-openings are provided. The size of the backsheet (60) is governed by the size of the absorbent core (58) and the exact design selected for the diaper. The upper sheet (56) of the diaper is flexible and soft in touch and is not irritating to the wearer's skin. In addition, the upper sheet (56) is permeable to liquids allowing them (eg, urine) to easily penetrate through their thickness. A suitable top sheet (56) can be made from a wide range of materials, for example porous foams, cross-linked foams, films with openings, or strips of woven or non-woven material of natural fibers (for example cotton or wood fibers) or from of a combination of natural and synthetic fibers. Preferably, it is made of a material that isolates the user's skin from the P1213 liquids retained in the absorbent core (58). There are several manufacturing techniques that can be used to make the upper canvas (56). For example, the topsheet (56) may be a non-woven film 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 topsheet (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.

P1 13

Claims (12)

1. CLAIMS; A human waste management device (10) comprising a bag (11), the bag (11) has an opening and a flange (12) surrounding the opening (21), the flange has a surface oriented towards the user (23) and a garment-facing surface (22), where the user-facing surface (23) comprises an adhesive (20) to be adhesively bonded to the perianal area of the wearer, characterized in that the adhesive ( 20) is an essentially water-insoluble, pressure-sensitive adhesive comprising a polymer that forms a three-dimensional matrix, and comprises less than 10% hydrocolloids.
2. A human waste management device (10) according to claim 1, wherein the adhesive comprises less than 5% by weight of the hydrocolloid adhesive.
3. 3. A human waste management device (10) according to claim 1, wherein the polymer is selected from acrylics, sulfonated polymers, vinyl alcohols, vinylpyrrolidine, polyethylene oxide or mixtures thereof.
4. 4. A human waste handling device according to claim 1, wherein the adhesive (20) further comprises a plasticizer.
5. 5. A human waste management device P12-3 (10) according to claim 4, wherein the plasticizer is selected from polyhydric alcohols, polyethylene glycols, glycerol, sorbitol, water or mixtures thereof.
6. 6. A human waste management device (10) according to claim 1, wherein the adhesive is hydrophilic, or a hydrophilic-hydrophobic mixed-phase adhesive.
7. 7. A human waste management device (10) according to any of the preceding claims, wherein the surface (23) of the flange (12), facing the user, comprises from 20 g / m2 to 2500 g / m2 of the adhesive.
8. 8. A human waste management device (10) according to any of the preceding claims, wherein the surface (23) of the flange (12), facing the user, comprises at least a non-adhesive portion (13) .
9. 9. A human waste handling device (10) according to any of the preceding claims, wherein the adhesive is applied to the surface (23) of the flange (12), facing the user, by slot coating.
10. A human waste management device (10) according to any one of the preceding claims, wherein the bag (11) is essentially shaped P1213 truncated cone.
11. 11. The use of a human waste handling device (10) according to any of the preceding claims in conjunction with a disposable diaper (50).
12. 12. The use of a fecal management device (10) according to claim 11, wherein the fecal management device (10) is first placed between the user's back and then the disposable diaper (50) is placed over the device of fecal management (10) and conventionally secured around the trunk of the user. P1213