MXPA01001182A - Disposable human waste management device with improved adhesive for skin attachment - Google Patents

Abstract

The present invention relates to a disposable human waste management device such as faecal and urine management devices (10) which are provided with adhesives for attachment of the device to the skin which adhesives (20) provide secure attachment and are pleasing to the skin upon application, yet cause no discomfort upon removal.

Description

DISPOSABLE ARTICLE FOR THE HANDLING OF HUMAN WASTE WITH ADHESIVE IMPROVED TO JOIN WITH THE SKIN FIELD OF THE INVENTION The present invention relates to disposable devices for the management of human waste such as devices for the handling of urine and devices for the handling of fecal matter for infants, children or adults, which will bind directly to the skin between Buttocks of the user. The device uses an improved adhesive in order to facilitate the application and removal of the user's device, while ensuring the maintenance of the device in the desired position.

BACKGROUND OF THE INVENTION The devices for handling urine and faecal matter are known articles of manufacture that are designed to be used mainly by people suffering from incontinence and in particular by patients who must stay in bed. These devices are attached to the natural anal region or artificial anus of the user and / or to the uro-genital area and are intended to receive / trap and immediately contain urine, fecal matter and other bodily discharges. These devices, as they are well known, are nowadays designed to be used by patients who must stay in bed. In itself, the devices are constituted of a relatively long and narrow duct, at an extremity of which there is an opening and a device for joining the skin in which an adhesive can be applied. Examples of these bags are disclosed, for example, in U.S. Patent 3,577,989, which details a disposable bag for removal-entrapment, for persons suffering from incontinence, among which a container member having an open portion is included. -superior and a flange secured to the container member around the open-top portion. The flange may include a layer of adhesive on its surface as a means of joining the bag to the user or alternatively exposes the use of elastic strips to attach the bag to the user. U.S. Patent 4,784,656 also describes a receptacle for collecting fecal matter from people suffering from incontinence. The fecal collector comprises a package, conductive means or a cylinder and a receptacle; the receptacle and the conductive means each are formed of two sheets of thermoplastic film against odors which is thermally bonded along their side edges, respectively and the side surface of the package is coated with a layer of adhesive; GB 2 152 387, shows a fecal collector for people suffering from incontinence comprising a collection bag and a ring, which is provided with an adhesive. The fecal material collector comprises a pair of panels of thermoplastic sheet material bonded to its margins to define an elongated bag having an opening at one end. GB 1 078 588 discloses a urine collector comprising a liquid-proof bag of similar configuration to a tube having an opening surrounded by a bonding means in the form of adhesive-containing material. Other types of bags for the handling of fecal material having a flattened shape are known from EP 245 064. EP 245 064 discloses bags having a front and a rear wall, the front wall contains the opening and the means of attachment to the body. The attachment means is a water-resistant material, compatible with the skin such as a hydrocolloid and a viscous, elastic, water-insoluble binder. Due to their elongated shape and typical dimensions, these devices in particular when used by active users, such as infants or incontinent adults who should not stay in bed, can easily twist around the user's thighs and / or can cause training. of bends and defects in the devices themselves. Under these circumstances, the pressure and tension exerted on the bag will naturally increase due to the movement of the user and the pressure of the user's body on the bag. Therefore, the likelihood that the urine or fecal matter excreted and contained within the bag will exert pressure on the device attachment means will increase. As a result of this, not only will the storage capacity of the device be adversely affected, but also, most importantly, this may result in an unintentional detachment of the user's device during use. This incident is unacceptable causing consequences of discomfort for both the user and the person caring for him.

Therefore, it is critical that urine and / or fecal material handling devices are designed in such a way that they attach securely to the user's skin and do not detach unintentionally during all circumstances of use. In order to provide the desired level of adhesion of the device to the user, the prior art typically exposes the use of certain adhesives having very high cohesive strengths such as, for example, rubber based adhesives and acrylics. These adhesives are then applied as thick layers over the entire surface of the flange of the device to maximize the adhesive force by which the device is secured to the wearer's skin. Indeed, it is evident that these devices, and in particular the adhesives, have been designed to be used in stool handling devices used by bedridden patients, in particular those who have an artificial anus so maximum adhesion it takes precedence over any other criteria such as patient comfort. However, the adhesive must have a composition compatible with the skin and must not be rough or aggressive to the skin or cause irritation or inflammation thereof. It is also preferred that the adhesive be smooth with the user's skin to achieve maximum skin surface contact between the adhesive and the skin. In addition, it is also desirable to provide an adhesive such that the absorbent article can be easily removed from the user, without the user experiencing any unacceptable level of pain. This is particularly important under circumstances where the device is moved from its place and removed; and wherein it is required that the device be reapplied one or even several times and / or to ensure the application of these devices on sensitive skin and user groups such as, for example, infants. However, on the other hand, the desired level of adhesion, however painless, must of course also be maintained during multiple applications of the article. Therefore, there is a need to provide disposable devices for the handling of human waste having an adhesive for secure attachment and the painless removal of the skin device between the gluteus of the user in order to be suitable for use in the sensitive skin of an infant and thus an object of the present invention is to provide this device. Another object of the present invention is to provide an adhesive that exhibits an ability to adhere to the skin at the time of re-application, in particular in multiple reapplication for example, when the device is moved from its place, as long as it is still allowed the elimination without pain. A further object of the present invention is to provide an adhesive which, in combination with the flange material, provides flexibility, stretchability and shrinkability so that it is able to adapt to the contours of the body during all body movements and therefore be comfortable for the user of the device, while still having sufficient adhesive capacity for secure attachment during its use. In addition to the above objects of the present invention, it is also desirable for the adhesives to provide additional benefits such as release / dispersion of a compound or composition that is beneficial to the skin or to the body in general. > It has now been surprisingly found that the above disadvantages will be substantially overcome by providing the flange of the device for handling human waste with an adhesive as will be defined below. The adhesive provides a secure bond, is pleasant to the skin at the time of application and does not even cause discomfort at the time of removal and maintains its adhesive strength for a longer period in which the user is even exposed to excess liquids. In another aspect of the present invention, the disposable device for handling human waste with its specific adhesive as defined herein, can be advantageously used in combination with a reusable undergarment or preferably with a disposable diaper.

BRIEF DESCRIPTION OF THE DRAWINGS It is believed that the invention will be better understood from the foregoing description together with the accompanying drawings in which: Figure 1 is a perspective view of a disposable device for the handling of fecal matter in accordance with the present invention, Figure 2 shows a perspective view of a disposable device for the handling of fecal matter together with a disposable diaper; and Figure 3 is a partially sectioned perspective view of a disposable diaper characterizing a fecal handling device of the present invention, Figure 4 is a plan view of a disposable device for urine handling of the present invention.

BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention, a disposable device for handling human waste together with the adhesive as defined herein is provided. Typically, the devices for handling urine and faecal matter comprise a bag (11) having an opening (21) and a flange (12) surrounding the opening of the junction with adhesive to the uro-genital area and / or the area perianal of a user as can be seen from Figure 1. The adhesive allows the attachment of the disposable device for the handling of human waste to the user's skin, the adhesive is provided as a layer having a certain thickness or caliber C measured in millimeters (mm), typically on at least part of the surface of the flange facing the user. Detailed analysis of the sequence of common situations that occur from the application of absorbent articles when removing a device has shown that the specific adhesive characteristics need to be met preferably to achieve the desired performance objectives, in particular to ensure initial bonding , the safe union during its use and the withdrawal without pain after being used. The characteristics that have been considered in this context are the elastic modules that describe the elastic behavior of the material and the viscous modules that describe the viscous behavior of the adhesive material. The viscous behavior of the adhesive should be interpreted to represent an indication of the ability of the adhesive to bond quickly and securely to a particular surface. The elastic behavior can be interpreted as an indication of the "hardness" behavior of the adhesive. This value is also important for a good initial bond. It is believed that their combination is an indicator of the force required at the time of withdrawal. It is considered that the relationship between the elastic and viscous modulus is an indication on which the fraction of the elimination energy within the adhesive will be dissipated and whose fraction is available to cause the actual removal. In order to provide topical adhesives for a safe and prolonged initial bonding and easy / painless removal, the relationship between the elastic modulus and the viscous modulus as well as its dynamic behavior is also important. The adhesive has an elastic modulus at a temperature of 37 ° C (100 ° Fahrenheit) abbreviated G'37, a viscous module at a temperature of 37 ° C (100 ° Fahrenheit) of G "37, and a viscous modulus at a temperature of 25 ° C (77 ° Fahrenheit) of G" 25. The adhesive used in the present invention preferably satisfies the following conditions: G'37 (1 rad / sec) in the range of 500 Pa to 20,000 Pa, preferably 700 Pa to 15,000 Pa, more preferably 1000 Pa to 10,000 Pa. riUiMMá ^ lMliilki G "37 (1 rad / sec) in the range of 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, more preferably 300 Pa to 5000 Pa. in the proportion of G '37 (1 rad / sec) / G "37 (1 rad / sec) in the range from 1 to 30. With the proviso that the above rheological conditions are satisfied, the adhesives will also satisfy the conditions such as for example, sufficient cohesiveness (to avoid adhesive residue on the skin) that are important for the commercial use of these adhesives and evident to those skilled in the art. Adhesive compositions that satisfy the above criteria can be used as adhesives for the flange provided they also meet the common safety requirements for use on human or animal skin during use and in general after discarding the device. Hygienic appearance criteria such as those of adhesive compositions that are transparent or white at the time of application are often preferred. It has been determined that the ratio between the thickness or gauge C, measured in millimeters (mm), of the layer in which the adhesive is provided, typically over at least a portion of the surface of the flange facing the user and the module viscous G "2s to approximately 100 rad / sec of the adhesive, it is important for the scope to provide an easy and painless removal of the skin of the user of this adhesive applied on at least a portion of the surface of a device for the handling of fecal material facing the user for the attachment of the article to the skin of a user.Preferably, the adhesive used in the present invention in this way is provided as a layer having a thickness C such that the viscous modulus G " 25 (100 rad / sec) and thickness C preferably satisfy the following empirical equation: G "25 = [(7.00 + C) x 3000] Pa and preferably also the following empirical equation: G "25 < [(5.50 + C) x 1700] Pa DETAILED DESCRIPTION OF THE INVENTION In accordance with the present invention, the adhesive can be used on devices for handling human waste such as devices (10) for the handling of urine or fecal material that is applied to the perianal area of a user as can be seen in Figure 1. The word "skin" according to the present invention is not only related to the user's specific dermis but includes mucosal tissue as well as the hair typically found in the genital region The adhesive is provided with the preferred pattern, typically on the surface (23) of the flange (12) of the device (19) facing the user, as a layer having a thickness or gauge C which is preferably constant, preferably the layer may be continuous or alternatively discontinuous, for example, in the form of dots, spirals or stripes, even though the adhesives are used as adhesives sens Because of the pressure on the hair of human skin and mucosal tissues, it should be understood that adhesive compositions could only be considered with difficulty as typical pressure sensitive adhesives (referred to as PSA below) on the basis of rheological behaviors more characteristic that identify these materials. In fact, as the person skilled in the art of adhesives knows, the most characteristic nature that distinguishes a PSA from other substances that can temporarily adhere objects (e.g., water between two glass plates) is the fact that its rheological and especially the Elastic Modulus G 'vary greatly with the frequency of applied tension. More particularly, the G 'of PSA can be increased by a few orders of magnitude, while the frequency of applied pressure varies from the typical junction frequency to the typical disbonding frequency, i.e. 1 rad / s to 100 rad / s as will indicate later. As a first consequence, it is therefore inadmissible to define materials intended to be used as "adhesives" by providing values of rheological parameters and especially of G 'at a fixed frequency value. This can be misleading due to the absence of other features such as surface chemistry which will include materials that have no practical value. Therefore, it is necessary that the rheological characteristics should be based on dynamic considerations. This applies not only to the Elastic Module G 'but also to the viscous module G "and therefore also to (d) = G" / GA It is well known that typical PSAs not only have a high variation of G' through of the frequencies considered, but also there is a uniform greater variation of G "that can approach or even be greater than the value of G that is to say that (d) is approximately or even greater than 1, particularly in the frequencies that are typical However, without wishing to be limited by theory, this can be interpreted as a high fraction of the energy applied for disintegration dissipating within the adhesive (so that this is not effective to cause disintegration) and through the interface of the adhesive and the skin, while this fact macroscopically causes the recording of a very high level of adhesive strength As indicated above, the useful, adhesive materials for use in the present invention They have rheological characteristics that are measured at a reference temperature of 37 ° C (as the usual body temperature of humans) and a frequency interval. It has been found that at the time of application of a device for handling human waste with an adhesive, the adhesive contact is formed at a low frequency, while the disintegration occurs at the speed of removal of the article. This speed is expressed as a frequency of 100 rad / s, while the low frequency of formation of the adhesive bond has been found to be in the order of 1 rad / s. Therefore, the frequency range to be used according to the present invention is between 1 and 100 rad / s. In order to provide good bonding conditions, ie, at a frequency between about 1 rad / sec, the absolute values of the elastic modulus should not be so high, otherwise the adhesive is too hard and is not able to bind intimately or molded to the surface to which it is expected to adhere. It is also important to have an absolute low value of G "in order to have good cohesion while the material remains soft and is able to adhere smoothly to the skin.The ratio of G J7 (1 rad / sec) to G" 37 (1 rad / sec) is important to ensure that these two values are balanced at the time of adhesion to the skin.

Importantly, the proportion of G A (100rad / sec) -G "37 (100rad / sec; G '37 (lrad / sec) - G" 37 (l rad / sec) it needs to be large enough to ensure that the dynamic behavior of both the elastic and the viscous modulus are maintained in a relationship that provides secure adhesion and easy and painless removal. Finally, the person skilled in the art will also recognize that the Vitrea Tg Transition Temperature of the adhesive composition, the specific thermal capacity and the specific thermal conductivity are parameters that are useful to more fully define the group of useful adhesives. The following set of characteristics should preferably satisfy the adhesive for use in the present invention: GA (1 rad / sec) is in the range of 500 Pa to 2000 Pa, preferably 700 Pa to 15000 Pa, more preferably 1000 Pa to 10000 Pa. G "37 (1 rad / sec) is in the range of 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, more preferably 300 Pa to 5000 Pa. The proportion of G '37 (1 rad / sec) / G "37 (1 rad / sec) is in the range of 1 to 30. the ratio G'37 (100rad / sec) -G "37 (lOOrad / sec) G'37 (lrad / sec) -G" 37 (l rad / sec) is not less than 0.5, preferably in the range from 0.7 to 3, most preferably in the range from 1 to 1.8.

The value of the proportion of GA7 / G? 7 at least for the previous frequency range 1 rads / up to 100 rads / s preferably should not be less than 0.5, preferably from 0.7 to 10 and more preferably from 1 to 7 The rheological behavior can also be related to the values of the Transition Temperature Vitrea Tg. For the topical adhesives that are used in the present invention, preferably Tg must be less than 0 ° C, more preferably less than -5 ° C and still more preferably less than -10 ° C.

In order to provide adhesive compositions that satisfy the requirements of the above rheological and physical characteristics of an adhesive, any medically-suitable, water-insoluble, pressure-sensitive adhesives comprising a polymer that forms a three-dimensional matrix that meets with these characteristics. In accordance with the present invention, the three-dimensional matrix also referred to herein as a gel, comprises an essential component, a polymer that can be physically or chemically crosslinked. The polymer can be derived naturally or synthetically. The uncrosslinked polymer includes repeating units or monomers derived from vinyl alcohols, vinyl ethers and their copolymers, carboxy vinyl monomer, vinyl ester monomers, esters of carboxy vinyl monomers, vinyl amide monomers, vinyl anion monomers, hydroxy vinyl monomers, cationic monomers vinyl containing amines or quaternary groups, N-vinyl lactam monomers, polyethylene oxides, polyvinylpyrrolidone (PVP), polyurethanes, acrylics such as, for example, methyl acrylate, 2-hydroxyethyl methacrylate, methoxydietoxyethyl methacrylate and methacrylate hydroxydiethoxyethyl, acrylamides and sulphonated polymers such as, for example, sulfonated polymers with acrylamide, for example, 2-acryl lamido-meth i-propan-sulfonic acid and (3-sulphopropyl) acrylic acid ester and mixtures thereof. Also acrylonitrile, methacrylamide, N, N, -dimethylacrylamide, acrylic esters such as, for example, methyl, ethyl and butyl acrylates. Alternatively, the uncrosslinked polymer may be a homopolymer or copolymer of a polyvinyl ether, or a copolymer derived from a maleic ester half ester. Similarly, any other compatible polymer monomer units can be used as copolymers such as, for example, polyvinyl alcohol and polyacrylic acid or ethylene and vinyl acetate. As another alternative, the polymers can be block copolymer thermoplastic elastomers such as, for example, ABA block copolymers such as styrene-olefin-block copolymers or ethylene-propylene block copolymers. Most preferredThese polymers include the styrene / isoprene / styrene (SIS) and styrene-butylbenzene (SEBS) and styrene / propylene / styrene (SEPS) of hydrogenated grade. Particularly preferred polymers are acrylic sulfonated polymers such as, for example, polymers sulfonated with acrylamide, vinyl alcohols, vinyl pyrrolidone, polyethylene oxide and mixtures thereof. Nitrogen-containing polymers are more preferred. According to the present invention, the three-dimensional adhesive matrix also essentially comprises a plasticizer, which is preferably a liquid at room temperature. This material is selected such that the polymer can be solubilized or dispersed within the plasticizer. For embodiments in which irradiation through the junction must be carried out, the plasticizer must be compatible to the junction through irradiation in such a way that it does not inhibit the binding process through irradiation of the polymer. The plasticizer can be hydrophilic or hydrophobic. Suitable plasticizers include water, alcohols, polyhydric alcohols such as, for example, glycerol and sorbitol, and glycols and ether glycols such as, for example, polyalkylene glycol mono- or di-ethers, polyalkylene glycol mono or diester, polyethylene glycols (typically up to a molecular weight) about 600), glycollates, glycerol, sorbitan esters, citric and tartaric acid esters, imidazoline derived from amphoteric surfactants, lactams, amides, polyamides, quaternary ammonium compounds, esters such as phthalates, adipates, stearates, palmitates, sebacates or myristates, and combinations thereof. In particular, polyhydric alcohols, polyethylene glycol (with a molecular weight of up to about 600), glycerol, sorbitol, water and mixtures thereof are preferred. Typically, the adhesive comprises a polymer to plasticizer ratio by weight of between 1: 100 and 100: 1, more preferably between 50: 1 and 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 the plasticizers used and can be easily selected by the person skilled in the art. For example, a high molecular weight polymeric material will require a greater amount of plasticizer than a low molecular weight polymer. Other common additives known in the art such as, for example, preservatives, antioxidants, pigments, mineral fillers and mixtures thereof may also be comprised within the adhesive composition in amounts of up to 10% by weight each, respectively. In accordance with the present invention, the polymeric component of the adhesive can be physically or chemically crosslinked in order to form the three-dimensional matrix. Physical cross-linking refers to polymers that have cross-links that are not chemical covalent bonds although they are of such a nature that in the areas in the three-dimensional matrix they have high crystallinity or areas that have a high glass transition temperature. Chemical crosslinking refers to polymers that are linked by chemical bonds. Preferably, the polymer is chemically crosslinked by radiation techniques such as, for example, thermal, E-beam, ultra-violet (UV), gamma or micro-wave radiation. In addition, when chemical crosslinking is formed in the system, a polyfunctional crosslinker and / or a free radical initiator may be present in the premix to initiate crosslinking at the time of irradiation. This initiator can be present in amounts of up to 5% by weight, preferably between 0.02% and 2%, more preferably between 0.02% and 0.2%. Suitable photoinitiators include 1-α-hydroxy-betones and benzylidene and 1-betols for example, Irgocure 651 which is believed at the time of irradiation initiates polymerization from benzoyl radicals. In particular, 1-hydroxycyclohexyl phenyl ketone (available under the trade name Irgacure 184 from Ciba Specialty Chemicals) is preferred. further, thermal initiators between 0.02% and 2% can also be used. The performance of hydrogels as adhesives is related to the surface energy of the adhesive and the adhesion surface (for example, mammalian skin) and to the viscoelastic response of the overall adhesive. The requirement that the adhesive wet the adhesion surface to maximize adhesion performance is well known. This requirement is generally met when the adhesive has a surface energy similar to or lower than the adhesion surface. The viscoelastic properties, in particular the elastic or storage modulus (GA and the viscosity module (G ") with important, are measured by dynamic mechanical test at different rad / s.Their values at low rad / s (approximately 0.01 to 1 rad / s) and high rad / s (100 to lOOOrad / s) has been related to the wetting / sliding behavior and the shell / fast adhesion properties, respectively The choice, incorporation and processing of the ingredients of the adhesive Hydrogel are usually focused on the manufacture of a material with a balance of properties suitable for pressure-sensitive adhesive applications.A balance between the amounts and nature of the polymer, plasticizer, and the degree of re-icing / emulation should be achieved. loses water from the hydrogel, it is likely that the adhesive properties change in a harmful way, while it has been claimed that the presence of glycerol or other poly alcohols Hydrogens in other reported formulations provide humectant properties to the hydrogel, it has been found that the most important parameter to avoid water loss is the water activity within the hydrogel which in turn depends on the nature and proportions of the other components and the form of processing. The aqueous activity in the hydrogel adhesive depends mainly on the water content and the nature of the polymer components and the way in which they are processed. The aqueous activity has been shown to have a better correlation with the growth of bacteria and fungi than the water content. It has been found that organisms struggle to grow in water activities less than 0.8. Enzymatic activity has also reported that activity significantly decreases below 0.8. The aqueous activity has also been found to influence the adhesiveness of the adhesive with hydrogel and that in aqueous activities above about 0.75, they become less adhesive. At present, a bioadhesive composition having an adequate balance of characteristics set forth above has surprisingly been found. According to the invention, a bioadhesive composition is provided characterized in that it has: (i) an aqueous activity of 0.4 to 0.9; (ii) an elastic module at 1 rad / s from 700 to 15,000 Pa; (iii) an elastic modulus at 100 rad / s from 2000 to 40,000 Pa; (iv) a viscous modulus at 1 rad / s from 400 to 14,000 Pa; (v) a viscous modulus at 100 rad / s from 1000 to 35,000 Pa; wherein the viscous modulus is smaller than the elastic modulus in the frequency range of 1 to 100 rad / s. The examination of the rheological properties of the compositions has been successfully used to characterize and differentiate the adhesive behavior. Typically, the elastic modulus (GA) and the viscous modulus (G ") are measured over a range of 0.01-100 rad / sec at a certain temperature.For applications to the skin, the appropriate temperature is 37 ° C. lower rad / s are related to the initial bond of the adhesive to the skin and the greater to changes in the values of the modules associated with the disintegration.The methods for measuring G 'and G "are well known, for example, use a Rheometric Scientific RS-5 rheometer.The aqueous activity of the composition can be measured using impedance methods with devices such as, for example, the Rotronic AWVC (manufactured by Rotronic.) Water activity can also be determined by placing the composition in controlled humidity and temperature environment and measure changes in weight.

(RH) in which the composition does not change in weight corresponds to the activity of the water in the gel (RH / 100). The use of solutions saturated with salt to provide suitable environmental conditions is well known. All compositions exposed directly to relative humidity lower than those corresponding to water activity will be allowed to lose water thermodynamically. The composition will gain weight by exposing it to higher relative humidity. Preferably, the bioadhesive composition comprises an aqueous plasticizer, a copolymer of a first water-soluble, unsaturated hydrophilic monomer and a second water-soluble, unsaturated hydrophilic monomer and a cross-linking agent, preferably the first monomer has a tendency to improve the bioadhesive properties of the composition. Preferably, the first monomer also has a tendency to improve the mechanical strength of the composition according to the invention and / or the second monomer preferably has a tendency to increase the aqueous activity of the composition. The bioadhesive composition is preferably obtained by polymerizing an aqueous reagent mixture comprising the first monomer, the second monomer and a crosslinking agent. According to the invention, there is further provided a biomedical electrode comprising a bioadhesive composition according to the invention in association with an electrically conductive interface. The biomedical electrode optionally and additionally comprises a support. The electrically conductive interface preferably comprises a layer of electrically conductive material that is preferably applied to the support, when present. The invention also provides a suitable fixative product for attaching a biomedical device to the skin (or to the human body), for example, a catheter, conduits, wires or cables, the product comprises a bioadhesive composition according to the invention. In preferred embodiments, the first and second monomers will be monomers based on acrylates selected for their ability to polymerize rapidly in water and having substantially the same molecular weight whereby they can be varied in a mixture of the two relative proportions without significantly altering the Molar characteristics of the composition. The first preferred monomer is a compound of the formula wherein R1 is an optionally substituted hydrocarbon entity, R2 is hydrogen or optionally substituted methyl and ethyl and M represents hydrogen or a hydrogen cation. R1 is preferably an optionally substituted alkyl, cycloalkyl or aromatic entity. Preferably R1 represents a saturated entity of an aromatic entity. R1 preferably contains from 3 to 12 carbon atoms, preferably from 3 to 6 carbon atoms. A preferred entity in which R1 is represented is where R3 represents hydrogen or a straight or branched chain alkyl group, optionally substituted having 1 to 6 carbon atoms and R4 represents a straight or branched chain alkyl group, optionally substituted and that has 1 to 6 carbon atoms. The second monomer is preferably a compound of the formula wherein R5 represents hydrogen or optionally substituted methyl or ethyl, R6 represents hydrogen or a cation and R7 represents an optionally substituted alkyl entity of 1 to 4 carbon atoms. Preferably R7 represents n-propyl optionally substituted. R1, R2, R3, R4, R5 and R7 are optionally substituted by a group that preferably has a tendency to increase the water solubility of the compound. Suitable groups will be well known to someone skilled in the art. A preferred optional substituent is a hydroxyl, amino or ammonium group or a halogen atom (eg, chlorine, bromine or iodine). A suitable cation is an alkali metal cation, especially sodium or potassium. More preferably, the first monomer is 2-acrylamido-2-methyl-1-propansulonic acid or an analog thereof or a salt thereof, for example, an alkali metal salt such as a sodium, potassium or lithium salt, while the second monomer is a polymerizable sulfonate or a salt, for example, an alkali metal salt such as a sodium, potassium or lithium salt, of (3-sulphopropyl) acrylic acid ester or an analog thereof. Particularly preferred examples of these respective monomers are the sodium salt of 2-acrylamido-2-methyl-1-propanesulphonic acid, commonly known as NaAMPS and the potassium salt (3-sulfopropyl) ester of acrylic acid, commonly known as SPA. NaAMPS is currently commercially available from Lubrizol either as a 50% aqueous solution (reference code LZ2405) or a 58% aqueous solution (polyhydric code such as glycerol and the addition of glycerol to the mixture of the former and Second monomer improves the solubilization process It has been found that the combination of the two monomers allows greater control over the water content that can be achieved otherwise This can be important because it has also been found that the compositions made with the final water content as an integral part of the pre-gel mixture have different properties from those made with an excess of water and then dried for the final composition.For example, the hydrogels with a final composition obtained by the evaporation of Water in general have lower elastic or storage modules than those made without water evaporation. Ares of elastic modules, the amount of crosslinker required in the above materials is greater. The evaporation of water and the extra crosslinker are added to the cost of the process. This problem is avoided by the present invention where in general a final drying step is not required. Conventional crosslinking agents are used to provide the necessary mechanical stability and control the adhesion properties of the composition. Although the compositions can be produced with suitable adhesive and electrical properties, a sufficient amount of a suitable crosslinker should be used; if very little crosslinker is used, it becomes impossible to convert the material into a complete electrode. Typical crosslinkers include tripropylene glycol diacrylate, ethylene glycol dimethacrylate, alkoxylated triacrylate, polyethylene glycol diacrylate (PEG400 or PEG600), methylene acrylamide bis. The aqueous reactive mixture optionally further comprises a surfactant, an additional monomer, a processing aid (which is preferably a hydrophobic polymer), a water-soluble polymer suitable for forming a polymer network of permeation, a non-hydrophilic polymer and / or a antimicrobial agent (for example, citric acid, stannous chloride). The process used to prepare the bioadhesive compositions according to the invention comprises mixing the ingredients to provide a reaction mixture in the form of a liquid formulation with initial aqueous base of pre-gel, which is then converted to a gel by a reaction of polymerization of free radicals. This can be achieved for example, using conventional thermal initiators and / or photoinitiators or by ionization reaction. Photoinitiation is a preferred method and will usually be applied by subjecting the pre-gel reaction mixture containing a suitable photoinitiating agent to UV light after it has been sprayed or coated as a layer of a siliconized release paper or other substrates solid The processing in general will be carried out in a controlled manner that includes a precise predetermined sequence of mixing and heat treatment or history. A preferred feature according to the invention is that the water is removed from the hydrogel after its manufacture.

Additional Monomer The composition according to the invention preferably comprises one or more additional monomers. A suitable additional monomer is a non-ionic monomer or ionic monomer. If the monomer is ionic, it is either anionic or cationic. Additional monomers, when present, are preferably included in an amount of up to 10% by weight.

A preferred nonionic monomer is an N-di-substituted acrylamide (preferably an N, N-dialkylalkyl amide) or an analogue thereof. In particular, N, N-dimet and lacrylamide (NNDMA) and / or an analogue thereof is preferred. A preferred cationic monomer is a quaternary ammonium salt. An especially preferred cationic monomer is (3-acrylamidopropi 1) t rimet i 1 ammonium chloride or [2- (acryloyl loxy) ethyl] trimethyl ammonium chloride. A preferred anionic monomer is an acrylate-based monomer such as, for example, acrylic acid or a salt or ester thereof.

The compositions according to the invention generally comprise, in addition to a crosslinked polymer network, an aqueous plasticizing medium and, optionally, additional electrolyte. Plasticizers in general are used in the invention to control the adhesive properties. The optional aqueous plasticizer means and additionally comprises a polymeric or non-polymeric polyhydric alcohol (such as glycerol), an ester derived therefrom and / or a polymeric alcohol (such as polyethylene oxide). Glycerol is the preferred plasticizer. An alternately preferred plasticizer is an ester derived from boric acid and a polyhydric alcohol (such as glycerol). The aqueous reactive mixture preferably comprises from 10% to 50%, preferably from 10% to 45%, of plasticizer (other than water) by weight of the mixture. It is well known that water in hydrogels can be present in at least two forms, frozen and not frozen, as measured by Differential Scanning Calorimetry. In many examples of commercially available hydrogels, water is present only as unfrozen water. However, it has been found that compositions with useful adhesive properties comprising the first and second monomers can be produced to have both frozen and unfrozen water and the aqueous activity in these gels is generally high. An advantage of including the second monomer is that it has a tendency to increase the likelihood that the compositions will contain frozen water. The advantage obtained by the presence of frozen water becomes evident in the application of these gels to ECG to monitor the tension. In certain cases, the preferred means to perform the interface of the monitoring instrument with the body is a "wet gel". It has been suggested that the advantage obtained by the "wet gels" is in the humectation of the skin and the consequent decrease in the impedance of the skin, although it has been found in clinical trials that the hydrogels with frozen water can adapt to the performance of the "wet gels." Competentives The compositions preferably additionally comprise a water soluble polymer suitable for the formation of a blended polymer network. Hydrogels based on compenetrating polymer networks (IPN) are well known. An IPN has been defined as a combination of two polymers, each in the form of a network, at least one of which has been synthesized and / or cross-linked in the presence of the other. As will be appreciated, this combination in general will be a physical combination instead of a chemical combination of the two polymers. IPN systems can be described by way of example as follows: The monomer 1 is polymerized and crosslinked to provide a polymer which is then expanded with the monomer 2 plus its crosslinker and initiator. If only one polymer is crosslinked in the system, the network formed is called a semi-IPN. Although they are also known as IPN, this is only if there is a total mutual solubility that presents a total rapport. In most IPN there is, therefore, some phase separation although this can be reduced by the tangle of chain between the polymers. It has also been reported that semi-IPN can be made in the presence of carrier solvents (eg, water in the case of hydrophilic components). It has been found that the polymerization and crosslinking of water-soluble monomers in the presence of water-soluble polymers, water and polyhydric alcohols produces hydrogel materials with improved rheological properties and consequently adhesives. Water-soluble polymers suitable for the formation of semi-IPNs include poly (2-acrylamido-2-methylpropansulonic acid) or one of its salts and its copolymers, potassium salt of polyacrylic acid (3 - sulopropyl ester), copolymers of NaAMPS and SPA, polyacrylic acid, polymethyl acrylic acid, polyethylene oxide, polyvinyl methyl ether, polyvinyl alcohol, polyvinyl pyrrolidone, their copolymers with vinyl acetate, dimethylaminoethyl methacrylate, terpolymers with methacrylate dimethylaminoethyl and vinylcaprolact ama, polysaccharides such as for example, gum arabic, karaya gum, xanthan gum, guar gum, carboxymethyl cellulose (CMC), NaCMC, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HEC) or combinations thereof. The amount of blended polymer used will depend on the mechanical and rheological properties required as well as the consideration of the processing conditions. If the blended polymer increases the viscosity of the pre-gel mixture beyond 5000 centipoises, it has been found that the monomers do not polymerize or crosslink on an acceptable time scale (it must be less than 60 seconds, preferably less than 10 seconds). seconds) . The viscosity depends on the nature and molecular weight of the blender and the nature of the pre-gel processing. Of the natural polysaccharides, gum arabic maltodextrin is usually preferred because of its solubility in cold water and the lower effect on viscosity compared to, for example, karaya gum. If desired, therefore, a higher concentration of gum arabic than karaya can be used, allowing a broader control of hydrogel properties. It has also been found that the processing steps to assemble the pre-gel formulation can be critical with respect to the properties of the manufactured hydrogel. For a given formulation, if the components congregate at 25 ° C and different curing and adhesive properties are obtained compared to those that have been heated to 70 ° C. While the adhesive properties can be improved, the electrical properties for example, the low frequency impedance, can decrease. Solutions containing natural polysaccharides become less opaque as indicative of improved solubility. The activity of the water in the compositions prepared from heat-treated pre-gels in general is lower than in the non-heat-treated pre-gels.

Other Additives The composition preferably comprises a hydrophobic polymer. The hydrophobic polymers can be incorporated either in the presence or in the absence of blended polymers to form separate phase materials. The preparation of two-phase compounds consisting of a hydrophilic polymer containing a continuous ionically conductive phase and a hydrophobic pressure-sensitive adhesive domain that improves adhesion to the mammalian skin has been reported in the US Pat. the United States 5338490. The preparation method described herein includes melting a mixture (as a solution and / or suspension) consisting of the phase containing hydrophilic polymer and the hydrophobic components on a substrate and then removing the solvent. However, it has been found that ionically conductive, adhesive hydrogels can be best prepared by combining the hydrophobic polymer (preferably as an emulsion) with the components of the pre-gel reaction mixture and melting these onto a substrate and curing. In other words, there is no need to remove a solvent to form the useful materials. In addition, the hydrophilic phase of the composition in addition to what will be a crosslinked network can also be an IPN or semi-IPN. It is believed that when the hydrophobic polymers are incorporated in this way, that the hydrophobic component segregates to the surface (as determined by deep sampling of total reflectance spectroscopy attenuated by infrared, Fourier, FTIR ATR transformation, approximate to 1 μm using a crystal of ZnSe of 0.25μm with a Germanium crystal) and that this is the amount of the hydrophobic component present in the surface that influences the adhesion for a wide variety of materials. The greater the amount of hydrophobic component on the surface, the greater the adhesion. In U.S. Patent 5338490 the proportion by weight of the hydrophilic phase to the hydrophobic phase of 60: 1 to 8: 1 is claimed. In hydrogel adhesives between 100 and 2000 microns thick made in accordance with the present invention, it has been found that the proportions of hydrophilic to hydrophobic components ranging from 7: 1 to 1:20 are preferred, especially when these proportions they are present on the surface of the adhesive composition. However, in the process of the present invention, it can take up to 72 hours from the initial curing of the adhesive hydrogel to complete the segregation of the hydrophobic materials to the surface, as defined by the ATR deep sampling. Preferably, the hydrophobic pressure sensitive adhesive in these embodiments is selected from the group consisting of polyacrylates, polyolefins, silicone adhesives, natural or synthetic derived rubber base and polyvinyl ethers or mixtures thereof. Preferably, the hydrophobic pressure sensitive adhesive, in these embodiments, is a copolymer of ethylene / vinyl acetate such as, for example, that denominated DM137 available from Harlow Chemicals or vinyl acetate dioctyl maleate such as, for example, the so-called Flexbond 150 and sold by Air Products. Those skilled in the art will also know that molecular weight and comonomeric proportions can be altered to control the properties of hydrophobic pressure sensitive adhesives. In general, the degree of surface segregation exhibited by this hydrophobic pressure sensitive adhesive (HPSA) will depend on factors such as, for example, the composition of the HPSA, the viscosity of the pre-gel mixture, the temperature and curing speed.

Surfactant The composition according to the invention optionally includes a surfactant. Any compatible surfactant can be used. Nonionic, anionic and cationic surfactants are preferred, either alone or in combination. The surfactant is preferably included in an amount of 0.1% to 20% by weight, more preferably 0.1% to 10% by weight. In certain circumstances, the reaction mixture preferably comprises from 3% to 20% and more preferably from 8% to 18% by weight of the reaction mixture, of a stabilized polymer dispersion which is used to provide a separate, stable phase system. Preferably, the polymer comprises any of the following either alone or in combination: vinyl acetate dioctyl maleate copolymer or acetate and i-lenvinyl copolymer. The copolymer of ethylene vinyl acetate is preferred, such as, for example, that sold under the trade name DM137 by Harlow Chemicals.

Therefore, the adhesive is typically formed by polymerizing an aqueous reaction comprising 5 to 50%, preferably 30% to 50% by weight of the reaction mixture or hydrophilic monomer, i.e., a monomer soluble in ionic water, from 10% to 50%, preferably from 15% to 45% by weight of the reaction mixture, from a plasticizer (other than water), from 10% to 50%, preferably from 15% to 30%, of higher 15% to 25% by weight preference of the reaction mixture of a non-ionic hydrophobic monomer, ie monomer soluble in non-ionic water, from 3 to 40% by weight of the water reaction mixture. To prepare the adhesive compositions for use in the invention, usually the ingredients will be mixed to provide a reaction mixture in the form of a liquid formulation with initial aqueous pre-gel base and this is then converted to a gel by a polymerization reaction by free radicals. This can be achieved, for example, by using conventional thermal initiators and / or photoinitiators or by ionization radiation. Photoinitiating is a preferred method and will usually be applied by subjecting the pre-gel reaction mixture containing a photoinitiating agent suitable for UV light after being sprayed or coated as a layer on siliconized release paper or other solid substrate. The incidental UV intensity, at a wavelength in the range of 240 to 420 nm, is ideally substantially 40mW / cmn. Processing in general will be carried out in a controlled manner including a precise predetermined sequence of mixing and heat treatment or history. It is preferred that the UV irradiation time scale should ideally be less than 60 seconds and preferably less than 10 seconds to form a gel with more than 95% conversion of the monomers and for a better conversion of 99.95% light exposure UV less than 60 seconds and preferably less than 40 seconds. Those skilled in the art will appreciate that the degree of irradiation will depend on the thickness of the reaction mixture, concentration of the photoinitiator and nature of the substrate on which the reaction mixture and the UV source are coated. These temporations are for lamps with mercury arc of medium pressure in the UV source that operates at 100 W / cm. The intensity of UV @ 254nm and 313nm reaching the substrate surface is approximately 150μW / cm2 and 750μW / cm2. For a given UV lamp the intensity is a function of the operating power and the distance of the reaction mixture from the UV source. In order to minimize and preferably eliminate the presence of any residual monomers, it is important to ensure that the reaction is terminated. This depends on several factors such as, for example, the substrate on which the adhesive will be applied, the type and intensity of ultra violet light and the number of passes with ultra violet light. Preferably, the conversion of the hydrophilic monomers present such as, for example, NaAMPS should be 98%, preferably 99.0%, most preferably 99.9% such that the amount of the monomer within the adhesive is 4600 microg / g or less , preferably 2300 microg / g or less, more preferably 230 microg / g or less. The adhesive is provided, typically on at least a portion of the surface of the article facing the user, as a layer having a thickness or gauge C that is preferably constant, or which may alternatively vary over the application surface of the adhesive. When considering in particular the removal phase of an adhesive composition for bonding to the wearer's skin, it is commonly recognized that good removal conditions are achieved, ie, at a frequency of approximately 100 rad / sec, of the applied adhesive to at least part of the surface of the article facing the user, when the adhesive can be easily removed from the skin and particularly the body hair that may be located in this area of the skin, where the article comes into contact with the body, without causing pain to the user, without adhering too firmly at the moment of removal, to the skin and the hair of the user. In addition, a good removal implies that the adhesive does not leave residues on the skin or on the hair. The ratio between the thickness or gauge C measured in millimeters (mm) of the adhesive layer typically on at least part of the user-facing surface of the absorbent article and the viscosity modulus G "25 at 25 ° C to about 100 rad / sec of the adhesive provides an indication of absence of pain and easy removal of the adhesive from the skin.Without being limited by any theory, it is believed that for values greater than G "25 to 100 rad / sec, which correspond totally to a greater adhesiveness of the composition, a wider gauge or thickness C of the adhesive layer is needed in order that the energy applied for the removal is distributed more evenly within the mass of the adhesive and is therefore transferred smoothly to the skin, avoiding in this way the energy peaks that typically provoke the sensation of pain in the user. In other words, thinner layers of the adhesive need an adhesive with a G "25 less than 100 rad / sec to achieve a reduced pain sensation at the time of removing the article In accordance with the present invention, preferably the adhesive it is provided as a layer having a thickness C such that the viscous modulus G "25 (100 rad / sec) and the thickness C of the adhesive layer satisfy the following empirical equation: G "25 = [(7 00 + C) x 3000] Pa and preferably the following empirical equation G "25 = [(5.50 + C) x 1700] Pa While in a preferred embodiment of the present invention the thickness C of the adhesive layer is constant, this adhesive layer may also have different thicknesses in different portions of the surface facing the user when applied, with the proviso that the aforementioned relationship beforehand between C and G "25 is satisfied in any case in each of the portions In order to evaluate the effect of the thickness C of the adhesive layer in this relationship with the viscous modulus G" 25 (100 rad / sec) of the adhesive of the present invention with respect to the removal of the adhesive used for the attachment of a device for the handling of human waste to the skin of a user, a test for the degree of withdrawal pain has been developed. In this test, the adhesion of standard substrates is achieved, on which the same adhesive has been provided in layers having different thicknesses, on the forearm skin of the members of a sensitive panel and at the time of the subsequent removal, the pain it was evaluated in terms of degree of pain as will be described later. In accordance with the present invention, any disposable device for handling human waste, known in the art, can be provided with the adhesive as defined herein.

Typically, devices for handling urine or faecal matter (10) comprise a bag (11) having an opening (21) and a flange (12) surrounding the opening for attachment preferably adhesive to the uro-genital area and / or the perianal area of a user as can be seen from Figures 1 and 4. In accordance with the invention, any device for the handling of fecal matter or urine, known in the art, can be provided with an adhesive as define in the present. The bag (11), as used herein, is a flexible receptacle for containing urine and excreted fecal matter. The bag (11) can be provided in any shape or size depending on the intended use thereof, i.e., if the device is intended to be used for patients who must remain in bed or active patients suffering from incontinence or requiring an artificial intestine. or for small children. For example, elongated pouches that are mainly tubular or rectangular, are typically used by bedridden patients and elderly people suffering from incontinence. For more active users, whether small children or adults, the disposable device for the handling of human waste should preferably have the anatomical form in such a way that the device follows the contours of the body and can be used discretely by the user under normal garments . In particular, the preferred forms are flat circular-type bags, cone-shaped bags, truncated-shaped bags and pyramidal or truncated pyramidal bags. In a more preferred embodiment of a fecal handling device of the present invention, the bag (11) has a substantially truncated cone shape. A preferred shaped bag for urine devices is shown in Figure 4. Typically, the bags will have a user facing portion (16) and a garment oriented portion (17). The user-facing portion (16) of the fecal material handling device (10) is positioned adjacent to the user's gluteus. As such, the user-facing portion (16) widely covers the user's buttocks and does not hang between the thighs thereof. In addition, the bag (11) preferably has a shape to allow at least the insertion and partial retention of the bag between the gluteus of the user and thereby ensure good contact between the flange and the user's skin. For example, the bag (11) may be provided with a neck portion or conduit. The bag (11) is preferably designed to provide a sufficient volume for urine and / or fecal matter under a variety of conditions of use, also when it is used by a user with free movement, that is, someone who should not keep a bed. When sitting on the bag, for example, it will result in a rather small volume in some areas of the bag. In this way, the bag (11) is preferably shaped to provide sufficient volume in the areas that are not subject to much pressure under conditions of use such as for example when sitting. The bag (11) is designed to contain and trap material safely, it will typically be impermeable to liquids, it can even be breathable. The bag (11) is designed with sufficient strength to withstand rupture during 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) may be provided with a unitary piece of material or several pieces of material separately, which may be identical or different and which they are sealed in their respective peripheries. In a preferred embodiment, the pouches herein have a user-facing portion (16) and a garment-oriented portion (17) that comprise pieces of material separately. The user-facing portion (16) and the garment-facing portion (17) are sealed at the periphery of the bag (11), thereby creating a peripheral edge in the bag (18). As can be seen from Figure 1, the user-facing portion (16) of the bag (11) can comprise two additional sections (19), which are secured to each other by means known to the person skilled in the art. , such as adhesive, thermocohesion or pressure cohesion in order to provide the desired bag configuration. The edge (18) can also be inside the bag, thus being coextensive with the inner surface (15) of the bag (11) instead of the external surface (30) of the bag (11). From > '1 * 58 preferably the bag (11) is asymmetric to the transverse axis, so 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 measured at the rear end of the bag (11). According to the present invention, the bag (11) may comprise one or several layers, preferably two or three layers. The layer on the inside the bag (11), which typically will at least partially come into contact with fecal matter is called the inner layer. The outermost layer of the bag, which typically at least partially will come into contact with the user's skin and the garments of it is called the outer layer. The layers of the bag material may be provided of any material, preferably, so that the bag is impermeable to liquids. The layers may comprise in particular any material such as non-woven materials or films. In a preferred embodiment of the present invention, a laminate may be formed of a non-woven layer and a film. The laminate can be formed by means known to the person skilled in the art. technique.

Any non-woven layer may comprise felt fabrics, lace fabrics, fabrics entangled by fluid jet, air-laying fabrics, wet-laid fabrics, dry-laid fabrics, blown fabrics, fibers-carded fabrics , spun fabrics, knitted fabrics, fabrics with openings, combinations of the previous ones or the like. Suitable film materials for any of the layers preferably comprise a thermoplastic material. The thermoplastic material can be selected from among all types of hot melt adhesives, polyolefins in particular polyethylene, polypropylene, amorphous polyolefins and the like; material containing melt-forming components comprising polymeric fibers or binders 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; binders such as high melt / bicomponent melt polymer, copolymer polyester, polyvinyl chloride, acet ato / polyvinyl chloride copolymer, polyamide copolymer, materials comprising blends wherein some of the constituent materials can not be melted; air and vapor 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 with the designation ESPOIR NO; and monolithic respirable materials such as Hytrel ™ available from DuPont and Pebax ™ available from ELF Atochem, France. In a preferred embodiment, a film that is composed of any layer, preferably is permeable to gases such as air and steam such as water vapor in order to avoid the problem of entrapment and condensation of moisture vapor from the user's body. and in this way the heat, humidity and uncomfortable conditions 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 wearer's skin and thus significantly reduce the problem of collusion and greatly 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 still another preferred embodiment of the present invention, the bag (11) comprises three layers, preferably one film and two nonwoven layers. In a 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 particularly pleasing feeling in contact with the wearer's skin. Even in 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 non-woven layer is hydrophobic. As a result, fluid penetration is resisted through the user-facing portion (16) and the garment-oriented portion (17) of the fecal material handling device (10). If the bag comprises a film or a hydrophobic nonwoven layer, the additional nonwoven layers can be hydrophilic. Typically, the non-woven layer is treated with a surfactant material, such as a luorochemical or other hydrophobic finishes to provide the required hydrophobicity. However, the non-woven layer can also be treated with coatings of liquid impervious materials such as hot melt adhesives or silicone coatings or other hydrophobic compounds such as rubber and vegetable and mineral waxes or can be physically treated using nano-part iculas or plasma coating techniques, for example. The non-woven layer can also be treated with agents to enhance the feeling of softness to the touch of the user-facing portion (16) and the garment-oriented portion (17). The agents include, without limitation, vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents is known to impart a feeling of softness or similar to flannel to the non-woven layer without giving the wearer a greasy or oily feel. Additionally, the surfactant material, which includes anionic, non-anionic, cationic and non-cationic surfactants, can be added to further improve the smoothness and surface smoothness. In addition, the non-woven layer may be impregnated with a lotion to provide desirable therapeutic or protective coating lotion benefits. The lotion coating on the user-facing portion (16) and the garment-facing portion (17) is transferred to the wearer's skin by normal contact and movement of the wearer and / or body heat. In general, mineral oil in the form of a lotion is recognized as effective in imparting a protective and soothing coating to the wearer's skin. It is also possible to impregnate the non-woven layer with a solid oil phase of cream formulation or to incorporate inside the non-woven layer an arrangement of capsules that can be broken by pressure, or thermally or with water containing, for example, oil for baby. In one embodiment of the present invention, the bag (11) 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 felt air. Examples of other suitable absorbent materials include creped cellulose wadding; meltblown polymers including joint formation; chemically hardened modified or cross-linked cellulose fibers; woven fabrics, including woven blankets and woven laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any other absorbent material or combinations of materials. The absorbent material can be placed in the bag (11) in any suitable form. For example, the absorbent material may be loosely arranged within the bag or may be secured to the inner layer of the bag (11) - Any known techniques may be used to secure the absorbent material to the non-woven and film substrates to secure the absorbent material to the inner layer of the bag. The absorbent material may also be arranged to have any desired shape or configuration (eg, rectangular, oval, circular, etc.). In the embodiment 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 user's body. Preferably, the adhesive patches (40) are placed on the outer surface of the bag (11) in such a way that they are secured to the user's abdomen at the time of 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 devices for handling urine according to the present invention, also preferably comprises an additional acquisition layer. The acquisition layer is typically 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 in such a way as to separate the user's genitals from direct contact with the absorbent material. The acquisition layer is permeable to fluids allowing ^ .- «The urine easily passes through so that it can be absorbed by the absorbent material. The acquisition layer can be manufactured from a wide range of materials, such as, for example, porous foams; cross-linked foams; plastic films with openings; or woven or nonwoven webs of natural fibers (e.g., wool or cotton fibers), synthetic fibers (e.g., polyester or polypropylene fibers), or a combination of natural and synthetic fibers. If the acquisition barrier layer includes fibers, the fibers may be spun, carded, wet-laid, blown, hydroentangled or otherwise processed as is known in the art. The acquisition layer is designed to have a pore size such that the absorbent material does not allow passage and is 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 that is 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 ^ áMM ^ Blí to increase its initial wetting capacity. However, when dealing with surfactant, the acquisition layer must be even less hydrophilic than the absorbent material. Suitable methods for treating the acquisition layer with a surfactant include spraying the acquisition layer 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 which the excreted matter is received from the body before being stored within the pocket of the bag. The opening (21) is surrounded by a flange (12) and can be provided with any shape or size, such as circular, oblong, heart-shaped and can be symmetrical or asymmetric, preferably the opening has an oblong configuration either in the longitudinal direction or in the transverse direction or in both directions, for example, the contours of the opening are in the form of two ellipses with the respective principal axes which are practically perpendicular. The flange (12) is attached to the bag (11) according to any means known to the person skilled in the art who can provide a permanent or releasable joint. However, preferably the flange is attached to the bag by adhesive. Typically, the bag may be attached to the flange towards the outer periphery of the flange in such a way that it does not cause any obstruction to the entering material. The tab can be provided in any size depending on the user group for which the device is intended. Similarly, the flange can be provided in any way and preferably has a symmetrical shape comprising a plurality of lobes (13). The flange (12) may comprise a front projection (28) and a posterior projection (29) towards the perineal and coccygeal area of a user. The flange comprises a garment-facing surface (22) and a user-facing surface (23). In a preferred embodiment there are two substantially flat, large surfaces, however, the flange may also comprise projections designed to fit the perineal or coccygeal area of the user. The flange (12) should be made of flexible and malleable, soft material to allow easy placement of the flange to the perianal area. Typical materials include nonwoven materials, fabrics, open cell thermoplastic foams, closed cell thermoplastic foams, open cell foam composites and drawn nonwoven materials and films. A closed cell polyethylene foam has been found to be effective, but more preferably an open cell polyurethane foam is used. Preferably, these foams have a thickness within the general range of 0.1 to 5 millimeters and a density of 5 to 250 g / iA more preferably 50 g / pJ Other thermoplastic foam materials, or other suitable plastic sheet materials having the described properties of these foams (ie, softness, flexibility, estirability and contractibility) could also be used. Preferably, the material of the garment-facing surface (23) of the flange (12) can extend into the defined opening area in order to form a skirt or flap of material that prevents unintentional adhesion of the edges surface of the flange that defines the opening with each other during use.

In accordance with the present invention, the adhesive (20) is preferably covered with a release means (not shown) in order to protect the adhesive (20), such as siliconized paper. The adhesive (20) can cover the entire user-facing surface (23) of the flange (12) or more preferably has at least one, preferably two to six non-adhesive portions. These portions may be free of adhesive or may contain inactivated or coated adhesives. As is evident from Figure 1, in a preferred embodiment, the adhesive is not applied to the entire user-facing surface area of the flange (12), to provide lobes (13) on either side of the flange (12) that is not adhesive and therefore can serve to facilitate the placement and removal of the device while avoiding contact with the adhesive. These lobes, however, are preferably also covered by the release means. Before the application of the device for handling fecal material (10) to the user's skin, the release means, if present, is removed. The adhesive (20) can be applied to the user facing surface of the flange (12) by any means known in the art such as aperture coating, spiral, or pearl application or printing. Typically, the adhesive is applied at a basis weight of between 20 g / m2 and 2500 g / m2, more preferably between 500 g / m2 and 2000 g / m2, most preferably between 700 g / m2 and 1500 g / m2 depending on the intended end use . For example, for the stool handling devices (10) that will be used for babies, the amount of the adhesive may be less than that of the stool handling devices (10) designed for active adults suffering from incontinence . The disposable device for handling human waste (10) of the present invention has been found to be particularly useful and beneficial when used in conjunction with a garment or diaper (50), preferably a disposable diaper - see Figure 2. Disposable device for handling human waste (10) preferably is first placed in the perianal area of the user before the disposable diaper is applied. In particular, the diaper (50) is placed on the disposable device for handling human waste (10) and is adjusted in a conventional manner around the body of the user. Furthermore, it has been found that by providing an excellent separation between urine and fecal matter, the combined system of disposable device for handling human waste (10) and diaper (50) effectively reduces skin irritation, which It can happen sometimes, especially since the typical user group includes very old users, the very young and those in poor health. Indeed, the presence of the disposable device for the handling of human waste (10) allows the formation of a separation layer between the user's skin and the diaper (50), ie a part of the absorbent core (58) of the diaper (10). The diaper (50) can be of a conventional type (a modality of which is described below although it is not a limiting example by any means) or it can be adapted to effectively and conveniently contain the disposable device for handling human waste (10) according to the teachings of the present invention. In the sense in which it is used herein, the term "disposable diapers" refers to articles that absorb and contain bodily excretions; and more specifically refers to articles that are placed against or in proximity to the user's body to absorb and contain the various excretions discharged from the body and intended to be discarded after a single use (i.e., they are not intended to be washed or otherwise). way to restore or reuse) and, preferably, will be recycled, composted or otherwise disposed of in an environmentally compatible manner. In the sense in which it is used herein, the term "diaper" refers to a general garment worn by young children or persons suffering from incontinence that is placed between the legs and fits around the wearer's waist. Figure 3 is a perspective view partially cut away from a diaper (50) characterizing the present invention before being placed on the user on the device for handling fecal material (10). As is apparent from Figure 3, a preferred diaper (50) comprises a body portion (52) and a resettable mechanical adjusting device (54). A preferred body portion (52) comprises a liquid permeable upper sheet (56) and an absorbent core (58), a liquid impermeable back sheet (60) and elastically contractible leg cuffs (62); each fold of the leg (62) preferably comprises a side flap (64) and one or more elastic members (66). For simplicity purposes, only one of the elastic members (66) is shown on the side flap (64). While the upper canvas (56), the absorbent core (58), the back canvas (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 is generally described in US Pat. No. 3,860,003 and even more preferred disposable diaper configurations are shown and are generally described in WO 93/16669. In this preferred diaper configuration, the backsheet (60) is joined to the top canvas (56); the absorbent core (58) is positioned between the upper canvas (56) and the back canvas (60); the side flaps (64) extend outwardly from each lateral edge and along the same of the absorbent core (58); and the elastic member (66) is operatively associated with each side flap (64). Figure 3 shows the body portion (52) in which the upper canvas (56) and the back canvas (60) are coextensive and have dimensions of length and width in general larger than those of the absorbent core (58). The upper canvas (56) is superimposed on the back canvas (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 a backsheet (60) is used, it typically forms the outer surface (76) of the side portion (52). The inner surface (74) is that surface of the diaper (50) opposite the outer surface (76) and in the mode shown typically is formed by the upper canvas (56). In general, the inner surface (74) of the diaper (50) is that surface coextensive with the external surface (76) and that 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 medium that can generally be compressed, shaped, that is not irritating to the wearer's skin, and capable of absorbing and releasing liquids such as urine and other discharges. bodily The absorbent core (58) can be manufactured in a variety of sizes and shapes (eg, rectangular, hourglass, "T" shape, asymmetric, etc.) and a wide variety of liquid absorbent materials commonly used in disposable diapers and other absorbent articles such as pulp from shredded wood which is generally called as felt air. Examples of other suitable absorbent materials include creped cellulose wadding, meltblown polymers, including joint formation, crosslinked cellulosic fibers, fabric including woven blankets, absorbent foams, absorbent sponges, superabsorbent polymers, absorbent gelling materials or any equivalent materials or combinations of materials. The configuration and construction of the absorbent core 58 can also be varied (for example, the absorbent core 58 can have zones of varying caliber, hydrophilic gradients, superabsorbent gradients or lower average density and lower average basis weight acquisition zones; 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 users ranging from small children 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. In the sense in which it is used in the present, the term "flexible" refers to materials that are docile and that will easily conform to the general shape and contours of the human body. The backsheet (60) prevents the exudates absorbed and contained in the absorbent core (58) from the dirt articles that are in contact with the diaper (50) such as underwear and bedding. The backsheet (60) of this form may comprise polymeric films such as polyethylene or polypropylene thermoplastic films, or composite materials such as non-woven film coated material. The commercial films are manufactured by Tredegar Industries, Inc. of Terre Haute, Ind., USA or BP-Chemical PlasTec, Rotbuchens t rasse 1, D-8000 München, Germany. The backsheet (60) is preferably textured to provide a more fabric-like appearance. In addition, the backsheet (60) may also allow the vapors to escape from the absorbent core (58) while even preventing the exudates from passing through the backsheet (60) for example, they are supplied with micro-openings. The size of the backsheet (60) is governed by the size of the absorbent core (58) and the exact diaper design selected. The upper sheet (56) of the diaper is docile, of soft feel and non-irritating to the wearer's skin. In addition, the upper sheet (56) is permeable to liquids allowing liquids (eg, urine) to easily penetrate through their thickness. A suitable top canvas (56) can be manufactured from a wide variety of materials, such as porous foams, cross-linked foams, films with openings; or woven or non-woven webs of natural fibers (e.g., wool or cotton fibers) or a combination of natural and synthetic fibers. Preferably, it is made of a material that isolates the user's skin from 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 upper canvas (56) may be a web of non-woven fibers. A top sheet (56) and empli ficat ive is thermally charged and bonded by means well known to those skilled in the art of fabrics. A canvas 't,, suitable top (56) is manufactured, for example, from Veratec Inc., a division of the International Paper Company of Walpole, Mass., USA. A particularly preferred top sheet (56) for incontinence garments comprises a formed thermoplastic film.

TEST METHODS TEST OF THE DEGREE OF PAIN OF WITHDRAWAL The Test of Grade of Pain of Withdrawal is used to evaluate the pain during the removal of the skin of a user from a sample provided with a layer of an adhesive and previously bound to the skin of the patient. user. The test specifically evaluates the pain at the time of withdrawing each sample as compared to the pain obtained when removing a reference sample constituted by a commercial strong medical patch.

Preparation of the sample The test is carried out on rectangular samples of 60 x 20 mm made of a 23 μm thick polyester film, such as the one sold by Effegidi S.p.A. from Colorno (Parma, Italy), provided on one side with a continuous layer of the adhesive having the selected thickness. The reference sample is a 60 x 20 mm sample of a non-woven, adhesive fabric, available from Beiersdorf A.G. Hamburg, Germany with the Commercial Name Fixomull Stretch.

Test method A panel of six test graders was selected. The test was performed in a controlled climate laboratory maintained at a temperature of 23 ° C and a Relative Unit of 50%. No special treatment of the user's skin was required beyond normal cleaning / washing with soap and water. The skin was then allowed to dry for at least two hours before the test to allow the skin to reach equilibrium with the ambient conditions. The different adhesives were evaluated in the test compared to the reference sample R. Each sample was applied manually by an operator to the inner part of the forearm of the grader, being centered between the wrist and the elbow, with the short side of the sample aligned along the arm. The operator exerts on each sample, with the palm of the hand, the same pressure that is typically applied to make a medical patch adhere to the skin. Each sample is used for the prescribed time and then removed from the grader skin by the operator by pulling slowly and evenly. Each of four series of a reference sample R were applied and the test samples were used and then removed from the user's skin; each sample was used for one minute, with about 5 minutes of waiting between the two subsequent samples of the same series and about 15 minutes of waiting between the two different subsequent series. The reference sample R was always applied, used and withdrawn as the first sample of this respective series. The sequence of application / use / withdrawal of the test samples in each of the first series of three is random, with the proviso that no repetition is allowed in each series and that the sequence in the first series of three is not repeated. . In the series of four, one of the test samples was tested twice, the reference sample R was always the first. Each of all the samples had to be tested an equal number of times (24 times). Graduates were asked to evaluate each sample using a pain scale ranging from 0 to 10, where 0 corresponds to no pain and 10 corresponds to pain at the time of withdrawing the reference sample R. The pain values for each sample were obtained as an average of 24 observations. The results collected from the test were analyzed by a statistical analysis program "Comparison of Population Mean-Paired Samples", which showed that the differences between the pain values of the samples are statistically significant.

ADHERENCE METHOD This is a quantitative method to determine the average strength of adhesion required for the removal of a skin at a specific angle and speed of adhesion.

EQUIPMENT Scissors Convenient Source Standard Rule Convenient Source Steel Roller 5.0kg mass, 13cm diameter and 4.5cm wide covered with 0.5mm thick rubber.

PET 23μ Polyester Film available from EFFEGIDI S.p.A., 43052 Colorno, Italy. Transfer Adhesive 3M 1524 available from 3M Italy S.p.a., 20090 Segrate Italy Stop watch Suitable source Voltage Tester Instron Model: 6021 (or equivalent) Test procedure A) Adhesion Adjustment Tester Voltage: ION load cell Test speed 1000 mm / min Clamp distance 25 mm to Clamp Pre-Load 0.2N Course of the Test "LM" 50mm Measurement variable F average (N) in "LM" B) Condition and Preparation of the Skin The sample is detached from the forearm. There are 3 skin conditions that were tested: 1) Drying: The forearm is untreated and has not been rubbed before the test or between repetitions. 2) Moistening: To a cotton disk (Dernak'up of 5.5cm in diameter, approximately 0.6g in weight), 3mi of distilled water was added. After the disc was rubbed with a light pressure 3 times on the test area on the forearm. (The forearm test area is a rectangle approximately 2cm wider and longer than the adhesive area).

C) Sample preparation 1. Allow the samples to adjust to the conditioned environment (23 ± 2 ° Celsius and 50 ± 2% RH) for approximately 1 hour. 2. Prepare rectangular samples of adhesive 260mm ± 2 long and 20mm ± 2 wide. 3. Join the polyester film on the sample surface (using the transfer adhesive to bond the polyester to the surface of the substrate). 4. Each specimen of the sample should be prepared individually and tested immediately. 5. Remove the release paper from the adhesive without touching it. Join one end to the skin (see section B). 6. Turn the 160mm Steel Roller along the adhesive strip, once in each direction.

D) Test Environment There are 2 environments where the adhesive can be tested: 1) Conditioned environment as described in Cl. 2) Humid Environment. Here, after step C4, the specimen is taken and placed in a controlled humidity oven for 3 hours at 85 ° C. Then it is removed and steps C5, C6 are carried out.

E) Realization 1 minute after Step C6, take the free end of the specimen (approximately 100mm long) and insert it in the upper end of the machine for adhesion test. Make sure the specimen is at a 90 degree angle to the forearm. Turn on the test machine.

F) Report Report the adhesion resistance average of the 5 tests. The individual values are the basis for calculating the standard deviation between the samples.

METHOD OF PROOF OF RESIDUAL MONOMER Test Sample 1 gram of a hydrogel sample is taken and immersed in 100 ml of 0.9% saline water.

The sample is left in saline at 40 ° C for 24 hours. An aliquot of the liquid is diluted and analyzed by LC / MS / MS electrospray.

Calibration Sample Dissolve 1 gram of the reference monomers (for example, NaAmps) in 100 ml of 0.9% saline water. An aliquot of the liquid is diluted and analyzed by LC / MS / MS electrospray.

Evaluation The concentration of the test and the calibration sample are determined by linear regression analysis using a software package such as, for example, VG Mass Lynx.

PREPARATION OF ADHESIVE Suitable adhesives were prepared as described in the following examples.

EXAMPLE 1 In 20 parts of polyethylene glycol diacrylate (pEGβOO) (product of UCB Chemicals sold under the trade name Ebacryl 11), 6 parts of 1-hydroxycyclohexy-1-phenyl ketone (product of Ciba and sold under the trade name designation) were dissolved. Irgacure 184). The solution thus produced was designated here as solution A (XL / PI). Separately50 parts of the potassium salt of 3-sulfopropyl acrylate (SPA) (Raschig product) was dissolved in 50 parts of water to form solution B. An additional solution designated as solution C consisted of 50 parts of water, 50 parts of the sodium salt of 2-acrylamide-2-methyl sulphonic acid (NaAMPS) product of the Lubrizol Corporation and sold as a 50% aqueous solution under the trade name LZ2405). The mixtures of solutions B and C in the proportions of 100: 0, 90:10, 60:40, 50:50, 40:60, 10:90 and 0: 100 were made to form pre-gel solutions. To 80 parts of each of these pre-gel solutions, 0.15 parts of solution A, 5 parts of potassium chloride and 20 parts of distilled water were added. The pre-gel solutions were coated on siliconized release paper at a coated weight of 0.8 kilograms per square meter and exposed to ultraviolet radiation by passing them under a mercury arc lamp at medium pressure at a rate of 5 meters per minute to form clear self-supporting gels. The residence time under the lamp was 4 seconds. The storage modules (GA of discs of 20mm diameter marked on the gels were recorded on a Rheometric Scientific RS-5 rheometer at 37 ° C. The G 'values at 1 rad were recorded in Table 1. Except for the gels containing 90 and 100 parts of SPA, the gels produced had an acceptable viscosity and adhesion properties on the skin.From the data in Table 1, relatively linear changes were obtained in the storage module with respect to the increase or decrease of the SPA to NaAMPS ratio In the above example and in the following examples, wherever parts are mentioned, they should be understood as parts by weight unless otherwise specified.

TABLE 1 EXAMPLE 2 In 20 parts of polyethylene glycol diacrylate (pEG600) (product of UCB Chemicals sold under the trade designation Ebacryl 11), 6 parts of 1-hydroxycyclohexy-1-phenyl ketone (product of Ciba and sold under the name designation) were dissolved. commercial Irgacure 184). (This solution was designated as solution A) (XL / PI). Separately, 58 parts of the potassium salt of 3-sulfopropyl acrylate (SPA) (Raschig product) were dissolved in 58 parts of distilled water to form solution D. An additional solution designated as solution E consisted of 42 parts of water, 58 parts of the sodium salt of 2-acrylamido-2-met-ilpropan sulfonic acid (NaAMPS) (a product of the Lubrizol Corporation marketed as a 58% aqueous solution under the trade name LZ2405A). The mixtures of solutions D and E in the proportions of 100: 0, 90:10, 60:40, 50:50, 40:60, 10:90 and 0: 100 were made to form pre-gel solutions. To 100 parts of each of these pre-gel solutions, 0.17 parts of solution A and 3 parts of potassium chloride were added. The pre-gel solutions were coated on siliconized release paper at a coating weight of 0.8 kilograms per square meter and passed under a mercury arc lamp at medium pressure at a rate of 5 meters per minute to form auto gels -support clear. The storage modules were measured in Example 1 and recorded in Table 2. As in the gels described in Example 1, the changes in the elastic or storage modulus G '(Pa) are linear with respect to the rate of increase or decrease of NaAMPS to SPA. All the gels produced possess an acceptable viscosity and an adhesion resistance against the skin. The gels with NaAMPS: SPA ratios in the range of 60:40 to 40:60, however, had a better balance of reuse capacity and adhesion strength.

TABLE 2 At the time of varying the amount of the crosslinking agent, a substantially linear change was also obtained in the elastic modulus G as illustrated by the graph of Figure 5.

EXAMPLE 3 To 57 parts of a 58% solution of the sodium salt of 2-acrylamido-2-methylpropanesulfonic acid (NaAMPS) (LZ2405A), 10 parts of a 58% solution of potassium salt of acrylate were added. of 3-sulfopropyl (SPA) together with 5 parts of potassium chloride and stirred until the potassium chloride was dissolved. This solution was then mixed with 30 parts of glycerol for 30 minutes. To the last solution was added 0.15 parts of a solution containing 20 parts of polyethylene glycol diacrylate (pEG600) (product of UCB Chemicals marketed under the trade name Ebacryl 11) in which 6 parts of 1-hydroxycyclohexy 1 phenyl were dissolved ketone (product of Ciba and marketed under the trade name Irgacure 184). The pre-gel solution thus formed was then cured as in Example 1. Good skin adhesion properties were obtained for this gel.

EXAMPLE 4 To 34.7 parts of a 58% aqueous solution of the sodium salt of 2-acrylamido-2-methylpropan sulfonic acid (NaAMPS) (LZ2405A), 34.7 parts of a 58% aqueous solution of the potassium of 3 -sulphopropy acrylate (SPA) together with 4.6 parts of potassium chloride and 3 parts of distilled water, and stirred until the potassium chloride dissolved. This solution was then mixed with 23.2 parts of glycerol for 30 minutes. To the last solution was added 0.15 parts of the solution A prepared as described in Example 1. The pre-gel solution thus formed was then cured as in Example 1.

EXAMPLE 5 To 20 parts of glycerol, 3 parts of a hydrophobic ethylene / vinyl acetate copolymer emulsion (50% solids) (product of Harlow Chemicals marketed under the trade name DM137) and 10 parts of polyethylene glycol (MW molecular weight) were added. 600) and stirred until a uniform color was obtained. To this mixture was added 50 parts of a 58% solution of the sodium salt of 2-acrylamido-2-met-ilpropan sulfonic acid (NaAMPS) (LZ2405A), 16 parts of potassium salt of 3-sulphopropyl acrylate (SPA) and 5 parts of potassium chloride, and the solution was heated with stirring at 60 ° C for one hour. The mixture had a change from an opaque whitish appearance to a transparent whitish. The turbidity of the solutions as measured in a portable turbidity meter, product code H193703 marketed by Hanna, had a change from 254uft to 107uft. The solution was cooled to 20 ° C and then 0.13 parts of the solution A prepared as described in Example 1 was added. This final solution was stirred for 1 hour and then cured as in Example 1. The resulting gel had a G 'value at 1 rad of 5328 Pa. The water activity in the gel, as determined by placing the gel inside the cabinets at humidity variation levels at 40 ° C (40, 52, 64 and 80% RH) and the measurement of absorption or loss of weight and the extrapolation for the zero weight change was 0.62. The adhesion to the skin of this gel was significantly greater than that described in the previous examples. Analysis of the gel by attenuated total reflectance infrared spectroscopy revealed that in the surface regions (approximately 1 miera or less), either the surface to the air or the surface in contact with the release paper, the concentration of the acetate copolymer of ethylene / vinyl relative to NaAMPS was significantly enhanced compared to the overall composition.

EXAMPLE 6 The method of Example 5 was carried out with the exception that 3 parts of gum arabic were added to the glycerol. The resulting gel had a G 'value of 1 rad of 5406 Pa. The water activity as determined by the method of Example 5 was 0.55. The adhesion to the skin of this gel was significantly greater than that described in the previous examples. Analysis of the gel by attenuated total reflectance infrared spectroscopy revealed that in the surface region (about 1 miera or less), either the surface to the air or the surface in contact with the release paper, the concentration of the ethylene / vinyl relative to NaAMPS was significantly enhanced compared to the overall composition.

EXAMPLE 7 The formulations shown in Table 3 were prepared using the following method which was used for formulation 7a. To 33 parts of glycerol, 10 parts of a hydrophobic ethylene / vinyl acetate copolymer emulsion (50% solids) (product of Harlow Chemicals marketed under the trade name DM137) were added and stirred until a uniform color was obtained. To this mixture was added 35 parts of a 58% solution of the sodium salt of 2-acrylamido-2-methylpropan sulfonic acid (NaAMPS) (LZ2405A) and 15 parts of potassium salt of 3-sulphopyl acrylate (SPA) and the solution was heated with stirring at 80 ° C for one hour. The solution was cooled to 20 ° C and then 0.15 parts of the solution A prepared as described in Example 1 was added. This signal solution was stirred for one hour and then cured as in Example 1. To prepare the formulation 7b , the same method used for formulation 7a was repeated with the exception that the parts by weight were changed to the figures given in Table 3. To prepare formulation 7c, the method used for formulation 7a was repeated, with the exception of that a block copolymer surfactant with propylene oxide / ethylene oxide (designated PE / F127 and manufactured by BASF) was added with the glycerol and the parts by weight were changed to the figures given in Table 3.

TABLE 3 As will be appreciated, the invention presents several different aspects and it should be understood that all novel and inventive features and aspects described herein are implied or implicitly and either individually or in combination with each other within its scope. Also, many detailed modifications are possible and, in particular, the scope of the invention should not be interpreted to be limited by the illustrative examples or by the terms and expressions used herein simply in a descriptive or explanatory sense.

Claims (11)

1. CLAIMS: 1. A device for handling human waste comprising a bag, the bag has an opening and a flange that surrounds the opening, the flange has a surface facing the user and a surface facing the underwear, where the user-facing surface comprises adhesive, wherein the adhesive has: (vi) an aqueous activity of 0.4 to 0.9; (vii) an elastic modulus of 1 rad / s from 700 to 15,000 Pa; (viii) an elastic modulus at 100 rad / s from 2000 to 40,000 Pa; (ix) a viscous modulus at 1 rad / s of 450 a 14,000 Pa; (x) a viscous modulus at 100 rad / s from 1000 to 35,000 Pa; (xi) 500 MHz impedance less than about 10 ohms; wherein the viscous modulus is smaller than the elastic modulus in a frequency range of 1 to 100 rad / s.
2. 2. A device for handling human waste according to the Rei indication 1, wherein the adhesive comprises a hydrophobic polymer, wherein the concentration of the polymer on the surface is greater than the concentration in the volume of the adhesive i or.
3. 3. A device for handling human waste according to claim 1, wherein the adhesive comprises an aqueous plasticizer, a copolymer of a first water-soluble, unsaturated, hydrophilic monomer and a second water-soluble, unsaturated, hydrophilic monomer and a crosslinking agent , the first monomer has a tendency of preference to improve the bioadhesive properties of the composition.
4. 4. A device for handling human waste according to claim 1, wherein the adhesive can be obtained by polymerizing an aqueous reactive mixture comprising a first water-soluble, unsaturated, hydrophilic monomer and a second unsaturated, water-soluble hydrophilic monomer and a crosslinking agent, the first monomer ai. it has a tendency of preference to improve the bioadhesive properties of the composition.
5. 5. A device for handling human waste according to Claim 3 or Claim 4, wherein the first monomer has a tendency also to improve the mechanical strength of the composition according to the invention and / or the second monomer has a tendency of preference to increase the aqueous activity of the composition.
6. 6. A device for handling human waste according to any of Claims 3 to 5, wherein the first monomer is a compound of the formula wherein R1 is an optionally substituted hydrocarbon entity, R2 is hydrogen or optionally substituted methyl and ethyl and M represents hydrogen or a cat ion.
7. 7. A device for handling human waste, according to any of the Claims 3 to 6, characterized in that the second monomer is a compound of the formula wherein R5 represents hydrogen or optionally substituted methyl or ethyl, R6 represents hydrogen or a cation and R7 represents an optionally substituted alkylene entity of 1 to 4 carbon atoms.
8. 8. A device for handling human waste according to any of Claims 2 to 7, wherein the first monomer is 2-acyl-2-methyl-2-methylpropansulonic acid or an analogue thereof or one of its salts, and / or the The second monomer is a polymerizable sulfonate or a salt of (3- sulphopropyl) acrylic acid ester or an analogue of the same.
9. 9. A device for handling human waste according to any of Claims 3 to 8, wherein the ratio of the first monomer to the second monomer by weight is from 20: 1 to 2: 3.
10. 10. A device for handling human waste according to any of Claims 4 to 9, wherein the aqueous reactive mixture optionally further comprises a surfactant, an additional monomer, an electrolyte, a water-soluble polymer suitable for forming a blended polymer network, a lipid micelle-forming polymer, a non-hydrophilic polymer and / or an antimicrobial agent.
11. 11. The use of a device for handling human waste according to any of the above indications in combination with a disposable diaper.