EP1087798A1 - Dispositif de collecte de substances d'elimination dote d'un bord adhesif - Google Patents

Dispositif de collecte de substances d'elimination dote d'un bord adhesif

Info

Publication number
EP1087798A1
EP1087798A1 EP99931779A EP99931779A EP1087798A1 EP 1087798 A1 EP1087798 A1 EP 1087798A1 EP 99931779 A EP99931779 A EP 99931779A EP 99931779 A EP99931779 A EP 99931779A EP 1087798 A1 EP1087798 A1 EP 1087798A1
Authority
EP
European Patent Office
Prior art keywords
adhesive
management device
wearer
human waste
waste management
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99931779A
Other languages
German (de)
English (en)
Inventor
Gianfranco Palumbo
Vincenzo D'acchioli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Procter and Gamble Co
Original Assignee
Procter and Gamble Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Procter and Gamble Co filed Critical Procter and Gamble Co
Publication of EP1087798A1 publication Critical patent/EP1087798A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/45—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the shape
    • A61F13/49—Absorbent articles specially adapted to be worn around the waist, e.g. diapers
    • A61F13/495—Absorbent articles specially adapted to be worn around the waist, e.g. diapers with faecal cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/56—Supporting or fastening means
    • A61F13/66—Garments, holders or supports not integral with absorbent pads
    • A61F13/82—Garments, holders or supports not integral with absorbent pads with means for attaching to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles

Definitions

  • the present invention relates to a disposable human waste management devices such as urine management devices and faecal management device for babies, children or adults to be attached directly to the skin of the wearer.
  • the device utilises an improved adhesive having a specified rheology and application thickness in order to attach the device to the skin of the wearer so as to facilitate easy application and removal of the device from the wearer without pain, whilst ensuring maintenance of the device in the desired position, particularly on moist and wet skin for the entire period of wear, including circumstances or periods of wear during which the wearer is active, i.e. not bedridden.
  • Urine faecal management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and in particular by bedridden patients. Such human waste management devices are attached to the natural anal region or artificial anus of the wearer and or the uro genital region and are intended to entrap and immediately contain faecal material and other bodily discharges.
  • Such devices as they are mostly known today are designed to be worn by bedridden patients.
  • the devices are constituted of a relatively long and narrow tube, at one extremity of which there is an aperture and a skin attachment device upon which an adhesive can be applied.
  • US 3,577,989 details a disposable elimination-trapping bag for incontinence sufferers including a container member having an open-top portion, 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 attachment of the bag to the wearer or alternatively discloses the use of elastic straps to attach the bag to the wearer.
  • US 4,784,656 also describes a receptacle for collecting faecal matter from incontinence sufferers.
  • the faecal collector comprises a gasket, conduit means or a cylinder and a receptacle; the receptacle and conduit means are each formed from two sheets of odour barrier thermoplastic film that are heat sealed along their side edges, respectively and the side surface of the gasket is coated with a layer of adhesive;
  • GB 2 152 387 teaches a faecal collector for incontinence sufferers comprising a collection bag and a ring, which is provided with an adhesive.
  • the faecal collector comprises a pair of panels of thermoplastic sheet material joined at their margins to define an elongate bag having an opening at one end.
  • GB 1 078 588 describes a urine collector comprising a liquid proof bag of tube like configuration having in opening surrounded by an attachment means in the form of an adhesive material.
  • EP 245 064 discloses bags having a front and a rear wall, the front wall containing the aperture and attachment means to the body.
  • the attachment means is a skin compatible water resistant material such as a hydrocolloid and a water insoluble viscose elastic binder.
  • the urine and/or faecal management devices are designed such that they are securely attached to the skin of the wearer and do not become unintentionally unattached during all circumstances of use.
  • the prior art typically discloses the utilisation of certain adhesives having very high cohesive strengths such as rubber based adhesives and acrylics. These adhesives are then applied as thick layers over the entire surface of the flange of the device to maximise the adhesive force by which the device is secured to the skin of the wearer. Indeed it is apparent that these devices and in particular the adhesives have been designed for use on faecal management devices utilised by bedridden patients particularly those having an artificial anus whereby maximum adhesion takes priority over any other criteria such as patient comfort.
  • the adhesive must have a skin compatible composition and not be harsh or aggressive towards the skin or cause skin irritation or inflammation. Also it is preferred if the adhesive is compliant with the skin of the wearer such that maximum skin surface contact between the adhesive and the skin is achieved. Moreover, it is also desirable to provide an adhesive such that the device can be readily removed from the wearer, without the wearer experiencing any unacceptable pain level. This is particularly important under circumstances, where the device is misplaced, and removal and reapplication of the device once or even a number of times is required and or to ensure the application of such devices on sensitive skin and wearer groups such as infants. However, on the other hand the desired level of adhesion, albeit painless should of course also be maintained during such multiple applications of the device.
  • the problem of the achieving the desired adhesion level is further exacerbated under wet skin conditions.
  • the skin is cleaned and is usually as a result moist.
  • the currently available adhesives such as hydrocolloids, however often do not immediately strongly adhere to the skin and may need to be held in place until sufficient minimum adhesion occurs.
  • the overall adhesive ability of such adhesives tends to be significantly reduced on wet skin surfaces per se, so that the device will typically not remain attached to the skin during wearer if any pressure is exerted onto the device, for example by the movement of the wearer or during the defaecation process.
  • Moist and wet skin however is not just a problem which is prevalent at the device application stage, as a significant amount of moisture is also generated during the use of the device from the wearer by perspiration and from the material contained in the bag.
  • the resulting humid environment naturally further increases when the device is utilised in combination with a diaper.
  • current adhesives typically cannot absorb this moisture and again the adhesive strength is reduced to such an extent that the device will often become detached under exertion of pressure during wear. It is hence very important to provide an adhesive which maintains its adhesive strength on wet skin.
  • WO 97/42985 discloses a wound dressing comprising a layer of absorbent foam material which is coated with a layer of skin adhering hydrophobic gel which have a lower specific adhesivity.
  • absorbent such as for example sanitary napkins, as described in for example US statutory invention registration H1602 or WO 96/33683 and WO 95/16424.
  • the latter discloses sanitary articles having a topical adhesive which is applied on the wearer facing side of a sanitary napkin along the entire periphery.
  • WO 96/13238 discloses a topical adhesive which is described in terms of frequency dependency.
  • EP-638 303 discloses the use of a topical adhesive on side cuffs of sanitary napkins in order to keep the cuffs in an upright position.
  • Swiss publication CH-643730 discloses the use of a very long sanitary napkin having chamfered outer edges with a topical adhesive at the four corners of the outer edges in order to provide a topical adhesive area well outside the region of pubic hair growth.
  • urinary management devices Similarly from the field of urinary management devices it is known, for example from WO 92/11825, to provide a urinary incontinence pad having a resilient body on the exterior surface of which is applied a layer of adhesive such as a hydrophilic hydrogel adhesive.
  • urinary absorbent devices have to meet entirely different functional criteria than the faecal devices of the present invention.
  • faecal management devices contain solid or semi solid waste which can readily move within the confines of the bag and exert pressure upon the orifice and thereby cause dis-attachment of the device from the wearer.
  • the adhesive will adhere to moist or wet skin, independent of whether this is direct application of the device onto wet skin, or moisture which is generated on the skin surface during the wearing period of the device.
  • the adhesives are also desirable for the adhesives to provide additional benefits such as delivery/dispersal of a compound or composition which is beneficial for the skin or for the body in general.
  • the adhesive provides secure attachment, is pleasing to the skin upon application, and yet causes no discomfort upon removal. This is achieved by selecting the characteristics of the topical adhesive, particularly in terms of the viscous modulus G" of the topical adhesive and the thickness C of the layer of topical adhesive applied to the device.
  • the overall performance of the devices is further improved, if the bags are provided with a particular configuration, thus allowing the utilisation of the devices for a number of wearer groups such as babies, children and active adult incontinence sufferers, in addition to bedridden adult incontinence suffers.
  • the faecal management device with its specific adhesive can be advantageously used in combination with a reusable underwear garment or preferably with a disposable diaper.
  • Figure 1 is a perspective view of a faecal management device in accordance with the present invention.
  • Figure 2 shows a perspective view of the faecal management device in conjunction with a disposable diaper
  • Figure 3 is a partially cut-away perspective view of a disposable diaper embodying the present invention.
  • Figure 4 is a plan view of a disposable urine management device of the present invention.
  • any human waste management device such as a urine management device or a faecal management device known in the art can be provided with the adhesive according to the present invention.
  • these devices comprise a bag (11 ) having an aperture (21 ) and a flange (12) surrounding the aperture for adhesive attachment to the uro genital area and or the perianal area of a wearer as visible from Figure 1.
  • the adhesive allows attachment of devices to the skin of the wearer, the adhesive being provided as a layer having a certain thickness or calliper C measured in millimetres (mm), typically on at least part of the wearer facing surface of the flange.
  • the viscous behaviour of the adhesive can be interpreted to represent an indication of the ability of the adhesive to quickly attach and securely adhere to a particular surface.
  • the elastic behaviour can be interpreted as an indication of the "hardness" behaviour of the adhesive. Its value is also critical for good initial attachment. Their combination is believed to be an indicator of the required force upon removal.
  • the relation between elastic and viscous modulus is considered to be an indication on which fraction of the removal energy will be dissipated within the adhesive and which fraction is available to trigger the actual removal.
  • the adhesive has an elastic modulus at a ' temperature of 37 C C (100° Fahrenheit) abbreviated G' 37 ⁇ a viscous modulus 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 according to the present invention preferably satisfies the following conditions;
  • G' 37 (1 rad/sec) is in the range 1500 Pa to 20000 Pa, preferably 1500 Pa to 15000 Pa, most preferably 3000 Pa to 10000 Pa.
  • G" 37 (1 rad/sec) is in the range 1 )0 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, most preferably 300 Pa to 5000 Pa. and the ratio of G' 37 (1 rad/sec) / G" 37 (1 rad/sec) is in the range of 1 to 30.
  • the rheological behaviour can also be related to the values of the Glass
  • Tg Transition Temperature
  • Tg should preferably be less than -15°C, more preferably less than - 20°C and most preferably less than -25°C.
  • the rheological behaviour and acceptance of a adhesive can also be related to the specific heat capacity.
  • the specific heat capacity of the adhesive is less than 4 J/g/K, more preferably less than 3 J/g/K and most preferably less than 2 J/g/K.
  • the rheological behaviour and acceptance of a topical adhesive can also be related to the specific heat conductivity of the adhesive.
  • the specific heat conductivity is as low as possible, preferably between 1 and 0.1 W/m/K, most preferably between 0.6 and 0.1 W/m/K.
  • Adhesive compositions which satisfy the above criteria can be used as adhesives for the flange provided they also satisfy the common requirements of being safe for use on human or animal skin during use and generally after disposal of the device.
  • adhesive compositions which are medically suitable substantially water insoluble pressure sensitive adhesives comprising a polymer which forms a 3-dimensional matrix, and comprising less than 10%, preferably less than 5% by weight of said adhesive of hydrocolloids.
  • the polymeric compound or composition is preferably selected from the group consisting of acrylics, sulphonated polymers, vinyl alcohols, vinyl pyrrolidine, polyethylene oxide, or combinations thereof.
  • the adhesive also preferably comprises a plasticiser.
  • the plasticising compound or composition is preferably selected from the group consisting of water, alcohols (preferably glycerol), glycols, polyglycols, or combinations thereof.
  • the relation between the thickness or calliper C, measured in millimetres (mm), of the layer in which the adhesive is provided, typically onto at least a portion of the wearer facing surface of the flange, and the viscous modulus G" 25 at about 100 rad/sec of the topical adhesive is relevant to the scope of providing an easy and painless removal from the wearer's skin of such a topical adhesive applied on at least part of the wearer facing surface of a faecal management device for attachment of said device to the skin of a wearer.
  • the adhesive of the present invention is provided as a layer having a thickness C such that the viscous modulus G" 2 (100 rad/sec) and the thickness C satisfy the following empirical equation:
  • the adhesive can be utilised on faecal management devices (10) which are applied to the perianal area of a wearer as visible from Figure 1 and for urine management devices as shown in figure 4.
  • the word "skin" according to the present invention does not only relate to the specific derma of the user but includes the mucous tissue as well as the hair which is typically found in the genital region.
  • the adhesive is provided with the preferred pattern, typically on the wearer facing surface (23) of the flange (12) of the device (10), as a layer having a thickness or calliper C that is preferably constant.
  • the layer can be preferably continuous or alternatively discontinuous, e.g. in form of dots, spirals, or stripes.
  • PSA typical pressure sensitive adhesive
  • this can be interpreted as meaning that a high fraction of the energy applied for the debonding is dissipated within the adhesive (so it is not effective in causing the debonding) and through the interface of the adhesive and the skin, while this fact causes macroscopically the recording of a very high level of adhesive force.
  • materials useful as adhesives according to the present invention have rheological characteristics which are measured at a reference temperature of 37°C (as usual body temperature of humans) and in a range of frequencies. It has been found that upon application of a human waste management device with a adhesive the adhesive contact is formed at a low frequency, while debonding happens at the speed of removing the device. This speed is expressed as a frequency of 100 rad/s, while the low frequency of forming the adhesive bond has been found to be on the order of 1 rad/s. Therefore, the frequency range for use according to the present invention is between 1 and 100 rad/s.
  • the adhesive bonding characteristics are selected most appropriately at human body temperature. Since the adhesive according to the present invention is used directly on skin and the person skilled in the art is directed to select the adhesive composition to have a small specific heat capacity (e.g. preferably less than 4 J/g/K) the actual temperature of the adhesive will reach 37°C very quickly or even be warmed up by a human prior to application.
  • a small specific heat capacity e.g. preferably less than 4 J/g/K
  • the absolute values of the elastic modulus should not be too high, otherwise the adhesive is too hard and it is not able to intimately join or mold to the surface to which it is expected to adhere. It is also important to have a low absolute value of G" in order to have good cohesion which is particularly valuable for use with faecal management while the material remains soft and capable of gently adhering to skin.
  • the ratio of G' 37 (1 rad/sec) over G" 37 (1 rad/sec) is important to ensure that these two values are balanced upon adhesion to the skin.
  • the Glass Transition Temperature Tg of the adhesive composition is parameters which are useful to more fully define the group of useful adhesives.
  • G' 37 (1 rad/sec) is in the range 1500 Pa to 20000 Pa, preferably 1500 Pa to 15000 Pa, most preferably 3000 Pa to 10000 Pa.
  • G" 37 (1 rad/sec) is in the range 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, most preferably 300 Pa to 5000 Pa.
  • the ratio of G' 37 (1 rad/sec) / G" 37 (1 rad/sec) is in the range of 1 to 30.
  • G' 37 (1 rad/sec) - G" 37 (1 rad/sec) is not less than 0.5, preferably in the range 0.7 to 3, most preferably in the range 1 to 1.8.
  • the value of the ratio GVG' at least for the frequency range from above 1 rad/s up to 100 rad/s should preferably be 3.3 or above, more preferably 5 or above, most preferably 10 or above, while not exceeding about 30, preferably 20, anywhere in the frequency interval.
  • the rheological behaviour can also be related to the values of the Glass Transition Temperature Tg.
  • Tg should preferably be less than -15°C, more preferably less than - 20°C and most preferably less than -25°C.
  • the rheological behaviour and acceptance of a adhesive can also be related to the specific heat capacity.
  • the specific heat capacity of the topical adhesive is less than 4 J/g/K, more preferably less than 3 J/g/K and most preferably less than 2 J/g/K.
  • the rheological behaviour and acceptance of a topical adhesive can also be related to the specific heat conductivity of the adhesive.
  • the specific heat conductivity is as low as possible, more preferable between 1 and 0.1 W/m/K, most preferably between 0.6 and 0.1 W/m/K.
  • any medically suitable substantially water insoluble pressure sensitive adhesives comprising a polymer which forms a 3-dimensional matrix, and comprising less than 10%, preferably less than 5% by weight of said adhesive of hydrocolloids, meeting the these characteristics may be utilised .
  • hydrocolloid refers to colloidal absorbent materials, mixtures of colloidal absorbent materials selected from starch, modified starches such as dextrin, cellulose ester such as carboxymethycellulose, natural gums such as pectin karaya, gelatin, guar gum, gum arabic, locust bean gum, and carboxypolymethylene.
  • the 3 dimensional matrix also referred to herein as a gel, comprises as an essential component a polymer which can be physically or chemically cross linked.
  • the polymer may be naturally or synthetically derived.
  • the uncrosslinked polymer includes repeating units derived from vinyl alcohols, vinyl ethers and their copolymers, carboxy vinyl monomer, vinyl ester monomers, esters of carboxy vinyl monomers, vinyl amide monomers, hydroxy vinyl monomers, cationic vinyl monomers containing amines or quaternary groups, N-vinyl lactam monomer, polyethylene oxides, polyvinylpyrrolidon (PVP), acrylics such as hydroxyethylmethacrylate, methoxydiethoxyethyl methacrylate and hydroxydiethoxyethyl methacrylate and sulphonated polymers such as acrylamide sulphonated polymers and mixtures thereof.
  • PVP polyvinylpyrrolidon
  • the uncrosslinked polymer may be a homopolymer or copolymer of a polyvinyl ether, or a copolymer derived from half ester of maleic ester.
  • any other compatible polymer monomer units may be used as copolymers such as for example polyvinyl alcohol and polyacrylic acid or ethylene and vinyl acetate.
  • the polymers may be block copolymer thermoplastic elastomers such as ABA block copolymers such as styrene-olefin-styrene block copolymers or ethyle ⁇ e-propylene block copolymers. More preferably such polymers include hydrogenated grade Styrol/Ethyle ⁇ e-Butylene/Styrol (SEBS), Styrene/lsoprene/Styrene (SIS), and Styrol/Ethylene-Propylene/Styrol (SEPS).
  • SEBS Styrol/Ethyle ⁇ e-Butylene/Styrol
  • SIS Styrene/lsoprene/Styrene
  • SEPS Styrol/Ethylene-Propylene/Styrol
  • Particularly preferred polymers are acrylics, sulphonated polymers such as acrylamide sulphonated polymers, vinyl alcohols, vinyl pyrrolidine, polyethylene oxide and mixtures thereof.
  • the 3 dimensional adhesive matrix also essentially comprises a plasticiser, which is preferably a liquid at room temperature.
  • a plasticiser which is preferably a liquid at room temperature.
  • This material is selected such that the polymer may be solubilized or dispersed within the plasticiser.
  • the plasticiser must also be irradiation cross linking compatible such that it does not inhibit the irradiation cross linking process of the polymer.
  • the plasticiser may be hydrophilic or hydrophobic.
  • Suitable plasticisers include water, alcohols, polyhydric alcohols such as glycerol and sorbitol, and glycols and ether glycols such as mono- or diethers of polyalkylene gyicol, mono- or diester polyalkylene glycols, polyethylene glycols (typically up to a molecular weight of about 600), glycolates, glyceril, sorbitan esters, esters of citric and tartaric acid, imidazoline derived amphoteric surfactants, lactams, amides, polyamides, quaternary ammonium compounds, condensation products of polyethylene imine and epichlorohydrin, liquid polybutenes, esters such phthalates, adipates, stearates, palmitates, sebacates, or myristates, natural or synthetic oils such as vegetable oils, mineral oils, and combinations thereof. Particularly preferred are polyhydric alcohols, polyethylene glycol (with a molecular weight up to about 600),
  • the adhesive comprises a ratio of polymer to plasticiser by weight of from 1 : 100 to 100:1 , more preferably from 50:1 to 1 :50.
  • the exact amounts and ratios of the polymer and plasticiser will depend to a large extent on the exact nature of polymer and plasticisers utilised and can be readily selected by the skilled person in the art. For example a high molecular weight polymer material will require a greater amount of plasticiser than a low molecular weight polymer.
  • the adhesive may comprise a number of optional additional components for example the composition may comprise from 0% to 50% by weight of the composition, of a tackifying resin.
  • tackifying resins are particularly useful in combination with ABA block copolymer adhesive compositions.
  • Suitable tackifying resins include for example rosin derivatives, terpene, and terpene-phenolic resins, hydrocarbon resins such as C s and C5 C 9 resins, aromatic resins and hydrogenated resins.
  • suitable optional ingredients include from 0% to 10 % and more preferably form 0% to 5 % by weight of substances for further facilitating and stabilising the 3-dimensional matrix and the matrix forming process.
  • these may be fatty acids of C8 to C22, their metallic salts and their polyoxo-derivatives; lanolin derivatives; silica; bentonite, montmorillonite and their derivatives; waxes or mixtures thereof.
  • additives known in the art such as preservatives, antioxidants, anti UV agents, pigments, mineral fillers and mixtures thereof may also be comprised within the adhesive composition in quantities up to 10% each respectively.
  • the polymer component of the adhesive can be physically or chemically cross linked in order to form the 3 dimensional matrix.
  • Physical cross linking refers to polymers having cross links which are not chemical covalent bonds but are of a physical nature such that there are areas in the 3 dimensional matrix having high crystallinity or areas having a high glass transition temperature.
  • Chemical cross linking refers to polymers which are linked by chemical bonds.
  • the polymer is chemically cross linked by radiation techniques such as thermal-, E beam- , UV-, gamma or micro-wave radiation.
  • a polyfunctional cross linker and/or a free radical initiator may be present in the premix to initiate the crosslinking upon irradiation.
  • a free radical initiator can be present preferably in quantities up to 5% by weight.
  • the resulting adhesive compositions may be divided into three family types; hydrophilic, hydrophobic and mixed phase compositions dependant upon the nature of the components of the adhesive.
  • Hydrophilic adhesives are compositions in which typically the plasticiser is water or glycerol or glycol and/or mixtures thereof and the polymeric phase is of synthetic (e.g. polyacrylics).
  • such compositions may comprise up to 10% by weight of colloid natural gums.
  • Hydrophobic adhesives are compositions in which the plasticiser is typically an oil or blend of oils of vegetable or mineral origin and the polymer is usually a synthetic polymer, preferably an elastomer, which is soluble or dispersible in such oils.
  • Mixed phase adhesives are compositions in which both hydrophobic and hydrophilic components, possibly in both plasticisers and polymers, form two or more separate phases.
  • an emulsifier is preferably present at a suitable level to form stable emulsions between the incompatible phases.
  • the preferred adhesive compositions for use in the present invention are hydrophilic as these are particularly effective in adhering to wet skin.
  • Suitable adhesives for use herein include Promeon, available from Promeon Division of Medtronic Inc., Minneapolis Minnesota, USA and hydrogel adhesive available from 3M.
  • the adhesive is provided, typically on at least a portion of the wearer facing surface of the flange, as a layer having a thickness or calliper C that is preferably constant, or that alternatively can vary over the surface interested by the application of the adhesive.
  • the relationship between the thickness or calliper C measured in millimetres (mm) of the layer in which the adhesive is provided, typically onto at least part of the wearer's facing surface of the flange of the faecal management device, and the viscous modulus G" 2 s at 25°C and at about 100 rad/sec of the topical adhesive gives an indication on the painless and easy removal of the adhesive from the skin.
  • G" 25 at 100 rad/sec which overall correspond to a higher adhesiveness of the composition, a thicker calliper or thickness C of the adhesive layer is needed so that the energy applied for the removal is more evenly distributed within the mass of the adhesive, and is therefore transferred smoothly to the skin, so avoiding peaks of energy that typically cause the pain sensation to the wearer.
  • thinner layers of the adhesive necessitate an adhesive with a lower G" 25 at 100 rad/sec to achieve a reduced pain sensation upon removal of the device.
  • the adhesive of the present invention provided as a layer having a thickness C measured in millimetres (mm), is such that the viscous modulus G" 25 (100 rad/sec) and the thickness C of the adhesive layer satisfy the following empirical equation:
  • the thickness C of the adhesive layer is constant, such adhesive layer can also have different thicknesses in different portions of the wearer facing surface of the flange where it is applied, provided that the above mentioned relationship between C and G" 25 is in any case satisfied.
  • a Removal Pain Grade Test has been developed. In this test the adhesion of standard substrates, on which the same topical adhesive has been provided in layers having different thicknesses, on the skin of the forearm of members of a sensory panel is achieved, and upon successive removal the pain is evaluated in terms of pain grade as described herein after.
  • any disposable human waste management device known in the art can be provided with the adhesive according to the present invention.
  • urine faecal management devices comprise a bag (11 ) having an aperture (21) and a flange (12) surrounding the aperture for preferably adhesive attachment to the perianal area of a wearer as visible from Figure 1.
  • a faecal or urine management device known in the art can be provided according to the present invention.
  • the bag (11 ) as used herein is a flexible receptacle for the containment of excreted faecal matter.
  • the bag (11 ) can be provided in any shape or size depending on the intended use thereof, i.e. whether the device is intended for bedridden patients or active patients suffering from incontinence or requiring an artificial bowel or for infants.
  • the disposable human waste management device should preferably be anatomically shaped such that the device follows the contours of the body and can be worn inconspicuously by the wearer under normal garments.
  • the bag (11 ) has a substantially truncated cone shape.
  • a preferred shape for urine bags is shown in figure 4.
  • the bags will have a wearer facing portion (16) and a garment facing portion (17).
  • the wearer facing portion (16) of the human waste management device (10) is disposed adjacent the buttocks of the wearer. As such, the wearer facing portion (16) amply covers the buttocks of the wearer and does not hang between the thighs of the wearer.
  • the bag (11 ) is preferably shaped to allow at least partial insertion and retention of the bag in-between the buttocks of the wearer and thereby ensure good contact between the flange and the skin of the wearer.
  • the bag (11 ) may be provided with a neck portion or conduit.
  • the bag (11 ) is preferably designed to provide sufficient volume for excreted material under a variety of wearing conditions, also when worn by a freely moving, i.e. not bedridden wearer. Sitting on the bag, for example, will result in a largely reduced volume in some areas of the bag.
  • the bag (11 ) is preferably shaped to provide sufficient volume in areas which are not subjected to much pressure in wearing conditions such as sitting.
  • the bag (11 ) is designed to safely contain any entrapped material, typically it will be liquid impermeable, yet it may be breathable.
  • the bag (11 ) is designed of sufficient strength to withstand rupture in use, also when pressure on the bag (11 ) is exerted in typical wearing conditions, such as sitting.
  • the bag (11 ) may be provided from a unitary piece of material or from a number of separate pieces of material, which may be identical or different and which are sealed at their respective peripheries.
  • the bags herein have a wearer facing portion (16) and a garment facing portion (17) which comprise separate pieces of material.
  • the wearer facing portion (16) and the garment facing portion (17) are sealed at the periphery of the bag (11 ), thus creating a bag peripheral rim (18).
  • the wearer facing portion (16) of the bag (11 ) may comprise two further sections (19), which are secured to each other by means known to the man skilled in the art, such as adhesive, thermobonding or pressure bonding in order to provide the desired bag configuration.
  • Said rim (18) may also be inside the bag, thus being coextensive with the inner surface (15) of the bag (11 ) rather than with the outer surface (30) of the bag (11 ).
  • the bag (11 ) is asymmetrical to the transversal axis, so that the distance measured in the longitudinal direction from the centre of the aperture (21 ) to the front end of the bag (11 ) is shorter than the distance measured to the rear end of the bag (11 ).
  • the bag (11 ) can comprise one or multiple layers, preferably two or three layers.
  • the layer on the inside of the bag (11 ), which will typically at least partially come in contact with excreted material is called the inner layer.
  • the layers of the bag material may be provided from any material, preferably so that the bag is liquid impervious.
  • the layers may in particular comprise any material such as non-wovens or films.
  • a laminate may be formed from a non-woven layer and a film.
  • the laminate can be formed by means known to the man skilled in the art. Any non-woven layer can comprise felt fabrics, spunlaced fabrics, fluid jet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laid fabrics, melt-blown fabrics, staple fibre carding fabrics, spunbonded fabrics, stitch-bonded fabrics, apertured fabrics, combinations of the above or the like.
  • thermoplastic material can be selected from among all types of hot-melt adhesives, polyolefins especially polyethylene, polypropylene, amorphous polyolefins, and the like; material containing meltable components comprising fibres or polymeric binders including natural fibres such as cellulose - wood pulp, cotton, jute, hemp; synthetic fibres such as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene metal, polyimide; binders such as bicompo ⁇ ent high melt/low melt polymer, copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloride copolymer, copolymer polyamide, materials comprising blends wherein some of the constituent materials are not meltable; air and vapour permeable materials including microporous films such as those supplied by EXXON Chemical Co., Ill, US under the designation EXXA
  • a film which is comprised in any layer, is preferably permeable to gases such as air and to vapour such as water vapour in order to avoid the problem of entrapment and condensation of moisture vapour given off by the body of the wearer and thus, the hot, clammy and uncomfortable conditions after a short period of use.
  • the outer layer of the bag is preferably provided with a non-woven layer.
  • Such material layers present an uneven surface to the skin of the wearer and thus reduce significantly the problem of occlusion and greatly improve skin healthiness.
  • the bag comprises two layers.
  • the outer layer comprises a non-woven layer and the inner layer comprises a film.
  • the bag (11 ) comprises three layers, preferably one film and two non-woven layers.
  • the film is interposed between the two non- woven layers. This sequence of layers results in a closed fibrous structure, which has a particularly pleasing sensation on contact with the skin of the wearer.
  • the inner layer comprises a film and the other two layers comprise non-wovens.
  • the non-woven layer or the non-woven layers comprised by the bag (11 ) may be hydrophobic or hydrophilic. If the bag (11 ) does not comprise a film layer, preferably at least one non-woven layer is hydrophobic. As a consequence, fluid penetration is resisted through the wearer facing portion (16) and the garment facing portion (17) of the human waste management device (10). If the bag comprises a film or a hydrophobic non-woven layer, further non-woven layers may be hydrophilic.
  • the non-woven layer is treated with a surface active material, such as a fluorchemical or other hydrophobic finishings, to provide the requisite hydrophobicity.
  • a surface active material such as a fluorchemical or other hydrophobic finishings
  • the non-woven layer may equally be treated with coatings of liquid impervious materials such as hot-melt adhesives or coatings of silicone or other hydrophobic compounds such as ' rubbers and vegetable and mineral waxes or it may be physically treated using nano-particulates or plasma coating techniques, for example.
  • the non-woven layer can also be treated with agents to improve the tactile perceivable softness of the wearer facing portion (16) and the garment facing portion (17).
  • the agents include but are not limited to vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents are known to impart a silky or flannel-like feel to the non-woven layer without rendering it greasy or oily to the tactile sense of the wearer.
  • surfactant material including anionic, non-ionic, cationic and amphoteric surfactants, may be added to further enhance softness and surface smoothness.
  • the non-woven layer may be impregnated with a lotion to provide desirable therapeutic or protective coating lotion benefits.
  • the lotion coating on the wearer facing portion (16) and the garment facing portion (17) is transferable to the skin of the wearer by normal contact and wearer motion and/or body heat.
  • mineral oil in the form of a lotion is recognised as being effective in imparting a soothing, protective coating to the skin of the wearer.
  • the bag (11 ) may contain absorbent material.
  • the absorbent material may comprise any absorbent material which is capable of absorbing and retaining liquids.
  • the absorbent material may comprise a wide variety of liquid-absorbent materials commonly used in disposable diapers and other absorbent articles such as comminuted wood pulp, which is generally referred to as airfelt.
  • suitable absorbent materials include creped cellulose wadding; meltblown polymers, including coform; chemically stiffened, modified or cross-linked cellulosic fibers; tissue, including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any other known absorbent material or combinations of materials.
  • the absorbent material may be positioned in the bag (11 ) in any suitable manner.
  • 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 for securing absorbent material to nonwoven and film substrates may be used 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 (e.g., rectangular, oval, circular, etc.).
  • the outer surface of bag (11 ) is provided with patches of adhesive (40) for securing the bag (11 ) to the body of the wearer.
  • the patches of adhesive (40) are positioned on the outer surface of bag (11 ) such that they are secured to the abdomen of the wearer in use. Any number, size and shape of adhesive patches (40) may be used depending on the intended use of the device.
  • the human waste management device in particular urine management devices according to the present invention also preferably comprise an additional acquisition layer.
  • the acquisition layer is typically secured to the inner surface of bag. However, the acquisition layer may also be secured to the flange, or both the flange and the inner surface of bag.
  • the acquisition layer is preferably positioned such that it separates the genitalia of the wearer from coming into direct contact with the absorbent material.
  • the acquisition layer is fluid pervious allowing urine to readily pass through so that it may be absorbed by absorbent material.
  • the acquisition layer may be manufactured from a wide range of materials, such as porous foams; reticulated foams; apertured plastic films; or woven or nonwoven webs of natural fibers (e.g., wood 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 spunbond, carded, wet-laid, meltblown, 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 is not allowed to pass through and contact the wearer's skin.
  • the acquisition layer preferably has a pore size which is greater than the pore size of the absorbent material.
  • the acquisition layer is less hydrophilic than the absorbent material.
  • the acquisition layer may be treated with a surfactant to increase its initial wettability. When treated with surfactant, however, the acquisition layer should still be less hydrophilic than the absorbent material. Suitable methods for treating the acquisition layer with a surfactant include spraying the acquisition layer with the surfactant and immersing the material into the surfactant. Alternatively, a surfactant may be incorporated into the acquisition layer.
  • the bag (11 ) is provided with an aperture (21 ) whereby excreted matter is received from the body prior to storage within the bag cavity.
  • the aperture (21 ) is surrounded by a flange (12) and may be provided in any shape or size, such as circular, oblong, heart shaped and may be symmetrical or asymmetrical, preferably the aperture has an oblong configuration either in the longitudinal or in the transversal direction or in both directions, e.g. the contours of the aperture are in the shape of two ellipses with the respective main axes being substantially perpendicular.
  • the flange (12) is attached to the bag (11 ) according to any means known to the man skilled in the art which may provide permanent or releasable attachment. Preferably however, the flange is attached to the bag by adhesive.
  • the bag will be attached to the flange, towards the outer periphery of flange so as not to cause any obstruction for the entering excreted matter.
  • the flange may be provided in any size depending on the wearer group for which the device is intended. Similarly the flange may be provided in any shape and preferably has a symmetrical shape preferably comprising a plurality of lobes (13).
  • the flange (12) may comprise a front projection (28) and a rear projection (29) to the perineal and coccygeal area of a wearer.
  • the flange comprises a garment facing surface (22) and a wearer facing surface (23). In an preferred embodiment these are two large, substantially flat surfaces, however, the flange may also comprise projections designed to fit the perineal or coccygeal area of the wearer.
  • the flange (12) should be made of soft, flexible and malleable material to allow easy placement of the flange to the perianal area.
  • Typical materials include nonwoven materials, wovens, open celled thermoplastic foams, closed-cell thermoplastic foams, composites of open celled foams and stretch nonwoven, and films.
  • a closed-cell foam of polyethylene has been found effective, but more preferably an open celled polyurethane foam is used.
  • foams have a thickness within the general range of 0.1 to 5 millimetres and a basis weight of 5 to 250 g/m 2 , more preferably 50 g/m 2 .
  • thermoplastic foam materials or other suitable plastics sheet materials having the described properties of such foams (i.e., softness, pliability, stretchability, and contractability) might also be used.
  • the material of garment facing surface (22) of the flange (12) may extend into the defined aperture area so as to form a skirt or flap of material which prevents unintentional adhesion of the surface edges of the flange defining the aperture to oneanother during use.
  • 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 wearer facing surface (23) of the flange (12) or more preferably have at least one, preferably two to six non-adhesive portions. These portions may be adhesive free or may contain inactivated or covered adhesives. As is evident from Figure 1 , the adhesive is in one preferred embodiment not applied to the entire wearer facing surface area of the flange (12), so as to provide lobes (13) on either side of the flange (12) which are non-adhesive and can thereby serve to facilitate placement and removal of the device whilst avoiding contact with the adhesive. These lobes are however preferably also covered by the release means. Before application of the human waste management device (10) to the skin of the wearer, the release means if present is removed.
  • the adhesive (20) can be applied to the wearer facing surface of the flange (12) by any means known in the art such as slot coating, spiral, or bead application or printing.
  • the adhesive is applied at a basis weight of from 20g/m 2 to 2500g/m 2 , more preferably from 500g/m 2 to 2000g/m 2 most preferably from 700g/m 2 to 1500g/m 2 depending on the end use envisioned.
  • the amount of adhesive may be less than for human waste management devices (10) designed for active adult incontinence sufferers.
  • the disposable human waste management device (10) of the present invention has been found to be particularly useful and beneficial when used in conjunction with a garment, or diaper (50), preferably a disposable diaper - refer to Figure 2.
  • the human waste management device (10) is preferably first positioned in the perianal area of the wearer before the disposable diaper (50) is applied.
  • the diaper (50) is positioned over the human waste management device (10) and fastened in a conventional manner around the body of the wearer. It has been found that, in addition, to providing excellent separation between urine and faecal material, the combined human waste management device (10) and diaper (50) system actually reduces skin irritation, which may at times occur, especially since the group of typical wearers includes the very old, the very young and the unhealthy wearers.
  • the presence of the human waste management device (10) permits the formation of a separation layer between the skin of the wearer and the diaper (50), i.e. a part of the absorbent core (58) of the diaper (10).
  • the diaper (50) can be of the conventional type (an embodiment of which is described below although not a limiting example by any means) or can be adapted to contain in an effective and comfortable manner the human waste management device (10) according to the teachings of the present invention.
  • the term "disposable diapers” refers to articles which absorb and contain body extrudates; and more specifically, refers to articles which are placed against or in proximity to the body of the wearer to absorb and contain the various extrudates discharged from the body and which are intended to be discarded after a single use (i.e., they are not intended to be laundered or otherwise restored or reused) and, preferably, to be recycled, composted or otherwise disposed of in an environmentally compatible manner.
  • the term “diaper” refers to a garment generally worn by infants or incontinence sufferers that is drawn up between the legs and fastened about the waist of the wearer.
  • FIG 3 is a partially cut-away perspective view of a diaper (50) embodying the present invention prior to it being placed on the wearer over the faecal management device (10).
  • a preferred diaper (50) comprises a body portion (52) and a refastenable mechanical fastening device (54).
  • a preferred body portion (52) comprises a liquid pervious topsheet (56), and absorbent core (58), a liquid impervious backsheet (60), and elastically contractible leg cuffs (62); each leg cuff (62) preferably comprising a side flap (64) and one or more elastic members (66). For simplicity purposes, only one elastic member (66) is shown in the side flap (64).
  • topsheet (56), the absorbent core (58), the backsheet (60), the side flaps (64), and the elastic members (66) may be assembled in a variety of well-known configurations.
  • a preferred disposable diaper configuration is shown and generally described in US 3,860,003, an even more preferred disposable diaper configuration is shown and generally described in WO 93/16669.
  • the backsheet (60) is joined to the topsheet (56); the absorbent core (58) is positioned between the topsheet (56) and the backsheet (60); the side flaps (64) extend outwardly from and along each side edge of the absorbent core (58); and the elastic member (66) is operatively associated with each side flap (64).
  • Figure 3 shows the body portion (52) in which the topsheet (56) and the backsheet (60) are coextensive and have length and width dimensions generally larger than those of the absorbent core (58).
  • the topsheet (56) is superposed on the backsheet (60) thereby forming the periphery (68) of the body portion (52).
  • the body portion (52) has an inside surface (74) and an outside surface (76). When a backsheet (60) is used, it typically forms the outside surface (76) of the body portion (52).
  • the inside surface (74) is that surface of the diaper (50) opposite the outside surface (76) and in the embodiment shown is typically formed by the topsheet (56).
  • the inside surface (74) of the diaper (50) is that surface coextensive with the outside surface (76) and which is for the greater part in contact with the wearer when the diaper (50) is worn.
  • the absorbent core (58) of the body portion (52) may be any absorbent means which is generally compressible, conformable, non-irritating to the skin of the wearer, and capable of absorbing and retaining liquids such as urine and other certain bodily discharges.
  • the absorbent core (58) may be manufactured in a variety of sizes and shapes (for example, rectangular, hour-glass, "T"-shaped, asymmetric, etc.) and from a wide variety of liquid absorbent materials commonly used in disposable diapers and other absorbent articles such as comminuted wood pulp which is generally referred to as airfelt.
  • absorbent materials examples include creped cellulose wadding, meltblown polymers including coform, crosslinked cellulosic fibers, tissue including tissue wraps, 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) may also be varied (for example, the absorbent core (58) may have varying caliper zones, hydrophilic gradients, superabsorbent gradients, or lower average density and lower average basis weight acquisition zones;. or may comprise one or more layers or structures). Further, the size and absorbent capacity of the absorbent core (58) may be varied to accommodate wearers ranging from infants to adults.
  • the backsheet (60) is impervious to liquids (for example, urine) and is preferably manufactured from a thin plastic film, preferably a thermoplastic film, although other flexible liquid impervious materials may also be used.
  • the term "flexible” refers to materials which are compliant and which will readily 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 soiling articles which are in contact with the diaper (50) such as undergarments and bedding.
  • the backsheet (60) may thus comprise polymeric films such as thermoplastic films of polyethylene or polypropylene, or composite materials such as film-coated non-woven material. Exemplary films are manufactured by Tredegar Industries, Inc. of Terre Haute, Ind., USA or BP- Chemical PlasTec, Rotbuchenstrasse 1 , D-8000 M ⁇ nchen, Germany.
  • the backsheet (60) is preferably textured to provide a more clothlike appearance. Further, the backsheet (60) may also permit vapours to escape from the absorbent core (58) while still preventing exudates from passing through the backsheet (60) by, for example, being supplied with microapertures.
  • the size of the backsheet (60) is dictated by the size of the absorbent core (58) and the exact diaper design selected.
  • the topsheet (56) of the diaper is compliant, soft feeling and non-irritating to the skin of the wearer. Further, the topsheet (56) is liquid pervious permitting liquids (for example, urine) to readily penetrate through its thickness.
  • a suitable topsheet (56) may be manufactured from a wide range of materials, such as porous foams, reticulated foams, apertured films; or woven or non-woven webs of natural fibres (for example, wood or cotton fibres) or from a combination of natural and synthetic fibres. Preferably, it is made of a material that isolates the skin of the wearer from liquids retained in the absorbent core (58).
  • the topsheet (56) may be a non- woven web of fibres.
  • An exemplary topsheet (56) is carded and thermally bonded by means well-known to those skilled in the fabric art.
  • a suitable topsheet (56) is manufactured by, for example, Veratec Inc., a division of International Paper Company, of Walpole, Mass., USA.
  • a topsheet (56) particularly preferred for incontinence garments comprises a formed thermoplastic film.
  • the adhesives meeting the defined rheological properties may in addition to their utilisation in faecal management devices also find application to attach other articles to the skin. Suitable articles may be disposable absorbent articles such as sanitary napkins and panty liners.
  • the present invention may also find utility to attach to the skin or wear protective articles such as genital-, knee- or elbow-protectors or bandages; clothing such as bras, surgical gowns, or parts of garments during fitting at a tailor; nasal plasters; prosthesis such as breast replacements or wigs; heat wraps, pads, and/or packs, e.g. for topical relief of pain or simply to provide warmth; cold wraps e.g. to provide pain relieve from bruises and to reduce swelling; hearing aids; protective face masks; ornamental articles such as jewellery, earrings, guises, tattoos; goggles or other eye wear.
  • Such articles are non-absorbent for bodily liquids.
  • the Removal Pain Grade Test is utilized to evaluate the pain during removal from the skin of a wearer of a sample provided with a layer of a adhesive and previously attached to the wearer's skin. The test specifically evaluates the pain upon removal of each sample as compared to the pain obtained by removing a reference sample constituted by a commercial strong medical plaster.
  • the test is performed on rectangular samples 60x20 mm made of a polyester film 23 ⁇ m thick, such as that sold by Effegidi S.p.A. of Colorno (Parma, Italy), provided on one side with a continuous layer of the topical adhesive having the selected thickness, applied with an Acumeter Model LH-1 extruder.
  • the reference sample is a 60x20 mm sample of a of an adhesive non woven fabric available from Beiersdorf A.G. Hamburg, Germany under the Tradename Fixomull stretch.
  • Test method A panel of six graders is selected for the test. The test is performed in a climatically controlled laboratory maintained at a temperature of 23 °C and a Relative Humidity of 50%. No special treatment of the wearer's skin is required beyond normal cleaning/washing with water and soap. The skin is then allowed to dry for at least two hours before the test to allow the skin to reach equilibrium with the room conditions. Different adhesive are evaluated in the test in comparison with the reference sample R. Each sample is applied by hand by an operator to the inner part of the grader's forearm, being centred between the wrist and the elbow, with the short side of the sample aligned with the length of the arm.
  • each sample is worn for the prescribed time, and then it is removed from the grader's skin by the operator with a slow and smooth pull.
  • each sample is worn and then removed from the wearer's skin; each sample is worn for one minute, with a 5 minute wait between two subsequent samples of the same series, and a 15 minute wait between two different subsequent series.
  • the reference sample R is always applied, worn and removed as the first sample of its respective series.
  • the sequence of application/wear/removal of the test samples in each of the first three series is random, provided that no repetition in each series is allowed, and that no sequence is repeated in the first three series.
  • one of the test samples is tested twice, the reference R always being the first one. Overall each sample has to be tested an equal number of times (24 times).
  • the graders 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 the pain upon removal of the reference sample R.
  • the pain values for each sample were obtained as a mean of 24 observations.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Adhesives Or Adhesive Processes (AREA)
  • Adhesive Tapes (AREA)

Abstract

Dispositifs de collecte de substances d'élimination humaines, tel qu'un dispositif de collecte (10) d'urine et un dispositif de collecte de matières fécales, qui sont dotés d'adhésifs destinés à attacher localement lesdits articles sur la peau. La présente invention concerne en particulier des adhésifs (20) qui permettent une fixation sure et qui sont agréables pour la peau lorsqu'ils sont appliqués, mais ne provoquent pas de désagrément lorsqu'ils sont enlevés. Cet effet est obtenu par le choix de la composition chimique et des caractéristiques rhéologiques des adhésifs, en particulier du module de viscosité G'' en combinaison avec l'épaisseur C de la couche adhésive déposée sur le bord (12) du dispositif (10) destiné à être attaché sur la peau.
EP99931779A 1998-06-26 1999-06-11 Dispositif de collecte de substances d'elimination dote d'un bord adhesif Withdrawn EP1087798A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
WOPCT/US98/13287 1998-06-26
PCT/US1998/013287 WO2000000123A1 (fr) 1998-06-26 1998-06-26 Collecteur de selles avec moyen de fixation a collerette adhesive ameliore pour faciliter le retrait avec un degre de douleur faible
PCT/US1999/013003 WO2000000236A1 (fr) 1998-06-26 1999-06-11 Dispositif de collecte de substances d'elimination dote d'un bord adhesif

Publications (1)

Publication Number Publication Date
EP1087798A1 true EP1087798A1 (fr) 2001-04-04

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
EP99931779A Withdrawn EP1087798A1 (fr) 1998-06-26 1999-06-11 Dispositif de collecte de substances d'elimination dote d'un bord adhesif
EP99928511A Withdrawn EP1089774A1 (fr) 1998-06-26 1999-06-11 Article absorbant jetable dote d'adhesif a appliquer sur la peau

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP99928511A Withdrawn EP1089774A1 (fr) 1998-06-26 1999-06-11 Article absorbant jetable dote d'adhesif a appliquer sur la peau

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EP (2) EP1087798A1 (fr)
JP (2) JP2003524441A (fr)
KR (1) KR20010053192A (fr)
CN (1) CN1311699A (fr)
AU (3) AU8267098A (fr)
BR (2) BR9912217A (fr)
CA (2) CA2334818A1 (fr)
PE (2) PE20000782A1 (fr)
TW (2) TW418086B (fr)
WO (3) WO2000000123A1 (fr)

Families Citing this family (68)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000061040A1 (fr) * 1999-04-12 2000-10-19 The Procter & Gamble Company Dispositif pour recueillir des excrements avec feuille detachable adaptee
US6565549B1 (en) * 2000-02-15 2003-05-20 The Procter & Gamble Company Absorbent article with thermally activatable adhesives
US6572600B1 (en) 2000-02-15 2003-06-03 The Procter & Gamble Company Disposable article with deactivatable adhesive
US6623465B1 (en) * 2000-02-15 2003-09-23 The Procter & Gamble Company Absorbent article with water-activatable topical adhesives
JP4599005B2 (ja) * 2001-05-22 2010-12-15 ユニ・チャーム株式会社 生理用ナプキン
ATE409447T1 (de) 2003-02-12 2008-10-15 Procter & Gamble Bequem windel
ES2452317T3 (es) 2003-02-12 2014-03-31 The Procter & Gamble Company Núcleo absorbente para un artículo absorbente
EP1468661A1 (fr) * 2003-04-17 2004-10-20 The Procter & Gamble Company Collecteur d'excréments jetable
US7475435B2 (en) 2004-02-23 2009-01-13 Nike, Inc. Swim goggles
US7833208B2 (en) 2004-12-29 2010-11-16 Kimberly-Clark Worldwide, Inc. Multilayer absorbent article
US20060264861A1 (en) 2005-05-20 2006-11-23 Lavon Gary D Disposable absorbent article having breathable side flaps
JP4630138B2 (ja) * 2005-07-01 2011-02-09 朱美 金築 排泄物処理装具
EP1749470A1 (fr) * 2005-08-05 2007-02-07 The Procter and Gamble Company Article nettoyant pour les surfaces dures comportant un adhésif
WO2007019201A1 (fr) * 2005-08-05 2007-02-15 The Procter & Gamble Company Article de nettoyage de surface dure comprenant un adhésif
JP5259705B2 (ja) 2007-06-18 2013-08-07 ザ プロクター アンド ギャンブル カンパニー ほぼ連続的に分布した吸収性粒子状ポリマー材料を含む封止された吸収性コアを備える使い捨て吸収性物品
ES2580953T3 (es) 2007-06-18 2016-08-30 The Procter & Gamble Company Artículo absorbente desechable con material polimérico absorbente en forma de partículas distribuido de forma sustancialmente continua y método
US8251969B2 (en) 2007-08-03 2012-08-28 Kimberly-Clark Worldwide, Inc. Body adhering absorbent article
US7947027B2 (en) 2007-12-28 2011-05-24 Kimberly-Clark Worldwide, Inc. Body adhering absorbent article
US8672911B2 (en) 2007-08-03 2014-03-18 Kimberly-Clark Worldwide, Inc. Body adhering absorbent article
US8292862B2 (en) 2007-08-03 2012-10-23 Kimberly-Clark Worldwide, Inc. Dynamic fitting body adhering absorbent article
US8734413B2 (en) 2007-08-03 2014-05-27 Kimberly-Clark Worldwide, Inc. Packaged body adhering absorbent article
US7976525B2 (en) 2008-02-13 2011-07-12 Kimberly-Clark Worldwide, Inc. Compound absorbent article with improved body contact
WO2009134780A1 (fr) 2008-04-29 2009-11-05 The Procter & Gamble Company Procédé de fabrication d'une partie centrale absorbante avec un revêtement central résistant à la déformation
US11147722B2 (en) 2008-11-10 2021-10-19 Kimberly-Clark Worldwide, Inc. Absorbent article with a multifunctional acrylate skin-adhesive composition
US10022468B2 (en) 2009-02-02 2018-07-17 Kimberly-Clark Worldwide, Inc. Absorbent articles containing a multifunctional gel
EP2329803B1 (fr) 2009-12-02 2019-06-19 The Procter & Gamble Company Appareil et procédé pour le transfert d'un matériau à particules
US8758547B2 (en) 2011-02-08 2014-06-24 Kimberly-Clark Worldwide, Inc. Method of manufacturing a body adhering absorbent article orientated in the cross-machine direction with reduced curl
US8764922B2 (en) 2011-02-08 2014-07-01 Kimberly-Clark Worldwide, Inc. Method of manufacturing a body adhering absorbent article orientated in the machine direction with reduced curl
PL2532332T5 (pl) 2011-06-10 2018-07-31 The Procter And Gamble Company Pieluszka jednorazowego użytku o zredukowanym połączeniu pomiędzy wkładem chłonnym a warstwą spodnią
BR112013030599A2 (pt) 2011-06-10 2016-09-27 Procter & Gamble núcleo absorvente para artigos absorventes descartáveis
JP2014515983A (ja) 2011-06-10 2014-07-07 ザ プロクター アンド ギャンブル カンパニー 使い捨ておむつ
US9468566B2 (en) 2011-06-10 2016-10-18 The Procter & Gamble Company Absorbent structure for absorbent articles
EP2532329B1 (fr) 2011-06-10 2018-09-19 The Procter and Gamble Company Procédé et appareil pour la fabrication de structures absorbantes à partir d'un matériau absorbant
EP3287109B1 (fr) 2011-06-10 2023-11-29 The Procter & Gamble Company Structure absorbante pour articles absorbants
PL2532328T3 (pl) 2011-06-10 2014-07-31 Procter & Gamble Sposób i urządzenie do wytworzenia struktur chłonnych z materiałem chłonnym
WO2013000480A1 (fr) * 2011-06-30 2013-01-03 Coloplast A/S Accessoire pour stomie
FR2997842B1 (fr) 2012-11-13 2021-06-11 Procter & Gamble Articles absorbants avec canaux et signaux
US10639215B2 (en) 2012-12-10 2020-05-05 The Procter & Gamble Company Absorbent articles with channels and/or pockets
EP2740450A1 (fr) 2012-12-10 2014-06-11 The Procter & Gamble Company C'ur absorbant à haute teneur en matériau superabsorbant
EP2740449B1 (fr) 2012-12-10 2019-01-23 The Procter & Gamble Company Article absorbant à haute teneur en matériau absorbant
US9216116B2 (en) 2012-12-10 2015-12-22 The Procter & Gamble Company Absorbent articles with channels
PL2740452T3 (pl) 2012-12-10 2022-01-31 The Procter & Gamble Company Wyrób chłonny o wysokiej zawartości materiału chłonnego
US9216118B2 (en) 2012-12-10 2015-12-22 The Procter & Gamble Company Absorbent articles with channels and/or pockets
US8979815B2 (en) 2012-12-10 2015-03-17 The Procter & Gamble Company Absorbent articles with channels
PL3254656T3 (pl) 2013-06-14 2022-01-10 The Procter & Gamble Company Wyrób chłonny i wkład chłonny tworzący kanały w stanie mokrym
EP4040805A3 (fr) 2013-08-09 2022-10-05 MED-EL Elektromedizinische Geräte GmbH Système de prothèse auditive à conduction osseuse
US9987176B2 (en) 2013-08-27 2018-06-05 The Procter & Gamble Company Absorbent articles with channels
JP6334705B2 (ja) 2013-08-27 2018-05-30 ザ プロクター アンド ギャンブル カンパニー チャネルを有する吸収性物品
WO2015034582A2 (fr) 2013-09-04 2015-03-12 Otorix Usa Inc. Système de prothèse auditive implantable
US11207220B2 (en) 2013-09-16 2021-12-28 The Procter & Gamble Company Absorbent articles with channels and signals
MX2016003391A (es) 2013-09-16 2016-06-24 Procter & Gamble Articulos absorbentes con canales y señales.
EP3351225B1 (fr) 2013-09-19 2021-12-29 The Procter & Gamble Company Noyaux absorbants ayant des zones exemptes de matériau
US9789009B2 (en) 2013-12-19 2017-10-17 The Procter & Gamble Company Absorbent articles having channel-forming areas and wetness indicator
EP2886092B1 (fr) 2013-12-19 2016-09-14 The Procter and Gamble Company Noyaux absorbants ayant des joints et des zones formant un canal
EP2905001B1 (fr) 2014-02-11 2017-01-04 The Procter and Gamble Company Procédé et appareil de fabrication d'une structure absorbante comprenant des canaux
EP2949300B1 (fr) 2014-05-27 2017-08-02 The Procter and Gamble Company Âme absorbante pourvue d'un motif de matériau absorbant
SE538635C2 (en) * 2014-09-15 2016-10-04 Observe Medical Aps Method for sterilizing a body fluid drainage system
CN107405223B (zh) 2015-03-16 2021-03-02 宝洁公司 具有改善的强度的吸收制品
GB2555016B (en) 2015-03-16 2021-05-12 Procter & Gamble Absorbent articles with improved cores
MX2017014428A (es) 2015-05-12 2018-04-10 Procter & Gamble Articulo absorbente con adhesivo mejorado del nucleo al lienzo inferior.
CN107683126A (zh) 2015-05-29 2018-02-09 宝洁公司 具有槽和润湿指示标记的吸收制品
EP3167859B1 (fr) 2015-11-16 2020-05-06 The Procter and Gamble Company Noyaux absorbants ayant des zones exemptes de matériau
EP3238678B1 (fr) 2016-04-29 2019-02-27 The Procter and Gamble Company Noyau absorbant avec des lignes de pliage transversales
EP3238676B1 (fr) 2016-04-29 2019-01-02 The Procter and Gamble Company Noyau absorbant avec profil de distribution de matériau absorbant
TWI615275B (zh) * 2016-11-14 2018-02-21 國立高雄大學 具親水性及疏水性之兩性貼片構造
US10799385B2 (en) * 2017-12-22 2020-10-13 Coloplast A/S Ostomy appliance with layered base plate
GB201814501D0 (en) 2018-09-06 2018-10-24 Concepts For Success C4S Faeces separation sheet
CN114099150A (zh) * 2021-11-19 2022-03-01 爹地宝贝股份有限公司 男性轻度失禁尿片及其制备方法

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3366116A (en) * 1965-03-11 1968-01-30 Charles M. Huck Pediatric urine collector
US3292626A (en) * 1965-05-25 1966-12-20 Hollister Inc Urine collector
US3577989A (en) * 1968-10-31 1971-05-11 Jean O Anderson Disposable plastic, elimination-trapping bag for incontinent patients
CA1218954A (fr) * 1982-02-25 1987-03-10 David L. Sieverding Colle de contact elastomere hydrophile
US4445898A (en) * 1982-03-16 1984-05-01 Hollister Incorporated Fecal incontinence device with separable release sheets
US4593053A (en) * 1984-12-07 1986-06-03 Medtronic, Inc. Hydrophilic pressure sensitive biomedical adhesive composition
US5015244A (en) * 1988-11-08 1991-05-14 Smiths Industries Public Limited Company Adhesive ring assemblies for collection bags
DE69018650T2 (de) * 1989-12-28 1995-12-14 Minnesota Mining & Mfg Verbundstoff aus einem dispergierten gel in einer adhesiven matrix und verfahren zu seiner herstellung.
GR1002418B (el) * 1992-07-29 1996-08-21 Johnson & Johnson Consumer Products Inc. Βιοεπισυναπτομενες συνθεσεις θεραπειας και μεθοδοι χρησης.
CA2122660A1 (fr) * 1993-12-14 1995-06-15 John Philip Vukos Article absorbant a bande adhesive
JPH08117261A (ja) * 1994-10-24 1996-05-14 Yoshio Beppu おむつ
JP3947564B2 (ja) * 1994-10-28 2007-07-25 キンバリー クラーク ワールドワイド インコーポレイテッド 接着剤付き吸収性物品
US5593397A (en) * 1995-07-13 1997-01-14 Hollister Incorporated Fecal collector with elastic attachment patch
US5559165A (en) * 1995-08-08 1996-09-24 National Starch And Chemical Investment Holding Corporation Hot melt adhesives for bonding to sensitive areas of the human body
US5695484A (en) * 1995-12-12 1997-12-09 Cox; Brian J. Anal patch for fecal incontinence
WO1997024149A1 (fr) * 1995-12-29 1997-07-10 Minnesota Mining And Manufacturing Company Compostions adhesives, lipophiles, polaires et sensibles a la pression, et instruments medicaux faisant appel a ces compositions
JP2001505797A (ja) * 1996-12-13 2001-05-08 ウロメッド コーポレーション 尿失禁装置

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0000236A1 *

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PE20000782A1 (es) 2000-10-28
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AU4556299A (en) 2000-01-17
PE20000648A1 (es) 2000-09-22
BR9912217A (pt) 2001-10-16
AU752479B2 (en) 2002-09-19
AU4821199A (en) 2000-01-17
CA2334818A1 (fr) 2000-01-06
CN1311699A (zh) 2001-09-05
AU8267098A (en) 2000-01-17
JP2003524441A (ja) 2003-08-19
WO2000000123A1 (fr) 2000-01-06
EP1089774A1 (fr) 2001-04-11
JP2003526387A (ja) 2003-09-09
TW415838B (en) 2000-12-21
WO2000000236A1 (fr) 2000-01-06
WO2000000235A1 (fr) 2000-01-06
CA2336202A1 (fr) 2000-01-06
BR9912213A (pt) 2002-11-05

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