DK174511B1 - Sealing device for ostomy appliances - has first adhesive component to fit round stoma, coupling element and porous adhesive element to contact skin at distance from stoma - Google Patents

Abstract

Composite skin barrier comprises (a) a first component comprising an adhesive layer and an outer polymeric film, and having a centrally located stomal opening adapted to fit the barrier around a stoma; (b) a second component comprising a concentrically shaped coupling element having an outwardly-extending flange which is permanently fixed to the polymeric film of the first component in an area surrounding the stomal opening and (c) a third component comprising a microporous adhesive layer and an outer porous backing layer, the microporous adhesive layer overlapping the coupling element flange and polymeric film and extending beyond the borders of the first component. The attachments are light in weight and easily fixed to the skin, giving a stronger bond with the skin and not being subject to cracking,creasing or lifting as the anatomy underneath bends or stretches. The coupling is designed for the easy attachment of colostomy and ileostomy bags, etc..

Description

DK 174511 B1 i

BACKGROUND OF THE INVENTION The present invention relates to a fastener for application to the skin of a patient around an exposed opening (stoma) for connecting equipment, an ostomy bag comprising a coupling component with a cylindrical portion and a radial outer flange, as well as adhesives for holding the flange to the skin.

Greater abdominal surgery for a number of diseases involving different parts of the gastrointestinal tract and urinary tract may cause the patient to be provided with a 10 abdominal stoma. The three most common types of sub-life stoma are colostomy, ileostomy and ileo-ileostomy ("ileal conduit"). In ileostomy, ileo-ileostomy, and many colostomy operations, the patient is unable to control the passage of stools and must use a device attached to the body to collect this material.

Several devices have been proposed for this purpose. Most can be characterized as a system in either one or two pieces. The one-piece device conventionally consists of a pouch having an opening in a side wall of the stoma around which a plastic cover is permanently bonded. The faceplate comprises an outer layer of adhesive material intended to attach the device directly to the body or to an intermediate skin barrier or sealing gasket. The two-piece device conventionally consists of a mounting ring secured to the body by means of an elastic belt.

Recently, a two-piece device described in GB Patent No. 1,571,657 has achieved considerable commercial success. This device consists of a skin barrier having a coupling portion of the type with the protruding ribs attached to its outer surface and a pouch with a channel-shaped coupling portion surrounding the stoma opening in the side wall of the bag. The bag can be securely attached to the skin barrier by pressing it on the ribs. The skin barrier used is that described in U.S. Pat.

in DK 174511 B1 2 3,339,546, and it comprises an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethyl cellulose and polyisobutylene and an outer water-insoluble polyethylene film to which the rib coupling part is attached.

It is an object of the invention to provide a fastener of the kind mentioned in the preamble which allows easier and more secure placement of auxiliary equipment, e.g. a bag, on the patient's body.

This object is fulfilled by a device of the kind mentioned in the introduction, characterized in that the adhesive is constituted by an adhesive component with an adhesive layer and a polymer film with a central opening opening adapted to the stoma opening and to which the outer flange of the coupling component is attached. by means of an intermediate reinforcement sheet having an opening aligned with the center opening of the adhesive component and comprising a microporous adhesive layer and an outer porous supporting layer extending beyond the outer edges of the adhesive component.

The device according to the invention has an improved flexibility and is lighter and more comfortable on the body than most commonly used. As a result of its increased flexibility, the skin barrier provides a stronger connection with the skin and is not subject to cracking, folding or loosening when the skin beneath or bending or stretching.

The invention will be explained in more detail by way of example and with reference to the accompanying drawings, in which: FIG. 1 shows a section through the device according to the invention with components A, B and C at a certain distance from each other; FIG. 2 shows the front side of an ostomy bag with a coupling element for attachment to the device shown in FIG. 1, and FIG. 3 shows an enlarged section through the coupling element of the bag.

3 DK 174511 B1

As shown in detail in FIG. 1, the device consists of three components. Component A comprises an adhesive layer 11 and an outer polymeric film 12 and is provided with a centrally located opening 20 which can be expanded to fit exactly around a stoma. Component B is a coupling member comprising a cylindrical member 22, a radial outer flange 23 and a coupling edge 23, 24. Component C consists of a flexible microporous supporting layer 32 and an adhesive layer 31.

Component C is bonded directly to the polymeric film layer 12 10 of component A. Component C extends beyond the edges of component A such that the adhesive layer 31 contacts the skin at some distance from the stoma, while the adhesive layer 11 contacts the skin. right by the stoma. Component B is bonded directly to the porous supporting layer 32 by impulse heat welding or by using adhesives so as to surround the central aperture 20. Component C extends over the entire polymer film 12 and has an aperture that aligns with the aperture 20. Alternatively, component C ends directly below the region where the flange 21 and wall 22 20 meet, so that the skin barrier within component B comprises only the middle portion of component A.

The fastener according to the invention is used in conjunction with an ostomy bag having a coupling element which is designed to fit with component 25 (coupling element) B. As shown in FIG. 2 and 3, a bag 40 comprises a channel portion coupling portion 44 seen in any radial cross-section and having a radially inner wall 53 and a radially outer wall 55. An edge 58 extends inwardly around the inner periphery of wall 55 and defines together with wall 53 a defined annular orifice 58A into which the wall 22 of the coupling part B is pushed in use so that the bag is connected to the fastener. Edge 58 interacts with edge 24 to provide additional mechanical safety. The coupling part 44 is sealed to the bag 40 around the stoma opening 46 by heat sealing to the surface 45. The coupling 44 is preferably of the same polymeric material as in the coupling part B.

The adhesive layer 11 is a homogeneous mixture of one or more pressure-sensitive adhesive materials in which one or more water-soluble hydrocolloid gums are intimately dispersed. Optionally, one or more thermoplastic elastomers may be contained in the pressure-sensitive adhesive materials and may contain one or more water-swellable or inert cohesive reinforcing agents in the hydrocolloid gums.

Suitable pressure-sensitive adhesives for inclusion in the adhesive layer 11 are various natural or synthetic, viscous or elastomeric materials such as natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, polyisobutylene, etc., which either exhibit dry adhesion per se or develop attachment by the addition of a plasticizer. Low molecular weight polyisobutylenes with an average molecular weight determined from the viscosity of approx. 36,000 to approx. 58,000 (Florey) having pressure-sensitive adhesive properties are preferred. Such polyisobutylenes are commercially available under the name "Vistanex" from Exxon as the grades LM-MS and LM-MH.

Optionally, one or more thermoplastic elastomers may be included in the pressure-sensitive adhesives to provide the rubbery extensibility and both rapid and complete recovery after module loads. Suitable thermoplastic elastomers include medium molecular weight polyisobutylenes having an average molecular weight determined from the viscosity of approx. 1,150,000 to 1,600,000 (Florey), butyl rubber, which is a copolymer of isobutylene with a minor amount of isoprene, and having a molecular weight determined from the viscosity of ca. 300,000 to approx. 450,000 (Florey), and styrene copolymers such as styrene-butadiene-styrene (SBS), styrene-isoprene-styrene (SIS) and styrene-ethylene / butylene-styrene (S-EB-S), commercially available, .g.

35 from Shell Chemical Co. under the name "Kraton" as "Kraton D1100", "Kraton D1107", "Kraton 4000", "Kraton G1600" and

- - · ------........- 141 mi »· i ··· i · i ····. mmt ui ii m i., n. i i i; nn j ιι: μμμ ·· μη i · m: ι αι · ι III

5 DK 174511 B1 "Kraton G4600". Preferred thermoplastic elastomers are butyl rubber having an average molecular weight determined from the viscosity of approx. 425,000 (commercially available as grade 077), polyisobutylene having an average molecular weight of 5 determined from the viscosity of approx. 1,200,000 (commercially available under the name "Vistanéx" from Exxon as grade L-100) and styrene-isoprene-styrene (S-I-S) co-polymers (commercially available from Shell as "Kraton D 1107").

The pressure-sensitive adhesive component containing the optional thermoplastic elastomer is present in an amount of 30 to 70% by weight of the adhesive layer 11, preferably in an amount of 40 to 50% by weight. The thermoplastic elastomer can be used in an amount of up to three times the weight of the 15 pressure-sensitive elastomeric fabrics, but the thermoplastic elastomer will preferably, if present, be present in an amount of 20 to 40% by weight of the pressure-sensitive elastomeric fabric. .

Suitable water-soluble hydrocolloids for inclusion in the adhesive layer 11 are sodium carboxymethyl cellulose, pectin, gelatin, guar gum, carob gum and karaya gum. These rubbers provide wet adhesion, ie. ability to adhere to damp surfaces, of the adhesive layer 11. One or more water-swellable cohesive reinforcing agents may optionally be included in the water-soluble hydrocolloids to control the rate of hydration of water-soluble gums. Suitable cohesive reinforcing agents include finely divided, substantially water-insoluble cross-linked sodium carboxymethyl cellulose, finely divided, substantially water-insoluble starch-acrylonitrile graft polymer, e.g. as disclosed in U.S. Patent No. 3,661,815, finely divided, substantially water-insoluble cross-linked dextran, such as that available commercially under the name "Sephadex", finely purified wood cellulose, such as that available in the trade under the name "Solka-Floc", and finely divided inert natural or synthetic fiber material such as cotton.

6 DK 174511 B1

The water-soluble hydrocolloids and any water-swellable or inert cohesive reinforcing agents are present together in amounts of approx. 35 to approx. 65% by weight of the adhesive layer 11, preferably in an amount of approx.

45 to approx. 60% by weight.

The polymeric film 12 is laminated to the surface of the adhesive layer 11 and is a thin continuous or discontinuous film of polymeric material such as polyethylene, polypropylene, polyurethane, polyvinyl chloride, etc. In component 10A, the adhesive layer will vary in thickness from approx. 0.25 to approx.

And the film 12 will vary in thickness from approx. 0.025 mm to approx. 0.25 mm.

Smaller quantities, ie less than approx. 10% by weight of the adhesive layer 11, of other ingredients may be included 15 in the adhesive layer 11. For example, a plasticizer such as mineral oil, an antioxidant such as butylated hydroxyanisole, a deodorant or a perfume may be included. In addition, small amounts of a pharmacologically active ingredient may be included in the adhesive composition, e.g.

An antibiotic or antimicrobial agent such as neomysin, an antiseptic such as povidone iodine, or an anti-inflammatory agent such as hydrocortisone or triamcinolone acetonide.

Component A is prepared as follows. A premix of the water-soluble gums, water-swellable or inert cohesive reinforcing agent and other optional substances is prepared. The premixed powder is then placed in a high-shear sigma blade mixer or in a similar type mixer. The viscous pressure-sensitive adhesive component is then added in two or three equal parts. Mix for approx. 10 minutes between each addition of the viscous material. The resulting dough like mass is then extruded, rolled or pressed to the desired thickness. When working with large portions of material, the dough-like mass can be kneaded before the extrusion step. Alternatively, the process can be varied by first processing the viscous pressure-sensitive adhesive material in the mixer for approx. 10 minutes and then add the powder mixture to two or three equal parts with stirring for approx. 15 minutes between 5 each addition. When the pressure-sensitive adhesive component contains a certain amount of the optional thermoplastic elastomer, such elastomer is first mixed by geometric dilution with the pressure-sensitive adhesive material in a heated high-displacement sigma blade mixer or in a mixture of similar type. . The polymeric film 12 is then laminated on one side of the adhesive layer and the silicone coated soluble paper is laminated on the other side to form large pieces or a continuous web of the adhesive laminate. Component A of the desired shape containing a hole 20 is then punched.

Component B is formed of suitable polymeric material such as polyethylene, polypropylene, etc.

The microporous adhesive layer may be of the type described in U.S. Patent No. 3,121,021. However, the adhesive layer 31 20 is preferably made of the same components as the adhesive layer 11, the microporosity being due to a difference in the method of manufacture. Thus, the adhesive layer 31 is preferably a homogeneous mixture of one or more pressure-sensitive viscous or elastomeric materials in which 25 intimately dispersed one or more water-soluble hydrocolloid gums and optionally containing one or more thermoplastic elastomers and / or one or more water-swellable cohesives. reinforcing agents. In addition to the various optional ingredients which are present in lesser amounts and may be incorporated into both layers 11 and 31, such as antioxidants, preservatives, plasticizers, etc., the coating layer 31 may also contain up to 25% by weight of an adhesive substance. such as terpene resin.

The adhesive layer 31 preferably contains as a pressure sensitive adhesive and thermoplastic elastomer a mixture of low molecular weight polyisobutylene (quality LM-MH or LM-MS) and medium molecular weight polyisobutylene (quality 8 DK 174511 B1 L-100). Such elastomeric materials make up 30 to 60% by weight of the adhesive layer 31, preferably 35 to 50% by weight. The water-soluble hydrocolloids and any water-swellable cohesive reinforcing agents are present in an amount of 20 to 65% by weight of the adhesive layer 31, preferably 30 to 60% by weight. The adhesive layer 31 preferably contains a plasticizer in an amount of up to 10% by weight in the form of mineral oil and up to 25% by weight terpene resin.

The adhesive layer 31 varies in thickness from approx. 0.025 mm, 10 to approx. 0.25 mm and contains holes or pores with a size of approx. 10; 300 µm and has a porosity 3 2 of approx. 0.15 to approx. 15.5 cm / sec / cm as determined by the ASTM D-726-71 method using a Gurley Denso meter 4110 and a pressure difference of 12.4 cm water column.

The porous supporting layer 32 may be formed of woven or nonwoven fabric, such as the rayon fabric described in U.S. Patent No. 3,121,021, an open web of polymeric material such as an open web of polyethylene or polypropylene, or a polymeric foam such as polyurethane foam, polyethylene foam, etc., or a nonwoven material made of polyester fibers, polypropylene fibers, nylon fibers, composite olefin fibers or commercially available fibers.

These nonwoven spunbonded materials are the 25 preferred porous supporting layers. The porous supporting layers may vary in thickness from approx. 0.075 mm to approx.

0.51 mm.

Component C is prepared by the procedure of U.S. Patent No. 3,121,021 when the adhesive layer 31 is an acrylic type adhesive. When the adhesive layer 31 is a mixture of elastomeric substances and hydrocolloids, component C is prepared by dispersing the viscous or elastomeric pressure sensitive adhesives, thermoplastic elastomers, water-soluble hydrocolloids, water-swelling cohesive reinforcing agents, plasticizers, adhesives

...... ....................... '.............' Mi Mil IIIHIIIIIIIIII INI li UlliΙΙΙ · ΜΙ 'ΙΙΙΜlH

9 DK 174511 B1 and other optional ingredients in a hydrocarbon solvent, such as toluene, heptane or hexane or mixtures thereof, to form a slurry. The slurry is then deposited by means of a knife over roll on a web of silicone coated soluble paper. . The slurry is deposited in a wet thickness of approx. 0.13 to approx. 1.0 mm, preferably approx. 0.25 mm. The detachable paper with the adhesive layer 31 is then passed through a drying tunnel, e.g. a multi-zone hot air oven in which it is dried to less than 1% by weight of residual solvent. The air temperature and velocity through the drying zone are regulated such that several small bubbles are formed upon evaporation of the solvent, causing voids in the adhesive layer to provide the desired microporosity. The dry adhesive layer is then laminated onto a web of porous support material 32 which is appropriately positioned so that the adhesive layer 31 is pressed into close contact with the porous support material 32.

Component C of the desired shape is then punched out by the web.

The invention is illustrated by the following examples.

10 DK 174511 B1

Example 1

A skin barrier is prepared as follows:

Component A

An adhesive consisting of:

Component Weight%, of adhesive-coated polyisobutylene ("Vistanex LM-MH") 40 sodium carboxymethyl cellulose 20 pectin 20 10 gelatin (powder) 20

A premix is prepared by mixing 2 kg of sodium carboxymethyl cellulose, 2 kg of gelatin and 2 kg of pectin. The mixed premix is added to a powerful sigma-blade mixer, after which 4 kg of polyisobutylene is added. The mixing is continued until the mixture is homogeneous (about 25 minutes).

While the resulting doughy mass is still hot and soft, it is extruded and flattened to a thickness of 1.8 mm. A 0.05 mm thick polyethylene film is laminated on one side and silicone coated soluble paper is laminated on the other. The resulting laminate is die cut into circular pieces with a diameter of approx.

6.4 cm which has a hole in the center with a diameter of approx.

1.3 cm.

Component B

A polyethylene coupling element as shown in FIG. 1-3 are made by injection molding. The circular rib 22 30 has a diameter of approx. 4.4 cm and a height of approx. 0.46 cm.

The flange is attached to the polyethylene film of component A by ultrasonic welding.

Component C

35 A microporous adhesive is made up of: .................................. ι · ιιιιι «« ιιιι · ι Ml ....... ntan «· ΙΜΙΙΙΙ · Ι (| ιι ·· ιιι» ιι * Μ «·· ΐ ··· ηΐΙΙΙΐ · ΐ I · ΜΙΙΙΙΙΙΙ 11 DK 174511 B1

Component Weight% in microporous adhesive layer polyisobutylene ("Vistanex L-100") 20 polyisobutylene ("Vistanex LM-MH") 18 sodium carboxymethyl cellulose 18 5 gelatin (powder) 15 terpene resin 20 mineral oil 8.5 butylated hydroxytoluene 0.5 10

The above-mentioned solids are dispersed in a sufficient amount of heptane to form a slurry containing 40% by weight solids. The slurry is applied by means of a knife-over roller on silicone-coated soluble paper in a wet thickness of 0.25 mm. The material is then passed through a multi-zone oven with a residence time of 5-10 minutes, so that the solvent content is reduced to less than 1%. The resulting dry adhesive layer has a thickness of approx. 0.05-0.08 mm and a porosity 2Q of approx. 0.8 cm / sec / cm. As the dry adhesive film comes out of the furnace, it is laminated to a woven spunbond polyester fiber ("Du Pont Sontara 8003") which comes from a roll which is conveniently positioned so that the adhesive is pressed into close contact with the spunbonded __ material. .

The resulting microporous band is punched out to 10.1 cm squares with a hole in the center of approx. 5.1 cm. Part of the silicone-coated release paper around the hole in the center is removed and the microporous tape is pressed into contact with the 3Q flange 21 of the coupling member.

The exterior dimensions of components A and C and the diameter of the circular rib 22 of component B are varied to provide skin barriers that can be used for different sized stomas.

35 12 DK 174511 B1

Examples 2-11

Proceed as described in Example 1, but other skin barriers according to the invention are prepared using the following ingredients in the adhesive layer 11 in component A. The ingredients are listed in weight percent of the adhesive layer.

10 15 20 25 30 ............. ................................ .................................. '·· ......... 111 ... .... 1 Ί I "................

.............

35 DK 174511 B1 13 «ιΠ rH oo oo σι

iH ro I <N I <—i _ I I I I

o mm τη i m m i i i i h <h

T CN

σι m in m in

T I CN I rH I I I rH

oo o in m m i ni i i i i cn i r ~ o in o in

ro I CN I I I I ΓΜ rH

vo i ίο i m i i i o I

ro CM CN

a cn o o o

Γ0 I I I I CN CN CN I

to o cn oo

TJ * I ro I 1 I I rH rH

ro i m m i in i i ι I

T CM rH

(NO O

T I O I I I I I I

QJ

to o

In rH

S m -η Ih SS I 0) H 0) C I C I> 1 to h-> o

(USOJS

H J Η Η O Ή C> ί->. > 1 -η λ 3 x: a Η-ΡΧΗΧ -H £ Ih Ή .p -Ρ o> 3 <i> 3 φ -h g g oh o æ c

Ti ^ cjac gg 3 tu υ <ι> ό £ o ό o to o ttj g 3 re go c>, rn c WH CO -P 3 ij \ G CS-H 3 Ή 3 X ιΰ (8 H to H tn t ? Λ> 1 + J Η> Ί Λ o 3 -P> 1 -H> iH 1-, o -u «J ttj Sh-C Ih Λ tf IO ^ I> rH> (C Jh O IhHP + J f« jH <O) O = O = 3rtja) n30) rtj <l)> njs

CQ d, w u CJ £, 5 ^ O 2g E-> O

i 14 DK 174511 B1 m pH * · r-t I i i σι i lti o

pH I I I I I I

σ> i i i i i i i

00 I I I I I I I

island

Γ— I I pH I I I

o t pH i σ> i i

m I i i i oo oo I

'T 1 I I I I I

m m

PH III II

nj I I I I I I I

pH

µ c - 4- »(C = p— H (Jl> 4 0 = C C -ι-i m o O ή in u r- o

pH ΪΛ I Γ-C pH

> i> HtniH ms: o a> i μ ω o> <ι> το o r- ^ ph J u e o e o s.

H fl S0 S 4-> X rH -H 4J X

O) I rH μ pH —- (DO) pH g 30) Ό 11 oa oo Ό13 gxic ό wa. Oh o cm c c om

Cphoc ph 3 x: o o 'm 4) m

Π3 <U O · Η I -Q CU 44 pH -H tn pH

4->> o ιβ a <μα) m>)> .- h c w -η o μ μ i «to μ 4J μ> £ Ο 4J ou om> = χ; 3 0 = 0 m to a— un E- * ^ = (ΒΟ, '-' ΟΟ ................ -............ .. ......—---------------------- ----- 1 N ............ ..................... IIBIIIIIIIII! Illlllll! .11 II |] ||||||||||; ii ;; ||| Mil I IIHHHHmilDI ! III III! IQ ||| ΒΒ! |||! 15 DK 174511 B1

Examples 12-19

Proceed as described in Example 1, but other skin barriers according to the invention are prepared using the following ingredients in the microporous 5 adhesive layer 31 of component C. The components are listed in weight percent of the adhesive layer.

10 15 20 25 30 35 16 DK 174511 B1 σν [oo o m

H I I H (N I I I I rH I

CO I ID ld vo

H | <N I <—I I I I I rH I

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<-1 | I CM CM I | | ) H rH

full o lD o o

1 — T1 CNI I I CM I I I rH rH

ml O O O O

rH I I CM CM I I Η I rH I

t j m o o o

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ml o o in

rh | CM I CM I I I I I rH

cm I o one

HI I CM m I I I I I I

0) w o

In pH

- - E 3

= s d rH

3 * CO Η H

X rJ I <D Ih <D

C I C i> 1 W -P o (DSOS X O lirlr H i4 H J O H C 5-1 => 1> i -Η Λ 3 A Οί

Η .p X .p X H g J-irHHJ + J

1) 3 ¢ 1 3 Hl Η ε g (0 Η 0) 0) C

TD Λ C Λ C Ε Ε d 0) Ο Ο Ό Ε d> d f tf Ο> 0 Ε d CncEUC> ιη c in η-j innJ d tr- C dH d-π d X rt (O-HW-HCO bl Λ H>, 4J h>, λ od

P> i -H 5h-H P Ο -P d (C P £. P .0 CT

w Η> Η> Π3 p U PH -P -P tø p <0) 0 = 0 = dcooioa) coo)> io = «CH — Di— ϋ u (¾« Ο 2E Eh 0 '17 DK 174511 B1 in in σ> | oo

rHl I I {N oo O I I {N

in a <x> I o * - in r- <| i i (we oo o i i h r- | in in rHI o - v m I I {N 10 o i — i i i m m vol in - »m

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Ή i — I i — I

P I c - O

• P D> <3 = 4-> -r-> r-, -H C I Ih O>, = s

C -H in + J in X r »O

0 «rtMU 0 r- · o

-H Μ Μ I Ih O C rH

> i Ih Φ ΡΦ 2 W Ό = = <U I

'Ih Φ 0 <L> 2 U ^ H J

OEOp -HOXIO> i

rH (O ^ IhSUXOc-H rH -H -P X

<U I rH (¾ rH® (UlHrHHJrH g 3 Φ TJ Φ 0 ΟΤ3Τ3) 0θ (υ gxic Ό W Οι C 0Λ (5 £ H in C 3 O Ό

CrHO-H 3 .C C rrJ (D O CP OT -P

fl Jl O fl · Λ a il Ih H -P H -H OT

-P> ti (Ui dl α II> | (U> 1> 1 · Η tn vH Ό (J)) η (Η CO PC -P p HH rH> Φ -POS 0> = Φ -H 3 «3 0 = CQ CO a — UEH— Eh S CQ = ffl

Claims (11)

1. A fastener for applying to the skin of a patient around an exposed opening (stoma) for attaching equipment, e.g. an ostomy bag (40) comprising a coupling component (second component B) having a cylindrical portion (22) and a radial outer flange (21), and adhesives (first component A) for holding the flange to the skin, characterized by, the adhesive is constituted by an adhesive component (first component A) having an adhesive layer (11) and a polymer film (12) having a through-center opening (20) adapted to the stoma opening and to which the outer flange (21) of the coupling component is secured by means of an intermediate reinforcement sheet (C) having an opening aligned with the center aperture (20) of the adhesive component (A) and comprising a microporous adhesive layer (31) and an outer porous supporting layer (32) extending beyond the outer edges of the adhesive component (A). Device according to claim 1, characterized in that the microporous adhesive layer (31) on the reinforcing sheet (third component C) has a porosity of 0.155-15.5 cm 2 / sec / cm 2 and consists of a homogeneous mixture of one or more several pressure-sensitive, natural or synthetic, viscous or elastomeric adhesives which may, if desired, contain one or more thermoplastic elastomers and wherein there may be dispersed one or more water-soluble hydrocolloid gums which may optionally contain one or more water swelling and cohesive reinforcing agents and other optional ingredients selected from antioxidants, preservatives, plasticizers and adhesives and the porous support layer (32) of the third component (30) consists of a woven or non-woven fabric, an α-turret polymer material made of polyester fibers, polypropylene fibers, polyamide fibers, composite olefin fibers or cellulose fibers. Device according to claim 2, characterized in that the microporous adhesive layer (31) of the third component consists of a homogeneous mixture of 30-60% by weight of a pressure sensor. > --— »- -I ...... a .. PI III Hl llll ΙΗΝΗΜΜΗΜΗΝΜΗΜμ! In DK 174511 B1 19 as an adhesive selected from natural rubber, silicone rubber, acrylonitrile rubber, low molecular weight polyurethane rubber and polyisobutylene, as well as one or more optional thermoplastic elastomers selected from medium molecular weight polyisobutylene 20, butyl rubber and styrene-rubber, % by weight of one or more water-soluble hydrocolloids selected from sodium carboxymethyl cellulose, pectin, gelatin, guar gum, locust bean gum and karaya gum, and one or more optional water-swellable and cohesive reinforcing agents selected from 10 up to 10 weight percent mineral oil and up to 25 weight percent terpene resin. Device according to claim 3, characterized in that the microporous adhesive layer (31) of the third component 15 consists of a homogeneous mixture of 35-50 wt.% Of a mixture of low molecular weight and medium molecular weight dispersed. 30-60% by weight of one or more water-soluble hydrocolloids selected from sodium carboxymethyl cellulose, pectin, gelatin, guar gum, john bread gum and karaya gum and one or more optional water swellable and cohesive reinforcing agents selected from cross-linked sodium carboxymethyl cellulose cellulose graft copolymers and crosslinked dextran, up to 10% by weight mineral oil and up to 25% by weight terpene resin. Device according to claim 4, characterized in that the third component (C) comprises a microporous adhesive layer (31) consisting of a mixture of approx. 18% by weight of low molecular weight polyisobutylene, approx. 20% by weight of average molecular weight polyisobutylene, approx. 18 wt% sodium carboxymethyl cellulose, approx. 15% by weight of gelatin, approx. 20% by weight · terpene resin, approx. 8.5% by weight mineral oil and approx. 0.5% by weight butylated hydroxy-toluene and that the porous supporting layer consists of spin-debonded polyester fibers. Device according to one of claims 1-5, characterized in that the microporous adhesive layer (31) has a porosity of approx. 0.775 cm3 / second / cm2. 20 DK 174511 B1 Device according to claim 6, characterized in that the adhesive layer (11) of the first component (A) is approx. 1.8 mm thick, the polyethylene film (12) is approx. 0.05 mm thick, the microporous adhesive layer (31) of the third component (c) is 0.05-0.08 mm thick, and the porous supporting layer (32) of the third component (C) is approx. 0.25 mm thick. ' Device according to one or more of claims 1-7, characterized in that the adhesive layer (11) of the first component (A) comprises a homogeneous mixture of one or more pressure-sensitive, natural or synthetic, viscous or elastomeric substances which the wish may contain one or more thermoplastic elastomers and wherein may be dispersed one or more water-soluble hydrocolloid gums which, if desired, contain one or more water-swellable or inert, natural or synthetic, fibrous, cohesive reinforcing agents and other optional ingredients selected from antioxidants , preservatives and plasticizers. Device according to claim 8, characterized in that the adhesive layer (11) of the first component (A) comprises a homogeneous mixture of 30-70% by weight of a pressure-sensitive substance selected from natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber and polyisobutylene with low molecular weight and one or more optional thermoplastic elastomers selected from medium molecular weight polyisobutylene, butyl rubber and styrene copolymers, wherein 35-65% by weight of one or more water-soluble hydrocolloids selected from sodium carboxymethyl cellulose, pectin, gelatin, , locust bean gum and karaya gum, and one or more optional 30 water swelling or inert cohesive enhancers selected from cross-linked sodium carboxymethyl cellulose, starch acrylonitrile pod copolymers, purified wood cellulose, cross-linked dextran and cotton. Device according to claim 9, characterized in that the adhesive layer (11) of the first component (A) consists of a homogeneous mixture of 40-50 wt% polyisobutylene with low molecular weight and one or more optional elastomers selected from medium molecular weight polyisobutylene, butyl rubber, and styrene-isoprene copolymers dispersing 45-60% by weight of one or more water-soluble hydrocolloids selected from sodium carboxymethyl cellulose, pectin, gelatin, guar gum, locust bean gum and cara cohesive reinforcing agents selected from cross-linked sodium carboxymethyl cellulose, starch-acrylonitrile-graft copolymers, cross-linked dextran, purified wood cellulose and cotton. Device according to claim 10, characterized in that the adhesive layer (11) of the first component consists of a mixture of approx. 40% by weight polyisobutylene, approx. 20% by weight sodium carboxymethyl cellulose, approx. 20% by weight pectin and approx. 20% by weight of gelatin and that the polymer film (12) consists of polyethylene. in