DK158768B - Adhesive for medicinal purposes, and the use thereof - Google Patents

Description

DK 158768 B

The present invention relates to an adhesive for medical purposes as well as its use.

Major surgical procedures for a variety of diseases affecting different parts of the gastrointestinal tract and the urinary tract may result in the patient having an abdominal stoma. The three most common types of abdominal stoma are colostomy, ileostomy and ileus duct. In the case of an ileostomy, an ileus duct, and many co-loss surgery, the patient is unable to control the discharge of body wastes and relies on an aggregate attached to their body to collect these substances.

Several systems have been used in the past for this purpose. Colostonates generally use a disposable assembly consisting of either one or two parts. The term "one-cancs" refers to the fact that the pocket or bag in the unit can be discarded after being used once. A closed pocket sealed along all edges and provided only with an opening for the stoma is suitable for this purpose. The disposable two-piece assembly consists of such a bag which is suspended in a multi-use mounting ring and supported by a belt. The single-cell assembly may be a disposable bag having an adhesive disk-lined plate affixed to the body as shown in U.S. Patent No. 3C55,368, a disposable bag having a mounting package supported by a belt and watch. may include a closure of karaya and glycerol as disclosed in U.S. Patent No. 3,302,647, or a disposable bag supported by a closure of karaya and glycerol, an adhesive ring and a belt as disclosed in U.S. Patent No. 3,351,061 .

People with an ileostomy or urinary stoma usually use a permanent (ie more than 35 times) system or a semi-permanent system. This alludes to the fact that the bag that collects the 2

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the faids have a valve or other types of closure at the bottom. This allows the device to remain on the body for several days. These systems are also available either as ag- in about gregates in one or two parts.

5 The unit with only one part that can be used several times consists of a bag with a bottom valve or other closure and a permanently attached flat rubber or plastic disc.

The flat disc has a centrally located opening to the stoma and can be attached directly to the body by means of latex cement or a plate that is pressure sensitive on both sides. It is also common to attach the flat disc to the skin barrier that fits around the stoma rather than to the skin. As a further security, a belt plate with belt attachment and a molding or metal ring may be used to fit between the flat disk and the bag. After several days, the adhesive attachment between the planar disc and the body or skin barrier will weaken and the aggregate removed. The assembly is cleaned and the remaining adhesive is removed from the planar disk so that the donor can be reapplied. Eventually, with the exception of the pressure plate, the entire unit must be discarded due to erosion or odor formation in the bag.

Semi-permanent one-piece assemblies for use in conjunction with ot iloostomy histoma with a 25 karaya closure attached to the planar disc are commercially available.

The two-part multi-purpose assembly consists of a rubber flange with an opening for the stoma, which flange or adhesive is attached directly to the body or skin barrel, and with a separate bag with a bottom valve oil, other closures fitting close to the flange.

U.S. Patent No. 3,339,546 discloses a dressing having an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethyl cellulose and polyisobutylene, and a water-insoluble polyethylene film. This bandage is still used as a skin barrier by ostomates and is also available with a permanently attached flange.

3

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from.

Other commercially available skin barriers include a layer of knitted fabric or woven polyethylene long between two adhesive layers. The adhesive layers comprise a conventional pressure-sensitive adhesive and a hydrocolloid.

Other attempts have been made to develop cstomy closure discs of materials other than the karaya-glycerol gel disclosed in U.S. Patent No. 3,302,647.

Thus, U.S. Patent No. 3,612,053 discloses an ostomy sealing disc formed of an oil-stretched block copolymer with an adhesive on one surface which is activated in water. U.S. Patents 3,712,304 and 3,799,166 disclose an ostomy slug made of starch. and gelatinized starch cross-linked with glyoxal. U.S. Pat.

3,878,847 discloses a thin membrane in contact with the stoma, U.S. Patent No. 3,908,658 discloses an ostomy closure formed from a gel of mineral oil, styrene isobutylene copolymer and an ethylene / vinyl acetate copolymer, and in United States patents 3,877,431 and 3,980,084 discloses ostomiluccor formed from polymeric materials.

The present invention relates to an improved adhesive for medical purposes specially developed for use in the field of ostomy.

The adhesive according to the invention is characterized in that it comprises a substantially homogeneous mixture, 25 by weight, of 15 to 40% guar gum, locust bean gum or mixtures thereof, from 0 to 25% pectin, karaya gum or mixtures thereof, the total amount of guar gum , locust bean gum, karaya gum and pectin are from 20 to 55%; from 40 to 60% of a low molecular weight polyisobutylene mixture having a viscosity average molecular weight of 36,000-58,000 on the Flory scale, and butyl rubber having a viscosity average molecular weight of 300,000-450,000 on the Flory scale, where polyisobutylene is present a weight ratio of 3: 1 to 5: 1? and as adhesive reinforcing agent from 2 to 12% of an inactive or synthetic fibrous material or from 10 to 30% 4

DK 158768 B

of a finely divided cellulose, a finely divided, water-insoluble, cross-linked dextran, a finely divided, virtually water-insoluble, cross-linked sodium carboxymethyl cellulose or a finely divided, water-insoluble starch / α-5-crylonitrile pod copolymer.

The invention further relates to the use of the adhesive according to the invention, optionally laminated to a thin, continuous or discontinuous polymer film, as skin barrier in an ostomy device or ostomy closure disc.

The adhesive consists of a mixture of a hydrochloric rubber, a pressure-sensitive adhesive and an agent which increases the adhesive strength of the agent. Part of adhesive strengthening agent is either an inactive natural or synthetic fibrous material, a finely divided purified wood cellulose, a crosslinked dextran, a crosslinked carboxymethyl cellulose or a starch / acrylonitrile pod copolymer.

In order for the adhesive to be applied in the ostomy field, it must possess several properties. As the agent is in contact with the body around the 20 stoma, it must not contain ingredients that irritate this already sensitive skin area.

When the adhesive is used as a skin barrier, it must be able to carry the weight of the attached assembly into 6t or two pieces and yet allow,

Λ C

that the unit is removed when discarded or cleaned without removing the barrier from the skin. It is desirable, both from an economic and medical point of view, to have a skin barrier that can stay in place for a week or more.

30

The adhesive, whether used as a skin barrier, designed as closure rings or applied directly to the flat disc of a die assembly or as a flange to a two-piece assembly, can withstand erosion caused by leakage of stoma leaks. In particular, in the case of a urinary tract stoma, an ileostomy or a "wet" colostomy, the excipients are highly ethereal.

DK 158768B

5 and can erode adhesives, thereby causing the dressing to fail, and partially dissolved adhesive material may flow into the bag and block the drain valve at the bottom. Likewise, erosion of the adhesive may cause this corrosive residue to come into contact with the skin and cause severe irritation.

As discussed above, previous attempts to develop an adhesive possessing these properties included the incorporation of various hydrocolloid gum materials into the adhesive. It was believed that these hydrocolloid materials would absorb moisture such as sweat and cause the agent to be wet sticky. It was also known that the bonding strength of the adhesive was an important factor. This enhancement was achieved, as discussed above, in the presence of an outer polymer film and a knitted fabric or polyethylene fabric inserted into the adhesive.

It has been found, according to the invention, that an adhesive having such properties as long adhesion and cohesive strength can be obtained by using certain hydrocolloid gums, pressure sensitive adhesives and an adhesive strengthening agent. It has been found that certain hydrocolloid gums, although capable of absorbing surface moisture such as sweat, are in fact not suitable for use in the fabric because they swell too quickly and become a soft gelatinous mass. This swelling and loss of texture provides an adhesive that erodes and degrades.

The hydrocolloid rubber component of the adhesive must have a high ability to absorb moisture, be able to adhere 30 wetly, and must also hydrate and swell relatively slowly so that no degradation of the adhesive is induced. Guar gum, locust bean gum and mixtures thereof have proved suitable, with guar being preferred, and such gums may be present with x to 40% by weight of the adhesive.

An additional rubber material that has soothing or 6 healing properties can be included in the adhesive. Pectin, karaya gum and mixtures thereof have proved suitable, with pectin being the preferred and may be present with from 0 to 25% by weight of the adhesive, provided that the total amount of gum in the adhesive is from 20 to 55% by weight.

The pressure-sensitive adhesive component of the agent provides dry adhesion and holds the entire agent together. Suitable for this purpose are various natural or synthetic viscous substances which are either dry adhesive in themselves or develop such adhesive by the addition of a plasticizer such as natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, low molecular weight polyisobutylenes, etc. and with a viscosity average molecular weight of from 36,000 to 58,000 (Flory) is preferred. Such polyisobutylenes are commercially available under the trademark "Vistanex" from Exxon Co. in grades LM-MS and LM-MH. To increase the elasticity and tear strength of the adhesive, the polyisobutylene is blended with butyl rubber which is a copolymer of isobutylene 20 with a minor amount of a viscosity average molecular weight of from 300,000 to 450,000 (Flory) .Butyl rubber having a viscosity average molecular weight of about 425,000 (commercially available as grade 077) is preferred. which is a pressure sensitive adhesive, and the larger molecular weight butyl rubber, which is an elastomer, is used in a ratio of 3: 1 to 5: 3 by weight, with 4: 1 being the most preferred.

The adhesive strengthening agent acts in the adhesive by increasing the resistance to tearing, by reducing the tendency to erode and degrade by absorbing moisture and silently combating the swelling of the hydrocolloid rubber types and by combating seepage. Leakage is due to the cold flow of the polyisobutylene and occurs when the adhesive is stored for several months. Leakage increases when DK 1587688 /

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the adhesive is heated or irradiated with gamma rays.

Materials suitable for use as an adhesive strengthening agent include natural and synthetic inert fibrous materials such as cotton and dacron, finely divided cellulose materials including purified wood cellulose, e.g. as commercially available under the trademark "Solka-Floc" and microcrystalline cellulose as that obtained under the name "Avicel", comminuted, practically insoluble cross-linked dextran, as obtained under the trademark "Sephadex" , comminuted virtually water-insoluble crosslinked sodium carboxymethyl cellulose as available in the trade under the trademark "Acrualon" or as disclosed in United States Patent Nos. 3-o9,364 and sold by T3? e Buckeye Cellulose Ccrp. ice-taken waterless starch / acrylonitrile pod copolymer as disclosed in U.S. Patent No. 3,661,815 and sold by The Grain Processing Corp. The fibrous material is used with approx. 2 to about 12% by weight of the adhesive and cellulose, crosslinked dextran, crosslinked sodium carboxymethylcellulose or starch / acrylonitrile podeccline are used with from approx. 10 to approx.

2 C weight percent of the adhesive. Cotton and purified wood cellulose are preferred adhesive reinforcing agents.

Small quantities, ie less than 5% by weight of the adhesive of other fabrics may also be incorporated, e.g. a plasticizer such as mineral oil, an antioxidant such as butylated hydroxyanisole, a deodorizing agent or a fragrance.

The adhesive is manufactured by homogeneous dispersion 3C to the pressure sensitive adhesive and the elastomer in a heavy mixer, e.g. an alte mixer or a mixer with S-shaped leaves. The hydrocolloid rubber washers, the adhesive reinforcing agent and any other substances are added and the mixture is continued until a homogeneous dough is 35. Optionally, the elastomer is first degraded by mixing for several meters, adding an 8

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part of the pressure sensitive adhesive and other ingredients and the mixture is continued until a homogeneous mass is formed. The rest of the pressure-sensitive adhesive is then added and the mixture is continued until a homogeneous dough is formed. This dough can then be extruded and shaped as desired.

Optionally, a thin continuous or non-continuous film of polymeric material such as polyethylene, polyurethane, PVC, PVDC eto. is laminated on one side of the adhesive material as described in U.S. Patent No. 3,339,546. The film is present in a thickness of from approx. 0.025 to approx. 0.25 mm and will, of course, increase the adhesive capacity of the adhesive. The free side of the adhesive or both sides, if the film is omitted, is covered with a piece of silicone-coated paper. A flange can be attached directly to this skin barrier for use by those ostomats who prefer a two-part system.

The adhesive can also be designed so that it can be used as an ostomy closure disc.

The adhesive according to the invention, with or without the outer polymeric film layer, can also be attached to the planar disk or mounting gasket on an ostomy bag e.g. as disclosed in U.S. Patent Nos. 3,302,647 and 3,351,061, or the adhesive may be applied directly to the ostomy bag, without the outer polymeric layer, as in U.S. Patent No. 3,055,368.

The adhesive of the invention is particularly described for use in the ostomy field, but it is also useful for related medical purposes. Thus, the adhesive 30 can be used to attach various devices to the body such as a catheter, an electronic probe, a wound drain as described in United States Patent Nos. 3,568,675 and 3,954,105 or may be applied directly to a subcutaneous wound.

The adhesive of the invention can be sterilized by gamma irradiation.

Preferred adhesives of the invention include

DK 158768 B

? by weight from 2 to 12% cotton or from 10 to 30% finely divided purified wood cellulose as adhesive reinforcer, from 15 to 40% guar gum, from 0 to 25% pectin, provided that when the adhesive reinforcer is cotton / constitutes guar gum and 5 pectin together from 35 to 55%, and when the adhesive enhancer is wood cellulose, guar gum and pectin together form from 20 to approx. 45%, and from 45 to 55% of the low molecular weight polyisobutylene-butyl rubber mixture, wherein the low molecular weight polyisobutylene to butyl rubber ratio is about 10%. 4: 1 by weight.

The invention will now be further illustrated by way of example. Other suitable adhesives may be obtained from minor variations of the anverite amounts of ingredients.

15

Example 1

This example concerns the preparation of an adhesive having the following composition: 20

Bestanddel_Vægtprocent

Polyisobutylene having a viscosity average molecular weight (Flory) of 36,000 to 45,000 ("Vistanex" LM-MS from Exxon) 40 Butyl rubber with a viscosity average molecular weight (Flory) of 425.Q00 (Exxon, quality 077) 10

High-quality guar gum extra-fine powder ("Jaguar Λ-40-F" from Stein Hall Co.) 30 30 Finely purified wood cellulose ("Solka Floe BW-100" from

Brown Co.) 20 100 35 * 10 0

DK 158768B

2 kg of butylgununi break up by mixing in on knob mixer for 2-4 minutes. 4 kg of the low molecular weight polyisobutylene is added and mixed with the butyl gum for 2-4 minutes. 6 kg of guar gum and 4 kg of finely purified 5 wood cellulose are combined in a powder mixer, and the resulting powder is added to the mixture of polyisobutylene and butyl rubber. Mixing of the ingredients is continued until a homogeneous mass is formed in which the polyisobutylene and butyl rubber are completely dispersed (about 10- 10-20 minutes). The other 4 kg of low molecular weight polyisobutylene is added and the mixture is continued until a homogeneous dough is formed (about 10-20 minutes).

This dough is extruded while warm and soft and made flat. A sheet of polyethylene having a thickness of 0.04 mm is pressed over one side and silicone coated release paper on the other. The material thus produced is cut into the desired shape.

Example 2-26 20

By leaving as described in Example 1, but using the following ingredients by weight, other adhesives are prepared for use in the closure of the invention.

25 30 35 11

DK 158763 B

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DK 158768 B

t - <µ 50 C <D C s- Oø — I f-l X w X — i o) µ It o g o o cx. o ø «*> <*> <# tt o o X« «· m o o \ CJ µ f-H · -> I I · r-I CM r-l 0 <y Ai o o W T> At O —t o C t — t

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Example 27 13

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DK 158768 B

This example relates to the preparation of an adhesive having the following composition:

Bestanddel_Vægtprocent

Polyisobutylene having an average viscosity molecular weight of 36,000 to 45,000 (Flory) ("Vistanex LM-MS" from Exxon) 38.0 Butyl rubber having a viscosity average molecular weight (Flory) of 425,000 (Exxon, grade 077) 9.5

High quality extra-fine powder rubber ("Jaguar A-40-F" from Stein Hall Co.) 28.5

Pectin 19.0 15

Cotton 5.0 100.0 1.9 kg of butyl rubber is broken up by mixing in a kneader mixer for 2-4 minutes. 3.8 kg of the low molecular weight polyisobutylene is added, which is mixed with the butyl rubber for 2-4 minutes. 5.7 g of guar gum and 3.8 kg of pectin are combined in a powder mixer and the resulting powder is added to the low molecular weight polyisobutylene and butyl rubber mixture to which 1 kg of cotton is added. The mixing of the ingredients is continued until a homogeneous mass is obtained, wherein the polyisobutylene and butyl rubber are completely dispersed (about 10-20 minutes). The last 3.8 kg of low molecular weight polyisobutylene is added and the mixture is continued until a homogeneous dough is obtained (about 10-20 minutes). Add the last 3.8 kg of low molecular weight polyisobutylene and continue mixing until a homogeneous dough is formed (about 10-20 minutes).

This dough can then be extruded and laminated with a sheet of polyethylene as described in Example 1.

DK 158768 B

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Examples 28-36

By proceeding as described in Example 27, but using the following ingredients based on weight percent 5, other adhesives for use in closures of the invention can be prepared.

10 15 20 25 30 35 15

DK 158768 B

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Claims (8)

An adhesive for medical purposes, characterized in that it comprises a substantially homogeneous mixture, by weight, of 15 to 40% guar gum, locust bean gum or mixtures thereof, from 0 to 25% pectin, caraya gum or mixtures thereof, the total amount of guar gum, locust bean gum, karaya gum and pectin being from 20 to 55%; from 40 to 60% of a low molecular weight polyisobutylene mixture having a viscosity average molecular weight of 36,000-58,000 on the Flory scale and butyl rubber having a viscosity average molecular weight of 300,000-450,000 on the Flory scale including polyisobutylene in the polyisobutylene scale a weight ratio of 3: 1 to 5: 1; and as adhesive reinforcing agent from 2 to 12% of an inactive natural or synthetic fibrous material or from 10 to 30% of a finely divided cellulose, a finely divided, water-insoluble, cross-linked dextran, a finely divided, virtually water-insoluble. soluble, crosslinked sodium carboxymethyl cellulose or a finely divided, practically water-insoluble starch / acrylonitrile graft copolymer. Adhesive according to claim 1, characterized in that the adhesive reinforcing agent is made up of 2 to 12% cotton. Adhesive according to claim 2, characterized in that it comprises 15 to 40% guar gum, 0 to 25% pectin, the total amount of guar gum and pectin being 35 to 55% and 45 to 55% of the low molecular weight polyisobutylene mixture. and butyl rubber, wherein the weight ratio of polyisobutylene to butyl rubber is approx. 4: 1. Adhesive according to claim 3, characterized in that it comprises 5% cotton, 28.5% guar gum, 19% pectin and 47.5% of a 4: 1 mixture of polyisobutylene with a viscosity average molecular weight of 36,000-45,000 on the Flory-35 scale and butyl rubber with a viscosity average molecular weight of approx. 425,000 on the Flory scale. DK 158768 B 5. Adhesive according to claim 1, characterized in that the adhesive reinforcing agent consists of 10 to 30% finely divided, purified wood cellulose. Adhesive according to claim 5, characterized in that it comprises 15 to 40% guar gum, 0 to 25% pectin, the total amount of guar gum and pectin being 20 to 45% and 45 to 55% of the low polyisobutylene mixture. molecular weight and butyl rubber, wherein the weight ratio of polyisobutylene to butyl rubber is approx. 4: 1. Adhesive according to claim 6, characterized in that it comprises 20% finely divided purified wood cellulose, 30% guar gum and 50% of a 4: 1 mixture of polyisobutylene with a viscosity average molecular weight of 36,000-45,000 on the Flory scale and butyl rubber with a viscosity gene -15 leakage weight of approx. 425,000 on the Flory scale. Use of adhesive according to claim 1, optionally laminated to a thin, continuous or discontinuous polymer film, as a skin barrier in an ostomy device or ostomy closure disc.