CA1187231A

CA1187231A - Stoma seal adhesive

Info

Publication number: CA1187231A
Application number: CA000398375A
Authority: CA
Inventors: Donald F. Doehnert; Arthur S. Hill
Original assignee: Johnson and Johnson Products Inc
Current assignee: Johnson and Johnson Hospital Services Inc
Priority date: 1981-03-16
Filing date: 1982-03-15
Publication date: 1985-05-14
Also published as: ZA821730B; JPS57168970A; DE3209374A1; BR8201392A; JPH0216786B2; AU8154382A; IN155486B; MX173767B; ES8305815A1; MX161551A; PH16755A; ATA102282A; GR76361B; IT8247976A0; FR2501707A1; FR2501707B1; AU554204B2; AT392796B; GB2094809A; ES510450A0

Abstract

ABSTRACT OF THE DISCLOSURE

A pressure sensitive adhesive having the capacity to absorb from about 15 to about 40 percent of its weight in water that has a desirable combination of plasticity and wet-stick characteristics, as well as good dry skin adhesion, and is particularly suitable for use as a stoma seal adhesive, is disclosed. The adhesive composition comprises (I) from about 30 to about 80 parts by weight each of (a) a pressure sensitive adhesive component comprising a synthetic or natural gum-like substance and (b) a moisture absorbing component comprising a synthetic carbohydrate or natural water soluble or swellable hydrocolloid together with (II) from about 2 to about 20 percent by weight, based on the total weight of the adhesive composition, of silica.

Description

~87%3~ J&J 10~4 STOMA SEAL AD~ESIVE

BACKGROUND OF T~E INVENTION

1. Field of ~he Invention This invention relates to pressure-sensitive adhesives having the capacity to absorb moisture and therefore adhere to moist body surfaces for a prolonged period of time. More particularly, this invention relates to an improvement in ~uch adhesives which affords them a combination of high plasticity and "wet-stick~ adhesion at accepta~le levels of moisture absorption over prolonged periods of time, which renders the adhesive particularly suitable for such applications as stoma seal adhesives.
This invention also re~ates to surgical sheet materials such as adhesive tapes and to adhesive bandages and dressings, including plasters that are particularly suitable for use in connection with o~tomy appliances as well as for coverings for cuts, abrasions and the like, ~0 which comprise a flexible backing member, one of whose major surface~ has adhered thereto a coating of a pressure-sensitive adhesive of the present inventionO

Various types of pressure-sensitive adhesives have been proposed and utilized as the adhesive component in adhesive bandages, adhesive tapes and the like. Acrylate polymers, polyolefinic polymers and compounded systems based on natural or synthetic rubber polymers have all been tried or utilized as pressure-sensitive adhesives with varying degrees of success.

A pressure-sensitive adhesive must have certain characteristics to be useful. It must be sufficiently tacky, i.e., have sufficient "grab" or quick-stick," to adhere quickly to the surface to which it is to be adhered. It must also continue to adhere to that surface 1~723~

over e~tended periods of time~ A pressure-sensitive adhesive composition should also have sufficient internal strength to prevent splitting and leaving particles of adhesive on a surface to which an article coated with the adhesive has been adhered when the article is removed.
Where the pressure-sensitive adhesive is designed for application to the skin, the problems of adherence are substantially increased. Although the initial tack or ~tick may be good, adherence over an extended period of time for many pressure-sensitive adhesives requires relatively high shear adhesion to withstand movement of the underlying skin. Also, the adhesive must be tailored to accommodate the nature of the underlying skin surface, as where perspiration and other surface changes may occur.
The problem is further complicated by the fact that any pressure-sensitive adhesive designed for application to the skin must release from the skin sufficiently readily to permit removal without skin damage. Where the adhesive is too strongly adhered to the skin and has substantial internal strength, small particles of the upper layer of skin are removed with the adhesive with resulting irrita-tion to the skin. As a result, although many pressure-sensitive adhesives are available for various commercial uses, relatively few have been found which are suitable for articles for skin applications~ particular in tha~
many of those having desirable, high sheer adhesion, have an undesirably high resistance to removal, or peel adhesion. This problem is further complicated when the adhesive is intended in such applications as those involving ostomy appliances, where it is required to maintain adhesion for prolonged periods of time while in contact with body fluids, and at the same time to prevent leaka~e o such fluids therethrough.

A colostomy is tlle surgical creation of a new opening for the colon on the surface of the body, while an ileostomy ~372~3~

is the surgical creation of an opening for the ileum. In an ileostomy the entire colon, the rectum, and sometimes a small portion of the ileum, is removed. In a colostomy the rectum, and sometimes a portion o~ the colon, is removed.

Both ileostomy and colostomy operations involve the crea tion of an artiEicial opening (stoma) in the abdomen to which the distal end of the healthy intestine is attached.
Generally, the stoma is placed low on the abdomen and to one side. A related enterostomy for which the stoma seal adhesive of the present invention might be useful is the urinary diversion. It involves the formation of a permanent fistula through which the ureter may discharge its contents.

As a result of the ostomy procedure, means must be pro-vided for conveniently and hygenically collecting human waste material from the resulting stoma. While there are many such ostomy appliances, a common problem experiences with them, as indicated above, is the establishment and maintenance of both good skin adhesion and an adequate seal to prevent waste material coming in contact with the patient's skin. This requires, inter alia, an adhesive material that has good adhesion to both dry and wet skin, adequate moisture absorptivity and sufficient elastic modulus or plasticity to prevent either inadvertent detachment from wet skin or inordinate difficulty or discomfort to the user when the device i5 intentionally removed.

2. Description of the Prior Ar_ U.S. Patent No. 3,339,546, issued September 5, 1967, to Chen, discloses an adhesive composition, that is a blend of a wat2r soluble or swellable hydrocolloid admixed with ~3723~

a water insoluble viscous gum-like elastomer binder, that has been found useful for ostomy appliances.

U.S. Patent No. 3~925,271, issued December 9, 1975, to Balinth, discloses an uncured pressure-sensitive adhesive that does not have moisture absorbing properties compris-ing an uncured elastomer, a tackifier and at least 1~ by weight of silica. The silica is disclosed to provide the adhesive composition with improved tack and holding power at moderately high temperatures, particularly when in contact with metal surfaces. The adhesive is said to be particularly suited to be used on tapes for joining and sealing together sections of metal ventilating ducts, and the electrical insulation of fractional horsepower elec-trical motors. This patent also refers to U.S. PatentNo. 2,909,278 as disclosing the inclusion of small amounts of silica in a pressure-sensitive adhesive composition comprising an elastomer and a tacki~ier in order to improve the aging characteristics of pressure-sensitive adhesi~e tape.

U.K. Patent Application Publication G~ 2038661A ~iled November 20, 1978 as Application No. 7845281 and published July 30, 1980, entitled "Surgical Sealant Composition", is concerned with providing material for effecting a seal around a surgically created stoma. The adhesive sealing composition of the invention described and claimed in this British application comprises 100 parts by weight of a non-biodegradable, tacky polymeric binding agent--such as polyisoprene, polyurethane, silicone or polyisobutylene--preferably polyisobutylene, VISTANEX LM/MS (trade mark) by Esso Chemicals being particularly preferred, from 12 to 25 parts by weight of an inert reinforcing filler--the only disclosed examples of suitable material being preci-pitated o~ fume silica, a particularly preferred examplebeing AEROSIL 200V, (trade mark), a form of fume silica ' ~'f ~L~L87;~3~iL

sold by Degussa, and from 5 to 150 parts by weight of a wa~er-activated adhesive thickener--the only disclosed suitable example being a polyacrylamide, preferably that sold by Cyanamid under the trade mark CYANOMER P250 S

Another recent patent that addresses the problem o~
providing adequate sealing for ostomy devices and contains a discussion of the prior art at columns 2 and 3 is U.S.
Patent No. 4,231,369, issued November 4, 1980, to Sorensen et al. That patent is directed to the use, as ostomy sealing means, of a shaped, gel-like composition compri-sing a selected cross-linked elastomer, a hydrocolloid dispersed therein, and a hydrocarbon tackifier.

lS SUMMARY OF THE INVENTION

We have discovered, quite unexpectedly, that the addition of from about 2 to about 20~ by weight, based on the total weight of the adhesive composition, of silica to a blend of from about 30 to about 80 parts by weight of a pressure sensitive adhesive component that is a gum-like substance and from about 30 to about 80 parts by weight of a moisture absorbing component that is a water soluble or swellable synthetic hydrocarbon or natural hydrocolloid provides significantly improved plasticity to the resulting adhesive composition while maintaining good "wet stick" and "dry-stick" characteristics, thereby 2roviding a highly desirable adhesive for stoma seal and similar uses.
DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general, the pressure-sensitive adhesive compositions o~ this invention comprise a pressure-sensitive adhesive component selected ~rom the natural and synthetic gum-like substances, including natural and synthetic elastomers, a -Z3~

moisture absorbing componen~ selected from the synthetic carbohydrate and natural water swellable and water soluble hydrocolloids, and silica. Each of the pressure-sensitive adhesive component and the moisture absorbing component is present in the composition of the invention in an amount of from about 30 to about 80 parts by weight, preferably from about 40 to about 60 parts by weight, while the silica is present in an amount of from aout 2 to about 20 ~eight percent, preferably from about 5 to about 12 weight percent, based on the total weight of the adhesive composition.

Generally the silica should be of a sufficiently small particle size to provide a surface area of at least 130 square meters per gram. Particles having an ultimate particle size of less than 0.03 microns are desirable, while those having an ultimate particle size in the range of 0.020 to 0.030 microns are preferred.

As used herein, the term silica is meant to describe a material having a composition which comprises Sio2 as the major component, usually greater than 80%~ It is recognized in the art that silica, however obtained, whether from fumed silica, precipitated silica or natural mined silica, will contain various amounts of other metal oxides such as magnesium oxide, together with some water of crystallization, varying amounts of which can be driven off upon ignition. The presence of these impurities does not alter the properties imparted to the adhesive composition in any observable way. However, to insure uniEormity of product, the commercially available silica HI-SIL 233 (trade mark) manufactured by PPG, Pittsburgh, Pennsylvania, is preferred.

Suitable natural and synthetic gum-like substances which may be used singly or in admixture as the pressure-~q ~

723~

sensitive adhesive eomponent in the adhesive eompositionso~ this invention inelude natural rubber, silieone rubber, acrylonitrile rubber, polyurethane rubber, polyiso-butylene, acrylie polymers and other like substances.
Particularly preferred are the polyisobutylenes tsuch as those supplied commercially by Exxon as VISTANEX L100 and VIST~NEX LM-MH) and aerylie polymers (sueh as Acrylate QR667 (trade mark) from Rohm & Haas~. The gum-like substanee acts as a binder for the hydroeolloid partieles and, in addition, renders the final bonding composition elastie and pliable.

Suitable synthetie earbohydrate and natural water s~ell-able or soluble hydroeolloids for use, singly or in admixture, as the moisture absorbing eomponent inelude karaya gum, locust bean gum, sodium acrylates, polyvinyl-alcohol, powdered peetin, gelatin, carboxymethylcellulose, high moleeular weight earbowax, earboxypolymethylene and other like substances.
If desired, the pressure-sensitive adhesive eompositions of the present invention can inelude from 0 to about 10%
by weight of the usual modifiers, fillers, extenders, taekifiers, antioxidants, stabilizers, plastieizers, and other sueh ingredients known in the art for inelusion in such compositions. Thus, for e~ample, plastieizers or solvents, such as mineral oil or petrolatum may be added to improve adhesive charaeteristies and/or to provide the desired consisteney. Particularly when the gum-like substance eo~prises a polyisobutylene, a low moleeular weight polybutene (sueh as VISTAC 300 (trade mark) from Exxon) may be ineluded as a taekifier. The extenders can inelude finely divided clays, bentonites, carbonates sueh as ealeium carbonate, diatomaeeous earth, starehes or other inert inyredients normally used in adhesive com-positions. Antioxidants and stabilizers can be utilized at levels of -F~

2~

from about 0.2% to about 3% by wei~ht of the total compo-sition, preferably from about 1% to about 2~. Suitable antioxidants and stabilizers include butyl zimate;
2,6,ditert.-butyl-4 methyl phenol, sold under the trade-mark Ionol by Shell Chemical Company; 2,5-di(tertamyl)-hydroquinone, sold under the trademark Santowar A by Monsanto Chemical Company; a mixture of alkylated diphenyl-amines sold under the trademark Agerite Stalite by Vanderbilt Chemical Company, and the like. These stabilizers and antioxidants give improved shelf life characteristics and prevent degradation of the pressure-sensitive adhesive compositions of the present invention.

It has further been found that to obtain pressure-sensitive adhesive compositions with the desired charac-teristic~, it is necessary for such compositions to have a Williams plasticity measurement of from about 2 mm to about 4 mm, preferably about 2.3 mm to about 2.7 mm. If the Williams plasticity is below 2 mm, the adhesive compositions will be too soft and exhibit undesirable flow, and have an undesirably high tendency to leave particles of adhesive adhered to the skin upon removal. If the Williams plasticity is above 4 mm, the adhesive compositions will be too hard and exhibit poor tackiness.
In addition to the use of the adhesive compositions of this invention by themselves, very satisfactory surgical sheet materials are obtained when a thinr pliable substrate has coated on one side thereof a layer of an adhesive bonding composition of this invention. Suitable substrates which may be employed in the practice of this invention include various papers, woven and non-woven fabrics, such as cellulose acetate cloth, polymeric films prepared from such materials as polyethylene polymers, polypropylene, copolymers of vinylidene chloride, fluorohalocarbon film, condensation products of ethylene

3~
g glycol and terephthalic acid, polyamide films and other like flexible sheet materials.

In the preparation oE pressure-sensitive surgical shee~
materials for application to the skin, such as pressure-sensitive adhesive tapes, adhesive bandages, surgical drapes, and the like, the pressure-sensitive adhesive compositions of the present invention are coated onto a flexible backing material in accordance with known techniques, such as calendering, extrusion, deposition using organic media, and the like.

The film or other substrate which may be employed in the practice o~ this invention may have a thickness of from 0.0005 inch to 0.05 inch, more preferably from 0.0005 to 0.002 inch. The adhesive composition is applied to a surface of the ilm in sufficient amount to afford adequate adhesion in use.

EXAMPLES

Specific embodiments of the present invention are illustrated by the following examples. It will be understood, ho~rever, that the present invention is not confined to the specific limitations set forth in the individual examples, but rather to the scope of the appended claims.

Example 1 A pressure-sensitive adhesive composition was prepared on a two roll laboratory mill at a temperatures of about 240F as follows: 510 grams of polyisobutylene were mixed for 10 minutes. Next, 300 grams of carboxymethylcellu-lose, 200 grams of karaya gum and 100 grams of silica were blended as dry powders and slowly sprinkled onto the L87~3~

mill over about 10 minutes and mixing continued for an additional 15 minutes. 90 grams of li.quid polybutene were then slowly poured onto the adhesive and milled until uniform in appearance.

The adhesive composition was then pressed into 4 inch square wafers, 60 mils thick, and tested for wet stick, moisture absorption and adhesive properties.

Examples 2-8 _ Following the procedure of Example 1, pressure-sensitive adhesive compositions illustrative of the present invention were prepared, having the compositions shown in the following table:

Example No. 2 3 4 5 6 7 8 Rlastomer Polyisobutylene 530 200 - - 600 510 510 Acrylate copolymer - 400 600 600 - - -Polybutene 70 - ~ - - 90 70 Hydrocolloid Carboxymethylcellulose 180 350 350 - 300 300 300 300aya Gum - 150 150 - 200 200 Gelatin 175 - - 100 - - 100 Pectin 175 - - 100 - - 100 Silica 70 100 100 100100 100 100 As will be apparent to those skilled in the art, and as indicated above, many modifications and variations of the foregoing detailed description are possible within the spirit and scope of the present invention.

~l~8723iL

Having thus described our invention, what we desire to secure by Letters Patent is defined in the appended claims.

Claims

The embodiments of the invention in which an exclu-sive property or privilege is claimed are defined as follows:

1. A pressure-sensitive adhesive composition having the capacity to absorb from about 15 to about 40% of its own weight in water comprising:

(a) from about 30 to about 80 parts by weight of a pressure-sensitive adhesive component selected from the group consisting of natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, polyisobutylene and acrylic polymers;

(b) from about 30 to about 80 parts by weight of a moisture absorbing component selected from the group consisting of karaya gum, locust bean gum, sodium acrylates, polyvinylalcohol, powdered pectin, gelatin, carboxymethylcellulose, high molecular weight carbowax, and carboxypolymethylene; and (c) from about 2% to about 20% by weight based on the total weight of said adhesive composition of silica.

2. The composition of claim 1 wherein the silica is present in an amount of from about 4 to about 12% by weight.

3. The composition of claim 1 wherein the adhesive component is selected from polyisobutylene and acrylic polymers.

4. The composition of claim 1 wherein the moisture absorbing component is selected from carboxymethylecellu-lose, karaya gum, pectin and gelatin.

5. The composition of claim 1 which comprises from about 40 to about 60 parts by weight of each of said adhesive component and said moisture absorbing component.

6. The composition of claim 5 wherein the adhesive component is polyisobutylene and the moisture absorbing component comprises carboxymethylcellulose and karaya gum.

7. The composition of claim 5 wherein the adhesive component is a blend of polyisobutylene and an acrylate copolymer and the moisture absorbing component comprises carboxymethylcellulose, gelatin and pectin.

8. The composition of claim 6 further comprising polybutene.

9. A pressure-sensitive surgical sheet material comprising a thin pliable substrate bearing on at least one surface thereof the composition of claim 1.