Title:
Seal and appliance for ostomy patients
United States Patent 3908658


Abstract:
An appliance and sealing system for application to patients who have had surgery for colostomy, ileostomy or the like, for sealing a pouch or bag to the patient's skin around the stoma so the pouch is in position to receive discharge from the stoma. The sealing system is a mass or ring of water insoluble pressure sensitive gel-like material which adheres to both the pouch and the patient's skin. The adhesive can contain some water soluble ingredients if desired. The pressure sensitive adhesive may be made by preparing a melt mix of mineral oil, an aromatic-aliphatic polymer such as a copolymer styrene and isobutylene and a vinyl polymer such as an ethylene-vinyl acetate copolymer. The melt mix is poured into suitable molds and permitted to gel to form the seal. Both the external surface and the internal mass of the seal have properties of pressure sensitive tack, elasticity, flexibility, compressibility and kneadability. The adhesive mass can be marketed in combination with the pouch or as an individual item in the form of a ring-shaped seal having release liner on both surfaces.



Inventors:
MARSAN ARTHUR E
Application Number:
05/388491
Publication Date:
09/30/1975
Filing Date:
08/15/1973
Assignee:
MARSAN; ARTHUR E.
Primary Class:
International Classes:
A61F5/443; A61L24/04; (IPC1-7): A61F5/44
Field of Search:
128/283,294,295
View Patent Images:
US Patent References:
3799166STARCH TYPE GEL SEALS FOR OSTOMY PATIENTS1974-03-26Marsan
3712304STARCH SEAL AND APPLIANCE FOR OSTOMY1973-01-23Marsan
3667469POST-SURGICAL DRAINAGE POUCH1972-06-06Marsan
3612053OSTOMY SEALING WASHER1971-10-12Pratt
3302647Sealing pad for a post-surgical drainage pouch1967-02-07Marsan



Primary Examiner:
Truluck, Dalton L.
Parent Case Data:


CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part and improvement of my application Ser. No. 255,543 filed May 22, 1972 now Pat. No. 3,799,166 issued Mar. 26, 1974, entitled Starch-Type Gel Seals for Ostomy Patients which in turn is a continuation-in-part and improvement of my application Ser. No. 884,842 filed Dec. 15, 1969, now U.S. Pat. No. 3,667,469, issued Jan. 6, 1972.
Claims:
1. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the container, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesion gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, said gel consisting essentially of a mixture of mineral oil,

2. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the container, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesion gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, said gel consisting essentially of a mixture of mineral oil, styrene-isobutylene copolymer and ethylene-vinyl acetate copolymer,

3. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the container, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesive gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, wherein said gel comprises a mixture of a water insoluble oleaginous liquid, a normally solid water insoluble thermo-plastic tackifying aromatic-aliphatic copolymer which is miscible and compatible with said oleaginous liquid and a normally solid water insoluble thermoplastic tackifying vinyl polymer which is miscible and compatible with said liquid, said copolymers being present in amounts sufficient to

4. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the contaianer, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesive gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, wherein said gel comprise a mixture of a water insoluble oleaginous liquid, a normally solid water insoluble thermo-plastic tackifying aromatic-aliphatic copolymer which is miscible and compatible with said oleaginous liquid and a normally solid water insoluble thermo-plastic tacifying vinyl polymer which is miscible and compatible with said liquid, said copolymers being present in amounts sufficient to gel said liquid as a tacky pliable pressure sensitive adhesive mass, and wherein said aromatic-aliphatic copolymer is a styrene-isobutylene

5. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the container, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesive gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, wherein said gel comprises a mixture of a water insoluble oleaginous liquid, a normally solid water insoluble thermo-plastic tackifying aromatic-aliphatic copolymer which is miscible and compatible with said oleaginous liquid and a normally solid water insoluble thermoplastic tackifying vinyl polymer which is miscible and compatible with said liquid, said copolymers being present in amounts sufficient to gel said liquid as a tacky pliable pressure sensitive adhesive mass, and wherein said gel contains normally solid particulate water soluble

6. In an appliance for ostomy conditions and the like, a container for receiving discharged material from a patient's body, the container having a stoma receiving opening through which the stoma discharges into the container, and sealing means adhered to the container around the stoma receiving opening and projecting from the container for adhering to the patient's skin around the stoma, said sealing means being water insoluble and composed essentially of a pressure sensitive adhesive gel body having uniform surface and internal properties of tack, cohesive strength providing elasticity, flexibility, and compressibility and manual kneadability, wherein said gel consists essentially of about 12.5% by weight ethylene-vinyl acetate copolymer, about 25% by weight No. 9 USP mineral oil, about 37.5 parts by weight styrene-isobutylene copolymer and

7. A structure for use in securing a pouch having an opening to an ostomy patient with the pouch opening surrounding the patient's stoma, said structure consisting of a flat ring-shaped gelled mass of a mixture of from about 5 to about 25% ethylene-vinyl acetate copolymer, from about 10 to about 40% by weight mineral oil, from about 10 to about 50% by weight of styrene-isobutylene copolymer, from 0 to about 50% by weight of a water sensitive filler material, and from 0 to about 0.1% by weight of coloring material.

Description:
BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an improved sealing system for use with a surgical drainage pouch to receive waste discharged from a patient who has undergone such abdominal surgery as a colostomy, ileostomy, ureterostomy or the like, resulting in an opening in the abdominal wall which permits drainage from the interior of the abdominal cavity. The sealing system seals the pouch opening around the abdominal opening or stoma of the patient so that the pouch receives the discharge from the stoma.

2. Brief Description of the Prior Art

A number of ostomy sealing devices have been proposed for sealing the openings of pouches around the stoma of the patient. One problem with such seals is that some leakage from the stoma occurs between the drainage pouch and the patient's skin, causing irritation to the skin. For example, the constant flow of digestive juices on the skin can cause digestion of some of the skin, known as excoriation. Thus, it has been important to attempt to prevent the leakage between the pouch and the skin by providing a sealing system.

Probably the most important commercial sealing system heretofore provided is exemplified in my U.S. Pat. No. 3,302,647. That patent describes sealing pads or rings formed of glycerol and karaya, using a sufficient amount of karaya to gel the glycerol when mixed. This seal was the first of its type and started a new trend in post-operative care for ostomy patients.

Karaya seals have been effective for prevention of skin irritation, skin excoriation and leakage on clothing and bedding for many patients and the seals have proved to be of great benefit.

However, some problems have been reported. For example, with some patients the use of the karaya-glycerol seal has resulted in irritation, rash and itching. More important, both the karaya powder and glycerol are water soluble and the seals have exhibited a lack of durability due to seal breakdown and dissolution at a more rapid rate than desired. The dissolution results not only from aqueous liquid discharge from the body but also from water which may be present in the form of perspiration from the body. Moreover, the high cost of karaya and the relatively low durability of the seal creates an economical problem. The kayaya seals presently cost the patient from about 25 to about 50 cents each and some patients require the use of several seals every 24 hours, creating a significant financial burden to the patient.

Further, karaya gum powder is used as a substantial ingredient in such seals and since it is a natural product of exuded resin from a tree it acts as a food for bacterial growth that may become contaminated. Also, exposure to the atmosphere can contaminate the gum with impurities such as sand, dirt and bark. Additionally, as with most natural products, the properties of the karaya gum are not always uniform. Other disadvantages of karaya gum, especially when used as a major constituent of the seal, are set forth in my U.S. Pat. No. 3,712,304.

SUMMARY OF THE INVENTION

The present invention provides a new and useful sealing system for sealing a container to the skin of a patient having an ostomy condition. The seal is a pressure sensitive adhesive which is basically composed of water insoluble or hydrophobic materials to provide a water insoluble seal, although hydrophilic agents can be added to the seal composition in varying predetermined amounts so as to provide a predetermined controlled rate or degree of solubility of the hydrophilic components. This controlled solubility can be desirable, for example, for releasing medicinal materials or the like from the seal into the area of the stoma.

The total mass of the seal, including both the external surface and the internal mass, has excellent properties of pressure-sensitive tack, elasticity, flexibility, compressibility and kneadability.

In a specific preferred form, the pressure sensitive adhesive seal is prepared as a melt mixture of mineral oil, styrene-isobutylene copolymer, and ethylene-vinyl acetate copolymer. The pressure-sensitive adhesive mass is usually provided in the form of a flat ring-shaped seal for surrounding the stoma and the opening to the pouch or other container.

While this invention is susceptible of an embodiment in many different forms, there is shown in the drawings and will herein be described in detail a specific embodiment and modification thereof, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiment illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary view of the abdominal section of the human torso showing post-surgical drainage pouch in use;

FIG. 2 is an enlarged face view of the back panel of the drainage pouch of FIG. 1 showing a form of sealing ring of this invention for sealing the pouch to the patient's body;

FIG. 3 is a section along line 3--3 of FIG. 2; and

FIG. 4 is a perspective view of a sealing ring of this invention prior to assembly with the pouch.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, in FIG. 1 there is shown a post-surgical drainage pouch or bag 10 secured to the torso 12 of a patient by means of a belt 14. As seen in FIG. 2 the bag 10 has an opening 16 for receiving the stoma of the patient. A rigid plastic support ring 18 (FIGS. 2 and 3) surrounds opening 16 and is secured to the back panel of the bag 10. A sealing pad or gasket 20 is secured to ring 18 and to the back panel of bag 10 around opening 16 for sealing the bag to the patient's skin.

Referring now to FIG. 4, the sealing gasket 20 can be prepared separately from the bag and distributed in the form of an assembly including the gasket 20 with its opposing faces covered by release liners 22 and 24 to protect the gasket 20 from adhesion to foreign substances during storage and distribution. One of the release liners 22 can be removed for securing the gasket 20 to the bag 10 and the other release liner 24 can then be removed to secure the gasket 20 to the patient's skin. Alternatively, the gasket 20 can be molded directly on the ring 18 and back panel of bag 10 in the position shown in FIGS. 2 and 3 and one release liner 24 can be applied to the exposed surface of the gasket 20.

The gasket 20 is advantageously a pressure-sensitive mass having a composition of mineral oil, a thermoplastic aromatic-aliphatic polymer such as styrene-isobutylene copolymer and a thermoplastic vinyl polymer such as ethylene-vinyl acetate copolymer. The composition can be prepared by blending the three ingredients at a temperature above the melt temperatures of the copolymers. The melt mixture can then be poured into suitable molds or molded directly on the back panel of bag 10 as indicated above. All three ingredients are water insoluble, as in the molded gasket. Thus, the basic composition is hydrophobic, although it is intended that hydrophilic agents can be included in the composition so as to provide that a predetermined controlled rate of solubility of the hydrophilic components where desired. For example, where it is desired for the composition to slowly release a medicinal material a hydrophilic medicinal material may be included.

In an advantageous form, starch, such as pregelatinized starch, which is hydrophilic, is included in the composition for a number of reasons. The starch can function as an extender, thereby replacing some of the more expensive polymers used in the composition. The starch can also function as a filler to give the composition additional strength where desired. The preferred basic material made from the mineral oil and two copolymers is fairly clear in its appearance, i.e., transparent to translucent and the starch, which is white and has a high degree of absorbency when present in the composition, permits ready visual detection of discharge leakage between the seal and the patient's skin. The starch also tends to absorb discharge fluids which may otherwise irritate the skin in the stoma area.

Both the vinyl copolymer and the aromatic-aliphatic copolymer are thermo-plastic so that the composition can be easily manufactured by heating the mineral oil to a temperature above the melting temperatures of the polymers and then adding and blending the polymers. The polymers exhibit appreciable tack when dissolved in the oil. As the vinyl polymer, I have used ethylene-vinyl acetate copolymer and I prefer those materials marketed by E. I. DuPont De Nemours & Co. under the trade name Elvax. As the aromatic-aliphatic polymer, I have used styrene-isobutylene copolymer and I prefer those materials marketed by Velsicol Chemical Corporation under the trade name Klyrvel. Reference is made to Shenfeld et al in U.S. Pat. No. 3,644,252 issued Feb. 222, 1972.

The Klyrvel polymers are commonly referred to simply as aromatic-aliphatic polymers and usually have number average molecular weight between about 1000 and 6000, depending upon the method used for determination, i.e., 1000 to 3000 by the Vapor Phase Osmometry Method and 3000 to 6000 by the Gel Permeation Chromatograph Method (standardized against polystyrene). The weight average molecular weight by this latter method is usually within the range of about 6000 to 12000. The copolymers are random copolymers and have ball and ring softening points between about 125° and 225°F. Further information can be obtained from suppliers of such materials.

The Elvax resins vary in their vinyl acetate unit content between about 10 and 50% and have ring and ball softening points ranging as low as about 175°F. up to about 400°F.

In my preferred compositions, I use from about 5 to about 25% of the vinyl polymer, from about 10 to about 40% mineral oil, and from about 10 to about 50% of the aromatic-aliphatic copolymer. Also, up to 50% of water sensitive compounds can be used and up to about 0.1% FD and C coloring agents are usually included, each based on weight of the total composition. Especially preferred compositions can contain more than 20% and often at least 25% mineral oil based on total composition weight.

The following examples are offered as illustrations of the practice of the present invention and are not intended to limit the invention in any manner.

EXAMPLE I

200 grams of Chevron No. 9 U.S.P. mineral oil were heated to 325°F. and 100 grams of Elvax 250 (an ethylene-vinyl acetate copolymer containing from about 27.2 to 28.8% vinyl acetate) were added while stirring until the Elvax dissolved. Then 300 grams of Klyrvel 90 (a copolymer of styrene and isobutylene containing 90% styrene and 10% isobutylene units) were added and stirring was continued until the Klyrvel dissolved. The molten mixture was then poured into ring-shaped molds and permitted to solidify. Alternatively, the molten mixture can be cast into sheets and then die cut to desired shape. The ring-shaped seals were removed from the molds and immersed in water for seven days to test their durability against aqueous fluids. No change in their shape or weight was noted. The seals exhibited excellent flexibility, elastibility, compressibility and pressure sensitive adhesive qualities of tackiness both before and after the seven day immersion.

Hydrophilic agents can be added to the composition where desired. For example, by adding a water sensitive gelling agent such as pregelatinized starch to the mixture in variable amounts, seals were made having variable controlled degrees of solubility in water. In working with such seals I have used two different starches and both have been acceptable. These starches are Snowflake Instant Stabilizer B919 Starch made by Corn Industrial Division of Corn Products Company, and experimental product F4-246 Starch, a cold water swelling tapioca starch made by A. D. Staley Manufacturing Company. The F4-246 starch had a moisture content of only 5% while the B191 starch had a higher moisture content of 9% so that the F4-246 starch produced less foaming action due to water vaporization in the high temperature blending process and as a result it was easier to work with.

EXAMPLE II

100 grams of Elvax 250, 200 grams of heavy mineral oil and 300 grams of Klyrvel 90 were blended at about 300°F. The temperature of the blend was then lowered to a temperature a little above 200°C. and 200 grams of pregelatinized starch were added while stirring. The hot mixture was then poured into ring-shaped molds and permitted to gel to form ring-like seals. When immersed in water over an extended period of time, these seals slowly release the pregelatinized starch although the seals retain their shape, flexibility, elasticity, compressibility and pressure sensitive adhesive qualities.

Other water sensitive agents can be used as a substitute for the pregelatinized starch. Such water sensitive agents can be either organic or inorganic and can be either natural or synthetic. Examples include the natural gum such as karaya, tragacanth, gelatin, arabic, pectin, guar, algin, and the various alginates as well as their alkali metal salts. Examples of synthetic materials are carboxymethylcellulose, polyvinyl alcohol, dextrin and other modified starches, hydroxy-ethylene oxide, polyvinyl methyl ether and the like. Inorganic water sensitive agents include clays such as kaolin and bentonite.

Due to irregularities of size and shape of the stoma, creases or folds in the abdominal wall, or scar tissue, is often desirable to use a sealing material that can be kneaded by squeezing with the fingers into a specific shape, like a putty for the purpose of filling voids. I have found that such a putty can be made by modifying the formula of Example II simply by substituting an ethylene-vinyl acetate copolymer containing a lower percentage of vinyl acetate units. Accordingly, I have prepared the following example:

EXAMPLE III

100 grams of Elvax 120 (having from about 17.5 to about 18.5% vinyl acetate units), 200 grams of heavy mineral oil and 300 grams of Klyrvel 90 were blended at about 300°F. The temperature was then lowered as in Example II and 200 grams of pregelatinized starch were added. The mix was permitted to cool and it gelled to putty-like consistance and except for the putty-like consistancy its properties were approximately the same as those of the composition of Example II.

I have made other modifications in the basic formulations for the purpose of altering properties. For example, by increasing the proportion of mineral oil in the composition, I have found that the seal becomes softer and more tacky. Such a seal was made by the following example:

EXAMPLE IV

100 grams of Elvax 250, 250 grams of heavy mineral oil and 300 grams of Klyrvel 90 were mixed and blended in accordance with the procedure of Example II. After cooling to about 200°F. 200 grams of pregelatinized starch and 0.4 grams of B-3014 FD and C yellow No. 5 Lakolene were added. The composition was poured into seal molds. The resulting seals were more tacky than those of Examples I through III and were preferred for use by some patients.

In other modifications of the seal I have prepared seals of varying colors using oil soluble dyes or mineral pigments which are approved for use in cosmetics. Such coloring ingredients include titanium dioxide, zinc oxide, ferric oxide, starch adn pregelatinized starch tinted with food coloring. Other acceptable coloring agents include FD and C yellow No. 5 Lakolene, FD and C red No. 3 Aluminum Lake, FD and C yellow No. 6 Lakolene, FD and C violet No. 1 Lakolene, FD and C blue No. 1 Lakolene and FD and C red No. 2 Lakolene. The different coloring agents are useful in identifying different formulations of seals. They are also useful in identifying and differentiating seals to be supplied to different distributors.

EXAMPLE V

As an example of a colored seal I blended 300 grams of Elvax 250, 750 grams of mineral oil and 90 grams of Klyrvel 90 at about 300°F. and then lowered the temperature to about 200°F. whereupon I added 600 grams of f4-246 Staley pregelatinized starch and 0.13 grams of B-3012 FD and C red No. 3 aluminum lake. When molded to ring shape the composition produced very pleasantly colored pink seals.

It is also contemplated that medicinal ingredients can be added to the compositions to aid in healing excoriated skin. Such medicinal ingredients are well known to the art, but exemplary are zinc oxide, aluminum hydroxide, hexachloraphene, nystatin, aluminum stearate, cortisone acetate, precipitated sulfur, zinc stearate, allantoin, stearic acid and sodium stearate. Emolients and other functional ingredients are also contemplated.

The seals of the present invention are a homogeneous mass of pressure sensitive adhesive material having uniform properties throughout. In general, the seal composition will include from 50 to 100% hydrophobic material and from 0 to 50% hydrophilic material. These materials can be proportioned so as to provide a predetermined controlled rate and degree of solubility of the hydrophilic components while still leaving a hydrophobic structure and not detracting from the adhesiveness or other properties of that structure, even after several days immersion in water.

Another important feature of the seals provided by the present invention is that body heat increases the aggressiveness of the tacky surface and causes tighter adhesion. The same tackiness or pressure sensitive quality enables the seal to be easily attached to a plastic drainage pouch surrounding the stoma receiving opening. Thus, only one adhesive composition provides good adherence to both types of surfaces having markedly different surface properties. In the form of the invention wherein the seal is formed by pouring the hot mixture directly onto the drainage pouch around the drainage pouch opening, it has been found that the resulting bond has greater strength than the polyethylene film which the pouch is made and pulling on the seal will tear the pouch before the seal breaks adhesion with the pouch.

All percentages given herein are percentages by weight unless otherwise indicated.