U.S. patent number 3,908,658 [Application Number 05/388,491] was granted by the patent office on 1975-09-30 for seal and appliance for ostomy patients.
Invention is credited to Arthur E. Marsan.
United States Patent |
3,908,658 |
Marsan |
September 30, 1975 |
Seal and appliance for ostomy patients
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. (Brownsville,
TX) |
Family
ID: |
26944761 |
Appl.
No.: |
05/388,491 |
Filed: |
August 15, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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255543 |
May 22, 1972 |
3799166 |
Mar 26, 1974 |
|
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884842 |
Dec 15, 1969 |
3667469 |
Jan 6, 1972 |
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Current U.S.
Class: |
604/336 |
Current CPC
Class: |
A61F
5/443 (20130101); A61L 24/043 (20130101); A61L
24/043 (20130101); C08L 25/04 (20130101); C08L
31/04 (20130101); C08L 5/00 (20130101); A61L
24/043 (20130101); C08L 25/04 (20130101); A61L
2400/14 (20130101) |
Current International
Class: |
A61F
5/443 (20060101); A61L 24/04 (20060101); A61L
24/00 (20060101); A61f 005/44 () |
Field of
Search: |
;128/283,294,295 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Parent Case Text
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.degree. and 225.degree.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.degree.F. up to about 400.degree.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.degree.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.degree.F. The
temperature of the blend was then lowered to a temperature a little
above 200.degree.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.degree.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.degree.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.degree.F. and then lowered the temperature to about
200.degree.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.
* * * * *