U.S. patent number 3,876,771 [Application Number 05/394,061] was granted by the patent office on 1975-04-08 for skin protective gel containing polyvinyl methylether or monoisopropyl ester of polyvinyl methylether maleic acid.
This patent grant is currently assigned to Hallister Incorporated. Invention is credited to Wilhelm G. Denner.
United States Patent |
3,876,771 |
Denner |
April 8, 1975 |
**Please see images for:
( Certificate of Correction ) ** |
SKIN PROTECTIVE GEL CONTAINING POLYVINYL METHYLETHER OR
MONOISOPROPYL ESTER OF POLYVINYL METHYLETHER MALEIC ACID
Abstract
The present invention provides a protective skin coating
material in the form of a gel primarily intended for use in
combination with ostomy appliances and the like. The gelatinous
material is made up of a film-forming protective colloidal material
in combination with a solvent and a gelling agent.
Inventors: |
Denner; Wilhelm G. (Chicago,
IL) |
Assignee: |
Hallister Incorporated
(Chicago, IL)
|
Family
ID: |
23557393 |
Appl.
No.: |
05/394,061 |
Filed: |
September 4, 1973 |
Current U.S.
Class: |
424/78.05;
424/78.02; 424/78.06; 514/781 |
Current CPC
Class: |
A61L
24/043 (20130101); A61L 24/043 (20130101); C08L
29/10 (20130101); C08L 39/06 (20130101); C08L
35/08 (20130101); C08L 33/02 (20130101); C08L
1/28 (20130101); A61L 24/043 (20130101); C08L
29/10 (20130101); A61L 2400/14 (20130101) |
Current International
Class: |
A61L
24/04 (20060101); A61L 24/00 (20060101); A61k
009/00 () |
Field of
Search: |
;424/78,80,81,362
;252/316 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Friedman; Stanley J.
Assistant Examiner: Clarke; Vera C.
Attorney, Agent or Firm: Hofgren, Wegner, Allen, Stellman
& McCord
Claims
I claim:
1. A gelatinous mixture for application to human skin,
comprising:
25 to 90% by weight of isopropanol,
0.1 to 5% by weight of a preservative selected from the group
consisting of sorbic acid, butyl para-hydroxybenzoate and methyl
para-hydroxybenzoate,
0 to 50% by weight of polyvinyl pyrrolidone,
5 to 50% by weight of a film forming agent selected from the group
consisting of monoisopropyl ester of polyvinyl methylether and
polyvinyl methylether, and
1.5 to 5% by weight of a gelling agent selected from the group
consisting of hydroxypropyl cellulose and water-soluble polyacrylic
acid crosslinked with 1% of polyallyl sucrose having an average of
about 5.8 allyl groups for each sucrose molecule.
2. A gelatinous mixture for application to human skin,
comprising:
25 to 90% by weight of isopropanol,
0.1 to 5% by weight of a preservative selected from the group
consisting of sorbic acid, butyl para-hydroxybenzoate and methyl
para-hydroxybenzoate,
0 to 5% by weight of polyvinyl pyrrolidone,
5 to 50% by weight of a film forming agent selected from the group
consisting of monoisopropyl ester of polyvinyl methylether and
polyvinyl methylether,
1.96 to 3% by weight of water-soluble polyacrylic acid crosslinked
with 1% of polyallyl sucrose having an average of about 5.8 allyl
groups for each sucrose molecule.
2 to 3% by weight of polyoxyethylene cocoamine having 15 oxy
groups.
3. A gelatinous mixture for application to human skin,
comprising:
63 to 80% by weight of isopropanol,
0.1 to 5% by weight of a preservative selected from the group
consisting of butyl para-hydroxybenzoate and methyl
para-hydroxybenzoate
1.0 to 5% by weight of polyvinyl pyrrolidone,
31 to 50% by weight of polyvinyl methylether,
2 to 3% by weight of water-soluble polyacrylic acid crosslinked
with 1% of polyallyl sucrose having an average of about 5.8 allyl
groups for each sucrose molecule, and
2.0 to 3% by weight of polyoxyethylene having 15 oxy groups
cocoamine.
4. A gelatinous mixture for application to human skin,
comprising:
25 to 90% by weight of isopropanol,
0.1 to 0.4% by weight of sorbic acid,
0 to 2% by weight of polyvinyl pyrrolidone,
5 to 20% by weight of water,
5 to 45% by weight of monoisopropyl ester of polyvinyl methylether,
and
2 to 10% by weight of hydroxypropyl cellulose.
5. A gelatinous mixture for application to human skin,
comprising:
63% by weight of isopropanol,
less than 5% by weight of methyl para-hydroxybenzoate and butyl
para-hydroxybenzoate
1.0% by weight of polyvinyl pyrrolidone,
31% by weight of polyvinyl methylether,
2% by weight of water-soluble polyacrylic acid crosslinked with 1%
of polyallyl sucrose having an average of about 5.8 allyl groups
for each sucrose molecule, and
2% by weight of polyoxyethylene cocoamine having 15 oxy groups.
6. A gelatinous mixture for application to human skin,
comprising:
80% by weight of isopropylalcohol,
less than 0.4% by weight of sorbic acid,
1% by weight of polyvinyl pyrrolidone,
5% by weight of distilled water,
5% by weight of hydroxypropyl cellulose, and
9% by weight of monoisopropyl ester of polyvinyl methylether.
Description
BACKGROUND OF THE INVENTION
Surgical correction of intestinal disorders is becoming a common
practice. Where the colon is damaged or infected, a portion or even
all of the large intestine may be removed (colostomy), and the new
terminus of the intestinal tract is led out through an opening made
in the abdominal wall to form a stoma. Where the disturbance is in
the small intestine or extends into the small intestine, the same
technique may be employed and the operation in this instance is
called an ileostomy. In the case of a colostomy, the waste material
discharged from the stoma is generally noncorrosive and appliances,
often referred to as ostomy appliances, are employed to collect and
retain the discharged waste material for subsequent disposal. In
the case of an ileostomy, the material discharged may still be
incompletely digested and the discharge may include a significant
amount of gastric juices which are still active and will attack the
skin of the patient if allowed to come in contact therewith. Again,
ostomy appliances are worn by the patient to collect the waste
discharged from the ileostomy stoma, but care must be taken to
effect a proper seal around the stoma not only to prevent soiling
of the clothes of the wearer and the escape of unpleasant odors,
problems common to both colostomy and ileostomy patients, but also
to prevent the still active gastric juices from coming in contact
with and damaging the skin.
As a consequence of the foregoing, ostomy appliances have been
provided with an adhesive face adapted to adhere to the skin
surrounding the stoma, and in some cases have used a gum karaya
seal such as the seal shown and described in U.S. Pat. No.
3,302,647. In all cases, a bag or other container is provided in
conjunction with the sealing means in order to collect the
discharged waste.
In the case of the ostomy appliance, which includes a ring-like
member having an adhesive face on one side and a bag to receive the
discharged material on the other, the application and removal of
the device often causes skin irritation even though there has been
no contact with discharged waste material. Repeated applications of
an adhesive device serves further to irritate the skin.
Attempts have been made in the past to remedy the situation
described above by providing a skin coating material in the form of
a liquid which may be applied to the skin by a sponge or other
means. Because the liquid was extremely fluid, it was difficult to
maintain the liquid in place until it had dried, and often the
patient was required to lie on his back while applying the liquid
and permitting the same to dry to form a protective coating. This
provided a far from satisfactory solution.
BRIEF SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a skin
coating or skin protective material in the form of a gel. The gel
is sufficiently stiff as to be able to support itself in position
without running, even when applied to the skin surface surrounding
the stoma while the patient is standing. The gel dries to a thin
protective coating against which the adhesive or other sealing
means of the ostomy appliance may be pressed, and the stress of
subsequently removing the appliance is directed primarily against
the coating material rather than directly against the skin.
DETAILED DESCRIPTION OF THE INVENTION
As previously indicated, the gel of the present invention comprises
film formers in a solvent mixed with preservatives and a gelling
agent. The preferred ingredients and their proportions are set
forth below, and where available the trade name and manufacturer,
as presently known, is also stated.
__________________________________________________________________________
Chemical Name Trade Name Manufacturer
__________________________________________________________________________
Isopropanol(70%) Isopropyl alcohol Shell or Exxon Methyl
para-hydroxybenzoate Methyl parasept Tenneco Heyden Div. -Butyl
para-hydroxybenzoate Butyl parasept do. Polyvinyl pyrrolidone
Polyvinyl pyrrolidone GAF having a molecular wt. K-30 of 40,000
Polyvinyl methylether Lutonal M-40 BASF Wyandotte having an acid
value of (1) and being soluble in water and low boiling alcohols
Modified polyacrylic acid Carbopol 934 B.F. Goodrich having a
molecular wt. of 3,000,000 Polyoxyethylene cocoamine Ethomeen C/25
Armour Chem. having 15 oxy groups Monoisopropyl ester of Gantrez ES
335 GAF polyvinyl methylether/maleic acid 2,4 Hexadienoic acid
Sorbic acid Pfizer Chem Co. Hydroxypropyl cellulose Klucel GF
Hercules Inc. having a molecular wt. of 300,000
__________________________________________________________________________
Of the ingredients set forth above, the isopropanol is, of course,
the solvent, Gantrez ES 335 I is a film former, as are polyvinyl
pyrrolidone K-30 and the Lutonal M-40. The Carbopol 934 and the
Klucel GF are the gelling agents, while the parasepts are the
preservatives and the Ethomeen C/25 is neutralizing agent for the
Carbopol 934.
Carbopol 934 is a water-soluble polyacrylic acid crosslinked with
about 1% of polyallyl sucrose having an average of about 5.8 allyl
groups for each sucrose molecule; U.S. Patent No. 3,133,865.
Gantrez ES 335 I has the following repeating unit ##SPC1##
Which is a clear viscous liquid with an acid number of 255-285, a
specific gravity of 0.957 and a density (pounds/gallon) of
7.98.
An example of the preparation and the method of mixing the same is
as follows:
______________________________________ Example 1 Ingredients Grams
Percent ______________________________________ Isopropanol (70%)
97.50 64 Lutonal M-40 48.00 31 Methyl parasept 0.214 0.14 Butyl
parasept 0.092 0.06 Polyvinyl pyrroli- done K-30 1.50 0.98 Carbopol
934 3.00 1.96 Ethomeen C/25 3.00 1.96
______________________________________
In forming the gel, the methyl and butyl parasepts are dissolved in
isopropanol and the polyvinyl pyrrolidone K-30 is added under
agitation. When completely dissolved, the Carbopol 934 is added
slowly while subjecting the mixture to high speed agitation. The
agitation should be continued until it is certain that no lumps
remain. The mixture is then neutralized with Ethomeen C/25. This
will form a thick gel. A second solution is made comprising 25%
Lutonal M-40 and 75% isopropyl alcohol. This Lutanol/isopropyl
alcohol mixture is then added to the thick gel under rapid
agitation, which agitation is continued until a homogenous mixture
has been formed. The resulting material will still be in gel form
and can be packaged as desired for use.
The proportion of ingredients set forth above may be varied and
still result in a gel usable for the purposes intended. The upper
and lower limits of the ingredients are set forth below.
______________________________________ Ingredient Upper Limit Lower
Limit ______________________________________ Isopropanol 80% 50%
Methyl and butyl parasepts 5% 1% Lutonal M-40 50% 5% Polyvinyl
pyrrolidone K-30 5% 1% Carbopol 934 5% 1% Ethomeen C/25 upper limit
and lower limit equal to percentage of Carbopol 934.
______________________________________
The isopropanol should, of course, be cosmetic grade.
______________________________________ Example 2 Ingredients Grams
Percent ______________________________________ Isopropyl alcohol 75
70.61 Sorbic Acid 0.214 0.20 Polyvinyl pyrrolidone K-30 1.0 0.94
Distilled Water 5.0 4.71 Klucel GF 5.0 4.71 Gantrez ES 335 I 10.0
9.41 Isopropanol 10.0 9.41
______________________________________
In mixing the ingredients for the example set forth just above, the
Klucel GF is added to the 75 grams of isopropyl alcohol under high
agitation. Continuing the agitation, the distilled water is added
which will initially result in a granular appearing mixture, which
will subsequently disappear during the mixing process.
The 10 grams of isopropanol is used to dissolve the sorbic acid and
then the polyvinyl pyrrolidone is added thereto. The Gantrez ES 335
I is then mixed into the isopropanol/sorbic acid/polyvinyl
pyrrolidone mixture and thoroughly mixed therein. The resulting
mixture is then combined with the mixture first formed, and the two
are thoroughly blended together. The result will be a gel of the
desired viscosity and characteristics.
The upper and lower limits of the ingredients in Example 2 are set
forth below.
______________________________________ Ingredient Upper Limit Lower
Limit ______________________________________ Isopropyl alcohol 90%
25% Sorbic acid 0.4% 0 Polyvinyl pyrrolidone K-30 2% 0 Distilled
water 20% 5% Klucel GF 10% 2% Gantrez ES 335 I 45% 5%
______________________________________
plus what additional isopropanol CG is required to dissolve the
polyvinyl pyrrolidone to form the second mixture described
above.
As previously indicated, the gel formed in accordance with the
formulation set forth may be applied without regard to the posture
of the patient. The gel will dry to a thin coating surrounding the
stoma and will not only improve the adhesion of the appliance, but
also serves to protect the skin of the user from irritation.
* * * * *