Note: Descriptions are shown in the official language in which they were submitted.
L4'~S
This invention relates to an adherent composition
applicable to the skin and removable therefrom without undue
discomfort or irritation, and particularly to a sealing ring
for use with an ostomy appliance.
. .
Ostomy appliances, such as draina~e pouches, are
worn by individuals after certain abdomina;L surgery. Certain -~
surgery such as colostomy, ileostomy, ureterostomy and the
like result in an opening in the abdominal wall, known as a
stoma, which allows for the discharge of waste material. A
10 reliable seal between the skin of the wearer surrounding the ;
; stoma and the ostomy bag is essential in order to prevent
the discharged material, which may include active gastric
uices, from attacking the skin and causing painful excoriatiQns.
Additionally, a reliable seal is needed to prevent the soiling
'I of apparel and embarrassing odor~.
Substantial alleviation of the foregoing problems has
been provlded by Karaya gum rings which are pressed against the
skin surrounding the stoma, and against which the ostomy appli-
ance is placed as it is positioned on the body. Karaya gum
20 however is obtained from the bark of a tree found in only cer- :
~! tain areas of the world. In recent years the supply of karaya
has diminished while the demand has substantially increased and
a need for a substitute for the karaya ring has developed.
~ It is, therefore, the object of this invention to ~- :
;~ . : -' '
provide a new adherent composition whlch can replace the Karaya
~` gum.
Thus, the present invention relates to an adherent
q composition applicable to the skin and removable therefrom with-
:1 out undue discomfort or irritatlon, comprising a polyisobutylene
-~, : : . ::
3D tackifier in admixture with a polyvinyl lower alkyl ether tacki- ; ;
fier and a microcrystalline wax, ssid compositlon containing on
J,~- 2 -
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a weight basis from 5 to 90~ of said polyisobutylene, from 5
to 70% of said polyvinyl ether, and from 5 to 50% of said wax.
The new composition when prepared in accordance with
the method described hereinafter, forms a substantially imper-
vious seal with the skin around the stoma, is resistant to
attac~ from gastric juices, is pliable such that it may be
formed around stomas of various sizes, and ~nce applied may be
removed without undue discomfort or irritation to the skin
around the stoma. Since the stoma tends to protrude from the
abdominal wall, the seal must have sufficient thickness to
prevent the bag or other appliance from touching the stoma.
The composition of this invention may be given a sufficient
thickness without losing its desirable properties. ~lterna-
tlvely, a ring may be formed from more than one layer of
materlal. For example lt may consist of a layer of the material
of this invention and a layer of a foam material such as poly- ~
ethylene foam or a textile material which would be bonded to -
the ostomy appliance, or the annular ring may comprise a plural- -
ity of layers made from the material of this invention and an
- 20 intermediate layer or layers of a flexible synthetic foam or
textile material. The new composition of my invention may be ;
produced by a process known as a calendering process and thus
formed into sheets of material from which annular rings of a
desired size may be cut. Multilayered material may be readily
formed from sheets of the new material and sheets of foam or
.. :.
textile material placed on top of each other.
DESCRIPTION OF DRAWINGS -
. . .
;'' Fig. 1 is a fragmentary view of an ostomy drawing pouch with
~ seal.
.. . .
Fig. 2 is a sectional view taken along line 2-2 of Fig. 1.
' Fig. 3 is a sectional view taken along line 2-2 of Fig. :L
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_ 3 _
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showing a triple layer seal.
- Fig. 4 is a sectional view taken along line 2-2 of Fig. 1
showing a dual layer seal. -
DESCRIPTION OF THE PREFERRED EMBODIMENTS
~ cording to a preferred feature, the composition
may also contain a strengthening agent consisting of a copoly-
merized beta pinene and dipentene or a condensation product
of cyclohexanone.
The composition of the invention provides an ostomy
appliance seal hsving the following desirable characteristis:
1) Low water and water vapor transmission.
2) Resistance to gastric juices.
' 3) Adherence to the skin.
; 4) Resistance to degradation by enzymes.
5) High degree of fo~mability, and low shrinkage :
~ and elasticity, allowing a seal to be shaped
; around the stoma and to retain its shape.
6) No melting or flowing at body temperature or ~-
at temperatures general-y encountered in
storage and shipment.
Several exemplary formulas are set forth below using :'
.. . .
ingredients listed in Table 1. In order to facilitate identi-
- fication of the ingredients, tra~ema~ks and their corresponding
'!~ manufacturer' 8 name are given in addition to the chemical names.
'' -', .,
l Table 1
Chemical Name Trademark Manufacturer
< Polyisobutylene Oppanol B-15 BASF Wyandotte
, Microcrystalline wa~ - a
mixture of alkylated naph-
thenes5 isoparaffins~ normal ~ultiwax
paraffins W-445 Witco Chemical Co.
Polyvinylisobutyl ether Lutonal I-60 BASF Wyandotte
Resin condensation product
30 of cyclohexanone Resin AW BASF Wyandotte
.:,
! Polymerized beta pinene and Nirez 1115 or Tenneco Chemicals,I
;~ dipentene Zonarez B-115 Arizona Chemicals,C
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The polyisobutylene forms the basic building material
or matrix for the composition of this invention. Other ingredients
act as modifiers of the polyisobutylene to obtain ~he desired
characteristics of the resulting composition. Polyisobutylene in
the molecular weight range of about 3,000 to about 30,000 may be
used. ~owever, it has been found that the preferable range of
molecular weights for polyisobutylene to obt:ain the most desirable
results is from about 10,000 to about 20,000. Particularly
suitable is polyisobutylene having a molecular weight of about
15,000 and commercially available under the designation Oppanol B-15.
As mentioned above, one of the desirable characteristics of the seal
in accordance with this invention is that it adheres to the skin
around the stoma. Thus the material must be tacky at body temper-
ature. While polyisobutylene itsel~ acts as a tackifier, even
greater tackiness is obtained by admixing therewith a polyvinyl
~lower alkyl) ether. Suitable for this purpose is a high viscosity
polyvinylisobutyl ether commercially available under the designation
Lutanol I-60. Also suitable is a Lutonal I-30 which is a low
.
viscosity polyvinylisobutyl ether. The viscosity of the
polyvinylisobutyl ether was not found to be critical and either
~utonal I-30 or Lutonal I-60 or a mixture of these two products
may be used. Other polyvinyl (lower alkyl) ethers such as
~utonal A~50 or A-25 which are high viscosity and low viscosity
polyvinyl ethyl ethers respectively, may also be used to provide
the tackiness desired in the seal.
', ' . ~`:.
Admixtures of polyisobutylene and polyvinyl (lower
alkyl) ethers, however, have a "cold flow" prohlem. A seal made
from these ingredients alo~e tends to loose its form, thus making
it unsuitable for use with an ostomy appliance. Furthermore, the `~
polyisobutylene~has rather severe shrinkage. This causes an annular
~ ring cut out of a sheet of the material to`shrink and presents
,! serious difficulties in manufacture. ~dditionally, the shrinka~e o~
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the polyisobutylene makes the material unsuitable fox a seal
for an ostomy appliance since it will not lend itself to being
formed around the stoma of the wearer. To counteract the mentioned
cold flow and shrinkage problems, a wax known as microcrystalline
wax is used. A Microcrystalline wax, as that term is used herein,
refers to a high boiling (residual)fraction obtained in the process
of de-waxing lubricating oils and is charac~erized by its micro-
crystalline structure, its high melting poin~, and a high
degree of plasticity. Such waxes are mixtures of alkylated
.
naphthenes, isoparaffins, and various amounts of normal paraffins.
Microcrystalline waxes have an average molecular weight of about
580 to about 700, and in some cases as high as about 900. Micro-
crystalline wax having a melting point from about 60 to 90C
as determined by ASTM Method D-127, may be used. A melting point
range of 75.to 8$C is preferred. Particularly suitable is
Multiwax W-445, listed in Table 1, which has a melting point of
, 75 to 85C (AS~M D-127) and needlepoint penetration at 25C of
,
' 25/35 (ASTM D-1321). If the wax is too soft, the resulting
.:,j . .
~i product will be stringy and unsuitable for use as a sealing ring
~ 20 with an ostomy appliance since the ring will not retain the
', shape given when formed around the stoma and cannot be conveniently
removed from the skin. If the wax is too hard, the seal becomes
too sti~f decreasing the tackiness of the seal and the seal may
chip or break. A needlepoint hardness in the range of 20 to 80
as determined by ASTM D-1321 a~ 25C may be conveniently used.
. i
~ A needlepoint hardness range of 25 to 40 is preferred, however.
... .
Certain resins may be added to the composition as a
strengthening agent. Ketone resins such as the commercially
available Resin AW may be used. The resin should have an acid
value near zero. A slightly acid condition in the ostomy seal
' is much preferred to an alkaline condition and is preferred even
:f to a neutral condition. It has been found that ketone resins having
~ - 6
4~S
" ~ftening point in thc range of 80 to 90C as determined by the
"Kramer-Sarnow-Nagel" method are desirable. This particular ketone
resin, Resin ~W, was tested and found to have a minimal skin irrita-
ti~n and therefore acceptable in this application as a seal for
use with an ostomy appliance. Other substantially non-irritating
ketone resins may also be used. Also suitable as strengthening agents
are the polyterpene resins which are beta-penene and dipentene ,
copolymers such as the commercially known Nirez 1115 and Zonarez
B-115. These particular resins have a Ball and Ring softening point
o~ 115C as determined by ASTM E2867. Similar polyterpene
resins having a Ball and Ring softening point of about 55 to
, 135C may also be used. A range of about 100 to llSC, however, ,-
,~ has been found to be preferred. Polyterpene resins of this type
generally result from the polymerization of terpene and ~ ;
hydrocarbons in the presence of Friedel-Crafts Catalysts at
moderately low temperatures. The molecular weight of such resins
generally is in the range of about 500 to about 20,0000 A
,~ molecular weight on the order o about 1,000 for the polyterpene
,~ , resins is pre~erred. Typical such resins are disclosed in
2~ U.S. Patent No. 3,737,418 of Ruchel et al.
.,. , , ~ , .
.. .. . .. ... .. . . ..... .. . . . . . . . .. . . . _ .
~ h,e invention is further illustrated by example~,as ~ollows~
.. . . . .
, , EXAMPLE 1
Parts By Weight Percentage
_ (Grams) y wei~ht
Polyisobutylene 30 30~
i (Oppanol B-15) ,
ll Microcrystalline Wax
,, (Multiwax W-445) 18 18~ ;
i' Polyvinylisobutyl ether
; (Lutonal I-60) 30 30
31 ` 3 Polyterpene resin
(Nirez 1115) 22 22%
- 7 - i-
' '' '
~' '
4~5
EX~PLE 2
Parts By Weight Percentage
. (Grams) b~ Weight
,:
Polyisobutylene
. ~Oppanol B-15) 30 30%
~ Microcrystalline Wax
- (Mu~tiwax W-445) 18 18%
Polyvinylisobutyl ether
; (Lutonal I-60) 30 . 30% ~. .
::: Ketone resin
(Resin AW) 22 22~ :
~; ' ~ . ' ;:
EX~qPLE 3 :
Parts By Weight. Percentage
(Grams) by Wei~ht
Polyisobutylene
. (Oppanol B-15) 30 30%
. ~ , .
' Microcrystalline Wax
.. (Multiwax W-445) 18 J.8%
.. l Polyvinylisobutyl ether
(Lutonal I-60~ 30 30~ : :
. Polyterpene resin
, (Zonarez Ei-115~ ~2 22%
:, .:::
,
EXAMPLE 4
; Parts by Weight Percentage
. ~Grams) by Weight
Polyisobutylene
(Oppanol B-15~ 20 90
. Microcrystalline Wax
i (Multiwax W-445) 1.1 5
' Polyvinylisobutyl ether
:~` (Lutonal I-60) 1.1 . 5%
~' EX~PLE 5
.;;~ . .
Several experiments were performed by varying one
~ 30 of the ingredients while holding constant the parts by
.,~ weight of the other ingredients. The results are com-
`. ` piled in Tables 2A - 2D.
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Table 2A
;~ Approximate w~ight percentage of Microcrystalline wax:
' 10%, 5%, 1%, 20%, 30%, 50%
Ingredients Amount (Grams)
- Polyisobutylene
. (Oppanol B-15) 7.5 7.5 7.57.5 7.5 7.5
i ~Sicrocrystalline Wax
(Multiwax W-445) 2.3 ~ 0.25.1 8.9 20.5
Polyvinylisobutyl ether
(Lutonal I-60) 7.5 7.5 7.57.5 7.5 7.5
Polyterpene resin
10 (Nirez 1115) 5.5 .5.5 5.55.5 5-5 5~5
. .
Table 28 .
Approximate weight Percentage of Polyisobutylene:
5%, 10%, 20%, 40~, 50%
. . .
In~redients Amount (Grams)
Polyisobutylene .~
~Oppanol B-15) .9S 1.9 4.412.0 17.5 - ;
Microcrystalline Wax
(Multiwax W-445) 4.5 4.5 4.54.5 4.5
., Polyvinylisobutyl ether
(Lutonal I-60) 7.5. ~7.5.7.5.7.5 7.5
Polyterpene resin
(Nirez 1115) 5.5 5.5 5.55.5 5.5
.. . .
Table 2C
Approximate Weight percentage of Polyvinylisobutyl ethér:
5%, 10%, 20%, 40%, 50%
.. . . . .
-1~ In~redients Amount (Grams)
Polyisobutylene .
ii (Oppanol B-15) 7.5 7.5 7.57.57.5
Microcrystalline Wax . -::
(Multiwax W-445) 4.5 4.5 4.54.5:4.5
Polyvinylisobutyl ether
(Lutonal I-60) 0.95 1.90 4.4 12.0 17.5 ~-:
30 Polyterpene resin . :
: (Nirez 1115) 5.5 5.5 S.S5.55.5
' i
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-, ;........ ..
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;:
Table 2D
Approximate Weight percentage of Polyterpene:
' 5%,1~%, 50%
Inyredients Amount ~Grams)
~-
Polyisobutylene
(Oppanol B-15) 7.5 7.5 7.5
~icorcrystalline Wax
(Multiwax W-4~5) 4~5 4.5 4.5
` Polyvinylisobutyl ether
(Lutonal I-60) 7.5 7.5 7.5
Polyterpene resin
(Nire~ 115) 1~1 2.2 19.6
In each of the foregoing instances a good quality
ostomy seal could be produced.
,
Furthermore, the percentages by weight of the in-
.
~l gredients set forth above may be increased or decreased within the
' limits set forth in Tables 3 and 4 by making compensating
.,J changes in the amount of the other ingredients.
~ Table 3
.1 .
Ingredient Upper Limit Lower Limit
Polyisobutylene
' ~Oppanol B-15) 70% 5
`' Microcrystalline Wax
~Multiwax W-445~ 50% 1%
Polyvinylisobutyl Ether
(Lutonal I-60) 70~ 5
` 3~ ~ Strengthening agent
~-1 (Nirez 1115, or ~ -
Zonarez B-115, or
Ketone Resin AW) 40% 5
, j . :
¦~ Table 4 ~
, .
~ ~ Up~r Limit Lower Limi~
.i ~ . .,
30 Polyisobutylene
~Oppanol B-15) 90% 30%
Polyvinylisobutyl Ether
~Lutonal I-60) 60% 5%
Mi~roc~ystallin~ Wax
(~lulti Wa~ W-4~5) 50~ 5
.
- l
.... . . . . . .. .
Z5
:,
In summary, polyisobutylene may be present in the ~;~
composition in amounts of about 5 to about 90 percent by
weight, microcrystalline wax may be present in amounts of
about 1 to about 50 percent by weight, polyvinyl (lower
alkyl) ether may be present in amounts of about 5 to about
70 percent by weight, and a strengthening agent such as
ketone resin or polyterpene resin may be present in a
amounts from 0 to about 40 percent by weight. The pre
ferred compositions are those containing about 5 to about S0
percent by weight of polyisobutylene, about 1 to about 50
percent by weight of microcrystalline wax, about 5 to about
50 percent by weight of polyvinyl (lower alkyl) ether and
a ketone or polyterpene resin in the amount of about 5 to
about 50 percent by weight.
` The ostomy appliance seal or sealing composition may
- be made by the following method. To make the compositions ~ ;
of Example 1, 30 parts by weight of the polyisobutylene - -
are first heated from 1~0 to 170C. Using, for example,
a Baker-Perkin ~ mixer or the like, 22 parts by weight of
the polyterpene resin are added and mixed in with the
polyisobutylene while allowing the temperature of the
mixture to drop to a range of about 120 to 130C. As
a fourth step, 18 parts by weight of the microcrystalline
wax are added and mixed, allowing the temperature to drop
` to about 100 to 110C. While the mixture is in a soft
:J ~ ~:
state and preferably at a temperature greater than about 75C.,
. ...................................................................... .
it may be pressed into a sheet for further handling in the
; manufacturing process wherein annular rings of material
~, of varying sizes may be cut from the sheet.
An alternate and preferred method of making sheets of
the ostomy appliance sealing composition comprises the steps of~
1. Heating the microcrystalline wax to a temperature of
approximately ~0 to gOC.;
B~
3~ 25i
2 Adding and mixing the polyterpene while ~ -
- increasing the temperature of the resulting mix to 120-130C;
3. ~dding and mixing the polyisobutylene and in~
creasing the temperature to about 140 to 150C;
- 4. Decreasing the temperature of the mixture to about
110-120~C and adding and mixing in the polyvinylisobutyl
ether;
5. Cooling the mixture to a temperature slightly above
75C and pressing the mi~ture into sheets.
.. , . ' , '
The second method, wherein the polyvinylisobutyl
ether is added as the last step, is preferred since this compound
tends to degrade if held at an elevated temperature Eor an extended
period of time.
.. . . .
The melting point of the composition prepared in accordan~
with either of the above methods falls in the range of about
90C to about 120C depending primarily on the proportions
of each of the ingredients used.
The mixinq operations described above also may be
~I 20 accomplished by means of known calendering machines having
-~ calendering rolls which may be heated to the desired temperatures.
. ~ . .
The mixture may ~hus be calendered to form sheets of the
new sealing composition, and suitable cutters may be employed
to cut out annular rings of the material.
A fragmentary view of an ostomy drainage pouch wl~h
seal is shown in Fig. 1. To ~acilitate wearing of the ostomy
pouch, a rather stiff polyethylene gasket 12, or the like, is
attached to the bag 10 around the opening 15. The gas~et may
be equiped with ears 13 having slotted openings 14 to allow
for attachment of a belt or other suitable means to support
.~ . .
.. , . .
- 12 -
"', ' ' ' :
`, :
.. . .
'.~ ZS
the bag. An annular ring 11 made from the sealing material in
accordance with the present invention, may be placed on the
polyethylene gasket 12 to serve as a seal between the area
around the stoma of the wearer and the pouch. Since the stoma
generally extends beyond the outer wall of the a~domen, it is
desirable to provide a seal of sufficient thickness to prevent -
the contact of the ostomy pouch with the extremity of the stoma.
Annular sealing rings of sufficient thickness to accomplish
this result may be formed from the material of this invention.
Fig. 2 is a sectional view taken along the line 2-2 of Fig. 1.
Figure 2 shows the pouch 10 of the polyethylene gasket 12 and
a ring made 11 in accordance with this invention.
Alternatively, a sealing ring of sufficient thickness
may be ormed by the use of a layer or layers of another mat-
erial in conjunction with thinner layer or layers of the
rings made in accordance with this invention. Fig. 3 is a
sectional view taken along the line 2 1 of Fig. 1 and showing
a sealing ring consisting of a sandwich comprising two layers
of khe composition according to this invention and a layer of
I 20 another material there between. The layers 11 and 31 consist
of the composition in accordance with this invention and the
layer 32 represents another matarial such as a polyethylene
oam. Any relatively flexible plastic foam materia~ may be
used for the interior of the sandwich since the new sealing
composition will provide the necessary protection around
' the s]cin of the stoma. A closed cell foam such as a polyolefin - -
~, foam, e.g. polyethylene foam is acceptable for these purposes.
A closed cell foam is preferred since this is highly resistant
l , :': .
to the transmission of water vapors and fluids. The new sealing ~ ;
material of this inventlon is a highly tacky material and
'I ' . , :: . ..
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will adhere to both the polyethylene gasket 12 and the plastic
foam material. Layer 31 serves primarily as an adhesive for
the foam and ma~ be replaced by another suitable adhesive.
Fig. 4 is a sectional view along the line 2-2 of
Fig. 1 and shows a dual layered seal. The outer annular ring
11 is made of the material of this invention and the inner
layer 41 may be any relatively flexible material, such as certain
textile materials. As a general rule, however, a textile material
can be expected to have a certain amount of capilary action, and
~onsequently may transmit juices and vapors. For this reason, it
is desirable to seal the inner exposed edge of the material 41 as
shown in Figure 4. The outer annular ring 11 being made from
the material of this invention is pliable and may be easily forme~
around the edge of the opening 15 as shown, and the folded over
portion 42 will form the desired seal for the textile material
or the like.
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