Note: Descriptions are shown in the official language in which they were submitted.
The present invention relates to ostomy appliances
and particularly those devices used by ostomy patients
having an integral or unitized thin barrier gasket formed
of a composition which has unique and desirable properties,
i.e., breathability, tack, resistance to leakage, dozily-
lion, and disintegration by fluids and cohesive strength.
More particularly, the invention relates to the combine-
lion of a specific gasket material which may be formed as composite panel with a hydrophobic backing, as for
example, a thermoplastic and which is adapted for integral
manufacture onto a conventional ostomy appliance such as a
colostomy bag or an ileostomy bag.
The present invention represents major improvements
over existing ostomy appliances especially by virtue of the
unique combination of properties afforded by the unitized
ostomy appliance and a skin barrier Utilizing the present
invention, high levels of conformability, strength and dry
and wet adhesion simultaneously and continuously serve to
overcome irregularities in the dynamic peristomal region and
serve to provide resistance to the leakage of fluids which
result in additional comfort to the wearer since there are
no flanges or rings as common with many prior art ostomy
appliances to interfere with body movements and to present
an objectionable appearance beneath clothing.
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Os-tomy appliance gaskets based upon the inclusion of
Corey powder, as disclosed in US. Patent 3,302,6~7, are
currently in general use. Corey has certain disadvantages
since it is a nutrient substance and capable of supporting
the growth of micro-organisms, not only in use, but when
contaminated in storage prior to use. Corey compositions
are lacking in cohesiveness, and therefore tend to disk
integrate as well as become slippery when wet, often times
necessitating the use of a special adhesive -to prevent
dislocation from the ostomy site.
In US. Patent 4,160,076, there are disclosed hydra-
Philip foams prepared from a capped polyoxyalkylene polyol
reactant having a defined average reaction functionality
greater than 2, an aqueous reactant and a carefully balanced
combination o E a non ionic surface-active agent and a liquid
deforming agent. The resultant foams are characterized by
a majority of large size cells and membranes which them-
selves are formed with small cells. In addition, large
amounts of many water-soluble or water-dispersable materials
such as cellulosic pigments, dyes, enzymes or the like may
be added to the aqueous reactant. By homogeneously disturb-
tying these materials in the aqueous reactant they may be
distributed throughout the finally prepared foam. Louvre,
the large cell size and membranes characteristic of the
hydrophilic polyurethane sponges do not possess the necessary
properties owe tack, elasticity, sealability and flexibility
needed in an ostomy gasket.
An ostomy gasket possessing varying degrees of tackiness
lubricity, and softness is disclosed in So Patent
3,980,084. The polymeric ostomy sealing gasket therein
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disclosed is formed by the polymerization of a hydroxy-
alkyd acrylate or methacrylate in the presence of a polyp
alkaline glycol, reducing agent, or chain terminator, and
water. In manufacturing the gaskets, it is essential that
the polymerization reaction be carried out in -the presence
of water. In this manner, a considerable quantity of water
it absorbed into the polymer matrix during the polymerize-
lion reaction. In addition, natural or synthetic gums or
ellulosic type materials to increase absorptive capacity
may be incorporated in-to the polymer matrix. However, the
material disclosed has a very low elongation at break and
will not return to its original shape after deformation.
In addition the materials are often highly viscous and
therefore lack the sealability preferred for use in an
ostomy device which may result in leakage around the ostomy
seal.
One ox the principal objects of the present invention
is to provide a new unitized ostomy appliance having a built
in seal formed from a special gasket composition.
A further object of the invention is the provision of
a unitary ostomy bag and seal which may be manufactured
utilizing conventional techniques and which offers great
comfort -to the wearer and ease in application.
Another object of -the invention is realized by provide
ivy a polymeric composition adapted for use in contact with
the skin derived from the non-aqueous reaction of a posy
iSocyanate and a polyoxyalkylene polyol moiety having a
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hydrophilic filler physically incorporated within the polyol
prior to the reaction.
A further object Go the invention is found in the
physical characteristics of the polymeric composition of
the present invention, which composition provides a seal
between the ostomy device and skin (epidermis) of the human
Cody having a high degree of tack, elasticity, flexibility,
and resistance to body fluids. This precludes movement of
the seal around the stimuli opening which can result in
leakage of body material thereby causing irritation and
excoriation if allowed to come into repeated or continuous
contact with the skin.
Another object of the invention is to the cohesive
conformability of the new composition. This property
enables the composition to be molded in preferred shapes
which inherently adheres to both the patient's skin and the
collection receptacle without the use of additional
adhesives. The new composition is soft and resilient,
minimizing discomfort to the wearer of an ostomy appliance.
Yet another object of the invention is to extend the
shelf life and resistance to contamination of the new
composition over Corey products which have a limited shelf
life and harden during storage.
accordingly, one aspect of the invention provides
all ostomy bag kelvin a front face provided with a stoma
opening therein, a backing of hydrophobic material welded
to the front face surrounding the opening, and a skin
barrier gasket on the exposed face of the backing, the
skin barrier gasket being a polymeric composition
comprising a non aqueous reaction product of an organic
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polyisocyanate, and a polyoxyalkylene polyol. moiety having
incorporated therein prior to the reaction of the pulse-
Senate and the polyol a hydrophilic Miller wherein there
is provided a polymeric matrix characterized by the physical
encapsulation of the hydrophilic filler within the polymeric
metrics.
Another aspect of the invention provides a polyp
metric composition err providing an elastomeric adhesive,
breathable, cohesive, conformable, body fluid generally
lo non-degradable product for adherent contact with the skin,
which comprises a reaction product derived from the generally
non aqueous reaction of an organic polyisocyanate.and a
polyoxyalkylene polyol moiety comprising a mixture of
a major portion of polyol having a dill functionality and
a minor portion of polyol having at least -trio functionality,
and having incorporated into the polyol moiety prior to
-the reaction of the polyisocyanate and the polyol moiety,
a hydrophilic filler wherein there is provided a polymeric
matrix characterized by the physical encapsulation of the
hydrophilic filler within the polymeric matrix.
A earthier aspect of the invention provides a
process for making a polymeric composition for providing
an e:Lastomeric adhesive, breathable, cohesive, conformable,
body :Elu:Ld generally non-degradable product for use in
con-tact with the skin, which comprises reacting under non aqueous
conditions an organic polyi.socyanate and a polyoxyalkylene
poLyol moiety comprising a mixture of a major puritan owe
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polyol having a dill functionality and a minor portion
owe polyol having at least trio functionality, and having
incorporated into the polyol moiety prior to the reaction
owe the polyisocyanate and -the polyol moiety, a hydrophilic
Miller wherein there is produced a polymeric matrix kirk-
terraced by the physical encapsulation of -the hydrophilic
filler within the polymeric matrix.
A sealing pad or gasket formed of the new compost-
-lion is interposed between a fluid resistant material,
such as a fabric, film, non-woven fabric, or the lice which
is welded -to the face of the ostomy device and the skin
of the user surrounding the stoma. The sealing pad serves
to contain
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the waste fluids that are highly irritating to the skin and
which may contain microorganisms of the intestinal tract,
and which also give off offensive odors. Additionally,
the sealing pad assists in retaining the appliance in place
and makes the appliance more comfortable to wear.
The sealing pad of the invention is especially adapted
for performing the foregoing functions. Owing to its coup-
oslt:ion, the pad may be cast in any desirable configuration,
and it will retain its shape and not break apart in use.
The composition for forming the pad or gasket is pro-
pared by the reaction of an organic polyisocyanate with one
or more dip or polyfunctional hydroxyl compounds for example
polyoxyalkylene polyols such as those derived from propylene
or ethylene oxide, preferably having equivalent weights of
at least 500. A hydrophilic filler, such as a cellulosic
or natural gum, is incorporated into the polyol moiety of
the urethane system prior to the reaction of the polyols
with the polyisocyanate moiety.
The soft polymeric matrix or adhesive composition that
is formed by the reaction physically encapsulates the unit
Eormly dispersed hydrophilic filler within the resulting
self-sustaining adhesive composition. Thus, -the product
resists welling and dissolution by or passage of bodily
fluids while being inherently breathable thereby readily
allowing migration and transfer of gases such as water vapor.
Our new ostomy bag which may be formed, for example,
either as an ileostomy pouch, urostomy pouch, or colostomy
bag utilizes the highly elastic, tacky, rubbery yam as the
gasket material and -the same is backed with a soft, fluid
resistant material and is cast with sufficient thinness to
allow the backing to be firmly welded or otherwise secured
in an integral fashion to the plastic film of the ostomy
appliance directly through the gasket.
Embodiments of the invention will now be described, by
way ox example, with reference to the accompanying drawings,
in which:
Figure 1 is a plan view of a typical colostomy bag of
aft embotlilllent of the present invention;
lo ~IGURF, 2 is an enlarged cross sectional view through
the bag of Figure 1, taken along the line 2-2 thereof; and
FIGURE 3 is a plan view of a typical ileostomy pouch
utilizing the present invention.
In the following detailed description of the embody-
mints shown in the drawings, like reference characters refer
to similar part throughout the description.
Referring now to the drawings, a unitary assembly of an
ostomy bag is shown generally at 10 which may be formed in
any of several well-known configurations. The bag in Figure
I 1 represents a typical colostomy bag of the type that are
normally used after surgery. A surgical procedure such as a
colostomy, ileostomy, or urostomy consists of the formation
ox an ope~nirlg, or stoma in the wall owe the intestine or
colon, which opening extends through the wall of the patients
skin. A urostomy consists of either bringing the ureters to
the abdominal skin (ureteros-tomy) or connecting -the ureters
to a section of the ilium which in turn is brought out to the
skin (ileal-conduit). 'rho stoma provides means for comma
unication between the inside
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of the organ and the external area through which various
bodily excretions may pass. Therefore, it is necessary for
the post-surgical patient to wear a collection receptacle
for this material such as a pouch or bag attached to the
stoma. It is further important that there be a seal between
the patient's skin and the collection receptacle. Especially
due to the noxious nature of the waste material which passes
-through the stoma, it is desirable that none of the materials
be allowed to leak past the seal since these materials are
irritating to the skin and can cause irritation if allowed to
come into repeated contact therewith. The bag as shown in
Figure 1 or receptacle is formed of flexible water-impervious
material such as polyethylene or polypropylene film or sheet
material having spaced walls 11 and 12 which are preferably
heat sealed at their edges as indicated at 13. An opening
14 is provided at an appropriate position on the front wall
11. This opening varies depending upon -the particular stoma
and can be for example from 12 to 65 millimeters in diameter.
With regard to the ileostomy container of Figure 3, the
bag is generally formed in the same manner although the shape
may vary and there is usually means at the bottom thereof to
permit emptying of waste liquid material. In this manner
the pouch or bag can remain on the body for several days.
In the Figure 3 embodiment, the bag has a narrow bottom
portion shown at 20 and the end Thor 21 is open but may
be sealed by use of the flexible clip 23 which is secured
thereto. In use, the bottom portion 20 is rolled upwardly
and the flexible clip 23 is bent over in a well-known manner
to close the exit port 21. Here again, an opening 14 is
provided.
In order to attach the appliance to the body it is
necessary to provide a tacky seal or a gasket Here a thin
patch of material shown at 25 is employed and the same
consists of a fluid resistant, hydrophobic material as
previously described. The material is quite thin, generally
lets than .050 inches, preferably about solo inches but also
as low as 0.001 inches in thickness. The highly elastic,
tacky, rubbery gum which is described in greater detail
later herein is applied to the fabric backing 25 and is
shown in Figures 2 at 26. Here the material is applied in
a thickness of from about .010 inches to .050 inches. float
sealing of the gasket 26 and backing 25 may take place
directly through the gasket material and a firm secure weld
will be insured as shown at 27.
In order to protect the gasket 26 prior to use, a thin
sheet of peel able material such as release paper or film 28
is applied over and adheres to the tacky gasket. This serves
to guard the gasket in storage and prevents adherence thereto
of dust or other foreign particles. It is gripped at a free
edge and readily torn off and discarded prior to the
application of the appliance.
The polyisocyanates used in preparing the gasket
compositions of the present invention are represented by the
formula R(NCO)n where n is at least 2, and R is selected
from the group consisting of aliphatic, alicyclic, elf-
phatic-alicyclic, aromatic or aliphatic-aromatic hydra-
carbon compounds.
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Examples of commercially available p~lyisocyanates
which may be used include liquid isocyanates or polymeric
isocyanates based on 4,4'-me.thyldiphenyldiisocyanates such
as Upjohn Company Isolate 143L, Upjohn Company PAP 901,
Moray Chemical Corporation Mender CUD, and Moray Chemical
Corporation Mender MRS-10.
Among the commercially available polyoxyalkylene
polyols which may be utilized in the practice of the invent
lion are, for example, Nix Polyol-PP~-3025 (Union Carbide
Corporation), Polliwog 55-37 (Olin Chemicals, Polliwog 35-28
(Olin Chemicals, and ~ultranol 3901 (Moray Chemical
Corporation).
The preferred polyols are Union Carbide Nix Polyol-
PPG-3025 and Moray Multranol 3901. The preferred pulse-
Senate is Upjohn Company Isolate 143L.
The proportions and molecular weights of the polyp
oxyalkylene polyols used, as well as the amounts of the
hydrophilic fillers, are governed by the desired character-
is tics of the final product. Trust one may tailor products
having a diverse range of properties such as -tackiness,
breathability, cohesiveness and the like.
For example, an elastomers matrix composition formed
with dill moieties having nominal equivalent weights of 1500
and trip moieties having nominal equivalent weights of 2000,
used in a ratio of approximately 4 to l (by equivalents) of
dill to trio, yields a particularly desirable product for
an ostomy scaling gasket having physically incorporated
therein a hydrophilic filler such as hydroxyethylcellulose,
hydroxypropyl cellulose or mixtures thereof in the range of
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approximately 20 to 50% by weight of the final plastic
composition.
It has been found that substantially more breathable
products are obtained with the use of hydroxyethylcellulose
and hydroxypropylcellulose than, for example, with sodium
carboxymethylcellulose, Corey gum or polyacrylamide based
polyelectrolytes.
In making the breathable elastomeric materials used in
this invention, the polyol moieties are blended with the
hydrophilic filler or fillers to form a homo~neousmixture,
the consistency of which may vary from a -thin cream to a
paste. The mixture is then reacted with the polyisocyanate
moiety. Techniques such as a one-shot or prepolymer reaction
procedure may be employed.
In the prepolymer reaction procedure, the polyol moiety
is reacted with an isocyanate to yield longer chains having
terminal NO groups which may later react with additional
polyol moieties. This defines in part the physical
characteristics of the resulting plastic composition.
For example, the elastomeric matrix product tends to
become harder and less conformable as the cross-link
density of -the structure increases, as for example, with
higher functionality polyol and/or NO moieties. These
physical characteristics also are evident ire the molecular
weight of -the polyol moiety is decreased. The reverse is
true, in that as the molecular weight of the polyol moiety
is increased, the composition tends to become softer and
weaker.
In addition, the stoichiometry effects the final
composition as follows: When thy COO ratio is increased,
there is a reduction in conformability and tack while a
decrease in the NCO/OH ratio yields a product with increased
tack, but decreased strength.
The reaction is catalyzed by known catalysts for such
reactions. Suitable catalysts include organic tin esters
such as dibutyltindilaurate, tertiary amine, and other
catalysts well known in the art.
In addition, a suitable surfactant, such as Dow Corning
Anti foam B, may be utilized to aid in controlling the
uniformity of flow and formation of the resulting plastic
compositions.
Many suitable adhesive compositions can be obtained
by minor variations in the amounts of ingredients employed.
The following examples are illustrative of the invention.
Example Al
35.0 grams (0.0233 equivalents) of Union Carbide Nix
Polyol PUG 3025 ~1500 Equivalent Weight polyether dill) and
11.0 grams (0.0055 equivalents) of Moray Multranol 3901
(2000 EWE polye-ther trio) were blended with 2 drops of M & T
Chemical Catalyst T-12 (dibu-tyltindilaurate) and l drop Dow
Corning Anti foam B silicone surfactant). To this mixture,
24.0 grams of Hercules Notoriously 250 HER hydroxyethylcellulose
were blended to form a smooth, homogeneous, creamy liquid.
Then, 4.2 grams (0.0292 equivalents) of Upjohn Isolate
143L (liquid isocyanate based on 4,4'-methyldiphenyldi-
isocyanate) were added and the mixture thoroughly blended
for 60-90 seconds, after which it was poured into an open
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I,
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12
I deep sheet mold constructed from silicone release
paper. The mixture was allowed to cure until set at room
temperature for 1 hour and then cured overnight at 45G.
The resulting product was a soft, flexible, tacky
elastomers that is light tan in color and possesses high
elasticity and conformability. It is breathable and highly
durable to body fluids. This combination of properties it
ideally suited for use as an ostomy barrier.
Example #2
The procedure of Example 1 is repeated, except that the
silicone surfactant was deleted. The resulting product was
identical to that of Example 1.
Example #3
The procedure of Example 1 was repeated using 28.8
grams (0.0192 equivalents) of PUG 3025 and 19.2 grams
(0.0096 equivalents) of Multranol 3901.
The resulting product was similar to Example 1, however
somewhat lower in tack and elasticity.
Example #4
The procedure for Example 1 was repeated using 21.6
grams ~0.0144 equivalents) of PUG 3025 and 28.8 grams
(0.0144 equivalents) of Multranol 3901.
The resulting product possessed less tack and
elasticity than Example 3.
example I
The procedure for Example 1 was repeated using 43.2
grams (0.0288 equivalents) of PUG 302S and no Multranol 3901
with 40 drops of catalyst T-12.
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The resulting product was highly tacky and soft,
exhibiting creep, and not suitable for an Tom gasket.
Example #6
The procedure for Example 1 was repeated using no PUG
3025 and OWE grams (0.0288 equivalents of Multranol 3901.
The resulting product tears easily and has low
conformability and tack rendering it unsuitable as an
Tom gasket.
Example I
The procedure for Example 1 was repeated using 36.4
grams (0.0243 equivalents) of PUG 3025 and 9.0 grams (0.0045
equivalents) of Multranol 3901.
The resulting product was very soft and tacky exhibit-
in a slight tendency to creep.
Example #8
The procedure for Example 1 was repeated using 11.7
grams (0.0233 equivalents) of Quaker Oats Polymer 1000
(500 EWE polytetramethylene ether glycol) and 11.0 grams
(0.0055 equivalents) of Multranol 3901.
The resulting product had lower conformability, tack,
elasticity and tear strength than Example 1.
sample #9
The procedure for Exempt 1 was repeated using 13.0
grams Hercules Closely HO hydroxypropylcellulose in place of
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Neutral.
The resulting product was whiter than but otherwise
similar to Example 1,
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14
Example ~10
The procedure for Example 1 was repeated using 16.0
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grams Notoriously 250 HER and 8.0: grams Closely HF.
The resulting product was lighter oilier than Example
1 but otherwise similar in properties.
Example #11
The procedure for Example 1 was repeated using an
initial cure at 45C for 15 minutes to set the material
hollowed by overnight cure at room temperature.
The resulting product is similar to Example 1.
Example #12
A prepolymer was prepared by mixing 35.0 grams (0.0233
equivalents) of PUG 3025 with 11.0 grams (0.0055 equivalents)
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of Multranol 3901 and drying the mixtures at 100-110C under
vacuum at 30 in. go
8.4 grams ~0.0584 equivalents) of Isolate 143L were
added slowly with thorough mixing and the mixture maintained
at 95C for 4 hours under nitrogen with frequent mixing. It
was then set aside under a nitrogen lid at room temperature
until the following day, when a homogeneous mixture of:
35.0 grams (0.0233 equivalents of PUG 3025,
11.0 grams (0.0055 equivalents) Multranol 3901,
4 drops of T-12 (dibutyltindilaurate).,
2 drops anti foam B, and
~8.0 grams Notoriously 250 HER
was added. The mixture was thoroughly blended for 60-90
seconds and poured into a sheet mold as in Example 1, cured
at room temperature for 1 hour and then at ~5C overnight.
The resulting product was identical to Example 1.
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Example #13
A quasi-prepolymer was prepared by mixing 10 grams
(0.0694 equivalents) of Isolate 143L into lo grams (0.00~6
equivalents) ox PUG 3025 (previously dried at 100-110C
under vacuum at 30 in. Hug.) The mixture was maintained
under nitrogen at 95UC for 4 hour with frequent mixing,
after which it was set aside under a nitrogen lid at room
temperature until the following day.
At that time, 8.4 grams of the quasi-prepolymer were
added to a homogeneous mixture consisting of the following:
30.8 grams (0.0205 equivalents) PUG 3025
11.0 grams (0.0055 equivalents) Multranol 3901
4 drops T-12
2 drops Anti foam B
24.0 grams Notoriously 250 HER
The mixture was thoroughly blended for 60-90 seconds
and poured into a sheet mold as in Example 1, cured at room
temperature for 1 hour, then at 45C overnight.
The resulting product was identical to Example 1.
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