CA1228440A - Breathable ostomy gasket composition and ostomy bag with integral breathable gasket - Google Patents
Breathable ostomy gasket composition and ostomy bag with integral breathable gasketInfo
- Publication number
- CA1228440A CA1228440A CA000432538A CA432538A CA1228440A CA 1228440 A CA1228440 A CA 1228440A CA 000432538 A CA000432538 A CA 000432538A CA 432538 A CA432538 A CA 432538A CA 1228440 A CA1228440 A CA 1228440A
- Authority
- CA
- Canada
- Prior art keywords
- polyol
- reaction
- polyisocyanate
- polymeric matrix
- hydrophilic filler
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L28/00—Materials for colostomy devices
- A61L28/0007—Materials for colostomy devices containing macromolecular materials
- A61L28/0015—Materials for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G18/00—Polymeric products of isocyanates or isothiocyanates
- C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
- C08G18/28—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the compounds used containing active hydrogen
- C08G18/40—High-molecular-weight compounds
- C08G18/4009—Two or more macromolecular compounds not provided for in one single group of groups C08G18/42 - C08G18/64
- C08G18/4063—Mixtures of compounds of group C08G18/62 with other macromolecular compounds
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G18/00—Polymeric products of isocyanates or isothiocyanates
- C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
- C08G18/28—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the compounds used containing active hydrogen
- C08G18/40—High-molecular-weight compounds
- C08G18/4009—Two or more macromolecular compounds not provided for in one single group of groups C08G18/42 - C08G18/64
- C08G18/4081—Mixtures of compounds of group C08G18/64 with other macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Materials For Medical Uses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
A new ostomy bag having an integral breathable ostomy gasket derived from the non-aqueous reaction of a poly-isocyanate and a polyoxyalkylene polyol moiety having a hydrophilic filler incorporated within the polyol moiety prior to the reaction of the polyisocyanate and the polyol.
The bay includes hydrophobic material welded to the bag serving as a backing for the gasket.
A new ostomy bag having an integral breathable ostomy gasket derived from the non-aqueous reaction of a poly-isocyanate and a polyoxyalkylene polyol moiety having a hydrophilic filler incorporated within the polyol moiety prior to the reaction of the polyisocyanate and the polyol.
The bay includes hydrophobic material welded to the bag serving as a backing for the gasket.
Description
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.
isle,, 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 ~;289L~
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 '' ~Z2~
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 ~z~
pa 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 ;, I
,,~;,~,.,', by 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 ~2~34~
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 I! ```
I
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.
..
.~.
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 * trademarks 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 * trademarks I, ~2~B~40 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.
* trademark I
~.~28~
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 *
Neutral.
The resulting product was whiter than but otherwise similar to Example 1, * -trademarks "
Example ~10 The procedure for Example 1 was repeated using 16.0 * *
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) *
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).,
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.
isle,, 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 ~;289L~
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 '' ~Z2~
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 ~z~
pa 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 ;, I
,,~;,~,.,', by 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 ~2~34~
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 I! ```
I
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.
..
.~.
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 * trademarks 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 * trademarks I, ~2~B~40 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.
* trademark I
~.~28~
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 *
Neutral.
The resulting product was whiter than but otherwise similar to Example 1, * -trademarks "
Example ~10 The procedure for Example 1 was repeated using 16.0 * *
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) *
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.
* trademarks I
. . ..
~15 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.
* trademarks
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.
* trademarks I
. . ..
~15 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.
* trademarks
Claims (16)
1. An ostomy bag having a front face provided with a stoma opening therein, a backing of hydrophobic material welded to said front face surrounding said opening, and a skin barrier gasket on the exposed face of the backing, said skin barrier gasket being a polymeric composition comprising a nonaqueous reaction product of an organic polyisocyanate, and a polyoxyalkylene polyol moiety having incorporated therein prior to the reaction of the polyisocyanate and the polyol a hydrophilic filler, wherein there is provided a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
2. An ostomy bag as defined in claim 1, wherein the hydrophobic backing is a fluid resistant material.
3. An ostomy bag as defined in claim 1, wherein the polymeric composition comprises a reaction product of an organic polyisocyanate of the general formula R(NCO)n where R is a polyoxyalkylene and n is at least 2, with the proviso that the polyol may be a combination of polyols, and having incorporated into the polyol moiety prior to the reaction of the polyisocyanate and the polyol, a hydrophilic filler wherein there is provided a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
4. An ostomy bag as defined in claim 3, wherein said polyol consists of diols of nominal equivalent weights of 1500 and triols of nominal equivalent weights of 2000 in a ratio of approximately 4 to 1 of diol to triol.
5. An ostomy bag as defined in claim 1, wherein said polyisocyanate is a liquid isocyanate based on 4,4'-methyl-diphenyldiisocyanate; and said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.
6. A polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product for adherent contact with the skin, which comprises a reaction product derived from the generally nonaqueous reaction of an organic polyisocyanate and a polyoxyalkylene polyol moiety comprising a mixture of a major portion of polyol having a diol functionality and a minor portion of polyol having at least triol 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.
7. A polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product adapted for use in contacting the skin, which comprises a product derived from the generally nonaqueous reaction of an organic polyiso-cyanate of the general formula R(NCO)n where R is independently selected from the class consisting of aliphatic, alicyclic, aliphaticalicyclic, aromatic and aliphatic-aromatic hydrocarbon compounds and n is at least 2, and a polyoxyalkylene polyol moiety of the general formula R(OH)n where R is a poly-oxyalkylene and n is at least 2, the polyol moiety comprising a mixture of a major portion of polyol having diol function-ality and a minor portion of polyol having at least triol 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.
8. A polymeric composition as defined in claim 6, wherein said polyol consists of diols of nominal equivalent weights of 1500 and triols of nominal equivalent weights of 2000 in a ratio of approximately 4 to 1 of diol to triol.
9. A polymeric composition in accordance with claim 6 in which:
said polyisocyanate is a liquid isocyanate based on 4,4'-methyldiphenyldiisocyanate; and said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.
said polyisocyanate is a liquid isocyanate based on 4,4'-methyldiphenyldiisocyanate; and said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.
10. A polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product for use as an ostomy appliance seal in adherent contact with the skin, which comprises a reaction product derived from the generally nonaqueous reaction of an organic polyisocyanate and a polyoxyalkylene polyol moiety comprising a mixture of a major portion of polyol having a diol functionality and a minor portion of polyol having at least triol 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.
11. A process for making a polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product for use in contact with the skin, which comprises reacting under nonaqueous conditions an organic polyisocyanate and a polyoxyalkylene polyol moiety comprising a mixture of a major portion of polyol having a diol functionality and a minor portion of polyol having at least triol 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 produced a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
12. A process for making a polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product adapted for use in contacting the skin, which comprises reacting a product derived from the generally nonaqueous reaction of an organic polyisocyanate of the general formula R(NCO)n where R is independently selected from the class consisting of aliphatic, alicyclic, aliphaticalicyclic, aromatic and aliphatic-aromatic hydrocarbon compounds and n is at least 2, and a polyoxyalkylene polyol moiety of the general formula R(OH)n where R is a polyoxyalkylene and n is at least 2, the polyol moiety comprising a mixture of a major portion of polyol having diol functionality and a minor portion of polyol having at least triol function-ality, and having incorporated into the polyol moiety prior to the reaction of the polyisocyanate and the polyol moiety, a hydrophilic filler wherein there is produced a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
13. A process for making a polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product for use as an ostomy appliance seal in direct contact with the skin, which comprises reacting under nonaqueous conditions an organic polyisocyanate and a polyoxyalkylene polyol moiety comprising a mixture of a major portion of polyol having a diol functionality and a minor portion of polyol having at least triol 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 produced a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
14. A process for making a polymeric composition for providing an elastomeric adhesive, breathable, cohesive, conformable, body fluid generally non-degradable product for use as an ostomy appliance seal in contact with the skin which comprises reacting a product derived from the generally nonaqueous reaction of an organic polyisocyanate of the general formula R(NCO)n where R is indepdendently selected from the class consisting of aliphatic, alicyclic, aliphaticalicyclic, aromatic and aliphatic-aromatic hydrocarbon compounds and n is at least 2, and a polyoxyalkylene polyol moiety of the general formula R(OH)n where R is a polyoxy-alkylene and n is at least 2, the polyol moiety comprising a mixture of a major portion of polyol having diol functionality and a minor portion of polyol having at least triol 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 produced a polymeric matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.
15. A process as defined in claim 11, wherein said polyol consists of diols of nominal equivalent weight of 1500 and triols of nominal equivalent weights of 2000 in a ratio of approximately 4 to 1 of diol to triol.
16. A process in accordance with claim 11 in which:
said polyisocyanate is a liquid isocyanate based on 4,4'-methyldiphenyldiisocyanate; and said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.
said polyisocyanate is a liquid isocyanate based on 4,4'-methyldiphenyldiisocyanate; and said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US398,913 | 1982-07-16 | ||
| US06/398,913 US4497914A (en) | 1982-07-16 | 1982-07-16 | Breathable ostomy gasket composition |
| US06/491,256 US4561858A (en) | 1983-05-03 | 1983-05-03 | Ostomy bag with integral breathable gasket |
| US491,256 | 1990-03-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1228440A true CA1228440A (en) | 1987-10-20 |
Family
ID=27016424
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000432538A Expired CA1228440A (en) | 1982-07-16 | 1983-07-15 | Breathable ostomy gasket composition and ostomy bag with integral breathable gasket |
Country Status (7)
| Country | Link |
|---|---|
| AU (1) | AU564734B2 (en) |
| BR (1) | BR8303734A (en) |
| CA (1) | CA1228440A (en) |
| DE (1) | DE3325299A1 (en) |
| DK (1) | DK326083A (en) |
| FR (1) | FR2531970A1 (en) |
| GB (2) | GB2125054A (en) |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH471846A (en) * | 1967-04-19 | 1969-04-30 | Elekal | Manufacturing process of a flexible and hydrophilic polyurethane foam |
| CH473852A (en) * | 1967-05-02 | 1969-06-15 | Elekal | Manufacturing process of a flexible and hydrophilic polyurethane foam |
| CH484220A (en) * | 1967-11-13 | 1970-01-15 | Elekal | Manufacturing process of a flexible and hydrophilic polyurethane foam |
| US3713445A (en) * | 1971-01-27 | 1973-01-30 | A Marsan | Sealing ring or pad for a post surgical drainage pouch |
| DE2403656A1 (en) * | 1974-01-25 | 1975-10-30 | Form Altstoff Handelsgesellsch | BINDERS BASED ON POLYOLS AND POLYISOCYANATE AND A PROCESS FOR THEIR PRODUCTION |
| DE2714838A1 (en) * | 1976-04-06 | 1977-10-20 | Grace W R & Co | POLYURETHANE FOAM AND METHOD FOR MANUFACTURING IT |
| LU76474A1 (en) * | 1976-12-24 | 1978-07-10 | ||
| GB2037304B (en) * | 1978-11-24 | 1982-12-01 | Grace W R & Co | Polyurethane foam |
| GB2046764B (en) * | 1979-02-08 | 1983-04-20 | Matburn Holdings Ltd | Polymeric sealant compositions |
| GB2070041B (en) * | 1980-02-20 | 1983-06-22 | Dunlop Ltd | Polyether-urethane foams |
| DE3106246C2 (en) * | 1981-02-20 | 1984-12-20 | Maizena Gmbh, 2000 Hamburg | Molding compound for rigid polyurethane foams filled with starch |
-
1983
- 1983-07-07 AU AU16660/83A patent/AU564734B2/en not_active Ceased
- 1983-07-08 FR FR8311446A patent/FR2531970A1/en not_active Withdrawn
- 1983-07-08 GB GB08318514A patent/GB2125054A/en not_active Withdrawn
- 1983-07-13 DE DE19833325299 patent/DE3325299A1/en not_active Withdrawn
- 1983-07-13 BR BR8303734A patent/BR8303734A/en unknown
- 1983-07-14 DK DK326083A patent/DK326083A/en not_active Application Discontinuation
- 1983-07-15 CA CA000432538A patent/CA1228440A/en not_active Expired
-
1985
- 1985-03-12 GB GB08506334A patent/GB2156833A/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| BR8303734A (en) | 1984-02-21 |
| DK326083D0 (en) | 1983-07-14 |
| GB2156833A (en) | 1985-10-16 |
| FR2531970A1 (en) | 1984-02-24 |
| AU1666083A (en) | 1984-01-19 |
| GB8318514D0 (en) | 1983-08-10 |
| DK326083A (en) | 1984-01-17 |
| AU564734B2 (en) | 1987-08-27 |
| GB2125054A (en) | 1984-02-29 |
| DE3325299A1 (en) | 1984-01-19 |
| GB8506334D0 (en) | 1985-04-11 |
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