GB2156833A

GB2156833A - Breathable ostomy gasket composition and ostomy bag seal formed therefrom

Info

Publication number: GB2156833A
Application number: GB08506334A
Authority: GB
Inventors: Douglas Allen; Eric Flam
Original assignee: CR Bard Inc
Current assignee: CR Bard Inc
Priority date: 1982-07-16
Filing date: 1985-03-12
Publication date: 1985-10-16
Also published as: BR8303734A; DK326083D0; FR2531970A1; AU1666083A; GB8318514D0; DK326083A; AU564734B2; CA1228440A; GB2125054A; DE3325299A1; GB8506334D0

Abstract

A new ostomy bag having an integral breathable ostomy gasket derived from the non-aqueous reaction of a polyisocyanate and a polyoxyalkylene polyol having a hydrophilic filler incorporated within the polyol prior to the reaction of the polyisocyanate and the polyol. The bag includes hydrophobic material welded to the bag serving as a backing for the gasket. The filler may be hydroxyethylcellulose and/or hydroxypropylcellulose. The filler is physically encapsulated within the polymer matrix.

Description

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GB2 156 833A 1

SPECIFICATION

Breathable ostomy gasket composition and ostomy bag seal formed thereof

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BACKGROUND OF THE INVENTION The present invention relates to ostomy appliances and particularly those devices used by ostomy patients having an integral or unitized 10 thin barrier gasket formed of a composition which has unique and desirable properties, i.e., breathability, tack, resistance to leakage, dissolution, and disintegration by fluids and cohesive strenght. More particularly, the in-15 vention relates to the combination of a specific gasket material which may be formed as a composite panel with a hydrophobic backing, as for example, a thermoplastic and which is adapted for integral manufacture 20 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 25 of properties afforded by the unitized ostomy appliance and a skin barrier. Utilizing the present invention, high levels of conformabil-ity, strength and dry and wet adhesion simultaneously and continuously serve to overcome 30 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 appli-35 ances to interfere with body movements and to present an objectionable appearance beneath clothing.

Ostomy appliance gaskets based upon the inclusion of Karaya powder, as disclosed in 40 U.S. Patent 3,302,647, are currently in general use. Karaya 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 45 prior to use. Karaya compositions are lacking in cohesiveness, and therefore tend to disintegrate as well as become slippery when wet, often times necessitating the use of a special adhesive to prevent dislocation from the os-50 tomy site.

In U.S. Patent 4,160,076, there are disclosed hydrophilic foams prepared from a capped polyoxyalkylene polyol reactant having a defined average reaction functionality 55 greater than 2, an aqueous reactant and a carefully balanced combination of a nonionic surface-active agent and a liquid defoaming agent. The resultant foams are characterized by a majority of large size cells and mem-60 branes which themselves are formed with small cells. In addition, large amounts of many water-soluble or water-dispersible materials such as cellulosic pigments, dyes, enzymes or the like may be added to the aque-65 ous reactant. By homogeneously distributing these materials in the aqueous reactant they may be distributed throughout the finally prepared foam. However, the large cell size and membranes characteristic of the hydrophilic polyurethane sponges do not possess the necessary properties of tack, elasticity, seala-bility and flexibility needed in an ostomy gasket.

An ostomy gasket possessing varying degrees of tackiness lubricity, and softness is disclosed in U.S. Patent 3,980,084. The polymeric ostomy sealing gasket therein disclosed is formed by the polymerization of a hydroxyalkyl acryalte or methacrylate in the presence of a polyalkylene 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 is absorbed into the polymer matrix during the polymerization reaction. In addition, natural or synthetic gums or cellulosic type materials to increase absorptive capacity may be incorporated into 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 seal-ability preferred for use in an ostomy device which may result in leakage around the ostomy seal.

OBJECTS OF THE INVENTION

One of 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 providing a polymeric composition adapted for use in contact with the skin derived from the non-aqueous reaction of a polyisocyanate and a polyoxyalkylene polyol moiety having a hydrophilic filler physically incorporated within the polyol prior to the reaction.

A further object of 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 body having a high degree of tack, elasticity, flexibility, and resistance to body fluids. This precludes movement of the seal around the stomal 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

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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 5 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 Karaya 10 products which have a limited shelf life and harden during storage.

SUMMARY OF THE INVENTION

A sealing pad or gasket formed of the new 15 composition is interposed between a fluid resistant material, such as a fabric, film, non-woven fabric, or the like which is welded to the face of the ostomy device and the skin of the user surrounding the stoma. The sealing 20 pad serves to contain 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 25 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 composition, the pad 30 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 prepared by the reaction of an 35 organic polyisocyanate with one or more di- or polyfunctional hydroxyl compounds for example polyoxyalkylene polyols such as those derived from propylene or ethylene oxide, preferably having equivalent weights of at 40 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.

45 The soft polymeric matrix or adhesive composition that is formed by the reaction physically encapsulates the uniformly dispersed hydrophilic filler within the resulting self-sustaining adhesive composition. Thus, the product 50 resists swelling and dissolution by or passage of bodily fluids while being inherently thereby readily allowing migration and transfer of gases such as water vapor.

Our new ostomy bag which may be formed, 55 for example, either as an ileostomy pouch, urostomy pouch, or colostomy bag utilizes the highly elastic, tacky, rubbery gum as the gasket material and the same is backed with a soft, fluid resistant material and is cast with 60 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.

65 DESCRIPTION OF THE DRAWINGS

In the drawings. Fig. 1 is a plan view of a typical colostomy bag of the present invention;

Figure 2 is an enlarged cross sectional view through the bag of Fig. 1 taken along the lines 2-2; thereof; and

Figure 3 is a plan view of a typical ileostomy pouch utilizing the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Further objects and advantages will become apparent from a consideration of the drawings and this detailed description wherein like reference characters refer to similar parts throughout the description.

The invention herein disclosed consists of a unitary assembly of an ostomy bag shown generally at 10 which may be formed in any of several well-known configurations. The bag in Fig. 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 of an opening, or stoma in the wall of the intestine or colon, which opening extends through the wall of the patient's skin. A urostomy consists of either bringing the ureters to the abdominal skin (ureterostomy) or connecting the ureters to a section of the ileum which in turn is brought out to the skin (ileal-conduit). The stoma provides means for communication between the inside 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 Fig. 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 Fig. 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

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Fig. 3 embodiment, the bag has a narrow bottom portion shown at 20 and the end thereof 21 is open but may be sealed by use of the flexible clip 23 which is secured 5 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.

10 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 previ-15 ously described. The material is quite thin, generally less than .050 inches, preferably about .010 inches but also as low as 0.001 inches in thickness. The highly elastic, tacky, rubbery gum which is described in greater 20 detail later herein is applied to the fabric backing 25 and is shown in Figs. 2 at 26. Here the material is applied in a thickness of from about .010 inches to .050 inches. Heat sealing of the gasket 26 and backing 25 may 25 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 peelable material such as 30 release paper or film 28 is applied over and adheres to the tacky gasket. This serves to guard the gasket 26 in storage and prevents adherence thereto of dust or other foreign particles. It is gripped at a free edge and 35 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 40 where n is at least 2, and R is selected from the group consisting of aliphatic, alicyclic, aliphatic-alicyclic, aromatic or aliphatic-aromatic hydrocarbon compounds.

Examples of commercially available polyiso-45 cyanates which may be used include liquid isocyanates or polymeric isocyanates based on 4,4'-methyldiphenyldiisocyanates such as UpJohn Company Isonate 143L, UpJohn Company PAPI 901, Mobay Chemical Corpo-50 ration Mondur CD, and Mobay Chemical Corporation Mondur MRS-10.

Among the commercially available polyoxyalkylene polyols which may be utilized in the practice of the invention are, for example, 55 Niax Polyol-PPG-3025 (Union Carbide Corporation), Poly-G 55-37 (Olin Chemicals), Poly-G 85-28 (Olin Chemicals), and Multranol 3901 (Mobay Chemical Corporation).

The preferred polyols are Union Carbide 60 Niax Polyol-PPG-3025 and Mobay Multranol 3901. The preferred polyisocyanate is UpJohn Company Isonate 143L.

The proportions and molecular weights of the polyoxyalkylene polyols used, as well as 65 the amounts of the hydrophilic fillers, are governed by the desired characteristics of the final product. Thus, one may tailor products having a diverse range of properties such as tackiness, breathability, cohesiveness and the like.

For example, an elastomer matrix composition formed with diol moieties having nominal equivalent weights of 1500 and tril moieties having nominal equivalent weights of 2000, used in a ratio of approximately 4 to 1 (by equivalents) of diol to triol, yields a particularly desirable product for an ostomy sealing gasket having physically incorporated therein a hydrophilic filler such as hydroxye-thylcellulose, hydroxypropyl cellulose or mixtures thereof in the range of 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 hydroxypropylcel-lulose than, for example, with sodium carbox-ymethylcellulose, karaya gum or polyacrylam-ide 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 homogeneous mixture, 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 NCO 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 NCO moieties. These physical characteristics also are evident if 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 affects the final composition as follows: When the NCO/OH 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 amines, and other catalysts well known in the art.

In addition, a suitable surfactant, such as Dow Corning Antifoam B, may be utilized to aid in controlling the uniformity of flow and

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formation of the resulting plastic compositions.

Many suitable adhesive compositions can be obtained by minor variations in the 5 amounts of ingredients employed. The following examples are illustrative of the invention.

Example #1 35.0 grams (0.0233 equivalents) of Union 10 Carbide Niax Polyol PPG 3025 (1500 Equivalent Weight polyether diol) and 11.0 grams (0.0055 equivalents) of Mobay Multranol 3901 (2000 EW polyether triol) were blended with 2 drops of M & T Chemical Catalyst T-12 15 (dibutyltindilaurate) and 1 drop Dow Corning Antifoam B (silicone surfactant). To this mixture, 24.0 grams of Hercules Natrosol 250 HHR hydroxyethylcellulose were blended to form a smooth, homogeneous, creamy liquid. 20 Then, 4.2 grams (0.0292 equivalents) of UpJohn Isonate 143L (liquid isocyanate based on 4,4'-methyldiphenyldiisocyanate) were added and the mixture thoroughly blended for 60-90 seconds, after which it was poured 25 into an open 1 /8" 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 45°C.

30 The resulting product was a soft, flexible, tacky elastomer 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 is ide-35 ally suited for use as an ostomy barrier.

Example #2

The procedure of Example 1 is repeated, except that the silicone surfactant was de-40 leted. The resulting product was identical to that of Example 1.

Example #3 The procedure of Example 1 was repeated 45 using 28.8 grams (0.0192 equivalents) of PPG 3025 and 19.2 grams (0.0096 equivalents) of Multranol 3901.

The resulting product was similar to Example 1, however somewhat lower in tack 50 and elasticity.

Example #4

The procedure for Example 1 was repeated using 21.6 grams (0.0144 equivalents) of 55 PPG 3025 and 28.8 grams (0.0144 equivalents) of Multranol 3901.

The resulting product possessed less tack and elasticity than Example 3.

60 Example #5

The procedure for Example 1 was repeated using 43.2 grams (0.0288 equivalents) of PPG 3025 and no Multranol 3901 with 40 drops of catalyst T-12.

65 The resulting product was highly tacky and soft, exhibiting creep, and not suitable for an ostomy gasket.

Example #6

70 The procedure for Example 1 was repeated using no PPG 3025 and 57.6 grams (0.0288 equivalents) of Multranol 3901.

The resulting product tears easily and has low conformability and tack rendering it un-75 suitable as an ostomy gasket.

Example #7

The procedure for Example 1 was repeated using 36.4 grams (0.0243 equivalents) of 80 PPG 3025 and 9.0 grams (0.0045 equivalents) of Multranol 3901.

The resulting product was very soft and tacky exhibiting a slight tendency to creep.

85 Example #8

The procedure for Example 1 was repeated using 11.7 grams (0.0233 equivalents) of Quaker Oats Polymeg 1000 (500 EW polytet-ramethylene ether glycol) and 11.0 grams 90 (0.0055 equivalents) of Multranol 3901.

The resulting product had lower conformability, tack, elasticity and tear strength than Example 1.

95 Example #9

The procedure for Exampl 1 was repeated using 13.0 grams Hercules Klucel HF hydrox-ypropylcellulose in place of Natrosol.

The resulting product was whiter than but 100 otherwise similar to Example 1.

Example #10

The procedure for Example 1 was repeated using 16.0 grams Natrosol 250 HHR and 8.0 105 grams Klucel HF.

The resulting product was lighter colored than Example 1 but otherwise similar in properties.

110 Example #11

The procedure for Example 1 was repeated using an initial cure at 45°C for 15 minutes to set the material followed by overnight cure at room temperature.

115 The resulting product is similar to Example 1.

Example #12 A prepolymer was prepared by mixing 35.0 120 grams (0.0233 equivalents) of PPG 3025

with 11.0 grams (0.0055 equivalents) of Multranol 3901 and drying the mixtures at 100-110°C under vacuum at 30 in. Hg. 8.4 grams (0.0584 equivalents) of Isonate 125 143L were added slowly with thorough mixing and the mixture maintained at 95°C for 4 hours under nitrogen with frequent mixing. It was then set aside under a nitrogen lid at room temperature until the following day, 130 when a homogeneous mixture of:

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35.0 grams (0.0233 equivalents) of PPG 3025,

11.0 grams (0.0055 equivalents) Multranol 3901,

5 4 drops of T-12 (dibutyltindilaurate),

2 drops antifoam B, and 48.0 grams Natrosol 250 HHR was added. The mixture was thoroughly blended for 60-90 seconds and poured into a 10 sheet mold as in Example 1, cured at room temperature for 1 hour and then at 45°C 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 Isonate 143L into 10 grams (0.0066 equivalents) of 20 PPG 3025 (previously dried at 100-110°C under vacuum at 30 in. Hg.) The mixture was maintained under nitrogen at 95°C for 4 hours with frequenc mixing, after which it was set aside under a nitrogen lid at room temper-25 ature 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) PPG 30 3025

11.0 grams (0.0055 equivalents) Multranol 3901 4 drops T-12 2 drops Antifoam B 35 24.0 grams Natrosol 250 HHR

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 45°C overnight. 40 The resulting product was identical to Example 1.

Claims

1. An ostomy bag having a front face 45 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 50 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 55 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, 60 wherein the hydrophobic backing is a fluid resistant material.

3. An ostomy bag as identified in claim 1, wherein the polymeric composition comprises a reaction product of an organic polyisocyan-

65 ate of the general formula R(NC0)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 1 500 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 isocy-anate based on 4,4'-methyldiphenyldiisocyan-ate;

said polyo! is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.

6. A polymeric composition for use in contact with the skin which comprises a reaction product of an organic polyisocyanate, and a polyoxyalkylene polyol moiety 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.

7. A polymeric composition adapted for use in contacting the skin which comprises a reaction product of an organic polyisocyanate of the general formula R(NC0)n where R is independently selected from the class consisting of aliphatic, alicyclic, aliphatic-alicyclic, and aromatic or aliphatic-aromatic hydrocarbon compounds and n is at least 2, and a polyoxyalkylene polyol moiety of the general formula R(0H)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.

8. A process for making a polymeric composition according to Claim 6,

45 in which said polyisocyanate is a liquid isocyanate based on 4,4' methyldiphenyldiisocyanate; and wherein said polyol moeity is a mixture of 1 500 equivalent weight polyether diol and 2000 equivalent weight polyether

50 triol.

Printed in the United Kingdom for

Her Majesty's Stationery Office, Dd 8818935, 1985. 4235 Published at The Patent Office. 25 Southampton Buildings, London, WC2A 1AY, from which copies may be obtained.

8. A polymeric composition as defined in claim 6 wherein said polyol consists of diols of nominal equivalent weights of 1 500 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;

said polyol is a mixture of 1 500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.

10. A polymeric composition for use as an ostomy appliance seal in contact with the skin which comprises a reaction product of an

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organic polyisocyanate and a polyoxyalkylene polyol moiety having incorporated into the polyol moiety prior to the reaction of the polyisocyanate and the polyol a hydrophilic 5 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

10 composition for use in contact with the skin which comprises reacting an organic polyisocyanate and a polyoxyalkylene polyol having incorporated into the polyol moiety prior to the reaction of the polyisocyanate and the 1 5 polyol 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

20 composition adapted for use in contacting the skin which comprises reacting an organic polyisocyanate of the general formula R(NCO)n where R is independently selected from the class consisting of aliphatic, aliphatic-alicyclic, 25 and aromatic or 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, with the proviso that the 30 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 produced a polymeric matrix characterized by 35 the physical encapsulation of the hydrophilic filler within the polymeric matrix.

13. A process for making a polymeric composition for use as an ostomy appliance seal in contact with the skin which comprises

40 reacting an organic polyisocyanate and a polyoxyalkylene polyol having incorporated into the polyol moiety prior to the reaction of the polyisocyanate and the polyol a hydrophilic filler wherein there is produced a polymeric 45 matrix characterized by the physical encapsulation of the hydrophilic filler within the polymeric matrix.

14. A process for making a polymeric composition for use as an ostomy appliance

50 seal in contact with the skin which comprises reacting an organic polyisocyanate of the general formula R(NCO)n where R is independently selected from the class consisting of aliphatic, alicyclic, aliphaticalicyclic, and 55 aromatic or 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, with the proviso that the polyol 60 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 produced a polymeric matrix characterized by 65 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 1 500 and triols of nominal equivalent weights of 2000 in a ratio of approximately 4 to 1 of diol to triol.

16. A polymeric composition in accordance with claim 11 in which:

said polyol is a mixture of 1500 equivalent weight polyether diol and 2000 equivalent weight polyether triol.

Amendments to the claims have been filed, and have the following effect.-

Claims 1 to 16 above have been deleted or textually amended.

New or textually amended claims have been filed as follows:-

1. A polymeric composition, for providing an elastomeric, adhesive, breathable, cohesive, conformable, body fluid generally non-degradable, shaped ostomy gasket, for use in adherent contact with the skin,

which composition comprises a product derived from the generally non-aqueous reaction of an organic polyisocyanate, and a polyoxyalkylene polyol moiety, which polyoxyalkylene moiety comprises a mixture of a major portion of polyol having a diol functionality and minor portion of polyol of at least triol functionality, the polyoxyalkylene polyol moiety incorporating, prior to its generally non-aqueous reaction with the polyisocyanate, a hydrophilic filler,

so that there is provided a polymeric matrix in which the filler is physically encapsulated.

2. A polymeric composition, according to Claim 1 wherein the organic polyisocyanate is of the formula

R(NCO)n where R is selected from the group consisting of aliphatic, alicyclic, aliphatic-alicyclic, and aromatic or aliphatic-aromatic hydrocarbon compounds and n is at least 2,

and wherein the polyoxyalkylene polyol moiety is of the formula

R(OH)n'

where R is a polyoxyalkylene and n' is at least 2.

3. A polymeric composition as defined in Claim 1 wherein said polyol moiety consists of diols of equivalent weights of the order of

1 500 and triols of equivalent weights of the order of 2000 in a ratio of approximately 4 to 1 of diol to triol.

4. A polymeric composition in accordance with Claim 1 in which:

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said polyisocyanate is a liquid isocyanate comprising 4,4' methyldiphenyldiisocyanate;

said polyol moiety being a mixture of 1 500 equivalent weight polyether diol and 2000 5 equivalent weight polyether triol.

5. A process for making a polymeric composition as defined in claim 1, the process comprising reacting, under generally nonaqueous conditions, an organic polyisocyanate

10 and a polyoxyalkylene polyol moiety, said polyoxyalkylene moiety comprising a mixture of a major portion of polyol having a diol functionality and a minor portion of polyol of at least triol functionality, the polyoxyalkylene

1 5 polyol moiety incorporating, prior to its generally non-aqueous reaction with the polyisocyanate, a hydrophilic filler, so that there is provided a polymeric matrix in which the hydrophilic filler is physically encapsulated.

20 6. A process for making a polymeric composition according to claim 5, wherein the organic polyisocyanate is of the formula

(RNCO)n

25

where R is selected from the group consisting of aliphatic, alicyclic, aliphatic-alicyclic, and aromatic or aliphatic-aromatic hydrocarbon compounds and n is at least 2,

30 and wherein the polyoxyalkylene polyol moiety is of the formula

R(0H)n'

35 where R is a polyoxyaklylene and n' is at least 2.

7. A process for making a polymeric composition according to Claim 6, wherein said polyol moiety consists of diols of equivalent

40 weight of the order of 1 500 and triols of equivalent weights of the order of 2000 in a ratio of approximately 4 to 1 of diol to triol.