Ostomy appliances and sealing elements
BACKGROUND 
     The present invention relates generally to appliances for use in collection of discharges from the stoma of an ostomy patient and more particularly relates to improved apparatus for forming a comfortable, reliable seal between the ostomy site and the interior of a collection pouch or drain. 
     Apparatus presently employed in the collection of a waste material ordinarily includes a relatively rigid, apertured base gasket which is supported on the abdominal wall of the patient by means of belts, adhesives and the like. Ordinarily such base gaskets include a centrally-disposed tubular flange designed to extend through an opening in the operative back wall of a disposable collection pouch which is adhered to the surface of the gasket. In operation, such gasket and pouch assemblies are mounted on the patient with the stoma protruding through the base gasket tubular flange in the direction of the pouch. The sensitive tissue of and around the stoma is protected from excoriation by the wastes through the use of a soft, pliable annular washer of karaya gum or other similar material. Such a washer is ordinarily disposed around the stoma between the base gasket and the wearer&#39;s abdomen. 
     The basic problem in the use of such a combination is the tendency for body heat to melt the washer element. The resultant oozing of washer material outwardly from the base gasket will soil the clothing and bed clothing of the patient. Another problem with such a combination results from the general bulkiness of the washer when disposed between the base gasket and the patient&#39;s abdomen. As a rule, longer lasting washers are thicker and thus make more difficult a close fit of the ordinarily rigid base gasket against the abdomen. 
     BRIEF DESCRIPTION 
     According to the present invention there is provided an improved collection appliance including sealing systems incorporating a base gasket having a central tubular flange, which flange has a radially outwardly-extending front wall provided with an annular depression. Also incorporated is a soft pliable washer element in the form of a stoma-accommodating flattened annular ring having a tubular flange member. The flange member is registerable within the gasket tubular flange and the ring pliably sealable in place through accommodation of a portion of the ring in the depression of the gasket flange front wall. 
     Also provided according to the invention are composite collection appliances including base gasket and washer elements as above-described together with pouch or drain elements and means for mounting the entire appliances together and in an operative position. 
    
    
     Other aspects and advantages of the present invention will be understood from the following detailed description of presently preferred embodiments, considered in connection with drawings wherein: 
     FIG. 1 is a front elevation of an assembly according to the disclosure of the invention in position on a wearer; 
     FIG. 2 is an exploded sectional view of a washer and base gasket element assembly of the invention; 
     FIG. 3 is a sectional view of an appliance according to the invention, shown operatively mounted in place; 
     FIG. 4 is an exploded perspective view of a gasket and washer element as in FIG. 2; and 
     FIG. 5 is an enlarged fragmentary view of a gasket element flange front surface according to the invention. 
    
    
     DETAILED DESCRIPTION 
     Illustrated in FIG. 1 is appliance 10 according to the present invention shown secured to the abdominal wall 11 of an ostomy patient. Mounting of the appliance 10 is illustrated in greater detail in FIG. 3 wherein the appliance is seen to include a base gasket 12, a pliable washer element 13 and a pouch or drain element 14 on the abdominal wall 11, about the stoma 15 of the patient. 
     Base gasket 12 is preferably fabricated of relatively rigid plastic material formed to provide an operative back surface 16 which in use abuts the abdominal wall 11 of the patient in the area surrounding the stoma 15. Extending from the operative front surface 17 of gasket 12 is a tubular flange 18, annularly disposed about gasket central aperture 19. At least one depression 20 is formed in the radially outwardly-extending front wall 21 of flange 18 and preferably is an annular depression as illustrated. 
     Base gasket 12 is ordinarily secured to abdominal wall 11 by means of surgical adhesions or an elastic belt 30 with fasteners 31, 31. 
     Washer element 13 has a form similar to that disclosed in U.S. Pat. No. 3.520,301, and as such has flattened annular ring portion 22 and a stoma-accommodating, generally tubular flange portion 23 which is dimensioned to allow its registry within aperture 19 of flange 18. Ring portion 22 is positioned and dimensioned so that, when tubular portion 23 is registered in aperture 19, at least a portion of ring 22 will pliably engage in depression 20 in gasket flange front wall 21. 
     Washer element 13 may be manufactured of any suitable gel-like material, such as a mixture of karaya gum and glycerol, to provide sufficient softness in areas of contact with the stoma 15 as well as sufficient pliability at ambient temperatures to allow firm engagement of a portion of ring 22 in depression 20. 
     Secure pliable engagement of a portion of ring 22 in depression 20 may be facilitated through the use of a bead or coating of adhesive material 24, applied either on ring 22 or in depression 20 or both. 
     Pouch or drain element 14 may be of standard plastic film construction and includes a stoma-accommodating opening 25 in its operative back wall 26. Opening 25 is preferably dimensioned to allow registry of flange 18 therethrough and consequently to provide direct access for the stoma to the interior 27 of bag 14. In the preferred embodiment of FIG. 3, and apertured gasket element 28 is sealed about opening 25 and, in operation, gasket 28 is sealingly secured to base gasket operative front surface 17 by an adhesive material 29. Alternatively, gasket 28 may be secured abutting base gasket front surface 17 by means of a belt 30 having fasteners 31 for releasably retaining gasket 28 superimposed on the base gasket. For such purpose gasket 28 would be provided with slots (not shown) laterally corresponding to slots 32 of base gasket 12. 
     FIG. 5 illustrates preferred embodiment base gasket tubular flange 18 wherein the surface area of depression 20 in wall 21 is increased through provision of one or more annular grooves 33. 
     Preferred embodiments of base gasket 12 may be fabricated with tubular flange 18 extending normally outwardly about 1/16 of an inch from gasket front surface 17, base gasket 12 itself having a thickness of about 1/16 of an inch. Flange front wall 21 preferably has transverse dimension of about 1/4 of an inch. Tubular flange 23 of washer 13 should preferably have an outer diameter somewhat less than the inner diameter aperture 19 of gasket 12 to permit easy registry therein and ring 22 should preferably extend radially outwardly at least about 1/8 of an inch to allow for pliable engagement in depression 20. 
     Obviously, modifications and variations of the above-described invention may be made without departing from the spirit and scope thereof. Therefore, only such limitations as are indicated by the appended claims should be placed thereon.