Title : Innovative user friendly medical device for colostomy stool emission control
Abstract:
Stoma surgery is a mutilating procedure that requires the formation of an opening between the intestine or ureters and the abdominal wall and in most cases is permanent. Patients must apply a stoma bag for the collection of urine and/or feces. The author has designed an innovative soft and permanent one-piece inflatable device to restore colostomy continence in the most natural way possible, avoiding surgical procedures and implantation in the peristomal tissues, and reversible at will at any time and in any bathroom. The device could improve the quality of life of patients by overcoming the drawbacks of colostomy bags and continence devices already on the market and is thSe result of more than forty years of research and an initial development of a previous rigid model handmade one at a time tailored for patients who participated in a previous study. It is now possible to produce a soft and deformable one-piece model and deformable enough to follow the body's movement without causing discomfort. It is therefore possible today to start industrial production because elastomeric materials and new technologies are available for molding liquid silicone in forms containing complex cavities hosting internal devices for the control and deodorization of gas emission when the prosthesis is in use. The device likely represents a milestone in stoma continence, as it intends to provide reversible stoma continence; easy to handle by the patient himself; allowing the use of normal toilets;. The colostomy becomes invisible under any clothing even on naked patients, since it can be colored as desired. It will be used for no more than 28 days, only during the day, since at night a colostomy bag can be used thus favoring the emission of feces during sleep and therefore limiting the need for evacuation during daytime activities. In deflated form, it can be easily inserted and extracted from the stoma. Made of soft silicone elastomer, it is resistant to acids, prevents colonization by bacteria and resists commonly used sanitizing treatments. It consists of a dome-shaped disk flattened on the outside of the stoma resting on the skin, with a stem with an elastic balloon inflatable by means of lateral deformation that allows a final toroidal shape applied to the end of the stem. The device in question is also environmentally friendly. Since colostomy bags used by colostomy patients can be more than one per day, no less than thirty bags full of feces must be disposed of in the waste. The device in question instead lasts 28 days and the single specimen, once rinsed, can be disposed of in household waste.
