Design and development of an inflatable latex balloon to reduce rectal and bladder doses for patients undergoing high dose rate brachytherapy

Multiple fractions of High Dose Rate (HDR) brachytherapy along with external beam therapy is the common method of treatment for cancer of the uterine cervix. Urinary bladder and rectum are the organs at risk (OARs) that receive a significant dose during treatment. To reduce the dose to these organs, a majority of hospitals use vaginal gauze packing, as it is a simple, nontraumatic, and easy method. This article describes the design and development of an inflatable balloon that can be used along with the applicator as a substitute for gauze packing. The balloon has two parts-the bladder part (B-part) and the rectum part (R-part), both of them are independently inflatable. The selection of the material, its width, length, and thickness are described. A mould/former for making the balloon was designed. Polished steel was used as the mould. This was dipped in specially prepared natural rubber latex (NRL) solution several times; the layers were dried and stripped to get the balloon. The composition of NRL and the compounding recipe of the latex are also described. Physical tests like tensile strength, elongation at break, bursting volume, and radiation attenuation caused by the balloon, were checked. Biological tests for assessing type I and type IV allergies, like dermal irritation and skin irritation tests, were also done.