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

Abstract

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.

Comparison of vaginal gauze packing technique with or without balloon in high-dose-rate brachytherapy of uterine cervical cancer: a crossover randomized controlled trial

“…Various methods to distance these organs away from high-dose regions have been attempted. These include simple techniques, such as vaginal gauze packing, speculum-based vaginal packing (SBVP), modified bladder and rectal spacer balloons, commercially available rectal retractors, and more invasive techniques, including instillation of hydro-colloid material posterior to the cervix (in the Douglas pouch) [24][25][26][27][28][29][30][31][32][33]. Rectal retractor has been shown to reduce the rectal dose significantly [33][34][35].…”

Bladder–Rectum Spacer Balloon versus Vaginal Gauze Packing in High Dose Rate Brachytherapy in Cervical Cancer: A Randomised Study (Part II)

“…It was then placed over the tandem and inserted together with it in the vaginal cavity. Once the ovoids were inserted, the balloons were positioned such that the bladder and the rectal part of the balloon lay above and below the ovoids, respectively [12]. After checking the position of the applicator, the bladder and the rectal part of the balloons were filled separately with diluted contrast (60e70 ml saline mixed with 4e5 ml iodinated contrast); 10 ml diluted saline was alternately inserted in the bladder and the rectal part of the balloon up to 25e30 ml in each balloon depending on vaginal capacity ( Figure 1).…”

Rectum Protection by Rectal Gel Injection in Cervical Cancer Brachytherapy: A Dosimetric Study via Deformable Surface Dose Accumulation and Machine-Learning-Based Discriminative Modeling

“…Some published studies reported that displacing the OARs away from the brachytherapy source is theoretically feasible in HDR-BT, minimizing radiation-induced complications (5)(6)(7)(8)(9)(10)(11). For example, Damato et al assessed the injection of a novel hydrogel between the cervix, rectum, and bladder in female cadavers and compared it with the standard gauze packing for OAR sparing in cervical cancer brachytherapy.…”