A Gastric Band with Adjustable Inner Diameter for Obesity Surgery: Preliminary Studies.

Gastric banding for morbid obesity is theoretically an attractive method, since it is easily reversible, does not require opening of the stomach or intestines, and is associated with a very low surgical risk. The disadvantage is the high rate of reoperation because of the difficulty to obtain an optimal stoma diameter. This led us to develop a new gastric balloon band in which it is possible to regulate the inner diameter between 0 and 40 mm. In this study of the technical properties, we have investigated the inner pressure of the band during filling, the breaking point of the balloon when overfilling, the strength of the band and finally the degree of diffusion through the system. We found that there is no pressure with filling up to 10 ml. The band is thus a low pressure system. It can be filled with five times its normal volume before breaking. A pressure of 300 mmHg can be applied inside the system without breaking it. Finally, when the system was filled with soya oil, there was no detectable diffusion through the system in a one-year trial. These findings are consistent with our preset specifications. Clinical trials have therefore been started.