WEIGHT LOSS BALLOON

Bariatric surgery has long been considered the gold standard for weight-loss treatments in individuals with severe obesity. Procedures such as gastric bypass and sleeve gastrectomy permanently alter the stomach’s size and shape, limiting food intake and promoting weight loss. While effective, these surgeries are invasive, come with significant risks, and are typically reserved for those with extreme obesity. For patients who are overweight or moderately obese, the need for safer, less invasive alternatives has become increasingly urgent.
A leading Gastroenterologist approached us with an innovative idea for a minimally invasive weight-loss solution: the Endoscopic Magnetic Appetite Control System. This system combines an intragastric device and an external magnetic control to stimulate the stomach’s nerves and induce a feeling of satiety. Unlike traditional bariatric surgery, this device avoids cutting or permanently altering the stomach and targets patients who are overweight or obese.
The company had an initial concept for a magnetized balloon stent combo. They tasked us with refining and prototyping the design as well as designing and developing a delivery device. They required that the device maintain its shape even if the balloon was punctured and deflated. Additionally, the device materials must allow multiple inflation and deflation cycles without affecting the overall shape or material integrity. Using an interdisciplinary team of engineers to address these challenges we:

• Transitioned the stent from external to internal so it would still maintain its shape if the balloon was compromised.
• Moved from a 3D printed to a durable silicone molded balloon, preventing it from losing its ability to reshape after extended time in the collapsed state.
• Added additional magnets at both ends of the device to ensure it maintained its shape inside the stomach and allowed precise positioning by the patient.
• Designed and developed a two-part delivery device that could both position the device and inflate it once in the stomach.
• Performed bench testing to refine the device’s performance and durability.
• Conducted proof-of-concept testing in cadavers to validate the design and functionality.
• Wrote initial quality documentation to support future regulatory submissions.
• Introduced a non-invasive solution to prevent the silicone balloon from sticking to itself, avoiding the need for chemical coatings that could interfere with adhesion points during assembly.
• Optimized the system for mass production through design for manufacturing (DFM).

The final result was a minimally invasive weight loss balloon system that, once deployed in the stomach, a patient could control magnetically to induce satiety. The refined device design ensured reliable operation and patient safety, while the internal stent maintained the balloon’s shape and functionality, representing a significant step forward in minimally invasive weight-loss treatments.