On-Demand Inflatable Gastric Balloon: A New Approach to Combat Obesity

Globally, obesity has more than doubled among adults since 1990. Today, an estimated one in eight people are obese. However, this disease increases the risk of developing diabetes, cardiovascular disease and certain cancers. Added to this are mobility problems and sleep disorders. Obesity is therefore a major public health problem. Unfortunately, effective long-term treatments remain limited. A new type of gastric balloon, developed by researchers at MIT, could be a game-changer.

Currently, first-line treatment of obesity generally relies on behavioral interventions (diet modification, physical exercise). In addition, certain drug treatments help limit the absorption of fats by the body or stimulate the secretion of insulin to provide a feeling of satiety. As a last resort, in cases of extreme obesity, surgical intervention may be considered. It essentially aims to restrict the ability to ingest food, by reducing the volume of the stomach.

Temporary gastric balloon placement, by endoscopy, offers a less invasive alternative to help patients lose weight. By occupying part of the stomach permanently, it provides faster satiety. But over time, the stomach “gets used to” the presence of the ball, which reduces the feeling of fullness. Thus, this approach becomes less effective approximately three months after placement of the balloon. The introduction of adjustable gastric balloons has made it possible to partially remove this limitation. We increase the volume of the balloon as soon as the effect is no longer felt, which leads to additional weight loss.

Two prototypes to induce satiety

These observations led us to hypothesize that the persistent mechanical occupation ofu gastric balloon likely manifested as a loss of satiety signaling over time », Explain the researchers in the journal Device.

To get around this problem, they imagined OSIRIS (oscillating satiety induction and regulation intragastric system). This is a “dynamic” gastric device, which distends the stomach just before meals, in order to limit food intake. Then, the dilation stops after meals. The objective here is to induce the feeling of satiety temporarily, to prevent gastric accommodation.

To implement this system, the researchers created two prototypes. One is a motorized extendable head; the other is a PVC balloon. The motorized device can be inserted into the stomach endoscopically. It has four arms, a slider and a motor that can operate the arms so that they exert pressure on the stomach wall. An elastomer envelope covers the whole, in order to protect the tissues.

dynamic gastric balloon and motorized extendable head

(A) Oscillating gastric balloon. (B) Motorized stimulator concept for satiety induction. Credits: Neil Zixun Jia et al., Device (2024)

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Like a traditional gastric balloon, the dynamic stimulation balloon is placed endoscopically. It is connected, via a percutaneous tube, to an external controller and a pump allowing the balloon to be inflated/deflated as needed. An abdominal incision is necessary to insert the tube into the stomach. The procedure would be similar to that used to install a feeding tube, the MIT press release said.

So there is already precedent for other systems that can stay in the body for a very long time. This gives us some confidence in the long-term compatibility of this system “, emphasizes Giovanni Traverso, associate professor of mechanical engineering at MIT, gastroenterologist at Brigham and Women's Hospital and lead author of the study.

Food intake reduced by more than 60%!

Traverso and his team began by testing the durability of the balloon, which had to be able to endure numerous inflation/deflation cycles. “ We observed stable performance over 2000 cycles, which allows us to consider the use of a single OSIRIS balloon system for two years, given that the balloon must inflate/deflate three times per day », they report.

assembly of the dynamic gastric balloon

(A) Air circulation system assembly. (B) Wiring and airflow diagram of the dynamic balloon satiety stimulation system. Credits: Neil Zixun Jia et al., Device (2024)

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The researchers tested their two prototypes in vivo on porcine models. They found that the mechanical arm device could actually expand and put pressure on the stomach tissue. They nevertheless decided to opt for the balloon, mainly for its recognized compatibility with the gastric cavity and its greater reliability. “ Our feeling was that the ball probably distributed force better. And to long term, if it is the ball which exerts the pressure, It is probably a safer approach “, explains Professor Traverso.

The balloon was inflated to 1.5 liters in one minute via the tube provided for this purpose. This volume made it possible to obtain sufficient distension to simulate the sensation of fullness in the upper gastric region. Distension was maintained throughout the meal. The animals were fed twice daily, for 30 minutes, with pelleted food. The team weighed the leftovers after each meal to assess their consumption.

Balloon dilation resulted in a significant reduction in food intake during meals. In the three pigs tested, food consumption decreased by more than 60%!

A potential alternative to bariatric surgery and medications

The researchers specify that the balloon has an internal pressure sensor, which allows the gas pressure to be controlled and prevents excessive inflation. Additionally, to minimize energy costs and extend operating time, the electronics go into sleep mode during periods of inactivity.

This study successfully demonstrated the effectiveness of OSIRIS in modifying feeding behavior in pigs. Full human trials remain to be conducted. According to the researchers, this type of device could constitute an interesting alternative for people who do not wish or cannot undergo more invasive treatments (sleeve, bypassetc.). It might also be suitable for those who do not respond well to weight loss medications.

>>Also read: A vibrating capsule reducing the feeling of hunger, to help treat obesity

Note that the study only extends over a period of one month. The researchers now plan to repeat the experiment in the longer term, to see if OSIRIS can ultimately induce weight loss. “ The deployment of traditional gastric balloons is generally six months or more. CIt is only then that we notice good weight loss. We will need to evaluate our device over a similar or longer period to prove that it really works better », Explains Neil Zixun Jia, first author of the study.

A long-term comparative study would indeed provide valuable information on the advantages of dynamic stimulation. Such research could confirm the benefits of this innovative technology and contribute to the development of more effective and less invasive obesity treatments.

OSIRIS could have a significant impact on society by reducing obesity-related healthcare costs and improving public health outcomes », conclude the researchers.

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