Swallowable Intragastric Balloon Pressure Control for Safe Inflation
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Solution Overview
Problem
Current intragastric volume-occupying devices for weight control require complex gastric procedures for insertion and lack control over inflation timing and safety, posing risks to the patient.
Innovation Solution
A swallowable, inflatable intragastric balloon system with a self-sealing valve and inflation control mechanism, allowing for safe inflation and deflation within the stomach using a computing device to monitor pressure and prevent damage to anatomical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex gastric procedures are used to insert intragastric devices, then the device can be implanted, but the procedure complexity and patient risk increase
Solution Approach 1:
The intragastric device is divided into separate components: an orally ingestible balloon and a separate inflation catheter. The balloon can be swallowed intact while the catheter is introduced through the mouth or nose, allowing independent delivery of each component and simplifying the overall implantation procedure.
Solution Approach 2:
The balloon is prepared in a deflated state and encapsulated in a protective coating or container that allows it to be swallowed intact. This preliminary preparation enables the balloon to reach the stomach safely before inflation, avoiding the need for complex surgical implantation procedures.
2Ease of operation
If intragastric devices are inflated without pressure control, then inflation is simple, but tissue damage risk increases
Solution Approach 1:
A pressure sensor is integrated into the balloon to provide real-time feedback on internal pressure during inflation. This feedback is transmitted to an external controller that automatically regulates the inflation process, stopping when a predetermined safe pressure threshold is reached, thereby preventing tissue damage.
Solution Approach 2:
The manual mechanical inflation process is replaced with an automated system that uses electronic pressure sensing and computer-controlled fluid delivery. This substitution eliminates the need for operator judgment and manual pressure estimation, providing precise control and preventing overinflation.
3Device complexity
If intragastric devices lack inflation timing control, then the device structure is simpler, but patient safety is compromised
Solution Approach 1:
The balloon incorporates an automated inflation system that activates upon reaching the stomach, using the body's own physiological conditions (such as temperature or pH changes) to trigger inflation. This self-service mechanism eliminates the need for external manual activation while ensuring safe and timely inflation.
Solution Approach 2:
Manual activation mechanisms are replaced with automated sensing systems that detect physiological parameters (temperature, pH, pressure) to automatically initiate inflation at the appropriate time and location, enhancing patient safety without significantly increasing structural complexity.
4Ease of operation
If swallowable intragastric balloons are used, then invasive procedures are reduced, but control over inflation becomes more difficult
Solution Approach 1:
A separate inflation catheter acts as an intermediary between the swallowed balloon and the inflation source. The catheter can be introduced through the mouth or nose and connected to the balloon's valve, providing a controlled interface for inflation while maintaining the benefit of oral ingestion for the balloon itself.
Solution Approach 2:
The inflation catheter serves multiple functions: it delivers the inflation medium, provides pressure control, and can be used for both initial inflation and subsequent adjustments. This multi-functional approach consolidates control mechanisms into a single device that works with the swallowable balloon.
Data Source
AI summary
Devices and methods for treating obesity are provided. More particularly, intragastric devices and devices for inflating and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.