Swallowable Intragastric Balloon with Controlled Inflation Timing
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Solution Overview
Problem
Current intragastric volume-occupying devices for weight management require complex gastric procedures for insertion and lack control over inflation timing, leading to discomfort and potential complications.
Innovation Solution
A swallowable, self-inflating or inflatable intragastric balloon system with a self-sealing valve and inflation catheter, allowing for non-invasive deployment and controlled inflation/deflation using a needle assembly and hydraulic pressure, and a polymeric wall made of biocompatible materials.
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 discomfort increase
Solution Approach 1:
The intragastric device is nested within a delivery catheter system, allowing the device to be transported and deployed through the gastrointestinal tract via the esophagus and stomach without requiring external surgical access. The device is contained within the catheter during insertion, then released and inflated within the stomach lumen, eliminating complex gastric procedures.
Solution Approach 2:
A delivery catheter serves as an intermediary tool that facilitates the non-invasive insertion of the intragastric device through the natural gastrointestinal passage. The catheter acts as a conduit, allowing the device to be positioned and deployed within the stomach without requiring surgical incisions or complex gastric access procedures.
2Ease of operation
If intragastric devices are inserted without controlled inflation timing, then insertion is simpler, but patient discomfort and complications increase
Solution Approach 1:
The device is prepared in a deflated state within the delivery catheter before insertion, allowing it to pass through the esophagus and stomach without occupying volume. Inflation is initiated only after the device reaches the appropriate position in the stomach, as indicated by pressure sensor feedback, ensuring controlled timing and preventing premature expansion that would cause discomfort.
Solution Approach 2:
Pressure sensors provide real-time feedback on the device's position and the stomach's internal pressure conditions. This feedback mechanism allows the control system to determine the optimal moment to initiate inflation, ensuring that the device is properly positioned and that inflation occurs under controlled conditions, thereby minimizing patient discomfort and complications.
3Reliability
If the balloon occupies large volume in the stomach, then satiety feeling is enhanced, but the risk of discomfort and complications increases
Solution Approach 1:
The balloon volume is made dynamically adjustable rather than fixed. The control system can inflate the balloon to different volumes based on real-time feedback from pressure sensors and patient response. This allows the balloon to occupy sufficient volume to provide satiety while preventing excessive expansion that would cause discomfort or complications, enabling adaptive volume control.
Solution Approach 2:
The balloon's key parameter (volume) is changed from a fixed value to a controllable variable. By adjusting the inflation pressure and volume parameters based on feedback signals, the system optimizes the balance between achieving sufficient satiety effect and avoiding excessive volume that would cause stomach discomfort, allowing precise control over the balloon's physical state.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables non-invasive insertion and controlled volume occupation in the stomach, reducing caloric intake by providing a feeling of satiety, with minimal patient discomfort and improved safety through controlled inflation and deflation mechanisms.
Implementation Method 1
a self-sealing valve system that allows for gas addition to the balloon and subsequent needle withdrawal while maintaining the seal
Implementation Method 2
controlled inflation/deflation using a needle assembly and hydraulic pressure
Data Source
AI summary
Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.