GI Balloon Check Valve Docking for In-Stomach Volume Control
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Solution Overview
Problem
Current gastrointestinal balloon systems face challenges in effectively adjusting balloon volume while the balloon is in the stomach due to difficulties in accessing and immobilizing the check valve, leading to low success rates and potential side effects like tissue trauma and intolerance.
Innovation Solution
A check valve system with a docking station that allows for the immobilization and simultaneous access to the valve, utilizing a housing with a plunger and attachment mechanism that can be aligned and operated using a grasping tool to control fluid flow into and out of the balloon, enabling inflation or deflation without removing components from the stomach.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the valve is kept stationary in the balloon and accessed via endoscope while in the stomach, then the components remain inside the stomach without removal, but direct access to the valve is extremely difficult and may not be feasible due to the need for pinpoint precision with head-on engagement
Solution Approach 1:
The device is divided into distinct functional segments: the balloon remains in the stomach while the valve assembly with attachment can be independently manipulated. This segmentation allows the valve to be accessed and operated separately from the balloon body, enabling reliable engagement without requiring precise endoscopic alignment with the stationary valve.
Solution Approach 2:
An attachment mechanism serves as an intermediary between the endoscope and the valve. This attachment provides a grasping interface that the endoscope can reliably engage, translating the endoscopic manipulation into precise valve operation without requiring direct endoscope-to-valve alignment.
2Ease of operation
If a stretchable inflation tube is used to bring the valve out of the stomach to the mouth for manual adjustment, then the balloon volume can be manually adjusted, but tissue trauma and difficulty grasping the tube may occur
Solution Approach 1:
The valve assembly is extracted from the traditional fully-internal configuration and positioned such that it can be accessed through the stomach wall or via endoscopic approach. This extraction eliminates the need for long external inflation tubes that traverse through tissue, thereby reducing tissue trauma while maintaining manual adjustability capability.
Solution Approach 2:
The manual manipulation of a long external inflation tube is replaced by an endoscopic-based mechanical system. The endoscope with its integrated grasping tool provides a more precise and controlled mechanism for valve operation, reducing the mechanical stress and trauma associated with long external tubes.
3Ease of operation
If the balloon is immobilized within the stomach to improve the ease of engaging the valve, then the valve can be accessed at the correct angle, but the balloon may move within the stomach during attempts to engage the valve
Solution Approach 1:
The valve assembly is pre-positioned and secured within the balloon before the engagement procedure. This preliminary securing action ensures that when the endoscope approaches, the valve is already in a stable, predictable position, eliminating the need for balloon immobilization techniques that could cause movement during engagement attempts.
Solution Approach 2:
The attachment mechanism acts as an intermediary that provides a stable engagement interface. This attachment serves as a fixed reference point that the endoscope can reliably grasp and manipulate, eliminating the need to immobilize the entire balloon to achieve proper engagement angles.
Data Source
AI summary
A gastrointestinal balloon system includes a gastrointestinal balloon and a check valve located within the gastrointestinal balloon. The check valve is configured to allow fluid flow into and out of the gastrointestinal balloon. The check valve includes a string coupled to the check valve, the string having a loop on a proximal end and a catheter having a lumen. The lumen is configured to receive a grasping tool. The grasping tool extends out a distal end of the catheter for grabbing the loop to align the catheter with the check valve. Also, a check valve, two-wat valve, and method of using the same in a gastrointestinal balloon.