Intragastric Balloon Insertion with Controlled Membrane Tearing
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Solution Overview
Problem
Existing devices for inserting inflatable intragastric balloons face issues such as oropharyngeal, laryngeal, or tracheal injuries, incorrect insertion, and damage to the esophagus or cardia, particularly in obese patients, due to the flexible structure of the preguiding filament and the use of respiratory tubes, leading to potential perforations and internal bleeding.
Innovation Solution
A device with a flexible distal piece and a tear or pre-tear line in the flexible membrane surrounding the inflatable balloon, ensuring controlled emergence and attachment to the device, minimizing the risk of uncontrolled tearing and damage during inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a flexible preguiding filament is used to guide the device through the esophagus, then the device can navigate the esophageal tract, but the filament becomes bent in the esophageal wall causing perforation risk
Solution Approach 1:
The device is divided into a rigid guide tube segment and a flexible filament segment. The rigid guide tube provides structural support to prevent bending and perforation, while the flexible filament maintains guiding capability. This segmentation resolves the contradiction by combining rigid and flexible properties in different parts of the system.
Solution Approach 2:
The rigid guide tube acts as an intermediary between the flexible filament and the esophageal wall. It mediates the mechanical stresses by providing a rigid pathway that prevents the filament from bending into the wall, thereby eliminating the perforation risk while maintaining the guiding function.
2Ease of operation
If the conical distal end of the guide tube is used to introduce the device, then the device can be inserted through the esophagus, but it gets stuck at bent points causing serious injury
Solution Approach 1:
Instead of forcing the conical distal end through bent pathways, the invention inverts the approach by using a rigid guide tube that maintains its straight configuration. The rigidity allows the tube to be pushed through the esophagus without conforming to bends, thereby avoiding getting stuck and preventing injury at bent points.
3Ease of operation
If the cardia acts as a stop for the inflated balloon during removal, then the balloon can be released, but serious damage and internal bleeding occur
Solution Approach 1:
The invention extracts the release mechanism from dependence on the cardia anatomy. By providing a dedicated release mechanism at the proximal end of the guide tube, the system removes the harmful interaction with the cardia entirely. The balloon can be released without using the cardia as a stop, thereby preventing internal bleeding while maintaining the release function.
4Reliability
If a respiratory tube is used to ensure the airway during insertion, then the airway is protected, but the procedure becomes more complex and discomfort increases
Solution Approach 1:
The invention extracts the airway protection function from the respiratory tube and integrates it into the guide tube design. By incorporating airway protection features directly into the insertion device, the system eliminates the need for a separate respiratory tube, thereby reducing procedure complexity and patient discomfort while maintaining airway protection reliability.
Data Source
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AI summary
A device for inserting an inflatable intragastric balloon of the type that uses a filament to guide same, characterized in that it comprises: - a first through channel from a proximal end to a distal end of said device, for the insertion of the guiding filament for said device; - said distal end having a flexible distal piece through which said first internal channel passes - an internal compartment arranged adjacent and proximal with respect to said distal end and adjacent to a medial area of the device, an inflatable balloon being housed in said compartment, said compartment comprising a flexible external membrane surrounding said balloon; - a second through channel from the proximal end to said internal compartment, said second channel being connected to a balloon arranged inside said internal compartment, in which said flexible external membrane is secured to said flexible distal piece and to the medial area of the device, said flexible membrane having a tear or pre-tear line to facilitate the emergence of the balloon during its inflation.