Single Lumen Occlusion Assembly for REBOA
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Solution Overview
Problem
Current REBOA procedures require sophisticated equipment and extensive surgical training, limiting their use in pre-hospital settings, especially in military and emergency situations where resources and expertise may be scarce.
Innovation Solution
A single lumen occlusion assembly with a streamlined construction, capable of being inserted through a 4 French sheath, which allows for easier insertion and reduced risk of bleeding, and can be used without external imaging, making it more portable and accessible.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a standard angioplasty balloon device is used for REBOA, then the procedure can be performed with conventional equipment, but the device profile is too large requiring large sheaths and extensive surgical training
Solution Approach 1:
The device separates the balloon inflation lumen from the guidewire lumen, allowing the balloon to be inflated after insertion through a small sheath. This segmentation enables the use of a smaller 4 French sheath compared to conventional devices that require larger sheaths for balloon access.
Solution Approach 2:
The guidewire is inserted through the inner lumen of the catheter, and the balloon is subsequently inflated within the vessel lumen. This nested arrangement allows compact insertion through small sheaths while maintaining full functionality.
2Force
If conventional REBOA equipment is used, then sufficient occlusion force can be achieved, but the equipment is not portable and requires sophisticated infrastructure
Solution Approach 1:
The device is designed to be self-contained with the balloon inflating directly within the vessel after wire insertion. The system uses simple components that can be deployed without complex imaging or sophisticated equipment, making it suitable for resource-limited settings while maintaining adequate occlusion force.
3Object-affected harmful factors
If a low profile catheter is used, then insertion and removal bleeding risk is reduced, but the device may not provide sufficient structural support for proper positioning
Solution Approach 1:
The guidewire acts as an intermediary that provides structural support and track for catheter insertion. The wire maintains the catheter's position and direction, compensating for the reduced structural support from the smaller catheter profile, while enabling safe insertion through a 4 French sheath.
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
The occlusion assembly provides a lower profile option for REBOA procedures, enabling use in a wider range of arterial locations and patient populations, including pediatric patients, and in diverse settings such as rough field conditions and in-hospital environments, while minimizing complications and training requirements.
Implementation Method 1
the inner lumen defining a flow channel for a fluid to inflate the inflatable balloon portion when the fluid is injected into the inner lumen
Data Source
AI summary
An occlusion assembly and its uses in a REBOA procedure is disclosed. The occlusion assembly includes a single elongate shaft having an inflatable balloon, a proximal neck portion, a distal neck portion. The shaft defines a single lumen through which a wire is positioned for support of the shaft and through which an inflation fluid is also passed to inflate the balloon.