REBOA Balloon Assembly for Low-Profile Aortic Occlusion Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing REBOA devices have large profiles, require tracking over an endovascular wire, and lack adjustable occlusion capabilities, posing challenges in insertion, bleeding risks, and limited control over blood flow, especially in emergency settings.
Innovation Solution
A low-profile occlusion device with an atraumatic J-tip and a self-similar, elastomeric balloon envelope that allows for variable inflation states, enabling smooth insertion through a 4 French introducer sheath, adjustable perfusion control, and safe overinflation to prevent vessel rupture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If conventional REBOA devices are used, then occlusion function is achieved, but device profile is large requiring 7-12 French introducer sheaths
Solution Approach 1:
The occlusion balloon is nested within the delivery catheter shaft, allowing the device to be delivered through a small-bore (4-5 French) introducer sheath. The balloon remains collapsed during insertion and only expands at the target aortic location, eliminating the need for large introducer sheaths required by conventional devices.
Solution Approach 2:
The device is divided into functional segments: a delivery catheter for navigation, a separate occlusion balloon for vessel closure, and an inflation system. This segmentation allows the occlusion function to be achieved while maintaining a low-profile delivery system that can pass through small vessels.
2Object-affected harmful factors
If conventional REBOA devices with large profiles are used, then occlusion is achieved, but bleeding risk at access site increases
Solution Approach 1:
By nesting the occlusion balloon within the catheter shaft and delivering it through a small-bore (4-5 French) introducer sheath, the access hole in the artery is minimized. This small access site significantly reduces bleeding risk compared to the 7-12 French sheaths required by conventional devices.
3Ease of operation
If conventional REBOA devices are used, then occlusion is achieved, but tracking over endovascular wire is required increasing procedure complexity
Solution Approach 1:
The device combines the delivery catheter and occlusion balloon into a single integrated system that can be advanced through the arterial system without requiring separate guidewire placement. The self-contained design eliminates the need for tracking over an endovascular wire, simplifying the insertion procedure.
4Adaptability or versatility
If conventional REBOA devices are used, then occlusion is achieved, but control over partial occlusion and blood flow adjustment is limited
Solution Approach 1:
The occlusion balloon is designed to provide dynamic control of blood flow through variable inflation. The balloon can be inflated to different volumes to achieve partial or complete occlusion, and can be deflated to restore flow. This dynamic adjustability allows clinicians to control perfusion to ischemic tissues according to patient needs.
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 device reduces insertion complications, minimizes bleeding risks, provides controlled blood flow adjustments, and ensures safe operation in emergency settings by maintaining a consistent shape during inflation and deflation, preventing vessel damage.
Implementation Method 1
a single elastomeric molded balloon that envelopes a portion of the elongate shaft and its central wire
Implementation Method 2
The central passage extends proximally along the length of the shaft to an inflation inlet port, into which inflation fluid for expanding the balloon envelope may be injected
Data Source
AI summary
An occlusion assembly for occluding the aorta of a patient is presented. The occlusion assembly includes an elongate shaft of two separate extrusions to which an elastomeric balloon envelope is bonded to an end of each. A support wire extends through the elongates shaft and the balloon envelope. At a distal end of the shaft, the support wire is provided with an atraumatic J-tip. At the proximal end of the shaft the proximal end of the support wire is secured to a proximal hub to give the entire assembly sufficient stiffness to be advanced into the vasculature of the patient. The balloon envelope is pre-molded to have a reverse teardrop or “ice cream cone” like shape and will maintain that general shape throughout inflation to the fully inflated state. If the balloon envelope is over inflated, the balloon envelope will advance distally and proximally (lengthening) along the support wire without damage to the surrounding vessel.