Multi-Balloon Stent Graft for Selective Hemorrhage Control
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Solution Overview
Problem
Current methods for controlling catastrophic bleeding from large and medium-sized vessels, such as the aorta or iliac arteries, often result in permanent damage to downstream organs due to complete occlusion of blood flow, which is not effectively managed by existing technologies like REBOA.
Innovation Solution
An endovascular device featuring a stent graft with an expandable tubular metallic frame, covered with material, and multiple balloons for controlled occlusion, along with sensors and a control unit to automate blood flow modulation, allowing for precise control of bleeding while preserving blood flow to downstream organs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complete occlusion of the aorta is performed to control catastrophic bleeding, then bleeding control is improved, but downstream organs and tissues suffer permanent damage due to lack of perfusion
Solution Approach 1:
The aorta is divided into multiple segments using separate occlusion balloons positioned at different locations. This allows selective occlusion of specific segments containing injuries while maintaining blood flow to other segments and downstream organs, resolving the contradiction between effective bleeding control and preservation of organ perfusion.
Solution Approach 2:
Different regions of the aorta receive different treatments through localized balloon occlusion. The occlusion is applied only where injuries are present rather than complete aortic occlusion, allowing blood flow to be preserved in regions without injury while still achieving effective hemorrhage control at the injury sites.
2Reliability
If prolonged complete occlusion is maintained to ensure bleeding stops, then hemorrhage control is improved, but tissue perfusion is compromised leading to organ damage
Solution Approach 1:
The occlusion is segmented into multiple localized balloons rather than a single prolonged complete occlusion. This allows the occlusion to be maintained only in specific segments where bleeding occurs, while other segments remain perfused, thereby reducing the overall duration and impact of occlusion on downstream organs.
Solution Approach 2:
The occlusion balloons can be inflated and deflated in a periodic manner to control bleeding episodes while allowing intermittent restoration of blood flow to downstream organs, reducing cumulative ischemic damage while maintaining hemorrhage control when needed.
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 effectively controls catastrophic bleeding by selectively occluding blood flow and re-establishing it to unaffected areas, reducing blood loss and minimizing damage to downstream tissues, thereby improving patient outcomes.
Implementation Method 1
The third balloon has a fully inflated configuration that fully occludes the lumen and a partially inflated configuration that partially occludes the lumen for modulating blood flow through the stent graft
Data Source
AI summary
Some implementations of an endovascular device include a stent graft with an expandable tubular metallic frame and a covering material disposed on at least a portion of the metallic frame. The stent graft defines a lumen therethrough. In a particular embodiment, a first balloon is disposed around an outer periphery of the stent graft, a second balloon is disposed around the outer periphery of the stent graft and spaced apart from the first balloon, and a third balloon is disposed within the stent graft lumen between the first balloon and the second balloon. The third balloon can be inflated to fully or partially occlude the lumen. The first and second balloons can be individually inflated to fully or partially shunt blood flow from a blood vessel through the stent graft. In some embodiments, sensors and an automated control unit are included to automate the operations of the endovascular device.