Variable Aortic Control Catheter for Hemodynamic Management
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Solution Overview
Problem
Current endovascular aortic occlusion devices, such as REBOA, lack the ability to provide variable and controlled aortic flow, leading to hemodynamic collapse and inadequate blood flow to vital organs during hemorrhagic events, due to their inability to transition smoothly from complete occlusion to partial occlusion and back, and are not adaptable to varying patient sizes.
Innovation Solution
The development of an endovascular variable aortic control catheter (EVACC) with a radially expandable and collapsible wire framework, an occlusion barrier, and adjustable passageways, allowing for precise regulation of aortic occlusion and reperfusion through various embodiments like Fenestrated Cylindrical Conduit, Single Aperture Reduction, and Captive Balloon designs, enabling dynamic control of blood flow and pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If complete aortic occlusion is used to stop hemorrhage, then blood loss is controlled, but hemodynamic collapse occurs due to inadequate blood flow to vital organs
Solution Approach 1:
The catheter employs a dynamic occlusion system that transitions from complete occlusion to partial occlusion. The balloon can be inflated to different volumes and positioned at different locations within the aorta, allowing the degree of occlusion to be adjusted dynamically based on patient response, thereby controlling hemorrhage while maintaining adequate perfusion to vital organs.
Solution Approach 2:
The system changes the parameter of occlusion degree from 100% to partial percentages. By controlling the balloon inflation volume and position, the device creates a gradient of occlusion that can be precisely tuned to stop distal bleeding while preserving proximal blood flow to the brain, heart, and lungs.
2Object-affected harmful factors
If open aortic cross-clamping is used to control hemorrhage, then blood loss is stopped, but the procedure is extremely invasive and causes ischemia
Solution Approach 1:
The invention replaces the mechanical open surgical aortic clamp with an endovascular balloon catheter system. Instead of requiring chest incision and direct mechanical clamping of the aorta, the device is delivered percutaneously through femoral artery access, using inflatable balloon technology to achieve occlusion, thereby eliminating the need for dramatic surgical intervention.
Solution Approach 2:
The balloon catheter acts as an intermediary device that achieves aortic occlusion without direct contact or clamping of the aortic wall. The inflatable balloon creates a controlled barrier within the aortic lumen, allowing hemorrhage control while avoiding the tissue damage and ischemia associated with open surgical clamping.
3Object-affected harmful factors
If REBOA is used to achieve aortic occlusion, then less morbidity is achieved compared to open clamping, but the device cannot provide variable and controlled aortic flow
Solution Approach 1:
The catheter system provides dynamic flow control through adjustable balloon inflation and repositioning. The device can transition between complete occlusion and partial occlusion states, and can be repositioned within the aorta to control flow to different vascular territories, enabling precise control of distal reperfusion and preventing hemodynamic collapse.
Solution Approach 2:
The aortic occlusion is segmented into controllable zones. By positioning the balloon at different locations and adjusting inflation volume, the device can selectively occlude or partially occlude different segments of the aorta, allowing independent control of blood flow to various organ systems and enabling graduated reperfusion protocols.
4Device complexity
If a single REBOA catheter is used, then device simplicity is maintained, but adaptability to varying patient sizes is limited
Solution Approach 1:
The device achieves adaptability through parameter adjustment rather than device variety. The single catheter can be inflated to different volumes and positioned at different locations within the aorta, creating variable occlusion effects that accommodate different aortic diameters and patient sizes. The system adapts to each patient's anatomy through controlled changes in balloon volume and position.
Data Source
AI summary
Endovascular variable aortic control catheters (EVACC) are provided that are adapted to augment upstream blood pressure and regulate downstream blood flow for patients in shock. The EVACC devices provide improved treatment for truncal wounds, which may be used for example on a battlefield, thereby increasing survivability of injured soldiers. The devices are a catheter-based system having a proximal hand piece for controlled deployment of the device through a delivery sheath. A collapsible, wire framework supports an expandable and collapsible occlusion barrier. The wire basket and occlusion barrier expand to fit within the lumen of the aorta. Various movable elements are used to adjust an adjustable passageway to regulate controlled anterograde blood flow.