Atraumatic Vessel Occluder With Chamber Pressure Sensing
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Solution Overview
Problem
Existing occlusion devices for veins face challenges in controlling balloon inflation due to larger diameters and weaker, less elastic vein structures, leading to complications like vessel rupture and dissection, while lacking accurate monitoring of interstitial fluid pressure affecting therapeutic uptake.
Innovation Solution
An atraumatic vessel occlusive system with a flexible tubular member and a diametrically adjustable occluder equipped with pressure sensors, allowing real-time monitoring of venous and systemic pressures to prevent over-pressurization and ensure therapeutic agent delivery to target tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon occlusion device is used in veins, then occlusion can be achieved, but the larger diameter and weaker vein structure lead to high radial forces causing vessel rupture and dissection
Solution Approach 1:
The invention changes the fundamental parameter of occlusion mechanism from radial expansion (balloon) to longitudinal compression (microvalve). The microvalve occluder compresses venous blood flow through axial movement along the vessel axis, reducing radial forces on the vessel wall while maintaining effective occlusion. This parameter change resolves the contradiction between achieving reliable occlusion and preventing vessel damage in fragile veins.
Solution Approach 2:
The invention replaces the balloon-based pneumatic/hydraulic expansion system with a mechanically actuated microvalve system. The microvalve occluder is deployed through longitudinal displacement of the inner catheter relative to the outer catheter, creating compression rather than radial expansion. This mechanical substitution eliminates the high radial forces that cause vessel rupture while maintaining occlusion effectiveness.
2Reliability
If traditional balloon occlusion is used, then occlusion is achieved, but precise control of inflation is challenging due to larger balloon diameters required for veins
Solution Approach 1:
The invention replaces the fluid-based inflation control system with a direct mechanical actuation system. The microvalve occluder is deployed through longitudinal displacement of the inner catheter, providing intuitive and precise control without requiring fluid pressure management. This mechanical substitution simplifies the operation and improves precision in controlling occlusion deployment.
Solution Approach 2:
The invention introduces a dynamic, adjustable occlusion mechanism where the microvalve can be deployed and positioned precisely through longitudinal movement. The system transitions from a static balloon that requires careful inflation monitoring to a dynamically controllable microvalve that can be precisely positioned and adjusted through catheter displacement, improving ease of operation.
3Reliability
If balloon occlusion is used in veins, then occlusion can be achieved, but the weaker and less elastic vein structure is less resistant to high radial force
Solution Approach 1:
The invention changes the force application parameter from radial to longitudinal. The microvalve occluder applies compression forces parallel to the vessel axis rather than radial forces perpendicular to the vessel wall. This parameter change allows effective occlusion while preserving the integrity of the weaker vein structure that cannot withstand high radial forces.
Solution Approach 2:
The microvalve occluder is designed as a flexible, compressible structure that can adapt to the vessel lumen without exerting excessive radial pressure. The flexible design allows the occluder to achieve occlusion through longitudinal compression while conforming to the vessel shape, reducing the risk of vessel wall damage in fragile veins.
4Device complexity
If occlusion devices are used without pressure monitoring, then simple design is maintained, but accurate information on pressurization and interstitial fluid pressure is not available
Solution Approach 1:
The invention integrates multiple functions into the occlusion system, including not only mechanical occlusion but also pressure monitoring capabilities. The pressure sensor provides real-time feedback on intravascular pressure, enabling the system to monitor both the occlusion effect and the physiological response, making the device multi-functional without significantly increasing complexity.
Solution Approach 2:
The invention incorporates a pressure sensor that provides real-time feedback on intravascular pressure conditions. This feedback mechanism allows the operator to monitor the effectiveness of occlusion and assess the physiological response, including interstitial fluid pressure effects on therapeutic uptake. The feedback information enables informed decision-making during the procedure without requiring complex additional systems.
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
Enables precise control of occlusion and therapeutic agent delivery by monitoring pressure gradients, preventing collateral flow and optimizing diffusion rates into tissues, thereby enhancing treatment efficacy.
Implementation Method 1
at least one pressure sensor positioned within the chamber of the occluder adapted to sense pressure within the vessel
Data Source
AI summary
An atraumatic vessel occlusive system includes a flexible tubular member with an infusion lumen, a vessel occluder mounted at the distal end of the tubular member, and a pressure sensor located within a chamber defined by the occluder. The occluder has a braided construct provided with a fluid impermeable membrane over its proximal portion and a fluid permeable covering over its distal portion. The pressure sensor is adapted to sense pressure within the vessel through the fluid permeable membrane without being subject to the effects of turbulent flow at the exit of the infusion lumen. The accurately sensed pressure can be used to determine a dwell time for the occluder.