Intravascular Dissection Device for Controlled Valve Leaflet Formation
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Solution Overview
Problem
Current methods for treating damaged or diseased vein valves in deep veins are invasive, carry significant risks, and have lengthy recovery times, with existing treatments failing to effectively address venous reflux and its associated symptoms.
Innovation Solution
A device and method for controlled intravascular dissection of tissue within a blood vessel wall, allowing for the creation of dissection pockets and valve leaflets using a dissection device with tensioning and dissection arms that can be deployed and controlled independently to separate tissue and form precise shapes within the vessel wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair or removal of diseased vein is performed, then valve function can be restored, but recovery time is lengthy and surgical risks are significant
Solution Approach 1:
The patent replaces traditional open surgical mechanical procedures with a minimally invasive catheter-based system that uses controlled mechanical dissection and tissue manipulation to create functional valves, avoiding large incisions and extensive surgical exposure
Solution Approach 2:
The patent introduces a catheter as an intermediary device that delivers dissection and valve-forming tools to the target vein through percutaneous access, serving as a mediator between the operator and the deep venous system without requiring direct surgical exposure
2Reliability
If surgical repair or removal of diseased vein is performed, then valve function can be restored, but surgical risks such as infection and clotting are exposed
Solution Approach 1:
The patent replaces open surgical procedures with percutaneous catheter-based mechanical dissection and valve formation, significantly reducing exposure to surgical site infections and clotting risks associated with large incisions and foreign body implantation
Solution Approach 2:
The patent utilizes the patient's own vein wall tissue to form functional valve leaflets through controlled dissection and shaping, eliminating the need for foreign implants or grafts that could provoke infection or thrombotic responses
3Reliability
If experimental treatments such as implantable venous valves are attempted, then valve function may be achieved, but significant shortcomings remain
Solution Approach 1:
The patent extracts and removes the need for complex implantable valve devices by using controlled tissue dissection and shaping to create functional valves from the vein wall itself, eliminating the complexity of foreign device implantation and long-term management
Solution Approach 2:
The patent creates a universal solution that can treat various valve pathologies (insufficiency, reflux, valve destruction) through a single catheter-based dissection and valve formation technique, regardless of the specific underlying disease process
4Reliability
If deep veins are treated surgically, then valve disease can be addressed, but the procedure becomes harder to perform
Solution Approach 1:
The patent uses a catheter as an intermediary tool that can navigate through the venous system to reach deep veins, making the treatment accessible without requiring direct surgical exposure or complex anatomical dissection
Solution Approach 2:
The patent replaces complex open surgical techniques for deep vein access with percutaneous catheter-based mechanical dissection and valve formation, dramatically simplifying the procedural approach to deep venous pathology
Data Source
Figure 1A~1C
Figure 2A~2D
Figure 2E~2F
AI summary
Devices, systems, and methods for treating damaged or diseased valves are disclosed. A representative embodiment includes an elongated shaft having a longitudinal axis, a proximal portion, and a distal portion, and a dissection arm at the distal portion. The dissection arm can have a longitudinal axis and be moveable between a low-profile state and a deployed state. In the deployed state, a portion of the arm can flex outwardly away from the longitudinal axis of the shaft. The arm is configured to be deployed within a space within a vessel wall such that, as the arm moves from the low-profile state to the deployed state, the arm pushes against vessel wall tissue at a periphery of the space, thereby separating tissue at the periphery to form a dissection pocket having a predetermined shape.