Percutaneous Venous Valve Creation via Intimal Dissection
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Solution Overview
Problem
Current methods for treating venous valve insufficiency are invasive and prone to complications such as thrombosis and biocompatibility issues, and existing percutaneous approaches using synthetic or xenograft materials are not effective in restoring normal venous circulation.
Innovation Solution
A percutaneous method and apparatus using a balloon catheter with a dissecting blade to create monocuspid, bicuspid, or tricuspid venous valves from autologous tissue by forming a subintimal longitudinal dissection within the vein wall, separating intimal tissue to create a flap and sinus that function as a venous valve, thereby addressing biocompatibility and thrombosis concerns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical reconstruction techniques or synthetic prostheses are used to treat venous valve insufficiency, then valve function can be restored, but the patient is exposed to high risk of thrombosis and biocompatibility issues
Solution Approach 1:
The patient's own vein wall tissue is utilized to form the valve leaflets through a dissection process. The intimal layer is separated and folded back to create functional valve leaflets that are biocompatible and thromboresistant, eliminating the need for synthetic materials or donor tissue.
Solution Approach 2:
The physical and biological properties of the vein wall are changed through controlled dissection and folding. The intimal layer is transformed from a flat lining into three-dimensional valve leaflets with specific geometric parameters that enable proper valve function while maintaining native tissue characteristics.
2Reliability
If invasive surgical reconstruction is performed to create venous valves, then valve competence can be achieved, but the procedure complexity and patient trauma increase
Solution Approach 1:
The vein wall is segmented into functional layers through dissection. The intimal layer is separated from the media and adventitia, allowing it to be independently manipulated and folded into valve leaflets while the remaining vein wall maintains structural integrity.
Solution Approach 2:
Instead of adding external structures to create valve function, the existing vein wall is inverted or folded back upon itself. The intimal layer is turned inside out to form leaflets that project into the lumen, creating valve function through reconfiguration rather than addition.
3Reliability
If traditional venous valve repair methods are used, then valve function may be preserved, but the treatment options are limited and often require open surgery
Solution Approach 1:
Traditional open surgical techniques are replaced with a percutaneous approach using a catheter-based dissection device. The mechanical action of blade dissection is delivered through a flexible catheter system that can be introduced through small punctures, replacing the need for large incisions and direct surgical exposure.
Data Source
AI summary
Percutaneous methods and apparatus for forming a venous valve from autologous tissue by creating at least one subintimal longitudinal dissection that forms at least one flap of intimal tissue are disclosed. In one method, a balloon catheter having a dissecting blade mounted thereon is delivered to a target site where a new venous valve is to be created. The balloon is inflated to deploy the blade against the vein wall, and the catheter is longitudinally translated such that the blade dissects a subintimal layer of the vein wall. The balloon is subsequently deflated such that the blade pulls a flap of the dissected tissue towards the vein lumen, thereby creating a leaflet and corresponding pocket/sinus in the vein that collectively act as a monocuspid venous valve. Methods of forming new bicuspid and tricuspid venous valves utilizing two or three dissecting blades mounted on the balloon are also disclosed.