Percutaneous Catheter for Creating Venous Valves
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Solution Overview
Problem
Current methods for treating venous valve insufficiency are invasive, prone to thrombosis, and do not adequately address biocompatibility issues, leading to complications such as blood pooling, varicose veins, and increased risk of deep vein thrombosis and amputation.
Innovation Solution
A percutaneous apparatus using a catheter with inflatable balloons and delivery shafts to create bicuspid venous valves from autologous tissue, allowing for minimally invasive formation of one-way valves by making intimal flaps and pockets within the vein wall, mimicking native valve structure to prevent backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical reconstruction techniques are used to repair or replace venous valves, then valve function can be restored, but the procedures are highly invasive and carry high risk of thrombosis
Solution Approach 1:
The patent replaces traditional surgical mechanical intervention with a percutaneous catheter-based system that uses inflatable balloons to create tissue flaps and pockets, thereby restoring valve function without open surgery. The mechanical action is substituted from surgical instruments to a minimally invasive catheter system
Solution Approach 2:
The patent introduces an intermediary substance (autologous tissue from the vein wall itself) to create the valve leaflets, avoiding the need for synthetic grafts or allografts that carry thrombosis risk. The intermediary is the patient's own tissue that is shaped in-situ to form functional valve leaflets
2Reliability
If synthetic, allograft or xenograft prostheses are placed to replace venous valves, then valve replacement can be achieved, but biocompatibility issues and thrombosis occur
Solution Approach 1:
The patent employs self-service by using the patient's own vein wall tissue to create the valve leaflets. The autologous tissue is harvested from the same vein where the valve is being created, eliminating the need for external grafts and ensuring biocompatibility. The tissue serves itself by forming the functional valve structure in-situ
Solution Approach 2:
The patent changes the fundamental parameter of valve material from synthetic or donor tissue to autologous tissue. This parameter change fundamentally resolves biocompatibility issues and thrombosis risk associated with foreign materials, while maintaining valve replacement functionality
3Object-affected harmful factors
If percutaneous methods are used to create venous valves, then invasiveness and thrombosis risk are reduced, but the procedure requires precise creation of intimal flaps and pockets
Solution Approach 1:
The patent applies preliminary action by first creating the intimal flaps and pockets through controlled balloon inflation before the final valve formation step. The balloon is inflated to a first volume to create the initial tissue dissection and flaps, then deflated and re-inflated to a second volume to refine the pocket formation, ensuring precise valve structure creation
Solution Approach 2:
The patent uses periodic action through cyclic balloon inflation and deflation. The balloon is inflated to create tissue flaps, deflated to allow catheter repositioning, and re-inflated to refine the pocket formation. This periodic mechanical action enables precise control over the complex tissue shaping process required for functional valve creation
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 solution enables the creation of functional, biocompatible one-way venous valves that reduce the risk of thrombosis and improve venous circulation, providing a minimally invasive alternative to surgical methods while addressing biocompatibility and thrombosis concerns.
Implementation Method 1
an inflatable balloon fluidly coupled to the inflation lumen... inflation of the balloon places the first and second distal ports in apposition with the vessel wall
Data Source
Figure 1A~2
Figure 3
Figure 4~7B
AI summary
Percutaneous apparatus for forming a bicuspid venous valve from autologous tissue are disclosed. A multilumen catheter is disclosed that includes a delivery shaft positioned on either side of the balloon. When the balloon is inflated within the vein at a treatment location where a bicuspid valve is to be created, the delivery shafts are pressed into the wall of the vein by the inflated balloon so that exit ports in the delivery shafts are at diametrically opposed locations. The delivery shafts may than be used to deliver puncture elements through the exit ports and into the vessel wall to gain access to a subintimal layer of the vein wall. In this manner, the inventive multilumen catheter aids in making properly positioned flaps of venous tissue for creating a bicuspid venous valve from autologous tissue.