Percutaneous Neovalve Creation Using Biocompatible Patch and Stent Scaffold
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Solution Overview
Problem
Current treatments for chronic venous insufficiency (CVI) require invasive surgery to replace damaged vein valves, which is costly and carries significant risks.
Innovation Solution
A minimally invasive device comprising a stent and a patch is used to create a neovalve. The device is delivered percutaneously, and the patch is left to form a growth layer on the vein wall before being removed, creating a functional valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to replace damaged vein valves, then functional valve replacement is achieved, but invasiveness and recovery time increase significantly
Solution Approach 1:
A biocompatible patch serves as an intermediary material that is delivered percutaneously through a catheter to the vein defect site. The patch acts as a temporary scaffold that facilitates valve formation while minimizing invasiveness, allowing the procedure to be performed through a small puncture rather than open surgery.
Solution Approach 2:
The body's own cellular mechanisms are harnessed to create the valve structure. Endothelial cells and smooth muscle cells naturally migrate onto and through the patch, forming a living tissue valve that integrates with the native vein wall. This self-organizing process eliminates the need for complex surgical valve construction.
2Reliability
If traditional surgical methods are used to create vein valves, then valve functionality is restored, but procedure complexity and cost increase
Solution Approach 1:
The valve replacement procedure is segmented into distinct phases: percutaneous delivery of the patch, in-situ valve formation through cellular ingrowth, and controlled patch removal. This segmentation allows each step to be optimized independently and performed with specialized equipment rather than requiring complex open surgical techniques.
Solution Approach 2:
The complex mechanical surgical procedure of valve creation is replaced with a minimally invasive delivery system that uses a catheter to insert the patch. The valve formation process is then substituted with biological processes rather than mechanical suturing and tissue manipulation.
3Reliability
If the patch is left in place indefinitely to form a growth layer, then valve formation is complete, but the patch becomes permanent and cannot be removed
Solution Approach 1:
The patch is designed with preliminary characteristics that enable both stable valve formation and subsequent removal. The patch material is selected to promote cellular attachment and valve development during an initial period, then allows for clean separation once the valve is formed. This preliminary design enables the dual function of temporary support followed by removal.
Solution Approach 2:
The patch's relationship with the surrounding tissue evolves dynamically over time. Initially, the patch provides structural support and promotes cellular ingrowth. As the valve matures, the connection between the patch and tissue transitions from strong adhesion to controlled separability, allowing the patch to be removed once its function is complete.
4Object-affected harmful factors
If the patch is removed after valve formation, then the procedure becomes minimally invasive, but the timing and control of removal become more difficult
Solution Approach 1:
The patch is designed to be extractable from the vein structure after serving its purpose. The separation interface between the patch and the formed valve is engineered to allow clean extraction, with the mature valve remaining intact on the vein wall while the patch is removed through the same percutaneous access point.
Solution Approach 2:
The patch serves as a temporary template or copy that guides the formation of the final native tissue valve. Once the body creates its own valve structure using the patch as a model, the original patch is no longer needed and can be removed, leaving the replicated valve structure in place.
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
This method allows for the creation of a functional vein valve with minimal invasiveness, reducing recovery time and associated risks compared to traditional surgical methods.
Implementation Method 1
the patch is left to form a growth layer on the vein wall
Implementation Method 2
The device is delivered percutaneously, and the patch is left to form a growth layer on the vein wall
Data Source
Figure 1A~2A
Figure 2B~2C
Figure 3
AI summary
A device includes a stent scaffold structure supporting a patch on an interior surface thereof. The device may be used to produce a neovalve in a percutaneous minimally invasive manner. Exemplary methods include implanting the device, permitting a growth layer to form over at least a portion of the patch, and separating the patch from the stent scaffold thereby forming a slit or gap in the vessel wall to act as a valve similar to the surgical neovalve.