Catheter Valve Barrier Prevents Migration
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Solution Overview
Problem
Current pulmonary valve replacement methods, including stented valves, face challenges such as calcification, misalignment, and migration due to blood flow forces, leading to inefficiencies and the need for repeated surgical procedures, especially in young patients as they grow, and difficulties in proper positioning within conduits.
Innovation Solution
A vascular valve replacement system featuring a prosthetic valve connected to an expandable support structure with a barrier member that prevents blood flow around the valve by contacting the conduit's inner wall, using directionally oriented microfibers, compressible foam, or a helical coil barrier to secure the valve in place and prevent migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stented valve is delivered transvenously using a catheter-based system, then the procedure becomes minimally invasive with reduced recovery time, but the valve may become misaligned or migrate due to blood flow forces
Solution Approach 1:
A barrier member is deployed from the catheter before the valve to create a physical barrier between the valve and blood flow. This preliminary action prevents blood flow from reaching the valve during deployment, eliminating the risk of misalignment or migration while maintaining the minimally invasive transvenous approach
Solution Approach 2:
The barrier member acts as an intermediary element between the blood flow and the valve. It intercepts the blood flow and redirects it, preventing direct interaction between the flow forces and the valve that would cause misalignment or migration
2Reliability
If the valve support structure is expanded to secure the valve in place, then migration is prevented, but blood flow may occur around the valve compromising its function
Solution Approach 1:
The solution separates the functions of securing the valve and preventing flow into two distinct components: the expandable support structure provides mechanical anchoring, while the barrier member specifically addresses the flow control function by creating a sealed barrier around the valve
Solution Approach 2:
The barrier member serves as an intermediary that blocks blood flow from reaching the valve while allowing the expandable support structure to maintain contact with the conduit wall for stable positioning
3Reliability
If repeated surgical procedures are performed to replace calcified or undersized valves, then valve function can be restored, but the physical and emotional burden on patients increases
Solution Approach 1:
The expandable support structure allows the valve to be deployed in a compressed state through the catheter and then expanded to its full size at the target location. This parameter change from compressed to expanded state enables a single procedure to provide a valve of appropriate size without requiring repeated surgeries
Solution Approach 2:
The barrier member is deployed first to create a protected environment, allowing the valve to be positioned and secured in a single procedure without risk of migration or flow interference, eliminating the need for subsequent corrective procedures
Data Source
AI summary
A system for treating abnormalities of the right ventricular outflow tract includes a prosthetic valve device having a barrier material contacting at least a portion of the outer surface of the valve device. One embodiment of the invention includes a barrier member attached to the exterior surface of the valve device. Another embodiment includes a barrier material that is injected within the vascular system. Yet another embodiment of the invention includes a method for replacing a pulmonary valve that includes forming a barrier around the outer surface of a replacement valve and preventing blood flow around the replacement valve.