Stepped Deployment Prosthetic Heart Valve Delivery System
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Solution Overview
Problem
Current percutaneous delivery systems for prosthetic heart valves face challenges in accurately positioning the valve due to the complexity of the procedure and the risk of leakage or dislodgement if incorrectly positioned.
Innovation Solution
A system comprising a delivery device with an inner shaft assembly, a primary capsule, and a secondary capsule, allowing for a stepped deployment of the prosthetic heart valve. This system enables the valve to be partially deployed and positioned accurately before full deployment, reducing the risk of incorrect placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a percutaneous delivery system is used to deliver a prosthetic heart valve, then the invasiveness of the procedure is reduced, but the precision of valve positioning deteriorates
Solution Approach 1:
The delivery system is divided into multiple segments: an outer catheter for delivery, an inner catheter for positioning, and a deployment mechanism. This segmentation allows the valve to be delivered percutaneously through the outer catheter while using the inner catheter to achieve precise positioning and control during deployment, thus resolving the contradiction between reduced invasiveness and positioning precision
2Device complexity
If the prosthetic valve is deployed in a single step, then the deployment process is simplified, but the risk of incorrect positioning and subsequent complications increases
Solution Approach 1:
The deployment process is extracted into distinct phases: first, the valve is partially deployed while still constrained by the inner catheter to achieve initial positioning; second, the inner catheter is retracted to allow full deployment. This extraction of the deployment process into controlled stages reduces the risk of incorrect positioning while maintaining procedural simplicity
3Loss of time
If the valve is fully deployed at once, then the procedure time is reduced, but the risk of leakage and dislodgement increases
Solution Approach 1:
The valve is preliminarily positioned and partially deployed while constrained by the inner catheter before full deployment. This preliminary action ensures correct positioning and stability before the valve is fully released, reducing the risk of leakage and dislodgement while maintaining efficient procedure time
Data Source
AI summary
A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.