Balloon-Expandable Valve Delivery With Independent Axial-Rotational Control
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Solution Overview
Problem
Existing transcatheter heart valve delivery systems face challenges in achieving precise alignment and deployment of prosthetic heart valves within the native heart valve annulus, particularly in terms of rotational and axial positioning, which can lead to inefficiencies and potential leakage.
Innovation Solution
A prosthetic heart valve delivery system with independent actuators for axial adjustment and commissure alignment, allowing for precise rotational and axial positioning of the valve relative to the native heart valve annulus, combined with a steerable catheter and motorized balloon inflation for controlled deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a single integrated delivery system is used for valve deployment, then device complexity is reduced, but precision of axial and rotational positioning cannot be independently controlled
Solution Approach 1:
The delivery system is divided into independent control modules: an axial adjustment mechanism for longitudinal positioning and a rotational adjustment mechanism for angular alignment. These segmented controls allow precise independent adjustment of axial and rotational positions without increasing overall system complexity, as each module operates independently with its own actuator and transmission mechanism.
2Productivity
If manual valve placement is used, then device complexity is minimized, but productivity and procedural efficiency decrease
Solution Approach 1:
The delivery system incorporates motorized actuators that automatically perform axial and rotational adjustments based on pre-programmed parameters or real-time feedback. The system can autonomously position the valve prosthesis at the target location and orientation, reducing the need for manual intervention and increasing procedural efficiency while maintaining controlled complexity through automation.
3Reliability
If the valve is delivered in an expanded state, then deployment time is reduced, but the risk of paravalvular leakage increases due to imprecise positioning
Solution Approach 1:
The valve prosthesis is delivered in a collapsed state and precisely positioned using the independent axial and rotational adjustment mechanisms before final deployment. This preliminary positioning ensures optimal alignment with the native valve annulus, preventing paravalvular leakage. Once positioning is confirmed, the valve is expanded in a single action, minimizing deployment time while maintaining sealing reliability.
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
Enables precise and controlled deployment of prosthetic heart valves, reducing the risk of paravalvular leakage and improving the accuracy of valve placement, thereby enhancing the efficacy of transcatheter valve replacement procedures.
Implementation Method 1
the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped condition into an expanded or deployed condition
Implementation Method 2
a self-expanding, mechanically-expandable, or balloon-expandable frame, often made of nitinol or another shape-memory metal
Data Source
AI summary
A prosthetic heart valve delivery system may include a handle, a delivery catheter with an inflatable balloon at a distal end thereof, and a prosthetic heart valve. An axial adjustment actuator may be positioned on the handle for translating the prosthetic heart valve distally or proximally relative to the handle when the prosthetic heart valve is collapsed onto the balloon. A commissure alignment actuator may be positioned on the handle for rotating the prosthetic heart valve about its central longitudinal axis when the prosthetic heart valve is collapsed onto the balloon. The axial adjustment and the commissure alignment actuators may be independently actuated, so that actuation of the axial adjustment actuator does not rotate the prosthetic heart valve, and actuation of the commissure alignment actuator does not translate the prosthetic heart valve.