Prosthetic Valve Delivery Force Limiter for Annulus Protection
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Solution Overview
Problem
Existing prosthetic heart valve deployment methods risk exerting excessive radial force on the native heart valve annulus, potentially leading to rupture during expansion.
Innovation Solution
A force limiting mechanism within the delivery apparatus, comprising a pivot arm and a biasing member, limits the applied force to the prosthetic heart valve by pinching the actuation member when excessive force is detected, allowing controlled radial expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a mechanical actuator is used to expand the prosthetic valve, then the valve can be deployed to its functional size, but excessive radial force may be applied to the native annulus causing rupture
Solution Approach 1:
The force limiting mechanism changes the force parameter by introducing a friction-based resistance that caps the maximum radial force transmitted to the prosthetic valve. The pivot arm and base portion create a friction interface that allows force transmission up to a threshold level, then prevents further force increase, thereby controlling the expansion force parameter to avoid annulus rupture.
Solution Approach 2:
The force limiting mechanism acts as an intermediary between the actuation member and the prosthetic valve. The pivot arm, base portion, and friction surface collectively form a mediating structure that transmits controlled force while limiting excessive radial force, preventing direct transmission of uncontrolled expansion forces to the native annulus.
2Ease of operation
If the actuation member is allowed to move freely, then the prosthetic valve can expand radially, but uncontrolled force may be applied to the native heart valve annulus
Solution Approach 1:
The force limiting mechanism is self-regulating through friction between the pivot arm and base portion. As the actuation member moves and applies force, the friction interface automatically engages to limit excessive force without requiring external control systems, sensors, or additional actuation steps, making the system self-protecting while maintaining ease of operation.
3Object-affected harmful factors
If a force limiting mechanism is added to control expansion force, then excessive force on the native annulus is prevented, but the device complexity increases
Solution Approach 1:
The force limiting mechanism is segmented into distinct functional components: the pivot arm for force transmission, the base portion with friction surface for force limiting, and the actuation member for actuation. This segmentation allows each component to perform its specific function while keeping the overall structure relatively simple and maintainable.
Solution Approach 2:
The force limiting function is extracted as a separate mechanism from the main actuation system. The pivot arm and base portion form a distinct force-limiting subsystem that can be independently designed, adjusted, and maintained, separating the force control function from the valve deployment function and simplifying the overall system architecture.
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
Prevents excessive force from being applied to the native heart valve annulus, ensuring safe and controlled deployment of the prosthetic heart valve.
Implementation Method 1
The force limiting mechanism can be configured to pinch the actuation member between the pivot arm and the base portion when the force applied to the actuation member exceeds a predetermined force
Implementation Method 2
A force limiting mechanism within the delivery apparatus, comprising a pivot arm and a biasing member, limits the applied force to the prosthetic heart valve by pinching the actuation member
Data Source
AI summary
A method of implanting a prosthetic heart valve can include advancing a delivery apparatus with a prosthetic heart valve mounted on a distal end portion of the delivery apparatus in a radially compressed configuration distally until the prosthetic heart valve is disposed at a selected implantation site. The method can further include radially expanding the prosthetic heart valve by applying a proximally directed force to at least one actuation member of the delivery apparatus that is coupled to the prosthetic heart valve. When the proximally directed force applied to the at least one actuation member exceeds a predetermined force during the radially expanding the prosthetic heart valve, the method can include arresting movement of the at least one actuation member and stopping radially expanding the prosthetic heart valve.