Pneumatically Assisted TAVI Delivery Handle
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Solution Overview
Problem
Current devices and methods for transcatheter delivery of collapsible prosthetic heart valves, particularly self-expanding valves, face challenges in reducing the force required for deployment and reseathing, as they encounter significant friction during the expansion and retraction processes.
Innovation Solution
The development of an operating handle with proximal and distal pressure chambers that provide force assist during deployment, reducing the user's effort by utilizing a pneumatic switch and threaded rod mechanism to manage the distal or proximal force, thereby aiding in the expansion and retraction of the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If manual deployment of collapsible prosthetic heart valve is used, then device complexity is reduced, but force required for deployment increases significantly
Solution Approach 1:
The patent employs a pneumatic cylinder system where a piston moves within a cylinder to generate mechanical force. Pressurized gas or liquid acts on the piston to create the necessary force for deploying and reseathing the prosthetic valve, reducing the manual force burden on the operator while maintaining controlled deployment.
Solution Approach 2:
The patent replaces purely manual mechanical deployment with a hybrid system incorporating pneumatic assistance. The operator triggers deployment through a lever or button that activates the pneumatic system, substituting heavy manual force requirements with controlled pneumatic actuation while retaining mechanical control elements for precision.
2Ease of operation
If pneumatic force assist is added to reduce deployment force, then ease of operation improves, but device complexity increases
Solution Approach 1:
The patent introduces a pneumatic cylinder and piston as intermediary components between the operator's manual input and the deployment force application. This intermediary system amplifies the operator's input force through pneumatic pressure, providing force assistance while maintaining a relatively simple operating interface through levers or buttons.
Solution Approach 2:
The operating handle is segmented into distinct functional modules: a trigger mechanism (lever or button), a pneumatic activation system, a piston-cylinder assembly, and connection mechanisms to the delivery catheter. This segmentation allows each component to perform its specific function independently, simplifying the overall design while providing comprehensive force assist capability.
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 solution reduces the force needed to rotate the deployment actuator, making the deployment and reseathing processes more manageable by providing 8-10 lbs of force assist, thus overcoming the resistance encountered during these procedures.
Implementation Method 1
a pneumatic switch in fluid communication with the pressure chamber, the pneumatic switch adapted to provide a pressurized fluid to the pressure chamber to apply a force to the piston in the longitudinal direction
Implementation Method 2
Movement of the piston in the longitudinal direction in the piston cylinder may move the distal sheath between the closed condition and the open condition
Data Source
AI summary
A delivery device for a collapsible prosthetic heart valve may include an operating handle and a catheter assembly. The handle may include a housing, a piston cylinder, a piston longitudinally slidable within the piston cylinder, the piston and the piston cylinder together defining at least one pressure chamber, a deployment actuator coupled to the housing and rotatable relative thereto, and a pneumatic switch adapted to provide a pressurized fluid to the pressure chamber to apply a longitudinal force to the piston. The catheter assembly may include a first shaft around which a valve-receiving compartment is defined, the first shaft being operatively connected to the housing, and a distal sheath operatively connected to the piston, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment. Longitudinal movement of the piston may move the distal sheath between the closed and open conditions.