TAVI Motorized Handle Actuators for Valve Alignment
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Solution Overview
Problem
The challenge in transcatheter aortic valve replacement (TAVR) is achieving precise and controlled deployment of collapsible and expandable prosthetic heart valves to ensure proper seating and minimize paravalvular leakage, particularly due to the complexity and stress of the medical procedure.
Innovation Solution
A delivery device with a handle incorporating actuators for catheter deflection, axial position fine adjustment, and rotation to achieve native valve commissural alignment, along with a motorized and automated balloon inflation system, enhances the control and precision of prosthetic heart valve deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual balloon inflation is used, then the deployment process is simple, but procedural control and precision are insufficient
Solution Approach 1:
The patent replaces manual mechanical balloon inflation with an automated motorized system. The motorized actuator automatically controls balloon inflation and deflation, eliminating manual operation while providing precise control over the expansion process. This substitution improves deployment precision by enabling controlled, repeatable inflation sequences without requiring manual dexterity during the critical deployment moment.
Solution Approach 2:
The delivery system incorporates self-service capabilities through automated actuators that can independently control balloon inflation and deflation sequences. The system includes sensors and control mechanisms that automatically monitor and adjust the deployment process, reducing the need for continuous manual intervention and improving procedural control while maintaining simplicity through automation.
2Measurement precision
If multiple manual adjustments are made during deployment, then positioning accuracy can be achieved, but procedural time increases
Solution Approach 1:
The patent implements preliminary action by providing automated actuators that can pre-position the delivery catheter and balloon before the actual deployment moment. The system can perform preliminary alignment adjustments, pre-inflate the balloon to desired pressures, and position the prosthetic valve in preparation for deployment. This pre-positioning capability reduces the need for time-consuming manual adjustments during the critical deployment phase, thereby decreasing overall implantation time while maintaining alignment accuracy.
3Ease of operation
If automated control systems are added, then procedural control improves, but device complexity increases
Solution Approach 1:
The patent applies multi-functionality by designing automated actuators that perform multiple functions within a single integrated system. The motorized actuator can control balloon inflation, deflation, and potentially catheter positioning and alignment. By consolidating multiple control functions into unified automated components, the system improves procedural control without proportionally increasing complexity, as one automated mechanism replaces multiple manual control elements.
Data Source
AI summary
In some embodiments, delivery device includes a delivery catheter, and a handle coupled to the delivery catheter, the handle having a housing and including at least two actuators, each of the at least two actuators being configured to control one of three primary functions, the three primary functions including (1) delivery catheter deflection, (2) delivery catheter axial position fine adjustment, and (3) delivery catheter rotation to achieve native valve commissural alignment.