Valve Prosthesis Deployment Assembly with Simultaneous Sheath Control
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Solution Overview
Problem
Current prosthetic valve delivery systems face challenges in deploying heart valves through a trans-aortic pathway, particularly in patients with a short ascending aorta, as they require a longer catheter length, increasing the risk of damage to surrounding tissues and limiting the procedure's applicability.
Innovation Solution
The delivery systems incorporate a handle assembly with a thumbwheel and gear-type mechanism allowing simultaneous movement of an inner shaft and outer sheath, reducing the required catheter length within the ascending aorta and minimizing tip travel, enabling quicker deployment and recapture of the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional delivery system is used to deploy prosthetic valves through trans-aortic pathway, then the valve can be deployed, but the catheter length within the ascending aorta is excessive, increasing the risk of damage to surrounding tissues
Solution Approach 1:
The delivery system employs dynamic coordination between the inner shaft and outer sheath movement. The gear-type mechanism enables synchronized advancement of the inner shaft and retraction of the outer sheath, optimizing the deployment process and reducing the required catheter length within the ascending aorta while maintaining reliable valve deployment.
Solution Approach 2:
The gear-type mechanism acts as an intermediary between the operator's input and the delivery catheter components. This mechanism translates rotational motion into coordinated linear movement of the inner shaft and outer sheath, enabling precise control and reducing the overall catheter length needed while ensuring safe deployment.
2Reliability
If the catheter length is reduced to minimize tissue damage risk, then safety improves, but the ability to deploy the valve accurately may be compromised
Solution Approach 1:
The gear-type mechanism provides inherent feedback through its mechanical design, where the interlocking gears ensure that the inner shaft and outer sheath move in a coordinated manner. This mechanical feedback system maintains deployment accuracy by preventing uncontrolled movement, even with a shorter catheter length, thereby preserving both safety and precision.
3Productivity
If conventional delivery systems are used, then valve deployment is possible, but the procedure time and recapture complexity increase
Solution Approach 1:
The delivery system merges the functions of inner shaft advancement and outer sheath retraction into a single coordinated action through the gear-type mechanism. This integration allows simultaneous movement of both components, streamlining the deployment process and simplifying recapture operations, thereby improving procedure efficiency without excessive complexity.
Data Source
Figure 1A~1B
Figure 2A~2D
Figure 3~4
AI summary
The delivery systems (100) disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly (102) and a delivery catheter (202). In certain embodiments, the inner shaft (116) and the outer sheath (124) can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel (104) acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss (512) associated with the outer sheath and a second boss (514) associated with the inner shaft to move in opposite directions.