Transapical Mitral Valve Delivery Sheath Segmentation
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Solution Overview
Problem
Current devices and methods for transcatheter delivery and deployment of collapsible prosthetic heart valves, particularly self-expanding valves, require improvements for more precise and efficient deployment within the mitral valve annulus, as existing systems lack precise control over the deployment process and may lead to incomplete or accidental deployment.
Innovation Solution
A delivery device comprising a catheter assembly with a distal sheath having proximal and distal segments and an operating handle with independently movable elongated elements and actuators, allowing for controlled longitudinal movement to deploy and re-sheathe the prosthetic heart valve, ensuring precise positioning and full expansion within the native valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single sheath is used to cover the prosthetic valve, then the device structure is simpler, but precise control over deployment is reduced
Solution Approach 1:
The distal sheath is divided into a proximal segment and a distal segment that can move independently relative to each other. The proximal segment is coupled to a first elongated element controlled by a first actuator, while the distal segment is coupled to a second elongated element controlled by a second actuator. This segmentation allows independent control of each sheath segment for precise valve deployment.
2Productivity
If the prosthetic valve is fully deployed at once, then the procedure is faster, but the risk of accidental incomplete deployment or mispositioning increases
Solution Approach 1:
The delivery device enables preliminary positioning of the prosthetic valve within the native valve annulus before final deployment. The operator can first position the valve using the dual-segment sheath system, verify correct placement, and then complete the deployment. This preliminary action reduces the risk of mispositioning while maintaining procedural efficiency.
3Stability of the object's composition
If the distal sheath segments are tightly coupled, then the device is more stable during delivery, but the ability to control independent movement for deployment is reduced
Solution Approach 1:
The coupling between the proximal and distal sheath segments is designed to be dynamic rather than fixed. The segments can move independently relative to each other during deployment, allowing the system to transition from a stable bundled configuration during delivery to a flexible, independently controllable configuration during valve deployment.
Data Source
AI summary
A delivery device for a prosthetic heart valve includes a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment for the heart valve is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The handle may include a first lead screw coupled to the proximal segment and a second lead screw coupled to the distal segment. Actuation of the first lead screw operates to move the proximal segment of the distal sheath proximally and actuation of the second lead screw operates to move the distal segment of the distal sheath distally to uncover the compartment and deploy the heart valve.