Transcatheter Valve Delivery Suture Routing and Sheath Segmentation
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Solution Overview
Problem
Current transcatheter stented prosthetic heart valve delivery devices face challenges in navigating tortuous paths to the native valve annulus due to the need for a robust yet flexible outer sheath, and existing methods lack efficient mechanisms for adjusting and releasing the prosthetic valve during deployment.
Innovation Solution
The use of a delivery device with an optional outer sheath assembly, inner shaft assembly, and handle assembly that employs sutures to compress and adjust the prosthetic valve, allowing for independent expansion and contraction, and a release mechanism to disengage the sutures from the stent frame after deployment, facilitating precise placement and expansion of the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a robust outer sheath assembly is used to resist radial forces from the self-expanding stent frame, then the stent frame can be effectively contained and deployed, but the delivery device cannot navigate tortuous paths to the native valve annulus
Solution Approach 1:
The outer sheath assembly is divided into multiple segments or sections along its length, with varying degrees of flexibility and stiffness. The proximal portion can be more flexible for navigation, while the distal portion maintains structural integrity for stent containment and deployment.
Solution Approach 2:
Different portions of the outer sheath assembly have different mechanical properties - the proximal section is designed with higher flexibility for navigating tortuous paths, while the distal section has higher radial strength for resisting forces from the self-expanding stent frame during deployment.
2Ease of operation
If the prosthetic valve is compressed within the delivery device for transcatheter delivery, then minimally invasive implantation is enabled, but precise adjustment and release during deployment becomes difficult
Solution Approach 1:
Sutures are introduced as intermediary elements that connect the prosthetic valve to the delivery device. These sutures can be selectively released to allow controlled expansion of the valve, providing a simple yet effective adjustment mechanism without complex actuation systems.
Solution Approach 2:
The prosthetic valve is designed with self-expanding capability through its self-expanding stent frame, which automatically expands when released from compression. The sutures simply need to be released, allowing the valve to self-adjust to its final configuration without requiring complex external adjustment mechanisms.
3Reliability
If sutures are used to compress and retain the prosthetic valve, then controlled deployment is achieved, but suture tangling occurs during navigation and deployment
Solution Approach 1:
The suture system is divided into multiple independent suture strands rather than a single continuous suture. Each strand can be independently managed and released, reducing the likelihood of tangling and allowing controlled sequential deployment of different portions of the prosthetic valve.
Solution Approach 2:
The sutures are routed and tensioned in a manner that creates symmetrical and balanced forces around the prosthetic valve, ensuring uniform compression and reducing uneven suture tension that could lead to tangling during deployment.
Data Source
Figure 1~2B
Figure 3~4
Figure 5A
AI summary
The present disclosure relates to numerous delivery devices (10) and methods for transcatheter prosthetic heart valve (100) loading, deployment and delivery utilizing at least one suture (20, 22, 24). Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.