Expandable Stability Tube for Transcatheter Heart Valve Delivery
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Solution Overview
Problem
Current percutaneous transcatheter techniques for delivering self-expanding stented prosthetic heart valves face challenges with frictional resistance between the introducer device and delivery sheath, leading to unintended movement of the prosthesis during deployment, which can result in incorrect positioning and complications such as leakage or dislodgment.
Innovation Solution
A delivery device comprising an inner shaft assembly, a delivery sheath assembly, an outer stability tube with a radially expandable distal region, and a handle, which allows the stability tube to transition from a low-profile first shape to a larger second shape, providing enhanced stabilization and minimizing frictional resistance during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the delivery sheath is advanced through the introducer device, then the prosthetic heart valve can be delivered percutaneously, but frictional resistance causes unintended movement of the prosthesis during deployment
Solution Approach 1:
A stability tube is introduced as an intermediary component between the delivery sheath and the prosthesis. The stability tube extends beyond the introducer device distally, providing a stable reference point and reducing the transmission of frictional forces from the delivery sheath to the prosthesis, thereby preventing unintended prosthesis movement during deployment
2Volume of moving object
If the delivery device is made compact for percutaneous delivery, then it can traverse the vasculature, but stability and support during deployment are reduced
Solution Approach 1:
The stability tube is designed to be dynamically extendable beyond the introducer device during the deployment phase. This dynamic configuration allows the delivery device to maintain a compact profile for vascular traversal while providing extended stability support when needed during prosthesis deployment, resolving the contradiction between compactness and stability
3Reliability
If the distal region of the stability tube is expanded to a larger diameter, then frictional resistance is reduced and stability is enhanced, but the device profile increases
Solution Approach 1:
The stability tube is segmented into different radial configurations: a compressed state with smaller diameter for navigation through the vasculature, and an expanded state with larger diameter for stable deployment. This segmentation allows the device to optimize its profile at different stages of the procedure, reducing frictional resistance when expanded while maintaining a compact form when navigated
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
The solution enables precise and stable deployment of the prosthetic heart valve by reducing frictional resistance and maintaining the expanded shape of the stability tube, ensuring accurate positioning and reducing the risk of complications associated with incorrect placement.
Implementation Method 1
The distal region is configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter
Data Source
AI summary
A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft assembly, a delivery sheath assembly, an outer stability tube, and a handle. The sheath assembly is slidably disposed over the inner shaft, and includes a capsule and a shaft. The capsule compressively contains the prosthesis over the inner shaft. The stability tube is slidably disposed over the delivery sheath, and includes a distal region configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter. In a first delivery state, the distal region assumes the first shape, providing a low profile appropriate for traversing a patient's vasculature. In a second delivery state, the distal region has the expanded diameter second shape, sized to receive the capsule, such as when retracting the capsule to implant the prosthesis.