Self-Expanding Valve Delivery with Exposed Cuff
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The delivery of transcatheter prosthetic heart valves with high-volume outer cuffs poses a challenge due to the increased profile of the delivery system, which can be too large for patients with small access vessels, leading to potential sub-optimal performance and perivalvular leaks.
Innovation Solution
A delivery device design that includes an inner shaft, an outer shaft, and a distal sheath forming a compartment to house the prosthetic heart valve, where the high-volume outer cuff is left partially or completely uncovered during delivery, allowing it to fill space normally occupied by the capsule structure, thereby maintaining a smaller profile for the delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a high-volume outer cuff is added to the prosthetic heart valve to improve sealing and reduce perivalvular leaks, then the sealing performance is improved, but the delivery system profile increases making it unsuitable for patients with small access vessels
Solution Approach 1:
The outer cuff is extracted from the encapsulated configuration and left exposed during delivery. The distal sheath is designed to terminate before the proximal end of the prosthetic heart valve, leaving the outer cuff uncovered and exposed. This allows the high-volume outer cuff to provide enhanced sealing without requiring additional space within the delivery system capsule, thereby maintaining a smaller delivery profile suitable for small access vessels while improving sealing performance.
2Length of moving object
If the distal sheath completely covers the prosthetic heart valve during delivery to maintain a compact profile, then the delivery system profile is reduced, but the outer cuff cannot be exposed to provide adequate sealing
Solution Approach 1:
The distal sheath is designed with a specific length that terminates before the proximal end of the prosthetic heart valve, creating a localized exposed region for the outer cuff while maintaining coverage for the valve body. This local differentiation allows the outer cuff to be exposed for optimal sealing contact with the native annulus, while the rest of the valve remains protected within the delivery system, achieving both compact profile and reliable sealing.
3Length of moving object
If the outer cuff is left exposed during delivery to reduce delivery profile, then the delivery system profile is reduced for better patient compatibility, but the outer cuff may not be properly positioned or protected during delivery
Solution Approach 1:
The delivery device incorporates multiple functional components: the distal sheath provides protection and positioning control for the valve body, the distal tip provides additional protection and guidance, and the exposed outer cuff provides sealing function. This multi-functional design allows the system to maintain ease of operation through the sheath and tip while the exposed cuff provides its sealing function, achieving both reduced profile and proper positioning control.
Data Source
AI summary
A prosthetic heart valve includes a self-expanding frame, a valve assembly, and an outer cuff. A delivery device includes an inner shaft, an outer shaft, and a distal sheath disposed about a portion of the inner shaft to form a compartment with the inner shaft. The inner shaft and the distal sheath may be axially translatable relative to one another. A distal tip may be disposed at a distal end of the delivery device. In a delivery condition of the system, the distal sheath may be in a distal-most position in which the distal sheath overlies portions of the prosthetic heart valve but a distal end of the distal sheath leaves the outer cuff uncovered. In the delivery condition, a gap distance may exist between the distal end of the distal sheath and a proximal end of the distal tip, the outer cuff being positioned along the gap distance.