Heart Valve Delivery Sheath for Controlled Retrograde Deployment
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Solution Overview
Problem
Existing prosthetic heart valves, particularly self-expanding ones, tend to 'jump' out of the delivery sheath quickly, making precise and controlled delivery difficult, and may not anchor sufficiently to non-stenotic native valves, requiring additional anchoring devices that can cause complications.
Innovation Solution
A delivery apparatus with a rotatable second shaft and a sheath retaining ring that moves axially along threads or grooves, allowing controlled deployment of the prosthetic valve, and a valve-retaining mechanism to prevent axial and rotational movement, ensuring precise placement and anchoring without extending into non-diseased areas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a self-expanding prosthetic valve is advanced from the delivery sheath, then the valve expands to its functional size, but the valve jumps out quickly from the end of the sheath making controlled delivery difficult
Solution Approach 1:
The delivery sheath is designed with a distal end that is crimped or compressed to a smaller diameter than the expanded state of the prosthetic valve. This preliminary compression of the sheath allows the self-expanding valve to be contained and controlled during delivery, preventing premature expansion and jumping out, while still allowing controlled expansion at the target site.
2Ease of manufacture
If a self-expanding prosthetic valve is used, then the valve can be delivered via catheter, but the valve may not anchor sufficiently to non-stenotic native valves requiring additional anchoring devices
Solution Approach 1:
The prosthetic valve assembly integrates multiple functions into a single device: the self-expanding frame provides both the valve structure and anchoring capability through radial expansion force. The frame's expansion against the native valve annulus creates sufficient anchoring in non-stenotic valves without requiring separate anchoring devices, while maintaining catheter delivery capability.
3Reliability
If additional anchoring devices are added to the prosthetic valve, then anchoring to non-stenotic valves is improved, but the devices extend into non-diseased areas causing complications
Solution Approach 1:
The prosthetic valve frame is designed with varying structural characteristics along its length, with the distal portion having enhanced radial strength and expansion force concentrated at the level of the native valve annulus. This localized quality ensures sufficient anchoring force is applied precisely where needed (at the diseased valve site) without extending anchoring structures into non-diseased proximal or distal areas.
Data Source
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Figure 5A
AI summary
Certain embodiments of the present disclosure provide a prosthetic valve (2400) (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.