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

VSEngineering 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

Engineering Contradiction:
Improveexpansion speedVSAvoidcontrolled delivery
Core Design Contradiction:
SpeedVSEase of operation

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.

Inventive Principle:
Principle #10Preliminary action

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

Engineering Contradiction:
Improvecatheter delivery capabilityVSAvoidanchoring sufficiency
Core Design Contradiction:
Ease of manufactureVSReliability

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.

Inventive Principle:
Principle #5Merging (Combining)

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

Engineering Contradiction:
Improveanchoring strengthVSAvoidtrauma to non-diseased tissue
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP4035625B1Prosthetic heart valve delivery apparatus
Publication Date: 2026.03.11 EDWARDS LIFESCIENCES CORP
  • EP4035625B1 patent drawingFigure 1~2
  • EP4035625B1 patent drawingFigure 3~4
  • EP4035625B1 patent drawingFigure 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.