Mitral Valve Delivery System with Flipping Anchors

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Solution Overview

Problem

Developing prostheses, such as replacement heart valves, that can be compactly delivered and controllably expanded for secure placement within the body, particularly challenging due to the need for atraumatic securing to intralumenal tissue and navigating tortuous vasculature during minimally invasive procedures.

Innovation Solution

A delivery system comprising an elongate shaft assembly with subassemblies that allow a radially compressed prosthesis to be expanded and secured using anchors that flip positions to engage with the native valve annulus, enabling controlled deployment and positioning of the prosthesis within the heart, specifically designed for percutaneous or transapical delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a replacement heart valve is delivered in a radially compressed condition through tortuous vasculature, then the device can be delivered percutaneously with less trauma, but the device cannot be securely anchored to the native valve annulus

Engineering Contradiction:

Improvetrauma to patientVSAvoidsecuring of prosthesis to native valve annulus

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The prosthesis is divided into multiple segments including an expandable frame with anchors, a valve body, and delivery system components. The anchors are segmented to flip from a compressed delivery configuration to an expanded anchored configuration, allowing secure attachment to the native valve annulus while maintaining compact delivery

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The prosthesis transitions from a static compressed state during delivery to a dynamic expanded state at deployment. The anchors dynamically flip from pointing distally in the compressed state to pointing proximally in the expanded state, enabling secure anchoring to the native valve annulus while maintaining compact delivery through tortuous vasculature

Inventive Principle:

Principle #15Dynamics

2Reliability

If anchors are released from radially compressed condition to flip positions and engage native valve annulus, then secure anchoring is achieved, but the delivery system complexity increases

Engineering Contradiction:

Improveanchoring of prosthesisVSAvoiddelivery system structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The delivery system combines multiple functions into integrated components: the elongate shaft assembly contains both the retention mechanism for the compressed prosthesis and the release mechanism for anchor deployment. The subassemblies merge delivery, retention, and deployment functions into a unified system that reduces overall complexity

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The anchors are designed to self-flip from the compressed to expanded configuration upon release from the delivery system. This self-service mechanism eliminates the need for complex external actuation systems, reducing delivery system complexity while achieving reliable anchoring

Inventive Principle:

Principle #25Self-service

3Ease of operation

If the prosthesis is fully released from the delivery system after anchor deployment, then the valve can function properly, but control over deployment positioning is lost

Engineering Contradiction:

Improvedeployment controlVSAvoidproper positioning of prosthesis

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The anchors are deployed first to engage the native valve annulus before full prosthesis release. This preliminary action establishes a stable foundation that maintains control over prosthesis positioning during the subsequent release and expansion process

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The deployment process is segmented into distinct phases: anchor release and flipping, partial prosthesis expansion, positioning verification, and final full release. This segmented approach maintains control over positioning while enabling proper prosthesis function

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS12156810B2Supra and sub-annular mitral valve delivery system

Publication Date: 2024.12.03 EDWARDS LIFESCIENCES CORP

AI summary

Methods are described herein for delivering a replacement valve to a native valve location. In one method, ventricular anchors of the replacement valve are released and allowed to reverse orientation while positioned in the atrium of a human heart. After reversing orientation, the ventricular anchors extend in a generally proximal direction. The ventricular anchors can then be advanced through the annulus into the ventricle and then moved back toward the atrium to capture native valve leaflets between the main body and the ventricular anchors of the replacement valve. In one modification, the ventricular anchors are allowed to reverse orientation at a level adjacent the annulus. The implantation methods described herein are preferably performed via a transseptal delivery approach or a transapical delivery approach.