Radially Expandable Sleeve for Valve Prosthesis Paravalvular Leakage

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Solution Overview

Problem

Current systems for delivering heart valve prostheses face challenges in minimizing the crossing profile of catheters, ensuring sealing of the valve prosthesis to the native valve wall, and facilitating atraumatic delivery to the target site, particularly for mitral valve replacement.

Innovation Solution

A delivery system comprising an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is compressed for delivery and expands upon deployment, with the radially-expandable sleeve transforming from a delivery state to a deployed state to prevent paravalvular leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sealing sleeve is included to prevent paravalvular leakage, then sealing effectiveness is improved, but the crossing profile of the catheter increases

Engineering Contradiction:

Improvesealing effectivenessVSAvoidcatheter crossing profile

Core Design Contradiction:

ReliabilityVSLength of stationary object

Solution Approach 1:

The sealing sleeve is designed to be radially expandable, transitioning from a compressed delivery state to an expanded sealing state. This dynamic transformation allows the sleeve to provide effective sealing at the native valve wall while minimizing the catheter crossing profile during delivery through the vasculature.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The sealing sleeve is integrated onto the valve prosthesis in a nested configuration, allowing it to be contained within the delivery catheter when compressed. This nesting approach enables the sealing function to be incorporated without permanently increasing the catheter's crossing profile.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Length of stationary object

If the valve prosthesis is compressed for delivery, then the crossing profile is minimized, but the valve prosthesis may damage native anatomy during delivery

Engineering Contradiction:

Improvecatheter crossing profileVSAvoiddamage to native anatomy

Core Design Contradiction:

Length of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The radially expandable sealing sleeve acts as an intermediary protective layer between the compressed valve prosthesis and the native anatomy. During delivery, the sleeve remains compressed with the valve prosthesis, providing a protective barrier that prevents direct contact and potential damage to surrounding tissues.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If a capsule is used for delivery, then positioning is facilitated, but the crossing profile increases and capsule travel within the left atrium is limited

Engineering Contradiction:

Improvepositioning capabilityVSAvoidcatheter crossing profile

Core Design Contradiction:

Ease of operationVSLength of stationary object

Solution Approach 1:

The traditional rigid capsule is extracted from the delivery system in favor of a radially expandable sealing sleeve that is integrated onto the valve prosthesis. This extraction eliminates the need for a separate capsule, reduces the crossing profile, and allows the sealing function to be performed directly by the valve prosthesis at the target site.

Inventive Principle:

Principle #2Taking out (Extraction)

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 system effectively minimizes the catheter crossing profile, ensures proper sealing of the valve prosthesis to the native valve wall, and facilitates atraumatic delivery, thereby addressing the challenges of paravalvular leakage and procedural complexity.

Implementation Method 1

a radially-expandable sleeve integrated thereon. The radially-expandable sleeve is configured to transform from a delivery state in which the radially-expandable sleeve has a first diameter to a deployed state in which the radially-expandable sleeve has a second diameter greater than the first diameter

Methodology Applied

Scientific EffectRadial expansion: Elasticity

Implementation Method 2

at least one cinching suture configured for coupling the valve prosthesis to the elongated shaft component. The at least one cinching suture is removable and radially compresses the valve prosthesis into the compressed configuration for delivery

Methodology Applied

Scientific EffectRadial compression: Compression

Data Source

PatentUS12239535B2Valve prosthesis having a radially expandable sleeve integrated thereon for delivery and prevention of paravalvular leakage

Publication Date: 2025.03.04 MEDTRONIC VASCULAR INC

AI summary

A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.