Elevated Outer Cuff for Prosthetic Heart Valve Sealing

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Solution Overview

Problem

Collapsible prosthetic heart valves often experience paravalvular leaks due to imperfect sealing between the valve and native cardiac tissue, leading to complications such as retrograde blood flow.

Innovation Solution

The design incorporates a stent with a first and second cuff, where the second cuff is annularly disposed radially outward of the first cuff, forming pockets to enhance sealing. The method of implantation positions the prosthetic heart valve such that a sub-annular portion of the stent extends beyond the native valve annulus, with the second cuff in direct contact with the native valve annulus to minimize leaks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a collapsible prosthetic valve is delivered via catheter, then invasiveness is reduced, but sealing performance deteriorates causing paravalvular leaks

Engineering Contradiction:

Improveinvasiveness of deliveryVSAvoidsealing performance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent implements a nested cuff structure where an inner cuff is positioned within an outer cuff, creating multiple sealing layers. The inner cuff provides primary sealing against the native valve annulus, while the outer cuff provides secondary sealing, effectively addressing paravalvular leaks without requiring more invasive delivery methods.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent employs flexible cuff materials that can conform to the native valve annulus geometry. The cuffs are designed with compliant properties allowing them to adapt to irregular surfaces, creating effective seals while maintaining the minimally invasive catheter-based delivery approach.

Inventive Principle:

Principle #30Flexible shells and thin films

2Reliability

If the stent extends beyond the native valve annulus, then sealing contact is improved, but stent fatigue life deteriorates

Engineering Contradiction:

Improvesealing contactVSAvoidstent fatigue life

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent divides the sealing function into two separate components: the stent structure and the cuffs. The stent is designed to extend beyond the native valve annulus to provide structural support and positioning, while the cuffs are specifically designed to provide the sealing contact. This segmentation allows the stent to maintain adequate length for stability without bearing the full sealing load, thereby reducing fatigue stress.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cuffs act as intermediary elements between the stent and the native valve annulus. Instead of the stent directly contacting and sealing against the annulus (which would create high stress concentrations), the cuffs serve as intermediate sealing surfaces that distribute loads more evenly, protecting the stent from excessive fatigue.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Device complexity

If a single cuff is used, then device complexity is reduced, but sealing effectiveness deteriorates

Engineering Contradiction:

Improvecuff structureVSAvoidsealing effectiveness

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent utilizes a nested cuff configuration where the inner cuff is positioned within the outer cuff. This nested arrangement creates multiple sealing interfaces without requiring completely separate components, achieving enhanced sealing effectiveness while maintaining relatively compact and manageable device complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent adds an radial dimension to the sealing approach by implementing cuffs at different radial positions (inner and outer cuffs). This multi-dimensional sealing strategy creates redundant sealing barriers, improving reliability without proportionally increasing complexity since both cuffs are integrated into the same valve assembly.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

Data Source

PatentEP3902503B1Elevated outer cuff for reducing paravalvular leakage and increasing stent fatigue life

Publication Date: 2025.01.29 ST JUDE MEDICAL CARDILOGY DIV INC

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Figure 3B

AI summary

A prosthetic heart valve (400) may include a valve assembly (404) disposed within a stent (402), and first (406) and second (450) cuffs. The stent may extend from an inflow end to an outflow end. The first cuff may be annularly disposed adjacent the stent. The second cuff may have a proximal edge (452) facing toward the inflow end of the stent and a distal edge (458) facing toward the outflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff. The distal edge of the second cuff may be coupled to the first cuff and/or the stent at a plurality of locations to form a pocket(s) between the first and second cuffs. The proximal edge of the second cuff may be coupled to first cuff and/or to the stent at a spaced distance from the stent's inflow end.