Pleated Prosthetic Heart Valve Cuff for Sealing and Anchoring

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Solution Overview

Problem

Existing prosthetic heart valves face challenges such as perivalvular leakage, valve migration, mitral valve impingement, and conduction system disruption due to excessive radial force, particularly in patients with calcified or stenotic aortic valves, necessitating improved designs that seal and anchor without harming nearby anatomy and physiology.

Innovation Solution

A prosthetic heart valve design featuring a stent body with a tubular annulus region and a cuff that includes pleats, biasing elements, and mobile portions to facilitate secure engagement with native tissues, reducing the need for excessive radial force, and incorporates features like pleats and biasing elements to enhance sealing and anchoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the cuff thickness and radial force are increased to improve sealing and prevent perivalvular leakage, then sealing effectiveness is improved, but the risk of mitral valve impingement and conduction system disruption increases

Engineering Contradiction:

Improvesealing effectivenessVSAvoidmitral valve impingement and conduction system disruption

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The cuff is divided into multiple pleats (folds) that can independently deform. This segmentation allows the cuff to conform to the annular geometry without requiring excessive radial force, as each pleat can adjust locally to match the underlying tissue contours.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cuff transitions from a static structure to a dynamic one through the incorporation of pleats that can deform elastically. This dynamic capability allows the cuff to adapt to variations in annular shape and size, maintaining effective sealing while reducing peak radial forces on critical structures.

Inventive Principle:

Principle #15Dynamics

2Ease of operation

If the stent body is collapsed to a small diameter to facilitate advancement, then ease of delivery is improved, but the ability to securely engage native tissues is compromised

Engineering Contradiction:

Improveease of deliveryVSAvoidengagement with native tissues

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The valve components (cuff, stent body, valve elements) are nested within each other in a compact configuration for delivery. The cuff is collapsed around the stent body, which itself is collapsed to a small diameter, allowing the entire assembly to be delivered through small access sites while maintaining structural integrity for secure engagement upon deployment.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Reliability

If the cuff material thickness is increased to improve sealing, then perivalvular leakage is reduced, but the collapsed valve diameter increases

Engineering Contradiction:

Improveperivalvular leakage preventionVSAvoidcollapsed valve diameter

Core Design Contradiction:

ReliabilityVSLength of moving object

Solution Approach 1:

The cuff is constructed from thin, flexible material that is folded into pleats. This thin-film approach maintains effective sealing through the pleated configuration rather than material thickness, allowing the valve to collapse to a small diameter while still providing adequate seal against the annulus.

Inventive Principle:

Principle #30Flexible shells and thin films

4Stability of the object's composition

If radial force is increased to prevent valve migration, then anchoring stability is improved, but the risk of conduction system disruption increases

Engineering Contradiction:

Improvevalve anchoring stabilityVSAvoidconduction system disruption

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The cuff and stent body apply force locally at multiple contact points around the annulus rather than uniformly. This distributed local engagement provides stable anchoring while preventing excessive force concentration on the conduction system, which passes through specific vulnerable areas.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS12582519B2Collapsible and re-expandable prosthetic heart valve cuff designs and complementary technological applications

Publication Date: 2026.03.24 ST JUDE MEDICAL LLC

AI summary

A prosthetic heart valve for replacement of a native heart valve having a native valve annulus includes a stent body having a proximal end adjacent an inflow end and a distal end adjacent an outflow end and including an annulus section, the stent body having a radially collapsed condition and a radially expanded condition, one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a cuff coupled to the stent body, the cuff having a mobile portion that is moveable relative to the stent body, and at least one engagement element remote from the stent body.