Prosthetic Valve Anchoring and Sealing for Irregular Native Annuli

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Solution Overview

Problem

Existing prosthetic heart valves face challenges in securing to intralumenal tissue atraumatically and preventing paravalvular leakage, particularly when deployed in non-circular native valve annuli with recesses.

Innovation Solution

The prosthetic valve includes multiple anchors and sealing mechanisms that conform to the shape of the native valve, with outward-facing and inward-facing anchors securing to the native valve leaflets and a sealing body reducing fluid flow, along with adjustable diameter features for secure anchoring and sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If replacement valves are designed to be delivered through minimally invasive procedures, then patient trauma is reduced, but the ability to securely anchor the valve to intralumenal tissue becomes more difficult

Engineering Contradiction:

Improvepatient traumaVSAvoidanchoring security

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The prosthetic valve system is divided into separate functional components: an expandable frame for structural support, tissue anchors for securement, sealing elements for preventing leakage, and a delivery catheter for minimally invasive placement. This segmentation allows each component to be optimized independently while working together as an integrated system.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tissue anchors are pre-positioned on the expandable frame in a compressed state within the delivery catheter. Upon deployment, the anchors are automatically positioned to engage the native valve tissue before the sealing elements are deployed, ensuring secure anchoring is established prior to sealing.

Inventive Principle:

Principle #10Preliminary action

2Ease of manufacture

If the prosthetic valve uses a standard circular shape, then manufacturing is simplified, but it cannot properly conform to non-circular shaped native valve annuli with recesses

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidconformability to native valve shape

Core Design Contradiction:

Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The expandable frame is designed with an asymmetric, non-circular geometry that includes protrusions and recesses matching the natural anatomy of native valve annuli. This asymmetric design allows the prosthetic valve to conform precisely to irregular native valve shapes while maintaining manufacturability through modular construction.

Inventive Principle:

Principle #4Asymmetry

Solution Approach 2:

Different portions of the expandable frame are designed with locally optimized geometries: some sections have protrusions to engage with elevated portions of the native annulus, while other sections have recesses to accommodate native valve recesses. This local customization of frame geometry enables precise conformability without requiring complete custom manufacturing for each patient.

Inventive Principle:

Principle #3Local quality

3Device complexity

If the prosthetic valve uses simple anchoring mechanisms, then device complexity is reduced, but the ability to secure the valve in an atraumatic manner is compromised

Engineering Contradiction:

Improveanchoring mechanism complexityVSAvoidtissue trauma

Core Design Contradiction:

Device complexityVSObject-affected harmful factors

Solution Approach 1:

The tissue anchors serve as intermediary elements between the expandable frame and the native valve tissue. These anchors are designed with tissue-compatible materials and geometries that distribute mechanical loads across larger tissue areas, reducing stress concentrations and minimizing trauma while maintaining secure anchoring.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The anchors are designed to change their mechanical parameters during deployment: they transition from a compressed low-profile state during delivery to an expanded high-strength state after deployment. This parameter change allows the anchors to be delivered through small access sites while providing strong,atraumatic securement once deployed.

Inventive Principle:

Principle #35Parameter changes

4Reliability

If the prosthetic valve uses rigid sealing structures, then sealing effectiveness is improved, but adaptability to non-circular shaped annuli is reduced

Engineering Contradiction:

Improvesealing effectivenessVSAvoidadaptability to annulus shape

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The sealing elements are constructed from flexible, compliant materials that can deform and conform to the irregular geometry of native valve annuli. These flexible sealing structures maintain effective sealing contact across non-circular annulus shapes while providing sufficient radial force to prevent paravalvular leakage.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentEP4729028A2Prosthetic valve systems and apparatuses

Publication Date: 2026.04.22 EDWARDS LIFESCIENCES CORP

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AI summary

Apparatuses, systems, and methods for prosthetic valves. Embodiments of prosthetic valves may be directed to improvements in anchoring to an implantation site and/or sealing flow at an implantation site, which may comprise a native valve. Embodiments may be configured to conform to a shape of a native valve, which may be a non-circular shape. Such native valves may include native valve annuli having oval shapes and/or shapes that include one or more recesses. Improvements in anchoring to implantation sites are disclosed as well.