Transcatheter Valve Docking and Delivery for Precise Mitral Positioning

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Solution Overview

Problem

Existing transcatheter heart valves face challenges in accurately sizing and securing prosthetic valves within varying mitral and tricuspid valve anatomies, leading to inefficiencies and paravalvular leakage.

Innovation Solution

The development of docking devices, delivery systems, and suture lock assemblies that facilitate precise placement and securement of prosthetic heart valves, including features like suture lock assemblies with directional selectors and delivery systems with coaxial pusher and sleeve shafts for controlled deployment and flushing mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transcatheter heart valves are used to treat mitral and tricuspid valves, then less invasive treatment is achieved, but difficulty in sizing and securing the valve arises due to varying anatomy

Engineering Contradiction:

Improveinvasiveness of treatmentVSAvoidsizing accuracy of prosthetic valve

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The delivery system incorporates expandable and collapsible components that allow dynamic adaptation to varying valve anatomies. The prosthetic valve can be compressed for delivery through catheters and then expanded at the target site to match the specific anatomical dimensions of each patient's mitral or tricuspid valve, enabling precise sizing without requiring multiple pre-fabricated sizes.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system allows for adjustable parameters including the expansion radius and longitudinal positioning of the prosthetic valve during deployment. These parameter changes enable the valve to be customized in-situ to match the specific anatomical variations of different patients, resolving the sizing accuracy problem while maintaining the less invasive transcatheter approach.

Inventive Principle:

Principle #35Parameter changes

2Device complexity

If standard delivery systems are used for prosthetic valves, then simplified delivery process is achieved, but paravalvular leakage occurs due to improper positioning

Engineering Contradiction:

Improvecomplexity of delivery systemVSAvoidsealing effectiveness of prosthetic valve

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The delivery system incorporates positioning markers and guidance features that are prepared in advance to ensure accurate placement of the prosthetic valve before deployment. The system allows for preliminary positioning adjustments and verification of proper alignment with the native valve annulus, preventing paravalvular leakage while maintaining manageable system complexity.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The delivery system includes feedback mechanisms such as radiopaque markers and positioning indicators that provide real-time information to the operator during deployment. This feedback enables continuous adjustment of valve position and orientation to ensure optimal sealing against the native valve, thereby improving reliability without significantly increasing device complexity.

Inventive Principle:

Principle #23Feedback

3Volume of moving object

If prosthetic valves are expanded at the implantation site, then functional size is achieved, but positioning accuracy is compromised without docking mechanisms

Engineering Contradiction:

Improvefunctional volume of prosthetic valveVSAvoidpositioning accuracy of prosthetic valve

Core Design Contradiction:

Volume of moving objectVSMeasurement precision

Solution Approach 1:

The system introduces a docking mechanism or anchoring structure as an intermediary between the prosthetic valve and the native valve annulus. This intermediary provides reference points and mechanical guidance that enhance positioning accuracy during the expansion process, ensuring the valve is correctly positioned before it reaches its full functional volume.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The delivery system employs a nested structure where the prosthetic valve is contained within a delivery catheter that itself is nested within an outer sheath. This nested arrangement allows for controlled deployment and positioning, with each layer providing guidance and constraints that maintain positioning accuracy as the valve expands to its functional size.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS20250352340A1Systems, devices, and methods for treating heart valves

Publication Date: 2025.11.20 EDWARDS LIFESCIENCES CORP

AI summary

Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic implants can be used to repair or reshape native heart valves and, in some examples, to secure prosthetic heart valves at a specific location and position relative to a native heart valve. Delivery systems can be used to deploy a prosthetic implant into the heart, including a lubricous sleeve in the delivery system. Packaging and storage systems suitable for the delivery systems are described.