Transcatheter Heart Valve Docking for Secure Fit and Leak Sealing

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Solution Overview

Problem

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

Innovation Solution

A docking system, including a suture lock assembly and delivery system, is used to secure prosthetic valves in position, utilizing a docking device with a coil design that creates multiple points of contact and a soft covering to reduce leakage, along with a delivery system that includes a pusher and sleeve shaft for precise implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a prosthetic valve is implanted using a transcatheter technique, then the invasiveness of the procedure is reduced, but the ability to appropriately size and secure the valve in varying valve anatomies deteriorates

Engineering Contradiction:

ImproveinvasivenessVSAvoidability to size and secure valve

Core Design Contradiction:

Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The delivery system is divided into multiple functional components including an outer shaft, pusher shaft, sleeve shaft, and docking system. This segmentation allows each component to perform specific functions during delivery and implantation, enabling precise control and adaptation to varying valve anatomies while maintaining the less invasive transcatheter approach

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A docking system is introduced as an intermediary component between the prosthetic valve and the native valve annulus. The docking system with its anchoring features provides an adaptive interface that secures the valve in position while accommodating variations in valve anatomy, thus resolving the contradiction between minimally invasive delivery and proper valve securing

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If a prosthetic valve is used to treat valve insufficiency, then valve function is improved, but the surrounding tissue may not be strong enough to hold the valve in position, leading to potential displacement

Engineering Contradiction:

Improvevalve functionVSAvoidtissue holding strength

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The docking system is deployed ahead of the prosthetic valve to prepare the implantation site. The docking system's anchoring features are positioned and secured in the native valve annulus before the prosthetic valve is released, creating a secure foundation that compensates for weak surrounding tissue and prevents valve displacement

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The docking system serves as a mediator between the prosthetic valve and the surrounding tissue. It provides enhanced anchoring features that distribute forces and improve holding strength in situations where the native tissue is too weak to secure the valve directly, thus maintaining valve function without relying solely on tissue strength

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If the native valve shape is accommodated, then patient-specific anatomy is respected, but paravalvular leakage around the prosthetic valve increases

Engineering Contradiction:

Improveanatomy accommodationVSAvoidparavalvular leakage

Core Design Contradiction:

Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

The docking system incorporates localized sealing features and anchoring elements positioned at specific locations around the valve annulus. This local quality approach allows the system to adapt to patient-specific anatomy while providing targeted sealing at critical areas to prevent paravalvular leakage, rather than requiring uniform modification throughout the entire valve structure

Inventive Principle:

Principle #3Local quality

4Manufacturing precision

If a docking system is introduced to secure the prosthetic valve, then valve positioning is improved, but the device complexity increases

Engineering Contradiction:

Improvevalve positioningVSAvoidsystem complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The docking system is integrated with the prosthetic valve as a combined assembly, with the docking features built into the valve structure itself. This merging reduces the number of separate components and simplifies the delivery system while maintaining precise positioning capabilities, thus improving valve positioning without proportionally increasing device complexity

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12472061B2Systems, devices, and methods for treating heart valves

Publication Date: 2025.11.18 EDWARDS LIFESCIENCES CORP

AI summary

Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic valves can have integrated coverings or flanges. Prosthetic valves can have a flange attached to the inflow end of the annular frame and designed to extend outwardly therefrom. Docking devices can be used to repair or reshape native heart valves and 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 docking device into the heart, including a lubricous sleeve in the delivery system. Packaging and storage systems suitable for the delivery systems are described.