Twisted Wire Locking for Prosthetic Heart Valve Expansion

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Solution Overview

Problem

Current transcatheter heart valve technologies and delivery systems face challenges in effectively expanding and locking prosthetic valves at the implantation site, leading to potential complications and inefficiencies in minimally invasive procedures.

Innovation Solution

A prosthetic valve system with a guide member, base member, and wire assembly that utilizes a sleeve and actuation assembly to expand and lock the valve by approximating the guide and base members, forming a twist that secures the valve in place, while allowing for easy retrieval of the delivery apparatus.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a mechanical actuation mechanism is used to expand the prosthetic valve, then the valve can be expanded to a functional size, but the complexity of the delivery system increases due to multiple actuation/locking assemblies

Engineering Contradiction:
Improvevalve expansion reliabilityVSAvoiddelivery system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the expansion and locking functions into a single integrated wire mechanism. The first and second wires work together as a unified system where both wires must be pulled simultaneously to expand the valve, and the same wires then lock the valve in place. This merging of functions reduces the number of separate actuation/locking assemblies needed in the delivery system.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The wires serve multiple functions throughout the procedure: they act as actuation members during expansion, transition into locking members after expansion, and remain as retention elements. This multi-functionality eliminates the need for separate actuation and locking mechanisms, simplifying the overall delivery system while maintaining reliable valve deployment.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If the valve is locked in place after expansion, then recompression is prevented, but the delivery system cannot be easily retrieved

Engineering Contradiction:
Improvevalve position stabilityVSAvoiddelivery apparatus retrieval
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The locking mechanism is designed to be dynamic rather than permanent. The wires remain under tension to maintain the locked state, but this tension can be released by pulling the free ends of the wires. This allows the system to transition from a locked state (preventing recompression) to an unlocked state (enabling delivery system retrieval), resolving the contradiction between stability and ease of retrieval.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The wires act as intermediaries between the delivery system and the implanted valve. During deployment, the wires transmit force to expand and lock the valve. After implantation, the wires remain as flexible connections that can be severed or released to free the delivery system, allowing retrieval while maintaining valve stability throughout the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If multiple wires are used for expansion and locking, then the valve can be securely positioned, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvevalve locking reliabilityVSAvoidassembly manufacturing
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The locking mechanism is segmented into multiple independent wire elements rather than a single complex component. Each wire can be manufactured and tested separately, then assembled into the valve framework. This segmentation simplifies the manufacturing process compared to creating a single integrated locking mechanism, while still providing reliable multi-point locking.

Inventive Principle:
Principle #1Segmentation

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system enables secure expansion and locking of the prosthetic valve, preventing recompression and ensuring a stable implantation, thereby enhancing the reliability and efficiency of minimally invasive heart valve replacement procedures.

Implementation Method 1

the wire comprises a plastically deformable material

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentEP4161446B1Expansion and locking assemblies with intertwined wires
Publication Date: 2024.12.18 EDWARDS LIFESCIENCES CORP
  • EP4161446B1 patent drawingFigure 1
  • EP4161446B1 patent drawingFigure 2
  • EP4161446B1 patent drawingFigure 3

AI summary

The present invention is directed toward prosthetic heart valves that include an expandable frame provided with expansion and locking assemblies, which can be kept in a locked state by a twist formed along a portion of a wire of each expansion and locking assemblies. The present invention is further directed toward delivery assemblies that include actuation assemblies configured to actuate the expansion and locking assemblies, and to methods of utilizing the actuation assemblies and the expansion and locking assemblies.