Expandable Prosthetic Heart Valve Actuator and Locking Mechanism

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Solution Overview

Problem

Existing prosthetic heart valves face challenges with bulky and complex expansion and locking mechanisms, which are costly to manufacture and difficult to use, and self-expanding valves often struggle to fully expand and retain their functional size within calcified native annulus.

Innovation Solution

The development of prosthetic heart valves with an annular frame, actuator member, and locking element that allows for controlled radial expansion and locking, featuring a tension member and locking mechanism that enables self-expansion and mechanical actuation, allowing for tighter control over expansion and re-compression without the need for disengaging locking mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing mechanical actuators and locking mechanisms are used for prosthetic heart valve expansion, then the valve can be expanded and locked, but the mechanisms become bulky, complicated to use, and costly to manufacture

Engineering Contradiction:
Improvevalve expansion and locking capabilityVSAvoidactuator and locking mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the actuator member and locking element into a single integrated assembly that performs both expansion and locking functions. The actuator member with locking element works as a unified mechanism where the locking element is positioned to engage with the frame at a specific location, eliminating the need for separate bulky mechanical actuators and locking mechanisms.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent extracts the essential locking function from complex mechanical locking mechanisms and implements it through a simplified locking element that engages with the frame. The locking element is designed to work with the actuator member in a streamlined manner, removing unnecessary complexity while maintaining reliable locking capability.

Inventive Principle:
Principle #2Taking out (Extraction)

2Ease of operation

If self-expanding valves are used, then the valve can expand automatically, but the valve struggles to fully expand and retain functional size within calcified native annulus

Engineering Contradiction:
Improveautomatic expansion capabilityVSAvoidexpansion completeness and retention in calcified annulus
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent utilizes the self-expanding property of the frame made from shape-memory material that automatically expands when released from the delivery sheath. The frame is configured to radially self-expand from the radially compressed state to at least a partially radially expanded state, providing automatic expansion capability.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent prepares the frame with predetermined memory characteristics during manufacturing so that it is pre-formed in a radially expanded state. This preliminary configuration ensures that when the frame is released, it automatically expands to the correct functional size and shape, even within calcified native annulus, without requiring additional manual intervention.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If existing locking mechanisms are used, then the valve can be locked in expanded state, but the mechanisms are bulky and difficult to use

Engineering Contradiction:
Improvevalve locking capabilityVSAvoidlocking mechanism usability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the locking function from complex mechanical mechanisms and implements it through a simplified locking element that works in conjunction with the actuator member. The locking element is designed to engage with the frame in a straightforward manner, making the locking mechanism easier to use while maintaining reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The locking element is designed to automatically engage with the frame when the actuator member is positioned correctly, reducing the need for manual manipulation of complex locking mechanisms. The system performs the locking action through the natural movement of the actuator member, making it easier to operate.

Inventive Principle:
Principle #25Self-service

4Reliability

If existing mechanical actuators are used for valve expansion, then the valve can be expanded, but the actuators are bulky and costly to manufacture

Engineering Contradiction:
Improvevalve expansion capabilityVSAvoidactuator manufacturing cost and complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent combines the actuator member and locking element into a single integrated assembly, reducing the number of separate components that need to be manufactured and assembled. This merging of functions simplifies the manufacturing process and reduces costs while maintaining reliable expansion capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent extracts the essential expansion function from complex mechanical actuators and implements it through a simplified actuator member that works in conjunction with the locking element. This extraction of core functionality eliminates unnecessary components, making the actuator easier and less costly to manufacture.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This solution provides a prosthetic heart valve with improved expansion and locking mechanisms that are simpler, easier to manufacture, and more cost-effective, allowing for controlled expansion and re-compression, ensuring a secure fit with native tissue and minimizing the risk of collapse.

Implementation Method 1

the frame is configured to radially self-expand from the radially compressed state to at least a partially radially expanded state

Methodology Applied
Scientific EffectElastic recovery: Elasticity

Implementation Method 2

such self-expanding valves can be constructed from a shape-memory material and can be pre-formed in a radially expanded state

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS20240074855A1Expandable prosthetic heart valves
Publication Date: 2024.03.07 EDWARDS LIFESCIENCES CORP
  • US20240074855A1 patent drawing
  • US20240074855A1 patent drawing
  • US20240074855A1 patent drawing

AI summary

This disclosure is directed to prosthetic heart valves having expansion and locking assemblies. As one example, a prosthetic heart valve can include an annular frame and an expansion and locking assembly that is configured to radially expand the frame to a radially expanded state and/or to lock the prosthetic valve in the radially expanded state to prevent the prosthetic valve from collapsing (i.e., radially compressing). In some examples, the prosthetic heart valve can be configured to radially self-expand to a partially radially expanded state, and can then be further radially expanded to the radially expanded state and/or locked in the radially expanded state by pulling an actuator member of the expansion and locking assembly. In some examples, the actuator member can extend through openings in vertical struts of the frame.