Transcatheter Mitral Valve Delivery Actuator Mechanism

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Solution Overview

Problem

Current transcatheter prosthetic valve delivery systems face challenges in effectively deploying and anchoring mitral valve replacements due to the complexity of the native mitral valve apparatus, particularly in elderly patients and those with aortic and mitral valve disease, where traditional open-heart surgery poses significant morbidity and cost.

Innovation Solution

A delivery device comprising a catheter assembly with a sheath, hub, and handle assembly, including a valve holding tube and actuator, allows for controlled deployment of a transcatheter mitral valve prosthesis with an expandable metal stent body and tethers, enabling incremental movement and expansion within the heart, reducing the need for extra-corporeal circulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open-heart surgery is used for valve replacement, then complete valve replacement can be achieved, but morbidity and cost significantly increase due to extra-corporeal circulation

Engineering Contradiction:

Improvevalve replacement effectivenessVSAvoidmorbidity and cost

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses a catheter-based approach. The prosthetic valve is delivered through a catheter to the heart, eliminating the need for thoracic opening and extra-corporeal circulation machinery, thereby reducing morbidity and cost while maintaining valve replacement effectiveness

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a delivery catheter as an intermediary device that transports the compressed prosthetic valve to the target location in the heart. This intermediary enables the valve to be positioned and deployed without direct surgical access to the heart, avoiding the harmful effects of open-heart surgery

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If transcatheter delivery is used for mitral valve replacement, then morbidity and cost are reduced, but device complexity and anchoring difficulty increase due to native mitral valve apparatus complexity

Engineering Contradiction:

Improvemorbidity and costVSAvoiddelivery device complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The delivery device is segmented into multiple functional components: a catheter for delivery, a holding tube for securing the compressed valve, an expandable stent structure for the prosthetic valve, and tethers for anchoring. This segmentation allows each component to perform its specific function, managing the overall complexity through modular design

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The prosthetic valve is nested within an expandable stent structure, which is in turn nested within the delivery catheter and holding tube during delivery. This nested configuration allows the complex multi-component system to be delivered through a relatively simple catheter-based approach, reducing the apparent complexity at the delivery interface

Inventive Principle:

Principle #7Nested doll (Nesting)

3Length of moving object

If the prosthetic valve is delivered in compressed configuration, then delivery through catheter is enabled, but deployment control and anchoring precision become more challenging

Engineering Contradiction:

Improvevalve delivery sizeVSAvoiddeployment control and anchoring precision

Core Design Contradiction:

Length of moving objectVSManufacturing precision

Solution Approach 1:

The prosthetic valve transitions from a static compressed state during delivery to a dynamic expanded state at deployment. The expandable stent structure allows the valve to dynamically change shape and size, enabling precise deployment control and accurate anchoring to the native mitral valve apparatus after catheter delivery

Inventive Principle:

Principle #15Dynamics

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 facilitates a minimally invasive transcatheter mitral valve replacement with controlled deployment and anchoring, potentially reducing morbidity and costs associated with traditional open-heart surgery, while providing a safer and more effective procedure for patients.

Implementation Method 1

the prosthetic valve is free to move to a biased expanded configuration

Methodology Applied

Scientific EffectElastic recovery: Elasticity

Data Source

PatentUS11096783B2Apparatus and methods for delivery of transcatheter prosthetic valves

Publication Date: 2021.08.24 TENDYNE HOLDINGS INC

AI summary

In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.