Transatrial Prosthetic Mitral Valve Delivery via Inverted Frame

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Solution Overview

Problem

Current methods for delivering and deploying prosthetic mitral valves are complex and often require open-heart surgery, which is risky and poorly tolerated by elderly patients, especially due to the need for extra-corporeal circulation, and there is a lack of effective transcatheter approaches for mitral valve replacements compared to aortic valve replacements.

Innovation Solution

The development of devices and methods for delivering and deploying prosthetic mitral valves via transatrial or transjugular approaches, where the prosthetic valve has an outer frame with a biased expanded configuration that is inverted and collapsed for insertion through a delivery sheath, and then expanded within the heart, secured using an epicardial pad device and tether.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open-heart surgery is used for valve replacement, then the valve can be replaced effectively, but the procedure carries high morbidity and mortality risk due to the necessity for extra-corporeal circulation

Engineering Contradiction:

Improvevalve replacement effectivenessVSAvoidmorbidity and mortality risk

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 delivery sheath and deployment mechanism to implant the prosthetic valve through a catheter, eliminating the need for thoracotomy and extra-corporeal circulation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a delivery sheath as an intermediary device that allows the prosthetic valve to be delivered through a minimally invasive transseptal or transapical approach, serving as a mediator between the operator and the heart valve replacement procedure

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the prosthetic valve is delivered in a collapsed configuration through a delivery sheath, then the procedure becomes minimally invasive, but the valve structure must be inverted and collapsed which adds device complexity

Engineering Contradiction:

Improveminimally invasive procedureVSAvoidvalve inversion and collapse mechanism

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The patent inverts the outer frame of the prosthetic valve relative to the inner frame before delivery, allowing the valve to be collapsed into a compact configuration that can be inserted through the delivery sheath, and then reinverts it during deployment to achieve the correct orientation

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The patent nests the inner frame containing the valve leaflets within the outer frame, both of which can be collapsed and inserted through the delivery sheath together, with the inner frame nested within the lumen of the outer frame structure

Inventive Principle:

Principle #7Nested doll (Nesting)

3Volume of moving object

If the outer frame of the prosthetic valve is inverted relative to the inner frame prior to delivery, then the valve can be collapsed for insertion, but the valve structure becomes more complex to manufacture

Engineering Contradiction:

Improvevalve collapsed sizeVSAvoidinverted frame construction

Core Design Contradiction:

Volume of moving objectVSEase of manufacture

Solution Approach 1:

The patent inverts the outer frame relative to the inner frame during manufacturing to enable the collapsed configuration, accepting the increased manufacturing complexity as a necessary trade-off to achieve the compact deliverable size

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The patent creates an asymmetric relationship between the outer and inner frames where the outer frame is inverted relative to the inner frame, allowing the two frames to nest together in a collapsed configuration that would not be possible with symmetric construction

Inventive Principle:

Principle #4Asymmetry

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 approach allows for minimally invasive procedures with reduced morbidity and cost, limiting the number of body incisions, and enabling safer, more repeatable procedures with expedited recovery and reduced complications.

Implementation Method 1

an outer frame of a prosthetic mitral valve can have a biased expanded configuration and be inverted relative to an inner frame of the prosthetic mitral valve prior to delivery

Methodology Applied

Scientific EffectElastic memory: Elasticity

Data Source

PatentUS11318012B2Apparatus and methods for delivery of prosthetic mitral valve

Publication Date: 2022.05.03 TENDYNE HOLDINGS INC

AI summary

A method for delivery and deployment of a prosthetic mitral valve into a heart includes inserting an introducer sheath having a prosthetic mitral valve disposed therein in a collapsed configuration into the left atrium of a patient's heart, through a gap between the native mitral valve leaflets, the left ventricle and apex of the heart. An epicardial pad device coupled to the prosthetic valve via a tether is moved distally out of the sheath. The introducer sheath is withdrawn into the left atrium of the heart. An inner delivery sheath is extended distally from within the introducer sheath and disposed within the left atrium. The prosthetic mitral valve is moved distally out of the inner delivery sheath and assumes a biased expanded configuration. The valve is positioned within the mitral annulus of the heart, and secured in place via the tether and epicardial pad device.