Mitral Valve Cutting Apparatus for LVOT Obstruction Prevention

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Solution Overview

Problem

Current transcatheter mitral valve replacement (TMVR) technologies face challenges in safely and effectively replacing mitral valves due to the complex and unpredictable anatomy of the mitral valve annulus, often resulting in left ventricular outflow tract (LVOT) obstruction and complications during deployment.

Innovation Solution

An apparatus comprising a controller, a cutting section movable between collapsed and expanded positions for incising a mitral valve leaflet, and a guidewire, allowing for percutaneous access and precise placement of a prosthetic valve without invasive open heart procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional TMVR apparatus with anchoring features is used to securely attach prosthetic valve, then valve attachment reliability is improved, but left ventricular outflow tract obstruction occurs

Engineering Contradiction:

Improvevalve attachment reliabilityVSAvoidleft ventricular outflow tract obstruction

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The apparatus performs preliminary incision of the mitral valve leaflet before deploying the prosthetic valve. The cutting section incises the leaflet to create a precise opening, allowing the prosthetic valve to be positioned accurately without pushing the anterior leaflet under the aortic valve, thereby preventing LVOT obstruction while ensuring secure attachment

Inventive Principle:

Principle #10Preliminary action

2Reliability

If open heart procedure is performed to repair or replace mitral valve, then valve replacement reliability is improved, but patient morbidity and mortality risk increases

Engineering Contradiction:

Improvevalve replacement reliabilityVSAvoidpatient morbidity and mortality risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical open heart surgical system with a percutaneous catheter-based delivery system. The apparatus can be delivered through a blood vessel to the heart, eliminating the need for sternotomy and cardiopulmonary bypass, thereby reducing patient trauma and recovery time while maintaining effective valve replacement capability

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If percutaneous catheter-based delivery is used for mitral valve replacement, then patient trauma is reduced, but device precision and control during deployment deteriorates

Engineering Contradiction:

Improvepatient traumaVSAvoiddevice placement precision

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The apparatus is divided into distinct functional segments: a delivery catheter for percutaneous access, a cutting section with blades for precise leaflet incision, and a prosthetic valve component. This segmentation allows each component to perform its specific function with high precision while being delivered through a minimally invasive percutaneous approach

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cutting section acts as an intermediary tool between the delivery catheter and the prosthetic valve. It creates a precise opening in the mitral valve leaflet that guides the subsequent placement of the prosthetic valve, ensuring accurate positioning without requiring complex direct manipulation during deployment

Inventive Principle:

Principle #24Intermediary (Mediator)

4Manufacturing precision

If mitral valve leaflet is incised prior to prosthesis implantation, then prosthesis positioning precision is improved, but risk of fatal complications increases if positioning is not precise

Engineering Contradiction:

Improveprosthesis positioning precisionVSAvoidrisk of fatal complications

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The cutting section incises the mitral valve leaflet with a controlled pattern (such as a T-shaped or X-shaped incision) before prosthesis implantation. This preliminary action creates a precise opening that guides accurate prosthesis positioning, and the controlled nature of the incision minimizes the risk of complications by avoiding uncontrolled tissue damage

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12268597B2Apparatus for use in replacing mitral valves and methods of use thereof

Publication Date: 2025.04.08 VESALIUS CARDIOVASCULAR INC

AI summary

Apparatus and methods for replacing a mitral valve are provided. The apparatus comprises controller, a cutting section movable between a collapsed position for delivering the apparatus to a mitral valve and an expanded position for incising a mitral valve leaflet, and a guidewire. The apparatus is sized and dimensioned to enter a subject through a first access site, traverse through a subject's circulatory system, and exit the subject through a second access site so that a distal end of the guidewire and the controller are external to the subject's circulatory system when the apparatus is situated intravascularly. The method comprises inserting the apparatus percutaneously through the first access site, advancing the apparatus through the subject's circulatory system, advancing the apparatus through the second access site, incising a mitral valve leaflet, and delivering a prosthetic valve intravascularly over the guidewire to the incised mitral valve leaflet from the second access site.