Prosthetic Mitral Valve Self-Expanding Anchor

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Solution Overview

Problem

Current surgical and minimally invasive treatments for mitral valve regurgitation are often costly, difficult to deliver, and do not provide the best clinical results for all patients, necessitating the development of improved devices and methods for treating valvar insufficiency.

Innovation Solution

A prosthetic mitral valve with a self-expanding anchor portion and a delivery system that allows for transapical or transseptal implantation, featuring a radially expandable frame with an atrial skirt, annular region, and ventricular skirt to securely anchor the valve within the heart, while ensuring proper blood flow and minimizing obstruction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical methods are used to treat mitral valve regurgitation, then clinical results can be achieved, but the treatment is costly and requires open-heart surgery with significant patient morbidity

Engineering Contradiction:
Improveclinical resultsVSAvoidsurgical complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The prosthetic valve is divided into separate functional components: a self-expanding anchor portion that provides structural support and anchoring, and a valve portion with leaflets that controls blood flow. This segmentation allows each component to be optimized independently and simplifies the implantation process compared to traditional whole-valve replacement

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve portion is nested within the anchor portion, with the valve leaflets positioned inside the expanded anchor structure. This nested configuration allows the valve to be delivered in a compact state and then deployed in situ, avoiding the need for complex open-heart surgery while maintaining reliable valve function

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If minimally invasive transcatheter techniques are used, then patient morbidity is reduced, but delivery difficulty and device complexity increase

Engineering Contradiction:
Improvepatient recoveryVSAvoiddelivery system complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The anchor portion is designed with self-expanding properties using shape memory alloy or elastic materials, allowing it to automatically expand to its functional configuration upon deployment without requiring complex external expansion mechanisms. This self-service capability simplifies the delivery system while enabling minimally invasive implantation

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The anchor portion is pre-formed with the final three-dimensional configuration during manufacturing, utilizing shape memory effects or elastic recovery. This preliminary action allows the anchor to self-expand to its functional shape during implantation, eliminating the need for complex post-deployment adjustment mechanisms and reducing delivery system complexity

Inventive Principle:
Principle #10Preliminary action

3Reliability

If a self-expanding anchor portion is used, then anchoring security is improved, but device complexity and manufacturing difficulty increase

Engineering Contradiction:
Improveanchoring securityVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The anchor portion utilizes changes in material parameters, specifically the elastic properties and shape memory characteristics of the material, to achieve self-expansion. By selecting materials with appropriate elastic moduli and shape memory transformation temperatures, the anchor can be manufactured in a simple flat or compressed state and will automatically transform to its functional three-dimensional configuration during implantation, simplifying both manufacturing and deployment

Inventive Principle:
Principle #35Parameter changes

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 prosthetic mitral valve effectively reduces or eliminates valvar insufficiency by securely anchoring within the heart, optimizing blood flow patterns, and reducing the risk of complications associated with existing treatments.

Implementation Method 1

a self-expanding anchor portion

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a self-expanding anchor portion

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS12036117B2Prosthetic valve with natural blood flow
Publication Date: 2024.07.16 NEOVASC TIARA INC
  • US12036117B2 patent drawing
  • US12036117B2 patent drawing
  • US12036117B2 patent drawing

AI summary

A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.