Percutaneous Mitral Valve Replacement Anchoring and Sealing

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Solution Overview

Problem

Current methods for mitral valve replacement are invasive, complex, and often ineffective in reducing mitral regurgitation (MR) without causing negative physiological consequences such as stenosis or atrial fibrillation, particularly in patients with secondary or functional MR, where the risks of intervention outweigh the benefits.

Innovation Solution

A percutaneous or minimally invasive mitral valve replacement system that includes an anchoring structure and an artificial valve, utilizing a staged approach with an anchor element, sealing element, and valve element, which secures the valve without disrupting native valve function and maintains LV geometry, allowing for reliable and repeatable procedure with reduced invasiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current invasive methods for mitral valve replacement are used, then the valve can be replaced, but the procedure is invasive and complex with negative physiological consequences such as stenosis or atrial fibrillation

Engineering Contradiction:
Improveeffectiveness in reducing mitral regurgitationVSAvoidnegative physiological consequences such as stenosis or atrial fibrillation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The replacement valve is divided into multiple functional elements: an anchoring structure for securement, a sealing structure for preventing regurgitation, and a valve structure for flow control. These segmented components can be delivered and deployed separately through catheters, reducing the invasiveness of the procedure while maintaining effectiveness in treating mitral regurgitation without causing stenosis or atrial fibrillation

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A sealing structure acts as an intermediary element between the anchoring structure and the native valve tissue. This sealing component prevents direct contact between the rigid anchoring structure and the soft tissue, reducing the risk of tissue damage, atrial fibrillation, and other harmful physiological consequences while maintaining the reliability of mitral regurgitation reduction

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If surgical correction is performed early in the disease process, then the beneficial effects of eliminating MR are achieved, but the risk of surgery in healthy patients is high

Engineering Contradiction:
Improvebeneficial effects of eliminating MRVSAvoidrisk of surgery
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The traditional mechanical surgical approach (open chest, sternotomy, cardiopulmonary bypass, direct suture placement) is replaced with a less invasive mechanical system that delivers the valve replacement through catheters via venous access. This substitution maintains the beneficial effects of eliminating mitral regurgitation while dramatically reducing the procedural risks and invasiveness associated with traditional surgery

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If percutaneous or minimally invasive mitral valve replacement is performed, then invasiveness is reduced, but the procedure must be reliable and repeatable

Engineering Contradiction:
ImproveinvasivenessVSAvoidreliability and repeatability of procedure
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The anchoring structure is designed with pre-formed engagement features and delivery mechanisms that ensure proper positioning and secure attachment to the mitral valve apparatus before the valve structure is deployed. This preliminary anchoring action ensures the reliability and repeatability of the percutaneous procedure by establishing a stable foundation that can consistently withstand physiological forces

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The valve system incorporates adjustable parameters including the expansion force of the anchoring structure, the sealing pressure of the sealing elements, and the opening area of the valve structure. These parameter changes allow the procedure to be adapted to different patient anatomies and physiological conditions, ensuring reliability and repeatability across diverse clinical scenarios while maintaining minimal invasiveness

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2838475B1Valve replacement systems
Publication Date: 2022.11.30 CAISSON INTERVENTIONAL LLC
  • EP2838475B1 patent drawingFigure 1A~1B
  • EP2838475B1 patent drawingFigure 2A~2E
  • EP2838475B1 patent drawingFigure 3~5

AI summary

Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.