Staged Mitral Valve Anchor Assembly for Percutaneous MR Reduction

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Solution Overview

Problem

Current mitral valve therapies are invasive, complex, and often fail to adequately reduce mitral regurgitation (MR) while preserving native valve function and avoiding complications such as stenosis, LV wall stress, and atrial fibrillation, with percutaneous approaches lacking efficacy and safety.

Innovation Solution

A percutaneous mitral valve replacement system using an anchor assembly with anatomical gutter engagement, staged implantation, and a tri-leaflet structure for reliable, less invasive MR reduction, preserving LV geometry and function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical repair or replacement is performed, then mitral regurgitation is reduced, but the procedure is invasive and complex with high risk

Engineering Contradiction:

ImproveMR reduction efficacyVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system divides the valve replacement into separate functional components: an anchor assembly for securing the valve to the annulus, a valve body with leaflets for regurgitation reduction, and a delivery system for minimally invasive placement. This segmentation allows each component to be optimized independently and facilitates less invasive delivery.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchor assembly serves as an intermediary structure between the delivery system and the native valve annulus. It provides a stable platform for valve attachment while enabling minimally invasive placement through the left atrium, reducing the need for open surgical access.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If valve replacement is performed, then MR is reduced, but native valve function is lost and durability is compromised

Engineering Contradiction:

ImproveMR reductionVSAvoidvalve durability

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The anchor assembly is implanted and secured to the native annulus before valve placement. This preliminary anchoring ensures stable attachment of the replacement valve while preserving the structural integrity of the native valve annulus, potentially enabling future repair options and improving long-term durability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The valve assembly incorporates a tri-leaflet structure with specific leaflet configurations (anterior, posterior, and septal leaflets) designed to match the local hemodynamic requirements of the mitral valve position, optimizing both regurgitation reduction and durability.

Inventive Principle:

Principle #3Local quality

3Ease of operation

If percutaneous approach is used, then invasiveness is reduced, but efficacy and safety are insufficient

Engineering Contradiction:

ImproveinvasivenessVSAvoidprocedure efficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system replaces complex mechanical surgical tools with a self-expanding anchor assembly that utilizes balloon assistance for deployment. The anchor expands automatically after balloon deflation, eliminating the need for complex mechanical expansion mechanisms and reducing procedural complexity while maintaining percutaneous access.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The anchor assembly is pre-assembled and pre-positioned within the delivery system before crossing the mitral valve. This preliminary preparation ensures accurate positioning and secure anchoring in the left atrium, improving procedure efficacy while maintaining the minimally invasive percutaneous approach.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If valve therapy is performed, then MR is reduced, but complications such as stenosis and LV wall stress are created

Engineering Contradiction:

ImproveMR reductionVSAvoidstenosis and LV wall stress

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The valve assembly features a tri-leaflet structure with specifically designed leaflet geometry and annular contact surfaces that distribute forces evenly across the mitral annulus. This local optimization prevents stress concentration that could lead to LV wall stress or stenosis while effectively reducing regurgitation.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The anchor assembly is designed to engage with the native annular structure in a way that preserves physiological inflow patterns. By maintaining the natural geometry and flow characteristics of the mitral valve annulus, the system converts the potential harm of structural modification into a benefit by preserving healthy hemodynamics.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Data Source

PatentUS12491068B2Two stage anchor and mitral valve assembly

Publication Date: 2025.12.09 CAISSON INTERVENTIONAL LLC

AI summary

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