Transcatheter Atrioventricular Valve Prosthesis With Annulus Clamping

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Solution Overview

Problem

Existing transcatheter atrio-ventricular valve prostheses face challenges with unstable anchoring due to inner radial forces, varying ring sizes and shapes, potential mitral paravalvular regurgitation, and limitations in sealing contact, which are not adequately addressed by current devices.

Innovation Solution

A transcatheter atrio-ventricular valve prosthesis with a radially expandable inner device and an outer device that forms a clamping mechanism to securely attach to the native valve annulus and leaflets, using a combination of expandable and contractible structures to ensure sealing and fixation, accommodating various sizes and shapes through a clamping mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a transcatheter atrio-ventricular valve prosthesis uses inner radial forces for anchoring, then the device can be implanted minimally invasively, but the anchoring becomes unstable

Engineering Contradiction:
Improveminimally invasive implantationVSAvoidanchoring stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The prosthesis is divided into two separate devices: an inner device with expandable support structure and an outer device with contractible ring. This segmentation allows each device to perform its specific function - the inner device provides structural support while the outer device provides stable anchoring through clamping, resolving the contradiction between minimal invasiveness and anchoring stability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The connection channel wall structure acts as an intermediary element between the inner and outer devices. The clamping mechanism uses this intermediary structure to transmit and distribute forces, enabling stable anchoring while maintaining minimal invasive implantation through the coordinated action of inner and outer devices.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If the prosthesis uses a fixed ring structure, then the manufacturing is simplified, but it cannot accommodate various sizes and shapes of valve annulus

Engineering Contradiction:
Improvering structure simplicityVSAvoidaccommodation of various valve annulus sizes and shapes
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The outer device incorporates a contractible ring structure that can dynamically adjust its circumference to match different valve annulus sizes and shapes. This dynamic capability allows the prosthesis to accommodate various anatomical variations while maintaining a relatively simple manufacturing process for the ring structure itself.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The prosthesis design achieves universality through the combination of expandable inner support structure and contractible outer ring, enabling a single device design to accommodate multiple valve annulus sizes and shapes. This multi-functional capability resolves the contradiction between manufacturing simplicity and adaptability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of manufacture

If the prosthesis uses standard sealing structures, then the design is conventional and easier to manufacture, but it cannot prevent mitral paravalvular regurgitation

Engineering Contradiction:
Improvesealing structure conventionalityVSAvoidmitral paravalvular regurgitation
Core Design Contradiction:
Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

The prosthesis employs local quality enhancement at the sealing interface through the coordinated clamping action of inner and outer devices. The connection channel wall structure is specifically targeted for sealing contact, with the contractible outer ring providing localized compression to prevent paravalvular regurgitation while maintaining conventional overall design.

Inventive Principle:
Principle #3Local quality

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

Provides stable anchoring and sealing contact, minimizing peri-prosthetic leaks and adapting to different valve annulus sizes and shapes, facilitating minimally invasive implantation on a beating heart.

Implementation Method 1

an inner device to be disposed in the interior of the connection channel, the inner device having a circumferential support structure or circumferential support body which is radially expandable

Methodology Applied
Scientific EffectRadial expansion:

Implementation Method 2

an outer device to be disposed on the exterior side of the connection channel, wherein the outer device at least partly extends around (circumferentially around) the inner device in a radial distance to the inner device, wherein the inner device, for example the circumferential support structure of the inner device, and the outer device form a clamping mechanism for clamping the circumferential connection channel wall structure of the connection channel therebetween

Methodology Applied
Scientific EffectRadial contraction:

Data Source

PatentEP4032502B1Transcatheter atrio-ventricular valve prosthesis
Publication Date: 2025.10.29 HIGHLIFE
  • EP4032502B1 patent drawingFigure 1
  • EP4032502B1 patent drawingFigure 2A
  • EP4032502B1 patent drawingFigure 2B

AI summary

A transcatheter atrio-ventricular valve prosthesis (1) for functional replacement of a mitral or tricuspid atrio-ventricular valve (9) in a connection channel (18), having a circumferential connection channel wall structure (18'), between atrial (3) and ventricular (5) chambers of a heart (7), comprising an inner device (19) to be disposed in the interior of the connection channel (18), the inner device (19) having a circumferential support structure (21) which is radially expandable and having a valve (22) attached to the circumferential support structure (21), and an outer device (25) to be disposed on the exterior side of the connection channel (18), wherein the outer device (18) at least partly extends around the inner device in a radial distance to the inner device, wherein the circumferential support structure (21) of the inner device (19), and the outer device form a clamping mechanism for clamping the circumferential connection channel wall structure (18') of the connection channel (18) therebetween, wherein the outer device (25) comprises arms extending at the outer periphery of the inner device (19) in a radial distance thereto, to thereby be able to clamp the circumferential connection channel wall structure (21) radially between the arms and the inner device (19).