Mitral Valve Prosthesis Leaflet-Locking Anchoring Structure

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Solution Overview

Problem

Existing cardiovascular valve prostheses face challenges in achieving reliable anchoring and sealing at the implantation site, particularly for the mitral valve, due to its complex anatomy and high pressure differences, leading to potential displacement, migration, and paravalvular leaks, as well as interference with the natural heart function.

Innovation Solution

A prosthetic system with a support structure and anchoring member that locks onto the valve leaflets, allowing secure integration without requiring surgical removal, using a delivery system for transluminal implantation, and featuring adjustable components for stability and sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a prosthesis is anchored to the mitral valve annulus using radial force, then anchoring is attempted, but the unstable and prolapsed annulus structure causes the anchoring to be unreliable and leads to prosthesis displacement

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidannulus structural stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The invention extracts the anchoring function from the annulus by introducing a separate anchoring member that engages with the valve leaflets instead. The anchoring member is positioned independently of the annulus, capturing the leaflets between the anchoring member and the support structure, thereby eliminating dependence on the unstable annulus structure for anchoring reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The valve leaflets serve as an intermediary element between the support structure and the anchoring member. By anchoring to the leaflets rather than directly to the unstable annulus, the system creates a reliable connection point. The leaflets are captured between the anchoring member and support structure, providing a stable anchoring mechanism that does not rely on annulus integrity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If radial force is applied to the mitral valve annulus to anchor the prosthesis, then anchoring is achieved, but this counter-productively affects the prolapsed annulus and creates unstable anchoring

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidnegative impact on prolapsed annulus
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention removes the harmful radial force application to the annulus by extracting the anchoring function from the annulus itself. The anchoring member engages with the valve leaflets at a location independent of the annulus, eliminating the counter-productive radial force that worsens prolapse and creates anchoring instability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The valve leaflets act as an intermediary that transfers the anchoring function away from the harmful annulus interaction. The anchoring member captures the leaflets without applying radial force to the annulus, thereby eliminating the harmful effect on the prolapsed annulus structure while maintaining reliable anchoring.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the prosthesis is expanded to anchor to the annulus, then anchoring is attempted, but this causes deformation of the mitral valve and creates interference with arterial blood flow (SAM effect)

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidSystolic Anterior Motion interference
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The invention extracts the source of SAM effect by removing the annular expansion mechanism. Instead of expanding the prosthesis against the annulus, the anchoring member engages with the valve leaflets at a position that does not deform the mitral valve or interfere with arterial blood flow during systole.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The valve leaflets serve as an intermediary anchoring point that eliminates the need for annular expansion. The anchoring member captures the leaflets without deforming the mitral valve structure, thereby preventing SAM effect while maintaining reliable anchoring.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If sutures or staples are used to anchor the prosthesis in the tissue, then anchoring is achieved, but the implantation procedure becomes complex and requires open heart conditions

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidimplantation procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention replaces the complex mechanical suturing or stapling system with a simpler anchoring mechanism. The anchoring member engages with the valve leaflets through a capture and lock mechanism that does not require threading sutures through tissue or deploying staples, thereby simplifying the implantation procedure while maintaining reliable anchoring.

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

Solution Approach 2:

The valve leaflets serve as an intermediary anchoring surface that simplifies the anchoring mechanism. Instead of requiring complex tissue penetration and suture placement, the anchoring member captures the leaflets, providing reliable anchoring through a simpler mechanical interaction that can be performed through catheter-based techniques.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3415119B1Prosthesis for cardiovascular valve
Publication Date: 2026.05.06 INNOVHEART SRL
  • EP3415119B1 patent drawingFigure 1
  • EP3415119B1 patent drawingFigure 2
  • EP3415119B1 patent drawingFigure 3

AI summary

A prosthesis for a cardiac atrio-ventricular valve, comprising valve leaflets, comprises a support structure (210) having a peripheral wall which defines a through-hole, The prosthesis also comprises a valve structure which is supported by the support structure (210) and which comprises prosthetic leaflets (220a-220c) which are configured to selectively close the through-hole of the support structure (210) so as to restore, during use, the functionality of a unidirectional valve. The prosthesis also comprises an anchoring member (225). The anchoring member (225) and the support structure (210) are configured so as to be coupled each other, after implantation in the body of a patient, co-operating in order to entrap and lock the valve leaflets (135a - 135b) of the cardiac atrio-ventricular valve of the patient between the peripheral wall of the support structure (210) and the anchoring member (225) so as to keep the prosthesis (200) in position. A seating (230) is defined on the support structure (210), conjugate to the anchoring member (225). The support structure (210) and the anchoring member (225) are configured and have dimensions so that they are connected with interference so as to lock the anchoring member (225) in the seating (230).