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
Engineering 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
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.
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.
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
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.
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.
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)
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.
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.
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
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.
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.
Data Source
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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).