Two-Part Artificial Heart Valve for Catheter-Based Inner Valve Replacement
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Solution Overview
Problem
Current heart valve prostheses, both biological and mechanical, face issues such as limited functional life due to degeneration, particularly calcification, necessitating surgical replacement, which is risky, especially for older patients, and there are challenges with anchoring and positioning during catheter-based implantations leading to complications like paravalvular leakage and arrhythmia.
Innovation Solution
A two-piece artificial heart valve system comprising an outer valve with anchoring formations and an inner valve with compressible structures, allowing for catheter-based explantation and reimplantation without the need for open-heart surgery, using a flexible sheath and automated tools for precise positioning and replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical valve replacement is performed, then complete valve replacement is achieved, but patient risk increases and post-operative treatment phase lengthens
Solution Approach 1:
The artificial heart valve is divided into two separate components: an outer valve with anchoring formations that remains permanently implanted, and an inner valve that can be independently removed and replaced. This segmentation allows the anchoring structure to stay while only the degradable inner valve is exchanged, reducing surgical risk for repeat procedures
Solution Approach 2:
The inner artificial heart valve is designed to be inserted into and nested within the outer artificial heart valve. The inner valve contains the functional heart valve pockets while the outer valve provides the anchoring structure. This nested configuration allows the inner valve to be replaced independently through catheter-based access without removing the outer anchoring valve
2Reliability
If biological heart valve prostheses are used, then initial functionality is achieved, but functional life is limited due to degeneration and calcification
Solution Approach 1:
The inner artificial heart valve is designed with the understanding that it will degrade over time due to calcification and other degenerative processes. When degradation occurs, the inner valve can be removed and replaced through catheter-based procedures while the outer anchoring valve remains in place. This allows for planned replacement before complete failure, extending the overall system functional life
Solution Approach 2:
The valve system transitions from a static, permanent implant to a dynamic, replaceable system. The inner valve can be exchanged periodically through minimally invasive procedures, allowing the valve system to adapt and renew itself over time, thereby extending functional life beyond what a single permanent implant could provide
3Object-affected harmful factors
If catheter-based implantation is used, then patient stress is reduced and ECMO is avoided, but anchoring and positioning challenges arise leading to complications
Solution Approach 1:
By separating the anchoring function (outer valve) from the functional valve leaflets (inner valve), the design allows the outer valve to focus exclusively on secure anchoring and precise positioning through its anchoring formations, while the inner valve focuses on providing functional leaflets. This division of function improves positioning accuracy without compromising patient stress reduction
Solution Approach 2:
The outer artificial heart valve acts as an intermediary structure that provides stable anchoring and precise positioning within the vessel wall. It serves as a fixed platform that mediates between the delivery catheter and the inner valve, ensuring accurate positioning while allowing the inner valve to be exchanged through minimally invasive catheter-based procedures
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
Enables safe, minimally invasive, and repeatable replacement of inner heart valves, reducing patient risk and avoiding the need for extracorporeal membrane oxygenation, improving life expectancy and quality of life for patients with artificial heart valves.
Implementation Method 1
The inner artificial heart valve (8) has a shape-variably compressible wire-like meandering structure
Data Source
AI summary
The invention relates to an artificial heart valve having a two-part design, consisting of an outer artificial heart valve having means for permanently anchoring the artificial heart valve at the implantation site and an inner artificial heart valve, which can be replaced independently of the outer artificial heart valve anchored at the implantation site and can be inserted into the outer artificial heart valve and which has artificial heart valve cusps, wherein the outer artificial heart valve has formations for defined placement of the inner artificial heart valve and the inner artificial heart valve for anchoring the inner artificial heart valve in the outer artificial heart valve. The invention also relates to a device for performing a catheter-based implantation of an artificial heart valve, to a method for explanting an artificial heart valve, and to a method for reimplanting an artificial heart valve.