Two-Part Cardiac Valve Implantation for Repeatable Catheter Replacement
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current heart valve replacement procedures, particularly for the aortic valve, face challenges such as inadequate anchoring and positioning of prostheses, leading to issues like atrioventricular blocks, paravalvular leaks, and organ fatigue, while biological valves suffer from calcification and require surgical replacement, posing significant risks to patients.
Innovation Solution
A two-part heart valve replacement system comprising an outer and inner valve component, anchored securely with nitinol structures and markers for automated positioning, allowing for catheter-based replacement without ECMO, using a flexible sheath and explantation tools for easy removal and reimplantation of worn valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single-part heart valve prosthesis is used, then the implantation procedure is simpler, but the ability to replace worn valves without open-heart surgery is limited
Solution Approach 1:
The heart valve prosthesis is divided into two independent parts: an outer prosthesis with anchoring elements and an inner prosthesis containing the valve leaflets. This segmentation enables the inner prosthesis to be replaced separately through catheter-based procedures while the outer prosthesis remains in place, resolving the contradiction between implantation simplicity and replacement versatility.
Solution Approach 2:
The inner heart valve prosthesis is designed to be inserted into and contained within the outer prosthesis. The outer prosthesis acts as a permanent housing that provides anchoring, while the inner prosthesis can be exchanged through the same access point, combining the simplicity of a single implantation procedure with the versatility of repeatable replacements.
2Reliability
If biological heart valve material is used, then the valve is initially functional, but calcification occurs over time requiring surgical replacement
Solution Approach 1:
The inner prosthesis containing the biological valve material is designed as a replaceable component with a finite lifespan. When calcification or wear occurs, the entire inner prosthesis is removed through the catheter access point and a new one is implanted, allowing periodic replacement without open-heart surgery. This resolves the contradiction by accepting limited lifespan in exchange for simplified replacement procedures.
3Reliability
If current anchoring methods are used, then the prosthesis is fixed in place, but secure anchoring leading to complications like atrioventricular blocks and paravalvular leaks occurs
Solution Approach 1:
By separating the anchoring function (outer prosthesis) from the valve function (inner prosthesis), the design allows the outer prosthesis to provide stable, well-positioned anchoring that prevents migration and complications, while the inner prosthesis can be independently replaced. This segmentation resolves the contradiction by optimizing anchoring stability without compromising safety.
4Reliability
If surgical valve replacement is performed, then complete valve replacement is achieved, but ECMO support and cardiac arrest are required
Solution Approach 1:
The segmentation of the prosthesis into permanent outer and replaceable inner components enables a minimally invasive approach where only the inner prosthesis needs to be exchanged. This eliminates the need for ECMO and cardiac arrest while achieving complete valve replacement functionality, resolving the contradiction between replacement completeness and procedure complexity.
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
Facilitates multiple interventional replacements of the inner valve module, reducing patient risk and eliminating the need for open-heart surgery, improving life expectancy and quality of life by ensuring secure anchoring and minimizing complications.
Implementation Method 1
outer and inner valve component, anchored securely with nitinol structures
Implementation Method 2
self-expanding stent, connected to folded biological heart valves
Data Source
Figure 1
Figure 2
Figure 3
AI summary
The invention relates to a device for performing a catheter-based implantation of a heart valve replacement, consisting of a tube-like flexible initial implantation sheath, a guide wire movable within the initial implantation sheath, and the two-part heart valve replacement, consisting of an outer heart valve replacement and an inner heart valve replacement or a movable inner heart valve insert for insertion into a previously pre-implanted outer heart valve insert.