Mitral Valve Support Structure for Non-Calcified Leaflet Anchoring
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Solution Overview
Problem
Existing methods for replacing native heart valves, particularly those without calcified leaflets, face challenges such as unreliable anchoring, annulus dilation, and difficult delivery due to self-expanding prosthetic valves' outward force and larger size requirements, especially in treating aortic or mitral insufficiency.
Innovation Solution
A support structure is delivered to the native heart valve surface, and an expandable prosthetic valve is secured within its interior, using methods like a support stent or band to frictionally secure native leaflets, allowing for balloon-expandable or self-expanding prosthetic valves to be anchored securely without continuous outward pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If self-expanding prosthetic valves are used, then the valve can be implanted without calcified leaflets, but the continuous outward force causes annulus dilation and makes delivery difficult
Solution Approach 1:
The system is divided into two separate components: a support structure (stent) and a prosthetic valve. The support structure is implanted first to provide a stable foundation, then the prosthetic valve is mounted on it. This segmentation allows the support structure to bear the anchoring load without requiring continuous outward force from the prosthetic valve, thereby preventing annulus dilation while maintaining applicability to non-calcified valves.
Solution Approach 2:
The support structure is implanted into the native valve annulus before the prosthetic valve is installed. This preliminary action creates a pre-formed anchoring structure that eliminates the need for the prosthetic valve to exert continuous outward force, thus preventing annulus dilation while enabling treatment of non-calcified valves.
2Adaptability or versatility
If self-expanding prosthetic valves are used, then the valve can be implanted without calcified leaflets, but the outward biasing force causes rapid ejection from the delivery sheath
Solution Approach 1:
The system separates the support structure implantation from the prosthetic valve deployment. The support structure is implanted first and remains stationary, while the prosthetic valve is then mounted on it within the delivery sheath. This segmentation eliminates the rapid ejection problem because the prosthetic valve no longer needs to exert outward force during delivery.
Solution Approach 2:
The support structure is implanted and secured in the native valve annulus before the prosthetic valve is introduced. This preliminary action creates a stable platform that allows the prosthetic valve to be delivered without rapid ejection, improving ease of operation while maintaining applicability to non-calcified valves.
3Adaptability or versatility
If balloon-expandable valves are used with non-calcified leaflets, then the valve can be treated, but the leaflets are too soft to provide sufficient support for anchoring
Solution Approach 1:
The system divides the anchoring function from the valve function. The support structure (stent) is implanted first to provide reliable anchoring in the native valve annulus, independent of leaflet calcification. The prosthetic valve is then mounted on this stable foundation, ensuring anchoring reliability even when native leaflets are too soft to provide support.
Solution Approach 2:
The support structure is implanted into the native valve annulus before the prosthetic valve is installed. This preliminary action creates a pre-formed anchoring structure that compensates for the insufficient support from soft, non-calcified leaflets, thereby ensuring reliable anchoring while maintaining treatability of non-calcified valves.
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
The method provides reliable anchoring and secure placement of prosthetic heart valves, reducing annulus dilation and improving delivery safety by using a support structure to frictionally secure the prosthetic valve, suitable for aortic or mitral insufficiency treatment.
Implementation Method 1
the one or more native leaflets are frictionally secured between the support structure and the expanded prosthetic heart valve
Data Source
AI summary
A method for treating a deficient native mitral valve includes advancing the distal end portion of a delivery catheter into a heart, advancing a second catheter from the first catheter, the second catheter containing a support member stretched into a linear form, and deploying the support member from the second catheter around native leaflets of the mitral valve using a pusher shaft such that the support member is disposed in a plane substantially parallel to a plane of an annulus of the native mitral valve. The support member can extend in a circumferential direction around the native leaflets and around an axis extending from a left atrium of the heart through the native mitral valve to the left ventricle.