Mitral Valve Support Structure for Soft Leaflet Anchoring
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Solution Overview
Problem
Current methods for replacing native heart valves with prosthetic valves are challenging, especially for conditions like aortic or mitral insufficiency, where the native valve leaflets are soft and cannot provide sufficient support for balloon-expandable prosthetic valves. Additionally, self-expanding prosthetic valves can cause further dilation of the valve annulus and are difficult to deliver due to their outward biasing force.
Innovation Solution
The use of a support structure, such as a support stent or band, is delivered to the native heart valve. This support structure defines an interior space where an expandable prosthetic heart valve can be placed and expanded, securing the native leaflets between the support structure and the prosthetic valve. The support structure can be radially compressible and self-expandable, and is designed to be positioned adjacent to the native valve leaflets to provide a secure anchoring point for the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon-expandable prosthetic valve is used, then the valve can be anchored to hardened calcified leaflets, but the valve cannot be securely anchored when leaflets are soft and non-calcified
Solution Approach 1:
A support structure acts as an intermediary between the prosthetic valve and the soft native leaflets. The support structure is first delivered and expanded to provide a rigid foundation, then the prosthetic valve is delivered and expanded against this support structure, enabling secure anchoring without relying on calcified leaflets.
Solution Approach 2:
The support structure is deployed before the prosthetic valve to prepare the implantation site. This preliminary action creates a stable foundation that enables subsequent valve anchoring, addressing the issue of soft, non-calcified leaflets that cannot provide sufficient anchoring on their own.
2Device complexity
If a self-expanding prosthetic valve is used, then the valve can be delivered with less complexity, but the outward biasing force causes further dilation of the valve annulus
Solution Approach 1:
The support structure is deployed first to counteract the harmful effect of annulus dilation. By providing a rigid framework before the self-expanding valve is delivered, the support structure prevents the valve's outward biasing force from causing further annulus dilation.
Solution Approach 2:
The support structure serves as an intermediary that absorbs and redirects the outward force of the self-expanding valve, preventing this force from acting directly on the native annulus and causing dilation.
3Ease of operation
If a self-expanding prosthetic valve is used, then the valve can be delivered more easily, but the outward biasing force causes the valve to be ejected quickly from the delivery sheath
Solution Approach 1:
The support structure is deployed first to counteract the ejection force of the self-expanding valve. By providing a stable framework in place before valve delivery, the support structure prevents the valve from being ejected uncontrollably from the delivery sheath.
Solution Approach 2:
The support structure acts as an intermediary that absorbs the outward biasing force of the self-expanding valve during delivery, preventing this force from causing uncontrolled ejection from the delivery sheath while still allowing the valve to expand to its functional size.
4Reliability
If open heart surgery is used for valve replacement, then the valve can be securely implanted, but the surgery is dangerous and prone to complications
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter-based system. The support structure and prosthetic valve are delivered through catheters via the vascular system, eliminating the need for sternotomy and cardiopulmonary bypass while maintaining secure implantation through the support structure's anchoring mechanism.
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
This approach allows for precise and controlled delivery of prosthetic valves, even in cases where the native valve leaflets are soft or the valve annulus is dilated. The support structure provides a stable foundation for the prosthetic valve, reducing the risk of annulus dilation and improving the reliability of valve placement.
Implementation Method 1
The support structure can be radially compressible and self-expandable
Implementation Method 2
an expandable prosthetic heart valve is delivered into the native heart valve and into the support-structure interior. The expandable prosthetic heart valve can be expanded while the expandable prosthetic heart valve is in the support-structure interior
Implementation Method 3
one or more native leaflets of the native heart valve to be frictionally secured between the support structure and the expanded prosthetic heart valve
Data Source
AI summary
A method of treating a deficient native mitral valve includes advancing a steerable distal end portion of a first catheter through a patient's vasculature, advancing the distal end portion of the first catheter into the patient's heart to position the distal end portion of the first catheter adjacent the native mitral valve, advancing a distal end portion of a second catheter from a distal end of the first catheter, the distal end portion of the second catheter forming a second curve when advanced from the first catheter, and deploying a support structure from the second catheter such that the support structure extends around native leaflets of the native mitral valve within a left ventricle of the heart, the support structure extending 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.