Expandable Valve Anchor with Clamping Struts
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Solution Overview
Problem
Current methods for implanting prosthetic heart valves, especially for the mitral valve, face challenges such as valve migration, insufficient radial strength for stent-type fixation, and complications due to the unique anatomy of the mitral valve.
Innovation Solution
The use of an anchor device with an expandable tubular body and undulating struts that can be advanced to the native valve annulus and deployed to provide clamping portions for securing a prosthetic heart valve, along with upstanding vertical posts to support the atrial portion and prevent leakages.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional stent-type fixation is used for mitral valve, then valve security is improved, but the anterior side of the native valve distorts due to insufficient radial strength, risking occlusion of the left ventricular outflow tract
Solution Approach 1:
The anchor device is divided into multiple independent struts that can be selectively positioned and deployed. Each strut acts as an independent anchoring element, allowing the device to provide secure fixation without requiring the entire native valve annulus to withstand uniform radial compression, thus preventing distortion of the anterior valve side.
Solution Approach 2:
The anchor device applies localized clamping force at specific positions around the valve annulus rather than uniform radial compression. The struts are positioned to engage with the valve leaflets and annulus at optimal locations, providing secure anchoring while preserving the structural integrity and shape of the anterior mitral valve side.
2Reliability
If radial engagement with the native annulus is used for fixation, then valve anchoring is improved, but treatment fails as the size and shape of the annulus changes over time
Solution Approach 1:
The anchor device incorporates expandable struts made of shape memory alloy that can dynamically adjust to the changing size and shape of the native annulus. The struts can be deployed in different configurations and expanded to different degrees, allowing the device to adapt to annular remodeling over time while maintaining secure anchoring.
Solution Approach 2:
The device allows for changes in the physical parameters of the anchor struts, including their expansion ratio, positioning, and configuration. This enables the anchor device to accommodate variations in annular dimensions and geometry, maintaining effective anchoring despite changes in the native valve annulus over time.
3Productivity
If sutureless techniques are used, then procedure time is reduced, but valve migration occurs due to insufficient fixation
Solution Approach 1:
The anchor device is deployed and secured to the native valve annulus before the prosthetic valve is implanted. This preliminary anchoring action creates a stable foundation that prevents valve migration, allowing the subsequent prosthetic valve implantation to proceed quickly without requiring time-consuming suturing operations.
Solution Approach 2:
The anchor device serves as an intermediary between the prosthetic valve and the native annulus. It provides a secure mechanical foundation that transfers and distributes the forces acting on the prosthetic valve, preventing migration while enabling the sutureless implantation technique to maintain reliability.
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 solution effectively secures the prosthetic valve in place, reduces the risk of valve migration, and addresses the anatomical challenges of the mitral valve by providing a robust anchoring mechanism that adapts to the native valve's shape and size changes.
Implementation Method 1
an expandable tubular body about a vertical axis and comprising struts
Implementation Method 2
The tubular body can have one, two, three, or more leaflet clamping portions. Each can be defined by at least one peak extending upward. There can also be a downward valley on the tubular body adjacent the at least one peak.
Data Source
AI summary
Anchor devices and methods used to secure a prosthetic valve to a native valve annulus are described. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.