Inflatable Mitral Valve Anchoring for Leak-Resistant Sealing
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Solution Overview
Problem
Catheter-based mitral valve replacement faces challenges due to the lack of a natural anchor for prosthetic valves, instability under high heart pressure, and anatomic variations leading to leaks and potential disruption, necessitating more secure and less bulky anchoring and sealing solutions.
Innovation Solution
An inflatable anchor system with an elongate element and wire is used to stabilize the mitral valve prosthesis, guided under the native mitral valve and between the left ventricular wall and chordae tendinae, with inflatable structures and anchoring arms to secure the prosthesis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anchoring systems are used to secure the mitral valve prosthesis, then the valve stability is improved, but the device becomes bulky and less adaptable to anatomic variations
Solution Approach 1:
The anchoring system is divided into multiple independent anchoring arms (typically 3-6 arms) that can be individually deployed and positioned. Each arm can be independently adjusted to accommodate different anatomical configurations, allowing the system to adapt to various annulus sizes and shapes without requiring a single bulky anchoring structure.
Solution Approach 2:
The anchoring arms are designed with dynamic characteristics, allowing them to be deployed, repositioned, and adjusted after initial placement. This dynamic capability enables the operator to optimize the anchoring configuration for each patient's specific anatomy, improving adaptability without increasing overall device bulkiness.
2Reliability
If the anchoring system is made more secure to prevent leaks and disruption, then the valve stability is improved, but the device becomes more bulky
Solution Approach 1:
The anchoring arms are designed to engage with specific local anatomical features such as the mitral valve annulus, chordae tendineae, or leaflet tissue. Each arm can be configured to interact with different tissue structures based on the patient's anatomy, providing secure anchoring through localized engagement rather than requiring a large-scale anchoring structure.
Solution Approach 2:
The anchoring arms are designed to nest within the cardiac chamber and engage with existing cardiac structures. The arms can be positioned to interact with the annulus, chordae, or leaflets, utilizing the patient's own anatomy as part of the anchoring mechanism, thereby reducing the need for additional bulky anchoring components.
3Adaptability or versatility
If larger anchoring structures are used to accommodate anatomic variations, then the adaptability is improved, but the device becomes more bulky and harder to deliver
Solution Approach 1:
The use of multiple separable anchoring arms allows the system to adapt to different annulus sizes and shapes by selectively deploying and positioning individual arms. This segmented approach provides anatomical versatility without requiring a single large anchoring structure, as each arm can be independently sized and positioned to match the patient's specific anatomy.
Solution Approach 2:
The anchoring arms are designed with multi-functional capabilities, allowing them to engage with different tissue structures (annulus, chordae, leaflets) depending on the anatomical configuration. This universal design enables a single device to accommodate a wide range of anatomic variations without requiring multiple different device sizes or configurations.
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 system provides secure anchoring and sealing, reduces the risk of leaks, and adapts to varying anatomies by adjusting inflation, enhancing the stability and function of the left ventricle.
Implementation Method 1
an elongate inflatable element configured to be inflated to a predetermined size and shape
Data Source
AI summary
Methods, devices and systems for anchoring and/or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis (202). Inflatable elements (204, 206) are used to seal and anchor the mitral valve prosthesis (202) and/or other elements associated with repairing a native mitral valve.