Mitral Valve Annulus Support for Minimally Invasive Shape Restoration
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Solution Overview
Problem
Heart valve annulus distortion leads to improper valve closure, causing blood regurgitation, which existing methods struggle to correct effectively without invasive and time-consuming surgical procedures.
Innovation Solution
A tool with a stabilizing body and attachment device that allows for remote-controlled expansion and contraction of a support structure, featuring flexible wires and tubes to attach a support to the annulus, enabling quick and precise restoration of the annulus shape and size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a ring or support is attached to the annulus to restore its shape, then the valve closure is improved, but the procedural time and complexity increase due to individual sutures or clips
Solution Approach 1:
Multiple attachment points (sutures or clips) are merged into a single integrated support structure that can be deployed as one unit. The support structure includes multiple attachment points along its circumference, allowing simultaneous attachment to the annulus at multiple locations, thereby reducing procedural time while maintaining reliable valve closure.
Solution Approach 2:
The support structure is pre-formed with the correct geometry and attachment points before deployment. The radial members are pre-positioned to engage with the annulus at optimal locations, eliminating the need for time-consuming individual suture placement or clip application during the procedure.
2Reliability
If a ring or support is attached to the annulus to restore its shape, then the valve closure is improved, but the device complexity and invasiveness increase
Solution Approach 1:
The support structure is segmented into multiple radial members that can be independently positioned and attached to the annulus. Each radial member includes attachment points that can engage with the annulus tissue separately, allowing for simplified deployment while achieving the overall goal of restoring annular shape for proper valve closure.
3Manufacturing precision
If the support is expanded to attach at multiple locations around the annulus, then the annulus shape restoration is improved, but the force required for expansion increases
Solution Approach 1:
The support structure transitions from a compressed delivery state to an expanded functional state through a controlled expansion mechanism. The radial members are designed to expand outward from the delivery catheter, gradually engaging with the annulus tissue at multiple locations to restore the annular shape with distributed force rather than concentrated force.
Data Source
AI summary
Among other things, a tool to attach a support to a heart valve annulus includes a stabilizing body that includes features to stabilize an axial position of the tool relative to the annulus, and an attachment device connected to the stabilizing body, the stabilizing body and the attachment device being movable relative to one another under control from a location remote from the tool. The support may have an expandable tubular body having a plurality of struts, a plurality of tissue anchors extending from distally facing apexes in a distal direction post-deployment, wherein axial distal advance of the implantable annulus support causes the plurality of tissue anchors to axially engage tissue, and the implantable annulus support is self-contractible from a radially enlarged engagement configuration for engaging tissue of the mitral valve annulus, to a reduced, deployed configuration for modifying mitral valve annulus geometry.