Transcatheter Mitral Valve Anchoring Frame for LVOT Clearance
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Solution Overview
Problem
Transcatheter heart valve prostheses face challenges such as obstruction of the left ventricular outflow tract (LVOT) when implanted at native mitral valves and have a limited distance to the tricuspid valve, posing eligibility and risk issues for patients.
Innovation Solution
A transcatheter heart valve prosthesis with an anchoring frame and valve support, featuring a fixation portion, integration region, and lateral portion, along with a brim extending radially outward, and tissue engaging elements like barbs and safety cleats, to securely fix and integrate with native heart valves, minimizing protrusion into the ventricle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transcatheter heart valve prosthesis is implanted at a native mitral valve, then valve replacement is achieved, but obstruction of the left ventricular outflow tract (LVOT) occurs
Solution Approach 1:
The anchoring frame is divided into distinct functional portions: a fixation portion for securing to native tissue, an integration region for connecting to the valve support, and a lateral portion extending between them. This segmentation allows each portion to be optimized for its specific function, with the lateral portion specifically designed to clear the LVOT while the fixation portion ensures secure anchoring.
Solution Approach 2:
The anchoring frame employs a non-circular, elliptical cross-sectional geometry that conforms to the native valve annulus shape. This dimensional adaptation allows the frame to seat properly in the asymmetric mitral valve annulus while maintaining adequate clearance from the LVOT, resolving the conflict between secure fixation and avoiding obstruction.
2Strength
If the anchoring frame is designed to securely fix to native tissue, then fixation strength is improved, but the device complexity increases
Solution Approach 1:
The anchoring frame integrates multiple functions into a single unified structure: the fixation portion, lateral portion, and integration region are formed as one continuous component. This merging provides adequate fixation strength while avoiding the increased complexity that would result from assembling multiple separate fixation components.
Solution Approach 2:
The anchoring frame serves multiple functions simultaneously: it anchors the prosthesis to native tissue, provides structural support for the valve support, defines the positioning of the brim, and maintains clearance from adjacent structures. This multi-functionality in a single component achieves strong fixation without proportionally increasing device complexity.
Data Source
AI summary
Transcatheter heart valve prostheses include a valve support, a prosthetic valve mounted within the valve support, and an anchoring frame at least partially surrounding the valve support. The anchoring frame and the valve support are attached to each other at respective inflow ends thereof. The anchoring frame includes a fixation portion configured to securely fix the anchoring frame, to tissue at a native heart valve, an integration region configured to integrate the anchoring frame with the valve support, and a lateral portion extending between the fixation portion and the integration region. A brim is coupled to and extends radially outwardly from the anchoring frame at a transition between the lateral portion and the fixation portion.