Undulating Heart Valve Annulus Template for Regurgitation Reduction
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Solution Overview
Problem
Current less invasive surgical and percutaneous devices for heart valve repair are often large, complex, and have limited efficacy across various anatomical configurations, failing to match the effectiveness of open surgical procedures in addressing valve regurgitation and device migration.
Innovation Solution
A template device configured to reshape the heart valve annulus by applying radial forces, using a template with undulating shapes and tissue coupling mechanisms to stabilize and reshape the valve annulus, thereby addressing valve regurgitation and device migration issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If less invasive surgical and percutaneous devices are used for heart valve repair, then recovery time is reduced and complications are minimized, but device size becomes large and complexity increases
Solution Approach 1:
The device is divided into multiple components: a template component with undulating shape for reshaping the annulus, and separate tissue coupling mechanisms for securing the device. This segmentation allows each component to be optimized independently and simplifies the overall device structure while maintaining less invasive delivery capabilities
Solution Approach 2:
The template and tissue coupling mechanisms are designed to be nested together, with the coupling mechanisms integrated into or attachable to the template structure. This nested design reduces the overall device footprint for delivery while maintaining full functionality once deployed
2Object-affected harmful factors
If less invasive surgical and percutaneous devices are used for heart valve repair, then invasiveness is reduced, but efficacy and applicability to various anatomical configurations become limited
Solution Approach 1:
The template features undulating shapes with varying curvature and geometry along its length, allowing different sections to adapt to specific anatomical configurations of the valve annulus. This local variation in geometry enables the device to conform to diverse patient anatomies while maintaining a compact less invasive delivery profile
Solution Approach 2:
The template design with undulating shapes serves multiple functions: reshaping the annulus, providing structural support, and adapting to various anatomical configurations. This multi-functionality is achieved within a single integrated component that can be delivered via less invasive approaches
3Reliability
If traditional surgical techniques are used for heart valve repair, then effectiveness in addressing valve regurgitation is high, but invasiveness increases and recovery time extends
Solution Approach 1:
The device replaces open surgical mechanical manipulation with a self-expanding or deployable template structure that automatically reshapes the annulus upon deployment. This mechanical substitution maintains the effectiveness of annular reshaping while eliminating the need for open chest surgery and heart-lung bypass
Data Source
AI summary
A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coaption of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.