Undulating Heart Valve Annulus Template for Regurgitation Repair
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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 annulus, which can be coupled to the valve using screws, clips, sutures, or barbs, allowing for minimally invasive procedures that address valve regurgitation and are applicable to diverse valve configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If less invasive surgical and percutaneous devices are used for heart valve repair, then patient recovery time and surgical risk are reduced, but device size and complexity increase while efficacy decreases
Solution Approach 1:
The device is divided into multiple discrete components: a template component with undulating shape, tissue coupling mechanisms (screws, clips, sutures, or barbs), and a delivery system. This segmentation allows each component to be optimized independently - the template for reshaping function, the coupling mechanisms for secure attachment, and the delivery system for minimally invasive insertion.
Solution Approach 2:
The template device is delivered through a catheter-based delivery system that nests the template within the delivery catheter during insertion. The undulating template is compressed or folded within the catheter lumen, then deployed to its functional shape at the target annulus location, enabling percutaneous access without open chest surgery.
2Object-affected harmful factors
If less invasive percutaneous devices are used for valve repair, then surgical invasiveness is reduced, but device applicability to various anatomical configurations is limited
Solution Approach 1:
The template is designed with an undulating, non-rigid geometry that can dynamically adapt to different annular configurations. The undulations allow the template to conform to varying annulus shapes and sizes, accommodating different anatomical presentations while maintaining the reshaping function. The template can be adjusted or selected in different sizes and undulation patterns to match specific patient anatomy.
Solution Approach 2:
The template features localized undulations and varying curvature along its length, allowing different portions of the template to interact with different regions of the annulus. This local variation in geometry enables the device to address specific problematic areas of the annulus while adapting to the overall anatomical configuration, providing versatile applicability across diverse valve geometries.
3Reliability
If open heart surgical procedures are used for valve repair, then repair effectiveness is improved, but surgical risk and recovery time increase
Solution Approach 1:
The template device is designed to be self-retaining through tissue coupling mechanisms that secure the template to the annulus tissue without requiring continuous external support or complex anchoring systems. The undulating template maintains its reshaping force and position through its inherent mechanical properties and tissue integration, providing reliable repair effectiveness comparable to open surgery but through a minimally invasive approach.
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.