Mitral Valve Leaflet Fixation Device with Retaining Elements
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation often require open heart surgery, which is invasive and carries high mortality and morbidity risks. Additionally, existing minimally invasive techniques face challenges in securely capturing and retaining mitral valve leaflets during procedures.
Innovation Solution
A device designed for intravascular delivery, featuring proximal and distal elements with engagement surfaces and retaining elements, is used to approximate and securely engage mitral valve leaflets. The device includes an actuator for moving the elements between delivery, positioning, and secured configurations, and incorporates retaining elements to prevent leaflet disassociation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used to repair mitral valve regurgitation, then effective tissue approximation and fastening can be achieved, but patient trauma and procedural risk increase significantly
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a minimally invasive endovascular delivery system. The fixation device is delivered through catheters via the vasculature to the mitral valve, eliminating the need for sternotomy and cardiopulmonary bypass while achieving effective leaflet approximation and regurgitation treatment
Solution Approach 2:
The patent introduces a fixation device as an intermediary element that mediates between the delivery system and the valve leaflets. This device includes engagement structures that capture and approximate the leaflets, providing the necessary mechanical function without requiring direct surgical access to the heart
2Object-affected harmful factors
If minimally invasive fixation devices are used to treat mitral valve regurgitation, then patient trauma is reduced, but secure capture and retention of valve leaflets becomes more difficult
Solution Approach 1:
The fixation device is segmented into multiple functional elements including proximal and distal engagement structures, retaining elements, and a body. These segmented components work together to capture the valve leaflets securely through distributed contact points and mechanical interlocking features
Solution Approach 2:
The device incorporates localized engagement features with specific geometric properties optimized for tissue interaction. The proximal and distal elements have engagement surfaces and retaining structures with particular shapes and orientations that provide secure leaflet capture while minimizing trauma to the surrounding tissue
3Reliability
If complex fixation devices with multiple elements are used to securely engage leaflets, then leaflet retention improves, but device complexity and procedural difficulty increase
Solution Approach 1:
The patent merges multiple functional elements into an integrated fixation device structure. The proximal elements, distal elements, retaining elements, and body are combined into a single deployable unit that performs multiple functions (capture, retain, and approximate leaflets) through coordinated action of its components
Data Source
AI summary
The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.