Mitral Valve Docking Coil Geometry for Stable Annulus Sealing
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Solution Overview
Problem
The challenge of securely anchoring a replacement mitral valve in the native mitral valve annulus is complicated by the thinner, wider anatomy, which makes it difficult for current anchoring devices to maintain proper positioning and prevent paravalvular leakage.
Innovation Solution
A docking device with a reduced-turn coil construction, featuring a central region, stabilization turn, and encircling turn, along with varying cuts and pitches, allows for secure anchoring and maneuverability, utilizing a hypotube with an atraumatic covering and actuating wire for precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current anchoring devices are used in the mitral valve annulus, then the device can be deployed, but the thinner and wider mitral valve annulus anatomy makes it difficult to maintain proper positioning and prevent paravalvular leakage
Solution Approach 1:
The anchoring device features a reduced-turn coil construction with varying cuts and pitches along its length, creating different local characteristics. The central region has approximately one turn with specific pitch, while the stabilization turn and encircling turn have different diameters and pitch values, allowing each section to adapt to specific anatomical requirements of the mitral valve annulus for optimal positioning and sealing
Solution Approach 2:
The device utilizes varying pitch parameters along the coil structure, with the central region having a first pitch, the stabilization turn having a second pitch, and the encircling turn having a third pitch. These parameter changes allow the device to maintain flexibility for navigation while providing stable anchoring and adapting to the thinner, wider mitral valve annulus anatomy
2Reliability
If a reduced-turn coil construction is used, then the device achieves stable anchoring and reduced paravalvular leakage, but the device complexity increases due to varying cuts and pitches
Solution Approach 1:
The coil is divided into distinct segments: a central region with approximately one turn, a stabilization turn, and an encircling turn. Each segment has specific functional characteristics and pitch values, allowing the device to achieve stable anchoring through functional segmentation while the modular design facilitates manufacturing through standardized segment production
3Reliability
If the docking device secures the prosthetic valve closer to the native annulus, then paravalvular leakage is reduced and long-term stability is maintained, but the risk of abrasion and occlusion of the left ventricle outflow tract increases
Solution Approach 1:
The device employs a flexible coil construction with varying pitch that allows dynamic adaptation to the mitral valve annulus geometry. The reduced-turn design with specific pitch variations enables the device to conform to the thinner, wider annulus anatomy, securing the valve closer to the native annulus for better sealing while the flexible structure reduces rigid contact that could cause abrasion or occlusion
Data Source
AI summary
A coil implant for treating a native heart valve includes a coil. The coil extends along a central axis and includes an adjustable section having an adjustable curvature. The adjustable section of the coil includes a plurality of cuts to allow the adjustable section to be moved from a first position with a first radius of curvature to a second position with a second radius of curvature. The coil is configured to draw native valve anatomy radially inwards.