Adjustable Tether for Prosthetic Heart Valve Repositioning
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Solution Overview
Problem
Prosthetic mitral valves face issues with improper tensioning and angular misalignment of tethers, leading to suboptimal anchoring and potential migration, which can result in valve axis non-orthogonality to the annular plane, causing inefficiencies and complications.
Innovation Solution
The development of an adjustable tether and epicardial pad system that allows for repositioning and tension adjustment of the tether attached to a prosthetic heart valve, using a snare device or catheter to move the tether to a new location and secure it with an epicardial anchor, ensuring optimal positioning and tensioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tether is used to secure the prosthetic valve, then anchoring stability is improved, but positioning precision deteriorates due to improper tensioning and angular misalignment
Solution Approach 1:
The tether system is made adjustable and dynamic rather than fixed. The tether can be repositioned, retensioned, and reangled after initial deployment using catheter-based delivery systems and adjustment mechanisms, allowing the anchoring system to adapt to optimal positioning post-deployment
Solution Approach 2:
The system allows changing of tether parameters including tension, angle, and position after deployment. Adjustment mechanisms enable modification of these parameters to achieve optimal valve alignment and anchoring, transforming a static tether system into one with可调 parameters
2Strength
If the tether is tensioned to secure the valve, then anchoring strength is improved, but valve migration risk increases due to improper tensioning
Solution Approach 1:
The system incorporates feedback mechanisms through adjustment capabilities that allow clinicians to monitor and modify tether tension post-deployment. This enables optimization of anchoring strength while preventing excessive tension that could cause migration, creating a closed-loop control system for tether force
3Productivity
If the tether angle is fixed during deployment, then deployment speed is improved, but valve alignment deteriorates due to angular misalignment
Solution Approach 1:
The tether angle is made dynamic and adjustable after deployment rather than fixed. Rotation and repositioning mechanisms allow the tether angle to be optimized post-deployment, separating the speed of initial placement from the precision of final alignment
4Device complexity
If a simple tether system is used, then device complexity is reduced, but adjustment capability is lost for tension and position modification
Solution Approach 1:
The adjustment mechanisms are nested within or integrated with the existing tether structure. Catheter-based delivery systems and adjustment components are contained within compact configurations that minimize added complexity while providing full adjustment functionality for tension and position
Data Source
AI summary
Apparatus and methods are described herein for repositioning a tether attached to a prosthetic heart valve. In some embodiments, a method includes inserting a distal end portion of a snare device through an incision at a first location in a ventricular wall of a heart and within the left ventricle of the heart. A tether extending from a prosthetic mitral valve, through the left ventricle and out an incision at a second location on the ventricular wall of the heart is snared with the snare device. The tether is pulled with the snare device such that a proximal end of the tether is moved back through the incision at the second location on the ventricular wall and into the left ventricle. The snare device is pulled proximally such that the tether is pulled proximally through the incision at the first location in the ventricular wall of the heart.