Mitral Valve Tether Anchoring for Annulus Shape Restoration
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Solution Overview
Problem
Mitral valve regurgitation occurs due to dilation of the mitral annulus and left ventricle, leading to incomplete valve closure and backflow of blood, which existing treatments fail to effectively address by reshaping the mitral annulus and reducing leaflet stress.
Innovation Solution
The use of P1, P2, and P3 anchors anchored to the mitral valve's posterior leaflet, with a tether fixedly coupled to the P2 anchor and slidably coupled to the P1 and P3 anchors, pulled and anchored to a cardiac site anterior and inferior to the posterior leaflet, to decrease the mitral annulus circumference and restore a saddle shape, reducing leaflet stress and backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the mitral annulus is dilated due to disease, then the valve cannot close properly causing regurgitation, but traditional treatments do not effectively restore the saddle shape and reduce leaflet stress
Solution Approach 1:
The mitral annulus is divided into multiple segments (P1, P2, P3 anchors on posterior leaflet and anterior leaflet anchors) that can be independently adjusted. Each anchor segment can be individually positioned and tensioned to restore the complex saddle shape, allowing precise reconstruction of different annular regions rather than treating the annulus as a single unit.
Solution Approach 2:
The treatment addresses not only the circumferential dilation but also the anteroposterior dimension by restoring the saddle shape. The anchors are positioned to create both circular reduction and三维 shaping, transforming the flattened annulus back into its natural saddle configuration with appropriate curvature in multiple dimensions.
2Manufacturing precision
If anchors are fixedly coupled to all positions, then precise positioning is achieved, but the device complexity and difficulty of deployment increase
Solution Approach 1:
The system transitions from a static fully-fixed anchor design to a dynamic partially-fixed design. The P2 anchor on the posterior leaflet is fixedly coupled to provide a stable reference point, while the P1 and P3 anchors are slidably coupled to allow dynamic adjustment during deployment. This enables precise final positioning while simplifying the deployment process through selective fixation.
Solution Approach 2:
The P2 anchor is first fixedly coupled to establish a preliminary stable position on the posterior leaflet. This preliminary action creates a reference point that guides subsequent placement of the P1 and P3 anchors, which can then slide into their final positions along the tether. The preliminary fixation simplifies the overall deployment sequence.
Data Source
AI summary
Apparatus and methods are provided, including a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening. A housing holds each of the anchoring elements. A mandrel is reversibly disposable through the openings defined by the anchoring elements. The anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements. Other embodiments are also described.