Flexible Anchor Delivery for Precise Mitral Annulus Repair
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Solution Overview
Problem
Ischemic heart disease causes mitral regurgitation due to dilatation of the mitral valve annulus, leading to increased stroke volume and decreased cardiac output, which existing treatments have not adequately addressed.
Innovation Solution
An adjustable partial annuloplasty ring with flexible anchors is deployed through a steerable manipulator to anchor around the valve annulus, allowing for circumferential tightening and correction of the dilated annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a rigid anchor delivery system is used, then deployment precision is improved, but the risk of tissue damage increases
Solution Approach 1:
The patent employs a flexible, steerable manipulator with a soft outer covering that can be advanced through cardiac tissue. The manipulator includes a flexible shaft with a distal tip that can be steered to precise positions, allowing the anchor to be deployed with high precision while the flexible nature of the manipulator reduces the risk of tissue damage compared to rigid systems.
Solution Approach 2:
The manipulator acts as an intermediary between the operator and the anchor delivery system. It provides a controlled interface that translates operator inputs into precise anchor placement while isolating the anchor from direct contact with the tissue, thereby reducing the risk of damage during deployment.
2Productivity
If multiple anchors are deployed simultaneously, then treatment efficiency is improved, but the complexity of the delivery system increases
Solution Approach 1:
The anchor delivery system is segmented into multiple independent anchor units that can be deployed separately along the manipulator shaft. Each anchor can be independently positioned and released, allowing for efficient treatment of multiple locations without requiring a single complex delivery mechanism for all anchors simultaneously.
Solution Approach 2:
The system allows dynamic adjustment during deployment, where anchors can be released at different positions and times along the manipulator shaft. This dynamic capability enables the operator to adapt the deployment sequence to specific anatomical requirements, improving treatment efficiency without locking into a fixed complex system configuration.
3Measurement precision
If the manipulator is made steerable, then positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The steerable manipulator employs a nested structure where inner shafts are positioned within outer shafts, allowing for multiple degrees of freedom of motion. The nested configuration enables complex steering movements while keeping the overall device compact and manageable, achieving high positioning accuracy without excessive complexity.
Solution Approach 2:
The manipulator replaces complex mechanical steering mechanisms with a more simplified control system that uses wire or rod actuation through the nested shafts. This substitution reduces the mechanical complexity while maintaining the ability to achieve precise positioning through controlled movement of the distal tip.
Data Source
AI summary
An annuloplasty implant is implanted along a valve annulus of a heart of a subject using a driver that includes a flexible shaft and a deployment element at a distal end of the shaft by, for each of the anchors in turn, beginning with the distal anchor: (1) using the driver to move the anchor out of a corresponding anchor-storage area of a tool; (2) advancing the anchor distally through a tube of the tool, with the shaft of the driver extending past the anchor-storage area; (3) anchoring the anchor to tissue of the heart; (4) disengaging the driver from the anchor; and (5) retracting the driver proximally beyond the corresponding anchor-storage area and, at a successively-proximal anchor-storage area, engaging the anchor with the successive anchor. Other embodiments are also described.