Segmented Annuloplasty Ring with Piercing Wire Anchoring
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Solution Overview
Problem
Current annuloplasty procedures and devices face challenges in reliably anchoring an annuloplasty ring at a desirable location, particularly with percutaneous and less invasive techniques, due to anatomical complexities and risks associated with coronary sinus devices, such as compression of the circumflex coronary artery.
Innovation Solution
An annuloplasty device comprising an expandable member with radially extending lobes and a piercing wire, where the lobes are forced into heart tissue to deform it and allow the wire to create an interrupted attachment, enabling secure anchoring and cinching of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid structure is placed in the coronary sinus for percutaneous annuloplasty, then the annuloplasty ring can be anchored, but the circumflex coronary artery may be compressed causing dangerous effects
Solution Approach 1:
The annuloplasty device is divided into multiple lobes (at least three lobes) that can be independently positioned and anchored in different locations around the mitral annulus. This segmentation allows the device to achieve reliable anchoring without requiring a single rigid structure in the coronary sinus, thereby avoiding compression of the circumflex coronary artery while maintaining anchoring reliability.
2Strength
If a rigid structure is used to obtain required shape and support for the valve, then the valve repair is effective, but the device becomes cumbersome and difficult to implant
Solution Approach 1:
The device transitions from a static rigid structure to a dynamic expandable structure. The lobes are initially in a compressed or collapsed state for easy insertion through the catheter, then expand to their full operational size once positioned at the mitral annulus. This dynamic expansion provides the required structural support and shape for effective valve repair while maintaining ease of implantation.
3Reliability
If the mitral annulus is made smaller in the septal-lateral dimension to prevent regurgitation, then the valve leaflets can coapt more effectively, but the anchoring location becomes difficult to achieve with percutaneous techniques
Solution Approach 1:
The device anchors in multiple dimensions around the mitral annulus rather than relying on a single access point. By distributing anchoring points across multiple lobes positioned at different locations around the annulus, the device achieves reliable anchoring that enables effective reduction of the septal-lateral dimension for preventing regurgitation, while overcoming the limitations of single-point percutaneous anchoring techniques.
Data Source
AI summary
An annuloplasty device having an expandable member, a plurality of lobes, and a piercing wire is herein disclosed. In some embodiments, the lobes extend radially outwardly from the expandable member. The lobes each have a wire lumen disposed therethrough, and the piercing wire is extendable through the wire lumen of each lobe to secure the device to adjacent heart tissue. In some embodiments, the expandable member comprises an inflatable medical balloon. In addition, a method of implanting an annuloplasty device is disclosed.