Mitral Annulus Reshaping via Segmented Implant and Pivot Anchors
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Solution Overview
Problem
Current percutaneous methods for treating mitral regurgitation, such as mitral annuloplasty, face challenges in effectively applying forces from desired directions to reshape the mitral annulus, leading to suboptimal valve repair outcomes and complications like valve leakage and distortion.
Innovation Solution
A medical device with a reconfigurable implant member and tissue anchors that can be deployed percutaneously, featuring pivot joints and alignment surfaces to securely anchor and reshape the mitral annulus, allowing for precise control of tissue constriction and valve repair.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous mitral annuloplasty is performed using conventional devices, then the procedure is minimally invasive, but the ability to apply forces from desired directions to reshape the mitral annulus is limited
Solution Approach 1:
The implant member is divided into multiple segments that can be independently positioned and anchored. Each segment can be secured to the mitral annulus at different locations, allowing forces to be applied from multiple desired directions simultaneously while maintaining percutaneous access benefits
Solution Approach 2:
The device transitions from a single-dimensional catheter-based approach to a multi-dimensional anchoring system. The implant member can be positioned and anchored in three-dimensional space around the mitral annulus, enabling force application from multiple directions (anterior, lateral, posterior) while maintaining percutaneous delivery
2Manufacturing precision
If a reconfigurable implant member with pivot joints is used, then precise control of tissue constriction is achieved, but the device structure becomes more complex
Solution Approach 1:
The implant member incorporates pivot joints that allow dynamic adjustment of segment orientation and implant member configuration. This dynamic capability enables precise control over the direction and magnitude of constriction forces applied to the mitral annulus, while the modular segmented structure keeps the overall device complexity manageable
Solution Approach 2:
By dividing the implant member into segments connected by pivot joints, the device achieves precise local control at each anchor point while maintaining overall structural simplicity. Each segment can be independently positioned and angled to apply force in the desired direction
3Stability of the object's composition
If tissue anchors are securely embedded in the mitral annulus, then effective reshaping of the annulus is achieved, but the risk of tissue damage during anchoring increases
Solution Approach 1:
The device allows preliminary positioning and configuration of the implant member before final anchor deployment. The pivot joints enable adjustment of the implant member orientation and segment positioning prior to securing anchors, ensuring optimal force application directions are established before tissue penetration occurs
Solution Approach 2:
The anchoring system applies localized forces at specific segments of the mitral annulus rather than distributed forces. This allows precise targeting of dilated portions of the annulus while minimizing disturbance to healthy tissue regions, reducing overall tissue damage risk
Data Source
AI summary
A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a plurality of tissue anchors. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Each of the tissue anchors may be guided into precise position by an intravascularly or percutaneously techniques. Constriction of the orifice may be accomplished via a variety of structures, for example an articulated annuloplasty ring, the ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arched, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to reduce mitral regurgitation.