Implantable Cardiac Valve Anchor and Coupling Unit
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Solution Overview
Problem
Current medical devices for treating mitral valve regurgitation and chronic heart failure often face issues such as annuloplasty rings widening over time, insufficient coaptation of valve leaflets, and the need for open-heart surgery, which limits their effectiveness and invasiveness.
Innovation Solution
An implantable medical device featuring a permanently anchored anchor unit with a locking and coupling unit that stabilizes the anchor, prevents widening, and securely attaches valve leaflets for improved coaptation, allowing for minimally invasive procedures and cardiac assist device integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional annuloplasty rings are implanted to treat mitral valve regurgitation, then the valve annulus is reshaped, but the rings tend to widen over time allowing recurrent valve regurgitation
Solution Approach 1:
The device divides the annuloplasty function into separate components: an anchor unit with locking mechanism for stable anchoring, and a coupling unit for leaflet attachment. This segmentation allows each component to specialize in its function, with the locking unit preventing ring widening while the coupling unit ensures leaflet coaptation.
Solution Approach 2:
The anchor unit is implanted and locked into the valve annulus before the coupling unit is attached to the leaflets. This preliminary anchoring action ensures that the ring maintains its shape and prevents widening before the leaflet repair is completed, addressing the stability issue proactively.
2Adaptability or versatility
If stand-alone annuloplasty rings are used for valve repair, then the annulus is reshaped, but there is no possibility to attach leaflets against restrainment or prolapse
Solution Approach 1:
The device combines multiple functions into a single integrated system: the anchor unit provides stable anchoring, the coupling unit enables leaflet attachment, and the locking mechanism ensures long-term stability. This multi-functionality allows the device to address both annular reshaping and leaflet repair in one system.
Solution Approach 2:
The patent merges the anchor unit, locking mechanism, and coupling unit into a single integrated device that can be implanted together. This combination eliminates the need for separate procedures for annuloplasty and leaflet repair, reducing overall complexity while increasing functional versatility.
3Ease of operation
If open-heart surgery is performed for valve repair with annuloplasty rings, then comprehensive valve repair is possible, but the invasiveness and recovery time increase
Solution Approach 1:
The device uses a catheter-based delivery system as an intermediary to implant the anchor unit and coupling unit through minimal access points. This intermediary approach allows comprehensive valve repair functionality to be achieved without requiring open-heart surgery, maintaining repair completeness while reducing invasiveness.
4Reliability
If clips alone are used to attach valve leaflets, then mitral valve regurgitation is treated, but long-term stable reshaping of the leaflet annulus is not provided
Solution Approach 1:
The patent merges the leaflet clipping function with the annuloplasty ring function into a single integrated device. The coupling unit attaches to the leaflets like a clip, while the anchor unit simultaneously provides annular reshaping and stabilization. This combination achieves both leaflet attachment and long-term annular stability in one device.
Data Source
AI summary
An implantable medical device for transcatheter delivery, which includes an anchor unit (100) configured to be anchored at an annulus of a cardiac valve of a patient, at least one coupling unit (200) that extends along a first length radially from said anchor unit (100) towards a coaptation line of said valve and including an extension unit (400) extending along a second length. The extension unit (400) is configured to cross between the leaflets of the cardiac valve in order to fill out for an insufficient closing of the valve leaflets of said cardiac valve.