Transcatheter Mitral Valve Repair Device with Anchored Contact Face
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation due to leaflet flail, prolapse, and restricted motion are inadequate, as they often require invasive surgeries and lack effective devices for providing sustained contact pressure and coaptation support.
Innovation Solution
Development of systems and devices that include a contact face contoured to provide pressure on the affected leaflet, anchored within the vasculature or directly to the annulus, using materials like nitinol, cobalt-chrome, and polymeric materials, which can be delivered via a transcatheter approach to apply contact pressure and promote coaptation between leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcatheter devices are used to treat mitral valve regurgitation, then the invasiveness of the procedure is reduced, but the ability to provide sustained contact pressure and coaptation support is insufficient
Solution Approach 1:
The device employs a nested structure where the contact face is integrated within a delivery catheter system. The contact face can be deployed from the catheter to engage the leaflet, allowing the device to be delivered minimally invasively while still providing the necessary mechanical support for contact pressure and coaptation
Solution Approach 2:
The device is divided into functional segments including a contact face for pressure application, an anchor mechanism for securing the device, and a delivery system. This segmentation allows each component to be optimized for its specific function while enabling delivery through a catheter-based approach
2Reliability
If open heart surgery is performed for valve repair, then effective contact pressure and coaptation support can be achieved, but the invasiveness and surgical complexity increase significantly
Solution Approach 1:
The device acts as an intermediary between the catheter delivery system and the native valve leaflet. It provides the mechanical interface needed to deliver contact pressure and coaptation support without requiring direct surgical access to the valve, thereby reducing surgical complexity while maintaining therapeutic effectiveness
3Ease of operation
If existing transcatheter devices are used, then the procedure remains minimally invasive, but they lack effective mechanisms for providing sustained contact pressure
Solution Approach 1:
The contact face is pre-configured with the appropriate geometry and mechanical properties to provide sustained contact pressure upon deployment. The device is prepared in advance within the delivery system, ensuring that when deployed, it can immediately and durably engage the leaflet to provide the necessary contact pressure over time
Data Source
AI summary
An implant includes an interface and a wing that is coupled to the interface. A catheter is transluminally advanceable to a heart chamber upstream of a heart valve of a subject and houses the implant. A delivery tool comprises a shaft and a driver. Via engagement with the interface, the shaft is configured to (i) deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface; and (ii) position the implant in a position in which the interface is at a site in the heart and the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve. The driver is configured to secure the implant in the position by driving an anchor through the interface and into tissue at the site. Other embodiments are also described.