Double-Orifice Transcatheter Mitral Valve Replacement After Failed Repair
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Solution Overview
Problem
Existing transcatheter mitral valve replacement methods, such as edge-to-edge leaflet repair, have high failure rates due to residual mitral regurgitation or increased transmitral flow gradients, and many patients are unsuitable for double orifice repair due to anatomical features, lacking a percutaneous option for patients with failed edge-to-edge repairs.
Innovation Solution
A double-orifice transcatheter mitral valve replacement (DO-TMVR) device with a double-orifice structure that anchors to a patient's double-orifice mitral valve, utilizing a Y-shaped delivery system to deploy two replacement heart valves, which can be connected or unconnected, and made of prosthetic or bioprosthetic materials, expandable or self-expandable, with various anchoring mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If edge-to-edge leaflet repair is performed to treat mitral regurgitation, then leaflet coaptation is re-established, but the procedure has high failure rate due to residual MR or increased transmitral flow gradients
Solution Approach 1:
The invention divides the mitral valve treatment into two separate replacement valves, each deployed into one of the two orifices created by the prior edge-to-edge repair. This segmentation allows independent optimization of each valve orifice, addressing residual regurgitation and flow gradient issues that a single valve cannot resolve.
Solution Approach 2:
The invention changes the fundamental parameter of valve configuration from a single-orifice to a double-orifice structure, enabling separate control and optimization of blood flow through each orifice. This parameter change allows reduction of transmitral flow gradients and elimination of residual regurgitation by independently adjusting each replacement valve's characteristics.
2Adaptability or versatility
If traditional single-orifice valve replacement is used, then the procedure is simpler, but it is not suitable for patients with double-orifice mitral valve anatomy or failed edge-to-edge repairs
Solution Approach 1:
The delivery system is segmented into two separate catheter pathways, each capable of independently delivering a replacement valve to its designated orifice. This segmentation allows the complex double-orifice procedure to be performed using simplified, proven single-catheter delivery techniques for each valve, thereby expanding patient eligibility without proportionally increasing procedural complexity.
Solution Approach 2:
The invention creates a universal treatment approach that can accommodate both traditional single-orifice anatomy and complex double-orifice anatomy, as well as failed edge-to-edge repairs. The double-orifice replacement valve system can be adapted to various patient anatomies and prior repair configurations, significantly expanding patient eligibility.
3Reliability
If a single replacement valve is deployed, then the device structure is simpler, but it cannot adequately address mitral valve disease in patients with double-orifice anatomy
Solution Approach 1:
The treatment is segmented into two independent valve replacement procedures delivered through a coordinated system. Each replacement valve addresses one specific orifice, ensuring adequate treatment effectiveness for double-orifice anatomy. The segmentation allows each valve to be optimized for its specific location while maintaining overall system manageability.
Solution Approach 2:
The delivery system employs a nested configuration where two catheters are delivered through a single access sheath, with each catheter carrying its respective replacement valve. This nesting approach allows the complex dual-valve system to be delivered through a single vascular access point, reducing the practical complexity despite the increased number of components.
Data Source
AI summary
In various embodiments, provided herein are methods, devices and systems for transcatheter mitral valve replacement in a double-orifice mitral valve. These methods, devices and systems are used to treat patients with mitral valve disease, particularly those who have had failed edge-to-edge leaflet repair, or patients presently considered anatomically unsuitable for edge-to-edge leaflet repair alone.