Double Orifice Mitral Valve Anchoring and Trap Door Mechanism
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Solution Overview
Problem
Current treatments for mitral valve regurgitation often require open heart surgery, which is traumatic and associated with high mortality and morbidity, and may not effectively address persistent or recurring regurgitation issues after minimally invasive procedures.
Innovation Solution
Development of a mitral orifice valve device with an anchoring and manifold assembly that includes expandable anchoring rings and a trap door valve, allowing for minimally invasive endovascular deployment and attachment to the mitral valve or a fixation device, with the ability to selectively seal and open the valve orifice during different phases of the cardiac cycle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used for mitral valve replacement, then effective valve replacement can be achieved, but the procedure becomes traumatic with high mortality and morbidity
Solution Approach 1:
The mitral valve replacement device is divided into separate functional components: an anchoring assembly with expandable rings for securing the device, and a separate valve component with two orifices. This segmentation allows the device to be delivered through minimally invasive endovascular approaches rather than requiring open heart surgery, thereby reducing mortality and morbidity while maintaining effective valve replacement
Solution Approach 2:
The valve device is designed to be nested within a delivery catheter system, allowing it to be advanced through the vasculature to the heart in a compressed state. The expandable anchoring rings are similarly nested within the delivery system and expand after deployment. This nesting approach enables minimally invasive delivery without requiring open chest access
2Ease of operation
If a single orifice valve is used after fixation device installation, then minimally invasive replacement is achieved, but persistent or recurring regurgitation cannot be effectively addressed
Solution Approach 1:
The valve is divided into two separate orifices (first and second orifices) that can be independently controlled by separate trap door bodies. This segmentation allows each orifice to be opened or closed independently during the cardiac cycle, enabling the device to effectively address complex regurgitation patterns that a single orifice cannot handle, while maintaining minimally invasive deployment
Solution Approach 2:
The trap door bodies are designed to be dynamically controllable, allowing them to open and close in response to cardiac cycle phases. The first trap door body controls the first orifice during systole while the second trap door body controls the second orifice during diastole, creating a dynamic valve operation that effectively prevents regurgitation in both cardiac phases
3Ease of operation
If the valve device is designed with expandable anchoring rings and trap door valves, then minimally invasive endovascular deployment is enabled, but device complexity increases
Solution Approach 1:
The anchoring assembly with expandable rings serves multiple functions: it secures the device to the mitral valve, provides a framework for the valve structure, and enables stable positioning during cardiac motion. The trap door bodies serve dual purposes as both valve components and sealing mechanisms. This multi-functionality reduces the need for additional separate components, thereby managing complexity while enabling endovascular deployment
Data Source
AI summary
Valve devices for replacement of mitral valves while preserving valvular and subvalvular mitral valve apparatus. The valve device may be configured as a double orifice valve replacement device, and may include an anchoring and manifold assembly coupleable to a delivery catheter. The assembly may include means for anchoring the device to the mitral valve or to a fixation device already attached to the mitral valve. A peripheral ring anchoring system secured to the assembly may include at least one expandable anchoring ring that is expandable within an orifice of the mitral valve so as to surround the orifice perimeter. A helical suture may be helically disposable about the ring, securing the ring to adjacent leaflet tissue. A trap door valve including a trap door body that seals against the anchoring ring during systole and unseals during the diastolic portion of the cardiac cycle may be provided.