Self-Expanding AV Valve Prosthesis With Ventricular Wall Anchoring
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Solution Overview
Problem
Existing percutaneous heart valve replacement devices are unsuitable for tricuspid and mitral valves due to complex anatomy and fragile surrounding tissues, and radial force-dependent anchoring mechanisms risk annular disruption and atrioventricular nodal compression.
Innovation Solution
A self-expanding, non-thrombogenic, low-profile atrioventricular valve prosthesis with a flexible frame and a polymer valve structure, designed for percutaneous delivery via the venous system, anchored to the right ventricular endocardium or left ventricle, mimicking natural valve behavior.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radial force-dependent anchoring mechanism is used, then device can be anchored to valve annulus, but annular disruption and atrioventricular nodal compression occur
Solution Approach 1:
The patent introduces an intermediary anchoring mechanism that uses expandable arms with anchors engaging the ventricular wall rather than directly forcing the valve annulus. This mediator structure transfers the anchoring function from the vulnerable annulus to the more robust ventricular wall, preventing direct damage to the annulus and surrounding tissues while maintaining secure device positioning
Solution Approach 2:
The invention replaces the traditional radial force mechanical anchoring system with a longitudinal expansion mechanism. Instead of applying outward radial pressure on the annulus, the device uses axial expansion of arms that engage the ventricular wall, fundamentally changing the mechanical approach from radial compression to longitudinal engagement, thereby eliminating annular disruption risks
2Ease of operation
If percutaneous delivery approach is used, then open heart surgery is avoided, but device placement in tricuspid and mitral valves is difficult due to complex anatomy
Solution Approach 1:
The device incorporates dynamic features including expandable arms and adjustable positioning mechanisms that allow the device to adapt to the complex three-dimensional anatomy of the tricuspid and mitral valves during deployment. The arms can dynamically adjust their position and angle to engage the ventricular wall at optimal points, navigating the anatomical complexity without requiring open surgery
Solution Approach 2:
The percutaneous delivery system uses a nested configuration where the valve prosthesis is contained within a delivery catheter, which is guided through the venous system and across the valve. The device transitions from a compressed nested state during delivery to an expanded functional state at the implantation site, enabling minimally invasive access to complex valve locations
3Ease of operation
If self-expanding frame is used, then device can be delivered via catheter, but device profile is large
Solution Approach 1:
The device frame is segmented into multiple expandable arms or struts that can be compressed along the catheter axis for delivery and then expanded radially at the implantation site. This segmentation allows the device to transition from a low-profile linear configuration during delivery to a three-dimensional expanded structure for function, reducing the delivery profile while maintaining the required functional dimensions
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device can be securely placed in the tricuspid or mitral valve region without open heart surgery, mitigating heart block risks and providing durable, efficient valve replacement.
Implementation Method 1
a frame made from a flexible, self-expanding shape memory alloy
Implementation Method 2
a frame made from a flexible, self-expanding shape memory alloy and superelastic material
Data Source
AI summary
An atrioventricular prosthesis device is provided. The device includes a frame at least partially defining and enclosing a central cavity, the frame having a distal portion, a proximal portion, and a middle portion connected therebetween. The device further includes a valve construct formed, at least in part, from a cell growth scaffold, at least partially disposed within the central cavity defined by the frame. The valve construct includes: an annular portion defining an aperture and being connected to the frame for positioning the valve construct within the central cavity of the frame, and a plurality of leaflets extending longitudinally and radially inward from the annular portion. The frame and valve construct are transitionable to a deployed state, in which a diameter of at least a portion of the frame and the valve construct substantially conform to a diameter of a tricuspid and/or mitral valve opening.