Concentric Prosthetic Valve Frames for Dilated Annulus Anchoring
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Solution Overview
Problem
Ischemic heart disease leads to regurgitation of heart valves due to ischemic dysfunction of papillary muscles and ventricular dilation, causing displacement of valve annulus and preventing proper coaptation of valve leaflets, resulting in decreased cardiac output and ventricular weakening.
Innovation Solution
An apparatus for a prosthetic valve replacement, featuring a frame assembly with a tubular portion and an upstream support portion, expandable from a compressed state for delivery to an expanded state for implantation, ensuring proper valve function and anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the valve annulus is dilated due to ischemic heart disease, then the ventricular volume increases, but the valve leaflets cannot fully coapt resulting in regurgitation
Solution Approach 1:
The prosthetic valve is designed with an expanded frame structure that changes the geometric parameters of the valve annulus, providing a larger support surface area that enables proper leaflet coaptation even in dilated ventricles. The frame's radial expansion increases the effective valve diameter to match the dilated annulus dimensions.
Solution Approach 2:
The prosthetic valve frame acts as an intermediary structure between the dilated native annulus and the valve leaflets. This intermediate framework provides the necessary geometric support and alignment for the leaflets to coapt properly, compensating for the annular dilation that would otherwise prevent adequate sealing.
2Reliability
If the prosthetic valve frame is expanded to provide adequate support for valve function, then valve coaptation improves, but the delivery profile becomes too large for transluminal access
Solution Approach 1:
The prosthetic valve frame employs dynamic structural elements that allow it to transition between a compressed low-profile state for delivery and an expanded high-support state for function. The frame's mechanical design enables radial expansion from a small delivery diameter to a large functional diameter, providing adequate valve support only when deployed in the heart.
Solution Approach 2:
The prosthetic valve is designed with nested structural components where the valve frame can be compressed within a delivery catheter. The frame's ability to nest within a small-profile delivery system allows transcatheter delivery, while subsequent expansion provides the necessary structural support for valve function.
3Reliability
If the prosthetic valve is made highly durable to withstand ventricular pressures, then reliability improves, but the device complexity increases
Solution Approach 1:
The prosthetic valve frame is segmented into multiple modular components including the main support frame, leaflets, and sealing elements. This segmentation allows each component to be optimized for its specific function while collectively providing the durability needed to withstand ventricular pressures. The modular design also simplifies manufacturing and assembly.
Solution Approach 2:
The prosthetic valve employs composite material construction, combining materials with different properties to achieve both durability and simplified design. The frame may use shape memory alloys or other composite structures that provide structural integrity and pressure resistance without requiring overly complex geometries.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 2C~2E
AI summary
Apparatus is provided for use in a heart of a subject including a frame assembly defining: a tubular portion that defines a longitudinal lumen, an upstream support portion, coupled to the tubular portion, a plurality of flanges, coupled to the tubular portion; and a plurality of prosthetic valve leaflets, coupled to the tubular portion disposed within the lumen. The frame assembly has a compressed state for transluminal delivery to the heart, and has an expanded state, in which the upstream support portion extends radially outward from the tubular portion, the flanges extend radially outward from the tubular portion and toward the upstream support portion, the tubular portion has a transverse cross-sectional area, and the frame assembly defines a toroidal space between the flanges, the upstream support portion, and the tubular portion, the toroidal space circumscribing the tubular portion and having a cross-sectional area that is 5-10 percent of the transverse cross-sectional area of the tubular portion. Other embodiments are also described.