Undulating Cusp Prosthetic Heart Valve Reducing Pressure Gradient
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Solution Overview
Problem
Current bioprosthetic heart valves often result in significant pressure gradients and regurgitation, particularly in patients with small aortic roots or those requiring smaller valve sizes, which can lead to increased morbidity and mortality due to impaired blood flow and cardiac strain.
Innovation Solution
A prosthetic heart valve design featuring a support frame with undulating inflow cusps and outflow commissure posts that angle outward, allowing flexible leaflets to attach and coapt in a way that maximizes the outflow orifice area, reducing pressure gradients and regurgitation by promoting laminar flow and minimizing structural restrictions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional bioprosthetic heart valves with rigid support structures are used, then structural stability and reliable leaflet closure are improved, but pressure gradient increases and blood flow is restricted
Solution Approach 1:
The support frame transitions from a rigid static structure to a dynamic flexible structure that can adapt its shape. The frame includes bending zones that allow it to flex and conform to the natural movement of blood flow and heart motion, reducing turbulence and pressure gradient while maintaining structural integrity for reliable leaflet closure.
Solution Approach 2:
The invention changes the physical parameters of the support frame by using flexible materials with specific elastic properties. The frame's flexibility parameter is optimized to allow sufficient movement to reduce pressure gradient while maintaining enough rigidity to ensure proper leaflet closure and structural stability.
2Adaptability or versatility
If smaller valve sizes are used in patients with small aortic roots, then anatomical compatibility is improved, but pressure gradient increases significantly
Solution Approach 1:
The flexible support frame in smaller valve sizes can dynamically expand and flex to optimize blood flow pathways, compensating for the inherently smaller orifice area. This dynamic adaptation reduces turbulence and pressure gradient even in small-sized valves, making them suitable for patients with small aortic roots without sacrificing hemodynamic performance.
3Reliability
If rigid circular suture rings with metal inserts are used, then structural stability is improved, but adaptability to natural aortic changes is lost
Solution Approach 1:
The support frame replaces rigid circular suture rings with a dynamic flexible structure that can adapt to natural changes in the aorta. The frame's flexibility allows it to conform to aortic dilation, growth, or other physiological changes over time, while maintaining structural stability through its elastic properties and design.
4Ease of manufacture
If conventional valve designs are used, then manufacturing simplicity is maintained, but hemodynamic performance with reduced gradient is compromised
Solution Approach 1:
The invention uses flexible support frames made from elastic materials that can be manufactured using established techniques for flexible structures. The frame's flexibility is achieved through material selection and geometric design rather than complex assembly, maintaining manufacturing simplicity while dramatically improving hemodynamic performance by reducing pressure gradient through natural flow-conforming behavior.
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 design achieves a reduced pressure gradient across the valve, enhancing blood flow and reducing regurgitation, thereby improving patient outcomes and long-term survival rates by mimicking natural heart valve performance.
Implementation Method 1
A plurality of flexible leaflets attach to the support frame and extend inward toward the axis. Each leaflet has an arcuate cusp edge that conforms to a corresponding support frame cusp and attaches therealong between adjacent commissures, and a free edge that coapts with the free edges of the other leaflets to provide one way flow through the valve.
Implementation Method 2
each commissure of the relaxed support frame angles radially outward so as to provide an outflow orifice area greater than the maximum flow orifice area and induce laminar flow through the valve
Data Source
AI summary
A low pressure gradient prosthetic heart valve for implant in a human. The valve includes a support frame with undulating inflow cusps and outflow commissure posts to which flexible leaflets attach and coapt in a flow area. The commissure posts angle outward in a neutral state to widen the outflow orifice area. Also, the leaflets are designed to fit within the support frame and expand outward in a valve open state without creating a shelf or belly that would restrict flow.