Non-Cylindrical Prosthetic Heart Valve Frame for Lower Pressure Gradients

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Solution Overview

Problem

Existing prosthetic heart valves with cylindrical frames exhibit increased pressure gradients and turbulence due to narrower outflow orifices and additional components, leading to prosthesis-patient-mismatch and worsened hemodynamic function.

Innovation Solution

A radially expandable and compressible frame design with curved struts and non-cylindrical shape, allowing for improved expansion and compression mechanisms to minimize pressure gradients and reduce turbulence.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a cylindrical frame with mechanical actuators is used, then the valve can be expanded mechanically, but the outflow orifice becomes narrower than the inflow orifice, causing increased pressure gradients and turbulence

Engineering Contradiction:
Improvemechanical expansion capabilityVSAvoidpressure gradient and turbulence
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent applies asymmetry by designing a non-cylindrical frame with different diameters at the inflow end versus the outflow end. Specifically, the frame has a larger diameter at the outflow end compared to the inflow end, creating an asymmetric geometry that eliminates the narrowing effect at the outflow orifice. This asymmetric design allows the outflow orifice to be equal to or larger than the inflow orifice, thereby reducing pressure gradients and turbulence while maintaining mechanical expandability through the actuator system.

Inventive Principle:
Principle #4Asymmetry

2Extent of automation

If additional components are placed adjacent to the outflow end of the frame, then mechanical actuation is enabled, but the pressure gradient across the valve increases

Engineering Contradiction:
Improvemechanical actuationVSAvoidpressure gradient
Core Design Contradiction:
Extent of automationVSObject-generated harmful factors

Solution Approach 1:

The patent applies the extraction principle by removing the outflow end cap component that is typically present in cylindrical valve designs. This outflow end cap is extracted or omitted from the design, allowing the frame to have an open or reduced structure at the outflow end. This extraction eliminates the obstruction that would otherwise increase pressure gradients, while the mechanical actuation components are positioned in a way that does not interfere with the enlarged outflow orifice geometry.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of manufacture

If a cylindrical frame design is used, then manufacturing is simplified, but the effective outflow orifice is reduced, leading to prosthesis-patient mismatch

Engineering Contradiction:
Improveframe fabricationVSAvoidhemodynamic function
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies parameter changes by modifying the geometric parameters of the frame from a uniform cylindrical shape to a non-uniform shape with varying diameters along its length. Specifically, the frame parameters are changed such that the outflow end diameter is larger than the inflow end diameter. This parameter change is achieved through manufacturing techniques such as shaping the frame from a tapered tube or assembling struts at different angles, which maintains manufacturing feasibility while dramatically improving the effective outflow orifice area and overall hemodynamic performance.

Inventive Principle:
Principle #35Parameter changes

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 non-cylindrical frame design reduces pressure gradients and turbulence, enhancing hemodynamic function and reducing paravalvular leakage.

Implementation Method 1

Each strut can be curved helically with respect to a first, longitudinal axis of the frame

Methodology Applied
Scientific EffectHelical curvature: Helix

Implementation Method 2

Each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts

Methodology Applied
Scientific EffectPivoting connection: Hinge

Implementation Method 3

The design reduces pressure gradients across the prosthetic valve, mitigates paravalvular leakage, and improves hemodynamic function by increasing the outflow orifice

Methodology Applied
Scientific EffectPressure gradient reduction: Pressure Gradient

Data Source

PatentUS12616569B2Prosthetic heart valve having non-cylindrical frame
Publication Date: 2026.05.05 EDWARDS LIFESCIENCES CORP
  • US12616569B2 patent drawing
  • US12616569B2 patent drawing
  • US12616569B2 patent drawing

AI summary

An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.