Aortic Valve Annulus Measurement Device with Radial Expansion

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Solution Overview

Problem

Traditional methods for measuring the size of heart valve annuli in the human body do not account for the expansion caused by prosthetic valves, leading to inadequate sizing and potential resistance issues during medical procedures.

Innovation Solution

An apparatus comprising an orifice-expanding device, a pressure-measuring device, and a size-measuring device that allows for the radial expansion and independent measurement of the orifice, using components like inflatable balloons, coiled members with visual indicia, and strain gauges to determine the expanded size and pressure applied.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional sizing apparatus is used to measure the annulus, then the measurement process is simple, but the measurement does not reflect the expanded condition of the annulus under prosthetic valve pressure

Engineering Contradiction:
Improveaccuracy of annulus size measurementVSAvoidcomplexity of sizing apparatus
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the orifice-expanding device, pressure-measuring device, and size-measuring device into a single integrated apparatus. This merging allows the device to both expand the annulus to simulate prosthetic valve conditions and measure the resulting dimensions, thereby achieving accurate measurement of the expanded annulus while maintaining a unified, manageable device structure.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sizing apparatus is designed to perform multiple functions: it can expand the orifice radially, measure the pressure applied during expansion, and measure the dimensions of the expanded orifice. This multi-functionality eliminates the need for separate devices for each measurement stage, providing comprehensive annulus sizing capability in a single apparatus.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If the orifice is expanded to simulate prosthetic valve conditions, then the measurement reflects functional size, but the device complexity increases

Engineering Contradiction:
Improveaccuracy of expanded annulus measurementVSAvoidcomplexity of expanding and measuring system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The size-measuring device is positioned within the orifice-expanding device, and the pressure-measuring device is integrated into the expanding mechanism. This nesting arrangement allows all measurement components to be housed within the expanding device structure, reducing overall device complexity while enabling comprehensive measurement of the expanded annulus under simulated prosthetic valve conditions.

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Enables accurate measurement of the expanded orifice size, allowing for the selection and implantation of prosthetic heart valves that minimize resistance and reduce paravalvular leaks, while ensuring proper fit and axial stability.

Implementation Method 1

The orifice-expanding device can be radially expandable from a first configuration to a second, expanded configuration to cause corresponding radial expansion of the orifice

Methodology Applied
Scientific EffectRadial pressure: Pressure Increase

Implementation Method 2

The coiled member can surround at least a portion of the orifice-expanding device and can be configured to uncoil when the orifice-expanding device expands from the first configuration to the second configuration

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 3

The pressure-measuring device can be configured to measure a pressure applied to the orifice by the orifice-expanding device

Methodology Applied
Scientific EffectPressure measurement:

Data Source

PatentUS11412954B2Device for measuring an aortic valve annulus in an expanded condition
Publication Date: 2022.08.16 EDWARDS LIFESCIENCES CORP
  • US11412954B2 patent drawing
  • US11412954B2 patent drawing
  • US11412954B2 patent drawing

AI summary

An orifice-expanding device for measuring an expanded heart valve. The device includes a proximal handle having a shaft and an orifice-expanding device with a hub mounted to a distal end of the shaft and a plurality of arms evenly spaced around the axis and connected to the hub and extending therefrom in a distal direction to distal ends of the arms. The distal end of each arm has an expanding portion with an outer surface, the expanding portions being configured to move radially outward with respect to each other, wherein expansion of the expanding portions causes the distal ends of the arms to flex outward. A pressure-measuring device measures a pressure applied to the aortic valve annulus, and a size-measuring device measures a dimension of the aortic valve annulus after the annulus has been expanded.