Non-invasive LVEDP Measurement Using Optical Arterial Waveforms
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Solution Overview
Problem
Current methods for measuring left ventricular end diastolic pressure (LVEDP) are invasive, inaccurate in certain conditions, and limited to hospital or clinic environments, lacking non-invasive and portable solutions that do not require physiologic or pharmacologic maneuvers.
Innovation Solution
A non-invasive method using a portable device that combines arterial waveform measurement and electrocardiogram (ECG) data to calculate LVEDP, incorporating pre-ejection period (PEP) and isovolumic contraction time (ICT) with intrinsic frequencies, allowing for semi-invasive beat-to-beat evaluation and correction for valvular diseases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If direct measurement of LVEDP is performed during routine angiography catheterization, then measurement accuracy is improved, but invasiveness and patient risk increase
Solution Approach 1:
The patent replaces the mechanical invasive catheter-based measurement system with a non-invasive optical measurement system. The optical sensor detects arterial waveform characteristics that are processed to calculate LVEDP, eliminating the need for physical insertion of catheters into the heart or blood vessels, thus removing the harmful invasive effect while maintaining measurement capability.
Solution Approach 2:
The patent introduces an intermediary approach by measuring arterial pressure waveform characteristics as a proxy for LVEDP. Instead of directly measuring LVEDP through invasive means, the system uses the arterial waveform (an intermediate measurement) and processes it through computational algorithms to derive LVEDP values, thereby avoiding direct invasive contact with the heart.
2Object-affected harmful factors
If indirect evaluation using pulmonary capillary wedge pressure or pulmonary artery diastolic pressure is performed, then non-invasive access is achieved, but measurement accuracy deteriorates in certain disease conditions
Solution Approach 1:
The patent replaces the mechanical balloon catheter inflation method with a non-invasive optical sensing system. The optical sensor measures arterial waveform characteristics without requiring balloon inflation, and the computational processing algorithm accurately calculates LVEDP across various disease states including mitral valve disease and pulmonary vascular diseases, overcoming the accuracy limitations of traditional indirect methods.
Solution Approach 2:
The patent changes the measurement parameters from direct pressure measurements (which are inaccurate in certain conditions) to optical waveform characteristics (peaking rate, dicrotic notch timing, pulse pressure). These parameter changes enable accurate LVEDP calculation across diverse patient populations including those with mitral stenosis and pulmonary vascular diseases, where traditional indirect methods fail.
3Object-affected harmful factors
If non-invasive approximation methods based on imaging modalities are used, then invasiveness is reduced, but device complexity and portability are worsened
Solution Approach 1:
The patent extracts the essential measurement function from complex imaging modalities like echocardiography and MRI. Instead of using these bulky, complex imaging systems, the invention isolates the critical measurement capability into a simple, portable optical sensor that can be used at the patient's bedside or in home settings, dramatically reducing device complexity while maintaining non-invasive operation.
Solution Approach 2:
The patent employs a simple, inexpensive optical sensor that can be easily disposed or replaced, rather than relying on expensive, complex imaging equipment. This approach enables deployment in resource-limited settings and allows for portable, point-of-care measurement without requiring sophisticated infrastructure.
4Measurement precision
If non-invasive methods requiring Valsalva maneuver are used, then measurement capability is improved, but ease of operation and patient comfort are worsened
Solution Approach 1:
The patent enables the system to measure LVEDP autonomously without requiring the patient to perform the Valsalva maneuver. The optical sensor automatically captures arterial waveform characteristics during normal breathing, and the computational algorithm processes these signals to calculate LVEDP, making the measurement process passive and comfortable for patients while maintaining measurement accuracy.
Data Source
AI summary
A non-invasive and convenient method and apparatus for approximation of left ventricular end diastolic pressure (LVEDP) can be used in both hospital/clinic environments and nursing home or home environments. The method and apparatus use non-invasive sensors and a new “cardiac triangle” computational method to obtain an approximation of LVEDP. The computational method uses hemodynamic and electrocardiogram (ECG) waveforms as input, which can be collected by a portable device or devices.