Blood Pressure Validation Coupling Interface
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Solution Overview
Problem
Current non-invasive continuous blood pressure measurement systems require an extremity, such as a finger, to validate their accuracy, limiting standardized and repeatable test measurements, and making it difficult to reproduce problematic blood pressure curves for regulatory validation.
Innovation Solution
A method and device that allow validation of blood pressure measurement systems without an extremity by using a coupling interface to modulate light intensity based on a previously recorded blood pressure profile, with a simulation module calculating a comparator function to simulate the blood pressure curve and contact pressure, enabling the system to determine arterial blood pressure without a living subject.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If an extremity (e.g., finger) is used for validation of the blood pressure measurement system, then the measurement accuracy can be verified against actual blood pressure, but the validation process cannot be standardized and reproduced
Solution Approach 1:
The patent creates a simulated extremity model that copies the optical and mechanical properties of a real finger. The simulation module generates artificial plethysmographic signals that mimic the light absorption characteristics of blood vessels under varying pressure conditions, allowing standardized validation without requiring actual human subjects.
Solution Approach 2:
The patent introduces a simulation module as an intermediary between the validation system and the blood pressure measurement device. This module generates synthetic plethysmographic signals that mediate the interaction between the light source/detector system and the pressure control mechanism, enabling reproducible validation while maintaining measurement accuracy assessment.
2Reliability
If a living subject is required for validation, then realistic blood pressure curves can be obtained, but the validation cannot be repeated with identical conditions
Solution Approach 1:
The patent pre-programs various blood pressure scenarios and pathological conditions into the simulation module before validation begins. These predetermined blood pressure curves, including abnormal patterns, are stored and can be replayed identically across multiple validation runs, ensuring both realism and reproducibility of test conditions.
Solution Approach 2:
The simulation module allows dynamic adjustment of physiological parameters such as heart rate, blood pressure amplitude, and vascular compliance. By changing these parameters in controlled ways, the system can generate diverse realistic blood pressure patterns while maintaining exact reproducibility of each specific test scenario.
3Adaptability or versatility
If the light intensity is modulated based on recorded blood pressure curves without an extremity, then standardized validation is enabled, but the system must simulate the complex optical properties of tissue
Solution Approach 1:
The simulation module is designed to perform multiple functions: generating plethysmographic signals, modulating light intensity, simulating vascular responses to pressure changes, and emulating various pathological conditions. This multi-functionality reduces the need for separate testing apparatus while achieving standardized validation.
4Productivity
If the contact pressure is continuously adjusted to maintain maximum pulsation amplitude, then continuous blood pressure measurement is achieved, but the system requires a living extremity to provide feedback
Solution Approach 1:
The simulation module implements a virtual feedback mechanism that mimics the physiological response of a real extremity. When the control mechanism adjusts contact pressure, the simulation generates corresponding changes in the artificial plethysmographic signal amplitude, creating a closed-loop system that operates without requiring actual biological feedback.
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 standardized validation of non-invasive continuous blood pressure measurement systems, allowing for repeatable and reproducible measurements of blood pressure curves, facilitating regulatory approval and clinical use by decoupling the validation process from the need for a living subject.
Implementation Method 1
a light source (103) and at least one light detector (104)... the light intensity of at least one light source (103) is modulated according to a previously recorded blood pressure profile
Implementation Method 2
at least one light detector (104)... suitable - in a measurement phase - to acquire a plethysmographic signal at an extremity
Data Source
Figure 1
Figure 2
Figure 3a~3b
AI summary
The invention relates to a method and a device for validating a continuously measuring, noninvasive blood pressure measurement system (202), which is equipped with a plethysmographic system (203, 204) suitable for obtaining a plethysmographic signal v(t) at an extremity (101) in a measuring phase, the blood pressure measurement system comprising: - a control mechanism (206), to which the signal v(t) from the plethysmographic system (203, 204) is supplied and which changes the contact pressure pc(t) on the extremity (201) by means of a control value u(t); and - an evaluation unit, which continuously determines the curve of the arterial blood pressure pA(t) on the basis of the resulting contact pressure pc(t). According to the invention, the blood pressure measurement system (202) has an input interface (209), via which a signal derived from a previously recorded blood pressure curve can be input into the blood pressure measurement system (202) in a validation phase or test phase.