Integrated Elastography and Blood Test System for Liver Health
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Solution Overview
Problem
Current methods for determining liver health conditions using liver stiffness measurements and liver enzyme concentrations are cumbersome, requiring separate environments and personnel, leading to increased costs, potential errors, and reduced reproducibility due to decoupled serological and mechanical measurements.
Innovation Solution
A system and method that integrates an elastography device with a blood-test reader and disposable, allowing for concomitant measurement of liver stiffness and capillary blood enzyme levels, enabling a non-professional to collect a small blood sample for immediate analysis, reducing the need for extensive medical facilities and personnel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If liver stiffness measurement and liver enzyme concentration analysis are performed separately in different environments, then each measurement can be performed with specialized equipment and personnel, but the overall procedure becomes more complex, more expensive, and less reproducible
Solution Approach 1:
The patent combines the elastography device and blood test reader into an integrated system that performs both liver stiffness measurement and liver enzyme concentration analysis in a single examination environment. This merging eliminates the need for separate facilities and personnel, reducing procedural complexity while maintaining measurement precision through coordinated operation of both functions within one system.
Solution Approach 2:
The integrated system performs multiple functions - both mechanical elastography measurement and serological blood analysis - within a single device platform. This multi-functionality allows the system to replace multiple specialized devices while maintaining the precision of each individual measurement function, thereby reducing overall procedural complexity.
2Measurement precision
If liver stiffness measurement and liver enzyme concentration analysis are performed in different environments at different moments, then each measurement can be optimized independently, but the possibility of errors increases when transferring results and the overall cost increases
Solution Approach 1:
By merging the measurement and analysis functions into a single integrated system, the patent eliminates the need to transfer results between different environments and personnel. The system performs both liver stiffness measurement and blood enzyme analysis concurrently within the same examination setting, thereby eliminating transfer errors and improving diagnostic reliability while maintaining measurement precision.
Solution Approach 2:
The integrated system enables immediate feedback between the mechanical measurement and serological analysis components. The control unit coordinates both functions and processes results in real-time, allowing for cross-validation of findings and reducing the likelihood of diagnostic errors that could arise from independent, disconnected measurements.
3Quantity of substance
If venous blood is collected for liver enzyme analysis, then a sufficient sample can be obtained for accurate analysis, but the procedure requires trained health care professionals and specialized collection environments
Solution Approach 1:
The patent employs a disposable capillary tube integrated into the blood test reader for capillary blood collection. This disposable component eliminates the need for reusable collection equipment and specialized handling procedures, allowing untrained individuals to easily collect sufficient capillary blood samples without requiring trained health care professionals or specialized collection environments.
Solution Approach 2:
The system changes the sampling parameter from venous blood (requiring professional collection) to capillary blood (amenable to self-collection). This parameter change in sample type allows sufficient blood volume to be obtained through simple finger-prick methods using the integrated capillary tube, dramatically improving ease of operation while maintaining adequate sample quantity for analysis.
4Ease of operation
If blood sample collection and analysis are delayed, then the examination procedure becomes less urgent and can be performed in more relaxed conditions, but enzyme activity decreases and results become less accurate
Solution Approach 1:
By merging the blood collection and analysis functions into the same integrated system, the patent enables immediate processing of the capillary blood sample upon collection. The blood test reader is positioned within the examination environment, eliminating delays associated with transporting samples to separate laboratories, thereby maintaining enzyme activity and measurement precision while preserving procedural ease.
Solution Approach 2:
The system performs preliminary preparation of the blood analysis environment and reagents before sample collection. The blood test reader is pre-configured with necessary reagents and calibration, allowing the collected capillary blood sample to be analyzed immediately without delay. This preliminary preparation ensures that enzyme activity is preserved while maintaining the ease of operation through streamlined workflow.
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
This integration improves reproducibility, reduces costs, and enhances the reliability of liver health assessments by allowing simultaneous measurements within a single environment, minimizing delays, and maintaining enzyme activity for accurate results.
Implementation Method 1
an elastography device configured to measure at least one mechanical parameter relative to the propagation of shear waves in liver
Implementation Method 2
a blood-test reader configured to determine a concentration of at least one liver enzyme in the blood sample
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
A system (1) and method for determining a health condition of the liver of a subject, the system including an elastography device (2), a blood-test reader (3) and an associated blood-test disposable (10), the disposable including a capillary tube for collecting a capillary blood sample from the subject and including reagents appropriate to detect at least one liver enzyme in the blood sample, the blood-test reader being operatively connected to the elastography device, and a control and processing system (4), configured to control the elastography device and the blood test reader and to determine the health condition of the liver of the subject, taking into account both a value of at least one mechanical parameter measured by the elastography device and a value of the concentration of the at least one liver enzyme.