Ultrasonic Blood Hemostasis Assessment With Oxygen Transport Correction
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Solution Overview
Problem
Current in vitro diagnostics (IVDs) for hemostasis are limited in their ability to accurately assess the complex balance of coagulation and fibrinolysis, often failing to prevent postoperative bleeding despite normal perioperative measurements, and existing point-of-care (POC) tests neglect platelet function and interaction with the coagulation cascade.
Innovation Solution
A system utilizing an ultrasonic signal generator and processor to measure hemostasis and oxygen transport parameters in blood samples, including HCT, HGB, and MCV, which calculates corrected hemostasis parameters to guide transfusions and communicate clinical parameters through a graphical user interface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If endpoint biochemical assays (PT, PTT) are used to assess coagulation, then the tests are simple and widely used, but they measure only a part of the hemostatic process and fail to predict postoperative bleeding
Solution Approach 1:
The patent combines multiple hemostatic parameters (coagulation factors, platelet function, fibrinolytic activity) into a single integrated assessment system using viscoelastic measurement technology, allowing simultaneous evaluation of all hemostatic components rather than separate endpoint assays
Solution Approach 2:
The measurement system is designed to quantify multiple hemostatic parameters simultaneously (coagulation, platelet function, fibrinolysis) using a single platform, making it universally applicable for comprehensive hemostatic assessment rather than requiring multiple specialized tests
2Adaptability or versatility
If platelet aggregation assays are used to monitor platelet function, then the tests are available, but they use platelet aggregation as a proxy and neglect the interaction between platelets and coagulation cascade
Solution Approach 1:
The patent replaces traditional mechanical platelet aggregation assays with viscoelastic measurement technology that directly measures the mechanical properties of whole blood clots, providing more accurate information about actual clot formation and platelet-coagulation interaction
3Reliability
If TEG is used to measure viscoelastic properties of blood, then comprehensive hemostatic information is obtained, but the device is complex to operate and interpret
Solution Approach 1:
The system provides real-time feedback during the measurement process with automated interpretation, displaying hemostatic parameters and guiding the user through the measurement steps, thereby reducing operational complexity while maintaining comprehensive assessment capability
4Productivity
If TEG applies relatively large shear strains to measure viscoelastic properties, then measurement can be performed, but it transgresses the nonlinear viscoelastic regime and disrupts clot formation
Solution Approach 1:
The patent modifies the measurement parameters by applying small, controlled shear strains within the linear viscoelastic regime rather than large shear strains, enabling measurement without disrupting the natural clot formation process while still obtaining meaningful viscoelastic data
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 system provides a non-invasive, accurate assessment of hemostasis and oxygen transport parameters, enabling better management of bleeding complications during surgeries like cardiopulmonary bypass by quantifying coagulation factors, platelet function, and fibrinolysis, reducing transfusion requirements and improving clinical outcomes.
Implementation Method 1
an ultrasonic signal generator configured to generate and direct an ultrasonic signal to interact with the blood sample
Implementation Method 2
a receiver configured to determine at least one characteristic of the ultrasonic signal that interacted with the blood sample
Data Source
AI summary
An integrated system for determining a hemostasis and oxygen transport parameter of a blood sample, such as blood, is disclosed. The system includes a measurement system, such as an ultrasonic sensor, configured to determine data characterizing the blood sample. For example, the data could be displacement of the blood sample in response to ultrasonic pulses. An integrated aspect of the system may be a common sensor, sample portion or data for fast and efficient determination of both parameters. The parameters can also be used to correct or improve measured parameters. For example, physiological adjustments may be applied to the hemostatic parameters using a HCT measurement. Also, physical adjustments may be applied, such as through calibration using a speed or attenuation of the sound pulse through or by the blood sample. These parameters may be displayed on a GUI to guide treatment.