System and method for coagulation and platelet function related data collection and analysis
Inventors
Kunkel, Mark Allen • Rossi, Jason Matthew • Feiss, Gary Lee
Assignees
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Publication Number
US-12578350-B2
Publication Date
2026-03-17
Expiration Date
Abstract
A system for detecting and quantifying platelet function and coagulation function within a biological sample is provided. The system includes a detection instrument with computing capability. The system includes an assay device capable of receiving a biological sample. Introduction of the biological sample into the assay device results in a biological process by which fibrin and platelets may accumulate at a reaction zone of the assay device. The assay device is capable of receiving one or more chemical reagents compatible with the biological sample and usable for detecting the accumulation of the fibrin and platelets within the reaction zone. The fibrin and platelets, and their associated signals, accumulated at the reaction zone of the assay device are usable to determine at least one of a platelet function, a coagulation function, platelet normalcy, fibrin normalcy, platelet response to a drug, and coagulation response to a drug, within the biological sample.
Core Innovation
The invention relates to a system for detecting and quantifying hemostasis function within a biological sample. The system includes a multi-channel detection instrument that collects, processes, analyzes, and displays multiple independent biological signals in real time, and is programmed to mathematically and statistically compare one or more collected signals with a population data set to compute a hemostatic result for the biological sample.
The system further includes an assay device capable of receiving a biological sample such that manipulated introduction of the biological sample and physiological flow through the assay device result in directed biological processes in which clots accumulate at a discrete reaction zone of the assay device. The assay device is capable of receiving one or more chemical reagents compatible with the biological sample and is usable for detecting accumulation of the clots within the reaction zone.
In multiplexed hemostasis measurements, the invention is implemented to generate platelet and fibrin accumulation signals at the discrete reaction zone using fluorescent labeling and real-time optical imaging. The analyzed fluorescent signals are correlated to clot accumulation and mathematically and statistically compared against population data sets to compute platelet function, coagulation function, and normalcy determinations.
Claims Coverage
The provided independent claim covers a multi-channel hemostasis assay system that computes hemostatic results by comparing multiple biological signals in real time to population data sets. The inventive features refine this by adding platelet and fibrin fluorescent signals, assay-device receiving and flow structure, controllable assay conditions, and statistical comparison that yields functional and normalcy outputs.
Multi-channel hemostasis signal detection with population-data comparison
A multi-channel detection instrument programmed to collect, process, analyze and display multiple independent biological signals associated with the biological sample in real time, and to mathematically and statistically compare one or more collected signals with a population data set to compute a hemostatic result for the biological sample.
Directed clot accumulation at a discrete reaction zone using physiological flow
An assay device capable of receiving a biological sample wherein manipulated introduction of the biological sample into the assay device, and physiological flow of the biological sample through the assay device, result in directed biological processes by which clots accumulate at a discrete reaction zone of the assay device.
Controllable assay conditions experienced by the biological sample
Control functionality whereby conditions experienced by the biological sample in the assay device may be varied.
Detection of clot accumulation with chemical reagents compatible with the biological sample
An assay device capable of receiving one or more chemical reagents compatible with the biological sample, and usable for detecting the accumulation of the clots within the reaction zone.
Platelet and fibrin-specific fluorescent signals correlated to clot accumulation
Platelet-specific and fibrin-specific fluorescent labeling and a fluorescent detection assembly that provides measured fluorescent intensity correlated with accumulation of clots, producing platelet function and coagulation function including platelet or fibrin normalcy and platelet or coagulation response to a drug.
Population statistics, mathematical characteristics, and statistical methodologies for evaluation
A processing device that uses population statistics, mathematical characteristics, and statistical methodologies to evaluate a biological sample's signals against population data.
Percent platelet function, percent fibrin function, and categorical normalcy outputs
Population statistics, mathematical characteristics, and statistical methodologies used to determine percent platelet function, percent fibrin function, and/or a categorical normalcy determination for unmodified and modified samples.
Time-point and threshold-based comparisons of platelet and fibrin signals
Comparing a platelet signal and a fibrin signal independently or dependently with respect to population data over time or at fixed time points, including comparisons to one or more fluorescent-signal thresholds.
The inventive coverage centers on real-time multi-channel biological signal collection with mathematical and statistical comparison to population data to compute hemostatic results, using an assay device that generates clot accumulation at a discrete reaction zone under controllable conditions, with detection enabled by compatible chemical reagents and multiplexed platelet and fibrin fluorescent signals. The dependent features further specify population-statistics-driven evaluation that yields functional and categorical normalcy outputs and supports time-point and threshold-based comparisons of fluorescent platelet and fibrin signals.
Stated Advantages
Computes a hemostatic result for the biological sample using mathematically and statistically comparing collected biological signals with a population data set.
Provides multiple independent biological signals in real time and displays the results.
Enables platelet and fibrin accumulation detection at a discrete reaction zone of the assay device.
Produces functional outputs including percent platelet function and/or percent fibrin function and categorical normalcy determinations.
Supports evaluation of drug response by comparing signals to population reference datasets under varied assay conditions.
Documented Applications
Drug sensitivity testing using chemical reagents compatible with the biological sample, including comparison of hemostasis function results associated with drug response to population reference datasets under varied conditions.
Clinical and experimental comparison between healthy donors and patients on DOACs, assessing functional hemostasis differences and comparisons to quantitative drug concentration via reported study results.
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