Apparatus and method to determine stroke subtype
Inventors
Cohen, Eli • Raviv, Gabriel • Navickas, Irene
Assignees
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Publication Number
US-12607641-B2
Publication Date
2026-04-21
Expiration Date
Abstract
Apparatus and methods are provided to determine stroke subtype by hemostasis measurement at point of care or first response. A testing apparatus and methods may provide first test to determine an ischemic or hemorrhagic indication and a second test to provide a therapeutic influence before classifying a stroke substype.
Core Innovation
The apparatus determines whether a stroke subtype is ischemic or hemorrhagic by applying thrombelastography to a whole blood test sample. A transformative apparatus excites the sample, and a sensor measures a physical characteristic during transformation and provides representative data. A processor uses the data to determine a stroke index and provides a subtype indication according to the relationship between that index and a set of cutoff values.
The system includes a point-of-care whole-blood thrombelastography apparatus and a microfluidic cartridge that automates sample processing and supports multiple reagent-based assays. The measured physical characteristic includes resonant vibration frequency, while the cutoff values utilize reference clotting times and clot strengths. The apparatus demonstrates retrospective subtype classification accuracy of 85% to enable rapid stroke assessment in emergency and ambulance settings.
Claims Coverage
The relevant claims include one independent claim comprising six inventive features. The claim covers whole-blood thrombelastography, sensing and processing to determine a stroke index, and subtype indication using cutoff values; dependent claims add cartridge, measurement, cutoff, and output refinements.
Whole-blood transformation through thrombelastography
A transformative apparatus is configured to excite a whole blood test sample and cause its transformation through thrombelastography.
Measurement of a physical characteristic
A sensor positioned relative to the transformative apparatus measures a physical characteristic of the whole blood test sample during transformation and provides representative data. A dependent claim specifies resonant vibration frequency.
Stroke index and subtype indication
A processor controls operation of the transformative apparatus, receives the data, determines a stroke index based at least on the data, and provides an ischemic or hemorrhagic stroke subtype indication based on the relationship of the stroke index to cutoff values.
Cartridge with fluid-processing and sample-retention structures
A dependent claim adds a cartridge with a sample preparation portion and a sample testing portion, including fluid-processing and sample-retention structures connected by a fluidic passage.
Cutoff values based on clotting time and clot strength
Dependent claims specify reference clotting times and clot strengths as cutoff values, with corresponding first and second reference values differing from one another; the cutoff values may also comprise at least one biomarker.
Undetermined subtype indication
A dependent claim allows the stroke subtype indication to include an undetermined result.
The claims cover an apparatus that uses thrombelastography data from a whole blood test sample to determine a stroke index and indicate a stroke subtype using cutoff values. Dependent claims specify sample handling, a measured resonant vibration frequency, cutoff components, and an undetermined output.
Stated Advantages
The system is presented as enabling faster stroke assessment.
Documented Applications
Point-of-care assessment of stroke subtype, including use in emergency and ambulance settings.
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