Characterization of blood hemostasis and oxygen transport parameters

Inventors

Viola, Francesco • Walker, William F.

Assignees

Homosonics LLC • Hemosonics LLC

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Publication Number

US-10962524-B2

Patent

Publication Date

2021-03-30

Expiration Date


Abstract

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.

Core Innovation

The invention provides an apparatus and method that use a cartridge including a plurality of test chambers with a plurality of transducers to detect responses resulting from one or more measurement signals applied into the cartridge having a plurality of blood samples from a subject. The plurality of test chambers includes a first test chamber and a second test chamber, and the cartridge includes a fluid pathway with an inlet through which a blood sample is directed into the cartridge through application of a pressure differential applied through the receptacle.

The transducers associated with the first test chamber detect a first measurement signal associated with detection of a first set of hemostasis parameters and a third measurement signal associated with detection of an oxygen transport parameter, while a transducer associated with the second test chamber detects a second measurement signal associated with a second set of hemostasis parameters. The processor evaluates an assessed displacement of the blood sample associated with the respective first and second measurement signals for a viscoelastic response of the blood sample in the respective first and second chambers to determine the first set and second set of hemostasis parameters.

Each of the first and second sets of hemostasis parameters includes a parameter associated with clot stiffness and a parameter selected from clot time, clot formation rate, and lysis time, and the processor determines the oxygen transport parameter by evaluating the responses associated with the third measurement signal, wherein the oxygen transport parameter includes a parameter selected from hematocrit and hemoglobin concentration. The graphical user interface presents the determined oxygen transport parameter and the first and second sets of hemostasis parameters, and the presented oxygen transport and hemostasis parameter outputs are used to guide a transfusion and/or introduction of fresh frozen plasma, platelet concentrates, cryoprecipitate, antifibrinolytics, packed red blood cells, and drugs to address assessed deficiencies in hemostasis.

Claims Coverage

The partial content contains two independent claims: an apparatus claim and a method claim. Across these claims, the inventive subject matter centers on simultaneous displacement-based viscoelastic hemostasis parameter determination in first and second test chambers and oxygen transport parameter determination from a third measurement signal in the first test chamber, followed by GUI presentation to guide transfusion and/or introduction of specified blood products and drugs.

Cartridge with first and second test chambers for combined hemostasis and oxygen transport sensing

A cartridge with a plurality of test chambers including a first test chamber and a second test chamber, and a fluid pathway with an inlet through which a blood sample is directed into the cartridge through application of a pressure differential applied through a receptacle.

Transducers generating first, second, and third measurement signals across chambers

A plurality of transducers configured to detect one or more responses resulting from one or more measurement signals applied into the cartridge having a plurality of blood samples, where the plurality of transducers include one or more transducers associated with the first test chamber detecting a first measurement signal associated with detection of a first set of hemostasis parameters and a third measurement signal associated with detection of an oxygen transport parameter, and a transducer associated with the second test chamber detecting a second measurement signal associated with a second set of hemostasis parameters.

Displacement-based determination of viscoelastic hemostasis parameters

Receiving the one or more responses associated with the first, second, and third measurement signals, and determining the first set and second set of hemostasis parameters by evaluating an assessed displacement of the blood sample associated with the respective first and second measurement signals for a viscoelastic response of the blood sample in the respective first and second chambers, wherein each set includes a parameter associated with clot stiffness and a parameter selected from clot time, clot formation rate, and lysis time.

Third measurement signal evaluation for oxygen transport parameter (hematocrit/hemoglobin)

Determining the oxygen transport parameter by evaluating the one or more responses associated with the third measurement signal, wherein the oxygen transport parameter includes a parameter selected from hematocrit and hemoglobin concentration.

GUI presentation used to guide transfusion and drugs to address deficiencies

Presenting, via the graphical user interface, the determined oxygen transport parameter and the first and second sets of hemostasis parameters, wherein the presented outputs are used to guide a transfusion and/or introduction of fresh frozen plasma, platelet concentrates, cryoprecipitate, antifibrinolytics, packed red blood cells, and drugs to address assessed deficiencies in hemostasis.

Together, the independent claims define an apparatus and corresponding method that combine displacement-based viscoelastic hemostasis parameter determination in first and second test chambers with oxygen transport parameter determination from a third measurement signal in the first test chamber, and present the outputs on a graphical user interface for guiding transfusion and/or drug introduction.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Used to guide a transfusion and/or introduction of fresh frozen plasma, platelet concentrates, cryoprecipitate, antifibrinolytics, packed red blood cells, and drugs to address assessed deficiencies in hemostasis.

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