Granted Patent
B2
US 12,444,498 · App. 17/935,318 · Granted Oct 14, 2025
Hemostatic parameter display
Inventors:
Francesco Viola (Charlottesville, VA); William F. Walker (Charlottesville, VA); Gregory V. Browne (Victoria West, CA); Adam Looker (Victoria, CA); Bryan Roy (Cobble Hill, CA); Bjarne Hansen (Victoria, CA)
Assignee:
HemoSonics LLC
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Abstract
A system for displaying a plurality of hemostatic indexes is disclosed. The system includes a communication receiver configured to receive the hemostatic indexes and a graphical user interface (GUI) connected to the communication receiver and configured to simultaneously display the hemostatic indexes. The hemostatic indexes are derived from a plurality of independent measurements, such as the mechanical measurements determined using the sonorheometry systems and processes.
Claims (38)
1. A system for measuring physiologic parameters of one or more blood samples, the system comprising:
a receptacle assembly to receive one or more cartridges, including a first cartridge, the first cartridge having:
a plurality of sample wells including a first sample well and a second sample well; and
a plurality of channels including i) a first channel connected in fluid communication to the first sample well and ii) a second channel connected in fluid communication to the second sample well;
wherein the plurality of channels have a collective connection configured to establish fluid communication with at least of the one or more blood samples for drawing, from the one or more blood samples, portions for each of the first and second the sample wells including a first portion for the first sample well and a second portion for the second sample well, respectively;
a sensor system configured to couple with the receptacle assembly for interrogation of the plurality of portions of the one or more blood samples including the first and second portions of the one or more blood samples to yield a plurality of sets of independent measurements including a first set of independent viscoelastic measurements from the first portion and a second set of independent viscoelastic measurements from the second portion;
a processor connected to the sensor system to continually receive the plurality of sets of independent measurements, including a data set associated with the first set of independent viscoelastic measurements and a data sets associated with the second set of independent viscoelastic measurements of the one or more cartridges, the processor being configured, via a set of instructions stored in memory, to estimate physiologic parameters of the one or more samples; and
a graphical user interface (GUI) connected to the processor and configured to display in parallel functional hemostatic indexes derived from each of the plurality of independent measurements, wherein each displayed functional hemostatic index of the simultaneously displayed functional hemostatic indexes comprise a platelet function index representative of samples treated with clopidogrel and a platelet function index representative of samples treated with aspirin, wherein the graphical user interface comprises a graphical indicator for each of the displayed hemostatic indexes, and
wherein the displayed functional hemostatic indexes are used to assess reduced platelet function due to a presence of an antiplatelet drug.
2. The system of claim 1 , wherein the antiplatelet drug includes clopidogrel and/or aspirin.
3. The system of claim 1 , wherein the first cartridge includes pre-loaded reagent sets for the plurality of sets of independent measurements.
4. The system of claim 1 , wherein the one or more samples were pre-treated with clopidogrel from clopidogrel therapy.
5. The system of claim 1 , wherein the one or more samples were pre-treated with aspirin from aspirin therapy.
6. The system of claim 1 , wherein the one or more cartridges are used to direct administration of anti-platelet therapy.
7. The system of claim 1 , wherein the one or more cartridges are used to direct transfusion of platelets.
8. The system of claim 1 , wherein the one or more cartridges are used to assess reduced platelet function due to the presence of clopidogrel or aspirin in connection with a surgical procedure.
9. The system of claim 1 , wherein the one or more cartridges are used to additional assessed coagulation function and/or fibrinogen function.
10. The system of claim 1 , wherein the sensor system comprises mechanical transducers.
11. The system of claim 1 , wherein the sensor system comprises ultrasonic transducers.
12. The system of claim 1 , wherein the coagulation factor function includes an intrinsic activation factor or extrinsic activation factor.
13. The system of claim 1 , wherein graphical indicator includes i) a numerical output and a corresponding visual element that quantifies a function of the each of the simultaneously displayed functional hemostatic indexes and ii) relative positioning of the each of the simultaneously displayed functional hemostatic indexes to communicate a hemostatic condition of a subject, and wherein the relative positioning shows a range associated with normal physiological function.
14. The system of claim 1 , wherein the displayed functional hemostasis indexes further include a fibrinogen concentration or a fibrinolysis function.
15. The system of claim 1 , wherein the GUI is further configured to display a parameter selected from the group consisting of a hematocrit, hemoglobin concentration and red cell count.
16. The system of claim 12 , wherein the GUI is further configured to display the parameter selected from the group consisting of the hematocrit, hemoglobin concentration and red cell count simultaneously with the simultaneously displayed functional hemostatic indexes.
17. The system of claim 1 , wherein the receptacle assembly is configured to receive the one or more cartridges and is configured to position the first and second portions of the single blood sample of the first and second sample wells, respectively, in a spatial arrangement corresponding to the simultaneously displayed functional hemostatic indexes.
18. The system of claim 1 , wherein the GUI is configured to display the functional hemostatic indexes in a side-by-side serial arrangement corresponding to a spatial arrangement associated with the sample wells.
19. The system of claim 1 , wherein the GUI is further configured to display a history of the simultaneously displayed functional hemostatic indexes, wherein at least one portion of the history includes an array of graphical indicators, each of the graphical indicators representing one of the simultaneously displayed functional hemostatic indexes at some time in the history.
20. The system of claim 1 , wherein each of the graphical indicators includes the relative positioning that shows a range associated with abnormal physiological function for the each of the simultaneously displayed functional hemostatic indexes.
21. The system of claim 1 , wherein the GUI is further configured to display a treatment recommendation based on the simultaneously displayed functional hemostatic indexes.
22. The system of claim 21 , wherein the treatment recommendation is for guiding transfusion of a blood component selected from the group consisting of platelets, cryoprecipitate, fibrinogen, plasma, red cells, and antifibrinolytics.
23. The system of claim 22 , wherein the treatment recommendation is for guiding therapies of a drug selected from the group consisting an anti-platelet drug, an anti-coagulant drug, and a pro-fibrinolysis drug.
24. A method for measuring physiologic parameters of one or more blood samples, the method comprising:
receiving one or more cartridges, including a first cartridge, in a receptacle assembly;
interrogating one or more cartridges via a sensor system, including a first cartridge, to provide a plurality of sets of independent measurements including a first set of independent viscoelastic measurements from the first portion and a second set of independent viscoelastic measurements from the second portion; wherein the first cartridge has (i) a plurality of sample wells including a first sample well and a second sample well and (ii) a plurality of channels including a) a first channel connected in fluid communication to the first sample well and b) a second channel connected in fluid communication to the second sample well, wherein the plurality of channels have a collective connection configured to establish fluid communication with the single blood sample for drawing, from the single blood sample, portions for each of the first and second the sample wells including a first portion for the first sample well and a second portion for the second sample well, respectively;
continually receiving, by a processor connected to the sensor system, the plurality of sets of independent measurements of the one or more cartridges, including a data set associated with the first set of independent viscoelastic measurements and a data sets associated with the second set of independent viscoelastic measurements;
estimating, by the processor, physiologic parameters of the one or more blood samples, including a functional hemostatic index associated with the platelet function by differentially combining results derived from at least the first and second independent measurements; and
simultaneously displaying, via a graphical user interface, functional hemostatic indexes derived from each of the plurality of independent measurements, wherein each displayed functional hemostatic index of the simultaneously displayed functional hemostatic indexes comprise a platelet function of the one or more blood samples treated with clopidogrel and a platelet function of the one or more blood samples subjected with aspirin, wherein the graphical user interface comprises a graphical indicator for each of the displayed hemostatic indexes,
wherein the displayed functional hemostatic indexes are used to assess reduced platelet function due to a presence of an anti-platelet drug.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 11, 2023
From: VIOLA, FRANCESCO; WALKER, WILLIAM F.; BROWNE, GREGORY V.; LOOKER, ADAM; ROY, BRYAN; HANSEN, BJARNE
To: HEMOSONICS LLC
Reel/Frame 062346/0972 →
Continuity (4)
Provisional Application
61322049
· Apr 8, 2010
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