Devices, systems and methods for evaluation of hemostasis

• US 9,410,971 B2
• Filed: 01/21/2016
• Issued: 08/09/2016
• Est. Priority Date: 02/15/2011
• Status: Active Grant

• Current Assignee: Hemosonics LLC (Stago International SAS)
• Original Assignee: Hemosonics LLC (Stago International SAS)
• Inventors: Viola, Francesco, Walker, William F., Browne, Gregory V., Magyar, Robert S., Hansen, Bjarne, Denny, Christopher G.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): FISHER, BRITTANY I
• Application Number:
  US15/003,325
• Publication Number:
  US 20160139159A1
• Time in Patent Office: 201 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0647 Handling flowable solids, e.g. microscopic beads, cells, particles
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2300/14 Means for pressure control
• CPC Class Codes: B01L 2300/16 Surface properties and coatings
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2400/0436 acoustic forces, e.g. surface acoustic waves [SAW]
• CPC Class Codes: B01L 2400/0439 ultrasonic vibrations, vibrating piezo elements
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0666 : Solenoid valves
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502761 : specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules investigating characteristics of particles G01N15/00
• CPC Class Codes: B01L 3/527 : for a plurality of reagents
• CPC Class Codes: G01N 2800/224 : Haemostasis or coagulation
• CPC Class Codes: G01N 29/024 : by measuring propagation velocity or propagation time of acoustic waves
• CPC Class Codes: G01N 29/222 : Constructional or flow details for analysing fluids optoacoustic fluid cells G01N29/2425
• CPC Class Codes: G01N 33/86 : involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

Provided are devices, systems and methods for evaluation of hemostasis. Also provided are sound focusing assemblies.

Claims

1. A device for evaluation of hemostasis, comprising:

a plurality of test chambers each configured to receive blood of a test sample, each test chamber comprising a reagent or combination of reagents, wherein each chamber is configured to be interrogated to determine a hemostatic parameter of the blood received therein;

a first chamber of the plurality comprising a first reagent or a first combination of reagents that interact with the blood received therein, wherein the first reagent, or a reagent included in the first combination of reagents, is an activator of coagulation;

a second chamber of the plurality comprising a second combination of reagents that interact with blood of the test sample received therein, the second combination including an activator of coagulation and one or both of abciximab and cytochalasin D; and

an interrogation device that measures at least one viscoelastic property of the test sample.

2. The device of claim 1, further comprising:

a third chamber comprising a third reagent or combination of reagents that interact with blood of the test sample received therein;

a fourth chamber comprising a fourth reagent or combination of reagents that interact with blood of the test sample received therein; and

wherein the third and fourth chambers are configured to be interrogated to determine a hemostatic parameter of the test sample.

3. The device of claim 1, wherein the interrogation device is configured to use acoustic radiation force.

4. The device of claim 1, wherein the interrogation device is configured to transmit sound into one or more test chamber.

5. The device of claim 1, wherein the first reagent and the second combination of reagents are lyophilized prior to interacting with the test samples.

6. The device of claim 1, wherein each test chamber of the plurality of test chambers is at least partially defined by a housing.

7. The device of claim 6, wherein the device is configured for use with a single test sample.

8. The device of claim 7, further comprising a fluid pathway having an inlet for receiving a test sample, wherein the fluid pathway is in communication with at least one test chamber to deliver the test sample, or a portion thereof, to one or more of the test chambers.

9. The device of claim 8, wherein the housing defines at least a portion of the fluid pathway, and wherein at least a portion of the housing is thermally conductive.

10. The device of claim 9, wherein the thermally conductive portion of the housing defines at least a portion of the fluid pathway.

11. The device of claim 10, wherein the thermally conductive portion comprises a thermally conductive polymer.

12. The device of claim 8, wherein the fluid pathway further comprises a channel in communication with a least one test chamber, and wherein sample delivered from the channel into the test chamber results in mixing of at least a portion of the sample and the reagent within the test chamber.

13. The device of claim 12, wherein the fluid pathway further comprises a channel that opens into at least one test chamber on the side and at a tangent to the test chamber.

14. The device of claim 7, wherein one or more test chamber of the plurality of test chambers further comprises a magnetic stirring structure.

15. The device of claim 1, wherein the second chamber comprises a combination of reagents that includes a reagent comprised by the first chamber.

16. The device of claim 1, wherein the first chamber comprises a first combination of reagents including one or more of reagents selected from the group consisting of kaolin, celite, glass, thrombin, ellagic acid, and tissue factor, and wherein the second chamber comprises the second combination of reagents including one or more reagents selected from the group consisting of kaolin, celite, glass, thrombin, ellagic acid, and tissue factor.

17. A system for evaluation of hemostasis comprising:

a plurality of test chambers each configured to receive blood of a test sample, each test chamber comprising a reagent or combination of reagents;

wherein a first chamber of the plurality comprises an activator of coagulation that interact with the blood received therein;

wherein a second chamber of the plurality comprises an activator of coagulation and one or both of abciximab and cytochalasin D that interact with blood of the test sample received therein the combination including an activator of coagulation and;

wherein the first chamber is configured to be interrogated with ultrasound for a hemostatic parameter of the blood received therein to be determined;

wherein the second chamber is configured to be interrogated with ultrasound for a hemostatic parameter of the blood received therein to be determined;

a transducer for transmitting ultrasound into one or more test chamber and for receiving reflected ultrasound from the chamber and the sample therein; and

at least one processor in communication with the transducer, the processor being configured to determine the hemostatic parameters from signals transmitted to the processor from the transducer.

18. The system of claim 17, wherein the hemostasis parameters are selected from the group consisting of TC1, TC2, clot stiffness, clot formation rate (CFR), TL1, TL2, baseline viscosity, and post lysis viscosity.

19. The system of claim 17, wherein the processor is further configured to determine a coagulation factors index.

20. The system of claim 17, wherein the processor is further configured to determine at least one parameter selected from the group consisting of an intrinsic pathway coagulation factors index, an extrinsic pathway coagulation factors index, a platelets index, a fibrinogen index, and a fibrinolysis index.