Cuvette-Based Apparatus for Blood Coagulation Measurement and Testing

• US 20140161668A1
• Filed: 08/05/2013
• Published: 06/12/2014
• Est. Priority Date: 07/16/2008
• Status: Active Grant

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Colella, Gregory M., Huang, Henry D., Shishkin, Dimitri, Figueroa, Maria, Mawhirt, James A., Kuklo, Anthony F.
• Granted Patent: US 10,180,419 B2
• Time in Patent Office: Days
• US Class Current: 422/73
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/146 Employing pressure sensors
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/165 Specific details about hydrophobic, oleophobic surfaces
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/4915 using flow cells flow cytometry G01N15/14

Abstract

An apparatus for measuring blood clotting time includes a blood clot detection instrument and a cuvette for use with the blood clot detection instrument. The cuvette includes a blood sample receptor-inlet; a channel arrangement including at least one test channel for performing a blood clotting time measurement, a sampling channel having at least one surface portion that is hydrophilic, communicating with the blood sample receptor-inlet and the at least one test channel, and a waste channel having at least one surface portion that is hydrophilic, communicating with the sampling channel; and a vent opening communicating with the sampling channel. The sampling channel, the vent opening and the waste channel, coact to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel.

Claims

1. A cuvette with a self-filling sample channel for use with a blood clot detection instrument, the cuvette comprising:

a main body including;

a blood sample receptor-inlet;

a channel arrangement comprising;

at least one test channel for performing a blood clotting time measurement;

a sampling channel communicating with the blood sample receptor-inlet and the at least one test channel, at least the sampling channel having a hydrophilic surface portion; and

a waste channel communicating with the sampling channel through a restriction, the restriction having a smaller cross sectional area than the sample channel and the waste channel; and

a vent opening communicating with the sampling channel, the vent opening located between the at least one test channel and the restriction,

wherein the sampling channel, the vent opening and the waste channel are configured to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel,

whereby the hydrophilic surface portion of the sampling channel draws blood from the sample receptor-inlet into the sampling channel, the vent opening vents air from the sampling channel as the sampling channel automatically fills with blood, and the restriction delays filling of the waste channel until the requisite volume of blood has filled the sample channel.

3. The cuvette of claim 1, wherein the channel arrangement further comprises a vent channel connecting the vent opening with the sampling channel.

5. The cuvette of claim 1, wherein the channel arrangement is formed in a surface of the main body.

6. The cuvette of claim 5, further comprising a substrate for closing and sealing at least a portion of the channel arrangement formed in the surface of the main body.

7. The cuvette of claim 6, wherein the substrate forms the at least one surface portion of the sampling channel that is hydrophilic.

8. The cuvette of claim 6, wherein the substrate comprises a film with a hydrophilic surface, the hydrophilic surface of the substrate forming the at least one surface portion of the sampling channel that is hydrophilic.

9. The cuvette of claim 6, wherein the substrate comprises a film and a layer of hydrophilic material disposed on the film, the hydrophilic material forming the at least one surface portion of the sampling channel that is hydrophilic.

10. The cuvette of claim 9, wherein the hydrophilic material is an adhesive which attaches the substrate to the main body.

11. The cuvette of claim 1, further comprising a blood clotting reagent disposed in the at least one test channel.

12. The cuvette of claim 1, wherein the at least one test channel includes a section having at least one textured surface.

13. The cuvette of claim 1, wherein the at least one test channel includes a restriction.

14. The cuvette of claim 1, wherein the main body is made of one of a hydrophobic material, a hydrophilic material, or a combination of a hydrophobic material and a hydrophilic material.

15. The cuvette of claim 1, wherein the waste channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic.

16. The cuvette of claim 1, wherein the at least one test channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic or hydrophobic.

17. The cuvette of claim 3, wherein the vent channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic.

18. The cuvette of claim 1, wherein the restriction comprises a jumper channel or a restriction.

19. The cuvette of claim 18, wherein the jumper channel or the restriction has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic.

58. The cuvette of claim 1, wherein the hydrophilic surface is a coating, an insert, a liner, the material from which the main body is made, and any combination thereof.

59. The cuvette of claim 3, wherein the sampling channel has a larger cross-section than the vent channel.

2. (canceled)

4. (canceled)

20. (canceled)

60. The cuvette of claim 20, wherein the sampling channel has a larger cross-section than the jumper channel.

61. The cuvette of claim 60, wherein the waste channel has a larger cross-section than the jumper channel.

21. An apparatus for measuring blood clotting time, the apparatus comprising:

A) a blood clot detection instrument, the blood clot detection instrument comprising;

a pump module; and

at least one pressure sensor, and

B) a cuvette with a self-filling sample channel for use with the blood clot detection instrument, the cuvette comprising;

a main body including;

i) a blood sample receptor-inlet;

ii) a channel arrangement comprising;

a) at least one test channel for communicating with the pump module when the cuvette is operatively coupled to the clot detection instrument;

b) a sampling channel communicating with the blood sample receptor-inlet and the at least one test channel, at least the sampling channel having a hydrophilic surface portion; and

c) a waste channel communicating with the sampling channel through a restriction, the restriction having a smaller cross sectional area than the sample channel and the waste channel; and

iii) a vent opening communicating with the sampling channel, the vent opening located between the at least one test channel and the restriction,

wherein compressed air within the blood clot detection instrument and the at least one test channel, the sampling channel, the vent opening and waste channel, are configured to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel, and

wherein the at least one test channel of the cuvette, and the pump module and the at least one pressure sensor of the clot detection instrument, coact to perform a blood clotting time measurement on the requisite volume of the blood sample,

whereby the hydrophilic surface portion of the sampling channel draws blood from the sample receptor-inlet into the sampling channel, the vent opening vents air from the sampling channel as the sampling channel automatically fills with blood, and the restriction delays filling of the waste channel until the requisite volume of blood has filled the sample channel.

22-57. -57. (canceled)