Blood coagulation monitoring device with liquid crystal and gradient heater

• US 5,908,786 A
• Filed: 12/12/1997
• Issued: 06/01/1999
• Est. Priority Date: 12/12/1997
• Status: Expired due to Fees

• Current Assignee: TRINITY BIOTECH MANUFACTURING LIMITED AND TRINITY BIOTECH, PLC
• Original Assignee: Akzo Nobel N.V. (Nouryon BV)
• Inventors: Moreno, Mario, Wu, Jogin R.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US08/989,561
• Time in Patent Office: 536 Days
• Field of Search: 436/63, 436/69, 436/164, 436/165, 436/175, 436/177, 436/178, 422/55, 422/58, 422/73, 422/101, 422/102, 73/64.41, 73/64.43
• US Class Current: 436/69
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

A device and method are disclosed for determining whether or not an individual'"'"'s blood coagulation time is in a normal or abnormal range, and is particularly suitable for measuring prothrombin time and activated partial thromboplastin time coagulation values. The device includes a housing with an area for receiving a sample, a capillary channel or elongated area with an absorbent material, and a gradient heater. Liquid crystal and a coagulation agent can be disposed within the device to mix with a sample added to the device. The mixture passes along the capillary channel or absorbent material and stops moving when the sample has clotted. Due to the gradient heater and liquid crystal, the mixture may or may not change color, depending upon whether the individual has a an abnormally short, normal, or abnormally long clot time.

Claims

1. A device for determining whether or not an individual has a blood coagulation time in a normal range, comprising:

a housing comprising a blood sample receiving area;

a capillary channel in fluid communication with said blood sample receiving area;

a gradient heater disposed along the capillary channel, the gradient heater constructed so as to heat said capillary channel at a varying temperature along the length of the capillary channel and liquid crystal disposed at sample receiving area or between said sample receiving area and said capillary channel, said liquid crystal capable of mixing, at least in part, with a blood sample applied to the device.

2. The device of claim 1, further comprising a reagent chamber disposed between the sample receiving area and said capillary channel, said reagent chamber having said liquid crystal therein.

3. The device of claim 2, wherein said gradient heater is disposed adjacent both said reagent chamber and said capillary channel.

4. The device of claim 1, wherein said gradient heater is constructed so as to heat said capillary channel at a decreasing temperature in a direction away from said sample receiving area.

5. The device of claim 1, wherein said gradient heater is a resistive element having variable density.

6. The device of claim 5, wherein said gradient heater is a plurality of resistive elements, one resistive element having a different density than an adjacent resistive element.

7. The device of claim 1, wherein said liquid crystal changes color at a temperature that is within a temperature gradient along the capillary channel.

8. The device of claim 7, wherein a point along the capillary channel where the liquid crystal changes color is set to correspond to a point where a normal clot time changes to an abnormally long clot time.

9. The device of claim 7, wherein a point along the capillary channel where the liquid crystal changes color is set to correspond to a point where an abnormally short clot time changes to a normal clot time.

10. The device of claim 7, wherein the gradient heater has both increases and decreases of temperature along the capillary channel.

11. The device of claim 10, wherein the liquid crystal is capable of changing color multiple times along the capillary channel.

12. The device of claim 1, comprising more than one type of liquid crystal.

13. The device of claim 1, further comprising an interface port which connects to ends of said gradient heater so as to control voltage or current applied to said gradient heater.

14. The device of claim 1, wherein at said sample receiving area is disposed a sample cavity for receiving a fluid blood sample.

15. The device of claim 14, further comprising a membrane disposed adjacent the sample cavity for filtering out blood components from plasma.

16. A method for determining whether an individual has a blood coagulation time in an abnormal range, comprising:

a) adding a blood sample from said individual to the device of claim 1;

b) before or after step a), allowing the blood sample to mix with said liquid crystal and a blood clotting reagent to form a mixture and passing the mixture through said capillary channel;

c) after the mixture clots within the capillary channel, measuring the furthest distance of travel of the mixture in the capillary channel from said sample receiving area; and

d) based on the measurement in step c), determining whether the individual has a blood coagulation time in an abnormal range.

17. The method of claim 16, further comprising filtering the blood sample before or after step a) so as to obtain a blood sample comprised predominantly or entirely of plasma, after which the filtered blood sample is mixed with the liquid crystal and blood clotting reagent in step b).

18. The method of claim 16, wherein in step d) the abnormal range is an abnormally short or abnormally long blood coagulation time.

19. The method of claim 16, wherein in step b), the blood sample mixes with the liquid crystal and blood clotting agent in a reagent chamber.

20. The method of claim 19, wherein the reagent chamber comprises two compartments, one compartment having therein the liquid crystal, and the other compartment having therein the blood clotting reagent, said blood sample passing into and mixing with the liquid crystal and blood clotting reagent in each compartment before passing into the capillary channel.

21. The method of claim 16, wherein the blood clotting reagent is thromboplastin or platelin-L.

22. The method of claim 16, wherein in step d), the blood coagulation time is determined to be abnormal based on whether the liquid crystal undergoes a first color change at some point along the capillary channel.

23. The method of claim 22, wherein the blood coagulation time is determined to be normal based on whether the liquid crystal undergoes a second color change.