Hemostasis Analyzer and Method

• US 20070092405A1
• Filed: 06/22/2006
• Published: 04/26/2007
• Est. Priority Date: 10/20/2005
• Status: Active Grant

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemoscope Corp. (Haemonetics Corporation)
• Inventors: Kautzky, Hans
• Granted Patent: US 7,879,615 B2
• Time in Patent Office: Days
• US Class Current: 422/73
• CPC Class Codes: G01N 11/167 Sample holder oscillates, e.g. rotating crucible
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A method and device for blood hemostasis analysis is disclosed. A blood sample is displaced to reach a resonant state. The resonant frequency of the blood sample is determined before, during and after a hemostasis process. The changes in the resonant frequency of the blood sample are indicative of the hemostasis characteristics of the blood sample.

Claims

1. An apparatus for measuring hemostasis comprising:

a container adapted to hold a blood sample such that a surface of the blood sample is substantially unconstrained in one direction;

a shaker adapted to displace the container in order to cause an excitation of the blood sample and corresponding resonant displacement of the surface along the one direction; and

a sensor adapted to determine the resonant displacement of the surface along the one direction.

2. An apparatus according to claim 1, further comprising an analyzer coupled to the sensor to receive data from the sensor, the analyzer being adapted to derive a hemostasis characteristic of the blood sample based upon the data from the sensor.

3. An apparatus according to claim 1, wherein the shaker displaces the container with a frequency function having randomly selected frequency components selected from a range of frequencies.

4. An apparatus according to claim 1, wherein the shaker displaces the container at a displacement frequency and varies the displacement frequency responsive to changes in a resonant state of the blood sample.

5. An apparatus according to claim 1, wherein the container includes a self-sealing port for receiving the blood sample.

6. An apparatus according to claim 1, wherein the container is a sealed container.

7. An apparatus according to claim 1, wherein the container is safely disposable with the blood sample contained therein.

8. An apparatus according to claim 1, wherein the shaker displaces the container substantially along the direction.

9. An apparatus according to claim 1, wherein the direction is vertical.

10. An apparatus according to claim 1, wherein the direction is vertical and the surface is a bottom surface of the blood sample.

11. An apparatus according to claim 1, wherein the sensor is one of an optical sensor, an electric sensor or an acoustic sensor.

12. For use in an apparatus according to claim 1, a blood sample container comprising a cylinder disposed within a sealed enclosure, the cylinder for retaining a blood sample therein, the cylinder having an open bottom surface and a chamfered edge.

13. A method for measuring hemostasis comprising:

providing a blood sample;

exciting the blood sample to a resonant state by displacing the blood sample to create displacement of a surface of the blood sample in a direction;

observing the amplitude and frequency of the displacement of the surface of the blood sample;

determining a resonant frequency of the blood sample to provide a plurality of resonant frequencies of the blood sample based upon the observed amplitude and frequency of the surface; and

deriving a hemostasis characteristic of the blood sample from the plurality of resonant frequencies of the blood sample.

14. A method according to claim 13, further comprising displacing the blood sample at a frequency, and incrementally varying the frequency until a resonant frequency of the blood sample is determined.

15. A method according to claim 13, further comprising incrementally varying the frequency from the resonant frequency to determine a plurality of resonant frequencies of the blood sample before, during and after hemostasis of the blood sample, wherein the plurality of the resonant frequencies are indicative of the hemostasis characteristics of the blood sample.

16. A method according to claim 13, further comprising:

displacing the blood sample with a frequency function having randomly selected frequency components selected from a range of frequencies; and

determining a plurality of resonant frequencies of the blood sample before, during and after hemostasis of the blood sample;

wherein the plurality of the resonant frequencies are indicative of the hemostasis characteristics of the blood sample.

17. A method according to claim 13, wherein the blood sample is supported in a column, the surface comprising a bottom surface of the column and step of displacing the sample comprises displacing the sample along an axis of the column.

19. A method according to claim 13, wherein the determining a resonant frequency of the blood sample comprises either continuously determining a change in resonant frequency with time or periodically determining the resonant frequency.

18. A method according to claim 0, wherein placing the blood sample in the container further comprises injecting the blood into the container through a self-sealing port on the container.

20. For testing a blood sample, a sealed container for holding the blood sample comprising:

a wall defining an enclosed volume;

a self-sealing one-way port disposed on the wall and in communication with the enclosed volume; and

a cylinder having at least one open end supported within the volume, the cylinder being in communication with the self-sealing one-way port;

wherein the port is adapted to allow insertion of the blood sample into the cylinder and to retain the sample within the volume during testing of the sample.

21. A container according to claim 20 adapted to be safely disposable.