Fluid viscoelastic test apparatus and method

• US 5,138,872 A
• Filed: 04/10/1991
• Issued: 08/18/1992
• Est. Priority Date: 09/29/1989
• Status: Expired due to Term

• Current Assignee: Sienco, Inc.
• Original Assignee: Sienco, Inc.
• Inventors: Henderson, Jon H.
• Primary Examiner(s): Williams, Hezron E.
• Assistant Examiner(s): Roskos, Joseph W.
• Application Number:
  US07/682,981
• Time in Patent Office: 496 Days
• Field of Search: 73/54, 73/59, 73/64.1
• US Class Current: 73/64.41
• CPC Class Codes: G01N 11/16 by measuring damping effect upon oscillatory body
• CPC Class Codes: G01N 2291/02818 Density, viscosity
• CPC Class Codes: G01N 2291/2698 Other discrete objects, e.g. bricks
• CPC Class Codes: G01N 29/032 by measuring attenuation of acoustic waves
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G05D 23/1906 using an analogue comparing device
• CPC Class Codes: G05D 23/24 the sensing element having a resistance varying with temperature, e.g. a thermistor

Abstract

An instrument for testing the viscoelastic characteristics of fluids, such as blood, exhibits improved temperature regulation of the blood sample under test, includes probe drive circuitry to simplify calibration and signal conditioning, incorporates resonant frequency monitoring to detect mechanical noise disturbances, and provides automated analysis of a graphical signature, over time, of the viscoelastic characteristics of the blood sample, including a visual indication to the user of the activated clotting time period (ACT) and the rate of clot formation (RATE) of the blood sample under test, thereby improving the accuracy of the test results and simplifying operation of the instrument to permit its use by surgical personnel.

Claims

1. An instrument for measuring one or more viscoelastic properties of a fluid sample, the instrument comprising:

probe means disposed in contact with the fluid sample;

electromechanical transducer means coupled to the probe means for providing mechanical displacement of the probe means relative to the fluid sample;

first circuit means, connected to the electromechanical transducer means, said first circuit means comprising drive circuitry providing a drive signal for generating oscillatory mechanical displacement of the probe means relative to the fluid sample, said first circuit means further comprising response circuitry for monitoring a response signal generated by the electromechanical transducer means, the response signal being representative of the one or more viscoelastic properties of the fluid sample, said drive circuitry and response circuitry forming a feedback loop wherein the drive signal is developed from the response signal and vice versa;

second circuit means for regulating an amplitude of a first signal within said feedback loop, while allowing said feedback loop to operate at resonant oscillatory frequency determined by said probe means, said electromechanical transducer means, and said first circuit means; and

microcontroller means for receiving and analyzing said response signal to determine the one or more viscoelastic properties of the fluid sample represented by said response signal; and

digital output means, coupled to said microcontroller means, for visually displaying to a user one or more numbers representative of the one or more viscoelastic properties, respectively, of the fluid sample, as determined by said microcontroller means.

2. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 1 further comprising integrating A-D converter means coupled to said first and second circuit means for providing increased resolution of the amplitude of said response signal.

3. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 2 further comprising means for synchronizing an integration period of said integrating A-D converter means with a period of said drive signal for providing a correction for AC ripple that may be present on said drive signal.

4. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 3 further comprising polarity detector means coupled to said first and second circuit means for determining a polarity of said response signal and for synchronizing said integration period of said integrating A-D converter with determinations of polarity made by said polarity detector means.

5. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 4 wherein said microcontroller means is operative, in response to determinations of polarity of said response signal made by said polarity detector means, for detecting unexpected variances in a frequency of said response signal produced by extraneous noise sources and for disabling said integrating A-D converter means for a predetermined period of time following detection of said unexpected variances in the frequency of said response signal.

6. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 5 further comprising display means coupled to said microcontroller means for visually displaying messages to the user;

and wherein said microcontroller means is operative, following detection of unexpected variances in the frequency of said response signal, for generating a message on said display means indicating the presence of noise to the user.

7. An instrument as in claim 1 wherein said fluid sample is blood and one of said one or more viscoelastic properties is an activated clotting time.

8. An instrument as in claim 1 wherein said fluid sample is blood and one of said one or more viscoelastic properties is a rate of clot formation.

9. An instrument for measuring a plurality of viscoelastic properties of a fluid sample, the instrument comprising:

probe means disposed in contact with the fluid sample;

electromechanical transducer means coupled to the probe means for providing mechanical displacement of the probe means relative to the fluid sample;

first circuit means, connected to the electromechanical transducer means, said first circuit means comprising drive circuitry providing a drive signal for generating oscillatory mechanical displacement of the probe means relative to the fluid sample, said first circuit means further comprising response circuitry for monitoring a response signal generated by the electromechanical transducer means, the response signal being representative of the plurality of viscoelastic properties of the fluid sample, said drive circuitry and response circuitry forming a feedback loop wherein the drive signal is developed from the response signal and vice versa;

second circuit means for regulating an amplitude of a first signal within said feedback loop; and

microcontroller means for receiving and analyzing said response signal to determine said plurality of viscoelastic properties of the fluid sample represented by said response signal; and

digital output means, coupled to said microcontroller means, for visually displaying to a user one or more numbers, representative of one or more of said plurality of viscoelastic properties, respectively, of the fluid sample, as determined by said microcontroller means.

10. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 9 wherein the microcontroller means is responsive to said response signal for computing a time period thereof between a measurement start time and the occurrence of a viscoelastic change in the fluid sample represented by said response signal.

11. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 10 wherein the occurrence of a viscoelastic change in said fluid sample is represented by a point in time at which a signature amplitude of said response signal varies by one percent of a full scale amplitude from an initial steady state signature amplitude thereof, and wherein said time period represents an activated clotting time of said fluid sample.

12. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 11 further comprising display means coupled to said microcontroller means, said display means being operative for visually displaying said activated clotting time to the user.

13. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 10 wherein said microcontroller means is responsive to said response signal for computing a quantified intensity of said viscoelastic change in the fluid sample.

14. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 13 wherein said microcontroller means is responsive to said response signal for computing a first maximum slope of a signature of said response signal following the occurrence of said viscoelastic change in the fluid sample, said first maximum slope representing a rate of clot formation of said fluid sample.

15. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 14 further comprising display means coupled to said microcontroller means, said display means being operative for visually displaying said rate of clot formation computed by said microcontroller means.

16. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 9 further comprising integrating A-D converter means coupled to said first and second circuit means for providing increased resolution of the amplitude of said response signal.

17. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 16 further comprising means for synchronizing an integration period of said integrating A-D converter means with a period of said drive signal for providing a correction for AC ripple that may be present on said drive signal.

18. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 17 further comprising polarity detector means coupled to said first and second circuit means for determining a polarity of said response signal and for synchronizing said integration period of said integrating A-D converter with determinations of polarity made by said polarity detector means.

19. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 18 wherein said microcontroller means is operative, in response to determinations of polarity of said response signal made by said polarity detector means, for detecting unexpected variances in a frequency of said response signal produced by extraneous noise sources and for disabling said integrating A-D converter means for a predetermined period of time following detection of said unexpected variances in the frequency of said response signal.

20. An instrument for measuring one or more viscoelastic properties of a fluid sample as in claim 19 further comprising display means coupled to said microcontroller means for visually displaying messages to the user;

and wherein said microcontroller means is operative, following detection of unexpected variances in the frequency of said response signal, for generating a message on said display means indicating the presence of noise to the user.

21. An instrument as in claim 9 wherein said fluid sample is blood and one of said one of said plurality of viscoelastic properties is an activated clotting time.

22. An instrument as in claim 9 wherein said fluid sample is blood and one of said plurality of viscoelastic properties is a rate of clot formation.

23. A process for computing the activated clotting time of a fluid sample, the process comprising:

inserting a sensor into the fluid sample, the sensor producing a time varying signal responsive to a viscoelastic characteristic of said fluid sample;

determining a minimum value of said viscoelastic characteristic over a predetermined period of time;

comparing a current value of said viscoelastic characteristic with said minimum value;

determining a point in time at which the current value of said viscoelastic characteristic exceeds said minimum value by a predetermined amount, said point in time being the activated clotting time of said fluid sample; and

visually displaying said activated clotting time to a user.

24. A process for computing the rate of clot formation of a fluid sample, the process comprising:

inserting a sensor into the fluid sample, the sensor producing a time varying signal responsive to a viscoelastic characteristic of said fluid sample;

determining an instantaneous rate of change in the viscoelastic characteristic of said fluid sample;

comparing a current instantaneous rate of change in the viscoelastic characteristic of said fluid sample with a stored maximum value of the determined instantaneous rate of change in the viscoelastic characteristic of said fluid sample;

determining if the current instantaneous rate of change in the viscoelastic characteristic of said fluid sample is less than said stored maximum value by a predetermined amount; and

visually displaying said stored maximum value as said rate of clot formation if said current instanteous rate of change in the viscoelastic characteristic of said fluid sample is determined to be less than said stored maximum value by said predetermined amount.

25. A process for detecting the presence of mechanical noise during a measurement of one or more viscoelastic properties of a fluid sample, the process comprising:

inserting a mechanically oscillating sensor into the fluid sample, the frequency of oscillation of the mechanically oscillating sensor being responsive to a viscoelastic property of the fluid sample, and the mechanically oscillating sensor producing a time varying signal for analysis that is responsive to a viscoelastic property of the fluid sample;

measuring a time characteristic of each oscillation of the mechanically oscillating sensor;

comparing consecutive measurements of said time characteristic;

determining if any two consecutive measurements of said time characteristic differ from each other by more than a predetermined amount; and

suppressing analysis of said time varying signal for a predetermined period of time if any two consecutive measurements of said time characteristics are determined to differ from each other by more than said determined amount.