Method and apparatus for ultrasonic detection of air bubbles

• US 5,394,732 A
• Filed: 09/10/1993
• Issued: 03/07/1995
• Est. Priority Date: 09/10/1993
• Status: Expired due to Term

• Current Assignee: Gambro Renal Products, Inc. (Baxter International Inc.)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Mandel, William R., Dormont, William M., Welsh, Christopher J., Johnson, David A., Miller, Douglas P., Manica, Keith J.
• Primary Examiner(s): Williams, Hezron E.
• Assistant Examiner(s): ROSKOS, JOSEPH
• Application Number:
  US08/119,790
• Time in Patent Office: 543 Days
• Field of Search: 73/19.03, 73/19.1, 73/61.75, 73/61.79, 73/599, 73/600
• US Class Current: 73/19.1
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: G01N 2291/015 Attenuation, scattering
• CPC Class Codes: G01N 2291/02433 Gases in liquids, e.g. bubbles, foams
• CPC Class Codes: G01N 2291/02466 Biological material, e.g. blood
• CPC Class Codes: G01N 2291/102 one emitter, one receiver
• CPC Class Codes: G01N 29/032 by measuring attenuation of acoustic waves
• CPC Class Codes: G01N 29/223 Supports, positioning or alignment in fixed situation mounting transducers per se G10K11/004
• CPC Class Codes: G01N 29/32 Arrangements for suppressing undesired influences, e.g. temperature or pressure variations , compensating for signal noise
• CPC Class Codes: G01N 29/34 Generating the ultrasonic, sonic or infrasonic waves , e.g. electronic circuits specially adapted therefor
• CPC Class Codes: G01N 29/36 Detecting the response signal , e.g. electronic circuits specially adapted therefor
• CPC Class Codes: G01N 29/38 by time filtering, e.g. using time gates
• CPC Class Codes: G01N 29/4427 with stored values, e.g. threshold values

Abstract

Inclusions in a liquid flow, such as air bubbles in a blood flow, are detected by transmitting a signal through the fluid and receiving and interpreting the received signal based on the expected degree of attenuation for the liquid and the inclusions. The amplitude of the transmitted signal is automatically adjusted to maintain a constant average amplitude of the detected signal, thus compensating for changes in the detection environment. The average amplitude of the transmitted signal is controlled by integrating the received signal using an integrator with a time constant longer than the time constant of the expected inclusion signals, and comparing the integrated signal to a constant reference level.

The presence of microbubbles is detected and a signal comprising a string of high frequency pulses is generated while the microbubbles are present. By counting the pulses, in conjunction with knowledge about the flow of liquid and the anticipated size of the microbubbles, an estimate of the total amount of air infused into the patient within a given time period is calculated.

A tubing holder for retaining a flexible tube in an inclusion detector has tubing retention grooves formed into tubing engagement faces, the tubing engagement faces being spaced closer together than the tube diameter. The tube is inserted into the tubing holder by compressing and deforming it against the tubing engagement faces, until it reaches the tubing retaining grooves.

Claims

1. An inclusion detector for detecting the presence of inclusions in a flow of a liquid while compensating for changes in the detection environment comprising:

a conduit;

transmitting means for transmitting a signal through a liquid flowing in the conduit at a transmitted signal level;

receiving means for receiving and interpreting the signal transmitted by the transmitting means, a change in a received signal level being indicative of the presence of an inclusion in the liquid flow; and

signal adjusting means for adjusting the transmitted signal level to maintain an average value of the received signal level at a relatively constant value.

2. The inclusion detector defined in claim 1 wherein the inclusion is at least one bubble of at least one of air or gas.

3. The inclusion detector defined in claim 1 wherein the liquid is at least one of a biological or a pharmaceutical liquid.

4. The inclusion detector defined in claim 3 wherein the liquid is one of blood or a blood component.

5. The inclusion detector defined in claim 1 wherein the signal is an ultrasonic signal.

6. The inclusion detector defined in claim 5 wherein the conduit is flexible plastic medical tubing having a circumferential wall and the ultrasonic signals are transmitted and received through the wall of the tubing.

7. The inclusion detector defined in claim 5 wherein the transmitting means comprises:

an oscillator; and

a transmitting ultrasonic transducer electrically responsive to the oscillator.

8. The inclusion detector defined in claim 7 wherein the transmitting means further comprises a driver electrically responsive to the oscillator, the ultrasonic transducer being electrically responsive to the driver.

9. The inclusion detector defined in claim 8 wherein the adjusting means adjusts a level of voltage supplied to the driver to maintain a relatively constant voltage level at a predetermined point within the receiving means.

10. The inclusion detector defined in claim 9 wherein the driver comprises:

a first transistor; and

a second transistor; and

the first and second transistors are electrically responsive to the oscillator to alternately apply and remove the voltage supplied to the driver to and from the transmitting transducer.

11. The inclusion detector defined in claim 7 wherein the receiving means comprises:

a receiving ultrasonic transducer;

a rectifier electrically responsive to the receiving transducer; and

at least one signal comparator electrically responsive to the rectifier.

12. The inclusion detector defined in claim 11 wherein the receiving means further comprises:

am amplifier electrically responsive to the receiving ultrasonic transducer, the rectifier being electrically responsive to the amplifier; and

a filter electrically responsive to the rectifier, the at least one signal comparator being electrically responsive to the filter.

13. The inclusion detector defined in claim 12 wherein the level adjusting means adjusts the transmitted signal to maintain an average voltage level between the filter and the at least one comparator at a relatively constant value.

14. The inclusion detector defined in claim 11 further comprising:

another signal comparator substantially identical to the at least one comparator and electrically responsive to the rectifier.

15. The inclusion detector defined in claim 11 wherein the at least one signal comparator comprises:

a first signal comparator electrically responsive to the rectifier to detect the presence of a failure of the inclusion detector;

a second signal comparator electrically responsive to the rectifier to detect the presence of a relatively large inclusion; and

a third signal comparator electrically responsive to the rectifier to detect the presence of a relatively small inclusion.

16. The inclusion detector defined in claim 11 wherein the signal adjusting means further comprises:

an integrator electrically responsive to the rectifier; and

a supply voltage adjusting means electrically responsive to the integrator.

17. The inclusion detector defined in claim 1 wherein the inclusion is a solid particle.

18. The inclusion detector defined in claim 1 wherein the signal is a light signal.

19. A method for detecting the presence of inclusions in a liquid flowing in a conduit while compensating for changes in the detection environment comprising:

transmitting a signal through the liquid at a transmitted signal level;

receiving the signal at a received signal level;

interpreting the signal to detect the presence or absence of an inclusion, a sudden change in the received signal level being indicative of the presence of an inclusion; and

adjusting the transmitted signal level to maintain the received signal level at a relatively constant level.

20. The detecting method defined in claim 19 wherein the inclusion is at least one bubble of at least one of air or gas.

21. The detecting method defined in claim 19 wherein the liquid is at least one of a biological or a pharmaceutical liquid.

22. The detecting method defined in claim 21 wherein the liquid is one of blood or a blood component.

23. The detecting method defined in claim 19 wherein the signal is an ultrasonic signal.

24. The detecting method defined in claim 23 wherein the conduit is flexible plastic medical tubing having a circumferential wall and the ultrasonic signals are transmitted and received through the wall of the tubing.

25. The detecting method defined in claim 23 wherein the transmitting step comprises:

generating an oscillating signal; and

electrically driving a first ultrasonic transducer with the oscillating signal to produce ultrasonic mechanical vibrations.

26. The detecting method defined in claim 25 wherein the transmitting step further comprises amplifying the oscillating signal by a determined gain factor before the oscillating signal electrically drives the ultrasonic transducer.

27. The detecting method defined in claim 26 wherein the adjusting step comprises determining the determined gain of the amplifying step to maintain a relatively constant value of a voltage level that is proportional to the received signal level.

28. The detecting method defined in claim 25 wherein the receiving step comprises:

mechanically driving a second ultrasonic transducer with the ultrasonic mechanical vibrations produced by the first ultrasonic transducer to produce an electrical signal; and

rectifying the electrical signal to produce a rectified electrical signal.

29. The detecting method defined in claim 28 wherein the receiving step further comprises:

amplifying the electrical signal before it is rectified; and

filtering the rectified electrical signal to produce a filtered electrical signal.

30. The detecting method defined in claim 29 wherein the level adjusting step comprises adjusting the strength of the ultrasonic mechanical vibrations produced by the first ultrasonic transducer to maintain the average level of the filtered electrical signal at a relatively constant value.

31. The detecting method defined in claim 30 the signal adjusting step means further comprises:

integrating the value of the filtered electrical signal to produce an integrated electrical signal; and

adjusting the strength of the ultrasonic mechanical vibrations produced by the first ultra sonic transducer in response to the integrated electrical signal.

32. The detecting method of claim 29 wherein the interpreting step comprises comparing the filtered electrical signal to at least one predetermined reference signal.

33. The detecting method defined in claim 32 wherein the interpreting step further comprises:

comparing the filtered electrical signal to a first predetermined reference signal to detect the presence of a relatively large inclusion; and

comparing the filtered electrical signal to a second predetermined reference signal to detect the presence of a relatively small inclusion.

34. The detecting method defined in claim 19 wherein the signal is a light signal.

35. The detecting method detector defined in claim 19 wherein the inclusion is a solid particle.

36. An extracorporeal blood processing apparatus comprising:

a conduit for conveying blood;

transmitting means for transmitting an ultrasonic signal through the blood conveyed in the conduit at a transmitted signal level;

receiving means for receiving and interpreting the ultrasonic signal transmitted by the transmitting means, a relatively sudden change in a received signal level being indicative of the presence of at least one bubble of at least one of air or gas in the blood; and

signal adjusting means for adjusting the transmitted signal level to maintain an average value of the received signal level at a relatively constant value.

37. The processing apparatus defined in claim 36 comprising a dialysis apparatus.

38. A tubing holder for retaining flexible tubing in contact with at least one ultrasonic transducer comprising:

a first mounting block;

a first generally planar tubing engagement face having an axis and a first leading edge generally parallel to the axis;

a first tubing retaining groove recessed into the first tubing engagement face, the first tubing engagement groove being generally parallel to the axis and spaced a predetermined distance from the leading edge and having a generally arcuate cross sectional configuration;

a first ultrasonic transducer mounted in the first mounting block below and in proximity with the first tubing retaining groove;

a second mounting block;

a second generally planar tubing engagement face having an axis and a second leading edge generally parallel to the axis;

a second tubing retaining groove recessed into the second tubing engagement face, the second tubing engagement groove being generally parallel to the axis and spaced a predetermined distance from the leading edge and having a generally arcuate cross sectional configuration; and

a housing securing and supporting the first and second mounting blocks in a relationship wherein;

the first tubing engagement face faces the second tubing engagement face, is generally parallel to the second tubing engagement face and is spaced a predetermined distance from the second tubing engagement face;

the first leading edge is generally parallel to and opposite the second leading edge;

the first tubing retaining groove is generally parallel to and opposite the second tubing retaining groove; and

the predetermined distance is selected to permit the tubing to be inserted between the first tubing engagement face and the second tubing engagement face at the location of the first and second leading edges when the tubing is relatively greatly compressed, and retained in the first and second tubing retaining grooves when the tubing is relatively less compressed.

39. The tubing holder defined in claim 38 further comprising a second ultrasonic transducer mounted in the second mounting block below and in proximity with the second tubing retaining groove at a location generally opposite the location of the first ultrasonic transducer.

40. The tubing holder defined in claim 38 wherein the leading edges are beveled.

41. A method for measuring the amount of air in the form of microbubbles in a liquid flowing in a tube comprising:

transmitting a signal through the liquid at a transmitted signal level;

receiving the signal at a received signal level;

interpreting the signal to detect the presence or absence of a microbubble, a change in the received signal level being indicative of the presence of a microbubble;

generating at least one logic signal pulse for each microbubble detected;

counting the number of logic pulses generated over a predetermined time period;

establishing the number of logic signal pulses that represent one microbubble and

ascertaining the number of microbubbles in the tube during the predetermined time period;

wherein;

the logic pulses are generated at a predetermined frequency during a detection time period when a microbubble is detected; and

the establishing step comprises;

determining a value of a constant that is directly proportional to the frequency at which the logic pulses are generated and directly proportional to an expected microbubble size; and

dividing the constant by a flow rate of the liquid in the tube.

43. The method defined in claim 41 further comprising:

correlating the number of microbubbles ascertained in the predetermined time period with a volume of air in the flowing liquid during the predetermined time period.

44. The method defined in claim 41 further comprising:

comparing the number of microbubbles ascertained in the predetermined time period with an allowable number of microbubbles for the time period.

45. The method defined in claim 41 further comprising:

activating an alarm if the number of microbubbles ascertained in the predetermined time period exceeds the allowable number of microbubbles for the time period.

42. The method defined in claim 42 wherein the ascertaining step further comprises:

dividing the number of logic pulses counted over the predetermined time period by the number of logic pulses that represent one microbubble.