Fault detection apparatus and method for parenteral infusion system

• US 4,534,756 A
• Filed: 04/11/1983
• Issued: 08/13/1985
• Est. Priority Date: 04/11/1983
• Status: Expired due to Term

• Current Assignee: ALARIS Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Nelson, Peter E.
• Primary Examiner(s): Coven, Edward M.
• Application Number:
  US06/483,903
• Time in Patent Office: 855 Days
• Field of Search: 604/50, 604/65, 604/66, 604/67, 604/245
• US Class Current: 604/505
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

Abstract

Apparatus and related method for use in a parenteral administration system, for detecting fault conditions such as an infiltration, an open fluid line or an air bubble in the fluid line. The apparatus is particularly adapted for use with a parenteral administration system of the type that includes a pulsing infusion device for incrementally infusing fluid through a fluid tube to a patient'"'"'s venous or arterial system. The apparatus qualitatively evaluates the pressure in the fluid tube to detect characteristic patterns indicative of each such fault condition and actuates an alarm whenever one is detected.

Claims

1. Fault detection apparatus for use with a parenteral administration system having an infusion device for infusing parenteral fluid through a fluid tube to the vascular system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal;

fault detection means for evaluating the pressure signal over a period of time to detect characteristic patterns in the waveform of the pressure signal evaluated which are indicative of improper fluid communication between the fluid tube and the vascular system of the patient; and

means for producing a corresponding alarm signal whenever the fault detection means detects such a characteristic pattern.

2. Fault detection apparatus as defined in claim 1, wherein:

the infusion device infuses the parenteral fluid to the venous system of the patient in a pulsing fashion; and

the fault detection means detects an infiltration of the parenteral fluid into body tissue separate from the venous system by determining if the pressure signal does not return to a steady state level within a prescribed time duration following an infusion pulse.

3. Fault detection apparatus as defined in claim 1, wherein the fault detection means includes:

means for high-pass filtering the pressure signal to produce a filtered pressure signal; and

means for comparing the filtered pressure signal with a prescribed threshold signal and for producing the alarm signal whenever the filtered pressure signal exceeds the threshold signal for a prescribed time duration following each infusion pulse.

4. Fault detection apparatus as defined in claim 1, wherein the fault detection means includes pressure change sensing means for detecting if the pressure signal ever increases by more than a predetermined amount during a predetermined time duration and for producing the alarm signal whenver the pressure signal increases by more than a predetermined amount during a predetermined time duration.

5. Fault detection apparatus as defined in claim 4, wherein teh fault detection means further includes means for enabling the pressure change sensing means only when the rate of change of the pressure signal exceeds a prescribed level.

7. Fault detection apparatus as defined in claim 1, wherein:

the parenteral administration system is arranged to administer the parenteral fluid to the arterial system of the patient; and

the fault detection means which detects an infiltration of the parenteral fluid into body tissue separate from the arterial system includes

means for low-pass filtering the pressure signal to produce a filtering pressure signal; and

means for comparing if the filtered pressure signal with a predetermined threshold signal and producing the alarm signal whenever the filtered signal drops below the threshold signal.

8. Fault detection apparatus as defined in claim 7, wherein the fault detection means includes:

means for low-pass filtering the pressure signal to produce a mean pressure signal; and

means for comparing if the mean pressure signal with a predetermined threshold and producing the alarm signal whenever the signal drops below the threshold.

9. Fault detection apparatus as defined in claim 8, wherein the fault detection means includes:

means for high-pass filtering the pressure signal to produce a variable pressure signal; and

means for evaluating the variable pressure signal to detect a dropout in variable signal components attributable to the patient'"'"'s heartbeats and for producing the alarm signal whenever such an occurrence is detected.

10. Fault detection apparatus as defined in claim 9, wherein:

the infusion device infuses the parenteral fluid to the vascular system of the patient in a pulsing fashion;

the fault detection means detects a disconnection of the fluid tube or an air bubble in the fluid tube between the infusion device and the patient; and

the fault detection means includes

means for high-pass filtering the pressure signal to produce a variable pressure signal, and

means for comparing the variable pressure signal with a predetermined threshold signal, a disconnection in the fluid tube or an air bubble in the fluid tube being detected whenever the variable pressure signal is less than the threshold following each infusion pulse.

6. Fault detection apparatus as defined in claim 6, wherein the pressure change sensing means includes:

means for sampling the pressure signal at spaced intervals of time; and

means for comparing the current pressure signal with the previous pressure signal to determine if the pressure signal has increased by more than the predetermined amount during the interval between signals.

11. Infiltration detection apparatus for use with a parenteral administration system having a pulsing infusion device for incrementally infusing a parenteral fluid through a fluid tube to the venous system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

infiltration detection means for evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein the pressure signal fails to return substantially to a steady state level within a predetermined time period following an infusion pulse, and producing an infiltration alarm signal whenever such an occurrence is detected.

12. Infiltration detection apparatus as defined in claim 11, wherein:

the infiltration detection means includes

means for high-pass filtering the pressure signal to produce a filtered pressure signal, and

comparator means for comparing the filtered pressure signal with a prescribed positive threshold signal; and

the infiltration detection means produces the infiltration alarm signal whenever the comparator means determines that the filtered pressure signal remains higher than the threshold signal for longer than the predetermined time period.

13. Infiltration detection apparatus as defined in claim 12, wherein the infiltration detection means further includes means for sampling the comparator means after the predetermined time period following each infusion pulse.

14. Infiltration detection apparatus as defined in claim 11, wherein the predetermined time period is about 0.2 seconds.

15. Infiltration detection apparatus for use with a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the venous system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

infiltration detection means for evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein the pressure signal increases by more than a predetermined amount during a predetermined time period and producing an infiltration alarm signal whenever such an ocurrence is detected.

16. Infiltration detection apparatus as defined in claim 15, wherein:

the fault detection means includes

means for differentiating the pressure signal to produce a pressure derivative signal representative of the rate of change of the pressure signal, and

comparator means for comparing the pressure derivative signal with a prescribed threshold signal and producing a trigger signal whenever the pressure derivative signal first exceeds the threshold signal; and

the fault detection means evaluates the pressure signal to produce the alarm signal only when the comparator means produces the trigger signal.

17. Infiltration detection apparatus as defined in claim 16, wherein the fault detection means further includes:

first sampling means for sampling the pressure signal immediately after the comparator means produces the trigger signal, to produce a first signal;

second sampling means for sampling the pressure signal the prescribed time period after the comparator means produces the trigger signal, to produce a second signal;

means for comparing the first signal with the second signal and for producing the alarm signal whenever the second signal exceeds the first signal by more than a predetermined amount.

18. Infiltration detection apparatus for use with a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the arterial system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

infiltration detection means for evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein the mean value of the pressure signal drops below a predetermined threshold value and for producing an infiltration alarm signal whenever such an occurrence is detected.

19. Infiltration detection apparatus as defined in claim 18, wherein the infiltration detection means includes:

filter means for low-pass filtering the pressure signal to remove signal components attributable to the patient'"'"'s heartbeats; and

comparator means for comparing the filtered pressure signal with a prescribed threshold signal and producing the alarm signal whenever the filtered pressure signal drops below the threshold signal.

20. Infiltration detection apparatus for use with a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the arterial system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

infiltration detection means for evaluating the pressure signal to detect a dropout in signal components attributable to the patient'"'"'s heartbeats and for producing an infiltration alarm signal whenever such an occurrence is detected.

21. Infiltration detection apparatus as defined in claim 20, wherein the infiltration detection means includes:

filter means for high-pass filtering the pressure signal to pass only the variable signal components representing heartbeat signal components; and

heartbeat detection means for detecting a dropout of the heartbeat signal components in the filtered presssure signal and producing the alarm signal whenever such an occurrence is detected.

22. Infiltration detection apparatus as defined in claim 21, wherein the heartbeat detection means includes:

pulse detector means for detecting pulses in the filtered pressure signal and producing a corresponding pulse sequence signal; and

comparator means for comparing the frequency of the pulse sequence signal with a predetermined frequency threshold signal and for producing the alarm signal whenever the pulse frequency drops below the threshold signal.

23. Infiltration detection apparatus as defined in claim 22, wherein the pulse detector means detects only pulses in the filtered pressure signal having magnitudes corresponding to at least about 15 centimeters of water.

24. Open line detection apparatus for use with a parenteral administration system having a pulsing infusion device for incrementally infusing a parenteral fluid through a fluid tube to the vascular system of a patient, comprising:

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

open line detection means for detecting an underdamped characteristic in the pressure signal following each infusion pulse of the infusion device, such an underdamped characteristic indicating an open fluid line or an air bubble in the fluid line, the detection means producing an open line alarm signal when it detects such a characteristic.

25. Open line detection apparatus as defined in claim 24, wherein the open line detection means includes:

means for high-pass filtering the pressure signal to pass only its variable signal components; and

comparator means for comparing the filtered pressure signal with a prescribed negative threshold signal following each infusion pulse of the infusion device and for producing the alarm signal whenever the filtered pressure signal is more negative than the threshold signal.

26. Open line detection apparatus as defined in claim 25, wherein the negative threshold signal compared by the comparator means is a prescribed negative fraction of the peak positive value of the filtered pressure signal following each infusion pulse of the infusion device.

27. Open line detection apparatus as defined in claim 26, wherein the comparator means includes:

positive peak detector and hold means for monitoring the filtered pressure signal and producing a peak positive signal indicative of the peak positive value thereof following each infusion pulse of the infusion device;

amplifier means for amplifying the peak positive signal by a prescribed negative fraction to produce the negative threshold signal; and

means for comparing the filtered pressure signal with the negative threshold signal and for producing the alarm signal whenever the signal is more negative than the threshold signal.

28. Open line detection apparatus as defined in claim 27, wherein the negative fraction used in the amplifier means is about negative two-thirds.

29. A parenteral administration system for infusing a parenteral fluid into the vascular system of a patient, comprising:

an infusion device;

a fluid coupled between the infusion device and the vascular system of a patient, such that the device can infuse a parenteral fluid into the vascular system;

pressure transducer means for monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

fault detection means for evaluating the pressure signal over a period of time to detect characteristic patterns in the waveform of the pressure signal evaluated which are indicative of improper communication between the fluid tube and the patient'"'"'s vascular system; and

means for producing a corresponding alarm signal whenever the fault detection means detects such a characteristic signal pattern.

30. A parenteral administration system as defined in claim 29, wherein:

the infusion device infuses the parenteral fluid in a pulsing fashion, each infusion pulse infusing a predetermined volume of fluid;

the fluid tube couples the infusion device to the patient'"'"'s venous system; and

the fault detection means detects an infiltration of parenteral fluid into body tissue separate from the patient'"'"'s venous system by determining if the pressure signal after increasing fails to return to a steady state level within a predetermined time period following an infusion pulse.

31. A parenteral administration system as defined in claim 29, wherein:

the fluid tube couples the infusion device to the patient'"'"'s venous system;

the fault detection means detects an infiltration of parenteral fluid into body tissue separate from the patient'"'"'s venous system; and

the fault detection means includes

means for differentiating the pressure signal to produce a pressure derivative signal representative of the rate of change of the pressure signal,

comparator means for determining if the pressure derivative signal exceeds a predetermined level and for producing a corresponding trigger signal, and

means for detecting if the pressure signal increases by more than a predetermined amount within a predetermined time period following initiation of the trigger signal and for producing the alarm signal whenever such an occurrence is detected.

32. A parenteral administration system as defined in claim 29, wherein:

the fluid tube couples the infusion device to the patient'"'"'s arterial system;

the fault detection means detects an infiltration of parenteral fluid into body tissue separate from the patient'"'"'s arterial system; and

the fault detection means includes

means for low-pass filtering the pressure signal to produce a filtered pressure signal, and

means for comparing the filtered pressure signal with a predetermined threshold signal and for producing the alram signal if the filtered pressure signal ever drops below the threshold signal.

33. A parenteral administration system as defined in claim 29, wherein:

the fluid tube couples the infusion device to the patient'"'"'s arterial system;

the fault detection means detects an infiltration of parenteral fluid into body tissue separate from the patient'"'"'s arterial system; and

the fault detection means includes

means for high-pass filtering the pressure signal to produce a variable pressure signal, and

means for evaluating the variable pressure signal to detect a dropout in signal components attributable to the patient'"'"'s heartbeats and for producing the alarm signal whenever such an occurrence is detected.

34. A parenteral administration system as defined in claim 29, wherein:

the infusion device infuses the parenteral fluid in a pulsing fashion; and

the fault detection means determines that the fluid tube is disconnected from the patient or that an air bubble is present in the fluid tube by detecting an underdamped characteristic in the pressure signal following each infusion pulse of the infusion device, the fault detection means producing the alarm signal whenever it detects such an underdamped characteristic.

35. A method for detecting fluid infiltrations suitable for use in a parenteral administration system having a pulsing infusion device for incrementally infusing a parenteral fluid through a fluid tube to the venous system of a patient, comprising steps of:

monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

evaluating the pressure signal over a period of time to detect if the signal fails to return substantially to a steady state level within a predetermined time period following an infusion pulse, and producing an infiltration alarm signal whenever such an occurrence is detected.

36. A method for detecting fluid infiltrations as defined in claim 35, wherein:

the step of evaluating includes steps of

high-pass filtering the pressure signal to produce a filtered pressure signal, and

comparing the filtered pressure signal with a prescribed threshold signal; and

the step of evaluating produces the infiltration alarm signal whenever the step of comparing determines that the filtered pressure signal exceeds the threshold signal for longer than the predetermined time period.

37. A method for detecting fluid infiltrations as defined in claim 36, wherein the step of comparing is performed only at the end of the predetermined time period following each infusion pulse.

38. A method for detecting fluid infiltrations as defined in claim 35, wherein the predetermined time period considered in the step of evaluating is about 0.2 seconds.

39. A method for detecting fluid infiltrations for use in a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the venous system of a patient, comprising steps of:

monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein the pressure signal increases by more than a predetermined amount during a predetermined time period, and producing an infiltration alarm signal whenever such an occurrence is detected.

40. A method for detecting fluid infiltrations as defined in claim 39, wherein:

the step of evaluating includes steps of

differentiating the pressure signal to produce a pressure derivative signal representing the rate of change of the pressure signal, and

comparing the pressure derivative signal with a prescribed threshold signal and producing a trigger signal whenever the pressure derivative signal first exceeds the threshold signal; and

the step of evaluating produces the alarm signal only when the step of comparing produces the trigger signal.

41. A method for detecting fluid infiltrations as defined in claim 40, wherein the step of evaluating further includes steps of:

sampling the pressure signal immediately after the step of comparing produces the trigger signal, to produce a first signal;

sampling the pressure signal a prescribed time period after the step of comparing produces the trigger signal, to produce a second signal;

comparing the first signal with the second signal and producing the alarm signal whenever the second signal exceeds the first signal by more than a predetermined amount.

47. A method for detecting fluid infiltrations as defined in claim 40, wherein the step of detecting pulses detects only pulses in the filtered pressure signal having magnitudes corresponding to at least about 15 centimeters of water.

42. A method for detecting fluid infiltrations for use in a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the arterial system of a patient, comprising steps of:

monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein the mean value of the pressure signal drops below a predetermined threshold, and producing an infiltration alarm signal whenever such an occurrence is detected.

43. A method for detecting fluid infiltrations as defined in claim 42, wherein the step of evaluating includes steps of:

low-pass filtering the pressure signal to remove variable signal components attributable to the patient'"'"'s heartbeats; and

comparing the filtered pressure signal with a prescribed threshold signal, and producing the alarm signal whenever the filtered pressure signal drops below the threshold signal.

44. A method for detecting fluid infiltrations for use in a parenteral administration system having an infusion device for infusing a parenteral fluid through a fluid tube to the arterial system of a patient, comprising steps of:

monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal; and

evaluating the pressure signal over a period of time to detect a characteristic pattern in the waveform of the pressure signal evaluated wherein an indicative decrease occurs in variable signal components attributable to the patient'"'"'s heartbeats drop below a predetermined limit, and producing an infiltration alarm signal whenever such an occurrence is detected.

45. A method for detecting fluid infiltrations as defined in claim 44, wherein the step of evaluating includes steps of:

high-pass filtering the pressure signal to pass only variable signal components attributable to its heartbeat; and

detecting a dropout of the heartbeat signal components in the filtered pressure signal, and producing the alarm signal whenever such an occurrence is detected.

46. A method for detecting fluid infiltrations as defined in claim 45, wherein the step of detecting a dropout includes steps of:

detecting pulses in the filtered pressure signal, and producing a corresponding pulse sequence signal; and

comparing the frequency of the pulse sequence signal with a predetermined frequency threshold, and producing the alarm signal whenever the pulse frequency drops below the threshold.

48. A method for detecting an open fluid line suitable for use in a parenteral administration system having a pulsing infusion device for incrementally infusing a parenteral fluid through a fluid tube to the vascular system of a patient, comprising steps of:

monitoring the pressure of the fluid in the fluid tube and producing a corresponding pressure signal;

detecting an underdamped characteristic in the pressure signal following each infusion pulse for the infusion device, such an underdamped characteristic indicating an open fluid line or an air bubble in the fluid line; and

producing an open line alarm signal whenever the step of detecting detects such an underdamped characteristic.

49. A method for detecting an open fluid line as defined in claim 48, wherein:

the step of detecting includes steps of

high-pass filtering the pressure signal to pass only variable signal components thereof, and

comparing the filtered pressure signal with a prescribed threshold signal following each infusion pulse of the infusion device; and

the step of producing produces the alarm signal whenever the filtered pressure signal is less than the threshold signal.

50. A method for detecting an open fluid line as defined in claim 49, wherein the negative threshold compared in the step of comparing is a prescribed negative fraction of the peak positive value of the filtered pressure signal following each infusion pulse of the infusion device.

51. A method for detecting an open fluid line as defined in claim 50, wherein:

the step of comparing includes steps of

monitoring the filtered pressure signal and producing a peak positive signal indicative of the peak positive value thereof following each infusion pulse of the infusion device,

amplifying the peak positive signal by a prescribed negative fraction to produce the negative threshold signal, and

comparing the filtered pressure signal with a prescribed negative threshold signal; and

the step of producing produces the alarm signal whenever the step of comparing determines that the filtered pressure signal is more negative than the threshold signal.

52. A method for detecting an open fluid line as defined in claim 51, wherein the negative fraction used in the step of amplifying is about negative two-thirds.

53. A method of detecting faults in the operation of a parenteral administration system wherein an infusion device infuses a parenteral fluid through a tube to the vascular system of a patient in a pulsing fashion, said method comprising:

monitoring the pressure of the fluid in the tube and producing a corresponding pressure signal;

evaluating the pressure signal over a period of time to detect characteristic patterns in the waveform of the pressure signal evaluated which are indicative of improper fluid communication between the fluid tube and the vascular system of the patient; and

producing an alarm signal whenever such characteristic patterns are detected.