Drop discriminator system

• US 4,181,130 A
• Filed: 11/04/1977
• Issued: 01/01/1980
• Est. Priority Date: 11/04/1977
• Status: Expired due to Term

• Current Assignee: ALARIS Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Bailey, Wilber H.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/848,567
• Time in Patent Office: 788 Days
• Field of Search: 128/2.05 F, 128/214 E, 128/214 F, 73/194 R, 73/196, 73/207, 73/DIG. 11, 340/526, 340/603, 340/605, 340/606, 340/609, 340/619, 340/620
• US Class Current: 604/253
• CPC Class Codes: A61M 5/1689 Drip counters
• CPC Class Codes: G06M 1/101 by electro-optical means
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

An electronic method and apparatus for evaluation of the quality of drop detection in apparatus for parenteral administration of medical fluids, wherein the waveforms of electrical signals representing drop flow detection are evaluated for conformity with both prescribed amplitude and time duration characteristics. Separate counters record the total number of drop events evaluated and the portion of the total which are determined to be non-conforming, and the latter counter triggers alarms if a predetermined limit is exceeded within a prescribed number of total events.

Claims

1. In a drop detection system for use with fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

first means for generating electrical signals in response to detection of drop flow activity;

second means for receiving said electrical signals to determine the occurrence of individual drops;

third means, responsive to said second means, for providing drop signals indicative of drop flow events to the fluid flow control apparatus;

fourth means, also responsive to said second means, for qualitatively evaluating the waveforms of each of said electrical signals representing individual drop configurations to determine their conformity with prescribed waveform characteristics, whereby proper drop flow events may be qualitatively distinguished from improper drop flow events; and

fifth means, responsive to the electrical output of said fourth means, for providing an indication of nonconformity in the waveform characteristics of a prescribed number of said electrical signals to determine proper operation of the fluid flow control apparatus.

2. A combination as set forth in claim 1, wherein said fourth means includes means for evaluating the amplitude of each of said electrical signals to determine their conformity with prescribed amplitude characteristics.

3. A combination as set forth in claim 2, wherein said fourth means includes means for evaluating the amplitude of each of said electrical signals by comparing said amplitude with a plurality of prescribed amplitude levels.

4. A combination as set forth in claim 2, wherein said second means provides an indication of nonconformity in the amplitudes of a prescribed number of said electrical signals.

5. A combination as set forth in claim 1, wherein said fourth means includes means for evaluating the time duration of each of said electrical signals to determine their conformity with prescribed time duration characteristics.

6. A combination as set forth in claim 5, wherein said fourth means includes means for evaluating the time duration of each of said electrical signals by comparing said time duration with a plurality of prescribed time duration frames.

7. A combination as set forth in claim 5, wherein said second means provides an indication of nonconformity in the time durations of a prescribed number of said electrical signals.

8. A combination as set forth in claim 1, wherein said fourth means includes means for evaluating both the amplitude and the time duration of each of said electrical signals to determine their conformity with prescribed amplitude and time duration characteristics, respectively.

9. A combination as set forth in claim 8, wherein said fourth means includes means for evaluating the amplitude and the time duration of each of said electrical signals by comparing said amplitude and said time duration with a plurality of prescribed amplitude levels and a plurality of prescribed time durations, respectively.

10. A combination as set forth in claim 8, wherein said second means provide an indication of nonconformity in the amplitudes and time durations of a prescribed number of said electrical signals.

11. In a drop detection system for use with a fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

first means for generating electrical signals in response to detection of drop flow activity;

second means for receiving said electrical signals to determine the occurrence of individual drops;

third means, responsive to said second means, for providing drop signals indicative of drop flow events to the fluid flow control apparatus;

fourth means for qualitatively evaluating the amplitude of each of said electrical signals representing individual drop flow events during a prescribed time frame to determine their conformity with prescribed amplitude characteristics during said time frame, whereby proper drop flow events may be qualitatively distinguished from improper drop flow events; and

fifth means, responsive to the electrical output of said fourth means, for providing an indication of nonconformity in the waveform characteristics of a prescribed number of said electrical signals to determine proper operation of the fluid flow control apparatus.

12. A combination as set forth in claim 11, wherein said fourth means includes means for evaluating the amplitude of each of said electrical signals during a plurality of successive time frames to determine their conformity with prescribed amplitude characteristics.

13. A combination as set forth in claim 11, wherein said fourth means includes means for evaluating the amplitude of each of said electrical signals by comparing said amplitude with a plurality of prescribed amplitude levels.

14. A combination as set forth in claim 13, wherein said fourth means includes means for evaluating the amplitude of each of said electrical signals during a plurality of successive time frames to determine their conformity with prescribed amplitude characteristics.

15. In a drop detection system for use with fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

first means for generating electrical signals in response to detection of drop flow activity;

second means for receiving said electrical signals to determine the occurrence of individual drops;

third means, responsive to said second means, for providing drop signals indicative of drop flow events to the fluid flow control apparatus;

fourth means for qualitatively evaluating the time duration of each of said electrical signals representing individual drop flow events within a prescribed amplitude range to determine their conformity with prescribed time duration characteristics, whereby proper drop flow events may be qualitatively distinguished from improper drop flow events; and

fifth means, responsive to the electrical output of said forth means, for providing an indication of nonconformity in the waveform characteristics of a prescribed number of said electrical signals to determine proper operation of the fluid flow control apparatus.

16. A combination as set forth in claim 15, wherein said fourth means includes means for evaluating the time duration of each of said electrical signals within a plurality of prescribed amplitude ranges to determine their conformity with prescribed time duration characteristics.

17. A combination as set forth in claim 15, wherein said fourth means includes means for evaluating the time duration of each of said electrical signals by comparing said time duration with a plurality of prescribed time frames.

18. In a drop detection system for use with fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

sensing means for detecting drop flow activity;

means responsive to said sensing means for generating electrical signals representative of the individual drops detected;

means for qualitatively evaluating the waveforms of each of said electrical signals to establish the occurrence of individual drop flow events, whereby individual drop flow events may be qualitatively distinguished from artifacts, and for providing drop signals indicative of individual drop flow events to the fluid flow control apparatus;

amplitude discrimination means for qualitatively evaluating the amplitude of each of said electrical signals representing individual drop configurations to determine their conformity with prescribed amplitude characteristics, whereby proper drop flow events may be qualitatively distinguished from improper drop flow events;

timing means for establishing a time frame during which the amplitude of each of said electrical signals representing individual drop configurations is evaluated by said amplitude discrimination means; and

means responsive to qualitative evaluation of said drop flow events, for determining proper operation of the fluid flow control apparatus.

19. A combination as set forth in claim 18, and further including means for initiating said timing means in response to said amplitude discrimination means.

20. A combination as set forth in claim 18 wherein said timing means includes means for establishing a plurality of successive time frames during which the amplitude of each of said electrical signals is evaluated by said amplitude discrimination means.

21. A combination as set forth in claim 18, and further including:

indicator means for providing an indication of non-conformity in the amplitudes of a prescribed number of said electrical signals.

22. A method for determining the quality of the detection of drop flow activity during the parenteral administration of liquids through a feeding tube from a liquid source to a patient, comprising the steps of:

generating electrical signals in response to the detection of individual drops; and

qualitatively evaluating the waveforms of each of said electrical signals representing individual drop configurations to determine their conformity with prescribed waveform characteristics, whereby proper drop flow events may be qualitatively distinguished from improper events and artifacts.

23. A method as set forth in claim 22, comprising the additional step of:

indicating a lack of conformity in the waveforms of a predetermined number of said electrical signals.

24. A method for evaluating the quality of the detection of drop flow activity during the parenteral administration of liquids through a feeding tube from a liquid source to a patient, comprising the steps of:

generating electrical signals in response to the detection of individual drops; and

qualitatively evaluating the amplitudes of each of said electrical signals representing individual drop configurations during time frames of predetermined duration to determine the conformity of said electrical signals with prescribed waveform characteristics, whereby proper drop flow events may be qualitatively distinguished from improper events and artifacts.

25. A method as set forth in claim 24, and further including the step of:

indicating a lack of conformity in the amplitudes of a predetermined number of said electrical signals.

26. In a drop detection system for use with fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

sensing means for detecting drop flow activity;

means responsive to said sensing means for generating electrical signals representative of the individual drops detected;

first discriminator means for qualitatively determining whether the amplitude of each of said electrical signals exceeds a first level, whereby the occurrence of an individual drop flow event is detected;

second discriminator means for qualitatively determining whether the amplitude of each of said electrical signals representing an individual drop configurations exceeds a second level greater than said first level;

timing means responsive to said first discriminator means for establishing first and second successive time frames during which the amplitude of each of said electrical signals is compared with said second level; and

means responsive to qualitative evaluation of said drop flow events, for determining proper operation of the fluid flow control apparatus.

27. A combination as set forth in claim 26, and further including:

indicator means for indicating whether the amplitude of each of said electrical signals representing an individual drop flow event does not exceed said second level during said first time frame or does exceed said second level during said second time frame.

28. A combination as set forth in claim 26, and further including:

first counting means for counting each electrical signal with an amplitude exceeding said first level, whereby a count of individual drop flow events is provided; and

second counting means for counting each electrical signal counted by said first counting means and having an amplitude which also does not exceed said second level during said first time frame, whereby a count is provided of improper drop flow events as distinguished from proper drop flow events.

29. A combination as set forth in claim 28, and further including:

alarm means responsive to said first and second counting means for triggering an alarm when the ratio of the count in said first counting means to the count in said second counting means exceeds a prescribed level.

30. A combination as set forth in claim 29, including means for resetting both said first counting means and said second counting means if the count in said first counting means exceeds a prescribed level.

31. A combination as set forth in claim 26, further including:

first counting means for counting each electrical signal with an amplitude exceeding said first level, whereby a count of individual drop flow events is provided; and

second counting means for counting each electrical signal counted by said first counting means and having an amplitude which also exceeds said second level during said second time frame, whereby a count is provided of improper drop flow events as distinguished from proper drop flow events.

32. A combination as set forth in claim 31, further including:

alarm means responsive to said first and second counting means for triggering an alarm when the ratio of the count at said first counting means to the count at said second counting means exceeds a prescribed level.

33. A combination as set forth in claim 32, including means for resetting both said first counting means and said second counting means if the count in said first counting means exceeds a prescribed level.

34. In a drop detection system for use with fluid flow control apparatus, in the parenteral administration of liquids through a feeding tube from a liquid source to a patient, the combination comprising:

first means for generating electrical signals in response to detection of individual drops;

second means for qualitatively evaluating the waveforms of each of said electrical signals representing individual drop configurations to determine their conformity with prescribed waveform characteristics, whereby proper drop flow events may be qualitatively distinguished from improper events and artifacts; and

third means, responsive to the electrical output of said second means, for determining proper operation of the fluid flow control apparatus.

35. A combination as set forth in claim 34, wherein said second means includes means for evaluating the amplitude of each of said electrical signals to determine their conformity with prescribed amplitude characteristics.

36. A combination as set forth in claim 35, wherein said second means includes means for evaluating the amplitude of each of said electrical signals by comparing said amplitude with a plurality of prescribed amplitude levels.

37. A combination as set forth in claim 35, wherein said second means includes means for providing an indication of non-conformity in the amplitudes of a prescribed number of said electrical signals.

38. A combination as set forth in claim 34, wherein said second means includes means for evaluating the time duration of each of said electrical signals to determine their conformity with prescribed time duration characteristics.

39. A combination as set forth in claim 38, wherein said second means includes means for evaluating the time duration of each of said electrical signals by comparing said time duration with a plurality of prescribed time duration frames.

40. A combination as set forth in claim 38, wherein said second means includes means for providing an indicacion of non-conformity in the time durations of a prescribed number of said electrical signals.

41. A combination as set forth in claim 34, wherein said second means includes means for evaluating both the amplitude and the time duration of each of said electrical signals to determine their conformity with prescribed amplitude and time duration characteristics, respectively.

42. A combination as set forth in claim 41, wherein said second means includes means for evaluating the amplitude and the time duration of each of said electrical signals by comparing said amplitude and said time duration with a plurality of prescribed amplitude levels and a plurality of prescribed amplitude levels and a plurality of prescribed time durations, respectively.

43. A combination as set forth in claim 41, wherein said second means include means for providing an indication of non-conformity in the amplitudes and time durations of a prescribed number of said electrical signals.