Intravenous infusion flow rate monitoring device

• US 6,083,206 A
• Filed: 09/28/1997
• Issued: 07/04/2000
• Est. Priority Date: 12/07/1994
• Status: Expired due to Fees

• Current Assignee: Midex Marketing Limited
• Original Assignee: Midex Marketing Limited
• Inventors: Molko, Albert
• Primary Examiner(s): McDermott, Corrine
• Application Number:
  US08/849,563
• Time in Patent Office: 1,010 Days
• Field of Search: 604/65-67, 604/253
• US Class Current: 604/253
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 5/1689 Drip counters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

An infusion monitoring device including a programming console with a data input unit for inputting infusion parameters, a calculating unit for preconditioning the parameters, and an output interface for said parameters. The programming console may be used to program a large number of self-contained monitoring units each having a sensor combined with a drop-counting ampoule for sensing the presence or absence of the drop. Each monitoring unit has a housing for a timing and counting unit, a display unit, an alarm unit, a self-contained power supply, and input interface for receiving parameters preconditioned in the programming console, a memory unit for storing the parameters, and a separate calculating unit for controlling the counting/timing, in the display and the alarms.

Claims

1. A device for monitoring an infusion, comprising:

a sensor adapted for being combined with a drip cylinder to detect the presence or absence of a drop; and

a timing and counting unit timing and counting for the drops detected by said sensor;

said sensor comprising;

a) a source of infa-red radiation, said source of infrared radiation functioning in pulsed mode, and

b) an optical receiver, said optical receiver being activated synchronous to said source of infra-red radiation;

c) an integrating amplifier adapted for integrating the signal from said optical receiver and for providing as an output signal a mean value amplified by an adjustable factor; and

d) a comparator adapted for comparing said output signal with the non-integrated signal from said receiver and for generating a logic signal as an input signal for said timing and counting unit.

2. A device as claimed in claim 1, wherein said optical receiver comprises several photodiodes, said photodiodes being electrically connected in series and being distributed in an angular sector opposite said source of infra-red radiation.

3. A device for monitoring an infusion, comprising:

a) a sensor adapted for being combined with a drip cylinder to detect the presence or absence of a drop;

b) monitoring means connected to said sensor associated with said drip cylinder during the infusion;

said monitoring means comprising;

a memory unit for storing characteristic parameters of said infusion;

a unit for timing and counting the drops detected by said sensor and for generating a first signal indicative thereof;

a display unit;

an acoustic and/or visual alarm unit;

a first arithmetic and logic unit adapted for using a computer algorithm, said computer algorithm incorporating as parameters said signal from said timing and counting unit and said characteristic parameters of the infusion stored in said memory unit, in order to trigger said acoustic and/or visual alarm; and

an autonomous source of electrical power for supplying said memory unit, said timing and counting unit, said display unit, said acoustic and/or visual alarm unit and said first arithmetic and logic unit;

said memory unit, said timing and counting unit, said display unit, said acoustic and/or visual alarm unit, said first arithmetic and logic unit and said autonomous source of electrical power being integrated into a first housing so as to form an autonomous and independent unit;

c) an autonomous and independent programming console, said programming console comprising;

a data input unit adapted for entering characteristic parameters of said infusion;

a second arithmetic and logic unit, said second arithmetic and logic unit being adapted for preconditioning said characteristic parameters of said infusion entered into said data input unit; and

an output interface, said output interface being adapted for converting said preconditioned parameters into signals capable of being transmitted to said monitoring means;

said monitoring means further comprising an input interface adapted for reconstituting said preconditioned parameters from said signals generated by the said output interface of said programming console, so that said preconditioned parameters can be loaded into said memory unit of said monitoring means by temporarily coupling said input interface of said autonomous and independent monitoring unit to said output interface of said autonomous and independent programming console.

4. A device as claimed in claim 3, wherein said first arithmetic and logic unit includes an oscillator and said monitoring means further comprise means for inactivating said first arithmetic and logic unit by stoppage of its oscillator between two successive events, where an event is classed as the passage of a drop, the exceeding of the limiting time between two drops or a fault in the sensor.

5. A device as claimed in claim 4, wherein said timing and counting unit comprises

a) first logic means, said first logic means generating a transition of a first logic signal when an event of the first type occurs, said event of the first type corresponding either to the passage of a drop, to the exceeding of the limiting time between two drops or to a fault in the sensor, said first logic means restarting the oscillator of said first arithmetic and logic unit during an event of the first type;

b) second logic means, said second logic means generating a transition of a second logic signal solely during the passage of a drop, said second logic means triggering the execution of a computer algorithm during the passage of a drop in said first arithmetic and logic unit;

c) wherein an alarm is generated when there is a transition of said first logic signal and no transition of said second logic signal.

6. A device as claimed in claim 5, wherein said timing and counting unit further comprises:

a) a pulse counter for counting the pulses from a low frequency clock;

B) a data-latch circuit, said data-latch circuit being associated with said pulse counter and being connected to said first arithmetic and logic unit so that it can be interrogated by the latter;

said first logic means being connected to said pulse counter and to said data-latch circuit so as to freeze the counting down of the pulses in said data-latch circuit and to reset the pulse counters to zero during a transition of said first logic signal.

7. A device as claimed in claim 6, wherein said timing and counting unit further comprises a comparator constantly comparing the value on the pulse counter with a predetermined limiting time interval, said comparator causing a transition of said first logic signal when said predetermined limiting time interval is exceeded.

8. A device as claimed in claim 3, wherein said sensor comprises

a) a source of infra-red radiation, said source of infrared radiation functioning in pulsed mode, and

b) an optical receiver, said optical receiver being activated synchronous to said source of infra-red radiation.

9. A device as claimed in claim 8, wherein said optical receiver comprises several photodiodes, said photodiodes being electrically connected in series and being distributed in an angular sector opposite said source of infra-red radiation.

10. A device as claimed in claim 8, wherein said sensor further comprises:

a) an integrating amplifier adapted for integrating the signal from said optical receiver and for providing as an output signal a mean value amplified by an adjustable factor; and

b) a comparator adapted for comparing said output signal with the non-integrated signal from said receiver and for generating a logic signal as an input signal for the timing and counting unit.

11. A device as claimed in claim 3, wherein said first arithmetic and logic unit is adapted for continuously calculating an optimum number of drops, said optimum number of drops being displayed on said linear scale in the form of a cursor indicating the relative deviation of the said optimum number of drops from the number corresponding to zero deviation, defined as follows:

##EQU2##

12. A device as claimed in claim 3, wherein said data input unit comprises means for entering a margin of tolerance applicable to the number of drops detected in a time interval, said margin of tolerance being incorporated in said computer algorithm in order to delay the triggering of an alarm.

13. A device as claimed in claim 12, wherein said means for entering a margin of tolerance for the infusion flow rate comprise

means for entering a first margin of tolerance applicable to the number of drops detected in a time interval in the case where this number is less than a mean value calculated for the same time interval;

and

means for entering a second margin of tolerance applicable to the number of drops detected in a time interval in the case where this number is greater than a mean value calculated for the same time interval.

14. A device as claimed in claim 3, wherein said display unit comprises means for displaying said characteristic parameters of the infusion, said characteristic parameters being deduced from the parameters loaded into said memory unit of said monitoring means.

15. A device as claimed in claim 14, wherein said displayed characteristic parameters comprise the volume of the infusion, the duration of the infusion and the margins of tolerance.

16. A device as claimed in claim 3, wherein said display unit comprises means for displaying graphically on a linear scale the positive or negative difference between the number of drops detected during an interval of observation t1 and the number of drops there should have been during the said interval t1 in the case of a uniform distribution of drops over the total duration initially planned for the infusion.

17. A device as claimed in claim 16, wherein said first arithmetic and logic unit is adapted for continuously calculating an optimum number of drops, said optimum number of drops being displayed on said linear scale in the form of a cursor indicating the relative deviation of the said optimum number of drops from the number corresponding to zero deviation, defined as follows:

##EQU3##

18. A device as claimed in claim 3, wherein said data input unit comprises means for entering a volume of the infusion and means for entering a duration of the infusion.

19. A device as claimed in claim 3, wherein said data input unit further comprises means for entering parameters used in calibration.

20. A device as claimed in claim 3, wherein said data input unit comprises a keyboard, each key of said keyboard being dedicated to a precise value of a characteristic parameter of the infusion.

21. A device as claimed in claim 3, further comprising optical coupler, said optical coupler being adapted for temporarily coupling said input interface of said monitoring means to said output interface of said programming console.

22. A device as claimed in claim 3, wherein said monitoring means further comprise:

a) switching means for switching between a monitoring/alarm mode and an adjustment mode, said adjustment mode being used for adjusting the flow rate of said infusion, said acoustic alarms being out of action in said adjustment mode; and

b) an acoustic unit capable of producing an acoustic signal for each drop detected in said "adjustment of flow rate" mode.

23. A device for monitoring an infusion, comprising:

a) a sensor adapted for being combined with a drip cylinder to detect the presence or absence of a drop;

b) monitoring means connected to said sensor associated with said drip cylinder during the infusion;

said monitoring means comprising;

a memory unit for storing characteristic parameters of said infusion;

a unit for timing and counting the drops detected by said sensor and for generating a first signal indicative thereof;

a display unit, wherein said display unit comprises means for displaying graphically on a linear scale the positive or negative difference between the number of drops detected during an interval of observation t1 and the number of drops there should have been during the said interval t1 in the case of a uniform distribution of drops over the total duration initially planned for the infusion;

an acoustic and/or visual alarm unit;

a first arithmetic and logic unit adapted for using a computer algorithm, said computer algorithm incorporating as parameters said signal from said timing and counting unit and said characteristic parameters of the infusion stored in said memory unit, in order to trigger said acoustic and/or visual alarm.