Device for the pre-programmable infusion of liquids

• US 4,559,037 A
• Filed: 01/20/1984
• Issued: 12/17/1985
• Est. Priority Date: 12/28/1977
• Status: Expired due to Fees

• Current Assignee: Siemens AG
• Original Assignee: Siemens AG
• Inventors: Franetzki, Manfred, Prestele, Karl, Gagneur, Klaus
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/572,417
• Time in Patent Office: 697 Days
• Field of Search: 604/65-67, 604/19-21, 604/890, 604/891, 604/30-31, 604/27-28, 604/49-50, 604/131, 604/151, 604/153-154, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Particularly for diabetes therapy, it is desirable to continuously infuse insulin in different rates into the body of the patient, because the insulin requirements of the diabetic are subject to great fluctuations. Therefore, a control device serves as the program transmitter for a microdosing unit. The control device for the microdosing unit has memory means for a prescribable control program allocated to it, whereby the control program can be called up directly by the patient at the control device. The program sequence of the infusion is started only by means of the dialing-up of a plurality of insulin units to be delivered into the body or of relevant food values taken in by the patient with a meal and of a starting time (T₁, T₂). In addition, specific base rates of the infusion can be selected by the patient. With the invention device, diabetes patients can call up the necessary insulin administration according to short programs at meals.

Claims

1. Apparatus for the infusion of insulin into a patient'"'"'s body in diabetes therapy, comprising a microdosing unit for supplying said insulin to the patient'"'"'s body, control means selectively controlling said microdosing unit to supply respective different amounts of insulin with respective corresponding predetermined insulin infusion profiles as a function of time and with a limited time duration suitable to an individual meal, said control means selectively generating respective control signals which control the supply of the respective different amounts of insulin by the microdosing unit with the respective corresponding predetermined insulin infusion profiles, said control means having an input unit manually operable directly by the patient for entering, in accordance with the carbohydrate content of a meal, a selected input signal corresponding to a respective required amount of insulin to be delivered into the body of the patient, said input unit controlling said control means to supply a respective control signal according to the selected input signal, to said microdosing unit, such that said microdosing unit delivers the corresponding required amount of insulin into the patient'"'"'s body with the corresponding predetermined infusion profile as a function of time, said input unit having a selection range of input signals corresponding to a range of amounts of insulin such that the amount of insulin selectable by said input unit is individually adaptable to each of the patient'"'"'s meals.

2. Apparatus according to claim 1, with said microdosing unit supplying a constant basal rate of insulin greater than zero during a basal infusion time interval which is greater than the limited time duration of each predetermined insulin infusion profile.

3. Apparatus according to claim 2, with each predetermined insulin infusion profile having a limited time duration not greater than three hours.

4. Apparatus according to claim 1, with each predetermined insulin infusion profile having a limited time duration lying substantially within the range extending from one-half hour to three hours.

5. Apparatus according to claim 4, with said selection range of said input unit corresponding to a range of amounts of insulin extending from a low insulin amount to a high insulin amount many times greater than said low insulin amount.

6. Apparatus according to claim 1, with said selection range of said input unit corresponding to a range of amounts of insulin extending from a low insulin amount to a high insulin amount many times greater than said low insulin amount.

7. Apparatus according to claim 1, with said selection range of said input unit covering a multiplicity of different amounts of insulin.

8. Apparatus according to claim 1, with said selection range covering at least six different amounts of insulin.

9. Apparatus according to claim 1, with said control means controlling supply of a selectable basal rate of insulin in a range up to a given maximum basal delivery rate, and the input unit having a selection range corresponding to a number of different insulin amounts including at least five different amounts exceeding the amount supplied at the maximum basal delivery rate in a basal infusion time interval equal to said limited time duration.

10. An insulin infusion apparatus wherein diabetes therapy is under the manual control of the patient, without reliance on an implanted glucose sensor, said apparatus comprising a microdosing unit for dispensing said insulin into the patient, control means controlling said microdosing unit to supply a selected number of insulin units to the patient with an infusion profile as a function of time suitable for the patient after an individual meal, said control means having an input unit manually operable directly by the patient for entering, in accordance with the carbohydrate content of each individual meal, an input signal which selects a number representing the required number of insulin units to be delivered into the body of the patient, said control means being connected to be actuated by manual operation of said input unit by the patient to cause said microdosing unit to deliver the required number of insulin units according to the number selected by said input signal into the patient'"'"'s body with said infusion profile as a funtion of time, said input unit having a selection range such that the number of insulin units is individually adaptable to each of the patient'"'"'s meals by the operation of said input unit.

11. Apparatus according to claim 10, with said microdosing unit supplying a constant basal rate of insulin greater than zero during a basal infusion time interval.

12. Apparatus according to claim 11, with said infusion profile having a limited time duration not greater than three hours, and said basal infusion time interval being greater than said limited time duration.

13. Apparatus according to claim 10, with said infusion profile having a limited time duration lying substantially within a range extending from one-half hour to three hours.

14. Apparatus according to claim 13, with said selection range of said input unit corresponding to a range of amounts of insulin extending from a low number of insulin units to a high number of insulin units many times greater than said low number of insulin units.

15. Apparatus according to claim 10, with said selection range of said input unit corresponding to a range of amounts of insulin extending from a low number of insulin units to a high number of insulin units many times greater than said low number of insulin amount.

16. Apparatus according to claim 10, with said selection range of said input unit covering a multiplicity of different numbers of insulin units.

17. Apparatus according to claim 10, with said selection range covering at least six different numbers of insulin units.

18. Apparatus according to claim 10, with said control means controlling supply of a selectable basal rate of insulin in a range up to a given maximum basal delivery rate, and the input unit having a selection range corresponding to different numbers of insulin units including at least five different numbers of insulin units representing insulin delivery rates above said maximum basal delivery rate.

19. A glucose sensorless device for the preprogrammable infusion of insulin into a patient in diabetes therapy, comprising a microdosing unit for dispensing said insulin into the patient, control means including a program transmitter for transmitting a selected control program to said microdosing unit, said selected control program representing a selected infusion profile as a function of time, said control means having an input unit manually operable directly by the patient for entering, in accordance with the carbohydrate content absorbed by the patient at a meal, an input signal corresponding to a required number representing the insulin units to be delivered into the body of the patient, said control means being connected to be actuated by operation of said input unit by the patient to initiate via said program transmitter the infusion of said required number of insulin units, said microdosing unit thereby delivering said required number of insulin units into the patient'"'"'s body with an infusion profile in conformity with said control program, said input unit providing for a selection range such that the number of insulin units is individually adaptable to each of the patient'"'"'s meals by the operation of said input unit.

20. A glucose sensorless device according to claim 19, with said control means having storage means for storing at least one control program, said input unit being connected to said program transmitter to cause said program transmitter to transmit the selected control program via said storage means to said microdosing unit.

21. Apparatus for the pre-programmable infusion of liquids into a patient'"'"'s body, comprising

a microdosing unit having supply means for supplying the liquid at a controllable infusion rate in response to programming signals,

control means operable for supplying selected programming signals to said microdosing unit for correspondingly controlling the rate of supply of the liquid thereby,

said control means having program storage means for storing at least one predeterminable control program, which provides for the generation of respective different programmed sequences of infusion amounts as a function of time, each of the respective different programmed sequences of infusion amounts as a function of time providing for the delivery of a respective different total liquid amount by said supply means over a time span suitable to an individual meal, with the different total liquid amounts lying within a predetermined available range of amounts suitable for selection by the patient,

said program storage means being controllable by each of a respective series of manually generated selection signals each representing a respective different one of said total liquid amounts to be infused within said available range of amounts and beginning at a given starting point, to generate the respective corresponding one of said programmed sequences of infusion amounts as a function of time over said time span and in accordance with said one control program stored therein, such that the respective corresponding total liquid amount is supplied by said microdosing unit in said time span,

said control means having manually actuatable input means coupled with said program storage means and being selectively manually actuable by the patient to respective positions corresponding to respective total liquid amounts within said available range of amounts to supply respective ones of said series of said manually generated selection signals and to supply the given starting time to the program storage means, whereby the microdosing unit is responsive to patient manual selection of one of said total liquid amounts from said available range of amounts and a desired starting point based on actual real time patient need while supplying such patient-selected total amount over a time span and at a rate as a function of time which is pre-programmed.

22. Apparatus according to claim 21, with the liquid supplied by said supply means being insulin.

23. Apparatus according to claim 22, with said manually actuatable input means having indicia means for providing a display in accordance with the amount of insulin to be supplied in each of the respective positions of said manually actuatable control means.

24. Apparatus according to claim 21, with the liquid supplied by said supply means being insulin, and said control means having constant rate transmitting means for controlling said microdosing unit to supply insulin at a constant base rate, the respective different programmed sequences of infusion amounts as a function of time provided for by said program storage means being superimposed on said constant base rate.

25. Apparatus according to claim 24, with said constant rate transmitter means having manually adjustable means accessible for manual actuation to effect adjustment of said constant base rate within a predetermined range.

26. Apparatus according to claim 21, with the liquid supplied by said supply means being insulin, and said control program stored by said program storage means representing a delivery profile specifically corresponding to the insulin requirements of the patient during digestion.

27. Apparatus according to claim 21, with said control program stored by said program storage means providing for the generation of essentially rectangular waveform programmed sequences as a function of time, said manually actuatable input means in its respective positions selecting respective different amplitudes for said essentially rectangular waveform programmed sequences.

28. Apparatus according to claim 21, with said control program stored by said program storage means providing for the generation of essentially rectangular waveform programmed sequences as a function of time, said manually actuatable input means in its respective positions selecting respective different time durations for said essentially rectangular waveform programmed sequences.

29. Apparatus according to claim 21, with said control program stored by said program storage means providing for the generation of essentially rectangular waveform programmed sequences as a function of time, said manually actuable control input means in its respective positions selecting respective different values of both amplitude and time duration for said essentially rectangular waveform programmed sequences.

30. Apparatus according to claim 21, with said control program stored by said program storage means providing for the generation of essentially triangular waveform programmed sequences as a function of time, said manually actuatable input means in its respective positions selecting respective different values of both peak amplitude and time duration for said essentially triangular waveform programmed sequences.