Array and method for dosing a hormone regulating blood sugar in a patient

• US 20030104982A1
• Filed: 11/18/2002
• Published: 06/05/2003
• Est. Priority Date: 02/10/2000
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rinne, Helmut, Wittmann, Uwe, Gessler, Ralf, Pfleiderer, Hans-Joerg
• Granted Patent: US 7,556,613 B2
• Time in Patent Office: Days
• US Class Current: 514/3
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/62 Posture
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The invention concerns an array and a method for dosing a hormone regulating the blood glucose, especially insulin of a diabetic patient (10). In order to improve the administration of the hormone, the invention provides the following characteristic combination: a) a measuring device (16) to detect measured values correlatable with blood sugar; b) a controlling means (12) comprising a controller (44) and a hormone dosing device (46) for supplying a hormone dosage; c) a pilot control device (14) acting on the hormone fine dosage controlling means (12) for performing a coarse pre-control in accordance with at least one influence variable that influences blood glucose.

Claims

1. Array for dosing a hormone suitable for regulating the blood glucose of a patient (10) comprising

a) a measuring device (16) for detecting measured values correlatable with blood glucose;

b) controlling means (12) comprising a controller (44) to process the measured values according to a control algorithm and a hormone dosing unit (46) to administer a hormone dose;

c) a pilot control device (14) acting on the controlling means (12) to reduce the dead time of the control.

2. Array as claimed in claim 1, characterized in that the pilot control device (14) has a pre-controlling action on the controlling means (12) in accordance with at least one influencing variable that is detected by a sensor.

3. Array as claimed in claim 1 or 2, characterized in that the pilot control device (14) has an activity measuring unit (18) for the sensory detection of the degree of physical activity of the patient (10).

4. Array as claimed in one of the claims 1 to 3, characterized in that the pilot control device (14) has a position sensor (20) and in particular mercury switches or spirit levels to detect resting states of the patient (10).

5. Array as claimed in one of the claims 1 to 4, characterized in that the pilot control device (14) has a movement sensor (22) and in particular a pedometer to detect movement states of the patient (10).

6. Array as claimed in one of the claims 1 to 5, characterized in that the pilot control device (14) has a sensor (24) to detect body parameters of the patient (10) such as heart-rate, body temperature or skin conductivity.

7. Array as claimed in one of the claims 1 to 6, characterized in that the pilot control device (14) has a basal control element (26) for the continuous pre-administration of a preferably patient-related basal dose of the hormone.

8. Array as claimed in claim 7, characterized in that the basal control element (26) has a correction stage to adjust the basal dose to the diurnal variations of the hormone sensitivity of the patient (10).

9. Array as claimed in one of the claims 1 to 8, characterized in that the pilot control device (14) has a bolus control element (28) to pre-administer hormone boli depending on the food intake of the patient (10).

10. Array as claimed in one of the claims 1 to 9, characterized in that the pilot control device (14) has a timer for the time-dependent determination of a basal hormone dose or to determine the time for the administration of hormone boli.

11. Array as claimed in one of the claims 7 to 10, characterized in that the basal control element (26) and/or the bolus control element (28) are connected downstream of the activity measuring unit (18).

12. Array as claimed in one of the claims 1 to 11, characterized in that the pilot control device (14) has an input unit (34) to enter data and in particular the times of day and bread units of the patient'"'"'s food intake (10).

13. Array as claimed in one of the claims 1 to 12, characterized in that the pilot control device (14) has a set-point output (38) connected to the controller (44) in order to pre-set a command variable.

14. Array as claimed in one of the claims 1 to 13, characterized in that the pilot control device (14) and the controller (44) are connected on the output side via a summation element (54) to the hormone dosage unit (46).

15. Array as claimed in one of the claims 1 to 14, characterized in that the pilot control device (14) has means (40, 50) for selecting the control algorithm or to pre-set parameters of the controller (44).

16. Array as claimed in one of the claims 1 to 15, characterized in that the pilot control device (14) has a monitoring stage to monitor and limit the hormone dose optionally after registering critical conditions of the patient such as abnormal body temperature.

17. Array as claimed in one of the claims 1 to 16, characterized in that the measuring device (16) has a glucose sensor (60) which preferably utilizes microdialysis technology to detect tissue glucose values as measured values.

18. Array as claimed in one of the claims 1 to 17, characterized in that the operating range of the controller (44) is limited to positive values when the hormone is insulin.

19. Array as claimed in one of the claims 1 to 18, characterized in that the pilot control device (14) acts on the controlling means (12) while maintaining a reserve for adjustment.

20. Array as claimed in one of the claims 1 to 19, characterized in that the controller (44) is designed as a state controller in which the control algorithm has a program routine acting as observer of the measured values and hormone dosage values in order to estimate non-measurable variables of state.

21. Array as claimed in one of the claims 1 to 20, characterized in that the controller (44) has a proportional-integral element to deal with disturbance variables.

22. Array as claimed in one of the claims 1 to 21, characterized in that the hormone dosage unit (46) comprises a dosage pump (46) designed for preferably subcutaneous hormone infusion as the actuator of the controlling means (12).

23. Array as claimed in one of the claims 1 to 22, characterized in that the hormone dosage unit (46) has a triggering element to manually confirm a planned hormone administration.

24. Array as claimed in one of the claims 1 to 21, characterized in that the hormone dosage unit (46) is designed to display and/or provide a hormone dose which is administered by the patient himself.

25. Array as claimed in one of the claims 1 to 24, characterized in that the measuring device (16), the controlling means (12) and the pilot control device (14) are in the form of a small portable instrument that can be carried on the body of the patient (10).

26. Method for dosing a hormone suitable for monitoring the blood glucose of a patient (10) in which

a) measured values that can be correlated with blood glucose are detected;

b) the measured values are fed to a controlling means (12) in which a controller (44) processes the measured values according to a control algorithm and outputs a hormone dose to a hormone dosage unit (46);

c) the controlling means (12) is pre-controlled by a pilot control device (14) to reduce the dead time.