CONTROL UNIT FOR INFUSION PUMP UNITS, INCLUDING A CONTROLLED INTERVENTION UNIT

• US 20160228641A1
• Filed: 04/20/2016
• Published: 08/11/2016
• Est. Priority Date: 10/21/2013
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Gescheit, Iddo, Kuhr, Hans-Juergen
• Granted Patent: US 10,080,840 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A control unit for an electronically controlled pump unit controls the pump unit to infuse insulin into a diabetic'"'"'s body in a substantially continuous way according to a preset infusion schedule as a function of time. The control unit includes an intervention unit that continuously evaluates a blood-glucose indicative input for detecting an actual or expected hypoglycaemia and executes, in response to an actual or expected hypoglycaemia, a temporary hypoglycaemia intervention. The intervention includes, for an intervention time interval, overriding the preset infusion schedule by temporarily suspending insulin infusion or temporarily reducing insulin infusion below the preset infusion schedule. The intervention unit adapts its way of operation with respect to executing the hypoglycaemia intervention in accordance with a control signal that is separate from the blood-glucose indicative input. The control unit automatically generates the control signal as a function of time and/or based on sensor input.

Claims

1. A control unit for an electronically controlled pump unit, the control unit comprising:

a preset infusion schedule configured to control the pump unit to infuse insulin into a diabetic'"'"'s body in a substantially continuous manner as a function of time;

an intervention unit configured to continuously evaluate a glucose indicative input for detecting an actual or expected hypoglycaemia and to execute, in response to an actual or expected hypoglycaemia, a temporary hypoglycaemia intervention, the hypoglycaemia intervention including, for an intervention time interval, overriding the preset infusion schedule by temporarily suspending insulin infusion or temporarily reducing insulin infusion below the preset infusion schedule;

wherein the control unit is configured to automatically generate a control signal for the pump unit as a function of time and/or based on sensor input, the control signal being separate from the blood-glucose indicative input; and

wherein the intervention unit is configured to adapt execution of the hypoglycaemia intervention in accordance with the control signal.

2. The control unit according to claim 1, wherein the intervention unit is configured to execute the hypoglycaemia intervention upon a glucose value of the diabetic falling below a lower intervention threshold.

3. The control unit according to claim 1, wherein the intervention unit is configured to terminate the hypoglycaemia intervention within a given time interval after starting the hypoglycaemia intervention, or upon a glucose value of the diabetic rising above an upper intervention threshold, or upon a resuming command provided by a user.

4. The control unit according to claim 1, wherein the control signal includes at least one of a lower intervention threshold, an upper intervention threshold, the reduction of insulin infusion below the preset infusion schedule, and the intervention time interval.

5. The control unit according to claim 1, further comprising a clock unit configured to generate the control signal as a function of a time of day.

6. The control unit according to claim 5, wherein the control signal includes an enablement signal and the intervention unit is designed to selectively enable or disable the execution of the first hypoglycaemia interventions according to the enablement signal.

7. The control unit according to claim 1, wherein the control unit is configured to operatively couple to a physical activity sensor and is configured to generate the control signal according to the physical activity of the diabetic, the physical activity sensor comprising one or more of an accelerometer, a pedometer, or a pulse meter, an oxymeter, a breath sensor, body temperature sensors, heart rate sensor, ventilation rate sensor, amount of sweat and blood oxygen saturation sensor, EEG sensors and an ECG sensor.

8. The control unit according to claim 1, wherein the control unit is configured to operatively couple to a fasting period sensor and is further configured to generate the control signal according to a fasting period measure provided by the fasting period sensor.

9. The control unit according to claim 8, wherein the control unit is configured to enable execution of the hypoglycaemia intervention upon the fasting period measure indicating that the diabetic has fallen asleep, has gone to bed, or can be expected to fall asleep or go to bed soon.

10. The control unit according to claim 1, wherein the intervention unit is configured to execute, in case of an actual or expected hypoglycaemia of the diabetic, alternative hypoglycaemia handling routines, one of said alternative hypoglycaemia handling routines including executing the hypoglycaemia intervention.

11. The control unit claim 1, wherein the control unit is configured to determine an overshot bolus and a compensation rate based on an amount of insulin that would be infused in accordance with the preset schedule within a compensation time interval following the hypoglycaemia intervention, and, following the hypoglycaemia intervention, to control the pump unit to infuse the overshot bolus and to control, following the infusion of the overshot bolus, the pump unit to infuse insulin temporarily at the compensation rate for the compensation time interval.

12. The control unit according to claim 1, wherein the intervention unit is configured to execute, in response to an actual or predicted hyperglycaemia of the diabetic, a hyperglycaemia intervention, the hyperglycaemia intervention including controlling the pump unit to infuse a correction bolus.

13. The control unit according to claim 1, wherein the intervention unit is configured to adapt its way of operation during execution of the hypoglycaemia intervention.

14. The control unit according to claim 1, wherein the intervention unit is configured, when executing the hypoglycaemia intervention, to successively reduce insulin infusion and/or, when terminating the hypoglycaemia intervention, to successively resume insulin infusion back to the preset schedule.

15. The control unit according to claim 1, wherein the intervention unit is configured to determine a level of reduction of insulin infusion below the preset schedule and/or the intervention time interval in dependence of the blood-glucose indicative input.

16. A diabetes therapy system, comprising:

a pump unit configured to be carried by a diabetic; and

a control unit operatively coupled to the pump unit and configured to control operation of the pump unit, the control unit comprising;

a preset infusion schedule configured to control the pump unit to infuse insulin into a diabetic'"'"'s body in a substantially continuous manner as a function of time;

an intervention unit configured to continuously evaluate a glucose indicative input for detecting an actual or expected hypoglycaemia and to execute, in response to an actual or expected hypoglycaemia, a temporary hypoglycaemia intervention, the hypoglycaemia intervention including, for an intervention time interval, overriding the preset infusion schedule by temporarily suspending insulin infusion or temporarily reducing insulin infusion below the preset infusion schedule;

wherein the control unit is configured to automatically generate a control signal for the pump unit as a function of time and/or based on sensor input, the control signal being separate from the blood-glucose indicative input; and

wherein the intervention unit is configured to adapt execution of the hypoglycaemia intervention in accordance with the control signal.

17. The diabetes therapy system according to claim 16, further including a continuous glucose monitor.