Control unit for infusion pump units, including a controlled intervention unit

• US 10,080,840 B2
• Filed: 04/20/2016
• Issued: 09/25/2018
• 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
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US15/133,485
• Publication Number:
  US 20160228641A1
• Time in Patent Office: 888 Days
• 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 system for an electronically controlled pump unit, comprising:

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

an intervention unit configured to continuously evaluate a glucose indicative input from a glucose sensor 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;

a control unit configured to operatively coupled to a fasting period sensor and further configured to generate a control signal according to a fasting period measure provided by the fasting period sensor; and

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

2. The system 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 system 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 system 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 system according to claim 1, wherein the control unit is configured to operatively couple to a physical activity sensor and is configured to generate a second 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.

6. The system 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.

7. The system according to 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.

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

9. The system 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.

10. The system according to claim 1, wherein the intervention unit is configured to determine a level of reduction of insulin infusion below the preset schedule in dependence of the glucose indicative input.

11. The system according to claim 1, wherein the control unit is configured to automatically generate the control signal for the pump unit based on input from the fasting period sensor.

12. 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;

an intervention unit configured to continuously evaluate a glucose indicative input from a glucose sensor 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 operative couple to a fasting period sensor and is further configured to generate a control signal according to a fasting period measure provided by the fasting period sensor; and

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

13. The diabetes therapy system according to claim 12, wherein the glucose sensor comprises a continuous glucose monitor.

14. The diabetic therapy system in accordance with claim 12, wherein the control unit is configured to automatically generate the control signal for the pump unit based on input from the fasting period sensor.