Insulin pump

• US 9,283,323 B2
• Filed: 08/09/2012
• Issued: 03/15/2016
• Est. Priority Date: 08/12/2011
• Status: Expired due to Fees

• Current Assignee: Gene Onyx Limited
• Original Assignee: Gene Onyx Limited
• Inventors: Toumazou, Christofer, Sim, Calvin, Georgiou, Pantelis, Vinas, Pau Herrero
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/570,525
• Publication Number:
  US 20130041343A1
• Time in Patent Office: 1,314 Days
• Field of Search: 604/66, 604/67, 604/504, 604/890.1
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets

Abstract

The present invention relates to a controller unit and methods for controlling an insulin pump. The controller unit includes a user input that receives a gain factor. The gain factor has been calculated based on historical data in relation to a patient. The controller unit includes a measurement input for receiving data representative of a measured blood glucose level for the patient. Processing logic of the controller unit is configured to apply the measured blood glucose level to a pancreatic beta-cell insulin secretion computational model to predict an insulin output level, apply the gain factor to the predicted insulin output level to determine a patient insulin deficiency level, and calculate a control signal for controlling the insulin output level of the insulin pump based on the patient insulin deficiency level. Methods are provided for optimizing the gain factor based on the historical data in relation to the patient.

Claims

1. An apparatus for controlling an insulin pump, the apparatus comprising:

a user input for receiving a first gain factor, the first gain factor having been calculated based on historical data in relation to a patient;

a measurement input for receiving data representative of a measured blood glucose level for the patient; and

processing logic configured to;

apply the measured blood glucose level to an insulin secretion computational model to predict an insulin output level;

apply the first gain factor to the predicted insulin output level to determine a patient insulin deficiency level; and

calculate a control signal for controlling the insulin output level of the insulin pump based on the patient insulin deficiency level;

wherein the processing logic is configured to apply the first gain factor to the predicted insulin output level for a first period of time after ingestion of a meal by the patient;

wherein the first gain factor is arranged to be tuned to the patient by minimizing a predicted insulin output level cost function based on historical data of the patient; and

wherein the user input receives a second and third gain factors, the second and third gain factors having been calculated based on the historical data in relation to the patient, and the processing logic being configured to;

apply the second gain factor to the predicted insulin output level when the blood glucose level for the patient is equal to or above a predetermined glucose threshold; and

apply the third gain factor to the predicted insulin output level when the first period of time expires and when the blood glucose level for the patient is below the predetermined glucose threshold.

2. An apparatus according to claim 1, wherein the user input is configured to receive an indication of a meal to be ingested and the processing logic applies the indication to the insulin secretion computational model to predict the insulin output level for the patient.

3. An apparatus according to claim 2, wherein the processing logic is further configured to:

calculate a pre-meal insulin level based on the measured blood glucose level and the indication of a meal to be ingested; and

calculate the patient deficiency level and the control signal using the pre-meal insulin level.

4. An apparatus according to claim 3, wherein the indication of a meal to be ingested further includes data representative of the amount of carbohydrates of the meal to be ingested.

5. An apparatus according to claim 1, wherein the processing logic further configured to:

calculate a feedback insulin level based on estimating a plasma insulin concentration from the insulin output level of the insulin pump; and

calculate the patient deficiency level and the control signal using the feedback insulin level.

6. An apparatus according to claim 1, wherein the insulin secretion computational model is a pancreatic beta-cell computational model.

7. An apparatus according to claim 1, provided as an integrated circuit.

8. An apparatus according to claim 7, wherein the integrated circuit is a complementary metal-oxide-semiconductor (CMOS) device or chip.

9. An apparatus according to claim 1, wherein the measured blood glucose level is measured from a blood glucose sensor from the group of a subcutaneous blood glucose sensor, intravenous blood glucose sensor, and a non-invasive blood glucose sensor.

10. The apparatus according to claim 1, wherein the historical data comprises an amount of ingested carbohydrate and an insulin-to-carbohydrate ratio of the patent.

11. An insulin system for use by a patient comprising an insulin pump for the patient, a blood glucose sensor for the patient, and an apparatus according to claim 1 for use in controlling the insulin output level of the insulin pump, the apparatus connected to the insulin pump and the blood glucose sensor.

12. An insulin system according to claim 11, wherein the blood glucose sensor is a sensor from the group of a subcutaneous blood glucose sensor, intravenous blood glucose sensor, and a non-invasive blood glucose sensor.

13. An insulin pump comprising an apparatus according to claim 1 for controlling the output insulin level of the insulin pump.

27. A method of determining one or more gain factors for use in controlling an apparatus according to claim 1, comprising calculating one or more gain factors based upon historical data in relation to a patient and entering the one or more gain factors via the user input of the apparatus.

28. A method according to claim 27, further calculating a first gain factor for a first period of time after ingestion of a meal by the patient.

29. A method according to claim 28, further comprising:

calculating a second gain factor for when the blood glucose level for the patient is equal to or above a predetermined glucose threshold; and

calculating a third gain factor for when the first period of time expires and when the blood glucose level for the patient is below the predetermined glucose threshold.

30. A method according to claim 29, wherein the second and third gain factors are proportional to the first gain factor.

31. A method according to claim 27, wherein the gain factors are calculated based on the historical data and the insulin secretion computational model.

32. A method according to claim 31, wherein the insulin secretion computational model is a pancreatic beta-cell computational model.

33. A method according to claim 27, wherein the gain factors are calculated based on historical measured blood glucose levels for the patient.

34. A method according to claim 27, wherein at least one of the gain factors is calculated by minimising a predicted insulin output level cost function based on the historical data over a predetermined period of time for a given glucose profile.

35. A method according to claim 34, wherein the predicted insulin output level cost function (J) is defined by:

36. A method according to claim 27, further comprising calculating a set of gain factors determined from the historical data and a set of glucose profiles.

38. A computer readable medium comprising computer instructions stored thereon, the computer instructions, which when executed on a processor or by processing logic, are adapted for determining one or more gain factors for use in controlling an apparatus according to claim 1 by calculating one or more gain factors based upon historical data in relation to a patient and entering the one or more gain factors via the user input of the apparatus;

wherein the gain factor is arranged to be tuned to the patient by minimizing a predicted insulin output level cost function based on historical data of the patient.

14. A method for controlling an insulin pump, the method comprising:

receiving a first gain factor, the first gain factor having been calculated based on historical data in relation to a patient;

receiving data representative of a measured blood glucose level for the patient;

applying the measured blood glucose level to an insulin secretion computational model to predict an insulin output level;

applying the first gain factor to the predicted insulin output level to determine a patient insulin deficiency level; and

calculating a control signal for controlling the insulin output level of the insulin pump based on the patient insulin deficiency level;

wherein the first gain factor is arranged to be tuned to the patient by minimizing a predicted insulin output level cost function based on historical data of the patient.

15. A method according to claim 14, wherein the first gain factor is applied to the predicted insulin output level for a first period of time after ingestion of a meal by the patient.

16. A method according to claim 15, further comprising receiving second and third gain factors, the second and third gain factors having been calculated based on the historical data in relation to the patient, and the method further comprising:

applying the second gain factor to the predicted insulin output level; and

applying the third gain factor to the predicted insulin output level when the first period of time expires and when the blood glucose level for the patient is below the predetermined glucose threshold.

17. A method according to claim 14, further comprising receiving an indication of a meal to be ingested, wherein the step of applying the measured blood glucose level further includes applying the indication to the insulin secretion computational model to predict the insulin output level for the patient.

18. A method according to claim 17, further comprising:

calculating a pre-meal insulin level based on the measured blood glucose level and the indication of a meal to be ingested; and

calculating the patient deficiency level and the control signal using the pre-meal insulin level.

19. A method according to claim 18, wherein the indication of a meal to be ingested further includes data representative of the amount of carbohydrates of the meal to be ingested.

20. A method according to claim 14, further comprising:

calculating a feedback insulin level based on estimating a plasma insulin concentration from the insulin output level of the insulin pump; and

calculating the patient deficiency level and the control signal using the feedback insulin level.

21. A method according to claim 14, wherein the insulin secretion computational model is a pancreatic beta-cell computational model.

22. A method according to claim 14, wherein the measured blood glucose level is measured from a blood glucose sensor from the group of a subcutaneous blood glucose sensor, intravenous blood glucose sensor, and a non-invasive blood glucose sensor.

23. A method of controlling blood glucose levels within a patient, the method comprising:

calculating a gain factor for the patient based upon historical data in relation to the patient;

measuring a blood glucose level in the patient;

applying the measured blood glucose level to an insulin secretion computational model to predict an insulin output level;

calculating a patient insulin deficiency level based on said gain factor and the predicted insulin output level; and

using the patient insulin deficiency level as a control input for an insulin pump configured to pump insulin into the patient;

wherein the gain factor is arranged to be tuned to the patient by minimizing a predicted insulin output level cost function based on historical data of the patient.

24. A method according to claim 23, wherein the patient is a diabetic patient.

25. A method according to claim 23, wherein the insulin secretion computational model is a pancreatic beta-cell computational model.

26. A method according to claim 23, wherein the measured blood glucose level is measured from a blood glucose sensor from the group of a subcutaneous blood glucose sensor, intravenous blood glucose sensor, and a noninvasive blood glucose sensor.

37. A computer readable medium comprising computer instructions stored thereon, which when executed on a processor or by processing logic, are adapted to perform the steps of:

receiving a gain factor;

the gain factor having been calculated based on historical data in relation to a patient;

receiving data representative of a measured blood glucose level for the patient;

applying the measured blood glucose level to an insulin secretion computational model to predict an insulin output level;

applying the gain factor to the predicted insulin output level to determine a patient insulin deficiency level; and

calculating a control signal for controlling the insulin output level of the insulin pump based on the patient insulin deficiency level;

wherein the gain factor is arranged to be tuned to the patient by minimizing a predicted insulin output level cost function based on historical data of the patient.