Robust closed loop control and methods

• US 9,572,934 B2
• Filed: 08/01/2014
• Issued: 02/21/2017
• Est. Priority Date: 08/31/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary Alan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US14/449,677
• Publication Number:
  US 20140343529A1
• Time in Patent Office: 935 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Method of monitoring a control operation of a medication delivery system, determining whether a signal level received from an analyte sensor is associated with a fault condition and a potential fault condition, and adjusting a medication delivery rate executed by the control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or the potential fault condition, where the medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with the potential fault condition is provided. Devices, systems and kits for implementing the afore-mentioned method are also provided.

Claims

1. A method, comprising:

monitoring a control operation of a medication delivery system;

determining whether a signal level received from an analyte sensor is associated with a fault condition or a potential fault condition, wherein the fault condition and the potential fault condition are associated with improper functioning of the analyte sensor; and

adjusting a medication delivery rate executed by the control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or the potential fault condition;

wherein the medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with the potential fault condition.

2. The method of claim 1, including generating an output signal when the fault condition associated with the analyte sensor is determined based on the signal level.

3. The method of claim 2, wherein the output signal includes a prompt to replace the analyte sensor.

4. The method of claim 1, wherein the first predetermined range is narrower compared to the second predetermined range.

5. The method of claim 1, further comprising, when the determined fault condition persists over a predetermined time period, disabling the control operation, and initiating a pre-programmed medication delivery rate.

6. The method of claim 5, wherein the pre-programmed medication delivery rate includes a pre-programmed basal profile.

7. The method of claim 1, wherein the fault condition or the potential fault condition is associated with an early signal attenuation (ESA) condition of the analyte sensor.

8. The method of claim 1, further including outputting an instruction or a request to confirm or correct the fault condition or the potential fault condition.

9. The method of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

10. The method of claim 1, further comprising:

determining whether a fault condition or potential fault condition has been corrected; and

terminating the execution of the adjusted medication delivery rate when it is determined that the fault condition or potential fault condition has been corrected.

11. An apparatus, comprising:

one or more processors; and

a memory on which is stored a plurality of instructions that, when executed by the one or more processors, cause the one or more processors to monitor a control operation of a medication delivery system, determine whether a signal level received from an analyte sensor is associated with a fault condition or a potential fault condition, wherein the fault condition and the potential fault condition are associated with improper functioning of the analyte sensor, and adjust a medication delivery rate executed by the control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, wherein the medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with the potential fault condition.

12. The apparatus of claim 11, wherein the plurality of instructions, when executed by the one or more processors, cause the one or more processors to generate an output signal when the fault condition associated with the analyte sensor is determined based on the signal level.

13. The apparatus of claim 12, wherein the output signal includes a prompt to replace the analyte sensor.

14. The apparatus of claim 11, wherein the first predetermined range is narrower compared to the second predetermined range.

15. The apparatus of claim 11, wherein the plurality of instructions, when executed by the one or more processors, cause the one or more processors to disable the control operation, and initiate a pre-programmed medication delivery rate when the determined the determined fault condition has persisted over a predetermined period.

16. The apparatus of claim 15, wherein the pre-programmed medication delivery rate includes a pre-programmed basal profile.

17. The apparatus of claim 11, wherein the fault condition or the potential fault condition is associated with an early signal attenuation (ESA) condition of the analyte sensor.

18. The apparatus of claim 11, wherein the plurality of instructions, when executed by the one or more processors, cause the one or more processors to output an instruction or a request to confirm or correct the fault condition or the potential fault condition.

19. The apparatus of claim 11, wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

20. The apparatus of claim 11, wherein the plurality of instructions, when executed by the one or more processors, cause the one or more processors to determine whether a fault condition or potential fault condition has been corrected, and terminate the execution of the adjusted medication delivery rate when it is determined that the fault condition or potential fault condition has been corrected.