ANALYTE SENSING AND RESPONSE SYSTEM

• US 20110054391A1
• Filed: 06/03/2010
• Published: 03/03/2011
• Est. Priority Date: 07/28/2006
• Status: Abandoned Application

• Current Assignee: Oregon Health & Science University
• Original Assignee: Oregon Health & Science University
• Inventors: Engle, Julia, Castle, Jessica R., Ward, W. Kenneth
• Application Number:
  US12/793,632
• Publication Number:
  US 20110054391A1
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

Electrochemical systems for measuring an analyte concentration, and correcting any surplus or deficiency in the measured concentration. More specifically, systems for measuring an analyte level in a fluid with an implantable sensor, processing the measurements with a front-loaded delivery algorithm having a fluid delivery period and a refractory period, and determining an appropriate fluid infusion rate in response to the measurements.

Claims

1. An infusion system for infusing a fluid into a subject, comprising:

a first sensor configured to monitor concentration of an analyte in the subject and to generate a sensor output signal based on the monitored concentration, wherein the sensor output signal is used to generate a processor input signal;

a front-loaded fluid delivery processor configured to process the processor input signal and to generate a processor output signal having a fluid delivery period and a refractory period; and

a fluid delivery system configured to infuse fluid into the subject in a manner based at least partially on the processor output signal.

2. The infusion system of claim 1, wherein the analyte is glucose.

3. The infusion system of claim 1, wherein the fluid contains a glucose-increasing substance.

4. The infusion system of claim 1, wherein the processor includes a proportional derivative algorithm having a high proportional gain factor and a high derivative gain factor.

5. The infusion system of claim 1, wherein the first sensor includes a disc-shaped body having two opposing sides, a cathode and a plurality of anodes positioned on at least one of the sides.

6. The infusion system of claim 1, further comprising a membrane semi-permeable to the analyte covering at least a portion of the first sensor.

7. The infusion system of claim 6, further comprising an enzyme layer disposed between the first sensor and the membrane.

8. The infusion system of claim 1, further comprising a transmitter electrically coupled to the first sensor, wherein the transmitter is configured to receive the sensor output signal, to convert the first sensor output signal into the processor input signal, and to transmit the processor input signal to the processor.

9. The infusion system of claim 1, wherein the processor output signal is at least partially dependant on the body weight of the subject.

10. The infusion system of claim 1, wherein the fluid delivery period is at least partially dependant on at least one of a pre-determined maximum fluid delivery amount and a pre-determined maximum fluid delivery duration.

11. The infusion system of claim 1, wherein the duration of the refractory period is at least partially dependant on the fluid delivery period.

12. The infusion system of claim 1, further comprising a second sensor configured to monitor concentration of the analyte in the subject and to generate a sensor output signal based on the monitored concentration.

13. The infusion system of claim 3, wherein the fluid delivery system is configured to infuse the fluid containing the glucose-increasing substance into the subject and a fluid containing insulin into the subject.

14. A method of determining a fluid infusion rate for infusing a fluid into a subject, comprising:

monitoring concentration of an analyte in the subject;

generating a sensor output signal based on the monitored concentration;

generating a processor input signal from the sensor output signal;

processing the processor input signal using a front-loaded fluid delivery algorithm to generate a processor output signal having a fluid delivery period and a refractory period following the fluid delivery period; and

determining the fluid infusion rate based at least partially on the processor output signal.

15. The method of claim 14, further comprising infusing the fluid into the user at the determined fluid infusion rate.

16. The method of claim 14, wherein the analyte is glucose.

17. The method of claim 16, wherein the fluid contains a glucose-increasing substance.

18. The method of claim 17, further comprising delivering the fluid containing the glucose-increasing substance into the subject.

19. The method of claim 14, wherein monitoring concentration of an analyte in the subject includes at least a first sensor and a second sensor and the more accurate sensor output signal is used in generating a processor output signal.

20. The method of claim 16, further comprising

delivering insulin to the subject when the subject'"'"'s glucose concentration is rising at a rate above a pre-determined threshold, and the subject'"'"'s glucose concentration has risen above a pre-determined threshold level.

21. The method of claim 17, wherein the glucose-increasing substance is selected from the following:

(a) glucagon, (b) glucagon-like agent, (c) glucose, and (d) dextrose, and mixtures thereof.

22. The method of claim 14, further comprising receiving the sensor output signal at a transmitter electrically coupled to the sensor, converting the sensor output signal to the processor input signal with the transmitter, and transmitting the processor input signal to the processor with the transmitter.

23. The method of claim 14, wherein determining the fluid infusion rate is at least partially based on the body weight of the subject.

24. The method of claim 14, wherein determining the fluid infusion rate is at least partially based on at least one of the following:

a pre-determined maximum fluid delivery amount for the fluid delivery period and a pre-determined maximum fluid delivery duration for the fluid delivery period.

25. The method of claim 14, wherein the refractory period has a longer duration than the fluid delivery period.

26. A method of controlling concentration of an analyte in a mammal, comprising:

repeatedly measuring concentration of an analyte in a mammal with a first sensor implanted in the mammal;

using a front-loaded algorithm to compute a fluid delivery rate based on the measured analyte concentration; and

delivering fluid to the mammal at the computed fluid delivery rate, the computed fluid delivery rate including a fluid delivery period and a refractory period.

27. The method of claim 26, wherein the fluid delivery period is limited by at least one of a maximum time period for fluid delivery and a maximum fluid delivery amount.

28. The method of claim 26, wherein the analyte is glucose and the fluid contains a glucose-increasing substance.

29. The method of claim 26, wherein delivering fluid to the mammal includes delivering a glucose-increasing substance to the mammal with a glucose-increasing substance delivery device located outside the body of the mammal.

30. The method of claim 26, wherein delivering fluid to the mammal includes delivering a glucose-increasing substance to the mammal with a glucose-increasing substance delivery device implanted inside the body of the mammal.

31. The method of claim 26, wherein the front-loaded algorithm computes the fluid delivery rate based on a proportional derivative algorithm having a high proportional error gain factor and a high derivative error gain factor.

32. The method of claim 26, further comprising repeatedly measuring concentration of an analyte in a mammal with a second sensor implanted in the mammal;

and

using the more accurate measured analyte concentration from either the first sensor or the second sensor to compute the fluid delivery rate.

33. The method of claim 28, further comprising delivering insulin to the mammal when the mammal'"'"'s glucose concentration is rising at a rate above a pre-determined threshold, and the mammal'"'"'s glucose concentration has risen above a pre-determined threshold level.