Calibration factor adjustments for infusion devices and related methods and systems

• US 10,274,349 B2
• Filed: 05/19/2014
• Issued: 04/30/2019
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Nogueira, Keith, Agrawal, Pratik, Kannard, Brian T., Li, Xiaolong, Liang, Bradley C., Shah, Rajiv, Zhong, Yuxiang
• Primary Examiner(s): Betsch, Regis J
• Application Number:
  US14/281,770
• Publication Number:
  US 20150331418A1
• Time in Patent Office: 1,807 Days
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• 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: G01D 18/00 Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
• CPC Class Codes: G05B 23/00 Testing or monitoring of control systems or parts thereof monitoring of programme-control systems G05B19/048, G05B19/406

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves obtaining one or more uncalibrated measurements indicative of the physiological condition, obtaining one or more reference measurements of the physiological condition, determining a raw calibration factor based on a relationship between the one or more uncalibrated measurements and the one or more reference measurements corresponding to the respective uncalibrated measurements of the one or more uncalibrated measurements, and determining an adjusted calibration factor based at least in part on an expected calibration factor and the raw calibration factor, wherein operation of the infusion device to deliver the fluid is influenced by the adjusted calibration factor.

Claims

1. A method of autonomously operating an infusion device operable to deliver fluid to a user based on measurements indicative of a physiological condition of the user provided by a sensing arrangement during a startup period upon initialization of an interstitial glucose sensing element of the sensing arrangement, the fluid influencing the physiological condition of the user, the method comprising:

sampling, by a control module coupled to the interstitial glucose sensing element of the sensing arrangement, output signals provided by the interstitial glucose sensing element to obtain one or more uncalibrated measurements indicative of the physiological condition, wherein the output signals are influenced by the physiological condition;

obtaining, by the control module, one or more reference measurements of the physiological condition, each respective reference measurement of the one or more reference measurements corresponding to a respective uncalibrated measurement of the one or more uncalibrated measurements;

determining, by the control module, a raw calibration factor based on a relationship between the one or more uncalibrated measurements and the one or more reference measurements corresponding to the respective uncalibrated measurements of the one or more uncalibrated measurements; and

when the raw calibration factor is outside of a range of acceptable values during the startup period where the sensitivity of the interstitial glucose sensing element is unsettled and deviates from a likely long-term sensitivity;

dynamically determining, by the control module, an adjusted calibration factor based at least in part on an expected calibration factor as a function of an elapsed time since a time associated with the raw calibration factor and the raw calibration factor, wherein the adjusted calibration factor is dynamically adjusted from the raw calibration factor towards the expected calibration factor as the elapsed time increases by calculating the adjusted calibration factor using the equation CF_ADJ=CF_R+t(p₁CF_R+p₂), where CF_R is the raw calibration factor, t is the elapsed time since the time associated with the raw calibration factor, and p₁ and p₂ are scalar values configured to linearly adjust the adjusted calibration factor towards the expected calibration factor;

multiplying an uncalibrated measurement value obtained by sampling an output signal provided by the interstitial glucose sensing element by the adjusted calibration factor to obtain a sensed measurement value indicative of the physiological condition of the user; and

autonomously operating the infusion device to deliver the fluid in accordance with a delivery command determined using the sensed measurement value.

2. The method of claim 1, further comprising determining the adjusted calibration factor as a weighted sum of the raw calibration factor and the expected calibration factor after the startup period.

3. The method of claim 2, wherein operating the infusion device comprises:

determining a delivery command for operating a motor of the infusion device based on a relationship between the sensed measurement value and a target value for the physiological condition.

4. The method of claim 2, further comprising:

determining the expected calibration factor based at least in part on a current uncalibrated measurement indicative of the physiological condition and a recent reference measurement one or more reference measurements, wherein;

determining the adjusted calibration factor comprises determining the adjusted calibration factor as a weighted sum of the expected calibration factor and a preceding calibration factor based at least in part on a derivative metric associated with the current uncalibrated measurement prior to obtaining a recent uncalibrated measurement of the one or more uncalibrated measurements that corresponds to the recent reference measurement.

5. The method of claim 1, wherein determining the raw calibration factor comprises:

determining a first sum of products of each respective uncalibrated measurement of the one or more uncalibrated measurements, the respective reference measurement corresponding to the respective uncalibrated measurement, and one or more weighting factors associated therewith;

determining a second sum of products of a square of each respective uncalibrated measurement of the one or more uncalibrated measurements and the one or more weighting factors; and

determining the raw calibration factor as a ratio of the first sum to the second sum.

6. The method of claim 5, further comprising determining a first weighting factor of the one or more weighting factors as a function of the respective reference measurement corresponding to the respective uncalibrated measurement.

7. The method of claim 1, wherein:

dynamically adjusting the raw calibration factor comprises dynamically adjusting the raw calibration factor in response to identifying a recent uncalibrated measurement of the one or more uncalibrated measurements that corresponds to a recent reference measurement of the one or more reference measurements was obtained within a threshold amount of time of initialization of the interstitial glucose sensing element.

8. The method of claim 1, wherein:

dynamically adjusting the raw calibration factor comprises dynamically adjusting the raw calibration factor in response to identifying a low current condition for the interstitial glucose sensing element based on a relationship between a recent uncalibrated measurement of the one or more uncalibrated measurements that corresponds to a recent reference measurement of the one or more reference measurements.

9. A computer-readable medium having computer-executable instructions stored thereon that, when executed by a control module, cause the control module to perform the method of claim 1.

10. The method of claim 1, further comprising:

automatically terminating the dynamically adjusting when the adjusted calibration factor is within a range of acceptable values.

11. The method of claim 1, further comprising automatically suspending dynamically determining the adjusted calibration factor when a product of the adjusted calibration factor and a recent uncalibrated measurement indicative of the physiological condition is less than a threshold value.

12. An infusion system for autonomously delivering fluid to a user based on measurements indicative of a physiological condition of the user during a startup period upon initialization of an interstitial glucose sensing element, the fluid influencing the physiological condition of the user, the infusion system comprising:

a sensing arrangement including the interstitial glucose sensing element to provide output signals influenced by the physiological condition in a body of the user, the sensing arrangement determining uncalibrated measurements of the physiological condition based at least in part on the output signals; and

an infusion device comprising;

a motor operable to deliver the fluid to the body of the user; and

a control system to determine a delivery command for operating the motor based at least in part on a sensed measurement value obtained by multiplying an uncalibrated measurement value obtained by sampling an output signal provided by the interstitial glucose sensing element by an adjusted calibration factor for converting the uncalibrated measurements when the calibration factor is outside of a range of acceptable values during a startup period associated with the sensing arrangement where the sensitivity of the interstitial glucose sensing element is unsettled and deviates from a likely long-term sensitivity, wherein;

the calibration factor is dynamically adjusted based at least in part on an expected calibration factor as a function of a raw calibration factor and an elapsed time since a time associated with the raw calibration factor;

the raw calibration factor is calculated based on one or more reference measurements for the physiological condition and one or more of the uncalibrated measurements;

the adjusted calibration factor is dynamically adjusted from the raw calibration factor towards the expected calibration factor as the elapsed time increases by calculating the adjusted calibration factor using the equation CF_ADJ=CF_R+t(p₁CF_R+p₂), where CF_R is the raw calibration factor, t is the elapsed time since the time associated with the raw calibration factor, and p₁ and p₂ are scalar values configured to linearly adjust the adjusted calibration factor towards the expected calibration factor; and

each of the one or more of the uncalibrated measurements is paired with a respective reference measurement of the one or more reference measurements.

13. The infusion system of claim 12, further comprising a meter for obtaining the one or more reference measurements from the body of the user.

14. The infusion system of claim 12, wherein the calibration factor is determined as a weighted sum of the expected calibration factor and the raw calibration factor.

15. The infusion system of claim 14, wherein:

the raw calibration factor comprises a ratio of a first weighted sum to a second weighted sum;

the first weighted sum comprises a sum of products of each respective uncalibrated measurement of the one or more of the uncalibrated measurements, the respective reference measurement paired with the respective uncalibrated measurement, and one or more weighting factors associated with the respective pairing;

the second weighted sum comprises a sum of products of a square of each respective uncalibrated measurement of the one or more uncalibrated measurements and the one or more weighting factors; and

a first weighting factor of the one or more weighting factors is calculated as a function of the respective reference measurement of the respective pairing.

16. The infusion system of claim 12, wherein:

the physiological condition comprises a glucose level of the user; and

the fluid comprises insulin.

17. A device comprising:

an interstitial glucose sensing element to provide one or more signals influenced by a physiological condition of a user; and

a control module coupled to the interstitial glucose sensing element to;

sample the one or more signals provided by the interstitial glucose sensing element to obtain one or more uncalibrated measurements indicative of the physiological condition based on the one or more signals;

obtain one or more reference measurements of the physiological condition, each respective reference measurement of the one or more reference measurements corresponding to a respective uncalibrated measurement of the one or more uncalibrated measurements;

determine a raw calibration factor based on a relationship between the one or more uncalibrated measurements and the one or more reference measurements corresponding to the respective uncalibrated measurements of the one or more uncalibrated measurements; and

when the raw calibration factor is not within a range of acceptable values during a startup period where the sensitivity of the interstitial glucose sensing element is unsettled and deviates from a likely long-term sensitivity, dynamically determine an adjusted calibration factor based at least in part on an expected calibration factor as a function of the raw calibration factor and an elapsed time since a time associated with the raw calibration factor, wherein;

the adjusted calibration factor is dynamically adjusted from the raw calibration factor towards the expected calibration factor as the elapsed time increases by calculating the adjusted calibration factor using the equation CF_ADJ=CF_R+t(p₁CF_R+p₂), where CF_R is the raw calibration factor, t is the elapsed time since the time associated with the raw calibration factor, and p₁ and p₂ are scalar values configured to linearly adjust the adjusted calibration factor towards the expected calibration factor; and

autonomous delivery of a fluid influencing the physiological condition is influenced by a sensed measurement value obtained by multiplying an uncalibrated measurement value obtained by sampling an output signal provided by the interstitial glucose sensing element by the adjusted calibration factor.

18. The device of claim 17, wherein:

the physiological condition comprises a glucose level of the user; and

the fluid comprises insulin.