Adaptive signal processing for infusion devices and related methods and systems

• US 10,007,765 B2
• Filed: 05/19/2014
• Issued: 06/26/2018
• 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): Dejong, Eric S
• Application Number:
  US14/281,766
• Publication Number:
  US 20150328402A1
• Time in Patent Office: 1,499 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G05B 15/02 electric
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining a filtered measurement indicative of a physiological condition of a user, determining a metric indicative of a characteristic of the filtered measurement based at least in part on one or more derivative metrics associated with the filtered measurement, and determining an output measurement indicative of the physiological condition of the user based at least in part on the filtered measurement, the metric, and a previous output measurement.

Claims

1. A method comprising:

storing, by a control module coupled to a sensing element, a plurality of unfiltered measurement values obtained from a sensing element in a first buffer, the plurality of unfiltered measurement values comprising periodically sampled output electrical signals from the sensing element, wherein the output electrical signals are influenced by a physiological condition in a body of a user;

determining, by the control module, a plurality of filtered measurements indicative of the physiological condition of the user based on the plurality of unfiltered measurement values;

storing, by the control module, the plurality of filtered measurements in a second buffer;

determining, by the control module, a first derivative metric associated with a current filtered measurement of the plurality of filtered measurements and a second derivative metric associated with the current filtered measurement based on the plurality of filtered measurements;

determining, by the control module, a process variance metric indicative of a signal characteristic of a current filtered measurement based at least in part on the first derivative metric and the second derivative metric;

determining, by the control module, an output filtered measurement indicative of the physiological condition of the user based at least in part on the current filtered measurement, the process variance metric, and a previous output measurement; and

transmitting, by a communications interface coupled to the control module, the output filtered measurement to an infusion device, wherein operation of the infusion device to deliver fluid to the body of the user is influenced by the output filtered measurement, the fluid influencing the physiological condition in the body of the user.

2. The method of claim 1, wherein determining the process variance metric comprises:

determining a frequency estimate associated with the current filtered measurement based on the first derivative metric;

determining a noise estimate associated with the current filtered measurement based on the second derivative metric; and

determining the process variance metric as a function of the frequency estimate and the noise estimate.

3. The method of claim 2, wherein:

determining the frequency estimate comprises scaling the first derivative metric by a calibration factor for converting the output filtered measurement to a sensed value for the physiological condition, the first derivative metric comprising an average of first derivative values associated with the current filtered measurement and one or more preceding filtered measurements; and

determining the noise estimate comprises scaling the second derivative metric by the calibration factor, the second derivative metric comprising an average of second derivative values associated with the current filtered measurement and the one or more preceding filtered measurements.

4. The method of claim 2, further comprising:

determining a rate of change metric associated with the current filtered measurement based at least in part on the first derivative metric;

scaling the rate of change metric for the current filtered measurement based on the noise estimate when the noise estimate is less than a threshold value, resulting in a scaled rate of change metric; and

adding the scaled rate of change metric to the current filtered measurement to obtain an adjusted filtered measurement, wherein determining the output filtered measurement comprises determining the output filtered measurement based at least in part on the adjusted filtered measurement, the process variance metric, and the previous output measurement.

5. The method of claim 1, further comprising:

identifying a dropout condition based at least in part on one or more of the first derivative metric and the second derivative metric associated with the current filtered measurement; and

determining an adjusted filtered measurement in response to identifying the dropout condition, wherein determining the output filtered measurement comprises determining the output filtered measurement based at least in part on the adjusted filtered measurement, the process variance metric, and the previous output measurement.

6. The method of claim 5, further comprising modifying the process variance metric in response to identifying the dropout condition.

7. The method of claim 5, wherein identifying the dropout condition comprises identifying the dropout condition when the first derivative metric associated with the current filtered measurement is greater than a first derivative dropout threshold value and the second derivative metric associated with the current filtered measurement is less than a second derivative dropout threshold value.

8. The method of claim 1, further comprising adjusting the current filtered measurement to compensate for delay based at least in part on one or more of the first derivative metric and the second derivative metric associated with the current filtered measurement, resulting in an adjusted filtered measurement, wherein determining the output filtered measurement comprises determining the output filtered measurement based on the adjusted filtered measurement, the process variance metric, and the previous output measurement.

9. The method of claim 8, further comprising determining a noise estimate associated with the current filtered measurement based on the second derivative metric associated with the current filtered measurement, wherein adjusting the current filtered measurement comprises:

scaling a rate of change metric for the current filtered measurement based on the noise estimate when the noise estimate is less than a threshold value, resulting in a scaled rate of change metric; and

adding the scaled rate of change metric to the current filtered measurement to obtain the adjusted filtered measurement.

10. The method of claim 1, further comprising identifying an artifact condition when a difference between the current filtered measurement and a preceding filtered measurement of the plurality of filtered measurements exceeds a threshold value, wherein determining the output filtered measurement comprises maintaining the previous output measurement in response to the artifact condition.

11. The method of claim 1, further comprising:

determining a sensed value for the physiological condition of the user based on the output filtered measurement and a calibration factor associated with the sensing element;

determining a delivery command based at least in part on a difference between the sensed value and a target value for the physiological condition of the user; and

operating the infusion device to deliver the fluid to the user in accordance with the delivery command.

12. 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.

13. The method of claim 1, wherein determining the output filtered measurement comprises:

determining an intermediate error estimate based on a preceding output error estimate and the process variance metric;

determining a filter gain value based on the intermediate error estimate and a measurement error value; and

determining the output filtered measurement based on the current filtered measurement, the filter gain value, and the previous output measurement.

14. The method of claim 1, wherein determining the output filtered measurement comprises implementing a Kalman filter to filter the current filtered measurement using the previous output measurement and the process variance metric indicative of the signal characteristic of the current filtered measurement.

15. The method of claim 14, wherein implementing the Kalman filter comprises:

determining an intermediate error estimate based on a preceding output error estimate and the process variance metric;

determining a Kalman filter gain value based on the intermediate error estimate and a measurement error value; and

determining the output filtered measurement according to the equation i_out=i_out[n−

1]+k(i_sig−

i_out[n−

1]), where i_out is the output measurement value, i_out[n−

1] represents the preceding output measurement, i_sig represents the current filtered measurement, and k represents the Kalman filter gain value.

16. The method of claim 14, further comprising adjusting the current filtered measurement to compensate for delay based at least in part on one or more of the first derivative metric and the second derivative metric associated with the current filtered measurement, resulting in an adjusted filtered measurement, wherein determining the output measurement comprises:

determining an intermediate error estimate based on a preceding output error estimate and the process variance metric;

determining a Kalman filter gain value based on the intermediate error estimate and a measurement error value; and

determining the output filtered measurement according to the equation i_out=i_out[n−

1]+k(i_sig−

i_out[n−

1]), where i_out is the output measurement value, i_out[n−

1] represents the preceding output measurement, i_sig represents the adjusted filtered measurement, and k represents the Kalman filter gain value.

17. A sensing device comprising:

a sensing element to output electrical signals influenced by a physiological condition of a user;

a first buffer to maintain a plurality of unfiltered measurement values comprising periodically sampled output electrical signals from the sensing element;

a second buffer to maintain a plurality of filtered measurements;

a control module coupled to the sensing element, the first buffer, and the second buffer to;

determine the plurality of filtered measurements indicative of the physiological condition of the user based on the plurality of unfiltered measurement values;

determine a first derivative metric associated with a current filtered measurement of the plurality of filtered measurements and a second derivative metric associated with the current filtered measurement based on the plurality of filtered measurements;

determine a process variance metric indicative of a signal characteristic of the current filtered measurement of the plurality of filtered measurements based at least in part on the first derivative metric and the second derivative metric associated with the current filtered measurement; and

determine an output filtered measurement indicative of the physiological condition of the user based at least in part on the current filtered measurement, the process variance metric, and a previous output measurement; and

a communications interface coupled to the control module to transmit the output filtered measurement.

18. The sensing device of claim 17, wherein operation of an infusion device to regulate the physiological condition of the user is influenced by the output filtered measurement transmitted to the infusion device by the communications interface.

19. The sensing device of claim 17, wherein the control module is configured to determine a delivery command for operating a motor operable to deliver fluid influencing the physiological condition to a body of the user based at least in part on the output filtered measurement.