# US 10,869,624 B2 · Real time assessement of sensor performance and prediction of the end of the functional life of an implanted sensor

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- Number: US 10,869,624 B2
- Document ID: US10869624B2
- Status: Granted
- Kind: B2
- Application number: 15/786,954
- Filed: 2017-10-18
- Published: 2018-04-19
- Granted: 2020-12-22
- Earliest claimed: 2016-10-18
- Assignees: Senseonics, Incorporated
- Applicants: Senseonics, Incorporated
- Inventors: James Masciotti; Andrew Dehennis; Xiaoxiao Chen; Barkha Raisoni; Barbara Montgomery
- Web page: https://patentgrep.com/patent/US10869624B2

## CPC

- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/0062: {Arrangements for scanning}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2560/0247: for compensation or correction of the measured physiological value
- A61B 2560/0271: using a remote monitoring unit
- A61B 2560/0276: Determining malfunction
- A61B 2560/028: Arrangements to prevent overuse, e.g. by counting the number of uses
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/50: with microprocessors or computers
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An analyte monitoring system and method. The analyte monitoring system may include an analyte sensor and a transmitter. The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element. The transmitter may be configured to receive measurement information from the analyte sensor. The transmitter may be configured to assess in real time a performance of the analyte sensor based on at least the measurement information. The transmitter may be configured to determine whether the performance of the analyte sensor is deficient based at least on the assessed performance of the analyte sensor. The transmitter may be configured to predict an amount of time remaining before the performance of the analyte sensor becomes deficient based on at least the assessed performance of the analyte sensor.

## Claims

### Claim 1

An analyte monitoring system comprising:
an analyte sensor including an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element; and
a transmitter comprising a sensor interface device and a controller, and the transmitter is configured to:
(i) use the sensor interface device to receive measurement information from the analyte sensor,
(ii) use the controller to use at least the received measurement information to calculate two or more measures selected from the group consisting of:
(a) a responsiveness of the indicator element of the analyte sensor to changes in an amount or concentration of the analyte in proximity to the indicator element,
(b) a strength of the one or more detectable properties exhibited by the indicator element of the analyte sensor,
(c) an accuracy of the analyte sensor, and
(d) a response of a body in which the analyte sensor is located to the analyte sensor,
(iii) use the controller to calculate a minimum value of the calculated two or more measures,
(iv) determine whether a performance of the analyte sensor is deficient based at least on the calculated minimum value, and
(v) predict an amount of time remaining before the performance of the analyte sensor becomes deficient based on at least the calculated minimum value.

### Claim 2 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is further configured to receive one or more reference measurements, and the transmitter is configured to use at least the measurement information and the one or more reference measurements to calculate the two or more measures.

### Claim 3 (depends on 1)

The analyte monitoring system of claim 1, wherein one or more of the responsiveness, the strength, the accuracy, and the response of the body is weighted.

### Claim 4 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is configured to, in determining whether the performance of the analyte sensor is deficient, compare the calculated minimum value to a deficiency threshold.

### Claim 5 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is configured to, in determining whether the performance of the analyte sensor is deficient, determine whether the calculated minimum value is below a deficiency threshold for at least a period of time.

### Claim 6 (depends on 1)

The analyte monitoring system of claim 1, wherein the calculated minimum value is an assessment of the performance of the analyte sensor, and the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, train an autoregressive model using one or more assessments of the performance of the analyte sensor and using the trained autoregressive model to predict future performance of the analyte sensor.

### Claim 7 (depends on 6)

The analyte monitoring system of claim 6, wherein the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, compare the predicted future performance of the analyte sensor to a deficiency threshold, and the predicted amount of time remaining before the performance of the analyte sensor becomes deficient is based on when the predicted future performance of the analyte sensor crosses the deficiency threshold.

### Claim 8 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, compare the calculated minimum value to a first sensor performance threshold and predict that a first amount of time remains before the performance of the analyte sensor becomes deficient when the calculated minimum value is less than the first sensor performance threshold.

### Claim 9 (depends on 8)

The analyte monitoring system of claim 8, wherein the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, compare the calculated minimum value to a second sensor performance threshold and predict that a second amount of time remains before the performance of the analyte sensor becomes deficient when the calculated minimum value is less than the second sensor performance threshold.

### Claim 10 (depends on 9)

The analyte monitoring system of claim 9, wherein the second amount of time is less than the first amount of time, and the second sensor performance threshold is less than the first sensor performance threshold.

### Claim 11 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, compare a time since the analyte sensor was implanted to a first implant time threshold and predict that a first amount of time remains before the performance of the analyte sensor becomes deficient when the time since the analyte sensor was implanted is greater than the first implant time threshold.

### Claim 12 (depends on 11)

The analyte monitoring system of claim 11, wherein the transmitter is configured to, in predicting the amount of time remaining before the performance of the analyte sensor becomes deficient, compare a time since the analyte sensor was implanted to a second implant time threshold and predicting that a second amount of time remains before the performance of the analyte sensor becomes deficient when the time since the analyte sensor was implanted is greater than the second implant time threshold.

### Claim 13 (depends on 12)

The analyte monitoring system of claim 12, wherein the second amount of time is less than the first amount of time, and the second implant time threshold is greater than the first implant time threshold.

### Claim 14 (depends on 1)

The analyte monitoring system of claim 1, further comprising a display device comprising a display, wherein the display device is configured to (i) receive the predicted amount of time remaining before the performance of the analyte sensor becomes deficient from the transmitter and (ii) display the predicted amount of time remaining before the performance of the analyte sensor becomes deficient.

### Claim 15 (depends on 14)

The analyte monitoring system of claim 14, wherein the display device is configured to use a color to indicate a level of severity with respect to the predicted amount of time remaining before the performance of the analyte sensor becomes deficient.

### Claim 16 (depends on 1)

The analyte monitoring system of claim 1, wherein the transmitter is further configured to detect sensor delamination based on at least the measurement information.

### Claim 17

A method comprising:
using an indicator element of an analyte sensor to exhibit one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element;
using a sensor interface device of a transmitter to receive measurement information from the analyte sensor;
using a controller of the transmitter to use at least the received measurement information to calculate two or more measures selected from the group consisting of:
(a) a responsiveness of the indicator element of the analyte sensor to changes in an amount or concentration of the analyte in proximity to the indicator element,
(b) a strength of the one or more detectable properties exhibited by the indicator element of the analyte sensor,
(c) an accuracy of the analyte sensor, and
(d) a response of a body in which the analyte sensor is located to the analyte sensor;
using the controller of the transmitter to calculate a minimum value of the calculated two or more measures;
using the transmitter to determine whether the performance of the analyte sensor is deficient based at least on the calculated minimum value; and, if not deficient
using the transmitter to predict an amount of time remaining before the performance of the analyte sensor becomes deficient based on at least the calculated minimum value.
