# US 11,484,227 B2 · Method for conditioning of a sensor

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- Number: US 11,484,227 B2
- Document ID: US11484227B2
- Status: Granted
- Kind: B2
- Application number: 16/178,431
- Filed: 2018-11-01
- Published: 2019-05-02
- Granted: 2022-11-01
- Earliest claimed: 2017-11-01
- Assignees: WaveForm Technologies, Inc.
- Applicants: WaveForm Technologies, Inc.
- Inventors: Mihailo V. Rebec; Robert Bruce; Ralph Dutt-Ballerstadt
- Web page: https://patentgrep.com/patent/US11484227B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/14539: {for measuring pH}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/6849: {in combination with a needle set}
- G01N 27/3274: {Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771)}
- G01N 27/49: Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A method of in vivo conditioning of an indwelling sensor to reduce run-in time, (stabilization time) comprising: a) applying a first potential to the sensor and measuring a first current at the first potential; b) applying a second potential to the sensor and measuring a second current at the second potential; c) determining a relationship of the first current measured to the second current measured; repeating a, b, and c until the relationship between the first current measured and the second current measured has stabilized, thereby reducing sensor run-in time.

## Claims

### Claim 1

A method of conditioning of an indwelling sensor to reduce run-in time, comprising:
performing a plurality of conditioning cycles, wherein each conditioning cycle is performed by:
measuring a current of the indwelling sensor when applying a first potential to the indwelling sensor in a respective time period, wherein the first potential is greater than or equal to a running voltage of the indwelling sensor,
measuring the current of the indwelling sensor when applying a second potential to the indwelling sensor in a respective time period, wherein the first potential is greater than the second potential and the respective time period in which the first potential is applied to the indwelling sensor is greater than the respective time period in which the second potential is applied to the indwelling sensor, and
determining a ratio of the current measured when applying the first potential to the current measured when applying the second potential; and terminating the conditioning cycles when the ratio has stabilized.

### Claim 2 (depends on 1)

The method of claim 1, where the second potential is between about 200 mV and about 900 mV and the first potential is between about 300 mV and about 1000 mV.

### Claim 3 (depends on 1)

The method of claim 1, where the second potential is between about 200 mV and about 900 mV and the first potential is between about 700 mV and about 900 mV.

### Claim 4 (depends on 1)

The method of claim 1, where at least 3 of the conditioning cycles are performed.

### Claim 5 (depends on 1)

The method of claim 1, where in each conditioning cycle, the first potential is applied for about 30 seconds to about 15 minutes and the second potential is applied for about 10 seconds to about 3 minutes.

### Claim 6 (depends on 1)

The method of claim 1, where the method is repeated for between about 5 minutes and about 120 minutes.

### Claim 7 (depends on 1)

The method of claim 1, where the indwelling sensor comprises a glucose sensor.

### Claim 8 (depends on 1)

The method of claim 1, where the method is initiated before about 5 minutes after insertion of the indwelling sensor into a tissue of a subject.

### Claim 9 (depends on 1)

The method of claim 1, where the method is performed after a predetermined time period to determine if the indwelling sensor is functioning properly.

### Claim 10 (depends on 1)

The method of claim 1, where the method is performed in response to a determination that a signal drift as recorded by the indwelling sensor does not correspond to actual levels of an analyte the indwelling sensor is configured to measure.

### Claim 11 (depends on 1)

The method of claim 1, where the measured current when applying the first potential and when applying the second potential is between about 1 nA and about 50 nA.

### Claim 12 (depends on 1)

The method of claim 1, where in each conditioning cycle the ratio is between about 3 and about 14.

### Claim 13 (depends on 1)

The method of claim 1, where the method is performed prior to calibration of the indwelling sensor.

### Claim 14 (depends on 1)

The method of claim 1, where the method is performed in vitro prior to insertion of the indwelling sensor into a tissue of a subject.

### Claim 15 (depends on 1)

The method of claim 1, where the method is performed partially in vitro prior to insertion of the indwelling sensor into a tissue of a subject and partially in vivo after insertion of the indwelling sensor into the tissue of the subject.

### Claim 16 (depends on 1)

The method of claim 1, wherein in each conditioning cycle the respective time period in which the first potential is applied to the indwelling sensor is 10 minutes or more and the respective time period in which the second potential is applied to the indwelling sensor is 5 minutes or less.

### Claim 17 (depends on 1)

The method of claim 1, wherein in each conditioning cycle the respective time period in which the first potential is applied to the indwelling sensor is at least twice the respective time period in which the second potential is applied to the indwelling sensor.

### Claim 18 (depends on 1)

The method of claim 1, wherein in each conditioning cycle the respective time period in which the first potential is applied to the indwelling sensor is at least ten times the respective time period in which the second potential is applied to the indwelling sensor.

### Claim 19 (depends on 1)

The method of claim 1, wherein in each conditioning cycle the respective time period in which the first potential is applied to the indwelling sensor is at least five times the respective time period in which the second potential is applied to the indwelling sensor.

### Claim 20 (depends on 1)

The method of claim 1, wherein the second potential is used for estimating a completion of the run-in of the indwelling sensor.

### Claim 21 (depends on 1)

The method of claim 1, wherein in each conditioning cycle the respective time period in which the first potential is applied to the indwelling sensor is at least twenty times the respective time period in which the second potential is applied to the indwelling sensor.
