# US 11,298,058 B2 · Method and apparatus for providing analyte sensor insertion

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- Number: US 11,298,058 B2
- Document ID: US11298058B2
- Status: Granted
- Kind: B2
- Application number: 16/429,882
- Filed: 2019-06-03
- Published: 2019-09-19
- Granted: 2022-04-12
- Earliest claimed: 2005-12-28
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Gary Ashley Stafford
- Web page: https://patentgrep.com/patent/US11298058B2

## CPC

- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/0015: {characterised by features of the telemetry system}
- 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 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices and methods for positioning a portion of a sensor at a first predetermined location, displacing the portion of the sensor from the first predetermined location to a second predetermined location, and detecting one or signals associated with an analyte level of a patient at the second predetermined location are disclosed. Also provided are systems and kits for use in analyte monitoring.

## Claims

### Claim 1

A method, comprising:
actuating a button of an inserter to cause steps (a) and (b) to be performed without further user intervention:
(a) positioning a portion of a glucose sensor and a sharp at a first predetermined location at a first velocity, wherein the first predetermined location comprises an insertion site on a patient's skin, and
(b) after reaching the first predetermined location, positioning the portion of the glucose sensor to a predetermined insertion depth, and displacing the sharp to a second predetermined location at a second velocity different from the first velocity; and
detecting, by the glucose sensor, one or more signals associated with a glucose level of a bodily fluid of the patient, wherein the glucose level is an in vivo glucose level;
wirelessly transmitting, by a transmitter unit in electrical communication with the glucose sensor, data corresponding to the one or more signals associated with the glucose level to a first display device and a second display device; and
displaying on the first display device or the second display device the data corresponding to the one or more signals associated with the glucose level after a waiting period, wherein the waiting period is less than about one hour after the glucose sensor is positioned in the patient's skin.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first velocity comprises a first speed, and wherein the second velocity comprises a second speed different from the first speed.

### Claim 3 (depends on 2)

The method of claim 2, wherein the second speed is less than the first speed.

### Claim 4 (depends on 1)

The method of claim 1, wherein positioning the portion of the glucose sensor and the sharp at the first predetermined location comprises inserting the portion of the glucose sensor into the patient's skin.

### Claim 5 (depends on 4)

The method of claim 4, wherein the portion of the glucose sensor is inserted into the patient's skin at a predetermined angle.

### Claim 6 (depends on 5)

The method of claim 5, wherein the predetermined angle is an acute angle.

### Claim 7 (depends on 5)

The method of claim 5, wherein the predetermined angle is less than about 90 degrees.

### Claim 8 (depends on 5)

The method of claim 5, wherein the predetermined angle is 90 degrees.

### Claim 9 (depends on 1)

The method of claim 1, wherein the second predetermined location comprises a predetermined depth from a surface of the patient's skin.

### Claim 10 (depends on 9)

The method of claim 9, wherein the predetermined depth is between 3 mm to 9 mm from the surface of the patient's skin.

### Claim 11 (depends on 1)

The method of claim 1, further comprising:
releasing energy from a spring in response to the button being actuated by the patient, wherein the spring is configured to cause the positioning of the portion of the glucose sensor and the sharp at the first predetermined location without further user intervention.

### Claim 12 (depends on 11)

The method of claim 11, wherein the spring is a wound spring.

### Claim 13 (depends on 11)

The method of claim 11, wherein the button, the spring, and the sharp are part of a sensor inserter device.

### Claim 14 (depends on 1)

The method of claim 1, wherein the glucose sensor comprises an interferant-eliminating layer.

### Claim 15 (depends on 1)

The method of claim 1,
wherein the data corresponding to the one or more signals associated with the glucose level is displayed on the first display device or the second display device without requiring user calibration after the portion of the glucose sensor and the sharp are positioned at the first predetermined location.

### Claim 16 (depends on 1)

The method of claim 1, further comprising:
capturing, by an adhesive mount, a proximal section of the glucose sensor when the sharp is displaced to the second predetermined location.

### Claim 17 (depends on 16)

The method of claim 16, further comprising:
releasing the glucose sensor from the sharp after the sharp is displaced to the second predetermined location.

### Claim 18 (depends on 1)

The method of claim 1, further comprising:
retrieving, using one or more processors, a factory-determined calibration value stored in a memory storage component.

### Claim 19 (depends on 18)

The method of claim 18, wherein the factory-determined calibration value is not modified during a lifetime of the glucose sensor.

### Claim 20 (depends on 1)

The method of claim 1, wherein the waiting period is about thirty minutes.
