Analyte Sensor Introducer and Methods of Use

• US 20100249565A1
• Filed: 06/07/2010
• Published: 09/30/2010
• Est. Priority Date: 08/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Stafford, Gary Ashley
• Granted Patent: US 8,602,991 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

Method and apparatus for providing an introducer for transcutaneous placement of at least a portion of an analyte sensor through the skin of a patient is provided.

Claims

1. A method of introducing a sensor, comprising:

aligning a tapered end of an introducer substantially onto a sensor insertion site of a patient by positioning a housing over the insertion site;

piercing the skin at the sensor insertion site of the patient with the tapered end of the introducer with a drive mechanism coupled to the introducer;

guiding a sensor with the introducer through the skin, the introducer including a segment for limiting the movement of the sensor when the sensor is guided through the skin;

removing the introducer substantially completely from the patient while subcutaneously retaining at least a portion of the sensor in the patient; and

detachably removing the drive mechanism from the housing.

2. The method of claim 1 including maintaining the removed introducer within the housing.

3. The method of claim 1, wherein the sensor includes an analyte sensor.

4. The method of claim 3 wherein the analyte sensor is a glucose sensor.

5. The method of claim 1 wherein guiding includes substantially entirely retaining at least a portion of the sensor within a shaft portion of the introducer.

6. The method of claim 1 wherein the tapered end of the introducer includes a substantially sharp edge segment configured to pierce the skin.

7. The method of claim 6 wherein the sharp edge segment of the tapered end is substantially configured at an angle greater than 45 degrees relative to direction of the sharp edge segment piercing the skin.

8. An analyte monitoring system, comprising:

a housing;

a sensor having a portion provided within the housing;

an introducer coupled to the sensor and the housing, the introducer including;

a body portion; and

a shaft portion extending substantially from an edge of the body portion, the shaft portion including a tapered end and a segment, the shaft portion retaining the sensor, and further, the tapered end guiding the sensor through a skin layer during sensor insertion and the segment limiting the movement of the sensor when the sensor is guided through the skin layer the introducer retained within the housing after retraction from the skin layer and sensor insertion through the skin layer; and

a drive mechanism detachably coupled to the housing to provide insertion force to the introducer during sensor insertion, the drive mechanism detached from the housing after the sensor is guided through the skin layer and the introducer is positioned within the housing.

9. The system of claim 8 further including a receiver operatively coupled to a transmitter disposed in the housing, the receiver further configured to receive the data from the transmitter.

10. The system of claim 9 wherein the transmitter is configured to wirelessly transmit the data.

11. The system of claim 8, wherein the sensor is configured to monitor a level of an analyte.

12. The system of claim 11, wherein the analyte is glucose.

13. The system of claim 11, wherein after the sensor is guided through the skin layer, the sensor is in contact with the analyte.

14. The system of claim 8, wherein the drive mechanism is reusable.

15. The system of claim 8, wherein the housing includes a spring coupleable to the drive mechanism for providing the insertion force.

16. The system of claim 8, wherein the drive mechanism is one of a spring biased mechanism, magnetic force implementation, or a motor and gear combination.

17. The system of claim 8, wherein the drive mechanism is activated using one or more of an activation button, a lever, a plunger, a switch, or a knob.

18. The system of claim 8, wherein a transmitter unit is coupled to the housing after insertion of the sensor and detachment of the device mechanism from the housing.

19. The system of claim 18, wherein the transmitter unit is configured to transmit a level of an analyte to a remote device.

20. The system of claim 19, wherein the remote device includes a receiver unit, monitoring unit and/or an insulin pump.

21. The system of claim 19, wherein the transmitter unit is configured for wireless communication.

22. The system of claim 8, wherein the tapered end of the shaft portion is configured to pierce the skin layer.

23. The system of claim 8, wherein the shaft portion is substantially hollow.

24. The system of claim 8, wherein the shaft portion includes an opening substantially along the length of the shaft portion.

25. The system of claim 24, wherein the opening is configured to be wider than the width of the sensor retained therein, such that the sensor may be displaced out of the shaft portion through the opening.