Analyte sensor introducer and methods of use

• US 20070060814A1
• Filed: 08/30/2005
• Published: 03/15/2007
• Est. Priority Date: 08/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary
• Granted Patent: US 7,731,657 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. An introducer, comprising:

a body portion; and

a shaft portion extending substantially from an edge of the body portion, the shaft portion including a tapered end, the shaft portion configured to substantially retain a sensor, and further, wherein the tapered end is configured to guide the sensor through a skin layer.

2. The introducer of claim 1 wherein the shaft portion is substantially hollow.

3. The introducer of claim 1 wherein the shaft portion includes an opening substantially along the length of the shaft portion.

4. The introducer of claim 3 wherein the opening is configured to be wider than the width of a sensor retained therein such that the sensor may be displaced out of the shaft portion through the opening.

5. The introducer of claim 3 wherein the shaft portion is configured to retain at least a portion of the sensor substantially subcutaneously when the shaft portion is removed from the skin layer.

6. The introducer of claim 1 wherein the tapered end of the shaft portion is configured to pierce the skin layer, and further, wherein at least a portion of the sensor is substantially retained within the shaft portion while the tapered end is piercing through the skin layer.

7. The introducer of claim 1 wherein when the tapered end of the shaft portion is transcutaneously introduced to the skin layer, the sensor is substantially contemporaneously transcutaneously introduced through the skin layer.

8. The introducer of claim 1 wherein the sensor includes an analyte sensor.

9. The introducer of claim 8 wherein the analyte sensor is a glucose sensor.

10. The introducer of claim 8 wherein the introducer is configured to position an analyte sensor in fluid contact with the patient'"'"'s analyte.

11. A method of introducing a sensor;

comprising;

aligning a tapered end of an introducer substantially onto a sensor insertion site of a patient;

piercing the skin at the sensor insertion site of the patient with the tapered end of the introducer;

guiding a sensor with the introducer through the skin; and

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

12. The method of claim 11, wherein the sensor includes an analyte sensor.

13. The method of claim 12 wherein the analyte sensor is a glucose sensor.

14. The method of claim 11 wherein the guiding step includes the step of substantially entirely retaining at least a portion of the sensor within a shaft portion of the introducer.

15. The method of claim 11 wherein the tapered end of the introducer includes a substantially sharp edge segment configured to pierce the skin.

16. The method of claim 15 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.

17. An analyte monitoring system, comprising:

a sensor;

an 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, the shaft portion configured to substantially retain the sensor, and further, wherein the tapered end is configured to guide the sensor through a skin layer; and

a transmitter configured to operatively coupled to the sensor, the transmitter, further configured to transmit a data associated with a detected analyte level received from the sensor.

18. The system of claim 18 further including a receiver operatively coupled to the transmitter, the receiver further configured to receive the data from the transmitter.

19. The system of claim 18 wherein the transmitter is configured to wireless transmit the data.

20. An inserter kit, comprising:

a sensor;

an 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, the shaft portion configured to substantially retain the sensor, and further, wherein the tapered end is configured to guide the sensor through a skin layer of a patient;

a drive mechanism coupled to the body portion, the drive mechanism configured to drive at least a section of the shaft portion through the skin layer, and further, to retract the at least the section of the shaft portion substantially completely out of the patient;

wherein at least a portion of the sensor is placed subcutaneously when the at least the section of the shaft portion of the introducer is retracted from the skin layer such that the sensor is substantially in fluid contact with the analyte of the patient.