Sensor inserter methods of use

• US 7,582,059 B2
• Filed: 09/06/2007
• Issued: 09/01/2009
• Est. Priority Date: 11/05/2002
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Flynn, Stephen J., Funderburk, Jeffery V., Kelemen, Bradley D., Yamasaki, Duane O., VanHiel, Brian
• Primary Examiner(s): Mallari; Patricia C
• Application Number:
  US11/899,870
• Publication Number:
  US 20080064941A1
• Time in Patent Office: 726 Days
• Field of Search: 600/365, 600/347
• US Class Current: 600/365
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 50/00 ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte, such as blood glucose. An inserter having a retractable introducer is provided for subcutaneously implanting the sensor in a predictable and reliable fashion.

Claims

1. A method, comprising:

providing an introducer sharp assembly configured to releasably receive a glucose sensor;

positioning the introducer sharp assembly and the glucose sensor over an insertion site of the skin of a patient;

driving at least portions of the introducer sharp assembly and the glucose sensor into the skin of the patient at the insertion site;

releasing the glucose sensor from the introducer sharp assembly such that at least a portion of the glucose sensor remains in fluid contact with an interstitial fluid under the skin of the patient; and

separating the introducer sharp assembly and the glucose sensor such that the introducer sharp assembly is entirely withdrawn from under the skin of the patient;

wherein releasing the glucose sensor comprises using an adhesive member in cooperation with the sensor to release the glucose sensor from the introducer sharp assembly.

2. A method, comprising:

providing a sensor inserter device having a movable introducer sharp, the introducer sharp configured to releasably receive a sensor;

placing the sensor inserter device adjacent to the skin of a patient;

activating the inserter device to drive at least portions of the introducer sharp and the sensor into the skin of the patient; and

releasing the sensor from the introducer sharp such that at least a portion of the sensor remains in the skin of the patient as the introducer sharp is retracted from the skin;

wherein the step of releasing the sensor comprises using an adhesive member to pull the sensor from the introducer sharp; and

further

wherein the introducer sharp includes a skin piercing edge which cuts the skin as the introducer sharp and the sensor are driven into the skin of the patient.

3. The method of claim 2 wherein the cutting portion of the introducer sharp is beveled.

4. The method of claim 2 wherein the introducer sharp is retracted from the skin and into a housing of the inserter device.

5. A method, comprising:

providing a sensor inserter device having a movable introducer sharp, the introducer sharp configured to releasably receive a sensor;

placing the sensor inserter device adjacent to the skin of a patient;

activating the inserter device to automatically drive at least portions of the introducer sharp and the sensor into the skin of the patient; and

releasing the sensor from the introducer sharp such that at least a portion of the sensor remains in the skin of the patient as the introducer sharp is automatically retracted from the skin and into a housing of the inserter device;

wherein the step of releasing the sensor comprises using an adhesive member to pull the sensor from the introducer sharp.

6. The method of claim 5, wherein at least one of the introducer sharp and the sensor comprises a dimple to releasably retain the sensor on the introducer sharp.

7. The method of claim 5, wherein the step of placing the sensor inserter device adjacent to the skin of a patient further comprises attaching an adhesive mount to the patient'"'"'s body near an insertion site where the sensor is adapted to be inserted.

8. The method of claim 5 wherein the sensor includes an analyte sensor.

9. The method of claim 5 wherein the sensor includes a glucose sensor.

10. The method of claim 5 wherein activating the inserter device includes applying a force.

11. The method of claim 10 wherein applying the force includes applying a manual force on the sensor inserter device.

12. The method of claim 5 including detaching the sensor inserter device from the sensor.

13. The method of claim 12 wherein the sensor inserter device is detached from the sensor after releasing the sensor from the introducer sharp.

14. The method of claim 5 wherein the at least the portion of the sensor remaining in the skin of the patient includes a section in fluid contact with the interstitial fluid of the patient.

15. The method of claim 5 wherein the at least the portion of the sensor is positioned at a depth of approximately 2 to 12 mm under the skin.

16. The method of claim 5 wherein the at least the portions of the introducer sharp and the sensor are inserted into the skin of the patient at a predetermined speed.

17. The method of claim 5, wherein the introducer sharp includes a cutting portion which cuts the skin as the introducer sharp and the sensor are automatically driven into the skin of the patient.