Sensor inserter assembly

• US 8,029,442 B2
• Filed: 09/06/2007
• Issued: 10/04/2011
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Funderburk, Jeffery V., Kelemen, Bradley D., Vanhiel, Brian, Yamasaki, Duane O., Flynn, Stephen J.
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US11/899,917
• Publication Number:
  US 20080004512A1
• Time in Patent Office: 1,489 Days
• Field of Search: 600/365, 600/584
• 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 sensor inserter assembly comprising:

a housing detachably coupled to a mount;

an analyte sensor;

an introducer sharp having a retention element disposed on a planar surface for releasably retaining the analyte sensor; and

an actuator moving the introducer sharp and the analyte sensor in an insertion direction from within the housing to an extended position in which at least a portion of the introducer sharp and at least a portion of the analyte sensor protrude from the housing, the mount maintained in a fixed position relative to the housing while the introducer sharp moves in the insertion direction, the at least the portion of the analyte sensor adapted to be maintained in fluid contact with an analyte at the extended position, the actuator being automatically moved in a retraction direction when the at least the portion of the introducer sharp and the at least the portion of the analyte sensor protrude from the housing, wherein moving the actuator in the retraction direction causes the introducer sharp to move in the retraction direction from the extended position to a retracted position in which the introducer sharp is retracted entirely within the housing and separated from the analyte sensor, the analyte sensor detaching from the retention element of introducer sharp when the actuator moves the introducer sharp in the retraction direction, wherein the distance between the extended position and the retracted position is a fixed distance;

wherein the actuator is axially aligned with the sensor and the introducer sharp along the insertion and retraction directions.

2. The assembly of claim 1 wherein the analyte sensor includes a glucose sensor.

3. The assembly of claim 1 wherein the actuator includes a manual actuator for applying a manual force to move the introducer sharp in the insertion direction.

4. The assembly of claim 1 wherein the actuator includes a manual actuator for applying a manual force to move the introducer sharp in the retraction direction.

5. The assembly of claim 1 wherein the actuator includes a spring for applying a spring biased force to automatically move the introducer sharp in the insertion direction or in the retraction direction.

6. The assembly of claim 1 wherein the insertion direction is at an angle of approximately 90 degrees or less relative to the skin layer.

7. The assembly of claim 1 wherein the mount is detached from the housing after the introducer sharp is retracted within the housing and separated from the sensor.

8. A method, comprising:

detachably coupling a housing to a mount;

providing an analyte sensor;

providing an introducer having at least one cutting portion for releasably receiving the analyte sensor;

disposing a retention element on a planar surface of at least one of the introducer or the analyte sensor to releasably retain at least a portion of the analyte sensor adjacent to the introducer;

coupling an actuator to the introducer to displace the sensor and introducer in an insertion direction to an extended position in which at least a portion of the introducer and the analyte sensor protrude from the housing to pierce through a skin layer prior to reaching the extended position, coupling the actuator to the introducer including axially aligning the actuator with the analyte sensor and the introducer along the insertion and retraction directions; and

maintaining the mount at a fixed position relative to the housing when the introducer and the analyte sensor are displaced in the insertion direction to the extended position, the introducer automatically moving in a retraction direction from the extended position to a retracted position when the retention element releases the sensor from the introducer, the introducer being retracted within the housing when in the retracted position such that the introducer is retained entirely within the housing and physically separated from the analyte sensor.

9. The method of claim 8, wherein receiving the analyte sensor within the introducer includes slidably receiving the analyte sensor.

10. The method of claim 8, further comprising providing a safety to impede the actuator until the safety is deactivated.

11. The method of claim 8 wherein the actuator includes a manual actuator and displacing the introducer and the analyte sensor in the insertion direction comprises applying a manual force to move the introducer in the insertion direction.

12. The method of claim 8 wherein the actuator includes a manual actuator and moving the introducer in the retraction direction comprises applying a manual force to move the introducer in the retraction direction.

13. The method of claim 8 wherein the insertion direction is at an angle of approximately 90 degrees or less relative to the skin layer.

14. The method of claim 8 further comprising detaching the mount from the housing when the introducer is at the retracted position within the housing and separated from the analyte sensor.

15. The method of claim 8 further comprising coupling the mount to the housing prior to moving the sensor and the introducer to the extended position.

16. A sensor inserter assembly comprising:

a housing detachably coupled to a mount;

a sensor;

an introducer sharp having at least one cutting portion and arranged for releasably receiving the sensor;

a retention element disposed on a planar surface of at least one of the introducer sharp or the sensor, the retention element configured to releasably retain at least a portion of the sensor adjacent to the introducer sharp; and

an actuator coupled to the introducer sharp to move the sensor and introducer sharp in an insertion direction to an extended position in which at least a portion of the introducer sharp and the sensor protrude from the housing to pierce through a skin layer prior to reaching the extended position, the position of the mount maintained at a fixed position relative to the housing when the introducer sharp and the sensor move in the insertion direction to the extended position, the introducer sharp automatically moving in a retraction direction from the extended position to a retracted position when the retention element releases the sensor from the introducer sharp, the introducer sharp being retracted within the housing when in the retracted position such that the introducer sharp is retained entirely within the housing and physically separated from the sensor;

wherein the actuator is axially aligned with the sensor and the introducer sharp along the insertion and retraction directions.

17. The assembly of claim 16 wherein the sensor includes an analyte sensor.

18. The assembly of claim 17 wherein the analyte sensor includes a glucose sensor.

19. The assembly of claim 16 wherein the actuator includes a manual actuator for applying a manual force to move the introducer sharp in the insertion direction.

20. The assembly of claim 16 wherein the actuator includes a manual actuator for applying a manual force to move the introducer sharp in the retraction direction.

21. The assembly of claim 16 wherein the actuator includes a spring for applying a spring biased force to automatically move the introducer sharp in the insertion direction or in the retraction direction.

22. The assembly of claim 16 wherein the insertion direction is at an angle of approximately 90 degrees or less relative to the skin layer.

23. The assembly of claim 16 wherein the housing, the sensor, the introducer sharp, the retention element and the actuator are single use components.

24. The assembly of claim 16 wherein the mount is detached from the housing when the introducer sharp is at the retracted position within the housing and separated from the sensor.

25. The assembly of claim 16 wherein the mount is coupled to the housing prior to moving the sensor and the introducer sharp to the extended position.

26. The sensor inserter assembly of claim 16, wherein the sensor is slidably received within the introducer sharp.

27. The sensor inserter assembly of claim 16, wherein the assembly further comprises a safety to impede the actuator until the safety is deactivated.

28. The assembly of claim 16 wherein the sensor includes a transcutaneous sensor.