Sensor inserter assembly

• US 9,980,670 B2
• Filed: 04/03/2014
• Issued: 05/29/2018
• 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., Yamasaki, Duane O., VanHiel, Brian, Flynn, Stephen J., Kelemen, Bradley D.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US14/244,831
• Publication Number:
  US 20140221800A1
• Time in Patent Office: 1,517 Days
• 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. An assembly, comprising:

a mount configured for positioning on a skin surface;

a sensor comprising a proximal portion and a distal portion, wherein the distal portion of the sensor is configured to be transcutaneously positioned in contact with interstitial fluid;

an introducer configured to engage with the sensor for transcutaneous positioning of the sensor and comprising a proximal portion and a distal portion, wherein the distal portion of the introducer is configured to pierce through the skin surface; and

a sensor inserter housing configured to be detachably coupleable to the mount to form a sensor insertion assembly, wherein the sensor inserter housing is configured to decouple from the mount when opposing forces are applied to engaging members on opposing sides of the sensor insertion assembly; and

an actuator coupled to the introducer and configured to move the sensor and introducer in an insertion direction to an extended position in which at least part of the introducer and the sensor protrude from the housing to pierce through the skin surface prior to reaching the extended position, wherein a position of the mount is configured to be fixed relative to the sensor inserter housing when the introducer and the sensor move in the insertion direction to the extended position.

2. The assembly of claim 1, wherein the sensor inserter housing is configured to decouple from the mount after the distal portion of the sensor is transcutaneously positioned under the skin surface in contact with the interstitial fluid.

3. The assembly of claim 1, wherein the sensor is configured to be released from the introducer when the introducer moves in a retraction direction from the extended position to a retracted position.

4. The assembly of claim 3, wherein the introducer is configured to be retained entirely within the sensor inserter housing and physically separated from the sensor when in the retracted position.

5. The assembly of claim 3, wherein the sensor inserter housing is configured to decouple from the mount when the introducer is at the retracted position within the housing and separated from the sensor.

6. The assembly of claim 3, wherein the actuator is axially aligned with the sensor and the introducer along the insertion and retraction directions.

7. The assembly of claim 1, wherein the actuator includes a manual actuator configured to apply a manual force to move the introducer in the insertion direction.

8. The assembly of claim 1, wherein the mount is configured for positioning on the skin surface prior to moving the sensor and the introducer to the extended position.

9. The assembly of claim 1, wherein the mount is coupled to the sensor inserter housing prior to moving the sensor and the introducer to the extended position.

10. The assembly of claim 1, wherein the sensor insertion assembly includes one or more latch hooks coupled to one or more channels.

11. The assembly of claim 10, wherein the one or more latch hooks decouple from the one or more channels when the opposing forces are applied to the engaging members of the sensor insertion assembly.

12. The assembly of claim 1, wherein the introducer is configured to slidably receive the sensor therein.

13. The assembly of claim 1, wherein the distal portion of the introducer defines a skin-piercing edge.

14. The assembly of claim 1, wherein the introducer comprises stainless steel.

15. The assembly of claim 1, wherein the mount is configured to remain positioned on the skin surface after the sensor inserter housing is decoupled from the mount.

16. The assembly of claim 1, wherein the mount includes an adhesive layer configured to adhere to the skin surface.

17. The assembly of claim 1, further including a safety mechanism configured for detachably coupling to the actuator prior to moving the sensor and introducer in the insertion direction to the extended position.

18. An assembly, comprising:

a mount configured for positioning on a skin surface;

a sensor comprising a proximal portion and a distal portion, wherein the distal portion of the sensor is configured to be transcutaneously positioned in contact with interstitial fluid;

an introducer configured to engage with the sensor for transcutaneous positioning of the sensor and comprising a proximal portion and a distal portion, wherein the distal portion of the introducer is configured to pierce through the skin surface; and

a sensor inserter housing configured to be detachably coupleable to the mount to form a sensor insertion assembly, wherein the sensor inserter housing is configured to decouple from the mount when opposing forces are applied to engaging members on opposing sides of the sensor insertion assembly; and

an actuator coupled to the introducer and configured to move the sensor and introducer in an insertion direction to an extended position in which at least part of the introducer and the sensor protrude from the housing to pierce through the skin surface prior to reaching the extended position, wherein the mount is configured for positioning on the skin surface prior to moving the sensor and the introducer to the extended position.

19. The assembly of claim 18, wherein the sensor inserter housing is configured to decouple from the mount after the distal portion of the sensor is transcutaneously positioned under the skin surface in contact with the interstitial fluid.

20. The assembly of claim 18, wherein a position of the mount is configured to be fixed relative to the sensor inserter housing when the introducer and the sensor move in the insertion direction to the extended position.

21. The assembly of claim 20, wherein the sensor is configured to be released from the introducer when the introducer moves in a retraction direction from the extended position to a retracted position.

22. The assembly of claim 21, wherein the introducer is configured to be retained entirely within the sensor inserter housing and physically separated from the sensor when in the retracted position.

23. The assembly of claim 21, wherein the actuator is axially aligned with the sensor and the introducer along the insertion and retraction directions.

24. The assembly of claim 18, wherein the actuator includes a manual actuator configured to apply a manual force to move the introducer in the insertion direction.

25. The assembly of claim 24, wherein the sensor inserter housing is configured to decouple from the mount when the introducer is at the retracted position within the housing and separated from the sensor.

26. The assembly of claim 18, wherein the mount is coupled to the sensor inserter housing prior to moving the sensor and the introducer to the extended position.

27. The assembly of claim 18, wherein the sensor insertion assembly includes one or more latch hooks coupled to one or more channels.

28. The assembly of claim 27, wherein the one or more latch hooks decouple from the one or more channels when the opposing forces are applied to the engaging members of the sensor insertion assembly.

29. The assembly of claim 18, wherein the introducer is configured to slidably receive the sensor therein.

30. The assembly of claim 18, wherein the distal portion of the introducer defines a skin-piercing edge.

31. The assembly of claim 18, wherein the introducer comprises stainless steel.

32. The assembly of claim 18, wherein the mount is configured to remain positioned on the skin surface after the sensor inserter housing is decoupled from the mount.

33. The assembly of claim 18, wherein the mount includes an adhesive layer configured to adhere to the skin surface.

34. The assembly of claim 18, further including a safety mechanism configured for detachably coupling to the actuator prior to moving the sensor and introducer in the insertion direction to the extended position.