Analyte sensor and apparatus for insertion of the sensor

• US 9,402,544 B2
• Filed: 02/01/2010
• Issued: 08/02/2016
• Est. Priority Date: 02/03/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Yee, Phillip, Thomas, Christopher Allen, Hoss, Udo, He, Lei, Love, Michael Raymond
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US12/698,129
• Publication Number:
  US 20100324392A1
• Time in Patent Office: 2,374 Days
• Field of Search: 600/347, 600/365
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2560/0487 Special user inputs or interfaces
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3286 : Needle tip design, e.g. for improved penetration
• CPC Class Codes: C12Q 1/001 : Enzyme electrodes
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G06K 7/10366 : the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: H04L 67/12 : specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

An apparatus for insertion of a medical device in the skin of a subject is provided.

Claims

1. A method of operating an inserter comprising a base, a spring, an introducer mechanism, and a shuttle that is coupled with the introducer mechanism, the shuttle having a surface in contact with the spring, the method comprising:

positioning an end of the base of the inserter on a skin surface of a subject, the inserter containing an analyte monitoring assembly including a power source and electronics coupled to an analyte sensor and operable to communicate analyte data;

moving the shuttle, the shuttle surface in contact with the spring, the analyte monitoring assembly, and the introducer mechanism from a first position within the inserter to a second position where at least a portion of the analyte sensor of the analyte monitoring assembly is brought into contact with fluid in the subject; and

automatically retracting the shuttle and the introducer mechanism away from the skin surface and into the inserter with a force applied by the spring against the shuttle surface, while the end of the base is maintained on the skin surface.

2. The method of claim 1, further comprising, prior to positioning the end of the base, disengaging an end cap from a bottom end of the base to expose an interior space of the base.

3. The method of claim 1, wherein automatically retracting the shuttle and the introducer mechanism comprises automatically retracting the shuttle and the introducer mechanism upon the introducer mechanism reaching a predetermined position.

4. The method of claim 3, further comprising disengaging the introducer mechanism from a retention member upon reaching the predetermined position.

5. The method of claim 1, further comprising preventing the displacement of the analyte monitoring assembly within the inserter between the first position and the second position when an end cap is engaged with a bottom end of the housing.

6. The method of claim 1, wherein the analyte sensor is a glucose sensor.

7. The method of claim 1, further comprising maintaining the power source of the analyte monitoring assembly in an inactive state when the analyte monitoring assembly is positioned at or near one of the first position or the second position.

8. The method of claim 1, further comprising engaging the analyte monitoring assembly with at least a portion of the introducer mechanism within the inserter during movement from the first position to the second position.

9. The assembly of claim 1, wherein the electronics include an analyte sensor electronic circuit that is activated when the analyte monitoring assembly is at or near the second position.

10. The method of claim 1, further comprising positioning a portion of the analyte monitoring assembly on the skin surface at the second position.

11. The method of claim 10, further comprising activating the analyte monitoring assembly when the portion of the analyte monitoring assembly is positioned on the skin surface.

12. The method of claim 1, further comprising positioning at least a portion of the analyte sensor in contact with an analyte in interstitial fluid under the skin surface at the second position.

13. The method of claim 1, further comprising providing the analyte sensor to the analyte monitoring assembly such that the analyte sensor retains a bent characteristic at the first position and the second position.

14. The method of claim 1, further comprising providing one or more data associated with a monitored level of an analyte to a remote location.

15. The method of claim 14, wherein providing the one or more data comprises using one or more of radio frequency (RF) communication, infrared communication, short-wavelength digital radio communication, low-power digital radio communication, 802.1x communication, or WiFi communication.

16. The method of claim 15, wherein the remote location includes one or more of a remotely located computing device, a mobile telephone device, a personal digital assistant, or a communication enabled data processing device.

17. The method of claim 1, further comprising positioning the introducer mechanism through the electronics of the analyte monitoring assembly prior to positioning the end of the base on the skin surface.

18. The method of claim 17, wherein the introducer mechanism is positioned through a longitudinal aperture in the electronics of the analyte monitoring assembly prior to positioning the end of the base on the skin surface.

19. The method of claim 1, wherein the inserter further comprises a carriage, wherein the carriage, while releasably holding the analyte monitoring assembly, is moved with the shuttle, the shuttle surface in contact with the spring, the analyte monitoring assembly, and the introducer mechanism from the first position within the inserter to the second position.

20. The method of claim 19, wherein the shuttle and the introducer mechanism are automatically retracted away from the skin surface and the carriage while the carriage releasably holds the analyte monitoring assembly.

21. The method of claim 20, further comprising, after automatically retracting the shuttle and the introducer mechanism, removing the inserter from contact with the skin surface while leaving the analyte monitoring assembly adhered to the skin surface.

22. The method of claim 21, wherein the inserter comprises a handle that is movable with respect to the base, and wherein moving the shuttle, the shuttle surface in contact with the spring, the analyte monitoring assembly, and the introducer mechanism from the first position to the second position is accomplished by a user applying manual force to the handle.

23. The method of claim 22, wherein the carriage is part of an inner rail that contacts a handle surface.