Analyte sensor and apparatus for insertion of the sensor

• US 9,636,068 B2
• Filed: 06/24/2016
• Issued: 05/02/2017
• 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 A., Hoss, Udo, He, Lei, Love, Michael R.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/192,531
• Publication Number:
  US 20170020458A1
• Time in Patent Office: 312 Days
• 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. An apparatus adapted to insert a sensor through the skin of a subject, the apparatus comprising:

a sheath having a surface for placement on the skin of the subject;

a handle movable relative to the sheath;

an analyte monitoring assembly comprising the sensor;

a sharp support adapted to support a sharp; and

a spring in contact with a surface of the sharp support,

wherein the apparatus is configured such that advancement of the handle, while the spring is in contact with the surface of the sharp support, advances the sharp support, the sharp, and the analyte monitoring assembly from a first position within the apparatus to a second position where at least a portion of the sensor is brought into contact with fluid in the subject, and

wherein the spring is adapted to automatically retract the sharp support and sharp away from the skin with a force applied by the spring against the surface of the sharp support after the advancement of the handle.

2. The apparatus of claim 1, wherein the handle is at least partially disposed within the sheath.

3. The apparatus of claim 1, wherein the handle is at least partially disposed surrounding the sheath.

4. The apparatus of claim 1, wherein the sharp support is permanently fixed to the handle.

5. The apparatus of claim 1, further comprising a carriage adapted to releasably hold the analyte monitoring assembly.

6. The apparatus of claim 5, wherein the carriage is part of an inner rail that contacts a handle surface.

7. The apparatus of claim 5, wherein the apparatus is configured such that advancement of the handle, while the spring is in contact with the surface of the sharp support, advances the carriage, the sharp support, the sharp, and the analyte monitoring assembly from the first position to the second position.

8. The apparatus of claim 7, wherein apparatus is configured such that the spring automatically retracts the sharp support and sharp away from the skin and away from the carriage while the carriage releasably holds the analyte monitoring assembly.

9. The apparatus of claim 8, wherein the spring is positioned in contact with the surface of the sharp support and a surface of the carriage, and wherein the sharp support is automatically retractable by exertion of a force by the spring against the surface of the sharp support and the surface of the carriage.

10. The apparatus of claim 1, wherein the analyte monitoring assembly is adhesively securable to the skin.

11. The apparatus of claim 1, wherein the handle is advanceable by application of manual force to the handle.

12. The apparatus of claim 1, wherein the sensor is a glucose sensor.

13. The apparatus of claim 1, further comprising a removable cap.

14. The apparatus of claim 13, wherein the removable cap is adapted to removably couple with the handle.

15. The apparatus of claim 1, wherein the sharp support comprises a plurality of resilient extending fingers.

16. The apparatus of claim 1, wherein the analyte monitoring assembly comprises an aperture through which the sharp can pass.

17. The apparatus of claim 16, wherein the analyte monitoring assembly has a substantially circular profile.

18. The apparatus of claim 1, further comprising a hub coupled with the sharp.

19. The apparatus of claim 18, wherein the sharp support is coupled with the hub.