Analyte sensor and apparatus for insertion of the sensor

• US 10,786,190 B2
• Filed: 01/07/2020
• Issued: 09/29/2020
• 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
• Application Number:
  US16/736,728
• Publication Number:
  US 20200138353A1
• Time in Patent Office: 266 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. A sensor insertion assembly comprising:

an inserter device comprising;

an analyte sensor at least a portion of which is configured to be positioned under a skin surface of a subject,

a sharp coupled with a sharp support; and

a cap removably attached to a distal portion of the inserter device by a plurality of threads, the cap including a first interior space, wherein the at least a portion of the analyte sensor and at least a portion of the sharp are housed within the first interior space.

2. The sensor insertion assembly of claim 1, wherein the first interior space comprises a substantially sterile environment.

3. The sensor insertion assembly of claim 1, wherein the plurality of threads comprises a first plurality of threads disposed on an interior surface of the cap and a second plurality of threads disposed on an exterior surface of the inserter device.

4. The sensor insertion assembly of claim 3, wherein the inserter device further comprises a handle, and wherein the second plurality of threads is disposed on an exterior surface of the handle.

5. The sensor insertion assembly of claim 1, wherein the cap contains a desiccant configured to remove moisture from the first interior space.

6. The sensor insertion assembly of claim 5, wherein the desiccant comprises one or more of a silica gel or a molecular sieve.

7. The sensor insertion assembly of claim 5, wherein the desiccant comprises one or more of a plurality of granular pellets or a tablet.

8. The sensor insertion assembly of claim 1, wherein the cap is configured to be removed from the distal portion of the inserter device and to expose the at least a portion of the analyte sensor and the at least a portion of the sharp.

9. A sensor insertion assembly comprising:

an inserter device comprising;

an analyte sensor at least a portion of which is configured to be positioned under a skin surface of a subject,

a sharp coupled with a sharp support; and

a cap removably attached to a distal portion of the inserter device, the cap including a first interior space, wherein the at least a portion of the analyte sensor and at least a portion of the sharp are housed within the first interior space, wherein the cap comprises an upwardly extending boss including a second interior space, wherein the upwardly extending boss extends into the first interior space.

10. The sensor insertion assembly of claim 9, wherein the at least a portion of the analyte sensor and the at least a portion of the sharp are disposed within the second interior space of the upwardly extending boss.

11. The sensor insertion assembly of claim 9, wherein the upwardly extending boss comprises a cylindrical shape.

12. The sensor insertion assembly of claim 9, wherein the upwardly extending boss is disposed on an interior surface of the cap.

13. The sensor insertion assembly of claim 9, wherein the cap is removably attached to the distal portion of the inserter device by a plurality of threads.

14. The sensor insertion assembly of claim 9, wherein the inserter device further comprises:

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

a handle movable relative to the sheath; and

an analyte monitoring assembly including a power source and electronics coupled to the analyte sensor, wherein the analyte monitoring assembly comprises an aperture through which the at least a portion of the sharp can pass.

15. A sensor insertion assembly comprising:

an inserter device comprising;

an analyte sensor at least a portion of which is configured to be positioned under a skin surface of a subject,

a sharp coupled with a sharp support;

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

a handle movable relative to the sheath; and

an analyte monitoring assembly including a power source and electronics coupled to the analyte sensor, wherein the analyte monitoring assembly comprises an aperture through which the at least a portion of the sharp can pass; and

a cap removably attached to a distal portion of the inserter device, the cap including a first interior space, wherein the at least a portion of the analyte sensor and at least a portion of the sharp are housed within the first interior space.

16. The sensor insertion assembly apparatus of claim 15, wherein the handle is advanceable by application of manual force to the handle.

17. The sensor insertion assembly of claim 15, wherein the handle at least partially surrounds the sheath.

18. The sensor insertion assembly of claim 15, wherein the inserter device further comprises a spring configured to bias the sheath in a distal direction relative to the handle.

19. The sensor insertion assembly of claim 15, wherein the inserter device further comprises a carriage configured to releasably hold the analyte monitoring assembly.

20. The sensor insertion assembly of claim 15, wherein the analyte monitoring assembly has a substantially circular profile.