Analyte sensor and apparatus for insertion of the sensor

• US 9,993,188 B2
• Filed: 03/31/2017
• Issued: 06/12/2018
• 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:
  US15/475,647
• Publication Number:
  US 20170202497A1
• Time in Patent Office: 438 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, comprising:

an analyte sensor, comprising;

a sensor body having a proximal section, a distal section longitudinally aligned with the proximal section, an intermediate section, and a contact portion;

a plurality of electrodes on the distal section;

a plurality of conductive contacts on the contact portion; and

a plurality of conductive traces that connect the plurality of electrodes with the plurality of conductive contacts,

wherein the intermediate section is laterally displaced from at least the distal section and the proximal section, and a notch is between the laterally displaced intermediate section and the proximal section, and

wherein the contact portion is in a plane different than the distal and proximal sections.

2. The apparatus of claim 1, wherein the intermediate section is a longitudinal member.

3. The apparatus of claim 1, further comprising an insertion sharp having a slot.

4. The apparatus of claim 3, wherein the distal section of the sensor body has a width sized to fit within the slot of the insertion sharp, the insertion sharp having a diameter less than about 26 gauge.

5. The apparatus of claim 1, wherein the intermediate section includes a bendable portion.

6. The apparatus of claim 5, wherein the bendable portion allows the contact portion of the sensor body to be in the plane different than the distal section and the proximal section of the sensor body.

7. The apparatus of claim 6, wherein the contact portion and the distal section are in planes perpendicular to each other.

8. The apparatus of claim 1, wherein the contact portion has a profile with a curved portion.

9. The apparatus of claim 1, wherein the analyte sensor is bent such that the contact portion is in the plane different than the distal and proximal sections.

10. The apparatus of claim 1, wherein the plurality of electrodes are on the distal section of the sensor body.

11. The apparatus of claim 1, wherein the plurality of conductive traces are on the contact portion of the sensor body.

12. The apparatus of claim 1, wherein the plurality of conductive traces are on the distal section, intermediate section, and contact portion of the sensor body.

13. The apparatus of claim 12, wherein the plurality of electrodes are on the distal section of the sensor body.

14. The apparatus of claim 1, wherein at least one of the plurality of conductive traces or the plurality of electrodes comprises gold.

15. The apparatus of claim 1, wherein the analyte sensor is a transcutaneous analyte sensor.

16. The apparatus of claim 1, wherein the analyte sensor is a subcutaneous analyte sensor.

17. The apparatus of claim 1, further comprising:

an on body unit comprising electronics that receive a signal from the analyte sensor; and

an inserter comprising an insertion sharp that couples with the analyte sensor, wherein the inserter is adapted to insert the insertion sharp and the analyte sensor into a body of a subject.

18. The apparatus of claim 1, wherein the analyte sensor comprises a sensing layer.

19. The apparatus of claim 18, wherein the sensing layer comprises an electron transfer agent that is a redox mediator.

20. The apparatus of claim 1, wherein the plurality of electrodes are on the distal section, the apparatus further comprising an on body unit adapted for placement on a body of a subject such that the distal section is in the body while the proximal portion, intermediate portion, and contact portion remain outside of the body.