Analyte sensors and methods of manufacturing same

• US 9,237,864 B2
• Filed: 07/01/2010
• Issued: 01/19/2016
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Boock, Robert, Neale, Paul V., Bohm, Sebastian, Wightlin, Matthew, Pryor, Jack, Mitchell, Jason, Jackson, Jeff, Patel, Kaushik, Llevares, Antonio C.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US12/829,306
• Publication Number:
  US 20110028815A1
• Time in Patent Office: 2,028 Days
• Field of Search: 600/316, 600/309, 600345-361, 600/365
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• 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 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: B05C 3/02 the work being immersed in the liquid or other fluent material
• CPC Class Codes: B05C 3/10 the articles being moved through the liquid or other fluent material conveying articles through baths B65G, e.g. B65G49/02
• CPC Class Codes: B05C 3/125 the work being a web, band, strip or the like
• CPC Class Codes: B05C 5/0241 for applying liquid or other fluent material to elongated work, e.g. wires, cables, tubes
• CPC Class Codes: B05D 1/18 performed by dipping
• CPC Class Codes: B05D 3/06 by exposure to radiation B05D3/02 takes precedence ; plasma treatment B05D3/141
• CPC Class Codes: B23K 26/0823 Devices involving rotation of the workpiece
• CPC Class Codes: B23K 26/362 Laser etching
• CPC Class Codes: B29C 2791/009 Using laser curing using laser B29C2035/0838, welding using laser beams B29C65/16
• CPC Class Codes: C23C 2/00 : Hot-dipping or immersion processes for applying the coating material in the molten state without affecting the shape; Apparatus therefor

Abstract

Analyte sensors and methods of manufacturing same are provided, including analyte sensors comprising multi-axis flexibility. For example, a multi-electrode sensor system 800 comprising two working electrodes and at least one reference/counter electrode is provided. The sensor system 800 comprises first and second elongated bodies E1, E2, each formed of a conductive core or of a core with a conductive layer deposited thereon, insulating layer 810 that separates the conductive layer 820 from the elongated body, a membrane layer deposited on top of the elongated bodies E1, E2, and working electrodes 802′, 802″ formed by removing portions of the conductive layer 820 and the insulating layer 810, thereby exposing electroactive surface of the elongated bodies E1, E2.

Claims

1. A continuous analyte sensor configured for in vivo use, the continuous analyte sensor comprising:

an elongated conductive body comprising a first electrode comprising an electroactive surface, wherein the elongated conductive body further comprises a second electrode; and

a membrane covering at least a portion of the first electrode;

wherein the continuous analyte sensor has a yield strength at least 60 ksi, wherein the continuous analyte sensor has a fatigue life of at least 20 cycles of flexing from about 45°

to about −

45°

at a bend radius of about 0.031-inches.

2. The continuous analyte sensor of claim 1, wherein the elongated conductive body comprises an elongated core, an insulating layer covering at least a portion of the elongated core, a conductive layer comprising the second electrode and covering at least a portion of the insulating layer, and a membrane covering at least a portion the first electrode.

3. The continuous analyte sensor of claim 2, wherein the elongated core comprises an elongated body and a layer of conductive material covering at least a portion of the elongated body.

4. The continuous analyte sensor of claim 3, wherein the elongated body comprises at least one material selected from the group consisting of stainless steel, titanium, tantalum, and a polymer.

5. The continuous analyte sensor of claim 3, wherein the layer of conductive material covering at least a portion of the elongated body comprises a conductive material selected from the group consisting of platinum, platinum-iridium, gold, palladium, iridium, alloys thereof, graphite, carbon, and a conductive polymer.

6. The continuous analyte sensor of claim 2, wherein the conductive layer comprises a silver-containing material.

7. The continuous analyte sensor of claim 6, wherein the silver-containing material has a particle size associated with a maximum particle dimension that is less than about 100 microns.

8. The continuous analyte sensor of claim 7, wherein the silver-containing material has a particle shape that is substantially spherical.

9. The continuous analyte sensor of claim 2, wherein the insulating layer comprises at least one polymer selected from the group consisting of polyurethane and polyimide.

10. The continuous analyte sensor of claim 2, wherein a ratio of a thickness of the conductive layer to a thickness of insulating layer is from about 1:

5 to about 1;

1.

11. The continuous analyte sensor of claim 2 wherein the conductive material is a silver-containing material.

12. The continuous analyte sensor of claim 1, wherein the membrane comprises a polymer having a Shore hardness of from about 70 A to about 55 C.

13. The continuous analyte sensor of claim 1, having an ultimate tensile strength of from about 80 kPsi to about 500 kPsi.

14. The continuous analyte sensor of claim 1, having an ultimate tensile strength of from about 150 kPsi to about 280 kPsi.

15. The continuous analyte sensor of claim 1, having a fatigue life of at least 1,000 cycles of flexing of from about 28°

to about 110°

at a bend radius of about 0.125-inches.

16. The continuous analyte sensor of claim 1, which is configured for multi-axis bending.

17. The continuous analyte sensor of claim 16, wherein the multi-axis bending is associated with flexing in at least three directions.

18. The continuous analyte sensor of claim 1, wherein the elongated conductive body has a diameter of from about 50 microns to about 250 microns.

19. The continuous analyte sensor of claim 1, having a fatigue life of at least 40 cycles of flexing of from about 45°

to about −

45°

at a bend radius of about 0.031-inches.

20. The continuous analyte sensor of claim 1, having a fatigue life of at least 50 cycles of flexing of from about 45°

to about −

45°

at a bend radius of about 0.031-inches.

21. The continuous analyte sensor of claim 1, having a fatigue life of at least 60 cycles of flexing of from about 45°

to about −

45°

at a bend radius of about 0.031-inches.

22. The continuous analyte sensor of claim 1, having a fatigue life of at least 65 cycles of flexing of from about 45°

to about −

45°

at a bend radius of about 0.031-inches.

23. The continuous analyte sensor of claim 1, wherein the elongated conductive comprises an insulator separating the first electrode from the second electrode.

24. The continuous analyte sensor of claim 1, wherein the elongated conductive body has a yield strength from about 60 kPsi to about 319 kPsi.

25. The continuous analyte sensor of claim 1, wherein the elongated conductive body has a Young'"'"'s modulus from about 160GPa to about 220GPa.

26. The continuous analyte sensor of claim 1, wherein the elongated conductive body is non-planar.

27. The continuous analyte sensor of claim 1, wherein the first electrode is a working electrode.

28. The continuous analyte sensor of claim 1 wherein the second electrode is a reference electrode and/or counter electrode.

29. The continuous analyte sensor of claim 1, wherein the reference electrode is formed of pad printed silver-containing material.

30. The continuous analyte sensor of claim 1, wherein the membrane comprises polyurethane and an enzyme configured to react with glucose.

31. The continuous analyte sensor of claim 30, wherein the polyurethane comprises polyurethaneurea.

32. The continuous analyte sensor of claim 1, wherein the elongated conductive body has a planar shape.

33. The continuous analyte sensor of claim 1, wherein the elongated conductive body has a wire-shaped structure.