Analyte sensors and methods of manufacturing same

Patent metadata

Field	Value
Publication number	US-9237864-B2
Application number	US-82930610-A
Country	US
Kind code	B2
Filing date	Jul 1, 2010
Priority date	Jul 2, 2009
Publication date	Jan 19, 2016
Grant date	Jan 19, 2016

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 E 1 , E 2 , 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 E 1 , E 2 , 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 E 1 , E 2.

First claim

What is claimed is:

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.

Assignees

• Simpson Peter C
• Boock Robert
• Neale Paul V
• Bohm Sebastian
• Wightlin Matthew
• Pryor Jack
• Mitchell Jason
• Jackson Jeff
• Patel Kaushik
• Llevares Antonio C
• Dexcom Inc

Inventors

• Simpson Peter C
• Boock Robert
• Neale Paul V
• Bohm Sebastian
• Wightlin Matthew
• Pryor Jack
• Mitchell Jason
• Jackson Jeff
• Patel Kaushik
• Llevares Antonio C

Classifications

• C23C2/00

  Hot-dipping or immersion processes for applying the coating material in the molten state without affecting the shape; Apparatus therefor · CPC title

• B29C2791/009

  Using laser · CPC title

• B23K26/0823

  Devices involving rotation of the workpiece · CPC title

• B05D3/06

  by exposure to radiation (B05D3/02 takes precedence {; plasma treatment B05D3/141}) · CPC title

• B05D1/18

  performed by dipping · CPC title