ANALYTE SENSORS AND METHODS OF MANUFACTURING SAME

• US 20110027127A1
• Filed: 07/01/2010
• Published: 02/03/2011
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Bohm, Sebastian, Patel, Kaushik, Llevares, Antonio C., Pryor, Jack, Mitchell, Jason, Simpson, Peter C., Wightlin, Matthew, Jackson, Jeff, Neale, Paul V.
• Granted Patent: US 8,828,201 B2
• Time in Patent Office: Days
• US Class Current: 422/82.01
• 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, the continuous analyte sensor comprising:

an elongated core comprising a working electrode;

an insulating layer covering at least a portion of the elongated core;

a conductive layer comprising a reference electrode or a counter electrode, wherein the conductive layer covers at least a portion of the insulating layer; and

a membrane covering at least a portion the working electrode.

2. The continuous analyte sensor of claim 1, wherein the elongated core comprises an elongated body and a layer of conductive material covering at least a portion of the elongated body.

3. 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 D.

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

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

6. The continuous analyte sensor of claim 1, having a Young'"'"'s modulus of from about 160 GPa to about 220 GPa.

7. The continuous analyte sensor of claim 1, having a yield strength of at least 60 kPsi.

8. 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.

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

10. The continuous analyte sensor of claim 9, wherein the multi-axis bending is associated with flexing in at least three directions.

11. The continuous analyte sensor of claim 1, wherein the conductive layer comprises a silver-containing material.

12. The continuous analyte sensor of claim 1, wherein the silver-containing material has a particle size associated with a maximum particle dimension that is less than about 100 microns.

13. The continuous analyte sensor of claim 1, wherein the silver-containing material has a particle shape that is substantially spherical.

14. The continuous analyte sensor of claim 1, having a cross-sectional radius of from about 5 microns to about 200 microns.

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

to about −

45°

at a bend radius of about 0.031-inches.

16. 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.

17. 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.

18. 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.

19. 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.