CONTINUOUS ANALYTE SENSORS AND METHODS OF MAKING SAME

• US 20110027458A1
• Filed: 07/01/2010
• Published: 02/03/2011
• Est. Priority Date: 07/02/2009
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Zhang, Huashi, Mitchell, Jason, Jackson, Jeff
• Application Number:
  US12/829,340
• Publication Number:
  US 20110027458A1
• Time in Patent Office: Days
• US Class Current: 427/9
• 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

Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice. For example, a provided elongated conductive body 510 is advanced through a pre-coating treatment station 520, through a coating station 530, through a thickness control station 540, through a drying or curing station 550, through a thickness measurement station 560, and through a post-coating treatment station 570.

Claims

1. A method for manufacturing a continuous analyte sensor, the method comprising:

applying a conductive material to an elongated conductive body by advancing the elongated conductive body through a liquid comprising the conductive material;

drying or curing the applied liquid to form a coating of the conductive material on the elongated conductive body, the coating comprising a portion of the continuous analyte sensor;

determining whether a thickness of the coating is within a predetermined range; and

, if the thickness is below the predetermined range,

repeating steps of applying a conductive material and drying or curing the applied liquid until the thickness of the coating is determined to be within the predetermined range, whereby a continuous analyte sensor configured for in vivo use is obtained.

2. The method of claim 1, further comprising removing a fraction of the conductive material applied to the elongated conductive body.

3. The method of claim 1, wherein removing is performed by advancing the elongated conductive body through a die.

4. The method of claim 1, wherein the conductive material is Ag/AgCl.

5. The method of claim 1, wherein the predetermined range of the thickness of the coating is from about 1 micron to about 20 microns.

6. The method of claim 1, wherein the conductive material is platinum.

7. The method of claim 1, wherein the predetermined range is from about 1 micron to about 10 microns.

8. The method of claim 1, further comprising applying an adhesion promoter to the elongated conductive body before applying the conductive material.

9. The method of claim 1, further comprising etching a portion of the coating.

10. The method of claim 1, further comprising cutting the elongated conductive body into a plurality of sections.

11. The method claim 1, wherein each section is associated with an individual continuous analyte sensor.

12. The method of claim 1, wherein the conductive material is Ag/AgCl.

13. The method of claim 1, wherein the conductive material has a particle size associated with a maximum particle dimension that is less than about 100 microns.

14. The method of claim 1, wherein the elongated conductive body is a wire with a circular cross-sectional shape or a substantially circular cross-sectional shape.

15. The method of claim 1, wherein the elongated conductive body comprises an outer surface comprising an insulating material selected from the group consisting of polyurethane, polyethylene, and polyimide.

16. The method of claim 1, wherein applying a conductive material is performed by a reel-to-reel system.