Biosensor and method for providing a biosensor

• US 10,092,239 B2
• Filed: 07/31/2017
• Issued: 10/09/2018
• Est. Priority Date: 12/30/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Kube, Oliver
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): PREMRAJ, ANGELINE L
• Application Number:
  US15/664,560
• Publication Number:
  US 20170325745A1
• Time in Patent Office: 435 Days
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base

Abstract

A biosensor is proposed for insertion into the subcutaneous tissue of a user wherein the biosensor includes at least one flexible substrate and at least one electrode on at least one surface of the substrate and at least one contacting element. The contacting element is connected to the electrode. The substrate has at least one kink, at which the substrate is at least partly kinked such that the surface is subdivided into at least two interconnected outer surfaces.

Claims

1. A biosensor configured for insertion into subcutaneous tissue of a user for qualitative or quantitative detection of at least one analyte in a bodily fluid, the biosensor comprising:

a flexible substrate having an electrical pattern on a surface of the substrate; and

the substrate having a kink at which the substrate is at least partly folded, the kink dividing the surface into two interconnected outer surfaces and dividing the substrate into two substrate parts and two electrical pattern parts;

wherein the electrical pattern is disposed on the two outer surfaces of the biosensor when the biosensor is folded about the kink and inserted into the subcutaneous tissue of a user.

2. The biosensor of claim 1, wherein the two substrate parts have substantially the same shape and the two electrical pattern parts have substantially the same shape.

3. The biosensor of claim 1, wherein the two outer surfaces are arranged substantially parallel to one another when the biosensor is folded about the kink and inserted into the subcutaneous tissue of a user.

4. The biosensor of claim 1, wherein the two substrate parts are connected to one another.

5. The biosensor of claim 4, wherein the two substrate parts are adhesively bonded to one another at least in part.

6. The biosensor of claim 1, wherein the electrical pattern includes an electrode.

7. The biosensor of claim 6, wherein the electrode comprises a plurality of electrodes and at least one of the electrodes is arranged on each of the two outer surfaces.

8. The biosensor of claim 6, wherein the electrode comprises one or more of at least one working electrode, at least one reference electrode or at least one counter electrode.

9. The biosensor of claim 1, wherein one or more of a contacting element or an electrode are arranged on both the first and the second outer surface.

10. The biosensor of claim 9, wherein the kink is arranged at the contacting element.

11. The biosensor of claim 1, wherein the electrical pattern includes a conductor track arranged between a contacting element and an electrode.

12. The biosensor of claim 1, wherein the substrate has an elongate structure and an electrode and a contacting element are situated at mutually opposite ends of one of the outer surfaces.

13. An insertion kit for inserting a bio sensor into subcutaneous tissue of a user, the kit comprising a piercing element and a biosensor, the biosensor comprising:

a flexible substrate having an electrical pattern on a surface of the substrate, the electrical pattern including an electrode and a contacting element connected to the electrode, wherein the electrode is configured for insertion into subcutaneous tissue; and

the substrate having a kink at which the substrate is at least partly kinked, the kink (i) dividing the surface into two interconnected outer surfaces, (ii) dividing the substrate into two substrate parts, and (iii) dividing the electrical pattern into two electrical pattern parts, wherein the electrical pattern is disposed on the two outer surfaces of the biosensor when the biosensor is folded about the kink and inserted into the subcutaneous tissue of a user.

14. The insertion kit of claim 13, wherein the substrate parts and the electrical pattern parts have substantially the same shape.

15. The insertion kit of claim 13, wherein the piercing element is selected from:

a needle, a lancet, a flat lancet, a round lancet or a cannula.

16. The insertion kit of claim 13, wherein the piercing element is arranged between the two outer surfaces.

17. The insertion kit of claim 13, wherein the electrical pattern comprises a plurality of electrodes and at least one of the electrodes is arranged on each of the two outer surfaces.

18. The insertion kit of claim 13, wherein the two outer surfaces are arranged substantially parallel to one another when the biosensor is folded about the kink and inserted into the subcutaneous tissue of a user.

19. The insertion kit of claim 13, wherein the electrical pattern comprises one or more of at least one working electrode, at least one reference electrode or at least one counter electrode.

20. The insertion kit of claim 13, wherein the electrical pattern includes a conductor track arranged between a contacting element and an electrode.