Biosensor and Method for Providing a Biosensor

• US 20130296664A1
• Filed: 06/28/2013
• Published: 11/07/2013
• Est. Priority Date: 12/30/2010
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Kube, Oliver
• Granted Patent: US 9,844,343 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 (2) and at least one electrode (5) on at least one surface (9) of the substrate and at least one contacting element (3). The contacting element is connected to the electrode. The substrate has at least one kink (4), at which the substrate is at least partly kinked such that the surface is subdivided into at least two interconnected outer surfaces (9a, 9b, 9c).

Claims

1. A biosensor for insertion into subcutaneous tissue of a user, wherein the biosensor is configured for one or more of qualitative or quantitative detection of at least one analyte in a bodily fluid, wherein the biosensor comprises at least one flexible substrate and at least one electrode on at least one surface of the substrate and at least one contacting element, wherein the contacting element is connected to the electrode, wherein 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.

2. The biosensor of claim 1 wherein at least one electrode is arranged in each case on at least two of the outer surfaces.

3. The biosensor of claim 1 wherein the outer surfaces have at least two outer surfaces which are arranged substantially parallel to one another.

4. The biosensor of claim 1 wherein the substrate is subdivided into at least two interconnected substrate pieces by the kink, wherein the substrate pieces are connected to one another at least in part.

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

6. The biosensor of claim 1 wherein the at least one electrode comprises one or more of at least one working electrode, at least one reference electrode or at least one counter electrode.

7. The biosensor of claim 1 wherein one or more of at least one contacting element or at least one electrode are arranged on both the first and the second outer surface.

8. The biosensor of claim 1 wherein the kink is arranged in the contacting element.

9. The biosensor of claim 1 wherein at least one conductor track is arranged between the contacting element and the electrode.

10. The biosensor of claim 1 wherein the substrate has an elongate structure and in that the one electrode and the contacting element are situated at mutually opposite ends of at least one of the outer surfaces.

11. A substrate blank for producing a biosensor as claimed in claim 1, wherein the substrate blank has at least one flexible substrate and at least one electrode on at least one surface of the substrate and at least one contacting element, wherein the contacting element is connected to the electrode, wherein the substrate has at least one kink at which the substrate can be kinked at least in part such that the surface is subdivided into at least two interconnected outer surfaces.

12. The substrate blank of claim 11 wherein the kink is formed in a fashion selected from the following:

a slit, a perforation, a kink line with a groove or a combination therefrom.

13. An insertion kit for inserting a biosensor into subcutaneous tissue of a user, the kit comprising at least one biosensor as claimed in claim 1 and a piercing element.

14. 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.

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

16. A method for producing a biosensor for one or more of qualitative or quantitative detection of at least one analyte in a bodily fluid comprising the following steps:

providing at least one flexible substrate,

applying at least one contacting element and at least one electrode connected to the contacting element to at least one surface of the substrate, and

kinking the substrate at at least one kink such that the surface is subdivided into at least two interconnected outer surfaces.

17. The method of claim 16 wherein the biosensor has an elongate structure and the kinking takes place in a manner selected from:

kinking parallel to an axis of longitudinal extent of the biosensor;

kinking at an angle to an axis of longitudinal extent of the biosensor.

18. The method of claim 16, wherein the biosensor is configured for one or more of qualitative or quantitative detection of at least one analyte in a bodily fluid, and wherein the biosensor comprises at least one flexible substrate and at least one electrode on at least one surface of the substrate and at least one contacting element, wherein the contacting element is connected to the electrode, wherein 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.