Transdermal analyte sensor assembly and methods of using the same

• US 8,504,131 B2
• Filed: 07/12/2012
• Issued: 08/06/2013
• Est. Priority Date: 12/16/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brenneman, Allen J.
• Primary Examiner(s): Minnifield, Nita M
• Application Number:
  US13/547,890
• Publication Number:
  US 20120273370A1
• Time in Patent Office: 390 Days
• Field of Search: None
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

A transdermal test sensor assembly adapted to determine an analyte concentration of a fluid sample is disclosed. The assembly comprises a sensor support including at least one reservoir adapted to hold a liquid. The assembly further comprises a test sensor being coupled to the sensor support. The test sensor forms at least one aperture therein. At least a portion of the at least one aperture is adjacent to the at least one reservoir. The assembly further comprises a hydrogel composition positioned on the test sensor. The hydrogel composition is linked to the at least one reservoir via the at least one aperture.

Claims

1. A test sensor assembly for determining a concentration of an analyte in a fluid sample, the test sensor assembly comprising:

a sensor support including at least one reservoir configured to hold liquid;

a test sensor coupled to the sensor support, the test sensor forming at least one aperture therein, at least a portion of the at least one aperture being proximal to the at least one reservoir; and

a hydrogel composition positioned on the test sensor, the hydrogel composition being linked to the at least one reservoir via the at least one aperture.

2. The test sensor assembly of claim 1, wherein the sensor support further includes a recessed area within which is seated the test sensor, the recessed area having dimensions similar to dimensions of the test sensor such that the recessed area inhibits movement of the test sensor relative to the sensor support.

3. The test sensor assembly of claim 1, wherein the test sensor includes a plurality of electrodes, the hydrogel composition being positioned over at least a portion of the plurality of electrodes.

4. The test sensor assembly of claim 1, further comprising a liquid in the at least one reservoir, wherein the liquid hydrates the hydrogel composition.

5. The test sensor assembly of claim 1, further comprising a liquid in the at least one reservoir, wherein the hydrogel composition includes a first percentage of a solvent, and the liquid includes a second percentage of a solvent, the second solvent percentage of the liquid being greater than the first solvent percentage of the hydrogel composition.

6. The test sensor assembly of claim 1, wherein the test sensor further comprises a flexible coupling mechanism coupling the test sensor to the sensor support.

7. The test sensor assembly of claim 1, wherein the sensor support is configured to mechanically couple to a meter and the test sensor is configured to electrically couple to the meter.

8. The test sensor assembly of claim 1, wherein the hydrogel composition comprises at least one monomer and a solvent.

9. A transdermal analyte-testing assembly for determining an analyte concentration in a sample, the transdermal analyte-testing assembly comprising:

a sensor support including at least one reservoir configured to hold liquid;

a test sensor coupled to the sensor support, the test sensor forming at least one aperture therein, at least a portion of the at least one aperture being proximal to the at least one reservoir;

a hydrogel composition fluidly coupled to the at least one reservoir via the at least one aperture; and

an analyte-testing instrument coupled to the sensor support, the analyte-testing instrument being operable to determine the analyte concentration of the sample.

10. The transdermal analyte-testing assembly of claim 9, further comprising a liquid in the at least one reservoir, wherein the liquid hydrates the hydrogel composition through the at least one aperture.

11. The transdermal analyte-testing assembly of claim 9, further comprising a liquid in the at least one reservoir, wherein the hydrogel composition includes a first percentage of a solvent, and the liquid includes a second percentage of a solvent, the second solvent percentage of the liquid being greater than the first solvent percentage of the hydrogel composition.

12. The transdermal analyte-testing assembly of claim 9, wherein the sensor support further includes a recessed area having dimensions generally similar to dimensions of the test sensor, the recessed area being adjacent to the test sensor, the at least one reservoir being positioned within the recessed area.

13. The transdermal analyte-testing assembly of claim 9, wherein the hydrogel composition comprises at least one monomer and a solvent.

14. The transdermal analyte-testing assembly of claim 9, wherein the analyte-testing instrument is adapted to determine the analyte concentration at pre-selected time intervals.

15. A method of assembling a test sensor assembly for analyzing an analyte in a body fluid sample, the method comprising:

providing a sensor support with a reservoir configured to hold liquid;

positioning a liquid in the reservoir of the sensor support;

providing a test sensor with an aperture extending therethrough;

attaching the test sensor to the sensor support such that at least a portion of the aperture is proximal to the reservoir; and

positioning a hydrogel composition on the test sensor such that the hydrogel composition is fluidly coupled to the liquid in the reservoir via the aperture.

16. The method of claim 15, wherein the sensor support further includes a recessed area within which is seated the test sensor, the recessed area having dimensions similar to dimensions of the test sensor such that the recessed area inhibits movement of the test sensor relative to the sensor support.

17. The method of claim 15, wherein the test sensor includes a plurality of electrodes, the hydrogel composition being positioned over at least a portion of the plurality of electrodes.

18. The method of claim 15, wherein the hydrogel composition includes a first percentage of a solvent, the liquid of the at least one reservoir includes a second percentage of a solvent, the second solvent percentage of the liquid being greater than the first solvent percentage of the hydrogel composition.

19. The method of claim 15, wherein the test sensor further comprises a flexible coupling mechanism attaching the test sensor to the sensor support.

20. The method of claim 15, wherein the hydrogel composition comprises at least one monomer and a solvent.