Transdermal analyte sensor assembly and methods of using the same

• US 8,271,064 B2
• Filed: 12/14/2006
• Issued: 09/18/2012
• 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:
  US12/086,238
• Publication Number:
  US 20090312614A1
• Time in Patent Office: 2,105 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 transdermal test sensor assembly adapted to determine an analyte concentration of a fluid sample, the test sensor assembly comprising:

a sensor support including at least one reservoir holding a 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 adjacent 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,

wherein the hydrogel composition includes a first percentage of a solvent, and 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.

2. The assembly of claim 1, wherein the liquid hydrates the hydrogel composition.

3. The assembly of claim 2, further comprising a plurality of electrodes, wherein the hydrogel composition is positioned over the plurality of electrodes.

5. The assembly of claim 1, wherein the assembly further comprises a coupling mechanism coupling the test sensor assembly to an analyte-testing instrument.

6. The assembly of claim 1, wherein the hydrogel composition further comprises at least one monomer.

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

a sensor support including at least one reservoir adapted to hold a 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 adjacent 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,

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.

7. A transdermal analyte-testing assembly adapted to determine an analyte concentration of a sample, the analyte-testing assembly comprising:

a sensor support including at least one reservoir holding a 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 adjacent to the at least one reservoir;

a hydrogel composition linked 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 adapted to determine an analyte concentration of a sample,

wherein the hydrogel composition includes a first percentage of a solvent, and 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.

8. The assembly of claim 7, wherein the liquid hydrates the hydrogel composition.

9. The assembly of claim 7, further comprising a plurality of electrodes, wherein the hydrogel composition is positioned on the plurality of electrodes.

10. The assembly of claim 7, 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.

11. The assembly of claim 7, wherein the hydrogel composition further comprises at least one monomer.

12. The assembly of claim 7, wherein the analyte-testing instrument is adapted to determine the analyte concentration at pre-selected time intervals.

13. A non-invasive method of determining a concentration of at least one analyte in a body fluid, the method comprising the acts of:

providing a transdermal test sensor assembly including a sensor support, a test sensor, and a hydrogel composition, the test sensor support including at least one reservoir, the at least one reservoir including a liquid, the test sensor being 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 adjacent to the at least one reservoir, the hydrogel composition being linked to the at least one reservoir via the at least one aperture;

contacting the transdermal sensor to an area of skin such that the hydrogel composition is positioned between the skin and the test sensor;

coupling an analyte-testing instrument to the transdermal test sensor assembly; and

determining the concentration of the analyte using the analyte-testing instrument,

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.

14. The method of claim 13, further comprising pretreating the area of skin to thereby increase the permeability of the area of skin.

15. The method of claim 13, wherein the act of determining the concentration of the analyte using the analyte-testing instrument is repeated at pre-selected time intervals.

16. The method of claim 13, wherein the transdermal test sensor assembly further comprises a plurality of electrodes, the hydrogel composition being positioned over the plurality of electrodes.

17. The method of claim 13, 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.

18. The method of claim 13, wherein the hydrogel composition further comprises at least one monomer.

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

a sensor support first and second reservoirs each holding liquid;

a test sensor coupled to the sensor support, the test sensor forming first and second apertures each located immediately adjacent to a respective one of the reservoirs; and

a hydrogel composition positioned on the test sensor, the hydrogel composition being linked to at least one of the reservoirs via at least one of the apertures.

20. The assembly of claim 19, wherein the hydrogel composition includes first and second hydrogel compositions each located immediately adjacent to and covering a respective one of the apertures.