Biosensor strips and methods of preparing same

• US 20060278525A1
• Filed: 06/08/2005
• Published: 12/14/2006
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Laboratories
• Inventors: Savage, Andrew, Petyt, Adrian, Hector, Simon A.
• Granted Patent: US 7,905,999 B2
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A biosensor strip having a low profile for reducing the volume of liquid sample needed to perform an assay. In one embodiment, the biosensor strip comprises an electrode support; an electrode arrangement on said electrode support; a cover; a sample flow channel; and an incompressible element placed between said cover and said electrode support, the incompressible element providing an opening in at least one side or in the distal end of said sample flow channel to provide at least one vent in said sample flow channel. In another embodiment, the biosensor strip comprises an electrode support; an electrode arrangement on said electrode support; a cover; and a sample flow channel, the cover having a plurality of openings formed therein, at least one of the openings in register with said sample flow channel. The invention further includes methods for preparing such a biosensor strips in a continuous manner.

Claims

1. A biosensor strip for determining the concentration of an analyte in a sample of biological liquid, the biosensor strip comprising:

(a) an electrode support;

(b) an electrode arrangement on said electrode support;

(c) a cover;

(d) a sample flow channel having a proximal end where a liquid sample is introduced into the sample flow channel, a distal end toward which the liquid sample flows when it has been introduced into the sample flow channel, a first side extending between the proximal end and the distal end of the sample flow channel, and a second side extending between the proximal end and the distal end of the sample flow channel, the first side and the second side serving to retain the liquid sample in the sample flow channel; and

(e) an incompressible element placed between said cover and said electrode support, said incompressible element providing an opening in at least one side or in the distal end of said sample flow channel to provide at least one vent in said sample flow channel.

2. The biosensor strip of claim 1, wherein said at least one vent is in at least one side of said sample flow channel.

3. The biosensor strip of claim 1, wherein said at least one vent is in said distal end of said sample flow channel.

4. The biosensor strip of claim 1, wherein said incompressible element is selected from the group consisting of at least one filament, at least one thread, at least one ribbon, and at least one tape.

5. The biosensor strip of claim 1, wherein at least one layer of mesh is interposed between said cover and said electrode arrangement.

6. The biosensor strip of claim 1, wherein said cover comprises a backing having a layer of adhesive on one major surface thereof.

7. The biosensor strip of claim 6, wherein said adhesive is a pressure-sensitive adhesive.

8. The biosensor strip of claim 6, wherein said adhesive is a hot melt adhesive.

9. The biosensor strip of claim 1, wherein said incompressible element is in contact with said cover.

10. A method for forming the biosensor strip of claim 1, said method comprising the steps of:

(a) providing a row containing a plurality of uncompleted biosensor strips;

(b) providing a tape having a backing bearing a layer of adhesive on one major surface thereof;

(c) providing a length of a material suitable for preparing incompressible elements;

(d) combining said tape and said length of incompressible elements, whereby said tape and said length of incompressible elements form an assembly;

(e) feeding said row into a laminator;

(f) feeding said assembly into a laminator;

(g) laminating said assembly to said row, whereby said row contains a plurality of completed biosensor strips; and

(h) separating said biosensor strips in said row to provide a plurality of individual biosensor strips.

11. The method of claim 10, wherein said adhesive is a hot melt adhesive.

12. The method claim 11, wherein said tape is heated to a temperature sufficient to melt said hot melt adhesive.

13. The method of claim 10, wherein said adhesive is a pressure-sensitive adhesive.

14. The method of claim 10, wherein a segment of said length of incompressible elements forms a vent in said sample flow channel.

15. A biosensor strip for determining the concentration of an analyte in a sample of liquid, the biosensor strip comprising:

(a) an electrode support;

(b) an electrode arrangement on said electrode support;

(c) a cover; and

(d) a sample flow channel having a proximal end where a liquid sample is introduced into the sample flow channel, a distal end toward which the liquid sample flows when it has been introduced into the sample flow channel, a first side extending between the proximal end and the distal end of the sample flow channel, and a second side extending between the proximal end and the distal end of the sample flow channel, the first side and the second side serving to retain the liquid sample in the sample flow channel;

(e) said cover having a plurality of openings formed therein, at least one of said openings in register with said sample flow channel.

16. The biosensor strip of claim 15, wherein at least one layer of mesh is interposed between said cover and said electrode arrangement.

17. The biosensor strip of claim 15, wherein said cover comprises a backing having a layer of adhesive on one major surface thereof.

18. The biosensor strip of claim 17, wherein said adhesive is a pressure-sensitive adhesive.

19. The biosensor strip of claim 17, wherein said adhesive is a hot melt adhesive.

20. The biosensor strip of claim 15, wherein said openings have been formed by a laser.

21. The biosensor strip of claim 15, wherein said openings have been formed by a mechanical device.

22. A method for forming the biosensor strip of claim 15, said method comprising the steps of:

(a) providing a row containing a plurality of uncompleted biosensor strips;

(b) providing a tape having a backing having a layer of adhesive on one major surface thereof, said tape having a plurality of openings spaced apart at specified intervals;

(c) feeding said row into a laminator;

(d) feeding said tape into said laminator;

(e) laminating said tape to said row, whereby said row contains a plurality of completed biosensor strips; and

(f) separating said biosensor strips in said row to provide a plurality of individual biosensor strips.

23. The method of claim 22, wherein said adhesive is a pressure-sensitive adhesive.

24. The method of claim 22, wherein said adhesive is a hot melt adhesive.

25. The method claim 24, wherein said tape is heated to a temperature sufficient to melt said hot melt adhesive.

26. The method of claim 22, wherein said openings have been formed by a laser.

27. A biosensor strip for determining the concentration of an analyte in a sample of liquid, the biosensor strip comprising:

(a) an electrode support;

(b) an electrode arrangement on said electrode support;

(c) a cover; and

(d) a sample flow channel having a proximal end where a liquid sample is introduced into the sample flow channel, a distal end toward which the liquid sample flows when it has been introduced into the sample flow channel, a first side extending between the proximal end and the distal end of the sample flow channel, and a second side extending between the proximal end and the distal end of the sample flow channel, the first side and the second side serving to retain the liquid sample in the sample flow channel;

(e) said electrode support having a plurality of openings formed therein, at least one of said openings in register with said sample flow channel.

28. The biosensor strip of claim 27, wherein at least one layer of mesh is interposed between said cover and said electrode arrangement.

29. The biosensor strip of claim 27, wherein said cover comprises a backing having a layer of adhesive on one major surface thereof.

30. The biosensor strip of claim 29, wherein said adhesive is a pressure-sensitive adhesive.

31. The biosensor strip of claim 29, wherein said adhesive is a hot melt adhesive.

32. The biosensor strip of claim 27, wherein said openings have been formed by a laser.

33. The biosensor strip of claim 27, wherein said openings have been formed by a mechanical device.