Electrochemical sensor strip

• US 20050098433A1
• Filed: 11/06/2003
• Published: 05/12/2005
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Gundel, Douglas B.
• Granted Patent: US 7,387,714 B2
• Time in Patent Office: Days
• US Class Current: 204/403.02
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Provided is a single use electrochemical sensor strip having an active portion and an inactive portion. The inactive portion may be a handling strip. Another aspect provided is an article comprising an electrochemical sensor strip having a fluid-wicking channel that terminates at one end with a fluid sample entrance, wherein the fluid sample entrance traverses the end of the fluid-wicking channel at an angle of less than 90°. Another aspect provided an article comprising an electrochemical sensor strip having a fluid-wicking channel that extends across the width of a portion of the sensor strip which portion is narrower than the width of the remainder of the sensor strip. Also provided are methods for making electrochemical sensor strip.

Claims

1. An article comprising a single use electrochemical sensor strip having an active portion and an inactive portion.

2. The article of claim 1 wherein the inactive portion comprises a handling tab.

3. The article of claim 2 wherein the handling tab is bent at one or both ends.

4. The article of claim 2 wherein the handling tab is textured.

5. The article of claim 1 wherein the active portion comprises a fluid wicking channel.

6. The article of claim 1 wherein the inactive portion is about 5 mm to about 25 mm wide and about 10 mm to about 50 mm long.

7. The article of claim 1 wherein the active portion is about 3 mm to about 10 mm wide and about 5 mm to about 25 mm long.

8. The article of claim 1 wherein the active portion is at one end of the sensor strip.

9. The article of claim 1 wherein the active portion is in the center of the sensor strip.

10. The article of claim 1 comprising

a backing material,

a circuit laminated to a portion of the backing material to form the active portion, the remaining portion of the backing material forming the inactive portion, the circuit comprising:

a substrate,

a patterned conductive layer comprising contact pads, traces and electrodes,

a polymeric layer comprising a channel-forming material, and

a hydrophilic layer.

11. The article of claim 10 wherein a reagent layer is applied to the electrodes.

16. The article of claim 1 wherein the sensor strip is a blood glucose sensor strip.

12. An article comprising an electrochemical sensor strip having a handling tab.

13. The article of claim 12 wherein the handling tab is bent.

14. The article of claim 12 wherein the handling tab is textured.

15. The article of claim 12 wherein the sensor strip is about 5 to 25 mm wide and 13 to about 60 mm long and wherein the handling tab is about 5 mm to about 25 mm wide and about 10 mm to about 50 mm long.

17. An article comprising a blood glucose test kit comprising the electrochemical sensor strip of claim 17 and a glucose measuring device.

18. An article comprising an electrochemical sensor strip having a fluid-wicking channel that terminates at one end with a fluid sample entrance, wherein the fluid sample entrance traverses the end of the fluid-wicking channel at an angle of less than 90°

.

19. The article of claim 18 wherein the angle is 45°

.

20. The article of claim 19 wherein the fluid sample entrance is 1.4 times an entrance that intersects the fluid-wicking channel at an angle of 90°

.

21. An article comprising an electrochemical sensor strip having a fluid-wicking channel that extends across the width of a portion of the sensor strip which portion is narrower than the width of the remainder of the sensor strip.

22. The article of claim 21 wherein the fluid-wicking channel is open to the atmosphere at both ends.

23. The article of claim 21 wherein the fluid-wicking channel transports fluid to the electrodes by capillary action.

24. The article of claim 21 wherein the fluid-wicking channel has a volume of less than about one microliter.

25. A method for making multiple single use electrochemical sensor strips comprising

providing an array of aligned circuits, each circuit having at least on electrode,

applying at least one continuous strip of material across the electrodes of the aligned circuits whereby the continuous strip forms at least a portion of a fluid-wicking channel on each circuit.

26. The method of claim 25 further comprising separating the array into individual sensors.

27. A method for making multiple single use electrochemical sensor strips comprising

providing an array of circuits, each circuit having at least on electrode,

applying two parallel continuous channel-forming strips of material across the electrodes of the aligned circuits to form fluid-wicking channels on each circuit,

slitting the array of circuits into single or double columns of circuits,

forming a column of sensor strips by laminating a backing material to the backside of a column of circuits, and

singulating the columns into individual sensor strips.

28. The method of claim 27 wherein a reagent is applied between the channel-forming strips.

29. The method of claim 27 wherein a layer of hydrophilic material is applied over the channel-forming strips to form an enclosed channel.

30. The method of claim 27 wherein a bend is introduced into the backing material to provide a bent handling tab for the sensor strip.

31. A method for making multiple single use electrochemical sensor strips comprising

providing an array of circuits, each circuit having at least on electrode,

applying a single strip of material over the electrodes of the aligned circuits,

removing an interior portion of the material to expose portions of the electrodes and form a fluid wicking channel over the electrodes,

slitting the array of circuits into columns of circuits,

forming at least one column of sensor strips by laminating a backing material to the backside of a column of circuits, and

singulating the columns into individual sensor strips.

32. The method of claim 31 wherein the interior portion of the strip of material is removed using a rotary die cutting method.

33. A method for making a single use sensor strip comprising

providing a circuit having a front side and a backside, wherein the front side comprises contact pads, conductive traces, and electrodes,

laminating a channel-forming material on said circuit to form a channel over said electrodes,

laminating a hydrophilic film over said channel forming material,

applying a backing material to the backside of said circuit, and

bending the backing material to form a bent handling tab.

34. A method for making multiple single use electrochemical sensor strips comprising

providing an array of aligned circuits, each circuit having at least on electrode,

applying at least one continuous strip of material across the electrodes of the aligned circuits whereby the continuous strip defines at least one edge of an electrode.

35. The method of claim 34 wherein at least one electrode has a necked down portion.

36. A method for making multiple single use electrochemical sensor strips comprising

providing an array of aligned circuits, each circuit having at least one electrode,

applying at least one continuous strip of material across the electrodes of the aligned circuits whereby the continuous strip defines at least one edge of an electrode and at least a portion of a fluid-wicking channel.

37. The method of claim 36 wherein at least one electrode has a necked down portion.