Test sensor with a side vent and method of making the same

• US 7,797,987 B2
• Filed: 10/09/2007
• Issued: 09/21/2010
• Est. Priority Date: 10/11/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: VanSickle, Michael P., Creaven, John P.
• Primary Examiner(s): Williams; Hezron
• Assistant Examiner(s): Frank; Rodney T
• Application Number:
  US11/973,563
• Publication Number:
  US 20080087075A1
• Time in Patent Office: 1,078 Days
• Field of Search: 73/614.1
• US Class Current: 73/61.41
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A test sensor assisting in determining an analyte concentration in a fluid sample comprises a lid, a base and a spacer. The spacer has first and second spacer sections. The first spacer section has a first spacer side and a first spacer end. The second spacer section has a second spacer side and a second spacer end. The lid, base and spacer are attached such that a fluid chamber is formed between a portion of a lower lid surface and an upper base surface, and between the first and second spacer sides. The lower lid surface, the upper base surface, the first spacer end and the second spacer end form a side vent therebetween that is in communication with the fluid chamber.

Claims

1. A test sensor adapted to assist in determining the concentration of an analyte in a fluid sample, the test sensor comprising:

a lid having an upper lid surface and a lower lid surface;

a base having an upper base surface and a lower base surface; and

a spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end,

wherein the lid, base and spacer are attached such that a fluid chamber is formed between a portion of the lower lid surface and the upper base surface, and between the first and second spacer sides,

wherein the lower lid surface, the upper base surface, the first spacer end and the second spacer end form at least one side vent therebetween, the at least one side vent being in communication with the fluid chamber, the at least one side vent being generally perpendicular to the fluid chamber, the at least one side vent being in generally the same plane as the fluid sample flow in the fluid chamber.

2. The test sensor of claim 1, wherein the fluid chamber has a height of from about 3 to about 7 mils.

3. The test sensor of claim 2, wherein the fluid chamber has a width of from about 3 to about 7 mils.

4. The test sensor of claim 1, wherein the at least one side vent is exactly two side vents.

5. The test sensor of claim 1, wherein the at least one side vent is exactly one side vent.

6. The test sensor of claim 1, wherein the test sensor is an electrochemical test sensor and the base further includes a plurality of electrodes.

7. The test sensor of claim 1, wherein the test sensor is an optical test sensor.

8. The test sensor of claim 1, wherein the spacer includes exactly a first spacer section and a second spacer section, the sections being distinct and separated from each other.

9. The method of claim 1, wherein the lid and base are formed in the absence of an aperture.

10. A test sensor adapted to assist in determining the concentration of an analyte in a fluid sample, the test sensor comprising:

a lid having an upper lid surface and a lower lid surface;

a base having an upper base surface and a lower base surface; and

a spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end,

wherein the lid, base and spacer are attached such that a fluid chamber is formed between a portion of the lower lid surface and the upper base surface, and between the first and second spacer sides,

wherein the lower lid surface, the upper base surface, the first spacer end and the second spacer end form at least one side vent therebetween, the at least one vent being in communication with the fluid chamber,

wherein the spacer includes exactly a first spacer section, a second spacer section and a third spacer section, the sections being distinct and separated from each other.

11. The test sensor of claim 10, wherein the lower lid surface, the upper base surface, the first spacer end, the second spacer end and the third spacer end form two vents therebetween, the two side vents being in communication with the fluid chamber.

12. A method of determining an analyte concentration of a fluid sample using a meter, the method comprising the acts of:

providing a test sensor having a lid, a base and a spacer, the lid having an upper lid surface and a lower lid surface, the base having an upper base surface and a lower base surface, the spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end, the lower lid surface, upper base surface, the first spacer end and the second spacer end forming at least one side vent therebetween;

placing the fluid sample in the fluid chamber between the lower lid surface, the upper base surface, first spacer side, and the second spacer side, the fluid chamber being in communication with the at least one side vent, the at least one side vent being generally perpendicular to the fluid chamber, the at least one side vent being in generally the same plane as the fluid sample flow in the fluid chamber; and

determining the analyte concentration of the sample using the test sensor and the meter.

13. The method of claim 12, wherein the fluid sample enters into the fluid chamber via capillary action.

14. The method of claim 12, wherein the fluid sample is blood.

15. The method of claim 12, wherein the analyte is glucose.

16. The method of claim 12, wherein the at least one side vent is exactly two side vents.

17. The method of claim 12, wherein the at least one side vent is exactly one side vent.

18. The method of claim 12, wherein the spacer includes exactly a first spacer section, a second spacer section and a third spacer section, the sections being distinct and separated from each other.

19. The method of claim 12, wherein the lid and base are formed in the absence of an aperture.

20. A method of forming a test sensor that is adapted to assist in determining an analyte concentration of a fluid sample, the method comprising the acts of:

providing a lid having an upper lid surface and a lower lid surface;

providing a base having an upper base surface and a lower base surface;

providing a spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end;

attaching the lid, base and the spacer such that a fluid chamber is formed between a portion of the lower lid surface and the upper base surface, and between the first and second spacer sides; and

forming at least one side vent between the first spacer end, the second spacer end, the lower lid surface and the upper base surface, the at least one side vent being in communication with the fluid chamber, the at least one side vent being generally perpendicular to the fluid chamber, the at least one side vent being in generally the same plane as the fluid sample flow in the fluid chamber.

21. The method of claim 20, wherein the at least one side vent is formed with a reciprocating stepped platen.

22. The method of claim 20, wherein the at least one side vent is formed with a plurality of reciprocating platens.

23. The method of claim 20, wherein the at least one side vent is exactly two side vents.

24. The method of claim 20, wherein the at least one side vent is exactly one side vent.

25. The method of claim 20, wherein the spacer includes exactly a first spacer section, a second spacer section and a third spacer section, the sections being distinct and separated from each other.

26. The method of claim 20, wherein the lid and base are formed in the absence of an aperture.

27. A method of forming a test sensor that is adapted to assist in determining an analyte concentration of a fluid sample, the method comprising the acts of:

providing a lid sheet having an upper lid surface and a lower lid surface;

providing a base sheet having an upper base surface and a lower base surface;

providing a spacer sheet having a first spacer section and a second spacer section, the first spacer section including a first spacer side and a first spacer end, the second spacer section including a second spacer side and a second spacer end;

removing material from the spacer sheet that will assist in forming at least one vent and a fluid chamber;

attaching the lid sheet, base sheet and the spacer sheet such that the fluid chamber and at least one vent are formed, the fluid chamber being formed between the lower lid surface, the upper base surface, the first spacer side and the second spacer side, the at least one vent being formed between the first spacer end, the second spacer end, the lower lid surface and the upper base surface, the at least one side vent being in communication with the fluid chamber, the at least one side vent being generally perpendicular to the fluid chamber, the at least one side vent being in generally the same plane as the fluid sample flow in the fluid chamber; and

forming a plurality of test sensors from the attached lid sheet, base sheet and spacer sheet.

28. The method of claim 27, wherein the removing material from the spacer sheet is performed by punching material from the spacer sheet.

29. The method of claim 27, wherein the removing of material from the spacer sheet is performed by cutting material from the spacer sheet.

30. The method of claim 27, wherein the forming of the test sensors is performed by punching material from the attached base, lid and spacer sheets.

31. The method of claim 27, wherein the forming of the test sensors is performed by cutting material from the attached base, lid and spacer sheets.

32. A test sensor adapted to assist in determining the concentration of an analyte in a fluid sample, the test sensor comprising:

a lid having an upper lid surface and a lower lid surface;

a base having an upper base surface and a lower base surface; and

a spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end,

wherein the lid, base and spacer are attached such that a fluid chamber is formed between a portion of the lower lid surface and the upper base surface, and between the first and second spacer sides, the fluid chamber being substantially the same length as at least one of the first and second spacer sides,

wherein the lower lid surface, the upper base surface, the first spacer end and the second spacer end form at least one side vent therebetween, the at least one side vent being in communication with the fluid chamber, the at least one side vent being generally perpendicular to the fluid chamber.

33. A method of determining an analyte concentration of a fluid sample using a meter, the method comprising the acts of:

providing a test sensor having a lid, a base and a spacer, the lid having an upper lid surface and a lower lid surface, the base having an upper base surface and a lower base surface, the spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end, the lower lid surface, upper base surface, the first spacer end and the second spacer end forming at least one side vent therebetween;

placing the fluid sample in the fluid chamber between the lower lid surface, the upper base surface, first spacer side, and the second spacer side, the fluid chamber being in communication with the at least one side vent, the at least one side vent being generally perpendicular to the fluid chamber, the fluid chamber being substantially the same length as the first and second spacer sides; and

determining the analyte concentration of the sample using the test sensor and the meter.

34. A test sensor adapted to assist in determining the concentration of an analyte in a fluid sample, the test sensor comprising:

a lid having an upper lid surface and a lower lid surface;

a base having an upper base surface and a lower base surface; and

a spacer having at least a first spacer section and a second spacer section, the first spacer section having a first spacer side and a first spacer end, the second spacer section having a second spacer side and a second spacer end,

wherein the lid, base and spacer are attached such that a fluid chamber is formed between a portion of the lower lid surface and the upper base surface, and between the first and second spacer sides,

wherein the lower lid surface, the upper base surface, the first spacer end and the second spacer end form at least one side vent therebetween, the at least one side vent being in communication with the fluid chamber, the at least one side vent being in generally the same plane as the fluid sample flow in the fluid chamber, the at least one side vent bisecting the fluid chamber such that the at least one side vent and the fluid chamber are not aligned with each other.