TEST STRIP WITH SLOT VENT OPENING

• US 20110000610A1
• Filed: 09/15/2010
• Published: 01/06/2011
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Operations Limited (Roche Holding AG)
• Inventors: Burke, David W., Marquant, Michael
• Granted Patent: US 8,119,414 B2
• Time in Patent Office: Days
• US Class Current: 156/269
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 156/1059 Splitting sheet lamina in plane intermediate of faces
• CPC Class Codes: Y10T 156/1084 of continuous or running length bonded web

Abstract

Methods of manufacturing test strips are disclosed. Embodiments include laminating a two piece covering layer over a substrate with a series of cavities, wherein the two pieces are separated by a gap, the gap forming a vent opening for the cavities. Other embodiments include covering the sample receiving chamber with a cover thinner than the cover covering the body of the test strip, the thicker body cover absorbing more force than the chamber cover to reduce the possibility of adhesives squeezing out from under the chamber cover. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.

Claims

1. A method of manufacturing a plurality of test strips, said method comprising:

(a) providing a web of base substrate material;

(b) forming a plurality of electrode sets on the web;

(c) providing a reagent layer covering at least one electrode of each electrode set;

then

(d) providing a continuous web of spacing material having a series of cavities formed therein and laminating the web of spacing material over the web of base substrate material such that each one of the cavities aligns with a respective one of the electrode sets;

(e) providing a web of covering layer made from two pieces and laminating it over the web of spacing material such that the two pieces are separated by a gap and the gap is positioned over the series of cavities; and

(f) cutting the web into the plurality of test strips.

2. The method of claim 1, wherein the reagent layer is applied in a uniform thickness as continuous stripe along the web of base substrate material.

3. The method of claim 2, wherein step (c) further comprises depositing the reagent stripe over the plurality of electrode sets.

4. The method of claim 1, wherein step (b) comprises applying a conductive coating to the web of base substrate and then removing portions of the conductive coating to form the electrode sets.

5. The method of claim 4, wherein the portions of the conductive coating are removed by laser ablation.

6. The method of claim 5, wherein the laser ablation comprises broad field laser ablation.

7. The method of claim 1, wherein the two pieces have substantially straight edges, whereby the gap is substantially straight and extends over the series of cavities.

8. The method of claim 1, wherein each of the two pieces of covering material comprises an elongated continuous web.

9. The method of claim 8, further comprising making a series of substantially equidistant cuts between the electrode sets, the cuts being substantially perpendicular to the gap, whereby each individual test strip formed thereby has a gap extending across its covering layer, the individual gaps forming vent openings communicating with respective cavities.

10. The method of claim 9, wherein the cutting further comprises cutting one end of the web to form fluid receiving ends of the test strips with openings at their edges, each opening leading into a respective cavity.

11. The method of claim 10, wherein the fluid receiving ends are Y-shaped.

12. The method of claim 10, wherein the cavities extend from the openings at the edges of the test strips to the vent openings formed in the covering layers.

13. The method of claim 1, further comprising positioning the gap over an interior end of the series of cavities.

14. The method of claim 1, further comprising applying the two pieces to the web at substantially the same time.

15. The method of claim 1, further comprising providing one piece of the covering layer web with a hydrophilic surface and the other piece of covering layer web with a hydrophobic surface.

16. A method of manufacturing test strips, said method comprising:

(a) providing a first web of material having a series of spaced cavities formed therein, the cavities defining walls and a floor of a sample receiving chamber and the cavities being open on their tops;

(b) covering the first web of material with a second web of material, the second web having a first cavity covering portion having a first thickness and a second body covering portion having a second thickness greater than the first thickness, wherein the first portion is aligned over and covers the cavities; and

(c) cutting the structure produced in step (b) into the test strips.

17. The method of claim 16, wherein the thicker second body covering portion of the second web absorbs more of the force imparted to second web than the first cavity covering portion when the first and second webs are stored.

18. The method of claim 16, further comprising laminating the second web over the first web such that the first portion and the second portion are separated by a gap.

19. The method of claim 18, further comprising positioning the gap over the series of cavities.

20. The method of claim 19, further comprising configuring a hydrophobic region on the second body covering portion side of the gap to inhibit fluid from moving past the gap.

21. The method of claim 16, wherein the first portion and the second portion each have a substantially straight edge, whereby the gap is substantially straight and extends over the series of cavities.

22. The method of claim 16, further comprising forming a plurality of electrode sets on the first web of material.

23. The method of claim 22, further comprising aligning each one of the cavities with a respective one of the electrode sets.

24. The method of claim 22, further comprising providing a reagent layer covering at least one electrode of the electrode sets.

25. The method of claim 24, wherein the reagent layer is applied in a uniform thickness as a continuous stripe along the first web of material.

26. The method of claim 25, further comprising depositing the reagent stripe over the plurality of electrode sets.

27. The method of claim 16, wherein the second web comprises two layers of material that are separated by a gap that overlies the cavities.