BIOSENSOR WITH LASER-SEALED CAPILLARY SPACE AND METHOD OF MAKING

• US 20070278097A1
• Filed: 07/03/2007
• Published: 12/06/2007
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Razban, Ali, Bhullar, Raghbir
• Granted Patent: US 8,679,853 B2
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B23K 2101/42 Printed circuits
• CPC Class Codes: B23K 26/24 Seam welding
• CPC Class Codes: B29C 2035/0822 using IR radiation
• CPC Class Codes: B29C 2035/0827 using UV radiation
• CPC Class Codes: B29C 2035/0844 using X-ray
• CPC Class Codes: B29C 65/1606 Ultraviolet [UV] radiation, e.g. by ultraviolet excimer lasers
• CPC Class Codes: B29C 65/1612 Infrared [IR] radiation, e.g. by infrared lasers
• CPC Class Codes: B29C 65/1635 at least passing through one of the parts to be joined, i.e. laser transmission welding
• CPC Class Codes: B29C 65/1645 heating both sides of the joint, e.g. by using two lasers or a split beam
• CPC Class Codes: B29C 65/1664 making use of several radiators
• CPC Class Codes: B29C 65/1667 at the same time, i.e. simultaneous laser welding
• CPC Class Codes: B29C 65/1677 making use of an absorber or impact modifier
• CPC Class Codes: B29C 65/1696 making use of masks
• CPC Class Codes: B29C 65/8253 : by the use of waves or particle radiation, e.g. visual examination, scanning electron microscopy, or X-rays B29C65/8292 takes precedence
• CPC Class Codes: B29C 66/1122 : Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/43 : Joining a relatively small portion of the surface of said articles B29C66/45 takes precedence
• CPC Class Codes: B29C 66/45 : Joining of substantially the whole surface of the articles methods or apparatus for laminating B32B37/00
• CPC Class Codes: B29C 66/4722 : Fixing strips to surfaces other than edge faces fixing strips to edge faces B29C63/0026
• CPC Class Codes: B29C 66/53461 : joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/7352 : Thickness, e.g. very thin
• CPC Class Codes: B29C 66/73521 : of different thickness, i.e. the thickness of one of the parts to be joined being different from the thickness of the other part
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/7394 : characterised by the material of at least one of the parts being a thermoset
• CPC Class Codes: B29C 66/83413 : cooperating rollers, cylinders or drums
• CPC Class Codes: B29C 66/83415 : the contact angle between said rollers, cylinders or drums and said parts to be joined being a non-zero angle B29C66/83433 takes precedence
• CPC Class Codes: B29C 66/83417 : said rollers, cylinders or drums being hollow
• CPC Class Codes: B29C 66/932 : by measuring the speed
• CPC Class Codes: B29C 66/93451 : by controlling or regulating the rotational speed, i.e. the speed of revolution
• CPC Class Codes: B29C 66/961 : involving a feedback loop mechanism, e.g. comparison with a desired value
• CPC Class Codes: B29C 66/98 : Determining the joining area by using markings on at least one of the parts to be joined
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2995/0025 : Opaque
• CPC Class Codes: B29K 2995/0026 : Transparent
• CPC Class Codes: B29K 2995/0069 : non-permeable
• CPC Class Codes: B29L 2031/756 : Microarticles, nanoarticles
• 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: G01N 33/5438 : Electrodes

Abstract

A test strip or biosensor comprising a base substrate on which an electrode system is formed. One or more laminate layers overlie the base substrate to form a sample-receiving chamber in which a reagent is deposited. An opening is provided from the sample-receiving chamber to the exterior of the biosensor. The layers and the base substrate are laser welded to secure the biosensor. One of the layer and base substrate is light transmissive to allow laser welding at the interface therebetween. The biosensor may be formed from a series of continuous webs that are subsequently sliced to form individual biosensors.

Claims

1. A biosensor, comprising:

a base substrate,

at least one cover layer overlying the base substrate, wherein the base substrate and the cover layer cooperate to define a sample-receiving chamber;

one of the base substrate and the cover layer being more transmissive than the other;

a reagent positioned within the sample-receiving chamber;

the base substrate and the cover layer providing an opening for the sample-receiving chamber along an edge therebetween; and

at least one laser weld joining the base substrate to the cover layer to form the sample-receiving chamber.

2. The biosensor according to claim 1, further comprising an electrode formed on the base substrate.

3. The biosensor according to claim 2, wherein the electrode is a laser ablated electrode.

4. The biosensor according to claim 1, wherein the less transmissive one is black in color.

5. The biosensor according to claim 1, wherein the one that is more transmissive is substantially clear.

6. The biosensor according to claim 1, wherein the base substrate is substantially clear and the cover layer is substantially black.

7. The biosensor according to claim 1, wherein the base substrate is substantially black and the cover layer is substantially clear.

8. The biosensor according to claim 1, further comprising a spacing layer over the base substrate, the cover layer overlying the spacing layer, the at least one laser weld comprising at least one laser weld joining the base substrate to the spacing layer and at least one laser weld joining the spacing layer to the cover layer, wherein the base substrate, the spacing layer and the cover layer so joined form the sample receiving chamber.

9. The biosensor according to claim 8, wherein the cover layer and the base substrate are more transmissive than the spacing layer.

10. The biosensor according to claim 9, wherein:

the base substrate is substantially clear,

the spacing layer is black, and

the cover layer is substantially clear.

11. The biosensor according to claim 1, further comprising a spacing layer laser welded between the base substrate and the cover layer to define the sample receiving chamber.

12. The biosensor according to claim 11, further comprising:

a body cover attached to the spacing layer; and

the body cover being spaced apart from the cover layer to define a vent slot for venting air from the sample receiving chamber.

13. The biosensor according to claim 12, wherein the body cover is laser welded to the spacing layer.

14. The biosensor according to claim 1, wherein the reagent is hydrophilic.

15. The biosensor according to claim 1, wherein at least the cover layer has a channel indentation to form the sample-receiving chamber.

16. The biosensor according to claim 1, wherein at least one of the base substrate and cover layer are formed from polycarbonate.

17. The biosensor according to claim 1, wherein at least one of the base substrate and cover layer are formed from polyester.

18. The biosensor according to claim 1, wherein the cover layer defines a vent opening positioned to vent air from the sample receiving chamber.

19. The biosensor according to claim 1, wherein the base substrate and the cover layer being laser welded around at least a portion of the periphery of the sample-receiving chamber

20. The biosensor according to claim 1, wherein the base substrate and the cover layer have laser weld areas where the base substrate and the cover layer are welded together.

21. The biosensor according to claim 1, wherein the sample-receiving chamber has a volume of between about 20 and about 200 nL.

22. A biosensor, comprising:

a base substrate;

a cover layer;

one or more laser welds in cooperation with the base substrate and the cover layer defining a micro-capillary chamber sized to reduce hematocrit interference in a blood sample; and

a reagent disposed within the micro-capillary chamber to analyze the blood sample.

23. The biosensor of claim 22, wherein the one or more lasers welds directly weld the cover layer to the base substrate.

24. The biosensor of claim 22, further comprising a spacer laser welded between the base substrate and the cover layer to define the micro-capillary chamber.

25. The biosensor of claim 22, wherein the base substrate has one or more electrodes for analyzing the blood sample.

26. The biosensor of claim 22, wherein one of the base substrate and the cover layer is more absorptive of laser energy than the other at the one or more laser welds.

27. A method, comprising:

depositing a reagent on a base substrate; and

laser welding together the base substrate and a cover layer to form a sample-receiving chamber of a biosensor that contains the reagent.

28. The method of claim 27, further comprising:

forming a vent that communicates with the sample-receiving chamber.

29. The method of claim 27, wherein:

one of the base substrate and the cover layer is more transparent than the other; and

said forming the sample-receiving chamber includes laser welding through the one that is more transparent by directing a laser beam through the one that is more transparent.

30. The method of claim 29, wherein:

the base substrate is substantially transparent relative to the laser beam;

the cover layer is configured to substantially absorb the laser beam; and

said forming the sample-receiving chamber includes shining the laser beam through the base substrate and against the cover layer.

31. The method of claim 27, further comprising:

wherein the cover and base substrates have a common, co-extensive edge; and

forming an opening for the sample-receiving chamber along the co-extensive edge of the base substrate and cover layer.

32. The method of claim 27, further comprising:

providing continuous webs of the base substrate and the cover layer;

wherein said laser welding includes laser welding together the continuous webs of the base substrate and the cover layer to form a laminate, wherein the laminate includes multiple sample-receiving chambers containing the reagent; and

forming an opening for each sample-receiving chamber along an edge of at least one of the base substrate and cover layer.

33. The method of claim 32, wherein said laser welding includes:

rotating a rotary-type mask as the continuous webs of the base substrate and the cover layer move thereby, wherein the rotary-type mask includes a plurality of mask apertures; and

shining a laser beam through at least one of the mask apertures to form a laser weld between the continuous webs.

34. The method of claim 33, further comprising:

synchronizing speed of the web of the base substrate with the rotary mask so that the mask apertures are properly aligned during said laser welding.

35. The method of claim 32, further comprising:

dividing the continuous webs into multiple biosensor test strips.

36. The method of claim 27, wherein:

said laser welding includes laser welding around a perimeter of the sample-receiving chamber.

37. The method of claim 27, wherein:

said laser welding includes welding areas around the sample-receiving chamber.