Method and system of producing a plurality of analytical test strips

Patent metadata

Field	Value
Publication number	US-12103287-B2
Application number	US-202217806863-A
Country	US
Kind code	B2
Filing date	Jun 14, 2022
Priority date	Dec 19, 2019
Publication date	Oct 1, 2024
Grant date	Oct 1, 2024

Abstract

A method of producing a plurality of analytical test strips using a reel-to-reel process, comprising providing at least one continuous first layer web, having disposed on a first side at least one first electrode layer, the first layer web having a first layer edge; continuously disposing at least one continuous spacer layer web onto the first side of the first layer web, wherein the spacer layer web has a spacer layer edge, wherein the disposing is position-controlled in a master-slave fashion by using a position of the first layer edge as a master position and a position of the spacer layer edge as a slave position; and continuously disposing at least one continuous second layer web onto the spacer layer web, the second layer web having disposed on a first side at least one second electrode layer, wherein the second layer web has a second layer edge.

First claim

What is claimed is:

1. A method of producing a plurality of analytical test strips by using a reel-to-reel process, each analytical test strip comprising a first layer having a first electrode, a spacer layer, and a second layer having a second electrode, the method comprising:
i. providing a continuous first layer web, having disposed on a first side a first electrode layer, each analytical test strip being formed extending laterally of the first layer web, the first layer web having a continuous first layer edge corresponding to dosing ends of the produced analytical test strips;
ii. continuously disposing, in at least one first lamination station, a continuous spacer layer web onto the first side of the first layer web, wherein the spacer layer web has a spacer layer edge, wherein the disposing of the spacer layer web relative to the first layer web is based on the relative lateral position of the spacer layer edge to the first layer edge, the disposing of the spacer layer being position-controlled in a master-slave fashion by using a position of the first layer edge as a first master position and a position of the spacer layer edge as a first slave position,
wherein the disposing takes place such that the spacer layer edge is offset a fixed distance from the first layer edge and that, thereby, a portion of the first side of the first layer and a portion of the first electrode layer remain uncovered by the spacer layer web; and

iii. continuously disposing, in at least one second lamination station, a continuous second layer web onto the spacer layer web, the second layer web having disposed on a first side a second electrode layer, wherein the disposing is performed such that the second electrode layer faces the first layer web,
wherein the second layer web has a second layer edge, wherein the disposing of the second layer web relative to the first layer web is based on the relative lateral position of the second layer edge to the first layer edge, and takes place such that the second layer edge is aligned with the first layer edge,
wherein the disposing of the second layer web is position-controlled in a master-slave fashion by using a position of the second layer edge as a second slave position;
wherein in the master-slave fashion the slave position is adapted according to the master position; and
separating the test strips.

2. The method according to claim 1 , wherein step iii is performed such that the position of the first layer edge is used as the master position.

3. The method according to claim 1 , further comprising detecting, by using at least one alignment sensor downstream the second lamination station, an alignment between the second layer edge and the first layer edge and controlling the position of the second layer edge of the continuous second layer web being fed into the second lamination station.

4. The method according to claim 3 , wherein the alignment sensor comprises at least one optical distance sensor having a sensing direction essentially parallel to a plane of extension of the first layer web.

5. The method according to claim 4 , wherein the at least one optical distance sensor has a sensing direction onto and/or perpendicular to the first layer edge and the second layer edge.

6. The method according to claim 3 , wherein the alignment sensor comprises at least one laser sensor.

7. The method according to claim 6 , wherein the at least one laser sensor is a laser profile sensor.

8. The method according to claim 3 , wherein the alignment sensor is a superordinate sensor.

9. The method according to claim 3 , wherein deviations in alignment between the first layer edge and the second layer edge are at least partially corrected by correcting the position of the second layer edge of the continuous second layer web being fed into the second lamination station.

10. The method according to claim 1 , further comprising detecting, by using at least one off-set sensor downstream the first lamination station, an offset between the spacer layer edge and the first layer edge and controlling a position of the spacer layer edge of the continuous spacer layer web being fed into the first lamination station.

11. The method according to claim 1 , further comprising detecting, by using at least one first layer sensor, the position of the first layer edge of the continuous first layer web being fed into the first lamination station.

12. The method according to claim 1 , further comprising detecting, by using at least one spacer layer sensor, the position of the spacer layer edge of the continuous spacer layer web fed into the first lamination station.

13. The method according to claim 1 , further comprising detecting, by using at least one laminate sensor, the position of the first layer edge of a continuous intermediate laminate web generated in step ii., the laminate web comprising the first layer web and the spacer layer web, the laminate web being fed into the second lamination station.

14. The method according to claim 1 , further comprising detecting, by using at least one second layer sensor, the position of the second layer edge of the continuous second layer web being fed into the second lamination station.

15. The method according to claim 1 , wherein the first layer web is provided to the first lamination station with the first side of the first layer web being oriented in an upward fashion.

16. The method according to claim 1 , wherein the continuous second layer web is fed into the second lamination station with the first side of the second layer web facing downward.

17. The method according to claim 1 , wherein the continuous first layer web is fed into the first lamination station via a plurality of rollers, wherein the first side faces away from the rollers, wherein the continuous second layer web is fed into the second lamination station via a plurality of rollers, wherein the first side faces away from the rollers.

18. The method according to claim 1 , wherein the controlled disposing of the spacer layer web on the first layer web, and the controlled disposing of the second layer web on the spacer layer web by the master-slave control method creates a defined sample application zone having a controlled and defined depth.

19. A manufacturing system for producing a plurality of analytical test strips by using a reel-to-reel process, each analytical test strip comprising at least one first layer having at least one first electrode, at least one spacer layer and at least one second layer having at least one second electrode, the manufacturing system comprising:
I. at least one supplying device for providing at least one continuous first layer web, the first layer web having disposed on a first side at least one first electrode layer, the first layer web having a first layer edge corresponding to dosing ends of the produced analytical test strips;
II. at least one first lamination station, the first lamination station being configured for continuously disposing at least one continuous spacer layer web onto the first side of the first layer web, each analytical test strip being formed extending laterally of the first layer web,
wherein the spacer layer web has a spacer layer edge, wherein the disposing is position-controlled in a master-slave fashion by using a position of the first layer edge as a master position and a position of the spacer layer edge as a slave position, wherein the disposing of the spacer layer web relative to the first layer web is based on the relative lateral position of the spacer layer edge to the

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Detloff Andreas
• Humbek Egon
• Letkemann Artur

Classifications

• G01N27/3272

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title

• B32B2429/00

  Carriers for sound or information · CPC title

• B32B2309/105

  Thickness · CPC title

• B32B2041/04

  Detecting wrong registration, misalignment, deviation, failure · CPC title

• B32B38/185 Primary

  combined with the cutting of one or more layers · CPC title