Device and method for unit use sensor testing

• US 9,465,023 B2
• Filed: 07/31/2014
• Issued: 10/11/2016
• Est. Priority Date: 08/05/2013
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Samproni, Jennifer A.
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US14/910,147
• Publication Number:
  US 20160178606A1
• Time in Patent Office: 803 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/0887 Laminated structure
• 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: G01N 27/403 Cells and electrode assemblies
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms

Abstract

An analyte testing material web, method of making the analyte testing material web, and an analyzer are disclosed. The analyte testing material web has a material web and a plurality of distinct sample testing devices. The material web has a first surface, a second surface opposite the first surface, a first side, and a second side. The plurality of sample testing devices are positioned on the first surface of the material web. Each of the plurality of sample testing devices has an inlet, an outlet, a fluid channel, and one or more testing elements within the fluid channel and configured to analyze one or more analyte within a sample applied to the inlet of one of the plurality of sample testing devices.

Claims

1. An analyte testing material web, comprising:

a material web having a first surface, a second surface opposite the first surface, a first side, and a second side; and

a plurality of distinct sample testing devices positioned on the first surface of the material web, each of the plurality of sample testing devices having an inlet, an outlet, a fluid channel, and one or more testing elements within the fluid channel and configured to analyze one or more analyte within a sample applied to the inlet of one of the plurality of sample testing devices

wherein the material web is a first material web having a first surface, a second surface opposite the first surface, and a thickness extending between the first and second surfaces, and each of the plurality of distinct sample testing devices comprising;

the one or more testing elements connected to the first surface of the first material web;

a second material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, and a plurality of openings, the second surface of the second material web overlapping the first surface of the first material web such that the plurality of openings form a plurality of wells defined by the thickness of the second material web and the first surface of the first material web, each of the plurality of wells defining the fluid channel of one of the sample testing devices encompassing at least one of the one or more testing elements;

a third material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, a plurality of inlets, and a plurality of outlets, the second surface of the third material web overlapping the first surface of the second material web such that certain of the plurality of inlets and certain of the plurality of outlets enable fluid communication with each of the plurality of wells, wherein each of the plurality of inlets form the inlet of one of the sample testing devices and each of the plurality of outlets form the outlet of one of the sample testing devices; and

one or more testing elements positioned on the second surface of the third material web such that the at least one of the one or more testing elements of the third material web are encompassed along with the one or more testing elements of the first material web within the fluid channel of one of the sample testing devices.

2. The analyte testing material web of claim 1, wherein the material web has perforations substantially adjacent to the first side and the second side, the perforations configured to enable advancement of the material web via one or more sprocket-wheels.

3. The analyte testing material web of claim 1, wherein the one or more testing elements are electrochemical sensors and each of the plurality of sample testing devices has a contact electrically connected thereto.

4. The analyte testing material web of claim 3, wherein the contacts and the one or more testing elements are positioned on the first surface of the material web and the material web further comprising a dielectric material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, and a plurality of openings, the dielectric material web positioned to cover and thereby isolate the contacts and positioned such that certain of the plurality of openings of the dielectric material web are adjacent to the inlets and outlets of certain of the plurality of sample testing devices.

5. The analyte testing material web of claim 3, wherein the contacts are positioned on the second surface of the material web opposite the plurality of sample testing devices and connected to the one or more testing elements by vias extending between the first and second surfaces of the material web.

6. The analyte testing material web of claim 1, wherein the one or more testing elements are formed from one or more dry reagent material.

7. A method of making an analyte testing material web, comprising:

applying a plurality of testing elements to a first surface of a first material web, the first material web having the first surface, a second surface opposite the first surface, and a thickness extending between the first and second surfaces;

applying a second material web to the first surface of the first material web, the second material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, and a plurality of openings forming a plurality of wells defined by the thickness of the second material web and the first surface of the first material web, each of the plurality of wells defining a fluid channel encompassing at least one of the plurality of testing elements;

applying a third material web to the first surface of the second material web, the third material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, a plurality of inlets, and a plurality of outlets, the third material web being applied to the second material web such that certain of the plurality of inlets and certain of the plurality of outlets enable fluid communication with each of the plurality of wells; and

applying a plurality of testing elements to the second surface of the third material web such that the at least one of the plurality of testing elements of the third material web are encompassed along with at least one of the plurality of testing elements of the first material web within the fluid channel of one of the sample testing devices.

8. The method of claim 7, further comprising perforating at least one of the first, second, and third material webs substantially adjacent to a first side and a second side thereof, and wherein the perforations formed by perforating the at least one of the first, second, and third material webs enable advancement of the first, second, and third material webs via one or more sprocket-wheels.

9. The method of claim 7, wherein the one or more testing elements are positioned on the first material web by a method from a group consisting of:

screen printing, stencil, ink jetting, aerosol, jetting, electrodeposition, and rotogravure.

10. The method of claim 7, wherein the plurality of sample testing devices are positioned on the first material web and spaced a distance apart from one another along the first material web.

11. The method of claim 7, wherein the one or more testing elements are a plurality of testing elements and certain of the plurality of testing elements are positioned on the first material web grouped together to form a plurality of testing groups, the testing groups being spaced a distance apart from one another along the first material web.

12. The method of claim 7, wherein the one or more testing elements are electrochemical sensors and each of the one or more testing elements has a contact electrically connected thereto.

13. The method of claim 12, wherein the contacts and the one or more testing elements are positioned on the first surface of the first material web and the method further comprising applying a dielectric material web between the first surface of the first material web and the second surface of the second material web to cover and thereby isolate the contacts and positioned such that a plurality of openings of the dielectric material web are adjacent to the plurality of openings of the second web to form wells defined by the thickness of the second material web, a thickness of the dielectric material web, and the first surface of the material web.

14. An analyte testing device, comprising:

a housing having at least one opening;

a reel positioned within and supported by the housing; and

an analyte testing material web connected to the reel and wound about the reel, the analyte testing material web having a material web and a plurality of distinct sample testing devices positioned on the material web, the material web has a first surface, a second surface opposite the first surface, a first side, and a second side opposite the first side, and each of the plurality of sample testing devices having an inlet, an outlet, a fluid channel, and one or more testing elements configured to analyze one or more sample applied to one or more of the plurality of distinct sample testing devices;

wherein the material web is a first material web having a first surface, a second surface opposite the first surface, and a thickness extending between the first and second surfaces, and each of the plurality of distinct sample testing devices comprising;

the one or more testing elements connected to the first of the first material web;

a portion of a second web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, and an opening, the second surface of the second material web overlapping the first surface of the first material web such that the opening forms a well defined by the thickness of the second material web and the first surface of the first material web, the well defining the fluid channel of one of the sample testing devices encompassing at least one of the one or more testing elements; and

a portion of a third material web having a first surface, a second surface opposite the first surface, a thickness extending between the first and second surfaces, an inlet, and an outlet, the second surface of the third material overlapping the first surface of the second material web such that the inlet and the outlet enable fluid communication with the well.

15. The analyte testing device of claim 14, wherein the material web has perforations substantially adjacent to the first side and the second side, the perforations configured to enable advancement of the material web via the reel, wherein the reel is provided with an opening surrounded by a plurality of ridges.

16. The analyte testing device of claim 14, wherein the reel is a first reel positioned within the housing and a second reel is positioned within the housing, and wherein the analyte testing material web is connected to the first and second reels such that the analyte testing material web is wound about and transferrable between the first and second reels.

17. The analyte testing device of claim 14, wherein the plurality of distinct sample testing devices are positioned on the material web spaced a distance apart from one another along the material web.

18. The analyte testing device of claim 14, wherein certain of the one or more testing elements are positioned on the material web grouped together to form a plurality of testing groups, the testing groups being spaced a distance apart from one another along the material web.

19. The analyte testing device of claim 18, wherein the one or more testing elements are electrochemical sensors and each of the one or more testing elements has a contact electrically connected thereto and wherein the contacts are positioned on the second surface of the material web opposite the one or more of testing elements and connected to the one or more of testing elements by vias extending between the first and second surfaces of the material web.

20. The analyte testing device of claim 14, wherein the one or more of the testing elements are formed from one or more dry reagent material.