Mechanical cartridge with test strip fluid control features for use in a fluid analyte meter

• US 7,674,615 B2
• Filed: 05/04/2005
• Issued: 03/09/2010
• Est. Priority Date: 05/04/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Ramel, Urs A., Tay, Dillan
• Primary Examiner(s): Nguyen; Bao-Thuy L
• Assistant Examiner(s): DIRAMIO, JACQUELINE A
• Application Number:
  US11/121,972
• Publication Number:
  US 20060008847A1
• Time in Patent Office: 1,770 Days
• Field of Search: 422/55, 422/56, 422/58, 422/60, 422/68.1, 422/82, 422/99, 422/100, 422/102, 422/104, 435/287.1, 435/287.3, 435/288.7, 435/4, 435/7.1, 435/286.5, 436/501, 436/514, 436/164, 436/169
• US Class Current: 435/286.5
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/04 Closures and closing means
• CPC Class Codes: B01L 2300/049 Valves integrated in closure
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/089 Virtual walls for guiding liquids
• CPC Class Codes: B01L 2400/0457 passive flow or gravitation
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Claims

1. A pinch wall system for controlling fluid flow movement between a sample receiving pad and a test strip, comprising:

a sample receiving pad;

a test strip in contact with the sample receiving pad; and

a pinch wall sitting on top of the sample receiving pad, the pinch wall compressing the sample receiving pad, the pinch wall comprising;

a first portion separating a sample receiving portion of the sample receiving pad from a portion of the sample receiving pad positioned adjacent to the test strip, and a second portion separating the sample receiving portion of the sample receiving pad from a portion of the sample receiving pad positioned away from the test strip, wherein the portion of the sample receiving pad that receives sample thereon is positioned on an opposite side of the pinch wall from the portion of the sample receiving pad positioned away from the test strip, wherein the first portion of the pinch wall compresses the sample receiving pad to a lesser degree than the second portion of the pinch wall, wherein fluid seeps more quickly under the first portion of the pinch wall than under the second portion of the pinch wall, such that the test strip becomes saturated prior to excess fluid being absorbed in the portion of the sample receiving pad away from the test strip such that the test strip does not become flooded, the portion of the sample receiving pad positioned away from the test strip being sufficiently sized to absorb the excess fluid.

2. The system of claim 1, wherein the first and second portions of the pinch wall together continuously surround the sample receiving portion of the sample receiving pad.

3. The system of claim 1, wherein the pinch wall compresses the sample receiving pad such that fluid received onto the sample receiving pad preferentially tends to flow from the sample receiving portion of the sample receiving pad into the portion of the sample receiving pad positioned adjacent to the test strip, and less so from the sample receiving portion of the sample receiving pad to the portion of the sample receiving pad positioned away from the test strip.

4. The system of claim 1, wherein the second portion of the pinch wall compresses 60 to 90% of the height of the sample receiving pad and the first portion of the pinch wall compresses 2 to 30% of the height of the sample receiving pad.

5. The system of claim 1, wherein the second portion of the pinch wall compresses 70 to 80% of the height of the sample receiving pad and the first portion of the pinch wall compresses 5 to 15% of the height of the sample receiving pad.

6. The system of claim 1, further comprising:

a cartridge comprising;

a cartridge bottom; and

a cartridge top, wherein the sample receiving pad and test strip are received between the cartridge bottom and the cartridge top, and wherein the pinch wall extends downwardly from the cartridge top.

7. The system of claim 6, wherein the second portion of the pinch wall has a greater height than the first portion of the pinch wall.

8. The system of claim 6, wherein the cartridge is a single-use disposable cartridge.

9. The system of claim 1, wherein the pinch wall system is positioned in a single-use disposable meter.

10. The system of claim 6, wherein the cartridge top comprises a sample receiving aperture positioned above the sample receiving portion of the sample receiving pad.

11. The system of claim 1, wherein the test strip is a lateral flow assay test strip.

12. The pinch wall system of claim 1, wherein the portion of the sample receiving pad positioned away from the test strip absorbs said excess fluid resulting from said saturation of said test strip so as to prevent said flooding upon application of a conventional sample volume.

13. A pinch wall system for controlling fluid flow movement between a sample receiving pad and a test strip, comprising:

a sample receiving pad;

a test strip in contact with the sample receiving pad; and

a pinch wall sitting on top of the sample receiving pad, the pinch wall compressing the sample receiving pad, the pinch wall comprising;

a first portion separating a sample receiving portion of the sample receiving pad from a portion of the sample receiving pad positioned adjacent to the test strip, and a second portion separating the sample receiving portion of the sample receiving pad from a portion of the sample receiving pad positioned away from the test strip, wherein the portion of the sample receiving pad that receives sample thereon is positioned on an opposite side of the pinch wall from the portion of the sample receiving pad positioned away from the test strip, wherein the first portion of the pinch wall compresses the sample receiving pad to a lesser degree than the second portion of the pinch wall, wherein fluid seeps more quickly under the first portion of the pinch wall than under the second portion of the pinch wall, such that the test strip becomes saturated prior to excess fluid being absorbed in the portion of the sample receiving pad away from the test strip such that the test strip does not become flooded, and wherein the portion of the sample receiving pad away from the test strip is substantially uncompressed.

14. A pinch wall system for controlling fluid flow movement between a sample receiving pad and a test strip, the pinch wall system comprising:

a sample receiving pad having a first section, a second section, and a third section;

a test strip in contact with said sample receiving pad first section;

a first pinch wall partially compressing said sample receiving pad, said first pinch wall defining the boundary of said first section and said second section,

a second pinch wall partially compressing said sample receiving pad a greater degree than said first pinch wall, said second pinch wall defining the boundary of said second section and said third section;

wherein said second section of said sample receiving pad is adapted to receive sample fluid thereon,

whereby said sample fluid flows to said first section and said test strip more quickly than to said third section such that the test strip becomes saturated prior to excess fluid being absorbed in said third section, said third section being sized to accommodate said excess fluid.

15. The pinch wall system of claim 14, wherein said first pinch wall and said second pinch wall are portions of one pinch wall.

16. The pinch wall system of claim 14, wherein said first and second pinch walls together continuously surround said second section of said sample receiving pad.

17. The pinch wall system of claim 14, further comprising a cartridge having a top and bottom, wherein said sample receiving pad and said test strip are received between the cartridge top and bottom.