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EP-4739435-A1 - TWO-DIMENSIONAL MATRIX DROPLET ARRAY

EP4739435A1EP 4739435 A1EP4739435 A1EP 4739435A1EP-4739435-A1

Abstract

The present disclosure provides a device that may be used for a range of different assays such as immunoassays, nucleic acid analysis, metabolite analysis, clinical chemistry, and complete blood cell count. The device optionally contains a sample analysis region to analyze the samples processed in the device. The device comprises a top substrate bound to a bottom substrate wherein the top substrate bound to the bottom substrate forms two or more primary zones separated by one or more secondary zones, and wherein the top substrate has an opening in one or more of the primary zones.

Inventors

  • LUOMA, ROBERT P.
  • IKEDA, TOMOHIRO
  • YAMAGUCHI, KEISUKE
  • SONI, PATHIK H.
  • HARRIS, Jason N.
  • QIAO, LEI
  • HOUSE, Dustin L.
  • SAKIB, NAZMUS
  • PARDESHI, Irsha
  • YARNELL, Lyle
  • OMOKAWA, Yousuke

Assignees

  • Abbott Laboratories

Dates

Publication Date
20260513
Application Date
20240703

Claims (20)

  1. 1. A device, comprising: a top substrate bound to a bottom substrate, wherein the top substrate bound to the bottom substrate forms two or more primary zones separated by one or more secondary zones, and wherein the top substrate has an opening in one or more of the primary zones.
  2. 2. The device of claim 1 , wherein the top substrate has an opening in one or more of the secondary zones.
  3. 3. The device of claim 1 or 2, wherein the top substrate has an opening in each of the primary and secondary zones.
  4. 4. The device of any of claims 1-3, wherein the bottom substrate has uniform hydrophobicity.
  5. 5. The device of any of claims 1-4, wherein the top substrate has uniform hydrophobicity.
  6. 6. The device of any of claims 1-5, wherein the top substrate and bottom substrate form a first distance between the top substrate and bottom substrate within the primary zones and a second distance between the top substrate and the bottom substrate within the secondary zones.
  7. 7. The device of claim 6, wherein the first distance is less than the second distance.
  8. 8. The device of any of claims 1-7, wherein the top substrate in the primary zones forms a shape selected from the group consisting of a rectangle, a circle, a triangle, a pentagon, a hexagon, a heptagon, an octagon, a decagon, a dodecagon, an amoeboid, and a non-regular shape.
  9. 9. The device of any of claims 1-8, wherein the top substrate bound to the bottom substrate forms three or more primary zones separated by two or more secondary zones.
  10. 10. The device of any of claims 1-9, wherein the top substrate bound to the bottom substrate forms six or more primary zones separated by seven or more secondary zones.
  11. 11. The device of any of claims 1-9, wherein the top substrate bound to the bottom substrate forms nine or more primary zones separated by twelve or more secondary zones.
  12. 12. The device of any of claims 1-11, wherein the top substrate bound to the bottom substrate forms twelve or more primary zones separated by seventeen or more secondary zones.
  13. 13. The device of any of claims 1-12, wherein the top substrate bound to the bottom substrate forms fifteen or more primary zones separated by twenty-two or more secondary zones.
  14. 14. The device of any of claims 1-13, wherein the top substrate bound to the bottom substrate forms eighteen or more primary zones separated by twenty-seven or more secondary zones.
  15. 15. The device of any of claims 1-14, wherein the top substrate bound to the bottom substrate forms twenty-one or more primary zones separated by thirty-two or more secondary zones.
  16. 16. The device of any of claims 1-15, wherein the top substrate bound to the bottom substrate forms twenty-four or more primary zones separated by thirty-seven or more secondary zones.
  17. 17. The device of any of claims 1-16, further comprising a transition zone.
  18. 18. The device of any of claims 1-17, further comprising a sample analysis region.
  19. 19. The device of claim 18, wherein the sample analysis region comprise a tertiary zone.
  20. 20. The device of claim 18 or 19, wherein the tertiary zone comprises one or more wells.

Description

TWO-DIMENSIONAL MATRIX DROPLET ARRAY CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority benefit to the filing dates of U.S. Provisional Patent Application Serial No. 63/525,617, filed on July 7, 2023, and U.S. Provisional Patent Application Serial No. 63/601,393, filed on November 21, 2023, the disclosures of which applications are herein incorporated by reference in their entirety. INTRODUCTION [0002] Analyte analysis is usually performed by carrying out sample preparation step that is either performed manually or using complicated robotics. After sample preparation, the assaying of an analyte in the prepared sample further involves use of expensive and complicated systems for transporting the prepared sample to a machine that then performing analysis of an analyte in the prepared sample. [0003] Devices that can be used to prepare a sample for multiple types of assays and assay the prepared sample are highly desirable in the field of analyte analysis. Such devices would offer a low cost option and would considerably increase the ease of performing analyte analysis, especially in clinical applications, such as point-of-care applications. [0004] As such, there is an interest in devices for sample preparation because they allow for reduced sample volumes and reagent volumes, potential for higher sensitivity, and faster time to result. SUMMARY [0005] The present invention is defined by the appendant claims. [0006] The present disclosure provides a device that may be used for a range of different assays such as immunoassays, nucleic acid analysis, metabolite analysis, clinical chemistry, and complete blood cell count. The device optionally contains a sample analysis region to analyze the samples processed in the device. [0007] In an aspect, the invention provides a device that comprises a top substrate bound to a bottom substrate wherein the top substrate bound to the bottom substrate forms two or more primary zones separated by one or more secondary zones, and wherein the top substrate has an opening in one or more of the primary zones. [0008] In another aspect, the invention provides a sample processing device comprising a top substrate, a bottom substrate attached to the top substrate so as to form an interior volume, wherein the top substrate and/or bottom substrate substantially define a first plane, a sample processing region within the interior volume, wherein the sample processing region comprises two or more primary zones and one or more secondary zones, wherein each primary zone is separated from an adjacent primary zone in a direction substantially along the first plane by a secondary zone of the one or more secondary zones, wherein the top substrate comprises an opening into a respective primary zone of the two or more primary zones. [0009] In other aspects, the invention provides methods of using the discussed devices and sample processing devices. [0010] Also provided is an optional reagent delivery device that may be used with a version of the device. A pressure sample mixing device is also provided. [0011] As will be discussed further below, the sample processing device of the invention may comprise an internal volume formed by the top substrate and bottom substrate when attached to one another. This internal volume may itself be split into, or comprise, different regions which are connected to one another. For instance, the device may comprise a sample processing region within, or forming part of, the internal volume. This sample processing region may he used to perform one or more processing steps on a sample attached to a microparticle as the microparticle is moved through the sample processing region. [0012] The sample processing region may be connected to a sample analysis region, which sample analysis region can be used to analyze the processed sample. This analysis may be performed using external apparatus to, e.g. digitally image, the sample analysis region. In this context, a connection between regions is intended to mean that a microparticle can be moved between said regions, e.g. a path or channel exists for the microparticle to move from one region to another. The sample processing region may additionally or alternatively be connected to a sample mixing region. For instance, in use, a microparticle may be able to travel from a sample mixing region, into a sample processing region, and then into a sample analysis region. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 illustrates a top view of the top of the sample processing device according to one embodiment. [0014] FIG. 2 illustrates a top view of the top of the sample processing device according to another embodiment. [0015] FIG. 3 illustrates a top view of the top of the sample processing device according to another embodiment. [0016] FIG. 4 illustrates a top view of the top of the sample processing device according to another embodiment. [0017] FIG. 5 illustrates a top view of the top of the sam