Microfluidic metering and delivery system

• US 10,293,340 B2
• Filed: 10/03/2018
• Issued: 05/21/2019
• Est. Priority Date: 10/11/2017
• Status: Active Grant

• Current Assignee: Fitbit, Inc. (Alphabet Inc.)
• Original Assignee: Fitbit, Inc. (Alphabet Inc.)
• Inventors: Mai, Junyu, Gutes-Regidor, Albert, Ozel, Rifat Emrah, Prieto, Javier L.
• Primary Examiner(s): Wecker, Jennifer
• Application Number:
  US16/151,062
• Publication Number:
  US 20190111426A1
• Time in Patent Office: 230 Days
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/048 enabling gas exchange, e.g. vents
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/165 Specific details about hydrophobic, oleophobic surfaces
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0457 passive flow or gravitation
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 1/00 Sampling; Preparing specimens for investigation

Abstract

This invention provides devices, systems, and methods for performing point-of-care, analysis, including multiplexed analysis, of a biological fluid analyte, such as blood. The invention includes a cartridge for collecting the biological fluid analyte. The cartridge is configured to be inserted into an assay reader, in which one or more assay reactions may be performed. The assay reader is designed to read and report the results of the one or more assay reactions.

Claims

1. A cartridge for collecting a target analyte for testing, the cartridge comprising:

a metering stack configured to receive and distribute a target analyte along a first channel, wherein the first channel has a bottom that comprises a porous or mesh material and one or more venting holes located along the first channel;

an assay stack comprising at least one assay component, the assay component comprising one or more assay pads, each comprising a reagent for performing an assay on the target analyte or a portion thereof; and

a spacer layer disposed between the metering stack and the assay stack,

wherein the spacer layer provides a gap between the metering stack and the assay stack that prevents the target analyte from flowing from the metering stack into the assay stack when the cartridge is in an uncompressed state; and

wherein the porous or mesh material permits the target analyte to flow from the metering stack to the assay stack only when the cartridge is sufficiently compressed to bring the metering stack in contact with the assay stack.

2. The cartridge according to claim 1, wherein the first channel further comprises a plurality of receiving chambers, each configured to deliver a predetermined volume of the target analyte to the assay stack when the cartridge is sufficiently compressed to bring the metering stack in contact with the assay stack.

3. The cartridge according to claim 1 or 2, wherein the first channel further comprises a plurality of venting holes along the first channel.

4. The cartridge according to claim 1, wherein the target analyte is a biological fluid selected from the group consisting of blood, saliva, sweat, urine, lymph, tears, synovial fluid, breast milk, serum, plasma, bile, or a component thereof.

5. The cartridge according to claim 4, wherein the target analyte is blood and the assay stack comprises a separation layer that prevents erythrocytes from contacting the one or more assay pads.

6. The cartridge according to claim 1, wherein the first channel comprises a hydrophilic coating on at least part of an interior surface.

7. The cartridge according to claim 1, wherein the assay comprises in a color change to at least one of the one or more assay pads.

8. The cartridge according to claim 1, wherein the assay comprises a chemiluminescent reaction.

9. The cartridge according to claim 1, wherein the assay comprises an electrochemical reaction.

10. The cartridge according to claim 1, wherein the first channel is in fluid communication with a reservoir that is adapted to receive the target analyte.

11. The cartridge according to claim 1, wherein the cartridge further comprises a second channel in fluid communication with the first channel along at least a portion of the length of the first channel.

12. The cartridge according to claim 2, wherein the second channel further comprises at least one receiving chamber in fluid communication with a receiving chamber of the first channel.

13. The cartridge according to claim 12, wherein the at least one receiving chamber of the second channel has a larger volume than a volume of the corresponding receiving chamber of the first channel.

14. A method of fabricating a cartridge, the method comprising

obtaining a first layer comprising (1) a layer of polymeric material with a channel formed therein, wherein the channel comprises at least one venting hole disposed along the channel, and (2) a porous or mesh material attached on a bottom surface of the polymeric material such that the channel is bounded on a bottom surface by the porous or mesh material;

obtaining a second layer comprising one or more assay pads, each comprising a porous material capable of absorbing analyte from the bottom of the channel, and a reagent for performing an assay on the target analyte or a portion thereof; and

obtaining a compressible intermediate layer comprising a compressible material; and

combining the first layer, compressible intermediate layer, and second layer in a cartridge housing such that the compressible intermediate layer separates the first layer and the second layer when the compressible intermediate layer is in an uncompressed state, and the channel is aligned with the two or more assay pads in a direction perpendicular to the first layer.

15. The method of fabricating a cartridge according to claim 14, further comprising coating an interior surface of the channel with a hydrophilic coating.

16. The method of fabricating a cartridge according to claim 14, further comprising stacking a cover layer comprising a plurality of vent holes over the first layer, such that the vent holes are aligned with the channel in a direction perpendicular to the first layer.

17. The method of fabricating a cartridge according to claim 14, wherein the compressible intermediate layer provides a gap between the first layer and the second layer when the compressible intermediate layer is in an uncompressed state.

18. A cartridge for collecting blood for testing, the cartridge comprising:

a metering stack configured to receive and distribute the blood along a first channel, wherein the first channel has a bottom that comprises a porous or mesh material and one or more venting holes located along the first channel;

an assay stack comprising at least one assay component, the assay component comprising one or more assay pads, each comprising a reagent for performing an assay on the blood or a portion thereof; and

a spacer layer disposed between the metering stack and the assay stack,

wherein the spacer layer provides a gap between the metering stack and the assay stack that prevents the blood or any portion thereof from flowing from the metering stack into the assay stack when the cartridge is in an uncompressed state; and

wherein the porous or mesh material permits the blood or a portion thereof to flow from the metering stack to the assay stack only when the cartridge is sufficiently compressed to bring the metering stack in contact with the assay stack.

19. The cartridge according to claim 18, wherein at least one assay pad comprises a reagent for measuring the concentration of glucose in the blood.

20. The cartridge according to claim 18, wherein at least one assay pad comprises a reagent for measuring the concentration of creatinine in the blood.