# US 2013/0157286 A1 · Fluidic connectors and microfluidic systems

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- Number: US 2013/0157286 A1
- Document ID: US20130157286A1
- Status: Published application
- Kind: A1
- Application number: 13/765,042
- Filed: 2013-02-12
- Published: 2013-06-20
- Earliest claimed: 2007-05-04
- Assignees: OPKO Diagnostics, LLC
- Inventors: Vincent Linder; David Steinmiller; Samuel K. Sia
- Web page: https://patentgrep.com/patent/US20130157286A1

## CPC

- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- B01L 3/5027: {by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip}
- B01L 3/502707: {characterised by the manufacture of the container or its components}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/502761: {specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads or physically stretching molecules}
- B01L 3/563: {Joints or fittings; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors}
- B01L 3/565: {Seals}
- C12Q 1/6834: Enzymatic or biochemical coupling of nucleic acids to a solid phase
- G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)}
- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- G01N 33/5304: {Reaction vessels, e.g. agglutination plates (for solid-phase systems G01N33/543)}
- G01N 33/5306: {Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding}
- G01N 33/545: Synthetic resin
- B01L 2200/025: Align devices or objects to ensure defined positions relative to each other
- B01L 2200/027: for microfluidic devices
- B01L 2200/0689: Sealing
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2200/12: Specific details about manufacturing devices
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/021: Identification, e.g. bar codes
- B01L 2300/041: Connecting closures to device or container
- B01L 2300/0627: Sensor or part of a sensor is integrated
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/0838: Capillaries
- B01L 2300/0861: Configuration of multiple channels and/or chambers in a single devices
- B01L 2300/12: Specific details about materials
- B01L 2400/049: vacuum
- G01F 22/00: Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
- Y10T 403/22: with fluid pressure responsive component
- Y10T 436/11: Automated chemical analysis
- Y10T 436/25: including sample preparation
- Y10T 436/2575: Volumetric liquid transfer
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Fluidic connectors, methods, and devices for performing analyses (e.g., immunoassays) in microfluidic systems are provided. In some embodiments, a fluidic connector having a fluid path is used to connect two independent channels formed in a substrate so as to allow fluid communication between the two independent channels. One or both of the independent channels may be pre-filled with reagents (e.g., antibody solutions, washing buffers and amplification reagents), which can be used to perform the analysis. These reagents may be stored in the channels of the substrate for long periods amounts of time (e.g., 1 year) prior to use.

## Claims

### Claim 1

A method comprising:
providing a microfluidic system comprising a first microfluidic channel including at least one inlet and one outlet and a second microfluidic channel including at least one inlet and one outlet,
wherein the first microfluidic channel contains a first reagent disposed therein,
wherein the second microfluidic channel contains a second reagent disposed therein, and
wherein a seal covers the inlet of the first microfluidic channel and a seal covers the outlet of the first microfluidic channel so as to store the first reagent in the first microfluidic channel;
connecting a fluidic connector to the microfluidic system to cause fluid communication between the first and second microfluidic channels,
wherein the first and second microfluidic channels are not in fluid communication with one another absent connection via the fluidic connector.

### Claim 2

A method of storing reagents comprising:
providing a microfluidic system comprising a first microfluidic channel including at least one inlet and one outlet and a second microfluidic channel including at least one inlet and one outlet;
disposing a first reagent in the first microfluidic channel;
disposing a second reagent in the second microfluidic channel; and
sealing the at least one inlet and outlet of the first microfluidic channel so as to store the first reagent in the first microfluidic channel,
wherein the first and second microfluidic channels are not in fluid communication with one another after the sealing step.

### Claim 3 (depends on 1)

A method as in claim 1, wherein the microfluidic system comprises a reaction area in fluid communication with the second microfluidic channel prior to the connecting step.

### Claim 4 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a fluid path including a fluid path inlet and a fluid path outlet, wherein upon connection, the fluid path inlet connects to the outlet of the first microfluidic channel to allow fluid communication between the fluid path and the first microfluidic channel, and the fluid path outlet connects to the inlet of the second microfluidic channel to allow fluid communication between the fluid path and the second microfluidic channel.

### Claim 5 (depends on 1)

A method as in claim 1, wherein the first reagent disposed in the first microfluidic channel is a liquid reagent.

### Claim 6 (depends on 1)

A method as in claim 1, wherein the second reagent disposed in the second microfluidic channel is a substantially dry reagent.

### Claim 7 (depends on 1)

A method as in claim 1, wherein the first microfluidic channel comprises a third reagent disposed therein.

### Claim 8 (depends on 7)

A method as in claim 7, wherein the third reagent is a liquid reagent.

### Claim 9 (depends on 8)

A method as in claim 8, wherein the first and third reagents are separated by a fluid that is immiscible with said first and third reagents.

### Claim 10 (depends on 9)

A method as in claim 9, wherein the fluid immiscible with the first and third reagents is a gas.

### Claim 11 (depends on 10)

A method as in claim 10, wherein at least one of the first and third reagents is a rinse solution.

### Claim 12 (depends on 1)

A method as in claim 1, wherein the microfluidic system comprises a seal covering the inlet of the second microfluidic channel and a seal covering the outlet of the second microfluidic channel.

### Claim 13 (depends on 3)

A method as in claim 3, wherein the second reagent is disposed in the reaction area of the second microfluidic channel, and wherein the third reagent is a substantially dry reagent.

### Claim 14 (depends on 13)

A method as in claim 13, wherein the second reagent comprises at least one of an antibody or an antigen.

### Claim 15 (depends on 13)

A method as in claim 13, wherein the second reagent is adsorbed to a surface of the second microfluidic channel.

### Claim 16 (depends on 3)

A method as in claim 3, wherein the reaction area comprises at least one meandering channel region.

### Claim 17 (depends on 16)

A method as in claim 16, wherein the reaction area comprises at least two meandering channel regions connected in series.

### Claim 18 (depends on 17)

A method as in claim 17, wherein each of the at least two meandering channel regions comprises a chemical and/or biological species disposed therein that can undergo a chemical and/or biological reaction.

### Claim 19 (depends on 18)

A method as in claim 18, wherein the chemical and/or biological reaction is a binding event between at least two binding partners, and wherein at least one of the binding partners comprises an antibody.

### Claim 20 (depends on 3)

A method as in claim 3, wherein the reaction area comprises at least one cross-sectional dimension of less than 100 microns.

### Claim 21 (depends on 1)

A method as in claim 1, wherein the microfluidic system comprises a substrate comprising more than one substrate layers that are mated to one another.

### Claim 22 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a substantially planar substrate comprising a channel formed in at least a portion of the substantially planar substrate.

### Claim 23 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a monolithic device comprising a channel formed in at least a portion of the monolithic device.

### Claim 24 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a tube.

### Claim 25 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a fluid path having a volume between 1 μL and 1000 μL.

### Claim 26 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a fluid path comprising a reagent disposed therein.

### Claim 27 (depends on 26)

A method as in claim 26, wherein the reagent disposed in the fluid path of the fluidic connector is a substantially dry reagent that coats at least a portion of the fluid path.

### Claim 28 (depends on 26)

A method as in claim 26, wherein the reagent is an anti-coagulant.

### Claim 29 (depends on 1)

A method as in claim 1, wherein the fluidic connector comprises a fluid path and a volume control element that is constructed and arranged to introduce a controlled volume of a fluid sample from a biological entity into the fluid path.

### Claim 30 (depends on 29)

A method as in claim 29, wherein the volume control element is constructed and arranged to allow a fluid sample to fill the entire volume of the fluid path.

### Claim 31 (depends on 29)

A method as in claim 29, wherein the volume control element is constructed and arranged to allow a fluid sample to fill a portion, but not all, of the volume of the fluid path.

### Claim 32 (depends on 1)

A method as in claim 1, wherein the microfluidic system comprises a substrate comprising the first and second microfluidic channels formed therein.

### Claim 33 (depends on 1)

A method as in claim 1, comprising introducing a sample into the fluidic connector prior to the connection step.

### Claim 34 (depends on 33)

A method as in claim 33, wherein the fluidic connector contains a binding component disposed therein, the method comprising associating at least a portion of the sample with the binding component prior to the connecting step.

### Claim 35 (depends on 33)

A method as in claim 33, comprising applying a vacuum to an outlet of the microfluidic system and flowing at least the sample and the first reagent in series across an analysis region of the second microfluidic channel.