# US 10,864,522 B2 · Processing cartridge and method for detecting a pathogen in a sample

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- Number: US 10,864,522 B2
- Document ID: US10864522B2
- Status: Granted
- Kind: B2
- Application number: 16/541,893
- Filed: 2019-08-15
- Published: 2020-05-21
- Granted: 2020-12-15
- Earliest claimed: 2014-11-11
- Assignees: GenMark Diagnostics, Inc.
- Applicants: GenMark Diagnostics, Inc.
- Inventors: Scott Corey; Brian Murphy; Eric Schneider; David Walter Wright; Dominic Aiello; Andrew Fish; Jay Srinivasan; George Maltezos
- Web page: https://patentgrep.com/patent/US10864522B2

## CPC

- B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/502723: {characterised by venting arrangements}
- B01L 3/50273: {characterised by the means or forces applied to move the fluids}
- B01L 3/502738: {characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746)}
- 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 3/502792: {for moving individual droplets on a plate, e.g. by locally altering surface tension}
- B01L 3/505: {Flexible containers without fluid transport within}
- C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence)
- C12Q 1/6846: {Common amplification features}
- B01L 2200/027: for microfluidic devices
- B01L 2200/0668: Trapping microscopic beads
- B01L 2200/0673: Handling of plugs of fluid surrounded by immiscible fluid
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2200/14: Process control and prevention of errors
- B01L 2300/021: Identification, e.g. bar codes
- B01L 2300/022: Transponder chips
- B01L 2300/0609: Holders integrated in container to position an object
- B01L 2300/0636: Integrated biosensor, microarrays
- B01L 2300/0645: Electrodes
- B01L 2300/0663: Whole sensors
- B01L 2300/0681: Filter
- B01L 2300/0809: rectangular shaped
- B01L 2300/0858: Side walls
- B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
- B01L 2300/0867: Multiple inlets and one sample wells, e.g. mixing, dilution
- B01L 2300/087: Multiple sequential chambers
- B01L 2300/123: Flexible; Elastomeric
- B01L 2300/18: Means for temperature control
- B01L 2300/1805: Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
- B01L 2300/1827: using resistive heater
- B01L 2400/0427: Electrowetting
- B01L 2400/043: magnetic forces
- B01L 2400/0481: squeezing of channels or chambers
- B01L 2400/0487: fluid pressure, pneumatics
- B01L 2400/06: Valves, specific forms thereof
- 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

## Abstract

In one embodiment, a multiplex fluid processing cartridge includes a sample well, a deformable fluid chamber, a mixing well with a mixer disposed therein, a lysis chamber including a lysis mixer, an electrowetting grid for microdroplet manipulation, and electrosensor arrays configured to detect analytes of interest. An instrument for processing the cartridge is configured to receive the cartridge and to selectively apply thermal energy, magnetic force, and electrical connections to one or more discrete locations on the cartridge and is further configured to compress the deformable chamber(s) in a specified sequence.

## Claims

### Claim 1

A cartridge for processing a sample, the cartridge comprising:
a first substrate comprising:
a sample well,
a pump port, and
a mixing well in fluid communication with the sample well,
wherein fluid moves out of the sample well only via pressure applied through via the pump port; and
a second substrate comprising:
a microfluidic network to receive a processed sample from the first substrate, and
electrowetting pads configured to controllably move the processed sample in the second substrate, wherein the processed sample only controllably moves in the second substrate via the electrowetting pads.

### Claim 2 (depends on 1)

The cartridge of claim 1, wherein the second substrate further comprises an electrosensor array.

### Claim 3 (depends on 1)

The cartridge of claim 1, wherein the first substrate further comprises a deformable fluid chamber in fluid communication with the sample well.

### Claim 4 (depends on 1)

The cartridge of claim 1, wherein the mixing well further comprises capture beads.

### Claim 5 (depends on 1)

The cartridge of claim 1, wherein the mixing well further comprises a passive valve assembly.

### Claim 6 (depends on 1)

The cartridge of claim 1, wherein the first substrate further comprises a lysis chamber in fluid communication with the sample well.

### Claim 7 (depends on 6)

The cartridge of claim 6, wherein the lysis chamber further comprises a mesh filter having a pore size that retains lysis beads within the lysis chamber.

### Claim 8 (depends on 1)

The cartridge of claim 1, further comprising a lower shroud and an upper shroud.

### Claim 9 (depends on 8)

The cartridge of claim 8, wherein the lower shroud has rounded edges and the upper shroud has square edges.

### Claim 10

A cartridge for processing a sample, the cartridge comprising:
a first substrate comprising:
a sample well,
a pump port, and
a deformable fluid chamber in fluid communication with the sample well;
a second substrate comprising:
a microfluidic network for receiving a processed sample from the first substrate, and
electrowetting pads; and
an interstitial space between the first substrate and second substrate, wherein the interstitial space forms a void.

### Claim 11 (depends on 10)

The cartridge of claim 10, wherein the second substrate further comprises a bubble trap.

### Claim 12 (depends on 11)

The cartridge of claim 11, wherein the bubble trap further comprises a bubble hood.

### Claim 13 (depends on 10)

The cartridge of claim 10, wherein the second substrate further comprises an upper perimeter wall.

### Claim 14 (depends on 10)

The cartridge of claim 10, wherein the first substrate and second substrate are secured together by an adhesive gasket.

### Claim 15 (depends on 10)

The cartridge of claim 10, further comprising a lower shroud.

### Claim 16 (depends on 10)

The cartridge of claim 10, further comprising an upper shroud.

### Claim 17

A cartridge for processing a sample, the cartridge comprising:
a first substrate comprising:
a sample well, and
a pump port, wherein fluid moves out of the sample well only via pressure applied through the pump port; and
a second substrate to receive the fluid from the first substrate, the second substrate comprising:
electrowetting pads configured to move the fluid in the second substrate, wherein the fluid is moved in the second substrate only via digital microfluidics on the electrowetting pads.

### Claim 18 (depends on 17)

The cartridge of claim 17, wherein the pump port is connected to the sample well by a pressure conduit.

### Claim 19 (depends on 17)

The cartridge of claim 17, wherein the first substrate further comprises a lysis chamber, and wherein the lysis chamber comprises a motor with an impeller.

### Claim 20 (depends on 17)

The cartridge of claim 17, further comprising an interstitial space between the first substrate and second substrate, wherein the interstitial space forms a void.