Systems and devices for analysis of samples

• US 9,682,376 B2
• Filed: 05/01/2014
• Issued: 06/20/2017
• Est. Priority Date: 04/16/2010
• Status: Active Grant

• Current Assignee: Opko Diagnostics, LLC (Opko Health, Inc.)
• Original Assignee: Opko Diagnostics, LLC (Opko Health, Inc.)
• Inventors: Steinmiller, David, Taylor, Jason, Linder, Vincent
• Primary Examiner(s): HIXSON, CHRISTOPHER
• Application Number:
  US14/266,894
• Publication Number:
  US 20140234180A1
• Time in Patent Office: 1,146 Days
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• 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 2200/028 Modular arrangements
• CPC Class Codes: B01L 2200/0673 Handling of plugs of fluid surrounded by immiscible fluid
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2200/146 Employing pressure sensors
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/04 Closures and closing means
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/12 Specific details about materials
• CPC Class Codes: B01L 2300/14 Means for pressure control
• CPC Class Codes: B01L 2300/16 Surface properties and coatings
• CPC Class Codes: B01L 2300/168 Specific optical properties, e.g. reflective coatings
• CPC Class Codes: B01L 2300/1827 : using resistive heater
• CPC Class Codes: B01L 2300/1894 : Cooling means; Cryo cooling
• CPC Class Codes: B01L 2400/0475 : specific mechanical means and fluid pressure
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0666 : Solenoid valves
• CPC Class Codes: B01L 2400/082 : Active control of flow resistance, e.g. flow controllers
• CPC Class Codes: 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 B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B01L 7/52 : with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: G01N 21/05 : Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/59 : Transmissivity G01N21/25 takes precedence
• CPC Class Codes: G01N 21/64 : Fluorescence; Phosphorescence
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 2201/02 : Mechanical
• CPC Class Codes: G01N 2201/0612 : Laser diodes
• CPC Class Codes: G01N 2201/062 : LED's
• CPC Class Codes: G01N 2201/0621 : Supply
• CPC Class Codes: G01N 2201/0697 : Pulsed lasers
• CPC Class Codes: G01N 2333/96433 : Serine endopeptidases (3.4.21)
• CPC Class Codes: G01N 33/54313 : the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/57434 : of prostate
• CPC Class Codes: Y10T 137/0324 : With control of flow by a condition or characteristic of a fluid
• CPC Class Codes: Y10T 436/12 : Condition responsive control

Abstract

Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described. The microfluidic sample analyzers may be used to control fluid flow, mixing, and sample analysis in a variety of microfluidic systems such as microfluidic point-of-care diagnostic platforms. Advantageously, the microfluidic sample analyzers may be, in some embodiments, inexpensive, reduced in size compared to conventional bench top systems, and simple to use. Cassettes that can operate with the sample analyzers are also described.

Claims

1. A device comprising:

a first component comprising a first channel formed in a first material and including at least a first port, the first channel including at least one portion having a cross-sectional dimension greater than 200 microns, wherein the first material has a water vapor permeability of less than about 0.05 g·

mm/m²·

d;

a second component comprising a second channel formed in a second material and including at least a second port, the second channel including at least one portion having a cross-sectional dimension less than 200 microns, wherein the second material has an optical transmission of greater than 90% between 400 nm and 800 nm wavelengths of light;

a fluidic connector that can be connected to the first and second components, the fluid connector comprising a fluid path including a fluid path inlet and a fluid path outlet, wherein upon connection, the fluid path inlet fluidically connects to the first port and the fluid path outlet fluidically connects to the second port to allow fluid communication between the first and second channels,

wherein the first and second channels are not in fluid communication with one another absent connection via the fluidic connector,

wherein the first and second components are substantially planar and lie on top of one another, and

wherein both the first port and the second port are accessible from a top surface of the first component or the second component.

2. A device as in claim 1, wherein the first component comprises a feature complementary to a feature of the second component so as to form a non-fluidic connection between the first and second components.

3. A device as in claim 1, wherein the first and second components are integrally connected to one another.

4. A device as in claim 1, wherein the first and second components are reversibly attached to one another.

5. A device as in claim 1, wherein the at least one portion of the first channel of the first component is substantially enclosed by the second component, and/or the at least one portion of the second channel of the second component is substantially enclosed by the first component.

6. A device as in claim 1, wherein the at least one portion of the first channel of the first component is substantially enclosed by a first cover that is not the second component, and/or wherein the at least one portion of the second channel of the second component is substantially enclosed by a second cover that is not the first component.

7. A device as in claim 6, wherein the first and/or second cover is a tape.

8. A device as in claim 1, wherein the first material is different from the second material.

9. A device as in claim 1, wherein the first material has a water vapor permeability between about 0.01 g·

mm/m²·

d and about 0.4 g·

mm/m²·

d.

10. A device as in claim 1, wherein the first material has a higher melting temperature than the second material.

11. A device as in claim 1, wherein the second material has a melting temperature of less than about 100°

C.

12. A device as in claim 1, wherein the second material has an optical transmission of greater than 95% between 400 nm and 800 nm wavelengths of light.

13. A device as in claim 1, wherein the first material has an optical transmission of less than 10% between 400 nm and 800 nm wavelengths of light.

14. A device as in claim 1, wherein the first material comprises a cyclo-olefin copolymer.

15. A device as in claim 1, wherein the second material comprises polystyrene, PMMA, or a cyclo-olefin copolymer.

16. A device as in claim 1, wherein the at least one portion of the first channel has a root mean square surface roughness of greater than about 5 microns, and the at least one portion of the second channel has a root mean square surface roughness of less than about 5 microns.

17. A device as in claim 1, comprising a first reagent disposed in the first channel, wherein the first port of the first channel is sealed prior to first use so as to store the first reagent in the first channel, wherein the first reagent is a liquid.

18. A device as in claim 1, comprising a second reagent disposed in the second channel, wherein the second reagent is substantially dried and is adsorbed to a surface of the at least one portion of the second channel.

19. A device as in claim 1, wherein the second component comprises a reaction area in fluid communication with the second channel.

20. A device as in claim 19, wherein the reaction area comprises at least one meandering channel region.

21. A device as in claim 19, wherein the reaction area comprises at least two meandering channel regions connected in series.

22. A device as in claim 1, comprising an alignment element associated with the first or second components, extending from one of the first or second components and comprising a cavity constructed and arranged to receive and engage the fluidic connector and thereby position the connector in a predetermined, set configuration relative to the first or second components.

23. A device as in claim 1, wherein the fluid path of the fluid connector has a length of at least 2 cm.

24. A device as in claim 1, wherein each of the first and second components comprises at least one portion having a thickness of at least 2.5 mm.

25. A device as in claim 1, wherein each of the first and second components comprises at least a portion having a thickness of at least 2.5 mm, and wherein at least one of the first and second components comprises at least one portion having a thickness of less than 2.5 mm.

26. A device as in claim 1, wherein both the first port and the second port extend above a top surface of the first component or the second component.