MICROFLUIDIC ANALYTE DETECTION CARTRIDGE DEVICE, SYSTEM AND METHOD

• US 20140273265A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Hector Luis Penagos-Vargas, Joseph Feingold
• Original Assignee: Joseph Feingold
• Inventors: FEINGOLD, Joseph, Penagos-Vargas, Hector Luis
• Granted Patent: US 9,446,405 B2
• Time in Patent Office: Days
• US Class Current: 436/163
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502776 specially adapted for focusing or laminating flows
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/0353 Conveyor of successive sample drops
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/41 Refractivity; Phase-affecting properties, e.g. optical path length G01N21/21 takes precedence
• CPC Class Codes: G01N 21/55 Specular reflectivity
• CPC Class Codes: G01N 27/08 which is flowing continuously

Abstract

A microfluidic cartridge for assaying an analyte comprises one or more test channels, each having a lumen; one or more reference solution channels in fluid communication with the test channels; one or more sample channels in fluid communication with the test channels; one or more sensors at least partially exposed in the lumen of the test channels; and a processor coupled to the one or more sensors for measuring properties of the analyte to determine at least one of an identity, concentration, dose, and dosage of the analyte.

Claims

1. A method of determining at least one of an identity, concentration, dosage, and dose of an intravenous analyte to be tested prior to being administered to a patient, the method using a microfluidic device comprising a microfluidic sample channel and a microfluidic reference channel in fluid communication with a test microfluidic channel, and a processor, and comprising:

measuring, by the microfluidic device, within the test channel, at least one of electrochemical, chemical, physical, biological, biochemical, thermal and optical properties of the tested analyte in the presence of at least one reference solution;

generating, by the processor, a response profile for the tested analyte from said at least one measurement;

comparing, by the processor, the generated profile to a known response profile for a specified analyte;

estimating, by the processor, a likelihood that the generated profile and known response profile match within an acceptable range; and

generating, by the processor, an error signal when the likelihood of a match falls outside the acceptable range.

2. The method of claim 1, wherein, when the likelihood of a match falls outside the acceptable range, administering the analyte to the patient is at least one of prevented, stopped, and adjusted.

3. The method of claim 1, further comprising identifying, by the processor, said tested analyte, based on said at least one measurement.

4. The method of claim 1, further comprising determining, by the processor, a concentration of said tested analyte, based on said at least one measurement.

5. The method of claim 1, further comprising determining, by the processor, a dose of said tested analyte, based on said at least one measurement.

6. The method of claim 1, further comprising determining, by the processor, a dosage of said tested analyte, based on said at least one measurement.

7. The method of claim 1, further comprising analyzing, by the processor, the analyte or the concentration of the analyte for at least one of unsafe drug-drug interactions, conflicts with known characteristics of the patient, quality metrics, hospital treatment guidelines and protocols.

8. The method of claim 1, further comprising pulsing, by the microfluidic device, the test channel with a predetermined voltage and detecting current elicited to determine at least one of said measurements of the analyte and the reference solution.

9. A microfluidic device for use in a system comprising an intravenous delivery apparatus in fluid communication with the microfluidic device for providing an injectable test solution containing a test analyte to the microfluidic device, one or more intravenous lines with one or more ports to deliver the injectable test solution to the microfluidic device for analysis, a pump or pressure source to circulate the injectable test solution from one or more intravenous lines, and a reference solution, a valve in each of the intravenous lines for regulating flow of the injectable solution, and one or more controllers for operating the valves, the microfluidic device comprising:

one or more test channels, each having a lumen;

one or more reference solution channels in fluid communication with the one or more test channels;

one or more sample channels in fluid communication with the one or more test channels with each sample channel also in fluid communication with the injectable test solution;

a detector coupled to a plurality of sensors that are at least partially exposed within the lumen of the one or more test channels, the detector measuring at least one property of the test analyte;

one or more ionic reference solution reservoirs in fluid communication with the one or more reference solution channels; and

a processor that generates a response profile for the test analyte from said at least one measurement of a property, compares the generated profile to a known response profile for a specified analyte;

estimates a likelihood that the generated profile and known response profile match within an acceptable range; and

generates, an error signal when the likelihood of a match falls outside the acceptable range.

10. The microfluidic device of claim 9, wherein the detector measures at least one of electrochemical, chemical, physical, biological, biochemical, thermal and optical properties of the test analyte.

11. The microfluidic device of claim 9, wherein, when the processor outputs the error signal to the one or more controllers, the valve controlling flow of the injectable test solution is closed by the one or more controllers.

12. The microfluidic device of claim 9, further comprising a communication link to an alarm activated by the error signal.

13. The microfluidic device of claim 9, wherein information collected by the system by the processor is transmitted via an output interface.

14. The microfluidic device of claim 9, wherein the system further comprises an infusion pump that controls a flow rate of the injectable test solution, and wherein the flow rate is controlled by the processor communicating with the pump, based on the measured properties of the test analyte.

15. A method of assaying an analyte by a microfluidic device comprising one or more test channels, each having a lumen, one or more reference solution channels in fluid communication with the test channels, one or more sample channels in fluid communication with the test channels, a plurality of electrodes, each electrode at least partially exposed inside the lumen of the test channels and one or more reference solution reservoirs in fluid communication with the reference solution channels, the method comprising:

receiving one or more reference solutions into the one or more reference solution channels;

receiving one or more samples of a sample solution suspected of containing the analyte into the one or more sample channels;

mixing in the test channels the one or more reference solutions and the one or more samples to form a test solution;

measuring a response to a stimulus received by a sensor that is located within the test solution;

comparing the response to an acceptable range of predetermined values for mixtures of the reference solution and the sample solution; and

estimating whether one or more of the identity, concentration, dosage, and dose of the analyte are within the acceptable range based on the comparison.

16. The method of claim 15, wherein the reference solution comprises at least one of immunoglobulins, water, bio-molecules, antibodies and water soluble ionic salts.

17. The method of claim 15, further comprising:

applying voltage pulses as the stimulus to the test solution at one or more locations along the test channels,

wherein measuring the response to the stimulus received by the sensor comprises measuring current resulting from the voltage pulses.

18. The method of claim 15, wherein the stimulus is heat present in the test solution, and wherein the response is temperature measured at one or more locations along the test channels.

19. The method of claim 15, wherein the stimulus is at least one or more of hydrogen and hydronium ions in the test solution, and wherein the response is a pH measured at one or more locations along the test channels.

20. The method of claim 15, further comprising:

applying pulses from at least one or more of a laser, LED, and light source, as the stimuli to the test solution,

wherein the sensor comprises one or more photo detectors and the response is measured as at least one of light reflection and refraction.

21. A microfluidic cartridge for assaying an analyte, the microfluidic cartridge comprising:

one or more test channels, each having a lumen;

one or more reference solution channels in fluid communication with the test channels;

one or more sample channels in fluid communication with the test channels;

one or more sensors at least partially exposed in the lumen of the test channels; and

a processor coupled to the one or more sensors for measuring properties of the analyte to determine at least one of an identity, concentration, dose, and dosage of the analyte.

22. The microfluidic cartridge of claim 21, wherein the one or more sensors comprise a plurality of electrodes for applying voltage pulses at one or more locations along the test channels and currents between each of the plurality of electrodes are measured by the processor to determine at least one of the identity, concentration, dose, and dosage of the analyte.

23. The microfluidic cartridge of claim 21, wherein the one or more sensors comprise at least one thermal sensor for sensing heat at one or more locations along the test channel and the heat sensed by the thermal sensor is used by the processor to measure temperature to determine at least one of the identity, concentration, dose, and dosage of the analyte.

24. The microfluidic cartridge of claim 21, wherein the one or more sensors comprise at least one pH sensor for sensing at least one of hydrogen and hydronium ions at one or more locations along the test channel and at least one or more of the hydrogen and hydronium ions sensed by the pH sensor are used by the processor to measure pH to determine at least one of the identity, concentration, dose, and dosage of the analyte.

25. The microfluidic cartridge of claim 21, further comprising:

at least one of a laser, LED, and light source, for applying light pulses at one or more locations along the test channels,

wherein the sensor comprises one or more photo detectors for sensing at least one of light reflection and light refraction at one or more locations along the test channels in response to the light pulses, and

wherein at least one of the light reflection and light refraction sensed by the one or more photo detectors is used by the processor to determine at least one of the identity, concentration, dose, and dosage of the analyte.