# US 2019/0168213 A1 · System and method for determining efficacy and dosage using parallel/serial dual microfluidic chip

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- Number: US 2019/0168213 A1
- Document ID: US20190168213A1
- Status: Published application
- Kind: A1
- Application number: 16/186,513
- Filed: 2018-11-10
- Published: 2019-06-06
- Earliest claimed: 2017-11-10
- Applicants: Reliant Immune Diagnostics, Inc.
- Inventors: JOVAN HUTTON PULITZER; HENRY JOSEPH LEGERE, III
- Web page: https://patentgrep.com/patent/US20190168213A1

## CPC

- B01L 3/50273: {characterised by the means or forces applied to move the fluids}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/502738: {characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746)}
- C12Q 1/18: Testing for antimicrobial activity of a material
- F04B 13/00: Pumps specially modified to deliver fixed or variable measured quantities
- F04B 23/04: Combinations of two or more pumps
- F04B 43/046: {with piezoelectric drive}
- F16K 99/0007: {of cantilever type}
- F16K 99/0015: {Diaphragm or membrane valves}
- F16K 99/0057: {the fluid being the circulating fluid itself, e.g. check valves}
- F16K 99/0059: {actuated by a pilot fluid}
- G01N 33/4833: {of solid biological material, e.g. tissue samples, cell cultures (tissue in vivo A61B5/00; cell suspensions G01N33/48735)}
- B01L 2200/0605: Metering of fluids
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
- B01L 2300/087: Multiple sequential chambers
- B01L 2400/0638: membrane valves, flap valves
- B01L 2400/0655: pinch valves
- F16K 2099/0084: {Chemistry or biology, e.g. "lab-on-a-chip" technology}
- G01N 2333/195: from bacteria
- 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
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)
- F16K: VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING {(devices for emptying and evacuating the excess liquid in valves or conduits F16L55/07)}
- 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)

## Abstract

A method for determining a treatment agent and dosage level for a biologic material includes the biologic sample is pumped into each of a first plurality of parallel pathways from the first reservoir using a micro-pump. A separate treatment agent of the plurality of treatment agents is applied within each of the first plurality of parallel pathways. The treatment agent providing a best treatment efficacy for the predetermined biologic material within the biologic sample is determined. A second portion of the biologic sample is pumped into a selected second parallel pathway associated with the determined treatment agent of a second plurality of parallel pathways from the first reservoir using a second micro-pump. The determined treatment agent at a plurality of different dosage levels is applied within the selected second parallel pathway. A dosage level of the plurality of different dosage levels of the determined treatment agent is determined.

## Claims

### Claim 1

A method for determining a treatment agent and dosage level for a predetermined biologic material, comprising:
receiving a biologic sample, the biologic sample containing the predetermined biologic material for treatment by one of a plurality of treatment agents;
holding the biologic sample containing the predetermined biologic material within a first reservoir;
pumping a portion of the biologic sample into each of a first plurality of parallel pathways from the first reservoir using a micro-pump;
applying a separate treatment agent of the plurality of treatment agents within each of the first plurality of parallel pathways to the portion of the biologic sample within the parallel pathway;
determining the treatment agent of the plurality of treatment agents providing a best treatment efficacy for the predetermined biologic material within the biologic sample responsive to the plurality of treatment agents applied to the portion of the biologic sample within each of the first plurality of parallel pathways;
pumping a second portion of the biologic sample into a selected second parallel pathway associated with the determined treatment agent of a second plurality of parallel pathways from the first reservoir using a second micro-pump;
applying the determined treatment agent at a plurality of different dosage levels within the selected second parallel pathway to the second portion of the biologic sample within the second parallel pathway;
determining a dosage level of the plurality of different dosage levels of the determined treatment agent with respect to the predetermined biologic material providing the best treatment efficacy; and
providing an output indicating the treatment agent and the dosage level of the treatment agent providing the best treatment efficacy.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of applying further comprises:
coating an interior of a portion of each of a plurality of micro-channels interconnecting the first reservoir with a plurality of second reservoirs with one of the plurality of treatment agents; and
passing the biologic sample through the plurality of micro-channels to apply the plurality of treatment agents to the biologic sample.

### Claim 3 (depends on 1)

The method of claim 1, wherein the step of determining further comprises:
holding the portion of the biologic sample treated with one of a plurality of treatment agents in a plurality of second reservoirs; and
detecting efficacy of the plurality of treatment agents on the biologic material within the biologic sample through a plurality of second viewing windows each associated with one of the plurality of second reservoirs.

### Claim 4 (depends on 3)

The method of claim 3, wherein the step of pumping the portion further comprises pumping the portion of the biologic sample through the plurality of micro-channels into the plurality of second reservoirs.

### Claim 5 (depends on 1)

The method of claim 1, wherein the step of applying the determined treatment agent further comprises:
coating an interior of a portion of each of a second plurality of micro-channels interconnecting the first reservoir with each of the plurality of third reservoirs with a predetermined dosage level one of the plurality of treatment agents; and
passing the biologic sample through the micro-channel associated with treatment agent determined to provide the best treatment efficacy to apply the treatment agent determined to provide the best treatment efficacy at one or more dosage levels.

### Claim 6 (depends on 1)

The method of claim 1, wherein the step of determining the dosage level further comprises:
holding the second portion of the biologic sample treated with the treatment agent determined to provide the best treatment efficacy with the at least one dosage level in a plurality of third reservoirs; and
detecting efficacy of the at least one dosage level of the determined treatment agent on the biologic material within the biologic sample through at least one second viewing windows each associated with one of the plurality of third reservoirs.

### Claim 7 (depends on 6)

The method of claim 6, wherein the step of pumping the second portion further comprises pumping the second portion of the biologic sample through the plurality of micro-channels into the plurality of third reservoirs.

### Claim 8 (depends on 1)

The method of claim 1, wherein the step of applying the determined treatment agent further comprises applying the determined treatment agent in series at the plurality of different dosage levels to test an efficacy of the plurality of dosage levels one at a time.

### Claim 9 (depends on 1)

The method of claim 1, wherein the step of applying the determined treatment agent further comprises applying the determined treatment agent at the plurality of different dosage levels in parallel to test an efficacy of the plurality of dosage levels at a same time.

### Claim 10 (depends on 1)

The method of claim 1 further comprising the step of applying an affinity label to cells of the detected biologic material within the biologic sample using a cell counter.

### Claim 11

A method for testing a treatment agent for a predetermined biologic material, comprising:
receiving a biologic sample, the biologic sample containing a unique combination of the predetermined biologic material that must be treated via one of a plurality of treatment agents and a patient's biologic material;
testing a first portion of the biologic sample containing the unique combination of the predetermined biologic material and the patient's biologic material in a plurality of first parallel testing pathways, each of the plurality of first parallel testing pathways applying a different treatment agent to the first portion of the biologic sample;
determining a treatment agent providing a best treatment efficacy responsive to the tests performed in each of the plurality of testing pathways; testing a second portion of the biologic sample containing the unique combination of the predetermined biologic material and the patient's biologic material in a selected pathway of a second plurality of testing pathways, the selected pathway selected responsive to the determined treatment agent providing the best treatment efficacy, the selected pathway applying at least one dosage level of the determined treatment agent providing the best treatment efficacy to the second portion of the biologic sample;
determine a lowest dosage level of the determined treatment agent providing the best treatment efficacy responsive to the applied at least one dosage level; and
providing an indication of the determined treatment agent and the determined lowest dosage level.

### Claim 12 (depends on 11)

The method of claim 11, wherein the step of testing the second portion further comprises applying the determined treatment agent in series at the plurality of different dosage levels to test an efficacy of the plurality of dosage levels one at a time.

### Claim 13 (depends on 11)

The method of claim 11, wherein the step of testing the second portion further comprises applying the determined treatment agent at the plurality of dosage levels in parallel to test an efficacy of the plurality of dosage levels at a same time.

### Claim 14

A method for determining a treatment agent and dosage level for a predetermined biologic material, comprising:
receiving a biologic sample, the biologic sample containing the predetermined biologic material for treatment by one of a plurality of treatment agents;
holding the biologic sample containing the predetermined biologic material within a first reservoir;
pumping a portion of the biologic sample into each of a first plurality of parallel pathways from the first reservoir using a micro-pump;
applying a separate treatment agent of the plurality of treatment agents within each of the first plurality of parallel pathways to the portion of the biologic sample within the parallel pathway;
holding the portion of the biologic sample treated with one of a plurality of treatment agents in a plurality of second reservoirs;
detecting efficacy of the plurality of treatment agents on the biologic material within the biologic sample through a plurality of second viewing windows each associated with one of the plurality of second reservoirs.
determining the treatment agent of the plurality of treatment agents providing a best treatment efficacy for the predetermined biologic material within the biologic sample responsive to the detected efficacy of the plurality of treatment agents applied to the portion of the biologic sample;
pumping a second portion of the biologic sample into a selected second parallel pathway associated with the determined treatment agent of a second plurality of parallel pathways from the first reservoir using a second micro-pump;
applying the determined treatment agent at a plurality of different dosage levels within the selected second parallel pathway to the second portion of the biologic sample within the second parallel pathway;
holding the second portion of the biologic sample treated with the treatment agent determined to provide the best treatment efficacy with the at least one dosage level in a plurality of third reservoirs;
detecting efficacy of the at least one dosage level of the determined treatment agent on the biologic material within the biologic sample through at least one second viewing windows each associated with one of the plurality of third reservoirs;
determining a dosage level of the plurality of different dosage levels of the determined treatment agent with respect to the predetermined biologic material providing the best treatment efficacy; and
providing an output indicating the treatment agent and the dosage level of the treatment agent providing the best treatment efficacy.

### Claim 15 (depends on 14)

The method of claim 14, wherein the step of applying further comprises:
coating an interior of a portion of each of a plurality of micro-channels interconnecting the first reservoir with a plurality of second reservoirs with one of the plurality of treatment agents; and
passing the biologic sample through the plurality of micro-channels to apply the plurality of treatment agents to the biologic sample.

### Claim 16 (depends on 15)

The method of claim 15, wherein the step of pumping the portion further comprises pumping the portion of the biologic sample through the plurality of micro-channels into the plurality of second reservoirs.

### Claim 17 (depends on 14)

The method of claim 14, wherein the step of applying the determined treatment agent further comprises:
coating an interior of a portion of each of a second plurality of micro-channels interconnecting the first reservoir with each of the plurality of third reservoirs with a predetermined dosage level one of the plurality of treatment agents; and
passing the biologic sample through the micro-channel associated with treatment agent determined to provide the best treatment efficacy to apply the treatment agent determined to provide the best treatment efficacy at one or more dosage levels.

### Claim 18 (depends on 17)

The method of claim 17, wherein the step of pumping the second portion further comprises pumping the second portion of the biologic sample through the plurality of micro-channels into the plurality of third reservoirs.

### Claim 19 (depends on 14)

The method of claim 14, wherein the step of applying the determined treatment agent further comprises applying the determined treatment agent in series at the plurality of different dosage levels to test an efficacy of the plurality of dosage levels one at a time.

### Claim 20 (depends on 14)

The method of claim 14, wherein the step of applying the determined treatment agent further comprises applying the determined treatment agent at the plurality of different dosage levels in parallel to test an efficacy of the plurality of dosage levels at a same time.

### Claim 21 (depends on 14)

The method of claim 14 further comprising the step of applying an affinity label to cells of the detected biologic material within the biologic sample using a cell counter.
