# US 8,540,946 B2 · Portable sample analyzer cartridge

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- Number: US 8,540,946 B2
- Document ID: US8540946B2
- Status: Granted
- Kind: B2
- Application number: 13/220,449
- Filed: 2011-08-29
- Published: 2012-01-05
- Granted: 2013-09-24
- Earliest claimed: 2004-05-14
- Assignees: Honeywell International Inc.
- Applicants: Aravind Padmanabhan; James A. Cox; Cleopatra Cabuz
- Inventors: Aravind Padmanabhan; James A. Cox; Cleopatra Cabuz
- Web page: https://patentgrep.com/patent/US8540946B2

## CPC

- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- G01N 15/1484: {microstructural devices}
- G01N 35/00722: {Communications; Identification}
- B01L 9/527: {for microfluidic devices, e.g. used for lab-on-a-chip}
- B01L 2200/027: for microfluidic devices
- B01L 2200/04: Exchange or ejection of cartridges, containers or reservoirs
- B01L 2200/0636: Focussing flows, e.g. to laminate flows
- B01L 2200/146: Employing pressure sensors
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0877: Flow chambers
- B01L 2300/14: Means for pressure control
- B01L 2400/0487: fluid pressure, pneumatics
- G01N 2015/012: {Red blood cells}
- G01N 2015/018: {Platelets}
- G01N 2015/019: {Biological contaminants; Fouling}
- G01N 2015/1413: {Hydrodynamic focussing}
- G01N 2015/1486: {Counting the particles}
- G01N 2035/00891: {Displaying information to the operator}
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- 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 sample analyzer cartridge for use at a point of care of a patient such as in a doctor's office, in the home, or elsewhere in the field. By providing a removable and/or disposable cartridge with all of the needed reagents and/or fluids, the sample analyzer can be reliably used outside of the laboratory environment, with little or no specialized training.

## Claims

### Claim 1

A disposable analysis cartridge capable of performing at least part of a blood sample measurement, comprising:
two or more reagent storage reservoirs, a first one for storing a lysing reagent and a second one for storing a sphering reagent;
a lysing on the fly channel in fluid communication with the first one of the reagent storage reservoirs, the lysing on the fly channel having a first intersection region that receives a first reagent from the first one of the reagent storage reservoirs and at least part of the blood sample;
a sphering on the fly channel in fluid communication with the second one of the reagent storage reservoirs;
a first flow cytometry analysis channel structured to hydrodynamically focus a blood sample and to support optical light scattering measurements, the first flow cytometry analysis channel in fluid communication with and downstream of the lysing on the fly channel; and
a second flow cytometry analysis channel structured to hydrodynamically focus a blood sample and to support optical light scattering measurements, the second flow cytometry analysis channel in fluid communication with and downstream of the sphering on the fly channel;
wherein the first intersection region includes a first end and a second end and wherein a cross-sectional area of the first intersection region tapers from the first end to the second end, the first reagent fluidly connected to the first end of the first intersection region and the at least part of the blood sample entering the first intersection region downstream of the first end such that the first reagent flows circumferentially around the blood sample.

### Claim 2 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising:
one or more light absorption based measurement channels.

### Claim 3 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising:
one or more flow sensors for measuring a flow rate within at least selected ones of the lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel.

### Claim 4 (depends on 3)

The disposable analysis cartridge of claim 3 further comprising:
one or more pressure sensors for measuring a pressure within at least selected ones of the lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel.

### Claim 5 (depends on 4)

The disposable analysis cartridge of claim 4 further comprising:
a controller for determining if the fluid in the at least selected ones of the lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel has a viscosity that is outside of a predetermined threshold.

### Claim 6 (depends on 1)

The disposable analysis cartridge of claim 1, further comprising one or more additional reagent storage reservoirs, each of the one or more additional reagent storage each store a reagent selected from the group of: isotonic solutions (dilution), buffering agents, lysing agents, antibodies, cytochemical stains, fluorescent stains.

### Claim 7 (depends on 6)

The disposable analysis cartridge of claim 6 wherein the reagent is in a liquid form.

### Claim 8 (depends on 6)

The disposable analysis cartridge of claim 6 wherein the reagent is in a lyophilized form.

### Claim 9 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising an on-board whole blood acquisition device.

### Claim 10 (depends on 9)

The disposable analysis cartridge of claim 9 wherein the whole blood acquisition device includes a lancet.

### Claim 11 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising an on-board whole blood storage loop.

### Claim 12 (depends on 11)

The disposable analysis cartridge of claim 11 wherein at least part of the on-board whole blood storage loop is coated with an anticoagulant.

### Claim 13 (depends on 12)

The disposable analysis cartridge of claim 12 wherein the anticoagulant is an ethylenediaminetetraacetic acid (EDTA).

### Claim 14 (depends on 1)

The disposable analysis cartridge of claim 1 wherein at least part of the blood sample of the first flow cytometry analysis channel includes white blood cells, and the first flow cytometry analysis channel supports the measurement of one or more white blood cell parameters, and wherein at least part of the blood sample of the second flow cytometry analysis channel includes red blood cells, and the second flow cytometry analysis channel supports the measurement of one or more red blood cell parameters.

### Claim 15 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relate to a total white blood cell count.

### Claim 16 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relates to white blood cell differentiation.

### Claim 17 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relates to cell volume.

### Claim 18 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relate to a red blood cell count.

### Claim 19 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a platelet count.

### Claim 20 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a cell diameter.

### Claim 21 (depends on 14)

The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a hemoglobin concentration.

### Claim 22 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising an absorption channel that is configured to support optical absorption measurements.

### Claim 23 (depends on 1)

The disposable analysis cartridge of claim 1 further comprising an extinction channel that is configured to support optical extinction measurements.
