# US 9,519,000 B2 · Reagent cartridge

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- Number: US 9,519,000 B2
- Document ID: US9519000B2
- Status: Granted
- Kind: B2
- Application number: 13/747,945
- Filed: 2013-01-23
- Published: 2013-06-06
- Granted: 2016-12-13
- Earliest claimed: 2010-07-23
- Assignees: Beckman Coulter, Inc.
- Applicants: Beckman Coulter, Inc.
- Inventors: Brian D. Wilson; Alan N. Johnson; Charles S. Kraihanzel; Joshua D. Wiltsie
- Web page: https://patentgrep.com/patent/US9519000B2

## CPC

- G01N 35/04: Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)}
- B01L 3/021: {Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids}
- B01L 3/50825: {Closing or opening means, corks, bungs}
- B01L 3/5085: {for multiple samples, e.g. microtitration plates}
- B01L 3/50851: {specially adapted for heating or cooling samples}
- B01L 3/52: {Containers specially adapted for storing or dispensing a reagent (B01L3/02 takes precedence; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002)}
- B01L 3/545: {for laboratory containers}
- B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples}
- C12M 41/12: {of temperature (controlling the temperature of chemical or physical processes B01J19/0013, heating or cooling apparatus for laboratory use B01L7/00)}
- C12P 19/34: Polynucleotides, e.g. nucleic acids, oligoribonucleotides
- C12Q 1/68: involving nucleic acids
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 3/00: Condition responsive control processes (apparatus therefor C12M1/36; controlling or regulating in general G05)
- G01F 23/24: by measuring variations of resistance of resistors due to contact with conductor fluid
- G01F 23/26: by measuring variations of capacity or inductance of capacitors or inductors arising from the presence of liquid or fluent solid material in the electric or electromagnetic fields
- G01N 1/31: Apparatus therefor
- G01N 1/38: Diluting, dispersing or mixing samples
- G01N 35/00732: {Identification of carriers, materials or components in automatic analysers}
- G01N 35/0092: {Scheduling}
- G01N 35/0098: {involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation (magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C)}
- G01N 35/1002: {Reagent dispensers}
- G01N 35/1011: {Control of the position or alignment of the transfer device}
- G01N 35/1016: {Control of the volume dispensed or introduced}
- G01N 35/1081: {characterised by the means for relatively moving the transfer device and the containers in an horizontal plane (G01N35/1011 takes precedence)}
- G05B 13/02: electric
- G05B 13/0205: {not using a model or a simulator of the controlled system}
- G16B 25/20: Polymerase chain reaction [PCR]; Primer or probe design; Probe optimisation
- G16B 99/00: Subject matter not provided for in other groups of this subclass
- B01L 3/0275: {Interchangeable or disposable dispensing tips}
- B01L 2200/025: Align devices or objects to ensure defined positions relative to each other
- B01L 2200/0642: Filling fluids into wells by specific techniques
- B01L 2200/0668: Trapping microscopic beads
- B01L 2200/12: Specific details about manufacturing devices
- B01L 2200/147: Employing temperature sensors
- B01L 2300/021: Identification, e.g. bar codes
- B01L 2300/022: Transponder chips
- B01L 2300/024: Storing results with means integrated into the container
- B01L 2300/042: Caps; Plugs
- B01L 2300/044: pierceable, e.g. films, membranes
- B01L 2300/045: whereby the whole cover is slidable
- B01L 2300/046: Function or devices integrated in the closure
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/0851: Bottom walls
- B01L 2300/123: Flexible; Elastomeric
- B01L 2300/18: Means for temperature control
- B01L 2300/1822: using Peltier elements
- B01L 2300/1827: using resistive heater
- B01L 2400/043: magnetic forces
- G01N 2035/00435: {Refrigerated reagent storage}
- G01N 2035/00752: {bar codes}
- G01N 2035/00851: {process control parameters}
- G01N 2035/0413: {moving in one dimension}
- G01N 2035/0415: {moving in two dimensions in a horizontal plane}
- G01N 2035/0436: {with pre-packaged reagents, i.e. test-packs}
- G01N 2035/0465: {Loading or unloading the conveyor}
- G01N 2035/0475: {electric, e.g. stepper motor, solenoid}
- G01N 2035/1013: {Confirming presence of tip}
- G01N 2035/1025: {Fluid level sensing}
- G01N 2035/1048: {using the transfer device for another function}
- G01N 2035/1051: {for transporting containers, e.g. retained by friction}
- G01N 2035/1076: {plurality or independently movable heads}
- Y10T 436/113332: with conveyance of sample along a test line in a container or rack
- 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)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- C12P: FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE {(brewing of beer C12C; producing vinegar C12J; producing specific peptides or proteins C07K; producing enzymes C12N9/00; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; measuring or testing processes involving enzymes or microorganisms C12Q; measuring or testing processes involving nucleic acid amplification reactions C12Q1/6844; fermentation processes to form a food composition, A21 or A23; compounds in general, see the relevant compound class, e.g. C01, C07)}
- 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
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Systems and methods for processing and analyzing samples are disclosed. The system may process samples, such as biological fluids, using assay cartridges which can be processed at different processing locations. In some cases, the system can be used for PCR processing. The different processing locations may include a preparation location where samples can be prepared and an analysis location where samples can be analyzed. To assist with the preparation of samples, the system may also include a number of processing stations which may include processing lanes. During the analysis of samples, in some cases, thermal cycler modules and an appropriate optical detection system can be used to detect the presence or absence of certain nucleic acid sequences in the samples. The system can be used to accurately and rapidly process samples.

## Claims

### Claim 1

A reagent cartridge capable of being stored in a storage unit, the reagent cartridge comprising:
a containment section that comprises a plurality of reagent receptacles each comprising an access opening and a closed end, a horizontally planar containment floor, and a containment wall that extends vertically upward away from the closed ends of the plurality of reagent receptacles and from the periphery of the containment floor, the floor including access openings of the reagent receptacles;
a barrier lid comprising a polymeric support and a plurality of raised lips coinciding with the access openings in the containment section, wherein the barrier lid is a single part that spans the access openings of the reagent receptacles;
a gripping handle at a proximal end of the reagent cartridge;
an isolation portion between the gripping handle and the containment section, the isolation portion being attached to the containment section and thereby providing a separation between the gripping handle and the reagent receptacle;
a memory unit, wherein the memory unit contains information related to one of a manufacturing history and a usage history of the reagent cartridge; and
a mating feature at a distal end of the reagent cartridge.

### Claim 2 (depends on 1)

The reagent cartridge of claim 1, wherein at least one reagent receptacle contains one of a nucleic acid polymerase, a PCR primer sequence, and a PCR probe sequence.

### Claim 3 (depends on 1)

The reagent cartridge of claim 1, wherein at least one reagent receptacle contains one of a proteolytic enzyme and a microparticle suspension.

### Claim 4 (depends on 1)

The reagent cartridge of claim 1, wherein the information related to the manufacturing history includes one of an assay type, a serial number, a lot number, a reagent manufacturing date, a reagent expiration date, and a reagent stability after contents have been accessed.

### Claim 5 (depends on 1)

The reagent cartridge of claim 1, wherein the information related to the usage history includes one of a date that contents of the reagent cartridge have been accessed, a number of times that contents of the reagent cartridge have been accessed, and a number of assays supported by the current contents of the reagent cartridge.

### Claim 6 (depends on 1)

The reagent cartridge of claim 1, wherein the memory unit is one of: a one dimensional barcode, a two dimensional barcode, an RFID chip, and a contact memory device.

### Claim 7 (depends on 1)

The reagent cartridge of claim 1, wherein the isolation portion provides a separation distance of 0.5 inches to 1.5 inches in length between a portion of the gripping handle that is gripped by a user and the containment section.

### Claim 8 (depends on 1)

The reagent cartridge of claim 1, wherein the isolation portion provides a separation distance of about 1 inch in length between a portion of the gripping handle that is gripped by a user and the containment section.

### Claim 9 (depends on 1)

The reagent cartridge of claim 1, wherein the containment section is formed by a body, and wherein the body comprises a locating feature at the distal end of the reagent cartridge, wherein the memory unit is an electronic memory that is affixed to the locating feature.

### Claim 10 (depends on 1)

The reagent cartridge of claim 1, wherein the gripping handle further comprises a lower surface comprising a recess configured to receive a finger when a user grips the gripping handle.

### Claim 11 (depends on 1)

The reagent cartridge of claim 1, wherein the barrier lid comprises a plurality of elastomeric portions, the elastomeric portions being within the raised lips and being capable of at least partially re-sealing after being pierced.

### Claim 12 (depends on 1)

The reagent cartridge of claim 1, wherein the barrier lid comprises an orientation tab at one end.

### Claim 13 (depends on 1)

The reagent cartridge of claim 1, wherein the barrier lid comprises a plurality of elastomeric portions, the elastomeric portions being within the raised lips and being pre-scored.

### Claim 14 (depends on 1)

The reagent cartridge of claim 1, wherein the barrier lid is formed by overmolding the polymeric support to an elastomeric component.

### Claim 15 (depends on 9)

The reagent cartridge of claim 9, wherein the body comprises
a carbon-filled plastic having at least one of conductive properties and antistatic properties.

### Claim 16

A reagent cartridge comprising:
a containment section comprising a plurality of reagent receptacles, each comprising an access opening and a closed end, constituting all receptacles in the reagent cartridge, comprising a plurality of reagents, a horizontally planar containment floor and a containment wall that extends vertically upward away from the closed ends of the plurality of reagent receptacles and the periphery of the containment floor, wherein the floor includes access openings for the plurality of reagent receptacles;
a gripping handle at a proximal end of the reagent cartridge;
an isolation portion between the containment section and the gripping handle, wherein the isolation portion is attached to the containment section and provides separation between the gripping handle and the reagent receptacle;
a memory unit, wherein the memory unit contains information related to one of a manufacturing history and a usage history of the reagent cartridge; and
a barrier lid overlying the plurality of reagent receptacles in the containment section,
wherein the barrier lid further comprises raised lips and preformed caps that correspond to the access openings of the plurality of reagent receptacles, and wherein the barrier lid is a single part that spans the access openings of the plurality of reagent receptacles.

### Claim 17

A system comprising:
a reagent storage unit comprising a pivoting latch; and
a reagent cartridge comprising
a containment section that comprises a plurality of reagent receptacles each comprising an access opening and a closed end, a horizontally planar containment floor, and a containment wall that extends vertically upward away from the closed ends of the plurality of reagent receptacles and the periphery of the containment floor, the floor including access openings of the reagent receptacle,
a barrier lid comprising a polymeric support and a plurality of raised lips coinciding with the access openings in the containment section, wherein the barrier lid is a single part that spans the access openings of the reagent receptacles,
a gripping handle at a proximal end of the reagent cartridge,
an isolation portion between the gripping handle and the containment section, the isolation portion being attached to the containment section and thereby providing a separation between the gripping handle and the reagent receptacle, and
a memory unit, wherein the memory unit contains information related to one of a manufacturing history and a usage history of the reagent cartridge,
wherein the reagent cartridge further comprises
a mating feature at a distal end of the reagent cartridge and conformed to interact with the pivoting latch in the storage unit, wherein the mating feature is a latch pocket.

### Claim 18

A system comprising:
a reagent storage unit comprising a reader; and
a reagent pack comprising
a containment section comprising a plurality of reagent receptacles each comprising an access opening and a closed end, a horizontally planar containment floor and a containment wall that extends upward away from the plurality of reagent receptacles and vertically upward away from the closed ends of the plurality of reagent receptacles and the periphery of the containment floor, wherein the floor includes access openings of the reagent receptacles,
a barrier lid comprising a polymeric support and a plurality of raised lips coinciding with the access openings in the containment section, wherein the barrier lid is a single part that spans the access openings of the reagent receptacles,
a gripping handle at a proximal end of the reagent cartridge,
an isolation portion between the gripping handle and the containment section, the isolation portion attached to the containment section and thereby providing a separation between the gripping handle and the reagent receptacle,
a locating feature at a distal end of the reagent cartridge, and
a memory unit attached to the locating feature at the distal end of the reagent cartridge, wherein the memory unit contains information related to one of a manufacturing history and a usage history of the reagent cartridge, wherein the reader is configured to read the information.

### Claim 19

A system comprising:
a reagent storage unit comprising a reader; and
a reagent cartridge comprising
a containment section comprising a plurality of reagent receptacles, each comprising an access opening and a closed end, constituting all receptacles in the reagent cartridge, comprising a plurality of reagents, a horizontally planar containment floor and a containment wall that extends vertically upward away from the closed ends of the plurality of reagent receptacles and the periphery of the containment floor, wherein the floor includes access openings for the plurality of reagent receptacles,
a gripping handle at a proximal end of the reagent cartridge;
an isolation portion between the containment section and the gripping handle, wherein the isolation portion is attached to the containment section and provides separation between the gripping handle and the reagent receptacle,
a memory unit, wherein the memory unit contains information related to one of a manufacturing history and a usage history of the reagent cartridge, and
a barrier lid overlying the plurality of reagent receptacles in the containment section,
wherein the barrier lid further comprises raised lips and preformed caps that correspond to the access openings of the plurality of reagent receptacles, and
wherein the barrier lid is a single part that spans the access openings of the plurality of reagent receptacles.
