# US 10,871,498 B2 · Sample processing module array handling system and methods

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- Number: US 10,871,498 B2
- Document ID: US10871498B2
- Status: Granted
- Kind: B2
- Application number: 15/816,960
- Filed: 2017-11-17
- Published: 2018-05-24
- Granted: 2020-12-22
- Earliest claimed: 2016-11-18
- Assignees: Cepheid
- Applicants: Cepheid
- Inventors: Ronald Chang; Steven Montgomery; Gregory Mote; Brian Bliven
- Web page: https://patentgrep.com/patent/US10871498B2

## CPC

- G01N 35/025: {having a carousel or turntable for reaction cells or cuvettes}
- G01N 35/00029: {provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence)}
- G01N 35/00732: {Identification of carriers, materials or components in automatic analysers}
- G01N 35/00871: {Communications between instruments or with remote terminals}
- G01N 35/04: Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)}
- G01N 2035/00148: {Test cards, e.g. Biomerieux or McDonnel multiwell test cards}
- G01N 2035/00158: {Elements containing microarrays, i.e. "biochip"}
- G01N 2035/00326: {Analysers with modular structure}
- G01N 2035/00356: {Holding samples at elevated temperature (incubation)}
- G01N 2035/00445: {Other cooling arrangements}
- G01N 2035/00881: {network configurations}
- G01N 2035/0425: {Stacks, magazines or elevators for plates}
- G01N 2035/0427: {nestable or stockable}
- G01N 2035/0451: {composed of interchangeable sectors}
- G01N 2035/0453: {Multiple carousels working in parallel}
- G01N 2035/0465: {Loading or unloading the conveyor}
- 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 handling system for high throughput processing of a large volume of biological samples is provided herein. Such systems can include an array support assembly that supports multiple diagnostic assay modules in an array having at least two dimensions, a loader that loads multiple diagnostic assay cartridges within the multiple diagnostic assay modules. The array support assembly can be movable relative the loader to facilitate loading and unloading so as to provide more efficient processing.

## Claims

### Claim 1

A handling system for high throughput processing of a plurality of biological samples, each being within a respective diagnostic assay cartridge of a plurality of diagnostic assay cartridges, the system comprising:
a plurality of diagnostic assay modules in an array having at least two dimensions, each diagnostic assay module configured for receiving a diagnostic assay cartridge of the plurality and performing a diagnostic assay on the biological sample within the respective diagnostic assay cartridge;
an array support assembly adapted to support the plurality of diagnostic assay modules in an array having at least two dimensions, wherein the array comprises a plurality of rows, each row including a plurality of carriers for supporting the plurality of diagnostic assay modules, the plurality of carriers being securely attached to a frame that is rotatable about a central rotating hub, wherein the plurality of diagnostic assay modules in each row are coupled to power and communication while supported within the array support assembly;
a motor and drive mechanism operably coupled with the array support assembly and configured to incrementally rotate each row of the array support assembly;
a loader adapted to load the plurality of diagnostic assay cartridges within the plurality of diagnostic assay modules while supported within the array support assembly, the loader being translatable between rows of the array support assembly and including a grasper for grasping each of the plurality of diagnostic assay cartridges for loading and/or unloading the respective cartridge from any of the plurality of diagnostic assay modules, such that the diagnostic assay cartridge is loadable in any of the diagnostic assay modules within the array by moving the array support assembly relative the loader in combination with the loader; and
a controller configured to coordinate rotation of the array support assembly in combination with movement of the loader in response to sensors and/or determination of empty modules or spent cartridges based on communication with the plurality of modules to facilitate high throughput assays.

### Claim 2 (depends on 1)

The system of claim 1, wherein each of the diagnostic assay modules is adapted to perform a diagnostic assay independent from each other.

### Claim 3 (depends on 1)

The system of claim 1, wherein the array is a cylindrical array such that each row is circular in a horizontal direction and the plurality of rows are stacked in a vertical direction.

### Claim 4 (depends on 1)

The system of claim 1, wherein the array comprises a plurality of horizontal rows and the loader is translatable along a substantially vertical axis so as to be movable between horizontal rows of the cylindrical array.

### Claim 5 (depends on 1)

The system of claim 1, wherein the grasper is adapted to insert a cartridge supported by the grasper along a horizontal axis from a grasped position within the grasper to a loaded position within a diagnostic assay module of the array.

### Claim 6 (depends on 5)

The system of claim 5, wherein the grasper is further adapted to unload a cartridge loaded in a diagnostic assay module within the array from the loaded position and transport the cartridge away from the respective module.

### Claim 7 (depends on 5)

The system of claim 5, wherein the grasper is further adapted to concurrently support at least two cartridges of the plurality of cartridges to facilitate any of:
consecutive loading of the at least two cartridges,
consecutive unloading of the at least two cartridges from respective loaded positions,
unloading of one cartridge of the at least two cartridges from a given module and subsequent loading of another cartridge of the at least two cartridges within the same module, and
unloading of one cartridge of the at least two cartridges from a given module and subsequent loading of another cartridge of the at least two cartridges within a different module.

### Claim 8 (depends on 1)

The system of claim 1, wherein the array support structure comprises a stack of circular frames separated by slip rings that transmit power and communication data through a rotating union such that each module has a direct power and communication coupling.

### Claim 9 (depends on 8)

The system of claim 8, wherein each of the diagnostic assay modules comprises a rechargeable power source that is wirelessly rechargeable by near-field energy transfer.

### Claim 10 (depends on 1)

The system of claim 1, wherein the array support assembly includes one or more sensors associated with each module within the array, the one or more sensors being adapted to determine the location of the modules within the array.

### Claim 11 (depends on 7)

The system of claim 7, further comprising:
the controller having an input and an output, the controller being configured to output a control command to the loader to load a diagnostic assay cartridge in a particular diagnostic assay module of the plurality in response to an input received from the one or more sensors that the diagnostic assay module is available for loading.

### Claim 12 (depends on 11)

The system of claim 11, wherein the controller is configured to determine a preferred diagnostic assay module from a plurality of available diagnostic assay modules based on any of: proximity, a temperature measurement, a load balance, a heat balance, a distribution among levels or within a respective level, a time length of assay, or any combination thereof.

### Claim 13 (depends on 11)

The system of claim 11, wherein the one or more sensors are further configured to obtain a unique ID of each a diagnostic assay module and an associated cartridge loaded therein.

### Claim 14 (depends on 11)

The system of claim 11, wherein each diagnostic assay module includes a wireless communication unit adapted to communicate with the controller.

### Claim 15 (depends on 12)

The system of claim 12, wherein the wireless communication unit of each diagnostic assay module is configured to communicate to the controller that a diagnostic assay cartridge is associated with a particular diagnostic assay module of the plurality after loading of the cartridge in the respective module.

### Claim 16 (depends on 12)

The system of claim 12, wherein the controller is programmed to track which diagnostic assay module of the plurality is associated with each diagnostic assay cartridge of the plurality.

### Claim 17 (depends on 12)

The system of claim 12, wherein the controller is programmed to output a command to the loader to load a diagnostic assay cartridge within a diagnostic assay module that is not already associated with a diagnostic assay cartridge.

### Claim 18 (depends on 17)

The system of claim 17, wherein the controller is further programmed to output to the loader a command to unload a particular diagnostic assay cartridge after receiving an input that a diagnostic result has been received from the diagnostic assay module associated with the respective cartridge.

### Claim 19 (depends on 1)

The system of claim 1, wherein the system further includes a waste receptacle disposed beneath the array support, wherein the loader is further adapted to unload spent diagnostic assay cartridges for collection and discarding within the waste receptacle.

### Claim 20 (depends on 1)

The system of claim 1, wherein the system further comprises:
a loading track that conveys a plurality of diagnostic assay cartridges to the loader.

### Claim 21 (depends on 20)

The system of claim 20, wherein the loading track defines a plurality of recesses adapted to receive the plurality of diagnostic assay cartridges.

### Claim 22 (depends on 21)

The system of claim 21 wherein each recess is configured to maintain each of the plurality of diagnostic assay cartridges in a particular position and/or orientation relative the loading track to facilitate loading with the loader when received.

### Claim 23 (depends on 20)

The system of claim 20, wherein the loader includes a grasper adapted to grasp a diagnostic assay cartridge conveyed by the loading track when disposed at a particular loading position.

### Claim 24 (depends on 20)

The system of claim 20, wherein the array support defines a cylindrical array and the loading track is a ring that rotates around the cylindrical array.

### Claim 25 (depends on 24)

The system of claim 24, wherein the ring-shaped loading track and the cylindrical array rotate about a common longitudinal axis and the ring-shaped loading track is adapted to rotate independently from the cylindrical array.

### Claim 26 (depends on 20)

The system of claim 20, wherein the loading track includes one or more sensors adapted to detect when one or more diagnostic assay cartridges are placed in the loading track.

### Claim 27 (depends on 26)

The system of claim 26, wherein the loading track is adapted to transport the one or more diagnostic assay cartridges toward the loader in response to detection of the one or more cartridges.

### Claim 28 (depends on 1)

The system of claim 1, further comprising:
an air cooling system that directs air through a central column of the array assembly and through each level of the array assembly so as to maintain the entire array assembly within a range of suitable temperatures.

### Claim 29 (depends on 28)

The system of claim 28, wherein the range of suitable temperatures is between 65 and 95 degrees Fahrenheit to facilitate a PCR analysis.

### Claim 30 (depends on 28)

The system of claim 28, wherein the air cooling system includes a baffle between each level of the array assembly such that air flow is, at least partly, separated between levels.

### Claim 31 (depends on 28)

The system of claim 28, wherein the air cooling system includes an external air cooler communicatively coupled with one or more sensors in one or more levels of the array assembly.

### Claim 32 (depends on 1)

The system of claim 1, wherein each of the diagnostic assay modules is fixedly secured within the array support assembly yet remains removable to allow repair and/or replacement.

### Claim 33 (depends on 1)

The system of claim 1, wherein the array support assembly defines a cylindrical array having a diameter of about 34″ or less and a height of 80″ or less when secured within the assembled system such that the system is transportable through a standard-sized doorway of 80″ in height and 36″ in width.

### Claim 34 (depends on 1)

The system of claim 1, wherein the array support assembly comprises a plurality of stacked circular frames defining an open central column.

### Claim 35 (depends on 31)

The system of claim 31, wherein the system further includes an integrated cooling system that includes:
one or more cooling fans that draw a cool air intake upward from a bottom of the open central column toward a top of the open central column.

### Claim 36 (depends on 32)

The system of claim 32, wherein the system further includes circular baffles between each row so as to direct cooling air from the open central column directly to each row of modules within the cylindrical array.

### Claim 37 (depends on 1)

The system of claim 1, wherein the array support assembly is a cylindrical array that supports at least 50 modules and includes at least two stacked rows.

### Claim 38 (depends on 1)

The system of claim 1, wherein the array support assembly is a cylindrical array, each row supporting 25 modules, and having at least 4 rows such that the array support assembly supports at least 100 modules.

### Claim 39 (depends on 1)

The system of claim 1, wherein the array support assembly comprises two cylindrical arrays, each row supporting 25 modules, and each cylindrical array having at least 4 rows such that the system supports 200 modules.

### Claim 40 (depends on 20)

The system of claim 20, further comprising:
a cartridge preparer configured to perform one or more sample processes on a fluid sample within a diagnostic assay cartridge before analysis and to subsequently load the prepared diagnostic assay cartridge within the loading track.
