GB2475835A

GB2475835A - Sample Processing System

Info

Publication number: GB2475835A
Application number: GB0920783A
Authority: GB
Inventors: Miles Warwick Ashcroft; Andrew John Bowyer; Andrew Dixon; Mark Rayner Sims
Original assignee: MAGNA PARVA Ltd; University of Leicester
Current assignee: MAGNA PARVA Ltd; University of Leicester
Priority date: 2009-11-27
Filing date: 2009-11-27
Publication date: 2011-06-08
Also published as: GB0920783D0

Abstract

A system for the automated processing of chemical and biological samples having a universal base unit 1 attached to a series of disposable process modules 2 which are connected by a connecting member 3. The processing modules may be actuated and controlled by the base unit 1 which contains a power supply 8 and control electronics 7 to allow the unit to perform sample preparation and analysis tasks independently of a laboratory or any other such facilities. The connecting member is specific to the desired process and it defines the arrangement of the process modules 2 and the sequence of operations to be executed by the base unit 1. The connecting member 3 may further provide channels through which fluid samples can flow between the modules 2.

Description

Sample Processing System

Field of Invention

The present invention relates to automated systems for the processing and analysis of various fluids, gasses and suspensions of particulate matter. The invention has particular application to the fields of medicine and lorensics, but may be used in ny io application where fluids must be prepared or analysed.

Prior Art

Sample processing techniques are described in the patent literature. Representative patents include U.S. Pat. Nos. US4,039,286A; US4,692,308A; US5,580,524A; US5,098,660A and U.S. Pat. Appln. No. US2004/164,O1OA.

In current practice, the process of converting a raw sample into a suitable input for an analysis device or process is performed in a laboratory using standard, individual items of apparatus. A general process may involve the addition of a solvent to the sample in question, followed by heating in a water bath and agitation, either by manual shaking or the use of a machine. The sample may then be filtered and other reagents added. In this way, and through similar methodologies, the sample is prepared in a suitable manner.

Fig 1. Shows an example of a process used in the preparation of chemical or biological samples. A swab, which is to be tested for the presence of human blood, is placed into a small container and a quantity of a reagent added. The sample is agitated and then allowed to incubate for a specified amount of time. A quantity of the sample is treated with a further reagent and allowed to incubate for a further time interval, after which the sample may be applied to a chemical test strip or used in an analysis machine.

U.S. Pat. Appln. No. US2004/164,O1OA discloses a system for the automated processing of chemicals which includes several process modules. The successive process modules are configured such that they may be arranged in a number of ways, allowing a variety of chemical processes to be performed. The process modules may be easily interchanged. An electrical bus communicates data and electrical power to the respective modules, and a series of fluid channels supply common process fluids and transfer fluids to be processed between successive modules. Each module incorporates an electronic control unit that communicates via the data bus, with a control unit. The system as a whole is controlled by computer requiring the user to program a control unit to enable the prior art to function.

U.S. Pat. Appln. No. US2004/157,336A discloses a system that performs automated processing and analysis of biological samples. The analysis chemicals are stored in disposable modules, whilst a series of motor-driven needles transfer the various fluids between the input and anaiysis charribers. The system aUows the para!ie! processing of large numbers of samples and is automated, thus the prior art allows the automated treatment of samples.

U.S. Pat. Appin. No. US2009/053,689Ai. discloses an apparatus for the preparation and analysis of chemical and biological samples. The device uses a series of chambers separated by walls, which may be pierced to allow the fluid to flow between the chambers under the influence of gravity. The prior art allows the separation and analysis of samples and offers a measure of modularity in its arrangement but is large in size and requires the attention of a trained operator.

Statement of the Invention

The invention provides a system whereby the aforesaid processes may be enacted without the need for laboratory facilities or highly trained personnel. In particular, it relates to a novel arrangement which provides a simplification of the current state of the art methods such that savings in time and effort may be realised. Furthermore, the arrangement allows the integrity of the sample to be ensured as it is sealed and free from external interference during the processing and thereafter, the integrity may be verified at any point after the processing by interrogating memory devices within the processing elements.

According to one formulation of the invention, this and other objects are met by a series of disposable process modules that are arranged on a Base Unit and linked together by a Connecting Member. The process modules are generic and contain mechanisms and structures that perform various tasks such as mixing, heating filtering and so forth. In this way, a large range of processes may be performed by arranging the generic process modules in various configurations. This method has the advantage that the more expensive base unit can be used for a variety of processes, simply by the user arranging the process modules to suit a specific application. The Base Unit to which the process modules are attached contains systems that provide any such actuation forces, energy and monitoring as required by the modules. These systems are in turn controlled by a microprocessor. The process modules are interconnected by the connecting member, which incorporates a seres of channels by which fluids may be communicated between the modules. The process modules may be locked securely in place on the base unit by means of a clamping mechanism, or by means of a partial activation of the actuator assemblies.

Preferabiy, in order that the operation of the system is as simple as possib!e, and to io reduce the likelihood of human error causing the processing sequence to be incorrectly performed, the connecting member shall be specific to a given process or arrangement of process modules, and the fluid communication channels formed to suit this process. The member has a non-volatile memory embedded within it. The memory may contain data which may be read by the base unit, the data so read may be used to program the system, and can be overwritten or destroyed at the conclusion of the process to prevent re-use of the contaminated parts. A similar memory may be embedded within the sample output container or within the analysis module such that traceability information such as a timestamp may be recorded with the sample or analysis output. Further information may be written to any of the aforementioned memory devices such that any external influences such as tampering, power supply disruption, temperature fluctuations are recorded. Such information may be used to verify the integrity of a given sample or analysis result and could prevent the use of poorly-prepared samples or those that have been tampered with.

In any of the embodiments herein, the fluid connections between the connecting member and the process modules may be sealed by a polymer membrane, a metal foil cover or by some other means known to those skilled in the art. In order that the assembly of modules presents a rigid structure to react any actuation forces imparted by the base unit, the modules incorporate latches or clips that serve to lock the modules together. It is preferred that these latches should not be removable, such that the modules cannot be reused. It is an advantage of this embodiment that the disposable modules cannot be reused inadvertently, reducing the risk of contaminating the sample through operator error.

In the preferred embodiment of the invention, the fluid and mechanical interfaces to which the connecting member is applied are formed on the upper faces of the process modules when the process modules are arranged on the base unit. It is an advantage of this arrangement that the operator can easily see the connecting member and any information that may be displayed in fields on its exterior surfaces. This allows the user to easily assemble the process units in the required order according to this information or to a process diagram, and to easily detect errors in the assembly.

s In an alternative, exemplary embodiment of the invention, the fluid and mechanical interfaces to which the connecting member is applied are formed on either the front, the rear or both front and rear faces of the process modules when the process modules are arranged on the base unit. This embodiment is advantageous if the process modules require access from the top duririg the processing cyde; to insert a sample, or to remove a container of processes material for example. A further advantage of this embodiment is that the assembled system presents a lower profile, allowing stowage in a reduced volume.

A further advantage of the invention is that it may incorporate mechanisms that allow the internal battery to be charged by means of operator effort. Such a means could be a hand crank, foot pedal or a reciprocating mass which would drive a generator. Thus the system can be used in areas remote from an electrical power supply.

In a further exemplary embodiment of the invention, analysis processes can be performed by attaching an analysis module in place of the final process module. This analysis module may perform any analysis as required by the user, be it by means of an antigen assay, or using chemical detection means. It is an advantage of this embodiment that the output from an analysis module may be communicated to the user quickly via either a portable computer connected to the system, via a display on the base unit or via a display on the analysis module itself. In this manner, the user may obtain the results of an analysis rapidly in the field or at the point of sampling. It is an advantage of this method that portable computing apparatus already in use and known to the art may be employed as part of the analysis system, further reducing the cost to the user and allowing the system to be deployed outside of a laboratory in real-world situations.

Brief Description of the Drawings

Exemplary embodiments of the invention will now be described in greater detail with reference to the drawings; Fig. 1 is a process diagram illustrating a state of the art process for sample preparation; Fig.2 Is a simplified block diagram illustrating an exemplary embodiment of the system according to the invention, including a process-specific connecting member; Fig 3 Is a simplified perspective view of an exemplary embodiment of the system according to the invention; Fig. 4 Is an exploded view of the exemplary embodiment of the system according to the invention.

Fig. 5 Is a variant of the exemplary embodiment depicted in Fig. 3.

Fig. 6 Is a further variant of the exemplary embodiment depicted in Fig. 3.

Specific Description

FIG. 2 Shows a system for the automated treatment and preparation of samples prior to, or as part of an analysis process. In this instance, the term treatment may be taken as, for example processing a fluid or analyzing a fluid by chemical reaction or associated subsidiary process, such as mixing, filtering centrifuging, heating, cooling, etc. The system incorporated a series of generic processing modules (2), each of which carries out a specific function. In accordance with the aforementioned treatment functions, the process modules (2) may incorporate certain reagents or solvents, filter elements, heaters, mixers, metering pumps etc. Each process module (2) is provided as required with motive force, electrical power or useful forms of radiation by an actuator assembly (11) within the base unit (1).

The base unit (1) contains a battery operated power supply (8) which provides power to the actuator assemblies (11), to a control system (7) and to a user display (4).

The control system (7) controls each actuator assembly (11) such that the appropriate force, voltage, illumination or other input is applied at the correct point in the process. The control system (7) is provided with programming inputs that govern the aforementioned actuation inputs by means of a memory unit (10) installed in the connecting member (3), and accessed via a reader (6). The system is activated by a switch (5), and charging of the power supply (8) battery may be effected via the bi-directional communication port (13).

Information is communicated to the user concerning the status of the system by means of a visual display unit (4) and via an indicator (12). Further data transfer may be conducted buy means of an external bdirection& communication port (13) to which a computer running appropriate software may be connected. This port is intended for firmware upgrades, process monitoring, process development and other such purposes.

As shown in Figs. 3 and 4, Uie process modules (2) are locked together by means of latching elements (14), which engage such that they cannot be removed once assembled; similarly the connecting member (3) is locked to the process modules (2) such that it cannot be removed without damaging the component. The fluid transfer ports (15) form a part of this locking mechanism and are sealed by means of an impermeable membrane. Upon assembly, these membranes are pierced by corresponding features incorporated in the connecting member (3). This system ensures that the interior volumes of both the process modules and connecting member are hermetically sealed at the point of manufacture and remain so until they come into use. The aforementioned locking features further ensure that the modules and connecting member may not be reused, further reducing the likelihood of sample contamination.

To further ensure that contamination of a sample does not occur through the re-use of the connecting member (3) or the process modules (2), the memory (10) embedded within the connecting member (3) is overwritten following the completion of the processing sequence. This ensures that if the component is reused, the control system (7) will not begin the processing sequence and will display an error message on the user display (4). A further advantage of this system is that information concerning the time and conditions of the processing task or analysis may be stored on the memory (10).

The actuator assembly (11) is located within the base unit (1) such that it can act against the piston (16), to pump fluid between the respective process units and to provide any such electrical currents and photon fluxes as required by the process in question. Actuation of the piston is provided by means of an electric motor and gear mechanism, controlled by the control system (7). Passive valve structures within the modules serve to direct the fluid into the correct orifice in the connecting member (3), whereupon it flows through the channels indicated by the arrows under (17), which are specific to the connecting member designed for a particular sequence of processes.

The system depicted in Fig. 5 is distinct from that in Fig. 3 in that the connecting S member (3)is attached to the frontal faces of the process modules (2). This embodiment has the distinct advantage that the height of the unit is decreased, allowing the system to present a more compact volume. Furthermore, the upper faces of the process modules (2) are available for supplementary electrical and fluid connections. This configuration also &1OWS samples to be introduced into the process modules (2) at any stage in the process, thus allowing for any processes that require a solvent or reagent preparation stage.

The system depicted in Fig. 6 is further distinct from that in Fig. 3 in that the connecting member (3) is attached to the rear faces of the process modules (2). This configuration has the advantage that both the front and top of the process modules are unobstructed allowing display elements to be placed upon them as an aid to the operator, and to interface with other systems such as portable computers, etc. The above description of the preferred embodiment has been given by way of an example. From the disclosures given, those skilled in the art will understand the invention and its advantages, and will also find apparent changes and modifications to the structures and processes disclosed. It is sought therefore to cover all such changes that lie within the scope of the invention, as defined in the appended claims and equivalents thereof.

Claims

Claims 1. A system for the automated processing of chemical and biological samples comprising: a. a universal base unit; b. a quantity of processing modules capable of attachment to the base unit; and c. a connecting member capable of attachment to the processing modules, wherein the connecting member defines a configuration of the processing modules and a protocol for using the processing modules to carry out a required process.
2. The system as claimed in claim 1, wherein the connecting member defines a linear configuration in which the processing modules may be attached to the connecting member in a specific order to form a sub-assembly, this sub-Q assembly then being attached to the base unit.
3. The system as claimed in claim 1 or 2, wherein the connecting member incorporates channels through which fluids may flow and interfaces that can mate with corresponding interfaces on the process modules.

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4. The system as claimed in claim 3, wherein the fluid interfaces in the connecting member and process modules are sealed prior to use.
5. The system as claimed in claim 4, wherein the fluid interfaces in the connecting member and process modules are unsealed by the act of attaching them together.
6. The system as claimed in any of claims 1 to 5, further comprising features on both the process modules and connecting member to lock the respective parts together during assembly such that they cannot be separated.
7. The system as claimed in any of claims 1 to 5, further comprising features on both the process modules and connecting member to lock the process modules and connecting member releasably together during assembly.
8. The system as claimed in any of claims 3 to 5, wherein the base unit incorporates mechanical means arranged to cause fluids to be transferred between the process modules via the connecting member.
9. The system as claimed in any of claims 1 to 8, wherein the base unit incorporates electrical interfaces that engage with corresponding electrical interfaces in the process modules and through which electrical power or data may be communicated.
1O.The system as claimed in any of claims 1 to 9, wherein the connecting member contains means for data storage, wherein the data storage means may be either read by the base unit, written to by the base unit or both read and written to by the base unit.
11.The system as claimed in claim 10, wherein the parameters pertaining to a specific processing protocol are contained within the data storage means in the connecting member.
12.The system as claimed in claim 11, wherein the parameters pertaining to the processing protocol include at least one of the following parameters, namely: temperature, incubation time, centrifuge speed and reagent quantity.(0
13.The system as claimed in any of claims 1 to 12, wherein the connecting

C\J member carries an information field:a. wherein the information field indicates the physical configuration of process modules to be used with the connecting member; and b. wherein the information field indicates the chronological order in which the respective process modules should be attached to the connecting member.
14.The system as claimed in any of claims 1 to 13, wherein the process modules carry information fields, wherein each information field indicates the purpose and orientation of the respective process module to which it is attached.
15.The system as claimed in any of claims 1 to 14, a. wherein the base unit incorporates a plurality of electromagnets; -10 -b. wherein the electromagnets may be actuated to provide motive force to mechanisms within one or more of the process modules, or to induce electric current within one or more of the process modules.
16.The system as claimed in any of claims 1 to 15, a. wherein the base unit incorporates a plurality of ultrasonic transducers; b. wherein the transducers may be actuated to produce mechanical vibrations coupled to one or more of the process modules.
17.The system as claimed in any of claims 1 to 16, a. wherein the base unit incorporates a plurality of electric motors; b. wherein the motors may be actuated to produce rotary motion coupled to one or more of the process modules.
18.The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for heating a sample.
19. The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for cooling a sample.
20.The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for filtering a sample.
21.The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for centrifuging a sample.
22.The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for agitating a sample.
23.The system as claimed in any preceding claim, wherein at least one of the processing modules comprises means for transferring a fluid to a location external to the module.
24.The system as claimed in any preceding claim, wherein at least one of the processing modules can act so as to mix two or more fluids or to separate a fluid into two or more quantities.

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25.The system as claimed in any of claims 3, 4, 5 or 8, wherein the channels within the connecting member are arranged so as to cause mixing of two or more fluids.
26.The system as claimed in any of claims 3, 4, 5 or 8, wherein the channels within the connecting member are arranged so as to separate a fluid into two or more quantities.
27.The system as claimed in any preceding claim, wherein at least one of the processing modules can act so as to add a reagent or reagents to a sample.
28.The system as claimed in any preceding claim, wherein the base unit further comprises a power supply that is a battery charged by means of mechanical
29.The system as claimed in any preceding claim, wherein the base unit further comprises a power supply that is a battery charged by means of an external electrical supply.
30.The system as claimed in any preceding claim, wherein the base unit further comprises means for data communication with an external device or devices.(0
31.The system as claimed in any preceding claim, wherein the base unit further comprises means for recording information pertaining to the execution of a processing protocol.
32.The system as claimed in claim 31, wherein the parameters pertaining to the execution of the protocol may include the following parameters, namely: ambient temperature, time stamp, module identification serial number, connecting member identification serial number, operator serial number, ambient barometric pressure, GPS coordinates and power supply condition.
33.The system as claimed in any preceding claim, wherein one or more of the process modules is substituted with an analysis module or modules, allowing sample analysis tasks to be performed.