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WO2013043109A2 - Device and method for processing a patient sample - Google Patents

Device and method for processing a patient sample Download PDF

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Publication number
WO2013043109A2
WO2013043109A2 PCT/SE2012/050989 SE2012050989W WO2013043109A2 WO 2013043109 A2 WO2013043109 A2 WO 2013043109A2 SE 2012050989 W SE2012050989 W SE 2012050989W WO 2013043109 A2 WO2013043109 A2 WO 2013043109A2
Authority
WO
WIPO (PCT)
Prior art keywords
lid
container
sample
outlet
inlet
Prior art date
Application number
PCT/SE2012/050989
Other languages
French (fr)
Other versions
WO2013043109A3 (en
Inventor
Rafael Andrzej SIWECKI
Original Assignee
GISKE, Christian Georg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by GISKE, Christian Georg filed Critical GISKE, Christian Georg
Publication of WO2013043109A2 publication Critical patent/WO2013043109A2/en
Publication of WO2013043109A3 publication Critical patent/WO2013043109A3/en

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/10Devices for withdrawing samples in the liquid or fluent state
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J19/00Devices for receiving spittle, e.g. spittoons
    • A61J19/02Sputum flasks
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/34Purifying; Cleaning
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • G01N1/4005Concentrating samples by transferring a selected component through a membrane
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers

Definitions

  • This invention relates to a device for processing a patient sample containing sputum in a container for receipt of the sample, comprising a lid for closing the container.
  • the invention also relates to a method of processing a patient sample containing sputum using such a device.
  • Bacterial lower respiratory infections are a common cause of sickness and mortality in most age groups. When antibiotic resistance increases it is vital to perform adequate sampling from the lower respiratory tract to be capable of identifying bacteria causing pneumonia and then to determine the antibiotic susceptibility of these bacteria. As many bacteria may be present in lower respiratory tract without causing any infection, so called colonization, it is also of pivotal importance to quantify a bacterial finding. By such quantification it is possible to distinguish plausible infection from plausible colonization.
  • sputum wash is performed by using a strainer and tap water. The water flushes saliva away through the strainer, while sputum is left in the strainer.
  • sputum is homogenized by an enzyme. Homogenized sputum may then be cultured for analysis of the bacteria! content.
  • wash and homogenization of sputum is, however, performed only by a few microbiological laboratories. One reason for this is that this method is labor intensive. Another reason is the hazard of splashing sample material that may be pathogenic to laboratory staff.
  • An object of the present invention is to provide a device and a method of the kind initially defined that is capable of isolating and at least partially automate the pro- cessing of the patient sample so that it can be performed more safely and less labor intensive.
  • the device is characterized by:
  • an inlet in the lid for supplying processing fluids comprising washing fluid (including washing liquid and preferably also gas) and enzyme to the sample in the container for homogenization of the sample;
  • a separation unit in the lid interior of the outlet for separation of sputum from the washing fluid when removing the washing fluid.
  • the inlet and the outlet may be composed of suitably shaped inlet and outlet openings in the lid, for example openings allowing more or less free throughflow
  • the inlet and the outlet are provided as valves.
  • valves may be provided in components of an arrangement that respectively supplies and removes the processing fluids.
  • the inlet and/or outlet can have at least two separate openings in the lid for the different processing fluids; the inlet, for example, may have one inlet opening for washing liquid, one inlet opening for gas and one inlet opening for enzyme.
  • the valves may be remotely controlled valves, in another embodiment the valves are provided as check valves.
  • the check valve of the inlet opening may then, for example, be set to open at a lower inlet pressure than the lowest opening pressure of the outlet opening.
  • the inlet may also have a spreader interior of the separation unit for spreading the washing fluid and the enzyme when supplied to the container.
  • the spreader in turn may have at least one tangentially oriented spreader aperture.
  • the spreader may further have a screen controlling flow from the tangentially oriented spreader aperture along an interior face of the separation unit. Entering washing liquid and also enzyme may then effectively interact with the sample resting on the separation unit, such as a concave inner face of a filter.
  • the spreader may, however, be adapted to control the flow in one or more other arbitrary directions, such as axial, or angled between tangential and axial directions.
  • the inlet and outlet may also be provided at a common opening in the lid.
  • the lid can have a more simple design.
  • the lid can also have an external lid for sealing the inlet and the outlet from an exterior face of the lid. The inlet and the outlet may then be protected from contaminating the environment or from being contaminated by the environment.
  • the exter- nal lid may then be turned away to expose the inlet and the outlet and to accompany the lid during the processing of the sample.
  • the external lid can also be raisably and lowerably connected to the lid through the pivot joint. The external lid may then by means of suitable recesses be temporarily locked from being turned back on the lid.
  • the external lid can however also be separately opened and possibly removed be- fore the processing of the sample.
  • the method according to the invention is concerned with processing a patient sample containing sputum by use of a device according to the invention, comprising supplying washing fluid containing washing liquid to the sample for isolating sputum in the sample and supplying enzyme to the isolated sputum for homogenization of the sample; and
  • the processing of the patient sample can be performed in a labor-saving and safe manner in a shielded plant that can be more or less automated having a handling equipment comprising components known as such.
  • Such handling equipment can have a controlled and screened-off atmosphere and may be adapted, for example, to manipulate, orient and weigh the container, and connect and disconnect respective lines for washing liquid, gas and enzyme to the inlet as well as positioning the outlet in connection with a drainage and a secondary container for the completely processed sample.
  • the washing liquid By orienting the container having the lid positioned below the container, it will be possible in a simple manner for the washing liquid, on the one hand, to be introduced into the container immediately inside the lid to more directly contact the sample, and, on the other hand, to be removed from the container immediately inside the lid where the sample can be supported by a filter surface.
  • the washed sample By orienting the container having the lid positioned above the container, the washed sample can be moved to the bottom of the container by gravity and be separated from possible contaminations on the filter.
  • the enzyme When the enzyme is supplied, it may be allowed to act on the washed sample during a sufficient homogenization time out of contact with the inlet and outlet openings. While the enzyme is supplied with the lid positioned above the container in the embodiments yet be later described, it is to be noted that it is also conceivable to supply the enzyme with the lid positioned below the container.
  • the determination of the amount of remaining sample, i.e. isolated sputum, in the container can be performed in different suitable ways, such as weighing or volume determination, using methods known per se.
  • the components in the handling equipment that are adapted to orient the container may in a simple manner also be used to vibrate, rock or by other movements mix the sample so that it is capable of more effectively interacting with washing liquid and enzyme, respectively.
  • the components in the handling equipment that orients the container may then also be used to slant the container to a specified position, so that the homogenized sample being removed by means of gravity is brought to close proximity to the outlet.
  • the homogenized sample is of relatively low viscosity and can pass the separation unit to be withdrawn through the outlet. This sloping or inclination to a defined orientation may also be used for the foregoing removal of the washing fluid.
  • Supplying washing fluid can also include supplying gas besides washing liquid.
  • the wash may be performed with such a turbulence that as large as possible portions of the sample can be exposed to the washing liquid in order to obtain a good washing result.
  • the removal of the washing liquid through the outlet may be effected by gas overpressure in the inlet and expelling the washing liquid through the outlet by the overpressure. In this manner, substantially all washing liquid including the contamination removed from the sample can be safely and easily removed from the container. It is, however, additionally or alternatively also possible to use vacuum at the outlet to withdraw the washing liquid. It is to be noted that the removal, for example by vacuum, is not constrained to removal of washing liquid only, but may also include washing fluid, i.e. also gas. Further, supply and removal of washing liquid and/or washing fluid can also occur concurrently, for example by a continuous throughflow.
  • the removal of the processed, i.e. washed and homogenized sample can be performed by applying a secondary container, such as a test tube, at the outlet.
  • the removal may also be obtained by gas overpressure in the inlet and by expelling the homogenized sample through the outlet by the overpressure, and down into the sec- ondary container.
  • the secondary container can possibly be positioned free from contact with the outlet.
  • FIG. 1 is a view obliquely from above of a prior art container for receiving a patient sample containing sputum;
  • FIG. 2 is a view obliquely from above of a unit composed of a container shown in FIG. 1 having a lid comprising a device according to the invention
  • FIG. 3 is an exploded view obliquely from below, partly in lengthwise section of a lid having a device according to the invention
  • FIG. 4 is a view obliquely from below in lengthwise section of a container cut in half and having a lid substantially as in FIG. 2;
  • FIG. 5 is a perspective view obliquely from above with portions broken away of a container having a lid and removed external lid as in FIG. 4;
  • FIG. 6 is a perspective view obliquely from below of a container turned upside down and having an external lid turned away as well as a connected test tube;
  • FIGS. 7A-D diagrammatically show a number of different processing steps in a num- ber of different components of a plant according to the invention.
  • FIGS. 8A-D show a number of different processing steps in a component for performing a washing process in a plant according to the invention
  • FIG. 9 shows a component for weighing and enzyme supply in a plant according to the invention
  • FIG. 10 shows a component for performing a transfer process in a plant according to the invention
  • FIG.1 1 A is a block diagram showing a number of processing steps, and FIG. 1 1 B diagrammatically in parallel illustrates a portion of respective processing steps in a plant according to the invention;
  • FIG. 12 is a diagrammatic sectional view of a container according to the invention showing an alternatively designed filter;
  • FIG. 13 diagrammatically illustrates a position of a unit according to the invention
  • FIGS. 14-16 are views obliquely from below, showing three embodiments having integrated inlets and outlets according to the invention;
  • FIG. 17 is a perspective view obliquely from above showing another embodiment having integrated inlets and outlets according to the invention.
  • FIG. 18 is a diagrammatic lateral view of still another embodiment having integrated inlets and outlets according to the invention.
  • FIG. 19 is a diagrammatic view obliquely from above of an arrangement for transferring a processed sample according to the invention.
  • FIG. 1 shows a prior art portable sampling container or cup 10 for receiving a patient sample that may be later processed and analyzed in different ways.
  • the container 10 can be sealed with a lid (not shown), such as a simple screw cap, through an external thread 12.
  • FIG. 2 shows an entity composed of such container 10 provided with an arrangement in the shape of a modified cap, closure, cover or lid 20 according to the invention.
  • the geometry of the container 10 may be varied in different ways, for example for adaption to a plant 200 to be later described for processing the patient sample.
  • lid 20 is composed of a plurality of components and may also have a protective external lid 30.
  • Lid 20 has an integral lid body 40 comprising a lid plate 46 and a circular connecting flange 42 of reversed U-shape having an internal thread 44 for engagement with the external thread 12 of container 10 (FIG. 1 ).
  • a seal 43 (FIG. 4) may be provided between lid 20 and container 10.
  • Lid 20 further comprises an inlet 50 having a spreader 70 and an outlet 80. While other embodiments are possible, in the embodiment shown, inlet and outlet are each provided with respective check valves 60 and 90 provided at a pair of respective openings 52 and 82 in the lid plate 46.
  • Lid 20 also has an internal separation unit, in the shown embodiment comprising a filter 100. While the filter may be of varying shape and material, in the embodiment shown, the filter is a dome-shaped thin disk having a plurality of filter apertures 102 and a circular opening 104 for receiving an inlet pipe 72 of the spreader 70. Filter 100 is secured to lid body 40 by a shape or force joint, for example, to a circular inner seat 47 of the lid body 40. As is diagrammatically shown in FIG. 12, filter 100 may also be provided only in connection to outlet 80, so that inlet 50 and spreader 70 do not penetrate filter 100. One or more spreaders may also be built into the filter (not shown).
  • check valve 60 of inlet 50 has a valve housing composed of a valve seat 62 and spreader 70. More precisely, inlet pipe 72 of spreader 70 is inserted through the opening 52 of lock plate 46 to secure engagement with an inner face of valve seat 62. A valve body 64 is forced by a spring 66 in an upward closing direction against an upper opening defined by valve seat 62. Check valve 60 is opened in a downward closing direction by external overpressure from an inlet line, such as line 232 (FIGS. 6, 8), connected to valve seat 62.
  • an inlet line such as line 232 (FIGS. 6, 8
  • FIG. 3 shows four different embodiments of spreader 70 in different positions.
  • Spreader 70 has at least one spreader aperture 74 that may be tangentially oriented to cause turbulence and tangential flow in fluids in the container that flow into container through spreader 70.
  • spreader 70 may op- tionally also have a plurality of spreader apertures 74, such as an additional opposed tangentially oriented spreader aperture 74 and an axially oriented spreader aperture 74.
  • the spreader 70 may optionally also have a projecting screen or an external flange 76, shaped in different fashions and capable of directing the flow in various ways along an adjacent inner face of filter 100.
  • check valve 90 of outlet 80 has a valve housing composed of, one the one hand, an inner collar 84 formed at the upper face of lock plate opening 82, and, on the other hand, a spring retainer 92 having outlet openings 93.
  • Spring retainer 92 is force fitted between inner collar 84 and a concentric outer collar 86 also shaped at the upper face of lock plate opening 82.
  • a valve body 94 is forced by a spring 96 in a downward closing direction into the opening 82.
  • Splines or rifles 95 on the outer face of valve body 94 form a stop in the downward closing direction against a shoulder 83 defining the opening 82.
  • Outlet check valve 90 is opened in an upward closing direction by an interior overpressure in the entity, which overpressure can be higher than the lowest external overpressure that is capable to open the inlet check valve 60.
  • outlet check valve 90 can be connected free of contact with an outlet line 242 to a drain 244 (FIG. 7C), for fluids that are flushed through the entity, or with a secondary container, such as a test tube 120 (FIGS. 6, 7D, 10), for receiving the washed and homogenized patient sample.
  • a secondary container such as a test tube 120 (FIGS. 6, 7D, 10)
  • the spring retainer 82 can have an axial vent opening or channel at its outer face, for example in the shape of a outer segment 93 (indicated in phantom) cut-away from the spring retainer 92 for venting propelling gas in the indicated arrow direction.
  • External lid 30 is adapted to protect and cover the inlet and outlet of lid 20 substan- tially during all handling and transport of the entity outside a plant 200 diagrammati- cally shown in FIGS. 7 and 8.
  • external lid 30 has a circular slotted flange 32, the outer face of which sealingly engages the connection flange 42 of lid 20 in the assembled state shown in FIG. 4.
  • external lid 30 On its upper face, external lid 30 has an undercut slotted recess 36 allowing the external lid 30 to be opened by a tool only, such as the tool 222 shown in FIG. 2.
  • a tool 222 which can be controlled for example by the handling component 220 (FIG.
  • External lid 30 in the plant 200 to be later described, can accordingly be inserted and rotated 45° into the undercut recess 36 and thereafter lift external lid 30 from lid 20.
  • External lid 30 may then alternatively be fully removed or, connected to lid 20, be turned away 180° about a telescopic pivot joint formed by a cylindrical projection 38 formed on the external lid 30 and a tubular cylinder 48 formed on the lid plate 46 of led 20.
  • external lid 30 can be arrested in the turned-away state by being forced down to engagement between the connection flange 42 of lid 20 and a pair of arresting recesses on the external lid 30.
  • a semi-perforated sticker 37 can be present over the recess 36 of external lid 30.
  • An arrow (not shown), for example, on the sticker 37 indicates the location of inlet 50. It is thereby possible by an optical ma- chine reading to inform a control process to position correctly before an opening operation. Then opening tool 222 can penetrate the semi-perforated sticker 37 in the opening operation.
  • the penetrated sticker 37 may further function as an indication that the entity has been used.
  • Lid 20 and/or container 10 and/or external lid 30 may, however, also be provided with guides, such as grooves, capable of engagement with means of the plant 200 for aligning lid 20 with any of the handling components described below.
  • a pair of embodiments of a plant 200 according to the invention is described in the following with reference to FIGS. 7 and 8-10, respectively.
  • FIG. 7 In the diagrammatic embodiment of a plant 200 according to the invention, shown only as an example in FIG. 7, there is shown an arrangement having a movable holder 210 for the entity as well as a number of consecutive handling units 220, 230, 240, 250 relative to which the entity can be moved for performing different steps of a method according to the invention.
  • holder 210 can have a pair of individually movable clamping jaws 212 for holding the container 10 and is also capable of being moved upwards and downwards and along the different components in the plant 200.
  • a first handling component 220 can be provided with the above mentioned tool 222 to remove or move the external lid 30 of the entity to the turned away position to expose the inlet 50 and outlet 80 of lid 20.
  • Handling compo- nent 220 can also be provided with the above mentioned means for correctly positioning the entity prior to the opening operation (not shown).
  • a second handling component 230 can be provided with pressurizeable sources (not shown in detail) for washing liquid W, gas G and enzyme E (i.e. a solution of Sputolysin®) and corresponding lines and connectors (not shown in detail) for connection with inlet 50 of lid 20.
  • gas G and enzyme E i.e. a solution of Sputolysin®
  • corresponding lines and connectors not shown in detail
  • the component 230 and holder 210 can be commonly rotatable for angular alignment and overturning of the entity and for possible repeated rotational movements for mixing the content in the container 10.
  • a third handling unit 240 can be provided with an outlet line 242 to a drain 244.
  • Outlet line 242 can be adapted to receive fluids leaving the entity through the outlet 80 of lid 20 free from contact therewith.
  • a fourth handling unit 250 can be provided with a test tube 120 that likewise can be positioned free from contact at the outlet 80 of lid 20, in this case to receive homogenized sputum leaving the entity through outlet 80. Thereafter, in a manner not shown, test tube 120 can be delivered to an analysis component for further processing of its contents.
  • FIG. 8 shows an alternative embodiment 320 in four different steps A-D during a process for washing the sputum sample in a plant 200 according to the invention.
  • inlet line 232 is supported to be raisable, lowerable and rotatable in the component 320.
  • inlet line 232 can engage inlet 50 and lift entity (step B) and rotate entity to outlet line 242 as shown in step C where lid can already be considered as positioned below the container within the scope of the invention.
  • outlet line 242 is slidably and rotatably supported in the component 320 for being capable of connection to outlet 80 of the entity, i.e. in this case from below, in contact or free from contact therewith (step C).
  • FIG. 9 shows an alternative embodiment of a handling component 330 in a position during a process for weighing and supplying enzyme, and possibly gas for expelling the enzyme to the sputum sample in an entity in a plant 200 according to the invention.
  • inlet line 232 can be securely connected to component 330, while a yoke-shaped holder 210 can be raisable and lowerable, and possibly extendable and retractable relative to component 330.
  • FIG. 10 shows an alternative embodiment of a handling component 340 in a position during a process for transferring the completely processed sputum sample in a plant 200 according to the invention.
  • component 340 can have an inlet line 232 that also can engage the inlet (not shown) of the entity and lift and rotate the entity to a position where the entity can be connected to a secondary container such as a test tube 120.
  • the secondary container / test tube 120 can be forwarded to the outlet (not shown) of the entity by means of a holder 122, which is slidably and rotataby supported in the component 340 in a manner not shown in detail.
  • an entity according to the invention can be handled approximately in the manner that is apparent from what is briefly shown in steps a-j in FIG. 1 1 A and is il- lustrated approximately in parallel in FIG. 1 1 B.
  • the washing process can alternatively be performed by continually supplying, and removing washing liquid by pump-induced vacuum. Removal takes place by means of vacuum at the outlet. To facilitate removal, gas is supplied to the entity through inlet line or by disconnecting inlet line and opening valve.
  • the washing process can alternatively also be performed by pressurized washing liquid at the inlet and gravity- or pump-induced vacuum at the outlet, for example in a lid where the inlet and the outlet comprise openings allowing more or less unob- structed flow.
  • Outlet line may then be connected "by contact" and removal takes place by means of vacuum.
  • gas is supplied through inlet line or the inlet line is disconnected with entity in working position.
  • atmospheric pressure enters when the inlet line is disconnected. According- ly, this is possible without spillage, as then the inlet is above the liquid level, as dia- grammatically illustrated in FIG. 13.
  • inlet 50 and outlet 80 - that optionally may be provided check valves (not shown) - need not be separated at set apart openings in the lid 20 but may be integrated in an assembly 61 in a lid having only one opening, for example an opening corresponding to the opening 52 of FIG. 3.
  • inlet 50 is positioned below and outlet 80 is on the lateral face of the assembly 61 .
  • inlet 50 is connected to spreader 70, and the large opening of outlet 80 is communicating with an aperture in the lateral face of assembly 61 .
  • inlet 50 is on the lateral face of assembly 61
  • outlet 80 extends through an opening (not shown) in the top of assembly 61 .
  • both inlet 50 and outlet 80 are on the lateral face of the assembly 61 .
  • both inlet 50 and outlet 80 are on the top of the assembly 61 , which in a suitable manner is connected to the, in this case, single opening 52 of the lid 20.
  • FIG. 18 highly diagrammatically indicates that inlet 50 and outlet 80 may be positioned in still other ways in relation to each other, for example on arbitrary positions of a spherical surface of the assembly 61 .
  • an arrangement 124 can be used in the above described transfer of the sample to a test tube.
  • Arrangement 124 comprises, for example, a disposable connector in the shape of a T-pipe having, on the one hand, a line section 126 between the outlet (not shown) of the entity and the test tube (not shown), and, on the other hand, a branch 128 connected to a gas vacuum (not shown).
  • a semipermeable membrane 130 communicates the vacuum to line section 126 but prevents passage of liquid. Thereby, the processed sample can accordingly settle in the test tube, while the gas is withdrawn through the membrane 130.
  • the lines 232 and/or 242 can be provided with disposable connectors (not shown) for contacting the inlet 50 and outlet 80, respectively, when washing and supplying en- zyme.
  • a disposable connector can also be present between outlet and secondary container / test tube.
  • inlet and outlet can be disinfected and sealed by the external lid after completed process(es).
  • the external lid and possibly all external faces of the entity can be disinfected after sealing; conceivably also the connecting components in the handling equipment can be disinfected between process- es.
  • some washing liquid may need to be supplied when the lid is positioned over the container, before or during an overturning operation, to assist the sample material in sliding down to the separation unit.

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Abstract

Processing a patient sample containing sputum in a container (10) for receiving the sample. A device according to the invention comprises a lid (20) for closing the container (10), an inlet (50) in the lid (20) for supplying processing fluids comprising washing fluid and enzyme to the sample in the container (10) for homogenization of the sample, an outlet (80) in the lid for removing the washing fluid and the homogenized sample from the container (10), and a separation unit (100) in the lid (20) interior of the outlet (80) for separation of sputum from the washing fluid when removing the washing fluid. A method of processing a patient sample using such device is also disclosed.

Description

Device and method for processing a patient sample
TECHNICAL AREA
This invention relates to a device for processing a patient sample containing sputum in a container for receipt of the sample, comprising a lid for closing the container. The invention also relates to a method of processing a patient sample containing sputum using such a device.
BACKGROUND
Bacterial lower respiratory infections are a common cause of sickness and mortality in most age groups. When antibiotic resistance increases it is vital to perform adequate sampling from the lower respiratory tract to be capable of identifying bacteria causing pneumonia and then to determine the antibiotic susceptibility of these bacteria. As many bacteria may be present in lower respiratory tract without causing any infection, so called colonization, it is also of pivotal importance to quantify a bacterial finding. By such quantification it is possible to distinguish plausible infection from plausible colonization.
A common procedure of collecting material from the lower respiratory tract is to have the patient coughing up respiratory tract secretion. Often, an organized phlegm clot referred to as sputum is present at an infection site. When sputum is coughed-up, the sample material is contaminated by bacteria present in the oral cavity, indicating that the sample material to be analyzed is composed of a mixture of sputum and saliva from the oral cavity. It is known, and also recommended by among others the Swedish Institute for Communicable Disease Control, to separate sputum from saliva by so called sputum wash. In a simple way, sputum wash is performed by using a strainer and tap water. The water flushes saliva away through the strainer, while sputum is left in the strainer. If the wash is not performed, the sensitivity of the culture will be lower, i.e. it will then be more difficult to detect relevant pathogenic bacteria in a great variety of oral cavity bacteria. After the separation, sputum is homogenized by an enzyme. Homogenized sputum may then be cultured for analysis of the bacteria! content. Such wash and homogenization of sputum is, however, performed only by a few microbiological laboratories. One reason for this is that this method is labor intensive. Another reason is the hazard of splashing sample material that may be pathogenic to laboratory staff.
DISCLOSURE OF THE INVENTION
An object of the present invention is to provide a device and a method of the kind initially defined that is capable of isolating and at least partially automate the pro- cessing of the patient sample so that it can be performed more safely and less labor intensive.
This object is obtained by the features defined in the appended claims. In one aspect of the invention the device is characterized by:
an inlet in the lid for supplying processing fluids comprising washing fluid (including washing liquid and preferably also gas) and enzyme to the sample in the container for homogenization of the sample;
an outlet in the lid for removing the washing fluid and the homogenized sample from the container; and
a separation unit in the lid interior of the outlet for separation of sputum from the washing fluid when removing the washing fluid.
While the inlet and the outlet may be composed of suitably shaped inlet and outlet openings in the lid, for example openings allowing more or less free throughflow, in one embodiment of the invention, the inlet and the outlet are provided as valves. In the case inlet and the outlet are shaped as openings, valves may be provided in components of an arrangement that respectively supplies and removes the processing fluids. In the scope of the invention it is also conceivable that the inlet and/or outlet can have at least two separate openings in the lid for the different processing fluids; the inlet, for example, may have one inlet opening for washing liquid, one inlet opening for gas and one inlet opening for enzyme. While in turn the valves may be remotely controlled valves, in another embodiment the valves are provided as check valves. The check valve of the inlet opening may then, for example, be set to open at a lower inlet pressure than the lowest opening pressure of the outlet opening. The inlet may also have a spreader interior of the separation unit for spreading the washing fluid and the enzyme when supplied to the container.
The spreader in turn may have at least one tangentially oriented spreader aperture. The spreader may further have a screen controlling flow from the tangentially oriented spreader aperture along an interior face of the separation unit. Entering washing liquid and also enzyme may then effectively interact with the sample resting on the separation unit, such as a concave inner face of a filter. The spreader may, however, be adapted to control the flow in one or more other arbitrary directions, such as axial, or angled between tangential and axial directions.
The inlet and outlet may also be provided at a common opening in the lid. Thereby the lid can have a more simple design. The lid can also have an external lid for sealing the inlet and the outlet from an exterior face of the lid. The inlet and the outlet may then be protected from contaminating the environment or from being contaminated by the environment.
Between the external lid and the lid can further be an eccentric pivot joint. The exter- nal lid may then be turned away to expose the inlet and the outlet and to accompany the lid during the processing of the sample. The external lid can also be raisably and lowerably connected to the lid through the pivot joint. The external lid may then by means of suitable recesses be temporarily locked from being turned back on the lid.
The external lid can however also be separately opened and possibly removed be- fore the processing of the sample.
The method according to the invention is concerned with processing a patient sample containing sputum by use of a device according to the invention, comprising supplying washing fluid containing washing liquid to the sample for isolating sputum in the sample and supplying enzyme to the isolated sputum for homogenization of the sample; and
providing the patient sample in the container closed by the lid;
is performed by the following steps:
orienting the container with the lid positioned below the container;
supplying the washing fluid to the container through the inlet in the lid for washing the sample;
removing the washing liquid through the outlet in the lid by filtration;
orienting the container with the lid positioned above the container;
determining the amount of remaining sample in the container;
supplying the enzyme to the container through the inlet in the lid in a quantity dependent of the amount of remaining sample for the homogenization of the sample; orienting the container with the lid positioned below the container; and
removing the processed sample through the outlet in the lid. By such a device and such a method the processing of the patient sample can be performed in a labor-saving and safe manner in a shielded plant that can be more or less automated having a handling equipment comprising components known as such. Such handling equipment can have a controlled and screened-off atmosphere and may be adapted, for example, to manipulate, orient and weigh the container, and connect and disconnect respective lines for washing liquid, gas and enzyme to the inlet as well as positioning the outlet in connection with a drainage and a secondary container for the completely processed sample. By orienting the container having the lid positioned below the container, it will be possible in a simple manner for the washing liquid, on the one hand, to be introduced into the container immediately inside the lid to more directly contact the sample, and, on the other hand, to be removed from the container immediately inside the lid where the sample can be supported by a filter surface.
By orienting the container having the lid positioned above the container, the washed sample can be moved to the bottom of the container by gravity and be separated from possible contaminations on the filter. When the enzyme is supplied, it may be allowed to act on the washed sample during a sufficient homogenization time out of contact with the inlet and outlet openings. While the enzyme is supplied with the lid positioned above the container in the embodiments yet be later described, it is to be noted that it is also conceivable to supply the enzyme with the lid positioned below the container.
The determination of the amount of remaining sample, i.e. isolated sputum, in the container can be performed in different suitable ways, such as weighing or volume determination, using methods known per se. During wash and enzyme homogenization of the sample, the components in the handling equipment that are adapted to orient the container may in a simple manner also be used to vibrate, rock or by other movements mix the sample so that it is capable of more effectively interacting with washing liquid and enzyme, respectively. By orienting the container again having the lid positioned below the container, it is this time in a simple manner possible to remove the homogenized sample from the container through the outlet. The components in the handling equipment that orients the container may then also be used to slant the container to a specified position, so that the homogenized sample being removed by means of gravity is brought to close proximity to the outlet. The homogenized sample is of relatively low viscosity and can pass the separation unit to be withdrawn through the outlet. This sloping or inclination to a defined orientation may also be used for the foregoing removal of the washing fluid. Supplying washing fluid can also include supplying gas besides washing liquid.
Thereby the wash may be performed with such a turbulence that as large as possible portions of the sample can be exposed to the washing liquid in order to obtain a good washing result.
The removal of the washing liquid through the outlet may be effected by gas overpressure in the inlet and expelling the washing liquid through the outlet by the overpressure. In this manner, substantially all washing liquid including the contamination removed from the sample can be safely and easily removed from the container. It is, however, additionally or alternatively also possible to use vacuum at the outlet to withdraw the washing liquid. It is to be noted that the removal, for example by vacuum, is not constrained to removal of washing liquid only, but may also include washing fluid, i.e. also gas. Further, supply and removal of washing liquid and/or washing fluid can also occur concurrently, for example by a continuous throughflow.
The removal of the processed, i.e. washed and homogenized sample can be performed by applying a secondary container, such as a test tube, at the outlet. The removal may also be obtained by gas overpressure in the inlet and by expelling the homogenized sample through the outlet by the overpressure, and down into the sec- ondary container. In order not to contaminate the sample by possible wash residuals and other contaminants at the outlet, the secondary container can possibly be positioned free from contact with the outlet.
Other aspects and advantages of the invention may be apparent from the claims and the following description of exemplary embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view obliquely from above of a prior art container for receiving a patient sample containing sputum;
FIG. 2 is a view obliquely from above of a unit composed of a container shown in FIG. 1 having a lid comprising a device according to the invention; FIG. 3 is an exploded view obliquely from below, partly in lengthwise section of a lid having a device according to the invention; FIG. 4 is a view obliquely from below in lengthwise section of a container cut in half and having a lid substantially as in FIG. 2;
FIG. 5 is a perspective view obliquely from above with portions broken away of a container having a lid and removed external lid as in FIG. 4;
FIG. 6 is a perspective view obliquely from below of a container turned upside down and having an external lid turned away as well as a connected test tube;
FIGS. 7A-D diagrammatically show a number of different processing steps in a num- ber of different components of a plant according to the invention;
FIGS. 8A-D show a number of different processing steps in a component for performing a washing process in a plant according to the invention; FIG. 9 shows a component for weighing and enzyme supply in a plant according to the invention;
FIG. 10 shows a component for performing a transfer process in a plant according to the invention;
FIG.1 1 A is a block diagram showing a number of processing steps, and FIG. 1 1 B diagrammatically in parallel illustrates a portion of respective processing steps in a plant according to the invention; FIG. 12 is a diagrammatic sectional view of a container according to the invention showing an alternatively designed filter;
FIG. 13 diagrammatically illustrates a position of a unit according to the invention; FIGS. 14-16 are views obliquely from below, showing three embodiments having integrated inlets and outlets according to the invention;
FIG. 17 is a perspective view obliquely from above showing another embodiment having integrated inlets and outlets according to the invention;
FIG. 18 is a diagrammatic lateral view of still another embodiment having integrated inlets and outlets according to the invention; and FIG. 19 is a diagrammatic view obliquely from above of an arrangement for transferring a processed sample according to the invention.
In the drawing, same reference numbers are used for designating parts having same or similar function.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
FIG. 1 shows a prior art portable sampling container or cup 10 for receiving a patient sample that may be later processed and analyzed in different ways. To isolate the sample from the environment in the meantime, the container 10 can be sealed with a lid (not shown), such as a simple screw cap, through an external thread 12.
FIG. 2 shows an entity composed of such container 10 provided with an arrangement in the shape of a modified cap, closure, cover or lid 20 according to the invention. The geometry of the container 10 may be varied in different ways, for example for adaption to a plant 200 to be later described for processing the patient sample. As is most clearly apparent from the exploded arrangement shown in FIG. 3, according to the invention, lid 20 is composed of a plurality of components and may also have a protective external lid 30.
Lid 20 has an integral lid body 40 comprising a lid plate 46 and a circular connecting flange 42 of reversed U-shape having an internal thread 44 for engagement with the external thread 12 of container 10 (FIG. 1 ). A seal 43 (FIG. 4) may be provided between lid 20 and container 10.
Lid 20 further comprises an inlet 50 having a spreader 70 and an outlet 80. While other embodiments are possible, in the embodiment shown, inlet and outlet are each provided with respective check valves 60 and 90 provided at a pair of respective openings 52 and 82 in the lid plate 46.
Lid 20 also has an internal separation unit, in the shown embodiment comprising a filter 100. While the filter may be of varying shape and material, in the embodiment shown, the filter is a dome-shaped thin disk having a plurality of filter apertures 102 and a circular opening 104 for receiving an inlet pipe 72 of the spreader 70. Filter 100 is secured to lid body 40 by a shape or force joint, for example, to a circular inner seat 47 of the lid body 40. As is diagrammatically shown in FIG. 12, filter 100 may also be provided only in connection to outlet 80, so that inlet 50 and spreader 70 do not penetrate filter 100. One or more spreaders may also be built into the filter (not shown).
As also apparent from FIGS. 4 and 5, check valve 60 of inlet 50 has a valve housing composed of a valve seat 62 and spreader 70. More precisely, inlet pipe 72 of spreader 70 is inserted through the opening 52 of lock plate 46 to secure engagement with an inner face of valve seat 62. A valve body 64 is forced by a spring 66 in an upward closing direction against an upper opening defined by valve seat 62. Check valve 60 is opened in a downward closing direction by external overpressure from an inlet line, such as line 232 (FIGS. 6, 8), connected to valve seat 62.
FIG. 3 shows four different embodiments of spreader 70 in different positions.
Spreader 70 has at least one spreader aperture 74 that may be tangentially oriented to cause turbulence and tangential flow in fluids in the container that flow into container through spreader 70. As is further apparent from FIG. 3, spreader 70 may op- tionally also have a plurality of spreader apertures 74, such as an additional opposed tangentially oriented spreader aperture 74 and an axially oriented spreader aperture 74. As is still further apparent from FIG. 3, the spreader 70 may optionally also have a projecting screen or an external flange 76, shaped in different fashions and capable of directing the flow in various ways along an adjacent inner face of filter 100. With further reference to FIG. 3 in combination with FIGS. 4 and 5, check valve 90 of outlet 80 has a valve housing composed of, one the one hand, an inner collar 84 formed at the upper face of lock plate opening 82, and, on the other hand, a spring retainer 92 having outlet openings 93. Spring retainer 92 is force fitted between inner collar 84 and a concentric outer collar 86 also shaped at the upper face of lock plate opening 82. A valve body 94 is forced by a spring 96 in a downward closing direction into the opening 82. Splines or rifles 95 on the outer face of valve body 94 form a stop in the downward closing direction against a shoulder 83 defining the opening 82. Outlet check valve 90 is opened in an upward closing direction by an interior overpressure in the entity, which overpressure can be higher than the lowest external overpressure that is capable to open the inlet check valve 60.
Via the spring retainer 92, outlet check valve 90 can be connected free of contact with an outlet line 242 to a drain 244 (FIG. 7C), for fluids that are flushed through the entity, or with a secondary container, such as a test tube 120 (FIGS. 6, 7D, 10), for receiving the washed and homogenized patient sample. To otherwise allow gas emerging for example from the test tube 120 during expelling of a refined/washed and homogenized liquid sample in the test tube 120, the spring retainer 82, as indi- cated in FIG. 5, can have an axial vent opening or channel at its outer face, for example in the shape of a outer segment 93 (indicated in phantom) cut-away from the spring retainer 92 for venting propelling gas in the indicated arrow direction.
External lid 30 is adapted to protect and cover the inlet and outlet of lid 20 substan- tially during all handling and transport of the entity outside a plant 200 diagrammati- cally shown in FIGS. 7 and 8. In the embodiment shown, external lid 30 has a circular slotted flange 32, the outer face of which sealingly engages the connection flange 42 of lid 20 in the assembled state shown in FIG. 4. On its upper face, external lid 30 has an undercut slotted recess 36 allowing the external lid 30 to be opened by a tool only, such as the tool 222 shown in FIG. 2. Such a tool 222, which can be controlled for example by the handling component 220 (FIG. 7A) in the plant 200 to be later described, can accordingly be inserted and rotated 45° into the undercut recess 36 and thereafter lift external lid 30 from lid 20. External lid 30 may then alternatively be fully removed or, connected to lid 20, be turned away 180° about a telescopic pivot joint formed by a cylindrical projection 38 formed on the external lid 30 and a tubular cylinder 48 formed on the lid plate 46 of led 20. As is also shown in FIG. 6, external lid 30 can be arrested in the turned-away state by being forced down to engagement between the connection flange 42 of lid 20 and a pair of arresting recesses on the external lid 30.
As is indicated in phantom in FIG. 4, a semi-perforated sticker 37 can be present over the recess 36 of external lid 30. An arrow (not shown), for example, on the sticker 37 indicates the location of inlet 50. It is thereby possible by an optical ma- chine reading to inform a control process to position correctly before an opening operation. Then opening tool 222 can penetrate the semi-perforated sticker 37 in the opening operation. The penetrated sticker 37 may further function as an indication that the entity has been used. Lid 20 and/or container 10 and/or external lid 30 may, however, also be provided with guides, such as grooves, capable of engagement with means of the plant 200 for aligning lid 20 with any of the handling components described below.
A pair of embodiments of a plant 200 according to the invention is described in the following with reference to FIGS. 7 and 8-10, respectively.
In the diagrammatic embodiment of a plant 200 according to the invention, shown only as an example in FIG. 7, there is shown an arrangement having a movable holder 210 for the entity as well as a number of consecutive handling units 220, 230, 240, 250 relative to which the entity can be moved for performing different steps of a method according to the invention.
As shown in FIG. 7A, holder 210 can have a pair of individually movable clamping jaws 212 for holding the container 10 and is also capable of being moved upwards and downwards and along the different components in the plant 200.
As indicated in FIG. 7A, a first handling component 220 can be provided with the above mentioned tool 222 to remove or move the external lid 30 of the entity to the turned away position to expose the inlet 50 and outlet 80 of lid 20. Handling compo- nent 220 can also be provided with the above mentioned means for correctly positioning the entity prior to the opening operation (not shown).
As indicated in FIG. 7B, a second handling component 230 can be provided with pressurizeable sources (not shown in detail) for washing liquid W, gas G and enzyme E (i.e. a solution of Sputolysin®) and corresponding lines and connectors (not shown in detail) for connection with inlet 50 of lid 20. As further indicated in FIG. 7B, the component 230 and holder 210 can be commonly rotatable for angular alignment and overturning of the entity and for possible repeated rotational movements for mixing the content in the container 10.
As indicated in FIG. 7C, a third handling unit 240 can be provided with an outlet line 242 to a drain 244. Outlet line 242 can be adapted to receive fluids leaving the entity through the outlet 80 of lid 20 free from contact therewith.
As indicated in FIG. 7D, a fourth handling unit 250 can be provided with a test tube 120 that likewise can be positioned free from contact at the outlet 80 of lid 20, in this case to receive homogenized sputum leaving the entity through outlet 80. Thereafter, in a manner not shown, test tube 120 can be delivered to an analysis component for further processing of its contents.
FIG. 8 shows an alternative embodiment 320 in four different steps A-D during a process for washing the sputum sample in a plant 200 according to the invention. In this embodiment inlet line 232 is supported to be raisable, lowerable and rotatable in the component 320. As apparent, inlet line 232 can engage inlet 50 and lift entity (step B) and rotate entity to outlet line 242 as shown in step C where lid can already be considered as positioned below the container within the scope of the invention. In this embodiment, outlet line 242 is slidably and rotatably supported in the component 320 for being capable of connection to outlet 80 of the entity, i.e. in this case from below, in contact or free from contact therewith (step C). Thereafter, the entity and connected lines 232 and 242 be rotated together to a desired position (such as that in step D) relative to component 320 during the washing process. FIG. 9 shows an alternative embodiment of a handling component 330 in a position during a process for weighing and supplying enzyme, and possibly gas for expelling the enzyme to the sputum sample in an entity in a plant 200 according to the invention. In this case, inlet line 232 can be securely connected to component 330, while a yoke-shaped holder 210 can be raisable and lowerable, and possibly extendable and retractable relative to component 330. Thereby, the entity may first be weighed on a scale 260 and then be connected to the inlet line for supplying enzyme in a quantity dependent of the weight of the entity. FIG. 10 shows an alternative embodiment of a handling component 340 in a position during a process for transferring the completely processed sputum sample in a plant 200 according to the invention. Also in this case, component 340 can have an inlet line 232 that also can engage the inlet (not shown) of the entity and lift and rotate the entity to a position where the entity can be connected to a secondary container such as a test tube 120. The secondary container / test tube 120 can be forwarded to the outlet (not shown) of the entity by means of a holder 122, which is slidably and rotataby supported in the component 340 in a manner not shown in detail.
Other not shown arrangements and components for overturning, rotating etc. of con- tainers and/or processing entities, and also for opening and closing of external lids, connecting inlets and outlets etc., may also be apparent to a person skilled in the art.
In summary, an entity according to the invention can be handled approximately in the manner that is apparent from what is briefly shown in steps a-j in FIG. 1 1 A and is il- lustrated approximately in parallel in FIG. 1 1 B.
The washing process can alternatively be performed by continually supplying, and removing washing liquid by pump-induced vacuum. Removal takes place by means of vacuum at the outlet. To facilitate removal, gas is supplied to the entity through inlet line or by disconnecting inlet line and opening valve.
The washing process can alternatively also be performed by pressurized washing liquid at the inlet and gravity- or pump-induced vacuum at the outlet, for example in a lid where the inlet and the outlet comprise openings allowing more or less unob- structed flow. Outlet line may then be connected "by contact" and removal takes place by means of vacuum. To facilitate removal, gas is supplied through inlet line or the inlet line is disconnected with entity in working position. In the embodiment of FIG. 13, atmospheric pressure enters when the inlet line is disconnected. According- ly, this is possible without spillage, as then the inlet is above the liquid level, as dia- grammatically illustrated in FIG. 13.
Also other variants (not shown) where a washing or transfer process is performed by means of overpressure at the inlet and vacuum at the outlet are possible.
As is apparent from the embodiments shown in FIGS. 14-18, inlet 50 and outlet 80 - that optionally may be provided check valves (not shown) - need not be separated at set apart openings in the lid 20 but may be integrated in an assembly 61 in a lid having only one opening, for example an opening corresponding to the opening 52 of FIG. 3. In FIG. 14, inlet 50 is positioned below and outlet 80 is on the lateral face of the assembly 61 . In other words, inlet 50 is connected to spreader 70, and the large opening of outlet 80 is communicating with an aperture in the lateral face of assembly 61 . In FIG.15, inlet 50 is on the lateral face of assembly 61 , while outlet 80 extends through an opening (not shown) in the top of assembly 61 . In FIG. 16, both inlet 50 and outlet 80 are on the lateral face of the assembly 61 . In FIG. 17, both inlet 50 and outlet 80 are on the top of the assembly 61 , which in a suitable manner is connected to the, in this case, single opening 52 of the lid 20. FIG. 18 highly diagrammatically indicates that inlet 50 and outlet 80 may be positioned in still other ways in relation to each other, for example on arbitrary positions of a spherical surface of the assembly 61 .
As diagrammatically shown in FIG.19, also an arrangement 124 can be used in the above described transfer of the sample to a test tube. Arrangement 124 comprises, for example, a disposable connector in the shape of a T-pipe having, on the one hand, a line section 126 between the outlet (not shown) of the entity and the test tube (not shown), and, on the other hand, a branch 128 connected to a gas vacuum (not shown). A semipermeable membrane 130 communicates the vacuum to line section 126 but prevents passage of liquid. Thereby, the processed sample can accordingly settle in the test tube, while the gas is withdrawn through the membrane 130. Many modifications are conceivable within the scope of the invention. The lines 232 and/or 242, for example, can be provided with disposable connectors (not shown) for contacting the inlet 50 and outlet 80, respectively, when washing and supplying en- zyme. Such a disposable connector can also be present between outlet and secondary container / test tube. Moreover, inlet and outlet can be disinfected and sealed by the external lid after completed process(es). Also, the external lid and possibly all external faces of the entity can be disinfected after sealing; conceivably also the connecting components in the handling equipment can be disinfected between process- es. Further, some washing liquid may need to be supplied when the lid is positioned over the container, before or during an overturning operation, to assist the sample material in sliding down to the separation unit.
The foregoing detailed description is given primarily for clearness of understanding and no unnecessary limitations are to be understood therefrom. Modifications will become obvious to those skilled in the art upon reading this disclosure and may be made without departing from the spirit of the invention or the scope of the appended claims.

Claims

A device for processing a patient sample containing sputum in a container (10) for receiving the sample, comprising:
a lid (20) for closing the container (10);
characterized by
an inlet (50) in the lid (20) for supplying processing fluids comprising washing fluid and enzyme to the sample in the container (10) for homogenization of the sample;
an outlet (80) in the lid for removing the washing fluid and the homogenized sample from the container (10); and
a separation unit (100) in the lid (20) interior of the outlet (80) for separation of sputum from the washing fluid when removing the washing fluid.
The device according to claim 1 , wherein the inlet (50) and the outlet (80) comprise valves (60, 90).
The device according to claim 2, wherein the valves comprise check valves (60, 90).
The device according to any of claims 1 to 3, wherein the inlet comprises a spreader (70) interior of the separation unit (100) for spreading the washing fluid and the enzyme when supplied to the container (10).
The device according to claim 4, wherein the spreader (70) comprises a tangen- tially oriented spreader aperture (74).
The device according to claim 4 or 5, wherein the spreader (70) comprises an axially oriented spreader aperture (74).
The device according to claim 5 or 6, wherein the spreader (70) comprises a screen (76) for controlling flow from the tangentially oriented spreader aperture (74) along an interior face of the separation unit (100).
8. The device according to any of the previous claims, wherein the inlet (50) and the outlet (80) are arranged at a common opening (52) in the lid (20).
9. The device according to any of the previous claims, wherein the lid (20) comprises an external lid (30) for sealing the inlet (50) and the outlet (80) from an exterior face of the lid (20).
10. The device according to claim 9, comprising an eccentric pivot joint (38, 48) between the external lid (30) and the lid (20).
11. The device according to claim 10, wherein the exterior lid (30) is raisably and lowerably connected to the lid (20) through the pivot joint (38, 48).
12. A method of processing a patient sample containing sputum by use of a device according to any of the previous claims, comprising:
supplying washing fluid containing washing liquid to the sample for isolating sputum in the sample and supplying enzyme to the isolated sputum for homogeniza- tion of the sample; and
providing the patient sample in the container (10) closed by the lid (20);
characterized by
orienting the container (10) with the lid (20) positioned below the container;
supplying the washing fluid to the container (10) through the inlet 50 in the lid (20) for washing the sample;
removing the washing liquid (W) through the outlet (80) in the lid (20) by filtration; orienting the container (10) with the lid (20) positioned above the container (10); determining the amount of remaining sample in the container;
supplying the enzyme (E) to the container (10) through the inlet (50) in the lid (20) in a quantity dependent of the amount of remaining sample for the homoge- nization of the sample;
orienting the container (10) with the lid (20) positioned below the container; and removing the processed sample through the outlet (80) in the lid (20).
13. The method according to claim 12, wherein supplying the washing fluid comprises supplying washing liquid (W) and gas (G).
14. The method according to claim 12 or 13, wherein removing the washing liquid through the outlet (80) comprises application of overpressure in the inlet (50) and expelling the washing liquid out of the outlet by the overpressure.
15. The method according to any of claims 12-14, wherein removing the washing liquid through the outlet (80) comprises application of vacuum in the outlet.
16. The method according to any of claims 12-15, wherein removing the processed sample comprises applying a secondary container (120) at the outlet (80).
17. The method according to any of claims 12-16, wherein supplying and removing the washing liquid occur concurrently.
PCT/SE2012/050989 2011-09-19 2012-09-18 Device and method for processing a patient sample WO2013043109A2 (en)

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