WO2014001530A1 - Appareil automatique de coloration comprenant des tiroirs réfrigérés pour flacons de réactifs - Google Patents

Appareil automatique de coloration comprenant des tiroirs réfrigérés pour flacons de réactifs Download PDF

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Publication number
WO2014001530A1
WO2014001530A1 PCT/EP2013/063688 EP2013063688W WO2014001530A1 WO 2014001530 A1 WO2014001530 A1 WO 2014001530A1 EP 2013063688 W EP2013063688 W EP 2013063688W WO 2014001530 A1 WO2014001530 A1 WO 2014001530A1
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WO
WIPO (PCT)
Prior art keywords
bottles
drawers
drawer
reagent
staining apparatus
Prior art date
Application number
PCT/EP2013/063688
Other languages
English (en)
Inventor
Lars Winther
Original Assignee
Victorious Medical Systems Aps
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 Victorious Medical Systems Aps filed Critical Victorious Medical Systems Aps
Publication of WO2014001530A1 publication Critical patent/WO2014001530A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/30—Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
    • G01N1/31—Apparatus therefor
    • G01N1/312—Apparatus therefor for samples mounted on planar substrates
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00346—Heating or cooling arrangements
    • G01N2035/00435—Refrigerated reagent storage

Definitions

  • the present invention relates to an automated staining apparatus for staining of biological samples arranged on slides, notably to improvements of a reagent bottle bay section thereof.
  • the reagents are stored at ambient temperature in closed containers with built-in dispenser and are organized in a carrousel with a label reader at a fixed position. Reagents are dispensed directly onto slides organized in carousels below the reagent carousel.
  • ambient temperature reagent containers with build in dispenser are organized in an array and physically moved by a robot arm to a position over slides organized in arrays.
  • a label reader is placed in the robot head.
  • a so-called array design is provided with reagent bottles and slides organized in rows, the design comprising drawers and an overhead robot incorporating a sip and spit reagent probe and a label reader.
  • all the reagents are stored at ambient temperature, and handling of reagents can cause disturbance of the stainer's operation.
  • Biocare intellipath FLX incorporates two cold spots for intermediate storing of mixed chromogens but stores all the reagents at ambient
  • a stainer i.e. a staining apparatus
  • embodiments of the present invention seek to solve at least some of the following technical problems:
  • Managing of differently sized reagent bottles from less than 1 ml, 2, 5 and up to 25, 50 or 250 ml.
  • Allowing reagent handling during operations of the staining apparatus Allowing reagent handling during operations of the staining apparatus.
  • the present invention provides an automated staining apparatus for staining of biological samples arranged on slides, comprising
  • a reagent bay section for holding a plurality of reagent bottles
  • At least one optical reader for reading information provided on the surfaces of said bottles for identifying the contents of the respective bottles
  • an automated reagent dispensing system for receiving controlled amounts of reagent liquid from the bottles and for dispensing said amounts of reagent liquid onto the slides; an electronic control system operatively associated with the optical reader and said dispensing system, so as to control operation of the reader and of the dispensing system;
  • the reagent bay section comprises at least two drawers, each of which is slidably received in a drawer section of the staining apparatus, the drawers and the drawer section being configured to allow each of the drawers to be individually moved by rectilinear translational sliding movement between an open state, in which an interior section of the drawer can be accessed by a user for insertion and removal of the bottles, and a closed state, in which the interior section of the drawer is fully received in the drawer section of the staining apparatus, and in which the interior section of the drawer is accessible by the dispensing system only;
  • the apparatus comprises a cooling system for maintaining the interior section of each of the drawers at a temperature below 12°C, such as between 2°C and 8°C, when the drawer is in the closed state;
  • each of the drawers is configured to hold the reagent bottles in a matrix configuration; - each one of the drawers is further configured to hold bottles of at least two different sizes, shapes or volumes.
  • the combination of cooled drawers, a plurality of independent drawers and the matrix configuration of the bottle-holding structure of the drawers along with the ability to hold bottles of different sizes or shapes results in a number of benefits.
  • the design is compact, and hence a large number of different reagents can be managed by the apparatus and differently sized reagent bottles can be handled.
  • the ability to individually and independently open and close the drawers allows reagents to be handled during operation of the staining apparatus and loading of reagent bottles at any time.
  • the optical reader is preferably arranged in a section of the apparatus, which constitutes a frame structure for the drawers.
  • the optical reader may be integrated in or mounted to the frame structure for the drawers.
  • reagent bottle labels may be read independently from staining operations carried out by the apparatus, because the optical reader is not structurally integrated with the dispensing system or other elements used during staining.
  • the labels of the reagent bottles may thus be read when the drawers are being closed, and an operator of the apparatus may in turn be immediately alerted if an error or malfunction occurs.
  • Other operations, such as baking, dewaxing, target retrieval and staining preferably occur independently from the reading of bottle lables.
  • the apparatus is preferably configured such that the drawers may be opened and closed independently from one another. For example, one drawer may be opened while another drawer is open, and/or while reagents are being mixed in another drawer.
  • the apparatus is preferably also configured such that staining operations may take place, while one or more drawers are open.
  • the cooling system extends the shelf life of the reagents once the bottles are loaded into the apparatus, and hence the compact design allowing for a large number of bottles to be accommodated within the apparatus can be exploited to a maximum degree.
  • the slides may include biological samples arranged or mounted on the slides, such as more specifically, cell smears or cells mounted on microscope glass. More specifically, the invention is applicable with regard to immunohistochemistry (IHC), special stains (SS) or in-situ hydridzation (ISH) staining of FFPE tissue sections mounted on microscope glass slides.
  • the matrix configuration may be a rectilinear matrix configuration with bottles held in rows and columns, or an arcuate configuration, such as a circular, half-circular, oval or half-oval configuration.
  • the matrix of bottles is preferably a two-dimensional matrix coinciding with or extending parallel to with the plane, in which each of the drawers undertake the translational sliding movement between the open and closed positions.
  • the invention also provides a system comprising an automated staining apparatus according to any of the preceding claims and a plurality of said reagent bottles, wherein the bottles and the interior section of the drawers are polar to prevent incorrect placement and positioning of the bottles within the drawers.
  • the control system and the dispensing system may be configured to withdraw amounts of liquid from bottles from a first one of the drawers, while a second one of the drawers is in its open state.
  • the at least one optical reader may securely fixed to the drawer section of the staining apparatus at a position, in which said bottle information passes the reader, while the drawers close, so as to enable the reader to read the information, while the drawers undertake said rectilinear sliding movement between the open and the closed state.
  • the at least one optical reader may be releasably attachable to a plurality of positions at the drawer section of the staining apparatus, in which said bottle information of respective sets of drawers pass the reader, while the drawers undertake said rectilinear sliding movement between the open and the closed state.
  • a port structure may be provided, which is releasbly attached at the drawer section of the staining apparatus, the port section comprising the at least one optical reader.
  • the port structure may be movable, so as to be attachable at a plurality of drawer sites at the drawer section.
  • the at least one optical reader may comprise two or more optical readers arranged at respective sides of each drawer for reading information from bottles arranged at respective sides of the drawer.
  • the at least one optical reader may be securely fixed or attachable to the drawer section of the staining apparatus at a position between two neighbouring ones of the drawers, so as to enable one single optical reader to read information on bottles in the neighbouring drawers.
  • the information may be provided in barcodes printed onto the bottles or printed on labels attached to the bottles.
  • the at least one optical reader may be arranged in a non-cooled section of the drawer section.
  • the automated staining apparatus may further comprising robotics, control electronics and fluidics tubes, in which case said robotics, control electronics and fluidics tubes are preferably arranged in a non-cooled section of the staining apparatus.
  • the control system may be configured to determine if the bottles are correctly placed within the drawer and to generate an error or warning signal in the event of incorrect placement.
  • each of the drawers comprises an insulating front section
  • each drawer is covered by an insulating lid assembly at least in the closed state of the drawer, the dispensing system being configured to access the bottles through apertures in the lid;
  • the insulating lid assembly may comprise a plurality of overlapping perforated plates arranged to be mutually slidable between an access state, in which perforations of the plates co-extend to provide access to the bottles in the interior section of the drawer, and a non- access state, in which the perforations do not co-extend, whereby the plates provide a closed lid of the drawer.
  • Each of the drawers may comprise a removable tray insert for receiving the bottles.
  • the dispensing system may comprise a pipette or probe for withdrawing controlled amounts of reagent liquid from the bottles and optionally further a heating element for heating the pipette.
  • the bottles may comprise a bundle of bottles with only set of information thereon for identifying the contents of all of the bottles of the bundle.
  • FIGS. 1 - 3 are simplified sketches of embodiments of an automated staining apparatus according to the present invention.
  • Fig. 4 is a simplified drawing of an embodiment of an automated staining apparatus according to the invention.
  • Figs. 5 - 7 illustrate details of a drawer for an embodiment of an automated staining apparatus according to the invention
  • Fig. 8 depicts various reagent bottles and inserts.
  • the inventor has realized that introduction of a general cold storage for many different reagents in different volumes in combination with user-friendly reagent handling and a reliable and cost efficient instrument operation requires a fundamental redesign, compared to state of the art stainers.
  • the inventor has realized that in order to efficiently store reagents in the cold, the cooled volume should be reduced to a minimum.
  • the reagent bay should be both compact and easy to isolate thermally. Therefore, a matrix design with reagent bottles and an indirect sip and spit dispensing pipette design is preferable due to the compactness, ease of modification for different bottle sizes and low cost.
  • the reagent bottles should be organized in several independent sections and preferably in several independent drawers.
  • the instrument can extract reagents from bottles in the other drawers, while one drawer is open and being manipulated by the operator.
  • any bulky robotics with sensitive mechanics, electronics and fluidics lines should be kept outside the cooled area. Access to the reagents in the cooled storage room should therefore be through small ports in the lid. In one embodiment, this is achieved by a flat and isolated lid assembly consisting of two plates with small holes. By sliding one of the plates, the holes can automatically be opened or closed.
  • the optical label reader should be independent of the rest of the instrument ' s operation - i.e. not on the reagent robot head.
  • optical readers preferably should not be placed in the cold storage with the reagents, as relatively moist air sipping in from the outside during opening of the storage area could result in water condensation on the optical lenses and cause critical malfunction.
  • a heated optical lens system could reduce this problem but this would work against the efficiency of the cold storage area.
  • a preferable design is a set of optical readers at the drawers port and outside the cold area, (as illustrated in Fig. 5).
  • the readers are static while reading the passing bottle information while the drawer closes.
  • the same set of readers can be re-used for several drawers, and automatically be moved between the drawers ' ports.
  • the inventor has realized that reading the reagent bottle information while the drawer is closing is both an efficient and practical method. Especially, as the operator can immediately get feed back from the reader's software and database on whether the reagents are correctly loaded into the drawer.
  • the compartment consists of three individual drawers, each holding 2 (or 4) rows of up to 19 reagent bottles or containers
  • the storage compartment is cooled by peltier elements to 2-8°C
  • the storage compartment is thermally isolated from the rest of the stainer
  • the sip and spit reagent probe has access to the individual bottles through holes in the top lid which can be opened and closed
  • the isolated lid consists of two plates with holes. By sliding one of the plates a short distance, all holes can be closed or opened
  • the optical readers are placed outside the cold compartment, to avoid condensation of water on the lenses
  • the sip and spit pipette can extract reagents from the other drawers while one drawer is open
  • the reagents sit in a drawer insert with polar parking locations
  • the reagent bottles are polar in design Differently sized bottles will fit into the drawer insert using plastic inserts
  • Some bottles loaded can be prefilled with a dilution buffer and used for dilution series of e.g. antibodies or for automatic preparation of antibody solutions from concentrates If only a few reagents, e.g. a rare primary antibody, is to be loaded, the drawer is only partly opened to make room for the bottle change. This is in order to reduce the response time
  • a package, bundle or kit of several bottles can be loaded into the drawer as a single physical entity and with only one bar code. Thereby, the positions between the two rows can be filled with extra bottles.
  • Reagent bottle loading or offloading
  • the reagent change function is chosen in the software user interface
  • the drawer is selected by operator or software
  • the ID is read and the software performance an inventory check and update with the database
  • steps 4 to 11 are repeated for the next drawer Reagent sip and spit operation:
  • the sip and spit pipette is moved to a position over the selected reagent bottle
  • the dispensing is repeated in several drop channels
  • the pipette is moved to the washing station and cleaned inside and outside
  • the pipette robot arm is moved to a resting position
  • the sip and spit pipette is moved to a position over the selected reagent bottle
  • the pipette is lowered through a hole and into another bottle with e.g. chromogen buffer substrate (e.g. 5 ml)
  • An amount of reagent mixture (e.g. 1500 micro liter) is drawn (sipped) into the pipette, the pipette is moved slightly up or down and the reagent mixture is immediately spit out again into the bottle.
  • Step 10 is repeated several times to promote mixing of the components
  • RTU reagents, concentrates and mixed chromogens can be stored for prolonged periods. Even semi open bottles can be stored, without risk of evaporation Delicate chromogen mixtures can be made automatically and stored for prolonged time
  • the dispenser robotics is independent of the reagent loading/label reading and eliminates any scheduler problems and makes the instrument faster and more flexible
  • the reagents can be loaded at virtually any time and when most convenient for the operator
  • Figure 1 shows a simplified sketch of an embodiment of an automated staining apparatus with a functional skin, including touch screen (15.1), drawer for slide rack (15.2), three drawers for specific reagent containers (15.3), doors for access to bulk reagents (15.4) and waste containers (15.5) and a pull out table (15.6).
  • Figure 2 is a simplified sketch of an embodiment of an automated staining apparatus with a functional skin seen from the front and side, including a 170 cm tall reference person, including touch screen (16.1), pulled out drawer for slide rack (16.2) and specific reagents.
  • Figure 3 is a sketch of an embodiment of an automated staining apparatus with a functional skin. To the left with open door to the bulk reagents (17.1) and to the right with the top lid open for access to the robotics during repair and service (17.2).
  • an embodiment of an automated staining apparatus comprises several treatment modules and robots, including a drawer (6.1) for loading and off loading racks, an overhead gantry robot (6.2) that can grab, lift, transport, lower and release slide racks into the various positions in the apparatus, a storage room (6.3) for multiple slide racks, a warm air baking and drying module (6.4) harboring more than one slide rack, a dewaxing and rehydration module (6.5), a target retrieval module (6.6) with an array of target retrieval dip tanks, a staining module (6.7) with mixing grid, an overhead x-y-z reagent delivery robot (6.8) with a multidispensing reagent probe and air knife, a reagent bay or module (6.9) harboring multiple specific reagent containers under temperature control and accessible for loading and changing through separate drawers (6.10) .
  • the lower part of the staining apparatus comprises a number of bulk reagent containers (6.11) for wash and target retrieval buffer concentrates, dewaxing, rehydration and dehydration solutions, in addition to waste containers for organic (6.12) and toxic aqueous waste (6.13) and an internal water purification module (6.14) capable of purifying tap water for use in the apparatus.
  • the apparatus has a connection to the general sewage system for the non-toxic aqueous waste.
  • the apparatus has a supporting and stable frame (6.15) mounted with wheels (6.16).
  • the apparatus can store and process several slide racks at the same time.
  • the gantry robot moves the racks between the treatment, storage and loading modules.
  • Figure 5 shows a detail of a reagent bay including a drawer for holding reagent bottles.
  • the reagent bay holds the multiple reagent bottles under cooled (2-8°C) and controlled conditions.
  • one of the three drawers is automatically opened and the operator can load, change or remove the reagent bottles.
  • the individual reagent bottles of different sizes are securely placed in a reagent drawer tray insert (101).
  • the machine readable labels (102) on the reagent bottles pass a pair of optical readers on each side of the drawer (103) which register the bottle labels.
  • the stainer uses only two optical readers in the reagent bay, which can be moved from drawer to drawer on a rail.
  • FIG. 6 shows the reagent drawer of Fig. 5 in more detail.
  • the optical label readers are moved in position to read the labels from each side (103) .
  • the insert can be removed and the drawer emptied in one operation (101).
  • the independent drawer design allows for both flexible and nearly continuous reagent loading, while the stainer is operating. While one drawer is open, the reagent probe or pipette can still sip and spit reagents from bottles in the other drawers (106), here made visible with the lid removed.
  • Figure 7 shows the reagent drawer of Figs. 5 and 6 and a reagent tray insert 107.
  • the drawer tray insert holds the differently sized reagent bottles and containers and is polar, which prevents wrong placement and positioning of the reagent bottles.
  • the drawer insert (107) also facilitates removal of the entire content of a drawer in one simple operation.
  • Fig. 8 shows various reagent bottles and inserts for the apparatus and system according to the present invention.
  • the drawer is designed to hold many differently sized bottles in flexible configurations by means of inserts and bottles which fit together.
  • 50, 15, 5 and 2 ml bottles have the same height and opening mouth and placement of machine readable label.
  • the polar inserts allow the 15, 5 or 2 ml bottles to safely fit in the larger 50 ml bottle space in the reagent drawer for maximum loading and positioning flexibility.
  • the smaller bottles can be inserted as single or double configuration in each insert.
  • Bottles containing 50, 15, 5 and 2 ml (14.1, 14.2, 14.3, 14.4) and the corresponding insert (14.5) for the 15 and 5 ml bottles (14.2, 14.3) may occupy the space of a 50 ml bottle and the insert (14.6) for one or two 2 ml bottles (14.4).

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

La présente invention concerne un appareil automatique de coloration d'échantillons biologiques disposés sur des lames. Ledit appareil comprend une partie de type compartiment à réactifs pouvant accueillir une pluralité de flacons de réactifs, un lecteur optique capable de lire les étiquettes des flacons et un système automatique de distribution de réactif. La partie de type compartiment à réactifs comprend au moins deux tiroirs, dont chacun est accueilli de façon coulissante dans une partie dédiée de l'appareil de coloration, chacun des tiroirs pouvant coulisser isolément selon un mouvement de translation rectiligne entre l'état ouvert et l'état fermé. Un système de refroidissement est présent pour maintenir la partie intérieure de chacun des tiroirs à une température inférieure à 12 °C et, par exemple, à une température comprise entre 2 et 8 °C. Les flacons sont conservés selon un agencement de type matriciel au sein des tiroirs et chacun des tiroirs est conçu de façon à pouvoir accueillir des flacons d'au moins deux tailles ou formes différentes.
PCT/EP2013/063688 2012-06-29 2013-06-28 Appareil automatique de coloration comprenant des tiroirs réfrigérés pour flacons de réactifs WO2014001530A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261666221P 2012-06-29 2012-06-29
EP12174404.9 2012-06-29
US61/666,221 2012-06-29
EP12174404 2012-06-29

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WO2014001530A1 true WO2014001530A1 (fr) 2014-01-03

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Cited By (7)

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Publication number Priority date Publication date Assignee Title
WO2016064760A1 (fr) * 2014-10-19 2016-04-28 Peddinti Kamal Prasad Dispositif de coloration par lot automatisé pour l'immunohistochimie
CN105675369A (zh) * 2016-03-21 2016-06-15 广州深达生物制品技术有限公司 一种处理生物载片样品的装置和方法
WO2018182757A1 (fr) * 2017-03-31 2018-10-04 X-Zell Inc. Systèmes de coloration et de refroidissement automatiques de lames
WO2019048112A1 (fr) * 2017-09-11 2019-03-14 Thermo Shandon Limited Appareil de traitement de tissu pour le traitement de tissu biologique
CN113654867A (zh) * 2021-09-29 2021-11-16 广州万孚生物技术股份有限公司 自动染色系统及其控制方法
US11181450B2 (en) * 2015-12-03 2021-11-23 Ventana Medical Systems, Inc. Fluid coverage sensing system and method
CN114127532A (zh) * 2019-07-17 2022-03-01 系统科技公司 化学品取样设备

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US20030099573A1 (en) * 2001-11-26 2003-05-29 Lab Vision Corporation Automated tissue staining system and reagent container
US20050029914A1 (en) * 2003-08-05 2005-02-10 Zhenming Wang Highly flexible and accessible freezer drawer rack
US20060148063A1 (en) * 2003-05-14 2006-07-06 Fauzzi John A Method and apparatus for automated pre-treatment and processing of biological samples
US20100288056A1 (en) * 2009-05-15 2010-11-18 Gen-Probe Incorporated Contamination Control for Liquid Handling

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US20030099573A1 (en) * 2001-11-26 2003-05-29 Lab Vision Corporation Automated tissue staining system and reagent container
US20060148063A1 (en) * 2003-05-14 2006-07-06 Fauzzi John A Method and apparatus for automated pre-treatment and processing of biological samples
US20050029914A1 (en) * 2003-08-05 2005-02-10 Zhenming Wang Highly flexible and accessible freezer drawer rack
US20100288056A1 (en) * 2009-05-15 2010-11-18 Gen-Probe Incorporated Contamination Control for Liquid Handling

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016064760A1 (fr) * 2014-10-19 2016-04-28 Peddinti Kamal Prasad Dispositif de coloration par lot automatisé pour l'immunohistochimie
US10816443B2 (en) 2014-10-19 2020-10-27 Kamal Prasad Peddinti Automated batch stainer for immunohistochemistry
US11181450B2 (en) * 2015-12-03 2021-11-23 Ventana Medical Systems, Inc. Fluid coverage sensing system and method
CN105675369A (zh) * 2016-03-21 2016-06-15 广州深达生物制品技术有限公司 一种处理生物载片样品的装置和方法
CN105675369B (zh) * 2016-03-21 2019-02-01 厦门通灵生物医药科技有限公司 一种处理生物载片样品的装置和方法
WO2018182757A1 (fr) * 2017-03-31 2018-10-04 X-Zell Inc. Systèmes de coloration et de refroidissement automatiques de lames
CN110462370A (zh) * 2017-03-31 2019-11-15 X-Zell公司 自动载玻片染色和冷却系统
WO2019048112A1 (fr) * 2017-09-11 2019-03-14 Thermo Shandon Limited Appareil de traitement de tissu pour le traitement de tissu biologique
US11293844B2 (en) 2017-09-11 2022-04-05 Shandon Diagnostics Limited Tissue processing apparatus for processing biological tissue
CN114127532A (zh) * 2019-07-17 2022-03-01 系统科技公司 化学品取样设备
CN113654867A (zh) * 2021-09-29 2021-11-16 广州万孚生物技术股份有限公司 自动染色系统及其控制方法

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