Description:FIELD OF INVENTION
[0001] The present invention relates to an “automated device and method for processing the microscope slides carrying specimens with reagent fluids” and more particularly a controllable, flexible, efficient, accurate, precise, and reliable device and method to control the 5 staining process to get consistent results irrespective of internal and external operational conditions of the device.
BACKGROUND
[0002] “Staining” is a technique used in histology, cytology, histopathology, hematology, and cytopathology to identify the 10 presence, quality, quantity, structure of certain cells, cell organelles, and tissues in a specimen sample. It is a significant process used for diagnosis of diseases at microscopic level. The staining process involves the application of specific types of dyes, reagents, liquids, fluids, etc. sequentially in a specific manner which are also referred to 15 as “stains”, on a specimen mounted on a microscope slide.
[0003] The traditional method of manual staining is labor intensive and involves manual error, inconsistent results and consumes time. It may require skilled manpower and has less throughput which is a setback for laboratories where hundreds of specimen samples need to be processed 20 in a short span of time.
[0004] Another typical way of staining involves dipping a bunch of specimen carrying microscope slides in the container of staining reagent. The method involves dilution and contamination of reagent
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fluids as the transfer of slides dipped in one reagent and are dipped in 25 another reagent without complete removal of traces of first reagent from the slide surfaces. It may also lead to cross contamination of specimens and the specimens may get displaced and transferred from one slide to another. The specimens when submerged in liquid reagent may get dispersed in the reagent itself and later get transferred on to another 30 batch of specimen carrying microscope slides. These may inadvertently lead to misdiagnosis and improper analysis of the specimen.
[0005] Alternatively, using fresh reagent fluids for every new cycle of operation unnecessarily increases the costs of operation by using large volume of liquids. Furthermore, the reagent containers used in these 35 systems are open and exposed to atmosphere and external contamination and thus affects their performance, consistency, accuracy, and reliability which is of utmost importance in any scientific process.
[0006] Automated apparatuses for staining, process the slides only in a 40 particular way and have no manual control over the operations to enable staining various varieties of specimens to be analyzed and different reagents to be used.
[0007] Also, some automated apparatuses involve movement of either the specimen carrying microscope slides or the reagent delivery systems 45 that can lead to collisions and damage to the system and the specimens. [0008] It can also cause displacement of the specimen during the process. These systems are bulky and complex and very difficult to
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clean. This leads to increased time and costs of repair and maintenance, which invariably affects the work of the user. 50
[0009] In some apparatuses, the microscope slides carrying specimens are placed in vertical position, due to which there is not enough contact between the stain and the specimen to be analyzed. On the other hand, the horizontal placement does not allow for excess reagents to drain away. Moreover, improper method of placement of the microscope 55 slides during the process leads to unnecessary contact between the staining reagent and other faces of the microscope slides, which affects the visibility of the specimen on the microscope slide, when studying under a microscope.
[0010] Therefore, a simple, user-friendly, research-friendly, easy-to-60 use automated device for processing the microscope slides carrying specimens with reagent fluids that can eliminate all the mentioned problems and enable accurate, precise, reliable, controllable, flexible and consistent processing of the microscope slides carrying specimens with reagent fluids under all conditions. 65
OBJECTIVE OF INVENTION
[0011] The invention presented here is successfully designed so as to solve the existing problems and provide the optimum solution to simultaneous staining of a plurality of individual microscope slides.
[0012] The principal object of the invention is to provide a flexible, 70 controllable, accurate, precise, reliable, and consistent apparatus for simultaneous staining of a plurality of individual microscope slides
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regardless of the number of microscope slides, variety of specimens mounted on the microscope slides and the variety of staining reagents required for the process. 75
[0013] It is the purpose of this invention to provide an automated device that can execute the process of staining consistently at a high throughput irrespective of the number of slides carrying specimens and the number of reagents required.
[0014] It is the purpose of this invention to provide an automated device 80 that can execute the process of staining by keeping the microscope slides carrying specimen and the reagent delivery apparatus stationary during the process.
[0015] It is the purpose of this invention to provide an automated device that can execute the process of staining that uses precise and optimum 85 volumes of staining reagents to avoid wastage and lower the operating costs.
[0016] It is the purpose of this invention to provide an automated device that can execute the process of staining such that there is no cross contamination between the plurality of microscope slides carrying 90 specimen.
[0017] It is the purpose of this invention to provide an automated device that can execute the process of staining such that there is no dilution and/or contamination of staining reagent fluids.
[0018] It is the purpose of this invention to provide microscope slide 95 holding trays of various shapes and sizes to hold the microscope slides
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carrying specimen in a particular stationary position and orientation to avoid the displacement of specimen, the damage of microscope slides, the damage to system components, and the cross-contamination of microscope slides. 100
[0019] It is the purpose of this invention to provide an automated device that can execute the process of staining such that the system is free of external contamination and factors that can impede the clean, accurate and consistent process of staining.
[0020] It is the purpose of this invention to provide an automated device 105 that can execute the process of staining such that the user can control the various operational parameters including without limitation, the number of microscope slides carrying specimens, number of reagent fluids and their delivery sequence and quantity, the temperature of the reagent fluid in the system, etc. 110
[0021] It is the purpose of this invention to provide an automated device that can execute the process of staining such that the features of user-control over the process parameters, plurality of reagent fluids that can be employed and plurality of specimen carrying microscope slides that can be processed separately and simultaneously also enables the use of 115 this invention in a variety of experimentations and researches where the objective is to study the effects of the reagent fluids having certain chemical and physical properties on a certain type of specimens and further development of specific kinds of reagent fluids of specific chemical and physical properties, and new procedures for better and 120 faster results of processing various types of specimens.
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SUMMARY OF INVENTION
[0022] At least in some embodiments of the present invention, an apparatus for controlled processing of plurality of microscope slides with plurality of reagent fluids is provided, comprising an enclosure 125 (101) that houses the components of the apparatus and a portal (102), attached to the enclosure (101), providing access to the a staining area (201) which provides a specific space within the enclosure (101) for processing the plurality of microscope slides with the plurality of reagent fluids. The enclosure (101) is insulated from the outer 130 surroundings to eliminate the heat transfer between the device and the surroundings such that it provides a controlled environment for the device (100) to work at an optimum efficiency without external influence. The enclosure (101) keeps the system free of external contamination and factors that can impede the clean, accurate and 135 consistent process of staining.
[0023] Also, in an embodiment of the present invention, the enclosure (101) has a drain outlet (105) that transfers the used reagent fluids into a drain reservoir, vents with filters (106) for the flow of clean filtered air to keep the components of the device well-ventilated and a controller 140 (107) attached to the enclosure (104), enabling the user to exercise control over various parameters of the process and act as a communication interface between the user and the device.
[0024] In some embodiments of the present invention, the staining area (201) within the enclosure (101), has plurality of patterns of 145 arrangements to accommodate slide tray platforms (203), the slide trays
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(202) holding microscope slides carrying specimens, the support structures (204) and the collection trays (205) simultaneously in a specific configuration to enable the device (100) to perform at optimum level. 150
[0025] Also, in some embodiments of the present invention, the apparatus is provided with plurality of slide trays (202) having plurality of patterns of arrangements to hold the plurality of microscope slides separately and simultaneously in flat horizontal depressions or in inclined horizontal depression such that they are inclined throughout 155 the operating process, depending on the configuration of the slide tray (202) used. and a slide tray platform (203) having plurality of patterns of arrangements enabling to hold plurality of slide trays (202) separately and simultaneously.
[0026] In yet another embodiment of the present invention, the slide 160 trays (202) is provided with an opening on one side for placement and removal microscope slides into the slide tray (202) and a narrow opening on the lower side for discharge of fluids flowing over the specimen carrying surface of the microscope slides. The slide tray (202) is also provided with a gripping space that enables handling and access 165 to the slide tray (202) without contacting any surface of the microscope slide carrying the specimen and is detachable.
[0027] In an embodiment of the present invention, the slide tray platform (203) has spaced openings for outflow of used reagent fluids discharged from the slide trays (202) and is provided with a gripping 170 space that enables handling and access to the slide tray platform (203)
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without contacting any surface of the microscope slide carrying the specimen and is detachable. The slide tray platform (203) may also include an arrangement for collection and transfer of used reagent fluids to the drain outlet (105). 175
[0028] In an embodiment of the present invention, a collection tray (205) is placed below the slide tray platform (203) to collect all the used reagent fluids flowing over the surface of the microscope slides carrying specimens and through the discharge openings in the slide trays (202) and the slide tray platform (203). The collection tray (205) includes 180 walls to prevent the flow of used reagent fluids outside the collection tray (205) and guide the flow towards the drain outlet (105).
[0029] In some embodiments of the present invention, the apparatus is provided with the support structures (204) that enable the placement of plurality of slide tray platforms (203) from horizontal position to any 185 inclined angle, within the staining area (201), as per process and user requirements and also, depending on the configuration of the slide tray (202) used such that they are stationary throughout the operating process. the support structures (204) that enable the placement of the collection tray (205) at a specific angle and location within the staining 190 area (201) in a stationary position.
[0030] In yet another embodiment of the present invention, a reagent container (103), containing various types of plurality of reagent fluids required for the plurality of operating process cycle, are detachable, refillable, and even replaceable by the user whenever required, 195 therefore providing efficiency and flexibility of operation. The reagent
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containers (103) have a filter to prevent any contaminants or solid particles from entering the reagent fluids delivery system (400). The reagent containers (103) are connected to the intelligent sensors and indicators that retrieve the information regarding the volumes of the 200 reagent fluids present in the reagent containers, the types, and chemical and physical properties of the reagent fluids in the reagent containers communicate this information to the controller (107) for consequent action to be taken by the user. Also, a tube (104) is attached to the reagent containers (103) to enable the transfer of reagent fluids within 205 the reagent fluids delivery system (400).
[0031] In an embodiment of the present invention, the apparatus is provided with a motor pump (401) to transport the reagent fluids from the reagent containers (103) to the input of the subsequent manifold (402) within the reagent fluids delivery system (400). A manifold (402) 210 is provided, to transfer the reagent fluids received from the reagent containers (103), through a combination of plurality of detachable manifolds (402) within the reagent fluids delivery system (400) such that there is no flow of reagent fluids in the backward or reverse direction. The ultimate reagent fluid delivery manifold (403) is 215 provided, to dispense the reagent fluid on the specimen carrying surface of the microscope slides separately and simultaneously at the precise point on the surface of each microscope slide, while always keeping the microscope slides as well as all the components of the reagent fluids delivery system stationary and fixed. The manifolds (402) of the device 220 (100) are detachable, and the number of manifolds and their
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corresponding number of inputs and outputs may vary depending upon the requirement of process cycle.
[0032] In an embodiment of the present invention, the apparatus is provided with the controller (107) that is connected with various types 225 of plurality of sensors for detecting necessary parameters including, without limitation, temperature, pressure, fluid flow rate in the reagent fluid delivery system (400) at every manifold stage, operation run time, volumes of reagent fluids in the reagent containers (103), types, and chemical and physical properties of reagent fluids in the reagent 230 containers (103), drainage flow rate, manifold type detection, motor- pumps (400), fluid dispensing rate, the number of microscope slides placed in the staining area (201) and slide trays (202) placed in the system, the position of the slide trays (202) on the slide tray platform (203), etc. 235
[0033] In an embodiment of the present invention, the controller (107) stores the various plurality of preset configuration of parameters for the user to choose from and additionally, enables the user to set the parameters, according to their preference, to allow for optimum results under varying conditions of types reagent fluids, number of reagent 240 fluids, qualitative and quantitative variations of reagent fluids, variety of specimens on the microscope slides, number of microscope slides, number of slide trays and their position within the device, and technical procedure for a particular process that a user wants to execute with the device. 245
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[0034] In an embodiment of the present invention, the controller (107) does a run-check, where the controller () turns “ON” all the electronic components of the system for some time to check their smooth functioning as per parameters set by the user for a particular process cycle. 250
[0035] In an embodiment of the present invention, the controller (107) enables the device to pause and resume its operation in case of any inadvertent interruption such as opening of the portal by the user, power cut-off, etc. and provides an auto-switch mechanism wherein the device switches its operation from direct power to power backup sources such 255 as batteries, etc. making the device portable.
[0036] In an embodiment of the present invention, the duration of time required to process the plurality of specimen carrying microscope slides remains constant irrespective of the number of microscope slides, enabling high throughput in all conditions. 260
[0037] In an embodiment of the method of the present invention, plurality of microscope slides carrying plurality of specimens can be processed with plurality of reagent fluids separately and simultaneously with user-controlled parameters of the process cycle.
[0038] In an embodiment of the method of the present invention, the 265 parameters that can be user controlled include, without limitation, the type of reagent fluids, number of reagent fluids, the sequence for dispensing the reagent fluids, the flow rate of the reagent fluids in the reagent fluids delivery system, the duration of time for the dispensing the reagent fluids, the wait-time between dispensing of two successive 270
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reagent fluids, the number of microscope slides to be processed, the number of reagent containers to be selected for a particular cycle, the time of operation of the specific set of motor-pumps, the amount of reagent fluids to be dispensed on the specimen carrying microscope slides, selection of the particular configuration of slide tray and position 275 of the specimen carrying microscope slide within the staining area, the manifold type and sequence of manifolds for a particular process, the configuration of a combination of plurality of manifolds, the drain flow rate, etc.
[0039] In yet another embodiment of the method of the present 280 invention, the automatic device cleaning cycle keeps the reagent fluid delivery system (400) clear of any residue of reagent fluids use in the previous processes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is an isometric view of the automated device for 285 controlled processing of plurality of microscope slides with plurality of reagent fluids in accordance with an embodiment of the present invention.
[0041] FIG. 2 is a perspective view of the automated device for controlled processing of plurality of microscope slides with plurality of 290 reagent fluids showing staining area in accordance with an embodiment of the present invention.
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[0042] FIG. 3A is a perspective view of the slide tray with flat horizontal depression for microscope slide placement in accordance with an embodiment of the present invention. 295
[0043] FIG. 3B is an isometric view of the slide tray with inclined horizontal depression for microscope slide placement in accordance with an embodiment of the present invention.
[0044] FIG. 4 is a schematic diagram of the reagent fluids delivery system in accordance with an embodiment of the present invention. 300
[0045] FIG. 5 is a perspective view of the ultimate reagent fluids delivery manifold and a slide tray in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0046] This invention is illustrated in the accompanying drawings, 305 throughout which, like reference numerals indicate the corresponding parts in various figures.
[0047] FIG. 1 is an isometric view of the automated device for controlled processing of plurality of microscope slides with plurality of reagent fluids in accordance with an embodiment of the present 310 invention. In this embodiment, the device (100) includes an enclosure (101) which houses the various components of the device (100) to provide a specified space for executing the process, without external influence. The enclosure (101), in certain embodiments, includes an insulation to eliminate the heat transfer between the enclosure (101) and 315 the external surroundings, in order to maintain the controlled internal
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environment of the device (100) for optimized efficiency. The enclosure (101) includes a portal (102) for access to the slide tray platform (203). The enclosure (101) includes vents with filter (106) for the flow of clean air to keep the components of the device (100) well-ventilated. The 320 device (100) can include a controller (107) attached to the enclosure (101) for easy access to the user.
[0048] The reagent containers (103) containing various types of plurality of reagent fluids required for a plurality of operating process cycle are placed outside the staining area (201) such that they are 325 detachable, refillable, and even replaceable by the user whenever required. Further the intelligent sensors and indicators have been connected to the reagent containers (103) to retrieve the information regarding the volumes of the reagent fluids present in the reagent containers, the types, and properties of the reagent fluids in the reagent 330 containers (103) and communicate this information to the controller (107) for consequent action to be taken by the user. For instance, if the sensor detects that the type of reagent fluid required for a selected process cycle is not present or not in enough quantity to complete the process cycle, it will send this information to the controller (107), which 335 will then indicate, through its display screen or any other form of user-interface, to the user the action to be taken such as refilling the reagent fluids or attaching the reagent container (103) containing the reagent fluid necessary, as per the requirement of the selected process cycle. This feature enables the system and the user to execute plurality of 340 process cycles using plurality of reagent fluids which increases the
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efficiency, flexibility, controllability, and throughput of the device as well as saves time and resources.
[0049] The reagent containers (103) contain pure, clean, contaminant free reagent fluid which is protected from any external contamination 345 by keeping the containers closed and also within the controlled environment of the device (100). If any reagent fluid used for experimentation purposes has solid particles, they may further impede the reagent fluid flow rate within the reagent fluids delivery system (400) at different stages and may not give reliable results. Therefore, to 350 enable the device (100) to give reliable, accurate, consistent results under all types of reagent fluids used, the reagent containers (103) may also have a filter to prevent any contaminants or solid particles from entering the reagent fluids delivery system (400). As a result of which there is no event of blockage of the reagent fluids delivery system (400) 355 at any point of flow.
[0050] The tubes (104) attached to the reagent containers (103) help in transfer of reagent fluids from the reagent containers (103) to the subsequent destination within the reagent fluids delivery system (400).
[0051] The device (100) has a drainage system that transfers all the used 360 reagent fluids to the drain outlet (105) which may then further transfer this drained fluid to a drain reservoir or be connected to the laboratory waste system.
[0052] The controller (107) provides the user interface and can include any number of microprocessors or microcontrollers, printed circuit 365 boards, user interfaces in any form, various types of plurality of sensors
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for detecting necessary parameters including, without limitation, temperature, pressure, fluid flow rate in the reagent fluid delivery system at every manifold stage, operation run-time, volumes of reagent fluids in the reagent containers, types, and chemical and physical 370 properties of reagent fluids in the reagent containers, drainage flow rate, manifold type detection, motor- pumps, fluid dispensing rate, the number of microscope slides placed in the staining area (201) and slide trays (202) placed in the system, the position of the slide trays (202) on the slide tray platform (203), etc. The controller (107) can include, 375 without limitation, certain forms of volatile and non-volatile memory which stores the various plurality of preset configuration of parameters for the user to choose from and additionally, enables the user to set the parameters, according to their preference, to allow for optimum results under varying conditions of types of reagent fluids, number of reagent 380 fluids, qualitative and quantitative variations of reagent fluids, specimens on the microscope slides, number of microscope slides, number of slide trays and their position within the device, and technical procedure for a particular process that a user wants to execute with the device. 385
[0053] The controller (107) is connected to various components of the device (100) to provide the user control over the components. The parameters that can be user defined can include, without limitation, the number of reagent containers (103) to be selected for a particular cycle, the flow rate of the reagent fluid, the time of operation of the specific 390 set of motor-pumps (401), the amount of reagent fluids to be dispensed on the microscope slides carrying specimens, the sequence of
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dispensing the reagent fluids, selection of the particular slide tray and position of the microscope slide within the staining area, the manifold type and sequence of manifolds for a particular process, the drain flow 395 rate, etc.
[0054] The controller (107) can include a power source allowing the device (100) to be portable. The controller (107) enables the system to pause and resume its operation in case of any inadvertent interruption such as opening of the portal by the user, power cut-off, etc. the 400 controller also provides an auto-switch mechanism wherein the system switches its operation from direct power to power backup sources such as batteries, etc.
[0055] FIG. 2 is a perspective view of the automated device for controlled processing of plurality of microscope slides with plurality of 405 reagent fluids showing staining area in accordance with an embodiment of the present invention. The staining area (201) may have a plurality of patterns of arrangements to accommodate the slide tray platform (203), the slide tray (202) holding microscope slides carrying specimens, the support structures (204) and the collection tray (205) in 410 a specific configuration to enable the system to perform at optimum level.
[0056] The slide tray (202) may be of any shape, size, configuration, material composition and may accommodate any number of microscope slides for example 1 slide, 5 slides, 10 slides, etc. in a 415 particular arrangement including without limitation, central, linear, radial, square grid, rectangular grid, grid, etc. The slide tray (202) is
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provided with a gripping space that enables handling and access to slide tray (202) without contacting any surface of the microscope slide carrying the specimen, which eliminates any abrasion, contamination, 420 or specimen movement.
[0057] The slide tray platform (203) which is detachable is provided to accommodate plurality of slide trays (202) which are also detachable. The slide tray platforms (203) can include gripping space for accessing the slide tray platform (203) without contacting any surface of the 425 microscope slide carrying the specimen, which eliminates any abrasion, contamination, or specimen movement. In some embodiments, the slide tray platform (203) can include multiple rows and/or columns to accommodate plurality of slide trays (202) carrying plurality of the microscope slides carrying the specimen. The slide tray platform (203) 430 may be of any shape, size, configuration, material composition and may accommodate any number of slide trays (202) for example 1 slide tray, 5 slide trays, 10 slide trays, etc. in a particular arrangement including without limitation, central, linear, radial, square grid, rectangular grid, grid, etc. 435
[0058] The slide tray platform (203) is secured within the staining area (201) with the help of various support structures (204) that may include without limitation, supporting brackets, grooves, inserts, etc. in stationary position. Further the support structures (204) enable the placement of slide tray platform (203) from horizontal position to any 440 angle as per process and user requirements. The slide tray platform (203) also has spaced openings for outflow of used reagent fluids discharged from the slide trays (202). The slide tray platform (203) may
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also include an arrangement for collection and transfer of used reagent fluids to the drain outlet (105). 445
[0059] The collection tray (205) is placed below the slide tray platform (203) to collect all the used reagent fluids, flowing over the microscope slides carrying specimens and through the discharge openings in the slide trays (202) and the slide tray platform (203). The collection tray (205) may be of any shape, size, configuration depending upon the 450 pattern of arrangement of slide tray platforms (203) and slide trays (202) and their configurations. The collection tray (205) is provided with walls to prevent the flow of used reagent fluids outside the collection tray (205) and guide the flow towards the drain outlet (105). The support structures (204) are provided to secure the collection tray 455 (205) at a specific angle and location within the staining area (201).
[0060] Furthermore, the staining area (201) has plurality of patterns of arrangements to accommodate any number of slide tray platforms (203), the slide trays (202) holding microscope slides carrying specimens, the support structures (204) and the collection trays (205) in 460 a specific configuration to enable the system to perform at optimum level as per the particular operating process and user requirements.
[0061] FIG. 3A is a perspective view of the slide tray (202) with flat horizontal depression for microscope slide placement in accordance with an embodiment of the present invention. 465
[0062] FIG. 3B is an isometric view of the slide tray (202) with inclined horizontal depression for microscope slide placement in accordance with an embodiment of the present invention. The inclined depressions
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for the slide placement enable the user to place the slides in an inclined position if needed, even before they are placed in the system. 470
[0063] The slide tray (202) as shown in FIG. 3A may be placed on the slide tray platform (203) for inclined placement of slides as shown in FIG. 2. The support structures (204) also allow for horizontal placement of the slide tray platform (204) and thus the slides.
[0064] The slide tray (202) is provided with an opening on one side for 475 placement and removal microscope slides into the slide tray (202). The slide tray (202) also includes a narrow opening on the lower side for discharge of fluids flowing over the specimen carrying surface of the microscope slides. The microscope slides are to be placed in the depressions provided in the slide tray (202) with the specimen carrying 480 side facing upwards, so as to receive the fluids on this face, for further processing.
[0065] The inclined placement of microscope slides in the staining area (201) by employing various configurations of slide tray (202) and slide tray platforms (203), allow for uniform distribution of fluid over the 485 specimen carrying surface of the microscope slides and ensures that after the reagent fluid stays in contact with the specimen on the surface [0066] of the microscope slide for the required duration of time. It also allows for the used reagent fluid to be completely discharged from the narrow openings on the lower side of the slide tray (202). As a result of 490 which complete removal of traces of the previous reagent fluid from the specimen carrying surface of the microscope slides is achieved. This is extremely essential for proper processing of the microscope slides with
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plurality of reagent fluids as per scientific technical procedures to get accurate results. 495
[0067] Also, the microscope slides are held in a fixed place and therefore, are stationary throughout the process. This arrangement for separate and stationary placement of microscope slides within the device, eliminates the risk of cross-contamination of microscope slides and the specimens, the unnecessary contact of reagent fluids with other 500 faces of the microscope slides, etc. All the parts of the device (100) remain stationary during the process and the device does not employ any bulky complex components and/or systems for movement of parts within the staining area (201), which saves the costs and time required for repair and maintenance. 505
[0068] The support structures (204) for the slide tray platforms (203), enable the horizontal as well as inclined placement of the microscope slides depending on the configuration of the slide tray (202) used as shown in the figure. The user may want to place the slide tray platform (203) inclined when using the slide tray as shown in FIG. 3A and may 510 want to place the slide tray platform horizontal when using the slide tray as shown in FIG. 3B.
[0069] The slide tray (202) being detachable and removable enable the microscope slides to be placed into and removed from the slide trays with ease, care, and flexibility. Also, when a process is over for one 515 batch of slides the user can just change the slide trays and continue processing other batch of slides with other slide trays (202). Thus, saving time and increasing speed of operation.
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[0070] FIG. 4 is a schematic diagram of the reagent fluids delivery system (400) in accordance with an embodiment of the present 520 invention. The reagent fluids delivery system consists of reagent containers (103), tubes (104), various types of plurality of motor-pumps (401), and plurality of manifolds (402) of varying number of input and outputs used at various stages of the reagent fluids delivery system (400). The reagent containers (103) are connected to the variety of 525 plurality of motor-pumps (402) and valves that transport the fluids from the reagent containers to the input of the subsequent manifold through the tubes (104). The various types of motor-pumps that can be used include, without limitation, a centrifugal pump, vertical centrifugal pump, horizontal centrifugal pump, submersible pump, fire hydrant 530 type, diaphragm pump, gear pump, peristaltic pump, lobe pump, piston pump, etc. Further, the motor-pump may be of any size, shape, and configuration.
[0071] Each manifold (402, 403) then as per the number of their outputs and subsequent manifold position will transport the fluids to the next 535 manifold in the system. Therefore, the system may consist of a plurality of manifolds. The number of manifolds (402, 403) and their corresponding number of inputs and outputs may vary depending upon the requirement of the process cycle. The manifolds (402, 403) may have different shapes, sizes, configurations without deviating from the 540 scope of this invention. Moreover, each manifold (402, 403) is detachable and replaceable by the end user, thus adding to the functionality of the system. Every manifold (402, 403) is designed to prevent the backward or reverse flow of reagent fluids through it.
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[0072] For instance, if the user wants to execute a process that involves 545 three reagent fluids to be dispensed on the specimen carrying surface of the five microscope slides in a sequential manner. The user may select and attach the manifold with three inputs and five outputs directly to the system and communicate the information to the system through the controller for time, sequence, and amount of reagent fluids to be 550 dispensed in a process cycle. The controller (107) will then send instructions to the sensors, motor-pumps, etc. and execute the process as required by the user. Alternatively, the user may select the first manifold with three inputs and one output, and the second manifold with one input and five outputs and achieve the same results as when a 555 manifold with three inputs and five outputs is employed.
[0073] It is to be noted that the manifolds (402) receive the reagent fluids from the reagent containers (103) and then transfer the reagent fluids within the reagent fluids delivery system (400) through a combination of plurality of manifolds (402) having plurality of 560 combinations of inputs and outputs such that plurality of specimen carrying microscope slides are stained separately and simultaneously, thus, eliminating any cross-contamination of the microscope slides, carryover of specimen from one microscope slide to other due to dispersion in reagent fluid, dilution of reagent fluids, and also 565 contamination and cross-contamination of reagent fluids is eliminated due to a closed apparatus and design of components of the reagent fluids delivery system (400). The reagent fluids delivery system (400) being a stationary system also eliminates the drawbacks of bulky complex systems, that may lead to collisions of parts and increased costs of repair 570
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and maintenance. The simple, detachable, few number of components saves the time of the user and also reduces energy consumption for operating the device (100) significantly.
[0074] FIG. 5 is a perspective view of the ultimate reagent fluids delivery manifold (403) and a slide tray (202) in accordance with an 575 embodiment of the present invention. The manifold (402) that receives the reagent fluids from the reagent fluids delivery system (400) and dispenses it on the specimen carrying surface of the microscope slides is termed as the “ultimate reagent fluid delivery manifold (403)”. The reagent fluid after passing through a combination of manifolds reaches 580 the ultimate reagent fluid delivery manifold (403) and it dispenses the reagent fluid on the specimen carrying surface of the microscope slides separately and simultaneously at the precise point on the surface of each microscope slide, while always keeping the microscope slides as well as all the components of the reagent fluids delivery system (400) 585 stationary and fixed.
[0075] The ultimate reagent fluid delivery manifold (403) is designed to dispense small precise amounts of reagent fluids on the surface of each microscope slide, further the flow rate and flow time set by the user, will help in dispensing only required amounts of reagent fluids 590 and eliminating any wastage and over-use of reagent fluids.
[0076] The reduced wastage of reagent fluids decreases the costs and exploitation of resources as the requirement for the reagent fluids is reduced and the small volumes of reagent fluids can give high throughput with the application of the present invention. 595
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[0077] The device (100) is designed in such a way that the reagent fluids flow through the closed and clean reagent fluids delivery system (400) from the closed reagent containers (103), after being filtered, to various manifolds that are designed to prevent any back-flow or reverse flow of the reagent fluids and then comes in contact with the specimen carrying 600 surface of the microscope slides and further after it is used it gets transferred to the drain outlet (105). The clean contamination free reagent fluids when come in contact with the specimen, delivers excellent results of the processing as required by the scientific standard procedures. 605
[0078] When in operation in this embodiment, the user can place the microscope slides carrying specimen in the depressions provided in the slide trays (202), with the specimen carrying surface of the microscope slide facing upwards. Referring now to FIG. 2, subsequently, the slide trays (202) are placed on the slide tray platform (203), which can be 610 accessed after opening the portal (102) of the enclosure (101). The user may place the slide trays (202) having the microscope slides on the slide tray platform (203) outside the device and then place the slide tray platform (203) with the slide trays (202) in the staining area (201). The slide tray platform (203) can be placed at the required angle and position 615 with the help of support structures (204). The user after successfully placing the slide tray platform (203) can then close the portal (102), and select the required configuration of parameters for a process the user wants the device (100) to execute, such as the number of reagent fluids, the sequence for dispensing the reagent fluids, the duration of time for 620 the dispensing the reagent fluids, the wait-time between dispensing of
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two successive reagent fluids, the number of microscope slides to be processed, etc. through the user interface of the controller (107).
[0079] After the parameters are set by the user, the controller (107) will check if all the required conditions for successful execution of the 625 process cycle are fulfilled. The controller (107) may indicate to the user any necessary action to be taken, for instance, refilling the reagent fluids in reagent containers (103), attaching or detaching of any component of the reagent fluids delivery system (400), placement of any components in the staining area (201), etc. After all the necessary conditions for 630 successful execution of set process cycle are met the device (100) will successfully complete the process through the co-ordination of controller (107) with the sensors, motor-pumps, reagent fluid delivery system, eliminating any future interruption of the process cycle. The motor-pump (401) will start circulating the reagent fluids from the 635 reagent containers (103) at the set flow rate and for set time, through the reagent fluid delivery system (400) which will be configured for the set process cycle by the user.
[0080] The ultimate reagent fluid delivery manifold (403) when receives the reagent fluid will then dispense it on the specimen carrying 640 surface of the microscope slide at a precise point on the microscope slide. After the reagent fluid uniformly covers specimen carrying surface it will then drain through the narrow opening at the bottom of the depression in the slide tray (202). The used reagent fluid will then be discharged through spaced openings in the slide tray platform (203) 645 to the collection tray (205) placed below it at required angle and position with the help of support structures (204). The collection tray
28
(205) will guide the used reagent fluids towards the drain outlet (105) which then discharges the used reagents to the drain reservoir. This process of reagent fluid circulation repeats until all the selected reagent 650 fluids are dispensed in set sequence and time. At the end of the process the user is notified by the controller (107) of the completion of the process through an alarm and/or the display of the controller. Therefore, the device (100) can process plurality of specimen carrying microscope slides separately and simultaneously, in the same time duration as 655 required for a single slide under similar parameters of the process cycle.
[0081] In one embodiment of this invention, the user may first configure the device (100) and the parameters of the process cycle, let the controller (107) perform a run-check on all the components like the motor-pumps (401) and then place the slide tray platform (203) carrying 660 slide tray (202) with microscope slides carrying specimens within the staining area (201) after the instruction is received from the controller (107). During the run-check, the controller (107) turns “ON” all the electronic components of the system for some duration of time to check their smooth functioning as per parameters set by the user. 665
[0082] In one embodiment of this invention, the user may run the automatic device cleaning cycle after the required processes are completed to keep the reagent fluid delivery system (400) clear of any residue of reagent fluids used in the previous processes. During the cleaning cycle, the controller (107) may alert the user to remove the 670 slide tray platform, slide trays and microscope slides from the staining area. It is to be noted that the collection tray, the slide tray platform, the slide trays as well as the manifolds are detachable and hence can be
29
cleaned outside the device, which also saves time and reduces the repair and maintenance costs. 675
[0083] In some embodiment of this invention, the features of user-control over the process parameters, plurality of reagent fluids that can be employed and plurality of specimen carrying microscope slides that can be processed separately and simultaneously also enables the use of this invention in a variety of experimentations and researches where the 680 objective is to study the effects of the reagent fluids having certain chemical and physical properties on a certain type of specimens and further enables the development of specific kinds of reagent fluids of specific chemical and physical properties, and new scientific procedures for better and faster results of processing various types of 685 specimens.
[0084] It will be apparent to one with skill in the art that the automated device and method for processing the microscope slides carrying specimens with reagent fluids may be provided using some or all the features and components without departing from the spirit and scope of 690 the present invention. It will also be apparent to the skilled artisan that the embodiments described above are specific examples of a single broader invention which may have greater scope than any singular descriptions taught. There may be many alterations made in the descriptions without departing from the spirit and scope of the present 695 invention. , C , Claims:We claim:
1.
An apparatus for controlled processing of plurality of microscope 700 slides with plurality of reagent fluids, comprising:
an enclosure (101) that houses the components of the apparatus;
a portal (102), attached to the enclosure (101), providing access to the staining area (201);
at least a staining area (201) that provides a specific space within the 705 enclosure for processing the plurality of microscope slides with the plurality of reagent fluids;
at least a slide tray (202) having plurality of patterns of arrangements to hold the plurality of microscope slides separately and simultaneously; 710
at least a slide tray platform (203) having plurality of patterns of arrangements enabling to hold plurality of slide trays (202) separately and simultaneously;
at least a support structure (204) that enables to secure plurality of slide tray platform (203) within the staining area (201) in stationary 715 position;
at least a collection tray (205) placed below the slide tray platform (203) to collect all the used reagent fluids flowing over the surface of the microscope slides carrying specimens and through the discharge openings in the slide trays (202) and the slide tray platform 720 (203);
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at least a reagent container (103) containing various types of plurality of reagent fluids required for the plurality of operating process cycle;
at least a tube (104) attached to the reagent containers (103) to enable 725 the transfer of reagent fluids within the reagent fluids delivery system (400);
at least a motor pump (401) to transport the reagent fluids from the reagent containers (103) to the input of the subsequent manifold (402) within the reagent fluids delivery system (400); 730
at least a manifold (402) to transfer the reagent fluids received from the reagent containers (103), through a combination of plurality of detachable manifolds (402) within the reagent fluids delivery system (400) such that there is no flow of reagent fluids in the backward or reverse direction; 735
at least an ultimate reagent fluid delivery manifold (403) to dispense the reagent fluid on the specimen carrying surface of the microscope slides separately and simultaneously at the precise point on the surface of each microscope slide, while always keeping the microscope slides as well as all the components of the reagent 740 delivery system stationary and fixed;
at least a drain outlet (105) to transfer the used reagent fluids into a drain reservoir;
at least a vent with filter (106) for the flow of clean filtered air to keep the components of the device well-ventilated; 745
at least a controller (107) attached to the enclosure (104), enabling the user to exercise control over various parameters of the process
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and act as a communication interface between the user and the device (100).
2.
The apparatus of claim 1, wherein the enclosure (101) is insulated 750 from the outer surroundings to eliminate the heat transfer between the device (100) and the surroundings such that it provides a controlled environment for the device (100) to work at an optimum efficiency without external influence.
3.
The apparatus of claim 1, wherein the staining area (201) has 755 plurality of patterns of arrangements to accommodate slide tray platforms (203), the slide trays (202) holding microscope slides carrying specimens, the support structures (204) and the collection trays (205) simultaneously in a specific configuration to enable the device (100) to perform at optimum level. 760
4.
The apparatus of claim 1, wherein the slide tray (202) holds the plurality of microscope slides carrying specimens separately and simultaneously in flat horizontal depressions.
5.
The apparatus of claim 1, wherein the slide tray (202) holds the plurality of microscope slides carrying specimens separately and 765 simultaneously in inclined horizontal depression such that they are inclined throughout the operating process.
6.
The apparatus of claim 1, wherein the slide tray (202) is provided with an opening on one side for placement and removal microscope slides into the slide tray (202). 770
7.
The apparatus of claim 1, wherein the slide tray (202) includes a narrow opening on the lower side for discharge of fluids flowing over the specimen carrying surface of the microscope slides.
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8.
The apparatus of claim 1, wherein the slide tray (202) is provided with a gripping space that enables handling and access to the slide 775 tray (202) without contacting any surface of the microscope slide carrying the specimen and is detachable.
9.
The apparatus of claim 1, wherein the slide tray platform (203) is provided with a gripping space that enables handling and access to the slide tray platform (203) without contacting any surface of the 780 microscope slide carrying the specimen and is detachable.
10.
The apparatus of claim 1, wherein the slide tray platform (203) has spaced openings for outflow of used reagent fluids discharged from the slide trays (202).
11.
The apparatus of claim 1, wherein the slide tray platform (203) 785 includes an arrangement for collection and transfer of used reagent fluids to the drain outlet (105).
12.
The apparatus of claim 1, wherein the support structures (204) for the slide tray platforms, enable the placement of slide tray platform (203) from horizontal position to any inclined angle as per process 790 and user requirements and depending on the configuration of the slide tray (202) used such that they are stationary throughout the operating process.
13.
The apparatus of claim 1, wherein the collection tray (205) includes walls to prevent the flow of used reagent fluids outside the collection 795 tray (205) and guide the flow towards the drain outlet (105).
14.
The apparatus of claim 1, wherein the collection tray (205) is secured in place at a specific angle and location in the staining area (201) by the support structures (204).
34
15.
The apparatus of claim 1, wherein the reagent containers (103) are 800 detachable, refillable, and even replaceable by the user whenever required, therefore providing efficiency and flexibility of operation.
16.
The apparatus of claim 1, wherein the reagent containers (103) are connected to the intelligent sensors and indicators that retrieve the information regarding the volumes of the reagent fluids present in 805 the reagent containers, the types, and chemical and physical properties of the reagent fluids in the reagent containers communicate this information to the controller (107) for consequent action to be taken by the user.
17.
The apparatus of claim 1, wherein the reagent containers (103) have 810 a filter to prevent any contaminants or solid particles from entering the reagent fluids delivery system (400);
18.
The apparatus of claim 1, wherein the manifolds (402) are detachable, and the number of manifolds and their corresponding number of inputs and outputs may vary depending upon the 815 requirement of process cycle;
19.
The apparatus in claim 1, wherein the controller (107) is connected with various types of plurality of sensors for detecting necessary parameters including, without limitation, temperature, pressure, fluid flow rate in the reagent fluid delivery system (400) at every 820 manifold stage, operation run time, volumes of reagent fluids in the reagent containers (103), types, and chemical and physical properties of reagent fluids in the reagent containers (103), drainage flow rate, manifold type detection, motor- pumps (400), fluid dispensing rate, the number of microscope slides placed in the 825
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staining area (201) and slide trays (202) placed in the system, the
position of the slide trays (202) on the slide tray platform (203), etc.
20.
The apparatus in claim 1, wherein the controller (107) stores the various plurality of preset configuration of parameters for the user to choose from and additionally, enables the user to set the 830 parameters, according to their preference, to allow for optimum results under varying conditions of types reagent fluids, number of reagent fluids, qualitative and quantitative variations of reagent fluids, variety of specimens on the microscope slides, number of microscope slides, number of slide trays and their position within 835 the device, and technical procedure for a particular process that a user wants to execute with the device.
21.
The apparatus in claim 1, wherein the controller (107) does a run-check, where the controller (107) turns “ON” all the electronic components of the system for some duration of time to check their 840 smooth functioning as per parameters set by the user for a particular process cycle.
22.
The apparatus in claim 1, wherein the controller (107) enables the device to pause and resume its operation in case of any inadvertent interruption such as opening of the portal by the user, power cut-off, 845 etc. and provides an auto-switch mechanism wherein the device switches its operation from direct power to power backup sources such as batteries, etc. making the device portable.
23.
The method for controlled processing of plurality of microscope slides with plurality of reagent fluids, comprising: 850
36
placement of the microscope slides carrying specimen in the depressions provided in the slide trays (202), with the specimen carrying surface of the microscope slide facing upwards;
placement of the slide trays (202) having the microscope slides, on the slide tray platform (203) outside the device (100); 855
placement of the slide tray platform (203) with the slide trays (202) at the required angle and position with the help of support structures (204), in the staining area (201) accessed by the portal (102) on the enclosure (101);
select the desirable configuration of parameters for a process the user 860 wants the device (100) to execute, such as the type of reagent fluids, number of reagent fluids, the sequence for dispensing the reagent fluids, the flow rate of the reagent fluids in the reagent fluids delivery system, the duration of time for the dispensing the reagent fluids, the wait-time between dispensing of two successive reagent 865 fluids, the number of microscope slides to be processed, etc. through the user interface of the controller (107);
wait for the controller (107), to check if all the required conditions for successful execution of the process cycle are fulfilled and indicate to the user for any consequent action to be taken; 870
after all the necessary conditions for successful execution of set process cycle are met the device (100) will begin the process through the co-ordination of controller (107) with the sensors, motor-pumps (401), reagent fluid delivery system (400);
37
the motor-pump (401) will start circulating the filtered reagent fluids 875 from the reagent containers (103) through the reagent fluid delivery system (400) ;
the ultimate reagent fluid delivery manifold (403) when receives the reagent fluid it will then dispense it on the specimen carrying surface of the microscope slide at a precise point on the microscope slide; 880
the used reagent fluids from the surface of microscope slides then drain through the narrow opening at the bottom of the depression in the slide tray (202);
the used reagent fluid will then be discharged through spaced openings in the slide tray platform (203) to the collection tray (205) 885 placed below it;
the collection tray (205) will guide the used reagent fluids towards the drain outlet (105) which then discharges the used reagents to the drain reservoir;
at the end of the process the user is notified by the controller (107) 890 of the completion of the process through an alarm and/or the display of the controller (107).
24.
The method in claim 23, wherein the physical and chemical properties of reagent fluids, the number of reagent fluids, and amount of reagent fluids dispensed on the specimen carrying surface 895 of the microscope slide, the sequence in which the reagent fluid is dispensed on the specimen carrying surface of the microscope slide will depend on the physical and chemical properties of the specimen on the microscope slide and the parameters of the process cycle.
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25.
The method in claim 23, wherein ultimate reagent fluid delivery 900 manifold (403) dispenses the reagent fluids on the specimen carrying surface of the plurality of microscope slides separately and simultaneously, such that the reagent fluid uniformly covers specimen carrying surface of the microscope slides.
26.
The method in claim 23, wherein the duration of time required to 905 process the plurality of specimen carrying microscope slides is same as required for a single specimen carrying microscope slide, enabling high throughput in all conditions.
27.
The method in claim 23, wherein plurality of microscope slides carrying plurality of specimens can be processed with plurality of 910 reagent fluids separately and simultaneously with user-controlled parameters of the process cycle.
28.
The method in claim 23, wherein the parameters that can be user controlled include, without limitation, the type of reagent fluids, number of reagent fluids, the sequence for dispensing the reagent 915 fluids, the flow rate of the reagent fluids in the reagent fluids delivery system, the duration of time for the dispensing the reagent fluids, the wait-time between dispensing of two successive reagent fluids, the number of microscope slides to be processed, the number of reagent containers to be selected for a particular cycle, the time of 920 operation of the specific set of motor-pumps, the amount of reagent fluids to be dispensed on the specimen carrying microscope slides, selection of the particular configuration of slide tray and position of the specimen carrying microscope slide within the staining area, the manifold type and sequence of manifolds for a particular process, 925
39
the configuration of a combination of plurality of manifolds, the
drain flow rate, etc.
29.
The method in claim 23, wherein the automatic device cleaning cycle keeps the reagent fluid delivery system (400) clear of any residue of reagent fluids used in the previous processes. 930
30.
The method in claim 23, wherein the effects of the plurality of reagent fluids having certain chemical and physical properties on a certain type of plurality of specimens can be researched for further development of specific kinds of reagent fluids of specific chemical and physical properties, and new scientific procedures for better and 935 faster results of processing various types of specimens with various types of reagent fluids.