Automated device for the process of immunohistochemical staining

Abstract

The present invention describes an automated device for the process of immunohistochemical staining, which comprises an antibody dispenser for localising specific proteins in histological samples, and a receptacle that includes connectors for radial distribution of the samples to minimise handling, thereby preventing alterations in the results. The automated device for the process of immunohistochemical staining includes a container with separators that allows the placement of different types of reagents for the application of dyes to the samples. A control panel with a control module for fully automating sample processing is also installed in the device, and, using a screen, the necessary adjustments are made to initiate sample processing.

Description

[0001] AUTOMATED DEVICE FOR THE IMMUNOHYDROPHONE STAINING PROCESS IS TOQUI MI CO

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The present invention relates to the technical field of mechanical engineering, biomedical engineering, electronics, biology, chemistry, pathology, biotechnology and more specifically medical diagnosis, since it provides an automated device for the immunohistochemical staining process.

[0004] BACKGROUND OF THE INVENTION

[0005] Immunohistochemical (IHC) staining is a technique used in biology and medicine to detect and visualize specific proteins within biological tissues using antibodies. Its main objective is to identify the presence and location of molecules of interest, such as antigens, that may be linked to certain diseases, especially in the diagnosis of pathologies such as cancer.

[0006] The process begins with the preparation of a tissue sample, which is fixed and sectioned into thin slices for analysis. Next, specific antibodies are applied that bind to the target proteins present in the tissue. These antibodies are labeled with enzymes or fluorescent substances that allow visualization of the binding using a light or fluorescence microscope. The result is a stained image of the tissue where the areas containing the antigen are highlighted, facilitating microscopic analysis of the sample. IHC is widely used to identify the overexpression of cancer-related proteins, such as HER2 in breast cancer, and other proteins that act as tumor markers or indicators of disease. This technique provides a highly specific and detailed visualization of molecules within cells, making it a crucial tool for diagnostic pathology and biomedical research.

[0007] Automated immunohistochemical staining systems are high-precision instruments designed to perform the complex procedure of identifying antigens in tissue samples using antibodies. This process is essential in disease diagnosis, particularly in the detection of specific cancer types, and requires meticulous attention to detail to obtain consistent and reliable results. Automating this procedure allows for the standardization of techniques, reduces human error, and improves efficiency in pathology and biomedical research laboratories.

[0008] In immunohistochemical staining, automation helps control every critical step of the procedure. From antigen retrieval, the first step in exposing the epitopes to be detected by antibodies, to the application of primary and secondary antibodies, the device precisely manages reagent concentrations and incubation times. Automated systems also optimize the handling of enzyme-conjugated antibodies or fluorochromes, which allow visualization of the presence of specific proteins in tissue sections. Furthermore, automated equipment ensures consistent blocking of nonspecific reactions and the development of the visible signal, resulting in homogeneous staining and highly reproducible results.

[0009] One of the major advantages of these devices is their ability to handle multiple samples simultaneously, significantly increasing laboratory productivity. By automating the process, technicians can focus on other tasks, as the machine takes care of the entire staining cycle, from the initial preparation step to the final staining. Modern devices are typically equipped with intuitive user interfaces and allow for the programming of customized protocols based on assay or laboratory requirements, providing flexibility to adapt to different staining techniques or variations in reagents.

[0010] In addition to accuracy and efficiency, automated immunohistochemical staining devices contribute to standardization in medical diagnosis. In fields such as oncology, where the expression of certain biomarkers is crucial for determining the appropriate treatment, the ability of these devices to provide accurate and comparable results every time is invaluable. This reduces variability between laboratories and improves confidence in diagnoses, which can be decisive in choosing the right treatment for the patient.

[0011] The use of these devices also minimizes the risk of exposure to hazardous chemicals for laboratory personnel, as they automate the handling of potentially toxic reagents. Many automated systems are designed with safety features that limit direct contact with chemicals. Furthermore, automated sample handling ensures that antibodies and reagents are used in optimal quantities, which also contributes to cost reduction and optimized material usage, without compromising process quality.

[0012] Automated devices for immunohistochemical staining represent a technological advancement that improves accuracy, efficiency, and safety in pathology laboratories. Their ability to standardize complex processes, handle large sample volumes, and reduce human error makes them an essential tool in both clinical and research settings. The possibility of customizing protocols and adapting them to the specific needs of each assay further expands their utility in modern biomedicine.

[0013] A prior art search was conducted for automated devices for the immunohistochemical staining process, revealing that various devices have been developed for this purpose, as described in United States Patent Application No. US5425918 (A), dated June 20, 1995, entitled "APPARATUS FOR AUTOMATIC TISSUE STAINING FOR IMMUNOHISTOCHEMISTRY," which describes an apparatus for the automatic staining of tissues comprising a body on which a carousel rotates. The carousel can carry a series of slides containing tissue samples. A supply head assembly is mounted on the body to move along the diameter of the carousel. The head assembly contains a transparent nozzle and a spray nozzle.One version of the spray nozzle for spraying a fluid biochemical agent onto a slide has a main body, a plug in the main body, and a cap on the main body, between which is a swirl chamber through which the fluid passes from the body. The fluid enters the swirl chamber such that the flow in the chamber is concentric to the chamber axis and then flows out of the body through an outlet, thus minimizing damage to the biochemical agent.

[0014] Also found was the Japanese patent application document number JP2008527330 (A), dated July 24, 2008, which has the title "LOW TEMPERATURE SPARAFINATION", which refers to using a batch method or an automated device, by means of liquid composition, a method and apparatus for slowly removing an inclusion medium from a biological sample at a temperature below the melting point of the inclusion medium.

[0015] The documents cited above refer to an apparatus for automatic tissue staining and a low-temperature deparaffinization method, but they do not describe having an antibody dispenser installed to detect and locate specific proteins in tissue samples, nor do they show evidence of having a control module and a screen that allows for critical operating adjustments, such as the intensity of reagent application and the temperature at which they are applied, the application of antibodies, and the automatic positioning of samples.

[0016] The previous documents do not show evidence of having a receptacle that integrates connectors for holding slide holders that ensures a distribution of the samples, which minimizes handling since the application of the reagents is also controlled; the documents also do not refer to integrating a container with separators that allows the placement of different types of reagents that are used in the processing of the samples.

[0017] OBJECT OF THE INVENTION

[0018] The present invention aims to provide an automated device for the immunohistochemical staining process, which has an antibody dispenser for the localization of specific proteins in histological samples.

[0019] Another object of the present invention is to provide an automated device for the immunohistochemical staining process, which has a receptacle that integrates connectors for a radial distribution of the samples to minimize handling, and thus avoid alterations in the results.

[0020] An additional object of the present invention is to provide an automated device for the immunohistochemical staining process, which integrates a container with separators that allows the placement of different types of reagents for the application of dyes to the samples.

[0021] Another object of the present invention is to provide an automated device for the immunohistochemical staining process, which has a control module to fully automate the processing of the samples.

[0022] An additional object of the present invention is to provide an automated device for the immunohistochemical staining process, which integrates a screen for making adjustments and starting up the sample process.

[0023] BRIEF DESCRIPTION OF THE FIGURES

[0024] The characteristic details of this novel automated device for the immunohistochemical staining process are clearly shown in the following description and accompanying figures, as well as an illustration thereof, using the same reference symbols to indicate the parts shown. However, these figures are shown by way of example and should not be considered limiting to the present invention.

[0025] Figure 1 shows a top perspective view of the automated device for the immunohistochemical staining process.

[0026] Figure 2 shows a top view of the automated device for the immunohistochemical staining process.

[0027] Figure 3 shows a front view of the screen of the automated device for the immunohistochemical staining process.

[0028] Figure 4 shows a side view of the control module of the automated device for the immunohistochemical staining process.

[0029] Figure 5 shows a perspective view of the exploded view of parts of the automated device for the immunohistochemical staining process.

[0030] Figure 6 shows a detailed view of the receptacle of the automated device for the immunohistochemical staining process, without the container. Figure 7 shows a bottom perspective view of the base of the automated device for the immunohistochemical staining process, without the container, with the motor installed.

[0031] DETAILED DESCRIPTION OF THE INVENTION

[0032] For a better understanding of the present invention, the parts that make up the automated device for the immunohistochemical staining process are listed below:

[0033] 1. Base

[0034] 2. Receptacle

[0035] 3. Hole

[0036] 4. Engine

[0037] 5. Ring

[0038] 6. Connectors

[0039] 7. Microscope slides

[0040] 8. Support

[0041] 9. Deposit

[0042] 10. Dispenser

[0043] 11. Container

[0044] 12. Separators

[0045] 13. Bomb

[0046] 14. Hose

[0047] 15. Cover

[0048] 16. Extractor

[0049] 17. Control Panel

[0050] 18. Screen

[0051] With reference to the figures, the automated device for the immunohistochemical staining process consists of a prismatic base (1), preferably quadrangular, with a perforation (not illustrated) in its center; a receptacle (2), preferably concave and circular, is installed on top of the base (1). This receptacle (2) has an opening (3) in its center and is aligned with the perforation (not illustrated) of the base (1). A motor (4) is installed on the bottom of the base (1), where the perforation (not illustrated) is located; the shaft of the motor (4) is installed in the receptacle (2). This configuration allows rotary motion to be transmitted to the receptacle (2).

[0052] A ring (5) is installed on the upper periphery of the receptacle (2); on the inner periphery of said ring (5) are installed a plurality of connectors (6) which are arranged equidistantly, positioned on the upper part of the receptacle (2); a slide (7) is installed on top of each of the connectors (6); this configuration allows a coverslip (not illustrated) with histological samples to be placed on each of the slides (7) for processing. The ring (5) is configured to fix the connectors (6) radially on the receptacle (2) and eliminate movement of the samples on the slide (7).

[0053] A support (8) is installed vertically and at one end, at the top of the base (1), positioned on one side of the receptacle (2); a reservoir (9) is installed on top of the support (8), and is configured to store a solution with antibodies for sample processing; a dispenser (10) is installed at the bottom of the reservoir (9), aligned with the slides (7), this configuration allows the antibodies inside the reservoir (9) to be dispensed onto the samples on the slides (not illustrated) placed on the slides (7).

[0054] The motor (4) transmits rotary motion to the receptacle (2) to rotate it and position each of the slides (7) at the bottom of the dispenser (10) as the processing of histological samples progresses; the motor (4) can be an electric motor, a stepper motor, or a servomotor.

[0055] A container (11) is installed in the center of the top of the receptacle (2); a plurality of separators (12) are located longitudinally inside the container (11), this configuration allows different types of reagents to be stored, and by means of the separators (12) cross-contamination of said reagents is avoided.A pump (13) is installed inside the lower part of the container (11), in each of the spaces between the separators (12); a hose (14) is installed at one end on each of the pumps (13); the hoses (14) pass through the lower part of the container (11) extending over the upper part of the receptacle (2), such that the ends of said hoses (14) that are not connected to each of the pumps (13) are positioned at the height of each of the slides (7) that are in the connectors (6); This configuration allows, by means of the pumps (13), the distribution of the reagents from the container (11) through the hoses (14) and thus applying said reagent to the samples that are on each slide (not illustrated) placed on each of the microscope slides (7).

[0056] The container (11) is configured to store the reagents for carrying out multiple processes without having to refill said container (11) with the reagent solutions used; the container (11) is preferably conical in shape, and the base is preferably of larger diameter, which is in contact with the receptacle (2), allowing the collection of the residues of the applied reagents by means of said receptacle (2).

[0057] One lid (not illustrated) is installed on top of the dispenser (10), and another is installed on top of the container (11).

[0058] A prismatic cover (15), preferably quadrangular and taller than the base (1), is installed on top of the base (1). This configuration protects the components of the automated immunohistochemical staining device, as well as the reagents, antibodies, and samples on the slides (not shown) on each slide (7). The cover (15) is designed to seal hermetically, preventing contamination from external elements and thus ensuring the integrity of the staining results. The cover (15) is preferably made of a transparent material, allowing visualization of the operation and the staining process.

[0059] Openings (not illustrated) are located on the top of the cover (15), aligned with the reservoir (9) and the container (11), allowing passage through the cover (15) and protruding from the top. This enables replenishment of reagents or antibody solution without removing the cover (15). An extractor (16) is installed on the top of the base (1), preferably on one side of the dispenser (10). The extractor (16) protrudes from the side of the cover (15). This configuration allows the extraction of vapors generated inside the cover (15) when the dispenser (10) applies the antibodies and / or the pumps (13) supply the reagents to the samples on the slides (not illustrated) on each of the microscope slides (7).

[0060] A control panel (17), a rectangular prismatic structure with an inclined front face, is installed on one of the side faces of the base (1). This control panel (17) is configured to house a control module (not shown) consisting of a microprocessor (not shown) and a power supply (not shown), preferably a rechargeable battery. The motor (4), the dosing unit (10), the pumps (13), and the extractor (16) are connected to the microprocessor (not shown) via wiring (not shown). This configuration allows for powering and controlling operations during sample processing. The power supply (not shown) is connected to the microprocessor (not shown), providing energy to the microprocessor for the operation of the automated device for the immunohistochemical staining process.

[0061] A screen (18) is installed on the front face of the control panel (17). This screen is tilted and configured to perform adjustments, start-up, and display the status of the automated device for the immunohistochemical staining process. The screen (18) is preferably touch-sensitive. A switch (not illustrated) is installed on the outside of the control panel (17) and is connected to the power source (not illustrated). This configuration allows the automated device for the immunohistochemical staining process to be activated or deactivated.

[0062] A charging port (not illustrated) is installed on the outside of the control panel (17) and is connected to the power supply (not illustrated). This configuration allows one end of a cable (not illustrated) to be connected to the charging port (not illustrated) and the other end to be connected to a fixed electrical power supply, thereby recharging the power supply (not illustrated).

[0063] A wireless communication unit (not illustrated) may be located inside the control panel (17) connected to the control module (not illustrated). This configuration allows programming and commissioning of the automated device for the immunohistochemical staining process remotely and in real time, by means of a smart device such as a computer, tablet or smartphone; the wireless communication unit (not illustrated) may be via Bluetooth, WiFi (Wireless Fidelity) or UWB (Ultra-Wideband).

[0064] PREFERRED EMBODIMENT OF THE INVENTION

[0065] The following examples illustrate a preferred way of carrying out the present invention and should not be considered as limiting it. Example 1. Operation and functioning of the automated device for the immunohistochemical staining process.

[0066] With reference to the figures mentioned above, samples of organic tissue are placed on each of the slides (7), subsequently the solution with antibodies is added to the reservoir (9), as well as adding the necessary reagents to the separations of the container (11).

[0067] The switch (not illustrated) is pressed to activate the screen (18) and proceed with the programming. The operating settings are adjusted via the screen (18) to determine which samples on the slides (7) will receive antibodies via the dispenser (10), as well as to program which type of reagent will be supplied via the pumps (13). The programming settings determine the motor's rotation (4) for its positioning in the dispensers (10), as well as the quantity, intensity, and temperature of application for each reagent.

[0068] Once the operating parameters were established, the processing of the samples began via the screen ( 18 ).

[0069] In view of the foregoing, it is reiterated that the scope of the present invention shall not be limited by the specific embodiments described, and it shall be understood that variations may be made in several respects. Such variations shall not be considered a departure from the spirit and scope of the invention, and all such modifications may be obvious to a person skilled in the art and shall be included within the scope of the following claims.

Claims

RECLAIMS 1. An automated device for the immunohistochemical staining process, characterized in that it comprises: a base (1) having a perforation in its center; a receptacle (2) is installed on the top of the base (1), said receptacle (2) having an orifice (3) in the center and aligned with the perforation of the base (1); a motor (4) is installed on the bottom of the base (1), in the part where the perforation is located, the shaft of the motor (4) is installed in the receptacle (2) to transmit rotary motion to said receptacle (2); a ring (5) is installed on the upper periphery of the receptacle (2); a plurality of connectors (6) are installed on the inner periphery of the ring (5); A slide (7) is installed on top of each of the connectors (6), a coverslip is placed on top of each slide;A support (8) is installed vertically at one end on the top of the base (1), positioned on one side of the receptacle (2); a reservoir (9) is installed on top of the support (8), which reservoir (9) stores an antibody solution for sample processing; a dispenser (10) is installed at the bottom of the reservoir (9), aligned with the slides (7), to deliver the antibodies inside the reservoir (9) onto the samples on the slides (not shown) placed on the slides (7); a container (11) is installed in the center of the top of the receptacle (2); a plurality of separators (12) are located longitudinally inside the container (11);A pump (13) is installed inside the lower part of the container (11), in each of the spaces between the separators; (12); a hose (14) is installed at one end on each of the pumps (13); the hoses (14) pass through the bottom of the container (11) extending over the top of the receptacle (2); a cover (15) is installed on top of the base (1) to protect the parts that make up the device; openings are located on the top of the cover (15), aligned with the reservoir (9) and the container (11), allowing passage through the cover (15) and protruding from the top, thus enabling the replenishment of reagents or antibody solution without the need to remove the cover (15);An extractor (16) is installed on the top of the base (1), and protrudes from one side of the cover (15) to extract the vapors generated inside the cover (15) when the dispenser (10) applies the antibodies and / or the pumps (13) supply the reagents to the samples on the slides (not illustrated) on each of the slides (7); a control panel (17) is installed on one of the side faces of the base (1); said control panel (17) is configured to house a control module; and a screen (18) is installed on the front face of the control module (17).

2. The device according to claim 1 characterized in that the base (1) is of a quadrangular prismatic shape.

3. The device according to claim 1 characterized in that the receptacle ( 2 ) is concave in circular shape.

4. The device according to claim 1 because the connectors (6) are arranged equidistantly positioned on the top of the receptacle (2).

5. The device according to claim 1 characterized in that the ring (5) allows the connectors (6) to be fixed radially on the receptacle (2) and eliminates movement in the samples that are on the slide (7).

6. The device according to claim 1 characterized in that the motor (4) transmits rotary motion to the receptacle (2) to rotate it and position each of the slides (7) in the lower part of the dispenser (10) as the processing of histological samples progresses.

7. The device according to claim 1 characterized in that the motor (4) is an electric motor, a stepper motor or a servomotor.

8. The device according to claim 1 characterized in that the container (11) stores different types of reagents, and by means of the separators (12) avoids cross-contamination of said reagents.

9. The device according to claim 1 characterized in that the ends of the hoses (14) that are not connected to each of the pumps (13) are positioned at the height of each of the slides (7) that are in the connectors (6), so that by means of the pumps (13) the reagents from the container (11) are distributed through the hoses (14) and thus applied to the samples that are on each slide placed on each of the slides (7).

10. The device according to claim 1 characterized in that the container (11) is conical in shape, and the larger diameter base is in contact with the receptacle (2), allowing the collection of the residues of the reagents applied by means of said receptacle (2).

11. The device according to claim 1 characterized in that, one lid is installed on the top of the dispenser (10), and another is installed on the top of the container (11).

12. The device according to claim 1 characterized in that the cover (15) is preferably quadrangular in shape and taller than the base (1) • 13. The device according to claim 1 characterized in that the cover (15) is made of a transparent material to visualize the operation and the staining process of the samples.

14. The device according to claim 1 characterized in that the cover (15) closes hermetically and thus prevents contamination by foreign elements present in the environment, avoiding putting the integrity of the process results at risk.

15. The device according to claim 1 characterized in that the extractor (16) is located on one side of the dispenser (10).

16. The device according to claim 1 characterized in that the control panel (17) is a rectangular prismatic structure with an inclination on its front face.

17. The device according to claim 1 characterized in that the control module is comprised of a microprocessor and a power supply.

18. The device according to claim 17 characterized in that the power source is a rechargeable battery.

19. The device according to claims 1 and 17, characterized in that the motor (4), the doser (10), the pumps (13), and the extractor (16) are connected to the microprocessor via wiring, to power and control operations during sample processing.

20. The device according to claim 17 characterized in that the power supply is connected to the microprocessor to energize said microprocessor for the operation of the device.

21. The device according to claim 1 characterized in that the screen (18) is touch-sensitive.

22. The device according to claim 1 and 17, characterized in that a switch is installed on the outside of the control panel (17) and is connected to the power source, to activate or deactivate the device.

23. The device according to claims 1 and 17, characterized in that a charging port is installed on the outside of the control panel (17) and is connected to the power supply. This configuration allows one end of a cable to be connected to the charging port, and the opposite end to be connected to a fixed electrical power supply, thereby recharging the power supply.

24. The device according to claim 1 and 17, characterized in that a wireless communication unit is located inside the control panel (17) connected to the control module, for programming and starting the device remotely and in real time, by means of an intelligent device.

25. The device according to claim 24, characterized in that the smart device is a computer, a tablet, or a smartphone.

26. The device according to claim 24 characterized in that the wireless communication unit is Bluetooth, WiFi or UWB.

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