A filter fused guider device

Abstract

Disclosed herein is a filter fused guider device (100) for the application of liquid- based cytology device for PAP smear preparation in automated instrument The guider device (100) comprising an outer body (102). The guider device (100) also comprising a nylon filter mesh (104) fitted inside the outer body (102) and the nylon filter mesh (104) allowing separation and capturing of the particles / cells of the sample. The guider device (100) also comprising a rubber seal (106) fitted over the nylon filter mesh (104) and the outer body (102) and the rubber seal (106) capable of fixing the nylon filter mesh (104) to the outer body (102).

Description

A FILTER FUSED GUIDER DEVICEFIELD OF DISCLOSURE

[0001] The present disclosure relates generally relates to a device for cell separation, more specifically, relates to a cell separation device for monolayer of cells.BACKGROUND OF THE DISCLOSURE

[0002] Cell separation methods are techniques used to isolate specific cell types from a heterogeneous mixture, such as blood or tissue samples. The cell separations methods are having application in various fields, including biomedical research, diagnostics, and therapeutic applications.

[0003] There are many cell separation methods including Density Gradient Centrifugation, Magnetic-Activated Cell Sorting (MACS), Fluorescence- Activated Cell Sorting (FACS), Immunomagnetic Separation (IMS), Filtration, Microfluidic Devices, Affinity Chromatography, and more.

[0004] Each of these cell separation methods has its advantages and limitations, and the choice of method depends on factors such as the cell type of interest, sample volume, purity requirements, and available resources.

[0005] One of the commonly used methods is density gradient centrifugation, which relies on the density differences between different cell types. Cells are layered onto a gradient of a density gradient medium and as the centrifuge process starts, cells migrate through the medium based on their density, leading to the formation of distinct layers or bands containing different cell populations.

[0006] The major challenges associated with the density gradient centrifugation is maintaining integrity of fragile samples, as the use of centrifugal force may damage delicate structures or compromise the integrity of biomolecules. Further, the centrifugation process may last fromhours to days, that also adds to the challenge of maintaining sample integrity.

[0007] Also, procuring and maintaining equipment for the density gradient centrifugation is a costly affair. Operating such apparatus may also requires expertise in gradient preparation and centrifugation protocols. Therefore, this method as limited scalability and is not easy to setup for a large-scale sample processing.

[0008] Filtration is another commonly used method that involve passing a cell suspension through a porous membrane or filter with defined pore sizes. Cells larger than the pore size are retained on the filter while smaller cells and debris pass through.

[0009] One of the key disadvantages associated with this method is that the filters used can become clogged with cellular debris, proteins, or other particulate matter present in the sample that may reduce the efficiency of the filtration. Further, it is not suitable for sample containing heterogenous cells.

[0010] The method also has limited selectivity that limits its application, as it is ineffective in distinguishing diverse cell types. It also has limited resolution and in general, do not provide high resolution. This can impact the applicability of the method.

[0011] One of the major limitations of existing cell separation devices is complexity of operation. Such complex devices require specialized training or expertise to operate, which limits their wide spread use.

[0012] Another limitation is high cost associated with such complex devices. Additionally, such devices may also require more operating time and hence, are more time-consuming.

[0013] Yet another limitation is limited ability of many of the cell separation devices that hinders the processing of multiple samples collected. Loss of sample or contamination of sample while using cell separating device is another major limitation of many of the existing cell separating devices.

[0014] In addition to this, many of the existing device may lead to nonspecific results, which may lead to delay in the diagnostics results. Moreover, many of the existing cell separation method are not compatible with a wide range of sample types or cell sources.

[0015] Furthermore, while some cell separation devices offer automation capabilities, many still require manual intervention at various steps of the process and some are not suitable for automation.

[0016] Consequently, as the methods for cell separation are critically important in medical diagnostics and molecular biology, the devices utilized in such processes must have the ability to remove or collect cells of a predetermined size. Such devices must be able to prevent clogging and ascertain no contamination.

[0017] There is a need for a device for cell separation that may have flexibility to accommodate various cell types and processes. Further, there is a need for a device that may be compatible with automation technologies along with being cost and time effective and easy to use. Such device may also achieve high separation efficiency with any damage to the collected cells.

[0018] Thus, in light of the above-stated discussion, there exists a need for a liquid based cytology device for cervical cancer screening.SUMMARY OF THE DISCLOSURE

[0019] The following is a summary description of illustrative embodiments of the invention. It is provided as a preface to assist those skilled in the art to more rapidly assimilate the detailed design discussion which ensues and is not intended in any way to limit the scope of the claims which are appended hereto in order to particularly point out the invention.

[0020] According to illustrative embodiments, the present disclosure focuses on a liquid based cytology device for cervical cancer screeningwhich overcomes the above-mentioned disadvantages or provide the users with a useful or commercial choice.

[0021] The present disclosure solves all the above major limitations of a liquid based cytology device for cervical cancer screening. Further, the present disclosure ensures that the disclosed invention may fulfil following objectives.

[0022] An objective of the present disclosure is to develop a cell separation device suitable for liquid-based smear preparation in automated instrument.

[0023] Another objective of the present disclosure is to combine advantageous features of two different cell separation methods.

[0024] Another objective of the present disclosure is to develop a device for cell separation that is compatible with different slide sizes and formats commonly used in cell separation methods.

[0025] Another objective of the present disclosure is to develop a device for cell separation that is efficient and easy to operate.

[0026] Another objective of the present disclosure is to develop a device for cell separation that does not require special training or expertise.

[0027] Another objective of the present disclosure is to develop a device for cell separation that capable of handling different cell types and samples.

[0028] Another objective of the present disclosure is to develop a device for cell separation that is cost-effective.

[0029] Another objective of the present disclosure is to develop a device for cell separation that ascertains nominal or no contamination of the sample collected.

[0030] Yet another objective of the present disclosure is to develop a device for cell separation that act as a guide for cells.

[0031] Yet another objective of the present disclosure is to develop a device for cell separation is portable and reusable.

[0032] Yet another objective of the present disclosure is to develop a device for cell separation that is leakproof.

[0033] Yet another objective of the present disclosure is to develop a device for cell separation that is customizable.

[0034] Yet another objective of the present disclosure is to develop a device for cell separation that ensures no or minimal cell damage.

[0035] Yet another objective of the present disclosure is to develop a device for cell separation that has gentle cell separation capabilities.

[0036] Yet another objective of the present disclosure is to develop a device for cell separation that is highly efficient in separating monolayer of cells.

[0037] Yet another objective of the present disclosure is to develop a device for cell separation that ensures collection of desired amounts of cell population.

[0038] Yet another objective of the present disclosure is to develop a device for cell separation that is safe and secure to handle.

[0039] In light of the above, in an aspect of the present disclosure, a filter fused guider device 100 for liquid based cytology in cervical cancer screening is disclosed herein. The guider device comprising an outer body. The guider device also comprising a nylon filter mesh fitted inside the outer body and the nylon filter mesh allowing separation and capturing of the particles / cells of the sample. The guider device also comprising a rubber seal fitted over the nylon filter mesh and the outer body and the rubber seal capable of fixing the nylon filter mesh to the outer body.

[0040] In one embodiment, the outer body is hollow and cylindrical in shape.

[0041] In one embodiment, the outer body is made up of polypropylene material.

[0042] In one embodiment, the outer body with interior walls having a slanting angle of 5.72°.

[0043] In one embodiment, the outer body with interior walls having a diameter of 1 .9 cm at base.

[0044] In one embodiment, the outer body with interior walls having a diameter of 2.3 cm at top.

[0045] In one embodiment, the outer body has a length of 3 cm and a diameter of 2.5 cm.

[0046] In one embodiment, the nylon filter mesh is smaller than 1 .8 cm in diameter.

[0047] In one embodiment, the nylon filter mesh has a plurality of customized pores sized between 140 microns to 150 microns.

[0048] In one embodiment, the rubber seal is in the form of a circular disc with at least two diametrically opposite flaps attached to the outer edge.

[0049] In one embodiment, the rubber seal may be capable of preventing the liquid sample and reagent leaking during the centrifugation process.

[0050] In one embodiment, the rubber seal may be capable of defining the position of the guider device with respect to the pre-coated slide and placement in slide holder to ensure that the centrifugal forces are directed in the proper direction.

[0051] In one embodiment, the guider device is capable of capturing the cells in a mono layer that is more than five times the required quantity in the mono layer.

[0052] In one embodiment, the guider device is capable of guiding the direction of cell from the liquid / sample to slide.

[0053] These and other advantages will be apparent from the present application of the embodiments described herein.

[0054] The preceding is a simplified summary to provide an understanding of some embodiments of the present invention. This summary is neither an extensive nor exhaustive overview of the present invention and its various embodiments. The summary presents selected concepts of the embodiments of the present invention in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other embodiments of the present invention are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0055] These elements, together with the other aspects of the present disclosure and various features are pointed out with particularity in the claims annexed hereto and form a part of the present disclosure. For a better understanding of the present disclosure, its operating advantages, and the specified object attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated exemplary embodiments of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0056] To describe the technical solutions in the embodiments of the present disclosure or in the prior art more clearly, the following briefly describes the accompanying drawings required for describing the embodiments or the prior art. Apparently, the accompanying drawings in the following description merely show some embodiments of the present disclosure, and a person of ordinary skill in the art can derive other implementations from these accompanying drawings without creative efforts. All of the embodiments or the implementations shall fall within the protection scope of the present disclosure.

[0057] The advantages and features of the present disclosure will become better understood with reference to the following detailed description taken in conjunction with the accompanying drawing, in which:

[0058] FIG. 1 illustrates a block diagram showcasing the components of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0059] FIG. 2A illustrates a detailed view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0060] FIG. 2B illustrates a detailed side-view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0061] FIG. 2C illustrates a detailed side-view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0062] FIG. 2D illustrates a detailed view of the bottom of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0063] FIG. 2E illustrates a detailed view of the top of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0064] FIG. 3A illustrates a cross-sectional view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure;

[0065] FIG. 3B illustrates a horizontal sectional view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure; and

[0066] FIG. 3C illustrates a vertical sectional view of a filter fused guider device for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0067] Like reference, numerals refer to like parts throughout the description of several views of the drawing.

[0068] The liquid based cytology device for cervical cancer screening is illustrated in the accompanying drawings, which like reference letters indicate corresponding parts in the various figures. It should be noted that the accompanying figure is intended to present illustrations of exemplary embodiments of the present disclosure. This figure is not intended to limit the scope of the present disclosure. It should also be noted that the accompanying figure is not necessarily drawn to scale.DETAILED DESCRIPTION OF THE DISCLOSURE

[0069] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0070] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the present disclosure. It may be apparent to one skilled in the art that embodiments of the present disclosure may be practiced without some of these specific details.

[0071] Various terms as used herein are shown below. To the extent a term is used, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0072] The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items.

[0073] The terms “having”, “comprising”, “including”, and variations thereof signify the presence of a component.

[0074] Referring now to FIG. 1 to FIG. 3 to describe various exemplary embodiments of the present disclosure. FIG. 1 illustrates a block diagram showcasing the components of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0075] The guider device 100 may include an outer body 102, a nylon mesh filter 104, and a rubber seal 106.

[0076] The outer body 102 may act as a structural base for the guider device 100.

[0077] The guider device 100 may comprise a nylon filter mesh 104 fitted inside the outer body 102 and the nylon filter mesh 104 allowing separation and capturing of the particles / cells of the sample.

[0078] The guider device 100 may comprise a rubber seal 106 fitted over the nylon filter mesh 104 and the outer body 102 and the rubber seal 106 capable of fixing the nylon filter mesh 104 to the outer body 102.

[0079] The guider device may help to remove the artefacts while applying along with centrifugal force to isolate monolayer of cells from a cell suspension onto a circular area on a slide, which may be then utilized to generate a thin smear on a slide for microscopic examination.

[0080] FIG. 2A illustrates a detailed view of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0081] The outer body 102 may be hollow and cylindrical in shape.

[0082] The outer body 102 may be made up of polypropylene material.

[0083] In an embodiment of the present disclosure, the outer body 102 may be made up of any non-reactive material suitable for cell separation.

[0084] The outer body 102 may provide a structural support for nylon filer mesh 104, as detailed later, and holding the sample during centrifugation process by giving physical support during cell separation.

[0085] FIG. 2B and FIG. 2C illustrate a detailed side-view of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0086] In an embodiment of the present disclosure, the outer body 102 may have base or base part, top or top part, interior wall, and exterior wall. The polypropylene material is selected for making the outer body owing to its ease of availability and compatibility with easy to cast that may save time, cost, and effort.

[0087] In an embodiment of the present disclosure, the base part of the outer body 102 may act as an entry portal. In an embodiment of the presentdisclosure, the base part of the outer body 102 may allow entry of the monolayer of cell in the guider device 100.

[0088] In an embodiment of the present disclosure, the interior walls of the outer body 102 may acts as a guiding channel. In an embodiment of the present disclosure, the interior walls of the outer body 102 may guide the collected monolayer of cell.

[0089] In addition, the outer body 102 may also be intended to serve as a sample cell separation container that can be utilized in an automatic smearing device to obtain a high-quality smear quality consistently regardless of the state of the sample by separating monolayer of cells.

[0090] Referring to FIG. 1 , the nylon filter mesh 104 may be smaller than 1 .8 cm in diameter.

[0091] The nylon filter mesh 104 with smaller than 1.8 cm diameter may only fit in to the outer body 102. During the manufacturing process, the nylon filter mesh 104 will be inserted separately into the outer body 102. The fitting device may go inside and come out after placing the nylon filter mesh 104 in the outer body 102.

[0092] FIG. 2D and FIG. 2E illustrate a respective detailed view of the bottom and top of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0093] The nylon filter mesh 104 may have a plurality of customized pores sized between 140 microns to 150 microns.

[0094] The nylon filter mesh 104 may allow the cells which are less than 140 microns and most of the artefacts are more than 150 microns are retained above the filter mesh after the centrifugation.

[0095] In an embodiment of the present disclosure, the nylon filter mesh 104 may have pores of any desired shapes. In an embodiment of the present disclosure, the nylon filter mesh 104 may have a plurality of pores of different size as required for different cell separation or examination processes.

[0096] In an embodiment of the present disclosure, the nylon filter mesh 104 may be made up any suitable material as required for different cell separation or examination processes. The nylon used for making the nylon filter mesh 104 may be of any kind suitable and safe for application in medical and diagnostics.

[0097] In an embodiment of the present disclosure, the dimension of the nylon filter mesh 104 may vary as per the requirement of the application. In an embodiment of the present disclosure, the nylon filter mesh 104 may be changeable or replaceable. In an embodiment of the present disclosure, the guider device 100 may be disposable.

[0098] In an embodiment of the present disclosure, the nylon filter mesh 104 may have a plurality of pores that allows cells of particular size to pass through in the outer body 102 of the guider device 1 10. In an embodiment of the present disclosure, the nylon filter mesh 104 may ensures no or minimal clogging of the cells.

[0099] In an embodiment of the present disclosure, the nylon filter mesh 104 may be flexible or rigid. In an embodiment of the present disclosure, the nylon filter mesh 104 may be non-reactive to different reagents and samples. In an embodiment of the present disclosure, the nylon filter mesh 104 may be capable of withstanding extreme temperatures.

[0100] In an embodiment of the present disclosure, the nylon filter mesh 104 may maintain the monolayer of cells collected via a plurality of customized pores. In an embodiment of the present disclosure, the nylon filter mesh 104 may act as a sorting layer or separation layer.

[0101] In an embodiment of the present disclosure, the plurality of pores in the nylon filter mesh 104 may act as inlet feed holes. The pores may allow entry of cells of suitable size into the outer body 102 of the guiding device 100.

[0102] Referring to FIG. 1 , and FIG. 2A, the rubber seal 106 may be in the form of a circular disc with at least two diametrically opposite flaps attached to the outer edge.

[0103] In an embodiment of the present disclosure, the rubber seal 102 may have more than two flaps at the base part of the guider device 100. In an embodiment of the present disclosure, the diametrically opposite flaps may be used to avoid contact with the sample and ensure no contamination. The diametrically opposite flaps may be used in ensuring correct alignment and easy removal.

[0104] The rubber seal 106 may be capable of preventing the liquid sample and reagent leaking during the centrifugation process.

[0105] The rubber seal 106 may be capable of defining the position of the guider device with respect to the pre-coated slide and placement in slide holder to ensure that the centrifugal forces are directed in the proper direction.

[0106] FIG. 3A illustrates a horizontal sectional view of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0107] The outer body 102 with interior walls may be having a slanting angle of 5.72°.

[0108] The outer body 102 with interior walls may be having a diameter of 1 .9 cm at base.

[0109] The outer body 102 with interior walls may be having a diameter of 2.3 cm at top.

[0110] In a preferred embodiment, the thickness of the walls of the outer body 102 may vary in descending order, while moving from the base part to the top part. In a preferred embodiment, the internal dimensions of the outer body 102 may vary as per the requirement.

[0111] FIG. 3B illustrates a vertical sectional view of the filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0112] The outer body 102 may have a length of 3 cm and a diameter of 2.5 cm.

[0113] The surface area is of the outer body 102 may vary as per the requirement of the dimensions of the cell smear.

[0114] FIG. 3C illustrates a cross-sectional view of the base of the outer body 102 of a filter fused guider device 100 for liquid based cytology in cervical cancer screening, in accordance with an exemplary embodiment of the present disclosure.

[0115] In an embodiment of the present disclosure, the outer body 102 may not impact the chemical, physical or biological properties of the sample. In an embodiment of the present disclosure, the outer body 102 may not have any sharp edges to ensure smooth handling and reduce risk of minor cuts to the user.

[0116] In an embodiment of the present disclosure, the nylon filter mesh 104 may have a thickness of 0.5cm. In an embodiment of the present disclosure, the thickness of the nylon filter mesh 104 may vary.

[0117] In an embodiment of the present disclosure, the two diametrically opposite flaps may have a thickness of 0.17cm. In an embodiment of the present disclosure, the two diametrically opposite flaps may have a length and width of 0.49cm and 0.5 cm. In an embodiment of the present disclosure, the length, width, and thickness of the two diametrically opposite flaps may vary.

[0118] In an embodiment of the present disclosure, the rubber seal 106 may seal the entire setup during the centrifugation process. In an embodiment of the present disclosure, the rubber seal 106 may be in form of a circular ring. In an embodiment of the present disclosure, the rubber seal 106 may be detachable and easy to fix.

[0119] In an embodiment of the present disclosure, the rubber seal 106 may any mechanism to fix the nylon filter mesh 104 to the outer body 102, which may include any existing, prior art, or later developed technology or material. In an embodiment of the present disclosure, the rubber seal 106 may be non-reactive in nature.

[0120] In an embodiment of the present disclosure, the rubber seal 106 may be made up of translucent material. In an embodiment of the present disclosure, the rubber seal 106 may be able to withstand very high and very low temperatures.

[0121] The guider device 100 may be capable of capturing the cells in a mono layer that is more than five times the required quantity in the mono layer.

[0122] The guider device 100 may be capable of guiding the direction of cell from the liquid / sample to slide.

[0123] The surface area of the outer body 102 of the guider device 100 may capture enough cells in mono layer as per the criteria for making a smear. The guider device 100 may be able to make smear up to 1.8cm, which is the required cell smear size to evaluate by pathologist.

[0124] The guider device 100 may be of any colour. The outer body 102, the nylon filter mesh 104, and the rubber seal 106 may be of any colour or combination of colours. In an embodiment of the present disclosure, the guider device 100 may be translucent.

[0125] In a preferred embodiment, the rubber seal 106 may be securely placed only after fitting the nylon filter mesh 104 into the outer body 102. The two flaps attached may aid in securing the rubber seal in a secure and hygienic manner. In a preferred embodiment, the rubber seal 106 may be smaller in diameter than the base of the outer body (102).

[0126] In an embodiment of the present disclosure, the rubber seal 106 may cover the outer edges of the base of the outer body 102 and the outer edges of the nylon filter mesh 104 to secure the setup. The rubber seal 106 of the guider device 100 may not be rigid. The rubber seal 106 may be made up of any suitable material or combination thereof of to achieve desired level of flexibility.

[0127] In a preferred embodiment, the guider device 100 may be designed to align with sample holder device. In a preferred embodiment, the guiderdevice may be used only with pre coated slides. In a preferred embodiment, the guider device 100 may be oriented vertically.

[0128] In an embodiment of the present disclosure, the guider device 100 may hold up to 3.5ml of liquid solution, as per the maximum sample required for various cell analyses under this technique. In an embodiment of the present disclosure, the guider device 100 may be capable of making a circular smear. In an embodiment of the present disclosure, the guider device 100 may be positioned on the centre of the slide.

[0129] The position of the guider device 100 with respect to the pre-coated slide and placing in slide holder, it ensures that the centrifugal forces may be directed in the proper direction. These cells stay stuck on the microscopic slide following the application of the sample into the guider in the subsequent centrifugation process.

[0130] The position of the guider device 100 on the slide holder may resemble a sandwich assembly. The slide holder may act as bottom for the entire setup, followed by the charged slide and the guider device 100 may be placed and locked with sample holder which may be having half key lock mechanism.

[0131] In some embodiments, the slide holder may incorporate features such as clamps, or seals, to firmly secure the slide and guider device 100 in position and prevent any movement or displacement during centrifugation or filtration

[0132] The cell separation may be achieved through filtration and gradient centrifugation. The slide holder may be validated to achieve 100% leak proof and centre to the slide. Since, the slide holder is designed to place the sample guider into the centre of the slide.

[0133] The guider device 100 may act as physical support during the cell separation process through centrifugation forces with gradient accessory reagents. The cells in the sample may pass though the filter mesh and interact with positively coated slide.

[0134] Majority of the cells may be negative in charge and such cells are attached to the surface of the glass slide. Only one layer of cells may attach to the slide because of the available surface area to the cells saturated after the monolayer. The guider device may provide the direction of cell from the liquid / sample to slide.

[0135] In a preferred embodiment, the guider device 100 may help to remove the artefacts, when applying along with centrifugal force, which is one of the cell separation methods. In a preferred embodiment, the guider device 100 may be easy to sterilize. The guider device 100 may ensure sterile cell separation.

[0136] While combining filtration and gradient centrifugation techniques, complete leak proofing is ensured for effective and reliable cell separation. Particularly, absence of leakages and spill overs may minimize the chances of cross-contamination and enhance the integrity of results obtained.

[0137] The guider device 100 may isolate monolayer of cells from a cell suspension onto a circular area on a slide, which is then utilized to generate a thin smear on a slide for microscopic examination. The position of the guider device 100 may ensure cells stay stuck on the microscopic slide following the application of the sample into the guider device 100 in the subsequent centrifugation process.

[0138] The guider device 100 represents a significant advancement in cell isolation and preparation for microscopic examination. It may streamline sample preparation and enhances the efficiency and accuracy of cell analysis. One crucial aspect of the guider device 100 is its ability to ensure that cells remain securely adhered to the microscopic slide following the application of the sample and subsequent centrifugation process. This feature is essential for maintaining the integrity of the cell monolayer and preventing cell loss or displacement during handling and analysis.

[0139] Additionally, the rubber seal 106 ensures the precise positioning of the guider device 100, which may play a crucial role during the cell separation process. By accurately guiding the deposition of cells onto thedesignated circular area of the slide via the outer body 102 of the guider device 100, it minimizes the risk of cell detachment or smudging, thereby optimizing the quality and reliability of microscopic examination results.

[0140] Furthermore, the design of the guider device 100 may prevent cell migration or detachment under centrifugal forces. Thus, maintain the integrity of the cell monolayer separated using the nylon filter mesh 104 and ensure uniform distribution of cells across the slide surface.

[0141] Overall, the guider device 100 represents a sophisticated solution for isolating and preparing cell monolayers for microscopic examination. Its ability to optimize cell collection, and searing on microscopic slides may streamlines the sample preparation process and enhances the accuracy and reproducibility of cell analyses in various research and clinical settings.

[0142] The key advantages of the guider device 102 may include suitability and adaptability for automation. Another advantage is capability of handling a variety of cell sizes and different samples.

[0143] Another associated advantage is superior results as compared to exiting devices as it combines the attributes of two different cell separation methods. This guider device 100 may aid in filtration through centrifugation along with gradient solution, which may enhance the cell separation while compared to conventional individual cell separation methods.

[0144] Maintaining hygiene and purity of the sample during the cell separation process is another key advantage. The rubber seal 106 may aid in fixing the guider device 100 to the pre-coated slide, which may reduce the chances of sample contamination.

[0145] Ease of operation, time-effectiveness, and cost-effectiveness are also the benefits associated with the guider device 100. Further, using the guider device 100 may not require any extensive training or expertise. The guider device 100 may be compatible with slides of various sizes and formats that are commonly used in the cell separation methods.

[0146] While the invention has been described in connection with what is presently considered to be the most practical and various embodiments, itwill be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.

[0147] A person of ordinary skill in the art may be aware that, in combination with the examples described in the embodiments disclosed in this specification, units and algorithm steps may be implemented by electronic hardware, computer software, or a combination thereof.

[0148] The foregoing descriptions of specific embodiments of the present disclosure have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed, and many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described to best explain the principles of the present disclosure and its practical application, and to thereby enable others skilled in the art to best utilize the present disclosure and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but such omissions and substitutions are intended to cover the application or implementation without departing from the scope of the present disclosure.

[0149] Disjunctive language such as the phrase “at least one of X, Y, Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.

[0150] In a case that no conflict occurs, the embodiments in the present disclosure and the features in the embodiments may be mutually combined. The foregoing descriptions are merely specific implementations of thepresent disclosure, but are not intended to limit the protection scope of the present disclosure. Any variation or replacement readily figured out by a person skilled in the art within the technical scope disclosed in the present disclosure shall fall within the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.

Claims

I / WE Claim:

1. A filter fused guider device (100) for the application of liquid-based cytology device for PAP smear preparation in automated instrument, the guider device (100) comprising: an outer body (102); a nylon filter mesh (104) fitted inside the outer body (102), the nylon filter mesh (104) allowing separation and capturing of the particles / cells of the sample; and a rubber seal (106) fitted over the nylon filter mesh (104) and the outer body (102), the rubber seal (106) capable of fixing the nylon filter mesh (104) to the outer body (102).

2. The guider device (100) as claimed in claim 1 , wherein the outer body (102) is hollow and cylindrical in shape.

3. The guider device (100) as claimed in claim 1 , wherein the outer body (102) is made up of polypropylene material.

4. The guider device (100) as claimed in claim 2, wherein the outer body (102) with interior walls having: a slanting angle of 5.72°; a diameter of 1 .9 cm at base; and a diameter of 2.3 cm at top.

5. The guider device (100) as claimed in claim 1 , wherein the outer body (102) has a length of 3 cm and a diameter of 2.5 cm.

6. The guider device (100) as claimed in claim 1 , wherein the nylon filter mesh (104) is smaller than 1 .8 cm in diameter.

7. The guider device (100) as claimed in claim 1 , wherein the nylon filter mesh (104) has a plurality of customized pores sized between 140 microns to 150 microns.

8. The guider device (100) as claimed in claim 1 , wherein the rubber seal (106) is in the form of a circular disc with at least two diametrically opposite flaps attached to the outer edge.

9. The guider device (100) as claimed in claim 1 , wherein the rubber seal (106) is capable of: preventing the liquid sample and reagent leaking during the centrifugation process, defining the position of the guider device (100) with respect to the pre-coated slide and placement in slide holder to ensure that the centrifugal forces are directed in the proper direction.

10. The guider device (100) as claimed in claim 1 , wherein the guider device(100) is capable of: capturing the cells in a mono layer that is more than five times the required quantity in the mono layer; and guiding the direction of cell from the liquid / sample to slide.

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