WO2021232394A1 - Dispositif d'enrichissement de cellules rejetées de tube digestif - Google Patents

Dispositif d'enrichissement de cellules rejetées de tube digestif Download PDF

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Publication number
WO2021232394A1
WO2021232394A1 PCT/CN2020/091719 CN2020091719W WO2021232394A1 WO 2021232394 A1 WO2021232394 A1 WO 2021232394A1 CN 2020091719 W CN2020091719 W CN 2020091719W WO 2021232394 A1 WO2021232394 A1 WO 2021232394A1
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WIPO (PCT)
Prior art keywords
digestive tract
filter material
conveying pipe
push rod
exfoliated
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PCT/CN2020/091719
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English (en)
Chinese (zh)
Inventor
王洛伟
王征
施瑞华
冯亚东
梁燕
Original Assignee
怡早医学科技（南京）有限公司
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Priority to PCT/CN2020/091719 priority Critical patent/WO2021232394A1/fr
Publication of WO2021232394A1 publication Critical patent/WO2021232394A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M3/00—Tissue, human, animal or plant cell, or virus culture apparatus

Definitions

  • the invention relates to the field of medical devices, and in particular to a digestive tract exfoliated cell enricher.
  • a cell collector In the prior art, a cell collector is used, which usually collects cells through a rigid single-layer stretched net or through aspiration of fluid in the digestive tract and then collected in vitro. Capsule sponges have recently appeared, using spherical structure abrasives to scrape the mucosa and cells on the surface of the esophagus for tumor marker detection. The defect is that it is a minimally invasive sampling method, and the abrasives used are thorny in appearance. It is likely to take out mucosal tissue samples for histopathology and tumor marker related tests, and local anesthetics must be used before sampling to reduce patient discomfort and pain.
  • the number of exfoliated cells collected is too small to support cytopathological diagnosis; the specificity and sensitivity of the gastrointestinal tumor markers involved are not high, resulting in low accuracy; in addition, current research is still focused on its acceptance In terms of degree and safety, for example, the subject’s poor compliance during the use of the cell harvester, retrosternal pain, reflux, vomiting, burning after eating, heartburn, and even esophageal bleeding, perforation, etc. Infection and rupture have not been reported for large-scale esophageal cancer screening.
  • the present invention aims to provide an enrichment device for exfoliated cells in the digestive tract.
  • the embodiment of the present invention provides a digestive tract exfoliated cell enricher, which includes: a delivery tube, a push rod, a connecting line and a filter material, wherein:
  • the conveying pipe has a hollow inside and holes at both ends;
  • the filter material is located inside the duct of the delivery tube and is placed on the top of the push rod, and includes a plurality of through holes. After being in full contact with the inner wall of the digestive tract, it enriches the exfoliated cells in the mucus of the digestive tract lumen ;
  • the push rod is placed inside the duct of the conveying pipe and is used to push the filter material to the outside of the conveying pipe;
  • One end of the connecting line is connected with the filter material, and the other end is placed outside the conveying pipe for retrieving the filter material.
  • a wrapper located inside the duct of the conveying pipe, placed on the top of the push rod, and used for wrapping the filter material.
  • the wrapping shell releases the filter material after being dissolved in a liquid.
  • the wrapping shell is connected to the top of the push rod, and the connecting line is used to drag the filter material out of the wrapping shell.
  • the filter material is compressed in a dome shape formed by a plurality of circular arc-shaped polymer microporous flexible materials, and then arranged in the wrapper. After contacting the mucus of the digestive tract, it spreads loosely and enriches the mucus in the digestive tract cavity. Of exfoliated cells.
  • the polymer microporous flexible material includes flexible polyurethane foam, the density of the flexible polyurethane foam is 20 kg/m 3 -30 kg/m 3 , and the pore diameter of the micropores is 25 PPI to 35 PPI.
  • the flexible polyurethane foam includes 45% to 55% toluene diisocyanate, 15% to 25% polyether polyol, 20% to 30% polyether alcohol, silicone oil and water.
  • the part of the push rod placed inside the hollow passage of the conveying pipe is threadedly connected with the conveying pipe, and the filter material is pushed to the outside of the conveying pipe through rotation.
  • a color developing agent attached to the surface of the filter material or/and dispersed in the filter material, used for contacting the liquid of a specific part of the digestive system, and then exhibiting the liquid of the specific part of the digestive system. The corresponding color.
  • the color-developing agent includes anthocyanin-based food coloring, which is used to develop pink or pink color after contact with gastric juice.
  • a buckle used to stabilize the connection between the connection line and the filter material by passing through the filter material, and includes a first buckle component and a second buckle that cooperate with each other for buckling.
  • the buckle component fixes the part of the connecting line that does not pass through the filter material and the part of the connecting line extending after passing through the filter material between the first buckle component and the second buckle component after being buckled.
  • the present invention also provides the application of the above digestive tract exfoliated cell enricher for enriching the exfoliated cells of the oral cavity, pharynx, esophagus, esophagus-cardia junction, rectum and anal canal.
  • the enriched exfoliated cells are prepared and stained Later, it is used for cytopathological testing.
  • the present invention has the following significant advantages: the filter material is pushed to the part to be tested in the digestive tract through the push rod, the cells are enriched, and then the connecting wire is used to pull the filter material back, due to the through hole of the filter material
  • the existence of can fully contact with the mucus in the digestive tract cavity, thereby enriching more than 6 million exfoliated cells, significantly improving the accuracy of pathological cytology detection.
  • the cell enricher has a simple structure, can be made very small, does not require local anesthesia before use, does not cause pain, and is non-invasive to the surface of the digestive tract.
  • the entire cell enrichment process is simple, fast, safe and efficient. Patients can take samples at home, which is suitable for early screening of large-scale gastrointestinal tumors.
  • Figure 1 is a schematic structural diagram of a digestive tract exfoliated cell enricher provided in an embodiment of the present invention
  • Figure 2 is a schematic diagram of a filter material and a fastener provided in an embodiment of the present invention
  • Fig. 3 is a schematic diagram of the relationship between the filter material and the connecting line provided in the embodiment of the present invention.
  • FIG. 4 is a schematic diagram of the relationship between the fastener and the connecting line provided in the embodiment of the present invention.
  • Fig. 1 is a schematic structural diagram of a digestive tract exfoliated cell enricher provided in an embodiment of the present invention, which will be described in detail below with reference to the accompanying drawings.
  • An embodiment of the present invention provides a digestive tract exfoliated cell enricher, which includes: a delivery tube 5, a push rod 4, a connecting line 2 and a filter material 3, wherein:
  • the conveying pipe 5 has a hollow inside and holes at both ends;
  • the filter material 3 is located inside the empty channel of the delivery pipe 5 and is placed on the top end of the push rod 4, and includes a plurality of through holes. After being in full contact with the inner wall of the digestive tract, it is enriched in the mucus in the digestive tract cavity. Exfoliated cells
  • the push rod 4 is placed inside the empty channel of the conveying pipe 5, and is used to push the filter material 3 to the outside of the conveying pipe 5;
  • One end of the connecting wire 2 is connected to the filter material 3, and the other end is placed outside the conveying pipe 5 for retrieving the filter material 3.
  • the delivery tube 5 may be cylindrical or cone-shaped, etc., which is convenient to be inserted and placed in the digestive tract, and usually can be inserted through the mouth, anus, or the like.
  • the conveying pipe 5 has a hollow inside for placing other components, and the conveying pipe 5 has openings at both ends in the axial direction, and the openings are in communication with the inner hollow.
  • the push rod 4 is directly or indirectly movably connected with the conveying pipe 5.
  • Indirect movable connection that is, corresponding parts are arranged between the push rod 4 and the conveying pipe 5, for example, rubber is arranged between the push rod 4 and the conveying pipe 5, so that the push rod 4 can move relative to the conveying pipe 5.
  • the push rod 4 can be partly placed inside the conveying pipe 5 and partly placed outside the conveying pipe 5. By applying force to the part placed outside the conveying pipe 5, the push rod 4 can push the filter material 3 to the outside of the conveying pipe 5.
  • the delivery tube 5 is inserted and placed in the digestive tract, the filter material 3 can be pushed to the inside of the digestive tract, so that the filter material 3 can be delivered to the part to be tested.
  • the connecting wire 2 may be connected to the filter material 3 through through holes that pass through the filter material 3 multiple times (for example, as shown in FIG. 3).
  • the filter material 3 has a plurality of through holes penetrating through itself. After entering the digestive tract cavity and fully contacting the mucus in the digestive cavity, the mucus can flow downstream along the through holes and can fill the through holes. After that, the mucus can flow out through the through holes, and the exfoliated cells in the mucus are adsorbed, attached, and left on the surface and inside of the filter material 3.
  • the method of filtering the mucus in the digestive tract lumen and enriching exfoliated cells provided in the embodiments of the present invention will not cause pain and affect digestion.
  • the surface of the road is non-invasive.
  • the entire cell enrichment process is simple, fast, safe and efficient. Patients can take samples at home, which is suitable for early screening of large-scale gastrointestinal tumors.
  • the part of the push rod 4 placed inside the hollow passage of the conveying pipe 5 is threadedly connected with the conveying pipe 5, and the filter material 3 is pushed to the outside of the conveying pipe 5 by rotation.
  • the filter material 3 is placed at the top of the push rod 4, that is, between the top of the push rod 4 and the opening at the corresponding end of the delivery pipe 5.
  • the filter material 3 does not need to be connected to the push rod 4 or the delivery pipe 5 to facilitate The push rod 4 pushes the filter material 3 through the opening of the delivery pipe 5 to the outside of the delivery pipe 5.
  • one end of the connecting line 2 is connected to the filter material 3, and the other end is placed outside the delivery tube 5.
  • the connecting line 2 is placed outside the delivery tube 5
  • One end is located outside the digestive tract, and the filter material 3 can be withdrawn after the filter material 3 completes cell enrichment.
  • the connecting line 2 can be cotton thread, etc., and the retracting process will not cause pain to the body and will not damage the surface of the digestive tract.
  • the filter material 3 after the filter material 3 is pushed to the outside of the delivery tube 5, it can enrich the exfoliated cells in the mucus of the digestive tract after being fully contacted with the mucus in the digestive tract. Because the filter material 3 does not necessarily need to pass and digest The enrichment of cells can be completed by rubbing, so it will not cause pain to the body, and the existence of through holes can fully contact the mucus in the digestive tract cavity, and it can also enrich a sufficient amount of cells, which can satisfy the cell disease in quantity. Physical examination.
  • the digestive tract exfoliated cell enricher further includes: a wrapping shell 1, located inside the empty channel of the delivery pipe 5, placed on the top of the push rod 4, and used to wrap the filter material 3 .
  • the filter material 3 is protected by the wrapping shell 1 to prevent the filter material 3 from being polluted by the outside, and to ensure the safety of the tested person or organism.
  • the wrapping shell 1 dissolves in liquid and releases the filter material 3.
  • the wrapping shell 1 can be made of a liquid-soluble material, such as bioprotein glue, and after being dissolved in the liquid, the filter material 3 inside the wrapping shell 1 can fully contact the mucus in the digestive tract cavity.
  • a liquid-soluble material such as bioprotein glue
  • the wrapping shell 1 is connected to the top of the push rod 4, and the connecting line 2 is used to drag the filter material 3 out of the wrapping shell 1.
  • the wrapping shell 1 can be connected to the top of the push rod 4 to avoid accidentally staying in the digestive tract.
  • the filter material 3 is compressed in a dome shape formed by a plurality of circular-arc-shaped polymer microporous flexible materials, and then is arranged in the wrapping shell 1, and after fully contacting the mucus in the digestive tract cavity , Enrich the exfoliated cells of the digestive tract.
  • the polymer microporous flexible material can achieve fluffy diffusion after contact with the mucus in the digestive tract cavity, and can fully contact the mucus in the digestive tract cavity, which can enrich a sufficient amount of exfoliated cells and be used for subsequent follow-up Cytopathological examination.
  • the polymer microporous flexible material is very soft, does not cause pain, and has no trauma to the surface of the digestive tract.
  • FIG. 2 is a schematic diagram of the filter material 3 and the fastener 6 provided in the embodiment of the present invention.
  • the filter material 3 when it is tiled, it is a polymer made of multiple circular arcs (the circular arc, quarter, or unequal form can be applied depending on the actual scene).
  • the space When it is contracted in the wrapping shell 1, it is in the shape of a dome arch.
  • the space can be fully utilized to shrink the material to a small amount, avoiding the pain of the digestive tract due to excessively large objects.
  • Foreign body sensation on the other hand, can be dome-shaped when unfolded, which can fully contact the mucus in the digestive tract cavity, enriching more exfoliated cells, and collecting cells without scratching, avoiding the digestive tract caused by scratching Mucosal damage.
  • the polymer microporous flexible material includes flexible polyurethane foam
  • the density of the flexible polyurethane foam is 20kg/m 3 ⁇ 30kg/m 3
  • the pore diameter of the micropores is 25PPI ⁇ 35PPI
  • the flexible polyurethane foam includes 45%-55% toluene diisocyanate, 15%-25% polyether polyol, 20%-30% polyether alcohol, silicone oil and water.
  • the flexible polyurethane foam can be fluffy and diffuse after contacting the mucus in the digestive tract cavity, and fully contact the mucus in the digestive tract cavity.
  • Setting the density of the flexible polyurethane foam to 20kg/m 3 -30kg/m 3 can achieve a better effect of fluffy diffusion of the filter material 3, and a better choice is to set it to 25kg/m 3 .
  • the pore size of the micropores of the flexible polyurethane foam is set to 25PPI ⁇ 35PPI (25 ⁇ 35 pores per square inch) (PPI, par per inch), which can achieve better adsorption and enrichment of cells in the mucus in the digestive tract cavity.
  • the better choice is to set to 30PPI.
  • the content of toluene diisocyanate in the flexible polyurethane foam is set at 45%-55%, and a more preferable choice is set at 50%.
  • the content of the polyether polyol in the flexible polyurethane foam is set at 15%-25%, and a more preferable choice is set at 20%.
  • the content of polyether alcohol in the flexible polyurethane foam is set to be 20%-30%, and a more preferable choice is to be set to 25%.
  • silicone oil and water are used to form the foaming crosslinking agent, and both require only a small amount, 1% to 3%. Other materials can be added to the flexible polyurethane foam.
  • the digestive tract exfoliated cell enricher further includes: a chromogenic agent attached to the surface of the filter material 3 or/and dispersed inside the filter material 3 for use in contact with specific parts of the digestive system After the liquid is in contact, the color corresponding to the liquid in the specific part is displayed.
  • the color developer can be attached to the surface of the filter material 3, or can be dispersed in the interior of the filter material 3, that is, in the micropores.
  • the corresponding color developer can be selected.
  • the part to be tested is the esophagus-cardia junction, and the material of the color developer can show the corresponding color after contact with the gastric juice, which will be filtered through the connecting line 2.
  • the material 3 is pulled back, it can be judged whether the filter material 3 has reached the test site according to the color displayed by the color developer, so as to avoid the subsequent cytological pathological examination error due to the enriched material not reaching the sampling site.
  • the color developing agent includes anthocyanin food coloring, which is used to develop pink or pink color after contact with gastric juice.
  • anthocyanin food colorings are used, which can show pink or pink after contact with gastric juice, and show anthocyanin food colorings after contacting other liquids in the digestive tract and other liquids. With different colors, it can be judged whether the filter material 3 passes through the esophagus-cardia junction, so as to determine whether the enriched material can collect the exfoliated cells at the esophagus-cardia junction.
  • FIG. 3 is a schematic diagram of the relationship between the filter material 3 and the connection line 2 provided in the embodiment of the present invention
  • FIG. 4 is the relationship between the buckle 6 and the connection line 2 provided in the embodiment of the present invention Schematic diagram of the relationship.
  • the digestive tract exfoliated cell enricher further includes: a fastener 6 for securing the connection between the connecting line 2 through the filter material 3 and the filter material 3, including mutual The first buckle component 601 and the second buckle component 602 that are buckled together are fixed on the buckle between the part of the connecting line 2 that does not pass through the filter material 3 and the part of the connecting line 2 that extends after passing through the filter material 3 Between the rear first buckle component 601 and the second buckle component 602.
  • the first buckle component 601 has a protrusion
  • the second buckle component 602 has a corresponding groove, and the two cooperate to perform the buckle operation.
  • the connecting wire 2 can be connected to the filter material 3 through the through holes of the filter material 3 multiple times (as shown in Fig. 3), but this connection method is unstable and easily causes the connecting wire 2 to separate from the filter material 3.
  • the tacking method is used for stability, the force will be biased towards the tacking part when pulling the connection line 2. Due to the imbalance of the force, the filter material 3 may be pulled off on the one hand, and the connection line 2 may be pulled from The filter material 3 falls off and it is difficult to recover the filter material 3.
  • the path of the filter material 3 cannot be controlled predictably, which may cause the filter material 3 to touch the mucosa on the surface of the digestive tract. And then damage the surface of the digestive tract and other mucous membranes.
  • the connecting wire 2 passes through the through holes of the filter material 3 for multiple times to connect to the filter material 3, the end portion of the wire, that is, the part of the connecting wire 2 that extends after passing through the filter material 3, and the body of the connecting wire 2 , That is, the part of the connecting line 2 that does not pass through the filter material 3, and the two are firmly secured between the first buckle component 601 and the second buckle component 602 after being buckled.
  • the digestive tract exfoliated cell enricher is used to enrich the exfoliated cells of the oral cavity, pharynx, esophagus, gastroesophageal junction, rectum and anal canal. After the enriched exfoliated cells are prepared and stained, they are used For cytopathological testing.
  • the preparation methods used in the process of exfoliated cell detection include natural sedimentation, centrifugal slinging, membrane preparation, centrifugal sedimentation preparation, cell smear and cell wax block section; staining methods include Conventional HE staining, conventional Papaflicolaou Pap staining, Wright Wright staining, Wright Giemsa staining, DAN ploidy staining, thionine-eosin (Feuglen-Eosin) counterstain, thionine-Pap (Feuglen-EA) Staining and immunocytological staining; cell benign and malignant analysis methods include: doctors’ microscope reading, qualitative analysis based on cell morphological characteristics; computer quantitative analysis of DNA content, calculation of DNA ploidy content, assessment of cell disease and the degree of disease; Based on artificial intelligence deep neural network analysis, qualitative analysis and quantitative analysis are combined to analyze cell morphological characteristics and changes in DNA ploidy content in the nucleus.
  • the digestive tract exfoliated cell enricher has a simple structure, can be made very small, does not cause pain, and is non-invasive to the surface of the digestive tract.
  • the entire cell enrichment process is simple, fast, safe and efficient. Patients can take samples at home, which is suitable for early screening of large-scale gastrointestinal tumors.

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Abstract

La présente invention divulgue un dispositif d'enrichissement de cellules rejetées de tube digestif, comprenant un tuyau de transport, une tige de poussée, une ligne de raccordement et un matériau de filtration, un canal vide étant formé à l'intérieur du tuyau de transport, et des trous étant formés sur les deux extrémités du tuyau de transport ; le matériau de filtration est situé dans le canal vide du tuyau de transport et est disposé au niveau de l'extrémité supérieure de la tige de poussée, comprend une pluralité de trous traversants, et est en contact total avec la paroi interne d'un tube digestif et enrichit ensuite les cellules rejetées dans le mucus dans une cavité de tube digestif ; la tige de poussée est disposée dans le canal vide du tuyau de transport et est utilisée pour pousser le matériau de filtration vers la partie extérieure du tuyau de transport ; et une extrémité de la ligne de raccordement est reliée au matériau de filtration, et l'autre extrémité est disposée à l'extérieur du tuyau de transport et est utilisée pour récupérer le matériau de filtration. Le dispositif d'enrichissement de cellules a une structure simple, peut être fabriqué de façon à être très petit, évite de causer une sensation de douleur à une personne, et est non invasif pour la surface du tube digestif. Un procédé d'enrichissement de cellules entières est simple, rapide, sûr et efficace, et est approprié pour un criblage précoce à grande échelle des tumeurs du tube digestif.
PCT/CN2020/091719 2020-05-22 2020-05-22 Dispositif d'enrichissement de cellules rejetées de tube digestif WO2021232394A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024170904A1 (fr) * 2023-02-17 2024-08-22 Cyted Ltd Dispositif de prélèvement de cellules

Citations (5)

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Publication number Priority date Publication date Assignee Title
CN201211202Y (zh) * 2008-07-04 2009-03-25 上海联众基因科技研究院 一次性使用口腔脱落细胞采样棒
CN101869491A (zh) * 2004-07-07 2010-10-27 科隆尼克斯有限公司 结肠直肠细胞采样设备
CN209734017U (zh) * 2017-11-10 2019-12-06 杭州纽蓝科技有限公司 一种集成式唾液采集装置
CN110882013A (zh) * 2019-12-12 2020-03-17 苏州唯善生物科技有限公司 一种食管脱落细胞采样装置
CN210903121U (zh) * 2019-07-12 2020-07-03 姚香怡 一种用于哺乳动物消化腔内富集脱落细胞的装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101869491A (zh) * 2004-07-07 2010-10-27 科隆尼克斯有限公司 结肠直肠细胞采样设备
CN201211202Y (zh) * 2008-07-04 2009-03-25 上海联众基因科技研究院 一次性使用口腔脱落细胞采样棒
CN209734017U (zh) * 2017-11-10 2019-12-06 杭州纽蓝科技有限公司 一种集成式唾液采集装置
CN210903121U (zh) * 2019-07-12 2020-07-03 姚香怡 一种用于哺乳动物消化腔内富集脱落细胞的装置
CN110882013A (zh) * 2019-12-12 2020-03-17 苏州唯善生物科技有限公司 一种食管脱落细胞采样装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024170904A1 (fr) * 2023-02-17 2024-08-22 Cyted Ltd Dispositif de prélèvement de cellules

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