WO2020188489A1 - Dispositif d'échantillonnage cytologique de cellules exfoliées du col de l'utérus - Google Patents

Dispositif d'échantillonnage cytologique de cellules exfoliées du col de l'utérus Download PDF

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Publication number
WO2020188489A1
WO2020188489A1 PCT/IB2020/052446 IB2020052446W WO2020188489A1 WO 2020188489 A1 WO2020188489 A1 WO 2020188489A1 IB 2020052446 W IB2020052446 W IB 2020052446W WO 2020188489 A1 WO2020188489 A1 WO 2020188489A1
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WIPO (PCT)
Prior art keywords
collecting
aforesaid
collecting body
pole
shaped element
Prior art date
Application number
PCT/IB2020/052446
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English (en)
Inventor
Lorenzo AGONI
Andrea BUSI
Original Assignee
Agoni Lorenzo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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Publication of WO2020188489A1 publication Critical patent/WO2020188489A1/fr

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Classifications

    • 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
    • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
    • 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
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0074—Vaginal or cervical secretions
    • 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
    • A61B2010/0216—Sampling brushes

Definitions

  • the present invention places itself in the technical sector of tools used in the medical field and, in particular, the invention concerns a device for a so-named cytological sampling of exfoliated cells of the uterine cervix.
  • the invention concerns a device for a cytological sampling to perform an examination for the diagnosis of precancerous lesions of the uterine cervix in the context of cervical cancer prevention pathways.
  • the Pap test is a methodology that allows to sample cells exfoliating from the uterine cervix and to analyze them under a microscope to check for the possible presence of alterations that may be correlated to the presence of precancerous lesions therein, so that to be able to intervene promptly before the onset of the tumor.
  • the cells exfoliated from the uterine cervix are sampled with a spatula having a head with two lobes, wherein one is generally more pronounced than the other, and which is rubbed and rotated at 360° on the neck of the uterus after having been inserted into the vagina through a gynecological speculum.
  • the head of the spatula used for the sampling is rubbed on a microscope slide so that the cells removed are deposited on the slide, on which they are then fixed with a special liquid and subjected to a cytological exam.
  • a spatula with a single lobe or with symmetrical lobes or a small brush can be used.
  • the spatula or small brush used for the sampling are immersed into a liquid to carry out the so-named Pap test at the liquid stage instead of rubbing the spatula or small brush on a slide after sampling the cells.
  • the impossibility to trace the original position of the cells on the organ from which they were sampled does not allow to distinguish mild diffused alterations typical of the simple infection, from spatially concentrated alterations typical of the precancerous lesion of the uterine cervix.
  • the percentage of finding precancerous lesions at the level of the uterine cervix after a positive pap test can vary between 10%, in the event of Pap tests with slight alterations at the positivity limit, and 50-70%, in the event of unequivocally positive Pap tests.
  • the document US 5 231 992 A describes a device that allows a woman to autonomously sample and preserve a cell sample of the uterine cervix to be tested subsequently in a clinical analysis laboratory, wherein the device comprises a cylindrical body, in which a pole, adapted to move axially and rotatably through a grip, is housed, and a cell collector, which is geometrically configured to be retracted folded inside the cylindrical body at an end thereof and to expand outside the cylindrical body, in an extended state so that to cover most of the anatomical region of the cervix, wherein the device comprises a handle placed at an end of the cylindrical body inside which a container, delimited by a removable cap on a side and by a membrane on the opposite side, is obtained, wherein the container contains a liquid adapted to preserve the cell sample collected through the cell collector, wherein the cap and the membrane are provided with respective openings for the passage and sliding of the aforesaid pole and wherein the opening of the membrane allows the passage of the cell collector while the opening of
  • the document US 5 253 652 A describes a cytological sampling device for sampling cervical and vaginal cells from a uterine cervix and vagina, wherein the device comprises a flat and elongated stem with opposite end portions and a longitudinal portion extending between the opposite end portions, wherein a first brush is arranged on an end portion of the stem to sample endocervical cell samples by inserting an end portion into the vagina and inside the mouth of the cervix and by rotating the stem with the first brush against the endocervical wall, wherein the device further comprises an elongated actuator supported on the longitudinal stem portion and having a second brush on an end of the actuator to sample exocervical cells, wherein, by applying a pressure with the fingers to a gripping element on an opposite end of the actuator, the actuator is slidingly displaced with respect to the longitudinal portion of the stem so that to rotate the second brush from a position adjacent to the stem, which allows to easily be inserted into and removed from the vagina, to an unfolded position displaced from the
  • US 2013/267870 A1 describes a variety of embodiments of a device for sampling tissues by friction with an expandable balloon and abrasive material so that to obtain biopsy tissue samples, and which can be used to sample specific positions.
  • the document US 5 231 992 A describes a collector for sampling cells and mucus from the uterine cervix, comprising a main disc-shaped body consisting of a biologically inert high density non-absorbent and non-fibrous polyurethane foam with a porous membrane mounted in a collecting cavity of the main body, wherein, when the collector is in a position adjacent to the cervix of a patient, cells and fluids adhere to the outer surface of the membrane, wherein a material layer that dampens the cells is provided between the membrane and the inner surface of the cavity, i.e.
  • the material layer is arranged below the membrane, wherein the material for dampening the cells can be a pre-hydrated polymeric gel that releases water while sampling the cells to dampen the cells sampled through the pores of the membrane when the cells are made to adhere to the outer surface of the membrane, wherein the collector can stay in the vaginal cavity of the patient for at least 24 hours.
  • the devices described in the aforesaid documents also suffer from the drawback due to the impossibility of tracing, while analyzing the cells sampled, the original position of the cells on the organ from which they were sampled.
  • the technical problem underlying the present invention was to provide a cytological sampling device to perform an exam for the diagnosis of precancerous lesions of the uterine cervix in the context of cervical cancer prevention pathways, i.e. a device for the cytological sampling of exfoliated cells of the uterine cervix with structural and functional characteristics such as to overcome one or more of the drawbacks mentioned above with reference to the known art.
  • a device of the aforesaid type comprising:
  • a pole-shaped element extended between a gripping portion and a head portion, and a collecting body combined with the aforesaid pole-shaped element at the aforesaid head portion, characterized in that the aforesaid collecting body comprises a collecting face facing the opposite side with respect to the aforesaid gripping portion, wherein the aforesaid collecting face is apt, by contact, for the topographical sampling of exfoliated cells of the uterine cervix of a patient.
  • the aforesaid device allows to sample cells exfoliated from the uterine cervix by keeping the spatial ratios between them unchanged, thus reproducing the original topography they had on the uterine cervix onto the aforesaid collecting face.
  • the aforesaid collecting face is adapted to maintain the arrangement of the sampled cells, which is faithful to the original topography of the uterine cervix, at all steps of its use and possible preservation, i.e. until the analysis of the cells sampled.
  • the aforesaid collecting body, and precisely the aforesaid collecting face allow to sample cells exfoliated from the uterine cervix of a patient essentially by contact without rubbing, thus achieving an arrangement of the exfoliated cells on the aforesaid collecting face that is faithfully representative of the original topography of the uterine cervix, which, according to the present device, is maintained throughout all use steps of the device until the analysis of the sampled cells, which can occur, for example, directly on the aforesaid collecting face or following a transfer of the sampled cells on an appropriate support, for example a slide.
  • the aforesaid collecting face has characteristics of porosity and/or roughness and/or adhesiveness and/or other chemical-physical characteristics such as for example electrostatic load, such as to allow the exfoliated cells to adhere to it by contact, for example following a slight pressure, substantially without having to move the aforesaid collecting body, thus the aforesaid collecting face on the uterine cervix.
  • the aforesaid collecting body is at least partly made of a flexible and/or deformable material, for example a rubbery material, a plastic material, a solid foam for example polymeric, a fabric, a non-woven fabric, hydrogel, a hydrocolloid material, a fluoropolymer among which hydrophilic polytetrafluoroethylene, polysulfones, polycarbonates, cellulose esters among which cellulose nitrate and acetate.
  • a flexible and/or deformable material for example a rubbery material, a plastic material, a solid foam for example polymeric, a fabric, a non-woven fabric, hydrogel, a hydrocolloid material, a fluoropolymer among which hydrophilic polytetrafluoroethylene, polysulfones, polycarbonates, cellulose esters among which cellulose nitrate and acetate.
  • the aforesaid collecting body is semi-rigid.
  • the aforesaid collecting body is removably combined with the aforesaid pole-shaped element.
  • the aforesaid collecting body has a circular or elliptical shape.
  • the aforesaid collecting face has a circular or elliptical shape.
  • the aforesaid collecting body is movable with respect to the aforesaid pole-shaped element between a first position, so-named open, apt for the aforesaid cytological sampling, in which the aforesaid collecting face is substantially extended or unfolded and orthogonal to the aforesaid pole-shaped element, and a second position, so-named closed, in which the aforesaid collecting face or a portion thereof forms an angle of less than 90° with the aforesaid pole-shaped element, the aforesaid collecting face being tilted towards the aforesaid gripping portion, and/or wherein the aforesaid collecting body in the aforesaid second position has a substantially concave side opposed to the aforesaid collecting face and facing the aforesaid gripping portion.
  • the aforesaid collecting body can also be apt for the aforesaid cytological sampling in intermediate positions between the aforesaid first position, in which the aforesaid collecting face is substantially orthogonal to the aforesaid pole-shaped element, and the aforesaid second position, in which the aforesaid collecting face or a portion thereof forms an angle of less than 90° with the aforesaid pole-shaped element, the aforesaid first position and the aforesaid second position being limit positions.
  • the aforesaid device comprises movement means for the displacement of the aforesaid collecting body between the aforesaid first position and the aforesaid second position.
  • the aforesaid movement means are manually operated.
  • the aforesaid movement means comprise at least one sliding arm combined with the aforesaid collecting body, wherein the aforesaid at least one sliding arm is extended along at least one portion of the aforesaid pole shaped element.
  • sliding arms of the aforesaid type can also be independent of one another, i.e. the different sliding arms can be controlled by the user substantially one independently of the other.
  • the aforesaid movement means comprise at least one joining element interposed between the aforesaid collecting body and the aforesaid at least one sliding arm.
  • the aforesaid at least one joining element is jointed or mechanically articulated.
  • the aforesaid movement means comprise at least one combining element for combining the aforesaid at least one sliding arm with the aforesaid pole-shaped element, wherein the aforesaid at least one combining element is more preferably a clevis or a ring fixed to the aforesaid pole-shaped element.
  • the aforesaid at least one combining element is a sort of guide for the aforesaid at least one sliding arm and in fact allows the sliding by keeping it adherent to the aforesaid pole-shaped element.
  • the aforesaid device comprises combining means integral with the aforesaid collecting body for combining it with the aforesaid pole shaped element or which are removably interposed between it and the aforesaid pole-shaped element, wherein the aforesaid combining means are more preferably jointed or mechanically articulated.
  • the aforesaid collecting body has a diameter, or possibly a width and/or height, between 1.5 cm and 4.5 cm, more preferably between 2 cm and 4 cm.
  • the aforesaid collecting face has a diameter, or possibly a width and/or height, between 1.5 cm and 4.5 cm, more preferably between 2 cm and 4 cm.
  • the aforesaid device comprises at least one element of reference apt to identify the orientation of the aforesaid collecting face, wherein the aforesaid at least one element of reference is combined with the aforesaid collecting body.
  • the aforesaid collecting body comprises, or consists of, a membrane in which the aforesaid collecting face is a face of the aforesaid membrane and/or the aforesaid collecting face comprises a bottom and a collecting material apt to sample the exfoliated cells, for example a material with high viscosity, distributed on the aforesaid bottom.
  • the aforesaid collecting material is a gel
  • the aforesaid gel is more preferably a natural gel, a synthetic gel or a blend thereof, selected from the group comprising agar, agarose, methylcellulose, elastin, elastin-likes, hyaluronic gels, polypeptide gels, and respectively selected from the group comprising polyacrylamide, polymacon, polyethylene glycol, or other forms of hydrogels or polymer-based gels.
  • the aforesaid membrane is made of a material selected from the group comprising: polymeric foams, fabrics, non-woven fabrics, hydrogels, hydrocolloids, fluoropolymers among which hydrophilic polytetrafluoroethylene, polysulfones, polycarbonates, cellulose esters among which cellulose nitrate and acetate.
  • the aforesaid membrane has a circular or elliptical shape.
  • the aforesaid collecting body comprises a support, wherein more preferably the aforesaid support is shaped like a ring, disc or spoke-like.
  • the aforesaid support is removably combined with the aforesaid pole-shaped element.
  • the aforesaid at least one joining element is interposed between the aforesaid support and the aforesaid at least one sliding arm.
  • the aforesaid membrane is combined with the aforesaid support and is more preferably removably combined with the aforesaid support.
  • the aforesaid at least one element of reference is combined with the aforesaid collecting face and is more preferably combined with the aforesaid membrane.
  • FIG. 1 schematically shows a front perspective view of a device for the cytological sampling of exfoliated cells of the uterine cervix, in a first so-named open position, according to the present invention
  • figure 2 shows a back perspective view of the device of figure 1 ;
  • figure 3 shows a side view of the device of figure 1 ;
  • figure 4 shows a top view of the device of figure 1 ;
  • - figure 5 shows a front perspective view of the device of figure 1 , in a second so-named closed position, according to the present invention
  • - figure 6 shows a back perspective view of the device of figure 5;
  • figure 7 shows a side view of the device of figure 5;
  • figure 8 shows a top view of the device of figure 5;
  • FIG. 9 schematically shows a front perspective view of a device for the cytological sampling of exfoliated cells of the uterine cervix, in a first so-named open position, according to an embodiment variant of the present invention
  • figure 10 shows a back perspective view of the device of figure 9;
  • figure 11 shows a side view of the device of figure 9;
  • figure 12 shows a top view of the device of figure 9;
  • FIG. 13 shows a front perspective view of the device of figure 9, in a second so-named closed position, according to the present invention
  • figure 14 shows a back perspective view of the device of figure 13;
  • FIG. 15 shows a side view of the device of figure 13;
  • FIG. 16 shows a top view of the device of figure 13;
  • FIG. 17 schematically shows a front perspective view of a device for the cytological sampling of exfoliated cells of the uterine cervix, in a first so- named open position, according to a further embodiment variant of the present invention
  • figure 18 shows a back perspective view of the device of figure 17 ;
  • figure 19 shows a side view of the device of figure 17 ;
  • FIG. 20 shows a top view of the device of figure 17;
  • figure 21 shows a front view of the device of figure 17 ;
  • FIG. 22 shows a front perspective view of the device of figure 17, in a second so-named closed position, according to the present invention
  • FIG. 23 shows a back perspective view of the device of figure 22
  • FIG. 24 shows a side view of the device of figure 22
  • FIG. 25 shows a top view of the device of figure 22
  • FIG. 26 shows a front view of the device of figure 22
  • a device for the cytological sampling of exfoliated cells of the uterine cervix is generally denoted by 1.
  • the device 1 substantially comprises a pole-shaped element 2 extended between a gripping portion 3 and a head portion 4, and a collecting body combined with the pole-shaped element 2, at the head portion 4, generally denoted by 5.
  • the collecting body 5 is combined with the head portion 4 at an edge or peripheral portion thereof.
  • the collecting body 5 comprises a collecting face 6 facing the opposite side with respect to the gripping portion 3, which is apt, by contact, for the topographical sampling of cells exfoliated from the uterine cervix of a patient.
  • the pole-shaped element 2 is a small stick that can be made, for example although not only, of plastic material and which can have different shapes in the section, while the collecting face 6 of the collecting body 5 allows to sample the cells exfoliated from the uterine cervix of a patient essentially by contact without rubbing, thus achieving an arrangement of the exfoliated cells on the collecting face 6 that is faithfully representative of the original topography of the uterine cervix.
  • Achieving an arrangement of the exfoliated cells on the collecting face 6 that is faithfully representative of the original topography of the uterine cervix means that the exfoliated cells sampled through the collecting body 5 maintain unchanged the spatial ratios they originally had on the uterine cervix before the sampling thereof on the collecting face 6.
  • the collecting face 6 has characteristics of porosity and/or roughness and/or adhesiveness and/or other chemical-physical characteristics such as for example electrostatic load, such as to allow the exfoliated cells to adhere to it by contact, substantially without having to move the collecting body 5, thus the collecting face 6 itself on the uterine cervix.
  • the roughness and/or porosity and/or adhesiveness and/or electrostatic load of the collecting face can be selected within a range of values such as to have respective collecting bodies that better adapted themselves to more or less delicate cervical mucus, for example in the event of glandular atrophy or ectopia, and thus to modulate the quantity of cells and mucus that can be sampled when in contact with the collecting face.
  • the collecting body 5 is preferably at least partly made of a flexible and/or deformable material, in particular to be able to adapt themselves to possible anatomical irregularities of the uterine cervix.
  • the collecting body can also be a semi-rigid body.
  • the collecting body 5 comprises a support 7, in practice a ring-shaped body, and a membrane 8 combined with the support 7 such as to obstruct the central passage of the ring-shaped body of the support 7, wherein the collecting face 6 is a face of the membrane 8 facing the opposite side with respect to the gripping portion 3 of the pole-shaped element 2.
  • the ring-shaped body of the support 7 has a closed circular shape, the possibility to provide a support of a different shape, for example elliptical or disc-shaped, not however being excluded.
  • the support 7 is preferably at least partly made of a flexible and/or deformable material, for example a rubbery material, a plastic material, a solid foam for example a polymeric one, a fabric, a non- woven fabric
  • the membrane 8 is also preferably made of a flexible and/or deformable material, for example a material selected from the group comprising: polymeric foams, fabrics, non-woven fabrics, hydrogels, hydrocolloids, fluoropolymers among which hydrophilic polytetrafluoroethylene, polysulfones, polycarbonates, cellulose esters among which cellulose nitrate and acetate.
  • the collecting body 5 is movable, in particular with respect to the pole-shaped element 2, between a first position, so-named open, apt for the cytological sampling of cells exfoliated from the uterine cervix, in which the collecting face 6 is substantially extended or unfolded and orthogonal to the pole-shaped element 2, and a second position, so-named closed, in which the collecting face 6 forms an angle of less than 90° with the pole-shaped element 2, i.e. wherein the collecting face 6 is tilted towards the gripping portion 3 of the pole-shaped element 2.
  • the device 1 when the collecting body 5 is in the second position, the device 1 takes less space than the space it takes when the collecting body 5 is in the first position.
  • the device 1 For the displacement of the collecting body 5 between the aforesaid first position and the aforesaid second position, the device 1 comprises movement means which are preferably operated manually.
  • the aforesaid movement means comprise a sliding arm 9 combined with the collecting body 5 and extended along a portion of the pole-shaped element 2.
  • the sliding arm 9, a sort of sling, is combined with the pole shaped element 2 such as to be able to slide thereon and is preferably made of a rubbery material or a plastic material.
  • the sliding arm 9 has a first end combined with the support 7 at a portion of the same support 7 distal from the head portion 4 of the pole shaped element 2, and a second end, opposite the first end, at which a knob 10 is provided to facilitate the control of the movement of the sliding arm 9 by the user.
  • the aforesaid movement means further comprise at least one combining element for combining the sliding arm 9 with the pole-shaped element 2 and, according to the aforesaid figures, comprise a plurality of clevis-shaped combining elements, each denoted by 11.
  • the aforesaid movement means preferably comprise a joining element 12 interposed between the collecting body 5 and the
  • IB sliding arm 9 and specifically, according to the examples of the aforesaid figures, interposed between the support 7 and the sliding arm 9.
  • the joining element 12 is articulated or anyhow free to rotate with respect to the support 7, the possibility of having substantially a joint non-mechanically articulated between the support and the sliding arm not however being excluded, the possible relative movement being allowable by the type of material used.
  • the support 7 is also preferably removably combined with the pole-shaped element 2.
  • the device 1 comprises combining means 13 interposed between the collecting body 5 and the pole shaped element 2, and particularly between the support 7 and the head portion 4 of the pole-shaped element 2.
  • the combining means 13 can thus be means of the snap-fit, bayonet, screw type or the like, and/or jointed combining means, the possibility of having a joint substantially non-mechanically articulated between the collecting body, thus between the support, and the pole-shaped element, not however being excluded, the possible relative movement being allowable by the type of material used.
  • the membrane 8 is preferably removably combined with the support 7 and that, as the respective collecting face 6, it has a diameter of between about 1.5 cm and about 4.5 cm, more preferably of between about 2 cm and about 4 cm.
  • the separation of the membrane from the support can occur manually, the membrane being, for example, of the peelable film type, or the membrane can be separated by the support spontaneously once immersed into a liquid according to standard coloring procedures used in the Pap test method.
  • the collecting face 6 can have a substantially flat profile, at least partly concave, at least partly convex or variously defined, so that to better be able to adapt to uterine cervices with different anatomical characteristics.
  • figures 9-16 show a device for the cytological sampling of exfoliated cells of the uterine cervix generally denoted by 101 , which device is substantially similar to the device 1 shown above and to which description reference is made, and from which it substantially differs to provide a collecting body 150 which can acquire a second position (closed position) wherein, in addition to being tilted, it has a substantially concave side facing a gripping portion 3 of the device 101.
  • the collecting body 150 is a so-named self-bearing disc-shaped body comprising a collecting face 160 made in one piece.
  • the device 101 comprises a pole-shaped element 2 extended between the aforesaid gripping portion 3 and a head portion 4, wherein the collecting body 150 is combined with the pole- shaped element 2 at the head portion 4.
  • the collecting body 150 is thus movable with respect to the pole-shaped element 2 between a first position, so-named open, in which the collecting body 150 is substantially orthogonal to the pole-shaped element 2 and the collecting face 160 is extended or unfolded, and the aforesaid second position, so-named closed.
  • the device 101 For the movement of the collecting body 150, the device 101 comprises movement means active on the collecting body 150, which movement means, according to the examples of the figures, comprise a plurality of sliding arms 9 operable by the user.
  • the respective ends of the sliding arms 9 opposite the collecting body 150 are combined with a knob 10 to facilitate the control of the movement of the sliding arms 9 by the user.
  • the aforesaid movement means further comprise a plurality of clevis- shaped combining elements for combining the sliding arms 9 with the pole shaped element 2, each denoted by 11.
  • the aforesaid movement means further comprise a plurality of joining elements 12, each interposed between the collecting body 150 and a respective sliding arm 9.
  • the joining elements 12 can be articulated, mechanically articulated or one or more non-articulated joining elements 12, substantially fixed between the collecting body and the sliding arms, can also be provided, the possible relative movement being allowable by the type of material used.
  • the collecting body 150 is preferably removably combined with the pole-shaped element 2.
  • the device 101 comprises combining means 13 interposed between the collecting body 150 and the pole-shaped element 2, and particularly between the collecting body 150 and the head portion 4 of the pole-shaped element 2.
  • the combining means 13 can thus be means of the snap-fit, bayonet, screw type or the like, and/or jointed or mechanically articulated combining means, the possibility of having combining means for a substantially non- articulated joint between the collecting body and the pole-shaped element not however being excluded, the possible relative movement being allowable by the type of material used.
  • the collecting body 150 has characteristics of elasticity such as to be able to be bent in the aforesaid second position so that to further decrease its size when introduced into or extracted from the vagina, and to then return to an open configuration in the first position.
  • devices completely similar to the devices shown above, with reference to the examples of figures 1-8 and 9-16 and to which description reference is made, but different from the device 1 and respectively from the device 101 , substantially for the fact of having a collecting face comprising a bottom and a collecting material apt to sample cells exfoliated from the uterine cervix distributed on the bottom, can be provided.
  • the collecting material for example a material of high viscosity, is preferably a natural gel, a synthetic gel or a blend thereof, selected from the group comprising agar, agarose, methylcellulose, elastin, elastin-likes, hyaluronic gels, polypeptide gels, and respectively selected from the group comprising polyacrylamide, polymacon, polyethylene glycol, or other forms of hydrogels or polymer-based gels.
  • an elastic or anyhow flexible collecting body that is bent in addition to being tilted in the second position (closed position)
  • a device comprising a ring-shaped-body support of the type described above with reference to the examples of figures 1-8 and respective variants
  • a device comprising a disc-shaped-body collecting body of the type described above, with reference to the examples of figures 9-16 and respective variants, and which is tilted and not bent in the second position (closed position) can also be provided.
  • an elastic or anyhow flexible collecting body which is bent in the second position (closed position) can be provided in devices of the type considered above, in which in the second position the collecting body is not tilted but substantially orthogonal to the pole-shaped element.
  • figures 17-26 show a device for the cytological sampling of exfoliated cells of the uterine cervix generally denoted by 201 , which device is substantially similar to the device 1 shown above and to which description reference is made, and from which it substantially differs to provide a collecting body 250 having a spoke-like support 270, instead of a ring-shaped body, and to provide a second position of the collecting body 250 (closed position) in which it is not tilted, but closed like an umbrella, having a substantially concave side facing a gripping portion 3 of the device 201.
  • the support 270 comprises four spokes, the possibility of providing a different number of spokes not however being excluded.
  • the collecting body 250 thus comprises, in addition to the support 270, a membrane 8 which has a collecting face 6 on one side and a face adherent or anyhow constrained to the support 270 on the other.
  • the device 201 comprises a pole-shaped element 202 extended between the aforesaid gripping portion 3 and a head portion 204, wherein the collecting body 250 is combined with the pole-shaped element 202 at the head portion 204.
  • the collecting body 250 is combined with the head portion 204 at a central portion thereof.
  • the collecting body 250 is thus movable with respect to the pole-shaped element 202 between a first position, so-named open, in which the collecting body 250 is substantially orthogonal to the pole shaped element 202 and the collecting face 6 is extended or unfolded, and the aforesaid second position, so-named closed, in which the aforesaid substantially concave side facing the gripping portion 3 of the device 201 is opposite the collecting face 6.
  • the device 201 For the movement of the collecting body 250, the device 201 comprises movement means active on the collecting body 250, which movement means, according to the examples of the figures, comprise a plurality of sliding arms 9 operable by the user.
  • sliding arms 9 are provided combined with the support 270 at respective portions of the same support 270 distal from the head portion 204 of the pole-shaped element 202, i.e. at the respective portions distal from the aforesaid spokes, the possibility of providing a different number of sliding arms and/or, as mentioned, a different number of spokes and also a different position for combining the sliding arms with the spokes, for example at the respective middle portions of the latter, not however being excluded.
  • the aforesaid movement means further comprise a plurality of ring- shaped combining elements constrained to the pole-shaped element 2 for combining the sliding arms 9 with the pole-shaped element 202, each denoted by 211.
  • the aforesaid movement means further comprise a plurality of joining elements 12, each interposed between the collecting body 250 and a respective sliding arm 9 and specifically, according to the examples of the aforesaid figures, each interposed between the support 270 and a sliding arm 9.
  • the joining elements 12, according to the preferred embodiment shown in figures 17-26, are articulated, the possibility of having one or more substantially non-articulated joints between the support and the sliding arm not however being excluded, the possible relative movement being allowable by the type of material used.
  • the support 270 is preferably removably combined with the pole-shaped element 202.
  • the device 201 For the removable combining of the support 270 with the pole-shaped element 202 and to facilitate the aforesaid movement between the first position and the second position of the collecting body 250, the device 201 comprises combining means 213 made in one piece with the support 270 or removably interposed between the support 270 and the head portion 4 of the pole-shaped element 202, wherein the combining means 213 are preferably jointed or mechanically articulated, the possibility of having combining means substantially not jointed or mechanically articulated not however being excluded, the possible relative movement being allowable by the type of material used.
  • each of the aforesaid spokes of the support 270 is combined with, or made in one piece with, the combining means 213, any way so that to be able to acquire the aforesaid first open position and the aforesaid second closed position.
  • the head portion 4 has a tapered profile, i.e. that it tapers towards the collecting body 250, advantageously to facilitate the closing of the same collecting body 250 in the aforesaid second position, the possibility of providing a pole-shaped element 202 with different profile or a substantially constant section not however being excluded.
  • the device according to the present invention can possibly comprise at least one element of reference combined with the collecting body and preferably combined with the collecting face, apt to identify the orientation of the collecting face and not shown in the examples of the aforesaid figures.
  • the element of reference is a sort of marker that facilitates the orientation of the topography during the microscopic reading.
  • the aforesaid collecting body is the portion of the device that comes into contact with the uterine cervix and which, thanks to the aforesaid collecting face, allows to sample cells exfoliated from the uterine cervix so that to maintain substantially unvaried the spatial ratios between them.
  • the exfoliated cells sampled with the present device can then be released on a slide or other appropriate support or can be observed directly on the aforesaid collecting face, depending on the case, with a faithful arrangement representative of the original topography of the uterine cervix.
  • the proper use of the present device especially provides for displaying the uterine cervix of a patient through the vaginal insertion of a gynecological speculum.
  • the present device is subsequently inserted through the gynecological speculum by holding it through the pole-shaped element at the gripping portion which acts as the grip, until reaching the uterine cervix so that to be able to apply the collecting face on the uterine cervix.
  • the collecting face is substantially overlapping the uterine cervix.
  • the device is extracted with exfoliated cervical cells adhering to the collecting face, which are maintained in their original topography and can then be displayed and thus directly analyzed on the collecting face or transferred to a specific support, anyway maintaining the topographical characteristics of the sample.
  • the device comprises a collecting body that can acquire or, even better, move between the two aforesaid positions
  • the insertion of the gynecological speculum occurs with the device in the closed position so that to decrease the volume of the device while entering the vagina and, advantageously, also the removal from the vagina occurs with the device in the closed position
  • the device is brought to the substantially open position with the desired angle between the collecting face and the cervix, thus, as a function of the angle between the collecting body and the pole-shaped element, depending on the anatomic characteristics of the specific cervix, the switching between the different positions being controlled by the user.
  • a device for the cytological sampling of exfoliated cells of the uterine cervix is provided to perform an examination for the diagnosis of precancerous lesions of the uterine cervix in the context of cervical cancer prevention pathways, that allows to sample cells exfoliated from the uterine cervix so that to maintain substantially unvaried the spatial ratios between them and to have, at the time of the study of the exfoliated cells, for example microscopic, cytological or a anatom icopathologic one, a faithful arrangement representative of the original topography of the uterine cervix.
  • the present device is particular easy to implement and use, as well as economic and, thus, particularly appropriate for being widely used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif (1) pour l'échantillonnage cytologique de cellules exfoliées du col de l'utérus, comprenant : un élément en forme de bâton (2) s'étendant entre une partie préhension (3) et une partie tête (4), et un corps de collecte (5) combiné à l'élément en forme de bâton (2) au niveau de la partie tête (4), le corps de collecte (5) comprenant une face de collecte (6) faisant face au côté opposé par rapport à la partie préhension (3), la face de collecte (6) étant apte, par contact sans frottement, à l'échantillonnage topographique de cellules exfoliées du col de l'utérus d'un patient.
PCT/IB2020/052446 2019-03-20 2020-03-18 Dispositif d'échantillonnage cytologique de cellules exfoliées du col de l'utérus WO2020188489A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000004061 2019-03-20
IT102019000004061A IT201900004061A1 (it) 2019-03-20 2019-03-20 Dispositivo per prelievo citologico di cellule esfoliate della cervice uterina

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WO2020188489A1 true WO2020188489A1 (fr) 2020-09-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112535501A (zh) * 2020-12-02 2021-03-23 朱英宏 一种妇产科用宫腔取样装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5231992A (en) * 1990-06-04 1993-08-03 Leon Arnaldo C Low-impact cervical cell and fluid collector
US5253652A (en) * 1993-01-25 1993-10-19 Fast James I Cytologic sampling device for collecting cervical and vaginal cell specimens
US20120157878A1 (en) * 2009-08-28 2012-06-21 Arx Tech Llc Anatomically designed and collapsible intravaginal device for self-sampling and containment of cervical epithelial cells
US20130267870A1 (en) * 2012-04-06 2013-10-10 Histologics Llc Cell and tissue collection method and device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5231992A (en) * 1990-06-04 1993-08-03 Leon Arnaldo C Low-impact cervical cell and fluid collector
US5253652A (en) * 1993-01-25 1993-10-19 Fast James I Cytologic sampling device for collecting cervical and vaginal cell specimens
US20120157878A1 (en) * 2009-08-28 2012-06-21 Arx Tech Llc Anatomically designed and collapsible intravaginal device for self-sampling and containment of cervical epithelial cells
US20130267870A1 (en) * 2012-04-06 2013-10-10 Histologics Llc Cell and tissue collection method and device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112535501A (zh) * 2020-12-02 2021-03-23 朱英宏 一种妇产科用宫腔取样装置

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