Cytologic sampling device

Abstract

The present invention relates to a cytologic sampling device that can be assembled by the user in different configurations, according to the application. The cytologic sampling device comprise a handle having a longitudinal axis X, a sampling medium, suitable to collect cells for laboratory analysis, and a carrier for carrying the sampling medium. The carrier is removably attachable to the handle at an angle with respect to the longitudinal axis or with an offset with respect to the longitudinal axis. The device can be set up with the carrier not coaxial with the longitudinal axis of the handle, meaning that the carrier does not point at the longitudinal axis X, but points away from the longitudinal axis X; the carrier can therefore be attached to the handle with an angle, resulting in a more effective layout for reaching out tissues of the body that are not aligned with the opening through which the device is inserted in the body.

Description

[0001] Cytologic sampling device

[0002] Field of the Invention

[0003]

[0001] The present invention relates to the field of medical testing, and in particular relates to a cytologic sampling device for use in collecting cells for laboratory analysis.

[0004] Background

[0005]

[0002] Cytology is the branch of biology that deals with the study of cells, their structure, function, multiplication, pathology, and life history for abnormal morphology, DNA changes, and other characteristics. Cytology helps diagnose and understand various diseases, including cancer.

[0006]

[0003] Cytologic sampling devices are tools used to collect cells from various living tissues or fluids, in humans or animals, for subsequent cytological examination. The goal is to obtain a representative sample of cells, which a pathologist or a veterinary then examines to diagnose diseases, or perform screening or research.

[0007]

[0004] Among various types of cytologic sampling devices, the following main types can be named: fabrics, brushes, spatulas, needles, swabsfilms, and pads or combinations thereof. Brushes and spatulas are generally used in exfoliative cytology for studying cells obtained from the body surface through scraping or brushing, such as in Pap tests for cervical cancer screening. Needles are used in aspiration cytology for studying cells obtained through fine- needle aspiration biopsy, which involves inserting a thin needle into a suspicious area to collect cells. Swabs are mostly used in liquid-based cytology, to collect cells from bodily fluids. The choice of the specific device to be used in a given situation is made by the pathologist or the veterinary, depending upon the characteristic of the site chosen for the collection of the cells.

[0008]

[0005] Any cytologic sampling device should ensure effectiveness, meaning that it should permit to obtain a sample of cells that is sufficient and representative for accurate diagnosis without incurring in cell damage or contamination of the sample, comfort, meaning that it should imply the minimum discomfort or pain to the subject, human or animal, during the sampling process, and easy processing, meaning that, after sampling, the device should be processable in the most simple way with minimum effort by a laboratory technician, preferably with automatic testing machines and without risk of contaminating the sample. Nevertheless, not all the solutions available on the market fulfil these requirements altogether.

[0006] For example, tracheostomy sterile brushes are known, having nylon bristles and flexible stainless-steel handle, that are used to brush the throat. These brushes provide an acceptable level of comfort, but are not suitable for storage in a sampling tube or vial for the PCR test and, therefore, don’t provide easy processing after sampling. Moreover, flexibility of the handle can jeopardize the effectiveness of the brushing of deep body cavities, as the handle tends to adapt to the shape of the cavity.

[0009]

[0007] The company Rovers Medical Devices (The Netherlands) developed the following brushes for performing cervical cytology at the uterus, identified by their commercial name and well known among physicians:

[0010] - Cervex-Brush®, that features a handle and a brush head fitted to the handle. The brush head semi-circular soft and flexible hairs intended to sweep the portio and reach beyond the transformation zone into the cervical canal. The brush head is made of hydrophobic material, facilitating the release of cell material into fluid or onto a glass slide. US design patent USD 552,238S shows the structure of the brush head, which resembles a broom.

[0011] - EndoCervex-Brush®, that features a brush head with 600 separate thin collection bristles for simultaneous collection of cellular material.

[0012] Both these brushes have a longitudinal stiff handle, shaped as a thin rod, with a free end onto which the brush head is fitted in a detachable manner; when the sampling has been completed, the brush head can be separated from the handle, and dropped in a testing vial. These brushes can be used for HPV testing, conventional cytology and liquid based cytology and, over the time, have proven to be effective, to the extent that they have become one of the most used devices.

[0013]

[0008] The Applicant recognized that available cytologic sampling devices have some drawbacks that the present invention aims to overcome.

[0014]

[0009] Brushes provided with a stiff rod as handle, and a brush head at the tip of the rod, are intended to be rotated by the physician within the body cavity, to let the bristles or the hairs brushing the body cavity and collecting cell samples. Rotations imparted to the rod cause rotations of the brush head exactly on the longitudinal axis of the rod, meaning that the brush head always brushes the same one circular area. For example, the physician uses a speculum to open the vaginal cavity during cervical cytology sampling and proceed to insert a tip of the brush head into the endocervix with the outer bristles or hairs in contact with the ectocervix; then the physician rotates the rod on its longitudinal axis and performs at least five complete turns before extracting the brush from the vagina, separating the brush head from the rod and collect the brush head in a testing vial. Clearly, in the ideal condition when the uterus is perfectly in front or in the middle of the opening created by the speculum, the brush head is centred with the cervix; therefore, the brush head covers a circular area of the cervix which is symmetrical with respect to the longitudinal axis of the rod and all the hairs exert proper pressure on the body tissues while brushing. An example is shown in the video available at this internet link: On the contrary, when the uterus is not really in front or in the middle of the opening created by the speculum, it’s extremely difficult to reach over the inside of the cervix with the tip of the brush head, with the consequence that the brush head cannot be centred with the cervix and the area covered by the brush head would not be symmetrical with respect to the longitudinal axis of the rod; in this circumstance, a portion of the body tissue might be brushed with excessive pressure by the hairs of the brush head and another portion might be brushed lightly by the hairs.

[0015]

[0010] The same drawback arises in any body cavity that is not symmetric with the rod inserted in it, and arises also with swaps, that can only be rotated along the longitudinal axis of the swab.

[0016]

[0011] Available cytologic sampling devices have another drawback: the sampling cannot be performed by anyone other than an experienced physician. For example, the sampling at the cervix cannot be done by the subject herself, at home. In fact, the difficulties explained above about the correct procedure for collecting samples, when the device is not centred with the cervix, require that the sampling is performed by a skilled practitioner.

[0017]

[0012] Another drawback is that it can result complicated to separate the brush head from the rod, in order to drop the brush head in a testing vial. If the brush head doesn’t come off the rod easily, the user might be forced to grab the brush head with a hand or another tool, with the risk of contaminating the acquired sample. Another possibility is that, by applying sufficient force on the brush head to have it separated from the rod, the brush head may separate suddenly in an uncontrolled way, and fall off the table, getting contaminated. Again, a non-experienced user might easily contaminate the sample.

[0018]

[0013] Another drawback is that cytologic sampling devices like spatulas do not provide comfort, instead they tend to cause bleeding and pain. Therefore, it is desirable to replace such devices with solutions that provide more comfort.

[0019]

[0014] It is known from W02019 / 106408A1 a self-sampling device that uses a sampling cloth made of a flexible fabric with an absorbancy of 3.5 g / g or less, that is physically and mentally more comfortable and that is easy to use for self-sampling specimens like cells, ceil residues, DNA, RNA, proteins and / or other materials of interests from bodily cavities like the vaginal or rectal cavity. The sampling cloth is introduced in the bodily cavity by means of an applicator.

[0020]

[0015] However, the device described in W02019 / 106408A1 shares the same drawbacks as above in that it is challenging to access areas within bodily cavities that are not directly aligned with the applicator.

[0021] Summary of the Invention

[0022]

[0016] The aim of the present invention is to provide a cytologic sampling device, a kit and a method that allow for easily and efficiently collecting samples, also by the non-experienced person.

[0023]

[0017] A first aspect of the invention relates to a cytologic sampling device comprising:

[0024] - a handle having a longitudinal axis X, that can also be an axis of rotation,

[0025] - a sampling medium, configured to collect cells for laboratory analysis, and

[0026] - a carrier for carrying the sampling medium.

[0027] The carrier is removably attachable to the handle at an angle with respect to the longitudinal axis. Alternatively, the carrier is removably attachable to the handle with an offset with respect to the longitudinal axis X, that is, the longitudinal axis X is not the midline of the carrier. Thanks to this configuration, the device can be set up with the carrier not coaxial with the longitudinal axis of the handle, meaning that the carrier does not point at the longitudinal axis X, but points away from the longitudinal axis X; the carrier can therefore be attached to the handle with an angle, resulting in a more effective layout for reaching out tissues of the body that are not aligned with the opening through which the device is inserted in the body. In other words, the carrier can be attached to the handle at different orientations and this makes the device versatile, multipurpose, as it can be configured as desired. Basically, the orientation of the carrier relatively to the handle is selectable by the user in order to obtain a given orientation of the sampling medium with respect to the longitudinal axis X. Therefore, performing the sampling becomes a possibility also for non-experienced people, that have no specific knowledge about the best device to be used in a given situation.

[0028] The device according to the invention is specifically designed for efficient and effective sampling of specimens from various bodily cavities, for example specimens like cells, ceil residues, DNA, RNA, proteins and / or other materials. Bodily cavities include, but are not limited to, the vaginal, anal, oral, nasal, and urethral cavities. Additionally, the device is adaptable for use in less common sampling sites such as the otic (ear) and ocular (eye) cavities. The structural configuration of the sampling device is chosen to suit the unique anatomical features and physiological conditions of each specific cavity. This adaptability ensures that the device can collect cellular specimens with optimal efficacy and minimal discomfort to the user, thereby enhancing the reliability and accuracy of subsequent cytological analyses.

[0029] Definitions

[0030]

[0018] The handle is a component intended to be grabbed with one hand. The simplest handle is a rod. The handle may be stiff enough to avoid bending during use, although it may be manufactured with a material, for example polypropylene or polyethylene, that allows bending or minimum bending. In an alternative embodiment, the handle features a curved end, providing ergonomic advantages and facilitating easier manipulation of the device during use.,

[0031]

[0019] The sampling medium refers to any material or composition specifically designed to collect and preserve cells for the purpose of cytological analysis. The medium may be treated or untreated and is constructed to maintain the integrity, structure, and biochemical characteristics of the collected cells from the time of sampling to the time of analysis. For example, the sampling medium may be made of a textile material. In a preferred embodiment, the sampling medium may be a sampling cloth, such as, for example, the sampling cloth described in document WO2019 / 106408, hereby incorporated by reference. This is a thin, flexible sampling cloth made from a material chosen from the group of a woven or non-woven textile, for example made of synthetic fibers (such as polyester, polypropylene, polyethylene, polyamide, polyacetate, polyvinyl acetate), semi-synthetic fibers (such as viscose, modal, lyocell), plant fibers (such as cotton), animal fibers (such as silk), or combinations thereof. This material has little or no absorbency, so that only a small amount of the specimens is absorbed into the fabric of the sampling cloth. The absorbency should be less than 3.5 g / g, preferably less than 3 g / g, more preferably less than 2 g / g measured using the Syngina protocol for measuring the absorbency of tampons. The thickness of the sampling cloth should be of 3mm or less, preferably 2 mm or less, more preferably 1 mm or less, even more preferably 0.6 mm or less. The material of the sampling cloth may have a basis-weight of approximately 60 g / m2. The sampling medium should be suitable for processing in laboratory, for example suitable for being stored in a liquid. Preferably, the sampling medium may have holes and / or flaps intended to engage the carrier, in order to remain onto the carrier during the sampling, without slipping off, and permit voluntary detachment when the sampling medium is to be processed, for example when it has to be inserted in a testing vial.

[0032]

[0020] The carrier is a detachable component that can be united with the handle, and separated, manually without tools. The shape of the carrier can be adapted to fulfil requirements of specific sampling applications, or can have a shape that is suitable for use in most common applications, as long as it is suitable for insertion in a cavity of the body without causing harm. Coupling between the carrier and the handle is preferably achieved by shape fitting or interlocking.

[0033] Disclosure

[0034]

[0021] In a first embodiment of the cytologic sampling device the carrier is selectively attachable to the handle along two or more different directions of attachment, meaning that coupling the handle with the carrier can be done at two or more relative positions of these components. Each direction of attachment defines a correspondent angle between the carrier and the handle, and therefore between the carrier and the longitudinal axis. Alternatively, each direction of attachment defines an offset between the carrier and the handle, and therefore between the carrier and the longitudinal axis. This means that the user may select between at least two configurations for assembling the device, depending on the angle that the carrier forms with the handle, in order to best fit the device for the specific application for reaching over different areas of the body with the device.

[0035]

[0022] Preferably the longitudinal axis of the handle is also a rotation axis of the handle. In at least one attachment position of the carrier to the handle, the carrier is inclined relatively to the rotation axis X, and the carrier with the sampling medium fitted on the carrier substantially rotate about (around) the rotation axis X when the handle is rotated. In at least another one attachment position of the carrier to the handle, the carrier is coaxial with the rotation axis, and the carrier with the sampling medium fitted on the carrier rotate on the rotation axis X when the handle is rotated. The term coaxial is used to indicate that the carrier is attached to the handle in a way that the carrier is substantially symmetric with respect to the rotation axis; in other words, the carrier has a symmetric shape relatively to one attachment with the handle.

[0036]

[0023] Preferably the handle is a rod having an end configured for interlocking with any corresponding attachment seat of the carrier. Each attachment seat is oriented along a corresponding direction of attachment, for example Y, Z. This means that the user may choose between the at least two attachment seats, when coupling the handle with the carrier, and make the direction Z coaxial with the longitudinal axis X of the handle or, alternatively, the user can make the direction Y coaxial with the longitudinal axis X of the handle. The two exemplary configurations just described, i.e. Z=X or Y=X, differ in that when Z=X the carrier is coaxial and substantially symmetric with the longitudinal axis X, while when Y=X the carrier is inclined or offset with respect to the longitudinal axis X. When the handle is rotated by the user on the longitudinal axis X, the carrier follows corresponding different paths, as it will become clear in the following.

[0037]

[0024] Preferably the end of the handle, considered in cross-section on a section plane orthogonal to the longitudinal axis X of the handle, has a shape that is complementary to the shape of any corresponding attachment seat of the carrier, sot that when the end of the handle is inserted in a corresponding attachment seat of the carrier, interlocking is achieved that prevents rotation of the handle relatively to the attachment seat of the carrier.

[0038]

[0025] Preferably, in the first embodiment the carrier comprises at least two attachment seats for interlocking with the handle, a first attachment seat aligned with a first direction of attachment Z and a second attachment seat aligned with a second direction of attachment Y. The first direction of attachment Z is coaxial with the carrier and the second direction of attachment Y defines an angle with respect to the first direction of attachment Z. Therefore, when assembling the device, the user may fit the handle in the first attachment seat or in the second attachment seat, depending upon the specific task to be carried out.

[0039]

[0026] Preferably the carrier of the first embodiment has a frame onto which the sampling medium is fitted. Depending upon the direction of attachment Y or Z of the carrier to the handle:

[0040] - the frame is aligned with the longitudinal axis X of the handle (symmetric and coaxial configuration), or

[0041] - the frame forms an angle with the longitudinal axis X of the handle (inclined configuration), or

[0042] - is offset relatively to the longitudinal axis X of the handle (offset configuration).

[0043]

[0027] Preferably, the frame is shaped as a rectangular window having two longitudinal beams and two transversal beams delimiting an opening, i.e. a through hole. In a first way of attachment of the carrier to the handle (2), the longitudinal beams of the frame are parallel with the longitudinal axis X of the handle. In a second way of attachment of the carrier to the handle, the longitudinal beams of the frame are inclined relatively to the longitudinal axis X of the handle. In a third way of attachment of the carrier to the handle, the longitudinal beams of the frame are offset relatively to the longitudinal axis X of the handle. The term offset is used to indicate that the longitudinal beams of the frame are parallel with the longitudinal axis X of the handle but not centred with the axis X, meaning that the longitudinal axis X is not the midline of the frame.

[0044]

[0028] Preferably the two longitudinal beams of the frame are aligned with an attachment seat of the carrier intended to receive the handle.

[0045]

[0029] Due to the fact that the carrier can be coupled to the handle along different directions of attachment, the device can be assembled in several configurations that permit to cover different trajectories of the sampling medium when the handle is rotated. For example, in a first way of attachment of the carrier to the handle, along a first direction of attachment X=Z, the carrier is rotatable by the handle on a first circumferential path centred on the longitudinal axis X. Conversely, in a second way of attachment of the carrier to the handle, along a second direction of attachment X=Y, the carrier is rotatable by the handle on a second circumferential path offset relatively to the longitudinal axis X. The result is that the sampling medium reaches over different areas of the body subject to the sampling.

[0046]

[0030] Preferably the carrier is provided with at least one tip that cantileverly extends from the carrier, in particular from the frame of the carrier, at the opposite side with respect to the handle when the device is assembled. The tip is preferably made of a soft material and has one or more lamellas intended to collect cells or specimen from the body. Basically, the tip is intended to be inserted into a cavity to have the lamellas scrubbing the cavity walls and collecting specimen. The tip is preferably detachable from the carrier, so that the user may take it off when the tip is not needed. Also preferably, the tip has a length of 10 cm or less.

[0047]

[0031] In this embodiment, preferably the tip of the carrier is coaxial with the handle in a first way of attachment of the carrier to the handle, meaning that the tip extends along the longitudinal axis X when the device is assembled in this way.

[0048]

[0032] In this embodiment, preferably the carrier is provided with a lateral lobed portion having a coarse surface, intended to scrub or scratch bodily tissues for collecting specimen. For example, the lateral lobed portion extends from a longitudinal beam of the carrier frame, and is made of soft rubber.

[0049]

[0033] In a preferred embodiment, the sampling medium is textile and is blocked on the carrier by means of at least one blocking point that joins two parts of the textile sampling medium. The at least one blocking point may be obtained, without being limited to these methods, by sewing, welding (ultrasonic, thermal, laser), adhesive bonding, heat sealing, or other methods. In a preferred embodiment, the at least one blocking point is obtained by welding. The blocking points prevent the undesired slipping off of the textile sampling medium from the carrier. The blocking points should, preferably, be manually breakable to separate the textile sampling medium from the carrier when the sampling has been performed and the textile sampling medium has to be stored for laboratory analysis. Alternatively, or in addition, the sampling medium may have at least one hole intended to engage the tip of the carrier, and avoid slipping off during sampling; in this case, the lamellas on the tip retain the sampling medium.

[0050]

[0034] In another embodiment of the present invention, the carrier can be coupled to the handle in such a way that the carrier remains substantially orthogonal to the handle, for example with the frame orthogonal to the longitudinal axis X. This assembling, that is similar to a rake, is suitable for collecting cells and specimen in the throat.

[0051]

[0035] A second aspect of the present invention relates to a cytologic sampling kit comprising the cytologic sampling device described above and a collecting vial. Upon separating the carrier with the sampling medium from the handle, or upon separating the sampling medium from the carrier, these components can be stored in the collecting vial for subsequent laboratory analysis. The kit is simple to assemble and use by any user.

[0052]

[0036] A third aspect of the present invention relates to a method of sampling cells or specimen from human or animal body. The method comprises: a) providing the cytologic sampling device disclosed above, b) coupling the handle to the carrier carrying the sampling medium, wherein step b) is carried out: b’) on a first direction of attachment Z of the handle to the carrier, or b”) on any different direction of attachment Y of the handle to the carrier, c) inserting the carrier in a cavity of the body and rotate the handle on the longitudinal axis X to respectively: c’) cause rotation of the carrier within a first circular path centred relatively to the longitudinal axis X, or c”) cause rotation of the carrier within a circular path offset relatively to the longitudinal axis X.

[0053] As described above, the two circular paths cover different areas of the body and permit to collect samples at different parts without having to change sampling device.

[0054]

[0037] When the carrier with the tip is used, the tip can be inserted into a cavity to act as a pivot for rotating the handle and the carrier. This can be done, for example, during cervical cytology by inserting the tip in the cervix and by rotating the handle to brush the cervix with the sampling medium.

[0038] Once the cells or specimen have been collected, either the carrier with the sampling medium are separated from the handle and dropped into a collecting vial, or the sampling medium alone is separated from the carrier and dropped into a collecting vial.

[0055]

[0039] A fourth aspect of the present invention relates to another method of sampling cells or specimen from a human or animal cavity, particularly suitable for the oral cavity, that provides using the device with the carrier orthogonal to the handle. According to this method, cells from the oral mucosa can be efficiently collected, that are crucial for the detection and diagnosis of conditions such as oral cancer. The method comprises: a) providing the cytologic sampling device, b) coupling the handle to the carrier carrying the sampling medium, so that the carrier (and the sampling medium) remains orthogonal to the longitudinal axis X, c) inserting the carrier in the cavity and move the handle up and down, in a direction perpendicular to the longitudinal axis X, to scrub the cavity with the sampling medium placed orthogonal to the longitudinal axis X.

[0056] Brief description of the drawings

[0057]

[0040] Further characteristics and advantages of the invention will be more evident by the review of the following specification of a preferred, but not exclusive, embodiment, which is depicted for illustration purposes only and without limitation, with the aid of the attached drawings, wherein:

[0058] - Figure 1 is an exploded view, and partially perspective, of the handle and the carrier (of a textile sampling medium) of a cytologic sampling device according to a first embodiment of the present invention;

[0059] - Figure 2 is a view in elevation of the carrier and a textile sampling medium intended to be fitted on the carrier;

[0060] - Figure 3 is a perspective elevation view of the carrier with the textile sampling medium fitted on it;

[0061] - Figure 4 is an elevation view, in cross section, of the carrier with the textile sampling medium fitted on it;

[0062] - Figure 5a is an elevation view of the first embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium being brought in attachment with the handle, along a first direction of attachment;

[0063] - Figure 5b is a front view of the first embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium attached to the handle along said first direction of attachment; - Figure 6 is a schematic view of the first embodiment of cytologic sampling device, as assembled in figure 5b (first direction of attachment), performing sampling at the cervix of a subject;

[0064] - Figure 7a is a front view of the first embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium being brought in attachment with the handle, along a second direction of attachment;

[0065] - Figure 7b is a front view of the first embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium attached to the handle along said second direction of attachment;

[0066] - Figure 8 is a schematic view of the first embodiment of cytologic sampling device, as assembled in figure 7b (second direction of attachment), performing sampling at the cervix of a subject;

[0067] - Figure 9 is a schematic view of the first embodiment of cytologic sampling device, as assembled in figure 5b (first direction of attachment), performing sampling at the cervix of a subject;

[0068] - Figure 10 is equivalent to figure 9, but with the textile sampling medium being removed or not shown;

[0069] - Figure 11 is a schematic view of the first embodiment of cytologic sampling device, as assembled in figure 7b (second direction of attachment), performing sampling at the cervix of a subject;

[0070] - Figure 12 is equivalent to figure 11 , but with the textile sampling medium being removed or not shown;

[0071] - Figure 13 is a perspective view of a carrier of a textile sampling medium of a cytologic sampling device according to a second embodiment of the present invention;

[0072] - Figure 14 shows the carrier of figure 13, with the textile sampling medium fitted on it;

[0073] - Figure 15a is a schematic perspective view of the second embodiment of the cytologic sampling device according to the present invention, with the carrier being brought in attachment with the handle along a first direction of attachment;

[0074] - Figure 15b shows the second embodiment of the cytologic sampling device of figure 15a, with the carrier attached to the handle along said first direction of attachment;

[0075] - Fig. 16 is a schematic view of the second embodiment of the cytologic sampling device performing sampling at the throat of a subject; - Figure 17 is a perspective view of a third embodiment of the present invention, assembled with the textile sampling medium fitted on the carrier;

[0076] - Figure 18 is a perspective view of the third embodiment of figure 18, without textile sampling medium;

[0077] - Figure 19 is a perspective vertical view of the carrier of a fourth embodiment of the cytologic sampling device according to the present invention, provided with three tips;

[0078] - Figure 20 is a perspective view of the fourth embodiment in a first configuration, without textile sampling medium;

[0079] - Figure 21 is a perspective view of the fourth embodiment in a second configuration, without textile sampling medium;

[0080] - Figure 22 is a view in elevation of the carrier and a textile sampling medium of a fifth embodiment of the present invention;

[0081] - Figure 23 is a perspective elevation view of the carrier of figure 22 with the textile sampling medium fitted on it;

[0082] - Figure 24 is an elevation view, in cross section, of the carrier of figure 22 with the textile sampling medium fitted on it;

[0083] - Figure 25 is an elevation view of the fifth embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium being brought in attachment with the handle;

[0084] - Figure 26 is a front view of the fifth embodiment of cytologic sampling device, with the carrier carrying the textile sampling medium attached to the handle;

[0085] - Figure 27 is a schematic perspective view of the sixth embodiment of the cytologic sampling device according to the present invention, with the carrier being brought in attachment with the handle;

[0086] - Figure 28 shows the sixth embodiment of the cytologic sampling device of figure 27, with the carrier attached to the handle.

[0087] Detailed description of the invention

[0088]

[0041] Figures 1 to 12 show a first embodiment of the present invention that is particularly suitable for performing cervical cytology.

[0089]

[0042] Figures 13 to 16 show a second embodiment of the present invention that is particularly suitable for performing throat cytology.

[0090]

[0043] Figures 17 and 18 show a third embodiment of the present invention that is particularly suitable for performing throat cytology.

[0044] Figures 19 to 21 show a fourth embodiment of the present invention that is particularly suitable for performing deep throat cytology or cytology of the abdomen.

[0091]

[0045] Figures 22 to 26 show a fifth embodiment of the present invention.

[0092]

[0046] Figures 27 and 28 show a sixth embodiment of the present invention.

[0093]

[0047] Figures 1-12 show the first embodiment 1 that comprises a handle 2, shaped as a stiff rod, and a carrier 4 of a textile sampling medium that is firstly shown in figure 2. The handle 2 is preferably made of a polymer, like PET or PP, and has a non-circular cross section 5’, 5”. The handle extends along a longitudinal axis X that is also an axis of rotation of the handle 2. The end 5 of the handle 2 is intended to selectively engage a corresponding attachment seat 6, 7 provided on the carrier 4; when the device is being assembled by a user, the user inserts the end 5 of the handle 2 into one of the attachment seats 6 or 7 of the carrier 4 to obtain a complete device 1 with the carrier 4 having a corresponding one orientation relatively to the handle 2. In other words, the orientation of the carrier 4 relatively to the handle 2 is selectable by the user depending upon the preferred orientation of the textile sampling medium 3 for best performing the sampling.

[0094]

[0048] The handle 2 interlocks with any attachment seat 6, 7 by virtue of complementary shapes of the end 5 and the seats 6, 7. In particular, as visible in figure 1 , the end 5 of the handle 2 has a non-circular cross section 5’, 5” to engage a corresponding complementary attachment seat 6, 7. This shape coupling prevents rotation of the handle 2 relatively to the attachment seats 6, 7.

[0095]

[0049] The carrier 4 may have more than two attachment seats 6, 7. In the example shown in figures 1-12 there are two seats, a first seat 6, that opens at the back of the carrier 4 along a first direction of attachment Z, and a second seat 7, that opens at the back of the carrier 4 along a second direction of attachment Y. Between the two directions Z and Y an angle is defined. When the user assembles the device 1 by inserting the end 5 of the handle 2 in the first attachment seat 6 of the carrier 4, obtaining X=Z, the carrier 4 substantially remains coaxial with the longitudinal axis X, meaning that it remains substantially symmetrical with respect to the longitudinal axis X. When the user assembles the device 1 by inserting the end 5 of the handle 2 in the second attachment seat 7 of the carrier 4, obtaining X=Y, the carrier 4 remains transversal to the longitudinal axis X.

[0096]

[0050] The carrier 4 has a frame 8 intended to support the textile sampling medium 3. In the example of the figures the frame 8 is shaped as a window having two longitudinal beams 9, 10 and two transversal beams 11 , 12 that altogether delimit an opening 13. When the textile sampling medium 3 is fitted on the carrier 4, as shown for example in figures 3 and 4, in order to prevent disengagement, i.e. slipping off, the two parts of the textile sampling medium 3 that extend on opposite sides of the frame 8 are welded one to another with at least one welding point 3’. In the example shown in the figures two welding points 3’ are provided to unite the two parts of the textile sampling medium 3 in correspondence of the opening 13 of the frame 8, as best shown in figure 4. In this way the textile sampling medium 3 is blocked onto the frame 8, unless the welding points 3’ are broken by the user to separate the textile sampling medium 3 from the carrier 4, on purpose.

[0097]

[0051] The carrier 4 is preferably made of a thermoplastic material, like polypropylene or polyethylene. In the example of figures 1-12 the carrier 4 is shaped as a longitudinal head with the frame 8, but other shapes are possible, for example conic, cylindrical, etc., as long as it does not pose risk to harm the subject of the sampling.

[0098]

[0052] A tip 14 projects out of the carrier 4, on the opposite side relatively to the attachment seats 6, 7 and the handle 2. The tip 14, that can be detachable, is made of a soft material, for example silicone, and is intended to be inserted into a cavity of the body, for sampling but also to act as pivot. Preferably, as shown in the figures, a plurality of lamellas 15 project from the tip 14 at different position. Lamellas 15 are shaped as umbrellas and are also made of a soft material. Lamellas 15 have the purpose of collecting cells, specimen within the body, especially from the cavity wherein the tip 14 is inserted. In detail, in the example shown in the figures, the tip 14 projects from the transversal beam 11 of the frame 8.

[0099]

[0053] The textile sampling medium 3 of this example is a non-woven textile made of any material certified for laboratory analysis. Although it is shown as a rectangular patch, it can have different shapes, for example it can be circular. As best shown in figure 2, the textile sampling medium 3 has a central through hole 17 that is intended to engage the tip 14 of the carrier 4.

[0100]

[0054] Positioning of the textile sampling medium 3 on the carrier 4 is performed during manufacturing. The producer places the textile sampling medium 3 onto the frame 8 and proceeds to apply welding at 3’ and connect the tip 14 to the frame 8 through the hole 17 of the textile sampling medium 3. Alternatively, if sufficient hygienic practice is put in place, the user may proceed to assemble the device and fit the textile sampling medium 3 onto the carrier 4.

[0101]

[0055] On a side of the carrier 4, in particular on a side of the longitudinal beam 10, a lobed portion 16 is provided, having a coarse surface for smoothly scrubbing or scratching bodily tissues. To this purpose, the lobed portion 16 of the carrier 4 is also preferably of a soft material like silicone. Any specimen collected by the lobed portion 16 can be processed together with the textile sampling medium 3 in a laboratory. Preferably also the lobed portion 16 is detachable, when not needed for a specific sampling.

[0102]

[0056] Figures 5a and 5b show the sequence of assembling the device 1 by inserting the end 5 of the handle 2 into the first attachment seat 6, that extends along the first direction of attachment Z, thereby obtaining that X=Z. In figure 5a the handle is being brought toward the carrier 4. As shown in figure 5b, when the device 1 is correctly and completely assembled, the carrier 4 is coaxial with the handle 2, i.e. with the longitudinal axis X. Also the tip 14 of the carrier is coaxial with the axis X. Any rotation imparted to the handle 2 on the longitudinal axis X, that is also a rotation axis, causes the rotation of the carrier 4 and the tip 14 on the same longitudinal axis X. Due to the shape of the frame 8 and the carrier 4, that is substantially symmetrical with respect to the attachment seat 6, the carrier 4 and the tip 14 rotate exactly on the longitudinal axis X. The textile sampling medium 3 wipes a circular area of the body that is centred on the longitudinal axis X, as best shown in figure 6.

[0057] Figure 6 schematically shows how the device 1 is used during sampling for performing cervical cytology at the uterus in the ideal circumstance when the cervix 21 is aligned with the vagina 20 and, therefore, a coaxial configuration of the device can be used. A user opens the vagina 20 of a subject with a speculum 19 through which the device 1 , assembled as shown in figure 5b, i.e. in the coaxial configuration, is inserted. The handle 2 of the device 1 is rotated with one hand 18 on the longitudinal axis X to perform the sampling, as best shown in the enlarged portion of the drawing in the black circle on the right. The tip 14 of the device 1 is inserted into the cervical canal and acts as a pivot to guide the rotation of the device 1 . As shown, the textile sampling medium 3 on the carrier 4 is brought into contact with the transformation zone 22 of the cervix 21 , next to the cervical canal; by rotating the handle 2 on the longitudinal axis X, the textile sampling medium 3 wipes a circular area at the transformation zone 22 and collects cells; the wiped circular area contains the axis X.

[0103]

[0058] Figures 7a and 7b show the sequence of assembling the device 1 in a non-coaxial configuration, thus in a configuration wherein the carrier 4 forms an angle a with respect to the longitudinal axis X. By inserting the end 5 of the handle 2 into the second attachment seat 7, that is aligned with the second direction of attachment Y, the device 1 is assembled with X=Y, i.e. with the second direction of attachment Y aligned with the longitudinal axis X. Also the tip 14 of the carrier 4 forms an angle a with respect to the longitudinal axis X. Any rotation imparted to the handle 2 on the longitudinal axis X, that is also a rotation axis, causes the rotation of the carrier 4 and the tip 14 not on the longitudinal axis X, but about the longitudinal axis X, meaning that the textile sampling medium 3 wipes an annular area that extends around axis X but does not contain the axis X. Therefore, the area covered by the device 1 with the coaxial configuration shown in figure 5b is different from the area covered by the device 1 with the inclined configuration shown in figure 7b.

[0104]

[0059] Figure 8 schematically shows how the device 1 is used during sampling for performing cervical cytology at the uterus in the circumstance when the cervix 21 is not aligned with the vagina 20 and, therefore, the inclined configuration of the device 1 suits better. A user opens the vagina 20 of a subject with a speculum 19 through which the device 1 , assembled as shown in figure 7b, i.e. in the inclined configuration, is inserted. The handle 2 of the device 1 is rotated with one hand 18 on the longitudinal axis X to perform the sampling, as best shown in the enlarged portion of the drawing in the black circle on the right. The tip 14 of the device 1 is inserted into the cervical canal and acts as a pivot to guide the rotation of the device 1 . As shown, the textile sampling medium 3 on the carrier 4 is brought into contact with the transformation zone 22 of the cervix 21 , next to the cervical canal; by rotating the handle 2 on the longitudinal axis X, the textile sampling medium 3 wipes a circular area at the transformation zone 22 and collects cells; the wiped circular area does not contain the axis X.

[0105]

[0060] By comparing the coaxial configuration of the device 1 shown in figures 5b-6 with the inclined configuration of the device 1 shown in figures 7b-8, it is clear what is meant with the term versatile, referred to the device 1 : it can be assembled in at least two configurations to adapt the device 1 to the anatomy of the subject. This can be done simply by the user, when attaching the handle 2 to the carrier 4.

[0106]

[0061] Figures 9-12 also help to understand the differences between the two configurations. In particular, figures 9 and 10 schematically show the device 1 assembled in the coaxial configuration during sampling at the cervix 21 aligned with the vagina 20, respectively with the textile sampling medium 3 fitted onto the carrier 4 and without the textile sampling medium 3. The tip 14 is inserted in the cervix canal, as explained above. When the handle 2 is rotated, the lobed portion 16 scrubs a corresponding portion 23 of the canal. Figures 9 and 10 schematically show the device 1 assembled in the inclined configuration during sampling at the cervix 21 inclined with respect to the vagina 20, respectively with the textile sampling medium 3 fitted onto the carrier 4 and without the textile sampling medium 3. The tip 14 is inserted in the cervix canal, as explained above. When the handle 2 is rotated, the lobed portion 16 scrubs a corresponding portion 23’ of the canal that is much larger compared to the portion 23 of figures 9 and 10.

[0062] Figures 13 to 16 show a second embodiment 1 of the present invention, particularly suitable for performing throat cytology, that features a carrier 4 having an attachment seat 7 that is oriented at 90° with respect to the frame 8. Figure 13 shows the carrier 4 alone and figure 14 shows the carrier 4 covered with the textile sampling medium 3, fitted by welding points 3’. Figures 15a and 15b show the sequence of assembling the device 1 in the orthogonal configuration, wherein the carrier 4 forms an angle a=90° with respect to the longitudinal axis X of the handle 2. By inserting the end 5 of the handle 2 into the attachment seat 7, that is aligned at 90° with respect to the frame 8, the device 1 is assembled and resembles a rake.

[0107]

[0063] Figure 16 schematically shows how the device 1 of the second embodiment is used during sampling for performing throat cytology. The device 1 , assembled in the orthogonal configuration, is inserted in the throat 24 of a subject. As visible in the enlarged portion within the circled area on the right side, the frame 8 of the device with the textile sampling medium 3 are brought under the epiglottis 25. By moving the handle 2 back and forth along the longitudinal axis X, the textile sampling medium 3 wipes a stripe of the throat and collects cells.

[0108]

[0064] Figures 17 and 18 show a third embodiment 1 that is similar to the second embodiment, with the difference that the carrier 4 features more than one attachment seat, a in particular has four attachment seats 7, 29, 30, 31. In figure 17 the device 1 is shown with the textile sampling medium 3; in figure 18 the textile sampling medium 3 has been removed. The attachment seat 7 is oriented orthogonal to the frame 8 and is arranged on the midline of the frame 8, similarly to the second embodiment. The attachment seat 29 is parallel to the frame 8 and is arranged at a side of the frame 8. Also attachment seat 31 is parallel to the frame 8, but is orthogonal to the attachment seat 29. The attachment seat 30 is in between the attachment eats 29 and 31 and is oriented at 45° relatively to either attachment seat 29 or the attachment seat 31. In this third embodiment the handle 2 can engage the carrier 4 in four different ways, i.e. in four different positions. Thus, the user may assemble the device 1 choosing the most appropriate attachment seat 7, 29-31 for fitting the handle 2 depending upon the specific application. For example, in figures 17 and 18 the handle 2 is engaging the attachment seat 7 to configure the device 1 as a rake, that best performs in the throat. Nevertheless, the same device 1 could have been assembled with a diverse configuration, by introducing the handle 2 in any of the attachment seats 29- 31 to obtain one of the other configuration described in this disclosure: coaxial, inclined, etc..

[0065] Figures 19 to 21 show a fourth embodiment 1 of the present invention, particularly suitable for performing deep throat cytology or cytology of the abdomen, featuring a carrier 4 provided with two attachment seats 26, 27, each defining a corresponding engagement angle with the handle 2. For simplicity, the textile sampling medium 3 is not shown. The carrier supports a frame 8 intended to carry the textile sampling medium 3. From the frame 8 a plurality of tips 14 extend, cantileverly projecting outwards opposite to the attachment seats 26, 27, each having a plurality of lamellas for collecting specimen. In the example shown in the figures, the tips 14 are three, arranged side by side as a trident. Tips 14 of this embodiment are longer than the tip 14 of the embodiments previously described, and permit to reach out for deeper body cavities.

[0109]

[0066] Figures 20 and 21 show the fourth embodiment 1 assembled in two corresponding configurations: in figure 20 the handle 2 is inserted into the attachment seat 27, that defines for a second direction of attachment that is not orthogonal to the frame 8; in figure 21 the handle 2 is inserted into the attachment seat 26, that defines for a first direction of attachment that is orthogonal to the frame 8, i.e. to the plane on which the frame 8 lays.

[0110]

[0067] Figures 22 to 26 show a fifth embodiment of the present invention that provides a carrier 8 that is intended to be coupled to the handle with an offset, i.e. not coaxially with the longitudinal axis X. Figure 22 shows the carrier 4 in elevation, ready to receive the textile sampling medium 3: the carrier 4 has one attachment seat 28 that is not median to the frame 8, meaning that the direction of attachment J is not centred relatively to the frame 8 or, in other words, the frame 8 is not symmetrical relatively to the direction of attachment J. Figure 23 shows, in a perspective view, the carrier 4 with the textile sampling medium 3 arranged on the frame 8 and fixed by means of two welding points 3’. Figure 24 is a section of figure 23 considered on a vertical plane orthogonal to the fame and containing the axis J. Figure 25 is a view in elevation of the device 1 during assembling, when the handle 2 is being brought in engagement with the attachment seat 28 of the carrier 4, already carrying the textile sampling medium 3.

[0111]

[0068] Due to the fact that the handle 2 is not centred relatively to the frame 8, but engages the carrier 4 closer to the longitudinal beam 9 of the frame 8 other than the longitudinal beam 10, when the handle 2 is rotated on the longitudinal axis X, the frame spans further away from the axis of rotation X, covering a circular area larger than the circular area that could be covered if the handle 2 engaged the carrier 4 in the middle, i.e. on the midline of transversal beams 11 and 12.

[0069] Figures 27 and 28 show a sixth embodiment of the present invention that is similar to the second embodiment shown in figures 15a and 15b, with a difference: in the sixth embodiment the attachment seat 7 is offset and not centred on the midline of the frame 8. As it can be seen, the attachment seat is located next to a corner of the frame 8.

Claims

Claims1. A cytologic sampling device (1 ) comprising:- a handle (2) having a longitudinal axis (X),- a sampling medium (3), configured to collect cells for laboratory analysis,- a carrier (4) for carrying the sampling medium (3), wherein the carrier (4) is removably attachable to the handle (2) at an angle with respect to said longitudinal axis (X) and / or with an offset with respect to the longitudinal axis (X).2 Cytologic sampling device (1) according to claim 1 , wherein the carrier (4) is selectively attachable to the handle (2) along two or more different directions of attachment (Y, Z), each direction of attachment defining a correspondent angle between the carrier (4) and the longitudinal axis (X) or defining an offset between the carrier (4) and the longitudinal axis (X3 Cytologic sampling device (1 ) according to claim 1 or claim 2, wherein said longitudinal axis (X) is a rotation axis of the handle (2), and wherein in at least one attachment position of the carrier (4) to the handle (2), the carrier (4) and the sampling medium (3) fitted on the carrier (4) are inclined or offset relatively to the rotation axis (X) and substantially rotate about the rotation axis (X) when the handle (2) is rotated.4 Cytologic sampling device (1 ) according to any of the preceding claims, wherein said longitudinal axis (X) is a rotation axis of the handle (2), and in at least one attachment position of the carrier (4) to the handle (2), the carrier (4) is coaxial with the rotation axis (X and the carrier (4) with the sampling medium (3) fitted on the carrier (4) rotate on said rotation axis (X) when the handle (2) is rotated.5 Cytologic sampling device (1 ) according to any of the preceding claims, wherein the handle (2) is a rod having an end (5) configured for interlocking with any corresponding attachment seat (6, 7) of the carrier (4) and wherein each attachment seat (6, 7) is oriented along a corresponding direction of attachment (Y, Z).6 Cytologic sampling device (1) according to claim 5, wherein said end (5) of the handle (2 considered in cross-section on a section plane orthogonal to the longitudinal axis (X),has a shape (5’) that is complementary to the shape of any corresponding attachment seat (6, 7) of the carrier (4), and rotation of the handle (2) within any attachment seat (6, 7) is prevented.

7. Cytologic sampling device (1) according to claim 5 or claim 6, wherein said carrier (4) comprises at least two attachment seats (6, 7) for interlocking with the handle (2), a first attachment seat (6) aligned with a first direction of attachment (Z) and a second attachment seat (7) aligned with a second direction of attachment (Y), and wherein the first direction of attachment (Z) is coaxial with the carrier (4) and the second direction of attachment (Y) defines an angle with respect to the first direction of attachment (Z).8 Cytologic sampling device (1 ) according to any of the preceding claims, wherein said carrier (4) has a frame (8) onto which said sampling medium (3) is fitted, and wherein, depending upon the direction of attachment (Y, Z) of said carrier (4) to said handle (2), said frame (8) is aligned with said longitudinal axis (X) of the handle (2) or forms an angle with said longitudinal axis (X) of the handle (2) or is offset relatively to said longitudinal axis (X) of the handle (2).9 Cytologic sampling device (1 ) according to claim 8, wherein said frame (8) is shaped as a rectangular window having two longitudinal beams (9, 10) and two transversal beams (11 , 12 delimiting an opening (13), and wherein in a first way of attachment of said carrier (4) to said handle (2), said longitudinal beams (9, 10) are parallel with said longitudinal axis (X) of the handle (2), and wherein in a second way of attachment of said carrier (4) to said handle (2 said longitudinal beams (9, 10) are inclined relatively to said longitudinal axis (X) of the handle (2), and wherein in a third way of attachment of said carrier (4) to said handle (2), said longitudinal beams (9, 10) are offset relatively to said longitudinal axis (X) of the handle (210 Cytologic sampling device (1 ) according to claim 9, wherein said two longitudinal beams (9 10) are aligned with an attachment seat (6) of the carrier (4) intended to receive the handle (2).11 Cytologic sampling device (1) according to any of the preceding claims, wherein in a first way of attachment of said carrier (4) to said handle (2), along a first direction ofattachment (Z), the carrier (4) is rotatable by the handle (2) on a circumferential path centred on said longitudinal axis (X) and wherein in a second way of attachment of said carrier (4) to said handle (2), along a second direction of attachment (Y), the carrier (4) is rotatable by the handle (2) on a circumferential path offset relatively to said longitudinal axis (X).

12. Cytologic sampling device (1) according to any of the preceding claims, wherein the carrier (4) is provided with at least one tip (14) that cantileverly extends from the carrier (4) at the opposite side of the handle (2), and wherein said tip (14) has one or more lamellas (15) intended to collect cells or specimen.

13. Cytologic sampling device (1 ) according to claim 12, wherein the tip (14) of the carrier (4) is coaxial with the handle (2) in a first way of attachment of said carrier (4) to said handle (2).

14. Cytologic sampling device (1) according to any of the preceding claims, wherein the carrier (4) is provided with a lateral lobed portion (16) with a coarse surface, intended to scrub or scratch bodily tissues for collecting specimen.

15. Cytologic sampling device (1) according to any of the preceding claims, wherein the sampling medium (3) is a textile sampling medium.

16. Cytologic sampling device (1) according to claim 15, wherein the textile sampling medium (3) is blocked on the carrier (4) by means of at least one blocking point (3’) joining two parts of the textile sampling medium (3), wherein any blocking point (3’) is breakable to separate the textile sampling medium (3) from the carrier (4).

17. Cytologic sampling device (1) according to any claim 15 or 16, wherein the textile sampling medium (3) has at least one hole (17) intended to engage a tip (14) of the carrier (4) and avoid slipping off during sampling.

18. Cytologic sampling device (1) according to any of the preceding claims, wherein in a way of attachment of said carrier (4) to said handle (2), the carrier is substantially orthogonal to said longitudinal axis (X) of the handle (2).

19. A cytologic sampling kit comprising a cytologic sampling device (1) according to any of the preceding claims and a collecting vial wherein the carrier (4) with the sampling medium (3), separated from the handle (2), or the sampling medium (3) alone, are intended to be stored.

20. A method of sampling cells or specimen from human or animal body, comprising: a) providing the cytologic sampling device (1 ) according to any of the preceding claims 1-18, b) coupling the handle (2) to the carrier (4) carrying the sampling medium (3), wherein step b) is carried out: b’) on a first direction of attachment (Z) of the handle (2) to the carrier (4), or b”) on any different direction of attachment (Y) of the handle (2) to the carrier (4), c) inserting the carrier (4) in a cavity of the body and rotate the handle (2) on the longitudinal axis (X) to respectively: c’) cause rotation of the carrier (4) within a circular path centred relatively to the longitudinal axis (X), or c”) cause rotation of the carrier (4) within a circular path offset relatively to the longitudinal axis (X).

21. The method of sampling cells or specimen according to claim 20, wherein the carrier (4) has a tip (14) cantileverly extending from the carrier (4) at the opposite side of the handle (2), and comprising using the tip as pivot within the body, for rotating the handle (2) and the carrier (4).

22. The method of sampling cells or specimen according to claim 20 or claim 21 , either comprising separating the carrier (4) with the sampling medium (3) from the handle (2) and dropping the carrier (4) with the sampling medium (3) into a collecting vial, or separating the sampling medium (3) from the carrier (4) and dropping the sampling medium (3) into a collecting vial.

23. A method of sampling cells or specimen from a human or animal cavity, in particular from an oral cavity, comprising: a) providing the cytologic sampling device (1 ) according to claim 18,b) coupling the handle (2) to the carrier (4) carrying the sampling medium (3), c) inserting the carrier (4) in the cavity and move the handle (2) up and down, in a direction perpendicular to the longitudinal axis (X) to scrub the cavity with the sampling medium (3) placed orthogonal to the longitudinal axis (X).

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