Instruments for self-collecting vaginal specimens

Abstract

The present invention relates to a device for self-collecting a vaginal specimen, comprising a shaft having a distal end configured to be inserted into the vaginal cavity, wherein the shaft is A specimen collector located at the distal end, A fracture section configured to separate a portion of the shaft, including the distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and It is equipped with.

Description

Technical Field

[0001] The present invention relates to an instrument formed to a size for self-collection of a vaginal specimen, or an instrument configured for self-collection, and a kit of parts including the instrument.

Background Art

[0002] ]> Medical screening programs are widely introduced as a public health cancer prevention business. Screening typically involves the collection of cells or tissues from a person for subsequent disease identification analysis. The analysis requires transferring the sample to a laboratory or testing center for analysis of targeted risk markers.

[0003] The collection of cells or tissues generally includes clinical-based tests performed by a person with specialized training such as a physician or a registered nurse. Specifically, in the case of cervical cancer screening, the collection for the screening test requires collecting from the cervix or near it to obtain relevant specimens, such as vaginal specimens and / or optionally cervical specimens or endocervical specimens. The relevant specimens can then be tested, for example, for the Human Papilloma Virus (HPV).

[0004] Cervical cancer screening previously relied on specimens collected by clinicians, but the recent implementation of molecular HPV technology as a primary screening method has made alternative collection methods such as self-collected samples possible. Similarly, tests for other sexually transmitted infections including Chlamydia and herpes virus can be performed on self-collected samples and then sent for laboratory analysis.

[0005] Introducing self-collected samples into cervical cancer screening programs is intended to get a higher percentage of women participating in cancer prevention efforts. Currently, about 25% of women recommended for screening do not participate despite regular reminders. Non-participants recommended for screening account for about 50% of newly diagnosed cancers, and therefore, self-collected samples, if widely and successfully implemented, could be considered a new and powerful modality for cancer prevention.

[0006] Screening programs that include devices for self-collection or self-assembly of vaginal specimens have been shown to significantly increase the scope of screening and, accordingly, lead to a substantial reduction in undiagnosed patients at risk.

[0007] However, for further improvement, there is a need for instruments that provide safer and more reliable self-collection, especially when applied by non-clinical physicians, and that offer more fail-safe devices. [Overview of the Initiative]

[0008] This disclosure provides an improved instrument for self-collection of biological specimens from body cavities. The improved instrument is particularly suitable for self-collection of vaginal specimens, and / or optionally cervical or cervicovaginal specimens, oral specimens, and / or anal specimens. The instrument is further suitable for the analysis of microorganisms (bacteria, fungi, and viruses) associated with infections such as HPV, Chlamydia, and herpesviruses.

[0009] The improved instrument provides a user-fail-safe device, reducing the risk of invalid sampling and injury to the device or patient during use. The improved instrument is also more useful for patients with reduced tactile sensitivity, such as rheumatoid arthritis and arthritis patients with decreased hand sensation. This patient group may be further limited in their participation in conventional clinical trials due to restricted access to clinics.

[0010] The improved instrument comprises a shaft comprising a specimen collector positioned at the distal shaft end of the shaft, configured for insertion into a body cavity such as the vaginal cavity, and a proximal handle positioned along a portion of the shaft at a distance from the specimen collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position. Furthermore, the defined finger gripping position may be adapted to provide improved user control of the collection process. The handle with the finger gripping position restricts further insertion into the body cavity by the finger gripping position defined and fixed in the inwardly curved portion of the concave portion, and therefore, as soon as insertion is made, a defined stopping point is provided when the gripping hand is in contact with an opening of a body cavity such as the vaginal opening and labia, thus the handle with the finger gripping position relative to the specimen collector facilitates safe, easy, effective, and reproducible self-collection, even in patients with reduced tactile sensitivity. For example, the handle may be configured to have a collection depth of 6 cm for safe and effective vaginal collection.

[0011] More preferably, the sample collector can be safely and hygienically partially or completely separated from the proximal handle via a break, after which the sample collector can be placed in the transport tube / container. For example, the break may be configured to form a fracture surface or hinge, thereby completely or partially separating the handle and the sample collector. Preferably, the break or hinge action is triggered via the proximal handle. Thus, the self-collected sample collector can be reliably and effectively transported to the transport tube / kit with reduced exposure to ambient contaminants before the transport tube / kit is further sent to the laboratory or testing center for analysis.

[0012] A first aspect of the present invention relates to a device for self-collecting a specimen from a body cavity, comprising a shaft having a distal end configured to be inserted into a body cavity, wherein the shaft is A specimen collector located at the distal end, A fracture section configured to separate a portion of the shaft having a distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and It is equipped with.

[0013] For example, the device may be configured to self-collect specimens from the vagina, oral cavity and / or anal cavity by a handle that is adjustablely positioned on a shaft, or a handle that is fixed in an adjustable manner, or a predetermined handle.

[0014] A further aspect of the present invention relates to a device for self-collecting a vaginal specimen, comprising a shaft having a distal end configured to be inserted into the vaginal cavity, wherein the shaft is A specimen collector located at the distal end, A fracture section configured to separate a portion of the shaft having a distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and It is equipped with.

[0015] A second aspect of the present invention relates to a kit of parts comprising an instrument according to the first aspect, a first transport tube for enclosing the instrument before use, and optionally a second transport tube for enclosing a separated portion of the shaft after use, wherein these parts are optionally packaged together.

[0016] The present invention will be described in more detail below with reference to the accompanying drawings. [Brief explanation of the drawing]

[0017] [Figure 1] One embodiment of the apparatus according to this disclosure is shown in a perspective view. [Figure 2] Two embodiments (A) and (B) of the apparatus according to this disclosure are shown in cross-sectional views. [Figure 3] Two embodiments (A) and (B) of Figure 2 are shown in perspective views. [Figure 4] An embodiment of an instrument according to the present disclosure is shown, and the instrument is grasped by hand at a defined gripping position of the handle. [Figure 5] A perspective view of an embodiment of an instrument according to the present disclosure is shown. [Figure 6] Two embodiments (A) and (B) of an instrument according to the present disclosure are shown in cross-sectional views. [Figure 7] Two embodiments (A) and (B) of FIG. 2 are shown in perspective views.

MODE FOR CARRYING OUT THE INVENTION

[0018] The present invention will be described below with reference to the accompanying drawings. Those skilled in the art will understand that the same features or components of the device are referred to by the same reference numerals in different figures. A list of reference numerals can be found at the end of the detailed description section.

[0019] FIG. 1 shows a perspective view of an embodiment of an instrument according to the present disclosure. The instrument includes a shaft 1 defining a longitudinal direction. The first and proximal ends of the shaft are configured to be grasped by the user's hand as shown in FIG. 4, while the other second and distal ends are configured to be slidably inserted into a body cavity such as a vaginal cavity through the vaginal opening. A specimen collector 2 is disposed at the distal end of the shaft so that the inserted distal end can be used to collect a sample from the body cavity. For example, the body cavity may be the vagina, and the specimen collector is adapted to collect a vaginal specimen. Alternatively, the body cavity may be the oral cavity or the anus, and the specimen collector is adapted to collect an oral or anal specimen.

[0020] The proximal end of the shaft is provided with a handle 4 configured to be grasped by the user's hand, for example, by being held between two gripping fingers, such as the thumb and index finger, as shown in Figure 4. The handle has a concave portion along its longitudinal contour, configured to match a convex shape such as the surface of a finger or fingertip, as shown in Figure 4. The term concave means an inwardly curved contour so that the handle can take the shape of a concave lens or hourglass, as shown in Figures 1 to 4. Thus, the contour curves inward toward the central longitudinal axis. Thus, the concave portion provides defined or predetermined finger gripping positions along the shaft by the inward curvature of the concave portion. The handle 4 extends longitudinally along a portion of the shaft, as shown in Figure 1, and the length of the handle is Lh. The handle 4 is positioned at a distance Ls from the sample collector 2, the distance Ls can be defined as the distance between the distal end of the handle and the distal end of the shaft, as shown in Figure 1. The distance Ls may be adjustable, fixed in an adjustable way, or predetermined, depending on the manufacturing method. For example, the distance may be predetermined if the shaft is made by injection molding, or it may be predetermined in an adjustable way if the shaft is made by 3D printing.

[0021] Therefore, the handle 4 can provide a defined finger gripping position or a predefined finger gripping position and a certain distance to the specimen collector. Therefore, as soon as the instrument is slidably inserted into the body cavity, the gripping hand abuts against the body cavity opening at a defined insertion depth corresponding to Ls, thus providing a stop point that limits further insertion into the body cavity. The defined insertion depth reduces the risk that a sample collected at a sampling depth that is too shallow will be invalid, and this risk is particularly problematic in vaginal specimens tested for microorganisms (bacteria, fungi, and viruses) associated with sexually transmitted infections such as HPV, Chlamydia, and herpes virus. The minimum sampling depth for obtaining a valid vaginal specimen is generally about 60 mm, and the optimal sampling depth with higher sampling rate effectiveness is approximately 55 - 95 mm depending on ethnicity. Therefore, the handle provides a more fail-safe instrument, reducing the risk that the sample will be invalid at a sampling depth that is too shallow or that the sampling is too deep and will damage the instrument or the patient during use. Therefore, the instrument is particularly suitable for self-collection, including self-collection for users with reduced tactile sensitivity, where a high degree of fail-safety is required.

[0022] In one embodiment of the present disclosure, the handle is disposed at a certain distance from the specimen collector. In a further embodiment, the distance between the handle and the specimen collector is 55 - 95 mm, preferably 60 mm.

[0023] In one embodiment of the present disclosure, the concave surface portion is configured to coincide with the convex contour of the surface of the finger or fingertip, thereby being configured as a defined finger gripping position and / or a predefined finger gripping position. In one embodiment of the present disclosure, the handle is configured to limit further insertion of the shaft into the vaginal cavity when grasped at the finger gripping position.

[0024] The distance Ls may be adjustable, fixed in an adjustable way, predetermined, or determined according to the manufacturing method and the purpose of collection. For example, the first distance may be appropriate for vaginal collection, while the second and third distances may be appropriate for oral and rectal collection, respectively.

[0025] After collection, the instrument is withdrawn from the body cavity, and the sample collector containing the collected sample is safely and hygienically partially or completely separated from the proximal handle via the break section 3. For example, the break section may be configured to form a fracture surface or hinge, thereby completely or partially separating the handle and the sample collector. Preferably, the break section is located next to or near the handle so that it is easy to break and separate when the user is gripping the handle. For example, the break section may be located distal to the handle at a distance of Lb, as shown in Figure 1.

[0026] Preferably, rupture and separation may be performed immediately after the instrument is withdrawn, while the user maintains a defined finger grip position, so that the specimen collector is not contacted by further biological surfaces and not exposed to contaminants before transport. Preferably, the separation rupture or hinge lock is triggered only by user contact to the proximal handle located distal to the rupture portion. For example, while maintaining a defined finger grip position, the user can slidably position the distal shaft end within the transport tube, which has a solid surface wall and a tube opening with a rim, and then trigger separation by bending the handle located outside the tube so that the rupture portion 3 bends around the rim of the tube opening. This corresponds to the shaft receiving a two-point bending force generated between the handgrip located on the handle, which is the first load point, and the solid surface of the tube, which is the second load point. The bending force for rupture or hinge lock may be configured to be different from the linear translational forces applied during insertion and withdrawal of the instrument, thus reducing the risk of unintended breakage within the body cavity.

[0027] In one embodiment of the present disclosure, the fractured portion is configured to partially or completely separate a portion of the shaft.

[0028] In one embodiment of the present disclosure, the fracture portion is configured to separate a portion of the shaft having a distal end when the shaft is subjected to a two-point bending force generated between the handgrip as a first load point and the solid surface as a second load point.

[0029] handle To ensure a clearly defined finger gripping position on the handle and thus a defined insertion depth of the specimen collector, the concave portion along the longitudinal contour of the handle is preferably configured to have a geometric shape that partially coincides with one or more fingers, as shown in Figure 4, so that the intended comfortable gripping position is evident. Thus, the longitudinal contour may include a concave portion having a tapered shape, and the tapered shape may include discontinuous steps and / or continuously straight or curved sections. Furthermore, the length Lh of the handle may be configured to clearly fit one or more fingers comfortably, regardless of hand size. For example, the length of the handle may preferably be 10 to 30 mm.

[0030] In one embodiment of the present disclosure, the concave portion has a longitudinal contour selected from the group consisting of tapered steps, straight tapered shapes, curved tapered shapes, and combinations thereof.

[0031] In one embodiment of the present disclosure, the handle has a length of 10 to 30 mm, more preferably 15 to 25 mm, for example, 20 mm.

[0032] In addition to defining the intended finger gripping position, the tapered concave shape of the handle has the further advantage of facilitating easy gripping and manipulation of the shaft. Thus, the handle can facilitate improved user control of the sampling process. Vaginal sample collection typically requires twisting or rotating the shaft containing the sample collector, and for safe use, an easily accessible gripping section is necessary, especially for users with reduced tactile sensitivity and / or reduced finger strength and mobility.

[0033] Furthermore, for simple and intuitive operation during insertion and extraction, and consequently to improve fail-safeness and the risk of damage during use, the handle is preferably arranged concentrically and rotationally along the shaft. For example, the handle may have a double-naped cone shape, as shown in the embodiment of Figure 1.

[0034] In one embodiment of this disclosure, the handle is concentric with the shaft. In a further alternative embodiment, the handle is rotationally symmetric about the longitudinal axis.

[0035] The concave portion of the handle can further reduce the risk of longitudinal finger slippage, distal slippage that is likely to occur during insertion, and proximal slippage that may occur during withdrawal. The anti-slip function is due to the inwardly curved concave portion, and handles having a roughly double-napped conical shape, such as an hourglass shape, saddle shape, V-shape, or spool shape, as can be seen in the longitudinal cross-section, can provide a suitable anti-slip for the fingers.

[0036] In one embodiment of the present disclosure, the concave portion is configured to restrict finger gripping in the shaft direction. In further alternative embodiments, the concave portion is in the shape of a double-napped cone, hourglass, saddle, V-shape, or spool.

[0037] As can be seen from Figure 1, the minimum concave portion of the handle can define the minimum thickness T of the handle between the thicker distal end and the thicker proximal end. In the case of a rotationally symmetric handle having a roughly double-knapped cone shape, the minimum thickness corresponds to the minimum diameter of the handle. To ensure a sufficiently robust, stable, and operable handle, the minimum thickness may be 2 to 5 mm, corresponding to approximately 30 to 70% of the maximum thickness of the handle. Figures 2 and 3 show cross-sectional and perspective views of two embodiments with different minimum thicknesses, as will be further described in Examples 1 and 2.

[0038] In one embodiment of the present disclosure, the minimum of the concave portion defines the minimum thickness of the handle between the distal and proximal ends. In further alternative embodiments, the minimum thickness is 30–70% of the maximum thickness of the handle, more preferably 40–60% of the maximum thickness of the handle, for example, 50% of the maximum thickness of the handle. In further embodiments, the minimum thickness is 2–5 mm, for example, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm.

[0039] Instruments for self-collecting vaginal specimens are preferably adapted to reduce the risk of insertion that is too deep or too deep. Overinsertion can cause damage to both the instrument and the patient, and may also render the collected specimen invalid. To reduce the risk of overinsertion, the distal end of the handle can preferably define the maximum thickness of the handle, which can have a thickness of 4 to 9 mm or a corresponding diameter.

[0040] In one embodiment of this disclosure, the distal end of the handle defines the maximum thickness of the handle. In further embodiments, the maximum thickness of the handle is 4 to 9 mm, for example, 5 mm, 6 mm, 7 mm, or 8 mm.

[0041] To simplify the manufacture of the instrument, the distal and proximal ends of the handle may be mirror-symmetric, as shown in Figures 1 to 3. Alternatively, the proximal end of the handle may be thinner than the distal end or have a correspondingly smaller diameter, which may reduce the risk of finger slippage in the proximal direction. For example, a sufficiently robust, stable, and operable handle can be obtained when the proximal end of the handle has a thickness or diameter of 4 to 8 mm.

[0042] In one embodiment, the distal and proximal ends of the handle are mirror-symmetric. In an alternative embodiment, the proximal end of the handle is thinner than the distal end, and optionally, the thickness of the proximal end is 4 to 8 mm, for example, 7 mm.

[0043] To provide a robust, stable, and operable grip, especially for users with reduced tactile sensitivity, and to further ensure clearly defined finger gripping positions, the handle may be provided with a structured surface. Preferably, since effective vaginal sample collection typically requires twisting or rotating the shaft containing the sample collector, the structured surface is configured to sense the rotation of the handle. Sensation of the rotation of the handle via the fingers can be achieved by a structured surface containing regularly or irregularly patterned protrusions. For example, the protrusions may take the form of surface roughness corresponding to ultrafine sandpaper detectable by the fingertip. Ultrafine sandpaper, such as 240-grit sandpaper, has surface roughness due to protruding abrasive grains, which have a height deviation of 40.5 μm or more compared to the contour mean line.

[0044] In one embodiment of the present disclosure, the handle comprises a structured surface configured to sense the rotation of the handle. In a further embodiment, the structured surface comprises a roughness corresponding to sandpaper with at least 240 grits having a height deviation of at least 40.5 μm.

[0045] The sensing of the handle's rotation and the physical requirements for rotating the handle can be further improved by a structured surface having longitudinally extending projections. Preferably, the projections consist of ribs or mesh extending longitudinally along the handle.

[0046] In further embodiments of the present disclosure, the structured surface comprises one or more projections extending in the longitudinal direction. In further embodiments, the structured surface comprises a regular pattern, such as a rib or mesh pattern.

[0047] Fracture As described above, the collected sample can be safely and hygienically separated from the proximal handle via the break section 3 of the shaft, which is located distal to the handle at a distance of Lb, while maintaining the defined finger grip position expected during insertion and withdrawal of the instrument. This has the advantage of reducing contamination before transport of the collected sample.

[0048] The bending force required to break the shaft at the fracture point with a two-point bending force depends on various factors, including the location of the fracture point, its thickness, its geometric shape, and the thickness and material of the shaft. Preferably, the fracture point is configured such that the bending force for fracture is different from the linear translational force generated during instrument insertion and withdrawal, thereby reducing the risk of unintended breakage within the body cavity. Controlled separation of a portion of the shaft at the fracture point is preferably brought to a fracture point located 1–9 mm from the distal end of the handle.

[0049] In one embodiment of the present disclosure, the fracture portion is located at a distance of 1 to 9 mm from the distal end of the handle, for example, at a distance of 3 mm, 4 mm, or 5 mm from the distal end of the handle.

[0050] Further controlled separation at the fracture may be brought about at a fracture having a thickness of 70–95% of the maximum thickness of the shaft, and the maximum thickness of the shaft may be 1–5 mm. The shaft may be cylindrical or may include a cylindrical portion, and therefore the thickness of the shaft corresponds to the diameter.

[0051] In one embodiment of the present disclosure, the fractured portion has a thickness of 70 to 95% of the maximum thickness of the shaft, more preferably 80 to 90% of the maximum thickness of the shaft. In a further alternative embodiment, the shaft has a maximum thickness of 1 to 5 mm, for example, 2 mm, 3 mm, or 4 mm.

[0052] Further controlled separation at the fracture can be achieved at the fracture having a notched geometric shape. For example, the notch may be rectangular or V-shaped, as seen in the cross-sectional views of Figures 1 to 3. The notch may be further positioned to provide a defined fracture direction. For example, similar to notches made in felled wood, the notch may be positioned at a single location on the shaft, at opposing locations on the shaft, or radially along the circumference of the shaft. In the case of a cylindrical shaft, this corresponds to a circular notch.

[0053] In one embodiment of the present disclosure, the fracture portion comprises a notch, such as a V-shaped notch, and the notch is optionally located at a single position on the shaft, at two opposing positions on the shaft, or as a circular notch.

[0054] Controlled separation at the fracture also includes a controlled fracture surface. Brittle materials tend to form serrated fracture surfaces, while more elastic materials may have smooth fracture surfaces. Preferably, the shaft and fracture portion include an elastic material having a formulation configured to have a smooth fracture surface. The elastic material is more preferably biocompatible and / or biodegradable. For example, the elastic material may be a suitable plastic having the indicated properties.

[0055] In one embodiment of the present disclosure, the shaft comprises a biocompatible and / or biodegradable plastic configured to be flexible, the plastic being selected from the group consisting of nylon, polystyrene, polyurethane, mesh polyurethane, wax-coated materials, and any combination thereof.

[0056] To further improve the user convenience and fail-safety of the device, the instrument or part of the instrument is preferably manufactured as a single, smooth component. This reduces the risk of unintended breakage in the body cavity and tissue damage from serrated edges. For example, a shaft including a break section, a handle, and optionally a sample collector can be manufactured by injection molding and / or 3D printing.

[0057] In one embodiment of the present disclosure, the instrument or part of the instrument is manufactured by injection molding and / or 3D printing.

[0058] shaft Preferably, the proximal end of the shaft is provided with a flange configured to engage with the user's fingers. For example, the flange may be a disc-shaped flange (D) located near or at the most proximal end of the shaft, as shown in Figures 5 to 7. Thus, the flange can act as a second defined stopping point for insertion and can therefore function as an additional safety device. For example, the flange can act as a safety stopper when it comes into contact with the opening of a body cavity such as the vaginal opening and labia, as described in Embodiment 3, in cases where too deep vaginal insertion may occur, for example, if the finger grip on the handle slips during insertion, or if the gripping hand is not applied to the handle so that the gripping hand cannot function as an insertion stopper.

[0059] The radially extending flange positioned on the shaft can further engage with the user's fingers in the same manner as the syringe finger-grip flange. Therefore, a stable and secure engagement can be achieved by positioning at least two fingers on either side of the shaft, allowing the instrument to be pulled back with minimal finger force.

[0060] In one embodiment of the present disclosure, the proximal end of the shaft is provided with a flange configured to engage with the user's fingers. In a further embodiment, the flange is configured to engage with at least two of the user's fingers in the form of a syringe finger rest flange.

[0061] To facilitate a stable, flexible, and fail-safe engagement with the user's fingers, the flange is preferably positioned concentrically and rotationally symmetrically with respect to the shaft, such that the finger grip is similar regardless of hand position. More preferably, the flange extends radially for a distance of 5 to 30 mm, such that the flange has a sufficient surface area available to the user's fingers. For example, the flange may preferably be a disc with a diameter of approximately 10 mm.

[0062] In one embodiment of the present disclosure, the flange is rotationally symmetric. In further embodiments, the flange is disc-shaped, preferably with a diameter of 5 to 30 mm, more preferably 7 to 20 mm, most preferably 9 to 15 mm, for example 10 mm.

[0063] Sample collector The sample collector can be adapted to collect cells or tissues from body cavities, such as vaginal specimens to be tested for microorganisms (bacteria, fungi, and viruses) associated with sexually transmitted infections, including HPV, Chlamydia, and herpesviruses. To increase the likelihood of successful sample collection and for user convenience, the sample collector preferably comprises a soft material with high cell uptake capacity. High cellular collection yields may be obtained when the sample collector makes shear and / or capillary contact with the specimen. Polyester fibers such as Dacron can provide high collection yields for vaginal specimens.

[0064] In one embodiment of the present disclosure, the specimen collector is configured to collect a vaginal specimen when it is in shear contact and / or capillary contact with the specimen. In further alternative embodiments, the specimen collector comprises a material selected from the group consisting of bristles, flocked plastics and polymers, such as flocked nylon, flocked polyamide polymers, flocked polyester polymers, flocked polypropylene polymers, and flocked fibrous materials such as polyester fibers.

[0065] Parts kit To facilitate self-sampling procedures, including testing, the apparatus according to this disclosure is preferably provided as a kit of parts. For example, the apparatus may be provided to the user as a kit of parts, and after performing self-sampling, the user sends the relevant parts to a laboratory for analysis.

[0066] The parts kit may comprise the instrument and a first transport tube for wrapping the instrument before use. The kit may further comprise a second transport tube for separating a portion of the shaft containing the sample collector and / or for wrapping the separated portion of the shaft after collection. Optionally, these parts are packaged together for easy transport to the user and laboratory.

[0067] One embodiment of the present disclosure relates to a kit of parts comprising the instrument described in any one of the preceding claims, a first transport tube for enclosing the instrument before use, and optionally a second transport tube for enclosing a separated portion of the shaft after use, wherein the parts are optionally packaged together.

[0068] Reference number 1 shaft 2. Sample collector 3. Fracture 4 handles Ls Distance between the handle and the sample collector Lb: Distance between the handle and the fracture point Lh Handle Length T thickness D flange diameter [Examples]

[0069] The present invention is further illustrated by the embodiments provided below.

[0070] Example 1 - Apparatus with a handle having a minimum thickness of 2.5 mm The prototypes of the devices shown in Figures 2A and 3A were fabricated using 3D printing. This study will compare the user experience of a self-collection device with that of commercially available self-collection devices. User experience will include the user's ability to perform vaginal collection by self-collection, as well as the user's perception of whether a valid vaginal sample is obtained correctly, whether the collection feels safe, and whether the collection is perceived as easy. The study may be expanded to include verification of the scope covered by the improved screening and clinical verification of the improved valid collection rate.

[0071] Example 2 - Apparatus with a handle having a minimum thickness of 4 mm The prototypes of the devices shown in Figures 1, 2B, 3B, and 4 were fabricated using 3D printing. This study will compare the user experience of the self-collection device with that of commercially available self-collection devices. User experience will include the user's ability to obtain a vaginal sample via self-collection, as well as the user's perception of whether a valid vaginal sample is obtained, whether the collection feels safe, and whether the collection is considered easy. The study may be expanded to include verification of the scope covered by the improved screening and clinical verification of the improved valid collection rate.

[0072] Example 3 - Apparatus with safety flange The prototype of the instrument shown in Figures 5-7, which features a proximal disc-shaped flange, is manufactured by 3D printing or molding. The instrument is particularly suitable for cases of excessive vaginal insertion when it contacts the opening of a body cavity, such as the vaginal opening and labia, for example, when the finger grip on the handle slips during insertion, or when the gripping hand is not applied to the handle so that the gripping hand cannot function as an insertion stopper. The disc-shaped flange acts as a second defined stopping point for insertion. After excessive vaginal insertion, the proximal flange engages with at least two fingers on both sides of the shaft in the same manner as a syringe finger-grip flange, allowing the instrument to be safely withdrawn from the body cavity.

[0073] item This disclosure can be further described by referring to the following items.

[0074] 1. A device for self-collecting a specimen from a body cavity, comprising a shaft having a distal end configured to be inserted into a body cavity, wherein the shaft is A specimen collector located at the distal end, A fracture section configured to separate a portion of the shaft having a distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and An instrument equipped with the necessary features.

[0075] 2. The apparatus described in item 1, configured for self-collection of specimens from the vagina, oral cavity, and / or anal cavity.

[0076] 3. A device for self-collecting a vaginal specimen, comprising a shaft having a distal end configured to be inserted into the vaginal cavity, wherein the shaft is A specimen collector located at the distal end, A fracture section configured to separate a portion of the shaft having a distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and An instrument equipped with the necessary features.

[0077] 4. An instrument described in any one of items 1-3, wherein the handle is positioned at a certain distance from the sample collector.

[0078] 5. An instrument as described in any one of items 1 to 4, wherein the distance between the handle and the sample collector is 55 to 95 mm, preferably 60 mm.

[0079] 6. The instrument described in any one of items 1-5, wherein the handle is configured to restrict further insertion of the shaft into the vaginal cavity when grasped in the finger-grasp position.

[0080] 7. The device according to any one of items 1 to 6, wherein the concave portion is configured as a defined finger gripping position and / or a predetermined finger gripping position.

[0081] 8. The apparatus according to any one of items 1 to 7, wherein the concave portion has a longitudinal contour selected from the group consisting of a tapered step, a straight tapered shape, a curved tapered shape, and combinations thereof.

[0082] 9. The apparatus according to any one of items 1 to 8, wherein the handle has a length of 10 to 30 mm, more preferably 15 to 25 mm, for example 20 mm.

[0083] 10. An instrument described in any one of items 1-9, in which the handle is concentric with the shaft.

[0084] 11. An instrument described in any one of items 1-10, wherein the handle is rotationally symmetrical about the longitudinal axis.

[0085] 12. The apparatus described in any one of items 1 to 11, wherein the concave portion is configured to restrict finger gripping in the shaft direction.

[0086] 13. An instrument described in any one of items 1 to 12, wherein the concave portion is in the shape of a double-napped cone, hourglass, saddle, V-shape, or spool.

[0087] 14. An instrument according to any one of items 1 to 13, wherein the smallest part of the concave portion defines the minimum thickness of the handle between the distal and proximal ends of the handle.

[0088] 15. The apparatus described in item 14, wherein the minimum thickness is 30-70% of the maximum thickness of the handle, more preferably 40-60% of the maximum thickness of the handle, for example, 50% of the maximum thickness of the handle.

[0089] 16. An instrument described in any one of items 14-15, with a minimum thickness of 2-5 mm, for example, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm.

[0090] 17. An instrument as described in any one of items 1 to 16, wherein the distal end of the handle defines the maximum thickness of the handle.

[0091] 18. The fixture described in item 17, with a handle thickness of 4 to 9 mm, for example, 5 mm, 6 mm, 7 mm, or 8 mm.

[0092] 19. An instrument described in any one of items 1 to 18, wherein the distal and proximal ends of the handle are mirror-symmetrical.

[0093] 20. An instrument described in any one of items 1 to 18, wherein the proximal end of the handle is thinner than the distal end of the handle, and optionally the thickness of the proximal end is 4 to 8 mm, for example, 7 mm.

[0094] 21. An apparatus according to any one of items 1 to 20, wherein the handle has a structured surface configured to sense the rotation of the handle.

[0095] 22. The apparatus according to item 21, wherein the structured surface has a roughness corresponding to sandpaper with at least 240 grits having a height deviation of at least 40.5 μm.

[0096] 23. The apparatus according to any one of items 21 to 22, wherein the structured surface comprises one or more projections extending in the longitudinal direction.

[0097] 24. An apparatus according to any one of items 21-23, wherein the structured surface has a regular pattern such as a rib or mesh pattern.

[0098] 25. The apparatus described in any one of items 1 to 24, wherein the fracture portion is configured to partially or completely separate a portion of the shaft.

[0099] 26. The apparatus according to any one of items 1 to 25, wherein the fracture portion is configured to separate a portion of the shaft having a distal end when the shaft is subjected to a two-point bending force generated between the handgrip as a first load point and the solid surface as a second load point.

[0100] 27. The apparatus described in any one of items 1 to 26, wherein the fracture portion is located at a distance of 1 to 9 mm from the distal end of the handle, for example, 3 mm, 4 mm, or 5 mm from the distal end of the handle.

[0101] 28. The apparatus according to any one of items 1 to 27, wherein the fractured portion has a thickness of 70 to 95%, more preferably 80 to 90%, of the maximum thickness of the shaft.

[0102] 29. An instrument described in any one of items 1 to 28, wherein the shaft has a maximum thickness of 1 to 5 mm, for example, 2 mm, 3 mm, or 4 mm.

[0103] 30. The apparatus according to any one of items 1 to 29, wherein the fracture section comprises a notch, such as a V-shaped notch, and the notch is optionally located at a single position on the shaft, or at two opposing positions on the shaft, or as a circular notch.

[0104] 31. The apparatus according to any one of items 1 to 30, comprising a shaft made of a biocompatible and / or biodegradable plastic configured to be flexible, wherein the plastic is selected from the group consisting of nylon, polystyrene, polyurethane, mesh polyurethane, wax-coated materials, and any combination thereof.

[0105] 32. The apparatus described in any one of items 1 to 31, wherein the proximal end of the shaft has a flange configured to engage with the user's finger.

[0106] 33. The instrument described in item 32, wherein the flange is configured to engage with at least two fingers of the user in the form of a syringe finger rest flange.

[0107] 34. An apparatus described in any one of items 32-33, wherein the flange is rotationally symmetrical.

[0108] 35. The fixture according to any one of items 32 to 34, wherein the flange is disc-shaped, preferably having a diameter of 5 to 30 mm, more preferably 7 to 20 mm, most preferably 9 to 15 mm, for example 10 mm.

[0109] 36. The instrument described in any one of items 1 to 35, wherein the specimen collector is configured to collect a vaginal specimen when it makes shear contact and / or capillary contact with the specimen.

[0110] 37. The apparatus according to any one of items 1 to 36, wherein the specimen collector comprises a material selected from the group consisting of bristles, flocked plastics and polymers, such as flocked nylon, flocked polyamide polymers, flocked polyester polymers, flocked polypropylene polymers, and polyester fibers, such as flocked fiber materials such as Dacron.

[0111] 38. An instrument described in any one of items 1 to 37, which is at least partially manufactured by injection molding and / or 3D printing.

[0112] 39. A parts kit comprising an instrument described in any one of items 1 to 38, a first transport tube for enclosing the instrument before use, and optionally a second transport tube for enclosing a separated portion of the shaft after use, wherein these parts are optionally packaged together.

Claims

1. A device for self-collecting a specimen from a body cavity, comprising a shaft having a distal end configured to be inserted into a body cavity, wherein the shaft is A specimen collector located at the distal end, A fractured portion configured to separate a part of the shaft having the distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and An instrument equipped with the necessary features.

2. The device according to claim 1, configured to self-collect specimens from the vagina, oral cavity and / or anal cavity.

3. A device for self-collecting a vaginal specimen, comprising a shaft having a distal end configured to be inserted into the vaginal cavity, wherein the shaft is A specimen collector located at the distal end, A fractured portion configured to separate a part of the shaft having the distal end, A handle positioned along a portion of the shaft at a distance from the sample collector, wherein the longitudinal contour of the handle includes a concave portion configured to define a finger gripping position, and An instrument equipped with the necessary features.

4. The apparatus according to any one of claims 1 to 3, wherein the handle is positioned at a certain distance from the sample collector.

5. The apparatus according to any one of claims 1 to 4, wherein the distance between the handle and the sample collector is 55 to 95 mm, preferably 60 mm.

6. The device according to any one of claims 1 to 5, wherein the handle is configured to restrict further insertion of the shaft into the vaginal cavity when grasped in the finger-grasp position.

7. The device according to any one of claims 1 to 6, wherein the concave portion is configured as a defined finger gripping position and / or a predetermined finger gripping position.

8. The apparatus according to any one of claims 1 to 7, wherein the concave portion has the longitudinal contour selected from the group consisting of a tapered step, a straight tapered shape, a curved tapered shape, and a combination thereof.

9. The apparatus according to any one of claims 1 to 8, wherein the handle has a length of 10 to 30 mm, more preferably 15 to 25 mm, for example 20 mm.

10. The apparatus according to any one of claims 1 to 9, wherein the handle is concentric with the shaft.

11. The apparatus according to any one of claims 1 to 10, wherein the handle is rotationally symmetric about the longitudinal axis.

12. The apparatus according to any one of claims 1 to 11, wherein the concave portion is configured to restrict slippage of the finger grip in the direction of the shaft.

13. The apparatus according to any one of claims 1 to 12, wherein the concave portion is in the shape of a double-napped cone, an hourglass, a saddle, a V-shape, or a spool.

14. The apparatus according to any one of claims 1 to 13, wherein the smallest portion of the concave surface defines the minimum thickness of the handle between the distal end and the proximal end of the handle.

15. The apparatus according to claim 14, wherein the minimum thickness is 30 to 70% of the maximum thickness of the handle, more preferably 40 to 60% of the maximum thickness of the handle, for example, 50% of the maximum thickness of the handle.

16. The apparatus according to any one of claims 14 to 15, wherein the minimum thickness is 2 to 5 mm, for example, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm.

17. The apparatus according to any one of claims 1 to 16, wherein the distal end of the handle defines the maximum thickness of the handle.

18. The apparatus according to claim 17, wherein the maximum thickness of the handle is 4 to 9 mm, for example, 5 mm, 6 mm, 7 mm, or 8 mm.

19. The apparatus according to any one of claims 1 to 18, wherein the distal end and proximal end of the handle are mirror-symmetric.

20. The apparatus according to any one of claims 1 to 18, wherein the proximal end of the handle is thinner than the distal end of the handle, and optionally the thickness of the proximal end is 4 to 8 mm, for example, 7 mm.

21. The apparatus according to any one of claims 1 to 20, wherein the handle comprises a structured surface configured to sense the rotation of the handle.

22. The apparatus according to claim 21, wherein the structured surface has a roughness corresponding to sandpaper with at least 240 grits having a height deviation of at least 40.5 μm.

23. The apparatus according to any one of claims 21 to 22, wherein the structured surface comprises one or more protrusions extending in the longitudinal direction.

24. The apparatus according to any one of claims 21 to 23, wherein the structured surface comprises a regular pattern such as a rib or mesh pattern.

25. The apparatus according to any one of claims 1 to 24, wherein the fractured portion is configured to partially or completely separate a part of the shaft.

26. The apparatus according to any one of claims 1 to 25, wherein the fracture portion is configured to separate a portion of the shaft having the distal end when the shaft is subjected to a two-point bending force generated between the handgrip as a first load point and the solid surface as a second load point.

27. The apparatus according to any one of claims 1 to 26, wherein the fractured portion is located at a distance of 1 to 9 mm from the distal end of the handle, for example, 3 mm, 4 mm, or 5 mm from the distal end of the handle.

28. The apparatus according to any one of claims 1 to 27, wherein the fractured portion has a thickness of 70 to 95% of the maximum thickness of the shaft, more preferably 80 to 90% of the maximum thickness of the shaft.

29. The apparatus according to any one of claims 1 to 28, wherein the shaft has a maximum thickness of 1 to 5 mm, for example, 2 mm, 3 mm, or 4 mm.

30. The apparatus according to any one of claims 1 to 29, wherein the fracture portion comprises a notch such as a V-shaped notch, and the notch is optionally arranged at a single position on the shaft, at two opposing positions on the shaft, or as a circular notch.

31. The apparatus according to any one of claims 1 to 30, wherein the shaft comprises a biocompatible and / or biodegradable plastic configured to be flexible, the plastic being selected from the group consisting of nylon, polystyrene, polyurethane, mesh polyurethane, wax coating materials, and any combination thereof.

32. The device according to any one of claims 1 to 31, wherein the proximal end of the shaft comprises a flange configured to engage with the user's finger.

33. The device according to claim 32, wherein the flange is configured to engage with at least two fingers of the user in the form of a syringe finger rest flange.

34. The apparatus according to any one of claims 32 to 33, wherein the flange is rotationally symmetric.

35. The apparatus according to any one of claims 32 to 34, wherein the flange is preferably disc-shaped with a diameter of 5 to 30 mm, more preferably 7 to 20 mm, most preferably 9 to 15 mm, for example 10 mm.

36. The apparatus according to any one of claims 1 to 35, wherein the specimen collector is configured to collect a vaginal specimen when it makes shear contact and / or capillary contact with the specimen.

37. The apparatus according to any one of claims 1 to 36, wherein the sample collector comprises a material selected from the group consisting of bristles, flocked plastics and polymers, such as flocked nylon, flocked polyamide polymers, flocked polyester polymers, flocked polypropylene polymers, and polyester fibers, such as flocked fiber materials like Dacron.

38. The apparatus according to any one of claims 1 to 37, which is at least partially manufactured by injection molding and / or 3D printing.

39. A parts kit comprising an apparatus according to any one of claims 1 to 38, a first transport tube for enclosing the apparatus before use, and optionally a second transport tube for enclosing the separated portion of the shaft after use, wherein these parts are optionally packaged together.

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