Utensil for self-sampling a vaginal specimen

Abstract

The invention regards a utensil for self-sampling a vaginal specimen comprising a shaft with a distal end configured for insertion into a vaginal cavity, said shaft comprising: - a specimen collector disposed at the distal end, - a break section configured for detaching a part of the shaft comprising the distal end, and - a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

Description

[0001] Utensil for self-sampling a vaginal specimen

[0002] Technical field

[0003] The present invention relates to a utensil sized or configured for self-sampling a vaginal specimen, and a kit of parts comprising the utensil.

[0004] Background

[0005] Medical screening programmes are broadly instituted as a public health cancer preventive enterprise. Screening typically includes sampling of cells or tissue from a person for subsequent disease specific analysis. The analysis requires transfer of the sample to a laboratory or test centre for analysis of the targeted risk markers.

[0006] The sampling of cells or tissue generally involves clinic-based exams carried out by a specialist trained person, such as a physician, a registered nurse or similar. Specifically for cervical cancer screening, where the sampling for screening testing requires sampling from or near the cervix to obtain a relevant specimen, such as a vaginal specimen and / or optionally a cervical or cervico-vaginal, which may then for example be tested for HPV (Human Papillomavirus).

[0007] Whereas cervical cancer screening previously has been relying on clinician collected specimens, the recent implementation of molecular HPV technology as primary screening methodology has opened for alternative sample methodologies, such as selfcollected samples. Similarly, testing for other sexually transmitted diseases including chlamydia and herpes virus, may be conducted as a self-collected sample, which are subsequently forwarded for laboratory analysis.

[0008] The introduction of self-collected samples into the cervical cancer screening programme is intended to induce a higher proportion of women to participate in the cancer preventive offer. Currently, approx. 25% of screening invited women do not participate despite regular reminders. The screening invited non-participants account for approx. 50% of newly diagnosed cancers, and as such self-collected samples are considered a new strong cancer prevention modality if implemented broadly and successfully. Screening programmes including utensils for self-sampling or self-collection of vaginal specimens have been shown to significantly increase the screening coverage, and result in a correspondingly significant reduction in the non-diagnosed risk patients.

[0009] However for further improvement, there is a need for utensils which provide a more safe and reliable self-sampling, especially a more fail-safe device when applied by nonclinicians.

[0010] Summary

[0011] The present disclosure provides an improved utensil for self-sampling of a biological specimen from a body cavity. The improved utensil is particularly suitable for selfsampling a vaginal specimen, and / or optionally a cervical or cervico-vaginal specimen, oral specimens, and / or anal specimens. The utensil is further suitable for analysis of microorganisms (bacteria, fungi, and viruses) related to infections, such as HPV, chlamydia, and herpes virus.

[0012] The improved utensil provides a user fail-safe device, where the risk of invalid sampling and damage to the device or to the patient during use, is reduced. The improved utensil is additionally applicable for patients with reduced tactile sensitivity, e.g. rheumatoid and arthritis patients with reduced hand perception. This patient group may further be detained from participating in conventional clinical testing due to their restricted access to clinics.

[0013] The improved utensil comprise a shaft comprising a specimen collector disposed at the distal shaft end of the shaft configured for insertion into a body cavity, such as a vaginal cavity, and a proximal handle disposed along a part of the shaft at a distance to the specimen collector, where the longitudinal profile of the handle comprises a concave section configured for defining a finger grip position. Further, the defined finger grip position may be adapted to provide improved user control of the sampling process. The handle including a finger grip position relative to the specimen collector facilitates safe, easy, valid and reproducible self-sampling even for patients with reduced tactile sensitivity, since a hand placed at the handle with the finger grip position will restrict a further insertion into the body cavity due to defined and fixed finger grip position at the inward curvature of the concave section, and thus provide a defined stopping point upon insertion when the gripping hand is abutting the opening of the body cavity, such as the vaginal opening and labia. For example, the handle may be configured for a sampling depth of 6 cm for safe and valid vaginal sampling.

[0014] Further advantageously, the specimen collector may be safely and hygienically partially or completely detached from the proximal handle via a break section, and the specimen collector subsequently placed in a transport tube / container. For example, the break section may be configured to form a fracture surface or a hinge, whereby the handle and specimen collector is completely or partially detached. Preferably the breaking or hinging is triggered via the proximal handle. The self-sampled specimen collectors may hence be reliably and validly transferred to a transportation tube / kit with reduced exposure to contaminants from the surroundings, before the transportation tube / kit is further shipped to the laboratory or test centre for analysis.

[0015] A first aspect of the invention relates to a utensil for self-sampling a specimen from a body cavity comprising a shaft with a distal end configured for insertion into a body cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

[0016] For example, the utensil may be configured for self-sampling a specimen from a vaginal, oral, and / or anal cavity, by the handle being disposed adjustable or adjustably fixed or predefined at the shaft.

[0017] A further aspect of the invention relates to a utensil for self-sampling a vaginal specimen comprising a shaft with a distal end configured for insertion into a vaginal cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

[0018] A second aspect of the invention relates to a kit of parts, comprising the utensil according to the first aspect, a first transportation tube for encasing the utensil before use, and optionally a second transportation tube for encasing the detached part of the shaft after use, wherein the parts are optionally co-packaged.

[0019] Description of Drawings

[0020] The invention will in the following be described in greater detail with reference to the accompanying drawings.

[0021] Figure 1 shows an embodiment of a utensil according to the present disclosure in a perspective view.

[0022] Figure 2 shows two embodiments (A) and (B) of the utensil according to the present disclosure in a cross sectional view.

[0023] Figure 3 shows the two embodiments (A) and (B) of Figure 2 in perspective view.

[0024] Figure 4 shows an embodiment of a utensil according to the present disclosure, where the utensil is seized by a hand at the defined grip position of the handle.

[0025] Figure 5 shows an embodiment of a utensil according to the present disclosure in a perspective view.

[0026] Figure 6 shows two embodiments (A) and (B) of the utensil according to the present disclosure in a cross sectional view.

[0027] Figure 7 shows the two embodiments (A) and (B) of Figure 2 in perspective view.

[0028] Detailed description

[0029] The invention is described below with the help of the accompanying figures. It would be appreciated by the people skilled in the art that the same feature or component of the device are referred with the same reference numeral in different figures. A list of the reference numbers can be found at the end of the detailed description section.

[0030] Figure 1 shows an embodiment of a utensil according to the present disclosure in a perspective view. The utensil comprises a shaft 1 defining a longitudinal direction. A first and proximal end of the shaft is configured for being seized by a user’s hand as indicated in Figure 4, while the other second and distal end is configured for slidable insertion into a body cavity, such as a vaginal cavity via a vaginal opening. A specimen collector 2 is disposed at the distal end of the shaft, such that the inserted distal end may be used to collect a sample from the body cavity. For example, the body cavity may be vaginal, and the specimen collector adapted for sampling a vaginal specimen. Alternatively, the body cavity may be oral or anal, and the specimen collector adapted for sampling an oral or anal specimen.

[0031] The proximal end of the shaft comprises a handle 4 configured for being seized by a user’s hand, e.g. pinched between two gripping fingers such as a thumb and index finger grip, as indicated in Figure 4. The handle comprises a concave section along the longitudinal profile which is configured to match a convex shape, such as a finger or surface of a finger tip, as shown in Figure 4. By the term concave is meant an inwardly curving profile, such that the handle may assume the shape of a concave lens or an hourglass, as shown in Figures 1-4. Thus, the profile is curved inwardly towards a central longitudinal axis. Hence, the concave section provides a defined or predefined finger grip position along the shaft due to the inward curvature of the concave section. The handle 4 extends in the longitudinal direction along a part of the shaft, with the length of the handle being Lh, as indicated in Figure 1. The handle 4 is located at a distance Ls to the specimen collector 2, where the distance Ls may be defined as the distance between the distal end of the handle and the distal end of the shaft, as indicated in Figure 1. The distance Ls may be adjustable or adjustably fixed or predefined according to the manufacture method. For example, the distance may be predefined if the shaft is made by injection molding, or adjustably predefined if the shaft is made by 3D printing.

[0032] It follows that the handle 4 may provide a defined or predefined finger grip position as well as a fixed distance relative to the specimen collector. Accordingly, upon slidable insertion of the utensil into a body cavity, the gripping hand will be abutting the cavity opening at a defined insertion depth corresponding to Ls, and thus provide a stopping point restricting the further insertion into the body cavity. The defined insertion depth reduces the risk of invalid samples collected at too low sampling depth, which is particularly an issue for vaginal specimens to be tested for microorganisms (bacteria, fungi, and viruses) related to sexually transmitted infections, such as HPV, chlamydia, and herpes virus. The minimum sampling depth to obtain a valid vaginal specimen is generally around 60 mm, and the optimum sampling depth with a higher sample rate validity is ca. 55-95 mm depending on ethnicity. Accordingly, the handle provides a more fail-safe utensil, where the risk of sampling at too low sampling depth, resulting in an invalid sample, or sampling too deep and risking damage to the utensil or the patient during use, is reduced. Thus, the utensil is particularly suitable for selfsampling, including self-sampling for users with reduced tactile sensitivity, where a high fail-safe degree is required.

[0033] In an embodiment of the disclosure, the handle is disposed at a fixed distance to the specimen collector. In a further embodiment, the distance between the handle and the specimen collector is 55-95 mm, and preferably is 60 mm.

[0034] In an embodiment of the disclosure, the concave section is configured as a defined and / or predefined finger grip position by being configured to match the convex profile of a finger or surface of a finger tip. In an embodiment of the disclosure, the handle is configured to restrict a further insertion of the shaft into the vaginal cavity, when seized at the finger grip position.

[0035] The distance Ls may be adjustable or adjustably fixed or predefined according to the manufacture method, and determined depending on the sampling purpose. For example, for vaginal sampling a first distance may be suitable, whereas for respectively oral sampling and anal sampling, a second and third distance may be suitable.

[0036] After sampling, the utensil is retracted from the body cavity, and the specimen collector now including the collected sample, is safely and hygienically partially or completely detached from the proximal handle via a break section 3. For example, the break section may be configured to form a fracture surface or a hinge, whereby the handle and specimen collector is completely or partially detached. The break section is advantageously located adjacent or in the proximity to the handle, such that breaking and detachment is facilitated when the user is gripping the handle. For example, the break section may be located distally to the handle at a distance of Lb, as indicated in Figure 1.

[0037] Advantageously, the breaking and detachment may be carried out immediately after retraction of the utensil, while the user maintains the defined finger grip position, such that the sample collector is not contacted by further biological surfaces and exposed to contaminants before shipping. Preferably, the detachment breaking or hinging is triggered via user contact to only the proximal handle located distally to the break section. For example, while maintaining the defined finger grip position, a user may slidably place the distal shaft end in a transportation tube comprising solid surface walls and a tube opening with an edge, and then trigger the detachment by flexing the handle present outside the tube, such that the break section 3 is flexed around the tube opening edge. This corresponds to the shaft being subjected to a 2-point bend force generated between the hand grip located at the handle being the first load point, and the solid surface of the tube being the second load point. The flexural force for breaking or hinging may be configured to differ from the linear translation forces applied during insertion and retraction of the utensil, and thus the risk of unintentional breakage inside the body cavity is reduced.

[0038] In an embodiment of the disclosure, the break section is configured for partially or completely detaching a part of the shaft.

[0039] In an embodiment of the disclosure, the break section is configured for detaching the part of the shaft comprising the distal end, when the shaft is subjected to a 2-point bend force generated between a hand grip as first load point and a solid surface as second load point.

[0040] Handle

[0041] To ensure a well defined finger grip position at the handle, and consequently a defined insertion depth of the specimen collector, the concave section along the longitudinal profile of the handle is advantageously configured to have a partly matching geometry with one or more fingers, such that an intended and comfortable grip position is evident, as indicated in Figure 4. Hence, the longitudinal profile may comprise a concave section with a tapered shape, where the tapered shape may include discrete steps, and / or continuously linear or curved sections. Further, the length of the handle Lh may be configured such that it evidently matches one or more fingers comfortably, irrespective of the hand size. For example, the length of the handle may preferably be 10-30 mm. In an embodiment of the disclosure, the concave section comprises a longitudinal profile selected from the group of: tapered steps, linearly tapered, curved tapered, and combinations thereof.

[0042] In an embodiment of the disclosure, the handle has a length of 10-30 mm, more preferably between 15-25 mm, such as 20 mm.

[0043] In addition to defining an intended finger grip position, the tapered concave shape of the handle further has the advantage of facilitating easy grip and manipulation of the shaft. Accordingly, the handle may facilitate improved user control of the sampling process. Sampling of vaginal specimens typically requires twisting or rotation of the shaft including the sample collector, and especially for users with reduced tactile sensitivity, and / or reduced finger strength and mobility, an easy and accessible grip is required for safe use.

[0044] Moreover, for simple and apparent manipulation during insertion and sampling, and thus improving the fail-safety and risk of damage during use, the handle is advantageously disposed concentrically and rotational symmetric along the shaft. For example, the handle may have the shape of a double napped cone, as shown in the embodiment of Figure 1.

[0045] In an embodiment of the disclosure, the handle is concentric to the shaft. In a further and alternative embodiment, the handle is rotational symmetric around the longitudinal axis.

[0046] The concave section of the handle may further reduce the risk of finger grip slips in the longitudinal direction, both slips in the distal direction which the fingers may be prone to during insertion, and slips in the proximal direction which may occur during retraction. The anti-slip function is due to the inward curvature concave section, and particularly handles having a generally double napped cone shape, such as a hourglass shape, saddle shape, V-shape, or spool shape as seen in longitudinal cross sectional view, may provide advantageous anti-slip of fingers.

[0047] In an embodiment of the disclosure, the concave section is configured for restricting finger grip slip in the shaft direction. In a further and alternative embodiment, the concave section is double napped cone shape, hourglass shaped, saddle shaped, V- shaped, or spool shaped.

[0048] As seen from Figure 1 , the concave minimum of the handle may define a minimum thickness of the handle T between the thicker distal end and the thicker proximal end of the handle. For a rotational symmetrical handle with a generally double napped cone shape, the minimum thickness will correspond to a minimum diameter of the handle. To ensure a sufficiently robust, stable, and manipulative handle, the minimum thickness may be 2-5 mm, and correspond to ca. 30-70% of the maximum handle thickness. Figures 2-3 show cross sectional views and perspective views of two embodiments having different minimum thickness, as further described in Examples 1-2.

[0049] In an embodiment of the disclosure, the concave minimum defines a minimum thickness of the handle between the distal end and the proximal end of the handle. In a further and alternative embodiment, the minimum thickness is 30-70% of the maximum handle thickness, more preferably 40-60% of the maximum handle thickness, such as 50% of the maximum handle thickness. In a further embodiment, the minimum thickness is 2-5 mm, such as 2.5, 3.0, 3.5, or 4.0 mm.

[0050] Utensils for self-sampling vaginal specimens are advantageously adapted to reduce the risk of too deep or excessive insertion. Excessive insertion may cause damage to the patient as well as the utensil, and further result in the sampled specimen being invalid. To reduce the risk of excessive insertion, the distal end of the handle may advantageously define a maximum handle thickness, and have a thickness or corresponding diameter of 4-9 mm.

[0051] In an embodiment of the disclosure, the distal end of the handle defines a maximum handle thickness. In a further embodiment, the maximum handle thickness is 4-9 mm, such as 5, 6, 7, or 8 mm.

[0052] To simplify the manufacture of the utensil, the distal end and the proximal end of the handle may be mirror symmetric, as shown in Figures 1-3. Alternatively, the proximal end of the handle may be thinner, or have a corresponding smaller diameter than the distal end, since the risk of finger grip slip in the proximal direction may be lower. For example, a sufficiently robust, stable, and manipulative handle may be obtained when the proximal end of the handle has a thickness or diameter of 4-8 mm.

[0053] In an embodiment, the distal end and the proximal end of the handle are mirror symmetric. In an alternative embodiment, the proximal end of the handle is thinner than the distal end of the handle, optionally wherein the thickness of the proximal end is 4-8 mm, such as 7 mm.

[0054] To further ensure a well defined finger grip position, which further provides a robust, stable, and manipulative grip, specifically for users with reduced tactile sensitivity, the handle may comprise a structured surface. Advantageously, the structured surface is configured for sensing a rotation of the handle, since sampling of a valid vaginal specimen typically requires twisting or rotation of the shaft including the sample collector. Sensing of handle rotation via the fingers may be obtained by a structured surface comprising protrusions in a regular or irregular pattern. For example, the protrusions may be in the form of a surface roughness corresponding to extra fine sandpaper, which is detectable by finger tips. Extra fine sandpaper, such as 240 grit sandpaper, has a surface roughness due to the protruding abrasive grains, which have a height deviation of 40.5 pm or more, compared to the profile mean line.

[0055] In an embodiment of the disclosure, the handle comprises a structured surface configured for sensing a rotation of the handle. In a further embodiment, the structured surface comprises a roughness corresponding to at least 240 grit sandpaper having a height deviation of at least 40.5 pm.

[0056] The sensing of handle rotation and the physical demands for rotating the handle may be further improved by the structured surface comprising protrusions extending in the longitudinal direction. For example, advantageously the protrusions include ribs or a mesh extending in the longitudinal direction of the handle.

[0057] In a further embodiment of the disclosure, the structured surface comprises one or more protrusions extending in the longitudinal direction. In a further embodiment, the structured surface comprises a regular pattern, such as a pattern of ribs or a mesh.

[0058] Break section As described above, the collected sample may be safely and hygienically detached from the proximal handle via a break section 3 of the shaft, located distally to the handle at distance of Lb, while maintaining the defined finger grip position assumed during insertion and retraction of the utensil. This has the advantage that contamination may be reduced before shipping of the collected specimen.

[0059] The flexural force required for breaking the shaft at the break section by a 2-point bend force will depend on various factors including the position of the break section, the thickness of the break section, the geometry of the break section, and the thickness and material of the shaft. Advantageously, the break section is configured such that the flexural force for breaking is differ from the linear translation forces generated during the insertion and retraction of the utensil, such that the risk of unintentional breakage inside the body cavity is reduced. Controlled detachment of a part of the shaft at the break section is advantageously obtained for a break section disposed 1-9 mm from the distal end of the handle.

[0060] In an embodiment of the disclosure, the break section is disposed at a distance of 1-9 mm from a distal end of the handle, such as 3, 4, or 5 mm from the distal end of the handle.

[0061] Further controlled detachment at the break section may be obtained for a break section having a thickness of 70-95% of the maximum shaft thickness, where the maximum shaft thickness may be 1-5 mm. The shaft may be cylindrical or comprise cylindrical sections, and the shaft thickness thus correspond to a diameter.

[0062] In an embodiment of the disclosure, the break section has a thickness of 70-95% of the maximum shaft thickness, more preferably 80-90% of the maximum shaft thickness. In a further and alternative embodiment, the shaft has a maximum thickness of 1-5 mm, such as 2, 3, or 4 mm.

[0063] Further controlled detachment at the break section may be obtained for a break section comprising a notch shaped geometry. For example, the notch may be rectangular or V- shaped as seen in cross sectional view, e.g. in Figures 1-3. The notch may further be arranged to provide a defined break direction. For example, similar to the notches made on tree felling, the notch may be placed at a single position of the shaft, at opposite positions of the shaft, or located radially along the circumference of the shaft.

[0064] For a cylindrical shaft, this corresponds to a circular notch.

[0065] In an embodiment of the disclosure, the break section comprises a notch, such as a V- shaped notch, wherein the notch optionally is arranged at single position of the shaft, at two opposite positions of the shaft, or as a circular notch.

[0066] Controlled detachment at the break section also includes a controlled surface of fracture. Brittle materials will be prone to form a jagged plane of rupture, whereas more elastic materials may have a smooth surface of fracture. Advantageously, the shaft and break section comprises an elastic material with a formulation configured to have a smooth surface of fracture. The elastic material is further advantageously biocompatible and / or biodegradable. For example, the elastic material may be a suitable plastic having the indicated properties.

[0067] In an embodiment of the disclosure, the shaft comprises biocompatible and / or biodegradable plastics configured to be flexible, wherein the plastics are selected from the group of: nylon, polystyrene, polyurethane, reticulated polyurethane, wax-coated materials, and any combinations thereof.

[0068] To further improve the user friendliness and fail-safety of the device, the utensil or parts of the utensil are advantageously manufactured as a single and smooth piece. This reduces the risk of unintentional breakage inside the body cavity and tissue damage due to jagged parts. For example, the shaft including the break section, handle, and optionally the specimen collector, may be manufactured by injection molding and / or 3D printing.

[0069] In an embodiment of the disclosure, the utensil or parts of the utensil is made by injection molding and / or 3D printing.

[0070] Shaft

[0071] Advantageously, the proximal end of the shaft comprises a flange configured to engage with a user’s fingers. For example, the flange may be a disc shaped flange (D) disposed in the vicinity or at the most proximal end of the shaft, as shown in Figures 5- 7. Accordingly, the flange may act as a second defined stopping point for the insertion, and thus function as an additional safety. For example, the flange may act as safety stopper in the cases, where too deep vaginal insertion may occur, e.g. where finger grip slip at the handle occurred during insertion, or where no gripping hand was applied to the handle such that the gripping hand cannot function as an insertion stopper, when abutting the opening of the body cavity, such as the vaginal opening and labia, as described in Example 3.

[0072] The radially extending flange disposed at a shaft may further engage with a user’s fingers in the same manner as a finger flange of a syringe. Accordingly, a stable and secure engagement may be obtained by placing at least two fingers at opposite sides of the shaft, such that the utensil may be retracted with a minimum of finger strength.

[0073] In an embodiment of the disclosure, the proximal end of the shaft comprises a flange configured to engage with a user’s fingers. In a further embodiment, the flange is configured to engage with at least two fingers of a user in the manner of a syringe finger flange.

[0074] To facilitate stable, flexible and fail-safe engagement with the user’s finger, the flange is advantageously disposed concentrically and rotational symmetric to the shaft, such that the finger grip is similar irrespective of the position of the hand. The flange further advantageously extend radially with a distance of between 5-30 mm, such that the flange has sufficient surface area available for a user’s finger. For example, the flange may preferably be a disc with a diameter of ca. 10 mm.

[0075] In an embodiment of the disclosure, the flange is rotational symmetric. In a further embodiment, the flange is disc shaped, preferably having a diameter of between 5-30 mm, more preferably between 7-20 mm, and most preferably between 9-15 mm, such as 10 mm. collector

[0076] The specimen collector may be adapted for sampling cells or tissue from a body cavity, such as vaginal specimens to be tested for microorganisms (bacteria, fungi, and viruses) related to sexually transmitted infections, such as HPV, chlamydia, and herpes virus. To increase the chance of a validly sampled specimen and for user friendliness, the specimen collector advantageously comprises a material which is both soft and has a high capacity for cellular uptake. A high cellular collection yield may be obtained when the specimen collector is subjected to shearing contact and / or capillary contact with the specimen. Polyester fibers, such as Dacron, may provide a high collection yield for vaginal specimens.

[0077] In an embodiment of the disclosure, the specimen collector is configured for collecting a vaginal specimen when subjected to shearing contact and / or capillary contact with the specimen. In a further and alternative embodiment, the specimen collector comprises a material selected from the group consisting of: bristles, flocked plastics and polymers, such as flocked nylon, flocked polyamide polymer, flocked polyester polymer, flocked polypropylene polymer, and flocked fibrous materials such as polyester fibers.

[0078] Kit of parts

[0079] To facilitate the self-sampling procedure including the test, the utensil according to the present disclosure is advantageously provided as a kit of parts. For example, the utensil may be provided as a kit of parts to the user, and after performing the selfsampling, the user ships the relevant parts to the laboratory for analysis.

[0080] The kit of parts may comprise the utensil and a first transportation tube for encasing the utensil before use. The kit may further comprise a second transportation tube for detaching the part of the shaft comprising the specimen collector and / or for encasing the detached part of the shaft after sampling. Optionally the parts are co-packaged for easy shipping to the user as well as the laboratory.

[0081] An embodiment of the disclosure relates to a kit of parts, comprising the utensil according to any of the preceding claims, a first transportation tube for encasing the utensil before use, and optionally a second transportation tube for encasing the detached part of the shaft after use, wherein the parts are optionally co-packaged.

[0082] Reference numbers

[0083] 1 - Shaft

[0084] 2 - Specimen collector

[0085] 3 - Break section

[0086] 4 - Handle Ls - Distance between handle and specimen collector

[0087] Lb - Distance between handle and break section

[0088] Lh - Length of handle

[0089] T - Thickness

[0090] D - Flange diameter

[0091] Examples

[0092] The invention is further described by the examples provided below.

[0093] Example 1 - Utensil with handle having a minimum thickness of 2.5 mm

[0094] A prototype of the utensil shown in Figures 2A and 3A was made by 3D printing.

[0095] A comparative study of the user experience of the utensil compared to commercially available self-sampling utensils is carried out. The user experience includes the user’s ability to conduct vaginal sampling by self-sampling, as well as the user’s impression of whether a valid vaginal specimen is correctly obtained, if the sampling feels safe, and whether the sampling is deemed easy. The study may be extended to include validation of improved screening coverage, and clinical validation of improved valid sampling fractions.

[0096] Example 2 - Utensil with handle having a minimum thickness of 4 mm

[0097] A prototype of the utensil shown in Figure 1 , 2B, 3B, and 4 was made by 3D printing. A comparative study of the user experience of the utensil compared to commercially available self-sampling utensils is carried out. The user experience includes the user’s ability to obtain vaginal specimen by self-sampling, as well as the user’s impression of whether a valid vaginal specimen is obtained, if the sampling feels safe, and whether the sampling is deemed easy. The study may be extended to include validation of improved screening coverage, and clinical validation of improved valid sampling fractions.

[0098] Example 3 - Utensil with safety flange

[0099] A prototype of the utensil shown in Figures 5-7 comprising a proximally disposed disc shaped flange is made by 3D printing or by molding. The utensil is particularly advantageous in case of too deep vaginal insertion e.g. where finger grip slip at the handle occurred during insertion, or where no gripping hand was applied to the handle such that the gripping hand cannot function as an insertion stopper, when abutting the opening of the body cavity, such as the vaginal opening and labia. The disc shaped flange acts as a second defined stopping point for the insertion. Following too deep vaginal insertion, the proximal disposed flange is engaged with at least two fingers at opposite sides of the shaft in the same manner as a syringe finger flange, and the utensil may be safely retracted from the body cavity.

[0100] Items

[0101] The presently disclosed may be described in further detail with reference to the following items.

[0102] 1. A utensil for self-sampling a specimen from a body cavity comprising a shaft with a distal end configured for insertion into a body cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

[0103] 2. The utensil according to item 1 configured for self-sampling a specimen from a vaginal, oral, and / or anal cavity.

[0104] 3. A utensil for self-sampling a vaginal specimen comprising a shaft with a distal end configured for insertion into a vaginal cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

[0105] 4. The utensil according to any of the preceding items, wherein the handle is disposed at a fixed distance to the specimen collector. 5. The utensil according to any one of the preceding items, wherein the distance between the handle and the specimen collector is 55-95 mm, and preferably is 60 mm.

[0106] 6. The utensil according to any one of the preceding items, wherein the handle is configured to restrict a further insertion of the shaft into the vaginal cavity, when seized at the finger grip position.

[0107] 7. The utensil according to any one of the preceding items, wherein the concave section is configured as a defined and / or predefined finger grip position.

[0108] 8. The utensil according to any one of the preceding items, wherein the concave section comprises a longitudinal profile selected from the group of: tapered steps, linearly tapered, curved tapered, and combinations thereof.

[0109] 9. The utensil according to any one of the preceding items, wherein the handle has a length of 10-30 mm, more preferably between 15-25 mm, such as 20 mm.

[0110] 10. The utensil according to any one of the preceding items, wherein the handle is concentric to the shaft.

[0111] 11. The utensil according to any one of the preceding items, wherein the handle is rotational symmetric around the longitudinal axis.

[0112] 12. The utensil according to any one of the preceding items, wherein the concave section is configured for restricting finger grip slip in the shaft direction.

[0113] 13. The utensil according to any one of the preceding items, wherein the concave section is double napped cone shaped, hourglass shaped, saddle shaped, V- shaped, or spool shaped.

[0114] 14. The utensil according to any one of the preceding items, wherein the concave minimum defines a minimum thickness of the handle between the distal end and the proximal end of the handle.

[0115] 15. The utensil according to item 14, wherein the minimum thickness is 30-70% of the maximum handle thickness, more preferably 40-60% of the maximum handle thickness, such as 50% of the maximum handle thickness. 16. The utensil according to any one of items 14-15, wherein the minimum thickness is 2-5 mm, such as 2.5, 3.0, 3.5, or 4.0 mm.

[0116] 17. The utensil according to any one of the preceding items, wherein the distal end of the handle defines a maximum handle thickness.

[0117] 18. The utensil according to item 17, wherein the maximum handle thickness is 4-9 mm, such as 5, 6, 7, or 8 mm.

[0118] 19. The utensil according to any one of the preceding items, wherein the distal end and the proximal end of the handle are mirror symmetric.

[0119] 20. The utensil according to any one of items 1-18, wherein the proximal end of the handle is thinner than the distal end of the handle, optionally wherein the thickness of the proximal end is 4-8 mm, such as 7 mm.

[0120] 21. The utensil according to any one of the preceding items, wherein the handle comprises a structured surface configured for sensing a rotation of the handle.

[0121] 22. The utensil according to item 21, wherein the structured surface comprises a roughness corresponding to at least 240 grit sandpaper having a height deviation of at least 40.5 pm.

[0122] 23. The utensil according to any one of items 21-22, wherein the structured surface comprises one or more protrusions extending in the longitudinal direction.

[0123] 24. The utensil according to any one of items 21-23, wherein the structured surface comprises a regular pattern, such as a pattern of ribs or a mesh.

[0124] 25. The utensil according to any one of the preceding items, wherein the break section is configured for partially or completely detaching a part of the shaft.

[0125] 26. The utensil according to any one of the preceding items, wherein the break section is configured for detaching the part of the shaft comprising the distal end, when the shaft is subjected to a 2-point bend force generated between a hand grip as first load point and a solid surface as second load point. 27. The utensil according to any one of the preceding items, wherein the break section is disposed at a distance of 1-9 mm from a distal end of the handle, such as 3, 4, or 5 mm from the distal end of the handle.

[0126] 28. The utensil according to any one of the preceding items, wherein the break section has a thickness of 70-95% of the maximum shaft thickness, more preferably 80-90% of the maximum shaft thickness.

[0127] 29. The utensil according to any one of the preceding items, wherein the shaft has a maximum thickness of 1-5 mm, such as 2, 3, or 4 mm.

[0128] 30. The utensil according to any one of the preceding items, wherein the break section comprises a notch, such as a V-shaped notch, wherein the notch optionally is arranged at single position of the shaft, at two opposite positions of the shaft, or as a circular notch.

[0129] 31 . The utensil according to any one of the preceding items, wherein the shaft comprises biocompatible and / or biodegradable plastics configured to be flexible, wherein the plastics are selected from the group of: nylon, polystyrene, polyurethane, reticulated polyurethane, wax-coated materials, and any combinations thereof.

[0130] 32. The utensil according to any one of the preceding items, wherein the proximal end of the shaft comprises a flange configured to engage with a user’s fingers.

[0131] 33. The utensil according to item 32, wherein the flange is configured to engage with at least two fingers of a user in the manner of a syringe finger flange.

[0132] 34. The utensil according to any one of items 32-33, wherein the flange is rotational symmetric.

[0133] 35. The utensil according to any one of items 32-34, wherein the flange is disc shaped, preferably having a diameter of between 5-30 mm, more preferably between 7-20 mm, and most preferably between 9-15 mm, such as 10 mm.

[0134] 36. The utensil according to any one of the preceding items, wherein the specimen collector is configured for collecting a vaginal specimen when subjected to shearing contact and / or capillary contact with the specimen. The utensil according to any one of the preceding items, wherein the specimen collector comprises a material selected from the group consisting of: bristles, flocked plastics and polymers, such as flocked nylon, flocked polyamide polymer, flocked polyester polymer, flocked polypropylene polymer, and flocked fibrous materials such as polyester fibers, e.g. Dacron. The utensil according to any one of the preceding items, made at least partially by injection molding and / or 3D printing. A kit of parts, comprising the utensil according to any one of the preceding items, a first transportation tube for encasing the utensil before use, and optionally a second transportation tube for encasing the detached part of the shaft after use, wherein the parts are optionally co-packaged.

Claims

Claims1 . A utensil for self-sampling a specimen from a body cavity comprising a shaft with a distal end configured for insertion into a body cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

2. The utensil according to claim 1 configured for self-sampling a specimen from a vaginal, oral, and / or anal cavity.

3. A utensil for self-sampling a vaginal specimen comprising a shaft with a distal end configured for insertion into a vaginal cavity, said shaft comprising: a specimen collector disposed at the distal end, a break section configured for detaching a part of the shaft comprising the distal end, and a handle disposed along a part of the shaft at a distance to the specimen collector, wherein a longitudinal profile of the handle comprises a concave section configured for defining a finger grip position.

4. The utensil according to any of the preceding claims, wherein the handle is disposed at a fixed distance to the specimen collector.

5. The utensil according to any one of the preceding claims, wherein the distance between the handle and the specimen collector is 55-95 mm, and preferably is 60 mm.

6. The utensil according to any one of the preceding claims, wherein the handle is configured to restrict a further insertion of the shaft into the vaginal cavity, when seized at the finger grip position.

7. The utensil according to any one of the preceding claims, wherein the concave section is configured as a defined and / or predefined finger grip position.

8. The utensil according to any one of the preceding claims, wherein the concave section comprises a longitudinal profile selected from the group of: tapered steps, linearly tapered, curved tapered, and combinations thereof.

9. The utensil according to any one of the preceding claims, wherein the handle has a length of 10-30 mm, more preferably between 15-25 mm, such as 20 mm.

10. The utensil according to any one of the preceding claims, wherein the handle is concentric to the shaft.11 . The utensil according to any one of the preceding claims, wherein the handle is rotational symmetric around the longitudinal axis.

12. The utensil according to any one of the preceding claims, wherein the concave section is configured for restricting finger grip slip in the shaft direction.

13. The utensil according to any one of the preceding claims, wherein the concave section is double napped cone shaped, hourglass shaped, saddle shaped, V- shaped, or spool shaped.

14. The utensil according to any one of the preceding claims, wherein the concave minimum defines a minimum thickness of the handle between the distal end and the proximal end of the handle.

15. The utensil according to claim 14, wherein the minimum thickness is 30-70% of the maximum handle thickness, more preferably 40-60% of the maximum handle thickness, such as 50% of the maximum handle thickness.

16. The utensil according to any one of claims 14-15, wherein the minimum thickness is 2-5 mm, such as 2.5, 3.0, 3.5, or 4.0 mm.

17. The utensil according to any one of the preceding claims, wherein the distal end of the handle defines a maximum handle thickness.

18. The utensil according to claim 17, wherein the maximum handle thickness is 4- 9 mm, such as 5, 6, 7, or 8 mm.

19. The utensil according to any one of the preceding claims, wherein the distal end and the proximal end of the handle are mirror symmetric.

20. The utensil according to any one of claims 1-18, wherein the proximal end of the handle is thinner than the distal end of the handle, optionally wherein the thickness of the proximal end is 4-8 mm, such as 7 mm.

21. The utensil according to any one of the preceding claims, wherein the handle comprises a structured surface configured for sensing a rotation of the handle.

22. The utensil according to claim 21, wherein the structured surface comprises a roughness corresponding to at least 240 grit sandpaper having a height deviation of at least 40.5 pm.

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

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

25. The utensil according to any one of the preceding claims, wherein the break section is configured for partially or completely detaching a part of the shaft.

26. The utensil according to any one of the preceding claims, wherein the break section is configured for detaching the part of the shaft comprising the distal end, when the shaft is subjected to a 2-point bend force generated between a hand grip as first load point and a solid surface as second load point.

27. The utensil according to any one of the preceding claims, wherein the break section is disposed at a distance of 1-9 mm from a distal end of the handle, such as 3, 4, or 5 mm from the distal end of the handle.

28. The utensil according to any one of the preceding claims, wherein the break section has a thickness of 70-95% of the maximum shaft thickness, more preferably 80-90% of the maximum shaft thickness.

29. The utensil according to any one of the preceding claims, wherein the shaft has a maximum thickness of 1-5 mm, such as 2, 3, or 4 mm.

30. The utensil according to any one of the preceding claims, wherein the break section comprises a notch, such as a V-shaped notch, wherein the notch optionally is arranged at single position of the shaft, at two opposite positions of the shaft, or as a circular notch.

31. The utensil according to any one of the preceding claims, wherein the shaft comprises biocompatible and / or biodegradable plastics configured to be flexible, wherein the plastics are selected from the group of: nylon, polystyrene, polyurethane, reticulated polyurethane, wax-coated materials, and any combinations thereof.

32. The utensil according to any one of the preceding claims, wherein the proximal end of the shaft comprises a flange configured to engage with a user’s fingers.

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

34. The utensil according to any one of claims 32-33, wherein the flange is rotational symmetric.

35. The utensil according to any one of claims 32-34, wherein the flange is disc shaped, preferably having a diameter of between 5-30 mm, more preferably between 7-20 mm, and most preferably between 9-15 mm, such as 10 mm.

36. The utensil according to any one of the preceding claims, wherein the specimen collector is configured for collecting a vaginal specimen when subjected to shearing contact and / or capillary contact with the specimen.

37. The utensil according to any one of the preceding claims, wherein the specimen collector comprises a material selected from the group consisting of: bristles,flocked plastics and polymers, such as flocked nylon, flocked polyamide polymer, flocked polyester polymer, flocked polypropylene polymer, and flocked fibrous materials such as polyester fibers, e.g. Dacron.

38. The utensil according to any one of the preceding claims, made at least partially by injection molding and / or 3D printing.

39. A kit of parts, comprising the utensil according to any one of the preceding claims, a first transportation tube for encasing the utensil before use, and optionally a second transportation tube for encasing the detached part of the shaft after use, wherein the parts are optionally co-packaged.

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