EP-4739220-A1 - 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.

Inventors

• BONDE, Jesper
• ANDREASEN, Emilie Korsgaard

Assignees

• Hvidovre Hospital

Dates

Publication Date

20260513

Application Date

20240702

Claims (20)

1. 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.
2. 2. The utensil according to claim 1 configured for self-sampling a specimen from a vaginal, oral, and/or anal cavity.
3. 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. 4. The utensil according to any of the preceding claims, wherein the handle is disposed at a fixed distance to the specimen collector.
5. 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. 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. 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. 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. 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. 10. The utensil according to any one of the preceding claims, wherein the handle is concentric to the shaft.
11. 11 . The utensil according to any one of the preceding claims, wherein the handle is rotational symmetric around the longitudinal axis.
12. 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. 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. 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. 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. 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. 17. The utensil according to any one of the preceding claims, wherein the distal end of the handle defines a maximum handle thickness.
18. 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. 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. 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.

Description

Utensil for self-sampling a vaginal specimen Technical field The present invention relates to a utensil sized or configured for self-sampling a vaginal specimen, and a kit of parts comprising the utensil. Background 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. 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). 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. 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. 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. Summary 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. 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. 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. 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