Cervicovaginal fluid collection device

#This application is the U.S. National Phase under 35. U.S.C. § 371 of International Application PCT/SG2020/050393, filed Jul. 9, 2020, which claims priority to Singapore patent application Ser. No. 10/201,906515, filed Jul. 12, 2019. The disclosures of the above-described applications are hereby incorporated by reference in their entirety.

#This invention relates to a cervicovaginal fluid collection device.

#The current protocol for collection of cervicovaginal secretion uses a speculum to open the walls of the vagina and a cotton swab inserted through the speculum to swab the cervix or vagina and obtain a secretion sample. This current protocol has multiple issues. Firstly, sample contamination through vulval or skin contact may occur during swab insertion and removal. Secondly, application of the speculum is invasive and is generally uncomfortable and embarrassing for the patient. Thirdly, it is time consuming for the healthcare provider. Therefore, it is desirable at times to be able to obtain a vaginal swab in a way that minimizes invasiveness to the patient while avoiding sample contamination.

#In order that the invention may be fully understood and readily put into practical effect, there shall now be described by way of non-limitative example only exemplary embodiments of the present invention, the description being with reference to the accompanying illustrative drawings.

#FIG. 1 is a perspective view of a first exemplary embodiment of a CVF collection device.

#FIG. 2 is a longitudinal cross-section view of the device of FIG. 1.

#Exemplary embodiments of a cervicovaginal fluid (CVF) collection device 100 will be described below with reference to FIGS. 1 to 13. The same reference numerals are used across the figures to refer to the same or similar parts.

#The presently disclosed CVF collection device 100 provides a simple and minimally-invasive method for sampling CVF. In order to achieve accurate test results, it is essential that a swab used to collect the CVF thereon is shielded from the vaginal wall during the insertion and removal from the vaginal cavity. To achieve this, the device 100 comprises a probe 10 that is enclosed by a cylinder or generally tubular housing 20, as shown in FIGS. 1-2 and 6-8. The housing 20 has an enclosed tip at a first end 21 and an open top or second end 22. The housing 20 is open at the second end 22 for the cotton swab 30 and probe 10 to be fitted into the housing 20. The enclosed tip 21 preferably has a rounded configuration for comfortable, non-damaging insertion into the vagina. A number of openings or through holes 23 are provided at or adjacent the enclosed tip 21 of the housing 20 from which CVF fluid can enter the housing 20 and be absorbed by the fluid-absorbing swab 30. The number of through holes 23 may be one or more as may be desired, for example, three, and edges of the through holes 23 are preferably rounded or smoothened to avoid scratching the vaginal walls. In exemplary embodiments, the housing 20 is preferably straight, may have a length of about 15 cm, may have an outer diameter of about 11 mm and a wall thickness of about 1 mm. Within the housing 20 is the probe 10 that stays completely within the housing 20 and does not protrude out of the tip 21 of the housing 20.

#The fit of the probe 10 in the housing 20 is such that rotation of the probe 10 within the housing 20 can be done with light finger force, but it is not free rotation and the probe 10 will not slip out of the housing 20 when device 100 is held inverted. To achieve this, the first end 11 of the probe 10 is provided with a screw-like structure 40 (as can be seen in FIGS. 2, 3, 7 and 10) that has a sliding fit with an inner bore 24 of the housing 20 as shown in FIGS. 2 and 7. At least a first end 41 of the screw-like structure 40 is provided at the enclosed tip 21 of the housing 20. The screw-like structure 40 comprises a helical structure 44 wrapped around a first end 461 of a central shaft 46 like a screw thread, wherein crests of the helical structure 44 effect the sliding contact with the inner bore 24 of the housing 20. In a preferred embodiment, the crests of the helical structure 44 may effect a fluid seal with the inner bore 24 of the housing 20 The central shaft 46 has a longitudinal axis that is colinear with a longitudinal axis of the probe 10 and a longitudinal axis of the housing 20. The rest of the probe 10 preferably comprises a rigid support shaft 14. A second end 462 of the central shaft 46 is connected to a first end 141 of the support shaft 14 while a second end 142 of the support shaft 142 (that forms the second end 12 of the probe 10) extends to at least the second end 22 of the housing 20 when the probe 10 is assembled with the housing 20, if not beyond. In an exemplary embodiment, the shaft 14 may have a diameter of about 7 mm and a length of about 12 mm while the screw-like structure 40 has a length of about 4 to 5 cm and a widest diameter that provides a sliding fit with the inner bore of the housing 20.