GB2617789A

GB2617789A - Cervical sampling brush

Info

Publication number: GB2617789A
Application number: GB2311820.1A
Authority: GB
Inventors: Emma Ben-Nathan Louise; Blondeck Alex; Badham Gary; Helmich Mark
Original assignee: Lbn Innovations Ltd
Current assignee: Lbn Innovations Ltd
Priority date: 2021-10-07
Filing date: 2021-10-07
Publication date: 2023-10-18
Also published as: GB202311820D0

Abstract

A cervical sampling brush 222 comprising a cervical sampling head 252 at the end of a stem 250, the sampling head having a central hub 254 and a lateral support 256, and a plurality of flexible sampling bristles 258. In a sampling condition, the lateral support has a first lateral extent relative to the elongate stem, and in a retraction condition, the lateral support is movable or foldable towards an axis of the elongate stem to adopt a second lateral extent which is less than the first lateral extent. Also disclosed is a cervical inspection device (10, Fig 1) for performing a smear test, the device comprising a tubular body (12, Fig 1) with an end (16, Fig 1) insertable into the vagina, the body defining a central bore (20, Fig 2) for receiving the sampling brush. A sheath (26, Fig 1) may be receivable over the body, and a brush housing (28, Fig 3) may be engagable with the body to form an inner barrier thereto, the inspection tool housing defining the brush receiving bore of the body. An expansion element (30, Fig 2), and/or a camera (40, Fig 2), may be provided at the insertion end.

Description

Cervical Sampling Brush The present invention relates to a cervical sampling brush particularly but not necessarily exclusively for use in performing cervical smear tests. The invention further relates to a cervical inspection device for facilitation of the smear test and which is suitable for use with the aforementioned cervical sampling brush. The invention also relates to a method of controlling a cervical inspection device for performing a cervical smear test.

Every woman over the age of 25 is invited to a cervical smear screening test every three to five years. This test collects cells from the transformation zone of the cervix to look for pre-cancerous changes. To obtain these cells a speculum is currently placed into the vagina and opened, which then allows the medical practitioner to visualise the cervix through the centre of the speculum. Once the cervix is visualised a collection device is inserted through the opened speculum and brushed over the cervix. The cells on the brush are then analysed for human papillomavirus (HPV) which if found is then analysed further for indications of cancer.

The brush commonly used in the UK is referred to as a Rovers (RTM) brush, which has a shaped head with flexible bristles adapted to the contours of the transformation zone of the cervix. This is an improvement over rigid spatulas and other less considerate endocervical devices. Rigid spatulas are also not compatible with the cytology solution used in the NHS in the UK. However, this brush is difficult to extract without loss of sample on extraction from the vagina, since touching the vaginal walls causes cross-contamination and potential loss of sample. In 2020, 40,000 samples were deemed inadequate. Lubrication can also cause contamination of samples, as can vaginal bleeding.

Furthermore, 1 in 4 women in the UK do not attend their cervical screenings. In 2020 this amounted to approximately 1.4 million women. Embarrassment on body shape, pubic hair and shape of their vulva are considered to be contributing factors. Inability to get an appointment at a convenient time is another. Pain is also postulated as being a contributing factor and this is not readily acknowledged for fear it will put off women turning up for the test. When women do express pain and are unable to complete the test, they are often made to feel that they are the problem, rather than the discomfort of the test itself.

Discomfort can be increased if a woman has a retroverted uterus, which occurs in around 1 in 5 patients. This means that instead of the uterus sitting forward over the bladder, it is directed backwards, or an alternative unorthodox position, over the rectum. If a woman has a retroverted uterus, when the smear test is performed whilst the patient is lain on her back, the cervix will not be linearly aligned to the vaginal canal. As such, a greater degree of force and movement of the speculum is required, which can cause pain, discomfort, and damage. The inability to use lubrication also increases the discomfort to the patient. Nulliparity, vaginismus, atrophy, and prior trauma are also possible reasons for painful examination, in addition to the selection of the incorrect size of speculum.

The present invention seeks to provide a means of performing a smear test accurately without the use of a speculum, as well as improving the ease with which the cervix can be located for the test.

According to a first aspect of the invention, there is provided a cervical sampling brush comprising: an elongate stem; and a cervical sampling head having a central hub and a lateral support, the cervical sampling head having a plurality of flexible sampling bristles thereon; wherein in a sampling condition, the lateral support has a first lateral extent relative to the elongate stem, and in a retraction condition, the lateral support is movable or foldable towards an axis of the elongate stem to adopt a second lateral extent which is less than the first lateral extent.

A speculum is an awkwardly-shaped device which can cause significant pain and discomfort to the patient. The size of the speculum is such that it can receive a standard cervical sampling brush therethrough. In the present invention, a cervical sampling brush is provided which has a reducible width in order to firstly be more comfortably receivable into the patient, since a smaller inspection device can be provided, and secondly, to provide an improved means of capture of the cervical smear sample on retraction. This latter point reduces the risk of loss of sample or contamination which would otherwise then require a repeat of the procedure.

Preferably, the lateral support may be engaged to the central hub via a hinge member.

A hinged engagement between the lateral support or supports and the central hub 30 provides a simple means of folding of the lateral supports away, during the retraction procedure.

Optionally, the hinge member may be a resiliently flexible hinge.

If the cervical sampling head can be formed so as to use a resiliently flexible hinge, then the cervical sampling head can be biased towards the open position, so that no complex mechanisms are required to be operated once the cervical sampling brush is inserted 5 into the vaginal canal. This reduces the likely discomfort for the patient.

Such a hinge axis for the lateral support may be parallel or substantially parallel with a longitudinal axis of the elongate stem.

Hinges which are present in parallel with the longitudinal axis allow for a furling and unfurling process to be achieved, gently opening the cervical sampling head. Even if 10 there is pressure on the head from the cervix itself, this will not inhibit the sampling process, since the bristles will still remain accessible.

A pair of diametrically opposed lateral supports may be provided respectively connected to the central hub via opposed said hinge members, the lateral supports having rotationally symmetric arcuate shapes.

Rotationally symmetric lateral supports also allow for the furling and unfurling process described above, whilst also folding neatly up to the central hub without risk of pinching of the wall of the vaginal canal or cervix in the process.

Preferably, a pair of diametrically opposed lateral supports may be provided, respectively connected to the central hub via opposed said hinge members, wherein hinge axes of 20 the hinge members are parallel to one another.

In a scenario in which the hinge members are parallel, and also preferably perpendicular to the primary axis of the cervical sampling brush, then the lateral supports act to trap the bristles during the extraction process, which may further serve to reduce the risk of cross-contamination or sample loss.

The lateral supports may be formed as linear supports. In an alternative embodiment, the lateral supports may be formed as fan-shaped supports.

Different shapes of cervical sampling head may yield different bristle configurations, which may be more appropriate for different cervical geometries, for example.

Optionally, a pair of diametrically opposed lateral supports may be provided, respectively connected to the central hub via opposed said hinge members, wherein hinge axes of the hinge members are co-axial. The lateral supports may be formed as linear supports.

The provision of co-axial hinges, typically formed using a single axle, may be the simplest 5 mechanical means of providing the retraction motion, which may be more appropriate if a resiliently flexible hinge cannot provide the necessary range of motion.

Optionally, the or each lateral support may have a tapered bristle-distal edge to urge the or each lateral support into the retracted condition upon application of an axial force.

By providing an edge of each lateral support having a taper, the appropriate retraction 10 movement into a cervical inspection device can be achieved, thus avoiding the need to provide any sort of actuator to change the configuration of the cervical sampling head inside the patient's vaginal canal.

According to a second aspect of the invention, there is provided a cervical inspection device for performing a cervical smear test, the device comprising: a tubular body having a first end which is engagable by an operator and a second end which is insertable into a patient's vaginal canal, the tubular body having a central bore which extends along its longitudinal axis; and a cervical sampling brush in accordance with the first aspect of the invention; wherein the central bore is dimensioned to receive the cervical sampling brush therethrough when the cervical sampling head is in the retraction condition.

The provision of a cervical inspection device capable of urging the reconfiguration of a cervical sampling brush naturally upon retraction into the central bore thereof enables comparatively pain-free cervical smear tests to be performed, when compared with those needing a speculum.

The tubular body may comprise a brush housing which includes a channel forming the 25 central bore.

If a dedicated unit is provided which forms the channel, this can be formed so as to be a housing for the cervical sampling brush once the sample is taken. This can further prevent contamination of the sample.

The brush housing may preferably be removable from the tubular body.

If the brush housing is completely removable, then the cervical sampling brush need never be exposed during the transfer process from sampling to cytology laboratory. This greatly reduces the risk of sample failure in transit.

Preferably, the brush housing may include a camera window at or adjacent to an end of 5 the channel.

The window of the brush housing provides a suitable barrier to prevent contamination of the camera lens, allowing the more complex parts of the cervical inspection device to be protected from the patient. This improves the between-patient sanitization process.

The cervical inspection device may further comprise a camera being positioned at or 10 adjacent to second end of the tubular body.

Having an in-built camera with the cervical inspection device greatly increases the utility of the device as a whole.

Preferably, the camera may be angled towards the central bore for monitoring the cervical sampling brush in use.

It is preferred that the camera be directed towards the expected target of the cervical sampling brush, to improve the accuracy of positioning of the cervical inspection device by the operator.

The cervical inspection device may further comprise an expansion element at or adjacent to the second end of the tubular body; and control means operable from the first end of 20 the tubular body for selectably expanding and/or contracting the expansion element.

Providing an expansion element and mechanism for control thereof allows for the walls of the vaginal canal to be gently urged out of the way, ensuring that a good visual path is provided between the camera and the transformation zone, and also providing a suitable access route for the cervical sampling brush.

The expansion element may comprise a flexible hood, the control means comprising a plurality of tabs for urging the flexible hood into an open condition.

A flexible hood which can be operated outwardly is a gentle means of pushing the vaginal walls without risk of snagging or pinching on closure.

The cervical inspection device may further comprise a sheath which is receivable over the tubular body.

A sheath overlying the tubular body provides a suitably santizable and/or disposable outer layer for the cervical inspection device which can be replaced or cleaned following 5 use. This protects the moving and delicate parts of the tubular body.

Preferably, the sheath may be connected to the brush housing.

If the sheath and brush housing are connected with one another, they can be removed as a unit, with the sheath providing additional protection for the sample enclosed within the brush housing on removal.

Optionally, an end of the sheath may form the flexible hood.

The outer layer of the sheath, being flexible, provides a suitable material for use as the flexible hood of the engagement element.

Preferably, the sheath may be formed from a silicone material.

Silicone is wipe-clean and easily disinfected, as well as providing a smooth outer surface 15 for the cervical inspection device which will not cause pain to the patient on insertion.

Further disclosed is a method of controlling a cervical inspection device for performing a cervical smear test, the method comprising the steps of: providing a cervical inspection device in accordance with the second aspect of the invention; pushing the cervical sampling brush through the central bore of the tubular body to permit opening of the cervical sampling head into the sampling condition; and pulling the cervical sampling brush into the central bore of the tubular body to urge the lateral supports of the cervical sampling brush to fold towards the central hub upon contact of the lateral supports with the tubular body.

Automatic closure of the cervical sampling brush on retraction provides a simple means 25 of using a cervical inspection device which obviates the need for a speculum, without needing to prepare complex moving parts.

Further disclosed is a cervical inspection device for performing a cervical smear test, the device comprising: a tubular body having a first end which is engagable by an operator and a second end which is insertable into a patient's vaginal canal; a sheath receivable over the tubular body; and a cervical inspection tool housing receivably engagable with the tubular body to form an inner barrier to the tubular body, the cervical inspection tool housing having a central bore which extends along a longitudinal axis thereof for receiving a cervical inspection tool therethrough.

The ability to dispose of the patient-contact portions of a cervical inspection device following use, in the form of internal and external barrier sheaths, allows for rapid sanitization not easily conducted with a speculum.

Preferably, the sheath may be connected to the cervical inspection tool housing.

Optionally, an end of the sheath may form a flexible hood of an expansion element of 10 the cervical inspection device.

In a preferred embodiment, the flexible hood may form a barrier for internal and external surfaces of the expansion element.

Preferably, the sheath may have an opening at an end thereof to permit a cervical inspection tool to pass therethrough.

Optionally, the cervical inspection device may have a camera positioned at or adjacent to the second end of the device.

Further disclosed is a sheath for use with a cervical inspection device preferably in accordance with the second or fourth aspects of the invention, the sheath comprising: an at least in part flexible body; a first opening at a first end of the body for receivably engaging over a said cervical inspection device, and a second opening at a second end of the body to permit a cervical inspection tool to pass therethrough.

A disposable sheath which can overlie a tubular body of the cervical inspection device is useful to protect the more complex components of the cervical inspection device from contact with the vaginal canal. This prevent or significantly reduces cross-contamination 25 between patients.

Preferably, the sheath further comprises a cervical inspection tool housing to form an inner barrier for said cervical inspection device, the cervical inspection tool housing having a central bore which extends along a longitudinal axis thereof for receiving a cervical inspection tool therethrough.

Further disclosed is a cervical inspection device for performing a cervical smear test, the device comprising: a tubular body having a first end which is engagable by an operator and a second end which is insertable into a patient's vaginal canal, the tubular body having a central bore which extends along its longitudinal axis for receiving a cervical inspection tool therethrough; an expansion element at or adjacent to the second end of the tubular body; control means operable from the first end of the tubular body for selectably expanding and/or contracting the expansion element; and a camera at or adjacent to second end of the tubular body.

By combining the features of a camera and an expansion element which can be activated 10 internally within the patient, the need for a speculum, and thus the discomfort which accompany such a device, can be eliminated.

The invention will now be more particularly described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 shows a perspective representation of a first embodiment of a cervical 15 inspection device in accordance with the second aspect of the invention for performing a cervical smear test; Figure 2 shows a perspective representation of the cervical inspection device of Figure 1 in an inspection condition; Figure 3 shows an exploded perspective representation of the cervical inspection 20 device of Figure 1; Figure 4 shows a perspective representation of a second embodiment of a cervical inspection device in accordance with the second aspect of the invention for performing a cervical smear test, the device including a cervical sampling brush in accordance with the first aspect of the invention; Figure 5A shows a perspective representation of the device body of the cervical inspection device of Figure 4 in a retracted condition; Figure 5B shows the device body of Figure 5A in an inspection condition; Figure 6 shows an end view of the cervical inspection device of Figure 4; Figure 7 shows a perspective representation of a first embodiment of a cervical sampling brush in accordance with the first aspect of the invention, in a closed condition; Figure 8 shows a plan view of the cervical sampling brush of Figure 7; Figure 9 shows a perspective representation of the cervical sampling brush of 5 Figure 7, in a sampling condition; Figure 10 shows a plan view of the cervical sampling brush of Figure 9; Figure 11A shows an end view of the cervical sampling brush of Figure 7; Figure 11B shows a side view of the cervical sampling brush of Figure 11A; Figure 110 shows an end view of the cervical sampling brush in Figure 9; Figure 110 shows a side view of the cervical sampling brush of Figure 11C; Figure 12A shows a perspective representation of a cervical sampling head of the cervical sampling brush of Figure 7, interacting with a brush housing of a cervical inspection device, in a retracted state; Figure 12B shows a perspective representation of the cervical sampling head 15 and brush housing of Figure 12A, in an extended state; Figure 13A shows a plan view of a second embodiment of cervical sampling brush in accordance with the first aspect of the invention, in an extended state; Figure 13B shows a perspective view of the cervical sampling brush of Figure 13A, Figure 13C shows an end view of the cervical sampling brush of Figure 13A; Figure 13D shows a side view of the cervical sampling brush of Figure 13A; Figure 14A shows a plan view of the cervical sampling brush of Figure 13A, in a retracted state; Figure 14B shows a perspective view of the cervical sampling brush of Figure 14A; Figure 14C shows an end view of the cervical sampling brush of Figure 14A; Figure 14D shows a side view of the cervical sampling brush of Figure 14A; Figure 15A shows a plan view of a third embodiment of cervical sampling brush in accordance with the first aspect of the invention, in an extended state; Figure 15B shows a perspective view of the cervical sampling brush of Figure 15A; Figure 15C shows an end view of the cervical sampling brush of Figure 15A; Figure 15D shows a side view of the cervical sampling brush of Figure 15A; Figure 16A shows a plan view of the cervical sampling brush of Figure 15A, in a 10 retracted state; Figure 16B shows a perspective view of the cervical sampling brush of Figure 16A; Figure 16C shows an end view of the cervical sampling brush of Figure 16A; Figure 16D shows a side view of the cervical sampling brush of Figure 16A; Figure 17A shows a plan view of a fourth embodiment of cervical sampling brush in accordance with the first aspect of the invention, in a retracted state; Figure 17B shows a perspective view of the cervical sampling brush of Figure 17A; Figure 17C shows an end view of the cervical sampling brush of Figure 17A; Figure 17D shows a side view of the cervical sampling brush of Figure 17A; Figure 18A shows a plan view of the cervical sampling brush of Figure 17A, in an extended state; Figure 18B shows a perspective view of the cervical sampling brush of Figure 18A; Figure 18C shows an end view of the cervical sampling brush of Figure 18A; and Figure 18D shows a side view of the cervical sampling brush of Figure 18A.

Referring to Figure 1, there is indicated a cervical inspection device, referenced globally at 10, which is adapted for performing a cervical smear test, in a manner which also permits inspection of the transformation zone of the cervix in use.

The cervical inspection device 10 has a tubular body 12 which has a first end 14 which is engagable by an operator, typically a nurse, and a second end 16 which is insertable into the patient's vaginal canal. A power cable 18 can be seen extending through the first end 14 to provide a power supply to the electronic components of the apparatus. It will be apparent that the power cable 18 could also be used as the conduit for information transfer to and from the device 10, such as a video feed, and that this could additionally or alternatively be performed wirelessly.

The tubular body 12 has a central bore 20 which extends along a longitudinal axis thereof, and this is best seen in Figure 2. A cervical sampling brush 22 can be seen housed inside the central bore 20 in a retracted state in Figure 2, the brush 22 being linearly actuated using a manually operable handle 24. The central bore 20 is designed to be dimensioned to receive the cervical sampling brush 22 therein when the cervical sampling brush 22 is in a retracted state. This will be discussed in more detail below.

The cervical inspection device 10 is here provided with a sheath 26 receivable over the tubular body 12. This provides a smooth insertion surface to prevent snagging on the walls of the vaginal canal. The sheath 26 may preferably be formed from a silicone material, or similarly disinfectable, sterilisable, or wipe-clean material. The sheath 26 is shown removed from the tubular body 12 in Figure 3.

The sheath 26 may be preferably connected to a, preferably disposable, brush housing 28 receivable into the tubular body 12 which forms the central bore 20. The brush housing 28, which may be a rigid unit, provides a physical barrier between the patient and the tubular body 12, which prevents contamination of the cervical inspection device 10 between patients. The brush housing 28 may therefore slot into a corresponding channel 29 formed in the tubular housing 12. The sheath 26 and brush housing 28 thus together form a complete barrier layer for the tubular housing 12, thereby allowing it to be inserted into a patient's vaginal canal without risk of contamination. The sheath 26 and brush housing 28 thus may be provided as a disposable unit, comprising external and internal barriers for the tubular housing 12 respectively.

This brush housing 28 can also act as a transferrable housing for the cervical sampling brush 22 to a cytological analysis laboratory, where this process is used, reducing the risk of cross-contamination. It will be apparent that the brush housing 28, where provided, need not necessarily be connected to the sheath 26; this is merely an advantageous feature which allows to two components to be safely removed from the tubular body 12 as one for sample transfer. In the depicted embodiment, however, the sheath 26 covers the end of the tubular housing 12 not otherwise covered by the brush housing 28, thereby completing the barrier between the patient and the tubular housing 12. This configuration allows the sheath 26 to have an open end through which the brush 22 can penetrate.

It is preferred that the cervical inspection device 10 include an expansion element 30 which is openable to allow for improved inspection capability at the transformation zone of the cervix, since such an expansion element 30 can push the walls of the vaginal canal out for improved visuals and to allow the brush to unfurl in an unhindered manner.

In the illustrated embodiment of Figures 1 to 3, the expansion element 30 is provided as a flexible hood 31 of the sheath 26, operated by a control means. The control means comprises a plurality of tabs 32 which are arranged to urge the expansion element 30 between the closed and open positions respectively shown in Figures 1 and 2. The flexible hood 31 covers the inside and outside surfaces of the tabs 32, so that they are occluded from the vaginal canal in use. The flexible hood 31 can thus connect to the outer edge of the brush housing 28 in order to form a continuous barrier protecting the tubular housing 28.

The tabs 32 may be hingeably connected to the second end 16 of the tubular body 12, being pivotable by a linear slider 34 which is positioned on the outside of the tubular body 12, typically under the sheath 26. Pushing the slider 34 towards the second end 16 will effectively push the tabs 32 into the closed condition based on the relative connection points of the pivot points with respect to a wire connection 36 between the slider 34 and the tabs 32. Pulling the slider 34 pulls on the wire connections 36 pulling the tabs 32 outwards, and opening the expansion element 30. The tubular body 12 may optionally have runners 38 within which the wire connections 36 are moveable, extending parallel to the longitudinal axis.

The use of the expansion element 30 to improve visual access to the transformation zone is useful since the cervical inspection device 10 includes a camera 40 at or adjacent to the second end 16. This may be protected via a camera window 42, which may be formed as a transparent or translucent cover on the brush housing 28. Preferably, there will also be an illumination element, such as an LED, associated with the camera 40 to ensure that visual inspection is feasible. A video feed may be transmitted via the same cable as the power cable 18. An aperture 43 forming the open end of the sheath 26 allows for the camera 40 to have an uninhibited view of the cervix on entry, in addition to providing access for the brush 22. The aperture 43 provides an unobscured visual path for the camera 40 even when the expansion element 30 is in the closed condition.

The camera 40 is preferably positioned radially outwardly of the central bore 20, so as not to obstruct the cervical sampling brush 22 in use. To this end, the camera 40 is 10 preferably angled towards the central bore 20 so as to be able to monitor the movements of the cervical sampling brush 22 in use.

An alternative embodiment of cervical inspection device 110 is shown in Figure 4, embodying many of the same principles as the first embodiment. As such, identical or similar features of the first embodiment will be referenced using identical or similar 15 reference numerals, and further detailed description will be omitted for brevity.

The cervical inspection device 110 is shown with an extended handle 144, which allows the user greater control over the whole device 110. A flange 146 is provided towards the first end 114 of the tubular body 112 in order to improve grip. It is not intended as a means of identifying an insertion depth of the device 110, since the device 110 is usable for all patients, which is a significant improvement over speculums having different dimensions.

The external slider is absent from the indicated embodiment; instead, the tabs 132, which are here formed as bent wire formations, are operated via movement of the tubular housing 112 itself. The range of movement of the tabs 132 can be seen in detail in Figures 5A and 5B. The brush housing 128 of the cervical inspection device 110 is adapted to be fixed relative to the tabs 132. The tabs 132 are provided so as to be outwardly biased, for example, by a spring member, which urges them into the open condition. When the tubular housing 112 is in a forward position towards the second end 116 of the device, as shown in Figure 5A, pins 147 are held captive towards a rear end of runners 138. The tabs 132 are held in position within the end of the tubular body 112 by compression of the tabs 132 towards one another by the internal surface of the tubular body 112. As the tubular body 112 is urged backwards, the pins 147 become positioned relatively forward within runners 138, until a spring force of the tabs 132 overcomes the compression thereof, and the tabs 132 become splayed relative to one another.

Figure 6 shows the dimensions of the brush housing 128 in detail, since the cervical inspection device 110 is viewed end on. The central bore 120 is formed as a cylindrical 5 void, and the cervical sampling brush 122 is adapted to fold or retract into a condition which is receivable within the central bore 120 fully. The folding or retraction means may be initiated or urged through contact with an outer rim 148 of the central bore 120 of the brush housing 128, or indeed any structure which forms or comprises part of the central bore 120. Alternatively, the cervical sampling brush could itself be provided with an 10 actuation mechanism to cause folding.

The structure of an indicative, and indeed presently preferred, embodiment of cervical sampling brush 222 is illustrated in Figures 7 to 11D. Figures 7, 8, 11A, and 11B show the cervical sampling brush 222 in a closed or retracted condition or state, and Figures 9, 10, 11C, and 11D show the cervical sampling brush 222 in an open or sampling condition or state.

The cervical sampling brush 222 has an elongate stem 250, which here is indicated as a generalised cylindrical handle, and is not necessarily depicted to scale. At one end of the elongate stem 250 is a cervical sampling head 252 which has a central hub 254 and a pair of lateral supports 256. The pair of lateral supports 256 are preferably diametrically opposed to one another for uniformity of movement. It is noted that a single lateral support could be considered, if this makes the folding process more straightforward, but having paired lateral supports 256 allows for a better matching of the shape of the cervical wall in the transformation zone.

The cervical sampling head 252 has a plurality of flexible sampling bristles 258 thereon, 25 which are preferably designed for best capture properties of a cervical sample. This will typically involve longer bristles 258 at the central hub 254, which gradually become shorter towards the lateral edges of the lateral supports 256.

The lateral supports 256 have, in the open condition, a first lateral extent, which could be characterised as a radial extent, and a second lateral extent, in the closed condition, 30 which is less than the first lateral extent. This is achieved by folding or moving of the lateral supports 256 towards the central hub 254.

The lateral supports 256 are preferably integrally formed with the central hub 254, being connected by a hinge member 260, which may preferably be a resiliently flexible hinge. This can be best visualised in Figures 11A and 11C which show the open and closed conditions of the lateral supports 256 most clearly. In this instance, a hinge axis of the hinge members 260 is parallel with or substantially parallel with the longitudinal axis of the cervical sampling brush 222.

In the closed condition, as is the case in Figures 11A and 11B, the inner surfaces 262 of the lateral supports 256 matingly meet with an outer surface of the central hub 254, and the approximate cross-section of the cervical sampling head 252 is circular.

In the open condition, as is the case in Figures 11C and 11D, the end surfaces 264 of the lateral supports 256 matingly meet with the outer surface of the central hub 254 instead, and thus the approximate cross-section of the cervical sampling head 252 becomes sinusoidal or serpentine. The hinge axes are not centrally positioned on said end surfaces 264, thereby ensuring ease of movement of the lateral supports 256.

The lateral supports 256 in the present embodiment are arcuate, and more preferably rotationally symmetric, when viewed along the longitudinal axis of the cervical sampling brush 222, which allows them to curl in a spiral fashion towards the central hub 254 on folding. The bristle-distal edges 266 of the lateral supports 256 may preferably be tapered so that, upon contact with the outer rim 148 of a cervical inspection device 110, the lateral supports 256 are urged into the closed condition gradually. In the illustrated embodiment, the bristle-distal edges 266 also include a recess 268 or groove which could be used to guide the lateral supports 256 into or out of the closed condition. This process is shown in Figures 12A and 12B, with the bristles having been omitted from the cervical sampling head 252 for clarity. For the cervical sampling head 252 shown, a twisting action which accompanies the longitudinal urging of the cervical sampling brush 222 may help to encourage closure, by rotating the central hub 254 to encourage the hinges 260 to follow and thus fold up the lateral supports 254.

The bristle-distal edges 266 contact with the outer rim 148 of the brush housing 128, with the hinge member 260 resiliently moving depending on the force applied to the bristle-distal edges 266 by said outer rim 148. Thus, the motion of the cervical sampling brush 222 alone, be that by axial or axial and rotational action, causes the opening and closing of the cervical sampling head 252 and no additional control mechanism is necessary.

On retraction of the cervical sampling brush 222, the bristles 258 remain parallel with one another during the folding process, and as such, there is minimal risk of loss of sample by collision of the bristles 258 with one another or the central bore 120 of the cervical inspection device 110.

To use the cervical inspection device 110 with the cervical sampling brush 222, the medical practitioner inserts the cervical inspection device 110 into the patient's vaginal canal. The camera 140 is used to find and locate the cervix, and specifically the likely transformation zone area of the cervix, once the cervical inspection device 110 has been inserted. The expansion element 130 can then be operated to urge the walls of the vaginal canal out of the way at the transformation zone, providing visual access for the camera 140. The cervical inspection device 110 can then be reoriented where required, based on the output of the camera 140.

Once the cervical inspection device 110 is correctly oriented, the cervical sampling brush 222 can be advanced by the medical practitioner towards the cervix. Upon leaving the central bore 120, the cervical sampling head 252 opens, with the force on the lateral supports 256 no longer being present from the brush housing 128. The resiliently flexible hinge members 260 open the lateral supports 256 into the open condition. The cervical sampling brush 222 can then be urged towards the transformation zone to collect a sample with the bristles 258.

Once sufficient sample is collected, the cervical sampling brush 222 can be retracted towards the cervical inspection device 110. Upon contact of the bristle-distal edges 266 with the outer rim 148 of the cervical inspection device 110, the taper of the bristle-distal edges 266 will gradually urge the lateral supports 256 towards the central hub 254. The cervical sampling head 252 thus closes up to itself to be receivable into the central bore 120.

Upon removal of the cervical sampling device 110 from the patient, the medical practitioner can remove the sheath 126 and brush housing 128 as one, to allow the tubular body 112 to be sanitized. The brush housing 128, containing the sampled-filled cervical sampling brush 222, can then be sent onwards for cytological analysis.

Alternatively, the brush 222 can be extracted from the device 110, and the sheath 126 and brush housing 128 disposed of For some cytological analysis approaches, there is a requirement for the cervical sampling brush 222 to have a removable cervical sampling head 252 which can be transferred separately from the stem and/or handle of the brush. This is anticipated as being feasible within all embodiments of the present invention.

Figures 13A to 14D show a second detailed embodiment of cervical sampling brush 322. Identical or similar features of the first embodiment will be referenced using identical or similar reference numerals, and further detailed description will be omitted for brevity.

The cervical sampling head 352 comprises a pair of diametrically opposed lateral supports 356 which are respectively connected to the central hub 354 at hinge members 360. The hinge axes of the hinge members 360 are parallel to one another, and as such, the two lateral supports 356 fold towards one another so as to overlie the bristles 358 of the central hub 354. The lateral supports 356 are formed as linear supports, having tapered bristle-distal edges 366 to close in a similar manner to the first brush embodiment.

Whilst the closing of the cervical sampling head 352 in this second embodiment brings bristles 358 into contact with one another, the closing mechanism may better protect the sample following extraction of the cervical sampling brush 322 from the patient, since the bristles 358 are no longer exposed. The risk of contamination decreases, reducing the risk of needing to reperform the cervical smear test.

Figures 15A to 16D show a third detailed embodiment of cervical sampling brush 422. Identical or similar features of the first and second embodiments will be referenced using identical or similar reference numerals, and further detailed description will be omitted for brevity.

The cervical sampling head 452 comprises a pair of diametrically opposed lateral supports 456 which are respectively connected to the central hub 454 at hinge members 460. The hinge axes of the hinge members 460 are co-axial and perpendicular to the longitudinal axis, and as such, the two lateral supports 456 fold towards one another without contacting one another. The lateral supports 456 remain spaced apart from one another either side of the central hub 454. The lateral supports 456 are formed as linear supports, having tapered bristle-distal edges 466 to close in a similar manner to the first and second brush embodiments.

Unlike the previous two embodiments, the hinge member 460 is here not formed as a resiliently flexible hinge, but as a continuous axle which extends through the cervical sampling head 452. Whilst a resiliently flexible hinge could be considered, a specific axle is less likely to break under the increased rotational stress.

Figures 17A to 18D show a fourth detailed embodiment of cervical sampling brush 522. Identical or similar features of the first, second, and third embodiments will be referenced using identical or similar reference numerals, and further detailed description will be omitted for brevity.

The cervical sampling head 552 comprises a pair of diametrically opposed lateral supports 556 which are respectively connected to the central hub 554 at hinge members 560. The hinge axes of the hinge members 560 are parallel to one another, and as such, the two lateral supports 556 fold towards one another so as to overlie the bristles 558 of the central hub 554. The lateral supports 556 are formed as fan-shaped supports which may allow novel bristle 558 configurations to be used which can better capture a cervical smear sample.

Again, whilst the closing of the cervical sampling head 552 in this fourth embodiment brings bristles 558 into contact with one another, the closing mechanism may better protect the sample following extraction of the cervical sampling brush 522 from the patient, since the bristles 558 are no longer exposed. The risk of contamination decreases, reducing the risk of needing to reperform the cervical smear test.

It will be appreciated that, although the cervical inspection device has been described for use with a cervical sampling brush, the device has a wide utility in cervical sampling contexts. In particular, there are other cervical inspection tools which are available which could be inserted through the central bore of the device, such as a sprayer suitable for spraying acetic acid onto the transformation zone in order to improve the identification of cellular markers. The brush housing which forms the central bore as herebefore described thus could readily be any cervical inspection tool housing, which could be disposed after use.

It is therefore possible to provide a generalised method of controlling a cervical 30 inspection device for performing a cervical smear test, the method comprising the steps of: providing a cervical inspection device as previously described; pushing the cervical sampling brush through the central bore of the tubular body to permit opening of the cervical sampling head into the sampling condition; and pulling the cervical sampling brush into the central bore of the tubular body to urge the lateral supports of the cervical sampling brush to fold towards the central hub upon contact of the lateral supports with the tubular body. Regardless of which brush type is used, the folding mechanism can be achieved, and a less stressful cervical smear test completed for the patient.

The presence of a camera and the engagement elements to allow for improved inspection of the cervical transformation zone is a significant advance over the state of the art, reducing the risk of discomfort to the patient, particularly those patients with retroverted uteruses. Irrespective of the brush or swab used, the present invention therefore also provides for a cervical inspection device for performing a cervical smear test, or other cervical inspection techniques, the device comprising: a tubular body having a first end which is engagable by an operator and a second end which is insertable into a patient's vaginal canal, the tubular body having a central bore which extends along its longitudinal axis; a cervical brush or swab insertable through the central bore of the tubular body; an expansion element at or adjacent to the second end of the tubular body; control means operable from the first end of the tubular body for selectably expanding and/or contracting the expansion element; and a camera at or adjacent to second end of the tubular body and which is positioned radially outwardly of the central bore. This achieves the aim of reduced-pain cervical smear testing, eliminating the need for a speculum.

Overall, the present invention provides a means of improving the overall experience of the cervical smear test for women, hopefully improving uptake, and reducing the risk of sample contamination.

The words 'comprises/comprising' and the words 'having/including' when used herein 25 with reference to the present invention are used to specify the presence of stated features, integers, steps, or components, but do not preclude the presence or addition of one or more other features, integers, steps, components, or groups thereof.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

The embodiments described above are provided by way of examples only, and various other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.

Claims

Claims A cervical sampling brush comprising: an elongate stem; and a cervical sampling head having a central hub and a lateral support, the cervical sampling head having a plurality of flexible sampling bristles thereon; wherein in a sampling condition, the lateral support has a first lateral extent relative to the elongate stem, and in a retraction condition, the lateral support is movable or foldable towards an axis of the elongate stem to adopt a second lateral extent which is less than the first lateral extent.
2. A cervical sampling brush as claimed in claim 1, wherein the lateral support is engaged to the central hub via a hinge member.
3. A cervical sampling brush as claimed in claim 2, wherein the hinge member is a resiliently flexible hinge.
4. A cervical sampling brush as claimed in claim 2 or claim 3, wherein a hinge axis for the lateral support is parallel or substantially parallel with a longitudinal axis of the elongate stem.
5. A cervical sampling brush as claimed in claim 4, wherein a pair of diametrically opposed lateral supports is provided respectively connected to the central hub via opposed said hinge members, the lateral supports having rotationally symmetric arcuate shapes.
6. A cervical sampling brush as claimed in claim 2 or claim 3, wherein a pair of diametrically opposed lateral supports is provided, respectively connected to the central hub via opposed said hinge members, wherein hinge axes of the hinge members are parallel to one another.
7. A cervical sampling brush as claimed in claim 6, wherein the lateral supports are formed as linear or fan-shaped supports.
8. A cervical sampling brush as claimed in claim 2 or claim 3, wherein a pair of 35 diametrically opposed lateral supports is provided, respectively connected to the central hub via opposed said hinge members, wherein hinge axes of the hinge members are coaxial.
9. A cervical sampling brush as claimed in claim 8, wherein the lateral supports are formed as linear supports.
10. A cervical sampling brush as claimed in any one of the preceding claims, wherein the lateral support is curlable in a spiral fashion towards an axis of the elongate stem.
11. A cervical sampling brush as claimed in any one of the preceding claims, wherein the or each lateral support has a tapered bristle-distal edge to urge the or each lateral support into the retracted condition upon application of an axial force.
12. A cervical sampling brush as claimed in claim 11, wherein the bristle-distal edge includes a recess or groove to guide the lateral support in or out of the closed position.
13. A cervical sampling brush as claimed in any one of the preceding claims, wherein lateral support is movable or foldable towards the axis of the elongate stem such that the plurality of flexible sampling bristles remain parallel to one another.
14. A cervical inspection device for performing a cervical smear test, the device comprising: a tubular body having a first end which is engagable by an operator and a second end which is insertable into a patient's vaginal canal, the tubular body having a central bore which extends along its longitudinal axis; and a cervical sampling brush as claimed in any one of the preceding claims; wherein the central bore is dimensioned to receive the cervical sampling brush therethrough when the cervical sampling head is in the retraction condition.
15. A cervical inspection device as claimed in claim 14, wherein the tubular body comprises a brush housing which includes a channel forming the central bore.
16. A cervical inspection device as claimed in claim 15, wherein the brush housing is removable from the tubular body.
17. A cervical inspection device as claimed in claim 15 or claim 16, wherein the brush housing includes a camera window at or adjacent to an end of the channel.
18. A cervical inspection device as claimed in any one of claims 14 to 17, further comprising a camera, the camera being positioned at or adjacent to second end of the tubular body.
19. A cervical inspection device as claimed in claim 18, wherein the camera is angled towards the central bore for monitoring the cervical sampling brush in use.
20. A cervical inspection device as claimed in any one of claims 14 to 19, further comprising an expansion element at or adjacent to the second end of the tubular body; and control means operable from the first end of the tubular body for selectably expanding and/or contracting the expansion element.
21. A cervical inspection device as claimed in claim 20, wherein the expansion element comprises a flexible hood, the control means comprising a plurality of tabs for urging the flexible hood into an open condition.
22. A cervical inspection device as claimed in any one of claims 14 to 21, further comprising a sheath which is receivable over the tubular body.
23. A cervical inspection device as claimed in claim 22 when dependent on claim 15, wherein the sheath is connected to the brush housing.
24. A cervical inspection device as claimed in claim 22 or claim 23 when dependent 25 on claim 20, wherein an end of the sheath forms the flexible hood.
25. A method of controlling a cervical inspection device for performing a cervical smear test, the method comprising the steps of: providing a cervical inspection device as claimed in any one of claims 14 to 24; pushing the cervical sampling brush through the central bore of the tubular body to permit opening of the cervical sampling head into the sampling condition; and pulling the cervical sampling brush into the central bore of the tubular body to urge the lateral supports of the cervical sampling brush to fold towards the central hub upon contact of the lateral supports with the tubular body.