GB2608619A

GB2608619A - Vaginal pessary

Info

Publication number: GB2608619A
Application number: GB2109731.6A
Authority: GB
Inventors: Pacey Clare; Nellist Emily
Original assignee: Her Health Lab Ltd
Current assignee: Her Health Lab Ltd
Priority date: 2021-07-06
Filing date: 2021-07-06
Publication date: 2023-01-11
Also published as: GB202109731D0

Abstract

A vaginal pessary 100 configured to bias against the vaginal wall and support a portion of the wall against prolapsing pelvic organs, comprising a pessary body having at least two flexion points 107, 109, wherein the points are configured to permit the body to bend. Further included are a holding means 125, 127, coupled to the body, the holding means configured such that in use, operation of the holding means causes the pessary body to flex about the flexion points to permit removal of the pessary from the vagina. Also disclosed is a pessary wherein the body comprises a ring-shaped circumferential member, a central hub and four spokes, wherein the coupling of the spokes to the ring and hub provide the flexion points. Operation of the holding means reduces the diameter of the ring-shaped member. The pessary may be inserted by an applicator having a tubular structure forming an internal cavity for receiving the pessary, an aperture at one end and a plunger at the other, the plunger configured to push the pessary through the aperture.

Description

Vaginal pessary

Field of the invention

The present disclosure relates to intimate activewear such as a vaginal pessary, and in 5 particular to a vaginal pessary for supporting the vaginal wall against prolapsing pelvic organs and/or descent during exercise.

Background

A vaginal pessary is a device that may be used to help support the vaginal wall against prolapsing pelvic organs. This may be needed, for example, following childbirth where damage and trauma has occurred to the vagina and the pelvic floor. A vaginal pessary may also be used, for example, to alleviate stress urinary incontinence, to support a female condom and/or to support a cup.

When women perform vigorous exercise such as impact / heavy lifting the vaginal tissues and organs can move and descend. 50% of women will have a prolapse after having a vaginal birth. At menopause -average age 51 -50% of women report urogenital symptoms. Humans as a species are living longer and expect more of their bodies -they are more active, and for longevity of bone health, cardiovascular fitness and muscle mass they need to be doing impact and resistance training but we also know this can increase intra-abdominal pressure (IAP) and with declining oestrogen as women age this can lead to sagging of vaginal tissues -leading to pelvic organ prolapse.

Vaginal pessaries such as the one described in US 6,216,698 are intended to be fitted by 25 clinicians or healthcare professionals. This means that patients may have to wait a long time to have one fitted and/or may not be able to change them frequently, for example for reasons of hygiene or for comfort.

A problem with pessaries such as those described in US 6,216,698 is that in the UK at 30 least these devices need to be fitted by a clinician which may involve a long wait to be seen by a clinician. -2 -

WO 2015/193700 describes an example vaginal pessary. However, this pessary requires a complicated applicator for inserting and delivering the pessary to the correct location in the vagina. Removal of this vaginal pessary is also difficult for a user or patient to perform themselves and therefore medical attention from a professional may still be needed for removing and/or fitting the pessary.

Summary of the invention

Aspects of the invention are as set out in the independent claims and optional features are set out in the dependent claims. Aspects of the invention may be provided in 10 conjunction with each other and features of one aspect may be applied to other aspects.

Embodiments of the disclosure effectively relate to a "sports bra" for the vagina. Most women when taking part in sports wear a sports bra. We know this helps performance and also supports breast tissue. Embodiments of the disclosure provide something similar for the vaginal tissues -intimate activewear that supports the vaginal tissues against gravity, impact and/or increases in intra-abdominal pressure during exercise.

Accordingly, in a first aspect there is provided a an item of intimate activewear such as a vaginal pessary configured to bias against the vaginal wall and support a portion of the vaginal wall against prolapsing pelvic organs and/or descent during exercise. The vaginal pessary may provide support even when a prolapse is not present and/or has not been diagnosed -i.e. the vaginal pessary may act in a way similar to a sports bra in that it can inhibit prolapse and/or descent of pelvic organs and support the pelvic tissues. The pessary comprises a pessary body comprising at least two flexion points, wherein each of the at least two flexion points is configured to permit the vaginal pessary body to bend. The pessary also comprises a holding means coupled to the pessary body, wherein the holding means are configured such that when the vaginal pessary is in use, operation of the holding means causes the vaginal pessary body to flex about the at least two flexion points to permit removal of the vaginal pessary from the vagina. As far as the inventors are aware, the pessary is a first of its kind in being adapted for use to support vaginal tissues even when a prolapse is not present and/or has not been diagnosed. This may find particular applicability in women who perform high intensity sport/exercise, -3 -for example, where the pessary/device may be used to inhibit descent even if a prolapse has not been diagnosed by a healthcare professional.

The pessary of the disclosure may allow women to be responsible for their own pelvic 5 health -they can purchase it without assessment or prescription and insert and remove it themselves in the same way as they might do with a sports bra. It is easily accessible and easier to use than a standard pessary as it is both foldable (via the flexion points) and accessible (via the holding means). It may also help women to inhibit and/or prevent prolapse occurring, particularly at times when they are susceptible (such as when newly-10 postnatal/breastfeeding and/or when performing high intensity exercise). It may also help improve performance in sport.

The at least two flexion points may be on opposing sides of the pessary body.

The vaginal pessary may comprise a pair of holding means, each holding means of the pair coupled to the pessary body at a region proximate to a flexion point. The holding means may comprise, for example, string. Each holding means may be coupled to the pessary body on opposing sides of the pessary body. The holding means may be string. In some examples the pair of holding means may be joined to form a loop to ease in 20 removal of the pessary.

The pessary body may be resiliently deformable. Each of the flexion points may be an integral part of the pessary body.

The vaginal pessary may be a vaginal ring pessary.

Additionally, or alternatively, the pessary body may be generally heart shaped.

Additionally, or alternatively, the pessary body may be the pessary body is generally 30 butterfly shaped.

Additionally, or alternatively, the pessary body may be at least a portion of the pessary -4 -body has a W shaped profile. For example, the pessary body may comprise a pair of opposing W-shaped profiles.

At least two of the flexion points may be configured to permit the pessary body to bend 5 through an angle of more than 90 degrees, for example to approximately 180 degrees.

In some examples the vaginal pessary comprises at least four flexion points. The flexion points may be equidistant around the circumference of the pessary body.

In some examples, two opposing flexion points may be configured to bend in a first direction forming an obtuse angle relative to the centre of the pessary body, and another two opposing flexion points may be configured to bend in a second direction forming an acute angle relative to the centre of the pessary body.

The pessary may be symmetrical in a first plane about a first axis.

In another aspect there is provided a vaginal pessary configured to bias against the vaginal wall and support a portion of the vaginal wall against prolapsing pelvic organs. The pessary comprises a pessary body comprising a ring-shaped circumferential member, a central hub, and four spokes extending from the hub to the ring-shaped circumferential member and coupling the hub to the ring-shaped circumferential member, wherein the coupling between the hub and each spoke, and each spoke and the ring-shaped circumferential member is configured to provide a respective flexion point. The pessary also comprises a holding means coupled to the hub, wherein the holding means are configured such that when the vaginal pessary is in use, operation of the holding means causes the hub to move relative to the pessary body about each the flexion points, thereby reducing the diameter of the ring-shaped circumferential member to permit removal of the vaginal pessary from the vagina.

The ring-shaped circumferential member may have a circumference configured to engage with the walls of the vagina, and the flexion points may be equidistant around the circumference of the ring-shaped circumferential member. -5 -

The central hub may be coaxial with the ring-shaped circumferential member, and wherein each of the spokes is of equal length.

The pessary may be symmetrical in a first plane about a first axis.

In some examples the pessary may comprise a flange or skirt portion, wherein the pessary body is symmetrical in a first plane about a first axis, and wherein the flange portion extends in a second axis in a direction transverse to the first axis and the first plane and is configured to provide support to the vaginal wall against prolapsing pelvic organs. Such examples may provide increased lift and support to the vaginal tissues. This is appropriate for those with mild symptoms as well as it will provide more support for those who require it, for example for users who may be hypermobile, newly postnatal, breastfeeding, and/or if the body is being challenged a lot -for example if the user is pregnant, performing high intensity activities such as trampolining, or if constipated. For some users they may simply find the increased supported provided by such examples to be more comfortable.

In some examples the pessary body has an outer circumference configured to engage with the walls of the vagina, the vaginal pessary further comprising a cup portion provided proximate to the pessary body, the cup portion configured to capture liquid such as blood when menstruating flowing within the outer circumference of the pessary body. Advantageously such a device may allow removal without causing tissue drag as it breaks a vacuum seal formed by the device engaging with the vaginal walls before it is removed. Tissue drag is a common problem with conventional vaginal cups.

Furthermore, the device is configured to be deep enough to hold liquid such as menstrual blood but short enough so that it is not felt by the user close to the entrance of the vagina. Advantageously it may also provide vaginal support as well as holding period blood.

In another aspect there is provided vaginal pessary system comprising the vaginal pessary of any of the aspects described above and an optional applicator. The optional -6 -applicator comprises a tubular structure forming an internal cavity for receiving the vaginal pessary and, further comprising an aperture at one end and a plunger at the other, wherein operation of the plunger is configured to push a vaginal pessary contained within the cavity of the applicator out of the applicator through the aperture into the vagina. The tubular structure may comprise a tapered portion leading to the aperture to facilitate insertion into the vagina. The tapered portion may be deformable and/or configured to expand when the plunger is inserted into the applicator, to enlarge the aperture and facilitate expulsion of the pessary from the applicator cavity and deployment into the vagina.

Drawings Embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: Fig. 1 shows a perspective view of an example vaginal pessary loaded in an applicator in a retracted configuration; Fig. 2 shows a perspective view of the example vaginal pessary of Fig. 1 deployed from the applicator in a deployed configuration; Fig. 3A shows a plan view of another example vaginal pessary; Fig. 3B shows a plan view of another example vaginal pessary; Fig. 4A shows a perspective view of another example vaginal pessary in a deployed configuration; Fig. 4B shows a perspective view of the example vaginal pessary of Fig. 4A in a retracted configuration; Fig. 5 shows a perspective view of another example vaginal pessary; Fig. 6A shows a perspective view of another example vaginal pessary; Fig. 6B shows a perspective view of another example vaginal pessary similar to the pessary of Fig. 6A; and Fig. 6C shows a perspective view of another example vaginal pessary similar to the pessaries of Figs. 6A and 6B.

It will be understood that the drawings relate to different examples that share features in -7 -common. It will be understood that like reference numbers are intended to show features with the same or similar functionality.

Specific description

Fig. 1 shows a perspective view of an example item of intimate activewear which in this example is a vaginal pessary 100 loaded in an optional applicator 150 in a retracted configuration. The vaginal pessary 100 comprises a pessary body 101 which in this example is generally ring-shaped when in a deployed configuration (as shown in Fig. 2 as described in more detail below). The pessary body 101 is resiliently deformable to permit operation of the pessary 100 between the retracted and the deployed configurations and is configured to engage with the vagina wall. Advantageously this permits the pessary to be inserted into the vagina when in the retracted configuration, and then to provide support to the vagina wall when in the deployed configuration.

In Fig. 1 the pessary 100 is contained within an applicator 150 (which is similar to a tampon applicator) for deploying the vaginal pessary 100 at the correct location in the vagina. The applicator 150 is a generally tubular structure forming a cavity therewithin configured to hold the pessary 100 in a retracted configuration therewithin, with an aperture 155 at one end and a plunger (not shown in Fig. 1) at the other. Upon actuation of the applicator 150 (for example by inserting the plunger into the applicator 150) the pessary 150 is pushed up and out of the applicator 150 through aperture 155 and into the vagina where it expands into the deployed configuration and engages with the vagina wall, for example in the form of an interference fit.

In this example the pessary body comprises four flexion points 103, 105, 107, 109, wherein the flexion points are equidistant around the circumference of the pessary body 101. The provision of four flexion points in this example advantageously enables the pessary 100 to be folded up into the retracted configuration and fit within the applicator 150 and thereby have a relatively small form factor for inserting into the vagina.

Advantageously this enables a patient to insert the vaginal pessary 100 themselves rather than requiring specialist medical attention. -8 -

Each of the flexion points 103, 105, 107, 109 is an integral part of the pessary body 101. For example, the pessary body 101 may comprise regions or portions of material having a different Young's modulus so that these regions preferentially bend before other regions of the pessary body 101. In some examples the pessary body 101 may 5 comprise regions or portions having a reduced thickness of material so that these regions or portions preferentially bend. In some examples the pessary body 101 may comprise regions or portions that are reinforced to provide increased resilience. For example, the regions of the pessary body 101 between respective flexion points may be reinforced, for example with a metal wire embedded within the material of the pessary 10 body 101.

It will be understood that in some examples the pessary body 101 is resiliently deformable, but that regions or portions may be configured to bend preferentially relative to other regions or portions so as to provide respective flexion points. In some examples the regions or portions of material may be a different material or comprise a different or additional material, but in other examples the vaginal pessary (other than the holding means 125, 127) may consist of a single material, such as medical grade silicone. If the pessary/device is made from a material such as medical grade silicone it may be reusable. Advantageously, making the device from medical grade silicone may mean that the device can last longer than other materials such as PVC. Medical grade silicone may also be easily cleaned and maintained, meaning that the pessary/device may last longer than a pessary/device made from PVC, and may last as long as five years.

In the example shown in Fig. 1 the pessary 100 comprises two holding means 125, 127 which in this example is string. The holding means 125, 127 are configured to be operated by a user to remove the vaginal pessary. In the example shown, each holding means 125, 127 is coupled to the pessary body 101 proximate to a corresponding flexion point 107, 109. In this way, operation of the holding means 125, 127 causes the corresponding flexion point 125, 127 to bend, thereby deforming the vaginal pessary 100 so as to reduce its form factor (such as diameter if ring-shaped as shown in Figs. 1 and 2) and thereby facilitate removal of the vaginal pessary 100 from the vagina. In some examples, operation of the holding means 125, 127 not only causes the corresponding -9 -flexion points 107, 109 to bend, but also causes the other two flexion points 103, 105 to bend also. In some examples operation of the holding means 125, 127 causes the vaginal pessary 100 to be operated between the deployed configuration and a retracted configuration.

Advantageously the pessary may be sized and fitted by the user themselves without the need for a clinician. An example method for sizing and fitting a pessary of embodiments of the disclosure may be as follows: * In standing, the user bends their knees slightly or place one leg on a stool; * The user then inserts their index and middle finger, palm up into their vagina as far as possible (most vaginas are approximately the length of one's finger); * The user then opens out their fingers making a V shape in the direction of their thighs until they feel the wall of the vagina on either side of their fingers. The user then takes a mental note of how wide they have opened their fingers; * The user then withdraws their fingers and reopens them to the same width to how they opened them internally; and * The user then measures this on a colour coded ruler/scale (for example provided to the user as part of a kit including a range of pessaries in different sizes and/or provided to a user before they purchase a pessary/device). The user then places one finger at the beginning of the ruler and whichever colour the second finger lands on is their fit (in some examples the range of pessaries may be colour coded to correspond to the colour ranges provided on the colour-coded ruler).

Although the above method may sound relatively straightforward, it would be how a medical professional would size the device and thus the user can size a well-fitted pessary themselves in the comfort of their own home and without a long wait to see a medical professional. As such the pessary of embodiments of the disclosure is more accessible to users.

In some examples the colour coding of the ruler/colour scale (from left to right) may be as follows: 45mm -Lilac -10 - 50mm -Apricot 55mm -Raspberry 60mm -Sky 65mm -Rose It will be understood that the user may then be able to select an appropriate colour-coded device/pessary that corresponds to the colour coding of the ruler. Women come in all shapes and sizes which is why there a collection of pessaries/devices available. There will be no mention of size on the pessaries/devices themselves, whether someone has had a baby or age. Instead a simple colour chart is provided with a corresponding pessary/device.

Once the correct size device has been determined, the user then may insert the device as follows: * The user should always wash their hands with soap and water before and after handling the pessary/device; * The user, either stands with knees slightly bent, or stands with one foot on a stool or reclined lying; * The user then parts the labia; * The user then pinches the pessary/device together where the holding means are attached so it folds, and the user then inserts the pessary/device into the vagina with their finger as if inserting a tampon; * In some examples the user may find it helpful to breathe in deeply into the diaphragm whilst inserting and keeping their tummy soft. This will relax their pelvic floor and make insertion easier; * Once inside the vagina, the pessary/device should open into the deployed configuration. If the pessary/device feels uncomfortable the user can insert a finger and push it a little higher up inside; * To check fit the user should be able to run a finger around the outside edge and be able to pass urine and open their bowels; * Once inserted the user should not be able to feel it if it's the right fit for them.

To remove the pessary/device, the user can do as follows: * Again, the user should wash their hands with soap and water before and after handling the pessary/device; * The pessary/device is easiest to remove in either standing with knees slightly bent, standing with one foot on a stool or reclined lying; * The user may then gently pull on the attached holding means to bring the pessary/device down to the entrance of the vagina. The user may then hook their finger inside around the rim of the pessary/device at the front and cough, twist and pull to remove.

* The pessary/device should then be washed with soap and water, dried and stored in the supplied case.

If the pessary/device is uncomfortable e.g. it pinches with bending and lifting or it can be felt it inside or the user notices they are unable to empty their bladder and/or bowels completely it may be too big for them, so the user may need to choose the next colour to left on the colour scale (i.e. a smaller pessary/device). Conversely, if the pessary/device slips down to the entrance of the vagina or comes out of the vagina for example when straining on opening bowels, it may be too small so the user may need to choose the next colour to the right on the colour scale (i.e. a larger pessary/device).

Fig. 2 shows a perspective view of the example vaginal pessary 100 of Fig. 1 deployed from the applicator 150 in a deployed configuration. As can be seen, the vaginal pessary 100 is generally ring-shaped, but may not be completely flat but rather may be configured to provide a hyperbolic paraboloid shape. Such a shape may improve support and engagement of the pessary 100 with the vagina wall. For example, the pessary body 101 may be configured to follow the circumference of a hyperbolic paraboloid shape.

At least two of the flexion points 103, 105 are configured to permit the pessary body 101 30 to bend through an angle of more than 90 degrees. In the example shown, each holding means 125, 127 is coupled to the pessary body 101 on opposing sides of the pessary body 101. In the example shown, two opposing flexion points 103, 105 are configured to -12 -bend in a first direction forming an obtuse angle relative to the centre of the pessary body 101, and wherein another two opposing flexion points 107, 109 (to which the holding means 125, 127 may be coupled) are configured to bend in a second direction forming an acute angle relative to the centre of the pessary body 101.

In use, the pessary 100 is folded and inserted into the applicator 150 in the retracted configuration. The applicator 150 is inserted into the vagina, with the pessary 100 held in the applicator 150 in the retracted configuration. Upon actuation of the applicator 150 (for example by inserting the plunger into the applicator 150) the pessary 150 is pushed up and out of the applicator 150 through aperture 155 and into the vagina where it expands into the deployed configuration and engages with the vagina wall, for example in the form of an interference fit.

As noted above, the vaginal pessary of Figs. 1 and 2 is generally ring-shaped. However, 15 it will be understood that in other examples the vaginal pessary may have a different shape, and yet may still be operable to operate between a retracted configuration for insertion/removal, and a deployed configuration for providing support.

Fig. 3A shows a plan view of another example vaginal pessary 200. In this example the vaginal pessary 200 has many features in common with the vaginal pessary 100 of Figs. 1 and 2, but instead of being ring-shaped in this example the pessary body 201 is generally heart shaped. It is hypothesised that a heart-shaped pessary provides an improved fit within the vagina for some people (see, for example, Barnhart et al., "Baseline dimensions of the human vagina", Human Reproduction Vol. 21, No. 6 pp. 1618-1622, 2006.). In this example, instead of having four flexion points the pessary 200 has two flexion points 207, 209. The two flexion points 207, 209 are at opposing sides of the pessary body 201, and in this example are at respective apices of the heart shape such that the two flexion points 207, 209 are on a line of symmetry of the pessary body 201.

Fig. 3B shows a plan view of another example vaginal pessary 300. In this example instead of being ring-shaped in this example the pessary body 301 is generally butterfly- -13 -shaped. It is hypothesised that a butterfly-shaped pessary provides an improved fit within the vagina (see, for example, Barnhart et al., "Baseline dimensions of the human vagina", Human Reproduction Vol. 21, No. 6 pp. 1618-1622, 2006.). In this example, as with the example of Fig. 3A, instead of having four flexion points the pessary 200 has two flexion points 207, 209. The two flexion points 207, 209 are at opposing sides of the pessary body 201, and in this example are at respective apices of the heart shape such that the two flexion points 207, 209 are on a line of symmetry of the pessary body 201.

It will be understood that for both the example of Fig. 3A and the example of Fig. 3B a 10 holding means may be provided proximate to a corresponding flexion point, for example such that each pessary 200, 300 may each have at least two holding means.

It will be understood that with both the heart-shaped example of Fig. 3A and the butterfly-shaped example of Fig. 3B, it may be described that at least a portion of the pessary body 201, 301 has a W-shaped profile. In the example of Fig. 3A, this would be the top portion of the heart forming the two respective "arches" of the heart. In the example of Fig. 3B there would be two opposing W-shaped profiles.

Fig. 4A shows a perspective view of another example vaginal pessary 400 in a deployed 20 configuration, and Fig. 4B shows a perspective view of the example vaginal pessary 400 of Fig. 4A in a retracted configuration.

In this example the vaginal pessary 400 comprises a pessary body 401 comprising a ring-shaped circumferential member 402, a central hub 411, and four spokes extending from the hub to the ring-shaped circumferential member 402 and coupling the hub 411 to the ring-shaped circumferential member 402. The coupling between the hub 411 and each spoke, and each spoke and the ring-shaped circumferential member 402 is configured to provide a respective flexion point 403, 405, 407, 409. In the example shown the central hub 411, the spokes and the ring-shaped circumferential member 402 are all integrally formed. For example, they all may be made from the same resiliently deformable material, such as medical grade silicone. In the example shown the central hub 411 is coaxial with the ring-shaped circumferential member 402, and each of the -14 -spokes is of equal length.

The ring-shaped circumferential member 402 has a circumference configured to engage with the walls of the vagina, and wherein the flexion points 403, 405, 407, 409 are 5 equidistant around the circumference of the ring-shaped circumferential member 402.

As can be seen, a holding means 425 (which in this example is string) is coupled to the hub 411. As shown in Fig. 4B, the holding means 425 are configured such that when the vaginal pessary 400 is in use, operation of the holding means 425 causes the hub 411 to move relative to the pessary body 401/the ring-shaped circumferential member 402 about each the flexion points 403, 405, 407, 409, thereby reducing the diameter of the ring-shaped circumferential member 402 to permit removal of the vaginal pessary 400 from the vagina. It will be understood that when the vaginal pessary 400 is in the reduced diameter configuration this may be described as a retracted configuration, similar to the retracted configuration described above for the examples of Figs. 1 to 3B. The vaginal pessary 400 of Figs. 4A and 4B may be loaded into an applicator such as the applicator 150 described above with reference to Fig. 1 to permit a patient or user to insert the pessary 400 themselves.

As with the examples of Figs. 1 to 3B, the vaginal pessary 400 of Figs. 4A and 4B is symmetrical in a first plane about a first axis, and is configured to deform via the application of a force (for example via the holding means) in a direction transverse to the first plane and in a second axis transverse to the first axis.

Fig. 5 shows a perspective view of another example vaginal pessary 500. The vaginal pessary 500 of Fig. 5 is similar to that shown in Fig. 3A described above in that it may be described as heart shaped. However, in this example the vaginal pessary 500 is configured to provide additional support to the vagina wall. In this example the vaginal pessary 500 comprises a flange portion 520. The flange portion 520 follows the profile of the pessary body 501 (which in this example is a rounded heart-shape) but extends in a plane transverse to the plane of the pessary body 501 (and the plane in which the pessary body 501 is symmetrical). In other words, in the example of Fig. 5, the pessary -15 -body 501 forms a heart shape that is symmetrical about a first axis in a first plane, and the flange 520 extends from the pessary body 501 in a second axis in a direction transverse to the first axis. In the example shown, the apex of the heart (corresponding to flexion point 509) is rounded so as to provide an improved and/or more comfortable fit for the user.

The flange portion 520 acts like a skirt and is configured to provide additional support to the vaginal wall against prolapsing pelvic organs. It will be understood that, as with the flexion points of the pessary body described above with respect to the examples of Figs. 1 to 4B, the flange portion 520 may also comprise flexion points to enable the pessary to be operated between a retracted configuration and a deployed configuration. The flexion points of the flange portion 520 may be the same as the flexion points 507, 509 of the pessary body 501, such that the flexion points of both the pessary body 501 and flange portion 520 remain in the same axis travelling in a direction parallel to the second axis.

In the example shown, a pair of holding means 525, 527 (in this example also string) are coupled to a bottom end of the flange portion (the bottom end being the end of the flange portion 520 opposite to the end that is coupled to the pessary body 501). In this example the pair of holding means 525, 527 are joined to form a loop which may improve ease of use. Operation of the holding means 525, 527 causes both the flange portion 520 and the pessary body 501 to bend or flex about a common pair of flexion points to permit the pessary 500 to be removed from the vagina.

It will be understood that in some examples the vaginal pessary further comprises a cup portion provided proximate to the pessary body, the cup portion configured to capture liquid flowing within the outer circumference of the pessary body. For example, the cup portion may form a domed cup that extends in a direction transverse to a plane of symmetry of the pessary body.

Figs 6A to 6C show perspective views of example pessaries comprising a cup portion. The examples shown in Figures 6A to 6C are similar to the example pessary shown in Fig. 5 that comprises a flange portion 520 for extra support. In the example shown in -16 -Fig. 6A the pessary body 601 is butterfly shaped with two opposing flexion points 607, 609 at each apex of the butterfly shape which lie on a plane of symmetry of the pessary 600. In the example shown the pessary also comprises a flange portion 620 and a cup portion 630. The flange portion 620 follows the profile of the pessary body 601 but extends in a plane transverse to the plane of the pessary body 601 (and the plane in which the pessary body 601 is symmetrical). In other words, in the example of Fig. 6A, the pessary body 601 forms a butterfly shape that is symmetrical about a first axis in a first plane, and the flange 620 extends from the pessary body 601 in a second axis in a direction transverse to the first axis.

As with the example of Fig. 5, the flange portion 620 acts like a skirt and is configured to provide additional support to the vaginal wall against prolapsing pelvic organs and/or descent during exercise. It will be understood that, as with the flexion points 607, 609 of the pessary body described above with respect to the examples of Figs. 1 to 5, the flange portion 620 may also comprise flexion points to enable the pessary to be operated between a retracted configuration and a deployed configuration. The flexion points of the flange portion 620 may be the same as the flexion points 607, 609 of the pessary body 601, such that the flexion points of both the pessary body 601 and flange portion 620 remain in the same axis travelling in a direction parallel to the second axis.

In the example shown, a cup portion 630 is coupled to the flange portion 620 and bounds the flange portion 620 to provide a cup or receptacle for receiving and retaining liquid such as menstrual blood. However, it will be understood that in other examples the cup portion 630 may be coupled directly to the pessary body 601 and no flange portion 620 may be necessary. Such examples may provide less support to the user and/or may provide a shallower device which may improve comfort if the user is particularly aware of something inserted near to the entrance of the vagina.

The cup portion 630 forms a domed cup that extends in a direction transverse to a plane 30 of symmetry of the pessary body 601 and transverse to the flange portion 620.

In the example shown, a pair of holding means 625, 627 (in this example a loop of string) -17 -are coupled to a bottom end of the flange portion 620 (the bottom end being the end of the flange portion 620 opposite to the end that is coupled to the pessary body 601). Operation of the holding means 625, 627 causes both the flange portion 620 and the pessary body 601, as well as the cup portion 630, to bend or flex about a common pair of flexion points to permit the pessary 600 to be removed from the vagina.

Fig, 6B shows another example pessary that it very similar to the pessary 600 shown in Fig. 6A but differs in that instead of the pessary body 601 forming a butterfly shape, in this example the pessary body forms a rounded heart shape.

Fig. 6C shows another example pessary that it very similar to the pessary 600 shown in Fig. 6A but differs in that instead of the pessary body 601 forming a butterfly shape, in this example the pessary body forms a circular shape. In this example the pessary 600 may have two, or may have more such as four flexion points, as described above for example with reference to the examples of Figs. 1 and 2.

Advantageously, the examples of Figs. 6A to 6C allow removal of the device without causing tissue drag, as due to the presence of the flexion points 607, 609 and the way in which the device can fold or bend when removed (in the retracted configuration), any seal formed with the vaginal walls (e.g. when in the deployed configuration) is broken before it is removed from the vagina. The devices of Figs. 6A to 6C also differ from a standard menstrual cup in that they are deep enough to hold blood and not leak but short enough so cannot be felt so close to the entrance of the vagina, as well providing vaginal support as well as holding period blood.

In some examples the pessary may be provided as part of a kit. The kit may comprise a case for holding the pessary/device, and may be made from soft silicone, and in some examples may be colour coded to match the colour of the pessary/device. The case may be a folding pouch and may comprise an air vent to enable the device to dry when not in use. In some examples the kit may also include the colour coded ruler/chart discussed above.

-18 -Before the pessary/device is used for the first time it should be cleaned thoroughly. This can also be completed monthly. This can be done by placing the pessary/device in boiling water for 5-7 minutes (in a pan you use just for this purpose). Alternatively, sterilising solution or tablets may be used. These are commonly used to sterilise baby equipment. The manufacturer's guidelines should be followed for dilution, and the pessary/device should be soaked for the minimum recommended time. The pessary/device should then be rinsed thoroughly with clean water.

In some examples the pessary/device is silicone and made to last so it's worth cleaning 10 and taking care of it properly. The better it is looked after the longer it will last.

The following should not be used to clean the pessary/device as they may cause damage or cause vaginal irritation; * Petrol based substances such as Vaseline * Oil based substances e.g. essential oils or coconut oil * Harsh cleaners * Strong or scented soaps * Dishwasher or microwave Silicone devices discolour with use over time.

To get rid of stains, the user can; * soak their pessary/device in sterilising solution or tablets, following the manufacturer's guidelines for dilution and soaking for the minimum time; or * use bicarbonate of soda. Get a clean, damp cloth or a toothbrush with plenty of bicarb and rub it onto the stained area.

Once the pessary/device has been cleaned, it should be rinsed thoroughly with clean water. The pessary/device is configured to be worn for up to 12 hours. The pessary/device should not be shared with others.

In the context of the present disclosure other examples and variations of the apparatus and methods described herein will be apparent to a person of skill in the art.

Claims

-19 -CLAIMS: 1. A vaginal pessary configured to bias against the vaginal wall and support a portion of the vaginal wall against prolapsing pelvic organs, the pessary comprising: a pessary body comprising at least two flexion points, wherein each of the at least two flexion points is configured to permit the vaginal pessary body to bend; a holding means coupled to the pessary body, wherein the holding means are configured such that when the vaginal pessary is in use, operation of the holding means causes the vaginal pessary body to flex about the at least two flexion points to permit 10 removal of the vaginal pessary from the vagina.
2. The vaginal pessary of claim 1 wherein the at least two flexion points are on opposing sides of the pessary body.
3. The vaginal pessary of claim 1 or 2 comprising a pair of holding means, each holding means of the pair coupled to the pessary body at a region proximate to a flexion point.
4. The vaginal pessary of claim 3 wherein each holding means is coupled to the pessary body on opposing sides of the pessary body.
5. The vaginal pessary of any of the previous claims wherein the pessary body is resiliently deformable.
6. The vaginal pessary of any of the previous claims wherein each of the flexion points is an integral part of the pessary body.
7. The vaginal pessary of any of the previous claims wherein the vaginal pessary is a vaginal ring pessary.
8. The vaginal pessary of any of claims 1 to 7 wherein the pessary body is generally heart shaped.
-20 - 9. The vaginal pessary of any of claims 1 to 7 wherein the pessary body is generally butterfly shaped.
10. The vaginal pessary of any of claims 1 to 7 wherein at least a portion of the pessary body has a W shaped profile.
11. The vaginal pessary of any of the previous claims wherein at least two of the flexion points are configured to permit the pessary body to bend through an angle of 10 more than 90 degrees.
12. The vaginal pessary of any of the previous claims comprising at least four flexion points, wherein the flexion points are equidistant around the circumference of the pessary body.
13. The vaginal pessary of claim 12 wherein two opposing flexion points are configured to bend in a first direction forming an obtuse angle relative to the centre of the pessary body, and wherein another two opposing flexion points are configured to bend in a second direction forming an acute angle relative to the centre of the pessary body.
14. A vaginal pessary configured to bias against the vaginal wall and support a portion of the vaginal wall against prolapsing pelvic organs, the pessary comprising: a pessary body comprising a ring-shaped circumferential member, a central hub, and four spokes extending from the hub to the ring-shaped circumferential member and 25 coupling the hub to the ring-shaped circumferential member, wherein the coupling between the hub and each spoke, and each spoke and the ring-shaped circumferential member is configured to provide a respective flexion point; a holding means coupled to the hub, wherein the holding means are configured such that when the vaginal pessary is in use, operation of the holding means causes the hub to move relative to the pessary body about each the flexion points, thereby reducing the diameter of the ring-shaped circumferential member to permit removal of the vaginal pessary from the vagina. -21 -
15. The vaginal pessary of claim 14 wherein the ring-shaped circumferential member has a circumference configured to engage with the walls of the vagina, and wherein the flexion points are equidistant around the circumference of the ring-shaped circumferential 5 member.
16. The vaginal pessary of claim 14 or 15 wherein the central hub is coaxial with the ring-shaped circumferential member, and wherein each of the spokes is of equal length.
17. The vaginal pessary of any of the previous claims wherein the pessary is symmetrical in a first plane about a first axis.
18. The vaginal pessary of any of the previous claims comprising a flange portion, wherein the pessary body is symmetrical in a first plane about a first axis, and wherein the flange portion extends in a second axis in a direction transverse to the first axis and the first plane and is configured to provide support to the vaginal wall against prolapsing pelvic organs.
19. The vaginal pessary of any of the previous claims wherein the pessary body has an outer circumference configured to engage with the walls of the vagina, the vaginal pessary further comprising a cup portion provided proximate to the pessary body, the cup portion configured to capture liquid flowing within the outer circumference of the pessary body.
20. A vaginal pessary system comprising the vaginal pessary of any of the previous claims and an applicator, the applicator comprising a tubular structure forming an internal cavity for receiving the vaginal pessary and, further comprising an aperture at one end and a plunger at the other, wherein operation of the plunger is configured to push a vaginal pessary contained within the cavity of the applicator out of the applicator through the aperture into the vagina.