Pessaries

Abstract

A pessary (50) having a generally rounded main body formed as a completely reticulated outer shell (52, 56, 58) surrounding a void (54) forming a hollow interior. The pessary is suitably spherical, ovoid or spheroidal and manufactured from an elastomeric material. This enables the pessary to be comfortably inserted into the vaginal cavity (22), where it can act (34) upon the cervix (32), and / or anterior / posterior walls of the vagina (22) to provide structural support to the cervix. The reticulated outer shell enables the pessary to compress radially inwardly so as to facilitate its insertion and extraction into or from the vaginal cavity.

Description

[0001] PESSARIES

[0002] This invention relates to pessaries.

[0003] Pessaries, in the context of the present invention, are inserted into the vagina for various therapeutic purposes. They generally fall into three main categories, namely: structural, medicinal, and hybrid. The principal function of a structural pessary is to provide physical support to the vaginal tissues / structures; a medicinal pessary is manufactured from, or is designed to administer, a medicamentto thevaginaltissues; and a hybrid pessary performs both physical and medicinal functions.

[0004] Prolapse is a relatively common problem, and can be caused by trauma (e.g. in postpartum women), by surgery or by disease. Prolapse generally occurs when the pelvic floor is disrupted or becomes dysfunctional, which can then result in ptosis whereby abdominal and / or pelvic structures descend, often to a point whereby they distend, and / or protrude through, the vaginal canal. In many such situations, a structural pessary is indicated to provide an upward or sideways restorative force to alleviate the symptoms of the prolapse, which can be any one or more of an anterior wall prolapse, a posterior wall prolapse, a urethral prolapse or a cervical prolapse, as the case may be.

[0005] Existing structural pessaries take many forms, but they are generally spherical, spheroidal or ovoid; cube / cuboidal; or disc-like in shape and are designed to be inserted into the vagina. The generally conical shape of the vagina provides a “wedge” against which the pessary can bearto provide the requisite upward / sideward reaction force. In otherwords, once inserted, the pessary is held up against / towards the cervix by the inner sidewalls of the vagina itself.

[0006] However, due to the generally frustoconical shape of the vagina, insertion of structural pessaries can be awkward and / or uncomfortable since the size of the pessary generally needs to be larger than the relaxed state size of vaginal opening itself. Moreover, subsequent removal of the pessary through an opening that is smaller than the pessary can be difficult. Whilst a tether can be attached to the pessary to facilitate its extraction, there is nevertheless usually some discomfort involved during the process of the pessary’s removal.

[0007] Further problems associated with known structural pessaries include adhesion to the inner sidewalls of the vagina, which can be ameliorated using lubricants. However, the use of lubricants can cause a seal to be formed between the cervix and / or interior structures and walls of the vaginal cavity and the pessary, meaning that during extraction of the pessary, a significant vacuum force may need to be overcome to release / dislodge the pessary from its in-situ position; and further, given that the force applied forextraction, whilst the pessary is sealed onto the cervix, is generally downward, this can exacerbate the prolapse problem that the pessary is intended to address.

[0008] A yet further problem associated with known structural pessaries is that when inserted, airflowwithin the vaginal cavity can be restricted, especially where the pessary is in contact with the innersidewalls of thevagina, and this can lead to discomfort, as well as contamination and / or disease.

[0009] Further, a relatively rigid pessary often requires insertion and removal by a trained healthcare professional, such as in a clinic setting. This means that appointments need to be made / kept, and the user of the pessary has little agency in the use of the pessary. Moreover, rigid pessaries often suffer the unfortunate drawback of being easily dislodged / displaced by natural body movements (e.g. by walking), and providing a hard surface against which the internal organs act during sneezing, coughing, defecating, and the like, which can be extremely uncomfortable for the wearer. There have even reports of faecal and / or urinary incontinence or retention caused by rectal / urethral occlusion by a pessary.

[0010] Along the above lines also is the need fora pessary that can be user-inserted and removed at intervals, to provide support only when needed. In particular, when engaging in sporting activities or standing for extended periods, many women would benefit from the support that a structural pessary would provide, although there are currently few user-friendly options on the market that enable a user to self-administer a pessary as and when required.

[0011] A need therefore exists for a new and / or improved type of structural pessary, which the present invention aims to provide.

[0012] According to the invention, there is provided a pessary as set forth in the appended independent claim or claims. Preferred and / or optional features of the invention are set forth in the appended dependent claims.

[0013] The pessary of the invention comprises a generally rounded main body formed as a reticulated outer shell surrounding a void forming a hollow interior.

[0014] Suitably, the rounded main body comprises a spherical, ovoid or spheroidal outer shell, the reticulation being formed by providing a plurality of through apertures in the outer shell.

[0015] The generally rounded main body enables the pessary to be comfortably inserted into the vaginal cavity, where it can act upon the cervix, and / or anterior / posterior walls of the vagina to provide structural support to the cervix. However, because the rounded main body is formed as a reticulated outer shell surrounding a void forming a hollow interior, it is possible to readily compress the pessary radially inwardly so as to reduce its overall dimensions / diameter, and this greatly facilitates insertion of the pessary into the vaginal cavity. The fact that the outer shell is reticulated and because there is a hollow interior void, the outer shell is able to relatively easily deform inwardly to occupy part of the internal void thereby enabling the pessary to “collapse” radially inwardly, or indeed to be compressed into an elongated form to facilitate insertion and / or removal.

[0016] Further, by manufacturing the pessary with a collapsible structure, it becomes more conformal and / oradaptiveto movement of the bodyduring use. I rigid pessary, on the other hand, can easily be dislodged or move as the wearer moves their body, and this is because at least 14 muscles operate inside pelvis, which when activated, can force a pessaries out of position, or completely out of the vagina. By making the pessary collapsible, as in the invention, it is able to move and deform dynamically, so as to easily react to dynamic forces within the vaginal cavity. This is especially the case during coughing, sneezing, laughing, defecating etc., where the ability of the pessary to “yield” as opposed to providing a rigid reaction force, in particularly advantageous.

[0017] Suitably, the rounded main body comprises a faceted outer shell formed by a plurality of polygons, the reticulation beingformed by providing material alongthe edges of the faceted outer shell and by through apertures in the faces of the faceted outer shell. By forming the main body as a faceted outer shell, this provides a set of relatively flat sub-surfaces, which can each engage separately with different features of the internal anatomy of the user. The fact that the pessary is generally faceted, as opposed to being completely rounded, means that rotation of the pessary once it is in-situ is inhibited or reduced. If the pessary were to be completely spherical, then it could potentially rotate to any position, and this may occur whilst it is being worn through movement of the user. This could lead to abrasion of the internal structure / tissues, which could prove to be uncomfortable overtime.

[0018] The through apertures in the main body advantageously provide useful locations to grasp the pessary using the fingers during insertion and / or removal thereof. In certain cases, a hooked accessory may be provided to facilitate removal of the pessary.

[0019] By providing a flexible pessary with a hollow core and a collapsible reticulated structure, it is relatively easy for it to be inserted. Moreover, once inserted, its resilience can cause it to expand naturally, and thus occupy a correct position within the vaginal cavity - in other words, it can be self-locating. Moreover, even if the pessary becomes dislodged in use, because it is resiliently deformable, it can simply adapt its own shape to conform with the new position / orientation. The pessary of the invention is, in many way, orientation-agnostic insofaras it expands and deforms to automatically correctly fill the vaginal cavity. Suitably, a cross-section of the material formed along the edges of the faceted outer shell is circular, oval or stadium shaped. Essentially, the edges of the faceted outer shell are filleted or rounded so as to provide a more comfortable fit and to reduce the likelihood of irritation and / or abrasion of the internal tissue structures.

[0020] Suitably, the faceted outer shell takes the general form of a dodecahedron formed by a twelve pentagonal faces. Alternatively, the faceted outer shell takes the general form of an icosahedron formed by a plurality of triangular faces. Alternatively, the faceted outer shell takes the general form of non-platonic solid formed by a plurality of dissimilar faces.

[0021] Suitably, the main body is manufactured from a resilient material such as an elastomeric material. By manufacturing the pessary from a resilient and / or an elastomeric material, it can be easily deformed during insertion / removal; and it is able to conform better to the internal geometry of the vaginal cavity in use.

[0022] Suitably, the main body is manufactured from any one or more of the group comprising: butadiene-, butyl-, nitrile- or silicone rubber; latex; perfluoroelastomer; ethylene propylene diene monomer; fluoroelastomer; and thermoplastic polyurethane. The use of biocompatible materials such as those listed above is advantageous since it ensures that the material of the pessary itself is not an irritant. Obviously, the choice of material will depend on the user and their particular sensitivities. For example, a latex pessary would not be used for a user with a latex allergy, although this may be indicated for other types of patient.

[0023] Preferably, the material from which the pessary is manufactured is readily washable and / or sterilizable, and in a preferred embodiment of the invention, it is manufactured from a dishwasher-safe material so as to facilitate domestic cleaning in the home.

[0024] Embodiments of the invention shall now be described, by way of example only, with reference to the accompanying drawings in which:

[0025] Figure 1 is schematic cross-sectional view of the female human anatomy illustrating a cervical prolapse, although the invention also works equally well for anterior wall, posterior wall prolapses too;

[0026] Figure 2 is a schematic cross-section al view of the female human anatomy showing how a pessary in accordance with the invention can be used to alleviate the symptoms of prolapse;

[0027] Figures 3 and 4 are perspective views of a further embodiment of a pessary in accordance with the invention;

[0028] Figures 5 and 6 are perspective views of a second type of pessary in accordance with the invention; Figure 7 is a perspective view of a third embodiment of a pessary in accordance with the invention; and

[0029] Figure 8 is a schematic split view of a pessary in accordance with the invention.

[0030] Referring nowto Figure 1 of the drawings, showing a cervical prolapse, a schematic cross- sectional view of the female anatomy in the pelvic region is shown. The anatomy 10 shown is extremely simplified for clarity, and essentially shows the leg 12 and the buttock 14 with the pubis 16 towards the left hand side. The bladder 18 and rectum 20 are shown on the left and right, with the vagina 22 shown towards the centre. Therefore, from left-to-right in the drawing are the Urethra 24, the Vulva 26, and the Anus 28. The Uterus 30 is shown above the Vagina 20 with the Cervix 32 in a prolapsed state having descended down into the Vagina 22.

[0031] The same anatomy 10 is shown in Figure 2 of the drawings, but in this case, a pessary 50 has been inserted into the vaginal cavity 22 so as to provide an upward restorative force on the cervix 32 restoring the cervix 32 and the uterus 30 to a non-prolapsed condition. As can be seen from Figure 2, due to the overall shape of the pessary 50, and the inward forces 32 provided by thevaginalwalls, the pessary 50 is pushed upwardly34 generally into engagementwith the cervix 32. This provides the requisite structural support to provide a relief from the symptoms of the prolapse shown in Figure 1 .

[0032] Figures 3 and 4 are perspective views of the pessary 50 shown in Figure 2 and it can be seen that the pessary is formed as a generally dodecahedral shape having twelve 5-sided faces. The edges 52 of the 5-sided faces form a reticulated structure surrounding an inner cavity or void 54. In other words, the pessary 50 is formed as a generally rounded body having a reticulated outer shell surrounding the void 54 in the middle. As can be seen from Figures 3 and 4, the edges and vertices of the reticulated outer shell are rounded, and this improves the comfort for the wearer in use. The pessary 50 shown in Figures 3 and 4 is generally a platonic solid - even though its outer profile 56 has been rounded so as to make it more comfortable to wear.

[0033] An alternative embodiment of the pessary 50 is shown in Figures 5 and 6, but in this case, the main body is actually spherical, but has a spherical internal void 54 and a series of pentagonal through apertures extending all the way through the main body. This creates a “rounder” overall pessary, but nevertheless has a reticulated outer shell surrounding a hollow void and the provision of the through apertures provides the necessary anchorage to prevent the pessary 50 from inadvertently or undesirably rotating once it has been inserted. Again, it can be seen that the edges of the apertures 58 are rounded straight so as to make the pessary 50 more comfortable to wear, as well as to facilitate cleaning etc. Ayet further embodiment of the invention is shown in Figure 7, which is broadly similar to that shown in Figures 5 and 6, except this time, the through apertures 60 are circular, rather than being generally pentagonal. Same considerations apply, regardless of the precise configuration of the apertures and the overall structures. To facilitate manufacturing the pessary 50, as shown in Figure 8, the through holes 60 suitably extend all the way through the main body as indicated by the dashed lines 62. This means that the pessary 50 can be manufactured in a generally spherical mould, but with through-pins being used to form the apertures and void, and thereby the reticulated outer shell structure. The internal void 54 is formed where the mould pins (not shown for clarity) extend through the interior of the pessary 50 during the manufacturing process.

Claims

CLAIMS1 . A pessary comprising a generally rounded main body formed as a completely reticulated outer shell surrounding a void forming a hollow interior.

2. The pessary of claim 1 , wherein the rounded main body comprises a spherical, ovoid or spheroidal outer shell, the reticulation being formed by providing a plurality of through apertures in the outer shell.

3. The pessary of claim 1 , wherein the rounded main body comprises a faceted outer shell formed by a plurality of polygons, the reticulation being formed by providing material along the edges of the faceted outer shell and by through apertures in the faces of the faceted outer shell.

4. The pessary of claim 3, wherein a cross-section of the material formed along the edges of the faceted outer shell is circular, oval or stadium shaped.

5. The pessary of claim 3 or claim 4, wherein the faceted outer shell takes the general form of a dodecahedron formed by a plurality of pentagonal faces.

6. The pessary of claim 3 or claim 4, wherein the faceted outer shell takes the general form of an icosahedron formed by a plurality of triangular faces.

7. The pessary of claim 3 or claim 4, wherein the faceted outer shell takes the general form of non-platonic solid formed by a plurality of dissimilar faces.

8. The pessary of any preceding claim, wherein the main body is manufactured from a resilient material.

9. The pessaryofanyprecedingclaim, wherein the resilient main bodyis manufactured from an elastomeric material.

10. The pessary of any preceding claim, wherein the main bodyis manufactured from anyone or more of the group comprising: butadiene-, butyl-, nitrile- or silicone rubber; latex;perfluoroelastomer; ethylene propylene diene monomer; fluoroelastomer; and thermoplastic polyurethane.

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