Gynecological pessaries

Abstract

A pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having first and second ends, the pessary body being elongate and having: a length defined by a distance between the first and second ends, wherein the length is about 50-90% of a total vaginal length of the user, a width defined by a span in a first lateral direction, and a depth defined by a span in a second lateral direction; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction, it causes the width to increase.

Description

GYNECOLOGICAL PESSARIESField of the Disclosure

[0001] The presently disclosed subject matter is directed to gynecological pessaries.Background

[0002] There are many conditions for which a first line of treatment is pessary placement in a vaginal canal of a user. Such conditions include Pelvic organ prolapse (POP), rectocele, cystocele, urinary or fecal incontinence, to name a few. These symptoms can dramatically affect a woman’s quality of life and can have a social, psychological, and sexual impact.

[0003] For example, POP is the abnormal descent or herniation of the pelvic organs from their normal attachment sites to or beyond the vaginal walls leading to discomfort in the vagina, leakage of urine and bowel problems. POP generally occurs when the normal anatomical support of the pelvic organs in women which is provided by the balanced interaction between pelvic floor muscles and connective tissue attachments is lost or weakened. This is typically due to childbirth, advancing age, obesity and pelvic surgery. It is regarded as a progressive disease, as mild prolapse can eventually lead to advanced stage disease.

[0004] Although, POP is likely to have a more diverse dynamic than other health conditions in women, it is treated as a "one-size-fits-all" problem in all cases. First-line treatments for POP include lifestyle and behavioral interventions, pelvic floor muscle training, and vaginal pessaries. The second line of treatment involves surgical intervention (e.g., pelvic reconstruction). It is estimated that 20% of patients will undergo pelvic floor surgery, which has lifelong risks such as incontinence, infertility, dyspareunia, and a 30% chance of developing another prolapse. Additionally, there have been several reported risks of complications associated with transvaginal mesh implants, which were banned by the United States Food and Drug Administration (FDA) in April 2019.

[0005] Due to these risks, it is imperative to focus on first-line treatments, such as pessaries, to facilitate the management of POP and other conditions. If used correctly, pessaries may help manage the condition and prevent unnecessary surgeries. Pessaries can be divided into two main categories including support and space-filling pessaries. Support pessaries are preferred for patients as they tend to be easier to remove and insert. Space-filling pessaries are primarily usedto support severe POP, especially when the vagina drops after a hysterectomy. As current pessaries are not designed to account for the natural variations within a female's pelvic anatomy, they often displace and do not provide effective symptomatic relief. In fact, pessary fittings have a 30% failure rate; and those that are successfully fitted, report a 50% reported drop rate within the first year, and a 56% complication rate. It is believed that the reason for such a high rate of discontinued use is due to the fact that commercially produced pessaries do not take into consideration anatomic variations of the patient attributed to their general health, weight, genetics, pregnancy experiences, lifestyles, and more. In fact, common pessaries are manufactured in a standard set of sizes and basic geometric / symmetrical shapes which thus limits their efficacy.

[0006] However, pessaries have some drawbacks which contribute to discontinuation of use and failure of this treatment, including bleeding and discharge, infection, extrusion, and pain. Moreover, generally two to three pessaries must be fitted per patient in order to maximize comfort, often due to factors such as high body mass index (BMI), elevated intra-pelvic pressure and short total vaginal length (TVL). In these cases, the pessary tends to slip out of the vagina when these patients walk, perform Valsalva Maneuvers, or void. In the case of TVL being short, maintaining the pessary above the levator plate in the middle of the vagina is difficult, causing expulsion or discomfort.

[0007] In addition, the vagina shows dynamic characteristics during various activities and postures. The lower part of the vagina is constrained by muscles, pubic bones, and the perineal body, reducing the variability displacement. However, the upper part of the vagina is relatively burdened less by spatial constraints and causes more shape and location deviations. Moreover, the vaginal canal changes rheological behavior in women with POP over time. These biochemical changes inside the vagina consequently change the biomechanical properties of vaginal canal tissues. For instance, prolapsed tissues are stiffer in POP patients compared to nonPOP women. The stiffer behavior of tissue noticeably increases displacement and disorientation of inserted pessaries. Also, there is a correlation between the biomechanical characteristics of the vaginal tissue and parameters like age or parity of patients. These parameters can change the biomechanical behavior of the vaginal tissue over time.

[0008] Most current pessaries have circular or oval shapes, due to the belief that the vagina is cylindrical, but upper vaginal cavities can be parallel, conical, or heart-shaped and the female pelvic is a dynamic system that provides three different levels of pelvic organ support. The upperthird of the vagina by the cardinal and uterosacral ligaments (level I) which makes the top level of the vaginal canal, an oval shape, paravaginal attachments of the middle half of the vagina to the arcus tendineus fascia (level II) which make the middle of vaginal canal rectangular shape or similar to an H shape, and the fusion of the lower third of the vagina to the perineal membrane and perineal body (level III) which usually looks like a circle or half a circle. These levels of supports have not been considered in the design of current pessaries which are only placed on either the posterior or anterior vaginal wall supports and are not always sufficient for properly supporting pelvic organs and preventing prolapse. To provide optimal support, a pessary may need to be placed more centrally within the vagina. For example, gellhom pessaries are located superiorly and anteriorly to the inferior pubic point, whereas ring pessaries are situated posteriorly or inferiorly. In general, they are designed to rest on the anterior and posterior walls of the vaginal canal; however, owing to the varying characteristics of the vaginal canal, it would be challenging to maintain the pessaries at the desired positions and treat POP. In addition, the mechanism of current pessaries increases the pressure applied to vaginal wall tissues, resulting in infections and vaginal discharge in POP patients. Moreover, applying force on the anterior and posterior walls leads to extreme pressure on organs such as the bladder and rectum. In Table 1, different types of pessaries and their success rates as well as the factors associated with discontinuation were compared.

[0009] Table 1

[0010] Therefore, there is a need for pessaries that overcome or minimize at least some of the abovementioned drawbacks.Summary of the Disclosure

[0011] Broadly, there is provided a pessary for a vaginal canal of a user which is configured to be modulated between a rest configuration, an expanded configuration and a compacted configuration. The pessary can direct a lateral force incumbent thereon to cause an increase in a spread of the pessary. For example, the pessary may widen at a portion thereof when a lateral force is applied to another portion of the pessary. The lateral force may be an anterior and / or posterior force. This can help to anchor the pessary in the vaginal canal during movements such as the user sneezing, coughing, laughing, defecating, or exercising.

[0012] In a first aspect, there is provided a pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having a first end and a second end, the pessary body comprising: a first body portion and a second body portion; a first end width defined by a span of at least one or both of the first body portion and the second body portion, in a first lateral direction, at the first end; a second end width defined by a span of at least one or both of the first body portion and the second body portion in the first lateral direction, at the second end; wherein the pessary body is configured such that when pressure is applied to the pessary body in a second lateral direction, different to the first lateral direction, it causes the first end width to increase, and wherein the modulation in the first end width is more than any modulation in the second end width.

[0013] From another aspect, there is provided a pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having first and second ends, the pessary body being elongate and having: a length defined by a distance between the first and second ends, a width defined by a span in a first lateral direction, and a depth defined by a span in a second lateral direction; wherein the length is at least as large as one or both of the width and the depth when the pessary is in a rest configuration; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction, it causes the width to increase.

[0014] From a yet further aspect, there is provided a pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having first and second ends, the pessary body being elongate and having: a length defined by a distance between the first and second ends, wherein the length is about 50-90% of a total vaginal length (TVL) of the user, a width defined by a span in a first lateral direction, and a depth defined by a span in a second lateral direction; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction, it causes the width to increase. In other embodiments, the length is about 30% to about 90% of the VGL, about 20% to about 90% of the VGL, about 60% to about 90% of the VGL, or about 70% to about 90% of the VGL.

[0015] In certain embodiments of any of the aspects, the length is more than the width or more than the depth in a rest configuration of the pessary. The depth may be smaller than the width. In some embodiments, the length is configured to be about 50 to about 90% of the Total Vaginal Length of the user.

[0016] In certain embodiments of any of the aspects, the pessary body comprises: a first body portion and a second body portion; a first end width defined by a span of at least one or both of the first body portion and the second body portion, in the first lateral direction, at the first end; a second end width defined by a span of at least one or both of the first body portion and the second body portion in the first lateral direction, at the second end; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction it causes the first end width to increase, and wherein the modulation in the first end width is more than any modulation in the second end width.

[0017] In certain embodiments of any of the aspects, a length of the pessary body is greater than one or both of the first end width and the second end width in a rest configuration.

[0018] In certain embodiments of any of the aspects, when the pessary is disposed in the vaginal canal of the user with the first end supporting uterus, the applied pressure is at least one of an applied anterior pressure and an applied posterior pressure.

[0019] In certain embodiments of any of the aspects, the first and second body portions are disposed laterally relative to each other and connected by a lateral connector.

[0020] In certain embodiments of any of the aspects, the first body portion comprises a first arm having a first distal end at the first end of the pessary body, the second body portion comprises a second arm having a second distal end at the first end of the pessary body, wherein the first end width is defined by a distance between the first and second distal ends, and the second end width is defined by a distance between the first and second arms. In certain embodiments, the first and second distal ends are angled towards each other. In certain embodiments, the width is defined by the span of the first and second arms in the first lateral direction and the depth is defined by the span of the first and second arms in the second lateral direction.

[0021] In certain embodiments of any of the aspects, the lateral connector comprises oppositely facing concave elements connecting the first and second arms, wherein applying the pressure to one or both of the concave elements to bring them closer together causes the first and second distal ends to move further apart.

[0022] In certain embodiments, applying the pressure to the first and / or second arms causes the firs and second arms to come together and causes one or both of the concave elements to move further apart (i.e. the depth to increase).

[0023] In certain embodiments of any of the aspects, the pessary further comprises an end connector connecting the first and second arms at the second end.

[0024] In certain embodiments of any of the aspects, one of the concave elements can be caused to nest in the other of the concave elements to reduce a depth of the pessary body. In some embodiments, the first and second arms are configured to be brought closer together in a compacted configuration of the pessary.

[0025] In certain embodiments of any of the aspects, the first and second body portions comprise first and second elongate cells, respectively, the first and second elongate cells being laterally spaced and the first end width being defined by a span of the first and second cells at the first end and the second end width being defined by a span of the first and second cells at the second end. In some embodiments, the width is defined by the span of the first and second elongate cells in the first lateral direction and the depth is defined by the span of the first and second elongate cells in the second lateral direction.

[0026] In certain embodiments of any of the aspects, the first and second cells are tapered such that, in a rest configuration, the first end width is more than the second end width. The taper may be concave or convex. The first and second cells may each be tapered irregular hexagonal prisms. The first and second cells may have open ends.

[0027] In certain embodiments of any of the aspects, wherein applying the pressure on one or both of the first cell and the second cell in the second lateral direction causes the first end width to increase.

[0028] In certain embodiments of any of the aspects, each of the first and second cells include at least one reinforcing member to avoid a longitudinal folding along a length of the first and second cell. The reinforcing member may comprise a strut extending along an inner wall of one or both of the first cell and the second cell. The first and second cells may be each six-sided, having sides separated by vertices. The width may defined as a distance between furthest vertices of the first and second cells. The sides may be of unequal length. The lateral connector may be an elongate member connecting the first and second cells along their lengths.

[0029] In certain embodiments of any of the aspects, the second body portion is an expandable body and the first body portion is a sleeve in which the expandable body is received, the sleevehaving at least one opening through which the expandable body can extend outwardly when pressure is applied to the pessary body.

[0030] In certain embodiments of any of the aspects, the first body portion limits the expansion of the expandable body other than through the at least one opening. One or both of the expandable body may be substantially pear-shaped. A transverse cross-sectional shape of the expandable body may be donut-shaped.

[0031] In certain embodiments of any of the aspects, the pessary further comprises a drainage channel extending longitudinally through the first and second body portions. In certain embodiments of any of the aspects, the pessary further comprises a valve communicatively coupled to the second body portion for controlling fluid flow therethrough. The valve may be configured to selectively extend from and retract towards the expandable body, wherein the valve is a self-sealing valve.

[0032] In certain embodiments of any of the aspects, the pessary body is expandable, the first body portion being a region on the pessary body which is less expandable than another region on the pessary body. The first body portion may be composed of a first material, and the second body portion may be composed of a second material, the second material having lower elasticity than the first material.

[0033] Other aspects and features of the present disclosure will become apparent, to those ordinarily skilled in the art, upon review of the following description of the various embodiments of the disclosure.Brief Description of the Drawings

[0034] Embodiments will now be described with reference to the attached drawings in which:

[0035] Figure 1 is a perspective view of a first embodiment of a pessary in a rest configuration, according to embodiments of the present technology.

[0036] Figure 2 is a top plan view of the pessary of Figure 1.

[0037] Figure 3 is a front view of the pessary of Figure 1;

[0038] Figure 4 is a side view of the pessary of Figure 1;

[0039] Figure 5 is the front view of the pessary of Figure 3, in the expanded configuration according to embodiments of the present technology.

[0040] Figure 6 is a top plan view of the pessary of Figure 5 in the expanded configuration.

[0041] Figure 7 is a side view of the pessary of Figure 4, in the compacted configuration according to embodiments of the present technology.

[0042] Figure 8 is a top plan view of the pessary of Figure 7 in the compacted configuration.

[0043] Figure 9 is a perspective view of a second embodiment of a pessary in a rest configuration, according to embodiments of the present technology.

[0044] Figure 10 is a top plan view of the pessary of Figure 9.

[0045] Figure 11 is a bottom plan view of the pessary of Figure 9.

[0046] Figure 12 is a front view of the pessary of Figure 9;

[0047] Figure 13 is a side view of the pessary of Figure 9;

[0048] Figure 14 is a transverse cross-sectional view of the pessary of Figure 9;

[0049] Figure 15 is the front view of the pessary of Figure 12, in the expanded configuration according to embodiments of the present technology.

[0050] Figure 16 is a top plan view of the pessary of Figure 15 in the expanded configuration.

[0051] Figure 17 is a side view of the pessary of Figure 13 in the compacted configuration.

[0052] Figure 18 is a top plan view of the pessary of Figure 17 in the compacted configuration.

[0053] Figure 19 is a perspective view of a third embodiment of a pessary in a rest configuration, according to embodiments of the present technology.

[0054] Figure 20 is a front view of the pessary of Figure 19.

[0055] Figure 21 is a side view of the pessary of Figure 19.

[0056] Figure 22 is a perspective view of a fourth embodiment of a pessary in a rest configuration, according to embodiments of the present technology.

[0057] Figure 23 is a side view of the pessary of Figure 22.

[0058] Figure 24 is a cross-sectional view through the line D-D of the pessary of Figure23.

[0059] Figure 25 is a front view of the pessary of Figure 22.

[0060] Figure 26 is a top plan view of the pessary of Figure 22.

[0061] Figure 27 is a bottom plan view of the pessary of Figure 22.

[0062] Figure 28 is the front view of the pessary of Figure 25 in the expanded configuration.

[0063] Figure 29 is the top plan view of the pessary of Figure 26 in the expanded configuration.

[0064] Figure 30 is the side view of the pessary of Figure 23 in the compacted configuration.

[0065] Figure 31 is the front view of the pessary of Figure 28 in the compacted configuration.Detailed Description of Embodiments

[0066] The following discussion is directed to several embodiments of the presently disclosed subject matter, and in many cases lists variations and permutations of various embodiments.

[0067] This summary is merely exemplary of the numerous and varied embodiments. Mention of one or more representative features of a given embodiment is likewise exemplary. Such an embodiment can typically exist with or without the feature(s) mentioned; likewise, those features can be applied to other embodiments of the presently disclosed subject matter, whether listed in this summary or not. To avoid excessive repetition, this Summary does not list or suggest all possible combinations of such features.

[0068] Still further, any discussion of specific combinations of features is not intended to limit the scope of protection of the present technology in any way. Moreover, any reference to “the present technology” is intended to refer to embodiments thereof.

[0069] According to aspects of the present technology, there are provided various embodiments of a pessary for gynecological use in a user with a vaginal canal. The pessary can be installed in the vaginal canal for the purposes of treatment, mitigation and / or prevention of various conditions such as, but not limited to, Pelvic Organ Prolapse (POP), rectocele (displacement of rectum), cystocele (displacement of bladder), control of vesicovaginal fistula, urinary incontinence, fecal incontinence, abnormal descent of the pelvic organs beyond vaginal walls, post-operative treatment from vaginal reconstruction surgery, prevention of vaginal stenosis (e.g. from post-cancer therapy), vaginismus, prevention of pre-term labour for women with cervical incompetence for women.

[0070] In some embodiments, the pessary is configured to be positioned in an upper portion of the vaginal canal and to rest on iliococcygeus and pubococcygeus muscles which serve as anchor points within the vaginal canal. However, in other embodiments, the resting position and location of the pessary will vary based on the user’s anatomical characteristics and the specific use of the pessary. The pessary has at least a portion configured to support a lateral vaginal wall and a portion to support a uterus.

[0071] From a broad aspect, the pessary is designed to change size and / or shape responsive to pressure, which helps it to remain in situ, stay comfortable, stay safe, etc. The pressure may come from various activities of the patient such as sneezing, coughing, exercising, laughing, defecating, etc.

[0072] According to certain embodiments, when pressure is applied in one direction to the pessary, the pessary modulates in dimension along another, different, direction. In some embodiments, the pessary is configured to direct a lateral force to cause an increase in a spread of the pessary. For example, the pessary may widen at a portion thereof when a lateral force is applied to another portion of the pessary. The pessary can thus be modulated between a rest configuration, an expanded configuration and a compacted configuration. In the compacted configuration, the pessary may be foldable.

[0073] In use, when disposed in the vaginal canal, the pessary can thus change shape, between the rest and expanded configurations, responsive to changes in pressure on the pessaryfrom lateral walls of the vaginal canal, such as when the user experiences a Valsalva maneuver or contractions, or otherwise laughs, coughs, sneezes, exercises, etc. Such a dynamic response of the pessary can assist in retention of the pessary in the vaginal canal through an anchoring effect of the widened portion in situ. It can also avoid pressure hot spots that can be painful to the user, as well as maintaining pressure to the surrounding muscles and tissues. In the compacted configuration, the pessary may have a reduced overall footprint or perimeter facilitating insertion into, and removal from, the vaginal canal.First embodiment

[0074] Referring now to Figures 1 to 4, there is shown a first embodiment of a pessary 100 having a pessary body 102, in the rest configuration, according to the present technology. Generally, the pessary 100 is in the rest configuration when there is no force being applied to the pessary body 102, or, put another way, equal force is being applied to the pessary body 102.

[0075] The pessary body 102 is generally elongate and has a longitudinal axis 104 (Figure 3). The pessary body 102 has a length 106, a width 108 and a depth 109. In certain embodiments, a dimension of the length 106 is at least the same if not larger than the width 108 and / or the depth 109. In certain embodiments, the length 106 is larger than the width 108 and / or the depth 109. In certain embodiments, the width 108 is larger than the length 106. Developers have discovered that in some cases, the length 106 being just as large as the width 108 and / or the depth 109 may reduce or avoid a rotation of the pessary 100 when it is disposed in the vaginal canal.

[0076] The pessary body 102 has a first end 110 and a second end 112. A distance between the first and second ends 110, 112 defines the length 106. When the pessary 100 is disposed in the user’s vaginal canal with the orientation as depicted, the first end 110 is a top end and the second end 112 is a bottom end. In such an orientation, the first end 110 of the pessary body 102 is configured to support the uterus of the user when the pessary 100 is disposed in an upper portion of the vaginal canal. Specifically, the first end 110 of the pessary body 102 may be sized and shaped to be received in the vaginal canal fomices, around the uterus. This may help retention of the pessary 100 in position in the vaginal canal. This may also help with maintaining support of the uterus even if the pessary 100 becomes tilted in the vaginal canal. The first end 110 may define a substantially round or oval shape. The pessary body 102 can also be oriented the other way such that the first end 110 is a bottom end and the second end 112 is a top end.

[0077] The pessary body 102 comprises a first body portion 114 and a second body portion 116. Each of the first and second body portions 114, 116 extend between the first and second ends 110, 112. The first and second body portions 114, 116 are laterally spaced from one another. In this embodiment, the first and second portions 114, 116 comprise a first arm 114 and a second arm 116, respectively. The first and second arms 114,116 have a first arm longitudinal axis 115 and a second arm longitudinal axis 117, respectively. In the rest configuration, the first and second arm longitudinal axes 115, 117 are parallel to the longitudinal axis 104 of the pessary body 102.

[0078] The first arm 114 has a first distal end 118 at the first end 110 of the pessary body 102. The second arm 116 has a second distal end 120 at the first end 110 of the pessary body 102. The first and second distal ends 118, 120 are free ends which are spaced from one another. The first and second distal ends 118, 120 are angled towards each other. In other embodiments, the first and second distal ends 118, 120 may not be angled relative to the first and second arms 114, 116. The first and second distal ends 118, 120 may be rounded, for comfort to the user.

[0079] An end connector 122 connects the first and second arms 114, 116 at the second end 112. The end connector 122 is arcuate and in certain embodiments is substantially u-shaped. In other implementations (not shown), the end connector 122 may be omitted. The first and second arms 114, 116 and the end connector 122, when present, he on the same plane. The first arm 114, the second arm 116 and the end connector 122 define a u-shaped frame.

[0080] A lateral connector 124 extends laterally between the first and second arms 114, 116, at a height along the longitudinal axis 104 which is between the first and second ends 110, 112. The lateral connector 124 may be disposed about midway along a length of the first and second arms 114, 116. The lateral connector 124 comprises two oppositely facing concave elements 124a, 124b. Each concave element 124a, 124b comprises an arcuate band. The concave elements 124a, 124b bulge outwardly and away from each other. Together, the concave elements 124a, 124b have a circular band configuration. The lateral connector 124 lies on a plane that is transverse to the plane of the first and second arms 114, 116. A height dimension of each concave element 124a, 124b along the longitudinal axis 104 may be between about one third and one quarter of the length 106 of the pessary body 102. An elongate dimension of each concave element 124a, 124b between the first and second arms 114, 116 is larger than the width 108 of the pessary body. The first and second arms 114, 116 and the end connector 122 meet at a position 125 along the longitudinal axis 104 which is below the lateral connector 124. In otherimplementations (not shown), the lateral connector 124 may comprise a single circular band, instead of two concave elements 124a, 124b.

[0081] As best seen in Figures 3 and 4, the width 108 is defined as a distance between the first and second arms 114, 116. However, in other implementations, the width 108 may also be defined as a distance between the first and second distal ends 118, 120. The depth 109 is defined as a largest distance between the concave elements 124a, 124b of the lateral connector 124. It will be appreciated that the definitions of the width 108 and the depth 109 may be reversed, the width 108 being defined by the lateral connector 124 and the depth 109 being defined by the first and second arms 114, 116. In yet other implementations, the first and second arms 114, 116 may have free ends at the second end 112.

[0082] Together, the first arm 114, the second arm 116, the end connector 122 when present, and the lateral connector 124 define the pessary body 102 that is hollow and porous, permitting fluid flow therethrough. The pessary body 102 is also foldable in a manner that will be described relative to the compacted configuration.

[0083] One or more of the first arm 114, the second arm 116, the end connector 122, and the lateral connector 124 may be made of a resilient material. The resiliency properties may be the same or different to one another. This can be achieved by using different materials for the different parts of the pessary, and / or by modulating a thickness of the different parts. In some implementations, the first and second arms 114, 116 are more stiff than the lateral connector 124. In this respect, the lateral connector 124 may include a support structure embedded therein to provide the required stiffness. In some embodiments, hinges (not shown) may be provided between the first and second arms 114, 116 and the lateral connector 124, in which case the first and second arms 114, 116 may be less stiff than the lateral connector. In some embodiments, a stiffness of the end connector 122 may be configured so that it provides a required stiffness in the lateral connector 124.

[0084] In use, the pessary 100 may be positioned with the first and second distal ends 118, 120 of the first and second arms 114, 116 pointing towards the user’s cervix / uterus. Depending on the rotational orientation of the pessary 100 in the vaginal canal, the lateral connector 124 will be in contact with the anterior / posterior portion of the walls of the vaginal canal, or the lateral walls when viewed from a transverse cross-section.

[0085] The pessary 100 may be tailored to the user in terms of size, such that the lateral connector 124 applies pressure to the lateral walls of the vaginal canal (e.g. anterior or posterior) when it is in the rest configuration. Furthermore, the length 106 can be sized to mitigate a risk of rotation in the vaginal canal, depending on the length of the vaginal canal of the user. In some embodiments, the length 106 is configured to be about 50-90% of the Total Vaginal Length of the user. A radius of the arcuate end connector 122 can be sized and shaped to customize it to a width of the vaginal canal of the user. A radius of the lateral connector 124 can be sized and shaped to customize the lateral and / or perimetral expansion. The pessary 100 may also be customized to fine-tune an expansion to force ratio depending on the user’s anatomy and needs. For example, a cross-sectional surface area (e.g. height or width) of one or more of the first and second arms 114, 116, the end connector 122 and the lateral connector 124 can be tailored to adapt the expansion to force ratio.

[0086] As alluded to earlier, the pessary 100 is configured to be modulated in size and shape reactive to applied force. In this respect, before describing the expanded and compacted configurations of the pessary 100 in detail, it is useful to define a first end width 126 which is a distance between the first and second arms 114, 116 at the first end 110, and a second end width 128 which is a distance between the first and second arms 114, 116 at the position 125 where the first and second arms 114, 116 meet the end connector 122. The position 125 is taken as an arbitrary measure point which is spaced from the first end 110 towards the second end 112. Other reference points are possible. In certain other implementations, the first end width 126 is defined by a distance between the first and second distal ends 118, 120. In the embodiment depicted, the length 106 of the pessary body 102 is greater than one or both of the first end width 126 and the second end width 128. In other embodiments, not depicted, the length 106 of the pessary body 102 may be the same as, or less than, the one or both of the first end width 126 and the second end width 128.

[0087] The dynamic configuration of the pessary 100 is a function of the location and magnitude of the applied force on the pessary body 102. In the rest configuration, as illustrated in Figures 1 to 4, the width 108 is constant along the first and second arms 114, 116: the width 108, the first end width 126 and the second end width 128 are the same. In other implementations (not shown), the rest configuration may differ, for example, the first and second arms 114, 116 may be angled and have a varying width along the longitudinal axis 104 in the rest configuration.

[0088] Figures 5 and 6 illustrate a front view and a top view, respectively, of the pessary 100, in the expanded configuration, when force is applied on one or both of the concave elements124a, 124b. As an example, an axis and direction of applied force is indicated by the arrows A in Figure 6, although it will be appreciated that the direction and magnitude of the applied force on one or both of the concave elements 124a, 124b may differ from that illustrated.

[0089] As a result of the applied force on one or both of the concave elements 124a, 124b, they are caused to deform, the arcuate configuration flattening and moving closer together. In turn, this causes the first and second distal ends 118, 120 to move away from each other (bilateral expansion) and the first end width 126 to increase. A shortening is seen along the axis of the applied force, in this case a depth axis, and a lengthening along another axis, in this case a width axis. In other words, applied force along one lateral axis causes expansion along another, different, lateral axis. The axes may be substantially perpendicular to one another. As a result of the application of the force on the lateral connector 124, a nominal increase may also occur in the second end width 128. However, the first end width 126 will extend more than the second end width 128 in a splaying action. In other words, when the depth 109 is caused to decrease from the applied force, the first end width 126 is caused to increase, the increase of the first end width 126 being more than an expansion, if any, of the second end width 128. A perimeter of the pessary 100 may also thus be caused to increase.

[0090] In the expanded configuration, the first and second arm longitudinal axes 115, 117 are not parallel to the longitudinal axis 104 of the pessary body 102, but are angled away from the longitudinal axis 104 at the first end 110. In implementations in which the first and second arm longitudinal axes 115, 117 are angled in the rest configuration, the angle may be increased in the expanded configuration.

[0091] In use, when the pessary is disposed in the vaginal canal with the first end 110 supporting the uterus, during movement of the user or events such as coughing, sneezing, hiccupping, exercise etc., the applied pressure by the walls of the vaginal canal is at least one of an applied anterior pressure and an applied posterior pressure. By virtue of the first and second distal ends 118, 120 flaring outwardly (i.e. the width increasing), an anchoring effect may thus be achieved when the pessary 100 is disposed in the vaginal canal.

[0092] Alternatively, if pressure is applied to the first and second arms, the applying the pressure to the first and / or second arms causes the first and second arms to come together and causes one or both of the concave elements to move further apart (i.e. for the depth to increase).

[0093] The pessary 100 can be considered to be temporarily and dynamically “oversized” laterally.

[0094] If the pessary 100 is inserted in the vaginal canal with the end connector 122 at the top and supporting the uterus, pressure exerted downwardly from the uterus to the end connector 122 causes the first and second arms 114, 116 to move further apart, increasing the first end width 126. In such implementations, decreasing the length 106 of the pessary from applied force to the second end 112, also causes an increase in the second end width 128. Lateral force to the pessary 100, will again cause a widening laterally along a different lateral axis than the applied lateral force.

[0095] Figures 7 and 8 illustrate a side view and a top view, respectively, of the pessary 100 in the compacted configuration, when force is applied to the first and second arms 114, 116. As an example, an axis and direction of applied force is indicated by the arrows B in Figure 8, although it will be appreciated that the direction and magnitude of the applied force on one or both of the first and second arms 114, 116 may differ from that illustrated.

[0096] As a result of the applied force on one or both of the first and second arms 114, 116, the first and second distal ends 118, 120 are caused to move closer together. This causes the width 108 to decrease. Both the first end width 126 and the second end width 128 decrease. The first end width 126 in the compacted configuration is less than the first end width 126 in the rest configuration and in the expanded configuration. The depth 109 also decreases as the concave elements 124a, 124b are caused to nest against each other and bulge in the same direction. This configuration is referred to as the compacted configuration because an overall footprint of the pessary 100 is reduced, specifically the width 108 and depth 106. It can be considered as a folding of the pessary 100 along the longitudinal axis 104. In use, the compacted configuration of the pessary 100 can facilitate insertion and / or removal of the pessary 100 into and out of the vaginal canal.Second and third embodiments

[0097] Turning now to Figures 9-18, there is shown a second embodiment of the pessary: pessary 200. The pessary 200 is depicted in the rest configuration in Figures 9 to 14, in the expanded configuration in Figures 15 and 16 and in the compacted configuration in Figures 17 and 18.

[0098] The pessary 200 comprises a pessary body 202. The pessary body 202 is generally elongate and has a longitudinal axis 204. The pessary body has a length 206, a width 208 and a depth 209. The length 206 is at least as long as the width 208 and / or the depth 209. In certain implementations, the length 206 is larger than the width 208 and / or the depth 209. Developers have discovered that this may reduce or avoid a rotation of the pessary 200 when it is disposed in the vaginal canal.

[0099] The pessary body 202 has a first end 210 and a second end 212. A distance between the first and second ends 210, 212 defines the length 206. When the pessary 200 is disposed in the user’s vaginal canal with the orientation as depicted, the first end 210 is a top end and the second end 212 is a bottom end. In such an orientation, the first end 210 of the pessary body 202 is configured to support the uterus of the user when the pessary 200 is disposed in an upper portion of the vaginal canal. The pessary body 202 can also be oriented the other way such that the first end 210 is a bottom end and the second end 212 is a top end.

[0100] The pessary body 202 comprises a first body portion 214 and a second body portion 216. Each of the first and second body portions 214, 216 extend between the first and second ends 210, 212. The first and second body portions 214, 216 are disposed laterally to each other and spaced from one another. In this embodiment, the first and second portions 214, 216 comprise a first cell 214 and a second cell 216, respectively.

[0101] Each of the first and second cells 214, 216 is hollow and elongate. The first and second cells 214, 216 have a first cell longitudinal axis 215 and a second cell longitudinal axis 217, respectively. The first and second cell longitudinal axes 215, 217 are angled with respect to one another, and different to the longitudinal axis 204.

[0102] The first cell 214 has a first distal end 218 at the first end 210 of the pessary body 202. The second cell 216 has a second distal end 220 at the first end 210 of the pessary body 202. The first and second distal ends 218, 220 are open ends of the first and second cells 214, 216, respectively. The first cell 214 at the first distal end 218 may be reinforced. The second cell 216 at the second distal end 220 may be reinforced.

[0103] A transverse cross-sectional shape of the first and second cells 214, 216 is polygonal. As depicted, the transverse cross-sectional shape has six sides si, s2, s3, s4, s5, s6 separated by vertices vl, v2, v3, v4, v5, v6. The sides are of unequal length. Specifically, sides si, s2 are the same length as each other, sides s3, s6 are the same length as each other anddifferent to sides si, s2, and s4, s5 are the same length as each other and different to the other sides. The sides si, s2 are adjacent to one another and longer than the other sides s3, s4, s5, s6. A vertex vl between the sides si, s2 of the first cell 214 is axially aligned with the vertex vl of the sides si, s2 of the second cell 216. The vertices are rounded. In other embodiments (not shown), the transverse cross-sectional shape has any number of sides such as one side, two sides, three sides, four sides, five sides, seven sides, eight sides, nine sides or ten sides. In other embodiments (not shown), all of the sides may be equally dimensioned. In some embodiments, the transverse cross-sectional shape may be circular or oval.

[0104] As best seen in Figures 12 and 14, the width 208 is defined as a span of the first and second cells 214, 216. As depicted, the width 208 is a distance between vertex vl of the first cell 214 and the vertex vl of the second cell 216. In some embodiments, the width 208 at the first end 210 may be different than the width at the second end 212. In this respect, the pessary body 202 has a first end width 226 at the first end 210 and a second end width 228 at the second end 212. In the rest configuration, the first end width 226 is larger than the second end width 228. The length 206 of the pessary body 102 is greater than each of the first end width 226 and the second end width 228.

[0105] The depth 209 is defined as a largest distance in a direction transverse to the width 208. As best seen in Figure 14, the depth 209 is a distance between vertices v2 and v6. It will be appreciated that the definitions of the width 208 and the depth 209 may be reversed.

[0106] In terms of overall shape, each of the first and second cells 214, 216 is wider at the first end 210 than at the second end 212. In other words, each of the first and second cells 214, 216 is funnel-like or tapered. As best seen in Figures 9, 12, 13, 15 and 17, a wall 222 of the first cell 214 bulges outwardly between the first and second ends 210, 212, and a wall 223 of the first cell 214 bulges outwardly between the first and second ends 210, 212. In other words, the walls 222, 223 have a convex configuration.

[0107] A different embodiment of the pessary 200 of Figures 9 to 18 is shown in Figures 19 to 21 (referred to herein as a “third embodiment”). The pessary 300 of Figures 18 to 20 differs from the pessary 200 in that walls 322, 323 of first and second cells 314, 316 are concave instead of convex.

[0108] Going back to the description of the pessary 200 of Figures 9 to 18, there is further provided a lateral connector 224 that extends laterally between the first and second cells 214,216, and connects the first and second cells 214, 216. As best seen in Figures 9 and 12, the lateral connector 224 extends from the second end 212 substantially to the first end 210. In other embodiments (not shown), the lateral connector 224 may be disposed only partially along the longitudinal axis 204. In some embodiments, there may be provided a plurality of lateral connectors 224 disposed along the longitudinal axis 204.

[0109] Ribs 230 are provided on an inner face 232 of the wall 222 of the first cell 214 and / or the second cell 216. In some embodiments, the ribs are provided on sides si, s2. These can help to maintain an integrity of the sides si, s2 of each of the first and second cells 214, 216 and avoid folding along their length. In other implementations, instead of ribs 230, other reinforcing structures are provided. In yet other implementations, no reinforcing structures are provided.

[0110] Extension members 234 are provided which serve to extend at least one of the sides of the first cell 214 and the second cell 216 and to close a gap therebetween. Specifically, extension members 234 are provided on sides s6, s6 of the first and second cells 214, 216. The extension members 234 extend longitudinally.

[0111] Together, the first cell 214, the second cell 216, and the lateral connector 124 define the pessary body 102 that is hollow and porous, permitting fluid flow therethrough. The pessary body 102 is also foldable in a manner that will be described relative to the compacted configuration.

[0112] One or more of the first cell 214, the second cell 216, and the lateral connector 224 may be made of a resilient material. The resiliency properties may be the same or different to one another. This can be achieved by using different materials for the different parts of the pessary, and / or by modulating a thickness of the different parts. In some implementations, the first and second cells 214, 216 are less resilient than the lateral connector 224.

[0113] In use, the pessary 200 may be positioned with the first and second distal ends 218, 220 of the first and second cells 214, 216 pointing towards the user’s cervix / uterus. Depending on the rotational orientation of the pessary 200 in the vaginal canal, the walls 222, 232 will be in contact with the lateral walls of the vaginal canal, such as the anterior / posterior portion of the walls of the vaginal canal.

[0114] The pessary 200 may be tailored in terms of size to the vaginal canal of the user such that the lateral connector 224 applies pressure to the anterior / posterior portion of the wallsof the vaginal canal, or the lateral walls when it is in the rest configuration. Furthermore, the length of the first and second cells 214, 216 can be sized and shaped to mitigate a risk of rotation in the vaginal canal, depending on the length of the vaginal canal of the user. The first end width 226 and the depth 209 can be sized to customize it to a width of the vaginal canal of the user. The pessary 200 may also be customized to fine-tune an expansion to force ratio depending on the user’s anatomy and needs. For example, a cross-sectional surface area (e.g. height or width) of one or more of the first and second cells 214, 216, and the lateral connector 124 can be tailored to adapt the expansion to force ratio.

[0115] As alluded to earlier, the pessary 100 is configured to be modulated in size and shape reactive to applied force. The pessary body 202 is configured such that applying pressure along the second axis which is a lateral axis causes a modulation in the first end width along the first axis, different to the second axis, and wherein the modulation in the first end width is more than a modulation in the second end width. The modulation in the first end width may comprise shortening along the second axis and lengthening along the second axis.

[0116] The dynamic configuration of the pessary 200 is a function of the location and magnitude of the applied force on the pessary body 202. Figures 15 and 16 illustrate a front view and a top view, respectively, of the pessary 200, in the expanded configuration, when force is applied on the first and second cells 214, 216. As an example, an axis and direction of applied force is indicated by the arrows A in Figure 16, although it will be appreciated that the direction and magnitude of the applied force on one or both of the first and second cells 214, 216 may differ from that illustrated. For example, the force may be applied to the extension members 230. The ribs 230 may be stiffer than the material of the first and second cells 214, 216.

[0117] As a result of the applied force A, the first and second cells 214, 216 are caused to deform, becoming more flat, oppositely facing sides coming closer together (such as sides si, s2 coming closer together, sides s3, s6 coming closer together, and sides s4, s5 coming closer together). This causes a decrease in the depth 206. In turn, this causes the vertices vl, vl of the first and second cells 214, 216 to move away from each other (bi-lateral expansion) and the first end width 226 to increase.

[0118] A shortening is seen along the axis of the applied force, in this case a depth axis, and a lengthening along another axis, in this case a width axis. The axes may be substantially perpendicular to one another. A nominal increase may also occur in the second end width 228.However, the first end width 226 will extend more than the second end width 228 in a splaying action. In other words, when the depth 209 is caused to decrease from the applied force, the first end width 126 is caused to increase, the increase of the first end width 226 being more than an expansion, if any, of the second end width 228. The extension members 234 of the respective first and second cells 214, 216 are also caused to move away from each other. A perimeter of the pessary 200 may also thus be caused to increase.

[0119] In the expanded configuration, an angle between the first and second cell longitudinal axes 215, 217 is greater than the angle in the rest configuration.

[0120] In use, when the pessary 200 is disposed in the vaginal canal with the first end 210 supporting the uterus, during movement of the user or events such as coughing, sneezing, hiccupping, exercise etc., the applied pressure by the walls of the vaginal canal is at least one of an applied anterior pressure and an applied posterior pressure. By virtue of the first and second distal ends 218, 220 flaring outwardly, an anchoring effect may thus be achieved when the pessary 200 is disposed in the vaginal canal. The pessary 200 can be considered to be temporarily and dynamically “oversized” laterally.

[0121] If the pessary 200 is inserted in the vaginal canal the other way round (with the second end 212 at the top and supporting the uterus), the same effect is observed, with the first and second cells 214, 216 moving further apart reactive to applied lateral pressure, increasing the first end width 226.

[0122] Figures 17 and 18 illustrate a side view and a top view, respectively, of the pessary 200 in the compacted configuration, when force is applied to the first and second cells 214, 216 at the vertices vl, vl. As an example, an axis and direction of applied force is indicated by the arrows B in Figure 17, although it will be appreciated that the direction and magnitude of the applied force on one or both of the first and cells 214, 216 may differ from that illustrated.

[0123] As a result of the applied force B on one or both of the first and second cells 214, 216, the vertices vl, v2 are caused to move closer together. Sides s2, s3 move closer together, as well as sides si, s6, and s4, s5. This causes the first end width 226 to decrease. A modulation of the first end width 226 from the rest configuration to the compacted configuration is more than a modulation of the second end width 228 from the rest configuration to the expanded configuration. The depth 209 increases. In the compacted configuration, the first and second cells 214, 216 may touch one another, whereas in the rest configuration, they are spaced fromone another. In use, the compacted configuration of the pessary 100 can facilitate insertion and / or removal of the pessary 100 into and out of the vaginal canal.Fourth embodiment

[0124] Turning now to Figures 22 to 31, there is shown a fourth implementation of the pessary: pessary 400. The pessary 400 is depicted in the rest configuration in Figures 22 to 27, in the expanded configuration in Figures 28 and 29 and in the compacted configuration in Figures 30 and 31.

[0125] Similar to the pessary 100, 200, the pessary 400 has a pessary body 402 which is generally elongate and has a longitudinal axis 404 (Figure 24). The pessary body 402 has a length 406, a width 408 and a depth 409 (Figures 23 and 25). In certain embodiments, the dimension of the length 406 is at least the same if not larger than the width 408 and / or the depth 409. In certain embodiments, the length 406 is larger than the width 408 and / or the depth 409. In other embodiments, the length 406 is smaller than the width 408 and / or the depth 409. Developers have discovered that this may reduce or avoid a rotation of the pessary 400 when it is disposed in the vaginal canal. The length 406 may be about 50-90% of the length of the total vaginal length.

[0126] The pessary body 402 has a first end 410 and a second end 412. A distance between the first and second ends 410, 412 defines the length 106. When the pessary 400 is disposed in the user’s vaginal canal with the orientation as depicted, the first end 410 is a top end and the second end 412 is a bottom end. In such an orientation, the first end 410 of the pessary body 402 is configured to support the uterus of the user when the pessary 400 is disposed in an upper portion of the vaginal canal. The pessary body 402 can also be oriented the other way such that the first end 410 is a bottom end and the second end 412 is a top end.

[0127] At least a portion of the pessary body 402 is configured to house fluid, such as gas or liquid. In certain embodiments, a volume of the fluid housed in the pessary body 402 can be modulated by inflation or deflation. The pessary body 402 comprises a first body portion 414 and a second body portion 416. Each of the first and second body portions 414, 416 extend between the first and second ends 410, 412.

[0128] The first portion 414 is a sleeve 414 and the second portion is an expandable body 416 housed within the sleeve 414, in the rest configuration. The sleeve 414 covers a portion ofthe expandable body 416 in the rest configuration, leaving other portions uncovered. The expandable body 416 houses the fluid in sealable manner. The sleeve 414 is configured to selectively restrict expansion of the expandable body 416 in part (the parts that the sleeve covers) and to selectively permit expansion of the expandable body 416 in part (the parts that the sleeve does not cover). Together, the first and second portions 414, 416 permit selective modulation of the width 408 and / or the depth 409 responsive to lateral force being applied to the pessary body 402.

[0129] The expandable body 416 is composed of an elastic material permitting expansion, like a balloon, while the sleeve 414 is composed of a flexible material which is malleable permitting insertion into the vaginal canal, but being less elastic than the expandable body 416. The sleeve 414 may also be made of a non-elastic material. Parts of the sleeve 414 that cover the expandable body 416 define restricted portions of the pessary body 402 that will expand less than non-restricted portions.

[0130] As best seen in Figure 24, the expandable body 416 has a substantially pear-shape outer configuration when in the rest configuration. In this respect, the rest configuration can be defined as when the inflatable body 416 contains fluid therein but there is not yet enough pressure inside to stretch the material. It retains its unexpanded, molded shape. The width 408 and breadth 408 increase from the second end 412 towards the first end 410, and narrow again at the first end 410.

[0131] The sleeve 414 has a shape which substantially conforms to the outer configuration of the expandable body 416. The width at the widest portion of the pessary body 402 is referred to herein as first end width 426, and the width at the second end 412 is referred to herein as second end width 426. The first end width 426 can be referred to as a lateral span of the wider of the sleeve 414 and / or the expandable body 416 at or near the first end 410. The second end width 428 can be referred to as a lateral span of the wider of the sleeve 414 and / or the expandable body 416 at the second end 412. It will be appreciated that in other embodiments, the shape of the expandable body 416 and the sleeve 416 may differ from that described and depicted herein.

[0132] In the rest configuration, at least a portion of the sleeve 414 is in contact with at least a portion of the expandable body 416 such that a lateral force applied to the sleeve 414 is transferred to the expandable body 416 beneath. The sleeve 416 has a wall 422 which isdiscontinuous: two openings 424 are defined in the sleeve 416. Thus, each opening 424 defines an unrestricted portion of the pessary body 402 which can expand more than restricted portion(s). The openings 424 are oppositely facing and he on substantially the same plane as each other (width axis). It is contemplated that the number of defined openings and positions of said openings may vary in various embodiments. For example, in some embodiments, the sleeve 416 may define a single opening. In another embodiment, the sleeve 416 may define three openings with two opposite from one another and a third positioned in between. In a further embodiment, the sleeve 416 may define four openings.

[0133] When force is applied to the sleeve 414, the force is transferred to the expandable body 416 body such that another portion of the expandable body 416 bulges out of the openings 424 (expanded configuration shown in Figures 28 and 29). The sleeve 414 has a larger surface area than the expandable body 416 in the rest configuration, and a smaller surface area than the expandable body 416 in the expanded configuration.

[0134] The dynamic configuration of the pessary 400 is a function of the location and magnitude of the applied force on the pessary body 402. In the rest configuration, as illustrated in Figures 22 to 27, the first end width 426 is more than the second end width 428. After application of a force, such as a force having an axis and direction indicated by the arrows C in Figure 29, the first end width 426 increases whilst the second end width 428 does not increase. It will be appreciated that the direction and magnitude of the applied force may differ from that illustrated.

[0135] In use, when the pessary 400 is disposed in the vaginal canal with the first end 410 supporting the uterus, during movement of the user or events such as coughing, sneezing, hiccupping, exercise etc., the applied pressure by the walls of the vaginal canal is at least one of an applied anterior pressure and an applied posterior pressure. By virtue of the expansion of the expandable body 416 through the openings 424 of the sleeve 414, an anchoring effect may thus be achieved. The pessary 400 can be considered to be temporarily and dynamically “oversized” laterally.

[0136] In other embodiments, the opening 424 may be positioned at a top end of the pessary. Expansion from the top thus can help support stress urinary incontinence.

[0137] Figures 30 and 31 illustrate a side view and a top view, respectively, of the pessary 400 in the compacted configuration. The compacted configuration is achieved bydeflating the expandable body 416 and squeezing the sleeve 416. The width 408 and the depth 409 decreases. This configuration is referred to as the compacted configuration because an overall footprint of the pessary 400 is reduced. It can be considered as a folding of the pessary 400. In use, the compacted configuration of the pessary 100 can facilitate insertion and / or removal of the pessary 100 into and out of the vaginal canal.

[0138] It will be appreciated that in other embodiments, there may be more or less than the two openings 424 provided on the sleeve 414. The opening(s) 424 may be disposed in any suitable position to provide a desired expanded configuration.

[0139] Optionally, a drainage channel 430 extends longitudinally through the sleeve 414 and the expandable body 416 to allow for drainage of discharge or other fluids when the pessary 400 is positioned in the vaginal canal. The drainage channel 430 is aligned with the longitudinal axis 404. A transverse cross-section through the pessary 400 is donut-shaped. The sleeve 414 further defines drainage openings 432 at the first and second ends 410, 412. It is contemplated that, in alternative embodiments, the drainage channel 432 may be defined in other locations. It is further contemplated that, in other embodiments, the drainage channel 432 may be omitted.

[0140] The pessary 400 further includes a valve 434 in communication with the expandable body 416. The valve 434 allows for inflation of the expandable body 416 once positioned within the vagina and for deflation of the expandable body 416to facilitate removal of the pessary 400 from the vagina. The valve 434 is connectable to a pump (not shown) for pumping fluid into or withdrawing fluid out of the expandable body 416. The pump may be a manual pump or an automatic pump.

[0141] The valve 434 is positioned at the second end 412 of the pessary. In some embodiments, the valve 434 is configured to selectively extend away from and retract towards the inflatable body. Any suitable mechanism may be provided for enabling the extension / retraction such as one or more of: an accordion structure, a telescopic structure or a nipple valve. The pessary 400 may include a string connected to the valve 434 to facilitate extending the valve 434 away from the expandable body 416 in use. When the pessary 400 is positioned within the vagina, the valve may also be positioned within the vagina. A length of the string is selected such that a portion of the string extends out of the vagina to allow a user to grab onto the string. Pulling on the string extends the valve 434 away from the expandable body 416. In some instances, the valve 434 may be extendable such that, when fully extended, the valve 434 is positioned outside of the vagina. In some instances, releasing the string causes the valveto retract back towards the expandable body 416. The valve 434 may be retractable such that, when fully retracted, the valve 434 is seated within the expandable body 416.

[0142] In alternative embodiments, the valve 434 may be a self-sealing valve. In these embodiments, the pessary 400 may include a string for opening the valve 434. It is appreciated that, although the valve 434 is depicted on a lower portion of the pessary 400, the valve 434 may be positioned differently in other embodiments. It is contemplated that, in alternative embodiments, the valve may be omitted.

[0143] Together, the sleeve 414, the expandable body 416, the drainage channel 430 when present, and the valve 434 when present define the pessary body 402.

[0144] In use, the pessary 400 may be positioned with the first end 410 pointing towards the user’s cervix / uterus. Depending on the rotational orientation of the pessary 400 in the vaginal canal, the wall 422 of the sleeve 414 will be in contact with lateral walls (such as the anterior / posterior portion of the walls of the vaginal canal).

[0145] The pessary 400 may be tailored to the user in terms of size, such that the sleeve 416 applies pressure to the lateral walls of the vaginal canal (e.g. anterior or posterior) when it is in the rest configuration. Furthermore, the length 406 can be sized to mitigate a risk of rotation in the vaginal canal, depending on the length of the vaginal canal of the user. A radius of the expandable body 416 and the sleeve 414 can be sized and shaped to customize it to a width of the vaginal canal of the user. The pessary 400 may also be customized to fine-tune an expansion to force ratio depending on the user’s anatomy and needs.

[0146] In alternative embodiments, instead of the sleeve 414 and the expandable body 416, the first and second body portions 414, 416 may comprise a one piece expandable body which includes restricted portion (s) (first body portion 414) and unrestricted portions (second body portion 416) that may be due to at least one of, or a combination of, wall thicknesses, material composition, and / or the inclusion of internal wall structure.

[0147] In some embodiments, the restricted portion of the expandable body 416 may have a wall thickness that is greater than a wall thickness of the unrestricted portions. In some embodiments, the restricted portion may be composed of a material which has less elasticity than that of the unrestricted portion. In another instance, the restricted portion may include an internal wall structure. In some embodiments, the restricted portion may include an internal wall structure, such as a lattice structure or a mesh structure. In some cases, the internal structure maybe composed of the same material. In other cases, the internal structure may be composed of different materials. In one specific example, a mesh may be inserted into the wall of the inflatable body. This may be achieved by blow molding the mesh, such that the mesh becomes inserted into the wall of the insertable body. Alternatively, the mesh may be blow molded and dip coated for smoothing, hydro-dipped, or powder coated and ionized.

[0148] In some embodiments, the restricted portion and the unrestricted portion may each have separate internal wall structures. The internal wall structure of the restricted portion may be configured to limit expansion more than the internal wall structure of the unrestricted portion.

[0149] In some embodiments, any of the above embodiments of the inflatable body may comprise a sleeve housing the inflatable body.

[0150] It is contemplated that the inflatable body may include any number of restricted and unrestricted portions, and any one of or any combination of the configurations of restricted and unrestricted portions as described above may be implemented in a single pessary.General

[0151] Advantageously, in certain embodiment, any one of the pessaries 100, 200, 300, 400 has a design that is based on and / or fitted to the anatomical shape of the upper vagina. The pessary 100, 200, 300, 400 has a better fit to the anatomical shape of the vagina compared to current gynecological prosthetics, in part because its design and flexibility enable it to expand in certain directions responsive to applied lateral force. This is an improvement over conventional gynecological prosthetics that are not expandable and compactable and / or not dynamic responsive to lateral forces.

[0152] In some implementations, one or more of the pessary 100, 200, 300, 400 can be formed of one or more materials, including but not limited to various types of elastomers such as medical-grade silicone, flexible plastics such as Agilus 30, hard plastic, steel, metal alloys and biocompatible materials such as silicone, etc. Other implementations are possible.

[0153] In some implementations, the pessary 100, 200, 300, 400 has a silicone layer coating. The silicone layer coating can cover all surfaces of the pessary 100, 200, 300, 400. In other implementations, there is no silicone layer coating. In some implementations, there is no silicone layer coating when the pessary 100, 200, 300, 400 is directly 3D printed using silicone.In some implementations, the pessary 200 has a biocompatible coating other than silicone. In some implementations, the pessary 100, 200, 300, 400 is coated with one or multiple coatings including but not limited to anti-fungus / anti-infection drugs, hormones and ph-balancers, to prevent balance the vaginal acidity and prevent odor-causing bacteria, infections and / or extreme discharge, and / or pigments for aesthetic purposes because silicone is normally clear. In some implementations, the pessary 100, 200, 300, 400 is coated with hormonal drugs to help decrease failure rate of the pessary 100, 200, 300, 400 or can be used as a contraceptive method, letting patients have simultaneous therapies (i.e. hormonal therapy along with prosthetic therapy). Other coatings are possible. In other implementations, there is no such coating.

[0154] In some implementations, the pessary body 102, 202, 402 are configured to enable a vaginal discharge to pass through the pessary 100, 200, 300, 400. By enabling a vaginal discharge to pass through the pessary 100, 200, 300, 400, the pessary 100, 200, 300, 400 can be used during menstruation. However, alternative implementations are possible in which the pessary 100, 200, 300, 400 does not enable a vaginal discharge to pass through, such that the pessary 100, 200, 300, 400 might be removed for any menstruation.

[0155] In some implementations, the pessary 100, 200, 300, 400 has an installation feature (applicator) (not shown), for example a sleeve around the pessary 100, 200, 300, 400 to maintain the pessary in the compacted configuration, and which can be removed when the pessary is in position in the vagina to permit the pessary to resume the rest configuration. In some implementations, the applicator may include a tubular body for housing the pessary in the compacted configuration and a plunger for pushing the pessary out of the applicator and into the vaginal canal.

[0156] Also disclosed is a kit having any one or more of the pessaries 100, 200, 300, 400 as described and / or depicted herein, and the applicator as described and / or depicted herein.

[0157] In some implementations, the pessary 100, 200, 300, 400 is disposable. In some implementations, the pessary 100, 200, 300, 400 is biodegradable. In other implementations, the pessary 100, 200, 300, 400 is not disposable and can be re-used, for example up to two years or some other suitable time-frame. In some implementations, the pessary 100, 200, 300, 400 is multi-use and can be repeatedly removed and reinserted for up to 29 days or more for example.

[0158] In some implementations, one or more of the pessaries 100, 200, 300, 400 may be configured to take measurements from within the vaginal canal. The one or more of thepessaries 100, 200, 300, 400 may be provided with at least one sensor disposed on the pessary body 102, 202, 402.

[0159] Regarding the tailoring of dimensions of the pessary 100, 200, 300, 400 to the user, on or more of the following parameters may be taken into account: abdominal pressure; intra-vaginal pressure; pressure from pelvic floor muscles; atmospheric pressure; pressure from bladder towards vaginal canal; pressure from rectum towards vaginal canal; intra-abdominal pressure including both transvaginal and transrectal pressure; intravesical pressure; intra- abdominal pressure including transvaginal pressure; distance between ischial spines; distance between ischial spines and coccyx; distance between ischial spines and pubic symphysis; anterior fornix distance; posterior fornix distance; cervical size; cervical angle; gh (Genital Hiatus), TvL (Total Vaginal Length), Aa (Anterior Wall), (Ba) (Anterior Prolapse Degree), Ap (Posterior Wall), Bp (Posterior Prolapse Degree), Pb (Perineal Body), D (Posterior Fomix), C (Cervix / Cuff), BMI (Body Mass Index), IAP / BMI (Intra- Abdominal Pressure (both transvaginal and transrectal)), IVP / BMI (Intravesical Pressure), IAP / BMI (Intra-Abdominal Pressure (Transvaginal)), Distance Between Ischial Spines, Distance Between Ischial Spines and Coccyx, Distance Between Ischial Spines and Pubic Symphysis, Anterior Fomix Distance, Posterior Fomix Distance, Cervical Size, and Width of vaginal canal. Methods for custom designing the pessary, such as those described in PCT / CA2024 / 051454 fded November 1, 2024 and entitled “SYSTEMS AND METHODS FOR CUSTOM-DESIGNING A GYNECOLOGICAL PROSTHETIC”, are incorporated by reference in their entirety.

[0160] Any combination of the following parameters may be measured for the patient and provided to a computing device as part of a input data acquisition step: gh (Genital Hiatus), TvL (Total Vaginal Length), Aa (Anterior Wall), (Ba) (Anterior Prolapse Degree), Ap (Posterior Wall), Bp (Posterior Prolapse Degree), Pb (Perineal Body), D (Posterior Fomix), C (Cervix / Cuff), BMI (Body Mass Index), IAP / BMI (Intra- Abdominal Pressure (both transvaginal and transrectal)), IVP / BMI (Intravesical Pressure), IAP / BMI (Intra-Abdominal Pressure (Transvaginal)), Distance Between Ischial Spines, Distance Between Ischial Spines and Coccyx, Distance Between Ischial Spines and Pubic Symphysis, Anterior Fomix Distance, Posterior Fomix Distance, Cervical Size, and Width of vaginal canal.

[0161] Any one or more of the pessaries 100, 200, 300, 400 can be manufactured in any suitable manner, for example using 3D printing or by other manufacturing means. The pessary can be directly 3D printed, or a mold of its shape can be 3D printed and optionally coated. In some implementations, the pessary is manufactured using a medical -grade silicone and / or abiocompatible one or combination of multiple materials or to be molded and / or cast with the mentioned materials.

[0162] In some implementations, the pessary is 3D printed using PolyJet technology to combine at least two polymers in the pessary, and then the pessary is coated with a medical grade silicone or any other silicone based material. PolyJet technology is a 3D printing technology that can produce smooth, accurate parts, prototypes and tooling. With microscopic layer resolution and high accuracy, it can produce thin walls and complex geometries using a wide range of materials. In some implementations, the at least two polymers includes Agilus30 and Vero, which can be used to create flexible rubbers with varying and designed flexibility. Other polymers are possible. Note that this manufacturing method can be used to manufacture other gynecological prosthetics besides the pessaries 200, 300 and 400 that have been depicted and described herein. More generally, the manufacturing method can be used to manufacture any suitable pessary.

[0163] Other 3D printing methods that can be used, without limitation, include: fused deposition modeling (or fused filament fabrication), stereolithography, digital light processing, selective laser sintering.

[0164] In some alternative embodiments, a mold can be 3D printed and the pessary can be cast using a biocompatible material, such as medical-grade silicone. This method is often used in traditional pessary production.

[0165] Numerous modifications and variations of the present disclosure are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the disclosure may be practised otherwise than as specifically described herein.

Claims

CLAIMS1.A pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having a first end and a second end, the pessary body comprising: a first body portion and a second body portion; a first end width defined by a span of at least one or both of the first body portion and the second body portion, in a first lateral direction, at the first end; a second end width defined by a span of at least one or both of the first body portion and the second body portion in the first lateral direction, at the second end; wherein the pessary body is configured such that when pressure is applied to the pessary body in a second lateral direction, different to the first lateral direction, it causes the first end width to increase, and wherein the modulation in the first end width is more than any modulation in the second end width.

2. A pessary insertable into a vaginal canal of a user, the pessary comprising: a pessary body having first and second ends, the pessary body being elongate and having: a length defined by a distance between the first and second ends, a width defined by a span in a first lateral direction, and a depth defined by a span in a second lateral direction; wherein the length is at least as large as one or both of the width and the depth when the pessary is in a rest configuration; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction, it causes the width to increase.

3. A pessary insertable into a vaginal canal of a user, the pessary comprising a pessary body having first and second ends, the pessary body being elongate and having: a length defined by a distance between the first and second ends, wherein the length is about 50-90% of a total vaginal length of the user, a width defined by a span in a first lateral direction, and a depth defined by a span in a second lateral direction; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction, it causes the width to increase.

4. The pessary of claim 2 or 3, wherein the length is more than the width or more than the depth in a rest configuration of the pessary.

5. The pessary of any one of claims 2 to 4, the pessary body comprising: a first body portion and a second body portion; a first end width defined by a span of at least one or both of the first body portion and the second body portion, in the first lateral direction, at the first end; a second end width defined by a span of at least one or both of the first body portion and the second body portion in the first lateral direction, at the second end; wherein the pessary body is configured such that when pressure is applied to the pessary body in the second lateral direction it causes the first end width to increase, and wherein the modulation in the first end width is more than any modulation in the second end width.

6. The pessary of claim 1, wherein a length of the pessary body is greater than one or both of the first end width and the second end width in a rest configuration, or the length is smaller than or equal to the first end width and the second width.

7. The pessary of any one of claims 1-6, wherein when the pessary is disposed in the vaginal canal of the user with the first end supporting uterus, the applied pressure is at least one of an applied anterior pressure and an applied posterior pressure.

8. The pessary of any one of claims 1-7, wherein the first and second body portions are disposed laterally relative to each other and connected by a lateral connector.

9. The pessary of claim 8, wherein the first body portion comprises a first arm having a first distal end at the first end of the pessary body, the second body portion comprises a second arm having a second distal end at the first end of the pessary body, wherein the first end width is defined by a distance between the first and second distal ends, and the second end width is defined by a distance between the first and second arms.

10. The pessary of claim 9, wherein the lateral connector comprises oppositely facing concave elements connecting the first and second arms, wherein one or both of: applying the pressure to one or both of the concave elements to bring them closer together causes the first and second distal ends to move further apart; andapplying the pressure to the first and / or second arms causes the firs and second arms to come together and causes one or both of the concave elements to move further apart.

11. The pessary of claim 9 or claim 10, further comprising an end connector connecting the first and second arms at the second end.

12. The pessary of any one of claims 9-11, wherein one of the concave elements can be caused to nest in the other of the concave elements to reduce a depth of the pessary body.

13. The pessary of claim 8, wherein the first and second body portions comprise first and second elongate cells, respectively, the first and second elongate cells being laterally spaced and the first end width being defined by a span of the first and second cells at the first end and the second end width being defined by a span of the first and second cells at the second end.

14. The pessary of claim 13, wherein the first and second cells are tapered such that, in a rest configuration, the first end width is more than the second end width.

15. The pessary of claim 13 or claim 14, wherein applying the pressure on one or both of the first cell and the second cell in the second lateral direction causes the first end width to increase.

16. The pessary of any one of claims 13-15, wherein each of the first and second cells include at least one reinforcing member to avoid a longitudinal folding along a length of the first and second cell.

17. The pessary of any one of claims 1-7, wherein the second body portion is an expandable body and the first body portion is a sleeve in which the expandable body is received, the sleeve having at least one opening through which the expandable body can extend outwardly when pressure is applied to the pessary body.

18. The pessary of claim 17, wherein the first body portion limits the expansion of the expandable body other than through the at least one opening.

19. The pessary of claim 17 or claim 18, further comprising a drainage channel extending longitudinally through the first and second body portions.

20. The pessary of any one of claims 17 to 19, further comprising a valve communicatively coupled to the second body portion for controlling fluid flow therethrough.

21. The pessary of any one of claims 1-7, wherein the pessary body is expandable, the first body portion being a region on the pessary body which is less expandable than another region on the pessary body.

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