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WO2025151970A1 - Pessaires gynécologiques - Google Patents

Pessaires gynécologiques

Info

Publication number
WO2025151970A1
WO2025151970A1 PCT/CA2025/050079 CA2025050079W WO2025151970A1 WO 2025151970 A1 WO2025151970 A1 WO 2025151970A1 CA 2025050079 W CA2025050079 W CA 2025050079W WO 2025151970 A1 WO2025151970 A1 WO 2025151970A1
Authority
WO
WIPO (PCT)
Prior art keywords
pessary
width
body portion
lateral direction
pressure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CA2025/050079
Other languages
English (en)
Inventor
Negin ASHOURI
Mihnea GANGAL
Erfan FATEHI
Pooya SALEHI
Peter HYATT
Inara LALANI
Vincent CASTONGUAY-SIU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Femtherapeutics Inc
Original Assignee
Femtherapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Femtherapeutics Inc filed Critical Femtherapeutics Inc
Publication of WO2025151970A1 publication Critical patent/WO2025151970A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion

Definitions

  • a pessary insertable into a vaginal canal of a user 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.
  • a pessary insertable into a vaginal canal of a user 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.
  • 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.
  • 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.
  • 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.
  • the applied pressure is at least one of an applied anterior pressure and an applied posterior pressure.
  • 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
  • the first end width is defined by a distance between the first and second distal ends
  • the second end width is defined by a distance between the first and second arms.
  • the first and second distal ends are angled towards each other.
  • 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.
  • 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.
  • 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).
  • the pessary further comprises an end connector connecting the first and second arms at the second end.
  • 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.
  • the first and second arms are configured to be brought closer together in a compacted configuration of the pessary.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the pessary further comprises a drainage channel extending longitudinally through the first and second body portions.
  • 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.
  • 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
  • the second body portion may be composed of a second material, the second material having lower elasticity than the first material.
  • Figure 1 is a perspective view of a first embodiment of a pessary in a rest configuration, according to embodiments of the present technology.
  • Figure 2 is a top plan view of the pessary of Figure 1.
  • Figure 3 is a front view of the pessary of Figure 1;
  • Figure 4 is a side view of the pessary of Figure 1;
  • Figure 5 is the front view of the pessary of Figure 3, in the expanded configuration according to embodiments of the present technology.
  • Figure 6 is a top plan view of the pessary of Figure 5 in the expanded configuration.
  • Figure 7 is a side view of the pessary of Figure 4, in the compacted configuration according to embodiments of the present technology.
  • Figure 8 is a top plan view of the pessary of Figure 7 in the compacted configuration.
  • Figure 10 is a top plan view of the pessary of Figure 9.
  • Figure 12 is a front view of the pessary of Figure 9;
  • Figure 14 is a transverse cross-sectional view of the pessary of Figure 9;
  • Figure 15 is the front view of the pessary of Figure 12, in the expanded configuration according to embodiments of the present technology.
  • Figure 16 is a top plan view of the pessary of Figure 15 in the expanded configuration.
  • Figure 17 is a side view of the pessary of Figure 13 in the compacted configuration.
  • Figure 18 is a top plan view of the pessary of Figure 17 in the compacted configuration.
  • Figure 19 is a perspective view of a third embodiment of a pessary in a rest configuration, according to embodiments of the present technology.
  • Figure 20 is a front view of the pessary of Figure 19.
  • Figure 21 is a side view of the pessary of Figure 19.
  • Figure 22 is a perspective view of a fourth embodiment of a pessary in a rest configuration, according to embodiments of the present technology.
  • Figure 23 is a side view of the pessary of Figure 22.
  • Figure 24 is a cross-sectional view through the line D-D of the pessary of Figure
  • Figure 25 is a front view of the pessary of Figure 22.
  • Figure 26 is a top plan view of the pessary of Figure 22.
  • Figure 27 is a bottom plan view of the pessary of Figure 22.
  • Figure 28 is the front view of the pessary of Figure 25 in the expanded configuration.
  • Figure 29 is the top plan view of the pessary of Figure 26 in the expanded configuration.
  • Figure 30 is the side view of the pessary of Figure 23 in the compacted configuration.
  • 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.
  • 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.
  • 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.
  • the pessary when pressure is applied in one direction to the pessary, the pessary modulates in dimension along another, different, direction.
  • the pessary is configured to direct a lateral force to cause an increase in a spread of the pessary.
  • 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.
  • the pessary can thus change shape, between the rest and expanded configurations, responsive to changes in pressure on the pessary from lateral walls of the vaginal canal, such as when the user experiences a Valsalva maneuver or contractions, or otherwise laughs, coughs, sneezes, exercises, etc.
  • 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.
  • the pessary may have a reduced overall footprint or perimeter facilitating insertion into, and removal from, the vaginal canal.
  • FIG. 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.
  • 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.
  • 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.
  • a dimension of the length 106 is at least the same if not larger than the width 108 and/or the depth 109.
  • the length 106 is larger than the width 108 and/or the depth 109.
  • 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.
  • 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.
  • 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.
  • first and second arm longitudinal axes 115, 117 are parallel to the longitudinal axis 104 of the pessary body 102.
  • 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.
  • 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.
  • 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.
  • the lateral connector 124 may comprise a single circular band, instead of two concave elements 124a, 124b.
  • 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.
  • 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.
  • 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.
  • the first and second arms 114, 116 are more stiff than the lateral connector 124.
  • the lateral connector 124 may include a support structure embedded therein to provide the required stiffness.
  • hinges 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.
  • a stiffness of the end connector 122 may be configured so that it provides a required stiffness in the lateral connector 124.
  • 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.
  • 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.
  • 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.
  • 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.
  • the pessary 100 is configured to be modulated in size and shape reactive to applied force.
  • a first end width 126 which is a distance between the first and second arms 114, 116 at the first end 110
  • 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.
  • the first end width 126 is defined by a distance between the first and second distal ends 118, 120.
  • 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.
  • the concave elements 124a, 124b 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.
  • applied force along one lateral axis causes expansion along another, different, lateral axis.
  • the axes may be substantially perpendicular to one another.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first and second cells 214, 216 are less resilient than the lateral connector 224.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first end width 226 will extend more than the second end width 228 in a splaying action.
  • 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.
  • the applied pressure by the walls of the vaginal canal is at least one of an applied anterior pressure and an applied posterior pressure.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first and second cells 214, 216 may touch one another, whereas in the rest configuration, they are spaced from one another.
  • the compacted configuration of the pessary 100 can facilitate insertion and/or removal of the pessary 100 into and out of the vaginal canal.
  • pessary 400 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.
  • At least a portion of the pessary body 402 is configured to house fluid, such as gas or liquid.
  • 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.
  • 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.
  • 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.
  • the opening 424 may be positioned at a top end of the pessary. Expansion from the top thus can help support stress urinary incontinence.
  • the pessary 400 may be positioned with the first end 410 pointing towards the user’s cervix/uterus.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the pessary body 102, 202, 402 are configured to enable a vaginal discharge to pass through the pessary 100, 200, 300, 400.
  • the pessary 100, 200, 300, 400 can be used during menstruation.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 the pessaries 100, 200, 300, 400 may be provided with at least one sensor disposed on the pessary body 102, 202, 402.
  • 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 Genetic 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
  • 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
  • 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.
  • the pessary is manufactured using a medical -grade silicone and/or a biocompatible one or combination of multiple materials or to be molded and/or cast with the mentioned materials.
  • 3D printing methods that can be used, without limitation, include: fused deposition modeling (or fused filament fabrication), stereolithography, digital light processing, selective laser sintering.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un pessaire pouvant être inséré dans un canal vaginal d'une utilisatrice, le pessaire comprenant un corps de pessaire ayant des première et seconde extrémités, le corps de pessaire étant allongé et présentant : une longueur délimité par une distance entre les première et seconde extrémités, la longueur étant d'environ 50 à 90 % d'une longueur vaginale totale de l'utilisatrice, une largeur délimitée par une envergure dans une première direction latérale, et une profondeur délimitée par une envergure dans une seconde direction latérale ; le corps de pessaire étant conçu de telle sorte que, lorsqu'une pression est appliquée au corps de pessaire dans la seconde direction latérale, il amène la largeur à augmenter.
PCT/CA2025/050079 2024-01-21 2025-01-21 Pessaires gynécologiques Pending WO2025151970A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202463623298P 2024-01-21 2024-01-21
US63/623,298 2024-01-21
US202463571156P 2024-03-28 2024-03-28
US63/571,156 2024-03-28
US202463649004P 2024-05-17 2024-05-17
US63/649,004 2024-05-17

Publications (1)

Publication Number Publication Date
WO2025151970A1 true WO2025151970A1 (fr) 2025-07-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011116108A1 (fr) * 2010-03-16 2011-09-22 Pelvalon, Inc. Dispositif intravaginal pour l'incontinence fécale
CN102920529A (zh) * 2006-07-10 2013-02-13 麦克内尔-Ppc股份有限公司 治疗尿失禁的方法
US20140083433A1 (en) * 2012-09-24 2014-03-27 Suzanne Lee Lowry Inflatable multilevel vaginal pessary device
US20190282350A1 (en) * 2018-03-16 2019-09-19 Watkins-Conti Products, Inc. Intravaginal support devices and methods
US20200337889A1 (en) * 2019-04-26 2020-10-29 Wisconsin Alumni Research Foundation Compressible Vaginal Pessary for Treatment of Stress Urinary Incontinence
WO2022208081A1 (fr) * 2021-03-30 2022-10-06 Emm Technology Ltd Coupelle menstruelle
US20220331147A1 (en) * 2021-04-19 2022-10-20 Lyv Life Inc. DBA Cora Menstrual disc and methods of use

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102920529A (zh) * 2006-07-10 2013-02-13 麦克内尔-Ppc股份有限公司 治疗尿失禁的方法
WO2011116108A1 (fr) * 2010-03-16 2011-09-22 Pelvalon, Inc. Dispositif intravaginal pour l'incontinence fécale
US20140083433A1 (en) * 2012-09-24 2014-03-27 Suzanne Lee Lowry Inflatable multilevel vaginal pessary device
US20190282350A1 (en) * 2018-03-16 2019-09-19 Watkins-Conti Products, Inc. Intravaginal support devices and methods
US20200337889A1 (en) * 2019-04-26 2020-10-29 Wisconsin Alumni Research Foundation Compressible Vaginal Pessary for Treatment of Stress Urinary Incontinence
WO2022208081A1 (fr) * 2021-03-30 2022-10-06 Emm Technology Ltd Coupelle menstruelle
US20220331147A1 (en) * 2021-04-19 2022-10-20 Lyv Life Inc. DBA Cora Menstrual disc and methods of use

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