WO2025159727A1

WO2025159727A1 - Volumetric cross pessary

Info

Publication number: WO2025159727A1
Application number: PCT/UA2024/000020
Authority: WO
Inventors: Serhii Anatoliiovych SULTANOV; Artem Mykhailovych DOLZHENKO; Iryna Mykolaiivna KORNILOVSKA
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-01-22
Filing date: 2024-03-29
Publication date: 2025-07-31
Anticipated expiration: 2026-07-22

Abstract

The declared technical solution relates to medicine, namely, to medical devices that are inserted into the vagina to support organs, in particular, to correct prolapse of female pelvic organs. A shape of the pessary is formed by the intersection of two rings at right angles, where the points of intersection are diametrically opposite relative to the common center of symmetry of the specified rings.

Description

VOLUMETRIC CROSS PESSARY

The declared technical solution relates to medicine, namely, to medical devices that are inserted into the vagina to support organs, in particular, to correct prolapse of female pelvic organs.

A pessary according to document US2018296388 (Al) is known in the art, which has a collapsed state and an expanded state and is adapted to transition between these states. In the unfolded state, the pessary forms a three-dimensional structure that has a plurality of elastic arcs connected to each other. The device is inserted into the vagina in a folded state and unfolds. In some embodiments, the pessary is shaped like a ball/sphere, pear, box/cube/cube, ovoid, or the like. Throughout the specification, where "ball" is used, it can mean any conceivable three-dimensional shape suitable for prolapse correction. The disadvantage of the known solution is the complexity of the design, the impossibility of controlling the process of deployment of the pessary after placing it in the vagina. In addition, as a result of the forced deployment of the pessary, the patient may experience pain.

This problem is partially solved in the pessary according to document EA202290598.

A famous pessary urogynecological consists of two interconnected closed rings made of flexible elastic material.

The rings form a spatial body with a surface that surrounds it, approximately spherical or ovoid in shape. The axial circles of the rings are placed in different planes. Rings have outer diameters and inner diameters. Said rings have different outer diameters and different inner diameters. A ring with a smaller outer diameter is placed in a ring with a larger inner diameter and is rigidly connected to it in such a way that the rings have a single point of intersection of their axial circles.

However, the known technical solution, due to the unevenness of the three-dimensional figure formed by the pessary rings, causes inconvenience when it is installed in the vagina. In particular, inconvenience is manifested in the uneven distribution of elasticity in the pessary. A ring with a larger diameter has less elasticity than a ring with a smaller diameter. This causes unevenness of the elasticity applied by the pessary, which causes inconvenience both when installing the pessary and during its wearing.

The specified technical solution is accepted as the closest analogue. Common features of the claimed invention and the pessary known from document EA202290598 are the following: the Pessary Volumetric cross urogynecological, consists of two closed rings connected to each other with the formation of a spatial body, made of flexible elastic material.

Thus, there is a need for a pessary that provides installation and wear with minimal inconvenience.

The problem is solved due to the fact that the Pessary Volumetric cross urogynecological, consists of two closed rings connected together to form a spatial body, made of flexible elastic material, according to the technical decision, each closed ring has a center, an outer diameter, and an inner diameter, and the closed rings have a common center, the same outer diameter relative to the common center, and the same inner diameter relative to the common center, closed rings are located in planes that intersect at an angle, the value of which is close to the value of a right angle, in addition, each ring has a thickness, the value of which is the same for each of the rings, wherein the rings intersect each other twice in diametrically opposite places relative to the common center.

The invention provides that the spatial body has a spherical shape.

The technical result, which is achieved when implementing the disclosed solution, is to simplify the design of the pessary. This allows you to place it in the vagina and release it out comfortably, quickly and relatively painlessly.

Due to the more uniform distribution of stress caused by the shape of the pessary, the number of manipulations during its installation to be placed in the desired position is reduced.

Due to the simplicity and symmetry of the design of the pessary, its proper retention in the vagina after installation and the necessary support of the internal organs are ensured. The claimed invention is explained by the attached drawing, which serves as an explanation of the essence and is not intended to limit its implementation in other possible embodiments, which use the entire set of essential features given in the claims.

In Fig. shows the general view of the Pessary Volumetric cross urogynecological. As can be seen in the attached drawing, the shape of the pessary is formed by the intersection of two rings (or toruses) at right angles, where the points of intersection are diametrically opposite relative to the common center of symmetry of the specified torus.

The claimed pessary in the form shown in Fig. in the horizontal and profile projections forms a circle with a bridge across the diameter. In the frontal projection, the pessary is depicted as two perpendicular stripes. That is, the two rings that describe the pessary cross each other twice at an angle whose value is close to the value of a right angle. That is, the rings are crossed twice in diametrically opposite places relative to the common center.

In a three-dimensional presentation of the pessary, it should be clear by skilled person that it consists of two closed rings connected together to form a spatial body. Rings in this case should be understood as a torus-shaped volumetric body. Each ring is closed. The center of the rings is common and represents the center of symmetry of the pessary.

The rings have outer and inner diameters, which indicates that the rings are made of three-dimensional shapes, and the pessary itself is formed by the intersection of two torus at a right angle. The point of intersection can be described as the intersection of two cylindrical bodies, if we take the rings at the point of connection to be a cylindrical body.

The outer diameter is the same for two diametrically opposite points relative to the center of symmetry. That is, in the case of describing a sphere around the pessary, each point of the outer diameter would be located on the surface of this sphere. Therefore, we can say that the pessary as a spatial body has a spherical shape.

At the same time, the difference in the value of the size of the outer diameter and the inner diameter is a constant value, which indicates the same thickness of the rings.

In the implementation of the pessary, a flexible elastic material is used, which does not cause allergic reactions for most patients. In addition, the material must be chemically resistant to the flora of the vagina and medical drugs, the use of which is possible during the use of the pessary. This material can be, in particular, medical rubber, silicone, etc.

From the above description of the pessary, the following features of the claimed invention should be clear to a skilled person.

When installing the pessary, it is enough to squeeze it with your hand to give it an approximately oblong shape, where the ends of such an oblong shape are the places of the combination of rings pessary. However, it is permissible to compress the pessary in the places where the rings join to form an X-shaped volumetric figure for further introduction of the pessary into the vagina. The place of compression of the pessary should be determined based on how the correction or prevention of prolapse is expected, that is, how the pessary will perform its function. However, in any case, the elastic rings of the pessary will support the pelvic organs with uniform tension even with unforced displacement of the pessary after installation.

The applicant found that the claimed invention showed its best properties when used for its intended purpose, in particular, the percentage of patients who felt discomfort when the pessary was inserted was insignificant. Additional studies showed that the cause of pain in this group of patients was the presence of inflammatory processes.

The proposed pessary combines the advantages of filling pessaries (cubic, mushroomshaped), which can adjust all three types prolapse (centrocele, isthmocele and rectocele ), but does not have a 12-hour limit in continuous use. The pessary of the proposed form can be used continuously for up to 28 days. This reduces the need to visit a doctor, on the one hand, and removes the limitation of prolapse correction in elderly women who, for physical and/or mental reasons, cannot independently remove and install a pessary, enduring the 12-hour interval of its use.

The invention performed admirably as a means of correcting prolapse, as indicated by multiple surveys and a review of the control group. In particular, the results of the surveys noted the relief of well-being and the naturalness of movements during the use of the pessary. This indicates that the pessary has significant design advantages over prior art solutions. In view of the above, a skilled person will appreciate the design features and technical advantages of the claimed invention.

Claims

1. A pessary volumetric cross urogynecological, consists of two closed rings connected together to form a spatial body, made of flexible elastic material, wherein each closed ring has a center, an outer diameter, and an inner diameter, and the closed rings have a common center, the same outer diameter relative to the common center, and the same inner diameter relative to the common center, closed rings are located in planes that intersect at an angle, the value of which is close to the value of a right angle, in addition, each ring has a thickness, the value of which is the same for each of the rings, wherein the rings intersect each other twice in diametrically opposite places relative to the common center.

2. The pessary according to claim 1, wherein the spatial body has a spherical shape.