WO2014015975A1

WO2014015975A1 - Device for collecting a catamenial flow

Info

Publication number: WO2014015975A1
Application number: PCT/EP2013/002177
Authority: WO
Inventors: Sergio PITACCO; Giorgio Coretti
Original assignee: Pitacco Sergio; Giorgio Coretti
Priority date: 2012-07-24
Filing date: 2013-07-23
Publication date: 2014-01-30
Also published as: FR2993773A1; FR2993773B1

Abstract

A device for collecting a catamenial flow comprises a first deformable and substantially circular body (12) including two hollow portions (14, 20) and provided with an open end (16) adapted to be applied in a position adjacent to the uterine cervix, in its installed condition of use. The second portion (20) includes a cylindrical part (24) the diameter of which is substantially constant and smaller than that of the first portion (14), the outer surface of which is provided with an outer connecting formation (28). The device (10) comprises a second elongated body (36) substantially rigid and tubular, one end (40) of which is provided with a connecting formation (42) that can be engaged by the inner formation (28) of the first body (12), and is so shaped as to accommodate in it at least a predominant part of the second portion (20) of the first body (12) in the engaged condition of the connecting formations (28, 42) of the bodies (12, 36), to allow the first body (12) to be extracted from its installed condition of use.

Description

Device for collecting a catamenial flow

The present invention relates to devices for collecting a catamenial flow.

For this purpose, single-use sanitary napkins are commonly used, which however have the drawback that they constitute a considerable source of environmental pollution because their material, after use, can not be recovered or recycled. Moreover, single-use sanitary napkins may constitute a risk to the health of the user when used with poor hygienic precautions, and their use is relatively expensive because of the fact they can not be reused.

Reusable devices for collecting the catamenial flow are also common on the market, which are made of a non- absorbent material, typically of a flexible plastic material such as a thermoplastic rubber or silicone-based elastomer .

In particular, the invention relates to a device of the type defined in the preamble of appended claim 1.

A device of the type mentioned above is known, for example, from WO-2006/058 409, which includes an elongated hollow body having a substantially circular section, provided with an open end intended to be applied in a position adjacent to the uterine cervix in its installed condition of use. A cylindrical axial grasping appendage extends at the end of the hollow body opposite to its open end, which is intended to be grasped by a user through her fingers in order to remove the device from its installed condition, after use.

However, it may prove to be impractical or unpleasant to perform manually the operations of insertion and removal of the device, owing to the contact of the fingers of the user with the vagina, which could involve hygienical risks.

Also, devices intended to be placed close to the uterine cervix by tubular inserting means are known.

DE-589 643 discloses a pessary comprising two cup-shaped substantially rigid bodies, a ring of elastically deformable material being interposed between the peripheral edges of said cup-shaped bodies. The two bodies are mounted so as to be movable along a common axial direction one relative to the other, and are bound to each other by means of an elastic member intended to bring them close to each other so as to squash the deformable ring and expand it radially, in order that said deformable ring may constitute a sealing gasket. The pessary of this document is intended to be arranged close to the uterine cervix by means of a rod tool that comprises a device for temporary separating axially the two cup-shaped bodies, against the action of the elastic member, which tool includes a push rod one end of which that crosses a through hole formed in one of the two bodies, and engaging a seat formed in the other body at its side opposite to that intended to be arranged adjacent to the uterine cervix. In any case, this pessary is not intended nor suitable to allow collection of a catamenial flow .

US-7 165 550 concerns an equipment adapted to isolate the uterine cervix, for example with the aim of delivering a drug or collecting samples of cervical cells, which equipment includes a removable cup-shaped body provided with an axial through hole. The cup-shaped body can be introduced in the vagina by a tubular tool as far as it reaches the contact with the uterine cervix, through which a drug is delivered up to the cup body in order to allow the cervix to be reached. The equipment of this document is not intended nor suitable to allow a catamenial flow to be collected, at least because of its cup-shaped body is open to the outside owing to the presence of said through hole.

WO-2008/058 545 refers to a vaginal protection device the purpose of which is to constitute an abdominal protection, a contraceptive or a device for taking samples of cells. The device comprises a body of a deformable material that defines a substantially cup-shaped cavity and comprises a series of substantially radial sealing lips. The protection device can be placed in a position close to the uterine cervix by means of a rod-shaped insertion tool one end of which is fastened into a corresponding cavity of the body of the device, at its side opposite to its cup-shaped cavity. The device of this document is not intended nor suitable to allow a catamenial flow to be collected. The invention originates from the consideration that it would be useful for a user to have available a reusable device for collecting a catamenial flow that is convenient and practical to be used, and that can be inserted close to the uterine cervix and extracted, after use, without a direct contact of the finger with the vaginal cavity.

With the aim of reaching this object, the subject of the invention is a device of the type mentioned in the appended claims .

In particular, by virtue of the fact that the second portion of the first body includes a cylindrical part the diameter of which is substantially constant and smaller than the diameter of the first portion, the outer surface of said cylindrical part, close to the first hollow portion of the first body, being provided with at least one connecting formation projecting radially outwards, and of the fact that the device comprises a second elongate tubular body of a substantially rigid material, an axial end of which is provided with at least one connecting formation projecting radially inwards, that can be engaged by said connecting formation of the first body, such a second body being so shaped as to accommodate inside it at least a predominant part of said second portion of the first body in the mutually engaged condition of said connecting formations of the first and the second body, with the aim of allowing the first body to be extracted from its installed condition of use, the second portion of the first body being tapered between said cylindrical portion and said closed end, so that said closed end has a cross section smaller than the inner cavity of the second body so as to constitutes a guide portion for the centered insertion of the second portion of the first body into the second body upon their mutual coupling, before the engagement of said connecting formations of the first and the second body, it is possible to made a device for collecting a catamenial flow that is extremely practical in use, that can be removed easily after use and that turns out to be perfectly hygienic. Moreover, the structure of such a device is relatively simple, which allows to make it inexpensive to be manufactured.

According to a preferred feature of the invention, said connecting formations consist of corresponding threads. In this manner, the device of the invention is extremely effective and reliable, particularly during its removal step .

According to another preferred feature of the invention, the second body comprises another axial end, opposite to that provided with said at least one connecting formation, designed to accommodate inside it the first body in a contracted condition, generally folded, with the aim of allowing the first body to be inserted into its installed condition of use, the inner surface of said other axial end being substantially smooth in order to facilitate relative sliding of the first body with respect to the second body as well as the disengagement of such bodies after the first body has reached its installed condition of use. In this manner, the second body can be used also as an applicator of the first body, in order to facilitate insertion of the latter in its configuration of use.

Further characteristics and advantages of the invention will be more evident from the following detailed description, provided purely by way of non-limiting example and referred to the accompanying drawings in which:

Figure 1 is a side elevational view of a device according to the invention that comprises two bodies, which are arranged axially aligned in view of their coupling in order to position one of the two bodies in a condition for its use,

Figure 2 is a perspective view of the two bodies of Figure 1,

Figure 3 is a sectional view similar to that of Figure 1, in which the two bodies are coupled to each other before introduction of one of them in its condition of use,

Figure 4 is a perspective view of the two bodies of Figure 3,

Figure 5 is a front elevational view from arrow V of Figure 4,

Figure 6 is a perspective view of the two bodies of the device of Figures 1 to 5, in an axially aligned condition prior to their coupling in view of the extraction of one of them from its condition of use,

Figure 7 is a view similar to that of Figure 6, in which the two bodies are in their coupled condition of extraction,

Figure 8 is a sectional side elevational view of the two bodies in the condition of Figure 7,

Figures 9 and 10 are schematic side elevational and sectional views of two modifications of the device of the invention .

With initial reference to Figures 1 to 8, a device for collecting a catamenial flow according to the invention is indicated 10 as a whole.

The device 10 comprises a first elongated body 12 made of a deformable and non-absorbent material, such as as an easily flexible plastic material as a thermoplastic elastomer, for example a medical rubber or silicone-based material, the cross-section of the body 12 transverse to its general axis being substantially circular.

The body 12 includes a first wider hollow portion 14 having an open end 16, provided with an annular rounded sealing edge 18, and intended to be applied to the vagina of an user in a position adjacent to the uterine cervix, in its installed condition for use. This portion 14 of the body 12 is provided with a plurality of small transverse through holes 15 close to the edge 18, the purpose of which will be clarified below.

A second smaller hollow portion 20 provided with a closed end 22 at the side opposite to the open end 16, extends integrally from the portion 14 and delimits, together with the portion 14, a collection tank of the body 12.

In particular, the portion 20 comprises a cylindrical part 24 the diameter of which is substantially constant and essentially smaller than the diameter of the first portion 14, which part terminates, on the side opposite to the end 16, with a tapered, for example cone-shaped, portion 26, the central area of which corresponds to the closed end 22, and that, owing to its tapered shape, constitutes a guide portion of the first body 12, as will be clarified in the following .

A connecting formation, indicated 28, is integrally formed on an zone of the outer surface of the cylindrical portion 24 adjacent to the portion 14, which formation projects radially outwardly from the body 12 and preferably consists of a thread, as shown in the embodiment of Figures 1 to 8. The thread 28 is conveniently of the multi-start type, and preferably has a wave profile of the type known per se, called "Edison".

The thread 28 ends, on the side opposite to the portion 14, with a smooth cylindrical portion 28a, joined to the tapered portion 26 of the body 12.

The body 12 comprises a short button-shaped axial projection 30 at the closed end 22, which projection confers to the wall of such an end of the body 12, a greater thickness allowing the end 22 to be made substantially rigid and resistant against to an axial thrust applied to it from the outside. The projection 30 is preferably provided with a radially protruding edge 32, for the purposes that will be clarified in the following.

The device 10 also comprises a second elongated body 36 having a tubular shape, made of a substantially rigid material, for example of a thermoplastic material such as polyvinylidenefluoride (PVDF) or Teflon®. The opposite first and second axial ends 38 and 40, respectively, of the second body 36, are provided with respective rounded annular edges.

The first end 38 of the body 36 is defined by a tubular wall 41 the inner surface of which is substantially smooth and, preferably, slightly conical, so that it turns out to be divergent towards the end 38.

The second end 40 of the body 36 is defined by a cylindrical wall the inside diameter of which substantially corresponds to the outer diameter of the cylindrical part 24 of the portion 20 of the first body 12, that is greater than the diameter of the tapered portion 26. The inner surface of the wall of the body 36 adjacent to the second end 40, is provided with an integral connecting formation 42, that projects radially towards the inside of the body 36, and is made in an manner fully corresponding to the connecting formation 28 of the body 12, and intended to be engaged with it.

Reference means may be conveniently provided on the outer surface of the body 36 in order to make the two opposite ends 38 and 40 thereof immediately recognizable, at the sight and/or to the touch, from the outside of the body 36, for example implemented by signs or markings, such as axial ribs 44 formed at the connecting formation 42, and/or by differently colored parts.

The second body 36 is so shaped as to accommodate inside it at least a predominant part of the first body 12. In particular, when the body 12 is associated with the body 36 on the side of its first end 38 (Figures 1 to 5) , it is inserted almost completely within this end and kept in a configuration in which its open end 16 is partially folded or contracted, and in which the respective sealing edge 18 has a generally U-shaped configuration (Figures 4 and 5) so as to allow the body 12 to be easily inserted in its installed condition of use. Instead, when the body 12 is associated with the body 36 on the side of its second end 38 (Figures 7 and 8) with the respective connecting formations 28 and 42 mutually engaged, so as to allow extraction of the first body 12 from its installed condition of use, the body 36 houses inside it only a prevalent part of the body 12, that substantially corresponds to the portion 20 together with its closed end 22, while the portion 14 of the body 12 is arranged outside the second body 36.

In operation of the device 10, it is initially placed by a user in its condition of use, inside to the vagina, by using the body 36 as an applicator device for the body 12.

For this purpose, the body 12 is at first inserted axially through the first end 38 of the body 36, along the direction indicated by arrow A of Figures 1 and 2, until it is entirely arranged within this end, with the exception of its sealing edge 18. In this condition, the first portion 14 of the body 12 is deformed manually in order to contract it until its edge 18 reaches the aforementioned U-shaped configuration, and the body 12 remains firmly coupled to the second body 36.

As a result of the insertion of the unit constituted by the two bodies 12 and 36 in this configuration into the vagina, the edge 18 reaches a position close to the uterine cervix, and the user, by acting with one finger inside the cavity of the body 36, applies a small axial thrust on the body 12 through its axial projection 30, in order to facilitate sliding of the body 12 along the body 36, as well as its disengagement from it, without any need for a direct contact with the vagina. After the body 12 is released from the engagement with the body 36, the edge 18 reverts again to its undeformed circular configuration, so that it can adapt to the shape of the uterine cervix and fit to its outline so as to allow a radial seal to be achieve. The body 36 can then be extracted from the vagina, and separated from the body 12 that remains in its condition of use .

In order to remove the body 12 from its condition of use after the use thereof, the body 36 is used as an extractor device for the body 12, in a reverse configuration with respect to that of its insertion. For this purpose, the body 36 is inserted by the user into the vagina with its end 40 facing the body 12, according to the direction indicated by arrow B of Figure 6. The identification of the correct end to be introduced into the vagina in view of the removal of the body 12, is facilitated by said reference means .

As a result of the insertion of the body 36, the tapered portion 26 of the closed end 22 of the body 12 engages easily into the body cavity 36, by virtue of the fact that such a tapered portion 26 performs a function of a guide for insertion of the centered portion 20 into the body 36. The portion 20 of the body 12 can slide axially within the cavity of the body 36, again along the direction of arrow B, along a stroke the length of which corresponds to that of the smooth cylindrical portion 28a, until the ends of the connecting formations 28 and 42 reach a condition of mutual contact.

By rotating the body 36 relative to the body 12 in the direction shown by arrow C of Figure 6, which is favoured by the possible presence of the axial ribs 44, the two connecting formations 28 and 42 engage each other in order to make the bodies 12 and 36 fast to each other, as shown in Figures 7 and 8. Then, by applying a traction on the body 36, from the side of its end 38, the two bodies 12 and 36 can be extracted together, without the need for any direct contact of the fingers of the user with the vagina. A possible depression that might oppose the removal of the body 12 from its condition of use_. in contact with the uterine cervix, is drained through the small through holes 15 of the portion 14.

Even in the absence of the second body 36, the body 12 could be removed from its installed condition of use by grasping the radial edge 32 of the axial projection 30 of the closed end 22, by the fingers of the user.

The material constituting the bodies 12 and 36 allows them to be washed after use, and possibly sterilized, in view of a new use.

According to a modification of the invention schematically shown in Figure 9, in which the same reference numerals of the first embodiment have been used to indicate parts equal or similar to it, in the collection device, here indicated 10a, the connecting formations of the body 12 and of body 36, indicated 28a and 42a, respectively, are of the snap engagement grip type. In particular, and without prejudice to the other features of the device, that are similar or identical to those of the device 10, the body 12 has an integral connecting formation that projects radially outwardly from the body 12, that consists of a radial shoulder 28a having a transverse ratchet section intended to be engaged, as a result of its insertion into the end 40 of the body 36, by a series of elastic flaps 42a extending within the body 36, in order that the mutual engagement of the bodies 12 and 36 is achieved when the body 12 has to be removed from its installed condition of use.

According to another modification schematically shown in Figure 10, the collection device, here indicated 10b, comprises an appendage 24b that extends axially from the first body 12, at its side opposite to the open end 16, which is provided with a thread or a helical formation 28b intended to be engaged into a correspondingly shaped seat 42b formed inside the second body, here indicated 36b, having a substantially cup-shaped shape with an open end 40 facing the body 12.

Claims

1. Device for collecting a catamenial flow, comprising a first elongated body (12) having a substantially circular cross section, that is made of a deformable material such as an elastomeric material, and including a first hollow portion (14) having an open end (16) intended to be applied in a position adjacent to the uterine cervix in its installed condition of use, and a second hollow portion (20) connected to said first portion (14), having a closed end (22) at the side opposite to said open end (16), in order to delimit a collection tank of the first body (12), characterized in that said second portion (20) of the first body (12) includes a cylindrical part (24) the diameter of which is substantially constant and smaller than the diameter of said first portion (14), the outer surface of said cylindrical part (24), close to the first hollow portion (14) of the first body (12), being provided with at least one connecting formation (28, 28a, 28b) projecting radially outwards, and in that the device (10, 10a; 10b) comprises a second elongate tubular body (36, 36a, 36b) of a substantially rigid material, an axial end (40) of which is provided with at least one connecting formation (42, 42a, 42b) projecting radially inwards, that can be engaged by said connecting formation (28, 28a, 28b) of the first body (12), such a second body (36, 36a, 36b) being so shaped as to accommodate inside it at least a predominant part of said second portion (20) of the first body (12) in the mutually engaged condition of said connecting formations (28, 42, 28a, 42a, 28b, 42b) of the first (12) and the second body (36, 36a, 36b), with the aim of allowing the first body (12) to be extracted from its installed condition of use, the second portion (20) of the first body (12) being tapered between said cylindrical portion (24) and said closed end (22), so that said closed end (22) has a cross section smaller than the inner cavity of the second body (36; 36a, 36b) so as to constitute a guide portion (26) for the centered insertion of the second portion (20) of the first body (12) into the second body (36, 36a, 36b) upon their mutual coupling, before the engagement of said connecting formations (28, 42, 28a, 42a, 28b, 42b) of the first (12) and the second body (36, 36a; 36b) .

2. Device according to claim 1, characterized in that said first (14) and said second portion (20) of the first body (12) are integral one to the other.

3. Device according to claim 1 or 2, characterized in that the second body (36, 36a, 36b) has a portion (41) the inner diameter of which substantially corresponds to the outer diameter of the cylindrical part (24) of the second portion (20) of the first body (12).

4. Device according to any one of claims 1 to 3, characterized in that said connecting formations (28, 42, 28b, 42b) consist of corresponding threads.

5. Device according to claim 4, characterized in that said threads (28, 42) are of the multi-start type.

6. Device according to claim 4 or 5, characterized in that the profile of said threads (28, 42, 28b, 42b) is of the Edison type.

7. Device according to any of claims 1 to 6, characterized in that the second body (36, 36a, 36b) comprises another axial end (38), opposite to that provided with said at least one connecting formation (42, 42a; 42b) , designed to accommodate inside it the first body (12) in a contracted condition, generally folded, with the aim of allowing the first body (12) to be inserted into its installed condition of use, the inner surface of said other axial end (38) being substantially smooth in order to facilitate relative sliding of the first body (12) with respect to the second body (36, 36a, 36b) as well as the disengagement of such bodies after the first body (12) has reached its installed condition of use.

8. Device according to claim 7, characterized in that the diameter of said other axial end (38) of the second body (36, 36a, 36b) is greater than that of its opposite axial end (40), the shape of the second body (36; 36a, 36b) being slightly conical, at least in the vicinity of said other end (38), in order to facilitate the disengagement of the first body (12) along the axial direction of the second body (36, 36a, 36b) .

9. Device according to claim 7 or 8, characterized in that the first body (12) is provided with an axial projection (30) at its closed end (22), adapted to stiffen such a closed end (22) so as to allow an axial thrust to be applied to it in order to facilitate the disengagement of the first body (12) from the second body (36, 36a, 36b) when the installed condition of use of the first body (12) has been reached.

10. Device according to claim 9, characterized in that said axial projection (32) has a radially projecting edge (32) to facilitate manual grasping of the first body (12) upon removal.

11. Device according to any of claims 1 to 10, characterized in that said first portion (14) of the first body (12) is provided with a plurality of small through holes (15) close to said open end (16), in order to facilitate the removal thereof from its installed condition of use.