WO2024180574A1

WO2024180574A1 - Device for the intravaginal administration of substances

Info

Publication number: WO2024180574A1
Application number: PCT/IT2024/050041
Authority: WO
Inventors: Gianluca GIUBILEI
Original assignee: Ghosty Srl
Current assignee: Ghosty Srl
Priority date: 2023-02-27
Filing date: 2024-02-22
Publication date: 2024-09-06
Anticipated expiration: 2025-08-27
Also published as: CN121038842A; IT202300003465A1

Abstract

A device (1) for the intravaginal administration of substances of the type comprising a containment body (2) for the substances to be administered and a first veil (3) connected to said containment body (2) and made of material suitable for conveying said substances towards corresponding portions of the human body with which the veil (3) comes into contact; the device (1) is provided with blocking means (4) of the substances dispensed to prevent the unwanted outflow of the same substances from the portions of the human body in which they are administered towards the outside.

Description

TITLE

Device for the intravaginal administration of substances .

DESCRIPTION

The present invention relates to a device for the intravaginal administration of substances .

As better described below, the device of the invention is particularly suitable for the intravaginal administration of drugs and/or other substances for therapeutic, preventive and/or cosmetic purposes . The means used to convey active ingredients of various types to the vaginal level are essentially made up of creams , douching and vaginal ovules .

A drawback of creams is related to the di f ficulty of application and the insuf ficient safety of the correct interaction of the active ingredient with the corresponding parts interested in its absorption or its delivery . Similar drawbacks are presented by vaginal douching, which, moreover, compared to creams , involves a less prolonged period of contact and interaction over time and, therefore , a relatively milder action for the same active ingredient conveyed .

As regards vaginal ovules , these can allow a more prolonged administration, but can be negatively influenced by the possibility of drainage towards the outside of the active ingredient together with the excipients associated with it ; in practice , the use of ovules is usually limited to the night hours precisely because of the possible losses caused by them .

The invention which is the subj ect of international patent application no . W02020008245A1 has strongly reduced the aforementioned drawbacks with a device for the intravaginal administration of substances capable of conveying the active ingredient in a safe and correctly usable way . The device described in W02020008245A1 includes a core defining the support structure of the device and an underlying veil which, being in continuity with the core , conveys the substances with which the inside of the core of the device is soaked .

The aim of the present invention is to eliminate the aforementioned drawbacks with a device for the intravaginal administration of substances capable of conveying the active ingredient in an even safer and more correctly usable way and which is not negatively influenced by the possibility of unwanted leaks of the substance to be delivered .

The device obj ect of the present invention also has a structure that allows for a relatively simple and reproducible construction even in large numbers thanks to the manufacturing and assembly methods .

This result was achieved through the idea of the solution which is the subj ect of the independent claim . Other characteristics are described in the dependent claims .

Among the advantages of the present invention the following can be listed :

- the device releases a drug or an active ingredient at the times and in the quantities most suitable for correct therapy, prevention and/or cosmetic use thanks to the presence of a first veil of biocompatible material which defines a di f fusion surface of the substance to be administered, a surface which interacts with the walls of the vagina, allowing a release of the substance over time with a propagation not achievable by means of the known art ;

- the device is provided with means for eliminating or at least substantially limiting the unwanted dispersion of the substances to be administered; these means designed to block unwanted dispersion can advantageously comprise a second "veil" which combines with the first to form a barrier which cannot be crossed by the substances released by the device ;

- the veil copies the internal surfaces determining a continuous contact developed over an extremely large surface ; the device allows the release into the vaginal environment of substances with soothing-antiinflammatory aim and purposes to alleviate the common discomfort , itching and disorders that characteri ze the pathologies of the vaginal cavity;

- the device has an adj uvant action in the treatment of the most common pathologies such as inflammation of the vaginal tract , through the gradual release of biologically tested substances , containing, for example , pharmacologically active principles such as antibiotics or anti fungals ;

- with the device it is possible to perfume the vaginal environment and neutrali ze unpleasant odours ; the device can assist post-menopausal hormone replacement therapy by promoting the administration of hormones topically vaginally, avoiding atrophic and dystrophic problems of the female genitals ;

- the device allows to easily regulate the di f fusion and leakage of the compound inside the " core" or containment body simply by acting on the variation in the diameter of the holes in the core and on the viscosity of the solution contained therein .

The advantages and features of the invention will be more evident from the following description which refers to the attached drawings , provided by way of example and not by way of limitation, in which :

- Fig . 1 is a schematic perspective view of a possible example of implementation of the invention;

Fig . 2 is a schematic exploded side view with sectional parts of the implementation example of Fig . 1 ;

- Fig . 3 is a schematic side view with sectional parts in which the device is mounted, the veils are only partially represented and the retrieval cord is not present ;

- the Figs . 4 and 5 are two exploded perspective views of the device , in which the veils are not shown and the cord is visible ;

- the Figs . 6 and 7 are , respectively, a side view and a front view of the mounted device , without the representation of the veils but with the cord visible ( only in the side view) ;

- Fig . 8 is a side view of the device during assembly, without the representation of the plies but with the cord;

- Fig . 9 schematically shows a possible configuration of a package containing the device in question;

Fig . 10 schematically shows another possible configuration of a package containing the device ; and

- Fig . 11 schematically shows a possible alternative form of embodiment of the connecting between a cannula and a connecting body .

With reference to the attached drawings which, as expressed, provide a possible example of embodiment which does not exclude other forms of embodiment of the invention, a device (1) for the intravaginal administration of substances is of the type comprising a containment body (2) for the substances to be administered and a first veil (3) which is connected to the containment body (2) and is made of material suitable for conveying the substances towards corresponding portions of the human body with which the veil (3) comes into contact.

Advantageously, the device (1) is provided with blocking means (4) of the dispensed substances to prevent the unwanted outflow towards the outside of the same substances from the portions of the human body in which they are administered.

In Fig. 2, the axis (x) indicates a direction of longitudinal development of the device (1) in question along which its component parts are arranged in the represented embodiment of the invention.

Starting from the right side of the drawing, the containment body (2) is visible and it is formed by a substantially ovoid hollow body, provided with a series of through holes (21) which allow the substances contained in the body (2) to escape from the body (2) itself. The term ovoid means egg-shaped, that is, similar to an oval tapered at one end. In its proximal end, the containment body (2) is provided with a hole (20) , for example circular, which defines a seat for the stable reception of a corresponding distal end (50) presented by a connecting body (5) .

The connecting body (5) has a substantially cylindrical shape, crossed by an internal channel (51) and provided with the distal end (50) which is formed by two elastically yielding parts (52) which are spaced apart so as to be inserted into the hole (20) presented by the containment body (2) . The external walls of the parts (52) are conveniently shaped to define a series of sections that guarantee a stable fit with the containment body (2) .

The containment body (2) can be made of plastic material, for example of the TPU-like flexible resin type .

The connecting body (5) can be made of biocompatible plastic material.

The first veil (3) is arranged between the containment body (2) and the connecting body (5) together with a second veil (4) which is placed to the left of the first in the drawing and defines the blocking means (4) for the dispensed substances.

In practice, the device (1) includes two veils: the first veil (3) which serves to spread the substances contained in the containment body (2) and the second veil (4) which prevents the unwanted external outflow of the same substances from the portions of the human body into which they are administered.

The two veils (3) and (4) can be made up of two circular sheets, with the first veil (3) having a radius (R3) smaller than the radius (R4) of the second veil (4) . In this way, when the device is arranged with the containment body (2) placed at the top as in the example of Fig.l, the second veil (4) protrudes below the first (3) forming a sort of barrier to retain the substances.

The first veil (3) may be made of a polymeric material biologically tested and compatible with vaginal tissues, capable of exchanging cosmetic, adjuvant or pharmaceutical substances with the vaginal environment even gradually and for a prolonged period of time.

The second veil (4) will also be made of biologically tested material but it will preferably have absorbent properties .

The first veil (3) can be made of a Silky thin latex type material, while the second veil (4) can be made of cellulose fibre. The two veils have numerous junction points between the adjacent surfaces made with variable adhesion methods based on the specifications of the final materials used.

Again with reference to Fig.2, to the left of the connecting body (5) there is a cannula (6) that can be used for positioning the device (1) in the vagina.

The cannula (6) acts as an applicator and its use is substantially similar to that described in international patent application no. W02020008245A1.

In a possible embodiment, the body of the cannula (6) at its distal end (60) (on the right in Fig.2) has a shape suitable for accommodating the connecting body (5) inside it. In practice, the distal portion (60) of the cannula (6) is a hollow cylinder that contains the connecting body (5) , which is also cylindrical.

During use, the cannula (6) can be gripped at its proximal end (62) which defines a handle for convenient positioning .

In another embodiment, shown in Fig.11, the cannula (6) has a straight cylindrical shape and its engagement end (62) with the connecting body (5) is constituted by the distal portion (62) of the tubular body that constitutes it. In this case, the connecting body (5) will correspondingly be provided with a cylindrical reception seat (53) into which the cannula (6) is inserted.

The device (1) is also equipped with a retrieval cord (7) which serves to facilitate the extraction of the device (1) from the vagina. The cord can be made of cotton and have characteristics substantially similar to those of the cords used, for example, for absorbents or tampons .

The device (1) can also form a package (10) like the one schematically shown in Fig.9. In practice, the device (1) can be entirely covered by a casing (11) made, for example, of transparent PVC and placed in a vacuum.

The various parts that make up the device, in particular those most visible with the package (10) closed such as the first veil (3) and the containment body (2) , can be made of suitably coloured material corresponding to a specific substance to be administer; in this way it will be easier to recognize the type of device (1) during use .

The package (10) can also be made differently. For example, in the embodiment shown in Fig.10, the entire package casing (10) includes two sealed chambers (12) and (13) separated by a septum (14) permanently permeable or for example following mechanical action of crushing. The lower chamber (12) contains the device (1) while the upper chamber (13) contains a substance, for example a lubricant, enclosed in a tank (15) . During use, acting on the upper chamber (13) causes the lubricant (or other suitable substance) to be poured into the lower chamber (12) to facilitate, if necessary, the introduction of the device (1) into the vagina.

The package (10) can be opened at an easy-to-open portion (16) . The possible use of lubricant is an addition to improve the application of the device (1) and its use does not determine changes in the characteristics of the substances that the device (1) must deliver inside the vagina.

In conclusion, a device in accordance with the present invention includes a containment body (2) for the substances to be administered and a first veil (3) connected to said containment body (2) and made of material suitable for conveying said substances towards corresponding portions of the human body with which the veil (3) comes into contact; the device (1) is provided with blocking means (4) of the substances dispensed to prevent the unwanted outflow towards the outside of the same substances from the portions of the human body in which they are administered.

A device in accordance with the present invention can also present one or more of the following characteristics, even combined with each other:

- the first veil (2) is connected to said containment body (2) at one end (20) of said containment body (2) and extends with respect to said body (2) in a direction of development of the device (1) and said means for blocking the dispensed substances comprise a second veil

(4) fitted onto the device below the first veil (3) and extending in said direction of development of the device (1) for a value greater than that of extension of the first veil (2) ; the device includes a connecting body (5) stably fixable to said containment body (2) , said first veil (3) and said second veil (4) are arranged and held between said connecting body (5) and said containment body (2) , a retrieval cord (7) being provided which is stably connected to said connecting body (5) and/or to said containment body (2) ;

- the device is equipped with a cannula (6) that can be used for inserting the device (1) into the vagina, a positioning cannula (6) which has a body provided with a distal end (60) shaped to accommodate its inside the said connecting body (5) ;

- the containment body (2) is a hollow body with an ovoid development provided with through holes (21) ;

- the device (1) includes: a containment body (2) , a connecting body (5) , a first veil (2) , a second veil (4) , a positioning cannula (6) and a retrieval cord (7) , in which: - the containment body (2) is a hollow body provided with a fixing end (20) in which a corresponding distal end (50) of the connecting body (5) can be stably fixed by insertion; - said first veil (3) and second veil (4) are fitted coupled on said distal end (50) , with the first veil (3) placed in a distal position with respect to the second veil (4) ; - the positioning cannula (6) is provided with a distal end (60) into which said connecting body (5) can be inserted; - said connecting body (5) and said positioning cannula (6) are internally perforated so as to define an internal channel (51, 61) crossed by said retrieval cord (7) whose distal end is fixed to said containment body (5) ;

- the first veil (3) is made of silky thin latex type material, the second veil (4) is made of cellulose fibre ;

- the containment body (2) is made of flexible TPU like resin;

- the retrieval cord (7) is made of cotton; the positioning cannula ( 6 ) is made of flexible TPU like resin .

What is described is to be understood with reference to what is illustrated in the attached diagrams which constitute embodiments of the invention .

Furthermore , the execution details may in any case vary in an equivalent manner in the shape , dimensions , arrangement of the elements , nature of the materials used, without however departing from the scope of the idea of the solution adopted or of the inventive concept and therefore remaining within the limits of the protection granted from the claims that follow .

Claims

1. Device for the intravaginal administration of substances of the type comprising a containment body (2) for the substances to be administered and a first veil

(3) connected to said containment body (2) and made of material suitable for conveying said substances towards corresponding portions of the human body with which the veil (3) comes into contact, device (1) characterized in that it is provided with means for blocking (4) the substances dispensed to prevent the unwanted outflow of the same substances from the portions of the human body where they are administered to the outside.

2. Device according to claim 1, characterized in that said first veil (2) is constrained to said containment body (2) at an end (20) of said containment body (2) and extends with respect to said body (2) in a direction of development of the device (1) and in that said means for blocking the dispensed substances comprise a second veil

(4) fitted onto the device inferiorly to the first veil (3) and extending in said direction of development of the device (1) for a value greater than the extension value of the first veil (2) .

3. Device according to claim 2, characterized in that it includes a connecting body (5) stably fixable to said containment body (2) , in that said first veil (3) and said second veil (4) are arranged and retained between said connecting body (5) and said containment body (2) , and in that it includes a retrieval cord (7) which is stably connected to said connecting body (5) and/or to said containment body ( 2) .

4. Device according to claim 3, wherein the device is provided with a cannula (6) usable for inserting the device (1) into the vagina, device (1) characterized in that it is provided with a positioning cannula (6) with a body provided with a distal end (60; 62) shaped so as to accommodate said connecting body (5) inside it or to be accommodated by the latter in a corresponding seat (53) .

5. Device according to one or more of the previous claims, characterized in that said containment body (2) is a hollow body with an ovoid development provided with through holes (21) .

6. Device according to one or more of the previous claims, characterized in that it comprises: a containment body (2) , a connecting body (5) , a first veil (2) , a second veil (4) , a positioning cannula (6) and a retrieval cord (7) , in which:

- the containment body (2) is a hollow body provided with a fixing end (20) in which a corresponding distal end (50) of the connecting body (5) can be stably fixed by insertion;

- said first veil (3) and second veil (4) are fitted coupled on said distal end (50) , with the first veil (3) placed in a distal position with respect to the second veil ( 4 ) ;

- the positioning cannula (6) is provided with a distal end (60) into which said connecting body (5) can be inserted;

- said connecting body (5) and said positioning cannula

(6) are internally perforated so as to define an internal channel (51, 61) crossed by said retrieval cord

(7) whose distal end is fixed to said containment body (5) .

7. Device according to claim 2, characterized in that said first veil (3) is made of silky thin latex type material, said second veil (4) is made of cellulose fiber and in that the two veils are joined together at a given number of points.

8. Device according to one or more of the previous claims, characterized in that said containment body (2) is made of flexible TPU like resin.

9. Device according to claim 3 and/or 6, characterized in that said retrieval cord (7) is made of cotton.

10. Device according to claim 4 and/or 6, characterized in that said positioning cannula (6) is made of flexible TPU like resin.