EP3817803A1

EP3817803A1 - Device for intravaginal administration of substances

Info

Publication number: EP3817803A1
Application number: EP18762386.3A
Authority: EP
Inventors: Gianluca GIUBILEI
Original assignee: Giubilei Giuanluca; Polymed SRL
Current assignee: Ghosty Srl
Priority date: 2018-07-06
Filing date: 2018-07-06
Publication date: 2021-05-12
Also published as: WO2020008245A1

Abstract

The invention relates to a device for intravaginal administration of substances which comprises a core (2) defining the support structure of the device (1) and a covering veil (3) which wraps said core (2) and which is made of a material suitable for conveying the substances with which the device is soaked (1); the veil (3) has a free portion (30) which is not supported by said core (2) for a value of at least half of entire longitudinal development of the device (1).

Description

TITLE: DEVICE FOR INTRA VAGINAL ADMINISTRATION OF SUBSTANCES

DESCRIPTION

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

As better described hereafter, the device of the invention is particularly indicated in the intravaginal administration of drugs and/or other substances for therapeutic, preventive and/or cosmetic purposes.

The means currently used to convey various types of active ingredients at the vaginal level consist of creams, vaginal douches and vaginal suppositories.

A disadvantage of the creams is related to the difficulty of application and the insufficient safety of the correct interaction of the active substance with the corresponding parts involved in its absorption or its transmission.

Similar drawbacks are presented by vaginal douches, which, moreover, provide for a period of contact and interaction that is less prolonged over time with respect to creams and, therefore, have a relatively milder action with the same active substance being conveyed.

As far as vaginal suppositories are concerned, these can allow a longer administration, but they can be negatively influenced by the possibility of drainage to the outside of the active substance together with the excipients associated with it; in practice, the use of suppositories is usually limited to nighttime due to the possible losses determined by them.

An aim of the present invention is to eliminate or at least greatly reduce the aforementioned drawbacks with a device for intravaginal administration of substances capable of conveying the active substance safely and that is correctly usable.

This result was achieved by the idea of solution of the independent claim. Other features 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 substance in the times and quantities best suited to the correct therapy, prevention and/or cosmetic use thanks to the presence of a veil in biocompatible material that defines a diffusion surface of the substance to be administered, surface which interacts with the walls of the vagina, allowing a release of the substance over time with a propagation unreachable by the means of the prior art;

- the device allows the release in the vaginal environment of substances with a soothing purpose and anti-inflammatory aim to alleviate the common problems, itching and disorders that characterize the pathologies of the vaginal cavity;

- the device has an adjuvant action in the treatment of the most common diseases such as inflammation of the vaginal area, through the gradual release of biologically-tested substances containing, for example, pharmacologically active principles such as antibiotics or antifungal substances;

- with the device it is possible to perfume the vaginal environment and neutralize unpleasant odors.

The advantages and characteristics of the invention will be more evident from the following description which refers to the attached drawings, provided as a non-limiting example, in which:

- Fig. 1 is a schematic side view of a possible embodiment of the invention;

- Fig. 2 is a schematic perspective view of another embodiment of the invention;

- Fig. 3 shows a further example of embodiment of the invention, shown schematically in a perspective view, represented in use configuration in the left drawing and isolated in the right drawing;

- Fig. 4 is a diagram which illustrates the use of the device;

- Fig. 5 shows another example of embodiment of the invention, shown schematically in perspective view, in use configuration.

With reference to the enclosed non-limiting drawings, the device (1) of the invention comprises a core (2) consisting of a body preferably of ovoid or ellipsoid shape, which can be produced in semi-rigid polymeric or rubber material with good elastic properties. With the definition "good elastic properties" it is meant that the mechanical properties of the core (2) are such as not to allow permanent deformations of the core due to the stresses to which the device could be subjected during its use (transport in a casing, extraction from the casing, gripping with the fingers, insertion and permanence in the vaginal environment) with an elasticity that does not cause discomfort by adapting well to the vaginal cavity.

The core (2) is covered with a veil (3) of biologically tested polymeric material compatible with vaginal tissues, capable of exchanging cosmetic, adjuvant or pharmaceutical substances with the vaginal environment gradually and for a prolonged period of time.

In a possible embodiment, the core (2) can be constituted by a soluble structure contained within the veil (3), also constituting a single body with the same veil (3); in other words, the two components, core (2) and veil (3), can in practice be combined into a single whole. In this case, at the end of the treatment, the device (1) may consist only of the veil component (3).

The core (2) is also connected to a rigid cannula or hollow rod (5), which acts as an applicator, and to a string (4) which slides inside the rod (5) itself and which is used for the removal of the device (1) from the vagina.

Fig. 4 shows how the device (1) can be used. The procedure for applying the device can be summarized in the following steps: extraction of the device (1) from the casing in which it is contained; insertion of the device inside the vagina (V) using the hollow rod (5) as applicator; placement of the core (2) at the end of the cervix (C); extraction of the rod (5) with sliding of the same rod (5) along the string (4), which remains attached to the core (2). In Fig. 4 the other parts of the body are marked with the following references: (U) - uterus; (O) - urethral orifice; (A) - anus / rectum.

Repositioning with the fingers is possible if necessary.

An application method according to the present invention therefore comprises the steps of insertion inside the vagina (V) of a device comprising a veil (3) which allows to convey on the walls of the vagina (V) the substances with which the device is soaked and the use of the device for a pre-established period. The method can provide the preparatory phase to soak the core (2) and/or the veil (3) of these substances. The subsequent stay on site for the prescribed period of treatment, for example of the order of hours, allows the continuous transmission of the drugs or other indicated substances during the medical prescription or to be administered as non-therapeutic. By way of example, the substances that can be administered with the present device (1) may be drugs containing pharmacologically active principles such as antibiotics or antifungals or of another type indicated for a specific therapy, or soothing and/or refreshing substances, with the possibility of perfuming.

The veil (3) is fixed to the core (2) or is in a single body with it at the end of the device (1) in which the core (2) is placed; in the remaining part of the device (1) the veil (3) is loose and can adhere to the inner walls of the vagina, copying its profile. An interaction is determined by a remarkably high contact between the veil (3) and the inner walls of the vagina.

In the drawings the reference (Ll) indicates the value of the length of the entire device (1), the reference (L2) indicates the part of the device (1) occupied by the core (2) and (L3) indicates the part of the device occupied exclusively from the veil (3). In practice, the veil (3) is pendulous with respect to the core (2) and is that part of the device (1) that can vary its conformation precisely because it is bound to the core (2) only in a relatively small portion. By way of example, the value of the longitudinal development (L3) of the free or loose part (33) of the veil (3) with respect to the entire length (Ll) of the device (1) is greater than half and may be equal to 2/3 or 3/4 of this value (Ll).

Thanks to the relatively large surface of the veil (3) a diffusion of the drug, and/or of the other substances to be administered, is obtained inside the vagina, diffusion which was not obtainable by the means used up to now. With respect to the previously known techniques (douches, creams and vaginal suppositories), the difference in amplitude of the area directly affected by the interaction of the veil during the duration (measurable in hours) of the treatment performed is evident. The fact that the veil (3) can cover most of the walls of the vagina allows a constant and continuous administration of the drug and/or other substances.

After positioning and staying in place for the period necessary for the indicated treatment, it is possible to remove it using the designated string (4), similarly to the extraction of the internal tampons.

As indicated above, the device (1) is conveniently impregnated with the substance to be conveyed, a substance which, depending on the type of treatment and/or type of substance and/or the desired release times can be contained by the core (2), by the veil (3) or by both components of the device (1).

The core (2) is stably wrapped by the veil (3) and, therefore, does not come into direct contact with the vagina; it may contain or not the active ingredients depending on the purpose of use and the type of substances that must spread in the vagina. In the case in which the nucleus (1) contains substances to be conveyed into the vagina it will be cribrose or spongy to transmit these substances to the structure of the veil (3) of polymeric material (which constitutes the interaction surface between the device and the vaginal environment) that covers the core (2) and forms precisely the pendulous veil of the device. If the core (2) is free of substances to be diffused, it will be ovoidal (or ellipsoidal) shaped, not cribrose and the polimeric veil will be directly impregnated to form the diffuser for the vaginal environment.

Advantageously, the veil (3) determines a controlled drainage of the substances to be administered, allowing the release and the corresponding absorption to an optimal extent. The veil (3) will therefore be made of a polymeric material whose structure allows the substances to be administered to be conveyed gradually into the vaginal environment.

The rod (5) can be made of plastic material of a rigid nature (similar to those used for lollipops) and will be inserted in a cavity presented by the core (2), such that once the device is positioned (1) inside the vagina (V) it can be extracted with a minimum traction from the outside, possibly accompanied by a slight rotary movement of the rod itself to facilitate its extraction from the core cavity (2). The rod (5) can be constrained to the core (2) thanks to the particular shape of the seat provided on the core (2), seat which can be made so as to be conformed complementarily to the rod (5) to allow stable insertion of this last with slight interference. For example, with a cylindrical rod (5), the receiving seat will also be cylindrical with a diameter corresponding to that of the rod, but slightly higher to allow insertion and above all extraction with slight forcing.

The string (4) is firmly fixed to the core (2) in such a way as to allow the device to be removed after use by simply pulling the string itself.

The veil (3) constitutes the interaction surface between the device (1) and the vaginal environment. Its length will be such as to cover the vaginal wall portion that goes from the cervix to the vulva, with the possibility of leaking slightly to the level of the labia. It may be available in different sizes, depending on the age and the physical conformation of the user.

Moreover, the veil (3) is fixed to the core (2) (when the core is not cribrose) on its inner side with a minimum amount of biocompatible adhesive, i.e. with a fixing means that does not interact with the vaginal environment. In the case of a cribrose (2) core, containing gels and active substances to be diffused, the substantially rigid plastic material with a cribrose conformation is pervaded and invaded by the elastic polymer which conveys the substance to be administered, so that it is the same polymer that forms the coating which is modelled according to the ovoidal cribrose skeleton that contains the active substances.

In practice, the diffusion methods of the various substances which impregnate the polymer of the device (1) can be substantially two, with the core (2) which does not come into contact with the vagina but may contain or not the active principles depending on the purpose of use and the type of substances that must spread in the vagina.

In the first case, the veil (3) of the device (1) consists of a polymeric material of a matrix nature (for example hydrogel) capable of incorporating the molecules of the substance to be released and ensuring a gradual release over time.

In the second case, in which the core (2) contains substances to be conveyed into the vagina it will be cribrose for the veil (3) of polymeric material (which constitutes the surface of interaction between the device and the vaginal environment) that covers the core and form, as previously mentioned, the pendulous veil of the device.

The correct positioning of the device at the extremity of the cervix (C) takes place thanks to the fact that the dimensions of the device head (formed by the coated core) offer a greater encumbrance and resistance than the pendulous veil that instead, without a rigid skeleton, leaves the vaginal cavity almost completely closed under the ovoidal head.

The ability to self-position the device in other situations that require it can also be increased through modifications of the shaping of the polymeric portion which covers the core, as shown by way of example in Figs. 2, 3 and 5.

For example, with reference to Fig.3, transverse rings can be created slightly inclined with respect to the hypothetical longitudinal axis of the device, or orthogonal to the same, so as to form a sort of spiral or a multiple-ring conformation (31) which can be made on the rigid core (2) and then polymer coated or formed directly on the veil polymer (3). According to this possible embodiment, in correspondence of the area of connection between the beginning of the pendulous part (33) of the veil and the head containing the core, one or more transversal polymeric disks (31) of variable diameter can be applied, diameter that is however greater compared to that of the polymeric head so as to increase the pressure on the vaginal wall and the retaining in place.

In the embodiment shown in Fig.2, it is possible to make, on the polymeric edges of the ovaidal portion, mono-directional polimeric side skirts or spoilers (30), suitable for facilitating sliding in the introduction and preventing movement in the exit direction; these peripheral side skirts (30) can be made either on the rigid core (2) or directly on the veil polymer (3).

According to the embodiment of the invention illustrated in Fig. 5, it is possible to realize an irregular microvillary surface (32) on the head of the device (1); the microvilli (32) can be produced both on the rigid core and directly on the polymer which forms the veil (3). The term microvilli means any small elongated formation which protrudes from the external surface of the device (1). The microvilli (32) can have a double function: to stabilize the positioning of the device in the vagina and to increase the diffusion of the substance conveyed by device towards the outside of the device. What is described is intended with reference to what is illustrated in the attached diagrams which constitute embodiments of the invention.

Moreover, the details of execution may in any case vary in the form, size, arrangement of the elements, nature of the materials used, without however departing from the scope of the solution adopted or the inventive concept and therefore remaining within the limits of the protection afforded from the present patent.

Claims

1. Device for intravaginal administration of substances characterized in that it comprises a core (2) defining the support structure of the device (1) and a covering veil (3) which wraps said core (2) and which is made of a material suitable for conveying the substances with which the device is soaked (1), and in that said veil (3) has a free portion (30) which is not supported by said core (2) for a value of at least half of entire longitudinal development of the device (1).

2. Device according to claim 1, characterized in that said free portion (33) extends for a value of at least 2/3 of the entire longitudinal extension of the device (1).

3. Device according to claim 1, characterized in that said core (2) is of ellipsoidal shape.

4. Device according to claim 1, characterized in that said core (2) is of an ovoid shape.

5. Device according to one of the preceding claims, characterized in that said core (2) is made of a polymeric or rubbery material.

6. Device according to one of the preceding claims, characterized in that said veil (3) is made of a polymeric material shaped so as to exchange substances with the vaginal environment gradually.

7. Device according to one of the preceding claims, characterized in that said core (3) is permanently connected to a string (4) usable for the extraction of the device (1), said device (1) comprising a cannula (5) crossed from said cord (4), removably associated with said core (2) and usable for positioning the device (1).

8. Device according to one of the preceding claims, characterized in that said core (2) is impregnated with the substance to be administered and is cribrose in connection with said veil (3) to allow the passage of said substance to the veil (3).

9. Device according to any one of claims 1 to 7, characterized in that said veil (3) is impregnated with the substance to be administered through the device (1).

10. Device according to claim 1, characterized in that said core (2) and said veil (3) are made of a single body.

11. Device according to one of the preceding claims, characterized in that it has an external surface provided with protrusions or discontinuities (30, 31, 32) suitable for stabilizing the positioning of the device (1) inside the vagina.

12. Device according to claim 11, characterized in that said protrusions or discontinuities (30, 31, 32) are constituted by rings projecting from the outer surface of said core (2) and/or said veil (3).

13. Device according to claim 11, characterized in that said protrusions or discontinuities (30, 31, 32) consist of disks projecting from the outer surface of said core (2) and/or said veil (3).

14. Device according to claim 11, characterized in that said protrusions or discontinuities (30, 31, 32) consist of microvilli projecting from the outer surface of said core (2) and/or said veil (3).

15. Device according to one of the preceding claims, characterized in that the length (Ll) of the device (1) is of value equal to the vaginal wall portion that goes from the cervix to the vulva, with the possibility of coming out slightly at the level of the labia.