WO2024261719A1

WO2024261719A1 - Liquid drop dispenser

Info

Publication number: WO2024261719A1
Application number: PCT/IB2024/056086
Authority: WO
Inventors: Giuseppe Dionigi
Original assignee: Elitra Srl
Current assignee: Elitra Srl
Priority date: 2023-06-21
Filing date: 2024-06-21
Publication date: 2024-12-26
Anticipated expiration: 2025-12-21
Also published as: IT202300012846A1

Abstract

A liquid drop dispenser (1) comprising a container (2), which defines a storage volume (3), and a dispenser cap (4) coupled to the container (2) and provided with a. dropper spout (5) defining a dispensing outlet (6) for the liquid from the container (2). The liquid drop dispenser (I) further comprises a transfer head (9) provided pre-assembled with the dispenser cap (4) and designed to allow the liquid to be transferred from a vial (10) to the container (2) through the dropper spout (5) and to be manually removed from the dispenser cap (4) to enable the administration of the liquid through the dropper spout (5).

Description

LIQUID DROP DISPENSER

Cross-Reference to Related Patent Applications

This patent application claims priority to Italian Patent Application No. 102023000012846 filed on June 21, 2023, the contents of which are incorporated herein by reference in their entirety.

Technical Field of the Invention

This invention relates to a liquid drop dispenser, in particular for administering medical liquid drops, for example eye or oral drops.

Prior Art

As known, dispensers normally comprise a container closed by a dropper cap and provided with an elastically deformable side wall which, when compressed, causes predetermined doses of medical liquid to be the dispensed through the dropper cap.

A particular type of dispensers, to which this description explicitly refers, comprise dispensers that are marketed empty, i.e., without any medical liquid therein, and are intended to be filled by a user with a given quantity of medical liquid contained in a separate bottle from the dispenser. These dispensers are used, for example, whenever the medical liquid is not suitable for being stored for long periods in contact with materials, typically plastic, generally used for dispensers, or if the production line is not suitable for packaging the medical liquid directly in the dispensers.

In order for the medical liquid transferred from the bottle to the dispenser to be exposed as little as possible to the outside environment, with consequent risk of contamination, the known dispensers are normally configured to be filled via adaptors designed to place the bottle in fluidic communication with the dispenser.

Dispensers that are suitable for being filled via adaptors are known, for example, from W02018163201A1, US2014319141A1, DE102006009611A1, and WO2022233866A1.

These dispensers, although they have made it possible to overcome many problems connected to previous “fillable” dispensers, have, in any case, several drawbacks mainly deriving from the high number of components therein increasing their mechanical and functional complexity, to the detriment of production costs, ease of use, and integrity of the medical liquid during transfer. Subject and Summary of the Invention

The purpose of this invention is to provide a liquid drop dispenser, in particular for administering medical liquid drops, which overcomes the above-described drawbacks and be both simple and cost-effective to implement.

According to the present invention, a liquid drop dispenser is provided, as claimed in the appended claims.

Brief Description of the Drawings

Figure 1 shows, in cross-section, a preferred embodiment of a dispenser according to the present invention.

Figures 2 and 3 show the dispenser in Figure 1 during respective dispenser-filling configurations.

Figure 4 shows a second embodiment of the dispenser in Figure 1.

Figure 5 shows a third embodiment of the dispenser in Figure 1.

Figure 6 shows the dispenser in Figure 5 in a final dispenser-filling configuration.

Figure 7 A shows a particular of the dispenser in Figure 1 with a closing cap.

Figure 7B shows a particular of the dispenser in Figure 4 with a closing cap.

Figure 7C shows a particular of the dispenser in Figure 4 with an alternative closing cap to that in Figure 7B.

Detailed Description of Preferred Embodiments of the Invention

This invention will now be described in detail with reference to the figures attached to enable a person skilled in the art to produce it and use it. Various modifications to the embodiments described will be immediately clear to persons skilled in the art and the generic principles described may be applied to other embodiments and applications without, for this reason, departing from the protective scope of this invention, as defined in the attached claims. Therefore, this invention must not be considered as limited to the embodiments described and illustrated but they must be granted the widest protective scope compliant with the principles and features described and claimed herein.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning commonly understood by one of ordinary skill in the art to which the invention belongs. In case of conflict, the present specification, including the definitions provided, will control. In addition, the examples are provided purely for illustrative purposes and, as such, must not be considered as limiting. With reference to Figure 1, reference number 1 indicates, as a whole, a liquid drop dispenser, in particular for administering medical liquid drops, for example eye or oral drops.

In detail, the dispenser 1 belongs to a particular type of medical liquid drop dispensers i.e., those dispensers that are marketed empty, i.e., without any medical liquid therein, and are suitable for being filled by a user by transferring a given amount of medical liquid originally contained in a separate bottle to the dispenser.

This type of dispenser finds application, for example, in all those cases where, for reasons linked to the production line or the product's storage requirements, the medical liquid cannot be packaged, at the time of production, in containers that are also suitable for administering the medical liquid. Instead, it is packaged and marketed in other types of bottles, typically glass bottles closed by rubber caps with aluminium rings and without droppers.

As shown in Figure 1, the dispenser 1 comprises an empty, multi-dose container 2 defining an inner storage volume 3 for the medical liquid and having a mouth engaged by a dispenser cap 4.

Preferably, the container 2 has the shape of a common bottle for oral and eye drops and has a height ranging between 30 and 90 mm, a maximum diameter between 20 and 30 mm, and a nominal capacity between 3 and 20 ml.

The container 2 is made of a flexible plastic and comprises an elastically deformable side wall that enables the container 2 to be laterally compressible to allow drops to be ejected from the dispenser cap 4 and to return to its original shape once compression stops. To this end, the side wall of the container 2 is preferably less than 1 mm thick.

The container 2 is preferably made of plastic such as polyethylene [PE], polypropylene [PP], polyvinyl chloride [PVC] or a combination thereof.

As shown in Figure 1 , the dispenser cap 4 comprises a fastening portion and a dropper spout 5, which defines a dispensing outlet 6 so sized as to dispense medical liquid drops with a pre-determined amount, preferably between 0.02 and 0.06 ml.

In the examples shown in the attached figures, the mouth of the container 2 is delimited by an internally threaded cylindrical wall and the fastening portion of the dispenser cap 4 comprises a tubular connection 7 screwed inside the cylindrical wall.

In other embodiments not shown, the tubular connection 7 can be connected to the mouth of the container 2 via other assembly systems, such as an interference or snap or bayonet coupling. At its most external end, the tubular connection 7 comprises an annular flange 8, which abuts against a free edge of the mouth of the container 2, partially closes the mouth of the container 2, and defines a support base for the dropper spout 5.

As shown in Figure 1, the dropper spout 5 has an external conical shape, tapered towards the distal end of the dropper spout 5, and delimits an internal dispensing channel 6a adapted to place the storage volume 3 and the dispensing outlet 6 in fluidic communication.

In particular, the dropper spout 5 is externally shaped like a standard male Luer connector, more precisely a Luer-slip connector, adapted to create, as will be described below, a pressure coupling with a standard female Luer-slip connector.

The dispenser cap 4 is preferably made of stiff plastic, such as polyethylene [PE], polypropylene [PP], polyvinyl chloride [PVC], polycarbonate [PC], or polystyrene [PS], or a combination thereof.

In a variant not shown, the dispenser cap 4 can be made of a single piece with the container 2.

As shown in Figure 1, the dispenser 1 comprises, in addition to the container 2, a transfer head 9 removably connected to the dispenser cap 4. In particular, the transfer head 9 is pre-assembled to the dispenser cap 4 so as to define a single body with the container 2 when the latter is purchased by a user and is designed to allow a medical liquid to be transferred from a vial 10 to the container 2 through the dropper spout 5 and to be manually removed from the container 2 to allow liquid drops to be the administered.

Typically, the vial 10 comprises a bottle, made of plastic or, more frequently, glass, having a nearly cylindrical body and a neck closed by a pierceable cap 11, which is made of an elastic material, normally rubber or silicon, and, preferably, is fluid-tightly fastened to a free edge of the neck via a metal collar 12.

The transfer head 9 comprises a wall 13, which has an inlet opening 14 and is separably connected to the dropper spout 5 so that the inlet opening 14 faces and fluidically communicates with the dispensing outlet 6. The wall 13 preferably extends transversely to a longitudinal axis of the dropper spout 5.

The transfer head 9 further comprises a connection portion 15 supported by (he wall 13 and designed to connect the transfer head 9 to the vial 10 and place the inner volume of the vial 10 in fluidic communication with the inlet opening 14 and, thus, with the dispensing outlet 6 and with the storage volume 3 of the container 2, so as to allow the medical liquid to be transferred from the vial 10 to the container 2. The connection portion 15 comprises a hollow needle 16, which has an inner duct aligned with the inlet opening 14 and extends from the wall 13 in the opposite direction to the container 2 to allow it to be inserted, in use, in the vial 10 through the pierceable cap 11 and enable the medical liquid to be transferred from the vial 10 to the container 2 through the needle 16, the wall 13, and the dropper spout 5.

Conveniently, in order to make the connection between the transfer head 9 and the vial 10 more stable, the connection portion 15 comprises a coupling collar 17 surrounding the needle 16 and designed to be coupleable to a portion of the vial 10, in the example shown, the ring 12, so as to allow the transfer head 9 to be mechanically coupled to the vial 10. The coupling collar 17 is preferably designed to couple the transfer head 9 to the vial 10 irreversibly to cause the transfer head 9 to remain coupled to the vial 10 when the transfer head 9 is separated from the container 2. The coupling collar 17 is preferably configured to couple the transfer head 9 to the vial 10 via snap coupling.

The coupling collar 17 may be formed by a continuous ring-shaped member or multiple flexible fins distributed all around the needle 16.

The height of the coupling collar 17 preferably exceeds the length of the needle 16 so as to act as a safety device too and prevent the user from touching the needle, contaminating it, before transferring the liquid.

To further reduce the risk of contamination, the transfer head 9 may be provided with a sterilising filter positioned along the internal dispensing channel, for example at the opening 14.

The transfer head 9 is conveniently made of a single, stiff plastic member (e.g. PP, PC, or PS).

The removable connection between the transfer head 9 and the dispenser cap 4, more precisely between the wall 13 and the dropper spout 5, can be made in various ways.

In the embodiment shown in Figures 1 , 2, and 3, the wall 13 of the transfer head 9 is removably connected to the dropper spout 5 by means of a connector 18 borne by the wall 13 and coupled to the dropper spout 5.

The connector 18 is formed as a hollow cone which extends from the wall 13 in the opposite direction to the needle 16, defines an internal space communicating with the inlet opening 14 and is pressure-fitted on at least part of the dropper spout 5.

In particular, the connector 18 is shaped like a standard female Luer connector, more precisely a Luer-slip connector, compatible with the male Luer connector defined by the dropper spout 5. In this case, to transfer the medical liquid from the vial 10 to the container 2, the user must first connect the transfer head 9 to the vial 10, overturn the latter and penetrate the needle 16 into cap 11 until the coupling collar 17 engages the ring 12 so as to lock the vial 10 on the transfer head 9 (Figure 2).

At this point, by pressing and releasing the side wall of the container 2, the liquid is forced to pass from the vial 10 to the storage volume 3.

The transfer of the medical liquid according to the method described above is relatively precise since, if the capacity of the vial 10 is greater than that of the container 2, only part of the liquid contained therein can be withdrawn from the vial 10. To this end, the container 2 can be conveniently provided, on its side wall, with a graduated scale to indicate the filling level to the user.

As shown in Figure 3, at the end of the transfer, by pulling the container 2 and the assembly of the vial 10 and the transfer head 9 with suitable force in opposite directions, the user causes the transfer head 9 to detach from the dropper spout 5, i.e., separating the male Luer connector and the female Luer connector. The transfer head 9 remains attached to the vial 10 due to the holding action exerted by the connection portion 15.

The container 2, free from the transfer head 9, is now ready to be used as a common dropper bottle for eye drops.

With reference to Figure 7 A, the dispenser 1 may comprise a closing cap 19 as an accessory, which comprises a cup-shaped body provided, on a free end portion thereof, with an internal threading 20 adapted to be coupled to a corresponding external threading 21 formed on a cylindrical portion of the side wall of the container 2 extending around the mouth engaged by the dispenser cap 4.

In other embodiments not shown, the closing cap 19 may be closed by pressure or bayonet or any other locking system suitable for this purpose.

The closing cap 19 is preferably made of plastic, such as PE, PP, or PVC.

The embodiment shown in Figure 4 differs from that shown in Figure 1 in the male Luer connector borne by the dispenser cap 4 and female Luer connector by the transfer head 9 being not Luer-slip connectors, but Luer-Lock connectors, i.e., they are provided with a screw-on safety mechanism adapted to prevent accidental detachment of the transfer head 9 from the dropper spout 5.

To this end, the dispenser cap 4 comprises a sleeve 22 which surrounds the dropper spout 5 and has an internal threading removably engaged by a threading made on the external side surface of the connector 18. The dropper spout 5 and the sleeve 22 define the male Luer-Lock connector.

In this variant, the medical liquid is transferred from the vial 10 to the container 2 using the same method of the previous example as far as regards the connection of the vial 10, whereas removal of the transfer head 9 from the container 2 occurs by unscrewing the two Luer-Lock connectors so as to separate the connector 18 and the dropper spout 5.

In this case too, the transfer head 9 remains attached to the vial 10 due to the holding action exerted by the connection portion 15.

As shown in Figures 7B and 7C, the container 2 of the embodiment in Figure 4 can be closed, between one administration and the next, using a closing cap that, for example, may be the same as the closing cap 19 described with reference to Figure 7 A, potentially suitably sized to contain the sleeve 22 (Figure 7B). Alternatively, as shown in Figure 7C, the container 2 may be closed by a closing cap 23 comprising a hollow frustoconical appendage 24 shaped like a female Luer-Lock connector adapted to be coupled to the male Luer-Lock connector defined by the dropper spout 5 and the threaded sleeve 22.

Figures 5 and 6 show another embodiment of the removable connection between the transfer head 9 and the dispenser cap 4, more precisely between the wall 13 and the dropper spout 5.

In this case, the wall 13 is directly coupled to the top of the dropper spout 5 using a breaking portion 25 defined by a thin layer of material, for example plastic, adapted to cleanly break when, in use, the vial 10 with the transfer head 9 are laterally forced with a decisive movement to be tom apart by the container 2 (Figure 6).

In the case of this embodiment too, the container 2 may be fluid-tightly closed by the closing cap 19 between one administration and the next of medical liquid.

With regard to the above description, it should be noted that, whatever form of removable connection there is between the transfer head 9 and the dispenser cap 4, the transfer head 9 is designed so that, when it is connected to the dispenser cap 4 and the inlet opening 14 of the transfer head 9 faces the dispensing outlet 6 of the dropper spout 5, no part of the transfer head 9 is inserted inside the dispensing channel 6a.

This ensures that the shape and size of the dispensing channel 6a and the dispensing outlet 6 of the dropper spout 5 are not altered in any way by the transfer head 9 neither in the configuration pre-assembled with the dispenser cap 4, nor when it is detached from the latter. This ensures the successive dispensing of the drops through the dispensing outlet is accurate and can be reproduced. In addition, the fact that the container 2 is initially empty ensures that it is not necessary to provide any sealings for the dispensing outlet 6 to seal the container 2. The absence of these sealings reduces the risk of contamination connected to the need to manipulate the container 2 if these sealings need to be removed before filling the container 2. The assembly consisting of the empty container 2 and the pre-assembled transfer head 9 is conveniently sold in a sealed package that ensures sterility.

The above clearly reveals the additional advantages that the dispenser 1 enables compared to the majority of dispensers of the same type currently being sold.

First of all, the dispenser 1 makes it possible to extract a liquid from a vial without the use of needles, parts made of rubber or valves, and totally insulated from the external environment, preserving the microbiological quality of the liquid.

In addition, the fact that the transfer head 9 is pre-assembled to the container 2 drastically reduces the risk that the user may touch, contaminating them, exposed parts that are in contact with the liquid (like, for example, the dropper spout 5, or the male Luer connector).

Claims

1. A liquid drop dispenser (1) comprising: a container (2) defining a storage volume (3) adapted to receive an amount of liquid from a vial (10); a dispenser cap (4) coupled to the container (2) and comprising a dropper spout (5) defining an internal dispensing channel (6a) fluidically communicating with the storage volume (3) and ending in a dispensing outlet (6) for administering drops of the liquid contained in the container (2); characterised in that the container (2) is empty and the dispensing outlet (6) is open so that the container (2) is not sealed; and in that it further comprises a transfer head (9) removably connected to the dispenser cap (4) so that no part of the transfer head (9) is inserted in the dispensing channel (6a); the transfer head (9) is designed to allow the liquid to be transferred from the vial (10) to the container (2) through the dropper spout (5) and to be manually removed from the dispenser cap (4) so as to free the dropper spout (5) so that it can be used to administer the liquid.

2. The liquid drop dispenser (1) of claim 1, wherein the transfer head (9) comprises a wall (13), which is separably connected to the dropper spout (5) and has an inlet opening (14) aligned and fluidically communicating with the dispensing outlet (6) of the dropper spout (5); the transfer head (9) further comprises a connection portion (15) configured to connect the transfer head (9) to said vial (10) and put the internal volume of the vial (10) in fluidic communication with the storage volume (3) of the container (2) through the inlet opening (14) of the wall (13) and the dispensing outlet (6) of the dropper spout (5).

3. The liquid drop dispenser (1) of claim 2, wherein the connection portion (15) comprises a hollow needle (16), which has an inner duct aligned with the inlet opening (14) and extends from the wall (13) so that it can be inserted, in use, through a pierceable cap of the vial (10) to allow transfer of the medical liquid from the vial (10) to the container (2).

4. The liquid drop dispenser (1) of claim 3, wherein the connection portion (15) comprises a coupling element ( 17) configured to couple to the vial (10), thus securing the transfer head (9) to the vial (10) so that the transfer head (9) is coupled to the vial (10) when it is separated from the container (2).

5. The liquid drop dispenser (1) of any one of claims 2 to 4, wherein said wall (13) of the transfer head (9) is connected, in a removable manner, to the dropper spout (5) by means of a connector (18) carried by the wall (13) and coupled to the dropper spout (5).

6. The liquid drop dispenser (1) of claim 5, wherein said connector (18) is shaped like a female Luer-slip connector, and the dropper spout (5) defines a male Luer-slip connector coupled to said female Luer-slip connector.

7. The liquid drop dispenser (1) of claim 5, wherein said connector (18) is shaped like a female Luer-Lock connector, and the dropper spout (5) is part of a male Luer-Lock connector coupled to said female Luer-Lock connector and further comprising a sleeve (22) which surrounds the dropper spout (5) and has an internal thread engaged, in a removable manner, by an external thread of said connector (18).

8. The liquid drop dispenser (1) of claim 6, wherein the transfer head (9) is connected, in a removable manner, to the dropper spout (5) by means of a breaking portion (25) defined by a portion of material that connects the wall (13) to a top of the dropper spout (5) and is adapted to break clearly when, in use, the transfer head (9) with said vial (10) is forced in order to be separated from the container (2).

9. The liquid drop dispenser (1) of any one of the preceding claims, further comprising a closing cap (19; 23) couplable to the dropper spout (5) after separation of the transfer head (9) from the dispenser cap (4) to fluid-tightly close the storage volume (3).

10. The liquid drop dispenser (1) of claim 9, when depending on claim 7, wherein the closing cap (23) comprises a frustoconical appendage (24) shaped like a female Luer- Lock connector adapted to couple with the male Luer-Lock connector defined by the dropper spout (5) and by the sleeve (22).