The present invention relates to a dose counting device for coupling to a medical container filled with a certain number of doses of a product, such as a vial containing a pharmaceutical product, such as a vaccine, said dose counting device allowing for counting the doses withdrawn from the medical container in an aseptic manner.

In this application, the distal end of a component or apparatus must be understood as meaning the end furthest from the hand of the user and the proximal end must be understood as meaning the end closest to the hand of the user, with reference to the injection device intended to be used with said component or apparatus. As such, in this application, the distal direction must be understood as the direction of injection with reference to the injection device, and the proximal direction is the opposite direction, i.e. the direction of the transfer of the product from the vial to the injection device.

One of the ways to improve health is to immunize entire populations against a number of diseases. To date, injection administration is the most common method of administering vaccines.

Each year, numerous drugs, for example vaccines, need to be prepared throughout the world by healthcare institutions. Many vaccine compositions are usually not stable at room temperature and they must be stored at rather specific cold temperatures. Indeed, due to their biological nature, vaccines are complex to handle and to store. Vaccines are usually temperature sensitive and typically need to be maintained and stored at all time between 2 and 8 degrees Celsius (°C). Some vaccines will be more sensitive to heat exposure and others will be sensitive to freezing. Therefore, maintaining and monitoring the appropriate temperatures during the storage and the handling of vaccines is a critical issue in order to sustain their efficacy. Overexposure to heat as well as overcooling may result in the destruction of the biological elements of the vaccines. Use of vaccines not stored in appropriate conditions may lead to not effective vaccination of the populations against diseases and would lead to expensive campaigns with limited results.

Furthermore, it is critical that the cold chain be not interrupted from production of the drug at a pharmaceutical company to its administration to the patient. From a supply chain perspective, the most efficient vaccine packaging is the multidose container such as multidose vial, that is to say, vial that may contain up to 10, 100 or 1000 doses of vaccine, one dose being intended for one patient. These vials are usually closed by a septum. In preparation of an injection of a vaccine, the user pierces the septum of the vial with the needle of an empty syringe, he then fills the syringe with one dose of vaccine and proceeds to the injection of the vaccine to the patient.

As such, multidose vials imply that the septum of the vial be pierced successively a high number of times, namely as many as the number of doses present in the vial. In order to ensure safe injections, the sterility of the septum of the vial should be maintained during the whole time the vial is used.

Anyway, in locations where it is difficult to maintain good hygienic conditions such as remote locations which are far from towns and from hospital facilities, the multidose vials may be handled and manipulated at ambiant air. In such cases, the septum of the vial may be contaminated either by the ambiant air, or, each time a dose of vaccine is removed, by the needle of the empty syringe used.

In addition, in regions where there is limited or potentially no supply of energy to power cooling equipment such as a refrigerator, the multidose vials may be maintained in cold conditions by simple contact with ice packs. As time goes by, part of the ice may melt and turn into water, and the septum of the multidose vials may be in contact with such water that may contaminate the septum of the vial.

It may then happen that a multidose vial, such as for example a 10- dose vial, is opened and that only three doses are used, for vaccinating three patients only, the remaining content of the vial being wasted because not intended to be administered in a sufficiently short time after opening of the vial in order to guaranty the vaccine or drug sterility.

Vaccination campaigns can therefore be made difficult in some regions and a significant proportion of vaccines may be wasted by the time they reach their target. This has an unacceptable cost to the health organizations in charge of immunization campaigns. In addition, it may happen that in case of vaccination campaigns, or pandemic, hundreds of patients need to be vaccinated in a very short time, in locations where it is difficult to maintain good hygienic conditions such as remote locations which are far from towns and from hospital facilities. Therefore, it would be desirable to provide a device that would allow several successive piercings of a multidose vial septum and that would guarranty that said piercings be carried out in aseptic conditions, in particular that the septum be maintained sterile during the lifetime of the multidose vial, and that would allow to precisely count the number of doses of product already withdrawn from the vial or on the contrary still remaining in the vial.

Moreover there is a need to provide a device that enhances the supply chain of drugs and vaccines and that prevents wastage of valuable medicine during immunization campaigns.

In addition, there is a need for a dose counting device usable with a medical container, that would provide reliable information to the user regarding the number of doses of product already withdrawn from, or still remaining within, the container, even if the user happens to accidentally start to open the medical device before changing his mind and closing it.

A first aspect of the present invention is a dose counting device for coupling with a medical container filled with a number N of doses of a product to be withdrawn therefrom, said medical container being provided with an opening for access to said product, the dose counting device comprising :

- a gripping member for securing the dose counting device to the medical container, said gripping member including a hole intended to face said opening when said dose counting device is coupled to said medical container,

- a counting ring rotatably mounted with respect to said gripping member, said counting ring being provided with information data corresponding to the N doses,

- a cover movable with respect to said hole between a closed position, in which said cover prevents access to said hole, and an open position, in which it does not prevent access to said hole.

The dose counting device of the invention is intended to be mounted on and coupled with a medical container, such as for example a conventional vial for storing pharmaceutical products, such as multidose vials for vaccines. Such a vial 1 is shown on Figures 1A-1 C and generally comprises a tubular barrel 2 having a longitudinal axis A, closed at an end and having a collar 3 at the opposite end, said collar 3 forming an opening 3a closed by a septum 4. Usually, the septum 4 is fixedly attached to the collar 3 of the vial 1 by a peripheral band 5, said peripheral band 5 leaving a part of the septum 4, herein called outer surface 4a of the septum, directly facing the outside of the vial 1 , namely the outside environment. The septum 4 is usually made of a material impermeable to gas and liquid and it seals hermetically the content of the vial 1 . The septum 4 is also pierceable by the needle of an injection device intended to be filled with the product contained in the vial, said septum 4 being accessible to said needle via its outer surface 4a.

Alternatively, the dose counting device could be used in combination with a medical container that has an opening not closed by a septum.

Although the following description describes the use of the dose counting device of the invention with a vial closed by a septum as shown on Figures 1 A-1 C, the dose counting device of the invention could be used in combination with, and mounted on, a medical container free of any septum. For example, the medical container may be a bottle, an ampoule, a flask or any other container usable in the medical field as long as it is provided with an opening for accessing the product it contains, regardless from the fact that this opening is closed or not by a septum.

The dose counting device of the invention allows the user to be informed of how many doses of product are left in the medical container, for example a vial, while maintaining good hygienic conditions during the withdrawal of doses of product from the medical container, for example a vial. Indeed, the dose counting device of the invention allows protecting the opening of the medical container, for example a vial, during the whole lifetime of the med ical container, for example a vial , namely du ring the successive withdrawals of the N number of doses of product initially present in the medical container, for example a vial. The good hygienic conditions of the medical container are therefore maintained.

The gripping member of the dose counting device of the invention may be any member capable of securing the dose counting device on the medical container, and in particular around the collar of the medical container, either in a temporary or permanent way. The connection of the gripping member to the medical container may be a lateral or an axial connection.

In embodiments, the dose counting device further comprises an incrementing system coupled to said cover and to said counting ring, said incrementing system allowing the counting ring to automatically rotate on a predetermined angle, each time said cover moves from its closed position to its open position and back to its closed position. In particular, in embodiments, the dose counting device further comprises an incrementing system coupled to said cover and to said counting ring, said incrementing system allowing the counting ring to automatically rotate on a predetermined angle, each time said cover moves from its open position to its closed position. The user therefore needs not rotating manually the counting ring , as said counting ring is automatically incremented each time the user moves the cover from its closed position to its open position, and back to its closed position, and preferentially each time the user moves the cover from its open position to its closed position. In such embodiments, the dose counting device is therefore a passive device, as the user just has to open the cover and close it again, the cover itself completing the increment of the dose counting. The counting is done by the handling of the cover.

In embodiments, said incrementing system comprises an active surface and said counting ring comprises a complementary active surface, said active surface engaging and cooperating with said complementary active surface so as to rotate said counting ring, when said cover moves back from its open position to its closed position.

The rotation of the counting ring, which is provided with information data corresponding to the N doses, is therefore dependent on a two-step process, namely moving the cover from its closed position to its open position in a first step, and moving the cover from its open position to its closed position in a second step, the rotation of the counting ring taking place only during the second step. Th is system therefore tolerates incomplete or accidental manipulation of the cover by the user while preserving the reliability of the information data corresponding to the N doses which may be displayed to the user. Indeed, since the counting ring rotates only during the second step, if the user, accidentally or not, performs the first step only partially, then the rotation of the counting ring will not take place and the information data corresponding to the N doses provided on the counting ring will not change. The user is therefore provided with accurate information on the counting ring and risks of confusion are eliminated.

In embodiments, said cover being movable in rotation around an axis R with respect to said gripping member when said cover moves from its closed position to its open position and vice-versa, said incrementing system comprises a part of a gear wheel located on said cover, said gear wheel being rotatable around axis R and being provided with a plurality of radial teeth capable of cooperating with a plurality of complementary radial teeth provided on the periphery of the counting ring, when said cover moves back from its open position to its closed position.

Alternatively, said cover being movable in translation with respect to said gripping member, when said cover moves from its closed position to its open position and vice-versa, said incrementing system comprises a flexible leg located on said cover, said flexible leg being capable of escaping a sloped surface of the periphery of said counting ring when said cover moves from its closed position to its open position, said flexible leg engaging a radial surface of said periphery of said counting ring when said cover moves back from its open position to its closed position. Said flexible leg therefore causes movement, namely rotation, of the counting ring during the second step of the process when the cover moves from its open position to its closed position.

Alternatively, in other embodiments, said cover being movable in translation with respect to said gripping member, when said cover moves from its closed position to its open position and vice-versa, said incrementing system comprises a flexible leg located on said cover, said flexible leg being capable of engaging a radial surface of said periphery of said counting ring when said cover moves from its closed position to its open position, thereby causing rotation of the counting ring.

In embodiments, the dose counting device further comprises a pierceable elastomeric piece fixed with respect to the gripping member and intended to face the opening of the medical container when said dose counting device is coupled to said medical container, regardless from the position of the cover. In embodiments, the pierceable elastomeric piece is lodged within the hole of the gripping member of the dose counting device.

In the present application, "pierceable" means that the septum and the elastomeric piece may be pierced and traversed by the needle of an injection device such as a syringe, an auto-injector, or a reconstitution device, in order to reach the opening of the vial and withdraw a dose of product therefrom.

In embodiments, the elastomeric piece is made of a gas and liquid impermeable material capable of flexing under pressure. For example, the elastomeric piece has a thickness ranging from 1 to 8 mm, preferably from 2 to 4 mm. The elastomeric piece may show a hardness ranging from 10 to 100 Shore A, preferably from 40 to 70 Shore A, measured according to standard DIN 53505.

Suitable materials for the pierceable elastomeric piece of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis- polybutad iene, chloro or bromobutyl ru bber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone ru bbers , h exafl uoropropyl en e-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.

In embodiments, the pierceable elastomeric piece is self-resealing. "Self-resealing" means in the present application that the elastomeric piece closes automatically and rapidly the hole produced by the piercing of the needle, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece. This automatic closure step may occur a high number of times, for example as many times as necessary for removing the N doses of products contained in the multidose med ical container. Th is automatic obstruction restricts or prevents air and/or contaminants from entering inside the medical container, but also at the interface between the elastomeric piece and the septum, and thus allows asepsis maintenance. Moreover, the presence of the pierceable elastomeric piece gives time to the septum of the medical container to reseal, as the needle is still present in the pierceable elastomeric piece after it is removed from the septum. As such, neither air nor contaminants may be introduced in the medical container, or at the interface between the elastomeric piece and the septum, even if the medical container is maintained under negative pressure after the withdrawal of one or more doses of product. In addition, the septum of the medical container may itself be self-resealing.

Suitable materials for self-resealing pierceable elastomeric piece include synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof.

The dose counting device of the invention therefore allows access to, and for example by piercing the septum of, the medical container in good hygienic conditions multiple successive times. Indeed, when the user decides to fill in an empty syringe with a dose of drug contained in the medical container, he simply secures the dose counting device of the invention on the medical container by means of the gripping member. Once the dose counting device is secured on the medical container, the hole of the dose counting device faces the open ing of the med ical container, and the pierceable elastomeric piece, if present within said hole, is in contact with the outer surface of the septum, if present, of the medical container. Then, the user just has to open the cover of the dose counting device which protects the septum and/or the pierceable elastomeric piece. As a consequence, introducing the needle in the medical container implies that the needle pierces and traverses the elastomeric piece in the first place. Du ring th is step, the need le mechanically rubs against the material forming the elastomeric piece and it is naturally cleaned, as the potential bacteria are wiped out from the needle when said needle penetrates the elastomeric piece. In addition, once the needle protrudes out of the elastomeric piece, it directly enters the septum of the medical container and may therefore not be contaminated by foreign elements.

The user may repeat the piercing step with the needle of a new empty injection device until all the doses contained in the medical container are removed. The dose counting device of the invention acts as a protection of the septum.

In embodiments, the dose counting device further comprises biasing means for forcing the cover in its closed position. The biasing means ensures that the dose counting device is not left in the open position of the cover for an extended period of time and therefore reduces the risk of contamination of the pierceable elastomeric piece and/or the septum of the medical container.

Another aspect of the invention is an assembly comprising a medical container comprising an opening and filled with a number N of doses of a product to be withdrawn therefrom via said opening and a dose counting device as described above. Said opening may be closed by a septum . In embodiments, when said dose counting device is coupled to said medical container, said pierceable elastomeric piece is in contact with said septum.

As such, whatever the piercing location of the pierceable elastomeric piece by the needle, the user is ensured that the distal tip of the needle will directly pierce the septum after being passed through the pierceable elastomeric piece. Therefore, said distal tip is not in contact with ambient air or with other elements that would be trapped between the outer surface of the septum and the surface of the pierceable elastomeric piece. In particular, in such embodiments, the outer surface of the septum and the surface of the pierceable elastomeric piece match each other in such a way that they are in intimate contact together on their entire surface and lead to a closed interface.

The septum is therefore protected by the pierceable elastomeric piece. R i s ks of contaminating the septum by the needle are therefore decreased. In embodiments, said opening being a collar closed by a septum, said gripping member comprises a cl ip capable of substantially surrounding said collar. The dose counting device is therefore well secured on the vial.

The present invention will now be described in greater detail based on the following description and the appended drawings in which :

Figures 1 A-1 C are respectively a perspective view, a partial side view and a partial cross section view of a conventional vial on which the dose counting device of the invention is to be mounted,

Figure 2 is an exploded perspective view of a first embodiment of the dose counting device of the invention,

Figure 3 is a perspective view from the bottom of a part of the gripping member of the dose counting device of Figure 2,

Figure 4 is a perspective view from the bottom of the cover of the dose counting device of Figure 2,

Figures 5A-5C are respectively a perspective view, a top view and a cross section view along line Ι-Γ of Figure 5B, of the dose counting device of Figure 2 once mounted on the vial of Figures 1 A-1 C, in the closed position of the cover,

Figures 6A-6C are respectively a perspective view, a top view and a cross section view along line ΙΙ-ΙΓ of Figure 6B, of the dose counting device of Figure 2 once mounted on the vial of Figures 1 A-1 C, in the open position of the cover,

Figure 7 is a top view of the dose counting device of Figures 6A- 6C, once the cover has moved back to its closed position,

Figure 8 is a perspective view of a second embodiment of the dose counting device of the invention, mounted on the vial of Figures 1 A-1 C, in the closed position of the cover,

Figure 9 is a perspective view the dose counting device of Figure 8, in the open position of the cover,

Figure 10 is a perspective view of a part of the gripping member of the dose counting device of Figures 8-9, Figure 1 1 is a perspective view of the cover of the dose counting device of Figures 8-9,

Figure 12 is an exploded perspective view of a third embodiment of the dose counting device of the invention,

Figure 13 is a bottom view of a part of the gripping member of the dose counting device of Figure 12,

Figure 14 is a bottom view from of the cover of the dose counting device of Figure 12,

Figures 15A-15C are respectively a top view, a perspective view, and a bottom view of the dose counting device of Figure 12, in the closed position of the cover,

Figures 16A-16C are respectively a top view, a perspective view, and a bottom view of the dose counting device of Figure 12, in the open position of the cover,

Figure 17 is a top view of the dose counting device of Figures 16A-

16C, once the cover has moved back to its closed position.

With reference to Figure 2 is shown an exploded view of a dose counting device 10 in accordance with a first embodiment of the invention, intended to be coupled on a multidose vial 1 as shown on Figures 1 A-1 C.

As mentioned above, although the following description describes the use of the dose counting device 10 of the invention with a vial 1 closed by a septum as shown on Figures 1 A-1 C, the dose counting device of the invention could be used in combination with, and mounted on, a medical container free of any septum. For example, the medical container may be a bottle, an ampoule, a flask or any other container usable in the med ical field as long as it is provided with an opening for access to the product it contains, regardless of the fact that this opening is closed by a septum or not.

With reference to Figure 2, the dose counting device 10 comprises a gripping member 20 intended to secure it onto the vial 1 , a counting ring 30 intended to provide information on the number of doses of product already withdrawn from the vial 1 and/or still left in the vial 1 , a cap 40, intended to be fixed with the gripping member 20, and a cover 50, intended to prevent or allow access to the opening 3a of the vial 1 , once the dose counting device 1 0 is coupled to said vial 1 .

With reference to Figure 2, the gripping member 20 will now be described in detail . The gripping member 20 comprises a U-shaped body 21 , having a partially tubular wall 22 showing a height suitable for surrounding the collar 3 of the vial 1 (see figures 5A-C), with two free ends 22a corresponding to the ends of the branches of the U, the U-shaped body 21 therefore forming a clipping member. Close to each free end 22a, the tubular wall 22 is provided on its outer surface with radial peg 23 (only one being visible on Figure 2). Each free end 22a is further provided with a distal front projection forming a radial rim 24. In an embodiment not shown, the tubular wall does not have any free ends but is a closed annular ring, forming another kind of clipping member with the collar of the vial.

Still with reference to Figure 2, the counting ring 30 is made of a flat cylinder 31 provided with a plurality of outer radial teeth 32 distributed along its periphery 31 a. The flat cylinder 31 is further provided with a central hole 33 dimensioned and shaped so as to fit around a distal collar 47 of cap 40 as will be described later in reference to Figure 3. In the example shown in figures 2-7, the dose counting device 1 0 is intended to be coupled to a multidose vial 1 filled with ten doses of product. As a consequence, the counting ring 30 is provided with information data corresponding to these ten doses of product to be withdrawn from the vial 1 : in this view, the flat cylinder 31 is provided with printed dig its 34 ind icating the numbers 1 to 1 0, these digits being regularly distributed along the circumference of the flat cylinder 31 .

With reference to Figures 2 and 3, the cap 40 will now be described in detail . The cap 40 comprises a transversal wall 41 having a substantially circular shape except for a right angle forming a corner 41 a. A circular rim 42 extends from the transversal wall 41 in the distal direction. A U-shaped skirt 43 extends from the circular rim 42 in the distal direction, the free ends 43a of the U forming an opening 43b of the skirt 43. Close to each free end 43a, the skirt 43 is provided on its outer surface with a recess 43c (only one being visible on Figure 2). The circular transversal wall 41 is provided with a central hole 44 and with a side hole 45 offset from the central hole 44 in the direction of the opening 43a of the U-shaped skirt 43. As will appear from the description below, the central hole 44 is intended to face the opening 3a of the vial 1 when the dose counting device 1 0 is coupled to the vial 1 . The transversal wall 41 is further provided in its corner 41 b with a corner hole 46. In an embodiment not shown, the skirt is a closed circular skirt extending from the circular rim 42 in the distal direction, and has no opening. With reference to Figure 3, the distal face of the transversal wall 41 is provided with a distal collar 47 extending from the edge of the central hole 44, and provided with a distal outer rim 47a. Still with reference to Figure 3, the U-shaped skirt 43 is provided on its inner wall with a corner transversal rim 48 facing corner hole 46. The corner transversal rim 48 is provided with a central hole 48a.

The cap 40 is sized and shaped for receiving therein the counting ring 30 and the gripping member 20 : as shown on Figures 2 and 5A, the counting ring 30 is imprisoned inside the circular rim 42 and the U-shaped skirt 43 is aligned on the U-shaped element 21 of the gripping member 20 when the dose counting device 1 0 is in use. In an embodiment not shown, where the shirt has a circular shape, the skirt is aligned on an annular body of the gripping member.

With reference to Figures 2 and 4, the cover 50 will now be described in detail. The cover 50 comprises a sheet 51 having substantially the shape of the transversal wall 41 of the cap 40, with a corner 51 b intended to face the corner 41 b of the transversal wall 41 . The sheet 51 is provided on its proximal face with a printed arrow 52 indicating the counter clockwise rotation of the sheet 51 with respect to a vertical axis 53 located at the corner 51 b. In addition, on the example shown, a large planar section 51 a is defined on the proximal face of sheet 51 , in order to have space to write information thereon or stick a label . The sheet 51 is provided with a side hole 55 intended to face side hole 45 of the transversal wall 41 of the cap 40, when the dose counting device 10 is in use. With reference to Figure 4, the d istal face of the sheet 51 is provided at its corner 51 b with a shaft 56 extending in the distal direction and aligned on vertical axis 53, said shaft 56 being terminated by a distal outer rim 56a. Proximally spaced from its distal outer rim 56a, the shaft 56 is provided with a semi-gear wheel 57, in other words a gear wheel provided with outer radial teeth only on half (180°) or less of its circumference, said radial teeth facing the outside of the sheet 51 , as shown on Figure 4.

The sheet 51 may be made of any material such as as high-density polyethylene, polypropylene, polyvinyl chloride, acrylonitrile-butadiene-styrene (ABS), silicon resin or any other rigid polymer. Alternatively, materials such as metal, wood or glass may be used.

The use of the dose counting device 10 in connection with a vial of figures 1 A-1 C will now be explained with reference to Figures 2-7. In the use position of the dose counting device 10 of the invention, namely when the dose counting device of the invention is coupled to the vial, the cover 50 may adopt a closed position (Figures 5A-C, 7) or an open position (Figures 6A-C).

With reference to Figures 5A-5C, the dose counting device 10 is shown once coupled to a vial 1 and in the closed position of the cover 50. In addition, on these Figures, the dose counting device 10 of Figures 2-4 is further provided with a pierceable elastomeric piece 60 lodged in central hole 44 of the cap 40 and traversing the central hole 33 of the counting ring 30 so as to come in contact with the outer surface 4a of the septum 4 of the vial 1 . The central hole 44 and the pierceable elastomeric piece therefore face the opening 3a of the vial 1 .

In the present application, "pierceable" means that the septum and the elastomeric piece may be pierced and traversed by the needle of an injection device such as a syringe, an auto-injector, or a reconstitution device, in order for the needle to access the inside of the vial and withdraw the doses of product.

The pierceable elastomeric piece 60 has globally the shape of a flat cylinder and is dimensioned and shaped so as to be received with in central hole 44 of the transversal wall 41 of the cap 40 with friction. The pierceable elastomeric piece 60 is made of a material impermeable to gas and liquid capable of flexing under pressure.

Suitable materials for the pierceable elastomeric piece 30 of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis- polybutadiene, chlroro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone ru b b e rs , h ex af l u o ro p ropylene-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butad iene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.

Prefera b l y , th e e l a sto m e ri c p i ece i s s el f-resealing and it automatically seals the hole produced by the piercing of the needle, automatically and rapidly, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece. This automatic closure step may occur a high number of times, in particular as many times as necessary for removing the number N doses of product initially present in the multidose vial 1 . Su itable materials for self-resealing pierceable elastomeric piece include synthetic polyisopren e , n atu ra l ru bber, s i l i con e ru bber, th ermo-plastic elastomers, or the like or a combination thereof.

In the use position of the dose counting device 10 of the invention, as shown on Figures 5A-5C, the flat cylinder 31 is snap-fitted on the cap 40, by means of its central hole 33 being engaged on the distal collar 47 of said cap 40, and being blocked in the distal direction by distal outer rim 47a of distal collar 47, the flat cylinder 31 being able to rotate with respect to said distal collar 47. In addition, the cap 40 is itself snap-fitted on the gripping member 20, by means of its recesses 43c being engaged in radial pegs 23 of the tubular wall 22 of U-shaped element 21 of the gripping member 20. As a consequence, the cap 40, as well as the central hole 44, are fixed with respect to the gripping member 20. In embodiments not shown, the cap 40 and the U-shaped element 21 cou ld be integrate and form one single element, namely the g ripping member.

In the use position of the dose counting device 10 of the invention, as shown on Figures 5A-5C, the cover 50 is linked to the cap 40 by means of shaft 56 traversing corner hole 46 of the transversal wall 41 and being snap- fitted into corner transversal rim 48 after distal outer rim 56a of said shaft 56 has overcome central hole 48a of said corner transversal rim 48. The shaft 56 is allowed to rotate within corner hole 46, around axis 53 in counter clockwise rotation direction indicated by arrow 52.

On Figures 5A-5C, the dose counting device 10 is coupled to vial 1 . In this view, the gripping member 20 has been mounted on the collar 3 of the vial in a sliding way, and the radial rims 24 now surround said collar 3, thereby securing the dose counting device 1 0 on the vial 1 . In this coupled position of the dose counting device 1 0 on the vial 1 , the central hole 44 , in wh ich is lodged pierceable elastomeric piece 60, is al ig ned on the septum 4 and opening 3a of the vial 1 .

In addition, in the closed position of cover 50, as shown on Figures

5A-5C, the central portion of the sheet 51 closes central hole 44, thereby preventing any access to said central hole 44 and to opening 3a of the vial 1 by the needle of an injection device. In this position also, the side hole 55 of the sheet 51 faces the side hole 45 of the cap 40 and the user is allowed to see one digit printed on the flat cylinder 31 of the counting ring 30. In the example shown, with reference to Figure 5B, the digit "10" is visible, meaning for example that no dose has been withdrawn yet from the vial 1 and that ten doses are left therein.

When the user is ready to withdraw a first dose of product, he rotates the cover 50 in the counter clockwise direction so as to cause a 180° rotation of said cover 50, as shown on figures 6A-6C, where the cover 50 is in its open position. As shown on these Figures, in this position of the cover 50, the central portion of the sheet 51 does not cover the central hole 44 of the cap 40 anymore and access to the central hole 44 and to the opening 3a of the vial 1 by a needle capable of piercing the pierceable elastomeric piece 60 and the septum 4 is no more prevented. In addition, the rotation of the cover 50 from its closed position to its open position has not caused any movement of the flat cylinder 31 , which still displays the figure "1 0" through side hole 45 of the cap 40 as shown on Figure 6B. Indeed, during this rotation of the cover 50, the shaft 56 and the semi gear wheel 57 have also completed a 180° rotation : as a consequence, as shown on Figure 6C, in the open position of the cover, an end tooth of the semi gear wheel 57 becomes engaged with an outer radial tooth 32 of the flat cyl inder 31 , but has not cooperated yet with the plurality of outer radial teeth 32 of flat cylinder 31 in order to cause the rotation of the counting ring 30.

Once the user has withdrawn the dose of product from the vial 1 , he continues the counter clockwise rotation of the cover 50 in order to bring the cover 50 back in its closed position so as to cover again and protect central hole 44 of cap 40. During this second 180° rotation of the cover from its open position to its closed position, the teeth of the semi gear wheel 57 cooperate with the outer radial teeth 32 of the flat cylinder 31 in which they are engaged. The flat cylinder 31 is therefore caused to rotate and the following digit of the flat cylinder 31 , namely digit "9" is now displayed through side holes 45 and 55 as shown on Figure 7.

In the embodiment shown on Figures 2-7, the shaft 56 and the semi gear wheel 57 together with the outer radial teeth 32 of the flat cylinder 31 form an incrementing system for automatically rotating the counting ring 30 on a determined angle each time the user moves the cover from its open position to its closed position . The rotation of the counting ring and the change of digit displayed in holes 45 and 55 are therefore dependent on a two-step process, namely moving the cover 50 from its closed position to its open position in a first step, and moving the cover 50 from its open position to its closed position in a second step, the rotation of the counting ring taking place only during the second step . Th is system therefore tolerates incompl ete or accidental manipulation of the cover 50 without imped ing the rel iability of the digit that indicates the number of remaining doses and which is displayed to the user. Indeed, since the counting ring 30 only rotates during the second step, if the user, accidentally or not, only partially performs the first step, then the rotation of the counting ring 30 will not take place and the digit indicating the number of remaining doses will not change. In addition, the position of the cover 50 with respect to the digit may be tailored by varying the number of teeth of the semi- gear wheel 57. For example, the digit may be changed only when masked by the cover 50 during the second step, i.e. when not visible by the user, so that the user is not disturbed by this changing, the new digit being further clearly visible by the user through holes 45 and 55 once the second step is over. The user is therefore provided with accurate information on how many doses of product are left in the vial and all risk of confusion is eliminated.

Furthermore, with such an incrementing system, the dose counting device has a very compact size. This small size is particularly valuable as multidose vials are usually stored in cold places, such as medical refrigerator or medical cold box having limited space capacity. Furthermore, the dose counting device of the invention is easy to handle even with a single hand as the rotation of the cover can be easily realized.

With reference to Figures 8-1 1 , is shown a dose counting device 1 10 in accordance with a second embodiment of the invention, in which no incrementing system is present, and in which the user may rotate the counting ring manually. The reference signs designating the same elements as in embodiment of Figures 2-7 have been maintained.

With reference to Figure 10, the cap 140 comprises a transversal wall 141 from which extends a skirt 143 in the distal direction. The transversal wall 1 41 is provided with a central hole144. The cap 140 is provided with a window 142 allowing the flat cylinder 31 of the counting ring 30 (see Figures 8 and 9) to be reached by the hand of the user. At its corner 141 b, the proximal face of the transversal wall 141 is provided with a shaft 146 extending in the proximal direction.

With reference to Figure 1 1 , the cover 150 comprises a sheet 151 provided with a corner hole 156 at its corner 151 b. On Figure 8, the dose counting device 1 10 is shown coupled to the vial 1 with the cover 150 in the closed position. The cover 150 is linked to the cap 140 by means of shaft 146 being lodged within corner hole 156. When the user is ready to withdraw a dose of product from the vial 1 , he rotates the cover 150 in the clockwise direction around the axis of shaft 146 and causes said cover 1 50 to complete a 1 80° rotation, as shown on Figure 9. In this open position of the cover, access to the central hole 1 44 and to the pierceable elastomeric piece 60, to the septum and to the opening 3a of the vial 1 is not prevented anymore and the user may withdraw a dose of product from the vial 1 .

Once the dose of product is withdrawn, the user continues the clockwise rotation of the cover 150 in order to bring the cover 150 back to its closed position. During this second 180° rotation of the cover 150 from its open position to its closed position, no cooperation occurred between the flat cylinder 31 and any part of the cover 150. As a consequence, the user must manually rotate the flat cylinder 31 so as to display the number of doses left in the vial 1 : the user is able to complete th is step as he may reach the flat cylinder 31 through window 142, as shown on Figures 8 and 9.

With reference to Figures 1 2-1 7 is shown a dose counting device 210 in accordance with a third embodiment of the invention, in which the cover is movable in translation with respect to the gripping member.

The dose counting device 210 is intended to be coupled on a multidose vial 1 as shown on Figures 1 A-1 C. As mentioned before, although the following description describes the use of the dose counting device 210 of the invention with a vial 1 closed by a septum as shown on Figures 1 A-1 C, the dose counting device of the invention could be used in combination with, and mounted on, a medical container free of any septum. For example, the medical container may be a bottle, an ampoule, a flask or any other container usable in the med ical field as long as it is provided with an opening for accessing the product it contains, regardless of the fact that th is open ing is closed by a septum or not.

Li ke previous em bod iments, the dose counting device 210 comprises a gripping member 220 intended to secure it onto the vial 1 , a counting ring 230 intended to provide information on the number of doses of product already withdrawn from the vial 1 and/or still left in the vial 1 , a cap 240, intended to be fixed with the gripping member 220, and a cover 250, intended to prevent or allow access to the opening 3a of the vial 1 , once the dose counting device 210 is coupled to said vial 1 .

With reference to Figure 12, the gripping member 220 comprises a U-shaped body 221 , having a partially tubular wall 222 showing a height suitable for surround ing the collar 3 of the vial 1 , with two free ends 222a corresponding to the ends of the branches of the U , the U-shaped body 221 therefore forming a clipping member. Close to each free end 222a, the tubular wall 222 is provided on its outer surface with radial peg 223 (only one being visible on Figure 12). Each free end 222a is further provided with a distal front projection forming a radial rim 224. In an embodiment not shown, the tubular wall does not have any free ends but is a closed annular ring, forming another kind of clipping member with a collar of a vial.

Still with reference to Figure 12, the counting ring 230 is made of a flat cylinder 231 provided with a pl u ral ity of outer rad ial projections 232 distributed along its periphery 231 a. Each radial projection 232 is provided with a sloped surface 232a and with a radial surface 232b. The flat cylinder 231 is further provided with a central hole 233 dimensioned and shaped so as to fit around a distal collar 247 (see Figure 13) of cap 240 in the same manner as that described for embodiment of Figures 2-7. Like in previous embodiments, the dose counting device 21 0 is intended to be coupled to a multidose vial 1 filled with ten doses of product. As a consequence, the counting ring 230 is provided with information data corresponding to these ten doses of product to be withdrawn from the vial 1 like in previous embodiments.

With reference to Figures 12 and 13, the cap 240 will now be described in detail . The cap 240 comprises a transversal wall 241 having a substantially rectangular shape. A rim 242 extends from the transversal wall 241 in the distal direction. A U-shaped skirt 243 extends from the rim 242 in the distal direction, the free ends 243a of the U form ing an opening 243b of the skirt 243. Close to each free end 243a, the skirt 243 is provided on its outer surface with a recess 243c and with an outer peg 249. The transversal wall 241 is provided with a central hole 244 and with a side hole 245 offset from the central hole 244 in the direction of the opening 243a of the U-shaped skirt 243. As will appear from the description below, the central hole 244 is intended to face the opening 3a of the vial 1 when the dose counting device 210 is coupled to the vial 1 . In an embodiment not shown, the skirt is a closed circular skirt extending from the circular rim 42 in the distal direction, and has no opening. With reference to Figure 13, the distal face of the transversal wall 241 is provided with a distal collar 247 extending from the edge of the central hole 244, and provided with a distal outer rim 247a. Still with reference to Fig ure 3, the in ner wal l of cap 240 is provided with an oblique leg 248 extending towards the center of the cap 240.

The cap 240 is sized and shaped for receiving therein the counting ring 230 and the gripping member 220 : as shown on Figures 12 and 15C, the counting ring 230 is imprisoned inside the circular rim 242 and the U-shaped skirt 243 is aligned on the U-shaped element 221 of the gripping member 220 when the dose counting device 210 is in use.

With reference to Figures 12 and 14, the cover 250 will now be described in detail . The cover 250 comprises a sheet 251 having substantially the shape of the transversal wall 241 of the cap 240. The proximal face of the sheet 251 is provided with a large flat surface 251 a in order to provide an area to write information thereon or stick a label . The sheet 251 is further provided with a distal skirt 252 capable of receiving the cap 240 : as will appear from the following description, the cap 240 is movable in translation with respect to the cover 250 along the direction of the free ends of the U of the U-shaped skirt 243. The sheet 251 is provided with a side hole 255 intended to face side hole 245 of the transversal wall 241 of the cap 240, when the dose counting device 210 is in use. With reference to Figure 14, the inner wall of the distal skirt 252 of the cover 250 is provided with a flexible leg 253 capable of deflecting from a rest position , in wh ich it extends towards the center of the cover 250 to a stressed position, in which it is aligned with the wall of the distal skirt 252 and in which it is lodged into a transversal window 254 of said wall (see Figure 12).

The lateral walls of the distal skirt 252 are further provided with a transversal window 256 distally spaced from transversal window 254.

The use of the dose counting device 210 will now be explained with reference to figures 12-17. For sake of clarity, the vial 1 is not shown on these figures, but it is meant that the dose counting device 210 is coupled on a vial as shown on Figures 1 A-1 C, via its gripping member 220, in the same manner as described for previous embodiments, and that the central hole 244 faces the opening 3a of the vial 1 .

In the use position of the dose counting device 210 of the invention, the flat cylinder 231 is snap-fitted on the cap 240, by means of its central hole 233 being engaged on the distal collar 247 of said cap 240, and being blocked in the d istal d irection by distal outer rim 247a of distal collar 247 , the flat cylinder 231 being able to rotate with respect to said distal collar 247. In addition, the cap 240 is itself snap-fitted on the gripping member 220, by means of its recesses 243c being engaged in radial pegs 223 of the tubular wall 222 of U-shaped element 221 of the gripping member 220. As a consequence, the cap 240, as well as the central hole 244, is fixed with respect to the gripping member 220. In embodiments not shown, the cap 240 and the U-shaped element 221 could be integrated and could form one single element, namely the gripping member.

In the use position of the dose counting device 210 of the invention, as shown on Figures 15A-15C, the cover 250 is linked to the cap 240 by means of the outer pegs 249 of cap 240 being received in translation into the distal transversal window 256 of cover 250. With reference to Figure 15C, the oblique leg 248 of cap 240 is in abutment aga inst a rad ial su rface 232b of one projection 232 of the flat cylinder 231 , thereby preventing the flat cylinder 231 to rotate in the counter clockwise direction with respect to this Figure 1 5C. In addition, the flexible leg 253 is in its rest position and is in abutment against a sloped surface 232a of another projection 232 of the flat cylinder 231 .

In the closed position of cover 250, as shown on Figures 15A-15C, the central portion of the sheet 251 closes central hole 244, thereby preventing any access to said central hole 244 and so to the opening of the vial by the needle of an injection device. In th is position also, the side hole 255 of the sheet 251 faces the side hole 245 of the cap 240 and the user is allowed to see one d ig it printed on the flat cyl inder 231 of the counting ring 230. I n the example shown, with reference to Figure 15A, the digit "10" is visible, meaning for example that no dose has been withdrawn yet from the vial and that ten doses are left therein.

When the user is ready to withdraw a first dose of product, he pushes the cover 250 in the direction of the arrow F1 shown on Figure 15C, so as to move it to its open position, as shown on Figures 1 6A-16C. As shown on these Figures, in this position of the cover 250, the side hole 255 of the sheet 251 comes in regards to the central hole 244 of the cap 240 and access to the central hole 244 and to the open ing of the vial by a n eed le is no more prevented. In addition, the translation of the cover 250 from its closed position to its open position has not caused any movement of the flat cylinder 231 , wh ich still d isplays the figure "1 0" through side hole 245 of the cap 240 as shown on Figure 16A. Indeed , during th is translation of the cover 250, the flexible leg 253 has been caused to deflect inside the transversal window 254 by adjacent projection 232 of the flat cylinder 231 , said flat cylinder 231 being prevented from rotating in the counter clockwise direction with respect to Figure 1 6C, by means of the obl ique leg 248 being in abutment against a rad ial surface 232b of one projection 232. Once the cover 250 has reached it open position as shown on Figures 16A-C, the flexible leg 253 has escaped adjacent projection 232 and has come back to its rest position, as shown on Figure 16C.

Once the user has withdrawn the dose of product from the vial, he pushes back the cover 250 in the direction of the arrow F2 shown on Figure 16C order to bring the cover 250 back in its closed position so as to cover again and protect central hole 244 of cap 240. During this return translation of the cover 250 from its open position to its closed position, the free end of the flexible leg 253 comes in abutment against the rad ial surface of adjacent projection 232, and pushes on said radial surface 232b. The flat cylinder 231 is therefore caused to rotate in the clockwise direction with respect to Figure 16C, and the following digit of the flat cylinder 231 , namely digit "9" is now displayed through side holes 245 and 255 as shown on Figure 17. The translation movement of the cover 250 is easy to realize and the user can open and close the cover 250 of the dose counting device 210 with a single hand.

In another embodiment (not shown), the dose counting device 210 is provided with biasing means, such as a spring, forcing the cover 250 in its closed position. This spring ensures that the dose counting device is not left in the open position of the cover for an extended period of time and therefore reduces the risk of contamination of the pierceable elastomeric piece and/or the septum.

In the embodiment shown on Figures 12-17, the flexible leg 253, the oblique leg 248 together with the projections 322 of the flat cylinder 231 form an incrementing system for automatically rotating the counting ring 230 on a determined angle each time the user moves the cover from its open position to its closed position. As seen above, the rotation of the counting ring and the change of digit displayed in holes 245 and 255 are therefore dependent on a two-step process, namely moving the cover 250 from its closed position to its open position in a first step, and moving the cover 250 from its open position to its closed position in a second step, the rotation of the counting ring taking place only during the second step. This system therefore tolerates incomplete or accidental manipulation of the cover 250 without impeding the reliability of the digit that indicates the number of remaining doses and which is displayed to the user. Indeed, since the counting ring 230 rotates only during the second step, if the user, accidentally or not, only partially performs the first step, the rotation of the counting ring 230 will not take place and the digit indicating the number of remaining doses will not change. The user is therefore provided with accurate information on how many doses of product are left in the vial and all risk of confusion is eliminated.

In other embodiments not shown, the flexible leg may be capable of engaging a radial surface of the periphery of the counting ring when the cover moves from its closed position to its open position, thereby causing rotation of the counting ring. As an example, this embodiment could be useful to indicate to the user how many times the cover has been opened.

The dose counting device and assembly of the invention allow piercing the septum of a multidose vial yielding favorable hygienic and aseptic conditions multiple successive times while providing the user with accurate information on how many doses of product are left in the vial, as the counting ring may be automatically incremented each time a user moves the cover from its closed position to its open position, and then back to its closed position.

Additionally, in all the previous described embodiments of the dose counting device of the present invention, the dose counting device may be provided with a time monitoring system (not shown). Indeed, the content of the vial may be considered as contaminated after a l im ited period of time, for example until 28 to 30 days. Therefore, a time monitoring system may be added to the dose counting device accord ing to the invention in order to monitor the elapsing time from the first dose withdrawing or to indicate to the user what is the time remaining before the 28 or 30 days deadline.

Th is time monitoring system may be an el ectron ic timer or a system based on the diffusion of ink into a circuit. For example, the elapsing or remaining time can be mon itored by the kinetic of in k prog ression in a microfluidic circuit. Such systems are particularly attractive because they are small and reliable. For example, such a system could be integrated onto the large central planar section 51 a of the dose counting device 10 or onto the large flat surface 251 a of the dose counting device 210. Some time monitoring systems are commercially available under the trademark Timestrip®. Furthermore, the time monitoring system could be triggered either manually by the user or automatically. An automatic trigger could occur when the dose counting device is mounted on the col lar 3 of the vial 1 wh ich assumes a first dose withdrawing shortly afterwards. For example, such time monitoring system could be under the form of a label, sticked onto the dose counting device (10; 21 0) and could be triggered by an additional peg (not shown) placed into a bl ister intended to come in contact with the time monitoring system and therefore activate it when the user applies a distal pressure on said blister.

Such a system could prevent the injection of potentially expired vaccines or drugs to patients, but could also facilitate the supply chain or stock management in drugstores or even avoid wastage of valuable drugs and vaccines by encouraging the use of the first opened vials.

The user may repeat the piercing step with the needle of a new empty syringe until all the doses contained in the vial are removed. The dose counting device of the invention acts as a protection of the septum of the vial during the lifetime of the vial.

When present, the pierceable elastomeric piece and the septum of the medical container are in contact, for example in tight contact, once the dose counting device is secured onto the medical container. In embodiments where both the pierceable elastomeric piece and the septum of the medical container are self-resealing, no possibility of communication exist between the inside of the medical container and the outside environment at the time the needle of the injection device is removed from both the septum and the pierceable elastomeric piece, after withdrawal of a dose of product from the medical container. This therefore restricts or prevents the product contained in the medical container from being contaminated by outside contaminants such as bacteria, unpurified water, particles, viruses, etc... The dose counting device of the invention thus allows a hermetic sealing of the contents of the medical container it is secured on, even during the removal of the needle. The inside of the medical container is kept in aseptic conditions before, during and after a withdrawal of a dose from the medical container.

This dose counting device of the invention is very easy to use as it can be used with a single hand. Additionally, the dose counting device of the invention is very reliable as no battery neither electronic system are used avoiding any disturbance within time. Furthermore, during an immunization campaign, with the dose counting device of the invention, the number of injected doses can be quickly compared to the number of expected patients, thus ensuring that each patient received a dose of vaccine. Finally, the stock management is facilitated for drugstores and the supply chain can be optimized to reduce medicine wastage.