Patent Grant
9713574
This application is the United States national phase of International Application No. PCT/EP2013/066160 filed Aug. 1, 2013, and claims priority to European Patent Application No. 12305971.9 filed Aug. 3, 2012, the disclosures of which are hereby incorporated in their entirety by reference.
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vial containing a pharmaceutical product, such as a vaccine, said dose counting device allowing for counting the doses withdrawn from the medical container in an aseptic manner.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
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
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 medical container, for example a vial, namely during 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. This 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-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-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 medical container. This 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 opening of the medical 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. During this step, the needle 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. Risks 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 clip 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:
With reference to
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
With reference to
With reference to
Still with reference to
With reference to
With reference to
The cap 40 is sized and shaped for receiving therein the counting ring 30 and the gripping member 20: as shown on
With reference to
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
With reference to
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 within 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 rubbers, hexafluoropropylene-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.
Preferably, the elastomeric piece is self-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. 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.
In the use position of the dose counting device 10 of the invention, as shown on
In the use position of the dose counting device 10 of the invention, as shown on
On
In addition, in the closed position of cover 50, as shown on
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
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
In the embodiment shown on
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
With reference to
With reference to
On
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 this step as he may reach the flat cylinder 31 through window 142, as shown on
With reference to
The dose counting device 210 is intended to be coupled on a multidose vial 1 as shown on
Like previous embodiments, 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
Still with reference to
With reference to
With reference to
The cap 240 is sized and shaped for receiving therein the counting ring 230 and the gripping member 220: as shown on
With reference to
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
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 distal direction 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
In the closed position of cover 250, as shown on
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
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
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
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 limited period of time, for example until 28 to 30 days. Therefore, a time monitoring system may be added to the dose counting device according 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.
This time monitoring system may be an electronic timer or a system based on the diffusion of ink into a circuit. For example, the elapsing or remaining time can be monitored by the kinetic of ink progression 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 51a of the dose counting device 10 or onto the large flat surface 251a 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 collar 3 of the vial 1 which 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; 210) and could be triggered by an additional peg (not shown) placed into a blister 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.
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| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2013/066160 | 8/1/2013 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
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| WO2014/020099 | 2/6/2014 | WO | A |
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