Patent Publication Number: US-9889978-B2

Title: Protective cap for a dispenser and dispenser for discharging pharmaceutical and/or cosmetic liquids

Description:
APPLICATION AREA AND PRIOR ART 
     The invention relates to a protective cap for a dispenser and to a dispenser for discharging pharmaceutical and/or cosmetic liquids. Such a dispenser comprises a liquid reservoir and an exit opening, through which the liquid can be discharged into a surrounding atmosphere. 
     A liquid stored in the liquid reservoir is fed in the direction of the exit opening in order to be discharged, it being possible for this to take place by way of a large number of different mechanisms. For example, the liquid reservoir may be designed in the form of a squeeze bottle, of which the contents can be subjected to pressure as a result of the walls being deformed. It is also possible to use a separate pumping device. 
     Dispensers of the type in question are known from the prior art, for example from DE 10 2011 086 755 A1. The dispenser comprises an outlet channel and an outlet valve, which is arranged in the outlet channel and opens in a pressure-dependent manner or is manually actuable, wherein the outlet valve, in the closed state, closes the outlet channel. The outlet valve subdivides the outlet channel here into a first part and a second part, wherein the second part, adjacent to the exit opening, extends in the direction of the liquid reservoir. In other configurations, the second part corresponds to a droplet-forming surface at the exit opening. 
     As a result of the outlet valve, it is always the case that, following closure of the same, it is not possible for any liquid which has passed into a portion of the outlet channel on an outlet-valve side directed away from the liquid reservoir, or which has remained in the surroundings of the exit opening outside the outlet channel, to be sucked back into the dispenser. This therefore prevents the contents of the liquid reservoir from possibly being contaminated by liquid residues which have been sucked back. The residual liquid therefore remains in a region which is accessible from the outside. Upon contact with the atmosphere, the residual liquid dries up quickly. 
     In order also to make it possible for the residual liquid to dry up quickly when a protective cap is placed in position on the dispenser, DE 10 2011 086 755 A1 discloses providing the protective cap of the dispenser with ventilation openings which create a permanent connection between the region in which residual liquid can remain and exterior surroundings. However, it is possible for the ventilation openings, for their part, to cause contamination again. 
     In order to avoid contamination, DE 10 2011 086 755 A1 makes provision for surfaces of the outlet channel downstream of the outlet valve, as seen in the discharging direction, and/or an outer surface of a housing which surrounds the exit opening to be of antibacterial design, wherein the antibacterial design is restricted exclusively to these surfaces. 
     PROBLEM AND SOLUTION 
     It is an object of the invention to make available a protective cap which is intended for a dispenser, allows rapid drying and which alleviates the problem of microorganisms penetrating into the protective cap. A further object of the invention is that of making available a dispenser with a corresponding protective cap. 
     A first aspect of the invention provides for a protective cap for a dispenser for discharging pharmaceutical and/or cosmetic liquids, wherein the dispenser has a liquid reservoir and an exit opening, through which the liquid can be discharged into a surrounding atmosphere, and wherein the protective cap has at least one ventilation opening in order for an interior to communicate with exterior surroundings, and the protective cap has arranged on it an irreversibly removable sealing element, which covers the at least one ventilation opening and by means of which the at least one ventilation opening is closed in an air-tight and germ-proof manner prior to the dispenser being used for the first time. 
     A second aspect of the invention provides for a discharging device comprising a dispenser for discharging pharmaceutical and/or cosmetic liquids, having a liquid reservoir and having an exit opening, through which the liquid can be discharged into a surrounding atmosphere, and having a protective cap, which has at least one ventilation opening in order for an interior to communicate with exterior surroundings, wherein the protective cap has arranged on it an irreversibly removable sealing element, which covers the at least one ventilation opening and by means of which the at least one ventilation opening is closed in an air-tight and germ-proof manner prior to the dispenser being used for the first time. 
     The sealing element prevents germs from being introduced into an interior of the protective cap via the at least one ventilation opening prior to the dispenser being used for the first time, without it being necessary to put special measures in place for storage, transportation, etc. In other words, the sealing element prevents germs from being deposited on the dispenser and in the interior of the protective cap over the course of time, during storage, transportation, etc., even prior to the dispenser being used for the first time. Before or after the dispenser is used for the first time, the sealing element is removed so that, during subsequent usage, the residual liquid can dry up rapidly. On account of the dispenser being used for only a short period of time, any possible introduction of germs following initial use is not usually critical. 
     Germs within the context of the present invention are to be understood as being all microbial pathogens, in particular bacteria and viruses. A germ-proof and air-tight closure within the context of the application denotes a sealing arrangement in which the leakage rate is less than or equal to 10 −6  mbar l/s when the dispenser is stored under normal or standard conditions. The germ proofing is tested, for example, in accordance with DIN 58953. In other configurations, the sealing element is designed so as to satisfy the measured stipulated by standards DIN EN ISO 11607 and/or DIN EN ISO 11868. 
     The dispenser is suitable, in particular, for unpreserved ophthalmic preparations. In advantageous configurations, the dispenser has an outlet channel, which connects the liquid reservoir to the exit opening, and an outlet valve, which opens in a pressure-dependent manner or is manually actuable, wherein the outlet valve is arranged in the outlet channel and, in a closed state, closes the outlet channel. The outlet valve here prevents germs from penetrating into the liquid reservoir. The outlet valve is preferably an outlet valve which opens in a pressure-dependent manner and is opened by the liquid in the liquid reservoir, or an amount removed therefrom, being subjected to pressure and closes automatically again as soon as the corresponding positive pressure in relation to the surroundings is no longer present. It is also possible in principle here, however, to use other types of valves. Provision may thus be made, for example, for the liquid in the liquid reservoir to be subjected permanently to pressure and for the dispenser to be handled by way of a handle which is actuated manually to open the outlet valve. The outlet valve prevents discharged liquid from being sucked back into the liquid reservoir. The at least one ventilation opening on the protective cap causes said residual liquid to dry up rapidly. 
     In advantageous configurations, provision is made for the protective cap to comprise a cylindrical portion and a cover portion connected thereto, wherein the at least one ventilation opening is provided on the cylindrical portion and/or on the cover portion. In one configuration, the cylindrical portion has, on its inner wall, a latching geometry for latching to the dispenser and/or a clamping region which comes into contact with the dispenser. If the at least one ventilation opening is provided on the cylindrical portion, the region of the ventilation opening preferably does not coincide with the region of the latching geometry or the clamping region. The ventilation openings are preferably arranged in a region which, when the protective cap is in use, is arranged essentially in the region of the exit opening of the dispenser. 
     In one configuration, provision is made for the sealing element to be designed in the form of a pull-off, air-tight and germ-proof adhesive label. An adhesive label or sticky label within the context of the application denotes an element which has one or more layers and a non-adhesive upper side and an adhesive underside. In order to avoid contamination, the adhesive label, in advantageous configurations, can be pulled off cleanly. An adhesive for the adhesive label can be selected appropriately by a person skilled in the art, it being necessary to adhere to legal requirements on account of a liquid or the like being stored in the dispenser. An adhesive is preferably selected such that it is not possible for the adhesive label to re-adhere. Within the context of the application, however, an adhesive label which, contrary to normal practice, is re-fitted to cover the ventilation opening is denoted as being an irreversibly removable sealing element. In one configuration, an adhesive-label region which is arranged directly in the region of the exit opening when adhesion takes place has no adhesive. 
     The adhesive label is arranged on an inner side and/or an outer side of the protective cap, in the region of the at least one ventilation opening. In one configuration, the adhesive label extends over a region which surrounds the ventilation opening(s). In other configurations, the adhesive label extends over further regions. The adhesive label preferably exhibits text with instructions for use or the like. The adhesive label is preferably of sufficiently large dimensions for the text to be easily readable. 
     In one configuration, the adhesive label is connected to a tamperproof seal, so that the adhesive label is pulled off when the tamperproof seal is removed. As an alternative, or in addition, the adhesive label, in advantageous configurations, has a tear-open lug, by means of which a user grips the adhesive label in order to pull it off. 
     In another configuration, the sealing element is designed in the form of an air-tight and germ-proof film wrapper. The film wrapper here, in one configuration, covers merely the protective cap. The film wrapper can thus be fitted on the protective cap prior to the protective cap being latched on to the dispenser. In other configurations, the film wrapper covers the protective cap and the dispenser. The film wrapper, in one configuration, is designed in the form of a band which is wrapped around the protective cap or around the protective cap and the dispenser. 
     In advantageous configurations, the film wrapper is designed in the form of a wraparound film label which is closed on one side or is in the form of a sleeve. A wraparound film label within the context of the application denotes a tubular film into which the protective cap, or the dispenser with the protective cap, is introduced. Following introduction thereof, in advantageous configurations, shrink-fitting takes place. 
     As an alternative, or in addition, to shrink-fitting, the film wrapper, in advantageous configurations, is welded to the protective cap. The weld seam ensures air tightness and germ proofing. A weld seam here is arranged separately from a ventilation opening. This means that any residues which may possibly remain on the protective cap once the film wrapper has been torn off do not present a hazard. 
     In yet another configuration, the sealing element is designed in the form of a pull-off lug which is injection molded on the protective cap. The pull-off lug here can be produced along with the protective cap in the form of an integral constituent part of the same. It is thus possible to dispense with additional assembly steps or other production steps. In one configuration, the pull-off lug is coupled to a tamperproof seal, and this results in particularly straightforward handling for a user. 
     Following removal of the sealing element, the at least one ventilation opening provides for rapid drying. In order to alleviate the problem of germs being introduced via said ventilation opening, one configuration provides an antibacterial configuration of the surfaces, as is known from DE 10 2011 086 755 A1. Reference is made in full here to the contents of DE 10 2011 086 755 A1. 
     As an alternative, or in addition, an inner side of the protective cap has provided on it, in the region of the at least one ventilation opening, an absorber element, in particular an absorber element with filter properties, such as a microfiltration membrane or an ultrafiltration membrane. The absorber element assists in drying the dispenser by virtue of absorbing and distributing the residual droplet. In one configuration, the absorber element additionally has filter properties, in particular a microfiltration membrane or an ultrafiltration membrane is provided. This reduces the introduction of germs via the ventilation openings once the sealing element has been removed. A microfiltration membrane within the context of the application denotes a microporous membrane which has an average pore diameter or a cutoff of approximately 0.1 μm to approximately 0.3 μm, preferably approximately 0.2 μm. Bacteria have a size of approximately 0.2 to approximately 5 μm, and can therefore be filtered out efficiently by means of a microfiltration membrane. An ultrafiltration membrane within the context of the application denotes a microporous membrane which has an average pore diameter or a cutoff of approximately 10 nm. This means that viruses of a size of 15 nm can also be filtered out. The absorber element is configured, for example, in the form of a sponge-like element, woven fabric or membrane. In one configuration, the absorber element is made of a material from the group comprising polysulfone, polyethersulfone, cellulose, cellulose derivatives, polyvinylidene fluoride, polyamide, polyester and polyacrylonitrile and/or combinations thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further advantages and aspects of the invention can be gathered not just from the claims, but also from the following description of preferred exemplary embodiments of the invention, which will be explained hereinbelow with reference to the figures. The drawings use like reference signs to denote the same or similar components. Features illustrated or described as part of an exemplary embodiment can likewise be used in a different exemplary embodiment in order to achieve a further embodiment of the invention. In the drawings: 
         FIG. 1  shows a sectional illustration of a dispenser for discharging pharmaceutical and/or cosmetic liquids, 
         FIG. 2  shows a first exemplary embodiment of a protective cap for the dispenser according to  FIG. 1 ; 
         FIG. 3  shows a second exemplary embodiment of a protective cap for the dispenser according to  FIG. 1 ; 
         FIG. 4  shows an overall perspective illustration of a discharging device comprising a dispenser and a protective cap, 
         FIG. 5  shows a sectional illustration of the discharging device according to  FIG. 4 , 
         FIG. 6  shows an overall perspective illustration of an alternative configuration of a discharging device comprising a dispenser and a protective cap, 
         FIG. 7  shows a sectional illustration of the discharging device according to  FIG. 6 , 
         FIG. 8  shows a further exemplary embodiment of a protective cap for the dispenser according to  FIG. 1 , and 
         FIG. 9  shows yet another exemplary embodiment of a protective cap for the dispenser according to  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS 
       FIG. 1  shows, in the first instance, a dispenser  2  which is intended for discharging pharmaceutical and/or cosmetic liquids and is suitable, in particular, for unpreserved ophthalmic preparations. 
     Said dispenser  2  has a liquid reservoir  21 , which is delimited by a container body  20 . The liquid  4  is stored in the liquid reservoir  21 . An outlet subassembly  22  has been placed in position, and fastened by means of a latching connection, on the container body  20 . Said outlet subassembly  22  serves for directing liquid from the liquid reservoir  21  to an exit opening  24  through an outlet channel  23 . The exit opening  24  illustrated is configured in the form of a droplet-forming surface and widens conically in the discharging direction. 
     On account of the section plane in  FIG. 1 , the latter illustrates merely a final part of the outlet channel  23 . The outlet channel  23  has arranged in it an outlet valve  25  which, in a closed state, closes the outlet channel  23 , and therefore liquid located downstream of the outlet valve  25 , as seen in the discharging direction, cannot pass back into the liquid reservoir  21 . The outlet valve  25  illustrated comprises a valve body  27 , which can be adjusted counter to the force of a restoring spring  26  and interacts with a valve seat  28  formed on a housing wall. Air flows into the liquid reservoir  21 , for pressure-equalization purposes, via a filter element  29 . In advantageous configurations, the filter element  29  comprises a liquid filter, which is oriented in the direction of the liquid reservoir  21 , and a bacteria filter, which is oriented away from the liquid reservoir  21  and has a cutoff of approximately 0.2 μm, so that bacteria of a size of approximately 0.2 to approximately 5 μm are reliably held back by the bacteria filter. 
     The dispenser  2  illustrated is configured in the form of a so-called squeeze bottle. Said dispenser  2  is used by being placed upside down with the exit opening  24  oriented downward. Thereafter, walls of the container body  20  are pressed together in order for the liquid  4  in the liquid reservoir  21  to be subjected to pressure. This pressure causes the outlet valve  25  to open. More specifically, as soon as the liquid pressure in a part of the outlet channel  23  upstream of the outlet valve  25  is sufficiently high, the valve body  27  shifts counter to the force of the restoring spring  26  as a result of said pressure and frees the path for the liquid in the direction of the exit opening  24 . 
     Following a discharging operation, the outlet valve  25  is closed again. It is usual here for a residue of the liquid, the so-called residual droplet, to remain at the exit opening  24 , configured in the form of the droplet-forming surface, and in a part of the outlet channel  23  assigned to the exit opening  24  and located downstream of the outlet valve  25  as seen in the discharging direction. The outlet valve  25 , which opens in a pressure-dependent manner, precludes any possibility of the liquid flowing back into the liquid reservoir  12 . 
     Without a protective cap being placed in position, the residual droplets can dry up rapidly. In order to make it possible for rapid drying also to take place when the protective cap has been placed in position, protective caps of the type in question have at least one ventilation opening. 
       FIGS. 2 and 3  show a first and a second exemplary embodiment of a protective cap  3  for the dispenser  2  according to  FIG. 1 . The protective caps  3  illustrated each have a plurality of ventilation openings  30  in order for an interior  31  to communicate with exterior surroundings. The protective caps  3  each comprise a cylindrical portion  32  and a cover portion  33  connected thereto. In the case of the protective cap  3  according to  FIG. 2 , the ventilation openings  30  are provided on the cylindrical portion  32 . In the case of the protective cap  3  according to  FIG. 3 , the ventilation openings  30  are provided on the cover portion  33 . The number of ventilation openings  30  can be selected appropriately in each case by a person skilled in the art. In preferred embodiments, the protective caps  3  according to  FIGS. 2 and 3  each have four uniformly distributed ventilation openings  30 . The protective caps  3  are each produced in the form of an injection molding and have a tamperproof seal  34 , which is to be removed when the dispenser is used for the first time. In addition, latching elements  35  for latching to the dispenser  2  according to  FIG. 1  are provided on an inner wall. The latching elements  35  here are configured such that they prevent the protective cap  3  from being removed, and/or the outlet subassembly  22  from being pulled off, from the container body  20  without the tamperproof seal  34  being removed. The protective cap  3 , in addition, is configured such that it is possible for the protective cap  3  to be repeatedly removed from the dispenser  2  and be placed in position with clamping action thereon. For this purpose, the protective cap  3  is deformed to a slight extent when being placed in position, and therefore the elastic restoring forces of the protective cap  3  produced from plastics material generate a clamping action. In other configurations, latching elements are provided for this purpose. 
     According to the application, the protective cap  3  has arranged on it an irreversibly removable sealing element, which covers the ventilation openings and by means of which the ventilation openings  30  are closed in an air-tight and germ-proof manner prior to the dispenser being used for the first time. In other words, the sealing element prevents germs from being introduced into an interior  31  of the protective cap  3  via the ventilation openings  30  prior to the dispenser being used for the first time. 
     In the embodiments according to  FIGS. 2 and 3 , the sealing element is designed in the form of an air-tight and germ-proof film wrapper  5 . 
     The film wrapper  5  according to  FIG. 2  is configured in the form of a wraparound film label which is in the form of a sleeve and is provided on the cylindrical portion  32 , in the region of the ventilation openings  30 . The film wrapper  5  illustrated is welded to the protective cap  3  along the peripheral regions  50 . The film wrapper  5  preferably has a lug or the like (not illustrated), which can be gripped for the purpose of removing the film wrapper  5 . 
     The film wrapper  5  according to  FIG. 3  is configured in the form of a closed wraparound film label and covers essentially the entire protective cap  3 . The film wrapper  5  illustrated is connected to the tamperproof seal  34 , for example it is welded or adhesively bonded thereto and can thus be removed therewith. 
       FIGS. 4 to 7  show two configurations of a discharging device  1  comprising a dispenser  2  according to  FIG. 1  and a protective cap  3  in an overall perspective illustration ( FIGS. 4 and 6 ) and a sectional illustration ( FIGS. 5 and 7 ). For a description of the dispenser  2 , you are referred to the text above. The protective cap  3  according to  FIGS. 4 to 7  likewise corresponds essentially to the protective cap  3  according to  FIGS. 2 and 3 , and like reference signs are used for the same or similar components. 
       FIG. 8  shows a protective cap  3  similar to  FIG. 3  with ventilation openings  30  provided on the cover portion  33 . 
     In the embodiments according to  FIGS. 4 to 8 , the sealing element is designed in the form of an air-tight and germ-proof adhesive label  6 . 
     According to the configurations of  FIGS. 4 to 7 , an adhesive label  6  is arranged on an outer side of the protective cap  3 , in the region of the ventilation openings  30 . In the case of the configuration according to  FIG. 8 , the adhesive label  6  is arranged on an inner side of the protective cap  3 , in the region of the ventilation openings  30 . 
     In the case of the protective cap  3  according to  FIGS. 4 and 5 , the ventilation openings  30  are provided in the cover portion  33  and the strip-form adhesive label  6  extends from a region which surrounds the ventilation openings  30  in the cover portion  33 , via a region running parallel to the longitudinal axis of the protective cap  3 , to the tamperproof seal  34 . The adhesive label  6  according to  FIGS. 4 and 5  is thus of sufficiently large dimensions to allow for text with instructions for use or the like (not illustrated). The adhesive label  6  is also connected to the tamperproof seal  34 , so that the adhesive label  6  can be released when the tamperproof seal is removed, and can therefore easily be pulled off by a user. In addition, the adhesive label  6  has a tear-open lug  60 , by means of which a user can grip the adhesive label  6  in order to pull it off. 
     In the case of the protective cap  3  according to  FIGS. 6 and 7 , the ventilation openings  30  are likewise provided in the cover portion  33 . However, the strip-form adhesive label  6 , rather than extending to the tamperproof seal  34 , extends only over a region which surrounds the ventilation openings  30  in the cover portion  33 . A tear-open lug  60  is provided for the removal of the adhesive label  6 . The cover portion  33  has an aperture  330 , by way of which it is ensured that the tear-open lug  60  can be gripped straightforwardly. 
     It is also the case for the protective cap  3  according to  FIG. 8  that the ventilation openings  30  are provided in the cover portion  33 . The strip-form adhesive label  6  is fitted on an inner side of the cover portion  33  and has a tear-open lug  60  for removal purposes. On account of the complex handling, this ensures that a user, once he has pulled off the adhesive label  6 , cannot fit the latter on the inner side again. In advantageous configurations, the adhesive label  6  is fitted such that, when the protective cap  3  is pulled off in order for the dispenser to be used for the first time, the adhesive label is at least released, and preferably pulled off altogether, automatically, i.e. without any additional measures being taken by the user. 
       FIG. 9  shows a protective cap  3  similar to  FIGS. 3 and 8  with ventilation openings  30  provided on the cover portion  33 , wherein the sealing element is designed in the form of a pull-off lug  7  injection molded on the protective cap  3 . The protective cap  3  and the pull-off lug  7  can be produced in the form of a joint component, in particular in the form of an injection molding. It is preferable here for predetermined breaking points in the form of material weakenings  7 ′ or the like to be provided in a predetermined breaking region between the pull-off lug  7  and the protective cap  3 . The pull-off lug  7  illustrated here has a projecting end which can be gripped by the user. In a different configuration, the pull-off lug  7  is coupled to the tamperproof seal  34 , so that removal of the tamperproof seal causes the pull-off lug to be removed. This results in particularly straightforward handling for a user. 
     Once the sealing element  5 ,  6 ,  7  has been removed, the ventilation openings assist in rapid drying. In addition—as illustrated by way of example in  FIGS. 4 to 7 —in one configuration, an absorber element  8 , which assists in rapid drying of the dispenser  2  as a result of the liquid being transported away, is provided on an inner side of the protective cap  3 , in the region of the ventilation openings. The absorber element  8  has hydrophilic properties. The residual droplet is absorbed and distributed by the absorber element, and this therefore ensures rapid drying. In the exemplary embodiment illustrated, the absorber element  8  is arranged parallel to the cover portion  33 , and covers the ventilation openings  30 . In the exemplary embodiment illustrated, for the purpose of fastening the absorber element  8 , latching arms  37  are provided on the protective cap  3 , on an inner side of the cover portion  33 . As can be seen in  FIGS. 5 and 7 , when the protective cap  3  is in the latched-on state, the absorber element  8  is in contact with a point at the top of the dispenser  2 , assigned to the exit opening  24 . 
     Once the sealing element  5 ,  6 ,  7  has been removed, a usually tolerable introduction of germs via the ventilation openings  30  is conceivable. In order to alleviate the problem of germs being introduced via said ventilation opening  30  in critical applications, the absorber element  8 , in one configuration, is configured in the form of a microfiltration membrane. The microfiltration membrane has a cutoff of approximately 0.2 μm, and therefore bacteria of a size of approximately 0.2 to approximately 5 μm are reliably held back. As an alternative, or in addition, one configuration provides for the surfaces on which residual droplets collect downstream of the outlet valve  25  to be antibacterial.