Package for single doses of a liquid substance in particular of a medicating fluid
24 claims: 2 independent, 22 dependent
- 1Zastrzeżenia patentowe 1. Opakowanie dawek cieczy, zwłaszcza płynu leczniczego, aplikowanego zwłaszcza do oka, składające się z szeregu pojemników umieszczonych na wspólnym podłożu nośnym, znamienne tym, że każdy pojemnik ma górny arkusz (208, 20) tworzący pierwszą ściankę pojemnika z co najmniej jednym otworem (210) i dolny arkusz (226, 206, 22, 78) tworzący drugą ściankę pojemnika usytuowaną naprzeciwko pierwszej ścianki, przy czym górny arkusz (208, 20) i dolny arkusz (206, 22, 78) są oddzielnymi warstwami spojonymi ze sobą i tworzącymi obudowę (202) zawierającą jednostkową dawkę cieczy, przy czym górny arkusz (208, 20) ma kształt kopułki, w której górnej części znajduje się co najmniej jeden otwór (210), którego średnica minimalna wynosi co najmniej 10 mikrometrów a średnica maksymalna 1000 mikrometrów.
- 2Opakowanie według zastrz. 1, znamienne tym, że dolny arkusz (22) jest w przybliżeniu płaski.
- 3Opakowanie według zastrz. 1, znamienne tym, że dolny arkusz (206) ma kształt kopułkowy stanowiący uzupełnienie górnego arkusza (208).
- 4Opakowanie według zastrz. 1, znamienne tym, że otwór (210) jest przykryty zdejmowalnym arkuszem osłonowym (212, 24, 76).
- 5Opakowanie według zastrz. 1, znamienne tym, że wewnątrz obudowy (202) znajduje się osłabiona część (216), tworząca ściankę dzielącą która wraz z dolnym arkuszem (206) stanowią część szczelnej obudowy zawierającej dawkę cieczy.
- 6Opakowanie według zastrz. 5, znamienne tym, że osłabiona część (216) stanowi przegrodę dla wielokomorowego pojemnika.
- 7Opakowanie według zastrz. 1, znamienne tym, że zawarta w obudowie pojemnika dawka jednostkowa cieczy jest nie większa niż 10 mikrolitrów.
- 8Opakowanie według zastrz. 7, znamienne tym, że zawarta w obudowie pojemnika dawka jednostkowa cieczy jest płynem do leczenia oczu.
- 9Opakowanie według zastrz. 1, znamienne tym, że otwór (210) jest zwężony ku końcowi wylotowemu.
- 10Opakowanie według zastrz. 9, znamienne tym, że długość osiowa otworu (210) jest równa od 1 do 5 jego średnicy wylotowej.
- 11Opakowanie według zastrz. 1, znamienne tym, że zawiera pojemnik posiadający uszczelnioną komorę z warstwą pośrednią (214), której oddzielny element stanowi oddzielna część (216), zaś do warstwy pośredniej (214) jest przymocowany górny arkusz (208), zaś na wspólnym podłożu nośnym są umieszczone dolne arkusze (206) pojemników jednostkowych.
- 12Opakowanie według zastrz. 11, znamienne tym, że warstwa pośrednia (214) i osłabiona część (216) stanowią taśmę pojemników.
- 13Opakowanie według zastrz. 1, znamienne tym, że stanowi pojemnik (114), który posiada co najmniej jeden otwór (130), zaś ścianka obudowy (122) pojemnika (114) zawiera obszar przewodzący, natomiast pomiędzy pojemnikami (114) na taśmie (112) jest umieszczona część izolacyjna (134).
- 14Opakowanie według zastrz. 13, znamienne tym, że obudowa pojemnika (114) ma kształt pęcherzykowy.
- 15Opakowanie według zastrz. 14, znamienne tym, że dolna część pojemnika (114) stanowi płaską podstawę.
- 16Opakowanie według zastrz. 1, znamienne tym, że część górnego arkusza (20) stanowi arkusz folii z przynajmniej jednym wykonanym w niej galwanicznie otworem.
- 17Opakowanie według zastrz. 16, znamienne tym, że folia jest folią metalową (22, 78).
- 18Opakowanie według zastrz. 16, znamienne tym, że górny arkusz (20) posiada sieć otworów. 184 709
- 19Opakowanie według zastrz. 1, znamienne tym, że zaopatrzone jest w zdejmowalną osłonę (212) szczelnie pokrywającą co najmniej jeden otwór (210).
- 20Opakowanie według zastrz. 3, znamienne tym, że część szczelnej obudowy zawierającej dawkę cieczy stanowi oddzielną część składową pojemnika, do której jest przyłączony górny arkusz (208).
- 21Opakowanie według zastrz. 1, znamienne tym, że stanowi gruszkowato ukształtowaną torebkę (222) z osłabioną ścianką (228) znajdującą się w jej węższym końcu.
- 22Opakowanie według zastrz. 21, znamienne tym, że każda osłabiona ścianka (228) ma średnicę w zakresie 20 pm do 200 pm.
- 23Opakowanie dawek cieczy, zwłaszcza płynu leczniczego aplikowanego zwłaszcza do oka, znamienne tym, że stanowi pojemnik jednostkowy (94) na płyn leczniczy zawierający zamkniętą szczelnie sprężystą obudowę, przy czym co najmniej w jednej ściance (108) jest umieszczony co najmniej jeden otwór zasłonięty osłoną (106), zaś ścianka (108) zawiera obszar wzmocniony wewnętrznym odcinkiem (110).
- 24Opakowanie według zastrz. 23, znamienne tym, że zawiera dawkę jednostkową nie większą, niż 10 pl.
Independent claims24
121 paragraphs in 3 sections, as filed
The subject of the invention is the packaging of liquid doses, especially therapeutic fluid.
Ophthalmic healing fluids are usually dosed into the eye in the form of drops or ointments. The use of eye drops has a number of disadvantages, primarily due to the patient's difficulty in accepting the instillation. The drops are relatively large and the reflex blink caused by the drop reaching the eye limits the amount or part of the amount of fluid actually in contact with the target area on the eye. Usually less than 10% of 50 µl droplets are effective, the residue is lost due to runoff, either outside or through the nasal tear duct. This use of expensive fluids is a waste and also leads to considerable uncertainty regarding the effectiveness of the drug. Similar considerations apply to ointments, although the level of loss can be reduced by careful dosing. Higher viscosity of the ointments reduces their tendency to run down or wash out.
In the international patent application No. PCT / GB95 / 01482 various methods of administering the therapeutic fluid to the eye were proposed. They use systems in which the therapeutic fluid is sucked from the reservoir and drained in a controlled manner into the eye. Although these methods are useful, difficulties arise with the repeated use of the multi-dose nozzle. In particular, it is difficult to maintain the sterility of the medicinal fluid in a system in which the doses of fluid are successively sucked from the reservoir and pass through reusable nozzles, without the use of antiseptics. The use of antiseptics causes some trouble, as discussed on pp. 8-11 of the paper "Ophtalmic Drug Delivery Systems" "Drugs in the Pharmaceutical Sciences, vol. 58", published in 1993 by Marcel Dekker.
In US Patent No. 3,935,385, various mechanisms are introduced for introducing unit doses of therapeutic fluid into the human eye. The doses are held in dispensing tubes that are inserted into the mechanisms when drug delivery is needed. The mechanisms work with compressed air fed at one end of the tube causing the healing fluid to be pushed out from the other end.
The object of the invention is to package liquid doses, especially therapeutic fluid.
The purpose of the present invention is to minimize or eliminate the need for antiseptics in ophthalmic therapeutic fluids without the risk of contamination.
The liquid dose packaging, especially the therapeutic fluid applied especially to the eye, consisting of a series of containers disposed on a common support substrate, according to the invention is characterized in that each container has an upper sheet forming the first wall of the container with at least one opening and a lower sheet forming the second wall container opposite the first wall, with the top sheet and bottom 4
184 709 the sheet are separate layers bonded together and forming a casing containing a unit dose of liquid, the upper sheet being in the shape of a dome, in which the upper part has at least one opening, with a minimum diameter of at least 10 microns and a maximum diameter of 1000 microns.
Preferably the bottom sheet is approximately flat.
Preferably the bottom sheet has a dome shape in addition to the top sheet.
Preferably the opening is covered by a removable cover sheet.
Preferably, inside the housing there is a weakened portion forming a dividing wall which, together with the bottom sheet, forms part of a sealed housing containing a dose of liquid.
Preferably, the weakened portion is a partition for a multi-chamber container.
Preferably, the unit dose of liquid contained in the container housing is no more than 10 microliters.
Preferably, the unit dose of liquid contained in the container housing is an eye treatment fluid.
Preferably the opening is tapered towards the outlet end.
Preferably, the axial length of the hole is 1 to 5 of its outlet diameter.
Preferably, the package comprises a container having a sealed chamber with an intermediate layer, the separate element of which is a separate part, an upper sheet is attached to the intermediate layer, and lower unit container sheets are placed on a common support substrate.
Preferably, the intermediate layer and the weakened part constitute the container belt.
Preferably, the packaging is a container that has at least one opening and the wall of the container housing comprises a conductive area, while an insulating portion is arranged between the containers on the tape.
Preferably, the container housing is bubble-shaped.
Preferably, the bottom of the container is a flat base.
Preferably, part of the top sheet is a sheet of film with at least one galvanized opening therein.
Preferably the foil is a metal foil.
Preferably the top sheet has a network of holes.
Preferably, the packaging is provided with a removable cover sealing the at least one opening.
Preferably, the portion of the sealed housing containing the dose of liquid is a separate component of the container to which the top sheet is attached.
Preferably the packaging is a pear shaped bag with a weakened wall at its narrower end.
Preferably, each weakened wall has a diameter in the range of 20 to 200.
The packaging of liquid doses, especially of the therapeutic fluid applied especially to the eye according to the invention, is characterized in that it is a unit container for the medicinal fluid containing a sealed elastic housing, at least one wall with at least one opening covered by a shield, and the wall containing an area strengthened.
Preferably the package contains a unit dose of not more than 10 pl.
Thus, according to a first characteristic, the invention includes a medicinal fluid unit container provided with a sealed housing, one wall of which is formed with at least one opening, the housing being squeezed to eject its contents through the at least one opening whose diameter allows for the formation of a stream and / or discrete drops ejected from the housing of the medicinal fluid.
The wall part of the container according to the invention, formed with at least one opening, is usually a flat part of the housing wall, and the housing is usually a blister pack, with this wall part at the flat base of the bubble. However, the applicant has stated that certain benefits can be obtained by using a non-planar portion of the wall in which at least one opening is formed. More specifically, the use of a dome shape in the appropriate part of the wall can give greater efficiency to the container during its use, and facilitate some other beneficial use of the container. Thus, in preferred embodiments of the invention, the therapeutic fluid unit container comprises a housing, one part of the wall being dome shaped, and provided with at least one opening in the upper area of the dome shape, the housing allowing pressure to be applied to a sealed volume of fluid curative and allows squeezing to eject the contents of the enclosed space through at least one opening. Also, at least one other wall portion may have dome shapes complementary to that which is provided with an opening, and be able to overturn deep into the wall portion when discarding the contents of the container.
The housing of the unit container according to the invention can be pressurized by applying an external force to the housing side opposite the wall portion provided with at least one opening. When the respective wall portion is substantially flat, this way of exerting pressure on the contents of the housing can cause high stresses in this wall portion, especially around said at least one opening. In some situations, this can cause the wall portion itself to tear around at least one opening, and as a result, the contents may be discarded in a less predictable manner. By placing holes on the top of the dome shape, these stresses are reduced.
In the respective part of the container wall there can be either a single hole or a network of holes. It is possible to use different layouts, and the specific selection depends on a number of factors. A larger number of holes will result in the dispensing of therapeutic fluid over a larger area, smaller holes will produce narrower streams and / or smaller drops that will be subjected to greater inhibition in their journey to the target area. This may allow higher pressures to be used. A single hole can direct a stream or stream of drops exactly at a specific target area and minimize the time to dispense liquid drug until a blink reflex occurs.
The preferred minimum diameter of the hole diameter is at least 10 pm in order to avoid the formation of bundles of droplets with a linear momentum insufficient to achieve the goal. The use of a single hole with a diameter of 100 pm is particularly preferred. The goal is to produce droplets with a diameter of not less than, for example, 20 pm to avoid the formation of inhaled fog.
Another benefit of using the dome-shaped wall portion is that at least one opening can be chosen to facilitate the ejection of the entire contents of the housing. If the device used for exerting pressure is a piston or a pusher, then its working end may be shaped as complementary to the dome, so that when operating other walls of the housing, which can also be shaped as complementary to the dome, are inverted near the dome part of the wall causing basically empty the housing.
Part of the wall of the housing of the container according to the invention can be provided with a removable cover covering at least one opening, the cover being removed only before the ejection of the contents of the housing. Thanks to this, the contents are protected against environmental impact until use. In another design variation, at least one opening is closed by a membrane adapted to be broken when pressure is applied to the housing. These agents offer the possibility of maintaining sterility inside the containers of the invention. As a result, you can minimize or eliminate the need to add antiseptics to your content.
The use of the dome part of the wall facilitates the creation of separate sealed volumes inside the enclosure. Under these conditions, the removable cover covering at least one opening can be bypassed, or at least reduced the requirements for its tightness. According to this characteristic of the invention, which of course can also be applied to a container without a dome-shaped wall part with at least one housing opening, there is a partition wall that separates the wall part with at least one opening from the area inside the housing which constitutes a space tightly closed.
184 709 closed. The partition wall is adapted to tear it apart before the contents are thrown out of the housing. It is advantageous if the partition wall is adapted to burst when pressure is exerted on the housing as part of the stage of ejecting the contents of the sealed space through at least one opening in the wall part. However, the partition can also be adapted to tear after exerting an external force before applying pressure to the housing. In particular, when placing the container, either in the form of a separate unit or, for example, a portion of the strap, into the dispensing device, a mechanism can be used to exert a tensioning force on the container to tear the partition wall just before causing pressure inside the housing.
Although the container according to the invention constitutes a sealed volume together with a partition wall, it is obvious that this sealed fluid volume may constitute a separate component part of the container prior to attachment of a wall portion formed with at least one opening. This characteristic also has several special advantages, primarily in relation to the production of packages containing many complete containers. Manufacturing these components separately means that they can be inspected before being included in the package. This also makes it easier to stack packages containing containers with different doses, either with different medicated fluids or with different amounts of the same fluid, and also allows multiple separate components to be dispensed through a common dome-shaped wall portion to store liquids separately, but mixing them before discarding through at least one hole.
The containers according to the invention are intended for the successive or simultaneous production of a stream or small droplets, sometimes in the form of a stream of droplets or aerosol streams which may be divergent or collinear. A typical range of hole sizes in the wall part of the housing to achieve this goal should be up to 1000 pm, preferably 20 to 200 pm. A particularly preferred dimension range is 100 to 150 pm. A single hole or a network of holes may be used, preferably pierced, drilled, galvanized or laser shaped in plastic sheets or foils forming part of the wall. For galvanoplastic shaping, metal, usually nickel foil, is preferred.
The method of administration is appropriate for the particular ophthalmic treatment; that is, at least the dimensions of the holes, and their arrangement will depend on the need to achieve the appropriate feed speed to be able to arrive before the "blinking reaction" occurs, while minimizing the negative impact or unpleasant sensation in the eye. Thus, if there is a need to administer more fluid in order to manage before the patient has a blink reflex, while maintaining a speed that still tolerates shocks, to achieve the appropriate overall delivery speed, it is necessary to use multiple holes instead of a single hole.
The unit containers according to the invention can be loaded so that each housing limits a predetermined unit dose ejected therefrom, usually no more than 10 pl. However, it may be necessary to use larger volumes, e.g. 20, 50 or 100 µl, e.g. for irrigation. It is possible to bundle multiple containers, preferably on a common substrate, and in particular in the form of a strip with containers arranged along it in succession.
Ejection of the contents of the container according to the invention can most simply be accomplished by causing the housing wall to collapse towards the part with at least one opening, preferably by means of a mechanical system. The wall may have a reinforced area to direct its collapse. For example, the casing can be dented from the opposite side of the wall by means of a piston, a pusher or a mechanism with a fixed one-sided lever, the operation of which can be cushioned to stabilize the speed of the mechanism, providing sufficient momentum to eject the contents and reach a certain minimum distance . In contrast, the housing can be formed in the form of a cylindrical chamber with the opposite part
184 709 wall in the form of a piston moved towards the wall part in order to squeeze the contents of the housing through the opening or holes.
The object of the invention is illustrated in the embodiment in the drawing, in which Figure 1 is a cross-sectional view of an embodiment of the container according to the invention; Figures 2A, 2B and 2C show cross-sectional views of the various steps in the production of another preferred embodiment of the container according to the invention; Fig. 3 shows yet another embodiment of the container according to the invention, Fig. 4 - Containers in the form of bags according to the invention placed on a carrier tape, Fig. 5 - the method of placing the container of Fig. 4 in a simple squeezing device for ejecting the contents of the container, Fig. 6 the device of Fig. 5, activated for ejecting the contents of the container of Fig. 4, Fig. 7 - yet another embodiment of the dose container according to the invention, in cross section; Fig. 8 is a method for placing the container of Fig. 7 in a device for ejecting the contents of a container with medicament fluid. 9 - a method of arranging a package with therapeutic fluid doses according to the invention in a device for administering therapeutic fluids in the form of streams and / or small drops, in which the casing of the container with therapeutic fluid is crushed to eject the contents, Fig. 10 - the container of Fig. 9 placed in the pressing element from the device of Fig. 9, in detail view, Fig. 11 - the method of arranging the package according to the invention, in a device with a piston mechanism, shown in a perspective view, Fig. 12 - the package of Fig. 11 placed in the piston assembly of the device of Fig. 11, in a detailed view, Fig. 13 - the method of arranging a package according to the invention in a device with a piezoelectric element for ejecting the contents of the container of the medicament fluid, in perspective view, Fig. 14 - the package of Fig. 13 placed in the piezoelectric element of Fig. 13, in detail view, Fig. 15 - method of arranging the packaging in the form of a separate container in the device with a piezoelectric element, in perspective view, Fig. 16 - the container of Fig. 15 in cross section and the piezoelectric element of the device in Fig. 15 17, the method of arranging the packaging according to the invention in an electrostatic charging device, shown in perspective view, FIG. 18 - the packaging of FIG. 17 placed in the dispensing station of the device of Fig. 17, in detail view.
Figures 1 to 3 show various embodiments of the "twin-barrel" containers for use in the devices described below. The container of Fig. 1 has a housing 202 in which a certain amount of medicament fluid 204 is contained. The lower part of the container is formed in the form of a bubble protruding from the lower laminate sheet 206 of the foil laminate, which is covered by the upper sheet 208 of the laminate foil, also formed into a dome, which is the upper part of the housing 202. The lower sheet 206 and the upper sheet 208 are welded at the point of contact with with each other to close the housing 202 on the joint between them.
In the upper part of the upper sheet 208, an opening 210 is formed closed by a cover sheet 212 tightly in contact with the outer surface of the upper sheet 208 around the opening 210. The cover sheet 212 is usually a plastic sheet or sheet of metal foil.
In use, the container shown in Fig. 1 is inserted into a device that accurately aligns the housing 202 relative to an element such as a piston or a source of compressed air, applying pressure to the lower sheet 206 where it forms the lower portion of the housing 202 towards the opening 210 and top sheet 208. Shield sheet 212 is removed and the system is started. As a result, the healing fluid 204 contained in the housing 202 is ejected through the outlet opening 210 towards the selected destination.
Figures 2A, Fig. 2B, Fig. 2C show a container in which separate components can be made separately with the medicinal fluid inside, and then combined with the upper sheet closing the respective containers. Such a component is shown in Fig. 2A, and includes a bottom sheet 206 formed in the form of a bubble for storing a certain amount of medicament fluid 204. The bubble is closed with an intermediate layer 214 welded on the perimeter of the bubble to the bottom sheet 206,
184 709 but containing a weakened portion 216 which actually covers the bubble with fluid 204. However, the illustrated component is sealed and the therapeutic fluid 204 in the bubble is properly protected from contact with the external atmosphere. It also enables autoclave sterilization of a sealed space.
Figure 2B shows a section of the upper sheet 208 with an outlet 210 located above the bubble of the lower sheet 206 shown in Fig. 2A. Fig. 2C shows the container in its folded state.
Each of the components shown in Fig. 2A is manufactured in the form of a separate component, and can be subjected to quality control as a medicinal fluid dispensing component. After filling the container from which the medicinal fluid 204 can be discharged according to the invention, the upper sheet 208 is applied and its peripheral welded to the dome portion provided with the opening 210 located exactly opposite the bubble in which the therapeutic fluid 204 is located. If there is a need to shape the container strip, a continuous strip of top sheet 208 formed with a series of dome sections can be used to simultaneously close and interconnect the container package according to the invention. Such a packet is shown in Fig. 2C.
The use of the container of the type shown as part of the packet of Fig. 2C is generally similar to the use of the container of Fig. 1, with two significant differences. First, the sheeting sheet 212 is not critical, because the medicament fluid 204 is already sealed in a chamber within the container formed by the intermediate layer 214. Notwithstanding this, certain shapes of the cover sheet can still be used, although it is understood that the connection between the cover sheet 212 and the top sheet 208 around the openings 210 does not have to ensure the tightness of the housing to the same degree in the embodiment of Figure 1. Secondly, when the housing 202 is squeezed, and especially when the sealed bubble containing medicament fluid 204 is compressed, the first effect is to break the weakened portion 216 of intermediate layer 214, and the weakened portion 216 can be broken along a predetermined line.
The ejection of medicament fluid 204, in principle, is similar to that of the embodiment of Fig. 1. The weakened portion 216 can also absorb some of the indentation force occurring during the squeezing of the bubble, reducing pressure and reducing the tendency of the bubble to burst or tear.
If, due to a compression system used for one reason or another, it is necessary to tear the weakened portion 216 before the container housing 202 is actually compressed, this can be done. The ejection device used can be modified so that the laminate consisting of bottom sheet 206 and top sheet 208 and intermediate layer 214 is gripped on each side of the bubble, and stretched across the bubble to break the weakened portion 216 before, for example, the piston comes into contact with bottom sheet 206 to dent the container housing 202. The direction of this stretching is indicated by arrows placed adjacent to the container shown on the left of Fig. 2C.
Fig. 3 shows a container in which two medicament fluids can be placed separately in the same housing, inside respective sealed chambers, which are closed by weakened portions 216 of intermediate layer 214. The manufacture, assembly and use of the container are in principle similar to those described with reference to to Fig. 2, but Fig. 3 also shows a piston 218 squeezing medicinal fluids through the opening 210.
It is obvious that the shapes of the bubbles in the bottom sheet 206 and the domes in the top sheet 208 can be made complementary, such that when the piston 218 is applied to at least one bubble, as shown in Figure 3, the entire sheet portion constituting the bubble or the bubbles are finally in contact with the dome forming part in order to substantially empty the container housing from at least one therapeutic fluid. This is of course especially important when the dosage must be accurate.
The separate manufacture of individual components of the containers according to the invention facilitates not only quality control, but also sterilization and other preparation procedures. In the above-described embodiments, an upper laminate sheet 208 with only one hole 210 may be used. In contrast, when many holes are needed, the preferred material for the top sheet 208 is metal foil in which the holes are made by galvanoplastic shaping using photosensitive layers. The bonding of metal foils directly to the laminated bottom sheets can adversely affect the therapeutic fluid placed inside the blister. These interactions are greatly reduced when the treatment fluid is already in its own sealed chamber under the intermediate layer 214, and when the top sheet 208 is bonded to the intermediate layer 214.
Under certain circumstances, it may be desirable to gently eject medicinal fluid through at least one opening in the dome shaped wall portion, or at least one opening through which fluid is actually ejected from any of the containers described. For this purpose, it is advantageous if at least one opening tapers towards the discharge end, with an inlet diameter usually about three times larger than the outlet end. Preferably, the axial length of the at least one hole is 1 to 5 times the outlet diameter, and at the outlet the hole is cylindrical.
The terms "dome" and "dome" are used in the above description of Figures 1 to 3 in a very broad sense. They are not intended to determine the specific, and necessarily symmetrical shape of the housing in the containers of the invention. It is possible to use others with the same effect. It is important, however, to arrange at least one hole in its top region because the fluid ejected when the housing is squeezed is directed towards this at least one hole.
In the arrangement shown in Figures 4, 5 and 6, individual medicament fluid bags 222 are installed on tape 224. Each bag 222 has a pear-shaped shape and is held in the bottom sheet 226 until used as needed. Each bag 222 has a weakened wall 228 adjacent the notch in bottom sheet 226.
In use, the belt 224 is moved to a device (not shown) to place the bag 222 at the discharge station. At the ejection stand, two opposing pistons 230 are moved together in an accelerated motion. This compresses the bag 222 as shown in Fig. 6 to push the contents of the bag 222 in the direction shown. Then the pistons 230 are retracted, releasing the empty bag 222, which is then removed.
The weakened wall 228 can be very small to accurately focus the ejection on the selected target. In addition, it may have lines of weakness in the diameter, or a network of points of weakness torn apart in a given way.
The container 238 shown in Figure 7 contains sheets 232 and 234 stacked together made, for example, of a 30 pm aluminum foil laminate and a 40 pm copper foil formed and attached around a continuous line to the hot melt adhesive layer 236, forming a closed bubble in which it is enclosed is a unit dose of 8 pl medicinal fluid. Each sheet 232, 234 is essentially half the wall of the bubble, and a single 100mm diameter hole is made at the top of the dome formed by the copper sheet layer 234. This hole is usually made by piercing, drilling, electroplating or laser drilling. The hot melt adhesive layer 236 forms the flanges after each steep bubble, and it is possible to make a web of containers joined together by a continuous band of hot melt adhesive layer 236.
Fig. 8 shows the container 238 of Fig. 7 located at the dispensing station 240 between two 'pairs of clamping plates 242 which define the path of the container web of the type shown in Fig. 7, and the continuous flanges formed by the hot-melt adhesive layer 236 are located between the respective in pairs of plates 242. When the machine is ready for use, the plates 242 clamp together while holding the collar, and thus the bubble, in position in dispensing station 240. The plates 242 can be clamped by twisting the elements 244, or by an automatic mechanism actuated by triggering the device.
The location of the container is in front of the longitudinal piston 246 installed with the possibility of linear movement in the main housing 248. The piston 246 is supported on the rear plate 250 installed on the main housing 248, and is guided
184 709 at the front end through a guide pin 252 to which the piston 246 is attached. Between the back plate 250 and the guide pin 252 there is a compressed spring 258, and is kept compressed by a clip 254 that contacts the front surface of the guide pin 252. The activated clip 254 releases the guide pin 252 and the piston 246 which the spring driven 258 contacts with a "bubble" and pushes the contents out of the container through the 100 pm opening. In order to "repair" the device for the next use, all you have to do is pull back the piston 246 to the left, as shown, counteracting the spring 258, until the guide rod 252 engages with the catch 254. The guide rod 252 is balanced by a counterweight 256 located at the other end of the piston 246, which it can also be used to pull back piston 246 against spring force.
The containers according to the invention are placed in the device shown in Fig. 9, which comprises a housing 2 with an open cover 4 at one end at the dispensing station 6 of the device on its base. The device shown is for administering ophthalmic medications, and the cover 4 ensures that the dispensing station 6 is positioned correctly and is at the right distance from the eye to ensure effective drug delivery. The containers according to the invention are mounted on a belt 8, which extends from the feeding cord 10, around the front of the dispensing station 6 up to the take-up reel 12. To roll the tape 8 to introduce a fresh container at the dosing station 6 to throw away its contents, a roller 14 is used. The button 16 for operating the dosing station 6 in the correct state of charge is shown.
The housing of each container on the tape 8 has the shape of a bubble 18 protruding from the continuous substrate 20, which is better seen in Figure 10. The open surface of the bubble package 18 is closed by a continuous metal foil 22, and the metal foil 22 above each bubble 18 is provided with a galvanic method ten holes with a diameter of 40 pm. The metal foil 22 is covered with a covering layer 24, which is gradually removed from the metal foil 22 when the bubble wrap 18 reaches the dispensing station 6. The covering layer 24 is removed by means of a spring-loaded winding roller 26 which pulls the covering layer 24 around the guide post 28 after inlet side of the dosing station 6. A similar guide post 28 is on the exit side, and the band 8 is held against it by means of spring-loaded arms 30. The arms 30 are spaced at a distance substantially equal to the size of the bubble 18 along the band 8, so that they also serve for central placement in the station dispensing 6.
The dispensing station 6 shown in Fig. 10 includes a piston 32 located in block 34, which in turn is installed in the housing 36 and locked in it by a latch 38. To cause the contents of the bubble 18 to eject through the openings in the film 22, the button 16 is pressed to cause releasing the spring (not shown), which moves the piston 32 against the bubble 18 and induces it into the metal foil 22. The shaft 14 is rotated to move the next charged bubble 18 to the straight position of the piston 32, and the shaft 14 is also coupled to the piston 32 to retract it to its starting position before the fresh charged bubble 18 reaches the discharge position.
In the device shown in Fig. 11, the housing 40 of the unit container is installed on a loading belt 42, which, as in the embodiment according to Fig. 9, passes from the feeding spool 44 through the dispensing station 46 to the take-up spool 48, coupled to the roller 50 to ensure rolling . The device housing 52 has a cover 54, but it should be noted that the orientation of the housing 52 relative to the cover 54 is different.
At the dosing station, better seen in Figure 12, each unit container housing 40 is sequentially positioned straight ahead of the piston 55 of the cylinder mechanism 56. Each housing 40 is cylindrical and has a nozzle 58 with at least one opening at its front end. This front end is closed with a foil closure 60. The other end of the container housing 40 is closed by a silicone piston 62, and when the dispensing station is activated, the device piston 55 reaches the container silicone piston 62 and thereby squeezes the contents of the container housing 40. This squeezing causes the contents to push through the at least one orifice of the nozzle 58, while simultaneously removing the foil closure 60, and then the contents of the container are ejected in the form of an aerosol spray 64.
184 709
The device shown in Figs. 13 and 14 is somewhat similar to the device of Figs. 9 and 10, but in this embodiment, drug ejection is carried out by means of a piezoelectric element. The roller 68 winds the strip 66 with separate unit containers to place the container at the dispensing station 70. At the dosing station 70, the container housing is positioned directly in front of the piezoelectric transducer 74, when the cover layer 76 of the container is removed in substantially the same way as in the embodiment of Fig. 9. Removing the cover layer 76 also in this case exposes the metal foil 78 covering bubble 72 and provided with ten galvanically shaped holes.
As with the dispensing station shown in Fig. 14, in this embodiment the dispensing station comprises a piston 80 installed in the cylinder 82 located in the housing 84 by means of a latch 86. Pressing the button 88 activates a spring that moves the piston 80 towards the bubble 72, but only to place an annular piezoelectric transducer 74 around its housing. The appropriate means (not shown) then actuate the transducer 74 so that it clamps around the bubble 72 and thereby ejects its contents through the holes in the metal foil 78. Also in this case, as described above with reference to Figures 9 and 10 , rolling the tape 66 with the roller 68 causes the piston 80 to retract. However, in this embodiment, the shaft 68 also actuates the knife to separate the used bubble 72 from the belt 66, which is then ejected through the opening 89 in the device housing.
Figures 15 and 16 can be considered a simplified version of the embodiment shown in Figures 13 and 14. In this embodiment, the unit containers are placed separately, and the housing of the device is provided with a storage chamber 92 for feeding the unit container. When there is a need to use the device, it is necessary to remove the container from the storage chamber 92 and place it manually on the annular transducer 96 attached to the base of the shield 98 of the device housing 90. The battery 100 and the remainder of the electronics 102 are located in the chamber 104 between the storage chamber 92 and the annular transducer 96. To use the device loaded in this way, the cover 106 is removed from the visible side of the unit container 94 to reveal the wall 108 of the housing with a 50 micrometer nozzle. When the electronics 102 are actuated with a button (not shown), the annular transducer 96 clamps around the unit container 94, throwing its contents through the nozzle.
The container housing 94 is reinforced around its inner circumference with a section 110. This prevents the container housing 94 from breaking when the transducer 96 tightens, and its external shape also serves to increase the rate of fluid ejection from the container housing 94 through the nozzle.
Figures 17 and 18 show an embodiment in which the contents of the container housing are ejected by means of an electrostatic charging system. The coated belt 112 of the containers 114 is placed in the housing 116, and the belt 112 is moved by the roller 118 so that the container 114 is in the dispensing station 120, generally as described with reference to Figures 9 and 10. In this embodiment, however, the container housings 122 of the containers 114 are formed of electrically conductive material. In the dispensing station 120, there is a contact 124 for engaging the wall of the container housing 122, and a switch (not shown) actuated by the dispensing button 126 for feeding electrical potential from the generator 128 to the wall of the housing housing 122 to charge the content and force it ejected through hole 130. The power supply for generator 128 is provided by battery 132, also located in the housing 116 of the device. Since the wall of the housing 122 in each container 114 is conductive, the containers 114 must be insulated with each other. on tape 112. Thus, as shown in Figure 18, tape 112 has an insulating portion 134 sandwiched between containers 114.
In the devices according to the invention, it can be assumed that they are used to deliver various fluids to the destination at the complex administration of drugs. Thus, when delivering to the dispensing station, containers containing different liquids can be included, with
184 709 containers are mounted on a belt or tape in the assumed order. For example, anesthesia or diagnostic agent, e.g. fluorescein, may be included in some tape mounted containers.
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222
<img file="PL184709B1_D0001.tif" />
Fig. 4
<img file="PL184709B1_D0002.tif" />
<img file="PL184709B1_D0003.tif" />
Fig. 6
222
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230222-+<sup>7</sup>
<img file="PL184709B1_D0005.tif" />
<img file="PL184709B1_D0006.tif" />
AND
184 709
Fig. 7
<img file="PL184709B1_D0007.tif" />
Fig. 8
24S 253 <sup>2</sup>242
<img file="PL184709B1_D0008.tif" />
24& 252 ?4<sup>2</sup> 244
250
184 709
Fig. 9
<img file="PL184709B1_D0009.tif" />
· Figures<sup>10 </sup>3&
<img file="PL184709B1_D0010.tif" />
184 709
<img file="PL184709B1_D0011.tif" />
Figure 12
5&
<img file="PL184709B1_D0012.tif" />
184 709
Figure 13
<img file="PL184709B1_D0013.tif" />
7F
S2
184 709
<img file="PL184709B1_D0014.tif" />
184 709
<img file="PL184709B1_D0015.tif" />
UP Department of Publications. Circulation of 70 copies Price PLN 4.00
Contents3
22 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22
59 members in 25 offices
Priority claims16
| Document | Office | Kind | Date |
|---|---|---|---|
| 9417399 | United Kingdom | A | |
| 9417399 | United Kingdom | A | |
| 9505472 | United Kingdom | A | |
| 9505472 | United Kingdom | A | |
| 9505474 | United Kingdom | A | |
| 9505474 | United Kingdom | A | |
| 9502040 | United Kingdom | W | |
| 9502040 | United Kingdom | W | |
| 949417399 | – | – | – |
| 959505472 | – | – | – |
| 959505474 | – | – | – |
| 95GB9502040 | – | – | – |
| GB19940017399 | – | – | – |
| GB19950005472 | – | – | – |
| GB19950005474 | – | – | – |
| WO1995GB02040 | – | – | – |
Members59
| Document | Office | Kind | |
|---|---|---|---|
| GB9412665D0 | United Kingdom | D0 | |
| GB9417399D0 | United Kingdom | D0 | |
| GB9505472D0 | United Kingdom | D0 | |
| GB9505474D0 | United Kingdom | D0 | |
| WO9600050A1 | World Intellectual Property Organization (WIPO) | A1 | |
| CA2198892A1 | Canada | A1 | |
| CA2538944A1 | Canada | A1 | |
| WO9606581A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU3391495A | Australia | A | |
| NO970874D0 | Norway | D0 | |
| FI970706A | Finland | A | |
| GB9704403D0 | United Kingdom | D0 | |
| NO970874L | Norway | L | |
| GB2306902A | United Kingdom | A | |
| EP0778758A1 | European Patent Office (EPO) | A1 | |
| PL318935A1 | Poland | A1 | |
| KR970705356A | Republic of Korea | A | |
| BR9508672A | Brazil | A | |
| CN1163559A | China | A | |
| BG101365A | Bulgaria | A | |
| MX9701513A | Mexico | A | |
| HUT77167A | Hungary | A | |
| EP0845253A2 | European Patent Office (EPO) | A2 | |
| JPH10506028A | Japan | A | |
| CZ59697A3 | Czechia | A3 | |
| NZ292195A | New Zealand | A | |
| EP0778758B1 | European Patent Office (EPO) | B1 | |
| AT171858T | Austria | T | |
| ATE171858T1 | Austria | T1 | |
| DE69505266D1 | Germany | D1 | |
| ES2125654T3 | Spain | T3 | |
| AU703399B2 | Australia | B2 | |
| DE69505266T2 | Germany | T2 | |
| DK0778758T3 | Denmark | T3 | |
| EP0845253A3 | European Patent Office (EPO) | A3 | |
| BG63143B1 | Bulgaria | B1 | |
| HU220184B | Hungary | B | |
| RO117294B1 | Romania | B1 | |
| US6425888B1 | United States of America | B1 | |
| PL184059B1 | Poland | B1 | |
| NO313224B1 | Norway | B1 | |
| PL184709B1This record | Poland | B1 | |
| EP0845253B1 | European Patent Office (EPO) | B1 | |
| AT251433T | Austria | T | |
| ATE251433T1 | Austria | T1 | |
| DE69531902D1 | Germany | D1 | |
| DK0845253T3 | Denmark | T3 | |
| PT845253E | Portugal | E | |
| US6726665B1 | United States of America | B1 | |
| ES2208980T3 | Spain | T3 | |
| DE69531902T2 | Germany | T2 | |
| CZ294140B6 | Czechia | B6 | |
| US2004220537A1 | United States of America | A1 | |
| CN1195466C | China | C | |
| KR100439006B1 | Republic of Korea | B1 | |
| CN1669542A | China | A | |
| JP2005324051A | Japan | A | |
| RU2277900C2 | Russian Federation | C2 | |
| CA2198892C | Canada | C |
1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Decisions on the lapse of the protection rightsLapsedLAPS | LAPS |
Numbers
- Publication, DOCDB
- 184709
- Publication, EPODOC
- PL184709B
- Application
- 95345881
- Application, DOCDB
- 34588195
- Application, EPODOC
- PL19950345881
Titles2
- English
- PACKAGE FOR SINGLE DOSES OF A LIQUID SUBSTANCE IN PARTICULAR OF A MEDICATING FLUID
- Polish
- Opakowanie dawek cieczy zwłaszcza płynu leczniczego
Classification
- CPC, 11
- B05B11/0062
- A61F9/00
- A61F9/0008
- B05B9/0805
- B05B9/0838
- B05B11/0032
- B05B11/0072
- B05B17/0607
- B65D75/58
- B65D83/44
- A61M15/00
- IPC, 10
- A61F9 00
- A61J1 05
- A61F9 007
- A61M11 00
- A61M15 00
- B05B9 08
- B05B11 00
- B05B17 06
- B65D75 58
- B65D83 14
