BG64355B1 - Container for a medicinal liquid - Google Patents

Abstract

The container for medicinal liquid is designed for collapsible use as a substituted cartridge for the pulverizer which is not actuated by driving gas. It is gas and liquid impermeable and its manufacture is more economical, preserving its facility that its storage capacity can be determined depending on its intended usage. In case of very small underpressure the container is plastically and irreversibly shrunk and can be practically emptied completely. The container includes a discharge pipe connection in the form of a hollow piston which includes a pipe made of foil (11) closed at both its ends, and at least one of its ends is closed by a welding seam (13), stretching laterally to the axis of bag (11). It is deformed by external pressure, at pressure difference between the inner space ofthe container and its surrounding medium under 300 hPa (300 mbar). Flange (15) in a stable form is closely attached to bag (11) and is a connecting element for introducing the container over the discharge pipe connection. A guiding duct is fabricated in flange (15) with a sealing place in it and/or a pressing connection engaging the discharge pipe connection and a place for discharging the liquidto the guiding duct. The pipe connection is inserted into the duct and is submerged in medical fluid.

Description

Technical field

The invention relates to the use of a medical fluid reservoir, which is gas-tight and fluid-tight, and is used as a removable cartridge in a non-propellant gas powered atomizer.

The invention aims to make it more economical to produce such a disposable container without impairing its suitability, as well as its use as a cartridge in a dispenser for medicated use in medicine.

BACKGROUND OF THE INVENTION

EP 0 182 094 A2 provides a butyl-like package consisting of an outer container which is an easily deformable material filling bag. The blank for the package is produced by co-extrusion of two coaxial tube-like sections. The two sections are thermoplastic plastics and are not interconnected. The workpiece is molded by blowing. There is a weld seam on the flat bottom of the inner tank. The molded flat bottom of the outer tank has a slot. In the area of the emptying opening, the inner and outer tanks are connected to each other. Essentially, this packaging is produced in one working move.

The filled material in the package is drawn by means of a pump placed in the discharge opening, whereby the inner tank is deformed and its volume reduced. Through the open slot in the flat bottom of the outer tank, in the space between the outer tank and the deformed inner tank, air enters, thus avoiding the occurrence of pressure in this intermediate space. The inner tank, except in the area of the drainage hole, has no fixed contact with the outer tank. The package may be provided with an almost submersible tube reaching almost to its flat bottom, which holds the inner tank upright. This packaging can be used without any problems and can only be emptied completely in a certain spatial position.

EP-0 620 165 A1 describes a combination foil sachet. The composite film consists of at least one outer plastic film and one inner metal film. The hose bag is closed at both ends like a sack. It is provided with a predetermined interrupt location, which can be opened easily at this location. Such a sachet bag is used to store a solidified mass that is pushed out of the bag by a pressure device.

EP-0 068 653 A1 describes a disposable container made of foil, flexible and collapsible, which is placed in a reusable suction bottle. One end of the tank is open and the other end is closed by welding and fitted with a bar. The strap is tightened in a slot located at the bottom of the suction bottle. In this way, the bag-like reservoir is permanently held upright in the suction bottle.

EP-A-0 654 419 describes a container for separate storage of a liquid and a reactive substance therein, which consists of a reservoir and a nozzle provided with a puncture means. Fittings are provided for receiving the nozzle provided with a single notch, with a flat underside forming a locking surface for securing the package, and a flat top forming a sealing surface. The two substances are stored separately in compartments, whereby their separation is accomplished by a clamping element. Before use, the shackle is removed and the packaging, together with the substances contained therein, is shaken to mix.

EP-A-0 763 482 describes an inkjet packing unit designed as a container containing a nozzle and a plug provided therein for hygienic purposes. The nozzle is formed by a cylindrical outer tube which is located on the outside of the package and a base providing the connection of the nozzle to the inner surface of the package. The plug is separately attached to the upper end of the cylindrical outer tube and is coaxially arranged with it and occupies a position in which it is pressed into the tube.

EP 0 585 908 describes a container in the form of a collapsible bag that has a valve tube integrated. The pipe is immersed in a tank. Through the valve, the fluid from inside the tank can be vented outwards.

EP 0 322 980 describes a collapsible tank with a device for opening the tank from the inside to the outside. The device comprises a puncture element which is located inside the tank and a part with a guide channel positioned on the opposite side of the tank, opposite the puncture element. The piercing element can be pressed on the part with the leading channel and by this actuation it pierces the opposite wall and opens the tank on its inside.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a medical fluid reservoir which is gas tight and impermeable to liquids, the capacity of which is determined according to the intended use and which shrinks plastic and irreversibly in a predetermined manner at very low pressure and can almost completely is empty.

According to the invention, the problem is solved by the use of a gas-tight and liquid-impermeable reservoir, such as a replaceable cartridge for medical liquids, in an atomizer free of expulsion gas having a nozzle, in the form of a hollow piston. The reservoir includes a foil bag which is closed at both ends, at least one end of which is closed by a weld seam that extends substantially transversely to the axis of the foil bag and is deformed by external pressure when there is a pressure difference between the interior of the tank and its environment below 300 hPa (300 mbar); Stable-shaped flange, which is tightly attached to the foil bag and which is constructed as a detachable connecting element for inserting the reservoir onto the outlet nozzle, providing a guide duct formed in a stable-shaped flange, providing one sealing space formed in the guide duct and / or a press assembly that encloses the outlet nozzle and fluid outlet in the area of the guide duct in which the hollow piston-shaped outlet nozzle is inserted in use so that it is submerged en in the medical fluid.

In another embodiment of the invention, the compressible film bag is deformed by the external pressure at a pressure difference below 150 bPa (150 mbar), preferably below 80 hPa (80 mbar).

When used according to the invention, the foil bag is sealed at both ends by welding. The stable-shaped flange is tightly attached to the foil pouch, preferably welded close to one end of it.

According to the invention, it is possible to use a foil bag which is sealed tightly at one end by welding and at the other end by a stable flange. In this case, one end of the foil bag is welded to the stable-shaped flange, preferably along its circumference.

According to the invention, a reservoir is used in which the stable-shaped flange can be made of different shapes, preferably rotary-symmetrical, and is larger in size with the size of the end of the foil bag, if sealed at that end. . Using the stable flange, the foil bag is closed at one end.

In the stable-shaped flange, a guide channel with a sealing space may be formed. An outlet nozzle is inserted into the leading channel, which is located in the channel when the tank is upright.

A reservoir is used which, if appropriate, includes a stable-shaped flange fitted with a press assembly inside the guide duct that encloses the outlet nozzle.

The press assembly may be a segment of the guide duct that has a smooth inner face with an inner diameter that is very different from the outer diameter of the outlet nozzle.

In another embodiment of the reservoir, several indentations may be formed on the inside of the section of the guide channel. They may be, for example, three axially extending, symmetrically arranged and longitudinally formed recesses. Further, more axially spaced apart and azimuthally extending depressions that form, for example, two rings or which consist of more annular sections may be provided. In addition, the recesses may pass helically. They may consist of more spaced over the inner wall of the guide channel, sections of a spiral, or a single spiral whose length is greater than the circumference of the guide channel. Such a press assembly makes it possible to insert the reservoir onto the outlet nozzle, as well as a sufficiently strong joint of the flange in a stable shape with the outlet nozzle. Further, the tank, after being emptied, can be removed from the outlet nozzle without damaging it.

It is preferable to use a tank whose flange with a stable shape is made of thermoplastic plastic material.

The stable flange can be made of rubber, metal or plastic, especially thermoplastic plastic. It is advisable that the flange of a stable shape is made of the same plastic that the foil bag or the inside of the foil bag is made of.

Preferably, a reservoir is used in which the weld seam on one or both sides of the foil bag can be made in a U-shaped, V-shaped or shaped configuration. It extends substantially transversely to the axis of the bag of foil and is partly disposed in the direction of the axis of the bag. In this way, when the liquid from the bag of foil is emptied, it facilitates shrinkage.

Inside the guide duct or at one end thereof, a sealing space may be provided, which is in the form of a ring of elastic material which is disposed in a groove formed on the inner wall of the guide duct.

The cross-section of the ring may be O-shaped or rectangular in substance.

The ring may be provided with a cuff. It may be made of elastomer, thermoplastic elastomer or rubber. The sealing space closes the filling space of the tank mounted on the outlet nozzle, protecting it from the surrounding air, making it gas-tight and impermeable to liquids. It allows the draining tank to be withdrawn from the discharge port. A sealing space is required when the sealing action of the press assembly is insufficient.

A reservoir with an emptying space is used, which is shaped as a puncture site, preferably provided with a permeable membrane, which is punctured upon insertion of the reservoir onto the outlet nozzle. The membrane is preferably positioned between the sealing space and the fluid space in the foil bag.

The emptying point is provided with a puncture membrane that is inserted at the end or inside the guide duct. It is advantageous for the membrane to be part of a foil bag located at the end of the guide duct or near that end that is on the side of the fluid space. It can be part of a flange of stable shape, it can be produced simultaneously with it. The membrane may be of the same plastic material as the stable flange.

The piercing membrane acts as the original volume stopper for filling with foil bag fluid.

In another embodiment of the tank used according to the invention, the emptying site may be sealed with a sealing foil that is removed prior to insertion of the tank onto the outlet nozzle or punctured upon insertion of the tank onto the nozzle.

The stable-shaped flange may be of one or more parts. The flange with a stable shape of several parts, preferably made of two parts. The outer bottom of the stable-shaped flange is connected to the foil bag. This part contains an opening that is closed tightly from the inside. The two parts of the stable-shaped flange are interconnected, they can be screwed together, screwed together or soldered together by ultrasonic welding. The one-piece flange is similar to the two-part flange, but it does not contain any connecting elements.

The stable-shaped flange can be produced simultaneously with a press assembly, a sealing groove and a perforating membrane.

The foil bag may be formed by a tube that does not have an weld seam extending in the axial direction of the bag. In addition, it may be made of foil and have one or two longitudinally welded seams. It can be designed as a flat pouch or as a pouch with side folds. A bag with a longitudinally welded seam is preferred.

The weld seams of the foil bag can be from 0.7 mm to 3 mm wide. The width of the weld is selected according to the requirements for tightness and strength of the weld. The wide longitudinal seams of the foil bag may be bent after soldering to fit externally and not to increase excessively the width of the bag relative to the width of the non-soldered part between the welds.

It is preferable to use a reservoir with a film bag made of plastic material, metal or metal alloy, preferably aluminum, gold or copper. A bag made of plastic and in particular thermoplastics is also preferred.

In another embodiment, the foil bag may be made of a composite foil of plastic material and metal. The combination film preferably consists of two or three films connected together.

A foil bag can also be made of plastic foil that has a layer of metal, glass or ceramic layer applied, for example by evaporation.

The layers of plastic or metal are several micrometers thick. The thickness of the layers of metal, glass or ceramic deposited by evaporation is in the area of submicrometers.

It is advisable to use a reservoir, which preferably includes a foil bag, which is filled with a combined foil of two foils, one metal and one plastic sheet, which are connected.

The inner foil is plastic and the outer foil is metal. The metal foil may also form the inside of the compound foil.

In another embodiment, in the upright position, the combined film consists of two films of different plastic.

A reservoir is used in which, preferably, the foil bag is filled with a combination foil of three foils composed of two plastic foils, between which lies a foil of metal.

All three films are bonded together. In place of the metal foil there may be a layer of glass or ceramics, for example silica (SiO _x ), which is evaporated on the plastic foil.

The inner film of the combined film is a copolymer, preferably a polyethylene copolymer of ethylene acrylic acid.

Medium film is diffusion resistant and is made of metal or plastic or metal, glass or ceramic layer.

The outer film is made of plastic whose melting point is higher than the melting temperature of the inner film. The plastic is preferably polyethylene terephthalate, whose melting point is higher than the melting temperature of the plastic on the inner film. This facilitates the welding of the seams of the plastic on the inner foil during the production of the foil bag.

The combined film may optionally have a layer that promotes adhesion.

It is preferable to use a reservoir in which a film bag is made of plastic film with a thickness of 20 to 100 gm.

The foil bag may be made of combined foil consisting of an inner plastic foil of 20 to 100 gm thickness and an outer metal foil of 8 to 20 gm thickness.

In addition, the foil bag may be made of combined foil consisting of an inner foil of plastic from 20 to 100 gm thick, a medium foil of metal from 8 to 20 gm thick and an outer foil of plastic with a thickness of 10 to 40 gm .

Preferably a container is present which represents a fill volume between 0.5 and 5 ml, preferably between 1 and 4 ml.

It is advisable to use a tank having a filling volume between 1 and 4 ml or between 2 and 4 ml.

Welding seams of the foil bag, as well as welding in the space between the bag and the flange of a stable shape, are carried out by known methods, such as thermal welding, ultrasonic welding or induction welding in combination film with a metal layer, whereby welding points are preferred. pressed in the heated state. Such methods are described, for example, in EP 0 111 131 and EP 0 130 239.

The stable rubber or metal flange can be bonded to the foil bag by gluing or optionally by vulcanization.

In one preferred embodiment of the invention, the reservoir is housed in a metal or plastic casing with a stable shape, one end of which is connected to a stable-shaped flange, disassembled or non-removable, and the other end is optionally closed to the bottom.

The metal or plastic jacket of stable shape is preferably between 10 and 30 ml in diameter, preferably between 12 and 17 ml.

From a metal or plastic housing of a stable shape, it is advisable to project a flange of a stable shape, the total length of which is preferably between 20 and 60 mm, preferably between 30 and 50 mm.

It is advisable that the housing is substantially closed throughout the circumference, in a circle in which it has an opening, or at the junction with the flange there is a gap. It can be designed as a stable basket with multiple openings.

The reservoir may instead be housed in a housing formed by a U-shaped clamp, wherein the end of each arm of the clamp is secured to the flange of a stable shape and the arms are longer than the foil bag.

The tank housing is only connected to the tank in the case of a stable flange. The weld sealed end or the two ends sealed with a hand seam of the foil bag are not connected to the casing.

The tank has a peripheral groove formed in a stable flange.

As fluid flows from the reservoir into the outlet nozzle, the foil bag shrinks to a flat shape under the influence of external pressure. Through the opening in the casing or through the gap between the casing and the flange with a stable shape, air enters the space between the casing and the foil bag and this results in equalization of pressure. Thus, no valve is required in the foil bag and the liquid in it does not come in contact with air.

The foil bag is impermeable to the diffusion of medical fluid and its constituents as well as to gases. Accordingly, the material of the foil bag and optionally the structure of the combined foil is selected.

Diffusion-resistant, within the meaning of the present invention, means the loss of fluid (measured with ethanol at room temperature) from the diffusion tank to be less than 0.6 mg per day, preferably less than 0.4 mg per day, especially less than 0.2 mg and in exceptional cases less than 0.1 mg per day.

The inner foil, or the inside of the foil bag, is in contact with the poured liquid. For this foil a material is selected which is not attacked by the liquid and which does not affect it. This foil is defined as weldable foil.

One of the foils or, for example, a vaporized layer, appears as a diffusion barrier that prevents the diffusion of the liquid or its constituents, as well as the diffusion from or into the bag. It is advisable to protect the diffusion barrier against mechanical damage and against tearing when the foil is folded through an additional plastic foil applied to it to permanently prevent the diffusion of liquid or gases.

As the foil bag is impermeable to gas diffusion, the pressure due to the discharge of the fluid in the foil bag cannot be equalized by diffusing gas and the bag shrinks reliably, and the foil bag shrinks reliably as well as many times. of fluid from the tank.

The tank according to the invention is preferably used as a primary packaging for medical fluid that is consumed in a plurality of dosage amounts of the foil bag.

The liquid may be consumed from the foil bag in very small portions, for example 200 doses, spread over a longer period, for example three months.

The substantially enclosed container is inaccessible from the outside and cannot be damaged by the storage of the liquid and its insertion onto the outlet nozzle. A substantially enclosed casing or built-in basket with many openings, a stable casing or clamp facilitates storage of a thin-walled foil pouch and facilitates its handling by inserting it on the outlet nozzle and removing the empty reservoir from the nozzle.

According to the invention, a reservoir is used which is particularly suitable as a removable cartridge for drug solutions for inhalation in non-ejectable gas sprayers. Preferably, the volume of the container is from 1 to 4 ml, and particularly preferably from 1 to 3 ml or from 2 to 4 ml.

The use of the reservoir according to the invention is preferably directed to a reservoir constituting a primary medical fluid dispenser consumed in a plurality of portions withdrawn from the foil bag, the plurality of portions being distributed in doses between 10 and 50 μΐ, preferably between 15 and 20 μΐ.

The casing diameter may be from 10 to 30 mm, preferably from 12 to 17 mm. The length of the tank, including the protuberant portion of the stable-shaped flange, may be from 20 to 60 mm, preferably from 30 to 50 mm.

It is preferred to use a tank according to the invention as a cartridge containing an inhalation drug which is presented as a solution in ethanol or in ethanol / water or in water.

It is preferable to use the tank as a cartridge to accommodate a medical fluid, for example a drug dissolved in a solvent. For example, Berotec, (Phenoterolhydrobromide; 1- (3,5-dihydroxy-phenyl) -2- (1 (4-hydroxybenzyl) -ethyl] -amino] is used as medicines for inhalation with one active substance or with multiple active substances - ethanol-hydrobromide), Atrovent (Ipratropium bromide), Berodual (a combination of pheneterol-hydrobromide and Ipratroprium-bromide), Salbutamol (or Albuterol), Combivent, Oxivent (Oxitropium bromide), Ba 679 (Tiotropium bromide), BEA 2108 (BEA 2108) (thienyl) -glycolic acid tropenol ester), Beclomethason, Flunisolid, Budesonide and others.

WO 98/27959 discloses stabilized aqueous preparations of medicaments for the production of non-propellant aerosols.

The use of the reservoir according to the invention is preferably with a medicament for the treatment of diseases by inhalation with the active substances.

The use according to the invention is based on the fact that the nebulizer is an emptying tool provided with a connecting part.

The reservoir is then inserted into this emptying tool by a releasable plug snap located between the connecting portion and the flange with a stable reservoir shape.

In another preferred form of use of the reservoir according to the invention, engagement hooks of the snap hooks engage on the peripheral groove in the stable-shaped flange, which are located on the connecting portion when the reservoir is inserted into that connecting portion of the atomizer.

An ejector-free atomizer in which it is used as a replaceable element in the form of a reservoir for medical inhalation liquids according to the present invention, characterized in that it has a hollow piston-shaped connecting part, which is a withdrawal nozzle of fluid from the tank.

For example, the discharge nozzle is a hollow piston of a medical fluid dispenser. Such a nebulizer is described in DE 195

902.5 and in WO 97/12687 (in particular in Figures 6a and 6b).

The hollow piston of this atomizer is constructed as a discharge nozzle for the medical fluid contained in the tank according to the invention.

The tank is preferably inserted into the hollow piston positioned on the axis of the atomizer, the end of the hollow piston being inserted into the emptying point and thus immersed in the medical fluid. The sealing space in the stable-shaped flange tightly closes the inner space of the tank against the outer wall of the hollow piston. The press assembly can mechanically hold the hollow piston tank firmly.

It is advisable, instead of or in addition to the press assembly providing a force-closure connection between the tank and the outlet nozzle, to provide a detachable engagement connection between the stable-shaped flange and the outlet, such as a nebulizer. Such a connection may be a plug-in locking connection consisting of several engagement hooks provided in the connecting portion of the outlet.

When the reservoir is inserted into the outlet, the engagement hooks are engaged in a slot formed in the flange, for example, in a circular groove or behind an edge provided on a stable-shaped flange.

The hooks of the hooks are preferably rounded or bevelled in both directions of movement of the reservoir, so that a moderately large force can be used to remove the empty reservoir and fit a full reservoir into the drainage device.

The use of the medical fluid reservoir according to the invention has the following advantages. The tank is industrially derivative, is disposable and requires only a small consumption of material. It is sterile manufactured, filled and sealed. It is useful for the inhalation of certain medicines that exist as solutions in ethanol, ethanol / water or water. The fluid in the tank can be consumed sterile, without any air being sucked into the tank. The liquid does not come in contact with air, oxygen or carbon dioxide. According to the invention, the use of the tank allows the discharge of medical fluid without the formation of gas bubbles. The tank is impermeable to diffusion of liquids and gases. Depending on the drug, in the filled state, the tank is suitable for storage of the liquid for many years and meets the requirements of all official pharmacopoeias. It shrinks even at very low pressure. In a collapsed state, the tank is flat and approximately straight, retaining approximately its original length when emptying. It does not need a pressure equalization valve after using some of the fluid inside. The tank is emptied to a great extent, also when its position is changed, and when it is reversed. The foil bag is only connected to the flange with a stable shape. It is not attached to the casing available. The fill volume of the foil bag can be easily adjusted to a set value within a known range by changing its length and / or diameter. It can be filled before closing, before the sole or two weld seams are inserted. No special prison required. The tank can be used without or with a housing. The housing inside the tank is protected from external damage. The liquid in the foil bag is protected from light by the opaque foil and the enclosed, closed, opaque casing. The housing can be inserted into and removed from the extractor simply and without rotating movement.

Description of the attached figures

The tank according to the invention is explained by means of the accompanying figures, of which:

Figure 1 shows an inclined sachet bag according to one embodiment of the foil bag closed at both ends;

Figure 2 shows a bag with sealed edges in an inclined position according to another embodiment of the foil bag closed at both ends;

Figure 3 shows a side-fold bag according to another embodiment of the foil-enclosed bag at both ends;

Figure 4 shows a stable, one-section flange in section according to one embodiment of the invention;

Figures 5 a and 5 b represent a flange of stable shape, in several sections in section, according to another embodiment of the invention;

Figure 6 shows a cylindrical flange of stable shape, in several sections in section, according to another embodiment of the invention;

Figure 7 is a cross-sectional view of a flange of several sections according to another embodiment of the invention;

Figure 8a shows a stable, cross-sectional flange that is mounted on one side of the foil bag;

Figure 8b shows a cross-section of a three-layer laminate film from which the bag is made;

Figures 9a and 9b show, from the side and in cross-section, the U-shaped weld seam with which the bag is closed;

Figures 10a and 10b show, from the side and cross-sectional view, the V-shaped seam with which the foil bag is sealed;

Figures 11a and lib show, from the side and top view, the T-shaped seam with which the bag is closed;

Figures 12a through 12g schematically illustrate, in an inclined view, the production and filling of the tank according to one embodiment of the invention;

Figures 13a through 13f schematically show, in an inclined view, the production and filling of the tank according to another embodiment of the invention;

Figure 14 is a partial sectional view of a typical fluid filled tank housed in a metal casing;

Figures 15a and 15b show one embodiment of a detachable plug connection between the flange of the tank and the connecting part of the discharge device;

Figures 16a and 16b show another embodiment of a detachable plug connection between the flange of the tank and the connecting part of the discharge device.

Examples of carrying out the invention

Figures 1 to 3 show different forms of embodiment of the foil bag closed at both ends.

Figure 1 shows a sleeve bag lie cylindrical flange of stable shape 12 and a U-shaped cross seam 13 that closes one end of the sleeve bag 11 and extends partially in the longitudinal direction. The end 14 of the flange 12 is connected to the end of the hose bag 11. The hole 15 is formed along the axis of the flange 12 to insert a nozzle.

Figure 2 shows a bag of foil 21 with sealed edges, which is made of two foils stacked on top of each other. The foil pouch 21 has two longitudinally welded seams 22 and one transversely welded seam 23 made at one end thereof. The other end of the foil bag 21 is connected to a fishery flange 24 of stable shape. In the middle of the flange 24 there is an opening 25 for insertion of a discharge nozzle.

Figure 3 shows a bag with side folds 31 that are formed on both longitudinal sides, the bag 31 being closed with one transversely welded seam 32. On one flat side of the bag 31 is sealed a flange of stable shape 33, in which can be inserted by a withdrawal fitting.

4 to 7 are cross-sectional views of various embodiments of a stable-shaped flange.

Figure 4 shows a longitudinal section of a flange 41 made from a portion in which a cylindrical guide groove 42 is provided to be pressed into a cylindrical withdrawal nozzle. The outer end of the cylindrical guide channel 42 is tapered and its inner end is closed with a diaphragm 41 inclined towards the axis of the flange 41. The flange 41 is made in one working stroke. The end of the flange 41 is connected to a bag of foil 44.

Figure 5a illustrates in longitudinal section and Figure 5b in cross-section AA of Figure 5a, a cylindrical flange made of several parts, respectively, the lower portion 51 and the upper portion 52. The lower portion 51 of the flange is connected to a bag of foil 53 The upper portion 52 of the flange is inserted into an opening of the lower portion 51. The upper portion 52 is provided with a guide groove 54 in which there are three longitudinal projections 55 extending in the direction of the flange axis, forming a press assembly for the outlet nozzle, and a ring-like projection 56 provided as a seal. The lower portion 51 and the upper portion 52 are soldered to one another on the contact surface. The inlet with the bevelled edge of the leading groove 54 is closed with a sealing foil 58.

Figure 6 shows a cylindrical flange with a stable shape made of several parts. The lower part 61 is connected to a foil pouch 63 which is ring-shaped. The upper portion 62 extends to the annular lower portion 61. The upper portion 62 is provided with an O-ring seal 64 which is held by a compressed sealing sleeve 65. The opening in the sealing sleeve 65 serves as a guide channel for a discharge nozzle 67 On the inside of the seal of the upper portion 62 there is a circumferential recess 66, which is constructed as a press assembly. The outlet nozzle 67 is inserted into the leading groove. The reservoir is located on the outlet nozzle 67 by means of a 66-shaped press assembly. The lower portion 61 and the upper portion 62 are soldered to one another on the contact surface 68.

Figure 7 shows another flange of several parts. Ring-shaped lower part 71 which is provided with a collar and is connected to a foil pouch 73. The upper part 72 which is located in the collar-shaped ring-shaped lower part 71. The upper part 72 has a flat ring 74 as a seal which is held by a press sealing sleeve 75. Below the flat sealing ring 74 is a guide groove 76 for a discharge nozzle. The press assembly is made of two thread-like grooves 77 located inside the guide groove 76. Near the bottom end of the groove 76, a membrane 78 is inserted perpendicular to the axis of the flange, which penetrates upon insertion of the outlet nozzle into the tank. The membrane 78 is made in one working stroke with the upper part 72. The lower part 71 and the upper part 72 are soldered to one another on the contact surface 79.

Figure 8a is a cross-sectional view of a stable form 81 filled in one piece. The flange is mounted on one side of the foil bag 82. The flange 81 has an opening that serves as a guide groove 83 and a press assembly for the outlet nozzle 85. This flange 81 is closed on the outside by a sealing foil 84. When inserting the outlet nozzle 85 in the reservoir, the tapered end of the nozzle punctures the pouch of foil 82 at a location 86 below the inner end of the guide duct.

Figure 8b shows a cross-section of a three-layer commercial laminate film from which the pouch of foil 82 is filled. Inside foil 87 is made of polyethylene with 40 μπι thickness, medium foil 88, which is an aluminum diffusion barrier with 12 μπι thickness and externally foil 89 of 12 μιη thick polyethylene terephthalate.

Figures 9 to 11 illustrate various embodiments of the seam with which the foil bag is sealed.

Figure 9a shows a U-shaped weld seam 91 that extends partially in the longitudinal direction of a foil bag 92 and goes to a longitudinal weld 93 on one side.

Figure 9b shows a cross-section through a foil bag that passes through the line B-B indicated in figure 9a. In the welds 91 and 93, the inner layer of the folded multilayer film 94 is welded.

Figure 10a shows a V-shaped weld seam 101 that extends partially in the longitudinal direction of a foil bag 102. In this case, the foil bag is made of a hose foil without a longitudinal seam.

Figure 10b shows a cross-section of the foil bag along line C-C shown in figure 10a. In the weld seam 101, a folded single-layer film 103 is welded.

Figure 11a shows a T-shaped weld seam 111 in a side view and figure 1 lb is a top view of the welded end of a foil pouch 112. The three arms of the T-shaped weld seam 111 together are as long as a wide flat bent outside the seam 111, foil bag 112.

Welded with U-shaped weld 91, V-welded 101 or T-welded, foil bag, in the cross-sectional area is not larger than the diameter of the casing, in which case the bag of folios 92, 102, 112.

Figures 12 and 13 are schematically depicted in an inclined view, manufacture and filling of the tank according to the invention.

Figure 12a shows a folded strip of foil that is welded on the cut sides in a longitudinal direction by welding, then cut into sections and shaped as a tube. Manufactured by the injection molding method, the lower part of a cylindrical flange of two parts is welded with one end of the hose section. The other end of the pipe section is welded with a U-shaped weld, as shown in Figures 12b and 12c. The finished tank shown in Figure 12c is inserted into a cylindrical aluminum casing, which is shown in Figure 12d, the end of which is pressed into a groove formed at the end of the cylindrical flange. In this way the tank is firmly connected to the housing. The empty container inside the housing is filled with fluid through the bottom of the flange provided with an opening, as shown in Figure 12f. After filling the tank, the top of the flange is pressed into the bottom, as shown in Figure 12f, and the two parts are tightly connected to each other. The resultant element shown in Figure 12g is ready to be inserted into the outlet nozzle.

Another method of manufacture is shown in Figure 13. A portion of a longitudinal suture tube of foil, as shown in Figure 13a, is connected at one end to a flange formed by a portion which is closed with a sealing foil. This is shown in Figure 13b. The reservoir is filled with fluid through the other open end of the foil tube as shown in Figure 13c. The open end of the foil hose is closed with a U-shaped weld, which is shown in Figure 13d. The full tank is inserted into the plastic casing as seen in Figure 13f. The end of the plastic casing is secured by clicking the end of the flange in a stable shape. The resulting portion shown in Figure 13f is ready to be inserted into the outlet nozzle.

Figure 14 is a partial sectional view of a typical fluid-filled tank 141, which can be rested peacefully in a metal housing 142. The foil bag is welded at one end with a U-shaped seam 143 and at the other end with end 144 of the lower portion 145 of a cylindrical flange of stable shape, made of two parts. The metal casing 142 has a bottom 146 which houses an air intake opening between the metal casing and the foil bag. The open end of the metal housing 142 is inserted into a peripheral groove 147 formed at the end of the lower portion 145 of the stable flange. The housing 142 is firmly connected to the flange. The upper part 148 of the stable flange 142 is inserted into an opening of its lower part 145. The lower part 145 and the upper part 148 of the flange are connected with a engagement link 149 and are provided with a flat seal 150. The guide channel 151 is closed at one end by membrane 152 and is sealed at its outer end with a sealing foil 153.

The metal casing 142 shown in Figure 14 is made of aluminum. It is 43 mm long, has an outside diameter of 17 mm and a wall thickness of 0.5 mm. The two-piece flange is made of polyethylene and is manufactured by the injection molding method. The upper part 148 of the flange, together with the diaphragm 152, is made in one technological step. The leading groove 151 in the upper part of the flange 148 has an internal diameter of 2.5 mm in the place of the press assembly and fits snugly on the outlet nozzle.

FIGS. 15a and 15b show a detachable engagement plug connection between the flange with a stable tank shape 141 and the connecting portion of the discharge device.

Figure 15a shows a cross-section of the connecting part 154 located in the withdrawing device, which comprises a withdrawal nozzle 67 at its axis. The withdrawal nozzle 67 is surrounded by several engagement hooks 155 with engagement teeth 156 having a circular cross-section. The hooks 155 are separated from each other by intermediate spaces and may have a width of 10 to 60 degrees azimuth. There may be a section 157 between the two engagement hooks 155 which does not have a engagement tooth 156. This section is adhered by engagement to the outer wall of the tank.

Figure 15b shows a side view of the end of a reservoir 142 located in the metal casing 142, the flange of which has a stable shape having an upper part 148 extending over the metal casing 142. The casing 142 is preferably, as shown in figure 14, in the area of the upper part 148 of the flange protruding above the housing has a peripheral groove 158 in which the engagement teeth 156 of the reservoir inserted into the connecting portion 154 are engaged, thereby connecting the reservoir to the connecting part 154 by means of engagement.

Figures 16a and 16b show another embodiment of a detachable engagement plug connection.

Figure 16a shows a cross-section through a connecting part 161 in the leading device, which has an outlet nozzle 67 at its axis. The outlet nozzle 67 is surrounded by several uniform engagement hooks 162 with engagement teeth 163, whose profiles are tapered in both directions to the tank. The locking hooks 162 are spaced azimuth apart.

Figure 16b shows a side view of the end of a container 142 housed in a housing 142, with the upper portion 148 of a stable-shaped flange projecting over the housing 142. The engagement teeth 163 are gripped by the insertion into the connecting portion 154 of a reservoir in a peripheral groove 147 of the housing protruding 147. 142 the upper part 148 of the flange in a stable shape, thereby connecting the reservoir to the connecting part by disengaging by engagement.

Claims (33)

Claims 1. The use of a gas-tight and liquid-impermeable tank as a replaceable cartridge for medical liquids in a non-ejectable gas atomizer having a hollow piston-shaped nozzle, characterized in that the tank comprises: - a foil bag (11, 21, 31) which is closed at both ends, at least one end of which is closed by a weld seam (13, 23, 32) extending substantially transversely to the axis of the foil bag (11, 21, 31) and it is deformed by external pressure when there is a difference between the pressure in the inner space of the tank and that of the surrounding medium, below 300 hPa (300 mbar), - a stable-shaped flange (15, 25, 34) which is firmly attached to the foil bag (11, 21, 31) and which is constructed as a detachable connecting element for inserting the reservoir onto the outlet nozzle (67) as provided - one guide groove (42, 54) formed in the flange (15, 25, 34), provided - a sealing space (56, 64, 74) formed in the guide groove (42, 54) and / or a press assembly (55, 66, 77) that encloses the outlet nozzle (67), and - a fluid withdrawal point, in the area of the guide duct (42, 54), in which the hollow piston-shaped nozzle (67) is inserted in use so that it is immersed in the medical fluid. Use according to claim 1, characterized in that the compressible film bag (11, 21, 31) is deformed by the external pressure at a pressure difference below 150 hPa (150 mbar), preferably below 80 hPa (80 mbar) . Use according to Claims 1 and 2, characterized in that the reservoir includes a bag of foil (31) which is closed at both ends by a weld seam (32), and a flange (34) with a stable shape which is tightly attached. to the foil bag (31). Use according to claims 1 and 2, characterized in that the reservoir includes a bag of foil (11, 21), which is closed tightly at one end by a weld seam (13, 23) and at the other end by a flange (12, 24) in stable form. Use according to claims 1 to 4, characterized in that the tank comprises a stable-shaped flange (41, 51, 61), preferably of a rotationally-symmetrical shape, the size of which corresponds to the size of the foil bag (44). , 53, 63), and by which the foil bag (44, 53, 63) is closed at one end. Use according to claims 1 to 5, characterized in that the tank includes a stable-shaped flange (52, 62, 72) in which a guide channel (42, 45) is formed with a sealing space (56, 64, 74). ). Use according to any one of claims 1 to 6, characterized in that the reservoir includes a stable flange (52, 62, 72) flange (56, 66, 77) inside the conduit (42, 45), which encloses the outlet nozzle (67). Use according to any one of claims 1 to 7, characterized in that the reservoir comprises a stable-shaped flange (52, 62, 72), which is made of thermoplastic plastic material. Use according to claims 1 to 8, characterized in that the reservoir has a weld seam (91, 101) with a U-shaped (91), V-shaped (101) or T-shaped (111) configuration that passes substantially transverse to the axis of the foil pouch (92, 102) and partly extending in the direction of this axis. Use according to claims 1 to 9, characterized in that the reservoir includes a sealing ring (56, 64, 75) in the form of a ring of elastic material which is disposed in a groove formed on the inner wall of the guide duct. Use according to any one of claims 1 to 10, characterized in that the reservoir includes a discharge site, which is shaped as a puncture site. Use according to any of claims 1 to 11, characterized in that the reservoir includes a discharge space provided with a permeable membrane (43, 78, 152). Use according to claims 1 to 12, characterized in that the reservoir includes a discharge space provided with a permeable membrane (43, 78, 86, 152), wherein the membrane (43, 78, 152) is mounted at the end or inside the guide channel (42, 76, 83,151), or the membrane (86) is part of the foil bag (82) located at the end of the guide channel (83). Use according to any one of claims 1 to 13, characterized in that the reservoir includes a discharge space which is sealed with a sealing foil (58, 84, 153). Use according to claims 1 to 14, characterized in that the reservoir comprises a film bag (11, 21, 31) made of plastic material, metal or metal alloy, or a film bag made of combined film made of plastic material and metal, or a bag of foil made of plastic film with a layer of metal, glass or ceramic layer. Use according to claims 1 to 15, characterized in that the reservoir includes a bag of foil (73) which is filled with an inner foil of plastic and an outer foil of metal or with two foils of different plastic. Use according to Claims 1 to 15, characterized in that the reservoir includes a film bag (82) which is filled with an inner film (87) of a copolymer, preferably a polyethylene copolymer of ethylene acrylic acid, and is diffusion-resistant medium foil (88) of metal or plastic or diffusion-resistant medium foil (88) of metal, glass or ceramic layer and outer foil (89) of plastic whose melting point is higher than the melting temperature of the inner foil ( 87), which plastic is preferably polyethylene ter phthalate. Use according to Claims 1 to 17, characterized in that the tank comprises a foil bag (11, 21, 31) made of plastic foil 20 to 100 pm thick or a foil bag (73) filled from a composite film consisting of an inner plastic film of 20 to 100 pm thick and an outer metal foil 8 to 20 pm thick or a film bag (82) made of a combined film composed of an inner film (87) of plastic 20 to 100 μιη thick, medium foil (88) of metal 8 to 20 μπι thick and outer foil (89) of plastic with thickness from 10 to 40 μπι. Use according to claims 1 to 18, characterized in that the tank has a filling volume between 0.5 and 5 ml, preferably between 1 and 4 ml. Use according to claims 1 to 19, characterized in that the tank has a filling volume of between 1 and 4 ml or between 2 and 4 ml. Use according to any one of claims 1 to 20, characterized in that the tank is housed in a metal or plastic housing (142) with a stable shape which is connected to the flange with a stable shape (71). Use according to claims 1 to 21, characterized in that the tank is housed in a metal or plastic casing (142) of stable shape, with a diameter of between 10 and 30 mm, preferably between 12 and 17 mm. Use according to claims 1 to 22, characterized in that the tank is housed in a metal or plastic casing (142) of stable shape, from which a flange (71) with a stable shape extends, with their total length being between 20 to 60 mm, preferably between 30 and 50 mm. Use according to any of claims 1 to 22, characterized in that the housing (142) is substantially closed throughout the circumference, wherein the housing (142) has an opening or a gap formed at the junction with the stable flange (145). , the housing is constructed as a basket with multiple openings, or is shaped by a curved bracket. Use according to claims 21 to 24, characterized in that the reservoir has a peripheral groove (147, 158) formed in the flange (145) of stable shape. Use of the container according to claims 1 to 25 as a primary medical fluid dispenser consumed in a plurality of dosage amounts of the foil bag. Use according to claims 1 to 26, in the container as primary packaging for medical fluid to be consumed in portions withdrawn from the foil bag in multiple portions, in doses between 10 and 50 µΐ, preferably between 15 and 20 μΐ. Use according to claims 1 to 27, in the tank as a cartridge containing a medicament for inhalation, which is presented as a solution in ethanol or in ethanol / water or in water. Use according to claims 1 to 28, as a cartridge containing an inhalation drug filled with one active substance or with multiple active substances, such as Berotec, (Fenote rolhydrobromide; 1- (3,5-dihydroxy-phenyl) -2- [1 (4-hydroxy-benzyl) -ethyl] -amino] -ethanolhydrobromide), Atrovent (Ipratropium bromide), Berodual (a combination of pheneterol-hydrobromide and Ipratropium-bromide), Salbutamol (or Albuterol), Combivent, Oxivent (Oxitropium bromide), Ba 679 (Tiotropium bromide), BEA 2108 (Di - (- thienyl) glycolic acid tropenol ester), Beclomethason, Flunisolid, Budesonide. Use of the reservoir according to claims 1 to 29, with a medicament for the treatment of diseases by inhalation with the active substances. Use according to any one of claims 1 to 30, characterized in that the atomizer is an emptying tool provided with a connecting part (154, 161) in which the tank is inserted into the emptying tool by a releasable plug-in click connection. located between the connecting portion (154, 161) and the flange (148) with a stable tank shape. Use according to claim 31, characterized in that engagement teeth (156, 163) of the engagement hooks (155, 162) are engaged in the peripheral groove (147, 158) in the flange (145) by the snapping link. , which are located on the connecting portion (154, 161) when the tank is inserted into the connecting portion (154, 161) of the atomizer. 33. An ejector free gas atomizer using a replaceable element in the form of a reservoir for medical inhalation fluids as claimed in any of claims 1 to 32, characterized in that it has a hollow piston-shaped connecting piece constituting a discharge nozzle (67). to extract fluid from the tank.