Container for medical liquids and method for filling container of this type

Abstract

To provide a container for medical liquids known in the form of a prefilled syringe or cartridge and a method for filling a container of this type.SOLUTION: A container 1 for medical liquids comprises an inner container 3 having a distal end 5 and a proximal end 7, a first porous separating element 9 being arranged at the proximal end, the first porous separating element delimiting a holding space 15 for holding a medical liquid, and comprising an outer container 17, in which the inner container is arranged with the proximal end and with at least portions of the holding space. An outlet channel section 25 is connected to the distal end of the inner container, and at least portions of the outlet channel section are arranged outside of the outer container. A valve device 29 can be arranged in the outlet channel section, and the valve device is designed, in an open position, to open a fluid connection between a distal outlet opening 31 of the outlet channel section and the holding space and, in a closed position, to block the fluid connection between the distal outlet opening and the holding space.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a container for a chemical solution and a method for filling a container of this type.

Background Art

[0002] Containers for chemical solutions are particularly known in the form of prefilled syringes or cartridges. These often have at least one displaceable stopper made of pharmaceutical rubber, and the displaceable stopper can also be moved manually, motor-driven or pressure-operated in such medical containers in order to eject the chemical solution contained in the container from the container. In the case of manual medical containers in particular, there are disadvantages in terms of ergonomics and handling. In conventional syringes, this is a cumbersome method and is only possible in non-ergonomic hand positions, especially when the patient has to inject themselves. With conventional prefilled syringes or cartridges, there are also problems in supplying and measuring small amounts of less than 0.5 mL with high accuracy. Especially in the case of such small amounts, it is almost impossible to accurately measure the finally injected amount. Conventional containers have problems with multiple uses because of the formation of air bubbles and, as a result, the risk of air embolism. The pharmaceutical rubber used to form conventional stoppers is oxygen-permeable and is not suitable for storing oxygen-sensitive chemical solutions, such as adrenaline. In addition, such stoppers require a lubricant, especially silicone oil, for low-friction displacement inside glass containers, which can result in inappropriate exposure of the patient to the lubricant. Furthermore, such conventional containers have problems with the hermeticity of their seals under vacuum and / or pressure loads. Especially in the case of manual operation, the force applied to the stopper to supply the chemical solution inevitably varies, so a defined flow rate of the chemical solution can hardly be guaranteed when supplying it from the container. If it is necessary to remove air bubbles from the container before injection, an undesirable leakage of the chemical solution almost inevitably occurs when releasing the air bubbles. Finally, it must not be forgotten that this is also partly responsible for the fact that in conventional containers, small amounts can hardly be measured accurately.

Summary of the Invention

Problems to be Solved by the Invention

[0003] An object of the present invention is to provide a chemical solution container in which the above-mentioned drawbacks do not occur and a method for filling this type of container.

[0004] This object is achieved by creating the subject matter of the independent claims. Advantageous embodiments are described in the dependent claims.

[0005] This object is achieved by creating a chemical solution container having an inner container that has a distal end and a proximal end per se. A first proximal porous separation element is arranged at the proximal end. The first porous separation element demarcates a holding space for holding the chemical solution. The container also comprises an outer container in which the inner container is arranged therein together with the proximal end and at least a part of the holding space. The outer container extends airtightly around the inner container so that a gas under positive pressure can be introduced into the peripheral space of the outer container between the outer surface of the inner container and the inner surface of the outer container. In particular, the holding space has a pressure transmission connection with the peripheral space via the first porous separation element. The outlet channel portion of the container is connected to the distal end of the inner container, and at least a part of the outlet channel portion is arranged outside the outer container. A valve device can be arranged in the outlet channel portion, and preferably is arranged. The valve device is configured to open the fluid connection between the distal outlet opening of the outlet channel portion and the holding space in the open position and to shield the fluid connection between the distal outlet opening and the holding space in the closed position. The chemical solution can be held and stored in the holding space and can be discharged through the distal outlet opening via the outlet channel portion and the valve device by the gas under positive pressure in the peripheral space, which acts on the chemical solution via the first proximal porous separation element when the valve device is moved from its closed position to its open position. This does not require a movable stopper to move within the container, specifically neither within the inner container nor within the outer container. Rather, the chemical solution is discharged only by the gas under positive pressure in the peripheral space. In this way, manual displacement of an actuator or a displaceable stopper can be completely omitted so that the container can be used in an ergonomic, reproducible and simple manner with respect to injection. Due to the positive pressure in the peripheral space, the chemical solution coming out of the container has a defined flow rate. This liquid can be supplied with high precision via the valve device so that even a small amount can be dosed with high accuracy. The defined flow rate can be constant over time during the injection process or can vary in a specific way. After dosing a first desired amount of chemical solution less than the holding space, if it is returned from the open position to the closed position and then can be moved again from the closed position to the open position for further injection, multiple uses are easily possible using the valve device.This can be repeated as many times as desired until the chemical solution is completely supplied from the holding space. Depending on the gas introduced into the surrounding space, especially when low-oxygen or even oxygen-free gas is present in the surrounding space, the container can be easily used even for chemical solutions sensitive to oxygen such as adrenaline.

[0006] The distal direction is understood to mean the direction in which the chemical solution flows out of the container, especially when the container is oriented as intended towards the injection target, particularly in the direction of the patient's body or the like. The proximal direction is understood to mean the opposite direction, which is opposite to the intended outflow direction of the chemical solution from the container.

[0007] The second porous separation element is preferably arranged at the distal end of the inner container, and the first and second porous separation elements partition the holding space. The chemical solution can then be held, and preferably is held, in the holding space especially between the first and second porous separation elements. It can be discharged through the distal outlet opening via the second distal porous separation element, the outlet channel portion, and the valve device.

[0008] The first porous separation element preferably closes the inner container at its proximal end, especially directly at its proximal end. Particularly when the outlet channel portion is formed in some parts together with the inner container, the second distal separation element also preferably closes the inner container at its distal end, especially directly at its distal end. However, the outlet channel portion can also be arranged integrally with the inner container. In this case, the inner container, so to speak, follows the outlet channel portion, and in this case, the distal end of the inner container comes to be regarded as a virtual distal end that basically indicates the distal end of the holding space. This virtual distal end, and thus simultaneously the distal boundary of the holding space, is spaced from the distal outlet opening of the outlet channel portion when viewed in the proximal direction.

[0009] At least one porous separation element, namely a first porous separation element and preferably also a second porous separation element, is preferably fixedly arranged in place with respect to the inner container. In particular, it is preferred that the separation element is not displaceable with respect to the inner container. Rather, the separation element is preferably fixedly in place with respect to the inner container. Therefore, the separation element is not a displaceable stopper in particular.

[0010] However, alternatively, it is also possible to make at least one porous separation element displaceable. In particular, the proximal porous separation element can be arranged displaceably in the inner container and preferably can move together with its proximal interface during the discharge of the chemical solution. This can contribute in a particularly advantageous way to preventing the formation of air bubbles. The second distal separation element can alternatively or additionally be detachably attached to the inner container, in particular together with the outlet channel portion. In particular, the second separation element can be part of the outlet channel portion or can be firmly connected thereto. The second separation element can also be integrated into a closure member or a push-on cannula with an opening indication mechanism.

[0011] It is preferred that the container has no displaceable stopper. Therefore, it preferably has no displaceable stopper, and in particular preferably has no displaceable stopper made of pharmaceutical rubber. However, in principle, it is also possible to additionally provide a displaceable stopper, in particular between the first separation element and the second separation element in the inner container.

[0012] The first porous separation element and the second porous separation element delimit a holding space together with a wall of the inner container, in particular the inner wall, and the wall forms an inner circumferential surface that particularly surrounds the holding space, where the porous separation elements each form the terminal boundary of the holding space.

[0013] The peripheral space is preferably at least as large as the holding space. The gas volume of the peripheral space is thus such that, over the entire discharge of the total content volume of the holding space, continuous and unobstructed discharge of the chemical solution from the container is possible, preferably at a defined flow rate, and in particular corresponds at least to the volume of the chemical solution in the inner container between the porous separation elements.

[0014] The fact that gas is introduced into the peripheral space under positive pressure means in particular that the gas is introduced under a pressure higher than the ambient pressure of the container in the peripheral space, in particular the normal pressure, preferably a pressure higher than 1013 mbar. The positive pressure is preferably set such that the desired discharge operation of the chemical solution from the holding space is achieved. This particularly applies to a predetermined flow rate of the chemical solution.

[0015] The outlet channel portion is connected to the distal end of the inner container, in particular to allow flow, and is preferably separated from the peripheral space so as to prevent flow. This means that there is no direct fluid connection, in particular, between one outlet channel portion and the other peripheral space. Such a fluid connection is at most preferably mediated by a distal separation element, a holding space, and a proximal separation element, allowing the gas from the peripheral space to penetrate through the holding space and then preferably through the distal separation element and finally through the distal outlet opening into the outlet channel portion for discharging the chemical solution.

[0016] In a preferred embodiment, the inner container and / or the outer container can comprise or be composed of glass. In this way, in any case, a container that is gas-impermeable, in particular permanently pressure-stable, with respect to the external environment of the container can be provided. However, the inner container and / or the outer container can comprise or be composed of metal or metal alloy, plastic or ceramic.

[0017] When the valve device is opened for the first time, it preferably causes an irreversible change and is designed as a closure member with an opening indication mechanism so that it can be easily recognized later. For example, a fragile web, film, etc. that breaks or splits when operating for the first time can be provided in the valve device.

[0018] The cannula, syringe, needle, etc. can preferably be fixedly arranged at the distal outlet opening of the outlet channel portion. However, it is also possible that the distal outlet opening is arranged at the connecting element of the outlet channel portion for an injection device such as an infusion set including a fixed cannula, syringe needle, infusion tube, etc. In particular, the distal outlet opening can be formed in the Luer lock connection constituting the outlet channel portion.

[0019] Alternatively or additionally, the inner container is preferably elongated. The elongation of the inner container thus defines a longitudinal direction, particularly pointing from the distal end to the proximal end.

[0020] Alternatively or additionally, the inner container is preferably straight, particularly cylindrical. This represents a particularly simple and inexpensive form of the inner container. The inner container is particularly preferably of an annular cylindrical design.

[0021] Alternatively or additionally, the inner container is preferably wound, particularly spirally. The inner container is particularly preferably wound around an axis pointing in its longest elongation direction. In this way, the overall length of the container can be shortened compared to a container having a straight inner container whose length is equal to the length measured along its outer shape.

[0022] According to a further form of the present invention, the inner container can be designed as a capillary. This means that when the container is filled, the chemical solution is transported into the holding space by capillary force, and at the same time, the inner circumferential surface that particularly partitions the holding space is dimensioned as an interaction function with the inner container of the chemical solution, particularly the material of the inner circumferential surface, and as a surface tension function of the chemical solution so that the liquid completely fills the proximal porous separation element. In the case of a cylindrical inner container of any length, the inner circumferential surface is determined particularly by the inner diameter or inner radius of the inner container and is then dimensioned accordingly. The design of the inner container as a capillary allows even a small holding space to extend over a clearly recognizable length of the inner container, so that a relatively small inner diameter is also required here so that a simple scale can be marked in such a way that a visually easy determination of a smaller dosage amount can be made. Therefore, injection can be easily carried out. In particular, the length of the inner container is preferably several times larger than the inner diameter.

[0023] Even when the capillary force of the inner container is negligible, injection with the container in a vertical orientation is also possible.

[0024] The inner container preferably has an inner diameter of less than 10 mm, preferably less than 8 mm, preferably at most 4 mm, preferably less than 4 mm, preferably at most 3 mm, preferably less than 3 mm, and particularly preferably at least 2 mm to at most 3 mm.

[0025] According to a further form of the present invention, the outlet channel portion can be integrally formed with the inner container. The outlet channel portion with the inner container is particularly preferably designed as an integral glass part, and the second distal porous separation element preferably represents a separator between the inner container and the outlet channel portion, which is preferably arranged inside the integral configuration of the outlet channel portion and the inner container and is offset from the distal outlet opening in the proximal direction.

[0026] Alternatively, the outlet channel portion can preferably be formed in several parts together with the inner container. In particular, the outlet channel portion can be designed as an attachment to the inner container and can be inserted into it in a liquid-tight manner, especially at the distal end of the inner container, or can be connected to the distal end of the inner container in a liquid-tight manner in another way. The outlet channel portion is preferably designed as a plastic attachment. Thus, it can be manufactured particularly inexpensively, for example, by injection molding.

[0027] Regardless of whether the outlet channel portion is formed integrally with the inner container or as several parts, the outlet channel portion preferably has a receptacle for the valve device and can in particular be designed as a bore that traverses the outlet channel portion in a transverse direction, transverse to the outflow direction of the medicament from the distal outlet opening.

[0028] According to a further aspect of the invention, the first porous separation element and / or the second porous separation element can be designed as a sintered body. Such a porous separation element is preferably formed from a plurality of particles that are integrally joined to each other only in some of their regions. Such a sintered body is preferably manufactured by heating the particles in contact with each other to a temperature up to the softening temperature, preferably to a temperature lower than the melting temperature, in some regions, and softening or partially melting them in the edge regions and joining them to each other, especially at their contact regions. In particular, the closest adjacent particles are partially joined to each other. Dense channels that function like capillaries in particular remain between the particles. A particularly preferred embodiment of such a sintered body is a frit, and the first porous separation element and / or the second porous separation element are designed in particular as a frit, preferably as a glass frit or a ceramic frit.

[0029] However, the first porous separation element and / or the second porous separation element can also be designed as a filter or filter membrane having a pore size of particularly from a minimum of 0.5 μm to a maximum of 3 μm, preferably from a minimum of 1 μm to a maximum of 2 μm, preferably 1.6 μm. At least one separation element preferably has a boiling point of from a minimum of 0.1 bar to a maximum of 0.7 bar, preferably 0.4 bar.

[0030] Such a sintered body has filter characteristics so that particles present in the chemical solution can be filtered, particularly by the distal porous separation element, either when the chemical solution is filled into the container or afterwards when the chemical solution is discharged from the container. This is particularly preferable in the situation of using a chemical solution ophthalmically because very small particles do not enter the vitreous body of the eye at all or only in a small amount.

[0031] The porous separation element can also perform the following important functions. During filling of the medical container, the capillary force in the region of the first proximal porous separation element prevents the chemical solution from leaking from the holding space to the peripheral space. The capillary force spreads on the one hand into the inner container and on the other hand into the region of the first porous separation element, and as a result, the holding space is filled completely without air. Further, the first porous separation element has a role of transmitting the positive pressure of the gas in the peripheral space to the liquid, and when the valve device is open, it can be discharged through the distal outlet opening. Since the chemical solution no longer comes into contact with the liquid placed in the holding space and no longer flows out through the distal porous separation element when it comes into contact with the bubbles or gas present therein, the distal porous separation element very efficiently prevents the injection of bubbles. Therefore, the injection of undesirable gas can be effectively prevented.

[0032] To ensure that while gas can pass through the first proximal separation element for injection, on the other hand, the injection of gas through the second distal separation element is prevented, the first separation element and the second separation element preferably have different pore sizes or pore diameters. In particular, the first separation element and the second separation element have different boiling points and thus different flow path characteristics for gas.

[0033] However, since the pressure in the surrounding space drops during the injection process, it is also possible for the separation elements to have the same pore diameter and / or boiling point. The first separation element allows the gas to pass through at a higher gas pressure at the beginning of the injection, while the second separation element prevents the gas from passing through at the lower gas pressure at the end of the injection.

[0034] When the porous separation elements are designed as glass frits, it is preferred that they are fused to the inner container by melting. This is particularly possible in a stable and inexpensive way if the inner container also contains or is composed of glass.

[0035] Forming the inner container from glass has the further advantage that it is highly chemically inert to the chemical solution. Since no displaceable stopper is provided in the inner container, there is no use of lubricant, and in particular, silicone oil is not required. The chemical solution can thus be stored in the inner container with high purity without the risk of contamination.

[0036] According to a further aspect of the invention, it is possible for the distal porous separation element to be arranged outside the outer container. The connection point where the outer container is airtight and connected to the inner container is preferably fused and thus offset in the proximal direction with respect to the distal porous separation element. However, it is also possible for the distal porous separation element to be arranged inside the outer container or precisely in the region of the connection point between the outer container and the inner container.

[0037] According to a development of the invention, it is provided that the outer container is cylindrical. This indicates a simple and particularly easy-to-manufacture design of the outer container.

[0038] Alternatively or additionally, it is preferably possible for the outer container to be barrel-shaped or piston-shaped. This means in particular that the outer container can have walls curved in two directions perpendicular to each other. Such a configuration helps to avoid sharp-angle transitions and allows the outer container to be designed in such a way that the pressure is particularly stable.

[0039] Alternatively or additionally, the outer container is preferably convex, and this convex design is in the direction that an observer of the outer container sees from the outside. In this way, the outer wall of the container has an overall outward curvature or bulge, especially. This also contributes to a particularly pressure-stable outer container.

[0040] Alternatively or additionally, preferably the outer container can be oval or elliptical. Thereby, the outer container has a particularly preferably very pressure-stable shape and can be designed especially basically as an egg-shaped or light-bulb-shaped object.

[0041] According to a further aspect of the invention, the outlet channel portion can be arranged at a finite angle other than 0° with respect to the main direction in which the inner container extends. In particular, the longitudinal direction of the outlet channel portion having the distal outlet opening of the outlet channel portion, that is, in particular the outlet direction or the longitudinal direction of the outlet portion, extends at a finite angle other than 0° with respect to the main direction in which the inner container extends. The main direction of the extension of the inner container is, in at least some regions, when it is cylindrical, in particular the cylinder axis or the longitudinal axis of the inner container, or the direction of the longest dimension of the inner container around which the inner container can be wound particularly spirally, for example.

[0042] Since the outlet channel portion forms an angle other than 0° with the main direction of the extension of the inner container, the container can have a pistol-like shape, and on the one hand, the container can be easily and ergonomically held by one hand of the user, while on the other hand, the valve device can be easily and ergonomically operated by holding the container with the fingers of the hand in a natural hand position. In this way, it is made easy for the patient to inject themselves with the container without much effort.

[0043] According to a further form of the present invention, there is provided a container having a finger trigger operably connected to a valve device, the valve device being operable by the finger trigger. In this way, the valve device can be actuated by the user using a finger, particularly ergonomically. Particularly preferably, the outlet channel portion is at a finite angle other than 0° with respect to the main direction of extension of the inner container, and the container also comprises a finger trigger capable of actuating the valve device. The finger trigger acts like the trigger of a pistol that can be easily operated ergonomically. This has particular advantages with respect to simple and easy self-injection by patients. The finger trigger particularly has a simple curved bending element such as that of a pistol. However, it is also possible for the finger trigger to have a finger ring through which the user of the container can extend a finger, particularly a closed finger ring. In addition to opening the valve device, the finger ring also makes it possible to close it in a particularly simple manner, without the need to reach around it, particularly by moving the finger trigger backwards.

[0044] According to a further form of the present invention, the valve device can have a check valve, a manual valve, a switching valve, and / or a combined valve comprising a check valve and a manual valve. The check valve has been found to be particularly advantageous when filling the container, and the medicament can be introduced into the holding space under a pressure slightly exceeding the positive pressure of the gas with the check valve open in this functional state. In the normal storage state, the gas in the surrounding space and the medicament in the holding space are then held under this positive pressure, which presses the check valve against its sealing sheet against the normal pressure acting in the external environment of the container.

[0045] The manual valve can be easily opened and closed by the user, and the supply of the medicament through the distal outlet opening can be easily controlled. However, the switching valve can also be used for this purpose, particularly when the valve device has an electronic control device designed to control such a switching valve.

[0046] A combined valve provided with a check valve and a manual valve is particularly suitable. The combined valve satisfies the function of easily filling the container with a chemical solution and firmly holding it by the parts of the check valve, while at the same time performing the function of easily opening and closing the valve device by the parts of the manual valve. The parts of the manual valve and the check valve are preferably integrally formed with each other. The manual valve preferably has a seat for the check valve, and this seat simultaneously provides a flow channel for fluid connection between the holding space and the distal outlet opening. In particular, the manual valve can have a recess having a seat for the valve element of the check valve in the closed position, and this recess turns in the open position in such a way as to function as a channel for fluid connection between the holding space and the distal outlet opening.

[0047] In particular, the manual valve can be arranged obliquely, preferably vertically, in the output direction of the chemical solution from the container, turn in the direction of the holding space in the closed position, and have a rotatable cylinder having a recess formed to form a sealing seat for the valve element of the check valve. In the open position, the recess preferably turns by 90° in such a way that the liquid flow path between the holding space and the distal outlet opening opens through this recess. At the same time, the valve element of the check valve is further pressed in the sealing direction in the direction of the holding space by the non-recessed outer peripheral surface of the cylinder of the manual valve so that a fluid connection between the holding space and the distal outlet opening is constructed here. When the cylinder turns back to the closed position, the valve element of the check valve is then snugly received in the recess so that the fluid connection between the holding space and the distal outlet opening is blocked again.

[0048] The valve device is preferably made of or formed from plastic. This can be polyetheretherketone (PEEK), which is inert on the one hand and very smooth on the other, and also provides a good sealing effect. Then it may not be necessary to use additional lubricants and / or sealants for the valve device. For example, the cylinder of a manual valve can be sealed with an O-ring and can be preferably held and guided. Additionally or alternatively, in order that the chemical solution can escape only laterally through the distal outlet opening rather than through the gaps in the area of the valve device, in particular, at least one sealant such as wax is used in the area of the valve device to seal the container from the outside and / or to seal the fluid connection between the holding space and the distal outlet opening with respect to the outside of the container in the closed position of the valve.

[0049] It is also possible for the valve element of the check valve to be biased to its closed position by, for example, a spring element or other suitable biasing element. However, the valve device may also not have such a biasing element, in which case the pressure difference between the pressure in the holding space and, on the one hand, the pressure in the surrounding space and, on the other hand, the pressure in the external environment of the container is sufficient to push the valve element of the check valve into its seat.

[0050] According to a preferred embodiment, a valve device configured further or differently is also biased to its closed position. For example, whether designed as a composite valve by itself or in combination with a check valve, the manual valve is biased to its closed position by, for example, a biasing element engaged with an operating lever or the aforementioned finger trigger, in particular, a spring. The valve device then opens against the biasing force, and it is preferred that the valve device closes automatically as soon as the user releases or opens the valve device.

[0051] According to a further form of the present invention, it is possible for the inner container to be filled with a chemical solution and the outer container to be filled with a gas under positive pressure. The advantages described so far are realized in such a case. In particular, it is possible to fill the inner container with a chemical solution sensitive to oxygen, and when oxygen is insufficient or a gas without oxygen is used as the gas in the outer container, the chemical solution sensitive to oxygen can be safely stored in the container for a long time. In principle, any gas that does not react with the chemical solution, such as air, nitrogen, an inert gas, particularly an inert noble gas, can be used as the gas in the outer container.

[0052] According to a further form of the present invention, the first proximal porous separation element is covered by a cover element in at least some regions with respect to the peripheral space of the outer container, and the cover element can preferably cover the proximal porous separation element except for the central recess. The cover element can advantageously reduce the contact area between the pressurized gas and the chemical solution, and as a result, in particular, the evaporation loss from the holding space through the first proximal porous separation element into the peripheral space can be minimized. At the same time, the cover element provides protection against mechanical stress on the proximal porous separation element, in particular, protection against splashing when the container is exposed to impacts such as accidental dropping.

[0053] The cover element is preferably designed as a cover cap and in particular has a central bore. Alternatively, it is also possible for the cover element to be designed as a membrane, preferably one having a central recess.

[0054] As an alternative or addition to the cover element, it is also possible for the first porous separation element to have an outer diameter smaller than the free inner diameter of the holding space outside the proximal end of the inner container. In particular, the inner peripheral surface of the inner container can be thickened inwardly in the region of the proximal end, so that it projects radially inwardly, and the first porous separation element is arranged in the region where it becomes radially thick. In this way, the contact area between the gas and the chemical solution can be reduced, in particular minimized.

[0055] According to a further form of the invention, it is possible to arrange a predetermined breaking point at the distal connection point where the outer container is hermetically connected, in particular fused, to the inner container. When the container is subjected to an impact, in particular an impact due to a fall, the predetermined breaking point is preferably designed so that, in a controlled state, without any impact sound and without the leakage of the chemical solution, it is possible to release the gas. The predetermined breaking point is preferably designed as a hole or a bore, and in particular transverses the longitudinal axis of the container. When the gas escapes in a direction transverse to the longitudinal axis, this will at most cause the rotation of the container but will not cause its translational acceleration, which in particular prevents the container from accelerating like a rocket.

[0056] According to a further form of the invention, the container can be designed as a syringe or a cartridge. The advantages of the container already described are realized in a special way in this case.

[0057] The holding space preferably has a capacity of less than 2 mL, preferably less than 1.5 mL, preferably less than 1 mL, preferably less than 0.6 mL, preferably less than 0.5 mL, and is configured to provide, for the sake of convenience, an even smaller amount for accurate injection. The holding space preferably has a hollow dimension of 1 mL. The container is particularly preferably configured for ophthalmic injection, in particular for ophthalmic injection into the vitreous body of the eye.

[0058] The container is also preferably set to perform multiple-use injections, in particular in the case of subcutaneous or intramuscular use and / or in the case of a long period, such as over one month. In such a case, the valve device can be opened and closed as required, and the multiple-use injections are performed, for example, at different sites.

[0059] The container is particularly preferably designed for subcutaneous or intramuscular injection.

[0060] This object is also achieved by creating a method for filling a container for a chemical solution according to any one of the above-described exemplary embodiments. The method consists of the following steps. The surrounding space of the container is filled with gas at a first predetermined pressure. Subsequently, the holding space of the inner container is filled with the chemical solution at a second predetermined pressure, which is higher than the first predetermined pressure, and finally the valve device is closed. In this way, the holding space of the inner container can be filled particularly safely, reproducibly, and completely.

[0061] Particularly advantageously, the inner container is designed as a capillary, and the capillary force constructs a column of the chemical solution within the holding space during filling and at the same time holds it together when it is emptied later, so that the injection of gas is effectively avoided.

[0062] The surrounding space is preferably filled via not only the inner container and the first proximal porous separation element but also the outlet channel portion and the valve device. In particular, this is the only way to access the surrounding space of the outer container; otherwise, the outer container is completely airtight. The holding space is also filled via the outlet channel portion and the valve device. It is preferable that there is no other access route to the holding space.

[0063] When a gas other than air is used as the gas, it is preferable that the surrounding space of the container is evacuated several times and filled with the pure gas used, particularly via the outlet channel portion and the valve device, so that the surrounding space is sufficiently flushed. In this way, in particular, an atmosphere with low oxygen or no oxygen can be provided in the surrounding space.

[0064] The first predetermined pressure preferably corresponds to a predetermined final pressure for the subsequent discharge of the chemical solution from the container. As a result, the second predetermined pressure is set as the initial pressure within the container after the valve device is closed.

[0065] Upon filling, it is preferred that at least the outlet channel portion, and in particular the distal outlet opening, of the container is immersed in the chemical solution or connected to a pressure contact port to which the chemical solution is supplied. And filling is automatically performed by a second predetermined pressure higher than the first predetermined pressure and preferably by the capillary force acting on the inner container. These also enable a complete and bubble-free filling of the holding space, and the filling automatically stops as soon as the capillary force prevents the chemical solution from leaking into the peripheral space beyond the proximal porous separation element.

[0066] It is preferred that the check valve of the valve device automatically closes when the external second predetermined pressure is removed. Further valve components of the valve device, preferably a manual valve, can either be additionally attached here or, if already attached before filling, can be closed after filling.

[0067] During or before filling the peripheral space with gas, the partial pressure of at least one major component of the chemical solution, in particular its solvent, preferably in the gas, is preferably adjusted so that the partial pressure exactly matches the vapor pressure of at least this major component of the chemical solution or the partial pressure of the chemical solution in the inner container of the second predetermined pressure, and thus the permanent storage pressure of container 1. In this way, in particular the saturated vapor pressure of the chemical solution is set in the peripheral space under storage conditions. This advantageously serves to prevent at least the components of the chemical solution from evaporating into the peripheral space via the proximal porous separation element, which in particular prevents the proximal porous separation element from drying out.

Brief Description of the Drawings

[0068] The present invention will be described in more detail below with reference to the drawings.

Figure 1

Figure 2

Figure 3

Figure 4

Best Mode for Carrying Out the Invention

[0069] FIG. 1 shows a schematic view of a first embodiment of a container 1 for a chemical solution, which is designed particularly as a syringe or a cartridge. The container 1 has an inner container 3 having a distal end 5 and a proximal end 7. The first porous separation element 9 is preferably arranged at the proximal end 7, and the second porous separation element 11 is preferably arranged at the distal end 5. The first porous separation element 9 and the second porous separation element 11, together with the inner peripheral surface 13 of the inner container 3, define a holding space 15 configured to receive a chemical solution, particularly a liquid pharmaceutical active ingredient and / or excipient.

[0070] The container 1 also has an outer container 17, and the inner container 3 is arranged within the outer container 17 with its proximal end 7 and at least partially with the holding space 15. The outer container 17 hermetically surrounds the inner container 3 so that a gas under positive pressure with respect to the external environment of the container 1 can be arranged within a peripheral space 23 disposed particularly between the outer surface 19 of the inner container 3, which is the outer shell surface, and the inner surface 21 of the outer container 17.

[0071] The peripheral space 23 is connected to the holding space 15 via the first porous separation element 9 such that the pressure extending within the peripheral space 23 is transmitted to the holding space 15.

[0072] An outlet channel portion 25 is connected to the distal end 5 of the inner container 3 and is arranged at least partially outside the outer container 17, particularly distal to a connection point 27 where the outer container 17 is hermetically connected, preferably fused, to the inner container 3.

[0073] A valve device 29 is arranged within the outlet channel portion 25 and is configured to establish a fluid connection between the distal outlet opening 31 of the outlet channel portion 25 and the holding space 15 in an open position and to shield the fluid connection between the distal outlet opening 31 and the holding space 15 in a closed position.

[0074] Both the inner container 3 and the outer container 17 are preferably formed of glass. In particular, in the embodiment of FIG. 1, the inner container 3 is formed from a glass tube or glass cylinder that is straight (optionally wound), and the outer container 17 is preferably formed from a glass tube or glass cylinder or a glass bulb. The inner space of the outer container 17 is adapted to the inner container 3 such that the outer container 17 can accommodate at least a part of the inner container 3.

[0075] However, the inner container 3 and / or the outer container 17 can also be composed of plastic or be made of plastic. Ceramics or metal or metal alloy can also be used as the material for the inner container 3 and / or the outer container 17.

[0076] The proximal end 7 of the inner container 3 preferably projects freely within the outer container 17, and in particular is not connected to the outer container 17 at the proximal end 7. However, a mechanical support, a support element, in particular a radial web, or a plurality of such support elements, in particular radial webs, for the inner container 3 within the outer container 17 can be arranged between the inner container 3 and the outer container 17, and these support the inner container 3 at the inner surface 21 of the outer container 17. The outer container 17 is designed to close at its proximal end 33 at a distance from the proximal end 7 of the inner container 3, measured in the longitudinal direction of the container 1.

[0077] In the region of the connection point 27, which is arranged in the vicinity of the distal end 5 of the inner container 3 and is preferably offset therefrom in the proximal direction, the outer container 17 is airtight connected, in particular fused, to the inner container 3. In this way, the peripheral space 23 is airtight surrounded on all sides by the outer container 17.

[0078] The connection point 27 can also be provided at the height of the distal end 5 when viewed in the longitudinal direction of the container 1. In principle, the distal end 5 of the inner container 3 can also be arranged within the outer container 17, and a part of the outlet channel portion 25 extends into the outer container 17, and the connection point 27 can also be designed as a direct connection between the outer container 17 and the outlet channel portion 25.

[0079] The longitudinal direction of the container 1 is the direction that particularly refers to the longest direction of the container 1 and / or the direction of the axis of symmetry of the container 1. In Figure 1, this is the horizontal direction. The radial direction is perpendicular to the longitudinal direction. The circumferential direction concentrically surrounds the longitudinal direction.

[0080] The first porous separation element 9 closes the inner container 3 at its proximal end 7. The second porous separation element 11 delimits the holding space 15 in the region of the distal end 5 of the inner container 3.

[0081] The porous elements 9 and 11 are spatially fixed to the inner container 3, particularly to the inner circumferential surface 13 of the inner container 3, and thus cannot move within or relative to the inner container 3. In particular, it is also possible for the porous elements 9 and 11 to be integrally connected to the inner container 3, preferably fused.

[0082] The chemical solution placed in the holding space 15 can be supplied from the distal outlet opening 31 in its open position via the valve device 29 because the gas placed in the peripheral space 23 under positive pressure applies pressure to the chemical solution through the first porous separation element 9. The above-mentioned pressure is greater than the ambient pressure of the external environment of the container 1. Therefore, the chemical solution is discharged through the distal outlet opening 31 in the open position of the valve device 29. This is designed such that the container 1 has no stopper, particularly no displaceable stopper, and furthermore no displaceable stopper made of medical rubber, so that no movable parts are required, particularly no displaceable stopper.

[0083] The discharge of the chemical solution from the holding space 15 can be interrupted by moving the valve device 29 from its open position to its closed position. In this way, for example, multiple uses of the chemical solution are possible at different locations, for subcutaneous or intramuscular use, or over a longer period of time.

[0084] The peripheral space 23 preferably has at least the same size as the holding space 15, and preferably is larger than the holding space 15. As a result, the most uniform possible supply of the chemical solution through the distal outlet opening 31 can ensure a defined flow rate that varies, as necessary, in a constant or specific manner throughout the supply period.

[0085] The inner container 3 is preferably designed as a capillary tube with an inner diameter of less than 4 mm, preferably less than 3 mm. As a result, the liquid column of the chemical solution is advantageously held within the holding space 15, which on the one hand facilitates filling the holding space 15 and on the other hand prevents the formation of air bubbles when the chemical solution is being supplied, particularly in the region of the distal end 5 and thus especially in the region of the second porous separation element 11. Injection of air or gas can thus be advantageously prevented. Even after the chemical solution has been completely supplied from the holding space 15, the second porous separation element 11, which is still wet with the chemical solution, prevents the penetration and injection of gas by the capillary forces acting therein.

[0086] The capillary forces hold the liquid column of the chemical solution together during emptying so that the liquid column of the chemical solution does not stick to the inner circumferential surface 13 but rather completely detaches therefrom. Thus, the capillary properties of the inner container 3 can also completely empty the holding space 15.

[0087] In the first exemplary embodiment of the container 1 shown in FIG. 1, the inner container 3 is elongated, particularly straight, preferably in the form of a cylinder, particularly an annular cylinder.

[0088] In the first exemplary embodiment of the container 1 according to FIG. 1, except for the connection region in the region of the connection point 27, the outer container 17 is likewise cylindrical, preferably an annular cylinder.

[0089] The inner container 3 is filled in particular with a chemical solution, and the outer container is filled with a gas under positive pressure. The gas may be air, but may also be an inert gas, in particular nitrogen, a noble gas or a mixture of different gases, in particular nitrogen and / or at least one noble gas. If an oxygen-free or at least low-oxygen gas is introduced into the peripheral space 23, the chemical solution can also be a liquid sensitive to oxygen. The container 1 is therefore also suitable for the long-term storage of oxygen-sensitive chemical solutions such as adrenaline. This is not typically the case with conventional medical containers having stoppers made of medical rubber, since these stoppers have a certain permeability to oxygen. In contrast, the container 1 is airtight to the outside in the closed position of the valve device 29.

[0090] Here, the first proximal porous separation element 9 is at least partially covered by a cover element 35 with respect to the peripheral space 23 of the outer container 17, and the cover element covers the proximal porous separation element 9 except for the central recess 37. The cover element 35 can be designed in particular as a cap with a central bore or as a membrane with a small opening. Alternatively, the first porous separation element 9 can be made very small, i.e., with a small diameter, and arranged in the region of the inner circumferential surface 13 that increases in thickness radially inward, in particular by melting. The correspondingly reduced area through which the first porous separation element 9 contacts the gas in the peripheral space 23 advantageously reduces the possibility that at least a part of the chemical solution changes to the gas phase and thus the proximal porous separation element 9 dries out.

[0091] The predetermined breaking point is preferably arranged in the region of the connection point 27. By doing so, even if the container 1 is accidentally impacted, explosive destruction can be prevented. Rather, it is preferably possible to control the escape of the gas from the peripheral space 23 without substantial leakage of the chemical solution. The predetermined breaking point is preferably designed as a bore or hole in a direction transverse to the longitudinal direction, in particular in the radial direction. This prevents the gas escaping from the peripheral space 23 from accelerating the container 1 essentially like a rocket. As a result, the container 1 rotates at most once around its axis, i.e., perpendicular to the longitudinal axis, without translational displacement. The predetermined breaking point enhances the safety of the container 1 during operation.

[0092] Container 1 is preferably designed to hold a small amount of a medicament solution, particularly less than 1 mL, preferably less than 0.6 mL, preferably less than 0.5 mL, preferably 1 mL. It is particularly preferred that it is designed to hold a medicament solution intended for eye injection, and particularly for injection into the vitreous humor of the eye. In particular, in this case, it is advantageous that the distal second porous separation element 11 also has a filtering effect due to its porous nature, and thus particle injection into the eye can be effectively prevented.

[0093] The first porous separation element 9 and / or the second porous separation element 11, particularly preferably both of the porous elements 9 and 11, are preferably designed as a sintered body, particularly as a frit, preferably as a glass frit or a ceramic frit, or as a filter or a filter membrane.

[0094] The distal second porous separation element 11 is preferably arranged distal to the outside of the outer container 17, particularly from the connection point 27. However, as already mentioned above, the distal second porous separation element 11 can also be arranged at the height of the connection point 27 or even within the outer container 17.

[0095] The outlet channel portion 25 is in this case formed in several parts together with the inner container 3, and thereby is preferably designed as an attachment, particularly as a plastic attachment, which fits precisely onto the distal end 5 of the inner container 3 and is held there by particularly suitable holding and sealing means. However, alternatively, the outlet channel portion can also be integrally formed with the inner container.

[0096] The outlet channel portion 25 preferably has a suitable recess, particularly a transverse hole, for receiving the valve device 29.

[0097] FIG. 2 shows a schematic view of a second exemplary embodiment of the container 1. Since the same and functionally identical elements are given the same reference numerals, reference is made to the foregoing description in this regard. In this second exemplary embodiment, the inner container 3, which is preferably designed as a capillary, is wound, particularly spirally wound. Thereby, the overall length of the container 1 is shortened with the same holding space 15, particularly the same inner diameter of the inner container 3.

[0098] In the second exemplary embodiment, the outer container 17 is particularly in the shape of a convex barrel or piston shape, preferably oval or elliptical. In particular, it has at least two curved walls having a finite non-zero curvature in mutually vertical directions. With this shape, the outer container 17 is particularly pressure-stable because it has no corners or sharp changes in particular.

[0099] FIG. 3 shows a detailed schematic view of a third exemplary embodiment of the container 1. Since the same and functionally identical elements are given the same reference numerals, reference is made to the foregoing description in this regard. The preferred mode of operation and configuration of the valve device 29 is described in more detail with reference to FIG. 3. Here, the valve device 29 has a combined valve 39 that combines a check valve 41 and a manual valve 43 integrally formed with each other as the valve device 29. The check valve 41 has, in this case, a check valve element 45 designed particularly as a spherical valve ball. This check valve element 45 is pushed into a valve seat 47 formed at least partially in a valve element 49 of the manual valve 43 by a positive pressure in the holding space 15. The valve element 49 is preferably designed as a cylinder rotatably attached to the outlet channel portion 25 about a valve rotation axis. Since the valve rotation axis points in the radial direction, it is perpendicular to the longitudinal direction of the container 1. The valve seat 47 is formed as a recess or trough in the valve element 49, and thus as a depression in the outer peripheral surface 51 of the valve element 49.

[0100] The valve element 49 is here integrally connected to an actuating element 53, particularly a handle. The valve element 49 can be manually pivoted about the valve rotation axis by the actuating element 53, particularly.

[0101] Figure 3 shows the composite valve 39, and thereby also shows the valve device 29 in the closed position. This is because the check valve element 45 is pushed into the valve seat 47 by the positive pressure within the holding space 15, and the holding space 15 is sealed from the distal outlet opening 31.

[0102] When the valve element 49 turns, particularly by 90° around the valve rotation axis, the outer circumferential surface 51 outside the recess forming the valve seat 47 pushes the check valve element 45 in the direction of the holding space 15, thus to the right in Figure 3, and it is displaced from the valve seat 47. As a result, the blocking action of the check valve element 45 is canceled. At the same time, the recess of the valve element 49 forming the valve seat 47 then provides a fluid path through which the holding space 15 is in fluid connection with the distal outlet opening 31. The composite valve 39 and, together with it, the valve device 29 are consequently arranged in the open position. To return to the closed position, the valve element 49 is simply returned together with the valve seat 47 to a position where the check valve element 45 is received within the valve seat 47 and a seal can be made, particularly the position shown in Figure 3.

[0103] The valve element 49 is attached in a fluid-tight manner to the outlet channel portion 25, particularly in this way, via a seal 55 which is designed in particular as an O-ring.

[0104] As an alternative to the configuration shown here, the valve device 29 can also have a check valve, a manual valve, or a check valve and a manual valve or a switching valve formed separately from each other.

[0105] Figure 4 shows a schematic view of a fourth exemplary embodiment of the container 1. Since the same and functionally identical elements are provided with the same reference signs, reference is made to the foregoing description in this regard. In this fourth exemplary embodiment, the container 1 has a finger trigger 57 as the actuating element 53 of the valve device 29. As a result, the valve device 29 can be actuated particularly ergonomically, particularly when the patient administers an injection from the container 1 himself.

[0106] An embodiment example (not shown) of the container 1 in which the outlet channel portion 25 is arranged at a finite angle other than 0° with respect to the main direction of the extension of the inner container 3, particularly the longitudinal direction, is also preferable. In this way, it is possible to provide the container 1 having a pistol-like configuration that can be particularly ergonomically operated at a particularly comfortable hand position. This pistol-like configuration of the container 1 is preferably combined with a finger trigger 57 as an operating element 53 for the valve device 29, which further enhances the ergonomics and usability of the container 1, particularly for patients with limited mobility who wish to perform the injection themselves.

[0107] The method of filling the container 1 preferably involves filling the peripheral space 23 with gas at a first predetermined pressure that is higher than the external ambient pressure expected when the container 1 is later used, and thus, in particular, higher than the normal pressure of 1013 mbar. Subsequently, the holding space 15 of the inner container 3 is filled with the pharmaceutical solution at a second predetermined pressure, which is higher than the first predetermined pressure. In particular, the combination of the pressure conditions specifically mentioned here and the capillary properties of the holding space 15 results in the complete filling of the first proximal porous separation element 9 without air bubbles. The valve device 29 is then preferably closed to complete the filling. As a result, the second predetermined pressure spreads as the final pressure and, as a result, as a positive pressure within the peripheral space 23 and within the holding space 15. The injection characteristics of the container 1 and, in particular, the initial flow rate for discharging the pharmaceutical solution from at least the distal outlet opening 31 can thus be set by selecting the second predetermined pressure. The first predetermined pressure preferably determines the final pressure at the end of the injection.

[0108] Before or when the peripheral space 23 is filled, the partial pressure of at least one main component of the pharmaceutical solution, particularly the solvent, in the gas is preferably set such that this partial pressure corresponds to the vapor pressure of the pharmaceutical solution at the second predetermined pressure or at least the main component of the pharmaceutical solution within the inner container 3. As a result, under the storage conditions for the pharmaceutical solution, a saturated vapor pressure is set within the peripheral space 23, and evaporation into the peripheral space 23 through the first porous separation element 9 and, thereby, drying of the first porous separation element 9 are avoided.

[0109] The container 1 proposed here provides an infusion container that is particularly suitable for self-use by patients. In this case, the operator of the container 1 does not need to apply pressure to discharge the medicinal liquid from the holding space 15. Finally but importantly, this also makes it possible to pre-adjust an appropriate flow rate for the discharge of the medicinal liquid on the filling side of the container 1.

[0110] The container 1 is preferably configured to be used in an automatic infusion device, particularly an autoinjector or a pen, or is itself designed as an automatic infusion device.

[0111] Since the valve device 29 is located in the outlet channel portion 25 and thus distally in the container 1, it is arranged near the cannula provided for infusion and is connected to the distal outlet opening 31. It is also possible for the operator of the container 1 to grasp near the valve device 29 and the outlet channel portion 25 so that ergonomic one-handed operation is possible.

[0112] The container 1 is particularly characterized by a very low dead air space. Therefore, there is no need to bleed air before infusion.

[0113] Since there is no displaceable stopper, no lubricant is required and there is no need to use silicone oil.

[0114] The valve device 29 is preferably biased to its closed position such that active actuation is required only in the direction of the open position. This further simplifies the operation of the container 1.

[0115] Particularly due to the capillary design of the inner container 3 and its resulting elongated shape, it is easier to accurately measure even smaller dosages. By combining this with bubble-free filling and the elimination of the need to bleed air from the container 1 before infusion, the medicinal liquid placed in the holding space 15 can be used very economically. The medical container 1 can therefore be advantageously used not only for small infusion volumes but also in applications related to expensive or toxic substances. The container 1 is particularly ergonomically favorable and enables easy injection.

[0116] Particularly suitable for accurate and complex injections in ophthalmology and / or surgery.

Claims

1. an inner container (3) having a distal end (5) and a proximal end (7); A first porous separation element (9) is disposed at said proximal end (7); the first porous separation element (9) defines a holding space (15) for holding a medicinal solution, the inner container (3) comprises an outer container (17) disposed therein with the proximal end (7) and at least a portion of the holding space (15), the outer container (17) extends around the inner container (3) in an airtight manner such that gas under positive pressure can be disposed in a peripheral space (23) between an outer surface (19) of the inner container (3) and an inner surface (21) of the outer container (17); an outlet channel portion (25) connected to the distal end (5) of the inner container (3); At least a portion of the outlet channel portion (25) is disposed outside the outer container (17); A valve device (29) is disposed in the outlet channel portion (25), the valve device being configured to open a fluid connection between a distal outlet opening (31) of the outlet channel portion (25) and the holding space (15) in an open position and to block the fluid connection between the distal outlet opening (31) and the holding space (15) in a closed position.

2. 2. The container (1) of claim 1, wherein a second porous separation element (11) is disposed at the distal end (5), and the first porous separation element (9) and the second porous separation element (11) define the holding space (15).

3. The inner container (3) is a) as a capillary, and / or b) elongated; and / or c) in a straight line, in particular in a cylindrical shape, in particular in a ring-cylindrical shape, and / or d) A container (1) according to claim 1 or 2, which is wound, in particular spirally formed.

4. 4. The container (1) according to any one of claims 1 to 3, wherein the outlet channel portion (25) is formed integrally or in several pieces with the inner container (3), in particular as an attachment, in particular as a plastic attachment.

5. 5. The container (1) according to claim 1, wherein the first porous separation element (9) and / or the second porous separation element (11) is formed as a sintered body, in particular as a frit, preferably as a glass or ceramic frit, or as a filter or filter membrane.

6. 6. The container (1) according to any one of the preceding claims, wherein the second porous separating element (11) is arranged outside the outer container (17).

7. The outer container (17) is a) cylindrically, and / or b) in a barrel or piston shape, and / or c) at least partially convex, preferably completely convex, and / or d) A container (1) according to any one of claims 1 to 6, which is shaped as an oval or ellipse.

8. 8. The container (1) according to any one of the preceding claims, wherein the outlet channel portion (25) is arranged at a finite angle other than 0° to the main direction of extension of the inner container (3).

9. The container (1) according to any one of claims 1 to 8, wherein the container (1) has a finger trigger (57) operably connected to the valve device (29) such that the valve device (29) can be actuated by the finger trigger (57).

10. The valve device (29) a) a check valve (41), and / or b) a manual valve (43), and / or c) a switching valve, and / or d) A vessel (1) according to any one of claims 1 to 9, comprising a combined valve (39) comprising a check valve (41) and a manual valve (43).

11. The container (1) according to any one of the preceding claims, wherein the inner container (3) is filled with a medicinal liquid and the outer container (17) is filled with a gas under positive pressure.

12. the first proximal porous separation element (9) is at least partially covered with respect to the peripheral space (23) of the outer container (17) by a cover element (35); Container (1) according to any one of the preceding claims, wherein the cover element (35) covers the first proximal porous separation element (9), preferably except for a central recess (37).

13. Container (1) according to any one of claims 1 to 12, wherein a predetermined breaking point is arranged at a distal connection point (27) between the outer container (17) and the inner container (3).

14. The container (1) according to any one of the preceding claims, wherein the container (1) is formed as a syringe or a carpule.

15. Filling the peripheral space (23) of the container (1) with a gas at a first predetermined pressure; Filling the holding space (15) of the inner container (13) with a liquid medicine at a second predetermined pressure higher than the first predetermined pressure; A method for filling a container (1) for a medicinal liquid according to any one of the preceding claims, comprising closing the valve device (29).

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