DE102016108873A1 - Device for storing and metering a sterile fluid - Google Patents

Abstract

The invention relates to a device for storing and repeatedly dosing a sterile fluid, in particular eye drops, comprising a reservoir for storing the sterile fluid and a dispenser, wherein a subset of the sterile fluid within a dispensing cycle can be issued, which at least one idle state and a dispensing state includes. The device is characterized in that in the idle state there is a first fluidic connection between the reservoir and a metering device and a fluid transfer device is arranged in the metering device, wherein the first fluidic connection by means of the fluid transfer device can be closed by a first displacement of the metering device relative to the fluid transfer device wherein, by a further displacement of the metering device relative to the fluid transfer device, a second fluidic connection between the metering device and the delivery device can be opened by means of the fluid transfer device.

Description

The invention relates to a device for storing and repeatedly dosing a sterile fluid, in particular eye drops, comprising a reservoir for storing the sterile fluid and provided with an outlet dispensing device, wherein a subset of the sterile fluid within a dispensing cycle can be issued, which at least one Hibernation and a delivery state includes.

These sterile fluids are especially eye drops. As a rule, eye drops (Oculoguttae) are aqueous or oily solutions or suspensions. These are dripped into the conjunctival sac or on the cornea. Because the eye is one of the most sensitive organs in humans, ophthalmic products are subject to very high quality standards. In particular, according to the European Pharmacopoeia, eye drops must be sterile. Contamination of the eye drops or of the sterile fluid with microorganisms by contact with the environment or the user, for example the eye, should therefore be avoided. Such pathogens can cause serious eye infections.

For example, to ensure the sterility of eye drops, eye drops are offered in single doses. Since a single dose represents a relatively small amount of fluid, such a storage form requires excessive packaging. Furthermore, such a storage form is unwieldy for the user. Alternatively, multidose containers are offered. However, preservatives are usually added to the eye drops to suppress microbial contamination after onset. However, the addition of preservative has the disadvantage that these preservatives can cause undesirable side effects.

The prior art already discloses multi-dose containers or applicators which are suitable for use with preservative-free eye drops. To prevent unwanted contamination, for example, one-way valves are used which allow leakage of the fluid but prevent ingress of liquid into the container. Further, the containers have air filters or a collapsible container to prevent contaminated air from coming in contact with the sterile fluid. In such containers, the outer surfaces in the area around the application tip may be contaminated, for example by contact with the eye, and bacterial growth may take place on these surfaces. Due to structural gaps in the housing, such as the dispensing valve, bacteria or contaminants can get into the container and contaminate the sterile fluid.

Furthermore, multi-dose containers or applicators are known from the prior art which have an antibacterial coating inside. As a rule, oligodynamically acting substances are applied. Such oligodynamically active substances contain metal ions, for example silver or copper. In these devices, however, it must be ensured that sufficient contact of the sterile fluid or the eye drops with the oligodynamically acting substances is guaranteed. This requires a complex construction. Accordingly, such multi-dose containers or applicators cause high production costs.

The object of the present invention is therefore to provide a device for storing and dispensing a sterile fluid several times in which a contamination of the sterile fluid is prevented and which are simple and inexpensive to produce.

This object is achieved by a device for storing and repeated dosing a sterile fluid, in particular eye drops, comprising a reservoir for storing the sterile fluid and a dispenser, wherein a subset of the sterile fluid within a dispensing cycle can be issued, which at least one idle state and a delivery condition. The device is characterized in that in the idle state there is a first fluidic connection between the reservoir and a metering device and a fluid transfer device is arranged in the metering device, wherein the first fluidic connection by means of the fluid transfer device can be closed by a first displacement of the metering device relative to the fluid transfer device wherein, by a further displacement of the metering device relative to the fluid transfer device, a second fluidic connection between the metering device and the delivery device can be opened by means of the fluid transfer device.

By such a device according to the invention a contamination of the sterile fluid is effectively suppressed. In the idle state, only the first fluidic connection is open between the reservoir and the metering device. The metering device is advantageously arranged between the reservoir and the dispenser. As a result of the relative displacement of the metering device to the fluid transfer device, the device is switched from the idle state to an intermediate state in which the first one fluidic connection is closed by means of the fluid transfer device. Since the second fluidic between the metering device and the delivery device is also closed by the fluid transfer device in this intermediate state, the metering device is fluidically isolated from the reservoir and the delivery device. By a further relative displacement of the metering device to the fluid transfer device, the second fluidic connection between the metering device and the delivery device can be opened by means of the fluid transfer device. By this further displacement of the dispensing state is thus taken, in which a subset of the sterile fluid can be delivered. In other words, a type of lock is realized by the device, wherein a subset of the sterile fluid is passed through the device for dispensing. The reservoir of sterile liquid in the reservoir is thus protected by, for example, entering through the outlet opening impurities, since at no time there is a direct connection between the reservoir and the outside world.

In the following, the terms "distal" and "proximal" are used. The distal end of a component is the end which is closer to the site of application or exit of the sterile fluid. The proximal end is thus further away from the site of application. Analogously, the terms "distal and proximal direction" are to be understood.

Advantageously, the fluidic connections between the reservoir and the metering device as well as between the metering device and the delivery device, a fluid transfer. Preferably, this fluid transfer is due only to a drive by the weight of the sterile fluid. Thus, the sterile fluid need not be pressurized at any time. It is therefore not necessary to provide complicated to be produced pumping devices. The device is thus easier to design and cheaper to manufacture. The device only has to be positioned above the site of application, for example the eye in the case of eye drops, in order then to perform the corresponding displacements and to apply the subset of the sterile fluid.

Preferably, the reservoir and the metering device are non-positively and / or positively connected with each other and displaced as a unit. The metering device preferably comprises a first hollow-cylindrical section, which projects in sections into the storage container. Advantageously, the non-positive and / or positive connection between a region of the outer wall of the first portion and an inner wall of the reservoir. Such a connection could be, for example, a snap connection, engagement of one or more tabs with each other, or a frictional engagement between the inner wall of the reservoir and a portion of the outer wall of the first section. Preferably, the connection between the reservoir and the metering device is fluidly sealed. Accordingly, fluid can only enter from the reservoir into the metering device via the first fluidic connection. Furthermore, it is advantageous if the connection is airtight, so that no contaminated ambient air can enter the reservoir.

According to a preferred embodiment, the metering device comprises a second section designed as a metering chamber. It is advantageous for this dosing chamber to have a receiving volume which essentially corresponds to the volume of sterile fluid that can be dispensed in a dispensing cycle. Thus, after delivery of the sterile fluid, the metering chamber is substantially free of fluid. The volume of a single dose is preferably between 30 and 50 μl. Furthermore, the metering device preferably comprises a third section, in which the delivery device is arranged in sections. Advantageously, the third section has a smaller diameter than the second section.

According to an advantageous embodiment, the receiving volume of the reservoir is 10 ml. This corresponds to the prescribed by the European Pharmacopoeia receiving volume for containers of eye drops.

According to a preferred embodiment, the fluid transfer device comprises a base body and a piston-like closure element. Preferably, the base body is formed integrally with the dispensing device. In this case, the base body is advantageously formed substantially hollow cylindrical. In particular, a hollow cylinder with a circular base is preferred. Furthermore, the piston-like closure element is preferably arranged at least in sections within the base body.

Preferably, a first sealing device is arranged at a proximal end of the piston-like closure element, which advantageously projects in sections over a collar section of the base body. By means of this first sealing device, a passage opening between the reservoir and the metering device can preferably be closed. As a result of this advantageous arrangement, the first fluidic connection between the reservoir and the metering device can be closed by the closure element of the fluid transfer device. there the first sealing device is advantageously designed as a conical plug. Furthermore, it would be conceivable that the sealing device consists of an elastic material, for example an elastomer.

According to a further preferred embodiment, the basic body has an elongate section. Preferably, the elongated portion comprises at least one slot-like opening. Preferably, the piston-like closure element has at least one radially outwardly extending guide projection, which is guided in the slot-like opening. Moreover, it is advantageous that the piston-like closure element has at least one rib. Preferably, the at least one rib defines an intermediate receptacle or a clearance for temporarily receiving the sterile fluid in the fluid transfer device.

According to a further preferred embodiment, the elongate section comprises four slot-like openings. Preferably, the piston-like closure element has four guide projections extending radially outwards, which are guided in the slot-like openings. Moreover, it is advantageous that the piston-like closure element has four ribs. Preferably, the four ribs are sections lying opposite each other a slot-like breakthrough. The slot-like apertures, the radially outwardly extending guide projections and the ribs are preferably arranged like a cross. Accordingly, there are in each case two openings, guide projections or ribs diametrically opposite, wherein a connecting line between the respective two diametrically opposite elements perpendicular to a further connecting line between the other two other elements. Preferably, two ribs each define an intermediate receptacle or a clearance for temporarily receiving the sterile fluid in the fluid transfer device.

As the fluid enters the metering device through the port, it is transferred by the fluid transfer device into the metering chamber or second section of the metering device. The fluid first enters the collar portion and then along the piston-like closure member into the elongated portion of the body of the fluid transfer device. Here, the fluid is now in the intermediate receptacles between the ribs or in the free space, which is not filled by the one rib. Then, the fluid may enter the dosing chamber through the slit-like breakthrough / breakthrough (s) which is advantageously located adjacent to the interstices or clearance, respectively, until it is filled.

According to a further advantageous embodiment, the fluid transfer device has a projection provided with a second sealing device, which is arranged within the second section of the metering device or the metering chamber and which has a smaller diameter than the second section of the metering device. Preferably, the second sealing device is annular. Furthermore, the projection preferably has a larger diameter than the third section of the metering device, whereby a fluidic connection between the second and the third section of the metering device can be closed at rest. In the idle state, advantageously, a fluidic connection between the dosing chamber and the dispensing device, which is arranged in the third section of the dosing device, is also prevented.

Furthermore, a third sealing device is preferably arranged on the dispensing device. Preferably, this third sealing device is designed annular. Preferably, this third sealing device sealingly bears against an inner wall of the third section of the metering device, whereby in an intermediate state between the rest state and the delivery state, a fluidic connection between the metering device and an outlet opening of the delivery device is prevented.

Preferably, the third sealing means is in a distal direction (X ₁ ) arranged below the second sealing device. The dispensing device is preferably of cylindrical design and preferably has a chamber which has the outlet opening at its distal end and an inlet opening to the chamber. The inlet opening is preferably arranged on a side wall of the cylindrical dispenser. Advantageously, this inlet opening is arranged in the distal direction below the third sealing device. Further, a fourth sealing device is preferably arranged in the distal direction below the inlet opening, which sealingly bears against the inner wall of the third section of the metering device.

According to a further advantageous embodiment, the device comprises a ventilation device, which is closed at rest and which can be opened by the relative movement of the metering device to the fluid transfer device. Advantageously, the ventilation device is equipped with an antibacterial air filter. The sucked air is thus passed through a filter with an antibacterial agent, so that only pure air comes into contact with the sterile fluid.

Preferably, the ventilation device is arranged on the metering device. Preferably, the ventilation device is arranged on the second portion of the metering device. Preferably, the ventilation device can be opened by a non-positive contact with the projection of the dispensing device and can be closed by a force application of a spring element.

If the dosing device is displaced distally relative to the fluid transfer device from the idle state, first the first fluidic connection between the reservoir and the dosing device is closed. Likewise, the second and third portions of the metering device are displaced relatively distally relative to the projection of the fluid transfer device provided with the second sealing device, whereby the third portion is no longer separated by the second sealing device. As a result, the ventilation device experiences a non-positive contact and is activated.

At the same time, the third sealing device slides on the dispensing device along the inner wall of the third section, as it moves in the distal direction. In a further relative displacement, the second sealing device slides over the third section in the second section of the metering device. Thus, a fluidic connection between the metering chamber and the inlet opening of the dispenser is opened. By the fourth sealing device, which lies in the distal direction below the inlet opening, it is ensured that the sterile fluid can enter only into the inlet opening. At the same time, clean air is sucked in by the ventilation device, whereby a rapid transfer of the sterile fluid into the chamber of the delivery device is ensured.

After delivery of the sterile fluid, the dosage device is displaceable in the proximal direction. Thus, first, the fluidic connection between the metering chamber and the inlet opening of the dispensing device is closed by the third sealing device. In a further relative displacement, the second sealing device closes the third section relative to the second section of the metering device. Furthermore, the first fluidic connection is opened again by the relative displacement. The ventilation device is closed by the application of force to a spring element.

According to a preferred embodiment, the discharge opening of the delivery device has a geometry which promotes the formation of a drop, so that the dispensed amount of sterile fluid is delivered by a single drop. The volume of a drop is usually dependent on the density and viscosity of the fluid and the shape, or the dimension of the drop. The shape and the dimension are in turn dependent on the geometry of the outlet opening.

Advantageously, the storage container, the metering device and the delivery device are arranged in a housing. Preferably, this housing has a closed distal end and an open proximal end. Furthermore, an outlet opening is preferably recessed in the closed distal end, wherein the outlet end provided with an outlet end of the dispenser is arranged in the outlet opening of the housing. Advantageously, the reservoir protrudes at least in the rest state from the open proximal end of the housing sections.

Furthermore, it is preferred that the delivery device is connected by a non-positive and / or positive connection stationary with the housing. The dispenser is thus not displaceable relative to the housing. Preferably, the dispenser is fixed by a non-positive and / or positive connection in the outlet opening of the housing. Furthermore, it is advantageous if the metering device and preferably the reservoir are / is displaceable relative to the housing, the fluid transfer device and the delivery device. A transition from the idle state into the delivery state is preferably realized by a displacement in the distal direction (X ₁ ) of the dosing device. Thus, a user of the device may move the reservoir relative to the housing to initiate delivery of the sterile fluid. The reservoir is therefore to be regarded as an actuator. In this embodiment, therefore, an additional actuator is not necessary. Preferably, by displacing the metering device, a spring element arranged between the housing and the metering device can be compressed. By the application of force to this spring element, therefore, the displacement in the proximal direction is caused after the delivery of the sterile fluid. The spring element can be designed as a spiral spring element or as an elastomeric spring element. However, the invention is not limited to such embodiments.

According to a further preferred embodiment, the piston-like closure element is provided at its distal end with a spring element. Preferably, this spring element is an elastomeric spring element. However, other forms of spring elements are conceivable, for example a spiral spring element. The spring element contacted an inner wall at the distal end of the body of the fluid transfer device. A displacement of the metering device relative to the fluid transfer device advantageously leads to a closure of the passage opening between the reservoir and the metering device by the first sealing device. Accordingly, there is a frictional contact of the piston-like closure element with the metering device. In a further relative displacement of the metering device, the spring element of the piston-like closure element is compressed. As a result, a hard stop is avoided and ensures a more comfortable use of the device.

According to a further advantageous embodiment, a hollow cylinder-like attachment element is arranged at the distal end of the housing, which can be positioned over the eye. This ensures a certain distance between the distal end of the housing or the outlet opening of the dispenser. Thus, effectively preventing contamination of these elements. Further advantages are that the eyelid is held by the attachment element. The user no longer needs to keep the lid open. By the neck element, the outlet opening is further placed exactly above the eye, whereby a positionally accurate application is possible.

Preferably, the housing and the spacer element are integrally formed. However, it would also be conceivable that the spacer element is an individual, reusable element which can be arranged on the housing.

Preferably, an outer surface of the distal end of the housing, an inner surface of the neck member, and an end surface at the distal end of the neck member are provided with a superhydrophobic and / or antibacterial coating. Superhydrophobic surfaces have a micro or nanostructure which prevents wetting by a drop of water. Water droplets tend to minimize their surface area due to their high surface tension, which makes them spherical. Wetting of a surface is effected by appropriate adhesion forces. The microstructures or nanostructures are designed such that only small portions of the water droplet are in contact with the surface and thus do not act corresponding adhesion forces. The drops of water thus roll off the surface. Such superhydrophobic surfaces can already have an antibacterial effect. For one, many bacteria need water to grow. As water drips off the surface, bacteria on the surface dry out. Furthermore, the bacteria can adhere poorly to the small microstructures or nanostructures and are carried along by the beaded water droplets.

The surfaces that are most likely to be contaminated because they are in contact with the user are contaminant free by the superhydrophobic or antibacterial coating, respectively. Thus, contamination of the interior of the device from these surfaces is not possible.

The individual elements of the device, that is to say the reservoir, the delivery device, the metering device, the fluid transfer device and the housing are preferably made of one or more plastics. Preferably, the elements are made by a single or multi-component injection molding process.

Further advantages, objects and characteristics of the present invention will be explained with reference to the following description of the enclosed figures. Similar components may have the same reference numerals in the various embodiments.

In the figures show:

1 an exploded view of a device for storing and repeated dosed dispensing a sterile fluid;

2 a sectional view of a device for storing and repeated dosed dispensing a sterile fluid at rest;

3 a sectional view of a device for storing and repeated metered dispensing a sterile fluid in an intermediate state;

4 a sectional view of a device for storing and repeated dosed dispensing a sterile fluid in the delivery state;

5 an external view of a device for storing and repeated dosed dispensing a sterile fluid;

1 shows an exploded view of a Contraption ( 1 ) for storing and repeatedly dosing a sterile fluid ( 2 ), especially eye drops. The 2 . 3 and 4 each show a sectional view of the device in different states. 2 shows the device ( 1 ) at rest ( 5 ) 4 shows the device ( 1 ) in the delivery state ( 6 ) and 3 shows the device ( 1 ) in an intermediate state ( 27 ).

Contraption ( 1 ) for storing and repeatedly dosing a sterile fluid ( 2 ), in particular eye drops, comprising a storage container ( 3 ) for storing the sterile fluid ( 2 ) and a dispenser ( 4 ), wherein a subset of the sterile fluid ( 2 ) is deliverable within a delivery cycle, which at least one idle state ( 5 ) and a delivery state ( 6 ). The device ( 1 ) is characterized by the fact that at rest ( 5 ) a first fluidic connection ( 7 ) between the reservoir ( 3 ) and a metering device ( 8th ) and in the metering device ( 8th ) a fluid transfer device ( 9 ), wherein a first displacement of the metering device ( 8th ) relative to the fluid transfer device ( 9 ) the first fluidic connection ( 7 ) by means of the fluid transfer device ( 9 ) and is closed by a further displacement of the metering device ( 8th ) relative to the fluid transfer device ( 9 ) a second fluidic connection ( 10 ) between the metering device ( 8th ) and the dispenser ( 4 ) by means of the fluid transfer device ( 9 ) is openable.

Through the fluidic connections ( 7 . 10 ) takes place both between the reservoir ( 3 ) and the dosing device ( 8th ) as well as between the metering device ( 8th ) and the dispenser ( 4 ) a fluid transfer, wherein the fluid transfer only due to a drive by the weight of the sterile fluid ( 2 ) he follows.

The reservoir ( 3 ) is designed as a circular hollow cylinder, which has a first section ( 3b ) and a second section ( 3c ) having. The second section ( 3c ) has a smaller diameter than the first section ( 3b ) on. The reservoir ( 3 ) and the dosing device ( 8th ) are positively and positively connected and can be moved as a unit. The dosing device ( 8th ) comprises a first hollow cylindrical section ( 13 ), which in sections into the second section ( 3c ) of the storage container ( 3 ) protrudes. The frictional / positive connection exists between a region of the outer wall ( 13a ) of the first section ( 13 ) and an inner wall ( 3a ) of the storage container ( 3 ). This connection is accomplished, on the one hand, by an inner diameter of the second section ( 3c ) of the reservoir ( 3 ) decreases in the distal direction (X ₁ ). Because the outer diameter of the first section ( 13 ) of the dosing device ( 8th ) is constant, a press fit or a clamping connection between the reservoir ( 3 ) and the dosing device ( 8th ) realized. Furthermore, on an outer surface of the first section ( 13 ) of the dosing device ( 8th ) two projections each ( 31 ), which in corresponding recesses of the inner wall ( 3a ) of the storage container ( 3 ) intervene. Preferably, the projections ( 31 ) configured like a ring. Accordingly, a fluidic / airtight connection between the reservoir ( 3 ) and the dosing device ( 8th ).

The dosing device ( 8th ) comprises a second section formed as a metering chamber ( 16 ). The receiving volume of the dosing chamber essentially corresponds to the volume of sterile fluid that can be dispensed in a dispensing cycle ( 2 ). Furthermore, the metering device ( 8th ) a third section ( 17 ) in which the dispenser ( 4 ) is arranged in sections. The third section ( 17 ) has a smaller diameter than the second section ( 16 ) on.

The individual sections ( 13 . 16 . 17 ) of the dosing chamber are separated by two components ( 32 . 33 ) realized. The first component ( 32 ) comprises a proximal region ( 32a ) and a distal area ( 32b ), both areas ( 32a . 32b ) are formed as circular hollow cylinder. The proximal area ( 32a ) essentially represents the first section ( 13 ) of the dosing device ( 8th Furthermore, the distal area ( 32b ) of the first component ( 32 ) both a larger inner diameter and a larger outer diameter than the proximal region ( 32a ) on.

The second component ( 33 ) also includes a proximal region ( 33a ) and a distal area ( 33b ), both areas ( 33a . 33b ) are also formed as a circular hollow cylinder. The distal area ( 33b ) essentially represents the third section ( 17 ) of the dosing device ( 8th In addition, the proximal region ( 33a ) of the second component ( 33 ) both a larger inner diameter and a larger outer diameter than the distal region ( 33b ) on. The outer diameter of the proximal region ( 33a ) of the second component ( 33 ) is smaller than the inner diameter of the distal region ( 32b ) of the first component ( 32 ).

The second section or the dosing chamber ( 16 ) are formed in that the proximal region ( 33a ) of the second component ( 33 ) in the distal region ( 32b ) of the first component ( 32 ) is arranged. The outer wall of the proximal region ( 33a ) of the second component ( 33 ) is thus located on an inner wall of the distal region ( 32b ) of the first component ( 32 ), whereby a non-positive connection is given. Furthermore, on the outer wall of the proximal region ( 33a ) of the second component ( 33 ) a preferably annular projection ( 34 ), which in a corresponding recess on the inner wall of the distal region ( 32b ) of the first component ( 32 ), whereby a positive connection between the first ( 32 ) and the second component ( 33 ) given is. Such a configuration has the advantage that the fluid transfer device ( 9 ) simply within the metering device ( 8th ) can be arranged.

The fluid transfer device ( 9 ) comprises a basic body ( 11 ) and a piston-like closure element ( 12 ). The basic body ( 11 ) is integral with the dispenser ( 4 ) educated. In addition, the basic body ( 11 ) formed substantially as a circular hollow cylinder and the piston-like closure element ( 12 ) is at least partially within the body ( 11 ) arranged.

Further, at a proximal end ( 12a ) of the piston-like closure element ( 12 ) a first sealing device ( 19 ) arranged. This first sealing device ( 19 ) is formed as a conical plug, wherein the outer diameter of the plug tapers in the proximal direction (X ₂ ). The first sealing device ( 19 ) projects in sections over a collar section ( 21 ) of the basic body ( 11 ). Furthermore, a passage opening ( 20 ) between the reservoir ( 3 ) and the dosing device ( 8th ) by the first sealing device ( 19 ) lockable.

The basic body ( 11 ) has an elongated section ( 22 ), which has a wall with four slot-like openings ( 22a ). Furthermore, the piston-like closure element ( 12 ) four radially outwardly extending guide projections ( 18 ), which in the slot-like openings ( 22a ) are guided. The piston-like closure element ( 12 ) is thus in the distal (X ₁ ) and in the proximal direction (X ₂ ) relative to the main body ( 11 ) Displaceable, whereby this displacement by the slot-like breakthroughs ( 22a ) is guided. In addition, the piston-like closure element ( 12 ) four ribs ( 23 ), which with the guide projections ( 18 ) are aligned.

The slit-like breakthroughs ( 22a ), the radially outwardly extending guide projections ( 18 ) and the ribs ( 23 ) are preferably arranged like a cross. Accordingly, there are two breakthroughs each ( 22a ), Guide projections ( 18 ) or ribs ( 23 ) diametrically opposite, wherein a connecting line between the respective two diametrically opposed elements is perpendicular to a further connecting line between the other two other elements. Two ribs each ( 23 ) define an intermediate recording ( 30 ) for temporarily receiving the sterile fluid ( 2 ) in the fluid transfer device ( 9 ).

The piston-like closure element ( 12 ) is at its distal end ( 12b ) with an elastomeric spring element ( 35 ) Mistake. The elastomer spring element ( 35 ) contacts an inner wall ( 36 ) at the distal end of the body ( 11 ). When shifting the metering device ( 8th ) relative to the fluid transfer device ( 9 ), first the passage opening ( 20 ) between the reservoir ( 3 ) and the dosing device ( 8th ) by the first sealing device ( 19 ) locked. Accordingly, a frictional contact of the piston-like closure element ( 12 ) with the metering device ( 8th ). In a further relative displacement of the metering device ( 8th ) is the elastomeric spring element ( 35 ) of the piston-like closure element ( 12 ) compressible.

The fluid transfer device ( 9 ) has one with an annular second sealing device ( 25 ) provided edge ( 24 ) on. This is within the second section ( 16 ) of the dosing device ( 8th ) and has a smaller diameter than the second section (FIG. 16 ) of the dosing device ( 8th ) on. The lead ( 24 ) has a larger diameter than the third section ( 17 ) of the dosing device ( 8th ), whereby at rest ( 5 ) a fluidic connection between the second ( 16 ) and the third section ( 17 ) of the dosing device ( 8th ) is closable.

Furthermore, an annular third sealing device ( 26 ) at the dispenser ( 4 ) arranged on an inner wall ( 17a ) of the third section ( 17 ) of the dosing device ( 8th ) sealingly, whereby in an intermediate state ( 27 ) between hibernation ( 5 ) and the delivery status ( 6 ) a fluidic connection between the metering device ( 8th ) and an exit opening ( 4a ) of the dispenser ( 4 ) is prevented. The third sealing device ( 26 ) is distally (X ₁ ) below the second sealing device ( 25 ) arranged.

The dispenser ( 4 ) is integral with the fluid transfer device ( 9 ) designed. Furthermore, the dispenser ( 4 ) cylindrical and has a chamber ( 37 ), which has an outlet opening ( 4a ) at its distal end ( 4b ) having. The dispenser ( 4 ) further has an entrance opening ( 38 ), which is arranged on a side wall of the dispenser. The entrance opening ( 38 ) is in the distal direction (X ₁ ) below the third sealing device ( 26 ) arranged. Further, in the distal direction (X ₁ ) below the inlet opening, an annular fourth sealing device ( 39 ) arranged on the inner wall of the third section ( 17a ) of the dosing device ( 8th ) sealingly. By the fourth sealing device ( 39 ) ensures that, in the delivery state ( 6 ) the sterile fluid ( 2 ) only through the inlet opening ( 38 ) of the dispenser ( 4 ) occurs.

At the second section ( 16 ) of the dosing device ( 8th ) or on the first component ( 32 ) is a ventilation device ( 28 ) arranged. This ventilation device ( 28 ) may be at a relative displacement of the metering device ( 8th ) to the fluid transfer device ( 9 ) by a frictional contact with the projection ( 24 ) of the dispenser ( 4 ).

The reservoir ( 3 ), the metering device ( 8th ) and the dispenser ( 4 ) are in a housing ( 14 ), which has a closed distal end ( 14a ) and an open proximal end ( 14b ) having. In the closed distal end ( 14a ) is an exit opening ( 14c ) left out. That with an outlet ( 4a ) provided distal end ( 4b ) of the dispenser ( 4 ) is at the exit opening ( 14c ) of the housing ( 14 ) arranged. A central axis (M) of the outlet opening ( 4a ) of the dispenser ( 4 ) corresponds to the central axis (M) of the outlet opening ( 14c ) of the housing or a central axis (M) of the housing itself. 3 ) protrudes at least in the idle state ( 5 ) from the open proximal end ( 14b ) of the housing ( 14 ) in sections.

The dispenser ( 4 ) is by a positive and / or positive connection by means of a holding device ( 40 ) stationary to the housing ( 14 ) connected. The dosing device ( 8th ) and the reservoir ( 3 ) are as a unit relative to the housing ( 14 ), the fluid transfer device ( 9 ) and the dispenser ( 4 ) relocatable. A transition from hibernation ( 5 ) ( 2 ) into the delivery state ( 6 ) ( 4 ) is realized by a displacement of these elements in the distal direction (X ₁ ). Due to this displacement, a between the housing ( 14 ) and the dosing device ( 8th ) arranged spring element ( 15 ) compressed.

In 5 is an external representation of a device ( 1 ). The reservoir ( 3 ) projects in sections over the housing ( 14 ) and, in addition to its function to store the sterile fluid ( 2 ) as an actuator for delivering a dose of sterile fluid ( 2 ). On the housing ( 14 ) is furthermore a hollow cylinder-like attachment element ( 29 ) arranged. The housing ( 14 ) and the attachment element ( 29 ) are integrally formed. The neck element ( 29 ) has at its distal end ( 29c ) an end face ( 29b ), which rests against the skin of the user. When used, this approach element ( 29 ) positioned above the eye. The outer surface of the distal end ( 14a ) of the housing ( 14 ), an inner surface ( 29a ) of the neck element ( 29 ) and an end face ( 29b ) at the distal end ( 29c ) of the neck element ( 29 ) can be provided with a superhydrophobic and / or antibacterial coating.

In the following, the delivery of a specific dose by the device ( 1 ) based on 2 to 4 described.

The device ( 1 ) is in 2 at rest ( 5 ). At rest, there is a first fluidic connection ( 7 ) between the reservoir ( 3 ) and the dosing device ( 8th ). There is thus a fluid transfer from the reservoir ( 3 ) into the dosage device ( 8th ) only due to the weight of the sterile fluid ( 2 ). The fluid therefore does not have to be pressurized by a pumping arrangement. The sterile fluid ( 2 ) passes through the passage opening ( 20 ) into the dosage device ( 8th ). The sterile fluid ( 2 ) is by means of the fluid transfer device ( 9 ) to the dosing chamber or the second section ( 16 ) of the dosing device ( 8th ) transferred. For this, the sterile fluid ( 2 ) from the passage opening ( 20 ) in the collar portion ( 21 ) of the basic body ( 11 ) and then into the intermediate recording ( 30 ). Through the slit-like breakthroughs ( 22a ) the sterile fluid ( 2 ) then into the dosing chamber or the second section ( 16 ) of the dosing device ( 8th ).

A user moves the storage container ( 3 ) and thus the dosage device ( 8th ) in the distal direction (X ₁ ). The two elements shift as a unit relative to the fluid transfer device ( 9 ). As a result, first the first fluidic connection ( 7 ) between the reservoir ( 3 ) and the dosing device ( 8th ) locked. This is done in that due to the relative displacement of the through hole ( 20 ) by the first sealing device ( 19 ) is closed. At the same time also with the second sealing device ( 25 ) provided projection ( 24 ) of the fluid transfer device ( 9 ) relocated. This intermediate state ( 27 ) is in 3 seen. Although the second sealing device ( 25 ) now the fluidic connection between the second ( 16 ) and the third section ( 17 ) of the dosing device ( 8th ) no longer has a fluidic connection between the second section ( 16 ) of the dosing device ( 8th ) and the outlet ( 4a ) of the dispenser ( 4 ), since the third sealing device ( 26 ) sealing on the inner wall ( 17a ) of the third section ( 17 ) and thus a fluid transfer to the inlet opening ( 38 ) of the dispenser ( 4 ) prevented.

In a further relative displacement of the metering device ( 8th ) to the fluid transfer device ( 9 ) the delivery status ( 6 ) reached. This is in 4 shown. The third sealing device ( 26 ) is no longer sealing against the inner wall ( 17a ) of the third section ( 17 ), whereby a fluid transfer between the second section ( 16 ) and the chamber ( 37 ) of the dispenser ( 4 ) via the inlet opening ( 38 ) he follows. The displacement is achieved by a non-positive contact of the projection ( 24 ) with the ventilation device ( 28 ) this opened. The ventilation device ( 28 ) is equipped with an antibacterial air filter. It can now be pure air into the dosing chamber ( 16 ), whereby a complete transfer of the fluid ( 2 ) from the dosing chamber ( 16 ). From the chamber ( 37 ) of the dispenser ( 4 ) the sterile fluid passes through the outlet opening ( 4a ) of the dispenser ( 4 ) as well as the outlet opening ( 14c ) of the housing ( 14 ) as drops to the site of application.

Due to the above-mentioned relative displacement both the spring element ( 15 ) as well as the elastomeric spring element ( 35 ) compressed. After delivery, the user enters the storage container ( 3 ), whereby this driven by the spring force of the spring element ( 15 ) is displaced in the proximal direction (X ₂ ). Accordingly, first the fluidic connection between the dosing chamber ( 16 ) and the inlet opening ( 38 ) of the dispenser ( 4 ) by the third sealing device ( 26 ) separated. In a further relative displacement seals the second sealing device ( 25 ) the third section ( 17 ) of the second section ( 16 ) of the dosing device ( 8th ). Finally, the first fluidic connection is opened, since the first sealing device from the through-hole ( 20 ). The ventilation device ( 28 ) is closed by the application of force to a spring element (not shown in the figures). After another fluid transfer, as described above, the device is ready for operation again.

All disclosed in the application documents features are claimed as essential to the invention, provided they are new individually or in combination over the prior art.

LIST OF REFERENCE NUMBERS

1

contraption

2

sterile fluid

3

reservoir

3a

Inner wall of the reservoir

3b

first section of the reservoir

3c

second section of the reservoir

4

delivery device

4a

Outlet opening of the dispenser

4b

distal end of the dispenser

5

retirement

6

output state

7

first fluidic connection

8th

metering device

9

Fluid transfer device

10

second fluidic connection

11

body

12

piston-like closure element

12a

proximal end of the piston-like closure element

12b

distal end of the piston-like closure element

13

first section of the metering device

13a

Outer wall of the first section

14

casing

14a

distal end of the housing

14b

proximal end of the housing

14c

Outlet opening of the housing

15

spring element

16

second section of the metering device

17

third section of the metering device

17a

Inner wall of the third section

18

Guide projections of the piston-like closure element

19

first sealing device

20

Through opening

21

collar section

22

elongated section of the main body

22a

slit-like breakthrough of the wall of the elongated portion of the body

23

Rib (s)

24

head Start

25

second sealing device

26

third sealing device

27

intermediate state

28

aeration device

29

neck element

29a

inner surface of the neck element

29b

End face of the neck element

29c

distal end of the neck element

30

between shooting

31

head Start

32

first component of the metering device

32a

proximal region of the first component

32b

distal region of the first component

33

second component of the metering device

33a

proximal region of the second component

33b

distal region of the second component

34

head Start

35

Elastomer spring element

36

Wall of the main body

37

Chamber of the dispenser

38

inlet opening

39

fourth sealing device

40

holder

M

central axis

X ₁

distal direction

X ₂

proximal direction

Claims (15)

Contraption ( 1 ) for storing and repeatedly dosing a sterile fluid ( 2 ), in particular eye drops, comprising a storage container ( 3 ) for storing the sterile fluid ( 2 ) and a dispenser ( 4 ), wherein a subset of the sterile fluid ( 2 ) is deliverable within a delivery cycle, which at least one Hibernation ( 5 ) and a delivery state ( 6 ), characterized in that at rest ( 5 ) a first fluidic connection ( 7 ) between the reservoir ( 3 ) and a metering device ( 8th ) and in the metering device ( 8th ) a fluid transfer device ( 9 ), wherein a first displacement of the metering device ( 8th ) relative to the fluid transfer device ( 9 ) the first fluidic connection ( 7 ) by means of the fluid transfer device ( 9 ) and is closed by a further displacement of the metering device ( 8th ) relative to the fluid transfer device ( 9 ) a second fluidic connection ( 10 ) between the metering device ( 8th ) and the dispenser ( 4 ) by means of the fluid transfer device ( 9 ) is openable. Contraption ( 1 ) according to claim 1, characterized in that by the fluidic connections ( 7 . 10 ) both between the reservoir ( 3 ) and the dosing device ( 8th ) as well as between the metering device ( 8th ) and the dispenser ( 4 ), wherein the fluid transfer takes place merely due to a drive by the weight force of the sterile fluid ( 2 ) he follows. Contraption ( 1 ) according to one of the preceding claims, characterized in that the storage container ( 3 ) and the dosing device ( 8th ) are positively and / or positively connected with each other and are displaceable as a unit, wherein the dosage device ( 8th ) a first hollow cylindrical section ( 13 ), which in sections in the reservoir ( 3 protruding, wherein the non-positive and / or positive connection between a region of the outer wall ( 13a ) of the first section ( 13 ) and an inner wall ( 3a ) of the storage container ( 3 ) consists. Contraption ( 1 ) according to one of the preceding claims, characterized in that the metering device ( 8th ) a second section (FIG. 16 ), which has a receiving volume which essentially corresponds to the volume of sterile fluid which can be dispensed in a dispensing cycle ( 2 ) and a third section ( 17 ) in which the dispenser ( 4 ) is arranged in sections, wherein the third section ( 17 ) has a smaller diameter than the second section ( 16 ) having. Contraption ( 1 ) according to one of the preceding claims, characterized in that the fluid transfer device ( 9 ) a basic body ( 11 ) and a piston-like closure element ( 12 ), wherein the basic body ( 11 ) in one piece with the dispenser ( 4 ), wherein the base body ( 11 ) is formed substantially hollow cylindrical and the piston-like closure element ( 12 ) at least in sections within the body ( 11 ) is arranged. Contraption ( 1 ) according to claim 5, characterized in that at a proximal end ( 12a ) of the piston-like closure element ( 12 ) a first sealing device ( 19 ) is arranged, which sections over a collar portion ( 21 ) of the basic body ( 11 protrudes and through which a passage opening ( 20 ) between the reservoir ( 3 ) and the dosing device ( 8th ) is closable. Contraption ( 1 ) according to one of claims 5 or 6, characterized in that the basic body ( 11 ) an elongated section ( 22 ), which has a wall with at least one slot-like opening ( 22a ), wherein the piston-like closure element ( 12 ) at least one radially outwardly extending guide projection ( 18 ), which in the slot-like breakthrough ( 22a ), wherein the piston-like closure element ( 12 ) at least one rib ( 23 ), which has an intermediate receptacle ( 30 ) for the sterile fluid in the fluid transfer device ( 9 ) spatially defined. Contraption ( 1 ) according to one of claims 4 to 7, characterized in that the fluid transfer device ( 9 ) one with a second sealing device ( 25 ) provided edge ( 24 ), which within the second section ( 16 ) of the dosing device ( 8th ) and which has a smaller diameter than the second section (FIG. 16 ) of the dosing device ( 8th ), wherein the projection ( 25 ) a larger diameter than the third section ( 17 ) of the dosing device ( 8th ), whereby at rest ( 5 ) a fluidic connection between the second ( 17 ) and the third section ( 17 ) of the dosing device ( 8th ) is closable. Contraption ( 1 ) according to one of claims 4 to 8, characterized in that a third sealing device ( 26 ) at the dispenser ( 4 ) is arranged, which on an inner wall ( 17a ) of the third section ( 17 ) of the dosing device ( 8th ) sealingly, whereby in an intermediate state ( 27 ) between hibernation ( 5 ) and the delivery status ( 6 ) a fluidic connection between the metering device ( 8th ) and an exit opening ( 4a ) of the dispenser ( 4 ) is prevented. Contraption ( 1 ) according to one of the preceding claims, characterized in that the device ( 1 ) a ventilation device ( 28 ), which is closed at rest and which by the relative movement of the metering device ( 8th ) to the fluid transfer device ( 9 ) is openable, wherein the ventilation device ( 28 ) is equipped with an antibacterial air filter. Contraption ( 1 ) according to claim 10, characterized in that the ventilation device ( 28 ) at the metering device ( 8th ) and by a frictional contact with the projection ( 24 ) of the dispenser ( 4 ) is openable and can be closed by a force application of a spring element. Contraption ( 1 ) according to one of the preceding claims, characterized in that the storage container ( 3 ), the metering device ( 8th ) and the dispenser ( 4 ) in a housing ( 14 ), which has a closed distal end ( 14a ) and an open proximal end ( 14b ), wherein in the closed distal end ( 14a ) an outlet opening ( 14c ) is recessed, which with an outlet opening ( 4a ) provided distal end ( 4b ) of the dispenser ( 4 ) at the exit opening ( 14c ) of the housing ( 14 ) is arranged, wherein the reservoir ( 3 ) at least at rest ( 5 ) from the open proximal end ( 14b ) of the housing ( 14 ) projects in sections. Contraption ( 1 ) according to one of the preceding claims, characterized in that the dispensing device ( 4 ) by a non-positive and / or positive connection stationary with the housing ( 14 ), the metering device ( 8th ) relative to the housing ( 14 ), the fluid transfer device ( 9 ) and the dispenser ( 4 ) is displaceable, wherein a transition from hibernation ( 5 ) into the delivery state ( 6 ) by a displacement in the distal direction (X ₁ ) of the metering device ( 8th ) is realized and whereby by this displacement of the metering device ( 8th ) between the housing ( 14 ) and the dosing device ( 8th ) arranged spring element ( 15 ) is compressible. Contraption ( 1 ) according to any one of claims 12 to 13, characterized in that at the distal end ( 14a ) of the housing ( 14 ) a hollow cylinder-like attachment element ( 29 ), which is positionable over the eye. Contraption ( 1 ) according to claim 14, characterized in that an outer surface of the distal end ( 14a ) of the housing ( 14 ), an inner surface ( 29a ) of the neck element ( 29 ) and an end face ( 29b ) at the distal end ( 29c ) of the neck element ( 29 ) are provided with a superhydrophobic and / or an antibacterial coating.

Images