EP3250171B1 - Device for transferring a fluid between a storage container and at least one further container for use - Google Patents

Description

The invention relates to a device for transferring a liquid between a storage container and at least one further use container according to the preamble of claim 1. Furthermore, the invention relates to a set of such a transfer device and a storage container.

Such devices are known from the WO 2011/088471 A1 , from the WO 2014/152249 A1 , from the WO 98/32411 A1 , from the US 6,209,738 B1 , from the US 6,537,263 B1 , from the US 5,879,345 and from the WO 2012/119225 A1 , A generic transfer device is already out of the WO 2014/152249 A1 known.

It is an object of the present invention to develop a device of the type mentioned in such a way that their reliability, especially when used by an inexperienced patient or by a patient with limitations, e.g. in the motor skills, is improved.

This object is achieved according to a first aspect of the invention by a device having the features specified in claim 1.

The transmission for displacing the hollow needle assembly into the connection position, in which a fluid connection between the transfer device and the storage container is given, comprising a drive ring, allows a safe execution of the essential for the function of the transfer device displacement movement of the hollow needle assembly. The transmission can be designed such that a rotation of the rotary actuating element by more than 180 °, for example by 360 ° or even an even larger circumferential angle, the hollow needle between the rest position and the connecting position moves. Accordingly, such a displacement movement can be brought about with comparatively little effort. The hollow needle assembly may be guided against rotation in the base body. The drivers on the main body on the one hand and on the rotary actuator on the other hand, after the displacement of the hollow needle assembly in the connecting position be disengaged, so that the rotary actuator is removable from the body. The driving ring can be designed so that it is in the connecting position of the hollow needle assembly out of engagement with the complementary thread of the hollow needle assembly. This prevents unwanted return of the hollow needle assembly back to the rest position.

Such a device can be used in particular as a reconstitution device. In the storage container can then be a powdered drug, which with the transfer device in the connection position on the then connected utility container first is mixed with a solvent and then transferred via the transfer device in the same or another use container in dissolved form for further use.

The rotary actuator is an interface to the patient to perform the DrehBetätigung. The rotary actuator can be made in several parts and in particular in two parts. A portion of the rotary actuator may be configured as a termination cap and another portion of the rotary actuator as a coupling member for operatively cooperating with other components of the transfer device. In an alternative embodiment, the rotary actuator can also be made in one piece.

The embodiment according to claim 2 allows a force transmission over an outer circumference of the hollow needle assembly, which leads to a uniform distribution of the introduction of force. The driving ring can be designed with an inner driver, which is designed as an internal thread or as a plurality of female threaded segments. This again improves a force-transmitting contact between the rotary actuator and the hollow needle assembly via the transmission. A canting tendency of the hollow needle assembly relative to the base body is advantageously reduced or completely excluded by the uniform force introduced over the circumference of the hollow needle assembly.

At least one axial nose according to claim 3 leads to a secure rotationally fixed connection of the rotary actuating element with the driving ring. There may be a plurality of circumferentially distributed axial lugs, e.g. three axial lugs, be provided. The at least one axial nose can be integrally formed on a base body of the rotary actuating element. At least one section, which extends at least one axial nose parallel to the displacement movement axis of the hollow needle assembly.

An embodiment according to claim 4 gives an elegant double function of anti-rotation ribs in Grundköper the transfer device.

Another object is to make a handling of a rotary actuator in a transfer device of the type mentioned more convenient.

• mit einem Lagerbehälter-Dichtabschnitt zum dichtenden Anliegen eines Grundkörpers der Überführungs-Vorrichtung am Lagerbehälter
• mit einer Hohlnadel-Baugruppe mit einer Hohlnadel, wobei die Hohlnadel-Baugruppe mittels eines Getriebes relativ zum Grundkörper linear längs einer Bewegungsachse verlagerbar ist zwischen
  • - - einer eingefahrenen Ruhestellung und
  • - - einer ausgefahrenen Verbindungsstellung, in der die Hohlnadel einen Flüssigkeits-Verbindungskanal zwischen dem Lagerbehälter und der Überführungs-Vorrichtung schafft,
• mit einem Verbindungsabschnitt zum dichtenden Verbinden der Überführungs-Vorrichtung mit dem Gebrauchsbehälter,
• mit einem Dreh-Betätigungselement, welches über das Getriebe mit der Hohlnadel-Baugruppe in Wirkverbindung steht,
• mit einer Dichtung zur Abdichtung des Grundkörpers gegen das Dreh-Betätigungselement,
• wobei der Grundkörper einen Abhebe-Mitnehmer aufweist, der derart ausgeführt ist, dass er mit einem komplementär ausgeführten Gegen-Abhebe-Mitnehmer am Dreh-Betätigungselement zum die Dichtung entlastenden Abheben des Dreh-Betätigungselements vom Grundkörper während der Dreh-Betätigung des Dreh-Betätigungselements zusammenwirkt.

According to a second aspect, this object is achieved according to the invention by a device having the following characteristics:
Device for transferring a liquid between a storage container and at least one further use container

• with a storage container sealing portion for sealingly abutment of a body of the transfer device on the storage container
• with a hollow needle assembly with a hollow needle, wherein the hollow needle assembly by means of a transmission relative to the base linearly along a movement axis is displaced between
  • - - a retracted resting position and
  • an extended connection position in which the hollow needle creates a fluid communication channel between the storage container and the transfer device,
• a connection portion for sealingly connecting the transfer device to the use container,
• with a rotary actuating element, which is in operative connection via the gear with the hollow needle assembly,
• with a seal for sealing the base body against the rotary actuator,
• wherein the base body comprises a lift-off dog, which is designed such that it cooperates with a complementary executed counter-lift-driver on the rotary actuator for the seal relieving lifting the rotary actuator from the body during the rotary operation of the rotary actuator ,

It has been recognized that an actuating effort in a rotary actuator for displacing the hollow needle assembly from the rest position to the connecting position is significantly reduced by a release of the rotary actuating element from the base body which relieves the seal. This accordingly increases convenience in rotary operation for hollow needle displacement. The lifting of the base body for sealing relief can be matched to the rotary actuator via the rotary actuator, that a rotational movement range of the rotary actuating element, in which a lifting of the rotary actuating element from the base body, with a further rotational movement range of the Rotary actuating element, in which a puncture or piercing of the hollow needle of the hollow needle assembly by a closure body, such as a sealing membrane, to close the storage container, do not overlap each other. An unfavorable addition of overcoming forces on the one hand to lift the rotary actuator from the body, so the seal relief, and on the other hand for insertion or piercing of the closure body is thus avoided. In addition, a lifting of the seal can be adjusted to the rotational actuation, that in analogy, for example, to a rotatable beverage bottle closure suggests that on the rotary operation opening the transfer device and to activate the liquid transfer function. The seal for sealing the base body against the rotary actuating element can be an elastomer seal, for example made of silicone, in particular a silicone lamellar seal, or a hard / hard mechanical seal. The seal may have both a radial and an axial sealing seat or a radial / axial combined sealing seat. With the seal for sealing the base body against the rotary actuating element in particular a germ-tight sealing of an interior of the base body can be achieved. The counter-lifting driver can be arranged on a coupling sleeve of the rotary actuating element.

It is advantageous if the lift-off dog and / or the counter-lifting dog is designed as a thread. A threaded design of at least one of the drivers leads to a safe power transmission when lifting the rotary actuator from the main body of the transfer device.

Preferably, the lift-off driver is designed as external thread. One embodiment results in that the rotary actuating element is in engagement with the main body of the transfer device via the drivers from the outside. The rotary actuator can be performed in this case at the same time as a protective body for the main body of the transfer device.

Conveniently, there is a locking device for locking the hollow needle assembly on the main body in the connecting position. A locking device prevents the hollow needle assembly is undesirable relocated from the connection position, for example, in the rest position. An originality of the transfer device, which can be used exactly once, is thus guaranteed.

The transfer device according to the two aspects described above can also be embodied with other combinations of the features explained above.

The advantages of a kit according to claim 6 correspond to those which have already been explained above with reference to the transfer device. The set may also include at least one utility container, for example in the form of a standard syringe.

Fig. 1

perspektivisch eine Vorrichtung zum Überführen einer Flüssigkeit zwischen einem Lagerbehälter und mindestens einem weiteren Gebrauchsbehälter, dargestellt in montiertem Zustand vor einem Aufsetzen auf den Lagerbehälter;

Fig. 2

einen axialen Längsschnitt durch die Vorrichtung nach Fig. 1, dargestellt in einer auf den Lagerbehälter aufgesetzten, gebrauchsfertigen Dichtstellung mit einer Hohlnadel-Baugruppe in einer eingefahrenen Ruhestellung;

Fig. 3

eine zu Fig. 2 ähnliche Darstellung der Überführungs-Vorrichtung, bei der einige Komponenten weggelassen sind, dargestellt weiterhin mit der Hohlnadel-Baugruppe in der Ruhestellung;

Fig. 4

in einer zu Fig. 3 ähnlichen Darstellung die Überführungs-Vorrichtung mit der Hohlnadel-Baugruppe kurz nach Verlassen der Ruhestellung in einer Zwischenstellung zwischen der Ruhestellung und einer ausgefahrenen Verbindungsstellung, wobei die Hohlnadel in der Verbindungsstellung einen Flüssigkeits-Verbindungskanal zwischen dem Lagerbehälter und der Überführungs-Vorrichtung schafft;

Fig. 5

in einer zu den Fig. 3 und 4 ähnlichen Darstellung, allerdings mit aufgesetztem Deckel eines Dreh-Betätigungselements, die Überführungs-Vorrichtung in der Verbindungsstellung, in der ein Abnehmen des Dreh-Betätigungselements möglich ist;

Fig. 6

in einer zu Fig. 1 ähnlichen perspektivischen Darstellung die auf den Lagerbehälter aufgesetzte Überführungs-Vorrichtung mit der Hohlnadel-Baugruppe in der Verbindungsstellung nach Abnahme des Dreh-Betätigungselements;

Fig. 7

in einer zu Fig. 5 ähnlichen Darstellung die Überführungs-Vorrichtung nach Abnahme des Dreh-Betätigungselements mit angedeuteten Strömungswegen;

Fig. 8a/b

jeweils in einer zu Fig. 7 ähnlichen Darstellung vergrößert eine Darstellung von Strömungswegen einerseits durch einen Flüssigkeitskanal zum Transport von Flüssigkeit durch eine Hohlnadel der Hohlnadel-Baugruppe (Fig. 8a) und andererseits durch einen Lüftungs-Gaskanal zum Transport von Gas durch die Hohlnadel-Baugruppe (Fig. 8b);

Fig. 9

perspektivisch und vergrößert eine Nadelspitze am freien Nadelende der Hohlnadel der Hohlnadel-Baugruppe, wobei die eine dort ausmündende Gas-Kanalöffnung des Lüftungs-Gaskanals sowie eine von insgesamt zwei dort ausmündenden Flüssigkeits-Kanalöffnungen des Flüssigkeitskanals sichtbar ist;

Fig. 10

eine Aufsicht auf die Nadelspitze, gesehen also aus Blickrichtung X in Fig. 9;

Fig. 11a

in einer Unteransicht eine die Hohlnadel umgebende Nadelhülse der Hohlnadel-Baugruppe;

Fig. 11b

eine schnitt gemäß Linie XIb-XIb in Fig. 11a;

Fig. 12

die Nadelhülse, gesehen aus zur Blickrichtung nach Fig. 11 entgegengesetzten Blickrichtung, sodass zusätzlich ein Filterträger eines nicht dargestellten Luftfilters im Gaskanal sichtbar ist;

Fig. 13a/b

jeweils in einer zu Fig. 8b ähnlichen Darstellung eine alternative Ausführung einer Hohlnadel-Baugruppe mit einem zusätzlich in einem Ringraum zwischen der Hohlnadel und der Nadelhülse angeordneten Axial-Kanalkörper zur Verlängerung eines Axialweges des Gaskanals, wobei Fig. 13a einen Axialschnitt und Fig. 13b eine perspektivische Axialschnitt-Ansicht zeigt;

Fig. 14

in einer zu Fig. 1 ähnlichen Darstellung, allerdings schon auf dem Lagerbehälter aufgesetzt, eine weitere Ausführung einer Überführungs-Vorrichtung;

Fig. 15

die Überführungs-Vorrichtung nach Fig. 14 nach Axialverlagerung einer äußeren Dichtungs-Sicherungshülse zur Sicherung eines dichtenden Anliegens eines Dichtabschnitts der Überführungs-Vorrichtung am Lagerbehälter;

Fig. 16

die Überführungs-Vorrichtung nach Fig. 15 mit eingesetztem Verriegelungskörper zum Sichern einer eingefahrenen Ruhestellung einer Hohlnadel-Baugruppe der Ausführung nach Fig. 14 ff.

Fig. 17

einen Axialschnitt durch die Überführungs-Vorrichtung nach Fig. 15;

Fig. 18

in einer zu Fig. 15 ähnlichen Darstellung die Überführungs-Vorrichtung nach den Fig. 14 ff. nach Verlagerung der Hohlnadel-Baugruppe in die ausgefahrene Verbindungsstellung;

Fig. 19

einen Axialschnitt durch die Überführungs-Vorrichtung nach Fig. 18;

Fig. 20a/b

die Überführungs-Vorrichtung nach den Fig. 14 ff. in der Verbindungsstellung nach den Fig. 18 und 19 mit weggelassener Dichtungs-Sicherungshülse, wobei ein Druck-Betätigungselement der Überführungs-Vorrichtung zur Veranschaulichung einer Führungseinrichtung des Druck-Betätigungselements an einem Grundkörper der Überführungs-Vorrichtung gebrochen dargestellt ist;

Fig. 21

die Überführungs-Vorrichtung nach den Fig. 14 ff. in der Verbindungsstellung bei abgenommenem Druck-Betätigungselement.

Embodiments of the invention will be explained in more detail with reference to the drawing. In this show:

Fig. 1

in perspective, a device for transferring a liquid between a storage container and at least one further use container, shown in the assembled state before placing on the storage container;

Fig. 2

an axial longitudinal section through the device according to Fig. 1 , shown in a set on the storage container, ready-sealing position with a hollow needle assembly in a retracted rest position;

Fig. 3

one too Fig. 2 similar illustration of the transfer device, in which some components are omitted, further illustrated with the hollow needle assembly in the rest position;

Fig. 4

in one too Fig. 3 similar representation, the transfer device with the hollow needle assembly shortly after leaving the rest position in an intermediate position between the rest position and an extended connection position, wherein the hollow needle in the connection position creates a fluid communication channel between the storage container and the transfer device;

Fig. 5

in one of the Fig. 3 and 4 similar representation, but with the lid of a rotary actuator, the transfer device in the connecting position, in which a removal of the rotary actuator is possible;

Fig. 6

in one too Fig. 1 similar perspective view of the storage container patch transfer device with the hollow needle assembly in the connecting position after removal of the rotary actuator;

Fig. 7

in one too Fig. 5 similar representation of the transfer device after removal of the rotary actuator with indicated flow paths;

Fig. 8a / b

each in one too Fig. 7 1 shows a representation of flow paths on the one hand through a fluid channel for transporting fluid through a hollow needle of the hollow needle assembly ( Fig. 8a ) and on the other hand through a ventilation gas channel for the transport of gas through the hollow needle assembly ( Fig. 8b );

Fig. 9

in perspective and enlarges a needle tip on the free needle end of the hollow needle of the hollow needle assembly, the one opening out there gas channel opening of the ventilation gas channel and one of two out there opening out liquid channel openings of the liquid channel is visible;

Fig. 10

a view of the needle point, so seen from the direction X in Fig. 9 ;

Fig. 11a

in a bottom view, a needle sleeve of the hollow needle assembly surrounding the hollow needle;

Fig. 11b

a section according to line XIb-XIb in Fig. 11a ;

Fig. 12

the needle sleeve, seen from the direction of looking Fig. 11 opposite viewing direction, so that in addition a filter carrier of an air filter, not shown, is visible in the gas channel;

Fig. 13a / b

each in one too Fig. 8b a similar representation of an alternative embodiment of a hollow needle assembly with an additionally arranged in an annular space between the hollow needle and the needle sleeve Axial channel body for extending an axial travel of the gas channel, wherein Fig. 13a an axial section and Fig. 13b shows an axial cross-sectional perspective view;

Fig. 14

in one too Fig. 1 similar representation, but already placed on the storage container, another embodiment of a transfer device;

Fig. 15

the transfer device after Fig. 14 after axial displacement of an outer seal securing sleeve for securing a sealing abutment of a sealing portion of the transfer device to the storage container;

Fig. 16

the transfer device after Fig. 15 with inserted locking body for securing a retracted rest position of a hollow needle assembly according to the execution Fig. 14 ff.

Fig. 17

an axial section through the transfer device after Fig. 15 ;

Fig. 18

in one too Fig. 15 similar representation of the transfer device after the Fig. 14 ff. After displacement of the hollow needle assembly in the extended connection position;

Fig. 19

an axial section through the transfer device after Fig. 18 ;

Fig. 20a / b

the transfer device after the Fig. 14 ff. In the connection position after the FIGS. 18 and 19 with omitted seal securing sleeve, wherein a pressure actuating element of the transfer device for illustrating a guide device of the pressure actuating element is shown broken on a base body of the transfer device;

Fig. 21

the transfer device after the Fig. 14 ff. In the connection position with removed pressure actuator.

Based on Fig. 1 to 12 is a first embodiment of a device 1 for transferring a liquid between a storage container 2 (see. Fig. 6 ) and at least one further storage container 3 (see. Fig. 6 ). All moldings of the transfer device 1 are made of plastic and are designed in particular as injection-molded parts.

The transfer device 1 has a sealing portion 4 for the sealing abutment of a base body 5 (see. Fig. 2 ) of the transfer device 1 on the storage container 2. The sealing portion 4 is applied to an elastomeric sealing plug of the storage container 2a, which will be described below. The sealing portion 4 engages around a neck 6 of the storage container 2 (see. Fig. 5 ). An outer locking sleeve 7 of the transfer device 1 is used to secure the sealing portion 4 in its sealing position.

Fig. 1 shows the securing sleeve 7 in a transport position of the transfer device 1 prior to placement on the storage container 2. For example Fig. 6 shows the securing sleeve 7 in a pushed over the sealing portion 4 securing position, engage in the corresponding locking lug of the locking sleeve 7 in locking receptacles 8 of the sealing portion 4 and press this against the neck 6 of the storage container 2 sealing.

The transfer device 1 further has a hollow needle assembly 9 with a hollow needle 10 and a surrounding needle sleeve 11. The hollow needle 10 is designed as a plastic hollow needle. Alternatively, the hollow needle 10 may also be designed at least in sections as a steel cannula. Through the hollow needle 10 there is a liquid transfer between the utility container 3 and the storage container 2 and at the same time a ventilation of these containers 2, 3, as will be explained in more detail below.

The hollow needle assembly 9 is by means of a gear 12 relative to the main body 5 linearly along a movement axis 13 (see. Fig. 3 ) relocatable. This movement axis 13 extends coaxially to a central longitudinal axis 14 of the transfer device 1.

A displacement of the hollow needle assembly 9 takes place between one example in the FIGS. 2 and 3 shown, retracted rest position and one example in the Fig. 5 shown, extended connection position. In the connection position, the hollow needle 10 provides, inter alia, a fluid connection channel between the storage container 2 and the transfer device 1. This liquid channel extends between a free needle end 15 and an opposite connection portion 16 (see. Fig. 5 ). The connecting portion 16 is an integral part of the hollow needle 10. The connecting portion 16 is for sealing the connection of the transfer device 1 with the use container 3 and is designed as a Luer connection. Accordingly, the use container 3 is designed as a standard syringe with a complementary Luer connection.

As an alternative to a Luer connection, the transfer device 1 may also be connected differently to the utility container 3, for example by way of another embodiment of a conical connection.

The needle sleeve 11 is a separate component to the hollow needle 10. The needle sleeve 11 is circumferentially sealed to the hollow needle 10 at two axial positions, namely on the one hand in the region of the connecting portion 16 facing the end of the needle sleeve 11 (see Fig. 3 ) and on the other hand axially spaced at an opposite connecting portion 18. Between these connecting portions 17, 18 axially and between the hollow needle 10 and the needle sleeve 11 radially is an approximately hollow cylindrical annular space 19th

The transfer device 1 further has a multi-part rotary actuator 20 which is connected via the gear 12 with the hollow needle assembly 9 in operative connection.

The rotary actuator 20 has an annular cover 21 and an actuator base 22 (see, eg FIGS. 2 and 3 ). The rotary actuator 20 is rotatable relative to the main body 5 of the transfer device 1 about the central longitudinal axis 14.

The actuator base body 22 is against the base body 5 of the transfer device 1 via a base seal 23 (see, for example Fig. 2 ) sealed. This creates a closed and in particular germ-tight space within the body.

The rotary actuator 20 further includes an outer coupling sleeve 24 which is rotatably connected to the actuator base body 22 and can be understood as part of this body 22.

The transmission 12 has an axially and about the central longitudinal axis 14 rotatably mounted in the base body 5 of the transfer device 1 driving ring 25. Radially, the driving ring 25 is located between the base body 5 and the needle sleeve 11th

The driver ring 25 has an inner driver, which is designed as an internal thread 26 in the embodiment shown. The internal thread 26 interacts with a complementary thread 27, designed as external thread, the needle sleeve 11 for displacing the hollow needle assembly 9 together.

During the displacement of the hollow needle assembly 9 from the rest position to the connecting position of the driving ring 25 rotatably connected to the rotary actuator 20 is connected. For this purpose, the actuating element base body 22 has a plurality, for example three, axial projections 28 (cf., for example, FIG Fig. 3 ), which, as long as a rotationally fixed connection of the actuating element base body 22 with the driving ring 25, engage in associated axial receptacles 29 of the driving ring 25. The axial lugs 28 and the associated axial receptacles 29 are distributed in the circumferential direction about the central longitudinal axis 14. The axial lugs 28 are integral parts of the actuator base body 22nd

About inner axial ribs 30 (see, eg Fig. 4 ), which are executed in the main body 5 of the transfer device 1, a rotation of the hollow needle assembly 9 is given relative to the base body 5 to the central longitudinal axis 14. For this purpose, the needle sleeve 11 to the axial ribs 30 complementary axial guide grooves 31 (see, eg Fig. 11a and 12 ).

End faces 32 of these inner axial ribs 30 simultaneously represent an axial seat of the driving ring 25 in the main body 5 of the transfer device.

The main body 5 of the transfer device 1 has a lift-off driver 33 designed as an external thread. The latter interacts with a counter-lift-off carrier 34, designed as a complementary internal thread, of the coupling sleeve 24 of the rotary actuating element 20. In the rotary actuation of the rotary actuating element 20, which causes the displacement of the hollow needle assembly 9 from the rest position to the connecting position, the interaction of the lift-off cam 33 with the counter-lifting-driver 34 leads to a lifting of the rotary actuator 20 from Basic body 5 of the transfer device 1 for relieving the main body seal 23rd Fig. 4 shows by way of example the correspondingly relieved position in which the actuator base body 22 is lifted off the main body 5 axially.

The main body seal 23 may be designed as a silicone lamellar seal. Alternatively, the main body seal 23 may be designed as a hard / hard mechanical seal.

In the connection position (cf. Fig. 5 ), the drivers 33, 34 are disengaged, so that the entire rotary actuator 20 from the main body 5 of the transfer device 1 is removable.

The transfer device 1 additionally has a locking device 35 for locking the hollow needle assembly 9 in the connecting position. This locking is used to ensure the originality of the transfer device 1 by the displacement of the hollow needle assembly 9 is made irreversible in the connection position. The locking device 35 comprises a latching component 36 on the main body 5 of the transfer device 1, which cooperates with a detent counter-component 37 complementary thereto on the outer wall of the hollow needle 10 latching.

Fig. 6 shows the transfer device 1 with the hollow needle assembly 9 in the connecting position with removed rotary actuator 20. The connecting portion 16 of the hollow needle assembly 9 is now accessible from above and not covered by the ring cover 21 of the rotary actuator 20. Due to this accessibility of the connecting portion 16, this can be connected to the Luer connector of the utility container 3.

The storage container 2 is sealed in the region of its neck 6 by a stopper 38 in the form of an elastomeric sealing plug or a sealing membrane. For example, the Fig. 5 . 7 and 8a / b it can be seen that the hollow needle 10 has pierced the storage container 2 and the stopper 38 of the storage container 2 in the connecting position.

In the area of the free needle end 15, the liquid channel 39 already mentioned above in connection with the displacement of the hollow needle assembly 9 opens between the storage container 2 and the transfer device 1 via two liquid channel openings 40, 41 (cf. Fig. 10 ) outwards. The liquid channel 39 serves to transport liquid through the hollow needle 10.

In the area of the free needle end 15, a ventilation gas channel 42 also opens out of the hollow needle 10 via a gas channel opening 43. The ventilation gas duct 42 serves to transport gas through the hollow needle assembly 9, namely for venting or venting the storage container 2 or the use container 3.

The channel paths of the liquid channel 39 on the one hand and the gas channel 42 on the other hand are separated from each other. The liquid channel 39 on the one hand and the gas channel 42 on the other hand open axially along the hollow needle 10 adjacent to each other and in the circumferential direction about the central longitudinal axis 14 offset from each other. Between each one of the liquid channel openings 40, 41 and the circumferentially adjacent gas channel opening 43 extends in the longitudinal direction of the hollow needle 10 extending needle-separating edge 44, 45. Another, correspondingly extending in the longitudinal direction of the hollow needle 10 needle-separating edge 46 extends between the two liquid channel openings 40 and 41st

The two needle-separating edges 44, 45 between the liquid channel openings 40, 41 and the gas channel opening 43 reduces undesirable liquid transfer between the liquid channel 39 and the vent gas channel 42. In addition, the needle-separating edges 44 to 46 serve for reduction of piercing forces of the hollow needle 12 in the sealing plug 38 of the storage container 2. The needle-separating edges 44 to 46 have a cutting action when puncture in the sealing plug 38th

The liquid channel openings 40, 41 are axially at least as far away from the needle tip at the free needle end 15 as the gas channel opening 43. In the illustrated embodiment (see. Fig. 9 ), the liquid channel openings 40, 41 are axially further away from the needle tip at the free needle end 15 than the gas channel opening 43.

Starting from the gas channel opening 43, a gas flow path through the ventilation gas channel 42 initially runs via a gas channel section 47, which runs parallel to the central longitudinal axis 14 in the hollow needle 10. The gas channel section 47 opens via a passage opening 48 (cf. Fig. 8a / b ) in the annular space 19 between the hollow needle 10 and the needle sleeve 11 from. The annular space 19 thus forms a portion of the ventilation gas channel 42.

At the bottom of the annular space 19, the needle sleeve 11 has a plurality of needle sleeve passage openings 49. In total, eight such needle sleeve passage openings 49 are the same distributed around the central longitudinal axis 14 arranged around. The needle sleeve passage openings 49 provide a flow passage of the ventilation gas channel 42 between the annular space 19 and a further annular space 50 in a bottom side, ie the storage container 2 facing, portion of the needle sleeve 11 in this further annular space 50 is an annular disc-shaped filter carrier 51st arranged, which surrounds the hollow needle 10 annular. The filter support 51 carries a likewise annular air filter 52 of the transfer device 1. In the further flow path of the ventilation gas channel 42 after passing through the air filter 52 is a gas passage between the needle sleeve 11 and the main body 5 of the transfer device 1 and from there to the outer Environment possible.

In the ventilation gas duct 42, an inversion of an axial main gas flow direction takes place between the gas duct section 47 and the further gas duct section between the needle sleeve passage openings 49 and the air filter 52 in the region of the annular space 19. An axial flow component runs exactly opposite to one another in these two gas channel sections. The annular space 19 therefore represents a direction reversal channel section of the ventilation gas channel 42.

The transfer device 1 is used as follows:
First, the transfer device 1 in the after Fig. 1 present configuration on the neck 6 of the storage container 2, in which an example powdered medicine is present, placed. Subsequently, the seal securing sleeve 7 is pushed over the sealing portion 4. As a result, the transfer device 1 is secured on the neck 6 of the storage container 2, wherein in particular a tamper-evident closure can be ensured. In addition, this sealing section 4 is secured by the sliding of the sealing safety sleeve 7 via the sealing section 4 and the transfer device 1 seals against the storage container 2. Now, the rotary actuator 20 is rotated in the direction indicated by arrow symbols 53 on the outside of the ring cover 21 direction of rotation by 360 ° or an even larger angle of rotation. In this case, take the Axialnasen 28 the driving ring 25, which, axially mounted in the base body 5, now also rotates about the central longitudinal axis 14, thereby axially displaced against the base body 5 but not. Axially the driving ring 25 is secured over undercuts in the base body 5. By interaction of the threads 26, 27 now begins the displacement of the hollow needle assembly 9 relative to the base body 5 in the direction of the movement axis 13, ie to the storage container 2 to. At the same time the threads 33, 34 of the base body 5 of the transfer device 1 on the one hand and the coupling sleeve 24 on the other hand cooperate, so that the actuator base body 22 from the main body 5 of the transfer device 1 stands apart axially, as in Fig. 4 shown. Upon further rotation of the rotary actuator 20, the hollow needle assembly 9 in the connection position after Fig. 5 displaces and pierces the plug 38 of the storage container 2. This happens until on the one hand the threads 26, 27 and on the other hand, the threads 33, 34 are disengaged from each other. In the connecting position, the locking device 35 is engaged and the hollow needle assembly 9 is irreversibly secured in this position.

Now, the entire rotary actuator 20 can be removed and the use of container 3, so the standard hypodermic syringe, can be connected via the Luer coupling with the connecting portion 16 of the transfer device 1. In the use of container 3 is a matched to the drug in the storage container 2 solvent. Now this solvent is injected by actuation of a syringe plunger of the use container 3 via the transfer device 1 into the interior of the storage container 2. In this case, the solvent flows through the liquid channel 39 in the hollow needle 10 and exits via the two liquid channel openings 40, 41 from the hollow needle 10 into the storage container 2. The arrangement of the liquid channel openings 40, 41 relative to the gas channel opening 43 reduces an overflow of liquid droplets in the gas channel during injection, since the liquid does not flow in the direction of gravity down and thus during injection in the direction of the gas channel. According to the volume of liquid entering the storage container 2, air escapes from the storage container 2 via the gas channel opening 43 through the ventilation gas channel 42 via the gas channel section 47, the passage opening 48, the annular space 19, the needle sleeve passage openings 49, the annular space 50 , the air filter 52 and from there between the needle sleeve 11 and the main body 5 of the transfer device 1 to the outside. The design of the free needle end 15 with the needle-separating edges 44, 45, by the arrangement of the channel openings 40,41, 43 and by the design of the ventilation gas channel 42 in particular by the reversal of direction in the annular space 19 is effectively avoided that undesirable liquid over the ventilation gas duct 42 exits to the outside. If necessary, liquid droplets entering the ventilation gas duct 42 are split. In particular, clogging of the air filter 52 with liquid is thereby effectively prevented.

After complete injection of the solvent in the storage container 2, a solution of the initially powdered medicament in the solvent is brought about by shaking the assembly from the storage container 2, the transfer device 1 and the utility container 3. After the dissolution of the dissolved drug is transferred via the transfer device 1 from the storage container 2 in the use of container 3. In this case, the dissolved medicament flows via the liquid channel 39 through the hollow needle 10 to the storage container 2 into the use container 3. This flow of the dissolved medicament into the use container 3 is produced by mounting the use container 3 designed as a syringe. The transfer of the dissolved drug from the storage container 2 in the use of container 3 is usually in over-head position, in which the storage container 2 is disposed above the utility container 3. In this position, the liquid channel openings 40, 41 are closer to a residual solution of the dissolved drug, so that a residual emptying of the solution is improved. On the other hand, the gas channel opening 43 is further away from the remainder of the solution in this overhead position than the liquid channel openings 40, 41, so that the gas channel can perform its ventilation function well. According to the exiting liquid volume from the storage container 2, air flows through the ventilation gas channel 42 from the environment around the transfer device 1 through the air filter 52 into the storage container 2. The incoming air is sterile filtered through the air filter 52.

After complete retraction of the syringe plunger of the use container 3, the dissolved medicament is present in the interior of the use container and the use container 3 can now be withdrawn from the connection portion 16 of the transfer device 1.

Fig. 13a and 13b show a variant of a hollow needle assembly 54, which can be used instead of the hollow needle assembly 9 in the transfer device 1. Components and functions corresponding to those described above with reference to the embodiment according to Fig. 1 to 12 already described, bear the same reference numbers and designations and will not be discussed again in detail.

In the hollow needle assembly 54 after Fig. 13a / b, an axial channel body 55 is disposed in the annular space 19. This is designed so that a reversal of the direction of the vent gas channel 42 is not, as in the execution of the Fig. 1 to 12 , in the bottom side, the storage container 2 facing region of the annular space 19 takes place, but approximately at an axial height A of about two-thirds of the total axial height of the annular space 19. Before the direction reversal channel section of the axial channel body 55 performs a corresponding extension of an axial path of the Ventilation gas ducts 42. The axial channel body 55 effectively suppresses unwanted entrainment of liquid along the entire vent gas channel 42. The path of the gas through the gas channel 42 during venting of the storage container 2 is in the Fig. 13a indicated by a directional arrow 55a.

The axial channel body 55 is designed as up to a height of two-thirds of the entire axial height of the annular space 19 sealed sub-segment between the hollow needle 10 and the needle sleeve 11. In this sub-segment, the passage openings 48 are closed so that an ascent of the air flowing out of the storage container 2 is forced upon injection of the liquid into the storage container 2. The air then flows after the rise and the direction reversal through the remaining openings 48 of the unlocked segment. During the extended axial climbing path of the ventilation gas channel 42, inflowing liquid droplets are additionally distributed or deposited by gravity.

Another embodiment of a transfer device 56, which instead of the transfer device 1 after the Fig. 1 to 13a / b can be used, is described below on the basis of Fig. 14 ff. described. Components and functions corresponding to those described above with reference to FIGS Fig. 1 to 13a / b have already been described, bear the same reference numbers or designations and will not be discussed again in detail.

Fig. 14 shows the transfer device 56 after placement on the storage container 2 and before moving the seal securing sleeve. 7

Fig. 15 shows the transfer device 56 after moving the seal securing sleeve 7 in the securing position for the sealing portion. 4

Fig. 16 shows the transfer device 56 in a transport configuration. In this transport configuration is displaced in the securing position seal-securing sleeve 7 between this and a head portion 57 of a pressure-actuating element 58 of the transfer device 56 a removable securing element 59 introduced in the form of a locking half-ring. The securing element 59 is in a circumferential receiving groove 60 (see. Fig. 15 ) of the head portion 57 of the pressure actuator 58 is inserted. In this retracted position, the securing element 59 prevents a displacement of the pressure actuating element 58 relative to a base body 61 (cf. Fig. 17 ) of the transfer device 56 in the direction of the storage container 2 to. An unintentional pressure actuation of the pressure actuating element 58 is thus prevented.

With removed fuse element 59 is via the pressure-actuating element 58, a displacement of a hollow needle assembly 62 with hollow needle 63 between in the Fig. 17 shown rest position and in the Fig. 19 shown connection position allows. In this shift between the rest position and the connection position, the pressure actuator 58 is shear-resistant with the hollow needle assembly 62nd

The hollow needle assembly 62 is apart from an outer geometry of the needle sleeve 11 constructed as the hollow needle assembly 9. The outer geometry of the needle sleeve 11 of the embodiment according to the Fig. 14 ff. Is designed for a pushing movement and thus eg without the thread 27. Basically, the design of the hollow needle assembly 62 with respect to the liquid channel and the ventilation gas channel as in the hollow needle assembly 9 in connection with the Fig. 1 to 12 has already been explained.

For axial guidance of the pressure actuator 58 on the base body 61 in the displacement of the hollow needle assembly 62 from the rest position to the connecting position is a guide device 64. The latter has two guide pins 65 which are integrally formed on an inner side of a jacket wall of the pressure-actuating element 58. The guide pins 65 slide in the displacement of the rest position into the connecting position in each case an associated guide groove 66 which is executed in an outer wall of the main body 61 of the transfer device 56.

The guide device 64 is designed such that the displacement of the hollow needle assembly 62 from the rest position to the connecting position is irreversible.

The two guide grooves 66 each have a sawtooth profiled groove base 67, which in the Fig. 19 in cross-section and in the Fig. 20a / b is shown for one of the two guide grooves 66 in a perspective view. The profiling of saw teeth in groove base 67 is such that the guide pin 65 in the displacement of the pressure-actuating element 58 from the rest position into the connecting position can slide on inclined surfaces of the saw teeth. In the connecting position, a sliding back of the guide pin 65 in the guide grooves 66 upwards is not possible, since the guide pins 65 are then blocked by vertical surfaces of the sawtooth profiling.

At their end facing the storage container 2, the guide grooves 66 each continue into a guide helix 68. About this guide helixes 68 after reaching the connection position, a twisting of the pressure-actuating element 58 from the main body 61 of the transfer device 56 is possible, as indicated by directional arrows 69, 70 in the Fig. 20a / b indicated. The guide pins 65 of the pressure-actuating element 58 slide in each case in one of the two guide spirals 68 on the outside of the main body 61 of the transfer device 56 until the guide pin 65 at the end of the guide spirals 68 out of engagement with the main body 61.

After removal of the pressure actuator 58, the transfer device 56 is in the instantaneous position, which in the Fig. 21 is shown. In this instantaneous position, the connecting portion 16 of the hollow needle 63 is accessible from above, as described in connection with the transfer device 1 and the Fig. 6 has already been explained.

The transfer device 56 is used as follows:
After installation, the transfer device 56 is located together with the storage container 2, in which the powdered medicament is kept, first in the in the Fig. 16 shown transport position with inserted securing element 59 before.

When using the transfer device 56, the securing element 59 is first withdrawn. Then, pressure is applied to an upper end surface of the pressure actuator 58 from above and the pressure actuator 58 along the directional arrow 71 in the Fig. 17 transferred from the rest position to the connection position. In this shift the guide pin 65 rattling over the saw teeth in the groove bases 67 of the guide grooves 66 to the storage container 2 facing the end of the guide grooves 66. Now, the pressure actuator 58 by rotation are turned off from the main body 61 of the transfer device 56 according to the directional arrow 69, so that the pressure-actuating element can be removed from the base body 61. Now, the use of container 3, so the standard syringe, via the Luer connector to the connecting portion 16 are connected. The remaining handling is, as in connection with the execution of the Fig. 1 to 12 described.

Claims (5)

1. Apparatus (1) for transferring a liquid between a storage container (2) and at least one further use container (3),

   - having a storage-container sealing portion (4) for leaktight abutment of a main body (5) of the transfer apparatus (1) against the storage container (2),

   - having a hollow-needle assembly (9; 54) with a hollow needle (10), wherein the hollow-needle assembly (9; 54) is displaceable in a linear manner along a movement axis (13) relative to the main body (5) by means of a gear mechanism (12) between

   - - a retracted rest position and

   - - an extended connecting position in which the hollow needle (10) creates a liquid connecting duct between the storage container (2) and the transfer apparatus (1),

   - having a connecting portion (16) for connecting the transfer apparatus (1) to the use container (3) in a leaktight manner,

   - having a rotary-actuation element (20) which is operatively connected to the hollow-needle assembly (9; 54) via the gear mechanism (12),

   characterized in that

   - the gear mechanism (12) has a driver ring (25) that is mounted in the main body (5) axially and so as to be rotatable about the movement axis (13), said driver ring (25)

   - - interacting with a complementary thread (27) of the hollow-needle assembly (9; 54) for the displacement of the hollow-needle assembly (9), and

   - - being connected to the rotary-actuation element (20) for conjoint rotation during the displacement.
2. Apparatus according to Claim 1, characterized in that the driver ring (25) has at least one inner driver (26) which interacts with the complementary thread (27), embodied as an external thread, of the hollow-needle assembly (9; 54).
3. Apparatus according to Claim 1 or 2, characterized by at least one axial lug (28) via which the rotary-actuation element (20) interacts with an axial receptacle (29) in the driver ring (25) in order to be connected for conjoint rotation.
4. Apparatus according to one of Claims 1 to 3, characterized in that ribs (30) on the main body (5), which belong to a device for preventing the hollow-needle assembly (9; 54) from rotating in the main body (5), simultaneously specify an axial seat of the driver ring (25).
5. Set made up of a transfer apparatus according to one of Claims 1 to 4 and a storage container (2).

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