WO2007062775A1

WO2007062775A1 - Device for transferring liquids, suspensions, and/or solid materials from a first receptacle into a second receptacle

Info

Publication number: WO2007062775A1
Application number: PCT/EP2006/011224
Authority: WO
Inventors: Simone Bölinger; Harry Pütter; Andreas Ritz; Wilhelm Buchmüller
Original assignee: Clinico Betreiebsverpachtungs-Gmbh
Priority date: 2005-11-30
Filing date: 2006-11-23
Publication date: 2007-06-07
Also published as: DE102005057547A1

Abstract

Disclosed is a device for transferring liquids, suspensions, and/or solid materials from a first receptacle (7) encompassing a port that is closed by means of a membrane (6) into a second receptacle. Said device is to be connected in a fixed manner to the first receptacle (7) and comprises a cannula (1) which is guided so as to be movable in an axial direction, is provided with joining structures (10, 11) at the opposite, axial ends thereof, and encloses a transfer duct. The inventive device further comprises a guiding unit (3,8) for axially directing the cannula (1) as well as a fastening mechanism that is to be fixed to the port of the first receptacle (7) closed by means of the membrane (6). Said device is further developed such that the same can be processed in conventional filling stations. For this purpose, the fastening mechanism is formed by a conventional receptacle closure, e.g. a metal foil (5), preferably an aluminum foil, which is to be fixed directly to the receptacle (7) and can be attached to the first receptacle (7) by flanging the same above the port, at least one part (3) of the guiding unit (3, 8) being disposed in a fixed fashion on the receptacle closure.

Description

Device for passing liquids, suspensions and / or solids from a first vessel to a second one

vessel

The invention relates to a device for passing liquids, suspensions and / or solids from a first, having a membrane-sealed opening vessel in a second vessel for fixed connection to the first vessel, with at least one movably guided in the axial direction, to their Hollow needle provided opposite to, axial ends with connection structures and enclosing at least one transfer channel, a guide unit for axially guiding the hollow needle and a fastening device for fixing to the opening of the first vessel which is closed by the membrane.

In particular, in medical technology, it is customary to pack medicines, or medicinal agents, in small vessels, which are sealed with a membrane. Such vessels are, for example, so-called Viale. The medicine is filled into the vessels in a sterile manner, and the vessel is filled with a membrane. closed the plug of rubber or a similar flexible material. The stopper is usually closed with a crimp cap made of a metal foil, usually aluminum foil, which is placed over the stopper and crimped around a neck of the vessel. The cap has an opening in the middle, through which the membrane is accessible.

If necessary, the drug is removed from the vessel. To remove the remedy or medicinal active substance, be it this in liquid form, as a suspension or as a solid in the vessel, the piercing tip of the hollow needle pierces the opening of the vessel closing the membrane and the contents of the vessel either in whole or taken in the required amount.

In order to simplify removal from the vessel or a transfer of the contents of the vessel into another vessel and to reduce the risk of germ contamination of the vessel contents, devices for transferring the vessel contents are used, which have a hollow needle, which is placed on the opening of the vessel the membrane can pierce with a first tip and with a second connection structure, the first tip opposite connects to a second vessel. Such a device separate from the first vessel is disclosed in DE 36 27 231 A1.

Developments to the effect that such a device is firmly connected to the first vessel and can be delivered together with this as a unit, are described in EP 0 850 178 Bl and EP 1 115 361 Bl. The devices shown there, which show all the features of the preamble of claim 1, contain a guide sleeve, which by means of a snap connection directly on the only Attached with a membrane stopper sealed neck of a vessel. This guide sleeve has two properties in the device: It carries a hollow needle movable in the sleeve and serves as a safety closure for the membrane stopper, thus replacing the known from conventional metal vessels produced from a metal foil crimp caps.

The prior art devices have proven themselves in terms of serviceability in the application when transferring the contents of the first vessel into a second vessel. However, this device is a problem in the filling of the vessels or their closure. Existing bottling plants are predominantly designed to secure the sealing plugs with a crimp cap made of a metal foil. The systems have specially designed tools for this purpose. These tools can not be used for the application of the prior art devices, the systems are not or only at considerable expense convertible. Furthermore, the vials equipped with the known devices are usually first filled and later provided with the transfer device. This leads to sterility problems. While both the filling of the vial and the manufacture and packaging of the transfer device take place under sterile conditions, the conditions during the merging of the vial and the transfer device are often not sterile, so that there is a risk of microbial contamination.

Against this background, it is an object of the invention to develop a known device of the type mentioned so that it can be applied in conventional, possibly slightly modified, filling with on the first vessel. To solve this problem is proposed with the invention that the fastening device by a directly to be fixed to the vessel, conventional vessel closure, for example. A metal foil, preferably an aluminum foil which can be fixed by crimping over the opening to the first vessel, or by a screw cap or a "melt closure" (a closure formed from a Kunststoffschrumpffo- lie formed), on which the guide unit is fixedly arranged at least with a part and which can be fixed by crimping over the opening to the first vessel.

In other words, in contrast to the previously known device or the combination thereof with the vessel again recourse to a there deliberately omitted, for closing conventional vial or similar vessels usual vascular closure, such as. A crimp cap made of a metal foil resorted to. The device itself is firmly connected to such a vessel closure, for example a metal foil (flanging cap), and can be placed on common filling installations together with this closure, e.g. the crimp cap, be applied to a vessel to be closed. For this purpose, no or only minimal changes to the bottling plants are required. This procedure ensures in particular a highly sterile filling, since the usual filling systems are usually placed in highly sterile areas and work accordingly sterile.

The connection structures of the hollow needle can be piercing tips, but can also be other structures, such as, for example, a Luer connection or the like, in particular in the region of the end of the hollow needle opposite the fastening device. In the case of a metal foil as a vessel closure, this, as is usual in known crimp caps, also has an opening in the device according to the invention, specifically in the region which lies in axial extension in front of one of the connection structures, in particular a piercing tip, of the hollow needle ( Claim 2). As a result, the hollow needle for connecting to the contents of the vessel must pierce only the membrane, not even the metal foil.

The guide unit of the device can be fixed to the vessel closure, for example the metal foil, in any desired manner, preferably glued, clamped or welded (claim 3).

As described in claims 4 and 5, an advantageous development of the invention resides in that the guide unit has a guide sleeve and optionally a guide element guided on the hollow needle and guided by the guide sleeve. Together, these elements effect a secure axial guidance of the hollow needle, which facilitates a connection, in particular a piercing, of the same through the membrane into the interior of the first vessel.

A further development is provided on the guide unit locking means, which enable locking of the hollow needle in at least one end position (claim 6). In order to prevent premature puncturing of the membrane, in particular in the case of a puncture tip as a connection structure, the hollow needle can be latched in its starting position in which the device is delivered. Preferably, the hollow needle can be latched at least in a position in which it is connected to the contents of the first vessel, in particular the membrane has pierced with a piercing point, in order to ensure a safe transfer of the bone. b

haltes the first vessel in a second vessel to allow.

A tamper-evident closure as proposed in claim 7 is an aid with which the original state of delivery of the vessel connected to the device can be detected quickly and reliably. If this original closure is missing, it must be assumed that the device or the vessel connected to it and its contents have already been used or manipulated. The tamper-evident closure may, for example, have the form of a cap with which, in the case of a piercing tip as connecting device, the sharp tip of the needle is covered at the end opposite the first vessel and thus a risk of injury when used as intended is avoided. The cap can be reattached after use and locked with the closure in such a way that the free connection structure, in particular such a needle, is covered and can be disposed of in this state.

Finally, the invention provides a ready-to-use unit comprising a vessel and a device as described above (claim 8). Since this unit is formed and packaged directly at the time of filling the vessel under sterile conditions, the sterility of the unit as a whole is ensured until use.

Further features and advantages of the invention will become apparent from the following and illustrated in the figures embodiments. In the figures show:

1 shows a first variant of a device according to the invention connected to a vessel in an original packed position (b) and in a position ment in which the hollow needle has pierced the membrane of the sealing plug (a),

2 shows a second variant of a device according to the invention connected to a vessel in an original packed position (b) and in a position in which the hollow needle has pierced the membrane of the sealing stopper (a),

3 a third variant of a device according to the invention connected to a vessel in an original packed position (b) and in a position in which the hollow needle has pierced the membrane of the sealing stopper (a),

4 shows a fourth variant of a device according to the invention connected to a vessel in a three-dimensional view,

5 shows the arrangement shown in FIG. 4 in a view cut along a longitudinal center plane,

Fig. 6 is a representation similar to FIG. 5

Sectional view of the fourth variant after the hollow needle of the device has been pushed into a membrane closing off the vessel and the cap has been removed,

7 shows a fifth variant of a device connected to a vessel according to the invention in a starting position in a sectional view,

8 is a sectional view of the device according to the variant of FIG. 7 in a position in which the hollow needle has pierced the membrane of the sealing plug, and Fig. 9 is a sectional view of the device according to the variant of FIG. 7 with a syringe connected to the device as a second vessel.

In the figures, identical or identically acting elements are provided with the same reference numerals.

In Figures 1 to 6 a total of four embodiments of a device according to the invention are shown, which are each firmly connected to a closed by a sealing plug 6 vessel 7, here a drug vial. In all embodiments, the vessel closure is formed by a metal foil (crimp cap), without the invention being limited to such a type of closure.

In principle, the devices are of similar construction in all four variants. The device is composed in each case of an axially movably guided, here at both longitudinal ends with piercing tips 10, 11 provided hollow needle 1, a guide device and a Metallbördelfolie 5, on which the guide device is fixed with at least one of its sub-elements. On the other hand, this foil is flanged around the neck of the vessel 7 more precisely about a thickening arranged there for fastening the entire device to the vessel 7 on the one hand and for securing the sealing stopper 6 on the other hand. This process is done with already fixed to the metal flanging film device and in a conventional optionally slightly modified filling system for the vessel. 7

The individual variants differ only in the specific structure of the guide device and the attachment of the same to the metal flanging 5.

In all four variants, the guide device includes a guide sleeve 3, which with the metal flanging 5 (here an aluminum flanging) is firmly connected. In the example of Figures 1, 3 and 4 to 6, one fixed to the hollow needle 1, piston-like thickening 8 is guided in the guide sleeve. In the example of the variant shown in Fig. 2, the second part of the guide means by a fixed with the Hollow needle connected counter guide sleeve 12 is formed, which surrounds the guide sleeve 3 outside and is guided by contact of its inner wall with the outer wall of the guide sleeve 3 at this. In this example, locking projections 9 are each provided on guide sleeve 3 and counter guide sleeve 12, which allow latching of the hollow needle 1 in two end positions.

In the variants shown in Figures 1 and 2, the guide sleeve 3 is clamped to the Metallbördelfolie 5. For this purpose, a fitting sleeve 4 projects from the side opposite the guide sleeve 3 through an opening in the metal flange lens and engages with an extension in a corresponding recess in the central opening of the guide sleeve 3. In the example shown in FIG. 3, the guide sleeve 3 is placed directly on the metal flanging foil 5 and glued or welded thereto.

In the originally packaged delivery state (shown in FIGS. 1 to 3 in the illustration (b) for the fourth variant in FIG. 4), the hollow needle is covered in all variants shown by a tamper-evident closure 2 in the form of a cap.

In order to be able to remove the contents of the vessel 7, the tamper-evident closure 2 is removed, and the hollow needle 1 is guided through the membrane of the sealing stopper 6 with its piercing tip 10 facing the sealing stopper 6. The opposite piercing tip 11 can then be inserted into a second vessel and so a connection for passing the Contents are created from the first vessel 7 in this second vessel.

A fourth and currently preferred embodiment of the device according to the invention is shown in more detail in Figures 4 to 6 and will be described again in detail below. In Fig. 4 it can be seen that a device V is placed on a vessel 7. For this purpose, in the manner according to the invention, a metal flanging foil 5 is placed around an opening edge of the vessel 7 and flanged over. The vessel 7 can also be a vial in this variant as in all previously shown variants. From the outside in the illustration according to FIG. 4, a guide sleeve 3 and an original closure 2 in the form of a cap can also be seen in this device variant.

In the figures 5 and 6, the embodiment according to the fourth variant is shown again in each case in a sectional view, in the delivery state with existing tamper evident closure in Fig. 5 and in Fig. 6 after pressing the hollow needle 1 in the stopper 6 and the membrane of Vessel 7.

The tamper-evident closure 2 or the cap is connected to the guide sleeve 3 via a predetermined breaking point 13. For this purpose, the two said elements made of plastic, wherein the connection via the predetermined breaking point 13 is preferably carried out already in the production of said components.

In this variant, the Metallbördelfolie 5 is connected to the device according to the invention by jamming. For this purpose, a base plate 14 is guided from an underside through an opening in the Metallbördelfolie 5 and with the interposition of a clamping ring 18, the guide sleeve 3 is slipped over the base plate 14. Between the guide Retaining sleeve 3 and the clamping ring 18 on the one hand and the base plate 14 on the other hand, the Metallbördelfolie 5 is clamped.

In the base plate 14, a guide 16 for guiding the hollow needle 1 is formed. Further, latching hooks 15 are formed on the base plate 14, which correspond to formed in a lower region of the piston-like thickening 8 in a cavity latching hook 17 and can cooperate with these for locking.

In Fig. 5, the device can be seen in an original packed condition. If the device is now to be used, a user grasps the tamper-evident closure 2 or the cap from the outside and pushes it down in the axial direction of the hollow needle 1. This breaks the predetermined breaking point 13, the integrity of which makes the originality of the packaging recognizable. Furthermore, the force transmitted to the tamper-evident closure 2 is transmitted via a shoulder in the piston-like thickening 8 and the piston-like thickening 8 is guided in the guide sleeve 3 in the direction of the vessel 7. In the piston-like thickening 8, the hollow needle 1 is fixed, so that moves through this movement and the hollow needle 1 in the direction of the vessel, more precisely in the direction of the sealing plug 6 with membrane. In the further application of force, the hollow needle pierces 1 with its piercing tip 10, the membrane of the sealing plug 6 and thus establishes a connection to the interior of the vessel 7 forth. The tamper-evident 2 and with this the hollow needle 1 can be moved to an end position in the direction of the vessel. In this end position abuts the piston-like thickening 8 with its underside at the upper ends of the latching hooks 15 and the latching hooks 15 of the base plate 14 act with the latching hooks 17 in the kolbenar- term thickening 8 together to lock the piston-like thickening 8 and thus the hollow needle 1 in the end position.

Now the user removes the tamper-evident 2 in the form of the cap, whereby the piercing tip 11 of the hollow needle 1 is exposed. This can now be inserted into a closure membrane of another vessel, for establishing a connection between the interiors of the vessel 7 and the other vessel. After the application of the vessel with the device shown in this embodiment, the user can put the withdrawn protective cap (tamper-evident 2) again on the hollow needle 1, to ensure a needle guard even when disposing. This prevents a risk of injuries to the needle and thus infection automatically connected or an unwanted contact with medically active agents.

By handling as described above is excluded that a user can injure when piercing the hollow needle 1 in the membrane of the connection plug 6 of the vessel 7 at the piercing tip 11 of the hollow needle 1. This is secured until reaching the depressed end position of the hollow needle 1 through the tamper-evident closure 2 in the form of the cap. Only when the end position is reached and the hollow needle 1 is securely locked in its position (by interaction of the latching hooks 15 and 17) of the tamper-evident closure 2 is removed in the form of the cap. The engagement of the latching hooks 15 and 17 is both tactile and audible, so that it is easy for a user to recognize that the hollow needle 1 has reached the end position.

FIGS. 7 to 9 show a further exemplary embodiment of a device V according to the invention. This embodiment corresponds in its essential construction features to the embodiment shown in FIGS. 4 to 6. _χ 3

For this reason, reference is made to the description above with regard to the construction and the general function of this variant.

The embodiment shown in FIGS. 7 to 9, in an initial position in the view from the outside, does not differ from the view of the previous embodiment shown in FIG.

The only difference between the fifth embodiment and the fourth embodiment only by the nature of the closure plug 6 opposite connection structure of the hollow needle 1. Where in the example shown in Figures 4 to 6 as well as in the examples previously shown a piercing tip 11 is provided as a connection structure , In this example, the hollow needle has a Luer connection 19, more precisely a female Luer connection. This serves in particular for connecting a needleless syringe 20 as a second vessel, with a male luer connection 21 of the syringe 20 being introduced into the female luer connection 19 at the end of the hollow needle 1 (see FIGS. 8 and 9).

The connection of the device described with the vessel 7 via a metal flanging 5 makes it possible to use these on standard filling combi caps or Metallbörderfolien filling systems.

_{χ 44}

LIST OF REFERENCE NUMBERS

Hollow needle 21 Luer connector (male)

tamper-evident closure

Guide sleeve V device

fitting sleeve

Metallbördelfolie

Sealing plug with membrane

vessel

piston-like thickening

catch projection

piercing

Against the guide sleeve

Breaking point

baseplate

latch hook

guide

latch hook

clamping ring

Luer connector (female)

syringe

Claims

claims

1. A device for passing liquids, suspensions and / or solids from a first, with a membrane (6) closed opening having vessel (7) in a second vessel for fixed connection to the first vessel (7), comprising: at least one in the axial direction movably guided, at their opposite, axial ends with connection structures (10, 11, 19) provided and at least one transfer channel enclosing hollow needle (1), a guide unit (3, 8, 12) for axially guiding the hollow needle (1) , and fastening means for fixing to the opening of the first vessel (7) closed by the membrane (6), characterized in that the fastening device is formed by a conventional vessel closure, eg a metal foil (7) to be fixed directly to the vessel (7). 5), preferably an aluminum foil, which can be fixed by beading over the opening on the first vessel (7) is formed, on which the Guide unit (3, 8, 12) is fixedly arranged at least with a part (3).

2. Device according to claim 1, characterized in that the vessel closure is a metal foil (5), which has an opening in an area which lies in axial extension in front of one of the connection structures (10) of the hollow needle (1).

3. Device according to one of the preceding claims, characterized in that the guide unit (3, 8, 12) with at least one part (3) on the vessel closure is attached by gluing, jamming and / or welding.

4. Device according to one of the preceding claims, characterized in that the guide unit (3, 8, 12) has a fixed to the vessel closure guide sleeve (3).

5. Apparatus according to claim 4, characterized in that the guide unit (3, 8, 12) further comprises a on the hollow needle (1) arranged guide element (8, 12), which in cooperation with the guide sleeve (3), the axial guidance of Hollow needle (1) causes.

6. Device according to one of the preceding claims, characterized in that the guide unit (3, 12) latching means (9) which allow latching of the hollow needle (1) in at least one, preferably at least two, end positions.

7. Device according to one of the preceding claims, characterized in that a free end (11) of the hollow needle (1) by a tamper-evident closure (2) is covered.

8. A ready-to-use unit comprising a closed vessel (7) containing a product having a mouth with an opening, the opening of which is closed by a sealing plug (6) having a membrane, and a vessel attached to the vessel in a conventional manner, in the case of a metal foil ( 5) as vascular closure, for example, by crimping the metal foil (5) around the neck, fixed device according to one of claims 1 to 7.