EP0679380B1 - Device for transferring and dispensing of fluids out of bottles, bags or similar containers for medical purposes - Google Patents

Description

The invention relates to a device for transferring and removing Liquids from bottles, bags or similar containers for medical purposes Purposes with diagonally opposite axes practically on one axis Spikes, each with two flow channels. Such Devices are also referred to as transfer and removal spikes.

Various devices for transferring and removing liquids from bottles or bags for medical purposes are known, which contain at least two flow channels and one or two filters.
DE 3627231 A1 describes a transfer device for mixing medications located in different containers, consisting of two piercing mandrels which are directed in the opposite direction and are connected to one another, each of which is provided with a continuous liquid channel and a ventilation channel, and which is characterized in that the Transfer device consists of two components that can be coupled to one another, each component being provided with a piercing mandrel and the liquid channels being connected to one another in the coupled state, while each ventilation mandrel ends in a ventilation opening. This device is not only complicated to manufacture and handle, but also has the disadvantage that two air filters are required. In addition, there is no possibility of keeping the remaining liquid to be used closed in the storage vessel.

Furthermore, DE 3820204 A1 describes a device for the filtered supply or removal of liquid into or from a container, in particular a bottle, in which separate chambers for the liquid channel and the air channel are arranged in a carrier plate, each containing filter elements. The device has the disadvantage of complicated manufacture and handling. In addition, there is a higher flow resistance, which requires a long period of time for removing the media. This device is therefore only suitable as a removal and not as a transfer spike.
DE 4122221 A1 describes a transfer and removal spike in which a carrier plate is provided with piercing mandrels arranged diametrically to one another, through which two flow channels are guided, with which a shut-off element cooperates, which in an open position releases the flow through the flow channel and blocks the flow through the flow channel in a blocking position, wherein in the blocking position a liquid removal channel comes into flow connection with a section of the flow channel open to an injection syringe and the liquid removal channel opens into a connecting piece.
This device is not only complicated to manufacture, but also in terms of operation and functional reliability. Furthermore, massive tightness problems between the carrier plate and the shut-off element are to be expected during manufacture and handling. Here too, the bottle can only be sealed with the residual liquid at great expense.

DE 4010202 A1 describes a removal spike which consists of a carrier plate and there is a spike that forms a structural unit with a connecting piece and a filter element is welded to the carrier plate in the area of the inlet opening. With this device can only be removed, but not transferred.

DE 41 22 476 A1 describes a device for transferring two or two several sterile liquids in a closed system. This will be two Double cannulas inserted into each other and connected with a guide collar. This The disadvantage of the device is that it is only suitable for transferring and on the Guide collar sealing problems occur regardless of which direction the liquid exchange takes place.

Finally, EP 0 426 403 A1 describes a device for transferring and Extract liquids known in the two spikes one straight Have flow channel during gas exchange through two separate air filters should be done. The main disadvantage of this device is that it Air filters, if they are to serve their purpose, such a high flow resistance have that the transfer either does not start at all or only very slowly and is therefore time consuming.

The object of the present invention is to avoid the disadvantages of the prior art the technology, a device for transferring and removing liquids To create bottles, bags or similar containers that are not just quick Mixing two media, but also the storage of residual quantities and the targeted removal of partial quantities. It is intended with a view to environmentally friendly production and disposal from as few and small components as possible exist with light weight.

The object is achieved in that the device for transferring and Removing liquids from bottles, bags or similar containers for medical purposes with practically on one axis, diametrically opposite spikes, each with two flow channels are, the two plungers in a rotationally symmetrical body pass, which can be plugged into each other centrally, such that the one flow channel practically ensures a straight flow in the axial direction and after the principle of the modular system for removing the solution to be used, after the rotationally symmetrical body with the larger diameter from rotationally symmetrical body with the smaller diameter is separated via lower end of the rotationally symmetrical body with the smaller diameter provided threaded cams a housing consisting of an upper part and a Lower part arranged and the housing compared to the smaller one rotationally symmetrical body is sealed by means of a sealing surface, the other flow channel, which is in the area of the tip of the Spike has a capillary-like constriction between the two Spikes in the form of annular recesses within the rotationally symmetrical body is formed, the rotationally symmetrical Body seen in axial section are U-shaped and each have a larger and have a smaller diameter, such that the larger diameter a cylindrical guide and seal is arranged and in the larger area Diameter of the smaller rotationally symmetrical body in the radial direction known, circular or other suitable shape air filter is arranged, which has a recess and a means of a cam and of a cover with a flanged plug closable flow channel in Connected to the other flow channel and the housing Filter housing with transverse to the flow direction between the switched filter is and to protect the now exposed thread cam or the thread cam of the smaller rotationally symmetrical body or the lower part of the housing Protective cap on a connecting element flexibly connected to the device is provided, which after the piercing and removal as a closure of the Container in which there is still part of the solution is suitable.

Seen in axial section, the rotationally symmetrical bodies are U-shaped. The U-shaped design is designed such that a larger diameter cylindrical guide and seal is arranged while in the area of the smaller Diameter inside a conical guide and seal is arranged. Furthermore, it is advantageous to separate the two rotationally symmetrical bodies in the area of the smaller diameter cams in connection with radial ones inclined planes segments with a rotation range of preferably 90 ° arranged are.

To additionally secure the connection of the two rotationally symmetrical bodies, two or more snap hooks distributed symmetrically on the circumference are arranged in the region of the larger diameter of the rotationally symmetrical body.
In order to avoid twisting in the case of pierced piercing pins in a container, it is advantageous to arrange ribs or lamellae distributed over the circumference in the axial direction on the surface of the piercing pins or to give the piercing pins a cross-section other than circular.

The solution according to the invention has a number of decisive advantages.
It is thus possible to dissolve a mostly toxic dry substance with a liquid in a closed system without aerosols escaping into the environment and thus without any risk for the user or the patient.
Aeration of the containers during the liquid transfer is possible in a simple manner. After mixing, the solution can be drawn off by means of a syringe or an infusion line, optionally with an integrated drip chamber, after the smaller body has been separated from the larger, rotationally symmetrical body.

A particular advantage is that the two containers can be separated with a single movement and the container with the usable solution is thus available separately.
The device according to the invention is simple and inexpensive to manufacture. It has a small volume and thus generates little waste. It is also easy to handle, which is a great advantage in clinical operations. Due to the modular construction, the invention also provides a transfer set and a simple spike for pulling off a solution from a container at the same time
secure closure of the container and thus possible for safe storage of unnecessary amounts of solution possible.
By rotating one of the two rotationally symmetrical bodies, the two containers can be separated quickly and easily.
This simple and safe handling is made possible by the anti-twist protection of the spikes in the rubber-elastic plugs of the containers.
The invention will be explained in more detail using an exemplary embodiment and the drawing.

Fig. 1 :

eine Gesamtansicht der erfindungsgemäßen Vorrichtung,

Fig. 2 :

einen Axialschnitt durch die erfindungsgemäße Vorrichtung,

Fig. 2a :

eine Draufsicht entsprechend Fig. 2,

Fig. 2b :

eine Schnittdarstellung des Trennmechanismus,

Fig. 2c :

eine Ansicht der Rippen auf den Einstechdornen zur Verdrehungssicherung,

Fig. 2d :

eine Verengung des Strömungskanals im Einstechdorn,

Fig. 2e :

eine Variante zur Beschleunigung des Flüssigkeitsaustausches beim Transferieren,

Fig. 3 :

eine Schnittdarstellung der Schnapphaken,

Fig. 4 :

den Sitz der Schutzkappe in zwei Stellungen,

Fig. 5 :

einen Axialschnitt einer Variante mit eingebautem zweiteiligen Filtergehäuse und Schutzkappe,

Fig. 5a :

eine Variante der Anbringung des Filtergehäuseunterteils an dem kleineren rotationssymmetrischen Körper,

Fig. 6a :

eine Gesamtansicht mit den beiden Behältern, die die Ausgangsstoffe enthalten,

Fig. 6b :

eine Ansicht mit angesetzter Spritze zum Abziehen der Lösung, ohne Filtration,

Fig. 6c :

eine verschlossene und für die Aufbewahrung vorgesehene Flasche,

The drawing shows:

Fig. 1:

an overall view of the device according to the invention,

Fig. 2:

an axial section through the device according to the invention,

Fig. 2a:

2 shows a top view corresponding to FIG. 2,

Fig. 2b:

2 shows a sectional illustration of the separating mechanism,

Fig. 2c:

a view of the ribs on the spikes to prevent rotation,

Fig. 2d:

a narrowing of the flow channel in the spike,

Fig. 2e:

a variant for accelerating the liquid exchange during transfer,

Fig. 3:

a sectional view of the snap hook,

Fig. 4:

the seat of the protective cap in two positions,

Fig. 5:

an axial section of a variant with a built-in two-part filter housing and protective cap,

5a:

a variant of the attachment of the filter housing lower part to the smaller rotationally symmetrical body,

Fig. 6a:

an overall view with the two containers containing the starting materials,

Fig. 6b:

a view with attached syringe for withdrawing the solution, without filtration,

Fig. 6c:

a sealed bottle intended for storage,

The essence of the present invention consists in the modular principle, which was used or sought for all parts. In addition, there is the rotationally symmetrical design of all individual parts, so that simple manufacture, assembly and disassembly is possible with little effort and expense. In Fig. 1 the overall view of the device according to the invention is shown. The essential features of the invention become clear from the sectional illustration according to FIGS. 2 to 5a. The two rotationally symmetrical bodies 3 and 4, which form a physical unit with the piercing mandrels 1 and 2, each adjoin two diametrically opposite piercing mandrels 1 and 2, which are generally rotationally symmetrical. Both rotationally symmetrical bodies 3 and 4 can be plugged into one another centrally. The rotationally symmetrical body 4 engages over the rotationally symmetrical body 3. Both are U-shaped and are provided with an annular guide and seal 5 on the largest diameter. A conical guide and seal 6 are also provided at the opposite end of the two rotationally symmetrical bodies 3 and 4.
With this construction, the two rotationally symmetrical bodies 3 and 4 are centered and sealed from one another. In order to be able to loosen the two rotationally symmetrical bodies 3 and 4 again, two to three threaded cams 7 are advantageously arranged on the circumference at the lower end of the smaller rotationally symmetrical body 3, which preferably rotate by 90 ° when the two rotationally symmetrical bodies 3 and 4 are rotated sloping planes 8 slide and thus generate a rotary stroke movement to separate the connection. The rotatability is indicated by the arrow 9 in FIG. 2b. Two flow channels 12a and 13a or 12b and 13b are respectively arranged in the piercing mandrels 1 and 2. The arrangement of the flow channels 12a and 12b is such that they practically form an axial passage in the device according to the invention, so that, for. B. can get a liquid medium without additional flow resistance from the bottle 10 into the bottle 11. Instead of the bottles 10; 11, other containers or syringes or infusion lines known for medical purposes can also be used. The flow channels 13a and 13b are connected via an annular gap-shaped recess 14 formed between the rotationally symmetrical bodies 3 and 4
In order to provide the possibility of air or gas filtering when the media in the bottles 10 and 11 are exchanged, a cutout 15, for example a bore, is arranged at the end of the flow channel 13a perpendicular to the longitudinal axis, with the interposition of an air filter 16 known per se the recess 14 is connected.
An additional or alternative non-positive connection of the rotationally symmetrical bodies 3 and 4 is possible by means of snap hooks 17, which are arranged on the circumference of the larger rotationally symmetrical body 4 and overlap the circular surface of the rotationally symmetrical body 3 (cf. FIG. 3). To protect the spikes before using the device according to the invention, they are provided with protective caps 18 and 19. While the protective cap 18 is discarded, the protective cap 19 is connected to the device according to the invention via a flexible connecting element 20. After separating the device according to the invention, the remaining solution can be stored in the bottle 11 with the protective cap 19 which is pushed over the threaded cams 7. Part of the solution can thus be removed at any time via a syringe 21. To secure the piercing mandrels 1 and 2 against twisting in the rubber-like closures of the bottles 10 and 11, these can expediently be oval or in another non-rotationally symmetrical shape or be provided with ribs 22 which are distributed along the circumference and extend in the longitudinal direction.
Another advantageous embodiment of the device according to the invention which corresponds to the modular principle consists in the following. If after transferring the solvent from the bottle 10 into the bottle 11, the bottle 10 together with the larger rotationally symmetrical body 4 of
is separated from the smaller rotationally symmetrical body 3, a filter housing is attached to the smaller rotationally symmetrical body 3 via the threaded cams 7 and a thread 26 located at the base. The filter housing consists of an upper part 24 and a lower part 25 as well as a filter 23, which is known per se and arranged transversely to the flow direction. The sealing surface 28 is produced by means of a conical extension which engages in the end of the smaller rotationally symmetrical body 3. A syringe 21 can be attached via a threaded cam 27, which corresponds to the cam 7, and the content of the bottle 11 can be filtered out (see FIG. 5).
Furthermore, the modular principle, which the invention follows in the design of its individual parts, enables a pure removal spike for the filtered removal of liquids from the smaller, rotationally symmetrical body 3 by direct attachment of the filter 23 in connection with the lower part 25 of the filter housing, for example by welding or to produce solutions for medical purposes (see FIG. 5a).
It has been shown that the liquid transport from bottle 10 to bottle 11 is generally too slow when used as a transfer spike (see FIGS. 2 and 6a). The reason for this is that the air exchange from the bottle 11 to the bottle 10 via the air filter 16 has too high a resistance at the relatively small pressure difference.
Since the rotationally symmetrical bodies 3 and 4, due to the areal seals 5 and 6, do not allow any air exchange of the interior with the surroundings, the air exchange can expediently also take place in a different way than via the air filter 16 (see FIG. 2e). The air from the bottle 11 not only enters the bottle 10 via the cutout 14, the air filter 16, the cutout 15 and the flow channel 13a, but can also travel directly from the cutout 14 via the cutout 29, the flow channel 30 to the cutout 15 and continue via flow channel 13a to bottle 10.
After the liquid transfer has ended, the rotationally symmetrical bodies 3 and 4 are separated from one another by a rotating movement over the inclined planes 8. The cam 31 presses the cover 32 shut and the plug 33 closes the flow channel 30 in an airtight manner. The rotary movement should cover an angle of preferably 30 ° to 45 °.
After the rotationally symmetrical bodies 3 and 4 have been separated from one another (see FIG. 6c), gas exchange can then only take place via the air filter 16.
Instead of the cover 32 with a plug 33, another pluggable closure of the flow channel 30 is also possible, which can also be located at another location on the rotationally symmetrical body 3. Likewise, the flow channel 30 can be closed via a check valve or another suitable measure.
Furthermore, it has proven to be expedient to narrow the flow channel 13a at the tip of the piercing mandrel 1 in a capillary-like manner. This ensures a directional flow and prevents the ingress of liquid. A constriction 13a1 of one to ten millimeters in length and a diameter of preferably 0.2 to 0.6 millimeters has proven to be particularly advantageous.

List of the reference symbols used

1

Spike

2nd

Spike

3rd

rotaion-symmetrical body

4th

rotationally symmetrical body

5

poetry

6

poetry

7

Thread cams

8th

Inclined plane

9

arrow

10th

bottle

11

bottle

12a; 12b

Flow channel

13a; 13b

Flow channel

13a1

Narrowing

14

Recess

15

Recess

16

Air filter

17th

Snap hook

18th

protective cap

19th

protective cap

20th

Fastener

21

syringe

22

rib

23

filter

24th

Top

25th

Lower part

26

thread

27

Thread cams

28

Sealing surface

29

Recess

30th

Flow channel

31

cam

32

cover

33

plug

Claims (5)

1. Device for transferring and removing liquids from bottles (10; 11), bags or similar containers for medicinal purposes, having diametrically opposed piercing mandrels (1; 2), which lie virtually on one axis and in which there are two flow passages (12a; 12b; 13a; 13b) in each case, the two piercing mandrels (1; 2) merging into a respectively rotationally symmetrical body (3; 4), which bodies can be fitted into each other concentrically in such a way that one flow passage (12a; 12b) ensures virtually a rectilinear throughflow in axial direction, and, according to the principle of the modular system, in order to remove the solution to be used, a housing, which consists of a top part (24) and a bottom part (25), being arranged over thread lugs (7) after the rotationally symmetrical body (4) having the larger diameter is separated from the rotationally symmetrical body (3) having the smaller diameter, which thread lugs (7) are provided on the bottom end of the rotationally symmetrical body (3) having the smaller diameter, and the housing being sealed off from the smaller rotationally symmetrical body (3) by means of a sealing surface (28), the other flow passage (13a; 13b), which has a capillary-like constriction (13a1) in the region of the tip of a piercing mandrel (1), being designed in the form of annular-gap-shaped recesses (14) between the two piercing mandrels (1; 2) inside the rotationally symmetrical bodies (3; 4), the rotationally symmetrical bodies (3; 4), as viewed in axial section, being of bulky design and having in each case a larger and a smaller diameter such that a cylindrical guide and seal (5) is arranged at the larger diameter, and a circular air filter (16) or an air filter (16) designed in another suitable form is arranged in radial direction in the region of the larger diameter of the smaller rotationally symmetrical body (3), which air filter (16) is known per se and is connected to the other flow passage (13a) via a recess (15) and a flow passage (30), which can be closed by means of a lug (31) and a lid (32) having a flanged-on stopper (33), and the housing being a filter housing having a filter (23) connected transversely to the direction of flow, and a protective cap (19) being provided on a connecting element (20) flexibly connected to the device, which protective cap (19) is intended for the protection of the thread lug (7) or the thread lug (27), said thread lugs now being exposed, of the rotationally symmetrical body (3) having the smaller diameter or respectively the bottom part (25) of the housing and, after the piercing and removal, is suitable as a closure of the container in which some of the solution is still located.
2. Device according to Claim 1, characterized in that a conical guide and seal (6) is arranged in the interior in the region of the smaller diameter of the rotationally symmetrical bodies (3; 4).
3. Device according to Claims 1 to 2, characterized in that, to separate the two rotationally symmetrical bodies (3; 4), thread lugs (7) are arranged with a rotary range of preferably 90° in the region of the smaller diameter in combination with radially running inclined planes (8).
4. Device according to Claims 1 to 3, characterized in that, for the non-positive connection of the two rotationally symmetrical bodies (3; 4), two or more snap hooks (17), which are distributed symmetrically over the periphery, are arranged in the region of the rotationally symmetrical body (4) having the largest diameter.
5. Device according to Claims 1 to 4, characterized in that ribs (22) or lamellae, which are distributed over the periphery in axial direction, are arranged on the surface of the piercing mandrels (1; 2), or the piercing mandrels (1; 2) have a cross-section different from a circular cross-section.

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