DE2208704A1 - Safe and reusable sterile locking device against adulteration or contamination - Google Patents

Description

dr. W. Schalk dipl.-ing. P. Wirth dipl.-ing. G. Dannenberg DR. V. SCHMIED-KOWARZIK · DR.P. WEI NHOLD DR. D. GUDEL

6 FRANKFURTAM MAIN

CR. ESCHENHEIMER STRASSE 39

February 22, 1972 S.N. 120

Baxter laboratories, Inc. Morton Grove, 111.60053,

UNITED STATES.

Safe and reusable sterile locking device against adulteration or contamination

On many occasions it is desirable to be on different ones Times to dispense predetermined amounts of a sterilized solution from a container. For example, sterilized Water can be stored in a flexible bag-like container and for any general use in various serve medical procedures. Since it is uneconomical to pack small amounts of sterile solutions, it is im It is generally desirable to use flexible containers with a capacity of a few liters or more.

The sterile conditions required in medical procedures require, when using solution containers, which contain the sterile solution to be used at intervals, a sterile closure device that is safe against falsification of the container contents (tamperproof) and is reusable.

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Before medical or clinical personnel use the solution container, it must be ensured that the container was not opened. It is also necessary that the sterilized solution in the container even during at intervals the following use of predetermined amounts of solution remains sterile or is still sterile.

Safe or inviolable against falsification of the contents of the container and / or reusable closure devices are already known, but not one that is safe in this way and reusable closure device that remains sterile when reused. There are different known and inviolable closure devices for containers in the form of bags for receiving parenteral solutions, in which, after the breakable closure part has been separated from the rest of the closure device, a separate plug-shaped connection piece is inserted into an opening of the closure device is used to remove the contents of the solution container. These known closures, for example according to the US patents 3 368 560 and 3 509 879 are not reusable. Even if the locking devices are both secure against tampering as well as being reusable, such as in US Pat. No. 3,083,858, are the sealing surfaces in the closure device either before or after separating the breakable closure part from the rest of the closure device external influences exposed, so that the sterility is no longer guaranteed when the closure device is subsequently reused.

The invention is therefore based on the object secure a novel _r against adulteration or contamination of the container contents and to create reusable sterile closure device which ensures that the sterility is maintained for the BehäTterinhalts and during subsequent re-use.

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When carrying out the invention, a hygienic gripping device for a locking device is also to be created, which enables an operator to grasp the closure device with one hand and remove it from the container to remove, with which it is connected, and then to hold the locking device so that a contact with the hands of the user is avoided. The locking device according to the invention should have a simple design, easy to use, economical, mechanically safe and suitable for mass production.

The invention is illustrated below with reference to the drawings, for example explained in more detail, namely show:

Fig. 1 diagrammatically, a solution container with

one that is safe and reusable against adulteration or contamination of the container contents Locking device according to the invention;

Fig. 2 in a larger hatchet a partial side view of the locking device according to FIG. 1 to illustrate their attachment to the solution container;

Fig. 3 is a perspective exploded view of the parts of the locking device before assembling the illustrated parts, but after attaching them to the solution container;

4 shows, on a larger scale, a section through the closure device according to the invention before separating the frangible closure part from the rest of the device;

Fig. 5 also on a larger scale a section through the locking device

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according to the invention, after loosening the breakable closure part and the following therefrom telescopic assembly of the closure parts relative to one another;

Fig. 6 is a perspective view of a partial view of the preferred embodiment of the breakable effected release of the breakable locking part from the rest of the locking device, and

Fig. 7 is a perspective view, a fragmentary view showing the manner in which the Closure part are held after loosening from the rest of the locking device can that contact of the sealing surfaces of the closure part by the hand of the operator is avoided.

Fig. 1 shows a flexible, bag-like container which preferably is made of plastic and is usually referred to below as a solution container. The solution container 10 is open known type produced and filled with a sterilized solution. At one end of the solution tank 10 is a The pouring spout 12 formed in one piece with this is provided, the side parts 14 which are flattened on opposite sides has, by manually pressing the grommet 12 flat the operator is facilitated to regulate the amount of liquid dispensed or measured from the container will.

To maintain the sterile nature of the solution in the solution container 10 is against adulteration of the Safe and reusable sterile closure device for the contents of the container provided which is adapted to be snugly fit in the flexible pouring spout 12 of the solution container 10 can be attached. The mejiceder from the solution container

10 released liquid is therefore by the against adulteration of the container contents safe and reusable closure device 16 set and regulated.

The structure of the locking device 16 and the manner how it is connected to the flexible pouring spout 12 is best seen in FIGS. According to the expanded 3, the locking device 16 has an upper part 18 and a lower part 20, both of which are preferably molded from suitable plastic or, are molded as an injection molding. The upper part 18 of the closure device 16 has a tubular neck piece 22, which is provided with a smaller tubular extension portion 24 which is adapted to be snugly fitted into the flexible pouring spout 12 fits, and a tubular extension piece 26, the outer dimensions of which are chosen so that when the flexible pouring spout 12 over the tubular Extension piece 24 has been pushed on, the appearance of FIG. 2 results, after which the tubular extension piece 26 and the tubular part 24 together with the pouring spout 12 placed on it have the same outer diameter.

The tubular extension piece 26 is shown in dashed lines above that in FIG. 3 frangible part 28 shown connected to a cylindrical part 30, which is the cap of the closure device forms, as will be explained in more detail below.

The upper part 18 of the closing device 16 also has a connecting band 32 and an annular part 34; these parts and a hygienic gripping device 36 are connected to the cylindrical part 30. The connecting band can be bent so that the annular part 34 passes over the smaller tubular extension piece 24 and that happens, before the tubular extension piece 24 into the pouring spout 12

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is pushed. In this way it will be as further below is explained, the locking device in Richtiger.Lage zu the solution tank 10 held. The hygienic gripping device 36, which is also connected to the cylindrical part 28 is described in connection with a gripping device connected to the lower part 20 of FIG.

The lower part 20 of the closure device for the solution container has its parts according to FIG. 3, with the exception of its cylindrical or cap-shaped part 30 of the closure device, which is breakaway connected to the tubular neck piece 22, as described above. The lower part 20 is in one piece together with a middle washer-shaped Part 38 is formed having an annular collar 40, the radial dimension of which is generally equal to ν Thickness or the radius of the cylindrical cap-shaped part 30 is, so that the cap-shaped part 30 on the annular Collar 40 can be placed and firmly connected to the disk-shaped part 38. For the fixed connection shown in FIG These parts 38 and 40 together, a solvent-containing adhesive can be used. In this condition As can be seen, the cap-shaped cylindrical part 30 forms an integral part of the closure part 20.

The lower closure part 20 shown in FIG. 3 also has a stopper 42, on which a plurality of sealing rings 44 are integrally formed, and a hygienic gripping device 46. From Fig. 3 it can be seen that the plug 42 and the gripping device 46 are fixedly mounted on opposite sides of the disc-shaped ring 38 · The plug 42 is designed such that it can be mounted in to be described manner in the tubular neck piece 22.

After the upper portion 18 and lower portion 20 are brought from a suitable plastic material in the form shown in Figure 3, it is desirable, first the top 18

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to be connected to the lower part 20, so that the closure device 16 is formed and then to insert the closure device thus formed into the flexible pouring spout 12. The upper part 18 and the lower part 20 are fastened by applying a releasing adhesive, for example on the annular collar 40 of the disk-shaped part 38, ¹ WOdUrCh the lower end of the cap-shaped or cylindrical part 30 of the upper part 18 is attached. The parts then assume the position best shown in FIGS. After the annular part 34 has been attached to the tubular extension piece of smaller diameter 24, the latter is inserted into the flexible pouring spout 12 of the filled solution container 10. When the closure device 16 is connected to the flexible pouring spout 12, the closure device 16 can be used to pour predetermined amounts of the solution from a container and then to re-seal the solution container in a sterile manner, as will be explained in detail in the following description.

The closure device 16 according to the invention is secure against corruption of the container contents and can be reused, since it maintains the sterility of the solution in the solution container 10, it can best be seen from FIG. 4 that security against falsification or contamination is achieved by clearly indicating to the user, that the locking device has not been opened. It can be seen that the frangible connection 28 between the tubular neck piece 22 and the cap-like part 30 of the lower part 20 of the closure device the desired security gives. At the same time it is easy to see that the frangible connection 28 can be easily broken, so that the Closure part 20 is removed from the tubular neck piece 22 and the container contents can flow out.

In the undamaged state of the closure device, i.e. before the breakable connection 28 is broken, the plug 42

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of the closure part 20 within the cap-shaped part 30 and / or the tubular extension piece 26 of the tubular neck piece 22 is kept sterile, in the preferred embodiment the invention, the plug 42 is constructed and designed so that one of the sealing rings (44) on the inner wall 48 of the tubular neck piece 22 engages. With this preferred Embodiment of the invention, the plug 42 is not only used to center the closure part 20 with respect to FIG the tubular neck piece 22, but at the same time makes tight contact with the inner wall 28. Because the plug 42 is in front the breaking off of the cap-shaped part 30 from the tubular extension piece 24 is completely enclosed by the part 30, it remains in a sealed and sterile environment.

If a certain amount of liquid is to be removed from the solution container 10, the breakable part 28 can be broken and the closure device can be pivoted out of the opening path through the inner wall 48 of the tubular Neck piece 22 is formed. When the desired amount of liquid has been removed, the closure device can on the tubular neck piece 22 can be reattached and brought into a sterile sealing position. In particular, Fig. 5 shows that the sterile stopper 42, which in turn is inserted during the separation of the closure part 20 from the tubular extension piece 24 is protected by the cap-shaped member 30, so formed and with respect to the inner wall 48 of the tubular neck piece is arranged to be more sealing during reassembly or reattachment of the closure member 20 Slidable contact is made with this neck piece. The cap-shaped part 30 is also preferably designed and arranged that with the outer wall 50 of the tubular extension piece 24 sealing sliding contact is made. this is achieved in that the free end of the cap-shaped part 30 is integral with a radially inwardly directed

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Extension 52 is provided which remains integrally connected to the cap-shaped part 30 when the closure part 20 is released by breaking the connection with the tubular extension piece. It will be readily understood that it does not matter whether or not the outer wall 50 of the tubular extension 26 has been exposed to a non-sterile environment, since the cap-shaped member 30 and outer wall 50 are not used to seal the solution container 10. As mentioned above, the solution container 10 is always re-sealed by tight contact of the rings 44 or other suitable means formed on the plug 42 in contact with the inner wall 48 of the tubular neck piece 22.

It may also be desirable to form a sealing member 54 in one piece on the end wall of the tubular neck piece 22, which provides sealing contact with an inner face 56 which is between the cap-shaped part 30 and the Plug 42 of the closure part 20 is formed. This is best seen in Figure 4 where the sealing member 54 is in contact is shown with the inner end face 56 of the closure part.

It is important that when removing and reattaching the closure member 20 to the tubular neck piece 22, the Hand of the operator with the sterile sealing surfaces of the closure part 30 does not come into contact. Although serves the cap-shaped part 30 of the closure part 20 to protect the plug 42 from inadvertent contact by the hand of an operator To protect, but of course an operator can touch the stopper 42 and thereby the sterile Destroy properties of the locking device.

In order to facilitate removal and reattachment of the closure member 20 and to more easily hold the closure member 20 in the hand of an operator without destroying the sterile properties of this device, it is preferred

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- ίο -

Finger gripping strips 36 and 46 are used. Figures 6 and 7 show that the finger grip strips 36 and 46 are integral with the Outside 58 or the end face 60 of the closure part 20 are formed. Each of the finger gripping strips 36 and 46 has generally rectangular in shape, with the finger gripping strips 36, 46 arranged at a distance from one another on opposite sides Segments 62 are attached to facilitate gripping. The finger gripping strips 36 and 46 are generally arranged offset at right angles to one another, and the strip 36 is connected to the outer end face of the closure part 20 one of the frangible connection 28 adjacent point connected.

From Fig. 2 it can best be seen that the finger grip strip 36 runs essentially perpendicular to the axis of the closure device 16. With this construction, the strip ensures 36 for good leverage when removing the closure part 20 from the rest of the closure device 16 by breaking or tearing open the frangible connection 28. Figure 6 best illustrates the manner in which the closure member 20 is removed will.

The invention thus relates to the removal of the closure part 20 by using the finger grip strip 36 and the retention of the latch member 20 by the finger gripping tab 46. As best seen in Figures 6 and 7, that the finger gripping strip 36 is intended to be gripped by the operator with his thumb and forefinger in order to close the closure part 20 break up. The finger gripping strips 36 and 46 are arranged relative to one another so that the on the gripping of the finger gripping strip following slight pivoting movement of the closure part 20 the index and middle fingers of the user in gripping contact with the finger grip strip 46, as best shown in Fig. 7 can be seen.

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Removal, reattachment and holding of the closure member 20 is therefore by using the finger gripping strips 36 and relieved. The finger gripping strips 36 and illustrated here 46 are the preferred embodiment, but it should be understood that other puller and retainer members can be used For example, it is conceivable that the finger gripping strips 36 and 46 can be connected to one another by a connecting strip can be connected, which can be used both to break open and to hold the closure member ". Instead of the finger gripping tab 46 may further include, for example Button may be provided on the closure part 20, while the finger grip strip 36 is formed by in the closure part 20 recessed finger pegs can be replaced. There can also be similar examples in one piece or separately as implemented in the preferred embodiment,

From the above description it is clear that with the invention a new and unique, safe and reusable against falsification or contamination of the container contents sterile closure device is created, which maintains the sterility of the contents of a container with which the closure device connected, guaranteed.

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Claims (10)

2/22/72 Baxter Laboratories, Inc. PW / ks Morton Grove, 111. Patent or protection claims Against adulteration or contamination of the container contents Safe, sterile container closure device, with a tubular neck piece, which is used to remove the contents of the container serves and thereby connects the container with a closure part which keeps the container contents sterile and before the first opening and removal from the neck piece with this by means of an intermediate piece that breaks when opening is connected in one piece and liquid-tight and telescopically after each removal of a part of the container contents can be placed on the open end of the neck piece, characterized in that the closure part (20) has a plug (42) which can be inserted telescopically into the interior of the half-piece (22), and a cap portion (30) encompassing the stopper at a distance over the entire circumference, which cap portion (30) prior to being broken open of the intermediate piece (28) is connected via this to the neck piece and, after being broken open, this in the closed position overlaps telescopically, the plug (42) being designed and attachable in such a way that it engages sealingly and slidingly on the inner wall of the neck piece, while the cap part (30) extends over the outside Neck piece engages. 2. Closure device according to claim 1, characterized in that at least one actuating member (36) for breaking open the between the neck piece (22) and the intermediate piece (28) provided for the closure part (20) and for telescoping the closure part is provided on the neck piece (22). 209838/0727 220870A 3 · Closure device according to claim 1, characterized in that the cap part (20) so is designed and arranged to be in sliding and sealing contact with the outer wall of the neck piece (22) overlaps. 4. Closure device according to claim 1 or 3, characterized in that the breakable connection (28) of the cap part (3o) with the neck piece (22) is provided in the vicinity of the free ends of both parts. 5. Closure device according to claim 4, characterized in that g e k e η η shows that the breakable connection between the neck piece (22) and the cap part (30) producing Intermediate piece extends from the inner surface of the cap portion to the outer wall of the neck piece. 6. Closure device according to claim 1 to 5, characterized characterized in that the plug (42) also engages the inner wall of the neck piece (22) .if the break-off intermediate piece has not yet been broken off. 7. Closure device according to one of claims 2 to 6, characterized in that actuators (36 and 46) for breaking the between the Neck piece (22) and the closure part (20) provided intermediate piece (28) and for telescopic attachment of the closure part on the neck piece of at least two separate preferably provided with finger catches (62) Finger grip standing, one of which is on the side Wall of the closure part (20) and the other is connected to the front end of the closure part. 209838/0727 8. Closure device according to one of claims 1 to 7, characterized in that between the Neck piece (22) and the closure part (20) a connecting band (18) is attached in such a way that it is a complete Prevents the parts from separating from one another after the closure part has been broken off from the neck piece, 9. Closure device according to one of claims 1 to 8, characterized in that the neck piece (22) has sealing members (54) on its end face, which act on an inner end face (56) of the closure part (20), which is located between the cap part (30) and the plug (42) of the closure part is located. 10. Actuators for hygienic handling of the closure part of a container in order to remove this closure part from the container opening by means of finger grips when only one hand is used, to hold it firmly and to insert it into the container opening again, in particular also for the closure part of a closure device according to one of claims 1 to 9 , characterized in that at least one finger grip (36) is connected to the outer wall surface of the closure part (30) and is adapted to remove the closure part from the container, and that at least one second finger grip (46) is connected to the outer end wall of the closure part ( 30) is connected and arranged to facilitate the reapplication of the closure member on the container, and that the first finger grip (36) is designed so that it can be grasped by the operator of the closure member between the thumb and forefinger ¹ ? the second finger grip (46) is designed so that it can then be gripped between the forefinger and middle finger of the operator, 209838/0727 after the closure part has performed a short pivoting movement relative to the operator's hand, wherein the finger grips (36, 46) are preferably provided with finger catches (62). The patent attorney 209838/0727