EP0094101A2 - Sterile container for medical use - Google Patents

Abstract

1. Sterile container (10) for medical purposes of plastic in particular bottlepack bottle, for the dosed administration of liquids, whith a belows-like collapsible container body (12, 14), a bottle neck (18) and a discharge tube (20), which has a removable closure (24), on which container the container body (12, 14), the closure (24) joined to the discharge tube (20) and the bottle neck (18) are designed in one piece, and also with a protective cap (86) put over the closure (24), the discharge tube (20) and the bottle neck (18), with which protection cap the closure (18) can be opened by turning, characterized in that the bottle neck (18) is provided with an annular peripheral seal device (80), which interacts in a sealing manner with the inside surface of the protective cap (86), in that the closure (24) has a toggle-shaped handle (24), in that the protective cap (86) has on its inside surface at least one rib (100-104) running in the longitudinal axis of the container and in that the diameter of the toggle-shaped handle (24) corresponds approximately to the inside diameter of the protective cap (86), so that, after fitting and turning of the protective cap (86), the closure (24) can be separated from the discharge tube (20).

Description

The invention relates to a sterile container for medical purposes made of a plastic material, in particular a bottle-pack bottle, for the metered administration of liquids with a bellows-like, compressible container body and a dispensing tube which has a removable closure.

Sterile containers are used in the medical field for liquids to be kept sterile, in particular for infusion solutions. They consist regularly of a polymeric material, for example polyethylene, and, if they are used as bottle-pack bottles, are both molded and filled and sealed with the liquid to be used in one operation. In this case, plastic granulate is filled into a corresponding shape and shaped into a bottle according to the usual plastic processing techniques, which is filled with the above-mentioned liquid in a further working step and finally closed with a closure element, for example a cap that is attached.

Such bottle-shaped containers are suitable for single use, whereby after appropriate sterilization they can dispense the desired liquid, but generally cannot be used for manual dispensing of the liquid within a short period of time, since such conventional bottles with a smooth belly on the one hand are too bulky and on the other hand can only be emptied incompletely.

As a result, syringes are regularly used for the metered manual delivery of such liquids, for example in the daily care and cleaning of inserted bladder catheters, which have to be filled regularly with irrigation solutions. For this purpose, previously sterile rinsing liquid is removed from bottles via a catheter with a bladder syringe in order to rinse the bladder catheter on the patient. Such handling naturally represents an essential source of danger when the rinsing liquid is kept sterile for repeating the rinsing, so that the rinsing liquid is often contaminated with bacteria by airborne germs in the patient's room.

Moreover, such syringes must be sterilized after use before they can be used again. Such handling is of course time-consuming and personnel-intensive.

From DD-PS 47 995 a sterile container of the type mentioned is known, which has a bellows-like design of the bottle belly, so that it can be compressed. This bellows bottle is closed with a removable cap that is placed over the end of the outlet pipe.

Although this cap is to be placed on the outlet pipe by a press fit, it can be removed by improper use, so that the sterility of the container is often endangered.

Accordingly, such a container must be accommodated in a further packaging in order to reliably prevent the protective cap from being unintentionally pulled off or from penetrating through the slits between the cap.

Other sterile containers are known from FR-PS 22 59 624 and DE-OS 29 00 827.

The syringe arrangements with containers described in the above publications, however, in turn only have protective caps which are attached to the cannula and which are at most mechanically locked and can, as explained above, be removed by improper use. Furthermore, germs can penetrate through any slits between the protective cap and the cannula, so that the penetration of germs cannot be reliably prevented.

The above-mentioned containers can therefore not be regarded as sterile, since the protective sleeves can be removed without further ado, if necessary after removing a security sleeve. If the last-mentioned securing sleeve is present, improper storage cannot prevent germs whirled up by dust or the like from penetrating through slots to the cannula body and thus endanger sterility.

In this respect, sterile containers of this type must be provided in a second packaging which is hermetically sealed to the outside in order to ensure sterility safely.

The invention is therefore based on the object of providing a container of the type mentioned at the outset which is free from further closed packaging, is certainly sterile and can only be opened with certain hand movements.

This object is achieved in that the closure is integrally connected to the dispensing tube and has a knob-shaped handle.

The container according to the invention initially has the advantage that it can be manufactured in the factory like a conventional container for infusion solutions and filled with the appropriate solutions. Compared to the usual so-called Bottlepack containers only have to be modified in the blow mold for the container body in order to achieve the desired shape of a bellows. The bottle neck adjoins this bellows, the outlet opening of which is closed with a toggle piece by integral welding.

The weld seam between the toggle piece and the connection opening is advantageously kept so thin in terms of material that it serves as a line of weakness which can be severed by turning the toggle piece.

So while the manufacture of the container and its filling with sterile liquids and sterile closures are carried out at the factory, the above container is opened on the bedside similar to a bottle of the prior art and can be connected directly to a catheter tube without further transfer into a large-caliber syringe. As a result of the bellows-like configuration of the container shell, the latter can be pressed together like a syringe, the contents of the bottle being conveyed into the bladder through the bladder catheter sterile connected to the container. Since the folds of the bellows can close together, this bottle is almost completely emptied into the patient's bladder.

Since the bellows has a certain restoring force in the compressed state, an automatic aspiration of the rinsing liquid into the bottle usually takes place after the compressed bellows is released back. This aspiration can be supported by the soulful retraction of the bellows, which at the same time can restore the patency of a blocked bladder catheter.

With the use of the bellows bottle mentioned above, the use of an additional syringe and, in connection therewith, of course, also a filling and filling of this syringe are eliminated, which entailed considerable sterility problems. This eliminates the need for additional syringes, cleaning and re-sterilization. In addition, multi-dose containers are saved because the bellows-like disposable bladder syringe is completely sufficient for one-time use and is discarded after use.

While in the first embodiment the catheter tube is plugged onto the tubular connection of the container, which may be necessary for reasons of contamination. does not appear harmless, so that the connection should be sprayed with a disinfectant before use, according to a second embodiment the inner surface of the connection adjoining the connection opening can be equipped with a female cone into which the male cone of a connector can be inserted in a sealing manner. To ensure this tight fit, a corresponding locking device, for example a thread or the like, is provided on the outer surface of the connection, into which a complementary device of the connector can engage.

According to a further particularly preferred embodiment, the bellows bottle according to the first embodiment can be provided with a tightly fitting cap. This tight fit is achieved in that the cylindrical bottle neck, which is arranged between the bellows area on the one hand and the outlet pipe on the other hand, has a seal in the form of an O-ring which is connected to the Inner surface of the attached cap cooperates sealingly. After the bottlepack bottle has been filled, this arrangement is produced by fitting the cap and then sterilized in the autoclave at the appropriate temperature and pressure. As a result, of course, the entire space located within this cap is sterile, including the outer surface of the outlet pipe, although it should not be particularly pointed out that the toggle-shaped closure itself closes the bottle in a sterile manner.

According to a further advantageous embodiment of this last-mentioned embodiment, the inner surface of the protective cap is provided with at least one radially inwardly directed rib in such a way that it comes into contact with the toggle-like closure during rotation. Advantageously, at least two ribs are provided, each of which cooperate with the opposite gag parts, so that the gag can be twisted off without difficulty when the closure cap is turned. The area inside the protective cap remains sterile as a result of the seal provided by the O-ring, so that by removing the protective cap after the knob has been unscrewed, a catheter tube can be plugged onto the outlet pipe which is sterile on its outer surface until it is used.

• Fig. 1 einen Längsschnitt durch einen sterilen Behälter,
• Fig. 2 einen vergrößerten Längsschnitt durch den Anschluß des Behälters entlang der Linie II - II,
• Fig. 3 den Anschluß gemäß Fig. 2 im geöffneten Zustand mit aufgesetztem Konnektor,
• Fig. 4 einen vergrößerten Längsschnitt durch eine weitere Ausführungsform eines Anschlusses in ähnlicher Darstellung wie in Fig. 3,
• Fig. 5 eine Teilansicht einer weiteren Ausführungsform eines sterilen Behälters, wobei der faltenbalgartige Bauchbereich weggeschnitten wurde und eine Schutzkappe gestrichelt dargestellt ist, und
• Fig. 6 eine Schnittansicht der Schutzkappe.

Show it

• 1 shows a longitudinal section through a sterile container,
• 2 is an enlarged longitudinal section through the connection of the container along the line II - II,
• 3 shows the connection according to FIG. 2 in the open state with the connector attached,
• 4 shows an enlarged longitudinal section through a further embodiment of a connection in a representation similar to that in FIG. 3,
• 5 shows a partial view of a further embodiment of a sterile container, the bellows-like abdominal region having been cut away and a protective cap being shown in broken lines, and
• Fig. 6 is a sectional view of the protective cap.

1 shows a sterile container 10, the container body 12 of which is designed as a bellows 14. This bellows can be compressed in such a way that, for example, an approximately 200 ml container can be practically 100% emptied by compressing the bellows 14 if the container 10 is not completely filled.

This bellows 14 is connected to the base 16 and an essentially cylindrical bottle neck 18, which narrows at 19 and merges into an output tube 20, which can be seen in an enlarged form from FIGS. 2-4.

In the open state, this dispensing tube 20 has an opening 22 at its tip through which the sterile liquid can be transferred into a catheter connected to the container 10.

This opening 22 has been closed at the factory with the aid of a toggle-type closure 22 which has been integrally fused to the peripheral edge 26 of the opening 22. In the area of this peripheral edge 26, an annular circumferential line of weakness 28 is advantageously provided between the closure 24 and the peripheral edge 26. which can be easily cut by rotating the closure 24 while holding the container 10 in place. Thus, on the one hand, there is the opened container 10, on the other hand, the twisted closure 24, so that the container 10 is ready for use and can be connected to a corresponding connecting device, for example a connector, a hose or catheter.

A tube or a catheter is pushed over the tubular: dispensing tube 20 until a force fit is achieved. The dispensing tube 20 has of course been disinfected using a disinfectant solution before the closure 24 is unscrewed. Furthermore, this dispensing tube 20 advantageously has a shape that tapers conically in the direction of the peripheral edge 26, so that the desired frictional connection with the hose can be achieved without difficulty.

In a second embodiment, which is shown in FIGS. 2 and 3, the inner surface of the dispensing tube 20 can taper concentrically inward and thus form a female inner cone 32, which extends from the peripheral edge 26 in the direction of the container body 12. This inner cone preferably has 32 standard dimensions and is in particular a Luer cone.

As shown in FIG. 3, any customary connector 34 can be inserted into this inner cone 32, provided that it has a complementary outer cone 36. Such a cone is described for example in DE-OS 29 07 832, the disclosure of which is expressly incorporated by reference.

Such a connector 34 essentially consists of a tubular part 38 on which a flange-shaped part 40 is placed. The tubular part 38 is on one side of the flange-shaped part as an configured end connector 42, while on the other hand it has the outer cone 36 already mentioned above. This outer cone 36 is concentrically surrounded by the tube part 44, on the inner surface of which a fastening device, preferably a screw thread 46, is arranged.

The inner diameter of the tube part 44 essentially corresponds to the outer diameter of the dispensing tube 20, which according to this embodiment is cylindrical on its outside.

In order to arrange the connector 34 firmly on the dispensing tube 20, a complementary fastening element 48, preferably a screw thread, is provided on its outer surface, into which the screw thread of the connector 34 can engage. The fastening elements 46 and 48 can of course also be designed differently. For example, a suitably designed bayonet lock can also be used. According to this embodiment, at least one pin of a bayonet catch is provided on the outer surface of the dispensing tube 20 and can engage in a complementary bayonet opening in the connector 34.

According to the embodiment shown in FIG. 4, at least the inner surface 50 of the connection 20 is cylindrical. In this connection, a connector 52 can be inserted, which in turn has a central tubular part 54 of a cylindrical structure. This central tube part 54 is followed by a flange-shaped part 56, against which the peripheral edge 26 bears. The central tube part in turn has a connecting piece 58 on one side of the flange 56 and forms a cylindrical connecting tube 60 on the other side, the outer diameter of which corresponds approximately to the inner diameter of the dispensing tube 20.

To produce a liquid-tight connection between the dispensing tube 20 and the tube part 60, an annular groove 62 is advantageously provided on the outer circumference of the tube part 60, in which an O-ring 64 is inserted. This O-ring 64 lies close to the inner surface 50 when the tube part 60 is inserted into the connector 20. To securely hold this connector 52, the outer surface 66 of the connection 20 has an annular circumferential bead 68. This bead 68 can be engaged behind by at least one fastening device 70 of the connector 52, so that a secure fit of the connector 52 can be achieved.

4 is integrally connected to the outer periphery of the flange 50 and is in the form of two radially separable arms 72, one end of which is hook-shaped and the other end serves as a gripping surface for the fingers. Since the connector material is made of plastic, these arms can be moved apart on one side and the other side by compression, so that the connector 52 can be pulled off the dispensing tube 20.

A deformable plastic material, for example polyethylene and the like, is of course used as the material for the container 10. used. This plastic material is inserted in the form of a granulate in a blow molding machine and converted into the desired shape, then filled with the sterile liquid and then welded to the tip of the dispensing tube 20 in such a way that a breakable gag-like closure 24 is formed.

It need not be added that such a connection is not only conceivable for the container 10. Of course, plastic bags with a gag-like closure can also be provided on one or more connections.

Furthermore, the connections of such a bag made of a plastic material, such as polyethylene or PVC, can be provided with the connection devices shown in FIGS. 2-4, for example with the female inner cone shown in FIGS. 2 and 3 or with the one shown in FIG. 4 shown cylindrical shape of the inner surface of the connector.

5 and 6 a further, particularly preferred embodiment of the container 10 is shown.

This container 10 in turn has the bellows 14 in the abdominal region, to which the bottle neck 18 connects. As explained above, this bottle neck 18 has a substantially cylindrical region 18a, which is adjoined at 19 by a region 19a which tapers in the direction of the container opening. This area 19a then merges into the dispensing tube 20, which in turn is closed with the toggle-type closure 24 at its end.

In this respect, this embodiment does not differ from the first embodiment shown in FIGS. 1 and 2, so that reference is made to the description thereof.

The embodiment shown in FIG. 5, however, advantageously has an annular circumferential sealing device 80 with a raised structure in the cylindrical region 18a. This sealing device 80 is advantageously formed by a groove 82 and an O-ring 84 inserted into this groove. The groove 82 is already formed during the manufacture of the bottle and runs essentially annularly through the cylindrical region 18a adjacent to the location 19.

O-ring 84 is not only understood to mean a conventional O-ring made of a plastic material, for example polyethylene, which is inserted into this groove after the container has been removed from the mold, but also a raised elastic sealing arrangement, for example by injection and curing an elastomeric material.

Possibly. The raised, ring-shaped sealing device 80 can also be formed directly from the same container material in the form of a raised ring when the container 10 is blown.

As shown in FIG. 5, a protective cap 86 is placed on the container 10, which cooperates with the sealing device 80 in an elastically sealing manner. The axial length of the protective cap 86 corresponds at least to the distance of the sealing device 80 from the outermost edge of the closure 22, so that a tight fit is ensured.

6 shows a sectional view through the protective cap 86 according to a preferred embodiment.

The protective cap 86 initially has an essentially cylindrical main region 88, to which the cylindrical opening region 90 advantageously adjoins. The inner diameter of this cylindrical region 90 corresponds approximately to the diameter of the sealing device 80, both parts being essentially circular in shape. As a result, this opening area 90 can be pushed over the sealing device 80 substantially without exerting pressure.

In contrast, the inner diameter of the main area 88 is slightly smaller than the diameter of the sealing device 80, so that when the protective cap 86 is pushed on in the area of the step 92, that is to say the transition from the opening area 90 to the Main area 88 to which sealing device 80 force must be applied in order to overcome the elastic force of sealing device 80.

In order to prevent the protective cap 86 from being unintentionally removed from the container 10, that is to say in particular from the sealing device 80, the cylindrical main region adjacent to the step 92 is advantageously equipped on its inner surface 94 with an annular circumferential bead 96, the diameter of which is of course smaller than the inner diameter of the main area 88. The bead 96 is at such a distance from the cap tip 98 that it can just be pushed over the sealing device 80 with considerable effort and thus, when the protective cap 86 is in the attached state, its surface advantageously bears against the sealing device 80 . Thus, not only the inner surface of the main area 88 seals, but also advantageously the circumferential bead 96 with respect to the sealing device 80.

The protective cap 86 can advantageously be rotated relative to the sealing device 80 without the sealing effect and thus the sterility of the space enclosed by the protective cap 86 being canceled.

According to a particularly preferred embodiment, the inner surface 94 of the main region 88 has at least one radially inwardly directed rib. 6 shows three ribs 100, 102 and 104, with another rib having been cut away in this illustration. Usually, however, two ribs are already sufficient to unscrew the toggle-shaped closure 24 by rotating the protective cap 86 from the outlet pipe 20. In this case, two of the ribs 100, 102, 104 shown in FIG. 6 and the rib complementary to the rib 104 come into engagement with the toggle-shaped closure ₂₄ and take this along with the further rotation of the protective cap 86, until it is turned off and falls into the space enclosed by the protective cap 86. The sterility is basically maintained within this room. Accordingly, the distance from the tip edge of a rib 100, 102, 104 to the longitudinal axis of the protective cap 86 is somewhat less than the distance. The side edge 106 of the gag-shaped closure 24 from the central axis of the container 10. Advantageously, the diameter of the gag-shaped closure corresponds 24, that is the distance from the respective side edges 106, approximately the inner diameter of the cylindrical main region 88.

The last-mentioned embodiment is produced by first producing the container 10 in the form of a bottle-pack bottle and then filling it with the corresponding sterile liquid. The O-ring 84 is then inserted into the groove 82 and the protective cap 86, which preferably has the bead 96 and the ribs 100-104, is pushed onto this sealing device 80. It should also be noted that when two or more ribs are arranged, at least two are each in a plane passing through the longitudinal axis of the protective cap 86.

This is followed by the sterilization of the arrangement obtained in an autoclave at temperatures of approximately 104-106 ° C., the excess pressure occurring being compensated accordingly in order to prevent the container 10 from bursting.

The bellows bottle is suitable for internal and external use, such as perfusion of the extracorporeal system during hemodialysis, postoperative bladder irrigation for all urological interventions, irrigation in the gastrointestinal tract and of fistulas and drainage, as well as for wound treatment and for moistening wipes and bandages.

Claims (12)

1. Sterile container for medical purposes made of a plastic material, in particular bottle-pack bottle, for the metered administration of liquids with a bellows-like, compressible container body and a dispensing tube which has a removable closure, characterized in that the closure (24) with the dispensing tube (20) is connected in one piece and has a toggle-shaped handle. 2. Container according to claim 1, characterized gekennzenichnet that the peripheral edge (26) of the dispensing tube (20) via a line of weakness (28) is connected to the closure (24). 3. A container according to claim 1 or 2, characterized in that the outer circumference of the dispensing tube (20) has a cone tapering in the direction of the opening (22). 4. Container according to one of claims 1-3, characterized in that the inner surface (30) of the dispensing tube (20) has a female inner cone (32) which extends from the peripheral edge (26). 5. A container according to claim 4, characterized in that the outer surface of the dispensing tube (20) is provided with fastening elements (48). 6. Container according to claim 5, characterized in that the fastening element (48) is a screw thread. 7. A container according to claim 1 or 2, characterized in that the inner surface (50) of the dispensing tube (20) is cylindrical. 8. A container according to claim 7, characterized in that the outer surface (66) has an annular bead (68) which can be gripped behind by a fastening device of a connector. 9. Container according to one of claims 1-8, characterized in that between the bellows (14) and the discharge pipe (20) is provided a substantially cylindrical region (18 a) with an annular circumferential sealing device (80) with a raised structure can cooperate sealingly with the inner surface of a protective cap (86). 10. A container according to claim 9, characterized in that the sealing device (80) has a groove (82) and in this groove (82) inserted 0-ring (84). 11. A container according to claim 9 or 10, characterized in that the protective cap (86) has on its inner surface an annular circumferential bead (96) which, when the protective cap (86) is attached, is in the immediate vicinity of the sealing device (80) between it and the sealing device Bellows (14) is arranged. 12. Container according to one of claims 9 - 11, characterized in that the protective cap (86) has at least one radially inwardly directed rib (100, 102, 104) with which after the plugging and rotating of the protective cap (86) the gag-like Closure (24) can be unscrewed.

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