EP0094101B1 - Sterile container for medical use - Google Patents

Description

The invention relates to a sterile container for medical purposes according to the first part of claim 1.

Such a sterile container for medical purposes made of plastic material is known from US-A-4 213 933, with which liquids can be administered in doses. This container has a bellows-like compressible container body, to which an output tube connects, with which a gag-like closure is removably connected in one piece.

Both the opening of the dispensing tube and the base of the dispensing tube are connected to the toggle-shaped closure in one piece, which has the disadvantage that the container can only be used once and can no longer be re-sterilized because the cap is not placed on the dispensing tube in a sterile manner can be.

FR-A-1 241 250 describes a container which in one piece has a toggle closure provided therewith, which can also be unscrewed.

CH-A-591 855 describes a container for holding clinical solutions, which has a detachable stopper.

Furthermore, US-A 2 317 420 describes a metallic container, the neck of which is provided with a detachable closure. This closure is flange-shaped and received in a screwed cap on the bottle neck, which has an annular constriction on the inner surface. By unscrewing the cap from the thread of the container neck, the closure is broken off the neck in the axial direction. So this device must be equipped with a thread in the cap and on the neck. Furthermore, the inside of the cap must be undercut and the inside dimensions of the cap must be precisely adapted to the flange-shaped closure, which is particularly difficult in the manufacture of cheap containers.

Finally, US-A-4 258 867 describes a hermetically sealed container with an attached rotatable cap which has a pouring spout. The bottle neck is closed with a cap, on which there is a toggle-shaped closure that can be unscrewed with the aid of the attached cap.

This container is not suitable for the storage and administration of medical liquids to be kept sterile, since the pouring spout of the attached cap is already non-sterile. Furthermore, through the opening of the pouring spout, germs can penetrate into the interior of the cap up to the closure, so that when the closure is broken there is already a risk of the escaping liquid becoming contaminated. This container is therefore not suitable for single or repeated use of sterile medical fluids.

The invention is therefore based on the object of developing the container according to the non-characterizing part of claim 1 such that it not only remains sterile until use, but can also be used several times while maintaining sterility.

Furthermore, the invention has for its object to develop the container, in particular the BottlePack bottle according to the preamble of claim 1, that the container neck, which is usually non-sterile after bottle-pack production, remains sterile until use and that the toggle-shaped closure has no direct contact can be separated from the container by the operating personnel.

This object is achieved by the characterizing features of claim 1.

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 kept so thin that it serves as a line of weakness that 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 follows after the compressed bellows is released. This aspiration can be supported by the soulful retraction of the bellows, which at the same time blocks the passage of one Can restore bladder catheters.

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.

According to the invention, the bellows bottle is 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 an annular circumferential seal, preferably in the form of an O-ring, which cooperates in a sealing manner with the inner surface of the attached cap. 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 the appropriate pressure. As a result, of course, the entire space located within this cap is sterile, including the outer surface of the outlet pipe, although there is no particular reference to the fact 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 sealing by the O-ring, so that by removing the protective cap after correspondingly turning off the knob, a catheter tube can be plugged onto the outlet tube, which is sterile on its outer surface until it is used. It shows

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 24, 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 at the same time. Thus, on the one hand, the opened container 10 and, on the other hand, the twisted closure 24 are present, 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.

A deformable plastic material, for example polyethylene and the like, is of course used as the material for the container 10. Like. 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.

3 and 4 show further details of a particularly preferred embodiment of the container 10.

This container 10 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 adjacent to 19 adjoins 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.

The embodiment shown in FIG. 3 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. 3, a protective cap 86 is placed on the container 10, which cooperates with the sealing device 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.

4 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, force must be exerted on the sealing device 80 in order for the to overcome elastic force of the sealing device 80.

In order to prevent the protective cap 86 from being unintentionally removed from the container 10, 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.

The inner surface 94 of the main region 88 has at least one radially inward rib. 4 shows three ribs 100, 102 and 104, with another rib being 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. Here, two of the ribs 100, 102, 104 shown in FIG. 4 and the rib complementary to the rib 104 come into engagement with the toggle-shaped closure 24 and take it with the further rotation of the protective cap 86 until it is twisted off and into the Protective cap 86 enclosed space falls. 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 from 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 24 corresponds here , ie the distance from the respective side edges 106, approximately the inside diameter of the cylindrical main region 88.

The latter 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 sterilization of this arrangement obtained in an autoclave Temperatures of about 104 106 ° C, wherein the overpressure occurring is compensated accordingly 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 (4)

1. Sterile container (10) for medical purposes of plastic, in particular bottlepack bottle, for the dosed administration of liquids, with a bellows- 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) by a line of weakness (28), 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).

2. Container according to claim 1, characterized in that the sealing device (80) has a groove (82) running around the bottle neck (18) and an 0-ring (84) placed in this groove (82).

3. Container according to claim 1 or 2, characterized in that the bottle neck (18) has a substantially cylindrical area (18a) and in that the protective cap (86) has a substantially cylindrical main area (88) and an opening area (90), which adjoins the main area (88), interacts with the cylindrical area (18a) of the bottle neck (18) and whose inside diameter is greater than that of the main area (88).

4. Container according to one of claims 1 to 3, characterized in that the protective cap (86) has on its inside surface an annular peripheral bead (96), which is in the direct vicinity of the sealing device (80) between the latter and the bellows- like container body (12, 14) when the protective cap (86) is fitted.

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