System for storing / delivering a medical solution in / from a multi-dose container

Abstract

A system for storing a preferably sterile drug solution in a multi-dose container and for delivering a dose of drug solution at a time to a disposable syringe, characterized in that the multi-dose container is an airless container consisting of a rigid outer container and a shrunk inner container, the outer container and the shrunk inner container being in fluid communication with each other when the drug solution is delivered. The present invention relates to a disposable syringe comprising a multi-dose container having an inner container, no air entering the inner container for pressure equalization, having an adapter fastened to the multi-dose container, the adapter having a one-way valve and a female luer connection, and the disposable syringe being provided with a mating male luer connection, the male luer connection being connected to the one-way valve and the female luer connection. The disposable syringe can be docked with the adapter with the male luer connector to receive a dose of a drug solution by pulling up the disposable syringe.

Description

Technical Field

[0001] The present invention relates to a system for storing preferably sterile pharmaceutical solutions in multi-dose containers and for dispensing the pharmaceutical solutions one dose at a time into disposable syringes. Background Art

[0002] In the past, it was common to store drug solutions in so-called perforated ampoules or vials, which were sealed by a pierceable film or rubber stopper with the smallest thickness at the center. In order to take out a dose of drug solution, the rubber stopper or pierceable film is pierced by the needle of a standard disposable syringe, and then the drug solution is sucked into the syringe by lifting the syringe. There are several steps that are susceptible to the contamination of drug solution and syringe needle and are bound to cause the risk of operating errors. Perforated ampoules can usually accommodate drug solutions up to 200ml, so that multiple doses of drug solution are usually received in disposable syringes, and the stopper is pierced each time, so that pollutants may enter the drug solution. In addition, the surface of the stopper may be contaminated. In addition, due to time and cost reasons, it may occur to remove from the vial using the same needle and apply to the patient. During the removal process, the perforated ampoule will be kept in an inverted position, because air will enter the ampoule for the purpose of pressure balance when each removal. Furthermore, there is a nontrivial risk of needle stick injury at every removal from the pierceable ampoule. Summary of the invention

[0003] The object of the present invention is to provide a system which completely or largely avoids the above-mentioned disadvantages. It is ensured that the drug solution can be stored preferably in a sterile manner in a multidose container and that the individual doses are received in a standard disposable syringe in a few simple steps. Contamination of the drug solution in the container and also during the aspiration into the disposable syringe is to be eliminated as far as possible.

[0004] This object is achieved according to the invention by the features described below.

[0005] Advantageous embodiments of the invention are characterized by the features described below.

[0006] The multi-dose container provided by the present invention is an airless container consisting of a rigid outer container and an inner liner, and when dispensing the drug solution, no air enters the inner liner for pressure balance. Fastened to the multi-dose container is an adapter with a one-way valve and a Luer connector, and the Luer cone on a standard disposable syringe can be docked with the Luer connector for simple, easy and reliable pulling up of the syringe with the drug.

[0007] The structure is designed such that the adapter is provided with a female Luer connection and the disposable syringe has a matching male Luer connection, so that when the syringe is pulled up, there is a sealed connection between the multi-dose container and the disposable syringe.

[0008] The dead volume within the adapter and the one-way valve may additionally be provided with an antimicrobial material such as silver, so as to ensure that microbial contamination cannot enter the drug solution in the multi-dose container.

[0009] The reduced pressure in the multidose container that occurs during dispensing of the drug solution into the disposable syringe is balanced by the air that enters through the opening in the outer container into the gap between the outer container and the contracted inner liner, so that no air enters the interior of the inner liner. Therefore, completely air-free filling is possible.

[0010] The multi-dose container has a container neck, onto which an adapter with a Luer connection and a non-return valve is preferably snap-connected, crimped or screwed. The non-return valve preferably comprises a substantially bell-shaped outer cone, which is preferably made of a thermoplastic elastomer and seals the entire inner opening of the non-return valve except for a hole formed in the middle of the valve membrane, the edge of which, in the relaxed state of the valve membrane, rests on a valve seat pin, which sealingly closes the hole in the relaxed state of the membrane. Thus, air is prevented from entering the interior of the multi-dose container from the outside.

[0011] When a disposable syringe with a Luer connector is inserted into the conically widened outlet channel of the one-way valve and the disposable syringe is pulled up, the elastic outer cone or elastic valve membrane is lifted upward from the valve seat pin by suction, thereby drawing a dose of drug solution through the hole into the syringe. If an antimicrobial substance (such as a silver ring) is advantageously arranged on the inner surface of the female Luer connector, contamination drawn into the drug solution is virtually eliminated.

[0012] As another feature to ensure aseptic filling, it is advantageously suggested that the outlet opening in the Luer adapter can be closed by a cover, which is sealingly engaged on the upper surface of the outlet opening, and the cover is connected to two transverse webs, which are pivotally connected to the outside of the adapter so that the cover can swing sideways. The cover is also connected to one or two flexible spring arms, which are fastened to the outside of the adapter. The cover can be moved laterally on the outlet opening to expose the outlet opening of the Luer connector for the disposable syringe against the force of the flexible spring arms, whereby the flexible spring arms move the cover back to its closed position after the removal process. The cover can have an edge opening, into which the Luer connector on the disposable syringe can be engaged, to move the cover laterally, which has the advantage that the cover does not need to be touched by the user's hand for this purpose. Rotatable or tiltable variants of the cover are also feasible.

[0013] The system according to the invention ensures, on the one hand, that no air enters the multidose container, so that the drug solution can be filled aseptically with reduced or absolutely no preservative content. The one-way valve prevents air from entering the container, so that microbial growth from the outside to the inside is eliminated as much as possible, so that the dead volume in the one-way valve can be kept uncontaminated by silver or other antibacterial materials. Due to the Luer connection, pulling up the syringe is simple, easy and reliable, so that the risk of needle injuries when inhaling the medicament is reliably avoided. In addition, when the disposable syringe is introduced into the Luer adapter on the vial, the upside-down position is not required because there is no air inside the vial. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Further details of the invention will become apparent from the following description of preferred exemplary embodiments with reference to the accompanying drawings, in which:

[0015] Figure 1A One embodiment of a system according to the invention is shown in side view;

[0016] Figure 1B This embodiment is shown in a view rotated 90°;

[0017] Figure 1C is a top view of the embodiment;

[0018] Figure 1D is a vertical cross-sectional view through an upper region of the embodiment;

[0019] Figure 2 Positions 1 to 5 are shown when a dose of drug solution is taken out;

[0020] Figure 3 is a vertical cross-sectional view through the adapter and the non-return valve;

[0021] Figure 4 Shown on an enlarged scale Figure 3 Details of E;

[0022] FIG. 5 shows a further embodiment of an adapter having two spring elements in a side view and a top view. DETAILED DESCRIPTION

[0023] Figure 1A is an exploded view of a multidose container 1 containing a preferably sterile pharmaceutical solution, from which a dose of the pharmaceutical solution is removed one dose at a time by means of a disposable syringe 2. The multidose container is a so-called airless container, consisting of a rigid outer container and an inner liner, which shrinks after the pharmaceutical solution is removed, for which purpose the outer container is provided with at least one hole / opening through which air enters each time for pressure equalization when the pharmaceutical solution is delivered. Therefore, no air enters the inner liner for pressure equalization.

[0024] The multi-dose container may have any suitable shape, for example a cylinder or bulb shape having a container neck.

[0025] Fastened to the container neck of the multidose container 1 is an adapter 4 in which a one-way valve 3 is arranged, which will be described in more detail below. The outlet of the valve is constituted by a female Luer connector 5 on the adapter 4, into which a male Luer connector 6 on the disposable syringe 2 can be sealingly engaged in order to remove a dose of the drug solution from the multidose container 1.

[0026] The disposable syringe is conveniently introduced into the adapter 4 from above, as shown in FIG. Figure 1B As shown, this is possible because only the drug solution is contained in the inner liner.

[0027] In the unactuated state of the system, the Luer connector 5 on the adapter 4 is tightly sealed by a cap-like closure 6a, which is pivotably connected to the outside of the adapter 4 by means of webs 7 on both sides and can be pivoted into an open position against the force of a spring 8 to expose the Luer connector 5 for the disposable syringe 2. The closure 6a is pivotably connected to the adapter 4 at a transverse support pin 9. When the closure 6a is open, the bending spring 8 is deflected 90° on the closure 6a and is fastened to the adapter 4 and tensioned to pivot the closure 6a back to the closed position after the removal process.

[0028] Figure 2 The sequential steps of removing a drug solution from a multidose container 1 are shown. In position 1, the disposable syringe 2 is advanced together with the male Luer connection 6 to the closure 6a, which for this purpose may have an edge recess, which is not shown in the figure.

[0029] In position 2, the closure 6a is pushed to the side by the Luer connector 6 against the force of the spring 8, so that in position 3 the Luer connector 6 can be sealingly introduced into the Luer connector 5 on the adapter 4. Thereafter, the syringe 2 is pulled up in the usual manner, thereby receiving a dose of the drug solution from the liner of the multidose container 1. In position 5, the disposable syringe 2 is removed and the closure 6a is pivoted back to the closed position again by the force of the spring.

[0030] Figure 3 An adapter 4 with a Luer connection 5 is shown on an enlarged scale. The adapter 4 is snap-connected to the neck 10 of the multidose container 1. However, the invention is not limited thereto and, as an alternative, the adapter may also be screwed or crimped onto the container neck.

[0031] The adapter 4 tapers conically towards a female Luer connector 5 which constitutes the outlet opening of the non-return valve 3 housed in the adapter 4. The non-return valve is constituted by an inner cone 11 which is positioned at the upper edge of the bottle neck 10 and comprises an opening 12 for a drug solution located in a multi-dose container. The valve inner cone also comprises a central valve seat pin 13 which extends in the longitudinal direction of the adapter and abuts on its upper side against a valve outer cone 14. The valve outer cone 14 comprises a central hole 15, the edge region of which sealingly engages the upper side of the valve seat pin 13 in the unactuated state of the valve 3.

[0032] The valve outer cone 14 is sealingly fastened to the valve inner cone 11 at its lower edge region and extends upward in a conical or bell-shaped manner to its upper wall having an opening 15. A double row of sealing ribs 17 are arranged on the upper side of the upper wall 16, which engage with the inner wall of the adapter 4.

[0033] In the non-actuated state of the system, i.e. when no drug solution is being withdrawn, the valve outer cone 14 forms a sealed closure of the interior space of the multi-dose container 1, since the upper wall 16 of the valve outer cone 14 sealingly engages the upper side of the valve seat pin 13. However, when the disposable syringe 2 is docked with its male Luer connector 6 onto the adapter 4 and the disposable syringe is pulled up, the upper wall 16 of the valve outer cone 14 is lifted away from the upper side of the valve seat pin 13 by suction, so that the drug solution is sucked into the disposable syringe 2 through the opening 12 in the bottom wall of the valve and the upper hole 15 in the valve outer cone 14.

[0034] A silver coil 18 is wrapped around the valve seat pin 13 as a safety feature to prevent contamination of the drug solution, and a silver ring 19 is located in the lower region of the female Luer connector 5 .

[0035] Figure 3 It is also shown that the closure piece 6 a of the adapter is integrally connected with its two transverse webs 7 , which are pivotably connected to the housing of the adapter 5 via bearing pins 20 .

[0036] Figure 5A and Figure 5B In an alternative embodiment, two curved spring elements 21 are shown connecting the web 7 to the adapter 4 .

Claims

1. A system for storing a preferably sterile pharmaceutical solution in a multidose container (1) and for delivering one dose of the pharmaceutical solution at a time to a disposable syringe (2), characterized in that The multi-dose container (1) is an airless container consisting of a rigid outer container and a contracted inner liner. When delivering a drug solution, no air enters the inner liner for pressure balance. The multi-dose container (1) has an adapter (4) fastened to the multi-dose container (1). The adapter (4) has a one-way valve (3) and a female Luer container (5). The disposable syringe (2) is provided with a matching male Luer connector (6). The disposable syringe (2) can be docked with the adapter (4) using the male Luer connector (6) to receive a dose of drug solution by pulling up the disposable syringe.

2. The system according to claim 1, characterized in that The multidose container (1) has a container neck, and the Luer adapter (4) is snap-connected to the container neck.

3. The system according to claim 1 or 2, characterized in that: The female Luer connector (5) is a conically widening outlet channel in the one-way valve (3).

4. The system according to any one of claims 1 to 3, characterized in that The one-way valve (3) has an elastic valve membrane (14), which closes the entire internal flow opening of the one-way valve (3) except the hole (15). The edge of the valve membrane (14) rests on the valve seat pin (13) in a relaxed state, so that the one-way valve (3) is sealed closed.

5. The system according to claim 4, characterized in that When the docked disposable syringe (13) is pulled up, the valve membrane (14) is lifted from the valve seat pin and the flow of the drug solution is achieved.

6. The system according to any one of claims 1 to 5, characterized in that The outlet opening of the Luer connector (5) on the adapter (4) can be closed by a cover (6a), which is connected to two transverse webs (7) which are pivotably connected to the outside of the adapter (4), whereby the cover (6a) is also connected to at least one flexible spring arm (8, 21) which is compressed when the cover (6a) is pivoted into the open position.

7. The system according to claim 6, characterized in that The cover (6a) has an edge opening into which the Luer connector (6) on the disposable syringe (2) can engage in order to move the cover (6a) sideways.

8. The system according to any one of claims 1 to 7, characterized in that The dead volume within the adapter (4) is protected from microbial contamination by antimicrobial material (18, 19).

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