WO2022194500A1

WO2022194500A1 - Closure attachment

Info

Publication number: WO2022194500A1
Application number: PCT/EP2022/054416
Authority: WO
Inventors: Christopher Rosin; Thomas WORTELMANN
Original assignee: G.A.S. Gesellschaft Für Analytische Sensorsysteme M.B.H
Priority date: 2021-03-18
Filing date: 2022-02-22
Publication date: 2022-09-22
Also published as: EP4308295A1; DE102021106715A1

Abstract

The invention relates to a closure attachment for a closure (3) for closing an opening of a container (1) for the storage and, optionally, incubation of a sample and for the removal of the sample or of a sample constituent. The closure (3) has a septum (4) which closes the opening. The closure attachment can be placed onto a neck-type extension (2) surrounding the opening of the container (1). The closure attachment is characterized by: - a sleeve-shaped adapter (6), which can be placed onto the closure (3) and which has a central cannula (10), one end of the cannula being designed to pierce the septum (4) and the other end of the cannula having a connecting piece (12); - a tubular reservoir (7) having connecting pieces (13, 14) at both ends; - a syringe filter (8) having connecting pieces (15, 16) at both ends; and - an injection port (9) having a connecting piece (17) at one end and having a septum (18) at the other end; wherein the adapter (6), the reservoir (7), the syringe filter (8) and the injection port (9) are tightly connected to one another in succession by means of the connecting pieces (12, 13, 14, 15, 16, 17).

Description

locking attachment

The invention relates to a closure attachment for a closure for closing an opening of a container for storing and possibly incubating a sample and for removing the sample or a sample component, the closure having a septum closing the opening and the closure attachment having an opening of the container surrounding neck-like approach can be plugged.

Such a closure attachment is known from EP 2 160 337 B1. This publication relates to a closure for closing an opening of a container for the storage and removal of sterile or moisture-sensitive media with a closure cap which can be connected to the container in a liquid-tight manner and with a pierceable, self-sealing septum which has an off-centre removal opening in the closure cap liquid-tight seals, the closure having a rotatably mounted protective cap with a recess for releasing the removal opening, where the recess in the protective cap is adapted to the dimensions of the removal opening. The closure attachment is designed as a rotatably mounted closure cap. This closure cap has a plurality of extraction openings arranged off-centre, each of which is closed by a septum and over which the cutout, which is adapted to its dimensions, can be positioned by rotating the protective cap in order to release it. Through this The end design should protect the medium in the container from environmental influences as reliably as possible and at the same time enable the medium to be removed quickly and easily several times without impairing the functionality of the septum. In order to be able to remove a medium in the container, the septum is pierced with a cannula and the required amount of medium is removed. The septum is expediently made of a material which--like the container material--is inert to the medium to be stored in the container and at the same time can be easily pierced in order to automatically close again in a liquid-tight manner after the medium has been removed.

However, there are also applications in which it is less important that the septum is protected from being pierced too often at the same point, but in which it is to be avoided that the medium in the container is contaminated by the cannula inserted through the septum, or above all that the cannula is contaminated by the medium in the container and the cannula subsequently contaminates other media in other containers or other equipment, especially in the case of automated processes (e.g. with auto samplers). An example of such an application is the analysis of blood samples or the gaseous headspace above the blood sample in such sample containers. Thus, it would be desirable to be able to provide sterile removal from such a container without contaminating the removal cannula.

The object of the invention is to create a way with which a sample or a sample component can be removed from a container closed with a septum without contamination of the sampling cannula.

This object is achieved according to the invention with a closure attachment of the type described at the outset by a sleeve-shaped adapter that can be slipped onto the closure and has a central cannula, one end of which is designed to pierce the septum and the other end of which has a connecting piece, a tubular reservoir with connectors at both ends, a syringe filter with connectors at both ends, and an injection port with a connector at one end and a septum at the other end, wherein the adapter, the reservoir, the syringe filter, and the injection port are tightly connected to each other one after the other via the connecting pieces.

The closure attachment according to the invention essentially consists of four individual, commercially available elements. The adapter forms the connection option to the container, e.g. a blood culture bottle, and by penetrating the septum of the closure of the container with the cannula of the adapter, access to the interior of the container, e.g. to the headspace above a blood culture, which it contains as a sample component analyze applies. If there is a pressure difference between the container and the atmosphere, or if there are drops of liquid below the septum, liquid can penetrate the closure cap when penetrating the container septum. In order to prevent the liquid from wetting the syringe filter, which can be a conventional syringe filter and serves as a sterile filter for the closure attachment, a reservoir is arranged between the adapter and the syringe filter. For example, in order to sample the headspace using an autosampler syringe, an injection port with a septum is provided, which can be easily penetrated through the cannula of an autosampler syringe or similar, e.g. to take a gaseous sample from the container and then into the injector of a measuring system transport. This structure provides a sterile closure attachment that prevents the sample syringe or cannula from being contaminated by microorganisms, viruses, fungi or the like. This effectively prevents these germs from being carried over into a measuring system and other containers, e.g. blood culture bottles or injectors of measuring systems.

Provision is particularly advantageously made for the connecting pieces to be in the form of plug-in and/or rotary connectors. This simplifies the assembly and disassembly of the locking attachment. The connecting pieces are advantageously designed as Luer-Lock connectors, which ensure a tight connection that is easy to handle.

In a further advantageous embodiment, a valve is integrated into the reservoir and into the adapter, the valve of the reservoir opening through connection to the syringe filter and the valve of the adapter opening through connection to the reservoir. This prevents the sample from escaping and the interior of the container from coming into contact with the environment during assembly of the attachment, so that sterility is also guaranteed during assembly. The valve is only opened when the elements above it are attached or screwed on. From a practical point of view, the adapter and the reservoir can thus be attached one after the other without the liquid or solid sample or a sample component being able to escape from the container. The syringe filter and the injection port can then be preassembled or connected to the reservoir one after the other.

The invention is explained in more detail below with reference to the drawing. This shows in

Fig. 1 is a schematic exploded view of a container with a cap attachment.

A container for storing and, if necessary, incubating a sample and for taking the sample or a sample component, for example a blood culture bottle, is generally denoted by 1 . This container 1 has a neck-like attachment 2 on the upper side with an opening which is closed with a closure 3 placed on the neck-like attachment 2 . This closure 3 has a septum 4 closing the opening, which can be pierced and is self-closing in a known manner. In order to be able to remove a sample or a sample component, eg the headspace above the sample, from the container 1 through the septum 4 of the closure 3 in a sterile manner, a closure attachment 5 according to the invention is provided. This closure attachment 5 essentially consists of four individual elements that are to be connected to one another, namely a sleeve-shaped adapter 6 that can be pushed onto the closure 3 or the attachment 2 of the container 1, a tubular reservoir 7, a syringe filter 8 and an injection port 9. These elements are preferably made of a suitable plastic.

The adapter 6 has a central cannula 10 one end of which has a tip 11 for piercing the septum 4 of the closure 3 of the container 1 and the other end has a connecting piece 12 . The adapter 6 is designed in such a way that it can be tightly connected to the closure 3 or the attachment 2 of the container 1 in a positive and/or non-positive manner. Its shape is therefore adapted to the shape of the container 1 in question. The tubular reservoir 7 has connectors 13, 14 at both ends. The syringe filter 8 also has connecting pieces 15, 16 at the ends. The injection port 9 has a connec tion piece 17 at one end and is closed at the other, outer end with a pierceable, self-sealing septum 18. This septum 18 can be integrated into another connecting piece 19 which is an integral part of the injection port 9 .

The adapter 6, the reservoir 7, the syringe filter 8 serving as a sterile filter and the injection port 9 are to be connected tightly to one another one after the other via the connecting pieces 12, 13, 14, 15, 16 and 17. For this purpose, the connecting pieces 13, 15 and 17 are "male" and the connecting pieces 12, 14 and 16 are "female" in the exemplary embodiment, so that associated connecting pieces can be plugged into one another and or screwed or rotated.

The connecting pieces 12, 13, 14, 15, 16 and 17 are preferably designed as Luer lock connectors, if present also the connecting piece 19. A valve can be integrated into the reservoir 7 and into the adapter 6, which is not shown in each case. The valves are designed in such a way that the valve of the reservoir 6 opens through connection to the syringe filter 8 and the valve of the adapter 6 opens through connection to the reservoir 7.

The cap attachment 5 can be completely assembled by connecting all the elements (adapter 6, reservoir 7, syringe filter 8 and injection port 9) and then plugged onto the cap 3 of the container 1 with the adapter 6.

If the aforementioned valves are present, the adapter 6 and the reservoir 7 can first be attached to the container 1 one after the other without the fluid medium being able to escape from the container 1 . The syringe filter 8 and the injection port 9 can then be preassembled or connected to the reservoir 7 one after the other.

The adapter 6 forms the connection option to the container 1, for example a blood culture bottle. For this purpose, the sleeve-shaped area of the adapter for elastically and tightly slipping onto the closure 3 can have a plurality of spring shackles 20 distributed around the circumference. By penetrating the septum 4 of the closure 3 of the container 1 with the tip 11 of the cannula 10, the adapter 6 provides access to the interior of the container 1, eg to the headspace above a blood culture which is to be analyzed. In the event of a pressure difference between the container 1 and the atmosphere and if there are liquid droplets below the septum 4 , liquid can penetrate into the closure attachment 5 when penetrating the septum 4 . In order to prevent the liquid from wetting the syringe filter 8 , the reservoir 7 is arranged between the adapter 6 and the syringe filter 8 . In order, for example, to sample the headspace using an autosampler syringe, the injection port 9 is provided with a septum 18, which can be easily penetrated through the cannula of the autosampler syringe or the like can, for example, to remove a gaseous sample from the container 1 and transport it to closing in the injector of a measuring system. This structure provides a sterile closure attachment 5 which prevents the sample syringe or cannula (eg autosampler syringe) from being contaminated by microorganisms or the like. This effectively prevents these germs from being carried over into a measuring system and into other containers 1, for example other blood culture bottles.

Of course, the invention is not limited to the illustrated embodiments be. Further refinements are possible without departing from the basic idea. The connectors 12, 13, 14, 15, 16 and 17 can also be designed differently and can also be reversed, starting with a "male" connector 12 on the adapter 6.

reference list:

1 container

2 neck-like approach

3 clasp

4 septum

5 locking attachment

6 sleeve adapter

7 tubular reservoir

8 syringe filters

9 injection port

10 cannula

11 tip

12 connector

13 connector

14 connector

15 connector

16 connector

17 connector

18 septum

19 connector

20 spring tabs

Claims

Patent Claims:

1. Closure attachment for a closure (3) for closing an opening of a container (1) for storing and possibly incubating a sample and removing the sample or a sample component, the closure (3) having a septum (4) closing the opening and the closure attachment can be slipped onto a neck-like extension (2) surrounding the opening of the container (1), characterized by a sleeve-shaped adapter (6) that can be slipped onto the closure (3) and has a central cannula (10) whose one end adapted to pierce the septum (4) and the other end having a connector (12), a tubular reservoir (7) with connectors (13,14) at both ends, a syringe filter (8) with connectors (15,16 ) at both ends and an injection port (9) with a connector (17) at one end and a septum (18) at the other end, the adapter (6), the reservoir (7), the syringe filter (8) and the injection tion port (9) successively via the connec tion pieces (12,13,14,15,16,17) are tightly connected to each other.

2. Closure attachment according to claim 1, characterized in that the connecting pieces (12,13,14,15,16,17) are designed as plug and/or rotary connectors.

3. Closure attachment according to claim 2, characterized in that the connecting pieces (12, 13, 14, 15, 16, 17) are formed out as Luer lock connectors.

4. Closure attachment according to one or more of claims 1 to 3, characterized in that that a valve is integrated into the reservoir (7) and into the adapter (6), the valve of the reservoir (7) being connected to the syringe filter (8) and the valve of the adapter (6) being connected to the reservoir ( 7) opens.