WO2010105836A1 - Connecting unit having valve that is opened by the fluid pressure - Google Patents

Abstract

The present invention relates to a connecting unit and to a connecting system as well as to the use thereof for forming a sterile, bidirectional connection conducting a fluid substance for fluid-conducting components, such as containers, hoses and/or tubes, comprising a connector housing (12), which has at least two connecting pieces (22, 25) for a fluid-conducting component and at least one seal plug (14) received in the connector housing (12) in an axially displaceable manner from a closed position into a flow position, characterized in that the seal plug (14) is received in the connector housing (12) such that it can be displaced exclusively under the action of a pressure that can be transmitted via the fluid substance from the closed position into the flow position.

Description

 CONNECTION DEVICE WITH VALVE WHICH IS OPENED BY THE FLUID PRESSURE

description

The present invention relates to a connection device and a connection system for forming a sterile bi-directional connection of containers, hoses and / or tubes and delivery devices, which are provided in the medical field for storage, administration or for supplying and / or withdrawing pharmaceutical or biological fluids.

State of the art

Connecting devices and connection systems are in the medical field in a variety of variants in use. There are, for example, standardized connection systems, such as Luer-Lock connections according to DIN EN 1707, by means of which syringes, hose systems, bottles, bottle adapters, perfusion devices, catheters and the like fluid-carrying containers, hoses or pipes can be universally connected to each other depending on the purpose.

At such connecting devices high demands are made in particular from a hygienic point of view. Thus, the penetration of pathogenic substances, such as bacteria and germs, as well as dirt particles of any kind into a connecting device and thus fluid-permeable coupled container under all circumstances to avoid. Thus, for example, WO 03/090843 A1 describes a sterile fluid-transmitting valve with a longitudinally displaceably mounted in a housing piston. This piston has circumferential grooves for receiving sealing rings. It is provided that the piston comes to lie in the closed position with a sealing ring on a radially tapered portion of the housing. In order to open the valve, it is necessary to move the piston in the axial direction, so that the piston comes to lie in a radially widened portion of the housing and releases a flow-through opening for a fluid to be transferred. The transfer of the piston between a closing and a flow position, for example, via the actuation of a valve disposed on the actuating handle.

It may prove to be disadvantageous that those coupling device, depending on whether the piston is in the closed or open position, has a different longitudinal extent, or different external geometries.

WO 92/04064 describes a syringe valve which opens by the action of a transferable via the fluid substance pressure from the closed position into the flow position. The disadvantage here is that it is a unidirectional system, which does not allow to recycle a guided through the connection unit fluid.

task

In contrast, the object of the invention is to make available a connecting device for forming a sterile, bi-directional connection between containers, tubes and / or tubes and similar medical containers, which on the one hand is distinguished by particularly simple and safe handling and, on the other hand special which is inexpensive to produce and easy to assemble. Through the bidirectional connection, it should be possible, for example, pre-assembled syringes loaded with solvent by simple connection with a storage vessel containing a lyophilisate simply and safely bring the solvent in this and after dissolution of the lyophilizate to solve the solvent containing dissolved lyophilisate without the compound to be resumed in the syringe so that it can then be applied to a patient, for example.

invention

The problem underlying the invention is achieved by means of a connecting device according to claim 1 and a connection system according to claim 13 and a use according to claim 16. Advantageous embodiments of the invention are specified in the respective dependent claims.

The connecting device according to the invention is intended to form a sterile connection, bi-directional, fluid-tight and a fluid substance suitable connection of fluid-carrying components, such as containers, hoses and / or pipes. The connection device is universally suitable for the connection of any fluid-carrying systems and devices of the medical field, for example for the connection of bottles, ampoules, cartridges, cannulas, syringes, catheters, tubes, perfusion sets, etc. The connector includes a connector housing and a sealing plug slidably received in the connector housing. At least two connecting pieces for corresponding fluid-conducting components to be connected to the housing are formed on the connector housing. The plug is completely located inside the connector housing. It is axially displaceable at least between two end positions, namely a closure position and a flow position. With the Closure stopper in the closed position, a flow through the connecting device is blocked with a fluid substance, while, in the flow position, the connecting device connects the fluid-conducting components, such as containers, hoses or pipes fluid-electrically connected bidirectionally connected to her fluid-tight or coupled with her.

It is provided that the closure plug in its flow position provides a bidirectional flow through the piston chamber and guide channel. Furthermore, means are provided which prevent an automatic closing or blocking of the flow-through cross-section of the connecting device after a single or initial transfer of the sealing plug into its flow-through position. The connecting device according to the invention can thus provide a coupling which can be actuated only once for components to be connected thereto, such as containers, hoses, pipes or the like.

Such a configuration is for example for the preparation of a syringe of advantage. By means of the connection device according to the invention, for example, a disposable syringe, which has already been filled in advance with a solvent, can be connected to a container containing a substance to be dissolved. By applying sufficient pressure to the syringe plunger, the connector releases fluid communication between the syringe and the container through the pressure transmitted through the solvent. The solvent can flow into the container, for example an ampoule, and there dissolve the substance to be dissolved as intended.

Then, the substance dissolved in the container can, in the reverse direction than the solvent previously supplied to the container, flow through the connecting device in the direction of the syringe, so that the syringe is ready for use with the dissolved substance, then from the connecting device. separates and can be provided for proper administration, for example with an injection cannula.

According to an advantageous development of the invention it is provided that in the transition region of the guide channel and piston chamber radially outwardly directed and extending in the axial direction groove-like depressions are formed. These groove-like depressions can on the one hand provide an already sufficient radial broadening of the piston chamber with respect to the guide channel. In particular, they also serve to ensure that the guide channel and the piston chamber can flow through the piston chamber after a first or only transfer of the sealing plug into the piston chamber.

If the connecting device is oriented in such a way, for example, after the stopper has been transferred to the flow passage, then the groove-like depressions formed in the transition region still provide a cross section through which the fluid can flow sufficiently. An approximately gravity-related automatic closing of the connecting device can be prevented and a blockage by resealing in the course of a backflow can be counteracted.

The invention is characterized in particular by the fact that the sealing plug is accommodated displaceably in the connector housing exclusively under the influence of a pressure which can be transmitted via the fluid substance from the closed position into the flow-through position. That is, a transfer of the sealing plug from the closed position into the flow position is carried out according to the invention by and by means of the fluid substance to be transferred. In accordance with the overpressure to be applied by the substance itself or by an external force exerted on the substance by external force, the piston stopper designed in the manner of a piston can be moved into the flow-through position be moved, in which it releases a flow through the connecting means with the fluid substance.

On the user side, the handling of the connecting device according to the invention is advantageous insofar as the user does not have to carry out a separate work step for transferring the sealing plug into its throughflow position. It is only necessary to ensure that the fluid substance to be passed through the connecting device is subjected to a sufficient pressure.

According to an advantageous embodiment of the invention, it is provided that the housing, facing one of the connecting pieces, has a guide channel which is completely filled in cross-section by the closing plug in the closed position. This guide channel is preferably cylindrical and has an inner cross section corresponding to the diameter of the sealing plug. Facing away from the connecting piece, the guide channel transitions into a piston chamber that is widened in relation to the guide channel.

In addition to a radially symmetrical or cylindrical configuration of the guide channel and piston chamber, any other cross-sectional geometries are also suitable for the invention. For example, the guide channel and the contrast broadened piston chamber may also have a rectangular, square, oval, elliptical, triangular or polygonal cross-section. Typically, the sealing plug has a corresponding outer contour adapted to the cross section of the guide channel. It may for example be cylindrical or spherical but also angular.

While the closure plug, which is of cylindrical design, for example, can be almost completely disposed in the closed position within the guide channel. If it comes gen, it reaches at least partially, preferably even completely into the radially widened piston chamber, so reaching the flow position, so that the pressurized fluid substance, the sealing plug radially flushing, a fluid outlet can be supplied.

According to a development of the invention, it is provided in particular that a flow channel for the fluid substance opens into an end face of the piston chamber facing away from the sealing plug. At the same time, this end face of the piston chamber, which faces the connection piece and the guide channel, restricts the axial movement of the sealing plug when it is transferred to the flow position. In that regard, that end face forms an end stop for the axial displacement of the sealing plug which can be initiated by the fluid substance.

According to a further advantageous embodiment of the invention it is provided that the closure stopper has at its end portion facing away from the connecting piece at least one spacer, which comes to lie in flow-through position of the sealing plug outside of the opening into the end face of the piston chamber flow channel. In this way, it can be ensured that the flow channel, which functions as a fluid outlet, for example, remains connected in a fluid-transmitting manner with the piston chamber, even when the sealing plug is in the flow-through position.

For example, in the case of a cylindrically embodied sealing plug or piston and a round end section of the sealing plug facing the end of the piston chamber, it is possible to distribute a plurality of radially outer spacers over the circumference of the sealing plug and to arrange them at a distance from each other and centrically to arrange the flow channel for the fluid substance a radially inner portion of the piston chamber end face to provide. In this way, an over the fluid flowing into the guide channel and the piston chamber are fed through the intermediate spaces formed by the spacers to the flow channel as a fluid outlet.

Furthermore, it can be provided to provide the spacer or the spacers on the housing side and to arrange in a transition region of the piston chamber and the fluid channel. The spacers can be arranged, for example, on the piston chamber bounding the end wall laterally of the mouth of the fluid channel.

According to a development of the invention it is provided that the closure stopper has a circumferential sealing ring. In the closed position, this sealing ring provides a fluid-tight seal between the plug and the guide channel surrounding the plug.

In particular, it is provided to arrange the sealing ring in a circumferential groove of the sealing plug, so that it is held securely and firmly on the sealing plug, at least in the axial direction.

Alternatively, it may be provided that the closure plug is made entirely of an elastic material which seals the guide channel in the closed position. In this embodiment, the sealing plug can act as a seal over its entire axial extent.

According to a further advantageous embodiment of the invention, it is provided that the closure stopper has such a material nature and / or such a geometric configuration, by means of which a predetermined displacement resistance of the sealing stopper in the guide channel can be achieved. By selecting suitable materials with appropriate adhesive or sliding friction properties and / or appropriate degree of hardness of the sliding resistance of the sealing plug and thus of the Liquid for displacing the sealing plug to be applied pressure, depending on the requirements profile and intended use of the connecting device, can be set specifically. Suitable materials for the stopper natural or synthetic rubber materials, but also suitable elastomers into consideration.

According to a further advantageous embodiment of the invention, it is provided that the connection piece arranged on the connector housing, integrally formed thereon or fastened thereto, can be positively, forcefully and / or frictionally connected to a fluid-carrying container, for example a syringe, a tube or a hose. By forming a positive, force and / or frictional connection of the container and the connection piece, a fluid pressure initiating the transfer of the sealing plug into its flow position can be built up by or in the fluid-carrying container itself. The positive, force and / or frictional connection between the connection piece and the container is designed in such a way that it withstands the transferable pressure of the fluid substance.

Furthermore, it is provided that at least one of the connecting pieces has an inner or outer cone for receiving and / or coupling with a correspondingly formed counterpart of the fluid-carrying component. In this case, a mere telescoping of inner and outer cones of corresponding connecting pieces of connecting device and component to form a connection which maintains the fluid pressure can already be sufficient.

According to a further advantageous embodiment, the connecting pieces provided proximally and distally to the connecting device are designed as a receiving recess and / or as a base-like pin on the housing of the connecting device. The axially movable sealing plug is preferably located within the housing between the example in alignment mutually arranged fittings. In this case, it is further provided that the connecting pieces, regardless of whether they are formed as a recess or as a protruding pin, to be integrally arranged on the housing of the connecting device or to integrate into this. Due to the arrangement of the axially displaceable sealing plug between the two connecting pieces, the connecting device always maintains its geometric shape regardless of the position of the plug.

According to a further independent aspect, the invention relates to a connection system with a previously described connection device and with at least one first container, in particular a pre-filled with a fluid syringe. The container, or the syringe is connected by means of the connector sterile with the connecting device.

In this case, it is particularly advantageous if a second container is already connected to the connecting device in a sterile and fluid-transmitting manner in the pre-assembled delivery state, by exerting a pressure above the predetermined threshold value on the first container, for example by exerting a corresponding pressure on a syringe plunger Closing plug from the closed position is displaced into the flow position. As a result, the fluid of the first container can be transferred via the connection system into the second container. Optionally, after mixing or mutual dissolution of the substances contained in the first and second containers, the fluid product obtained in this manner can be rearranged in the reverse direction into the first container, such as the syringe.

In this case, it is of advantage that the entire connection system comprising the two containers and the connection device is assembled under sterile environmental conditions, packaged and commercialized Unit can be sold to the end user. For this it is no longer necessary, for example, to dissolve a lyophilisate, to manually sterilize a number of substance-carrying containers manually by means of suitable chemicals and then to connect them, for example, for introducing a solvent into a container containing the lyophilisate. Instead, the solvent may be commercially sold by the preconfigured compound system together with the lyophilisate-carrying container. This type of pre-assembly under sterile conditions can simplify the preparation and preparation of a solution for injection. Also, such a system provides increased operator safety and improved hygiene. Thus, the solvent suitable for the particular lyophilizate can be already connected to the manufacturer in the prescribed exact dosage, for example in a pre-filled syringe mechanically container containing the lyophilisate.

According to a further advantageous embodiment, it is provided that the first component is designed as a syringe having a solvent and is coupled in a fluid-transmitting manner to the connection device via the first connection piece. Furthermore, a second component, which has a drug dissolvable in the solvent, is optionally coupled to the second connector of the connector housing with the interposition of an adapter.

According to a further independent aspect, the invention relates to the use düng of the described connection device, in particular for forming a mono-, bi- or multidirectional fluid-transmitting connection between at least two fluid-carrying components, such as containers, hoses and / or pipes. The creation of the fluid-transmitting compound is used primarily for the preparation of a medicament to be administered, or for the preparation of a corresponding application of the medicament. Here, it is provided, at least a first component having a solvent and to couple a second, a drug to be dissolved receiving component sterile with designated fittings of the connecting device.

This coupling may preferably be done directly at the manufacturer of the drug under sterile conditions. Subsequently, for example with an end user, by building up an overpressure on the solvent contained in the first component, the sealing plug slidably received in the connector housing can be transferred from a closure position to a flow position, whereby the fluid connection of the first and second component becomes irreversible upon reaching the flow position provides.

Finally, the solvent can flow from the first to the second component and form a solution, suspension or dispersion there with the medicament. After such a mixing procedure, the fluid formed in this way can flow in the opposite direction from the first component to the second component, for example, be wound up by a syringe.

The coupling of the connecting device with the at least first and second component can be carried out directly via the provided on the connecting device fittings, possibly also with the interposition of adapters.

embodiments

Other objects, applications and advantages of the present invention will become apparent from the following description with reference to the drawings. All described and / or illustrated features in any meaningful combination but also in isolation form the subject of the present invention. Show it:

1 shows the connecting device according to the invention in cross section with the sealing plug in the closed position,

FIG. 2 shows the connection device according to FIG. 1 with the plug in flow-through position,

FIG. 3 the closure stopper in a top view from below,

FIG. 4 shows the sealing plug in side view;

Figure 5 is a cross-sectional view of the connector housing along the section line A-A of FIG. 6 and

Figure 6 the connector housing cut longitudinally.

The connecting device 10 shown in different configurations in FIGS. 1 and 2 has a connector housing 12 on which a connecting piece 22 is arranged at an upper end section and a connecting piece 25 is arranged at the opposite lower end section. The closure protrusion 23 for a component to be connected, such as a container, having connecting piece 22 has a receiving recess 24 with a cone 26. The underlying connector 25, however, is formed like a cone protruding from the connector housing 12. Also, this connector 25 has a correspondingly formed cone 28.

By means of the conical configuration 26, 28, a frictional connection with the components to be coupled to the connection device 10, such as containers, hoses, pipes, can already be made via the connection pieces 22, 25 directions are produced. It is also conceivable to provide the connecting pieces 22, 25 with a standardized connection mechanism, for example according to the Luer-Lock principle or with connection systems which are comparable in their mode of action.

Inside, the connector housing 12 has a cavity connecting the two fluid channels 20, 36. Adjacent to the upper fluid channel 36, a typically cylindrical guide channel 34 is provided, in which the closure plug 14 is in the occluding starting position shown in Fig. 1. Adjacent thereto is located opposite the guide channel 34 radially widened trained piston chamber 18, in which the stopper 14 comes to rest in the flow position shown in Fig. 2.

In the configuration according to FIG. 2, a fluid-flowable connection between the fluid channel 36 and the fluid channel 20 is formed by the broadening, but in particular by the radial and axial recesses 38 shown in FIGS. 1 and 2 made available. In the present exemplary embodiment, the bottom, approximately as fluid outlet functioning fluid channel 20 opens centrally into a lower end boundary of the piston chamber 18. The stopper 14, and its lower end wall 30 has a series of downwardly projecting spacers 32, which in Fig. 3 in Top view shown from below.

The spacers 32 formed in the manner of a circle segment are preferably distributed at regular intervals over the outer circumference of the end wall 30 of the sealing plug 14, so that when the flow position according to FIG. 2 is reached between the lower end wall 30 of the closure plug 14 and the lower end wall of the piston chamber 18 remains traversed by a fluid cross-section and a on the Fluid channel 36 can flow into the piston chamber 18 incoming fluid into the fluid channel 20.

According to an alternative, not explicitly shown embodiment, it would also be conceivable to arrange the spacers 32 or individual spacers directly adjacent to the end wall adjacent to the fluid outlet, or adjacent to its mouth in the end wall. In that regard, the spacers 32 would not necessarily be provided on the underside of the sealing plug 14.

The closure plug 14 can be converted into the flow position indicated in FIG. 2 by a fluid substance to be passed through the connection device 10, even from the closure position shown in FIG. 1. Once the closure stopper 14 is in the throughflow position shown in FIG. 2, a fluid can be exchanged as required between the two fluid channels 20, 36 and thus between the components which are fluid-coupled to the connection device. The groove-like depressions 38 running in the radial direction in the transitional area between the cylindrical guide channel 34 and the piston chamber 18 prevent the closure plug 14 from flowing through the cross-section between the guide channel 34 and the piston chamber due to gravity, or due to an entrainment effect which can originate from a fluid flowing back 18 automatically closes or blocks, such as when the entire device is turned upside down after filling a solvent in a lyophilizate container to remove the fluid substance formed thereby.

The closure stopper 14 shown in FIGS. 1 to 4 can also be designed in several parts. Advantageously, a circumferential groove-like depression on the closure plug 14 is formed, in which the sealing ring 16 comes to rest. The selection in particular of the sealing material as well as the specific geometric design of the sealing ring is attached to the Weil provided intended use of the connecting device. According to the coefficient of adhesion or sliding friction of the sealing ring, the size of the ring, in particular its thickness and its outer circumference, a displacement resistance for the sealing plug can be adjusted. It can be additionally provided to manufacture the closure plug itself from an elastic, acting as a sealant material.

For example, in a configuration in which a syringe filled with a solvent is inserted into the receiving recess 24 of the fitting 22, and where the fitting 25 is connected to a lyophilisate-receiving container, such as an ampoule, one may override a predetermined threshold lying pressure on the syringe plunger not explicitly shown in the figures, the solvent in the syringe via the fluid channel 36, the closure plug 14 act such that it is displaced under that pressure in the piston chamber.

Such an opening of the connecting device 10 is particularly intuitive and user-friendly and also gives the user a haptic feedback about a successful release of the flow-through cross section. By axial displacement of the sealing plug 14 in the piston chamber 18 of the total flow through the connector housing 12 is released irreversibly.

By a container already pre-filled with a solvent as well as a substance containing a substance to be firmly connected to the connecting device 10 and packaged as a commercial unit as an ensemble, eliminating the time-consuming and troublesome steps for the end user, a sterile as possible Manual connection of containers. Notwithstanding the embodiments shown in the figures, the connector housing 12 is not necessarily cylindrical form. Only in the region of the guide channel 34 is a rectilinear extent required for displacement of the sealing plug. Otherwise, the connector housing may have almost any contour and geometry. Thus, the connecting pieces, as shown, can be arranged in alignment with each other but arbitrarily to one another. It is also conceivable to design the housing L-shaped or as a T-piece.

LIST OF REFERENCE NUMBERS

10 connection device

12 connector housing 14 sealing plug

16 sealing ring

18 piston chamber

20 fluid channel

22 connecting piece 23 closure survey

24 receiving recess

25 connection piece

26 cone

28 cone 30 end wall

32 spacer

34 guide channel

36 fluid channel

38 deepening

Claims

claims 1. A connection device for forming a sterile connection of fluid-carrying components, such as containers, hoses and / or tubes, for example, comprising a connector housing (12) which has at least two connection parts (22, 25) for fluid-conducting components, which come to lie proximally and distally to a connector housing (12) and at least one in the connector housing (12) from a closed position into a flow position axially slidably received closure plug (14), characterized in that the closure plug (14) exclusively below Action of a transferable via the fluid substance pressure from the closed position to the flow position displaceable in the connector housing (12) is received and wherein the closure plug (14) in flow position bidirectional flow through Koben benkammer (18) and guide channel (34). 2. Connecting device according to claim 1, wherein at least in the transition region between the guide channel (34) and piston chamber (18) directed outward and extending in the axial direction recesses (38) are formed. 3. Connecting device according to claim 1 or 2, wherein the connector housing (12), facing the connecting piece (22), from the closure stopper (14) in the closed position in cross-section completely filled guide channel (34) which the connecting piece (22) facing away widening into a piston chamber (18), in which of the sealing plug (14) comes to rest at least partially when it reaches its flow position. 4. Connecting device according to one of the preceding claims, wherein a fluid channel (20) for the fluid substance in a closure plug (14) facing away from the end of the piston chamber (18) opens. 5. Connecting device according to claim 4, wherein the closure plug (14) at its the connecting piece (22) facing away Strinwand (30) at least one spacer (32), which comes to rest in the flow position of the sealing plug (14) outside the fluid channel (20) , 6. Connecting device according to one of the preceding claims, wherein the spacer (32) is arranged on the housing side and in Transition region of piston chamber (18) and fluid channel (20) comes to rest. 7. Connecting device according to one of the preceding claims, wherein the sealing plug (14) has a circumferential sealing ring (16). 8. Connecting device according to one of claims 1 to 7, wherein the sealing plug (14) consists of an elastic material, which seals the guide channel (34) in the closed position. 9. Connecting device according to claim 8, wherein the sealing ring (16) in a circumferential groove of the sealing plug (14) is arranged and one for achieving a predetermined displacement resistance for the displacement of the sealing plug (14) in the guide channel (34). having provided material properties and / or a corresponding geometric configuration. 10. Connecting device according to one of the preceding claims, wherein the connecting pieces (22, 25) form, force and / or frictionally connected to a container, a syringe, a tube or hose are connectable. 11. Connecting device according to one of the preceding claims, wherein at least one of the connecting pieces (22, 25) has an inner or outer ßenkonus. 12. Connecting device according to one of the preceding claims, wherein the proximally and distally provided to the connecting means connecting pieces (22, 25) as a receiving recess (24) and / or as a winkelartiges connection piece (25) on the connector housing (12) are formed. 13. Connection system characterized by a connecting device (10) according to one of the preceding claims and with at least a first fluid-carrying component, in particular with a pre-filled with a fluid syringe, which is connected by means of the connector (22) sterile with the connecting device. 14. The connection system according to claim 13, wherein a second fluid-carrying component sterile and fluid-transmitting with the connecting device (10) is connected and wherein by exerting a lying above a predetermined threshold pressure on the first container, the closure plug (14) from the closed position to the flow position displaceable and the fluid from the first to the second container and vice versa can be transferred. 15. The connection system according to claim 13, wherein the first component is designed as a tip having a solvent and is coupled in a fluid-transmitting manner to the connection device via the first connection piece and wherein a second component having a solvent-dissolvable medicament is provided. optionally under Interposing an adapter with the second connector (25) of the connector housing (12) is coupled. 16. Use of a connecting device according to one of the preceding claims 1 to 12 for forming a bi- or multidirectional fluidü-transmitting connection between at least two fluid-carrying components, such as containers, hoses and / or tubes, in particular for the preparation of a medicament, wherein at least a first , a solvent-containing component and a second component to be dissolved have a drug-containing component are sterilely coupled with designated fittings (22, 25) of the connecting device (10), wherein by building up an overpressure on the solvent contained in the first component a in the connector housing (12) slidably received closure plug (14) is transferred from a closure into a flow position and irreversibly provides a bidirectional fluid connection of the first and second component upon reaching the flow position.