DE102009023676B4 - Device for the application of fluid medicaments - Google Patents

Abstract

Three-way valve (1) for administering fluid medicaments, in particular cytostatics, comprising an at least two-part housing (2, 3) with at least two Luer connections (6, 7) and at least one integrated fluid absorption element in the form of a piercing spike (15) wherein a medicament is removable via the fluid receiving element from a medicament reservoir (70) and a medicament receptacle (73) is inflatable via a tubing connection, and wherein the three-way valve is shaped to have a first port with a second port Passage connects, parallel to a third passage blocks and thereby prevents exposure of liquid in the environment, characterized in that two housing parts (2, 3) are designed as a hollow body and outer housing walls (25, 29) and further to each other corresponding inner housing walls (20 , 26), one of which is cup-shaped and another cylindrical is, wherein both are rotatably supported each other and the cylindrical housing wall (20) has a radial (22) and axial flow channel (21), wherein the axial flow channel (21) through the cup-shaped housing wall (26) of the one housing part (2) and through the cylindrical housing wall (20) of the other housing part (3) is delimited, wherein the housing part (2) with the piercing spike (15) has a covering protective cap (4), and wherein a seal is provided which springs back over the piercing spike (15) and completely encloses it.

Description

The invention relates to a three-way valve for administering fluid medicaments, in particular cytostatics, comprising an at least two-part housing with at least two Luer connections and at least one integrated fluid intake element in the form of a piercing spike, wherein a drug via the fluid receiving element from a drug reservoir removable and a drug receptacle is fillable via a hose connection, and wherein the three-way valve is shaped so that it connects a first passage with a second passage, parallel blocks a third passage and thereby prevents exposure of liquid in the environment ,

Many medicinal products must be prepared in appropriate quantities before use, before they can be injected or perfused. Typically, these are liquid applications of drugs that are injected or infused directly via the intravenous route. In general, the commercially available drugs are available as solutions or emulsions. Drug solutions may be applied by adding suitable diluents, such as an isotonic saline, or may be administered by adding emulsifiers to an isotonic saline solution. The application and the dilution of medicaments are carried out in a conventional manner by means of syringes which are provided with a needle.

When a drug is to be dissolved in a liquid, a dilution solution is withdrawn from a corresponding container with a syringe and introduced into the container containing the drug. For this purpose, a septum is usually present on a medication container, which is pierced with a needle of the syringe. After adding a diluting solution to the drug, an injection device is then connected to the medicament container, or the containing diluent solution is withdrawn with medicaments by means of a syringe from the medicament container and the drug is injected into solution.

Furthermore, it is possible that a removal of a drug solution from a container via so-called "spikes" takes place, wherein a dilution solution using a spike, which usually has two tips, can get into the container. In this case, the container containing the medicament is usually below a container containing a dilution solution, so that an inflow of the dilution solution can take place via the mandrel into the container containing the medicament. After dissolution of the drug in the container, a removal of the prepared solution via the mandrel is possible, wherein a hose can establish a connection between the mandrel and an injection device, for example a needle. If the drug solution is withdrawn from the container via a syringe, then the syringe can then be used to inject it at a suitable injection site.

However, the aforesaid route for diluting injectable medicaments, by handling open, sharp objects such as the spike or needle, creates an inherent risk of contamination of the environment which may come in contact with the drug. This is of particular concern when the use of hazardous, such as toxic drugs is provided, such as in the context of the treatment of cancer with cytotoxic drugs. In such a case, the medical staff handling the medicines will be exposed to the danger that an exposure of the medicament will exert an effect on the organism whose treatment will result in an effect which will be effective in the therapeutic treatment of the medicament Patients should be counteracted. Thus exposure to cytotoxic agents may cause a carcinogenic effect on the medical staff, which should be avoided at all costs.

Also known as the prior art are devices which, upon removal of a medicament from a container, have a hydrophobic filter which is capable of preventing both the passage of aerosols to the outside and the ingress of microorganisms inwardly. However, such devices are not completely isolated since conventional devices simultaneously connect both the diluent solution container and the medicament container and allow subsequent withdrawal of the drug solution. Thus, after dissolution of the drug, a removal of the dissolved drug by another device, such as a syringe, take place, which brings with it the risk of contamination of the drug with the environment.

Furthermore, devices are known from the prior art in which an application of medicaments is made possible, in which the medicament is located within an evacuated container, which is connected via a valve with a syringe containing a diluting solution. To prepare a drug solution, the dilution solution is introduced into the evacuated container and the drug located there dissolved in the dilution solution. After mixing the Drug with the solution for injection is via an adjustment of the valve position between the container and syringe, a supply of the drug solution to a desired injection site possible without a re-puncturing of another container must be done. However, such a prior art has the disadvantage that for the drug filling a separate container must be present, which withstands a negative pressure, whereby conventionally existing application devices for infusions with such a closed system can not be operated. It is therefore necessary a high expenditure on equipment, which precludes the use of such a device.

From the WO 96/29113 a valve is known, which consists of a fully cylindrical valve element and a hollow cylindrical valve element, wherein both valve elements are rotated against each other. To the fully cylindrical valve element, a piercing spike is formed, which has an axial flow channel. The fully cylindrical valve element has a second flow passage extending along the circumference. For placing a liquid container, the fully cylindrical valve element has a container adapter.

US patent application US 2007/0088252 A1 discloses a medicament transfer system which comprises a T-shaped three-way valve. The three-way valve has on one side an adapter for receiving an ampoule within which a piercing spike extends. Furthermore, the three-way valve has a luer connection for connection to an infusion bag and a socket for receiving the tip of a syringe, by means of which a transfer of a medicament from an ampoule into an infusion bag takes place. A disadvantage of this system is in particular that the exposure of the user with toxic drugs was not sufficiently considered in its design, since the piercing spike after removal of an ampoule is first exposed and then manually a only the spike covering protective cap must be pushed onto this. Furthermore, the connection of the three-way valve with an infusion bag is exclusively via Luer connections, so that it can come with a connection of a new infusion bag to an exposure of the user.

The object of the invention is therefore to provide a device for the application of fluid drugs, which meets a high safety standard, has a sufficient density to prevent contamination and is compatible with injection devices of the prior art.

According to the invention the object is achieved in that two housing parts are formed as a hollow body and outer housing walls and further mutually corresponding inner housing walls, one of which is cup-shaped and another cylindrical, wherein both are rotatably supported each other and the cylindrical housing wall a radial and axial Flow channel, wherein the axial flow channel is limited by the cup-shaped housing wall of the one housing part and the cylindrical housing wall of the other housing part, wherein the housing part with the piercing mandrel has a protective cap, and wherein a seal is present, which springs back on the piercing and this completely encloses. Further advantageous embodiments of the invention will become apparent from the dependent claims.

The device according to the invention has two corresponding housing parts, wherein a housing part can be pressed into the other housing part, so that a positive connection between the first and second housing part is formed. Both housing parts each have an inner and an outer housing wall. Within a first housing part, an inner housing wall is present, which is designed cup-shaped and is provided for receiving a cylindrically shaped inner housing wall of the second housing part, so that a corresponding positive connection of the housing parts is possible. The outer housing walls are in this case surface compressible with each other, wherein the outer housing walls are connected by a tongue and groove so that both housing parts are mounted at least limited rotatable to each other after a compression. Thus, a rotation about a common axis of rotation of the two housing parts to each other is possible, wherein the inner cylindrical housing wall of the second housing part in the cup-shaped inner housing wall of the first housing part also undergoes a positive corresponding rotational movement and opens existing flow channels. The pot-shaped inner housing wall of the first housing part has three channels, wherein two channels lead to the arranged on the outer housing wall of the first housing part luer terminals and a channel opens into a liquid receiving element in the form of a piercing spike. The leading to the Luer terminals channels are arranged radially and the other channel partially axially and radially to a common axis of rotation. Depending on the position of the cylindrical inner housing wall in relation to the cup-shaped inner housing wall, a fluid (fluid) can pass alternately to the flow channels. At the same time the other channel is closed, if both Housing parts are rotated relative to each other by 90 ° and the previously obstructed channel is opened and the open channel is closed. Thus, alternately a connection of two channels can be opened and closed, whereby a fluid with changing flow direction passes from one channel to another channel. Thus, a controllable filling and / or removal of liquids from containers is possible, which are connectable to the three-way valve, wherein the filling and removal of liquid through the two luer fittings and a liquid receiving element is possible. To the luer fittings and the liquid receiving element are connected directly or via adapters or hose connections container with liquids and / or containers for liquid intake, so that a filling or the removal of a liquid depending on the position of the three-way valve of two interconnected containers is possible, wherein for removal preferably a connectable to a Luer connector syringe is provided, with which the liquid from a container, for example via the piercing spike is sucked and after rotation of the 3-way valve in another container, such as an infusion bag , can be given. Here, other removal options of liquids are readily conceivable, where appropriate, a mixing of drugs in liquid form is possible, for example by adding several liquids in a connected container.

Due to the design of the two housing parts with a cup-shaped inner housing wall on the one hand and a cylindrical inner housing wall on the other hand there is the advantage that a simple assembly of the housing parts can take place and a large sliding surface is formed between the housing parts. By the sliding surfaces tilting of the two housing parts is avoided during assembly and at the same time a sealing surface formed, which prevents leakage of liquid.

Preferably, two channels lead to the inner pot-shaped housing wall for the Luer connections, while a third channel opens into a liquid receiving element, which has a piercing spike. As connectable containers for the removal or filling of liquids, ampoules, injection bags or syringes can be used. Due to the configuration of the subject invention thereby a simple constructive possibility is created to controllably control a liquid flow between two containers.

In particular, the subject of the invention is intended for the containers used to contain medicaments, such as cytostatics, which are intended for intravenous administration into an organism. The device is capable of ensuring an exposure-free mixture of different liquids via the relative rotational position of the housing parts relative to one another, this being of importance in particular for hazardous medicaments for minimizing the risk of intoxication by the medical personnel. Thus, it is possible that dangerous drugs with appropriate dilution solutions can be brought to the desired concentration, with the design of the subject invention, the Luer connections, such as Luer-lock connections, and by sealing the piercing spike through a seal exposure From liquid over the connection points of the container is not to be feared.

The relative rotation through 90 ° of the two housing parts and thus the corresponding inner cylindrical and pot-shaped housing walls provides here that a blockage or connection between two containers via the channels formed, wherein the rotation of the housing parts to each other can be repeated as often. For example, in a first position of the corresponding housing walls, an axial passage for the removal of a medicament from a reservoir can be released and in a second position a radial passage can be released along the corresponding housing walls for filling an infusion bag.

In order to achieve a torsion protection is provided within a first housing part a stop element and in the end face of a second housing part form over 90 degrees extending recess, so that the movement of the housing parts is limited. The stop element is designed so that it engages in the end face of the other housing part. By a rotational movement of the housing parts to each other, a rotation of the inner housing walls can be limited to a range of 90 ° by the stop element. By changing the stop element or the recess optionally other angular ranges are conceivable. In this case, the recess may be smooth-surfaced or chop-shaped extended over a horizontal region, so that an adjustable adjustment of the position of the housing parts to each other in a range of less than 90 ° is possible.

The device also has a locking mechanism in which a spring and a groove mesh. If both housing parts inserted into one another, the spring engages on the inside of a housing part in the groove on the outside of the other housing part. The Intermeshing of the housing parts via tongue and groove allows a rotation of both housing parts through the annular groove.

Furthermore, the device has a positionable on the outside of a housing part rotational position indicator, which can visually detect the rotational position of the housing parts visible. This is an indication to the user of the device according to the invention, which connects two containers together.

Furthermore, the device has a spike, which contains two independent channels, wherein the two channels are designed so that they run parallel to one end and the other end of each other. In this case, a channel above the inner pot-shaped housing wall and the other supply channel opens into an air inlet opening for pressure equalization, which allows a compensating pressure compensation. Within the air inlet opening is provided that before, behind or inside the air inlet opening a deep filter is used, which may consist of a hydrophobic, fine-pored, activated carbon material that prevents the ingress of air or gas through the air inlet opening for pressure equalization, as well as exposure of liquid from a container connected to the three-way valve. Also, in a particular embodiment, a tie-down filter is provided within the device to filter the incoming gas antiseptically and / or aseptically. By this embodiment, a compensating pressure equalization between the environment and the container for removing a liquid is possible without a contaminated gas or an immunologically objectionable component can pass through the deep filter in the device according to the invention.

Furthermore, the invention is designed so that the piercing spike equipped with two independent channels has a seal above its inlet or outlet openings, which wipes off liquids adhering to the piercing spike when a storage container is removed. When removing a reservoir connected to the piercing spike, the seal is designed to prevent exposure of the liquid from a container so that it springs back over the spike and completely surrounds the piercing spike. In this case, the seal is made of different materials, such as rubber, plastic or other elastic material, so when piercing the seal for connection to a reservoir and subsequent removal of the reservoir, the existing seal of the piercing spine springs back and stripping adhering liquid from the piercing spike is possible.

It is further provided that the housing part with piercing spike has a covering protective cap, which must be removed before piercing a piercing spike into a reservoir in order to reduce the risk of injury to persons.

To remove the protective cap from the device, an annular perforated pull tab is provided, which is arranged above the protective cap and allows easy removal of the protective cap. In a particular embodiment, the piercing spike has at its piercing point on a chamfer, which runs at an angle bevelled or V-shaped, wherein the type of beveling depends on the particular application.

Furthermore, the device according to the invention has at least two Luer connections, wherein a container via a hose connection is directly or indirectly connectable to another container via a further Luer connection. In particular, a connection element, for example a hose connection with a connection adapter, can be used to connect two containers to one another. The hose connection has a Luer connection at one end and a connection adapter at the other end to protect people. The connection adapter has a hollow piercing spike for transferring the liquid and is shielded from the environment by elastic segments and a protective cap. A sealing lip, which is arranged above the hollow piercing spike, can be designed in such a way that, under pressure, the wall of the sealing lip of a connection can be pierced in order to produce the required connection, for example with an infusion bag.

The connection adapter provided for connecting two containers is designed in such a way that the piercing spike mounted in the connection adapter can be connected at one end to a hose via a Luer connection and at the other end has outlet openings which allow lateral escape of liquid from the hollow piercing spike , The lateral outlet openings are not fixed to a specific number of openings, so that, for example, a plurality of outlet openings may be present in the lateral region of the piercing spike. Furthermore, the hollow piercing spike for better function may have a so-called "pencil point" in the front area. Such a "pencil point" has a particular hardness and rigidity compared to the rest of the material of the piercing spike and facilitates the piercing of a seal or a connection of the container.

Alternatively, the device can be connected to at least two containers, with a first container for the removal of liquid is used and in particular may contain a drug, and a second container can be filled with a liquid, wherein the second container is in particular designed as an infusion bag.

In a particular embodiment of the device, a syringe is provided, which can be attached to a luer connection attachable to a first reservoir in conjunction and remove in or out of a first reservoir liquid or fill it with liquid. In general, the first reservoir represents a vial in a medical handling. Ampoules have standardized puncture sites, which are formed for example as a septum or as a rubber stopper. In such a pre-marked puncture site, a piercing spike can be introduced, it being necessary, depending on the container size, if necessary, to fix the puncture site and the first container. For this reason, an adapter is provided which provides for the fixation of the adjustment range for an ampoule and thereby provides a variable size setting for different ampoule diameter, the adapter is particularly suitable for ampoule diameter between 13 mm and 26 mm.

The device further comprises a container which is designed as an infusion bag and has at least two connections, wherein a connection for receiving a cannula of the connection adapter is used and a connection can be configured as a pressure relief valve. In this case, the pressure relief valve present on the container is configured in a preferred embodiment as a check valve to allow a pressure equalization.

Furthermore, the check valve can be configured as a combined non-return valve with septum, so that after filling a second container according to the invention a removal of the filled liquid via the combined pressure relief valve can be done without a injury and expositionsgefährdende new connection with the infusion container must be made.

Further, in a preferred embodiment, the device may be connected to another device in serial arrangement via the Luer ports. Thus, for example, two devices according to the invention can be combined with one another, wherein in each case a Luer connection of a first device can be connected to the Luer connection of a second device directly or via a suitable hose. It is possible that a liquid (medicament) from a first reservoir of a first device first passes into another container, which can be configured as a syringe and is connected via a Luer connection with a first device. After rotation of the housing parts of the first device by 90 °, a connection to a second device is produced. Subsequent rotation of the housing parts of the second device can then be followed by filling of a second container connected downstream of the second device. For this, the position of the first and second housing parts according to the invention must be selected so that a liquid flow can pass directly into a second container. The serial arrangement of the device and the filling of a second container is illustrated here by way of example only and allows the addition and mixing between liquids. However, another sequence of the filling process of a further container is possible, whereby the arrangement of the connections of the two devices, the connection itself as well as the sequence of the filling process must be adapted to the requirements of the individual case.

The invention will be explained with reference to the following figures.

It shows

1 in a perspective view of the device according to the invention,

2 in a perspective exploded view of the device according to 1 .

3 in a sectional perspective view of the device in the assembled state in a first rotational position,

4 in a perspective view of a first housing part,

5 in a sectional perspective view of the first housing part according to 4 .

6 in a further sectional perspective view of the first housing part according to 4 .

7 in a further perspective view of the first housing part according to 4 .

8th in a perspective view of the second housing part,

9 in a sectional perspective view of the second housing part according to 8th .

10 in a further sectional perspective view of the second housing part according to 8th .

11 in a perspective view an adapter,

12 in a perspective view of a connection adapter,

13 in a perspective sectional view of the connection adapter according to 12 .

14 a connection combination of the device according to the invention,

15 the connection combination 14 in a further step,

16 the connection combination 14 in a further step,

17 the connection combination 14 in a further step,

18 in a partially sectioned perspective view of the device according to 14 and

19 in a partially sectioned perspective view of the device in a cutout enlargement according to 16 ,

1 shows a perspective view of a device according to the invention 1 after the assembly. The device 1 consists of two housing parts 2 . 3 , which are cylindrical and engage in a form-fitting manner. On the first housing part 2 is a protective cap 4 placed, which conceals the piercing spike not recognizable from this drawing. To remove the protective cap 4 is an annular pull tab 5 intended. To the first housing part 2 are two luer connectors 6 . 7 molded, with the luer connector 7 with a union nut 8th is provided. Thus, there is the possibility of different connecting lines, syringes or reservoir for medicines to this housing part 2 to join. Between the protective cap 4 and the housing part 2 is an annular housing extension 13 molded, which is provided for receiving a filter. The housing extension 13 is through an air-permeable cap 14 closed, which simultaneously fixes the filter.

The second housing part 3 is from below into the first housing part 2 introduced and is held by a concealed locking device, wherein a rotational mobility due to the locking device used of the two housing parts 2 . 3 against each other is possible. The respective rotational position is determined by a rotational position indicator 10 in conjunction with a marker 9 indicated and can thus easily be visually recorded. The second housing part 2 points to its outer surface 11 circumferentially distributes a detent 12 on to the grip of the second housing part 3 to increase the rotational adjustment. The underside of the second housing part 3 is hollow-walled to save material, but this page is not intended to connect reservoirs.

2 shows in a perspective exploded view again the items of the device according to the invention 1 , namely the protective cap 4 with pull tab 5 , the first housing part 2 with the two luer connectors 6 . 7 and the union nut 8th and the second housing part 3 , which from below into the first housing part 2 can be inserted for mounting. Furthermore, from this illustration, the under the cap 4 lying piercing spike 15 visible, which by annular and integrally molded segments 16 insofar is protected that no direct contact with the piercing spike 15 can be done. The protective cap 4 is here on the segments 16 deferred until they with their lower edge on a projection 17 of the first housing part 2 to come to rest. Furthermore, it can be seen from this view that an air inlet opening 18 is present, in which a filter 19 can be used, the filter 19 To filter the surrounding atmospheric air and this air passes through the piercing spike in the aufzusetzenden reservoir for a drug and by the intended material thickness of the filter 19 Erosols are collected so that leakage of drug droplets is prevented. The filter 19 is after installation by a cap 14 fixed.

The further construction of the housing part 2 is apparent from the following, in particular cut views. The second housing part 3 with rotary position indicator 10 and outer detent 12 is also shown, it is already clear from this view that the second housing part 3 an inner cylindrical housing wall 20 has, which head side a first flow channel 21 with radial and axial extension and a second radial flow channel 22 having. The inner cylindrical housing wall 20 is here, as in particular from 3 seen in an inner cup-shaped housing wall of the first housing part 2 inserted, wherein the elongated design of the cylindrical housing wall 20 a simple assembly of the two-part embodiment of the device 1 is given as a 3-way valve. At the same time, the contact surfaces of the cylindrical housing wall serve 20 and the cup-shaped housing wall of the first housing part 2 as a sealing surface, so that the flowing fluids are not out of the device 1 can escape where appropriate, by further additional seals, the tightness can be further increased.

3 shows in a sectional perspective view of the device 1 after the assembly in a first rotational position of the second housing part 3 opposite the first housing part 2 , From this view, it can be clearly seen in particular that the first housing part 2 an outer cylindrical housing wall 25 and an inner cylindrical housing wall 26 having, wherein the inner cylindrical housing wall 26 cup-shaped, while the outer cylindrical housing wall 25 towards the cap 4 in individual integrally molded segments 16 passes. The protective cap 4 resting after being pushed on the ledge 17 and may at any time for the use of the device 1 subtracted from. The protective cap 4 serves to protect the piercing spike 15 because this is sharp-edged and thus persons with the device 1 come into contact, could possibly be injured. However, this is prevented by the protective cap and during later use of the piercing spike 15 plunged into a reservoir, not shown, so that the piercing spike 15 is secured at all times.

As already apparent from the preceding figures are to the first housing part 2 two luer connectors 6 . 7 molded, with the luer connector 7 a union nut 8th to the compound. The luer connectors 6 . 7 each have a flow channel 27 . 28 on, which allow access to the connected storage containers or connecting lines, wherein the flow channels 27 . 28 according to the position of the two housing parts 2 . 3 are partially locked, or to the piercing spike 15 can be opened. In the rotational position shown, the flow channel 27 directly with the channel of the piercing spike 15 connected while the flow channel 28 Is blocked. Opening and blocking the flow channels 27 . 28 is determined by the rotational position of the second housing part 3 causes, with the housing part 3 from an inner cylindrical housing wall 20 and an outer cylindrical housing wall 29 consists. The inner cylindrical housing wall 20 has a flow channel 22 on, which in a rotational position, not shown here, a direct passage of the two flow channels 27 . 28 allows. Furthermore, the inner cylindrical housing wall 20 a partially radial and axial flow channel 21 on which head side in the cylindrical housing wall 20 is trained. The flow channel 21 This is on the one hand by the inner cylindrical housing 20 of the second housing part 3 and the inner pot-shaped housing wall 26 of the first housing part 2 limited. In the illustrated rotational position, this flow channel connects 21 the piercing spike 15 with the flow channel 27 ,

From the 3 is further apparent that the two housing parts 2 . 3 with their outer housing walls 25 . 29 be pushed into each other and during assembly, the second housing part 3 on the outer housing wall 25 of the first housing part 2 is pushed, wherein a locking mechanism in the form of a groove 33 and a spring 34 a latching of the two housing parts 2 . 3 but at the same time allows a rotational movement of the two housing part 2 . 3 allowed against each other.

4 shows in a perspective view of the first housing part 2 in a detail, from which the outer cylindrical housing wall 25 with the two luer connectors 6 . 7 is apparent. At the Luer connector 7 In this case, the union nut is missing, so that the Luer connection as a conical neck 30 is formed while the luer connector 6 with a thread 31 is provided, which can be used to screw a union nut, so that compatibility with the usual in medical connection hoses and Luer connections 6 . 7 is guaranteed. Both luer connectors 6 . 7 are in a trough-shaped depression 32 in one piece to the first housing part 2 formed. The outer housing wall 25 of the first housing part 2 further includes the groove 33 on, in which the spring 34 of the second housing part 3 locks. Furthermore, this representation is a recess 35 visible, which as a stop for the rotational mobility of the two housing parts 2 . 3 serves, wherein a corresponding stop element of the second housing part 2 in this recess 35 intervenes. As already from the 2 the first housing part can be seen 2 on the head side in one piece integrally formed axial segments 16 over which a contact protection for the centrally arranged piercing 15 form. At the same time, the protective cap is pushed over these segments, so that the piercing spike 15 is secured. The protective cap 4 This is up to the lead 17 pushed and closes the housing part in the upper area completely. The segments 16 and the piercing spike 15 are here for receiving a reservoir, for example, for a drug, provided, wherein the piercing spike 15 can be inserted through a rubber seal of the reservoir. The liquid contained in the reservoir can via an opening 38 of the piercing spike 15 drain off, leaving at the same time another opening 39 allows an air supply, so that no vacuum is created in the reservoir. An air supply via the air-permeable cap 14 and the filter 19 in an air supply duct, which in the opening 39 empties.

5 shows in a perspective sectional view of the first housing part 2 again, in a sectional plane of the two luer connectors 6 . 7 , From this sectional view is in particular the recess 35 as well as the groove 33 in the outer housing wall 25 can be seen, wherein hereinafter the first housing part 2 an inner pot-shaped housing wall 26 having, for receiving the cylindrical housing wall 20 of the second housing part 3 is provided. Two flow channels 27 . 28 the luer connectors 6 . 7 open directly in the inner pot-shaped housing wall 26 and become dependent on the position of the second housing part 3 either with each other or with the piercing spike 15 connected. The supply channels of the piercing spike 15 are not apparent from this sectional view, but from the 6 clearly visible.

6 shows in a further sectional perspective view of the first housing part 2 in a sectional plane perpendicular to the two luer connectors 6 . 7 lies. From this sectional view is opposite to the drawing according to 5 the piercing spike 15 with the two channels 40 . 41 visible, which in an opening 38 respectively 39 lead. channel 40 runs axially and ends above the cup-shaped inner housing wall 26 while the channel 41 perpendicular to the air inlet opening 18 opens, the air inlet opening 18 is radially outwardly widened and in the housing extension 13 ends. In the air inlet opening 18 During installation, a filter is inserted, which through an air-permeable cap 14 is secured. Thus, filtered and purified air passes over the filter and channel used 41 through the opening 39 in the reservoir, not shown, while the other hand, the liquid, that is, the drug of the reservoir through the opening 38 in the channel 40 and thus in the interior of the first housing part 2 arrives. An escape of Erosolen is prevented by the filter.

7 shows in a further perspective view of the first housing part 2 , wherein in particular from this illustration, the lower edge 42 of the first housing part 2 is recognizable with the recess 35 which extends over a winding area of 90 °. The two attacks 43 . 44 thus limit the rotational mobility of the two housing parts 2 . 3 to each other. Furthermore, from this view again the groove 33 seen, which for receiving a spring of the second housing part 3 is provided.

8th shows in a perspective view of the second housing part 3 with an outer cylindrical housing wall 29 , which also has a detent 12 and an inner cylindrical housing wall 20 , which for insertion into the pot-shaped inner cylindrical housing wall 26 of the first housing part 2 is provided. From this view is also the spring 34 can be seen, which consists of individual annular segments arranged directly in the groove 33 of the first housing part 2 intervention. Furthermore, a stop element 45 formed, which in the recess 35 is guided and the rotational movement of the two housing parts 2 . 3 limited to each other. The inner cylindrical housing wall 20 has a flow channel 22 on which the two flow channels 27 . 28 the luer connectors 6 . 7 can connect with each other. Furthermore, there is a flow channel 21 present, which extends partially axially and radially, and also a connection to one of the two flow channels 27 . 28 and allows not from this drawing piercing spike. The piercing spike with its canal 40 opens directly centrally above the flow channel 21 , so that the liquid in one of the two flow channels 27 . 28 can get in dependence of the rotational position.

9 shows in a sectional perspective view of the second housing part 3 in a sectional view through the flow channel 22 , It can be seen from this illustration that the housing part 3 from an outer cylindrical housing wall 29 and an inner cylindrical housing wall 20 exists, which are hollow-walled on the bottom to save material, but this has no significance for the function.

10 shows in a further sectional perspective view of the second housing part 3 , this time in a sectional view across the flow channel 22 , so that from this representation again the partially radial and partially axially guided flow channel 21 is apparent. Furthermore, from this sectional view of the rotary position indicator 10 which is provided for visual presentation of the rotational position.

11 shows a bottle adapter 50 , which can be placed directly on a storage bottle and is designed annular. This bottle adapter 50 essentially serves to make different bottle sizes compatible and with the device 1 according to the aforementioned figures on the piercing spike 15 connect to. The bottle adapter 50 itself is annular and has a base 51 on, which at the top single integrally molded segments 52 owns, each hook-shaped with a projection 53 equipped, which lay around the neck of the bottle and thus allow a secure grip on the reservoir. The bottle adapter 50 can be made in different sizes to to allow an adaptation of different storage containers.

12 shows in a perspective view a connection adapter 60 , which consists of a housing part 62 with a luer connector 61 consists. To the housing part 62 are two movable thighs 63 . 64 molded, which at the height of the Luer connector 61 grooved pressure surfaces 65 . 66 exhibit. At the opposite end are two retaining claws 67 . 68 formed, which serve a bottleneck or a container connection to engage behind, so that the connection adapter 60 can be brought into a fixed position. The two thighs 63 . 64 , which can also be considered as rockers, because these with the housing part 62 over a narrow bridge 69 are connected, thus causing a jamming of the connection adapter 60 , By the shaping of the legs 63 . 64 This ensures that it is flexible with respect to the housing part 62 are movable and thus opening the two retaining claws 67 . 68 can be used to connect a storage container, etc. In the longitudinal direction of the Luer connector 61 is a protective cap 75 to recognize, behind which a stinging thorn 79 is located, as in particular from the following 13 seen. The protective cap 75 gets on the spike 79 deferred and serves to protect people working with the medical devices, thus a risk of infection or an unwanted adaptation of drugs through the spike 79 is prevented.

13 shows in a sectional perspective view of the connection adapter 60 , from this sectional view of the piercing 79 it can be seen, which via a connection channel 76 directly in the Luer connection 61 empties. The summit 77 of the piercing spike 79 serves to pierce into a port of a reservoir or in a bottle, through the existing there seal. A side opening 78 allows this entry of the liquid in the connecting channel 76 and thus in the Luer connection 61 ,

14 shows a first application in the form of a connection combination of the device according to the invention 1 , The device 1 with its two housing parts 2 and 3 is directly with a storage container 70 connected to a drug, further comprising a syringe 71 to a luer connector 6 is connected while the opposite luer connector 7 via a connecting hose 72 to an infusion bag 73 leads. This will be the connection adapter 60 used to connect the connecting hose 72 with the infusion bag 73 manufacture. The two housing parts 2 . 3 are in a rotational position, which is a connection of the Luer connector 6 or the existing there flow channel with the piercing spike 15 and thus with the reservoir 70 allows.

15 shows the off 14 known connection combination in a further step, after receiving the drug from the reservoir 70 into the syringe 71 by pulling out the piston 74 so the drug enters the syringe 71 arrives.

16 shows a connection combination 14 in a further step, namely now the device 1 together with the reservoir 70 turned 90 ° so that the reservoir 70 below the device 1 to come to rest. The connection was not interrupted, so that the drug in the syringe 71 located.

17 shows the connection combination 14 in a further step, wherein after rotation of the two housing parts 2 . 3 the device 1 the two flow channels 27 . 28 were opened and thus the drug from the syringe 71 over the two flow channels 27 . 28 in the connection hose 72 via the connection adapter 60 in the infusion bag 73 by confirmation of the piston 74 arrives.

18 and 19 shows the off 15 known arrangement of the device 1 with connection hose 72 and connection adapter 60 in a partially sectioned embodiment, from which it is apparent that, depending on the existing rotational position, first a connection from the piercing spike 15 over the flow channel 27 to the syringe 71 while, on the other hand, the Luer connector 7 Is blocked. After taking the drug, the rotation takes place on the one hand of the device 1 with the reservoir 70 so that the reservoir 70 below the device 1 comes to rest and on the other hand, the two housing parts 2 . 3 to each other, so that the flow channels 27 . 28 the two luer connectors 6 . 7 over the flow channel 22 connected to each other and the drug from the syringe 71 with the help of the piston 74 through the flow channels 27 . 28 in the connection hose 72 and thus in the connected infusion bag 73 can get.

The particular advantage of the device according to the invention 1 is that after placing the reservoir 70 the person does not come into contact with the medication and in particular through the tools piercing spike 15 , Luer connectors 6 . 7 and connecting hoses is secured so far that there is no danger and the drug can not escape into the environment. Thus, the drug from the reservoir 70 taken in a precisely exactly dosed form and into the infusion bag 73 be given, it is conceivable that successively several different reservoir 70 can be connected and thus virtually a drug cocktail in the infusion bag 73 can get. Alternatively, there is the possibility of having two or more devices 1 serially in series with different storage containers 70 be used, wherein according to the respective direction of rotation of the two housing parts 2 . 3 to each other initially a removal of the drug from the one reservoir 70 into the syringe and then by inserting the piston 74 in the infusion bag 73 passes and subsequently in dependence of the two rotational positions of the two housing parts 2 . 3 a removal of the second drug from another reservoir can be done, even in a precisely metered form, so then this second or any other drug also with the help of the syringe 71 in the infusion bag 73 can be introduced.

LIST OF REFERENCE NUMBERS

1

contraption

2

housing part

3

housing part

4

protective cap

5

pull tab

6

Luer connector

7

Luer connector

8th

Nut

9

mark

10

Rotary position indicator

11

area

12

latching

13

housing extension

14

cap

15

spike

16

segment

17

head Start

18

Air inlet opening

19

filter

20

housing

21

Flow channel

22

Flow channel

25

housing

26

housing

27

flow channel

28

flow channel

29

housing

30

Support

31

thread

32

deepening

33

groove

34

feather

35

recess

38

opening

39

opening

40

channel

41

channel

42

edge

43

attack

44

attack

45

stop element

50

bottle adapter

51

Base

52

segment

53

head Start

60

connection adapter

61

Luer connector

62

housing part

63

leg

64

leg

65

pressure surface

66

pressure surface

67

Retaining claw

68

Retaining claw

69

web

70

reservoir

71

syringe

72

connecting hose

73

infusion bag

74

piston

75

protective cap

76

connecting channel

77

top

78

opening

79

spike

Claims (21)

Three-way valve ( 1 ) for the administration of fluid medicaments, in particular cytostatics, comprising an at least two-part housing ( 2 . 3 ) with at least two luer connectors ( 6 . 7 ) and at least one integrated liquid receiving element in the form of a piercing spike ( 15 ), wherein a drug via the liquid receiving element from a drug reservoir ( 70 ) and a medicament receptacle ( 73 ) is fillable via a hose connection, and wherein the three-way valve is shaped so that it connects a first passage with a second passage, parallel closes a third passage and thereby prevents exposure of liquid in the environment, characterized in that two housing parts ( 2 . 3 ) are formed as hollow bodies and outer housing walls ( 25 . 29 ) and further corresponding inner housing walls ( 20 . 26 ), of which one cup-shaped and another cylindrical is formed, wherein both are rotatably supported each other and the cylindrical housing wall ( 20 ) a radial ( 22 ) and axial flow channel ( 21 ) having, wherein the axial flow channel ( 21 ) through the cup-shaped housing wall ( 26 ) of a housing part ( 2 ) and through the cylindrical housing wall ( 20 ) of the other housing part ( 3 ) is limited, wherein the housing part ( 2 ) with the piercing spike ( 15 ) a protective cover ( 4 ), and wherein a seal is present, which via the piercing spike ( 15 ) springs back and completely encloses it. Three-way valve ( 1 ) according to claim 1, characterized in that with a relative rotation of the corresponding housing walls ( 20 . 26 ) by up to 90 ° opening or blocking of a passage connection takes place. Three-way valve ( 1 ) according to claim 1 or 2, characterized in that in a first position of the corresponding inner housing walls ( 20 . 26 ) an axial passage for the removal of a drug from a reservoir ( 70 ) is released and in a second position, a radial passage for filling a medicament-receiving container ( 73 ) is releasable. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that within a first housing part ( 2 . 3 ) a stop element ( 45 ) and in the end face of a second housing part ( 2 . 3 ) extending over 90 ° degree recess ( 35 ) is formed, so that the movement of the housing parts ( 2 . 3 ) is limited. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the housing parts ( 2 . 3 ) by a groove ( 33 ) and spring ( 34 ) having locking mechanism are connected. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that a housing part ( 2 . 3 ) has an axial display element, as the rotational position indicator ( 10 ) is designed for the display of the three-way valve position. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the inner cylindrical housing wall of a housing part ( 2 . 3 ) a partially formed flow channel ( 21 ), which is radially widened on the head side. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the piercing spike ( 15 ) two independent channels ( 40 . 41 ) and a channel ( 40 . 41 ) for liquid transport and another channel ( 40 . 41 ) is provided for pressure equalization. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that upstream, behind or within an air inlet opening ( 18 ) an enclosure extension ( 13 ) to equalize a low-pressure filter ( 19 ) is arranged. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the deep filter ( 19 ) consists of a hydrophobic, activated carbon-containing material. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that above the piercing spike ( 15 ) a sealing lip is present, the removal of a reservoir ( 70 ) on the piercing spike ( 15 ) ablates adherent traces of medication. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the piercing spike ( 15 ) is bevelled end side and in the bevel side openings ( 38 . 39 ) having. Three-way valve ( 1 ) according to one of the preceding claims, characterized in that the piercing spike ( 15 ) covering protective cap ( 4 ) an annular perforated pull tab ( 5 ) having. Connection combination comprising at least one three-way valve ( 1 ) according to one of claims 1 to 13, a medicament storage container ( 70 ), a medication container ( 73 ) and a connecting tube ( 72 ), which is the three-way valve ( 1 ) with the medicament receptacle ( 73 ), characterized in that the connecting tube ( 72 ) at its the medicament receptacle ( 73 ) end facing a connection adapter ( 60 ) having a piercing spike ( 79 ) and an elastic protective cap ( 75 ) for the piercing spike ( 79 ) having. Connection combination according to claim 14, characterized in that the piercing spike ( 79 ) in the front area lateral outlet openings ( 78 ) and a pencil point. Connection combination according to claim 14 or 15, characterized in that the piercing spike ( 79 ) through the protective cap ( 75 ), which is an exposure of liquid after connection or removal from a drug receptacle ( 73 ) prevented. Connection combination according to claim 14, 15 or 16, characterized in that the medicament storage container ( 70 ) is designed as an ampoule and the medication receiving container as an infusion bag ( 73 ) is configured. Connection combination according to claim 17, characterized in that the medicament storage container ( 73 ) is an infusion bag with two connections, wherein at least one connection for receiving a piercing spike ( 79 ) of the connection adapter ( 60 ) and at least one connection is designed as a pressure relief valve. Connection combination according to claim 18, characterized in that the pressure relief valve is designed as a check valve. Connection combination according to one of claims 14 to 19, characterized in that the three-way valve ( 1 ) for the removal of liquids of different container sizes an adapter ( 50 ) having the three-way valve ( 1 ) with a medicament storage container ( 70 ) connects. Connection combination according to one of claims 14 to 20, characterized in that a plurality of three-way valves ( 1 ) are arranged serially.

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