WO2010023564A2

WO2010023564A2 - Device and method for transferring a substance from a closed source system into a target system

Info

Publication number: WO2010023564A2
Application number: PCT/IB2009/007798
Authority: WO
Inventors: Walter Pobitschka
Original assignee: Walter Pobitschka
Priority date: 2008-08-02
Filing date: 2009-07-30
Publication date: 2010-03-04
Also published as: DE102008035837A1; DE102008035837B4; WO2010023564A3

Abstract

The invention relates to a device and to a method for transferring a substance from a closed source system (G) into a target system (Z) having a casing body (1), inside of which the substance is present, wherein the casing body (1) comprises at least one connection (2, 3) to at least one target system (Z). For this purpose, it should be possible to select the target system and achieve a substance transfer to reduce the risk of contamination. According to two embodiments, the method is to reduce the risk of contamination during the transfer of the substance to a living organism. With respect to the device, the object is achieved in that the connection (2, 3) protrudes freely from the casing body (1) and is connected thereto in a sterile manner. With respect to the method, the object is achieved for one in that the free end of the connection is perforated directly before injection into the target system, and secondly in that the substance reaches an infusion set connected in a sterile manner via the connection of the source system, said infusion set being a closed target and source system, and that from there the substance reaches the target system.

Description

"Device and method for transferring a substance from a closed donor system to a target system"

The present invention relates to a device for transferring a substance from a closed donor system into a target system with an enveloping body, within which the substance is contained, wherein the enveloping body has at least one connection to at least one target system.

Furthermore, the present invention relates to a method for transferring a substance from a closed donor system into a target system, wherein substance reaches at least one target system from an enveloping body and its at least one connection.

Background of the invention is the practice practiced in the medical field of transferring liquids or suspensions into the human organism, which substance communicates with the environment during preparation and measurement. The same applies to supply lines and containers in which the substances are filled. In any case, there is an exchange with the unsterile atmosphere. This, of course, involves contamination risks. Especially with regard to the addition of an infusion within a hospital room with several patients, the bacteria and viruses contained in the hospital room come into direct contact with the liquid or suspension which is to be injected or infused into the patient.

Previous measures to limit the risk of contamination are that shortly before the application to the patient injection liquid is drawn up in syringes within a sterile bench. In addition, pre-filled syringes are already known, which are assembled under sterile conditions with liquids or suspensions. In addition, packaged infusion solutions are known in collapsible plastic bags, wherein the filling of the plastic bag in the factory takes place under sterile conditions. Although all of these measures reduce the risk of contamination of the contact of the substance to be administered with an unsterile atmosphere, but can not ensure a closure of a container until the substance exits.

Patients with permanently established fixed accesses require monitoring and care of these accesses. This is especially true for the mechanical coupling units

BESTATIGUNGSKOPIE these accesses, such. B. Luerlok or special valve systems. Very complex just need the coupling units to be disinfected before each substance transfer.

Regardless of the human or even animal organism as the destination of the substance transfer, the need for the least possible contamination naturally also applies to measuring instruments, reactors or containers which are provided with an inlet via a cannula. In addition, line systems or mechanical coupling systems or even sterile systems are among the target systems.

A device with which a substance is transferred under closed conditions from a donor system to a target system results from DE 101 51 343 A1. This document is about a bag system for the cryopreservation of body fluids. A predetermined number of bags are interconnected by conduits and substance is transferred within the closed systems. Due to the integration of all bags within a system, it is not possible to use the bags shown there in individual applications. The connections are part of a piping system and do not allow a different application.

Based on the state of the art, the object of the invention is to provide a device and a method, wherein the target system can be selected and a substance transfer can be achieved while reducing the risk of contamination. In a closed

System as a target system, the substance should be transferred without contamination, in an open system as a target system, the substance should be transferred low contamination. The

According to two embodiments, the method is intended to reduce the risk of contamination during the transfer of the substance to a living organism.

The above object is achieved with respect to the device by the features of claim 1. Thereafter, a device of the type in question is designed such that the terminal has a free end which protrudes freely from the envelope body and is connected to this sterile.

The above object is achieved with respect to the method according to a first alternative by the features of claim 32. After that, a procedure in question standing type designed and refined so that the free end of the connection is perforated immediately prior to injection into the target system.

The above object is achieved in terms of the method according to a second Altemati- ve by the features of claim 36. Thereafter, a method of the type in question is designed and developed such that the free end of the connection to the target system in the form of an infusion set is sterile connected, the substance passes from the infusion set to a next target system by a connection between the infusion set and the next target system is produced.

Starting from DE 101 51 343 A1, it has first been recognized that a largely contamination-free transfer of a substance is possible there within a closed system with a plurality of containers connected via predetermined connecting lines. It has also been recognized that it would be desirable for pharmaceutical and pharmaceutical substances to be generally transferable while reducing the risk of contamination. Particularly living organisms, patients, should be given medications that are not contaminated by environmental factors, such as pathogens. According to the invention, it has been recognized in an astonishingly simple manner to provide a closed donor system which can be connected to different target systems in order to transfer the substance contained therein. Finally, it has been recognized in constructive terms to make the connection freely projecting from the envelope, so that the connection with the target system can take place easily and without problems. A port with a free end that can come into contact with any target systems, both through sterile closed-system connectivity and through contact with an open system, such as devices, leads, and, ultimately, administration of injections while destroying the device connection. According to a preferred variant of the second alternative of the method, initially a sterile connection to an infusion set can take place, which is then coupled for the transfer of the substance into the last target system here, namely to the vascular access of a patient.

With regard to the first alternative of the method according to the invention, it has been recognized that in the case of injection devices as a closed donor system, the connection is perforated immediately before the transfer, before the injection takes place. The time within which an injection cannula comes into contact with the ambient air is very small. Therefore, that will Reduced risk of contamination. It is particularly preferred that this method be used in injections into the living organism, which of course does not preclude injection into conduits, devices and the like.

With regard to the second alternative of the method according to the invention, it has been recognized that in the case of an infusion set as a sterile connected target system, a further transfer of the substance into a next target system must necessarily follow. The prime consideration here is the living organism, the human or animal patient, to whom infusions must be administered. Due to the closed donor system, the sterile infusion set, the substance is not contaminated with pathogens from the environment. Only when the connection to the next target system is imminent, only in this short time window, does the substance come into contact with the ambient air. It is obvious that in accordance with the invention the risk of contamination is reduced.

According to a first, very simple embodiment, the substance is not contained in the envelope itself, but in a container. The envelope body could surround the container at a distance or encase. The container could be in the form of an ampoule with puncture stopper or vial. The coated ampoule with sterile connectable connection forms a closed donor system. In this first embodiment, the pressure equalization could be completely relocated to the target system and the resulting pressure difference in the donor system can be accepted, since the empty ampoule is disposed of after sterile separation from the target system. The target system could be present as an injection device, by means of which the substance is removable from the donor system in the form of the sheathed ampoule. The injection device could in turn be part of a closed system and comprise a connection which is already connected to the connection of the encoder system in the factory sterile. To remove the substance, the cannula of the injection device could puncture the elastomeric stopper, air or inert gas could be injected into the ampoule, so that the contents of the ampoule are under pressure and thus a fine metering is possible during removal or suction of the substance, without the negative pressure , The target system could be a closed system with two ports according to a variant of the fourth embodiment. A connection is used for sterile connection with the encoder system according to In the first exemplary embodiment, another connection is suitable for direct injection if the injection device itself becomes the transmitter system after being filled with the substance itself.

The container within the enveloping body could also be an infusion bottle or another vessel which is preferably resealable and whose opening and closing can be realized from outside via the enveloping body. In consideration but also Abbrechampullen, the contents of which is poured into the envelope and from there - after appropriate sterile connection with the target system - can be sucked. For ampoules, bottles or possibly a Karpullenkörper the closure could be in the form of a puncture stopper. The piercing plug could be made of elastomer and teflonized. As an alternative to a container in the form of an evacuated storage vessel with piercing stoppers, it is also possible to use commercial airtight containers which can be closed airtight with screw cap or snap closure. Preferably, containers made of rososilicate glass could be used, which are suitable for aggressive substances that attack plastic. An aggressive substance could be, for example, dimethyl sulfoxide (DMSO). It was a substance that preserves a patient's stem cells and supplies them under sterile conditions. It is advantageous that the storage stability of the substance DMSO in a container made of borosilicate glass is two years. A connection made of PVC, is contacted only briefly during the transfer of the DMSO, so that dissolution processes are not set in motion. Apart from DMSO, another substance can also be contained in the container which, for example, is incompatible with another component. Closed systems, which are pure target systems, could be hose and bag systems.

According to a second, likewise very simple embodiment of the device according to the invention, the enveloping body could directly contain the substance and be present as a collapsible, flexible pouch. This embodiment enables cost-effective production and storage of substances, such as preparation solutions, at the point of use while maintaining the integrity of the system. The enveloping body can have a volume of between 30 ml and 1000 ml in larger pack sizes. In small quantities, so-called "minibags" reach a volume of between 10 ml and 30 ml. These "minibags" are intended for individual use and may each contain the maximum amount of substance required for the intended preparation. In the second embodiment, the port could open into the container with one end and protrude minimally into the substance and be there provided with a resealable closure. The projecting free end of the connection according to the invention could be welded to another system in a sterile manner or already be sterile.

The reclosability of the end of the connection projecting into the substance makes possible the partial removal of substances, such as, for example, preparation solutions, of course taking into account the sterile connection and disconnection. Of particular importance for the second embodiment is the formation of the closure as a snap closure of sealing material, which is equipped with a mounting bridge and can be actuated via the flexible wall of the container. The attachment bridge serves for the captivity of the closure. The closure ensures that the substance is not introduced into the connection before the sterile connection has taken place and is possibly contaminated. The material of the bagged container is soft but strong enough not to be damaged during manipulation of the closure.

In terms of design, the enveloping body in bag form could comprise a base plate through which the connection is guided in a sealed manner. A pressure compensation device could be provided which opens into the area of the container filled with air or inert gas, which always points upwards in the operating position, while the substance, according to the gravitational force, fills the lower part of the bag and the connection with its outlet to the outlet Ground points.

Starting from the idea of an ampoule with puncture plugs within an enveloping body, according to a third exemplary embodiment of the device according to the invention based on the principle of gravitation, the connection could be welded into a base plate of the enveloping body in a sterile manner and comprise a short cannula. The opening of the ampoule closed with the piercing plug and the connection protruding from the enveloping body could face the bottom. As an alternative to a purely gravity-induced transfer, a suction device could also be used. In the third embodiment, it is particularly important to the formation of the envelope, since the short cannula in the operating position to pierce the puncture stopper of the ampoule, but should maintain a safe distance in the rest position.

For this purpose, at least a part of the wall of the enveloping body could be formed so flexible that the short cannula enters the container in the operating position, or is manipulated therefrom from the outside. A particularly easy to handle variant is that the flexible wall is designed in the form of a bellows. This bellows could be strongly deformed in all directions due to the extremely tear-resistant and thin material, which could also be stretchable beyond. This deformation is reversible. Due to the low material thickness, objects located inside the container can be grasped, connected or positioned or otherwise manipulated. Because of the gripping movement, it is particularly important that the wall comprises at least two opposite flexible areas. With regard to the production of the enveloping body, the bellows could be welded or glued sealingly to a base plate, possibly to a cover plate of the enveloping body.

In the third embodiment in question, in addition to the short cannula serving for transmitting the substance, a long cannula for supplying air or inert gas could be provided. Both cannulas could pierce the closure of the container in the operating position and protrude into this.

At rest, the bellows is extended and takes up the two cannulas. The cannulas are prevented by a holding device from puncturing the closure of the container. For fixing the holding device, the shape of the container can be exploited, also, the holding device can be supported on the base plate of the envelope. The holding device could be in the form of a flexible slotted sleeve according to a preferred structural embodiment, which is particularly easy to handle. As long as the cannulas are not used, they are arranged in the holding device, which protects the bellows of the enveloping body before piercing. The sleeve is supported in the resting state on the one hand against the base plate of the enveloping body, on the other hand against the shoulders of the container in the enveloping body. In the operating position, the sleeve is manipulated from the outside via the bellows, now lies around the container and the Cannulas pierce the closure. The bellows of the envelope is thereby moved together.

The long cannula could open with its end facing away from the container in the enveloping body, which is connected to a pressure compensation device. In this way, the long cannula in the operating position for the pressure equalization in the container. Since the material of the enveloping body could be stretchable, it is also possible to form a pressure compensation device from this property. The pressure compensation device would then be that escaping intrinsic air that passes from the container into the enveloping body, expands and fills the Hülkörper. If substance is removed from the container, system-internal air reaches the container via the long cannula from the stretched enveloping body.

With regard to readily salable units and with regard to the reduction of the handling effort for the user, overall encoder systems are designed according to a preferred embodiment, wherein the closed encoder system is already prefabricated with further closed systems and is sterile connected. In this case, the further closed system has indispensably not only a target function but also a donor function.

Both in the device according to the invention according to the second embodiment and in the device according to the invention according to the third embodiment, the above-described total donor system could include next to an infusion bottle or ampoule within an envelope as a pure donor system also a preferably calibrated drip chamber as another closed system. The overall system could alternatively or additionally have an infusion set as another closed system with donor as well as target function. Particularly preferred is the embodiment of the total donor system with calibrated drip chamber for volume-accurate transfer and with the infusion set for connection to the actual target system, namely the living organism, with the vascular connection of the connection of Infusionsbe- plug or the entire system is connectable. The metering system, the drip chamber and the infusion set could be assigned a dosing shut-off. In the embodiment of the third embodiment described above, the connection of the infusion set could initially be connected to a vent syringe, via which the substance is sucked from the drip chamber into the infusion set until the ambient air largely displaced from the infusion set. The venting syringe could also be associated with a dosing barrier and it itself could be contained in an enveloping body. Again, that a pressure equalization should take place via a pressure compensation device. Since the material of the enveloping body could be stretchable, it is possible to form a pressure compensation device from this property. The pressure compensation device would then be that escaping system-internal air, the envelope body expands and fills, especially in the bellows area. Alternatively, a pressure equalization container could be sterile connected to the enveloping body and fluidly connected.

The connection means between the venting syringe and the infusion set could be detachable, so that the connection means of the infusion set can be connected to the vascular access of an organism as the last target system after the removal of the venting syringe.

A filter device could be provided between the venting syringe and the infusion set. In this case, a bacterial filter with a pore size of about 0.2 microns could be used in an advantageous manner. Depending on the nature of the substance to be transferred and the pore size of the filter, it may be necessary that the filter device must be removed before connecting the infusion set to the vascular access, so as not to obstruct flow. During the release of the connection between the vent syringe and the infusion set capillary forces prevent the substance or infusion solution from escaping from the infusion set. The allocation of the filter device to the connection means of the infusion set is recognized as being particularly advantageous. When the solution is removed from the breather, the filter device protects the substance from contamination until it is removed just prior to connection to the vascular access.

With regard to a sterile connection of the encoder system to the target system, the connection could be in the form of a flexible plastic tube. It could be a thermoplastic which is suitable for known sterile bonding techniques such as "sterile docking" and "sterile welding". "DOCKING" is about creating cuts under the influence of temperature and directly fusing both ends of two plastic hoses. "WELDING" involves the separation of the joint, whereby compression under temperature leads to the formation of a homogeneous cross-sectional area and cutting that two closed cut surfaces arise. However, the sterile connection can also be carried out independently of the aforementioned connection steps. As the "Sterile Docking" and "Sterile Welding" are manufactured in a known manner by mounting and welding of plastic containers and hoses under clean room conditions and sterilization measures.

Regardless of whether the substance is contained directly in the enveloping body or in a container which is surrounded by the enveloping body, this could include a pressure compensation device. The pressure equalization could take place wherever volume changes of the substance occur. As a rule, this could occur both with the encoder system and with the target system as well as with an overall system and its integrated closed systems with target and encoder function.

According to a fourth embodiment of the device according to the invention, the container could be part of an injection device and have a connection made of easily penetrable material. The connection could be designed as a transparent flexible hose, for example as latex hose or latex corrugated hose. This allows for direct injection into a target system as an organism. The substance within the injection device is sealed off from the environment until puncture into the organism and only enters the atmosphere after piercing the connection by means of the cannula of the injection device. Thus, the substance is only minimally exposed to a contamination risk.

In the fourth exemplary embodiment, too, the enveloping body may have a flexible wall in regions, so that the injection device can be actuated from the outside. A variant which has proven itself in practice, provides for the formation of the flexible Hüllkörperwandung as a bellows before. As already explained in connection with the second and third embodiments, the enveloping body according to the fourth exemplary embodiment could also comprise a pressure compensation device. Alternatively, generous foil envelopes could also be used as enveloping bodies. These could contain intrinsic gas / air and allow pressure equalization.

In view of a convenient handling and a direct applicability of the device according to the invention, it is preferred if the injection device is pre-filled. This could be done at the factory under clean room conditions. The injection equipment However, tion could also be filled on site by substance is removed from a device according to the invention according to the first embodiment.

So that the special, easily perforable connection is not damaged, the injection device could be assigned a protective sleeve which engages over the free connection projecting from the enveloping body and is removed in the operating position. This protective sleeve could, for example, be screwed onto the baseplate of the enveloping body or else on the wrapper body additionally surrounding the throwing barrel of a carpule.

The fourth embodiment offers various applications. On the one hand can be injected with a cannula directly under perforation of the connection in the organism. On the other hand, however, the connection can first be perforated, then pushed up to the envelope body and finally the exposed cannula can be used normally. In the latter case, it is advantageous if the pushed-up connection does not hinder the injection and moves unintentionally in the direction of the needle tip. Therefore, fastening means could be provided on the enveloping body in the region of the connection, at which the perforated and pushed back connection can be fixed in the operating position.

According to a particularly preferred variant of the fourth embodiment, the injection device could have two ports, one of which is sterile connectable and the other consists of the easily perforable material. In this way, the user is free to transfer the substance contained in the injection device into another closed system after he has carried out a sterile connection or to inject the substance directly into a target system at the risk of a very low risk Kontaminati- ons. The target system may be a living organism but may also be a conduit system, a laboratory instrument or a measuring instrument.

The device according to the invention described in the fourth embodiment could contain a syringe and the container for the substance could be in the form of the syringe part, namely the ampoule cannula. The use of a calibrated syringe with an ampoule flask and an ampoule body allows an active metered transfer of the substance. The syringe can be manually operated on the envelope body, but also be introduced into a known per se electromotive pumping system in which the dosage can be programmed time and volume precision. However, tion could also be filled on site by substance is removed from a device according to the invention according to the first embodiment.

In order for the special, easily perforable connector is not damaged, the Injekti- could ^{'onseinrichtung} a protective sleeve be associated with that overlaps the protruding from the envelope body free port and is removed in the operating position. This protective sleeve could, for example, be screwed onto the baseplate of the enveloping body or else on the wrapper body additionally surrounding the throwing barrel of a carpule.

According to a particularly preferred variant of the fourth embodiment, the injection device could have two ports, one of which is sterile connectable and the other consists of the easily perforable material. In this way, the user is free to transfer the substance contained in the injection device into another closed system after he has carried out a sterile connection or to inject the substance directly into a target system at the risk of a very low risk Kontaminati- ons. The target system may be a living organism but may also be a conduit system, a laboratory instrument or a measuring instrument. It is also conceivable variant, with only a latex connection could be provided in pre-filled syringes.

The device according to the invention described in the fourth embodiment could contain a syringe and the container for the substance could be in the form of the syringe component, namely the cannula cartridge. The use of a calibrated syringe with an ampoule flask and an ampoule body allows an active metered transfer of the substance. The syringe can be manually operated via the enveloping body, but also in a known per se electromotive pumping system are introduced, in which the dosage can be programmed time and volume precision.

In terms of design, the prefilled ampule body of the syringe could be mounted in a holding device on the base plate of the enveloping body and protrude with the cannula into the connection in the form of a latex tube. At the end of the ampoule body facing away from the stopper, a stopcock could be provided. The sleeve-shaped holding device could have a recess through which an opening and closing of the stopcock can take place from outside via the bellows.

A variant of the present as a syringe embodiment provides the ampoule body to assign a cannula with a cannula closure, which can be opened and closed via the flexible wall of the envelope. A faster emptying and filling of the pressure compensation device according to the variable gas volume in Hüll- body is achieved if the enveloping body comprises two chambers with two connecting pieces for preferably a pressure compensation device or two smaller separate pressure compensation devices. In this case, the first chamber could contain the ampoule flask and the second chamber could contain the ampoule body with the cannula and the closure. Deviating from other embodiments, in which the connection is welded into a base plate of the enveloping body, the second chamber of the enveloping body could here at the end facing away from the first chamber for the ampoule flask at least the connection for the sterile connection with the connection of another closed system itself form. In addition or as an alternative, however, a connection could also be arranged on the enveloping body of the variant in question, which can easily be perforated.

Of particular advantage in terms of design is in the syringe variant, the space-saving design of the envelope either from a single full-length bellows between the base and cover plate or a combination of enclosure in the area of the vial body and a bellows in the area of the vial. As a result, the device according to the invention can be clamped better in a syringe pump known per se, since the enveloping body is reduced to a minimum. As an alternative to the variant of the fourth exemplary embodiment, which concerns a syringe, the device according to the invention could contain a cartridge. In this case, the container in which the substance is contained, in the form of Karpullenbestandteils, namely the Karpullenkörpes be present. The carpule body could be calibrated for metered delivery of the substance. The Karpulle includes a Karpullenkörper displaceable Karpullenkolben. Again, the envelope body could be constructed of two chambers, wherein a pressure compensation device is provided per chamber. In the first chamber, a cannula could be provided, which points with its tip to the body of the carcass, or its piercing plug and protrudes with its opposite end into the port. The connection could also be present here as a sterile connectable plastic tube for connection to a closed target system. Alternatively or additionally, an easily penetrable connection could also be provided, in particular if direct injection is to be undertaken.

The second chamber of the enveloping body could consist of a cylindrical portion and a bellows, wherein within a cylindrical portion of the Karpullenkörper is included and a part of the Karpullenkolbens and wherein contained within the bellows the rest of the Karpullenkolbens. With regard to the realization of the piercing operation, this chamber and a transfer barrel of the first chamber could be movable relative to one another relative to one another and preferably fixable to one another in a predetermined position. On Überwurftubus an external thread could be provided, on which a protective sleeve to protect the terminal and the cannula with a corresponding internal thread can be screwed.

The transfer of the substance takes place after production of the flow connection from the container to the connection in that the Karpullenkolben shifts a Gleitstopfen within the Karpullenkörpers. The Karpulle allows the portionwise and volume accurate delivery of the substance from the carpule body and could be particularly useful as disposable items.

A particular advantage of the device according to the invention is that in itself inexpensive containers, such as ampoules, bottles, syringes, carpules and connections, which are otherwise used in open systems, applied by the enveloping body with the freely projecting connection to fully closed systems can be. The arrangement of the low-cost donor systems in a corresponding envelope a closed system can be produced, which can interact with other closed or open systems. Thus, low-cost sensor systems can be used in the device according to the invention and made accessible to medical and scientific work. Basically, it is desirable to store each substance for complex preparation steps within a container within a closed system.

According to the first alternative, the method according to the invention could be designed so that the end face of the easily perforable connection contacts the target system before it is perforated by means of the injection device, in particular the cannula, and the substance is administered into the target system. The front side could preferably consist of a disc-shaped latex foil. This end-face latex film could be bordered by a latex ring, which can be fixed as required on the outside of the enveloping body in the region of the connection if the end face is already pierced. The piercing of the end face of the perforable connection could also be done without making contact between the connection and the target system. In this method, a device according to the invention can advantageously be used with an injection device according to the fourth embodiment.

The inventive method could be designed according to the second alternative so that the substance does not enter directly into the infusion set, but first into a drip chamber and from there into the infusion set. According to a preferred embodiment of the method, the substance could be sucked via a vent syringe from the drip chamber into the infusion set until the gas, for example. Inert gas or air is largely displaced from the infusion set. The connection between the vent syringe and the infusion set is then released and the infusion set is connected to a vascular access of an organism.

After the solution of the connection between the vent syringe and infusion set has been made, a possibly existing filter device could be removed with a for the substance to fine-pore filter before the connection of the infusion set takes place with the vascular access of the organism. Preferably, an apparatus according to the second and third embodiments of the device according to the invention can be used to carry out this method.

There are now various possibilities for designing and developing the teaching of the present invention in an advantageous manner. For this purpose, on the one hand to the claims subordinate to claim 1, on the other hand, to refer to the following explanation of several embodiments of the invention with reference to the drawings. In connection with the explanation of the cited embodiment of the invention, generally preferred embodiments and developments of the teaching are explained. In the drawing show

1 is a schematic representation of a front view of a device according to the invention according to a first embodiment,

Fig. 2 is a schematic representation of a front view of an inventive

Device according to a second embodiment,

Fig. 3 is a schematic representation of a front view of an inventive

Device at rest,

4 in a schematic representation, the object of FIG. 3 in the operating position,

5 is a schematic representation of a variant of the fourth embodiment of the device according to the invention with syringe and sterile connectable connection,

5B the device in a blister pack, in FIG. 5B the device during the connection of the closed system with a donor system, in FIG. 5C the device in operating position - here piercing an ampoule of the donor system, in Fig. 5D, the device in the operating position - here emptying of air into the ampoule of the encoder system, in Fig. 5E, the device in the operating position - here sucking the substance from the ampoule of the donor system, in Fig. 5F, the device in the operating position - here sterile

Separating the connection from the connection of the donor system, in FIG. 5G the device as a donor system in rest position - readiness for transfer of the filled substance into a target system, in FIG. 5H the unfilled device, prefabricated with a donor system,

6 is a schematic diagram of a detail of an enveloping body with two, different terminals according to a further variant of the fourth embodiment,

7 is a schematic representation of the subject of FIG. 6 with a sterile connected encoder system according to FIG. 1, FIG.

8 is a schematic representation of a variant of the fourth embodiment of the device according to the invention with syringe and perforable connection and

9 is a schematic representation of a variant of the fourth exemplary embodiment of the device according to the invention with cartridge and perforable attachment.

The figures show a device for transferring a substance from a closed donor system G into a target system Z with an enveloping body 1, within which the substance is contained, wherein the enveloping body 1 has at least one connection 2, 3 to at least one target system Z.

In FIGS. 1, 5, 6, 7 and 9 it is illustrated that the connection 2, 3 protrudes freely from the enveloping body 1 according to the invention and is connected to it in a sterile manner. In the apparatus according to the first, third and fourth embodiments, a container 4 is provided for the substance within the enveloping body 1. According to FIG. 1, the container 4 is an ampoule with puncture plugs 5. 6 denotes a metal seal. This donor system G according to FIG. 1 plays a role in connection with FIGS. 5B to 5F and FIG. 5H. There, the target system Z is an injection device within an enveloping body 1 with two chambers 7, 8 and a connection 2, by means of which the donor system G, the substance can be removed. While FIGS. 5B to 5F show the coupling, the substance transfer and the decoupling between the donor system G and the target system Z, FIG. 5H shows a factory-prefabricated unit from the injection device as a component of a closed system and donor system, the two connections 2 already connected sterile.

The second embodiment of the device according to the invention is shown in FIG. There, the enveloping body 1 is a collapsible bag, in which the substance is directly contained. The local connection 2 is already factory sterile connected to the cover plate 9 of a calibrated drip chamber 10 and this again sterile over its base plate 11 with an infusion set 12. The terminal 2 is welded into the base plate 11 of the envelope 1 and protrudes minimally with its hüllkörperseitigen end the substance in the enveloping body 1, so that when emptying a minimal amount of substance remains in the enveloping body. The terminal 2 has a snap closure 13 of sealing material with a mounting bridge 14. The snap closure 13 can be actuated via the flexible wall of the enveloping body 1. At the upper end of the enveloping body 1, an eyelet 15 is provided for suspending the device.

In Figs. 3 and 4, the third embodiment of the device according to the invention is shown, which has many similarities with the second embodiment. Differences are that a present as an infusion bottle container 4 is provided within the specially designed envelope 1. In addition, the port 2 comprises a short cannula 16. Furthermore, a long cannula 17 is provided. The eyelet 15 is arranged on the cover plate 9 of the enveloping body 1.

Fig. 3 shows that the short cannula 16 and the long cannula 17 are arranged in the rest position in a holding device 18 in the form of a slotted sleeve, which is supported on the one hand against the base plate 11 of the enveloping body 1, on the other hand against the container 4. In 4, wherein the bellows 19 of the enveloping body 1 is pushed together, the holding device 18 engages around the container 4, while the cannulas 16, 17 pierce the puncture stopper 5 of the container 4.

As in the second embodiment, the terminal 2, the base plate 11 of the enveloping body 1 is sterile welded and has in the operating position to the ground, so that the gravitational force can be exploited. Again, the port 2 is already factory sterile connected to the cover plate 9 a calibrated drip chamber 10 and this in turn sterile over its base plate 11 with an infusion set 12th

FIGS. 2 to 4 show that the enveloping body 1 and the drip chamber 10 each have a pressure compensation device 20. The long cannula 17 opens with one end in enveloping body 1 and provides in the operating position for pressure equalization in the container 4, since it projects into the air or inert gas region of the container 4 and not into the substance. In Fig. 4 it is clear that the pressure compensation device 20 is filled, since gas has been displaced by the compression of the bellows 19.

In the devices shown in FIGS. 2 to 4, the encoder systems G are part of a total encoder system G total, which in each case comprises two further closed systems G / Z, which have both donor and target function. A sterile connection with each other is guaranteed. Specifically, the overall donor system G total includes the infusion set 12 and the calibrated drip chamber 10 as further closed systems G / Z, which are both donor and target G / Z systems. The infusion set 12 interacts with its free end with a venting syringe 21, which is likewise arranged in an enveloping body 1 with a bellows 19 in the piston area and a connection 2. There are detachable connection means 22, 23 provided between the venting syringe 21 and infusion set 12. Between the connecting means 22, 23, a filter device 24 is provided, which is removed before the connecting means 23 of the infusion set 12 is connected to the target system Z, which is present here as a vascular access of an organism.

The port 2, the infusion set 12, the venting syringe 21 and the pressure compensation device 20 of the drip chamber 10 are each a Dosierabsperrung 25 assigned. The procedure is carried out that in the devices according to the second and third embodiment of FIG. 2, 3, 4

The substance drips from the donor system G into the drip chamber 10 - G / Z before reaching the infusion set 12,

The substance is sucked out of the drip chamber 10 - G / Z into the infusion set 12 - G / Z via the venting syringe 21 until the gas has largely been expelled from the infusion set 12,

• that the connection between vent syringe 21 and infusion set 12 is released

• and that the infusion set 12 is connected to a target system Z.

The connection 2 described so far is a flexible plastic tube which can be connected in a sterile manner with a closed system G / Z, Z.

In the fourth embodiment of the device according to the invention, a container 4 is also provided within the enveloping body 1. There, the container 4 is part of an injection device.

Already in consideration of the movable piston of an injection device, the enveloping body 1 has a bellows 19, via which the injection device can be actuated. In addition, a pressure compensation device 20 is also provided here. In FIGS. 5A to 5H, a pressure compensation device 20 is connected to two chambers 7, 8. In Fig. 9 per chamber 7, 8 each a pressure compensation device 20 is provided.

According to the different variants of the fourth embodiment shown in FIG. 5G and FIGS. 8 and 9, the injection devices, namely two syringes according to FIGS. 5G and 8, and a cartridge according to FIG. 9 are filled. In Fig. 5G, the filling is realized by the user, in Figs. 8 and 9 are factory-filled containers 4 in the form of ampoules bodies 26 of the two syringes and the Karpullenkörpers 27 of the carpal. The device according to FIG. 5G has in this state achieved its function as a donor system G and is ready for sterile connection to a target system Z and for subsequent substance transfer. Beforehand, the following process steps take place:

Removal of the device from the blister pack 28 shown in FIG. 5A,

Sterile connecting the terminal 2 of the closed target system Z to the terminal 2 of the donor system G and removing the cannula closure 29 from the outside via the bellows 19 of the chamber 8 of the enveloping body 1 in Fig. 5B, - in Fig. 5C: piercing the puncture plug 5 of the container 4 of the donor system G, introducing the cannula 30 into the container 4 of the donor system G, in Fig. 5D: Retraction of the ampoule piston 31 in the ampoule body 26 and introducing air from the ampoule body 26 in the substance containing container 4 of the donor system G, where an overpressure is formed there, thereby permitting fine metering of the substance during removal without a vacuum effect; When shrinking the chambers 7, 8, the pressure compensation device 20 is filled with gas from the chambers 7, 8, in Fig. 5E: beginning of the suction of the substance from the donor system G in the vial body 26 by pulling the vial plunger 31 from the ampule body 26th , or in the target system Z; When enlarging the chambers 7, 8 gas from the pressure compensation device 20 enters into this, in Fig. 5F: The suction of the substance from the donor system G in the vial body 26 is completed, it takes place the sterile Diskonnektieren the terminal 2 of the closed target system Z of the Connection 2 of the donor system G, in FIG. 5G: From the target system Z according to FIGS. 5A to 5F, a closed donor system G has become. There is readiness for the sterile connection with another closed target system Z ₁ to transfer the stored substance.

In the variant according to FIGS. 5A to 5H, the enveloping body 1 or its chamber 8 itself forms the connection 2, which can be connected in a sterile manner. FIGS. 6 and 7 show an alternative enveloping body 1 with two ports 2 and 3, wherein port 3 consists of easily penetratable material and allows direct injection into a target system Z, which is present here as an organism. Both terminals 2, 3 are welded into the base plate 11 of the enveloping body 1 sterile. FIG. 7 shows that the connection 2 is connected in a sterile manner to another enveloping body 1 which contains a container 4.

In the variant of the fourth embodiment shown in FIG. 8, the rest position is shown, in which case the terminal 3 is overlapped by a protective sleeve 32. The protective sleeve 32 is screwed with its internal thread, not shown in more detail on the likewise unspecified Asked external thread of the base plate 11 of the enveloping body 1 and is removed if necessary. The cover plate 9 is glued to the end of the ampoule piston 31. The filled with substance ampoule body 26 is seated in a holding device 33 which has a passage opening 34 through which a stopcock 35 at the end of the ampoule body 26 via the bellows 19 can be actuated.

The existing bellows bellows-shaped terminal 3 is welded in accordance with FIGS. 8 and 9 on the base plate 11 of the enveloping body sterile. On its front side there is a disc-shaped latex foil 36, which is surrounded by a latex ring 37. The latex sheet 36 is perforated by the cannula 30, 40, which is movable from the outside via the piston 31, 39 to the front. The latex ring 37 can be fixed to fastening means 38, which are arranged on the base plate 11 of the enveloping body, in the region of the connection 3. The fastening means 38 are in the form of a projection or a nose, on which the ring is secured after release of the cannula 30, 40.

In the variant of the fourth embodiment shown in FIG. 9, the rest position is also shown. This is a container 4 in the form of the Karpullenkörpers 27 a calibrated carpal. The enveloping body 1 here is constructed somewhat more complicated and comprises two chambers 7, 8. Each chamber 7, 8 is fluid-connected to one pressure-equalizing device 20 each. The chamber 7 contains the Karpullenkörper 27 and a Karpullenkolben 39. The chamber 8 contains at least partially a cannula 40. The cannula 40 has with a tip to the body of the cartilage 27 and protrudes in the rest position with its opposite tip into the port 3 inside. The Karpullenkörper 27 is closed with a puncture plug 5. By means of the Karpullenkolbens 39, a sliding plug 41 is displaceable. The Karpullenkolben 39 is disposed in the chamber 7, which includes a bellows 19 and a cylindrical portion in the form of a stable sleeve 42. The end of the Karpullenkolbens 39 is bonded to the cover plate 9, on which the bellows 19 is arranged. The bellows 19 then goes into the stable sleeve 42, which also receives the Karpullenkörper 27. At Karpullenkörperseitigen end of the sleeve 42, a radially inwardly facing annular shoulder 43 is provided, against which the Karpullenkörper 27 is supported. At the piston end of the Karpullenkörpers 27, the sleeve 42 also has a radially inwardly facing annular shoulder 44, which counteracts an axial movement of the Karpullenkolbens 39. While the annular shoulder 43 is already formed on the sleeve 42, the annular shoulder 44 is formed by the fact that after insertion of the Karpullenkörpers 27 into the sleeve 42, a ring is inserted into the sleeve 42, which is welded to the sleeve 42 and so the annular shoulder 44 trains.

The chamber 8 is welded to the annular shoulder 43 of the sleeve 42. The chambers 7, 8 are fluidly connected in the slightest extent, at least not sufficient to use only one pressure compensation device 1. In addition, the chamber 8 a Überwurftubus 45 and therein a welded to the base plate 11 bellows 19. The transfer tube 45 engages over the free end of the stable sleeve 42, both components are movable relative to each other and include locking means in the form of a recess 46 and a projection 47, which engage in the operating position and fix the position of the cannula 40 in the Karpullenkörper 27.

The present as a factory-filled with substance donor system G present device according to the fourth embodiment of the carpal is operated as follows:

Moving the Überwurftubus 45 with the bellows 19 and welded to the base plate 11 cannula 40 of the first chamber 8 on the stable sleeve 42 of the second chamber 7 to the recess 46, the cannula 40 the

Puncture stopper 5 of the substance filled Karpullenkörpers 27 pierces and immersed in the substance and the projection 47 engages in the recess 46; Here, the volume reduction of the chamber 8, the local pressure compensation device 20 is filled with air, the bellows 19 of the chamber 7 and the Karpullenkolben 39 are moved to Gleitstopfen 41, this is filled by the reduction in volume of the chamber 7, the pressure equalization device 20 there with gas, the slide plug 41 is moved in the Karpullenkörper 27 in the direction of cannula 40 and so substance in the cannula 40 displaces and the desired amount of

Transfer substance to the target system Z, wherein the port 3 is perforated. Before perforating, the protective sleeve 32 is removed, which is detachably connected via a thread 48 to the transfer tube 45.

To carry out the method according to the first alternative, a device according to the two variants of the fourth embodiment shown in FIGS. 8 and 9 can be used.

With regard to further features, not shown in the figures, reference is made to the general part of the description.

Finally, it should be noted that the teaching of the invention is not limited to the embodiments discussed above.

C o m p a n c e m e n t i o n s

1 envelope 30 cannula

2 connection 31 ampoule flask

3 connection 32 protective sleeve

4 container 33 holding device

5 piercing plugs 34 passage opening

6 metal seal 35 stopcock

7 chamber 36 latex foil

8 chamber 37 latex ring

9 cover plate 38 fastening means

10 calibrated drip chamber 39 Karpullenkolben

11 base plate 40 cannula

12 infusion sets 41 sliding plugs

13 snap closure 42 sleeve

14 Mounting bridge 43 Ring shoulder

15 eyelet 44 ring shoulder

16 Short Cannula 45 Transfer Cube

17 Long cannula 46 recess

18 holding device 47 projection

19 bellows 48 thread

20 pressure compensation device

21 breather

22 connecting means

23 connecting means

24 filter device

25 dosing shut-off

26 ampule bodies

27 carpule body

28 blister pack

29 cannula closure

G closed encoder system

Z target system

G / Z encoder and target system

Total master system consisting of G and G / Z

Claims

claims

1. A device for transferring a substance from a closed donor system (G) into a target system (Z) with an enveloping body (1), within which the substance is contained, wherein the enveloping body (1) at least one terminal (2, 3) at least a target system (Z), characterized in that the connection (2, 3) protrudes freely from the enveloping body (1) and is connected to it in a sterile manner.

2. Device according to claim 1, characterized in that a container (4) for the substance is provided inside the enveloping body (1).

3. Apparatus according to claim 2, characterized in that the container (1) is present as an ampoule with puncture stopper (5).

4. Apparatus according to claim 3, characterized in that the target system (Z) is an injection device by means of which the donor system (G), the substance is removable.

5. The device according to claim 4, characterized in that the injection device is part of a closed system and in turn a terminal (2) summarizes, which is connected to the terminal (2) of the encoder system (G) factory sterile.

6. The device according to claim 1, characterized in that the enveloping body (1) is a collapsible bag, in particular with a volume between 30 ml to 1000 ml or 10 ml to 30 ml.

7. The device according to claim 1 or 2, characterized in that the connection (2) opens at one end into the enveloping body (1) and preferably protrudes minimally into the substance.

8 .. Apparatus according to claim 6 or 7, characterized in that the connection (2) has a snap closure (13) made of sealing material with a mounting bridge (14) which can be actuated via the flexible wall of the enveloping body (1).

9. Device according to one of claims 1 to 3, characterized in that the terminal (2) on the one hand in a base plate (11) of the enveloping body (1) is welded in a sterile manner and a short cannula (16), wherein the terminal (2) pointing in the operating position to the ground.

10. The device according to claim 9, characterized in that at least part of the wall of the enveloping body (1), in particular by means of a bellows (19), is designed so flexible that the short cannula (16) in the operating position in the container (4). arrives.

11. The device according to claim 9 or 10, characterized in that the short cannula (16) and a long cannula (17) are arranged in the rest position in a holding device (18) in the form of a slotted sleeve, on the one hand against the base plate (11) of the enveloping body (1) is supported, on the other hand against the container (4) and in the operating position, the container (4) engages around while the cannulas (16, 17) pierce the closure of the container (1).

12. The device according to claim 11, characterized in that the long cannula (17) opens at one end in the with a pressure compensation device (20) connected to enveloping body (1) and in the operating position for pressure equalization in the container (4).

13. Device according to one of claims 1 to 12, characterized in that the encoder system (G) is part of a Gesamtgebersystems (Ggesamt), which includes at least one other closed system, which is both donor and target system (G / Z) and wherein a sterile connection is ensured with each other.

14. The device according to claim 13, characterized in that the Gesamtgebersystem (Ggesamt) comprises an infusion set (12) and / or a preferably calibrated drip chamber (10) as a further closed systems, which are both donor and target system (G / Z) ,

15. The apparatus according to claim 14, characterized in that both a calibrated drip chamber (10) and an infusion set (12) are provided and that the infusion set also cooperates with a venting syringe (21).

16. The apparatus according to claim 15, characterized in that the venting syringe (21) and the infusion set (12) connecting means (22, 23) which are detachable and that the connecting means (23) of the infusion set (12) with the vascular access of an organism as an open target system (Z) is connectable.

17. The device according to claim 16, characterized in that the connecting means (23) of the infusion set (12) and / or the connecting means (22) of the venting syringe (21) is associated with a filter device (24).

18. Device according to one of claims 1 to 17, characterized in that the connection (2) and / or the infusion set (12) and / or the venting syringe (21) is assigned in each case a Dosierabsperrung (25).

19. The device according to one of claims 1 to 18, characterized in that the connection (2) is present as a flexible plastic tube which is sterile connectable with a closed system (G / Z, Z).

20. Device according to one of claims 1 to 19, characterized in that the enveloping body (1) comprises a pressure compensation device (20).

21. The device according to claim 2, characterized in that the container (4) is part of an injection device and that the connection (3) consists of easily penetrable material.

22. The apparatus according to claim 21, characterized in that the enveloping body (1) comprises a bellows (19), via which the injection device is actuated.

23. The apparatus of claim 21 or 22, characterized in that the enveloping body (1) comprises a pressure compensation device (20).

24. Device according to one of claims 21 to 23, characterized in that the injection device is pre-filled.

25. Device according to one of claims 21 to 24, characterized in that in the rest position a connection (3) cross-protective sleeve (32) is provided,

26. The device according to one of claims 21 to 25, characterized in that the enveloping body (1) in the region of the terminal (3) fastening means (38) are provided, on which the perforated and pushed back terminal (3) can be fixed in the operating position.

27. The device according to one of claims 21 to 26, characterized in that the injection device comprises two ports (2, 3), wherein the port (2) is sterile konnek- tierbar.

28. Device according to one of claims 21 to 27, characterized in that the injection device is a syringe and that the container (4) as an ampoule body (26) with cannula (30) is present.

29. Device according to one of claims 21 to 28, characterized in that the injection device is a cartridge and that the container (4) is present as Karpullenkörper (27).

30. The device according to claim 29, characterized in that the enveloping body (1) comprises two chambers (7, 8), one of which receives the carpule body (27) and a carpule piston (39) and the other at least partially a cannula (40). contains.

31. The device according to claim 29 or 30, characterized in that the cannula (40) with a tip to the body of the carpule (27) and protrudes in the rest position with its opposite tip in the terminal (3).

32. Method for transferring a substance from a closed donor system into a target system, wherein substance reaches at least one target system from an enveloping body and its at least one connection, so that the free end of the connection is perforated immediately before injection into the target system.

33. Method according to claim 32, characterized in that the end face of the connection contacts the target system present in particular as a living organism before it is perforated by means of the injection device, in particular the cannula, and the substance is administered into the target system.

34. The method according to claim 32 or 33, characterized in that the connection is fixed after the perforation on a fastening device.

35. The method according to any one of claims 32 to 34, characterized in that the method is carried out using a device according to one of claims 21 to 31.

36. Method for transferring a substance from a closed donor system into a target system, wherein substance reaches at least one target system from an enveloping body and its at least one connection, characterized in that the substance passes via the connection of the donor system into a sterile connected infusion set, which is a closed target and donor system, and that the substance passes from there into the target system.

37. The method according to claim 36, characterized in that the substance passes from the donor system into a drip chamber before reaching the infusion set, that the substance is sucked into the infusion set via a vent syringe from the drip chamber until the gas is largely displaced from the infusion set the connection between the venting syringe and the infusion set is released and that the infusion set is connected to a vascular access of an organism.

38. The method according to claim 37, characterized in that a filter device is provided between the venting syringe and the infusion set, which is removed before the connection of the infusion set with the vascular access of the organism.

39. The method according to any one of claims 36 to 38, characterized in that the method is carried out using a device according to one of claims 15 to 20.