Patent ID: 12257211

DETAILED DESCRIPTION

As perFIGS.1-6, a medical fluid transfer apparatus1for use in an application-ready preparation of a health-hazardous liquid medicament F (FIG.3) is provided. The medical fluid transfer apparatus1may also be referred to as transfer system or closed system transfer device. The liquid medicament F is a so-called CMR (carcinogenic, mutagenic, reprotoxic) liquid medicament which is intended for use in a cancer therapy. The liquid medicament F can be carcinogenic, mutagenic and/or reprotoxic and consequently has to be classified as hazardous to health.

During the application-ready preparation of the liquid medicament F by medical personnel, the liquid medicament F is fed to a medical liquid container2, and/or is extracted therefrom, by means of a medical syringe (not illustrated in any more detail in the drawing). Here, in order to avoid a hazard to the health of the medical personnel, contamination of the surroundings with the liquid medicament F must be avoided. The fluid transfer apparatus1primarily serves this purpose.

The medical fluid transfer apparatus1has a first connector section3with a first passage4and has a second connector section5with a second passage6.

In the present case, the first connector section is in the form of a Luer lock connection3, this however not being absolutely necessary. Alternatively, the first connector section3may also be in the form of some other fluid coupling that is generally known in the field of medical technology. For fluid-guiding connection to the medical syringe, the Luer lock connection3is connected, in a basically known manner, to a complementary Luer lock connection which is arranged on the syringe at the outlet side.

In the present case, the second connector section is in the form of a piercing mandrel5, which, for fluid-tight connection to the liquid container2, is inserted through a section of the liquid container2that is provided for this purpose and into said liquid container. For this purpose, the liquid container2may have for example a pierceable plug, a diaphragm or the like. Such a design is also not absolutely necessary. Instead of the piercing mandrel5, a screw-type or plug-in connection to the liquid container2is in particular also conceivable.

The first passage extends through the first connector section3in the form of a lumen4extending in an axial direction A. Correspondingly, the second passage extends through the piercing mandrel5in the form of a lumen6in the axial direction A.

Extending between the first passage4and the second passage6is a fluid channel7, which inFIG.2is intended to be illustrated in a schematically highly simplified manner by a dashed line between the first passage4and the second passage6. In a state of the fluid transfer apparatus1in which it is connected to the syringe (not illustrated in the drawing) and to the liquid container2, the liquid medicament F can pass from the syringe into the first passage4and, from there, through the second passage6via the fluid channel7and into the liquid container2, and vice versa.

In the present case, the liquid container is in the form of a medicament bottle2, which may also be referred to as ampoule, phial or vial. The medicament bottle2may be manufactured from a dimensionally stable material, such as for example a plastic or glass.

The fluid transfer apparatus1moreover has a compensation container8with a fluid-tight compensation volume9of variable volume. The compensation volume9is (in a manner that will be described in more detail) connected in a fluid-conducting manner to the liquid container2and provided in particular for receiving a gas volume displaced from the liquid container2during the transfer of the liquid medicament F.

Here, it can be seen in particular inFIG.2that the first passage4and the second passage6are connected to one another in a fluid-conducting manner via the compensation volume9, wherein the compensation volume9forms a fluid channel section10of the fluid channel7.

If, proceeding from the configuration shown inFIG.2, liquid medicament F is fed to the liquid container2by means of the syringe via the first passage4, the fluid channel7(and the fluid channel section10) and, from there, through the second passage6, a displacement of gas volume (not referred to in any more detail) from the liquid container2naturally occurs. Said gas volume can be contaminated so as to be hazardous to health through contact with the liquid medicament F. Here, the compensation volume9serves for receiving the gas volume in a fluid-tight manner, so that the latter is not released into the surroundings. For this purpose, the compensation volume9is (in a manner that will be described in more detail) connected in a fluid-conducting manner to the liquid container2and moreover of variable volume. That is to say, when the gas volume flows into the compensation volume9, the compensation volume is correspondingly enlarged.

The specific configuration, shown inFIGS.1-6, of the fluid transfer apparatus1will be discussed in more detail below. The structural and functional features mentioned additionally in relation to this are not to be regarded as absolutely necessary, however.

In the present case, the compensation container is in the form of a corrugated bellows8. The corrugated bellows8is manufactured from an elastic material W. In the present case, an elastomer is selected as the elastic material W. As a result of the present material selection and the elastic configuration as a corrugated bellows, the compensation container8is extensible and compressible in a concertina-like manner in the axial direction A. Owing to this concertina-like movability of the corrugated bellows8, the compensation volume9can be correspondingly varied or enlarged and reduced in size. The corrugated bellows8has a circular-cylindrical basic shape, this however not being absolutely necessary.

The first connector section3and the second connector section5are arranged on face end regions11,12of the corrugated bellows8that are situated opposite one another in the axial direction A. For this purpose, in the present case, two housing parts13,14manufactured from a dimensionally stable material (not referred to in any more detail) are provided. At one end, the first housing part13is inserted in a fluid-tight manner at a face end side into an axial opening of the corrugated bellows8. Correspondingly, at the other end, the second housing part14is inserted in a fluid-tight manner into an opposite axial opening of the corrugated bellows8.

The corrugated bellows8can be moved manually by way of pumping in the axial direction A. As a result of this movability by way of pumping, the transfer of the liquid medicament F between the first passage4and the second passage6can (in a manner that will be described in more detail) be brought about and/or assisted.

In order to make possible facilitated manual movability of the corrugated bellows8by way of pumping, a first handling surface15and a second handling surface16are provided in the present case. The first handling surface15is arranged on the first housing part13and is oriented in the axial direction A. The second handling surface16is arranged on the second housing part14and is oriented, in the opposite direction to the first handling surface15, in the axial direction A. For the pumping movement of the corrugated bellows8, the handling surfaces15,16, for example between the fingers of one hand, can be moved toward one another in the axial direction A, wherein the corrugated bellows8is pressed together and the compensation volume9is correspondingly reduced in size.

Owing to its elastic configuration and/or the present selection of the material W, the corrugated bellows8generates a spring force F′ (FIG.1), which is directed oppositely in relation to the above-described pumping movement. The spring force F′ is oriented in the axial direction A. Instead of such a configuration, provision may be made for example of a separate spring device and/or a separate spring element which can be connected operatively to the corrugated bellows8and/or to the housing parts13,14.

Furthermore, a first valve17is provided in the present case. The first valve17is assigned to the first passage4and is arranged in the region of the first connector section3. The first valve17can be transferred between a blocking position (cf.FIG.4) and a throughflow position (cf.FIG.3), wherein, in the blocking position, the first passage4is separated in a fluid-tight manner from the compensation volume9and thus also from the fluid channel section10. In the throughflow position, the first passage4is, by contrast, connected in a fluid-conducting manner to the compensation volume9and to the fluid channel section10.

In the present case, the first valve is in the form of a manually actuatable shut-off valve17. The shut-off valve17has an actuation handle18. The design in this respect is to be understood purely as an example.

The fluid transfer apparatus1furthermore has a second valve19, which can likewise be transferred between a blocking position (FIG.3) and a throughflow position (FIG.4). In the blocking position, the compensation volume9is separated in a fluid-tight manner from the second passage6. By contrast, in the throughflow position, the compensation volume9is connected in a fluid-conducting manner to the second passage6.

In the present case, the second valve is in the form of a pressure valve19which, in a manner dependent on a pressure prevailing in the compensation volume9, can be transferred automatically between the blocking position and the throughflow position. In the present case, the pressure valve19is of diaphragm-like design and has a slit-like passage20which, in a manner dependent on said pressure in the compensation volume9, is opened up or closed off as a result of a pressure-induced elastic deformation.

In a delivery state (not illustrated in any more detail in the drawing) of the fluid transfer apparatus1, both the shut-off valve17and the pressure valve19assume the respective blocking position. Moreover, the compensation volume9is filled with a sterile gas (not referred to in any more detail). As a result of the filling with the sterile gas, which may for example be sterile air, a situation in which the compensation container8is undesirably pressed together is avoided.

The functioning of the fluid transfer apparatus1during feeding of the liquid medicament F into the liquid container2will be described in more detail on the basis ofFIGS.3and4.

For this purpose, proceeding from the configuration shown inFIG.2, firstly a syringe filled with the liquid medicament F is, in the above-described manner, connected in a fluid-tight manner to the first connector section3. The second connector section in the form of the piercing mandrel5is pushed in a fluid-tight manner into the liquid container2, wherein the second passage6extends in a fluid-conducting manner into the interior of the liquid container2. Here, the shut-off valve17—in deviation from the configuration shown inFIG.2—firstly assumes the blocking position and is manually transferred into the throughflow position (FIG.3) by means of an actuation of the actuation handle18. Afterwards, the liquid medicament F can be injected through the first passage4and into the fluid channel7by means of a basically known actuation of the medical syringe, and passes from said fluid channel onward into the fluid channel section10or the compensation volume9. Here, it is advantageous for the axial direction A of the fluid transfer apparatus1to be oriented parallel to the Earth's gravity vector g. Such an orientation is not absolutely necessary, however. Through the feeding of the liquid medicament F into the compensation volume9, a level (shown inFIG.3and not referred to in any more detail) of the liquid medicament F is formed in the corrugated bellows8. The volume of the liquid medicament F that is fed in this manner leads to an expansion of the corrugated bellows8in the axial direction A. In the present case, the pressure valve19is designed in such a way that, when the liquid medicament F is injected, the slit-like passage20firstly remains closed off, so that the pressure valve19assumes its blocking position.

Afterwards, the shut-off valve17is transferred manually into the blocking position (FIG.4). In order to transfer the liquid medicament F from the compensation volume9into the liquid container2, the corrugated bellows8is compressed by means of the above-described manual actuation of the handling surfaces15,16in the axial direction A. In this way, as a result of a pressure increase in the compensation volume9, the liquid medicament F is transferred through the slit-like passage20and, from there, onward via the second passage6into the liquid container2. In other words, the pressure valve19is transferred into its throughflow position as a result of the manual pumping movement of the corrugated bellows8.

The volume of the liquid medicament F that is fed in this manner to the liquid container2naturally leads to a displacement of a gas volume (not referred to in any more detail). Here, the gas volume flows via a fluid-conducting connection into the compensation volume9and, owing to the fluid-tight design of the compensation volume9, is received in a hermetic manner therein without contamination of the surroundings occurring.

The fluid-conducting connection between the compensation volume9and the liquid container2is realized in the present case by means of a third passage21, which extends in the form of a lumen through the piercing mandrel5. Such a design is not absolutely necessary, however.

The manual pumping movement can be repeated until the entire liquid medicament F has been transferred from the compensation volume9into the liquid container2.

The functioning of the fluid transfer apparatus1during extraction of the liquid medicament F from the liquid container2can be seen inFIGS.5and6.

Here, proceeding from a configuration in which the liquid container2is filled with the liquid medicament F, firstly the second connector section5is connected in a fluid-tight manner to the liquid container2. In the present case, for this purpose, the piercing mandrel5is inserted in the above-described manner into the liquid container2. The shut-off valve17in this case assumes its blocking position. Here, the medical syringe may already be connected in a fluid-tight manner to the first connector section3. Alternatively, this connection may also be realized for the first time at a later point in time.

In the present case, the extraction of the liquid medicament F is realized—just like the feeding illustrated inFIGS.3and4—in two stages. Firstly, the fluid transfer apparatus1is oriented, together with the liquid container2situated thereon, according toFIG.5, so that the piercing mandrel5points vertically upward counter to Earth's gravity vector g. The corrugated bellows8is then pressed together manually in the axial direction A. In this way, the compensation volume9is reduced in size and, as a result of the pressure increase brought about in this way, the pressure valve19is transferred into the throughflow position. Due to the reduction in size of the compensation volume9, a gas volume situated therein can pass via the slot-like passage20and, from there, onward through the second passage6and/or the third passage21and into the liquid container2. In this way, the liquid medicament F situated in said liquid container is displaced and passes via the second passage6or the third passage21and the slot-like passage20into the compensation volume9. In this way, a level (shown inFIG.5) of the liquid medicament F is formed in the corrugated bellows8. This process may be repeated until the liquid container2has been substantially emptied.

If it has not already happened, the medical syringe is connected in a fluid-tight manner to the first connector section3, the shut-off valve17is transferred manually into its throughflow position, and the liquid medicament F may be extracted by suction from the compensation volume9by means of a corresponding actuation of the medical syringe. Here, the compensation volume9is correspondingly reduced in size owing to the volume of the liquid medicament F that is extracted by suction.

Here, it is particularly advantageous that the liquid medicament F, in the configuration shown inFIG.6, can be readily injected back into the compensation volume9. In this way, any surplus liquid medicament F or air bubbles present in the medical syringe can be removed from the medical syringe in a simple manner and without having to turn the fluid transfer apparatus1over into the orientation shown inFIGS.3and4beforehand.

A further embodiment of a fluid transfer apparatus1aaccording to the invention can be seen inFIG.7. The fluid transfer apparatus1ainFIG.7corresponds substantially to the fluid transfer apparatus1described above on the basis ofFIGS.1to6. Therefore, in order to avoid repetitions, reference is made to the disclosure in relation toFIGS.1to6. Only the essential differences of the embodiment according toFIG.7are discussed below. In this case, functionally and/or structurally identical sections and parts of the embodiment according toFIG.7are denoted by identical reference-sign numbers with the lower-case letter a added.

The fluid transfer apparatus1ais primarily distinguished from the fluid transfer apparatus1by way of the configuration of the compensation container8a. In the present case, the compensation container8ahas multiple container parts22a,23aand24awhich are manufactured from a dimensionally stable material W′. The container parts22a,23a,24aborder the compensation volume9a. For variation of the volume of the compensation volume9a, the container parts22a,23aare displaceable relative to the container part24a.

Here, the first container part22ais, in the form of a cover, joined together in a fluid-tight and fixed manner at a face end side in the axial direction A with the second container part23a. In the present case, an ultrasonically welded joint is provided as a joining connection, this not however being absolutely necessary. The third container part24ahas, at a face side at one end, a chalice-like widened portion which bears in a fluid-tight manner against an inner wall (not referred to in any more detail) of the second container part23aand which is slidingly movable relative to said inner wall. For fluid-tight sealing between the second container part23aand the third container part24a, a sealing element in the form of an O-ring25ais provided in the present case.

At the other end, the third container part24ais joined together in a fluid-tight and fixed manner with a latching device26a. The latching device26ais manufactured from a dimensionally stable material (not referred to in any more detail) and is provided for non-detachable latching connection of the fluid transfer apparatus1to a liquid container corresponding to the liquid container2as perFIGS.1-6. For this purpose, in the present case, the latching device26ahas multiple latching elements27awhich are provided for form-fitting connection to a neck region of the liquid container2.

In the present case, the second connector section is again in the form of a piercing mandrel5a. The piercing mandrel5ais formed in one piece on the latching device26aand projects from a cup-like section (not referred to in any more detail) of the latching device26aat the bottom side in the axial direction A.

The compensation container8acan again be moved manually by way of pumping. In order to make possible facilitated movability by way of pumping, handling surfaces15a,16aare provided. The first handling surface15ais arranged on the first container part22aat the top side. The second handling surface16ais arranged on the latching device26aat the bottom side.

In order to achieve a simplified return movement of the compensation container8ain the case of a manual pumping movement, a spring device28aconnected operatively to the compensation container8ais provided in the present case. The spring device28ahas a spring element in the form of a helical spring29awhich is to be subjected to compressive loading. At one end, the helical spring29ais supported against the cup-like section of the latching device26a. At the other end, the helical spring29ais supported against the second container part23aat the bottom side.

Further details of the specific design of the container parts23aand24acan be seen inFIGS.8-11.

The third container part24ahas in particular multiple wing sections30awhich project in a wing-like manner in a radial direction. In the present case, provision is made of four wing sections30a, which are in each case arranged offset by 90° in a circumferential direction of the third container part24a. InFIG.9, it can be seen that the second container part23ahas a design which is complementary thereto, wherein provision is made of multiple slits31afor receiving in each case one of the wing sections30a, which slits are arranged offset in the circumferential direction and extend in a radial direction.