Spike with non-return valve function and filling device of a liquid system with spike

Disclosed is an anti-contamination device for preventing contamination of a fluid stored in a fluid container with a spike and a manually operable fluid blocking mechanism arranged directly downstream of the spike. A non-return valve is arranged between the spike and the fluid blocking mechanism, and that valve is adapted to allow only a flow from the spike in the direction of the manually operable fluid blocking mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is the U.S. national phase application of PCT International Application No. PCT/EP2014/057745 filed Apr. 16, 2014, which claims priority to German Patent Application No. DE 10 2013 103 986.3 filed Apr. 19, 2013, the contents of each application being incorporated by reference herein.

FIELD OF THE INVENTION

The invention in hand concerns a spike with a non-return valve function check valve function and the filling device of a fluid conducting system and/or liquid system, in particular of an extracorporeal blood treatment device, for example a dialysis or apheresis machine, that is equipped with the spike with non-return valve function.

BACKGROUND OF THE INVENTION

In particular, the hydraulic system (blood side fluid system) of a blood treatment device, for example a dialysis machine, has to be filled with fluid, for example an NaCl solution or another sterile physiological solution, before being connected up to a patient, in such a way that air pockets in the system that would be dangerous for a patient connected up to the fluids of the system are eliminated. Furthermore, the hydraulic system should optionally be flushed with the filled-in fluid for a certain period of time in order to filter/wash out any contaminants, dirt particles, etc. that may have deposited in the system before the system is connected up to the patient. On an extracorporeal blood treatment device, these two procedures are performed in the scope of a filling cycle and optionally a circulation cycle.

In the state of the art, there are fluid containers preferably in the shape of plastic bags designed especially for extracorporeal blood treatment devices of this relevant type in order to enable, among others, the device functions as defined above. This kind of fluid container is also manufactured and sold by the applicant filing the application in hand.

As a rule, such a fluid container has a fluid intake chamber and two preferably closable fluid connectors. On a first of the two connectors, an arterial line section, and on the second connector, a venous line section of the hydraulic system (fluid system or also referred to as fluid conducting system) of the extracorporeal blood treatment device can be connected. The fluid bag as well as the two line sections together constitute a circulation device of the extracorporeal blood treatment device.

For the fluid system filling process, first the arterial line section is connected to the first fluid connector of the bag, and after opening of the first fluid connector, the hydraulic system is filled. The venous line section of the system first remains open to the atmosphere or is connected to a drain, a container or a bag so that air inside the system can escape and be vented in the atmosphere. As soon as the filling process is completed, the venous line section is connected to the second fluid connector of the bag in order to circulate the fluid inside the hydraulic system of the extracorporeal blood treatment device for a certain period of time or a certain volume of flow through the bag chamber.

During this circulation process, the fluid flows through internal filtering devices in which remaining air pockets are removed/filtered out with the fluid. If necessary, the venous line section of the hydraulic system can again be disconnected from the second fluid connector of the fluid bag and the fluid inside the hydraulic system can be flushed out again under constant supply of fluid from the container.

Upon termination of the circulation process, the filling/circulation cycle preparing for patient treatment is completed so that the two line sections (venous and arterial) can be disconnected from the fluid bag and connected up to the patient for treatment.

The description above of the filling/circulation cycle of a hydraulic system/fluid conducting system of an extracorporeal blood treatment device (dialysis machine) known from the state of the art indicates that the fluid bag remains in the system circuit for the filling and circulation processes, i.e. that the fluid inside the system is circulated through the fluid bag and/or its fluid chamber. As a result, the fluid in the fluid bag may get contaminated. The consequence of this is that with each new treatment preparation of the extracorporeal blood treatment device, a new fluid bag with fresh, uncontaminated fluid is used for the following filling/circulation cycle, whereas the fluid bag for the filling/circulation cycle performed before is disposed of independently of its residual content. It is obvious that this procedure results in the wasting of a large quantity of fluid in case of a high patient treatment number because the fluid content of a fluid bag can only be used (incompletely) for one filling/circulation cycle.

Furthermore, the fluid bags for blood treatment devices effectively concern a custom-made design with two separate fluid connectors, as a result of which manufacturing becomes more expensive due to smaller numbers as compared with conventional NaCl bags/bottles on the whole.

SUMMARY OF THE INVENTION

Considering these problems, the purpose of the invention in hand is to make available a technical device in particular for a class-specific filling device of a fluid conducting system of this kind, preferably an extracorporeal blood treatment device, with which contamination of a fluid bag that is connected to it or can be connected to it can be prevented. Furthermore, it is a purpose of the invention in hand to make available a filling device and a filling procedure which can be operated more efficiently and so more cost-effectively as compared to the state of the art.

Furthermore, a purpose of the invention in hand is to make available a fluid system equipped with the filling device according to aspects of the invention, for example an extracorporeal blood treatment device, that can be operated in a simple manner and that enables the use of conventional fluid bottles (e.g. NaCl bottles).

This task is completed with an anti-contamination device (means for prohibiting contamination), a filling device of a fluid system/liquid system (means for filling a fluid liquid system), preferably an extracorporeal blood treatment device (dialysis, apheresis machine), a fluid conducting system (means for conducting fluid), and a procedure as set forth in the claims. Advantageous embodiments of the invention are the object of sub-claims.

The basic idea of the invention in hand is to design the class-specific filling device of a fluid conducting system, in particular an extracorporeal blood treatment system, in such a way and/or to equip it with such a device that a conventional (price-effective) fluid container of a known design such as a conventional NaCl bottle or a suitable bag with a single puncturable/connectable connector can be used.

Consequently according to aspects of the invention, a suitable anti-contamination device is provided with a spike (spike-like means) for connecting a fluid container (NaCl bottle/bag) and a manually operable fluid blocking mechanism for the optional fluid connecting of the fluid container with a fluid conducting system to be filled, which can be connected to the fluid blocking mechanism. Thus the fluid blocking mechanism (means for blocking fluid) is arranged directly downstream of the spike, whereby the fluid blocking mechanism can be coupled directly with the spike, or a connecting hose section can be interposed between the fluid blocking mechanism and the spike. In addition according to aspects of the invention, a non-return valve (means for allowing fluid flow only in one direction) is provided between spike and fluid blocking mechanism, which is adapted in such a way that it allows only one flow from the spike in the direction of the manually operable fluid blocking mechanism.

Furthermore, the filling device according to aspects of the invention has, as a central component, the so-called spike (means) for connecting up the single fluid connector of a conventional medical fluid container e.g. NaCl bottle (means for storing medical fluid), to which the manually operable fluid blocking mechanism, for example a stop valve, is connected downstream, which is adapted or provided in such a way so as to remain constantly fluidically connected with the spike. The fluid blocking mechanism has at least one fluid outlet connector, which is adapted so that a line section/hose of a fluid conducting system/fluid system, preferably the arterial line section of a blood purification device/dialysis machine, can be connected to it in a detachable manner. Here the non-return valve can be arranged in the spike outlet, in the connecting hose section or in the inlet of the manually operable fluid blocking mechanism to which the spike is connected.

As a result of the arrangement of the fluid blocking mechanism on the spike, the spike can remain on the conventional medical fluid container after puncturing of the container seal, whereas the arterial line section can optionally be connected to the fluid blocking mechanism for a filling process of the fluid conducting system and then be disconnected again from the fluid blocking mechanism without losing any fluid from the medical fluid container. As the arterial line section is uncoupled from the outlet connector of the fluid blocking mechanism (e.g. Luer-Lock fitting), the arterial line section can be reconnected to an arterial patient access immediately afterwards without any changes having to be performed on the arterial line section and/or its connector. This simplifies the handling of the filling device.

Furthermore, the non-return valve reliably prevents a reverse of flow in the fluid container independently of the activation position of the fluid blocking mechanism.

This means that even if the fluid blocking mechanism is activated unintentionally or erroneously or has a malfunction, the non-return valve acts as a “fail-safe” device.

Preferably, the fluid blocking mechanism is a 3-way switch, for example a Y- or T-piece, and more preferably a 3-way valve, whereby the conduits/connectors can optionally be shut off manually (for example with clamps on the conduits/connectors or with the valve) in order to close off the conduits completely and/or to fluidically connect the conduits optionally and/or to allow a fluid flow at least between two selected conduits. According to aspects of the invention, the 3-way switch, preferably the 3-way valve, is arranged directly downstream of this one, preferably universal medical fluid container. In the specific case, a first connector of the 3-way switch (of the 3-way valve) is coupled with the so-called spike (or a different connecting device) or is designed with it (integral with the spike), with which a fluid chamber of the fluid container can be tapped. To a second connector of the 3-way switch (of the 3-way valve), the arterial line section, and to a third connector of the 3-way switch (of the 3-way valve), a venous line section of the fluid system can be connected. The 3-way switch, preferably the 3-way valve, can furthermore preferably be put and/or switched manually in at least three positions from which in a first switch position, the first connector is exclusively fluidically connected with the second connector and/or a fluid flow between these two connectors is possible and the third connector is closed (flush position and/or supply switch position and/or single-pass switch position), in a second switch position, the second connector is fluidically connected with the third connector and/or a fluid flow between these two connectors is possible and the first connector is closed (circulation switch position), and in a third switch position, all three connectors are separated from each other and/or closed (therapy switch connector or closed switch connector).

A medical fluid/liquid system equipped in such a way enables the coupling of the conventional fluid container with the arterial line section for the filling process (with the venous line section disconnected) by putting the 3-way switch, preferably the 3-way valve, in the first switch position, and connecting the arterial line section with the venous line section for the circulation process by putting the 3-way switch, preferably the 3-way valve, in the second switch position. As the first connector of the 3-way switch, preferably the 3-way valve, is closed in this second switch position, the fluid container is disconnected from the hydraulic system/circuit of the extracorporeal blood treatment device so the remaining fluid in it is not contaminated by the fluid circulating in the hydraulic system. As in the third switch position of the 3-way switch, preferably the 3-way valve, all of its connectors are closed, the two line sections of the hydraulic system can be disconnected in this switch position and connected to the patient for treatment.

As a result, the fluid container can be used for several treatment steps or for several phases within a treatment depending on the fill volume so that no fluid is lost any more. Furthermore, the medical filling device is provided for a conventional/universal medical fluid container, which is more cost-efficient in comparison with the specially designed containers with two connectors for extracorporeal blood treatment devices. Finally, the fluid container used does not require any connector, in particular for the case that the so-called spike is connected to the 3-way switch, preferably the 3-way valve, or is combined with it into an integral modular unit. In the latter case, the spike can be connected effectively transition-free, i.e. without interposition of a (bridging) pipe section, directly with the first connector, preferably in one piece, or screwed on it.

The medical fluid system/fluid conducting system according to aspects of the invention, preferably a blood purification system (dialysis machine), has a filling device according to the design described above and a venous blood conduit section and an arterial blood conduit section, of which at least the arterial section is adapted in such a way that it is/can be optionally connected to the filling device.

Furthermore, at least the arterial line section has, directly downstream of its connector interacting with the filling device, (a component) a blocking mechanism (e.g. a hose clamp as further component) with which the arterial line section can be temporarily fluidically closed for reconnecting from the filling device to an arterial patient access and vice versa. Preferably the venous line section has the same components as the arterial line section.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

According toFIG. 1, an extracorporeal blood treatment device1, for example a dialysis or apheresis machine, has an internal hydraulic conducting system (hereinafter referred to as fluid conducting system) through which during a treatment phase on the machine side, for example, a blood purification fluid (dialysis fluid) is passed, and on the patient side, blood flows through it extracorporeally, whereby the machine-side and the patient-side fluid conducting systems are fluidically separated in case of a dialysis machine by a dialyser (filter) that is not shown in more detail.

For this purpose, the fluid conducting system has a venous line section and an arterial line2,4on the patient side, preferably with connectors (Luer-Lock fittings)6,8on each hose section arranged/formed on the ends in each case to which, for example, injection needles or cannulas (not depicted) can be connected as patient access, which can be introduced in a patient's body.

In order to avoid a possibly necessary washing out of possible contaminations, resulting from manufacturing, in the patient's body, the extracorporeal blood treatment device1has a filling device which enables a circulation process (consequently hereinafter referred to a circulation device) with which the fluid conducting system is cleaned as a rule before every patient treatment.

According toFIG. 1, the filling/circulation device according to aspects of the invention in hand has a fluid source, preferably in the form of a universal fluid container (NaCl bottle)10, with a single outlet11which is punctured in the exemplary embodiment in hand with a spike12of the filling device in order to tap fluid from the fluid container10. The design of spike12matches known spike structures so that its design does not have to be explained in more detail here. Furthermore, it is to be pointed out that, for example, in case of a Luer-Lock or another fitting on the container side, the spike may be replaced by a suitable connecting piece on the side of the filling/circulation device.

Furthermore the filling/circulation device according to aspects of the invention has a fluid blocking mechanism in the shape of a 3-way switch, preferably a 3-way valve14, which is arranged directly downstream of the spike12(connecting piece) in the direction of flow away from the fluid container10. In the case in hand, the spike12is directly (without interposition of an additional line section) connected to the 3-way valve14. As an alternative, the spike12can also be realised in one piece or as a modular unit with the 3-way valve14.

For that purpose, the 3-way valve14has a first connector or fluid inlet14athat is fluidically connected with the spike12and/or to which the the fluid source10can be/is connected. Furthermore, the 3-way valve14has a second connector14b, to which the arterial line section4of the patient-side fluid conducting system of the extracorporeal blood treatment device1can be connected. Finally, the 3-way valve14has a third connector14c, to which the venous line section2of the patient-side fluid conducting system of the extracorporeal blood treatment device1can be connected. The venous line section as well as the arterial line section2,4are each equipped with a hose clamp16,18or a similar blocking device in order to close the respective hose section temporarily as an option.

The 3-way valve14in hand has a manually operable rotary lock consisting of a rotating cylindrical valve piston20that is equipped/designed on the front side with a handle, preferably in the shape of (three) intervention vanes22. The valve piston has a central longitudinal bore, of which three radial bores branch off at equal distances in circumferential direction. The intervention vanes22are arranged in such a way that they are aligned along the radial bores and so indicate the flow direction of the radial bores. Such a 3-way valve is sufficiently known from the state of the art so that a further description, in particular of its function, can be dispensed with here.

FIGS. 2 to 5show the switch positions intended according to aspects of the invention of the 3-way valve14in dependence on the current operating phases of the extracorporeal blood treatment device1, which are described below in connection with the functions intended to be performed with it.

According toFIG. 2, the 3-way valve14is shown in a shut-off position in which all three connectors14a-14care closed. In this switch position, spike12can puncture the outlet12of the universal fluid reservoir10and so tap the fluid stored in there (in the chamber10aformed by the container) without losing fluid into the atmosphere.

FIG. 3shows the so-called “flush position” in which the first connector14ais fluidically connected with the second connector14b, while the third connector14cis closed. In this switch position, the arterial line section4is already connected to the second connector14b, but the venous line section2is open to the atmosphere or connected to a drain/receiver tank.

In this switch position, fluid (NaCl solution) is conducted from the conventional fluid container with a single connector through the 3-way valve14in the arterial line section4and thus the patient-side fluid conducting system is flooded constantly until the fluid runs out of the venous line section2or runs into a drain/receiver tank. This means that the venous line section2serves as air vent during this system filling process. It has to be pointed out that the hose clamps16,18are naturally open during this process.

As soon as the system has been filled with fluid from the fluid container10, the venous line section is connected to the third connector14cof the 3-way valve14, and the 3-way valve14is put in the switch position according toFIG. 4, which can be referred to as “circulation” switch position. In this switch position, the second and third connectors14b,14cof the 3-way valve14are fluidically connected with each other, whereas the first connector14ais closed.

If now the fluid contained in the fluid conducting system is circulated, it flows, starting from the venous line section2, through the 3-way valve14, and from there, is again passed on in the arterial line section4without fluid being able to enter the fluid container10. Consequently, the fluid stored in there remains uncontaminated.

After a predetermined time of circulation, the 3-way valve14is switched further in the switch position shown inFIG. 5, in which again all three connectors14a-14care closed. You can see that the switch position according toFIG. 5differs from the switch position according toFIG. 2because the valve piston20was not simply turned back all the way in the first shut-off position according toFIG. 2, but was turned back in the second shut-off position according toFIG. 5, which is consequently diametrically opposite the first shut-off position. If the valve piston20had been turned back all the way, it would at least temporarily have passed through the “flush position”, in which contaminated fluid from the fluid conducting system could possibly have penetrated the fluid container.

As soon as the 3-way valve14is closed, the venous line section2is now again disconnected from the 3-way valve14and the valve piston20is turned in the flush position according toFIG. 3in order to perform a repeated flushing after circulation. Upon completion of this process, the filling/circulation cycle is completed.

Finally, the 3-way valve14is closed again, all hose clamps16,18downstream of the 3-way valve14are put in the shut-off position, and the arterial line section is also disconnected from the 3-way valve14so that it can be connected together with the venous line section to the patient's body.

Here it has to be pointed out that according to the description in hand, the filling device according to aspects of the invention is designed with the 3-way switch as a fluid blocking mechanism so that a circulation mode can be performed. However, it is also conceivable to design the blocking mechanism according to aspects of the invention as a simple closing valve with an inlet connector and an outlet connector, which then allows only a “flushing mode” according to the definition above. In every case, the filling device according to aspects of the invention in hand allows a preferably manual closing of the spike outlet so that the spike can remain in the fluid container upon completion of the “flushing mode” and at least the arterial line section disconnected from it can be connected up with its internal connector to the patient access that was already established without further measures having to be taken.

Furthermore, it is conceivable to provide another (or alternatively to the fully closed switch position) switch position for the 3-way switch in which all three conduits are open and thus fluidically connected with each other. This position is technically relevant if sterile products are used, for example.

FIGS. 6a, 6b, 6c, and-6dshow the filling device of the figures above, in particular in the area of the anti-contamination device100according to aspects of the invention.

Accordingly, between the spike12and the one connector (inlet)14aof the 3-way valve14, a non-return valve110is provided, which allows a fluid flow from the spike12in the direction of the 3-way valve14and blocks a fluid flow in the opposite direction. The non-return valve110has a valve body112, which is pre-tensioned with a spring116against a valve seat114in order to close it against the fluid flow coming from the spike12.

FIGS. 6a, 6b, 6c, and-6dshow different variants for the positioning of the non-return valve110.

According toFIG. 6a, the non-return valve110is coupled directly with the spike12, and that without interposition of a connecting hose. For example, the non-return valve110could, in this case, be directly connected to the outlet connector of the spike12or even integrated in it. Furthermore, between the non-return valve110and the 3-way valve14, preferably a connecting hose element120of a predetermined length could be arranged, whereby the length is selected in such a way that a hose volume is created that suffices to absorb a certain quantity of back-flowing fluid before it reaches the non-return valve110and/or the spike. This means that the connecting hose element120constitutes a kind of buffer storage that contributes to improved anti-contamination, in particular if the non-return valve110is defective and does not close all the way.

According toFIG. 6b, in the connecting hose element120between the spike12and the 3-way valve14, a drip chamber130is interposed, which is equipped with a non-return valve function. Here the drip chamber130can also be mounted directly on the spike12, whereby the downstream connecting hose element120constitutes the buffer storage described above.

As an alternative to that, however, it is also possible to combine the non-return valve110according toFIG. 6awith a drip chamber130by arranging the non-return valve according toFIG. 6cdownstream of the drip chamber130or according toFIG. 6dupstream of the drip chamber130.

Finally it is to be pointed out that in particular the non-return valve110is an additional component, as compared to known devices, which could be damaged or yanked off by external impact. In order to avoid this, it is possible to connect the non-return valve110directly on the spike12and/or on the 3-way valve14or to integrate it in their connectors in order to create a modular unit in that way.

In summary, the invention in hand concerns a filling device, for example in the form of a circulation device of an extracorporeal blood treatment device1, with a preferably universal medical fluid container10, to which an arterial line section4of a fluid conducting system of the extracorporeal blood treatment device1can be connected as an option. Furthermore, the filling device has an anti-contamination device with a spike as well as a manual fluid blocking mechanism, for example a 3-way switch, preferably a 3-way valve, which is arranged (directly) downstream of the spike12. A conduit14aof the 3-way switch is coupled with the spike12or a similar connecting device or is formed in one piece together with it. Between the spike12and the manual fluid blocking mechanism14, a non-return valve110is interposed, which is aligned in such a way that it automatically blocks a fluid flow in the direction of the fluid container10.