DE102009018664A1 - External function device i.e. blood treatment cassette, for use in dialyzing device, has non-return valves, addition valves and single-needle blood valve that are integrated in housing body for controlling fluid passing via device - Google Patents

Abstract

The device has an arterial pressure measurement chamber (9), a chamber (15), a venous blood chamber (21) and a single-needle chamber (57) that are integrated in a housing body, for receiving a fluid i.e. blood. Arterial- and venous filter lines (17, 19) are integrated in the body, for guiding the fluid. Non-return valves (35, 39, 47), arterial-heparin- and venous-heparin addition valves (36, 40), pre-diluted- and post-diluted addition valves (51, 53) and a single-needle blood valve (61) are integrated in the body, for controlling the fluid passing through the device. Independent claims are also included for the following: (1) a blood treatment device comprising a control unit (2) a method for arranging or priming an external function device (3) a method for rinsing an external function device (4) a method for connecting an external function device with a patient (5) a method for operating an external function device (6) a method for returning blood from the external function device (7) a method for emptying the external function device.

Description

The The present invention relates to an external functional device according to claim 1. It further relates to a blood treatment device according to the preambles of the claims 31 and 49 and methods according to the claims 37 to 40 and 43 to 48.

The Cleaning the equipment used in blood treatments can be technically complicated. To ensure adequate hygiene at acceptable To be able to ensure workload as well as out other reasons, external functionalities, used like blood cassettes.

A Such blood cassette may be designed as possible many functions for the preparation and execution of To meet blood treatment procedures.

task It is the object of the present invention to provide another external functional device, in particular a blood treatment cassette. Further to a blood treatment device, which is such an external Having functional device or to their control or actuation is designed, and corresponding methods for their use be proposed.

The inventive object is achieved by an external functional device having the features of the claim 1.

The external functional device has at least one housing body, at least one integrated into the housing body Chamber for receiving medical fluids, at least one in the Housing body integrated channel for recording and / or guiding a medical fluid and at least one in the case body in whole or in part integrated valve device for controlling or regulating a external functional device by flowing fluid.

Of the Term "housing body", like as used herein refers to a three-dimensionally shaped one Body made of one used in a medical Treatment methods, such as a blood treatment method, suitable material, such as a plastic material, is formed. The housing body may, for example be produced by means of a casting or injection molding process.

Of the Term "chamber" as used herein denotes a volume which is used to hold at least one medical Fluids is suitable. The volume can be a closed space or be circumscribed by such. But it can also be an open one Be room or partially surrounded by such, and only by the presence of another body - one other than the case body - to one closed or down to supply or discharge for the Be fluid closed room.

chambers may be designed and provided to valves and / or Sensors or the like record.

Of the Term "channel" or "line" like As used herein, means for receiving and / or guiding medical fluids, such as Blood, Substituate and the like is suitable.

channels or lines can be partially closed and / or semi-open structures be configured. You can for example by means of a cover device to at least an open side closed and so against for example Components of a blood treatment device and / or against the Atmosphere be configured sealable.

Of the The term "valve device" as used herein denotes a device suitable for controlling or regulating, which the passage or passage of fluids through channels or lines and / or chambers of the external functional device can control. Valve means can by means of it provided control or regulating devices are controlled. An activation can for example be automated. suitable Control or regulating devices may, for example, in or be provided on the blood treatment device.

advantageous Further developments of the invention external Functional device are each the subject of the dependent claims.

In A preferred embodiment is the external functional device on at least one of its surfaces with a cover device provided which part of at least one integrated valve device is.

In Another preferred embodiment is the cover device at least in a section with the housing body non-positively and / or positively and / or materially connected. The cover device can, for example, by means of a circumferential Weld or otherwise revolving connection with be connected to the housing body. It can also other non-rotating or punctiform or local Welds or joints (eg glued or bonded joints) Pressings) of the cover device with the housing body be provided.

A Covering device may in particular be a film.

In In another preferred embodiment, the external Functional device connections to their connection with having an extracorporeal circuit in fluid communication.

The external functional device can in particular as a cassette to a or be designed for a blood treatment.

Further Preferably, the external functional device by means of two connectors with at least one - preferably two - peristaltic Pump (s) be connected in fluid communication. Roller pumps can be suitable peristaltic pumps.

The external functional device may at least one - preferably have two - pump hose segment (s) or for recording be designed or provided such a.

In a further preferred embodiment, the external Functional device at least one valve device, which at least one web and a portion of the cover having. The web is designed on the housing body. The web and cover device are arranged to communicate by means of a act on a web acting actuator of a blood treatment device for changing a fluid flow in the sense of a Valve to be actuated.

One such "bridge" may be one in the external functional device integrated or from a surface of the same in any Designate direction protruding component. This can be from the same material as the external functional device formed be. A bridge, for example, during manufacture the external functional device by means of casting or injection molding be designed.

In In another preferred embodiment, the fluid is which flows through the external functional device in their use a substituate, heparin or other pharmacological agent, blood, Air and combinations thereof.

The external functional device may in particular to a blood treatment device be coupled. More preferably, it can be configured and provided be by means of a receiving device of the blood treatment device be coupled to the blood treatment device. The external one Functional device can in particular with the cover device facing surface to the treatment device coupled be.

In In another preferred embodiment, the external Functional device to the rear in a tilt angle, in particular of substantially or exactly 8 °, relative to a vertical be coupled to the blood treatment device. The inclination especially the upper part of the external functional device in use affect.

In a further preferred embodiment, the external Functional device at least one substituate addition point, which a Berührschutzelement and / or drip protection having. Also other sections, especially any other section, the external functional device can be a Berührschutzelement and / or have a drip protection.

Of the Drip protection can, for example, by an integrated closure sleeve be realized.

The anti-drip may preferably serve to drip or run out of substituate during the removal of the external functional device from the receiving device of the blood treatment device to prevent. In this way, a hygienic handling of the used and impure external functional device can also be guaranteed outside the treatment device.

The external functional device according to the present invention Invention may be for use in a blood treatment procedure using a double-needle access or a single-needle access be suitable.

The External functional device may preferably at least one single-needle chamber in which a Blutschwallumleitungselement arranged is.

One such "blood flow diverting element" can for Achieving a flow slowdown to create a Turbulence and / or diverting the located in the single-needle chamber Blutschwalls suitable and provided. Such a blood flow diverting element can be designed in particular flow optimized. It can be in the form of an ellipsoidal or round column, for example be configured, which at least a portion of its circumference connected to a wall of the single-needle chamber.

The External functional device of the present invention may preferably have at least one venous blood chamber.

The Single-needle chamber may preferably be above, based on the Alignment of the external functional device during its Use, the venous blood chamber be arranged.

The venous blood chamber can by means of a cross-sectional taper the housing body in at least one upper Room and at least one lower room to be divided.

Of the upper space and lower space can be in fluid communication or connection with each other.

Of the Upper space may be configured to have a tangential inflow from the external functional device by flowing fluids to allow or create. The upper room can be an area for Generating a stable rotational flow of the external Having functional device through-flowing fluids.

Of the lower space may have an area that is substantially or completely free of rotational flow of the external functional fluid flowing through is.

Prefers can walls or wall sections of the upper room, and / or the lower space of the venous blood chamber of a Inclination of the external functional device against a vertical of the blood treatment device be adjusted. This can advantageously be a flow-optimized Flowing or flowing or flowing through allow the blood through the venous blood chamber.

In a further preferred embodiment of the external Functional device is the housing body as Hard part designed.

The external functional device may preferably be a disposable article, which is disposed of after a single use.

The inventive object is also solved by the blood treatment device according to the invention according to claims 31 and 49.

In A preferred embodiment is the blood treatment device for receiving at least one external functional device designed according to the present invention.

In In a further preferred embodiment, the blood treatment device at least one control device and / or actuators and / or sensors for driving and / or actuating the external functional device on.

The Control device may be configured as a CPU or part thereof.

The Control device and / or the actuators can, for example for operating or driving, d. H. for example, taxes or Rules, a valve device suitable and provided. she can at a location of the blood treatment device be arranged, which a valve device of the external functional device opposite in their coupled state.

In In another preferred embodiment, the blood treatment device at least one receiving device for receiving at least one external functional device according to the present invention Invention on. The receiving device may have a coupling surface for coupling the external functional device according to present invention. Such a coupling surface For example, it may be an angle to a vertical on the orientation of the blood treatment device during their use, be inclined, especially to the rear, in particular in an upper area of the receiving device. Such an angle For example, it may be substantially or exactly 8 °, for example.

The Blood treatment apparatus may be used to perform a procedure or a procedural step, as hereinafter and below With reference to the figures are described, be suitable.

In In another embodiment, the blood treatment device a controller - z. B. in the form of a CPU - for Driving or controlling an external functional device according to present invention and / or for carrying out a method or a method step, as described below and under With reference to the figures are described on.

Further For example, the blood treatment device may actuate at least one actuator an external functional device according to the present invention or a portion thereof for performing a method or a method step according to present invention.

The In particular, blood treatment apparatus can also be sensors for actuating an external functional device according to the present invention for carrying out a method or a method step according to the present invention Invention have.

The For example, a blood treatment device can be a dialysis device be.

The inventive object is also solved by the inventive method according to the claims 37 to 40 and 43 to 48. The methods are explained below.

The Blood treatment procedure is exemplified below as one Dialysis, such as a hemodiafiltration, adopted. The blood treatment device is, for example, a dialysis device.

The Dialyser has an extracorporeal circuit with a arterial and a venous section. The dialyzer further includes an arterial and a venous patient tube clamp on.

While dialysis is a patient over a patient access, such as a fistula, a shunt, for example in shape double-needle access or single-needle access, with which Connected extracorporeal circulation.

Of the Extracorporeal circulation can be a blood pump to promote of blood and a substituate pump for delivering substituate and have corresponding pump tube segments or in these be integrated.

The Blood pump and the substituate pump can be called peristaltic Pumps, for example, as a roller pumps, be designed.

A "conveying direction" or "flow direction" of Blood during a dialysis treatment denotes a direction in which the blood to be purified usually promoted becomes. In particular, it may designate a direction that the patient has over an arterial needle, an arterial section, a dialyzer (in the figures from bottom to top), a venous section and via a venous needle back to Patient runs.

A taking place against this direction of conveyance fluid delivery (in particular blood and substituate) is referred to as promotion or flow in the opposite direction.

The Blood treatment device has a dialysis device with a Dialysis fluid and a dialysis fluid on, wherein the dialysis fluid through the dialyzer in the opposite direction to the blood (in the figures from top to bottom) promoted can be.

One Substituate may be introduced through a substituate addition site and by a pre-dilution addition valve and / or a post-dilution addition valve be registered in the extracorporeal circuit.

The Terms "clockwise" or "against clockwise "refer to the figures. A Blood pump and a substituate pump usually promote counterclockwise, as is the usual conveying direction during a dialysis treatment.

At the Priming or filling may be the pre-dilution addition valve, the post-dilution addition valve and a single-needle blood valve initially open.

Preferably are also the arterial patient tube clamp and venous ones Patient tube clamp open.

Of the arterial patient port and the venous patient port are preferably interconnected.

One Hahn, via which a fluid connection between the extracorporeal Circulation and the atmosphere or a container can be produced and via which the external functional device flowing fluids from the extracorporeal circuit are discharged, is preferably also closed.

about Substituate addition site is added Substituate.

The Substituatpumpe is started, it is preferably against a Clockwise (relative to the plane of the attached Figures) operated. The blood pump is started, preferably in the Clockwise.

Preferably Substituate is promoted to or before the post-dilution addition valve. The post-dilution addition valve is preferably closed upon reaching.

substituate is conveyed through the pre-dilution addition valve, preferably in the direction of dialysis and / or in direction to the blood pump.

there can the substituate, which in the direction of the dialysis flows, the dialyzer and the venous Pass through the section of the extracorporeal circuit and into a venous blood chamber of the external functional device enter.

The Substituate which flows towards the blood pump can flow through the blood pump in a clockwise direction. Preferably The blood also flows through the connection between arterial and venous patient port, flows through one Clot trap the external functional device and passes into the venous blood chamber.

there it is possible that the substituate, which is in the direction Dialyzer flows with that Substituat, which towards the blood pump, in the venous Blood chamber is mixed.

If the venous blood chamber is filled, then preferably the pre-dilution addition valve 51 and the single-needle blood valve can be closed or closed automatically.

The Substituate pump preferably stops or stops. The pre-dilution addition valve, the post-dilution addition valve and the single-needle blood valve are preferably closed.

Under Operating the blood pump will substitute the extracorporeal Promoted circulation. Located in the single-needle chamber preferably no substituate.

When rinsing or rinsing, first preferably both the pre-dilution addition valve, the Post-dilution addition valve as well as the single-needle blood valve closed.

The arterial patient tube clamp and the venous patient tube clamp are preferably open at the beginning.

Of the arterial patient port and the venous patient port are still connected.

substituate is done by operating the blood pump through the extracorporeal circulation promoted, for example, no substituate in the single-needle chamber is located.

The Pre-dilution addition valve is now preferably opened, as well the cock.

Under Operating the substituate pump (preferably counterclockwise the drawing plane) and the blood pump (preferably in a clockwise direction) is preferably substituate continuously by extracorporeal Promoted circulation. The blood pump can be slower than that Rotate substituate pump.

The Substituate can be via a drain line from the extracorporeal Cycle exit and discarded.

to Carrying out a dialysis becomes a patient with the extracorporeal Connected circuit. The connection can, for example, help double-needle access or single-needle access respectively.

In a first variant of a patient connection can the pre-dilution addition valve, the post-dilution addition valve and the single-needle blood valve preferably closed.

One Patient can access via a double-needle access arterial needle and a venous needle to the extracorporeal Circuit can be connected.

The arterial patient tube clamp and the venous patient tube clamp may initially preferably be closed.

Then the arterial patient tube clamp can be opened.

The Blood pump can be operated (preferably counterclockwise) and preferably blood through the arterial needle into the extracorporeal Promote circulation.

substituate may be at the dialysis fluid exit from the extracorporeal Cycle discharged and discarded.

If the blood to be purified at a blood inlet at the dialyzer the arterial patient tube clamp may preferably closed and the venous patient tube clamp then be opened.

The Blood pump can be stopped.

Now Preferably, blood can pass through the venous needle into the extracorporeal Circulation and through the clot trap into the venous Blood chamber and through a venous filter line to a Blood discharge from the dialysis flow.

Subsequently Both the arterial and the venous patient tube clamps preferably closed.

alternative a patient can go through a patient connection in accordance with a second variant can be connected to the extracorporeal circuit.

First become the pre-dilution addition valve, the post-dilution addition valve and the single-needle blood valve preferably closed.

Of the Patient can, for example, again via a double-needle access via an arterial needle and a venous needle to the extracorporeal Circuit can be connected.

The Blood pump can now be operated (preferably counterclockwise) and blood through the arterial needle into the extracorporeal circulation promote. The blood may preferably be the dialyzer and flow through the external functional device. The Blood can preferably pass through the venous needle enter the patient.

The arterial and venous patient tube clamp can preferably remain open.

at a dialysis treatment without the addition of substituate can the pre-dilution addition valve and the post-dilution addition valve be closed. When performing a dialysis treatment using a double-needle access, the single-needle blood valve preferably be closed.

Further are the arterial patient tube clamp and venous Patient tube clamp preferably open, allowing blood to the extracorporeal Circulation can flow continuously.

Prefers The blood pump can send the blood through the arterial needle into the extracorporeal Cycle and through the venous needle back to the patient promote.

The Blood flows through the dialyzer, where it is in an advantageous Way by means of the opposite direction to the blood through the dialyzer flowing dialysis fluid to be cleaned can.

Of the Term "online HDF predilution" a dialysis method, in particular a hemodiafiltration, Substituate is added to the blood to be purified.

Preferably can use this method ("Online HDF Pre-dilution") the pre-dilution addition valve open, the post-dilution addition valve and the single-needle blood valve will be closed.

The arterial patient tube clamp and the venous patient tube clamp may preferably be open.

The Blood pump (runs preferably counterclockwise) can send blood through the arterial needle into the extracorporeal circulation and through the venous needle to the patient or in the Promote vascular system back, as already described above with respect to a dialysis treatment is.

The Substituent pump (runs preferably counterclockwise) may promote substituate arising at or from the pre-dilution addition valve in the arterial section of the extracorporeal blood circulation can mix with the blood.

The Dialysis fluid may, as described above, preferably in the opposite direction to the blood through the dialyzer are passed and for cleaning the dialysis also flowing blood can be used.

Of the Term "Online HDF Postdilution" refers to a Dialysis method, in particular a hemodiafiltration, Substituate is added to the purified blood.

Preferably can here the post-dilution addition valve open, the Pre-dilution addition valve as well as the single-needle blood valve be closed against it.

Of the Process flow essentially corresponds to the sequence of the above described "online HDF predilution", except that the substituate is at or after the post-dilution addition valve in the venous section to the purified blood and mix with it.

A referred to as "Online HDF Mischdilution" a process in which between a process of "Online HDF predilution "; as described above and a process of "online HDF post-dilution", as described above, can be switched.

there Any sub-process of predilution or post-dilution for a given interval. Everyone Sub-process can be repeated continuously.

alternative to a blood treatment using a double-needle access to the patient as described above, the blood treatment using a single-needle access ("Cassette Integrated Single Needle ").

One Single-needle access can be a Y-shaped branch in the arterial section and the venous section of the Have extracorporeal circulation.

The Pre-dilution addition valve and the post-dilution addition valve can be closed. The single-needle blood valve can on the other hand, preferably be open. This way you can a fluid communication between the venous blood chamber and a single-needle chamber.

The arterial patient tube clamp and the venous patient tube clamp can be closed.

Of the Patient is connected to the extracorporeal circuit and the arterial patient tube clamp can be opened preferably become.

The Blood pump can transfer blood through the extracorporeal circulation the venous blood chamber preferably into the single-needle chamber promote the external functional device.

If the single-needle chamber essentially or completely is filled, the blood pump can be stopped preferably. Then the venous patient tube clamp can be opened become.

Of the Dialysis process can be interrupted and the dialyzer is not operated.

By The venous section can send blood into the vascular system back to the patient or to the patient.

thereupon The arterial patient tube clamp is preferably opened.

Of the Operation can be as often as required and / or desired be repeated continuously or at certain intervals.

in the Following a blood treatment procedure may be after treatment in the extracorporeal circulation blood preferably in the Be returned to patients.

at a first variant of the blood return can the pre-dilution addition valve open and the post-dilution addition valve and the single-needle blood valve will be closed.

The Arterial patient tube clamp may preferably be closed on the other hand, the venous patient tube clamp is opened.

The arterial needle and the venous needle of a double-needle access may preferably remain on the patient.

The Substituent pump (runs preferably counterclockwise) may be operated and preferably substituate through the pre-dilution addition valve promote in the extracorporeal circulation.

The Substituate may be the dialyzer and the venous Pass through the section of the extracorporeal circuit. Just before the substituate reaches the venous needle, can the substituate pump are preferably stopped.

thereupon the arterial patient tube clamp can be closed and the venous patient hose clamp.

The Substituent pump (runs preferably counterclockwise) and the blood pump (runs preferably in a clockwise direction) can be operated.

The substituate may be delivered from the pre-dilution addition valve into the arterial section towards the patient. Shortly before reaching the arterial needle both pumps can preferably ge to be stopped.

In a second embodiment blood recycling process can the Pre-dilution Addition Valve, the Post-Dilution Addition Valve and the single-needle blood valve will be closed.

The arterial patient tube clamp and the venous patient tube clamp may preferably be closed.

Preferably may be a sensor / detector attached to the arterial patient tube clamp and a sensor / detector on the venous patient tube clamp be provided.

The arterial needle can be disconnected.

The Blood pump (runs preferably counterclockwise) can be operated and blood through the arterial needle in the promote extracorporeal circulation.

If the sensor / detector at the arterial patient tube clamp the Breathes detected by air, the blood pump may preferably as long as further promote until blood at pre-dilution addition valve arrives. Then the blood pump can be stopped.

Of the arterial patient connection can be closed.

The Substituate pump can be operated (runs preferably counterclockwise).

The Pre-dilution addition valve can be opened and the substituate pump may preferably be substituate through the pre-dilution addition valve promote in the extracorporeal circulation.

The Substituate can flow through the extracorporeal circuit and preferably displace the blood therein. When the sensor / detector of the venous patient tube clamp recognizes the occurrence of substituate, the substituate pump may preferably continue blood and substitute through the venous needle into the patient, encourage all blood from the extracorporeal Circulation was returned to the patient.

After all can pull the venous needle and the pumps preferably be stopped.

To the The pre-dilution addition valve can empty and the post-dilution addition valve open, the single-needle blood valve be closed against it.

The arterial patient tube clamp and the venous patient tube clamp can be closed.

Of the arterial patient port and the venous patient port may preferably be connected to each other.

To The process can begin with the arterial patient tube clamp and the venous patient tube clamp opened become.

At the or via the substituate addition site may preferably Substituate be introduced into the extracorporeal circulation.

The Substituent pump can be operated (runs counterclockwise) and substituate through the extracorporeal circuit to the pre-dilution addition valve and promote post-dilution addition valve.

consumed Substituate may preferentially exit the extracorporeal circuit at the dialysis fluid outlet leave and be discarded.

The Substituate can on the one hand by the pre-dilution addition valve and to the other by the post-dilution addition valve towards Be promoted dialyzer.

The Pre-dilution addition valve can be closed. The Blood pump can be started.

through Operating the blood pump (runs preferably counterclockwise) and the substituate pump (preferably runs counterclockwise) Substituate can through the extracorporeal circulation - starting upstream Post-dilution addition valve - by the venous Blood chamber, the clot trap, the venous section, the arterial section are conveyed in the direction of the dialysis. It may exit the extracorporeal circuit preferably through the dialysis fluid outlet leave. The used substituate can be discarded.

in the Below, the present invention will be described with reference to preferred embodiments same described with reference to the drawings. In the Figures of the drawing denote like reference numerals the same or identical elements. The following applies:

1 shows a side view of a provided at its front with a cover device according to the invention external functional device according to a preferred embodiment;

2 shows the external functional device of 1 with unfolded cover device;

3 shows the external functional device 1 and 2 from her backside;

4 schematically shows a simplified phase during the performance of a preparation or priming process according to the invention prior to performing a blood treatment process;

5 schematically shows a simplified phase during the performance of a rinsing or rinsing process according to the invention prior to performing a blood treatment process;

6 schematically shows a simplified phase during the implementation of a first inventive process for connecting a patient to an extracorporeal circuit of a blood treatment device;

7 schematically shows a simplified phase during the implementation of a second process according to the invention for connecting or connecting a patient to an extracorporeal circuit of a blood treatment device;

8th schematically shows a simplified phase during the performance of a first blood treatment process according to the invention;

9 schematically shows a simplified phase during the implementation of the blood treatment process of the invention 8th using predilution;

10 schematically shows a simplified phase during the implementation of the blood treatment process of the invention 8th using post-dilution;

11 schematically shows a simplified phase during the implementation of the blood treatment process of the invention 8th using mixed dilution (predilution);

12 schematically shows a simplified phase during the implementation of the blood treatment process of the invention 8th using mixed dilution (postdilution);

13 schematically shows a simplified phase during the implementation of a second blood treatment process according to the invention using a single-needle access;

14 schematically shows a simplified phase during the implementation of a first blood recycling process according to the invention;

15 schematically shows a simplified phase during the implementation of a second blood recycling process according to the invention; and

16 schematically shows a simplified phase during the execution of an emptying or emptying process according to the invention after execution of a blood treatment process.

For exemplifying the present invention, as the treatment device, there are blood treatment device and selected as a method of a blood treatment method.

The normal arrows in the figures show the direction of the bloodstream at. The block arrows each show the direction of the substituate stream at. The double block arrows each show the direction of the dialysis fluid flow at.

1 shows a side view of an external functional device, which at the surface, on the in 1 is provided with a cover device is provided.

The external functional device is exemplified here as a cassette 1000 designed.

The cassette 1000 has a hard part 1 on. As in 1 shown by way of example, has the hard part 1 Chambers, channels and valves on. As in 1 is further exemplified, the chambers, channels and valves in the hard part 1 integrated or at least partially from the hard part 1 designed.

The cassette 1000 of the 1 is at its front with a cover device, here for example a film 3 , Mistake. The cover device can flat, ie flat, on the hard part 1 be welded on.

The cover means may be the chambers and / or channels of the hard part 1 the cassette 1000 close, against one of the hard part 1 opposite side of the cover device and / or to the atmosphere.

As in 1 can be seen, the film is located on a circumferential sealing bar 4 on the hard part 1 the cassette 1000 on. The foil 3 is on a circumferential weld 5 with the hard part 1 the cassette 1000 welded.

The foil 3 may be at other local welds (not shown) with the hard part 1 the cassette 1000 be connected. These can also be circumferential, that is closed in the sense of a final boundary similar to a ring, and / or punctiform.

The cassette 1000 at least with the in 1 shown front to a blood treatment device (in 1 not shown). An example procedure for the suitable coupling of a cassette 1 to a coupling surface of a blood treatment device is described in the patent applications (08/53-d01 DE, FM19A22 entitled "Connection device for connecting at least one external functional device to an assembly, arrangement comprising such a connection device and method of connection", by the present applicant German Patent and Trademark Office (DPMA) 09/05 d01-DE, FM19A24 entitled "Apparatus for Connecting an External Functional Device to an Arrangement, Arrangement Having Such Apparatus and Method of Bonding", issued Mar. 10, 2009 filed with the DPMA; 09/01 d01-DE, FM19A25 entitled "Sealing Device for Sealing a Volume of a Medical Device Against Another Volume and Arrangement and Method", also filed with the DPMA on March 10, 2009) their respective disclosures hereby fully B is taken.

The cassette 1000 can match the plane of the slide 3 - or via this - are coupled to a coupling surface of the blood treatment device.

The coupling surface of the blood treatment device may, for example, at an in 1 upper section thereof at 8 ° to an in 1 from top to bottom vertical to the rear (in the 1 the direction extending from the viewer into the plane of the drawing).

The cassette 1000 has an arterial patient connection 7 on.

The cassette 1000 has an arterial pressure measuring chamber 9 on. This may have corresponding sensors. The sensors can preferably transmit signals wirelessly.

The cassette 1000 has a connector 11 for the blood leakage from the cassette 1000 as well as a connector 13 for the blood entry into the cassette 1000 on.

The two connectors 11 and 13 are connectable to a pump tubing segment or set of a blood pump.

The cassette 1000 also has a chamber 15 with a post or prefilter pressure measuring point.

The cassette 1000 has an arterial filter line 17 and a venous filter line 19 on.

The inside of the cassette 1000 has a venous blood chamber 21 on. The venous blood chamber 21 is an upper room 23 and a lower room 25 divided.

The upper room 23 the venous blood chamber 21 can allow a laterally tangential blood inflow. In doing so, blood can flow laterally through the inlet (the left side in 1 ) in the upper room 23 infuse and become tangent to the walls of the upper room 23 spread. A laterally tangential blood inflow may be a zone of substantially or fully stable rotational flow of the blood in the upper space 23 the venous blood chamber 21 produce.

The lower room 25 the venous blood chamber 21 may be a calming zone for blood flow. It is possible that there is substantially no or no rotational flow of the blood in such a calming zone.

The venous blood chamber 21 is through a cross-sectional taper 27 of the hard part 1 the cassette 1000 in the upper room 23 and the lower room 25 divided up. The cross-sectional rejuvenation 27 reduces the cross section of the venous blood chamber 21 so in its width and depth that results in a rapid flow, when crossing a venous blood chamber 21 the cassette 1000 flowing fluid assumes a slower flow rate. The upper room 23 and the lower room 25 are in fluid communication.

By such a construction, ie a division of the venous blood chamber 21 into a zone of substantially or fully stable rotational flow of the blood and into a calming zone for blood flow, an efficient separation for air from the blood or fluid can advantageously be achieved.

Walls of the upper room 23 and the lower room 25 the venous blood chamber 21 can suitably a slope of the upper portion of the cassette 1000 in 1 against the vertical, for example, a slope of the upper part of in 1 shown cassette 1000 8 ° backwards (into the plane of the drawing). They may be suitably rounded in such a way that they advantageously represent a flow-optimized contact surface for fluids containing the venous blood chamber 21 flow through.

The cassette 1000 has a clot trap 29 on.

The cassette 1000 has a venous patient connection 31 on.

The cassette 1000 has an arterial heparin delivery site 33 on. It should be noted that the heparin addition point 33 also for the addition of pharmacological agents other than heparin, which are preferably only anticoagulants, or combinations of active ingredients may be suitable and provided. This is always to be considered even if heparin is mentioned in any context before or in the following.

at The drugs to be added may be any form of Drugs act, regardless of whether the drug directly related to the extracorporeal blood treatment or only that given by the extracorporeal blood circulation Access to the patient's bloodstream is used to deliver medication To infuse other therapies.

It may preferably be present in suitable solutions Act drugs.

• – Vitamine, z. B. eine aktive Form des Vitamins D, z. B. Colecalciferol;
• – Erythropoetin (EPO);
• – Eisenpräparate, z. B. komplexiertes Eisen;
• – Antibiotika;
• – Chemotherapeutika.

In particular, the medicaments may be:

• - vitamins, eg. B. an active form of the vitamin D, z. For example, colecalciferol;
• - erythropoietin (EPO);
• - iron preparations, z. B. complexed iron;
• - antibiotics;
• - Chemotherapeutics.

It can be a single or it can be several different Medication can be infused consecutively or simultaneously.

The Drug or medications may be in a drug container or multiple drug containers that are over known or obvious supply systems with the point of addition the blood cassette can be connected. The connection the at least one medicine container can by a or several hose lines.

It is also possible, the direct connection by means of suitable To realize adapter.

It can be at the drug containers to container with rigid walls or containers with at least one flexible or elastic running wall or a sliding wall, z. B. in the form of a known syringe, act.

Especially the medication containers may be vials. In particular, the flexible medication containers flexible or elastic plastic containers, e.g. B. bag or tubes, or be.

The Infusion of the drug may, for example, due to a negative pressure take place in extracorporeal blood circulation. For medicine containers with a rigid wall, elements can be used to equalize the pressure be integrated. Furthermore, the medicine containers be suitable to connect elements for pressure equalization. Due to the emptying pressure changes can occur preferably be compensated thereby.

integrated Elements for pressure compensation can z. B. sterile membranes be integrated in the wall.

It but can also provide at least one branch line for pressure equalization be. The at least one stub can be plugged into an adapter for Connecting the medicine container integrated be.

Of the Pressure equalization can by the flow of gases and / or Liquids take place.

at The medicine containers can be disposable or to be reusable container.

The Addition may occur in the arterial and / or venous branch of the extracorporeal blood circulation, ie on the suction side and / or done on the pressure side of the blood pump.

The drug delivery may preferably via one of the addition point 33 and or 37 associated check valve 35 and or 39 the cassette - especially dosed - done.

The However, drug delivery can also be at any other appropriate Place, regardless of the specific design the functional device according to the invention. Therefore relate to the proposed versions of drugs and the nature of their addition or release of each invention Embodiment regardless of other features thereof.

The cassette 1000 has a check valve 35 the arterial heparin delivery site 33 on.

Exemplary check valves for use as a check valve 35 the arterial heparin delivery site 33 as well as further check valves of the cassette 1000 are disclosed in patent application (09/13-d01DE, FM19A26 entitled "Valve device, valve core, external functional device, treatment device and method" filed by the present applicant at the DPMA), the disclosure of which is hereby incorporated by reference in its entirety.

The cassette 1000 has an arterial heparin addition valve 36 on. Using the arterial heparin addition valve 36 may be the addition of heparin to the arterial filter line 17 be controlled or regulated.

The arterial heparin addition valve 36 can be configured as a so-called phantom valve.

A phantom valve for use as an arterial heparin adding valve 36 as well as further phantom valves of the cassette 1000 can with or from a web section of a channel on the hard part 1 the cassette 1000 and a section of the film opposite or opposite the web section 3 be designed.

phantom valves can be actuated by actuators of the blood treatment device become.

To close a phantom valve, the section of the film 3 be pressed on the bridge section. To open the phantom valve, the section of the film 3 be lifted off the bridge section again.

Further Examples and / or embodiments for phantom valves can the patent application (09/01-d01 DE, FM19A25 with the Title "Sealing device for sealing a volume a medical treatment arrangement against another volume as well as arrangement and procedure ", which on 10 March Submitted to the DPMA in 2009) Revelation hereby incorporated by reference.

The cassette 1000 has a venous heparin delivery site 37 on. The venous heparin delivery site 37 can be designed as a Luer valve.

The cassette 1000 has a check valve 39 the venous heparin addition site 37 on.

The cassette 1000 has a venous heparin addition valve 40 on. With the help of the venous heparin addition valve 40 may be the addition of heparin into the venous filter line 19 be controlled or regulated.

The cassette 1000 has a substituate addition site 41 on.

The substituate addition point 41 may be provided with a Berührschutzelement (not shown). The substituate addition point 41 may be provided with a drip guard (not shown). The drip protection can be realized by an integrated sealing sleeve. The drip guard may cause dripping of substituate residues upon release of the cassette 1000 and then removing the cassette 1000 prevent from the blood treatment device.

The cassette has a connector 43 for a substituate exit from the cassette 1000 as well as a connector 45 for a Sustituateintritt in the cassette 1000 on.

The connectors 43 and 45 are connectable to a pump tubing segment or set of a substituate pump.

The cassette 1000 has a check valve 47 for substituate addition.

Via actuation of the check valve 47 can substitute in a substituate line 49 be introduced.

The cassette 1000 has a pre-dilution addition valve 51 on. The pre-dilution addition valve 51 can be designed as a phantom valve.

The cassette 1000 has a post-dilution addition valve 53 on. The post-dilution addition valve 53 can be designed as a phantom valve.

The cassette 1000 has a single-needle sterile membrane 55 on.

The cassette 1000 has a single-needle chamber 57 on. The single-needle chamber 57 is in 1 above the venous blood chamber 21 arranged.

Inside the single-needle camera 57 is a blood surge redirecting element 59 arranged. The blood surge redirecting element 59 can serve to slow down and / or divert a blood surge.

The cassette 1000 has a single-needle blood valve 61 on. The single-needle blood valve 61 can as Phantom valve be configured.

The cassette 1000 has a suction point 63 on. The suction point 63 can be used for vacuum coupling of the cassette 1000 serve to the blood treatment device, as for example in the patent application DE 10 2007 042 964 A1 entitled "Apparatus and Method for Treating a Medical Fluid" filed with the DPMA on Sep. 10, 2007, the disclosure of which is incorporated herein by reference in its entirety.

The cassette 1000 has a primary orientation center 65 on. The primary orientation center 65 can be advantageous for aligning and / or locking the cassette 1000 serve at the blood treatment device.

The cassette 1000 has a secondary alignment site 67 on. The secondary alignment site 67 can be used to align and / or lock the cassette 1000 serve at the blood treatment device.

2 shows the cassette 1000 of the 1 , where the film 3 on the left edge of the cassette 1000 as well cut out above and below and to the right unfolded is recognizable. As in 2 shown, rejects the film 3 has a surface structuring.

2 shows the after cutting the film 3 in more detail to be recognized elements inside the cassette 1000 ,

To avoid repetition, reference is made to the above in the description of the 1 referenced embodiments of the individual elements referenced.

Good to see here is that the cassette 1000 a sealing bar 69 having. The sealing bar 69 For example, it may be used to design the pre-dilution addition valve 51 be used.

3 shows the cassette 1000 from her back. Is the cassette 1000 coupled to the blood treatment device, a viewer when opening a door of the blood treatment device for removing the cassette 1000 look at this back.

The cassette 1000 has a single-needle air connector 71 on. It can be provided on the device side and / or on the blood side, a support grid (not shown) of the single-needle sterile membrane 55 at the single-needle air connector 71 to arrange.

The cassette 1000 has several support webs. The support webs have different heights, related for example to the plane of the film 3 , on. The support bars rise in the viewer in 3 facing side of the cassette 1000 , so from the drawing level of the 3 out.

The cassette 1000 has support bars 73 with a height of 5 mm, supporting webs 75 with a height of 8 mm, supporting webs 77 with a height of 13 mm, supporting webs 79 with a height of 24 mm and support bars 81 with a height of 31 mm. Of course, the above and other numerical values are to be understood as purely exemplary.

The Support bars can serve the cassette in the coupled state to a blood treatment device against a Cover of a receiving device of the blood treatment device to support the cassette. Exemplary embodiments such a coupling of the cassette to the blood treatment device are in the patent application (09/05-d01 DE, FM19A24 entitled "device for connecting an external functional device to an assembly, Arrangement comprising such a device and method for connecting " submitted to the DPMA on 10 March 2009), to the relevant disclosure hereby fully Reference is made.

The following are based on the 4 to 16 various processes of the invention described which can be used by means of the external functional device according to the invention in blood treatment.

The blood treatment device has an external functional device, for example, the in the 1 to 3 explained cassette 1000 with the above in the 1 to 3 described elements on.

The blood treatment device further comprises a dialysis device 2000 with a Dialysierflüssigkeitseintritt 2001 and a dialysis fluid outlet 2003 on.

The blood treatment device also has an extracorporeal circulation 3000 on.

The extracorporeal circulation 3000 has an arterial patient tube clamp 83 and a venous patient tube clamp 85 on.

The extracorporeal circulation 3000 has a blood pump 87 with a pump hose segment 88 on.

The extracorporeal circulation 3000 has a substituate pump 89 with a pump hose segment 90 on.

The blood pump 87 and the substituate pump 89 may be configured as peristaltic pumps, for example roller pumps as in the figures.

Of the Term "conveying direction" or "flow direction" the usual during a blood treatment conveying direction of the blood to be purified from a patient to a dialyzer and the purified blood from the dialyzer into the patient back. This conveying direction runs in the drawing plane of the figure counterclockwise.

Analogously, the terms "conveying direction" or "flow direction" in connection with the flow of a substituate designate a conveying direction of the substituate from the substituate addition valve which is customary during a blood treatment 41 in the extracorporeal circulation 3000 ,

A against this conveying direction taking place fluid delivery (in particular blood and substituate) is considered as promotion or Called flow in the opposite direction.

The extracorporeal circulation 3000 has an arterial section 91 and a venous section 93 on.

The arterial section 91 the extracorporeal circuit 3000 extends from a section for arterial connection of a patient, for example an arterial needle, through the cassette 1000 up to a blood entry at the dialyzer 2000 , The arterial section 91 has several components. To form an arterial connection of a patient, the arterial patient connection 7 , the arterial patient tube clamp 83 , the arterial pressure measuring chamber 9 , the chamber 15 with arterial post or prefilter pressure measuring point, the pump tube segment 88 the blood pump 87 , the arterial filter line 17 and a blood inlet at the dialyzer 2000 each part of the arterial section 91 the extracorporeal circuit 3000 ,

The venous section 93 the extracorporeal circuit 3000 extends from a blood outlet at the dialyzer 2000 to a section for venously connecting a patient, for example a venous needle. The venous section 93 has several components. To form a blood outlet from the dialysis 2000 , the venous filter line 19 , the venous blood chamber 21 , the clot trap 29 , the single-needle chamber 57 , the venous patient connection 31 , the venous patient tube clamp 85 and a venous connection of a patient respectively part of the venous section 93 the extracorporeal circuit 3000 ,

4 shows a phase during the execution of a preparation process or priming process for filling the fluid lines used according to the inventive method.

The arterial section 91 and the venous section 93 the extracorporeal circuit 3000 are connected.

The pre-dilution addition valve 51 , the post-dilution addition valve 53 and the single-needle blood valve 61 the cassette 1000 are opened. The two patient tube clamps 83 and 85 are also open.

4 shows the described configuration as a snapshot or a phase during the preparation or priming process.

About the substituate addition point 41 becomes substituate in the extracorporeal circulation 3000 brought in.

The blood pump 87 and the substituate pump 89 are started. The blood pump 87 promotes in 4 clockwise. The substituate pump 89 promotes counterclockwise. The blood pump 87 and the substituate pump 89 can be offset from each other, for example, offset by a quarter turn against each other, operated. The substituate pump 89 can be faster than the blood pump 87 rotate. The term "clockwise" in the present application always refers to the drawing plane of the figures.

The substituate passes through the connector 43 out of the cassette 1000 into the pump hose segment 90 the substituate pump 89 , The substituate passes through the connector 45 back in the cassette 1000 one. The substituate flows through the check valve 47 and the substituate line 49 until pre-dilution addition valve 51 and the post-dilution addition valve 53 ,

The pre-dilution addition valve 51 will be opened. The post-dilution addition valve 53 stays closed.

The substituate flows into the chamber 15 and into the arterial filter line 17 ,

From the chamber 15 the substituate flows through the connector 13 into the pump hose segment 88 the blood pump 87 , The substituate flows through the pump hose segment 88 the blood pump 87 and enters through the connector 11 back in the cassette 1000 one.

The substituate flows at the arterial patient port 7 out of the cassette 1000 out and flows through the arterial section 91 the extracorporeal circuit 3000 ,

At the point of connection of the arterial section 91 with the venous section 93 is a cock 97 provided, leading to a drain line 95 leads. The rooster 91 is closed. The substituate therefore does not enter the drain line 95 ,

Rather, the substituate passes over the venous section 93 through the venous patient connection 31 in the cassette 1000 and from there into the clot trap 29 ,

The substituate enters the venous blood chamber 21 one. For the sake of simplicity, the venous blood chamber 21 in the 4 to 16 shown as a one-component element, although, as described above with respect to 1 and 2 discussed, advantageously from an upper room 23 and a lower room 25 is designed.

From the arterial filter line 17 the substituate flows into the dialyzer 2000 and from there into the venous filter line 19 ,

The substituate flows out of the venous filter line 19 into the venous blood chamber 21 Where it's on the extracorporeal circuit 3000 Substituate flowing through in the opposite direction hits.

When the venous blood chamber 21 filled, becomes the pre-dilution addition valve 51 closed and the substituate pump 89 stopped.

The blood pump 87 promotes the Substituate now through the closed extracorporeal circulation 3000 ,

In the substituate line 49 Substituate present is not promoted. The single-needle chamber 57 is free or substantially free of substituate.

5 shows a phase of a rinsing process or rinsing process according to the inventive method.

After the preparation or filling (priming) in the now closed extracorporeal circulation 3000 To remove circulating Substituat from this, the cock 97 open.

The substituate pump 89 will be turned on again. The pre-dilution addition valve 51 will be opened.

The blood pump 87 and the substituate pump 89 promote the substituate on the drain line 95 from the extracorporeal circulation 3000 out.

5 shows the configuration described as a snapshot or in a phase of the rinsing or rinsing process.

The blood pump 87 and the substituate pump 89 constantly promoting new substituate, allowing the extracorporeal circulation 3000 is rinsed. The used substituate is discarded.

The blood pump 87 and the substituate pump 89 each in a clockwise direction. The blood pump 87 and the substituate pump 89 can promote mutually offset. The substituate pump 89 can be faster than the blood pump 87 rotate.

6 shows a phase when connecting a patient 4000 to the extracorporeal circulation 3000 according to the inventive method in a first manner by means of a double-needle access 99 , 6 Therefore, in turn - as all figures to process steps - only one phase.

To connect a patient 4000 to the blood treatment device is a double-needle access 99 used.

The double-needle access 99 has an arterial needle 101 with a fixation 102 , z. A cuff, plaster and the like, and a venous needle 103 with a fixation 104 , z. As a cuff, a patch and the like on.

The arterial needle 101 is with the arterial patient connection 7 the cassette 1000 connected. The venous needle 103 is with the venous patient connection 31 connected to the cassette.

The venous needle 103 becomes the patient 4000 laid and fixed. The arterial needle 101 becomes the patient 4000 laid and fixed. The venous needle 103 can be in front of the arterial needle 101 with the patient 4000 be connected.

The extracorporeal circulation 3000 due to its filling is filled with substituate. The pre-dilution addition valve 51 , the post-dilution addition valve 53 and the single-needle blood valve 61 are closed.

First, both are patient tube clamps 83 and 85 closed.

The blood pump 87 is pressed. The arterial patient tube clamp 83 will be opened.

6 shows the configuration described as a snapshot with already opened arterial patient tube clamp 83 , just before starting the blood pump 87 ,

From the patient 4000 gets blood through the arterial needle 101 in the arterial section 91 the extracorporeal circuit 3000 promotes and displaces or promotes the substituate. The substituate is via the Dialysierflüssigkeitsaustritt 2003 the dialyzer 2000 promoted from the blood treatment device.

If the blood is from the arterial section 91 the extracorporeal circuit 3000 at a blood entry 105 at the dialyzer 2000 arrives, the arterial patient tube clamp becomes 83 closed and the blood pump 87 stopped.

The venous patient tube clamp 85 will be opened.

About the venous needle 103 Blood enters the venous section in the opposite direction 93 the extracorporeal circuit 3000 one. The blood pump 87 will not be pressed.

For example, the blood may be due to gravity in the venous section 93 enter.

The blood flows through the venous section 93 in the opposite direction and enters the clot trap 29 and the venous blood chamber 21 , The blood flows through the venous filter line 19 and passes in the opposite direction through the blood outlet 107 into the dialysis machine 2000 ,

7 illustrates a phase of a second way or an alternative process for connecting a patient 4000 to a blood treatment device.

The patient 4000 is via an arterial needle 101 and a venous needle 103 with the extracorporeal circulation 3000 konnektiert.

The arterial patient tube clamp 83 and the venous patient tube clamp 85 are opened. The pre-dilution addition valve 51 , the post-dilution addition valve 53 and the single-needle blood valve 61 are closed.

Throughout the extracorporeal circulation 3000 Substituate is (except in the single-needle chamber 57 ).

The blood pump 87 is started. The dialyzer 2000 is not turned on.

7 shows the described configuration as a snapshot. At this time, there is only substitute in the extracorporeal circulation 3000 ,

From the patient 4000 is under operation of the blood pump 87 Blood through the arterial needle 101 in the arterial section 91 the extracorporeal circuit 3000 promoted. The blood flows at the blood inlet 105 at the dialyzer 2000 in this one and from there by the blood outlet 107 the dialyzer 2000 in the venous section 93 the extracorporeal circuit 3000 ,

Via the venous filter line 19 the blood gets into the cassette 1000 and occurs when the post-dilution addition valve is closed 53 into the venous blood chamber 21 one, the blood being tangential to the upper space of the venous blood chamber 21 can flow in.

From the venous blood chamber 21 the blood gets over the clot trap 29 out of the cassette 1000 via the venous patient connection 103 to the patient 4000 back.

8th shows a phase of dialysis treatment using double-needle access to the patient.

The arterial patient tube clamp 83 and the venous patient tube clamp 85 are opened. The pre-dilution addition valve 51 , the post-dilution addition valve 53 and the single-needle blood valve 61 are closed.

8th shows the described configuration as a snapshot during a dialysis treatment while operating the blood pump 87 ,

The dialyzer 2000 is operated so that dialysis fluid enters the dialysis fluid 2001 into the dialysis machine 2000 entry. In the dialysis, the treatment of the patient's blood takes place. The dialysis fluid enters the dialysis fluid outlet 2003 from the dialyzer 2000 out. Used dialysis fluid can be discarded or purified.

The blood pump 87 promotes blood from the patient 4000 over the arterial needle 101 in the arterial section 91 the extracorporeal circuit 3000 where the blood is the cassette 1000 flows through and to the dialyzer 2000 is encouraged.

The blood flows through the dialyzer 2000 in the opposite direction to the dialysis fluid and is thereby cleaned. At the blood outlet 107 the dialyzer 2000 the purified blood leaves the dialyzer 2000 and flows through the venous filter line 19 in the cassette 1000 , enters the venous blood chamber 21 and the clot trap 29 and enters the venous patient port 31 out of the cassette 1000 out.

About the venous patient connection 103 the purified blood is returned to the patient 4000 recycled.

There is no supply of substituate. The substituate pump 89 is not operated.

9 shows a phase of using 8th presented blood treatment process using predilution of the blood with substituate ("Online HDF Pre-dilution").

The pre-dilution addition valve 51 will be opened. The post-dilution addition valve 53 and the single-needle blood valve 61 are closed. The blood pump 87 is operated. The substituate pump 89 is started. The substituate pump 89 can be in common with the blood pump 87 operate.

The configuration described is as a snapshot in 9 shown being between pre-dilution addition valve 51 and post-dilution addition valve 53 Substituate is located and the remaining extracorporeal circulation 3000 is traversed by blood.

The substituate pump 89 promotes substituate, which at the pre-dilution addition valve 51 in the arterial section 91 the extracorporeal circuit 3000 passes and mixes with the blood to be purified.

10 shows a phase of using 8th illustrated blood treatment process using post-dilution of the blood with substituate ("Online HDF Postdilution").

The post-dilution addition valve 53 is opened The pre-dilution addition valve 51 and the single-needle blood valve 61 are closed. The blood pump 87 is operated. The substituate pump 89 is started. The substituate pump 89 can be in common with the blood pump 87 operate.

The configuration described is as a snapshot in 10 shown being between pre-dilution addition valve 51 and post-dilution addition valve 53 Substituate is located and the remaining extracorporeal circulation 3000 is traversed by blood.

The substituate pump 89 promotes Substituate, which at Postdilutions addition valve 53 in the venous section 93 the extracorporeal circuit 3000 passes and mixes with the purified blood.

11 and 12 show stages of using 8th shown blood treatment process using a mixed dilution of the blood with substituate ("Online HDF Mischdilution - switched"). The term "mixed dilution" refers to a dilution of the blood with substituate taking place alternately from pre-dilution and post-dilution.

11 illustrates the predilution interval of the mixed dilution by means of a snapshot, 12 the postdilution interval of mixed dilution based on a snapshot.

The basis of 11 Process shown here corresponds to that of the basis of 9 shown process based on 12 Process shown to the one 10 ,

The blood pump 87 and the substituate pump 89 rotate in common mode. The blood pump 87 and the substituate pump 89 For example, they can rotate faster than the ones in the 9 and 10 illustrated method or method sections.

13 shows the cassette 1000 and the extracorporeal circulation 3000 in a phase of a dialysis treatment by means of a single-needle access to the patient ("Cassette Integrated Single Needle").

The patient 4000 is a single-needle access 109 placed and by fixation 110 been fixed. A fixation 110 For example, it can again be designed as a cuff, plaster or the like.

The single-needle access 109 has a Y-piece or a Y-shaped branch 111 in the arterial section 91 and the venous section 93 the extracorporeal circuit 3000 on.

The arterial patient tube clamp 83 will be opened. The venous patient tube clamp 85 is initially closed. This is in 13 not shown.

The blood pump 87 is started. The dialyzer 2000 is operated. Through the arterial section 91 gets blood from the patient 4000 into the dialysis machine 2000 promoted. In the dialysis machine 2000 the blood is purified. The purified blood gets into the venous section 93 the extracorporeal circuit 3000 brought in.

The blood enters the venous blood chamber 21 the cassette 1000 one. The single-needle blood valve 61 it is open. Blood flows into the single-needle chamber 57 one.

If the single-needle chamber 57 is almost filled, the blood pump 87 stopped and the venous patient tube clamp 85 will be opened as in 13 can be seen. The dialysis process is stopped.

The blood is released by gravity from the single-needle chamber 57 , the venous blood chamber 21 and the clot trap 29 out of the cassette 1000 discharged and in the patient 4000 recycled.

If the single-needle chamber 29 is almost emptied of blood, the blood pump 87 restarted.

These The phase of blood treatment is repeated as many times as necessary.

14 shows a phase of a first variant of a blood return process after completion of the blood treatment.

The arterial patient tube clamp 83 it is open. The venous patient tube clamp 85 is closed. The substituate pump 89 is operated.

In extracorporeal circulation 3000 there is blood. In the substituate line 49 there is substituate.

The pre-dilution addition valve 51 , the post-dilution addition valve 53 and the single-needle blood valve 61 are initially closed.

The pre-dilution addition valve 51 will be opened. Substituate is through the arterial section 91 the extracorporeal circuit 3000 in the direction of the dialysis 2000 promoted.

The extracorporeal circulation 3000 in the conveying direction behind or upstream of the pre-dilution adding valve 51 Blood is passing through the dialyzer 2000 and the venous section 93 to the patient 4000 promoted.

Just before the substituate to the venous needle 103 passes, the substituate pump 89 stopped.

The venous patient tube clamp 85 will be opened. The arterial patient tube clamp 83 will be closed.

14 shows the configuration of the cassette 1000 in a snapshot during the process wherein the substituate passes through the opened pre-dilution addition valve 51 upstream into the extracorporeal circuit 3000 is introduced and displaces the blood.

The blood pump 87 and the substituate pump 89 Are operated. The blood pump 87 rotates clockwise and thus against the conveying direction. The substituate pump rotates counterclockwise. The blood pump 87 and the substituate pump 89 can rotate offset from each other.

The substituate is from the post-dilution addition valve 53 out into the arterial section 91 the extracorporeal circuit 3000 and through the pump hose segment 88 the blood pump 87 in the direction of the patient 4000 promoted. The substituate displaces this in the arterial section 91 between the arterial needle 101 and the pre-dilution addition valve 51 located blood.

Just before the substituate the arterial needle 101 reached, become the blood pump 87 and the substituate pump 89 stopped.

15 illustrates a phase of an alternative blood recycling process.

At the arterial patient tube clamp 83 or the venous patient tube clamp 85 are each a sensor / detector 113 or a sensor / detector 115 for measuring the optical density of the line interior of the extracorporeal circuit 3000 and for automatically detecting the occurrence of substituate intended. Other and / or further suitable sensors can be used. Sensor and detector can be realized as a one-component component or as separate components.

The fixation 102 the arterial needle 101 is dissolved and the arterial needle 101 is pulled. The arterial patient tube clamp 83 it is open. The pre-dilution addition valve 51 is closed.

The venous needle 103 stays with the patient 4000 konnektiert. The venous patient tube clamp 85 is closed.

The blood pump 87 is operated in the conveying direction and promotes blood from the arterial section 91 the extracorporeal circuit 3000 ,

A corresponding snapshot of the process showing a state shortly after the process starts is in 15 shown.

The sensor / detector 113 detects the appearance of substituate. The blood is further promoted until there is the pre-dilution addition valve 51 reached. Then the blood pump 87 stopped.

The substituate pump 89 is started. The arterial patient tube clamp 83 will be closed. The venous patient tube clamp 85 will be opened.

The pre-dilution addition valve 51 will be opened. The substituate pump 89 promotes the substituate through the arterial section 91 the extracorporeal circuit 3000 , through the dialyzer 2000 and the venous section 93 the extracorporeal circuit 3000 until the sensor / detector 115 at the venous patient tube clamp 85 recognizes the occurrence of substituate.

The blood gets through the venous needle 103 to the patient 4000 conveyed back.

16 shows the cassette 1000 and the extracorporeal circulation 3000 in a phase of an emptying or emptying process.

The patient is no longer connected to the treatment device. The arterial section 91 and the venous section 93 the extracorporeal circuit 3000 are connected.

The arterial patient tube clamp 83 and the venous patient tube clamp 85 will be opened. The pre-dilution addition valve 51 and the post-dilution addition valve 53 are open as it is in 16 is illustrated in the form of a snapshot.

Through the substituate addition point 41 is under operation of the substituate pump 89 Substituate in the extracorporeal circulation 3000 entered. The substituate flows through the opened pre-dilution addition valve 51 and the open post-dilution addition valve 53 and thus enters the extracorporeal circulation 3000 ,

The substituate flows through the extracorporeal circulation 3000 and the dialyzer 2000 in the opposite direction.

The pre-dilution addition valve 51 is closed and the blood pump 87 operated. The blood pump 87 and the substituate pump 89 promote the Substituat in the conveying direction through the cassette 1000 into the dialysis machine 2000 , The substituate is at the Dialysierflüssigkeitsaustritt 2003 discharged. The substituate can be disposed of.

Further suitable methods for returning the blood to a patient and / or for emptying the extracorporeal circuit are described, for example, in the patent application (08/50-d01 DE: FM19A20 entitled "Method for removing blood from an extracorporeal blood circulation for a treatment device after quitting a blood treatment session and apparatus for carrying out the same, filed with the DPMA on Feb. 11, 2009), the disclosure of which is hereby incorporated by reference. LIST OF REFERENCE NUMBERS reference numeral description 1000 cassette 1 hard part 3 foil 4 sealing land 5 circumferential weld 7 arterial patient connection 9 arterial pressure measuring chamber 11 Connector for blood leakage from cassette 1000 13 Connector for blood entry in cassette 1000 15 Chamber with arterial post or prefilter pressure measuring point 17 arterial filter line 19 venous filter line 21 venous blood chamber 23 Upper space of the venous blood chamber 21 25 lower space of the venous blood chamber 21 27 Cross-sectional taper of the hard part 1 29 clot catcher 31 venous patient connection 33 arterial heparin delivery site 35 Check valve of the arterial heparin addition site 33 36 arterial heparin addition valve (phantom valve) 37 venous heparin delivery site 39 Check valve of venous heparin addition site 37 40 venous heparin addition valve (phantom valve) 41 Substituate addition site 43 Connector for substituate exit from the cassette 1000 45 Connector for Substituateintritt in the cassette 1000 47 Non-return valve for substituate addition 49 substituate 51 Pre-dilution addition valve (phantom valve) 53 Postdilution adding valve (phantom valve) 55 Single-needle sterile membrane 57 Single-needle chamber 59 Blood surge redirection element 61 Single-needle blood valve (phantom valve) 63 Extraction point for vacuum coupling 65 primary orientation center 67 secondary registration office 69 sealing land 71 Single-Needle-air connector 73 Support bars with 5 mm height 75 Support bars with 8 mm height 77 Support bars with 13 mm height 79 Support bars with 24 mm height 81 Support bars with 31 mm height 2000 dialyzer 2001 Dialysierflüssigkeitseintritt 2003 Dialysierflüssigkeitsaustritt 3000 extracorporeal circulation 83 arterial patient tube clamp 85 venous patient tube clamp 87 blood pump 88 Pump tube segment of the blood pump 87 89 substituate 90 Pump tube segment of the substituate pump 89 91 arterial section of the extracorporeal circuit 3000 93 venous section of the extracorporeal circulation 3000 95 drain line 97 tap 4000 patient 99 Double-needle access to the patient 4000 101 arterial needle 102 Fixation of the arterial needle 103 venous needle 104 Fixation of the venous needle 105 Blood entry at the dialyzer 2000 107 Blood leakage from the dialysis direction 2000 109 Single-needle access to the patient 4000 110 Fixation of the single-needle access 109 111 Y-shaped branch of the single-needle access 109 in the arterial section 91 and the venous section 93 113 Sensor / detector on the arterial patient tube clamp 83 115 Sensor / detector on the venous patient tube clamp 85

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 102007042964 A1 [0239]

Claims (52)

External functional device, comprising: at least one housing body, at least one chamber integrated in the housing body ( 9 . 15 . 21 . 57 ) for receiving medical fluids; at least one channel integrated into the housing body ( 17 . 19 . 49 ) for receiving and / or guiding a medical fluid; and at least one valve device completely or partially integrated in the housing body ( 35 . 36 . 39 . 40 . 47 . 51 . 53 . 61 ), for controlling or regulating a fluid flowing through the external functional device. External functional device according to claim 1, which is provided on at least one of its surfaces with a covering device which is part of at least one integrated valve device ( 35 . 36 . 39 . 40 . 47 . 51 . 53 . 61 ). External functional device according to claim 2, wherein the cover device at least in a section with the Housing body non-positive and / or positive and / or cohesive connected is. External functional device according to claim 3, wherein the covering device by means of a peripheral weld ( 5 ) is connected to the housing body. External functional device according to claim 3 or 4, wherein the cover means by means of another non-rotating or punctate or local welds is connected to the housing body. External functional device according to one of claims 2 to 5, wherein the covering device comprises a foil ( 3 ). External functional device according to one of the preceding Claims which connections to their connections having an extracorporeal circuit in fluid communication. External functional device according to one of the preceding claims, which is in the form of a cassette ( 1000 ) is designed for a blood treatment. External functional device according to one of the preceding claims, which by means of two connectors ( 11 . 13 . 43 . 45 ) is connectable in fluid communication with at least one peristaltic pump. An external functional device according to claim 9, wherein the peristaltic pump is a roller pump. External functional device according to one of claims 9 or 10, with at least one pump hose segment ( 88 . 90 ). External functional device according to one of the preceding claims, comprising at least one valve device ( 36 . 40 . 51 . 53 . 61 ), which comprises at least one web, which is designed on the housing body, and at least a portion of the cover device, wherein the web and cover means are arranged to be actuated by means of an acting on a web actuator of a blood treatment device for changing a fluid flow. External functional device according to one of the preceding Claims, wherein the fluid is part of the group, which substituate, Heparin, blood, air and combinations thereof. External functional device according to one of the preceding Claims which can be coupled to a blood treatment device is. External functional device according to claim 14, which is designed and provided to by means of a receiving device the blood treatment device to the blood treatment device to be coupled. External functional device according to claim 14 or 15, wherein the external functional device at an inclination angle, in particular of substantially or exactly 8 °, relative to a vertical to the Blood treatment device is coupled. External functional device according to one of the claims 14 to 16, wherein the external functional device with the cover device facing surface to a treatment device coupled is. External functional device according to one of the preceding claims, comprising at least one substituate addition point ( 41 ), which has a Berührschutzelement and / or a drip protection. An external functional device according to claim 18, wherein the drip protection by an integrated closure sleeve is realized. External functional device according to one of the preceding claims, for use in a blood treatment method using a double-needle access ( 99 ) to a patient ( 4000 ). External functional device according to one of claims 1 to 20, for use in a blood treatment method using a single-needle access ( 109 ) to a patient ( 4000 ). External functional device according to one of the preceding claims, which comprises at least one single-needle chamber ( 57 ), in which a blood flow diverting element ( 59 ) is arranged. External functional device according to one of the preceding claims, which has at least one venous blood chamber ( 21 ) having. An external functional device according to claim 22 or 23, wherein the single-needle chamber ( 57 ) above, based on the orientation of the external functional device during its use, the venous blood chamber ( 21 ) is arranged. An external functional device according to claim 23 or 24, wherein the venous blood chamber ( 21 ) by means of a cross-sectional taper ( 27 ) of the housing body in at least one upper space ( 23 ) and at least one lower space ( 25 ) is divided. An external functional device according to claim 25, wherein the upper space ( 23 ) and the lower room ( 25 ) are in fluid communication with each other and the upper space ( 23 ) is configured to allow or generate a tangential inflow of fluids flowing through the external functional device. An external functional device according to claim 25 or 26, wherein the upper space ( 23 ) has a region for generating a stable rotational flow of the fluids flowing through the external functional device. External functional device according to one of claims 25 to 27, wherein the lower space ( 25 ) has a region which is substantially or completely free of rotational flow of the fluids flowing through the external functional device. External functional device according to one of claims 16 to 28, wherein walls of the upper space ( 23 ) and / or the lower room ( 25 ) of the venous blood chamber ( 21 ) are adapted to a tilt of the external functional device against a vertical of the blood treatment device. External functional device according to one of the preceding claims, in which the housing body is used as a hard part ( 1 ) is configured. Blood treatment device, characterized in that they receive at least one external functional device according to one of claims 1 to 30 configured is. A blood treatment device according to claim 31, which at least one control device and / or actuators and / or sensors for driving and / or actuating the external functional device having. A blood treatment device according to claim 31 or 32, comprising at least one receiving device for receiving at least one external functional device according to one of claims 1 to 30th A blood treatment device according to claim 33, wherein the receiving device a coupling surface for coupling having the external functional device. A blood treatment device according to claim 33 or 34, wherein the coupling surface at an angle against a Vertical, relative to the orientation of the. Blood treatment device while in use, is inclined. Blood treatment device according to one of the claims 33 to 35, wherein the angle is substantially or exactly 8 °. Method for preparing or priming a primer external functional device, characterized by using an external functional device according to a of claims 1 to 30. Method for rinsing or rinsing a external functional device, characterized by using an external functional device according to a of claims 1 to 30. Method for connecting an external functional device to a patient ( 4000 ), characterized by using an external functional device according to one of claims 1 to 30. Method for the blood treatment of a patient ( 4000 ), characterized by using an external functional device according to one of claims 1 to 30. A method of blood treatment according to claim 40, characterized through its implementation in the double-needle method. A method of blood treatment according to claim 40, characterized through its implementation in the single-needle method. Method for operating an external functional device according to any one of claims 1 to 30 during a dialysis in the double-needle method with a predilution step. Method for operating an external functional device according to any one of claims 1 to 30 during Dialysis in the double-needle method with a post-dilution step. Method for operating an external functional device according to any one of claims 1 to 30 during a dialysis in the double-needle method with at least one predilution step and at least one post-dilution step. Method for operating an external functional device according to any one of claims 1 to 30 during Dialysis in the single-needle method. Method for returning blood from the external functional device according to a of claims 1 to 30. Method for emptying an external functional device according to one of claims 1 to 30. Blood treatment device to perform A method according to any one of the claims 37 to 48. A blood treatment device according to claim 49, which a controller for controlling or regulating an external functional device according to one of claims 1 to 30 and / or for performing a method according to a of claims 37 to 48. A blood treatment device according to claim 49 or 50, which at least one actuator for actuating an external Functional device or a portion thereof according to a of claims 1 to 30 for performing a method according to one of claims 37 to 48. Blood treatment device according to one of claims 49 to 51, which sensors for actuating ei ner external functional device according to one of claims 1 to 30 for carrying out a method according to one of claims 37 to 48.