DE102009024468A1 - External functional device e.g. blood cartridge, for use with dialysis device for processing medical fluid in patient, has reversal valves that are partially integrated in housing body for controlling of fluid that passes functional device - Google Patents

Abstract

The device i.e. cartridge (1000) has blood chambers (21) that are integrated in a housing body for receiving medical fluid i.e. blood, where the housing body is designed as a hard part (1). Filter lines (17, 19) are integrated in the housing body for guiding the medical fluid. Reversal valves (35, 36) are partially integrated in the housing body for controlling or regulating of the fluid that passes the functional device. A covering device is connected with the housing body via a circular welding seam (5). The covering device is designed as a foil (3). Independent claims are also included for the following: (1) a blood treatment device comprising a receiving device (2) a method for preparation and/or priming of the functional device (3) a method for rinsing of the external function device (4) a method for connection of the external functional device with a patient (5) a method for processing blood (6) a method for operation of the external functional device (7) a method for re-guiding of blood from the external functional device (8) a method for emptying the external functional 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 39, 59 and 63 and methods according to the claims 45 to 48 and 52 to 57.

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, heparin or other medicines, saline, Substituate and the like is suitable.

channels or lines can be partially closed and / or semi-open structures. 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.

The Foil may preferably be a plastic film. For this purpose, preferably any laser weldable that appears suitable to the skilled person Slide into consideration.

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 two - have pump tube 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 device 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 pharmacologically active agent, saline (especially 0.9% NaCl solution), blood, air and combinations the same.

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, preferably between 5 ° and 11 °, in particular at a tilt angle of substantially or exactly 8 °, relative to a vertical be coupled to the blood treatment device. The external one Functional device is preferably in an upper region thereof (in use) tilted backwards.

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.

A Closing function of the ports (one, some or all ports) of the External functional device may also be through septa or check valves will be realized.

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

Of the Drip protection can preferably serve to prevent it from dripping or running out substituate or blood or a mixture of substituate and Blood during the removal of the external functional device to prevent from the receiving device of the blood treatment device. In this way, a hygienic handling of the used and impure external functional device outside the Treatment device continues to be guaranteed.

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 Blood of the patient is preferably already during the Removal phase from the patient passed through the dialyzer, thereby dialysed, (preferably immediately) after passing through the dialyzer stored in the single-needle chamber and from there in the return phase returned to the patient. The blood is in the "fresh" state dialysed, in which it comes from the patient. This can be the means of the cassette according to the invention for Blood treatment performed advantageous method of those conventional methods differ, in which the Patients withdrew blood in a separate single-needle chamber stored, then dialyzed and over a venous air separator back to the patient is given.

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

One such "blood flow diverting element" or blood surge element may be to achieve a flow slowdown, to generate a turbulence and / or diverting the flowing into the single-needle chamber Blood or to extinguish the pulse of the blood 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.

Without Blutschwallumleitungselement could through the phantom valve inflowing blood possibly cause a fountain. This could lead to sloshing of the liquid level and / or lead to foaming. By means of the blood flow element the whole bloodstream is divided into two smaller blood glands, whereby the pulse of the whole blood pool are extinguished can and beneficial fountain formation, sloshing and / or Foaming can be avoided.

When Blutschwallumleitungselement may preferably a Blutschwallumleitungselement used as described in the present applicant Invention in the patent application (09/27-d04 DE, FM19A31) with the Title "Recording device for recording medical Fluids as well as external functional device and medical treatment device ", filed with the DPMA on June 10, 2009. Their disclosure in this regard is hereby incorporated in full Referenced.

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.

The upper space may be configured to allow tangential inflow from the external functions to allow or generate onseinrichtung flowing fluids. The upper space may have a region for generating a stable rotational flow of the fluids flowing through the external functional device.

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 space and / or the lower space of the venous blood chamber of a slope 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 of the blood through the venous blood chamber and the ascension of possibly airborne air for the purpose of separation enable.

The Venous blood chamber can be designed and in particular have an air separator effect, as in that of the Applicant of the present invention in the patent application (09/34-d04 DE, FM19A33) entitled "Air Separator, External Function Facility, Blood circulation and treatment device ", which was Filed with the DPMA on June 25, 2009. On their this disclosure is hereby incorporated by reference Referenced.

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

The hard part may be a housing body made substantially of one piece and a material. This can be an injection molded part. It may have a minimum stiffness of more than 400 N / mm ² , preferably 1200-1800 N / mm ² (bending modulus).

In a further preferred embodiment of the external functional device As a blood treatment cassette, in a further preferred Embodiment by the cover device or film therethrough the pressure in the extracorporeal blood circulation measured in front of the dialyzer become.

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 39, 59 and 63.

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

In In another 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. Such a Angle can be between 5 and 11 °, in particular essentially or exactly 8 °.

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 as information providers , wherein the information of the control unit as signals for actuating an external functional device according to present invention for carrying out a method or a method step according to the present invention Serve invention.

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

The Blood treatment device may include a controller for measuring one in the extracorporeal circuit or bloodstream as a blood treatment cassette designed external functional device according to the invention present parameter, for example, a pressure, a differential pressure and the same.

Of the Differential pressure can be integrated between the arterial cassette Chamber and the venous cassette integrated chamber measured become. The differential pressure can be used as a measure of blood pressure differential of the dialyzer can be used. The Control of the blood treatment device may be configured for Calculate this difference, if necessary to compare the pressure difference with reference values (which, for example, in the control or a memory can be deposited), and optional for Output of control signals.

in this connection can advantageously, for example, a beginning blockage of Dialysators are detected early or in time. Countermeasures can be taken.

These can the addition of anticoagulants, such as. B. heparin, z. B. via the cassette integrated addition points include or consist of.

Further can z. For example, the predilution can be increased. It can be switched from postdilution to predilution.

The cassette-integrated measuring points can also be advantageous a transmembrane pressure measurement across the dialyzer membrane away.

To There may be four measuring points at which by means of appropriate Equipment is measured and their measurement results by means of appropriate Facilities are evaluated: one at the filter input and at the filter outlet, both on the blood side and on the dialysate side.

The Blood treatment device may include a controller for driving the cassette valves. The controller may preferably be freely programmable between the cartridge-integrated pre- and post-dilution switch. It may preferably be the substituate stream (volume flow) change. Information providers can in particular the cassette integrated before and after the dialyzer Be pressure measuring points.

The inventive object is also solved by the inventive method according to the claims 45 to 48 and 52 to 57. 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 or a catheter for example in the form of a double-needle access or single-needle access, connected to the 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.

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 against this conveying direction taking place fluid delivery (especially blood and / or substituate) is considered 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 Cock, which is a machine-side valve (also known as "rinse port") is via which a fluid connection between the extracorporeal Cycle and the atmosphere or a collecting container to produce is and over which the external functional device flowing through Fluids can be discharged from the extracorporeal circulation is preferred 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 the pump tube segment, which is inserted in the blood pump, in Flow through in a clockwise direction. Preferably flows through the substituate further the connection between arterial and venous Patient connection, flows through a clot trap the external functional device and enters the venous Blood chamber.

At the or in the clot trap can according to the invention of Pressure in the extracorporeal circuit by means of a suitable pressure measuring device be measured. This can preferably be achieved by a cover device the external functional device, eg. B. as a blood treatment cassette designed, done. If this is designed as a film, so can the measurement is carried out through them or over the film. In this way, thus preferably the pressure in the extracorporeal Circuit measured in particular after passing through the dialyzer become.

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 or only a small amount of substituate in front.

• 1. Konnektion des automatischen Substituat-Konnektors.
• 2. Arterieller und venöser Patientenschlauch werden mit einem Rinse-Port der Blutbehandlungsvorrichtung verbunden, z. B. mittels eines geeigneten Verbinders, mit dem für das Ende des einen Patientenschlauchs ein Zugang in den anderen Patientenschlauch geschaffen wird. Das Ende des anderen Patientenschlauchs dient als Ablaufleitung in den Rinse-Port. Der Verbinder kann sich alternativ in der arteriellen oder der venösen Patientenleitung befinden.
• 3. Die venöse Patientenschlauchklemme wird geschlossen, das Postdilutionsventil wird geöffnet, das Prädilutionsventil wird geschlossen.
• 4. Füllen der venösen Kammer mittels der Substituatpumpe durch das Postdilutionsventil. Dabei erfolgt eine Luftabscheidung durch das Single-Needle-Ventil.
• 5. Die Blutpumpe läuft vorwärts und saugt aus der venösen Kammer Substituat an.
• 6. Sinkt der Pegel in der venösen Kammer, so wird über das Postdilutionsventil nachgefördert, bis ein Überschreiten der vorgegebenen Füllhöhe vom Level-Detektor erkannt wird. Während dieses sich bei Bedarf wiederholenden Vorgangs läuft die Blutpumpe kontinuierlich weiter.
• 7. Entlüften des Gerinnselfängers „von unten”: Alle drei Kassettenventile sind geschlossen. Die arterielle Klemme ist geöffnet und die venöse Klemme ist geschlossen. Der Rinse-Port ist geschlossen.
• 8. Die Blutpumpe läuft kurz rückwärts und fördert ein kleines Volumen. Dadurch wird venös ein Unterdruck und arteriell ein Überdruck im extrakorporalen Blutkreislauf erzeugt.
• 9. Öffnen der venösen Klemme solange, bis ein Druckausgleich stattgefunden hat.
• 10. Fortsetzen des Füllens des extrakorporalen Blutkreislaufs.
• 11. Spülen des gefüllten extrakorporalen Blutkreislaufs: Mittels des venösen Luftblasendetektors wird das Auftreten von Luftblasen detektiert. Sobald im Verlauf eines vorgegebenen Zeitintervalls keine Luftblasen oder nahezu keine Luftblasen detektiert wurden, gilt der extrakorporale Blutkreislauf als gefüllt.
• 12. Während des Spülens wird Substituat durch das Prädilutionsventil gefördert und durch den Rinse-Port („Hahn”) verworfen.
• 13. Dabei sind sowohl die arterielle als auch die venöse Klemme geöffnet. Die Blutpumpe läuft rückwärts und fördert einen Teil des Substituats in den Rinse-Port.

The online filling procedure can also be carried out according to the invention as follows:

• 1. Connection of the automatic substituate connector.
• 2. Arterial and venous patient tubing are connected to a rinse port of the blood treatment device, e.g. Example by means of a suitable connector, with the access to the other patient tube is created for the end of a patient's hose. The end of the other patient tube serves as drainage into the rinse port. The connector may alternatively be in the arterial or venous patient line.
• 3. The venous patient tube clamp is closed, the post-dilution valve is opened, the pre-dilution valve is closed.
• 4. Fill the venous chamber by means of the substituate pump through the post-dilution valve. In this case, an air separation takes place through the single-needle valve.
• 5. The blood pump advances and sucks substituate from the venous chamber.
• 6. If the level drops in the venous chamber, the postdilution valve is subsequently fed on until the level of the predetermined level is exceeded by the level detector. During this repetitive process, the blood pump continues to run.
• 7. Bleeding the clot catcher "from below": All three cassette valves are closed. The arterial clamp is open and the venous clamp is closed. The rinse port is closed.
• 8. The blood pump runs backwards for a short time and promotes a small volume. As a result, a negative pressure and arterial pressure in the extracorporeal blood circulation is produced venously.
• 9. Open the venous clamp until a pressure equalization has taken place.
• 10. Continue filling the extracorporeal blood circulation.
• 11. Rinsing the filled extracorporeal blood circulation: The venous air bubble detector detects the occurrence of air bubbles. As soon as no air bubbles or almost no air bubbles have been detected in the course of a given time interval, the extracorporeal blood circulation is considered filled.
• 12. During rinsing, substituate is delivered through the pre-dilution valve and discarded through the rinse port ("cock").
• 13. Both the arterial and venous clamps are open. The blood pump runs backwards and conveys some of the substituate into the rinse port.

alternative to fill online (the substituate will be online in the dialysis machine provided) is also the filling with an external bag of saline as a source possible for the filling liquid. To is the arterial patient line to the bag of saline connected. The venous patient lead is connected to a so-called waste bag as a sink for the used saline solution connected. The blood pump is running forward. By opening the pre-dilution valve and the post-dilution valve can also be located between these two valves line be filled.

at In both procedures, the patient is only after reaching a predetermined Rinse amount connected to the extracorporeal blood circulation.

At the Rinsing or rinsing are initially preferred 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 as the tap (a machine-side valve or a "rinse port").

Under Operating the substituate pump (preferably counterclockwise the drawing plane) and the blood pump (preferably in a clockwise direction) Substituate is preferably continuously through the 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.

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

First, the pre-dilution addition valve, the post-dilution addition valve, and the sing Preferably, the le-needle blood valve should be 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 Continuously flow through the circuit.

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 be cleaned flowing dialysis fluid can.

Preferably can also take both steps, namely the arterial Aspiration and venous suction - at least over a period - done in parallel.

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 so-called "Online HDF Mischdilution" refers to 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.

Of the temporal share of pre- or post-dilution may be fixed or changeable relationship and can changed depending on a measurand become.

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 preferably be stopped and the arterial patient tube clamp are closed. thereupon the venous patient tube clamp can be opened become.

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.

Also a combination of single-needle treatment with hemodiafiltration is possible.

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 flow through the dialyzer and the venous portion of the extracorporeal circuit, thereby displacing the blood. Just before the substituate reaches the venous needle, can the substituate pump are preferably stopped.

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

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

The Substituate may be from or at the pre-dilution addition valve in promoted the arterial section in the direction of the patient become. Just before reaching the arterial needle Both pumps are preferably stopped.

The Returned through the arterial and venous needle can also be done simultaneously. The substituate pump is running then at a higher rate forward and the blood pump backwards at a lower rate.

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 can at least one sensor / detector in the arterial part the extracorporeal blood circulation and at least one sensor / detector be provided in the venous part of the extracorporeal blood circulation.

The Arterial needle may be from the patient and / or the arterial patient line can be disconnected from the arterial needle. The arterial Patient tube clamp and the venous patient tube clamp are preferably opened.

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

If the sensor / detector in the arterial part of the extracorporeal blood circulation detects the occurrence of air, the blood pump may preferably Continue to boost until blood at pre-dilution addition valve arrives. Then, the blood pump may preferably 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. For emptying, air can be conveyed.

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 air can be promoted and thereby displace the substituate.

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) can air through the extracorporeal circulation - starting upstream of the post-dilution addition valve - through the venous blood chamber, the clot trap, the venous section, the arterial section in the direction be promoted the dialysis. It can do that extracorporeal circulation, 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 cover device opened after destructive cutting open;

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.

to exemplary explanation of the present invention are as a treatment device, a blood treatment device and as Method selected 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.

A Embodiment with a three-dimensional design of Welding and sealing contour is also according to the invention possible.

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.

Of the circumferential sealing bar can alternatively be exposed become.

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

The foil 3 can be punctiform or linear with the hard part of the cassette in local places 1000 connected, z. B. welded, be, in particular at the edge zones of the liquid-carrying channels.

The foil 3 Can be done by laser welding with the hard part of the cassette 1000 get connected. It is advantageous if the local heat input using light-absorbing components he follows. The light-absorbing component can be part of the material of the film and / or of the hard part or a layer which is arranged between the film and the hard part or over the film. The layer may be a foil layer.

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 patent applications 10 2009 012 633.3 (representative file FM19A24) entitled "Device for connecting an external functional device to an assembly comprising such device and method of bonding" published on 10th March 2009 at the DPMA and 10 2009 012 632.5 (representative file FM19A25) entitled "Sealing device for sealing a volume of a medical treatment device against another volume and arrangement and method", also filed with the DPMA on 10 March 2009, in which Related disclosures are hereby incorporated by reference.

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 may preferably be designed in three dimensions.

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 via a cabling. The sensors can also be designed so that they transmit wireless signals.

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 pressure measuring point for pressure measurement in the extracorporeal blood circulation in front of the dialyzer ("pre-filter") or after the pump ("post-pump").

At the chamber 15 can through the film 3 through or over the film 3 the pressure in the extracorporeal circuit before the dialyzer can be measured.

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 space 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, after 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.

When Clot trap may preferably be a clot trap used as described in the present applicant Invention in the patent application (09/32-d04 DE, FM19A32) with the Title "Clot trap, external functional device, Blood circulation and treatment device ", which was Filed with the DPMA on June 25, 2009. On their this disclosure is hereby incorporated by reference Referenced.

At the clot trap 29 can through the film 3 through or over the film 3 the pressure in the extracorporeal circuit are measured, ie in particular after passing through the dialyzer.

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 (as well as a venous heparin delivery site 37 ) also for the addition of other pharmacological agents than heparin, which are only preferably 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.

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 the Applicant's patent application (09/13-d01DE, FM19A26) entitled "Valve Device, Valve Core, External Functioning Device, Processor Apparatus And Method", filed with the DPMA on June 10, 2009, for which reference Revelation hereby incorporated by reference.

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.

Of the Term "phantom valve" as used herein is an element with an accessible by means of an actuator Actuator surface (here, for example, an actuator membrane), which can take over the function of a valve.

The Actuator membrane is applying a force thereto, for. B. one Compressive force, movable in one direction, expandable or archable or similar. By moving or expanding the actuator membrane This may be to an element, such as a sealing device, about a bridge, create or remove from this. The actuator membrane Thus, for example, can cause or enhance a seal or end or reduce.

If The force is taken back from the actuator membrane, this can in, for example, a home position, e.g. B. a non-curved State, return.

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 entitled "Sealing device for sealing a volume a medical treatment arrangement against another volume as well as arrangement and procedure ", which on 10 March Filed by the present Applicant with the DPMA in 2009, be removed. On their related disclosure is hereby incorporated by reference.

The cassette 1000 has a venous heparin delivery site 37 on. The venous heparin delivery site 37 Luer connector can be configured.

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 or a substituate connector.

The substituate addition point 41 may be a connection device as described in the Applicant's patent application (09/36-d01 DE, FM19A34) entitled "Connection device and method for connecting at least two fluid-carrying medical systems and medical device" on 10 June Filed by the present Applicant with the DPMA in 2009. Their disclosure in this regard is hereby incorporated by reference.

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 remnants of substituate and / or blood upon release of the cartridge 1000 and then removing the cassette 1000 prevent from the blood treatment device.

Of the Drip protection can be made removable. He can as Hood or lid be designed.

The substituate addition point 41 or another section of the cassette 1000 Further, it can provide tamper-evidence protection by which the user can easily, or at a glance, know if the cartridge is being used 1000 already used. This originality protection can be realized by means of the contact protection element, the closure sleeve or another structure. The corresponding structure may preferably have its position within or relative to the cassette 1000 change recognizably. It can preferably change its shape.

In addition, the substituate addition point 41 or another section of the cassette 1000 provide reuse protection or protection against reuse. Preferably, through a closure sleeve, the cassette 1000 - Preferably irreversible - made useless in the attempt to reuse. Should the cassette 1000 Nevertheless, sensors of the blood treatment device do not measure the waveforms that would be measured using a new cassette. This may be due to the fact that no liquid in the cassette 1000 or in the substituate addition point 41 can reach or at least not in sufficient or usual amount. The control unit of the blood treatment device can recognize this. A warning can be issued.

As tamper-evident or reusable protection, it is preferable to use tamper-evident or reuse protection as described in the patent application (09/36-d01 DE, FM19A34) entitled "Connector and Method" of the present invention ren for connecting at least two fluid-carrying medical systems, as well as medical device ", which was filed with the DPMA on 10 June 2009, was disclosed. Their disclosure in this regard is hereby incorporated by reference.

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 may be used to slow down a blood surge and / or extinguish its pulse.

A connection to an interior of the single-needle chamber 57 may be provided by means of a coupling device such as that disclosed in the Applicant of the present invention entitled "Device and External Device and Apparatus for Treating Medical Fluids" (09/26-d04 DE, FM19A30) at the DPMA on June 10, 2009 filed patent application. Their disclosure in this regard is hereby incorporated by reference.

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

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.

The cassette 1000 is filled with gas (eg sterile air) prior to priming. When priming the extracorporeal blood circulation, this gas filling must be displaced. A blood treatment cassette is generally a particular challenge, because there are both ascending and descending lines and also chambers in which no "air pockets" may remain. The present cassette 1000 has special design features for this purpose:
The chamber 15 For measuring the arterial pressure, it is designed so that all of the air into a pumptube segment (eg into the pumptube segment 90 , see, for. B. 4 ) can ascend. There are advantageously no dead spaces. Air from the arterial pressure measuring chamber into the pump tubing If the blood pump automatically ascends, the blood pump (eg through the rollers of a roller pump) is forcibly conveyed through the pump tube segment from the area of intervention. As soon as the pump has no influence (because, for example, the rollers go into action), the air automatically rises in the conveying direction into the cassette 1000 on.

The venous return line (or a venous section 93 of extracorporeal circulation such as in 4 shown) is a downpipe. From a certain volume flow (eg 200 ml / min at the in 1 shown cassette 1000 ) air bubbles in the blood are also "carried away" against the acceleration of gravity. This effect is exploited in the downpipes. The pipe cross-sections of the downpipes are designed so small that due to the flow velocity forced transport of the air bubbles also works contrary to the gravitational acceleration.

In the venous blood chamber 21 large cross-sections are provided, so that due to the slow or low flow rates there air bubbles can rise reliably against the main flow direction.

Further design features of the cassette 1000 are:
The phantom valves 40 . 51 and 53 are spatially aligned so that blood (which has a higher density than water or Substituat etc.) during operation of the cassette 1000 with blood can hardly penetrate "up" or "to the side" in opened phantom valves, because it sinks opposite the lighter water. Such an advantageous orientation is through the phantom valves 40 . 51 , and 53 realized. At the valve 36 On the other hand, there is no such requirement, ie orientation is not important.

The duct (branch channel) under the check valve 47 Substituent addition is constructed in ascending order for the same reason. In case of malfunction of the pre- and / or post-dilution valves 51 and 53 and a resulting blood bypass flow can not send blood into the substituate line 49 rising up. Rather, the blood flows past the mouth of the corresponding stub.

The inclination of the cassette 1000 is preferably 5 ° to 11 °, particularly preferably the already mentioned 8 °.

2 shows the cassette 1000 of the 1 , where the film 3 on the left edge of the cassette 1000 as well as above and below for better illustration destructively cut open and to the right unfolded is recognizable.

As in 2 shown, rejects the film 3 a surface structuring on.

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. The above and other numerical values are of course purely exemplary ver stand.

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.

In 3 is the cassette 1000 shown how the user / viewer looks at them after being connected to the machine interface. The inclination of the cassette 1000 the machine is "tilted backwards" so that the top edge is farther away from the user / viewer than the bottom edge.

The upward facing surfaces of the venous blood chamber 21 and the single-needle chamber 57 Accordingly, they have a tendency such that air bubbles despite the inclination of the cassette 1000 still reliably climb on the inside. In principle, of course, a cassette design is also possible, which does not provide a tilt of the cassette.

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 tube segment 88 on.

The extracorporeal circulation 3000 has a substituate pump 89 with a pump tube 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 different components on. To form an arterial convection 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 tubing 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 convection 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. For this purpose, the automatic substituate connector is connected. The arterial patient tube in the arterial section 91 the extracorporeal circuit 3000 and the venous patient tube in the venous section 93 the extracorporeal circuit 3000 are connected to a rinse port of the blood treatment device, e.g. Example by means of a suitable connector, with the access to the other patient tube is created for the end of a patient's hose. The end of the other patient tube serves as drainage into the rinse port. The connector may alternatively be in the arterial or venous patient line, ie the arterial section 91 or the venous section 93 , are located.

The venous patient tube clamp 85 is closed, the post-dilution addition valve 53 is opened, the pre-dilution addition valve 51 will be closed.

Filling the venous blood chamber 21 takes place by means of the substituate pump 89 through the post-dilution addition valve 53 , In this case, an air separation takes place through the single-needle blood valve 61 ,

The blood pump 87 runs forward and sucks out of the venous blood chamber 21 Substituate on.

When the level in the venous blood chamber 21 decreases, so is the post-dilution addition valve 53 nachgefördert until an exceeding of the predetermined filling level is detected by the level detector. During this repetitive process, the blood pump is running 87 continuously.

The clot trap 29 is vented "from below": All three cassette valves ( 51 . 53 . 61 ) are closed. The arterial patient tube clamp 83 is open and the venous patient tube clamp 85 is closed. The rinse port is closed.

The blood pump 87 runs backwards briefly and promotes a small volume. As a result, a negative pressure and arterial an overpressure in the extracorporeal circulation becomes venous 3000 generated.

The venous patient tube clamp 85 is opened until a pressure equalization has taken place.

Subsequently, the filling of the extracorporeal circulation 3000 continued.

By means of the sensor / detector 115 at the venous patient tube clamp 85 , z. B. a venous Bubble detector, the occurrence of air bubbles is detected. As soon as no air bubbles or almost no air bubbles have been detected in the course of a given time interval, the extracorporeal circulation applies 3000 as filled.

Then the filled extracorporeal circulation 3000 rinsed. During rinsing, substituate becomes through the pre-dilution addition valve 51 promoted and through the rinse port ("cock 97 " ) discarded.

Both the arterial patient tube clamp are 83 as well as the venous patient tube clamp 85 open. The blood pump 87 runs backwards and conveys part of the substituate into the rinse port.

As an alternative to online filling (the substituate is provided online in the dialysis machine), as already stated above, filling with an external bag of saline solution is also possible as the source of the filling liquid. For this purpose, the arterial patient line or the arterial section 91 the extracorporeal circuit 3000 connected to the bag of saline. The venous patient line or the venous section 93 the extracorporeal circuit 3000 is connected to a so-called waste bag as a sink for the used saline solution. The blood pump 87 runs forward. By opening the pre-dilution addition valve 51 and the post-dilution addition valve 53 It is also possible to fill the line between these two valves.

In both methods, the patient is only after reaching a predetermined flushing volume to the extracorporeal circuit 3000 connected.

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 between 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 tubing 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. 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 Air in the extracorporeal circulation 3000 entered. The air 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 air 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 convey the air in the conveying direction through the cassette 1000 into the dialysis machine 2000 , The air enters the dialysis fluid outlet 2003 out.

Further suitable methods for returning the blood in a patient and / or to empty the extracorporeal circuit are for example in the patent application 10 2009 008 346.4 (representative file FM19A20) entitled "Procedure for removing blood from a extracorporeal blood circulation for a treatment device after completing a blood treatment session and device to perform "filed on 11 February 2009 with the DPMA has been described, to their disclosure thereof is hereby incorporated by reference.

Such methods are further described in the applicant's patent application (G09 / 081; FM19A29) entitled "Method for Removing Blood from an Extracorporeal Blood Circulation Apparatus and Tube System" filed June 10, 2009 with the DPMA. Also to their disclosure in this regard 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-pump 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 [0261]

Claims (65)

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 claim 8, as a blood treatment cassette ( 1000 comprising at least one arterial cassette integrated chamber and at least one venous cassette integrated chamber in a portion of an extracorporeal circuit contained therein; 1000 ) at least one film ( 3 ) as a covering device, and wherein over the film ( 3 ) is an arterial and / or venous pressure, which prevails in the extracorporeal blood circulation, is measurable. An external functional device according to claim 9, which comprises means for measuring the arterial and / or venous pressure across the arterial and / or venous chamber via the foil ( 3 ) having. 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 11, wherein the peristaltic pump is a roller pump. External functional device according to one of claims 11 or 12, with at least one pump tube 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 at least one web, which is designed on the housing body, and at least a portion of the cover means, wherein the web and cover means are arranged to be actuated by means of the cover means 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, saline, air and combinations the same is included. 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 16, 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 16 or 17, wherein the external functional device at an inclination angle, in particular substantially or exactly 8 ° can be coupled to a vertical to the blood treatment device is. External functional device according to one of the claims 16 to 18, 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 20, 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 22, 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 23 or 24, 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 25 or 26, 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 27, 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 27 or 28, 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 27 to 29, 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 18 to 30, 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. External functional device according to one of the preceding Claims, with a tamper evidence. External functional device according to claim 33, wherein the tamper-evident protection by means of the design of the substituate addition point ( 41 ) is realized. External functional device according to claim 34, wherein the tamper-evident protection is realized by means of a contact protection element or the closure sleeve of the substituate addition point ( 41 ), based on a change in their position within or relative to the cassette ( 1000 ) and / or on a change of her shape. External functional device according to one of the preceding Claims, with a reuse protection. An external functional device according to claim 36, wherein the reuse protection by means of the design of the substituate addition point ( 41 ) is realized. External functional device according to claim 36 or 37, wherein a closure sleeve for reuse is made unusable. Blood treatment device, in particular a dialysis device, characterized in that it is for receiving at least one external functional device according to one of Claims 1 to 38 is configured. A blood treatment device according to claim 39, 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 39 or 40, comprising at least one receiving device for receiving at least one external functional device according to a of claims 1 to 38. A blood treatment device according to claim 41, wherein the receiving device a coupling surface for coupling having the external functional device. A blood treatment device according to claim 41 or 42, wherein the coupling surface at an angle against a Vertical, related to the orientation of the blood treatment device during their use or the center of the earth, inclined is. Blood treatment device according to one of the claims 41 to 43, wherein the angle between 5 and 11 °, in particular essentially 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 38. Method for rinsing or rinsing a external functional device, characterized by using an external functional device according to a of claims 1 to 38. 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 38. Method for the blood treatment of a patient ( 4000 ), characterized by using an external functional device according to one of claims 1 to 38. A method of blood treatment according to claim 48, characterized through its implementation in the double-needle method. A method of blood treatment according to claim 48, characterized through its implementation in the single-needle method. A blood treatment method according to any of claims 48 or 50, comprising the steps of: - Passing blood through the dialyzer ( 2000 ), in particular a dialysis filter, for dialyzing the blood; and - storing the blood after passing through the dialyzer ( 2000 ) in the single-needle chamber ( 57 ), wherein the blood is first in the dialysis ( 2000 ) is dialyzed before entering the single-needle chamber ( 57 ) entry. Method for operating an external functional device according to one of claims 1 to 38 during a dialysis in the double-needle method with a predilution step. Method for operating an external functional device according to one of claims 1 to 38 during Dialysis in the double-needle method with a post-dilution step. Method for operating an external functional device according to one of claims 1 to 38 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 one of claims 1 to 38 during Dialysis in the single-needle method. Method for returning blood from the external functional device according to a of claims 1 to 38. Method for emptying an external functional device according to one of claims 1 to 38. Method according to one of claims 45 to 57 with the step: - To verify by means of sensors of a blood treatment device, whether for use inserted into a blood treatment device external functional device already used. Blood treatment device to perform A method according to any one of the claims 45 to 58. A blood treatment device according to claim 59, which a controller for controlling or regulating an external functional device according to one of claims 1 to 38 and / or for performing a method according to a of claims 45 to 58. Blood treatment device according to one of the claims 59 to 60, which at least one actuator for actuating an external functional device or a portion thereof according to one of claims 1 to 38 for Perform a method according to a of claims 45 to 58. Blood treatment device according to one of the claims 59 to 61, which sensors for outputting signals as a basis for actuating an external functional device according to a of claims 1 to 38 for performing a method according to one of claims 45 to 58. Dialysis device for recording and controlling a cassette ( 1000 ) according to any one of claims 1 to 38. Dialysis machine according to claim 63 with at least one cassette ( 1000 ) according to any one of claims 1 to 38. Dialysis apparatus according to claim 63 or 64, configured according to one of claims 31 to 36 and / or after a of claims 59 to 62.