DE10011208C1 - Blood dialysis and/or filtration device filling and/or rinsing method uses sterile liquid filtered by passing through dialysis membrane or sterile filter with collection in empty reinfusion container - Google Patents

Abstract

The filling and/or rinsing method has a sterile liquid fed through the extracorporal blood circulation circuit of the blood dialysis and/or filtration device, with the sterile liquid filtered by passing it through the blood dialysis membrane or a sterile filter (14). A branch line (59) of the extracorporal blood circulation circuit allows the sterile liquid to be fed to an empty reinfusion container (61). Also included are Independent claims for the following: (a) a blood dialysis and/or filtration device; (b) a blood hose set for an extracorporal blood circulation circuit of a blood dialysis and/or filtration device.

Description

The invention relates to the field of filling and / or rinsing an extracorpo ral circulation of a hemodialysis and / or hemofiltration device.

Blood treatment methods such as hemodialysis and hemofiltration are used A patient's blood is circulated through an extracorporeal circuit that is adjacent to the Blood collection and removal cannulas from a blood tube system and the Hemodialyzer or hemofilter exists. In hemodialysis, substances are made removes a patient's blood by making the blood and a dialysis fluid one chamber each through a semipermeable membrane in two chambers flow through separate hemodialyzer and through the substances to be removed a concentration gradient from the blood through the membrane into the dialysis fluid diffuse. In addition, there is a slight pressure difference between the two Chambers that allow the patient's fluid balance to be regulated. With hemofiltration there is a greater pressure difference between the two Chambers of a hemofilter created so that fluid from the blood constantly into the  second chamber is pressed. Since ei If a substance requires filtration of several liters of liquid, the Patients have approximately the same amount of fluid at the same time - except for one small difference to the regulation of fluid balance - be infused.

At the beginning of such blood treatment procedures, it is necessary to remove the extracorpora Fill and flush the circulatory system with physiological saline. There residues can be removed on the one hand, and on the other hand this is Presence of the saline solution is absolutely necessary when the cannulas are attached to the Patients are connected and the transition to circulation and treatment to be created by blood. The air in the extracorporeal circuit would otherwise contribute to blood damage and additionally - since the air on none If infusion is allowed - make the filling process very critical.

In general, for filling and flushing the extracorporeal circuit used my pre-filled bag of physiological saline. This are manually connected to the arterial blood tube end. The equipment egg The blood pump then conveys the fluid through the extracorporeal circuit. The rinsing liquid finally enters one at the venous end of the blood tube Waste bag. After sufficiently circulated fluid, the extracorporeal is Circulation flushed and filled and thus prepared for blood treatment.

At the end of a blood treatment it is necessary that it is still extracorporeal Circulating blood, comprising a few 100 ml, to the patient ben. For this purpose, the arterial cannula is disconnected and, in turn, a bag with physiological saline is attached to the arterial end of the blood tube closed. With the help of the blood pump, the liquid is conveyed, the blood on is returned to the patient until the blood / saline medium limit venous cannula has passed.

From EP-B-0 560 368 it is known to thereby ver the filling and rinsing process simple that no saline solution provided in bags for filling or rinsing,  but the physiological one prepared by the hemodialysis machine Dialysis fluid is used. The dialysis fluid is dialyzed Liquid circulation through the semipermeable membrane of a hemodialyzer pressed into the extracorporeal bloodstream and sterile filtered. In EP-B-0 560 368 also describes the possibility of using the described method To displace blood from the extracorporeal circuit after treatment. For How this process works, however, no further details are given. With this method, it is disadvantageous that the dialysis fluid circuit continues must remain functional. Is z. B. due to a device problem the treatment If the lung is stopped, the blood must be returned to the manual described above Method can be re-infused.

DE 197 04 564 A1 describes a device for periodically flushing the ex tracorporal circulation presented a blood treatment device. This will a bag of irrigation solution upstream of the blood pump with the extracorporeal circle run linked to extracorporeal blood treatment without anticoagulation to enable tel. To fill the bag, liquid becomes a substituate source into the bag via a second access.

The invention has for its object a generic method for Filling and / or flushing an extracorporeal blood circuit of a hemodialysis and / or offer hemofiltration device that is even easier to use is simplified and at the end of treatment no further treatment of Dialysis fluid instructed to flush the extracorporeal blood circuit is. The invention also has the task of a hemodialysis and / or hemofiltra tion device to provide that the method according to the invention largely auto can perform matatised. Finally, the object of the invention is a blood tubing set for use in the hemodialysis and / or To provide a hemofiltration device.

The problem is solved with a method with the characteristics of the contractor claim 1, a hemodialysis and / or hemofiltration device with the features of claim 9 and a blood tube set with the features of claim 20.

For the interpretation of the invention it should first be clarified that with the expression "Hemodialysis and / or hemofiltration device" a hemodialysis device, a hemofil tration device or a hemodiafiltration device is meant. In the latter device the treatment methods hemodialysis and hemofiltration combined, and in general The hemodialyzer also takes on the function of the hemofilter.  

In the method according to the invention, hemodialysis and / or Hemofiltration device generated or prepared sterile liquid through or in promotes the extracorporeal blood circulation through the membrane of the hemodialysa filter or another sterile filter and over one of the extracorporeal blood circuit branching reinfusion line an empty reinfusion container with the Liquid partially or completely filled. This way, during the entire blood treatment, one already filled with sterile and reinfusion fluid Bags available either automatically and / or with less hand handles can be used for reinfusion. It is at the time of reinfusion no longer necessary on the functioning of the dialysis fluid and / or Substi tion fluid supply.

For filling and flushing the extracorporeal blood circuit, one can Further development of the invention the distal ends of the hemodia to the blood chamber lysators and / or filters leading line and the lead away from the blood chamber current line of the extracorporeal blood circuit with a short circuit ver be bound. Before initiating the filling of the reinfusion container then the filling or rinsing liquid circulates in the extracorporeal blood circuit.

To fill the reinfusion container, the device is expediently gene pump means of hemodialysis and / or hemofiltration device used.

In one embodiment of the method according to the invention, the Reinfusi onsleitung a first valve is provided that opened for filling and up to Reinfusion is closed. Before filling, the first valve remains closed so that the filling and / or flushing of the extracorporeal blood circuit can be waited for in progress. In a further development of the invention seen during the filling and / or rinsing process of the extracorporeal Blood circuit first into a second container via a second branch line to be discarded before the reinfusion container is filled.  

The invention further comprises a hemodialysis and / or hemofiltration device one through a semipermeable membrane into a first and a second chamber divided sterile filter, the first chamber via a liquid supply line, which passes through a liquid pumping medium, connected to a liquid source and the second chamber via a connection to an extracorporeal blood circuit is connected, in which blood circulates with the help of a blood pump with a control unit that is able to control the pumping means control that liquid from the liquid source through the sterile filter and the ver binding in the extracorporeal blood circuit to flush it and / or to fill. This device is characterized in that it is also a Reinfusion line branching off the extracorporeal blood circuit with one attached to it connected reinfusion container and that the control unit is an automa tized filling program can run, that first with the help of the pump the extracorporeal blood circuit is filled with filtered liquid and / or rinsed and then partially or completely the reinfusion container with filtered liquid filled. For this purpose, a switchable by the control unit can be in the reinfusion line first valve may be provided.

If the device is a hemodialysis machine, it can be used as a sterile film ter the hemodialyzer of the hemodialysis machine and a liquid source Find dialysis fluid source. On the other hand, it is a Hemofiltration device, a substitution fluid can be used as the fluid source source can be used. In both cases, it is also a liquid swell that provide physiological fluid.

In one embodiment of the hemodialysis and / or hemo according to the invention the control unit is still able to use a reinfusion liquid to carry out a speed promotion program in which the blood pumping agent is controlled in such a way that downstream of the branch of the reinfusion line through an opening of the first valve reinfusion liquid from the reinfusion container into the extra corporeal blood circulation can be promoted.  

In a particularly advantageous embodiment of the invention, the Reinfusi ons container a flexible and empty plastic bag upon delivery. So that results the weight increases for the compilation of extracorporeal blood components required only insignificantly. This also applies to the spatial expansion, since the bag can be folded and only a few liters Must be able to absorb liquid.

It is advantageous if the reinfusion line from the hemodialyzer or Hemofilter leading blood supply line branches. It is for handling still advantageous if the blood supply line is made in one piece with the reinfusion tube container is connected.

Because in many conventional hemodialysis and / or hemofiltration devices Blood pump means are provided in the blood supply line, it is appropriate to Branch of the reinfusion line upstream of the blood pump from the blood supply to branch line.

For the filling and / or rinsing process, it is conducive to a short-circuit piece Connect the distal ends of those leading to the hemodialyzer or hemofilter Blood supply line and that leading away from the hemodialyzer or hemofilter Insert blood drain line.

In a further embodiment of the hemodialysis and / or Hemofiltration device branches off a second line branch from the extracorpora len blood circulation, which can be interrupted by a second valve and is connected to a second liquid container. The automated filling pro grams may then be able to initially with the first valve closed to fill and / or flush extracorporeal blood circulation by opening and Close the second valve from the extracorporeal blood circuit draining rinsing or filling liquid into the second container, the second Close valve and then fill the reinfusion container.  

To control the automated filling program are anyway in the usual gene hemodialysis and / or hemofiltration devices existing pressure sensors in extracorporeal blood circulation and in the dialysis fluid supply line or sub Stitition liquid supply line used.

Finally, the invention also includes a blood tube set for use in the extra corporal blood circulation of a hemodialysis and / or hemo according to the invention filtration device. This blood tube set consists of a tube blood supply line to the hemodialyzer or hemofilter, from which a reinfu sions hose line branches, which is connected to an empty reinfusion bag is. The reinfusion bag has a second one provided with a connector Outlet that can be connected to the blood supply line. In the direction of the river the blood tube set according to the invention has the following components: a connector for connecting a cannula or a short-circuit piece Branch of the reinfusion line, a section for insertion into a blood pump tel, an arterial bladder trap with an optional additional outlet on highest point of the bubble trap and a connector for connection to the Hemodialyzer or hemofilter. At the optional outlet of the bubble trap a second bag can be connected via a hose or even be connected in one piece to the hose set.

Further details and advantages of the invention are based on in the drawing illustrated embodiments explained in more detail. Show it:

FIG. 1 shows an inventive hemodialysis;

FIG. 2 shows a hemofiltration apparatus according to the invention;

FIG. 3 shows an inventive blood tubing.

In Fig. 1, a hemodialysis machine according to the invention is shown. Such a device is divided in a manner known per se into a dialysis fluid circuit 1 and an extracorporeal blood circuit 2 . In the dialysis fluid circuit 1 , dialysis fluid passes from a dialysis fluid source 3 via a dialysis fluid supply line 5 to the hemodialyzer 30 . The hemodialyzer 30 is divided by a semipermeable membrane 33 into a dialysis fluid chamber 31 and a blood chamber 32 .

The dialysis fluid supply line 5 is divided into sections 5 a, 5 b and 5 c. The first section 5 a leads from the dialysis fluid source 3 via pump means 18 and valves 8 a referred to as a degassing pump to a balancing device 7 . In the embodiment shown, this consists of two parallel-connected bi lance chambers, each of which is divided into two halves of the balance sheet by an impenetrable, flexible membrane. Each half of the balancing chamber has an inlet and an outlet. The inlets can be closed by valves 8 a, the outlets by valves 8 b. Each half of the balancing chamber can receive fresh dialysis fluid via line 5 a, while the other contains used dialysis fluid coming from the hemodialyzer. Since the balancing chambers themselves are rigid in volume, the balancing chambers enable balanced balancing of the dialysing liquid flowing to the hemodialyzer with respect to the dialysing liquid flowing away from it. The valves 8 a, 8 b are switched during a mode called balancing mode in such a way that only one balancing chamber is directly connected to the hemodialyzer 30 , while the other balancing chamber is connected to the dialysis fluid source 3 and the drain 4 .

After the balancing device 7 , a second section 5 b of the dialysis liquid leads to the first chamber of a sterile filter 14 divided into two chambers by a semipermable membrane. The first chamber is connected for flushing purposes with a lockable bypass line 15 with the dialy fluid drain line 6 . The second section of the sterile filter 14 is followed by the third section 5 c of the dialysis fluid supply line, which extends to the inlet of the dialysis fluid chamber 31 of the hemodialyzer 30 and can be shut off by a valve. A conductivity and temperature sensor 17 and a test pump unit with pressure sensor 12 are also located at section 5 c. A second bypass line 16, which can be blocked with a valve, branches off from section 5 c to the dialysis fluid discharge line 6 .

At the outlet of the dialysis fluid chamber 31 there is a first section 6 a of the dialysis fluid discharge line 6 , which can be shut off by a valve 19 . The bypass lines 15 and 16 open into this line section 6 a, in which the pressure is measured by a pressure sensor 13 . Section 6 a ends at a dialysis fluid pump 9 . From the dialysis fluid pump 9 leads a second section 6 b of the dialysis fluid discharge line via the valves 8 a to the inlets of the respective second halves of the balance chambers of the balancing device 7 . In the balancing mode, the dialysis fluid is circulated by the dialysis fluid pump 9 from one balance chamber half to another balance chamber half of the same balance chamber. The outlets of these balance chamber halves are connected to a drain 4 via the valves 8 b via a third section 6 c of the dialysing liquid discharge line. The flow through the line section 6 c can be interrupted by a drain valve 22 .

In order to be able to remove liquid by ultrafiltration from the blood circuit 2 via the dialysing liquid circuit 1 , a line 10 branches off from the dialysing liquid line section 6 a, in which an ultrafiltrate pump 11 is located. This line bypasses the balancing device 7 and opens downstream into the line section 6 c.

In parallel to the ultrafiltration line 10 , an air separation line 20 branches off from the line section 6 c via which larger amounts of air can be removed from the system with simple means and which can be closed with the valve 21 .

In the extracorporeal blood circuit 2 , blood flows through a cannula, not shown, into the extracorporeal circuit during the blood treatment, the cannula being connected to the distal end of the section 50 a provided with a connector 66 from the blood supply line 50 . According to the invention, a line 59 branches off from this line, which line can be interrupted by a valve designed as a clamp 60 and leads to a cleaning container 61 designed as a bag. The reinfusion bag 61 can have a second outlet 65 , which is closed with a connector. The outlet 65 is suitable in this case to be connected to the connector 66 of the distal end of the section 50 a of the blood supply line.

An arterial pressure sensor 54 measures the pressure in the first section 50 a of the blood supply line, which extends further via blood pump means 53 designed as a roller pump to an arterial bubble trap 55 . At the top of the Bla senfängers 55 is connected via a connector connected to the exhaust line 62 , which can be closed with a valve 63 designed as a terminal. Finally, the discharge line 62 opens into a discard bag 64 , which may have a check valve (not shown in detail) in its inlet, in order to prevent reflux of discarded liquid.

From the arterial bladder 55 leads a second section 50 b of the blood supply line to the inlet of the blood chamber 32 of the hemodialyzer 30 . From the outlet of the blood chamber, the blood flows through a first section 51 a of the blood discharge line, to which the venous bladder trap 56 connects. At an upper point of the venous bladder trap, there is a derivation to the venous pressure sensor 57 , in which pressure can also be generated by a pump (not shown) and ventilation is possible via a valve (not shown).

From the outlet of the venous bladder trap equipped with an air detector, a second section 51 b of the blood discharge line leads via the venous clamp 58 to the distal end of the blood discharge line 51 provided with a connector, via which the blood is returned to the patient via the cannula (not shown).

According to the invention, a control unit 100 is now provided, which is connected via lines shown in the drawing to the actuators and sensors of the hemodialysis device. For better clarity, these lines are provided with reference numerals which consist of an "L" and a number that corresponds to the reference number of the actuator or sensor. In addition, these lines are only symbolically drawn on the control unit, but not as a continuous connection to the actuator or sensor, since the assignment of the lines is clear from the numbers.

For the automated application of the method according to the invention, the control unit is instructed by the user via an input device (not shown) to carry out the filling and rinsing method. The hemodialyzer and the components of the extracorporeal blood circuit were previously installed at the locations provided and the dialysis fluid circuit was filled in a known manner with physiological dialysis fluid. In addition, the distal ends of the blood supply and discharge line 50 and 51 have been connected by means of a short-circuit piece 52 . This short-circuit piece can have a further, closable outlet 67 . In an alternative embodiment, e.g. B. the exhaust line 62 can be connected to the outlet 67 .

At this point, the extracorporeal blood circuit is still filled with air. The control unit 100 now initiates the following processes: First, the valves 19 and 58 are closed. The same applies to the valve in the venous pressure sensor unit 57 . Terminal 60 in line 59 is also closed and terminal 63 in drain line 62 is open. The blood pump 53 is stopped and occludes the blood supply line 50 . The balancing chamber valves 8 a and 8 b are not switched according to the balancing mode, but according to a second mode, hereinafter referred to as the filling mode. For this purpose, the drain valve 22 is closed and the outlet valves 8 b located on the subsequent lines of section 6 c are opened. The two affected balance chamber halves correspond to the inlet valves 8 a, on the other hand, are closed, ie these two balance chamber halves are connected and represent a closed system. If one of the two remaining balance chamber halves is now filled with fresh dialysis fluid via the degassing pump 18 with the outlet closed, this leads since that liquid is exchanged between the two enclosed balance chamber halves and finally the fourth balance chamber half - which had previously been filled with fresh dialysis fluid - is emptied through its previously opened outlet. In this way, there is a net shift in dialysis fluid speed, which corresponds to a balance chamber volume. This liquid flows through the balancing device into the area of the dialysis fluid circuit 1 delimited by the balancing device 7 , but it does not flow back through the balancing device 7 .

The dialysis fluid is then sterile filtered through the sterile filter 14 . Since the valve 19 at the outlet of the dialysis fluid chamber 31 is closed, the dialysis fluid passes further via the membrane 33 into the blood chamber 32 . The dialysis fluid is sterile filtered a second time. For this reason, the sterile filter 14 is not absolutely necessary for carrying out the invention. The hemodia lyser itself also connects to the extracorporeal blood circuit. For safety reasons, Sterilfiter 14 is a useful addition.

From the blood chamber 32 of the hemodialyzer 30 , the liquid enters the lines 51 a and 50 b, the air enclosed in each case being compressed. If a limit pressure is detected at the pressure sensors 12 or 57 , the system switches to a further phase of the filling program. It has proven useful here to evaluate the pressure change during a balancing chamber emptying as the limit pressure. The valve on the venous pressure sensor unit 57 is then opened and the venous bladder trap is filled with dialysis fluid until the air detector detects a fluid level. The air escapes through unit 57 .

Now the valve on the pressure sensor unit 57 is closed again and the blood pump 53 is started at a first speed. In addition, the venous se 58 is opened. While dialysis fluid is still pressed from the dialysis fluid circuit 1 into the extracorporeal blood circuit 2 , this fluid circulates in the extracorporeal circuit and air still in the extracorporeal circuit is predominantly separated on the arterial bladder trap in the exhaust line 62 . It has proven to be advantageous to increase the blood pump speed to a second value after delivery of a certain filling quantity and to alternately open and close the clamp 63 in the discharge line in a clocked manner. After a further period of time, the blood pump is stopped again and the meanwhile dropped level in the venous bladder trap is increased by further supply of dialysis fluid and opening of the valve at the line 57 .

After the valve on the discharge line 57 is closed, the pressure change per balance chamber cycle is checked. When the necessary values are reached, the control unit 100 now recognizes that the extracorporeal circuit is sufficiently filled with liquid. The dialysis fluid circuit is put into the balancing mode by opening the valves 19 and 22 and a corresponding circuit of the valves 8 a and 8 b, the dialysis fluid being flushed by the pump 9 into the dialysis fluid circuit. In the extracorporeal blood circuit 2 , the clamp 63 in the discharge line 62 is closed and a flushing process is initiated by actuating the blood pump 53 .

After a termination criterion limiting the rinsing phase, the z. B. in the course of a certain time or in a certain delivery rate of the blood pump, the rinsing liquid is discarded in the discard bag 64 . For this purpose, the blood pump 53 is first stopped and the venous clamp 58 and the valve 19 are closed. The balancing device 7 now works again in the filling mode. After a limited amount of discard, which preferably consists of 150 ml, the liquid is circulated again in the extracorporeal blood circuit, ie the previously described flushing operation is resumed. After the liquid located downstream of the blood chamber has entered the arterial bladder trap and the line section 50 b and the blood chamber 32 itself, a new rejection phase is initiated. This means that the flushing solution in the extracorporeal circuit has been completely replaced with fresh dialysis fluid.

According to the invention, with the blood pump 53 standing still and the terminal 63 closed in the discharge line 62 , but the venous terminal 58 open and the terminal 60 open in the reinfusion line, the reinfusion bag 61 is filled with sterile liquid speed. After sufficient flow, the terminal 60 in the Reinfusi onsleitung can be closed again. The extracorporeal blood circuit and the reinfusion bag 61 are now filled with sterile and even physiological fluid, and the hemodialysis machine is ready for hemodialysis treatment.

After the hemodialysis treatment, the distal end 66 of the blood supply line section 50 a is disconnected from the cannula which has been connected in the meantime and connected to the second outlet 65 of the reinfusion bag. If the branch line 59 branches off from the first section 50 a of the blood supply line very close to the sem distal end, it may also be sufficient to interrupt the cannula connection and simply open the clamp 60 for connection to the reinfusion bag.

With the help of the blood pump 53 , the remaining blood in the extracorporeal circuit 2 is conveyed to be returned to the patient, while at the same time the reinfusion bag is emptied. The blood / reinfusion liquid phase boundary is clearly recognizable, and the reinfusion process is interrupted as soon as the phase boundary has reached the cannula.

In Fig. 2 is a hemofiltration apparatus according to the invention is depicted. Since this hemofiltration device has many identical components as the hemodialysis device shown in FIG. 1, the same reference numbers have been used for these components.

The previous dialysis fluid circuit is now replaced by a substitution / ultrafiltrate hydraulic unit with which sterile, physiological substitution fluid can be supplied to the extracorporeal circuit in compensation for the ultrafil to be withdrawn from the extracorporeal blood circuit. The hemofiltration device in FIG. 2 differs from FIG. 1 essentially in that the inlet of the filter element 30 , which is now effective as a hemofilter, to the chamber 31 is closed or does not exist at all. Furthermore, line 5 c now leads to the first chamber of a second sterile filter 70, which is divided by a semipermeable membrane into two chambers. The second chamber of the sterile filter is connected directly to the extracorporeal blood circuit 2 via a sub stitution line 71 in which liquid can be conveyed with the aid of a substitution pump 72 .

In FIG. 2, the substitution line 71 on the venous bladder trap 56 is closed, as a result of which the substitution solution is added downstream of the hemofilter 30 (post-dilution). However, it is alternatively possible to add it at any other point in the extracorporeal blood circuit - in particular upstream of the hemofilter (predilution).

The filling and flushing of the extracorporeal circuit can now be carried out in a manner analogous to that in FIG. 1. By now designed as a substitution liquid speed source 3 and the double-designed for safety reasons sterile filter 14 and 70 sterile, physiological liquid is provided, which lead to the filling and flushing of the extracorporeal circuit through the same processes of valve and pump control. The filling of the reinfusion bag and the return of the blood in the extracorporeal circuit are carried out in the same way as in the hemodialysis machine according to FIG. 1.

The hemodialysis or hemofiltration units presented in both FIGS. 1 and 2 can also be combined in the form of a hemodiafiltration unit. For this purpose, for example, the first chamber of the second sterile filter 70 can be placed directly in the line 5 c of the hemodialysis device shown in FIG. 1. This line then passes through this chamber and leads directly to the hemodialyzer or hemofilter 30 . In this case, the hemodialyzer is identical to the hemofilter and the substitution fluid is also the dialysis fluid.

FIG. 3 shows an embodiment of a blood tube set according to the invention for use in the devices shown in FIGS . 1 and 2. The blood tubing set 80 , which advantageously consists of a blood-compatible, flexible plastic, has a tubing 50 a starting from an arterial connector 66 , which extends to an arterial bladder catcher 55 designed as a cushion. From the tube 50 a branches off a line 59 , also designed as a tube, which leads to an empty reinfusion bag 61 . The reinfusion bag 61 has a second outlet 65 which is closed with an openable connector. This connector can then be connected directly to connection 66 . Furthermore, an intermediate piece or even a hose line for the arterial pressure sensor can be seen on the hose line 50 a.

Furthermore, the hose line 50 a is suitable to be inserted at one point in blood pump means configured as a roller pump. For this purpose, it is generally appropriate to provide a special hose section, but this is not shown in FIG. 3.

A further tube section 50 b finally extends from the arterial bladder trap 55 to an end provided with a connector 81 which is suitable for arterial connection to a hemodialyzer or hemofilter. At the upper point of the bubble trap 55 , an outlet 82, also provided with a connector, can be provided for connecting an exhaust line 62 , to which an empty discard bag 64 connects. The line 62 and the bag 64 can be designed to be separable or in one piece.

The question of how many parts are provided in one piece - permanently mounted or connected the ultimate question is whether the production advantages of the simultaneous sterilization the disadvantages of the further assembly steps and the possibly justify more complex packaging.

The possible uses of the hose set according to the invention are evident from the above statements regarding the devices shown in FIGS. 1 and 2.

Claims (23)

1. Method for filling and / or flushing an extracorporeal blood circuit ( 2 ) of a hemodialysis and / or hemofiltration device, in particular of blood tubing lines and hemodialyzers or hemofilters,
wherein sterile liquid produced or prepared by the hemodialysis and / or hemofiltration device is conveyed through or into the extracorporeal blood circuit,
the liquid passing through the membrane of the hemodialyzer ( 30 ) or one of its sterile filters ( 14 , 70 ) and being filtered thereby,
characterized by
that an empty reinfusion container ( 61 ) is partially or completely filled with the sterile liquid via a line ( 59 ) branching off from the extracorporeal blood circuit. 2. The method according to claim 1, characterized in that the distal ends of the blood supply line leading to the blood chamber ( 50 ) and the blood discharge line leading away from the blood chamber ( 51 ) of the extracorporeal blood circuit ( 2 ) are connected to a short-circuiting piece ( 52 ). 3. The method according to claim 2, characterized in that the liquid is circulated in the extracorporeal blood circuit ( 2 ) before initiating the filling of the reinfusion container ( 61 ). 4. The method according to any one of the preceding claims, characterized in that the device's own pumping means ( 18 , 53 ) of the hemodialysis and / or hemofiltration device are used to fill the reinfusion container ( 61 ). 5. The method according to any one of the preceding claims, characterized in that in the branching line ( 59 ) a first valve ( 60 ) is easily seen that is opened before filling and closed after filling. 6. The method according to claim 5, characterized in that the first valve ( 60 ) initially remains closed while the extracorporeal blood circuit ( 2 ) is filled and / or flushed with the liquid, and that after the end of this filling and / or Flushing the first valve ( 60 ) is opened to fill the reinfusion container ( 61 ). 7. The method according to any one of the preceding claims, characterized in that during the filling and / or rinsing process, a second container ( 64 ) via a second branch line ( 62 ) is partially or completely filled with liquid to be discarded before the reinfusion container ( 61 ) is filled. 8. hemodialysis and / or hemofiltration device,
with an extracorporeal circuit ( 2 ) in which blood passes through a hemodialyzer and / or hemofilter ( 30 ) with the aid of blood pumping means ( 53 ),
with a sterile filter ( 14 , 30 , 70 ) divided into a first and a second chamber by a semipermeable membrane,
wherein the first chamber is connected to a liquid source ( 3 ) via a liquid supply line ( 5 ) through which a liquid pumping medium ( 18 ) passes,
and the second chamber is connected to the extracorporeal blood circuit ( 2 ) via a connection ( 30 , 71 ),
with a control unit ( 100 ) which is able to control the pumping means ( 18 , 53 ) so that liquid from the liquid source ( 3 ) via the sterile filter ( 14 , 30 , 70 ) and the connection ( 30 , 71 ) enters the extracorporeal blood circuit ( 2 ) in order to flush and / or fill it,
characterized in that
the hemodialysis and / or hemofiltration device comprises a line ( 59 ) branching off the extracorporeal blood circuit with a reinfusion container ( 61 ) connected to it,
and that the control unit ( 100 ) can run an automated filling program which, with the aid of the pump means ( 18 , 53 ), fills and / or rinses the extracorporeal blood circuit ( 2 ) with filtered liquid and then partially or completely with the reinfusion container ( 61 ) filtered liquid filled. 9. hemodialysis and / or hemofiltration device according to claim 8, characterized in that a switchable by the control unit first valve ( 60 ) is provided in the branching line ( 59 ). 10. A hemodialysis machine according to claim 8 or 9, characterized in that the sterile filter is the hemodialyzer ( 30 ) of the hemodialysis machine and the liquid source is a fluid source of dialysis fluid ( 3 ). 11. Hemofiltration device according to claim 8 or 9, characterized in that the liquid source is a substitution liquid source ( 3 ). 12. hemodialysis machine and / or hemofiltration machine according to claim 9, characterized in that the control unit ( 100 ) is further able to run a method in which the blood pumping means ( 53 ) is controlled so that downstream of the branch of the line ( 59 ) to the reinfusion container ( 61 ) through an opening of the first valve ( 60 ) or through a connection of the distal end ( 66 ) of the blood supply line ( 50 ) with the reinfusion container ( 61 ) reinfusion liquid from the reinfusion container ( 61 ) into the extracorporeal Blood circulation ( 2 ) can be promoted. 13. Hemodialysis machine and / or hemofiltration device according to one of claims 8 to 12, characterized in that the reinfusion container ( 61 ) is a bag. 14. Hemodialysis machine and / or hemofiltration device according to one of claims 8 to 13, characterized in that the branching line ( 59 ) branches off from the blood supply line ( 50 ) leading to the hemodialyzer or hemofilter ( 30 ). 15. Hemodialysis machine and / or hemofiltration device according to claim 13, characterized in that the blood supply line ( 50 ) is connected in one piece via the line ( 59 ) to the reinfusion container ( 61 ). 16. Hemodialysis machine and / or hemofiltration device according to claim 14 or 15, characterized in that the blood pumping means ( 53 ) are provided in the blood supply line ( 50 ) and the branch of the line ( 59 ) to the reinfusion container ( 61 ) upstream of the blood pumping means ( 53 ) branches off from the blood supply line ( 50 ). 17. Hemodialysis machine and / or hemofiltration device according to one of claims 8 to 16, characterized in that a short-circuit piece ( 52 ) for connecting the distal ends of the blood supply line leading to the hemodialyzer or hemofilter ( 50 ) and the blood discharge line leading away from the hemodialyzer or hemofilter ( 51 ) is inserted. 18, hemodialysis machine and / or hemofiltration device according to one of claims 8 to 17, characterized in that a second line branch ( 62 ) is provided in the extracorporeal blood circuit ( 2 ), which can be interrupted by a second valve ( 63 ) and with a second Liquid container ( 64 ) is connected. 19. Hemodialysis machine and / or hemofiltration device according to claim 18, characterized in that the automated filling program is able to fill and / or flush the extracorporeal blood circuit ( 2 ) next when the first valve ( 60 ) is closed by opening and closing of the second valve ( 63 ) from the extracorporeal blood circuit ( 2 ) to be discarded flushing or filling liquid into the second container ( 64 ), to close the second valve ( 63 ), to open the first valve ( 60 ) and then to Fill the reinfusion tank ( 61 ). 20. Hemodialysis machine and / or hemofiltration device according to one of claims 8 to 19, characterized in that for controlling the automated filling program pressure sensors ( 12 , 54 , 57 ) in the extracorporeal blood circuit and in the dialysis fluid supply line or substitution fluid supply line ( 5 ) are provided. 21. blood tubing set ( 80 ) for use in the extracorporeal blood circuit of a hemodialysis and / or hemofiltration device according to one of claims 8 to 20,
with a blood supply line ( 50 ) designed as a hose to the hemodialy sator or hemofilter,
with a hose line ( 59 ) branching off from the blood supply line ( 50 ) and connected to an empty reinfusion bag ( 61 ),
the reinfusion bag ( 61 ) having a connector provided with a second outlet ( 65 ) which can be connected to the blood supply line ( 50 ). 22. blood tubing set according to claim 21, characterized in that the blood supply line ( 50 ) in the flow direction has the following components: egg nen connector ( 66 ) for connecting a cannula or a short-circuit piece ( 52 ), the branch of the hose line ( 59 ), a section for insertion into a blood pumping agent ( 53 ), an arterial bladder trap ( 55 ) with an additional outlet ( 82 ) at the highest point of the bladder trap and a conector ( 81 ) for connection to the hemodialyzer or hemofilter. 23. Blood tube set according to claim 22, characterized in that a second bag ( 64 ) can be ruled out at the further outlet ( 82 ) of the bubble trap.