Blood treatment device with oscillation device

EP4472697A1Pending Publication Date: 2024-12-11FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
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Patent Information

Application Number
EP2023702774
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-01-31
Filing Date
2023-01-30
Publication Date
2024-12-11

AI Technical Summary

Technical Problem

Existing blood treatment devices for hemodialysis and hemodiafiltration face challenges in preventing air bubbles from entering the patient's vascular system, which can lead to gas embolism and require manual intervention to resolve air bubble alarms, potentially resulting in blood loss and increased personnel costs.

Method used

A blood treatment device equipped with an air bubble detector, oscillating device, and control system that detects air bubbles, generates negative transmembrane pressure, and oscillates the extracorporeal blood circuit to effectively remove air bubbles without manual disconnection and reconnection of hoses, thereby simplifying the treatment process and enhancing patient safety.

Benefits of technology

The solution automates the removal of air bubbles, reduces the risk of blood loss, simplifies the treatment procedure, and enhances patient safety by eliminating the need for manual intervention and minimizing personnel costs.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a blood treatment device (100) comprising at least one blood pump (101), an air bubble detector (315), a further pump, an oscillation device (330) and a control or regulating device (150). The blood pump (101) is provided for pumping blood through an extracorporeal blood circulation system (300) during a blood treatment session during which the blood treatment device (100) is connected to the extracorporeal blood circulation system (300) and to a blood filter (303) comprising a semi-permeable membrane (303c). The air bubble detector (315) is provided for detecting air bubbles within the extracorporeal blood circulation system (300). The further pump is provided for conveying dialysis fluid and / or dialysate. The oscillation device (330) is provided and / or adapted to oscillate the extracorporeal blood circulation system (300), a portion thereof, or the contents thereof. The control or regulating device (150) is provided and programmed to control the blood pump (101), the further pump for conveying dialysis fluid and / or dialysate and the oscillation device (330).
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Description

[0001]Description Blood treatment device with oscillating device The present invention relates to a blood treatment device according to claim 1 or according to the preamble or generic term of this claim. Various types of blood treatment devices are known in practice. These include, for example, devices for hemodialysis, hemofiltration, and hemodiafiltration. During extracorporeal blood treatment, the blood flows in an extracorporeal blood circuit through a blood treatment unit. In the devices for hemodialysis, hemofiltration, and hemodiafiltration, the blood treatment unit is a dialyzer or filter, which, in simple terms, is separated by a semi-permeable membrane into a blood chamber and a dialysis fluid chamber. During blood treatment by means of hemodialysis or hemodiafiltration, the blood flows through the blood chamber,while a dialysis fluid flows through the dialysis fluid chamber. Air or microbubbles in extracorporeal circuits downstream of a venous air separation chamber can lead to gas embolisms in the patient's body. Embolisms can clog vessels and cause ischemia. To prevent gas from entering the patient's vascular system during dialysis, the venous air separation chamber is located in the venous blood tubing system. It partially reduces the flow velocity within the extracorporeal circuit so that gas bubbles rise against gravity according to Archimedes' principle and can be separated through an opening in an upper area of ​​the venous air separation chamber. In addition, the venous system downstream of the venous air separation chamber is monitored for the presence of air, e.g., in the form of microbubbles, by an air bubble detector.in the extracorporeal flowing blood. If the sensor detects the presence of air, an air bubble alarm is triggered, which interrupts the patient's blood treatment. After the cause of the air bubble alarm has been remedied by the responsible person, the blood treatment can be continued. The object of the present invention is to propose a further blood treatment device with an air bubble detector. The inventive object is achieved by the blood treatment device with the features of claim 1. According to the invention, a blood treatment device is thus proposed, wherein the blood treatment device has a blood pump and an air bubble detector for an extracorporeal blood circuit, and a pump for conveying dialysis fluid and / or dialysate on its hydraulic side, or is connected to such a device. The extracorporeal blood circuit, which is not part of the blood treatment device,but is connected or upgraded with it for the purpose of treating the blood of a specific patient prior to the start of their blood treatment session, can be provided entirely or partially on a blood cassette. The blood pump is intended to pump blood through the extracorporeal blood circuit or through the blood cassette during a blood treatment session when the latter is connected to the extracorporeal blood circuit and to a blood filter or dialyzer, the dialyzer in turn having a semi-permeable membrane. The air bubble detector serves to detect air bubbles within the extracorporeal blood circuit. It can be arranged, for example, between a venous air separation chamber and the venous patient access. Furthermore, the blood treatment device has an oscillation device by means of which the extracorporeal blood circuit, or at least a portion thereof,or in each case the contents or a part of the contents of the blood circuit or section can be set into oscillation, swung, moved or vibrated. The blood treatment device further comprises a control or regulating device or is connected to such a device. The control or regulating device is configured to initiate, carry out, control and / or regulate a method - in particular automatically - in cooperation with the blood treatment device or its devices or devices, in particular as disclosed herein. Thus, it is configured in particular to control the blood pump, the pump for dialysis fluid and / or dialysate, and to control the oscillation device. Such cooperation can include controlling,Be or include controlling or regulating. An interaction can be or require a signal connection. The blood treatment device according to the invention can have a correspondingly suitable and / or configured device or apparatus for each of the steps mentioned herein of the method disclosed herein, such as a pressure measuring device for pressure measurement or the like, or can be connected to such devices or apparatus. In all the above and following statements, the use of the expression "can be" or "can have" etc. is to be understood as synonymous with "is preferably" or "preferably has" etc. and is intended to explain an embodiment of the invention. Whenever numerical terms are mentioned herein, the person skilled in the art will understand this as indicating a numerical lower limit. Unless this leads to a contradiction recognizable to the person skilled in the art,Therefore, the person skilled in the art always reads "at least one" or "at least one" when referring to "a" or "an." This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one," wherever this is technically possible for the person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein. When "programmed" or "configured" is mentioned herein, it is also disclosed that these terms can be interchanged. When a venous air separation chamber, or simply an air separation chamber, is mentioned herein, this can also be a venous blood chamber, a venous bubble chamber, or a venous drip chamber. Advantageous further developments of the present invention are each the subject of subclaims and embodiments. When an embodiment is mentioned herein,This represents an exemplary embodiment according to the invention. If it is disclosed herein that the subject matter according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g., in the sense of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, for example, formulated as a negation, is also disclosed. Embodiments according to the invention can have one or more of the features mentioned above and / or below in any technically possible combination. In some embodiments, the oscillation device of the blood treatment device according to the invention is arranged in or on the extracorporeal blood circuit, or with an effect on it, with the aim of oscillating the extracorporeal blood circuit,at least a portion thereof or its contents, to vibrate, which is usually initiated by the correspondingly programmed control or regulating device. In some embodiments, the vibrating device is not (or not only) the venous tube clamp, at least not unless the control or regulating device is accordingly programmed to cause the venous tube clamp to generate a vibration by opening and closing it sufficiently quickly, e.g., as described herein. In some embodiments, the vibrating device is or comprises a venous tube clamp. Here, the control or regulating device is programmed to control the venous tube clamp in such a way thatthat it is automatically opened and closed again or otherwise actuated several times within a minute or second. This action of the venous tube clamp preferably occurs at a rate of at least once per second. When opening and / or closing the venous tube clamp, vibrations can be transmitted to the tube system by means of this. In certain embodiments in which the oscillating device is a venous tube clamp, vibrations of the tube system can be initiated by means of the pressures or negative pressures generated when opening and closing the tube clamp. In some embodiments, the oscillating device is or comprises a holding device for releasably holding at least a section of the extracorporeal blood circuit, in particular on a housing surface of the blood treatment device. The holding device can be a clamp for holding a flexible tube section, the drip chamber,or another section of the disposable. In some embodiments, the oscillation device is designed and controlled accordingly to oscillate at a frequency of 1 Hz, 5 Hz, or more. Oscillation is, in some embodiments, a left-right movement or an up-down movement. The oscillation preferably does not occur around a longitudinal or transverse axis and / or does not represent a rotational movement. In some embodiments of the blood treatment device according to the invention, the control or regulating device is configured to modulate the frequency of the vibrations generated by the oscillation device. This can be done, for example, by means of frequency sweep, amplitude modulation, and / or resonance excitation, or can comprise such methods, and can advantageously contribute toto remove the air within the extracorporeal blood circuit as effectively as possible. The resonance behavior of the air and / or the fluid is utilized. The direction of the vibration is not limited and can be radial or linear, for example, in the direction of the venous air separation chamber, or in any spatial direction, whereby certain directions (e.g., the buoyancy direction) can be used preferentially. In some embodiments, the control or regulating device is programmed or configured, during an extracorporeal blood treatment session, upon detection of air bubbles or air inclusions in the extracorporeal blood circuit, or after an air bubble alarm,to carry out the steps of one of the two alternative embodiments of the following method. In a first embodiment, the method comprises stopping the blood pump or reducing its delivery rate immediately before the air bubbles are detected, as well as generating a negative transmembrane pressure across the semi-permeable membrane of the blood filter. This negative transmembrane pressure can be achieved by appropriately controlling the pump to deliver dialysis fluid and / or dialysate on the hydraulic side while the blood pump is stopped or its delivery rate is reduced. The transmembrane pressure can be measured in a variety of ways, or its existence can be determined directly or indirectly. The detection of air bubbles or air inclusions in the extracorporeal blood circuit can be achieved using the air bubble detector. The air bubble detector can alternatively or additionally be suitable or configured toAs a result of the detection of gas, air, or air bubbles, triggering an air bubble alarm (alternatively: gas alarm), which in turn leads to the initiation or execution of the method. Air bubbles or air inclusions can be detected, for example, by an air bubble alarm, by fulfilling conditions that trigger an air bubble alarm or are sufficient to trigger an air bubble alarm. Alternatively, in a second embodiment, the method comprises reversing the flow direction of the blood pump,This means that it conveys the blood backwards. In the method carried out by means of the control or regulating device of the blood treatment device according to the invention, the generation of a negative transmembrane pressure across the semi-permeable membrane occurs in some embodiments with the venous tube clamp fully or partially closed. In some embodiments, the method comprises, as a further step, opening the venous tube clamp when a negative transmembrane pressure has already been generated or is present, while maintaining a negative transmembrane pressure. Due to the negative transmembrane pressure, a (transmembrane) plasma water transfer takes place across the semi-permeable membrane, and the blood in the dialyzer is hemoconcentrated. In this process, the fluid volume pumped into the hydraulic system or shifted from the extracorporeal blood circuit across the semi-permeable membrane to the hydraulic side due to the pressure difference is replaced by blood.which is caused to flow counter to (herein also: retrograde) its usual flow direction within the bloodstream via the venous part of the tubing system from the latter and from the patient's vascular system by hemoconcentration and negative pressure. The air bubbles or air inclusions (e.g., gas and microbubbles) in the line are transported retrograde back into the venous air separation chamber and separated there, usually into the environment. In some embodiments, the venous tubing clamp is opened when a pressure sensor of the blood treatment device detects that a negative minimum transmembrane pressure has been reached. In some embodiments, a negative transmembrane pressure is generated by the pump on the hydraulic side of the blood treatment device.while an optional substitution pump of the blood treatment device is stopped or not delivering. In some embodiments, the generation or maintenance of the negative transmembrane pressure by means of the control or regulating device is terminated as soon as a negative transmembrane pressure of approximately -300 mmHg to -500 mmHg is reached, or when a volume of at least 20 ml to 60 ml of blood has been delivered past the air bubble detector toward the venous air separation chamber by means of the generated transmembrane pressure. In some embodiments, the delivery by means of the pump on the hydraulic side of the blood treatment device for generating a negative transmembrane pressure is terminated,after the air bubble detector no longer detects any air bubbles or air inclusions and / or the air bubble alarm is no longer present and / or at least 20 ml to 60 ml of blood have been pumped retrogradely. In some embodiments of the blood treatment device, the control or regulating device is programmed to initiate some or all of the method steps disclosed herein in any combination, at least in a temporally overlapping manner. In some embodiments, the pump for pumping dialysis fluid and / or dialysate is an optionally provided ultrafiltration pump, by means of which, for example, a negative transmembrane pressure can be generated.which in turn can cause a reverse flow of blood in the extracorporeal blood circuit. In some embodiments, the blood treatment device according to the invention is connected to an extracorporeal blood circuit and a blood filter or dialyzer with a semi-permeable membrane. In some embodiments, the extracorporeal blood circuit is a blood tubing set and / or a blood cassette, or comprises a blood tubing set and / or a blood cassette. In some embodiments, the blood treatment device is configured as a hemodialysis device, hemofiltration device, hemodiafiltration device, or as a device for performing a separation process. In some embodiments, the method initiated by the control or regulating device comprises determining whether the generated negative transmembrane pressure or its magnitude is within predetermined limits, exceeds or falls below a limit value,exceeds a minimum value and / or does not exceed a maximum value. This can be done based on at least one criterion (limit value, range, maximum value, etc.), which can be stored, for example, in a memory device, such as the blood treatment device. In some embodiments, the method initiated by the control or regulating device comprises only issuing or emitting an acoustic and / or optical or other signal-based air bubble alarm if, during or after the procedure, a condition still exists or recurs that would have already led to an air bubble alarm for the responsible person and / or the blood treatment device before the start of the procedure. Thus, it can be provided that the user is only visually and / or acoustically notified of the presence of an air bubble alarm and / or that the blood treatment is only automatically interrupted ifif, after detecting air bubbles, the removal of the detected air by means of the method carried out according to the invention by the blood treatment device was not successful. In some embodiments, the further pump is a positive displacement pump, in particular a diaphragm pump, eccentric diaphragm pump, peristaltic pump, roller pump, or piston pump. When a signal or communication connection between two components is mentioned herein, this can be understood to mean a connection existing in use. In some embodiments, the method disclosed herein, which is initiated by the control or regulating device, can comprise, as a further optional step, the initiation of a vibration, movement, oscillation, or the like. This step will preferably take place simultaneously or overlapping with other method steps as described herein. Initiating a vibration, movement,Oscillation or the like can be a method step in all embodiments of the disclosed method. In some embodiments, the blood treatment device does not have a drive device that is arranged and / or controlled to cause rotation, shaking, or vibration of the dialyzer or blood filter. The control or regulating device can preferably not be configured to cause such rotation (e.g., about a longitudinal axis or about a transverse axis), shaking, or vibration. By means of some embodiments of the invention, one or more of the advantages mentioned herein can be achieved, including the following: By means of the solution according to the invention, a procedure requiring considerable effort on the part of the user in the event of an air bubble alarm can be advantageously avoided. In the conventional case, this would require the patient's venous connection.This involves a hygienically critical loosening of a tube connection of at least one tube segment filled with whole blood, and then connecting the venous tube system, for example, to a saline bag, in order to pump the blood volume of the venous line, in which the detected air bubbles or air inclusions are present, into the saline bag at a low flow rate. If the user recognizes in this conventional method that the line is now free of gas, they reconnect the venous line to the patient and continue the treatment. Thus, by means of the present invention, both the treatment can be simplified and patient safety can be further increased. A further advantage of the present invention can be that the patient does not experience any blood loss by discarding whole blood, e.g., into the aforementioned saline bag, when using the inventive procedure.This also contributes advantageously to the patient's well-being and patient safety. By means of the present invention, a completely automated and hygienically perfect method for treating air bubble alarms in the venous line with induced separation of microbubbles can be carried out. This can advantageously help to reduce personnel expenditure and increase patient safety. Air that is located within the disposable and is to be removed can be more easily released from the inner wall of the disposable due to the vibration to which the bloodstream is subjected. If the contents of the disposable are additionally placed under negative pressure, the volume of the air bubbles increases, which further facilitates their removal. It has also been shownthat the applied vibration particularly advantageously contributes to this and promotes the effective detachment of air bubbles and / or inclusions. This contributes significantly to patient safety. The invention is described below using preferred embodiments thereof with reference to the attached drawing. The blood treatment device according to the invention is described using the example of a hemodialysis device, but it can also be used in the same way in other blood treatment devices, for example a hemodiafiltration device. In the figures: Fig. 1 shows a simplified schematic view of a fluid line structure of a blood treatment device according to the invention in a first embodiment; Fig. 2 shows a simplified schematic view of part of the blood treatment device of Fig. 1 during the method disclosed herein,which can be carried out by means of the control or regulating device of a blood treatment device according to the invention; Fig. 3 shows a schematically simplified part of a blood treatment device according to the invention in a first embodiment; Fig. 4 shows a schematically simplified part of a blood treatment device according to the invention in a second embodiment; Fig. 5 shows a schematically simplified part of a blood treatment device according to the invention in a third embodiment; and Fig. 6 shows a schematically simplified sequence of the method which can be carried out by means of the control or regulating device of a blood treatment device according to the invention. Fig. 1 shows a schematically simplified fluid line structure of a blood treatment device 100 according to the invention in a first embodiment. The blood treatment device 100 is connected to an extracorporeal blood circuit 300,which can be connected to the vascular system of the patient (not shown) for treatment by means of double-needle access (see, for example, Fig. 5), or using, for example, an additional Y-connector (reference symbol Y) as shown, for example, in Fig. 1, by means of single-needle access. The blood circuit 300 can optionally be present in sections thereof in or on a blood cassette. Pumps, actuators, and / or valves in the region of the blood circuit 300 are connected to the blood treatment device 100 according to the invention or to a control or regulating device 150 comprised therein, for example. The blood circuit 300 has an arterial tube clamp or patient tube clamp 302 as the first tube clamp and an arterial connection needle of an arterial section or an arterial patient line, an arterial line section,a blood withdrawal line or first line 301 (or is connected thereto). The blood circuit 300 further comprises a venous tube clamp or patient tube clamp 306 as a second tube clamp and a venous connection needle of a venous section, a venous patient line, a venous line section, a blood return line, or second line 305 (or is connected thereto). A blood pump 101 is provided in or on the first line 301; a substituate pump 111 for conveying substituate is arranged on a substituate line 105, which can be fluidically connected to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered in a further filter stage F2. By means of the substituate pump 111, substituate can be delivered by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a into line sections,For example, they can be introduced into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber 329 of the blood circuit 300). The blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305. A dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a, which conducts dialysate, i.e., used dialysis fluid. For this purpose, suitable connectors are used on the dialysis fluid supply line 104 or on the dialysate drain line 102 on the one hand and on the dialysate ports on the other hand, which, in particular detachably,can be connected to each other. Dialysis fluid chamber 303a and blood chamber 303b are separated from each other by a mostly semi-permeable membrane 303c. This represents the dividing wall between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis fluid or dialysate circuit, which is shown in Fig. 1 to the left of the membrane 303c. The arrangement of Fig. 1 comprises an air bubble detector 315 for detecting air and / or blood, preferably in the venous line section 305, e.g., at the location shown. The arrangement of Fig. 1 optionally further comprises one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 ("pre-hemofilter")) at the locations shown in Fig. 1. Additional pressure sensors can be provided,e.g., the pressure sensor PS3 downstream of the venous air separation chamber 329. An optional single-needle chamber 317 is used in Fig. 1 as a buffer and / or compensation container in a single-needle procedure, in which the patient is connected to the extracorporeal blood circuit 300 via only one of the two blood lines 301, 305. The arrangement of Fig. 1 also includes an optional detector 319 for detecting air bubbles and / or blood. A heparin addition point 325 can optionally be provided. On the left in Fig. 1, an optional mixing device 163 is shown, which provides a predetermined mixture for the respective solution for use by the blood treatment device 100 from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168). The solution contains water from the water source 155 (online, e.g. as reverse osmosis water or from bags),which is heated, for example, in the heating device 162. A pump 171, which can be referred to as a concentrate pump or sodium pump, can be fluidly connected to the mixing device 163 and a source of sodium, such as container A, and / or, if provided, pumps from there. An optional pump 173, which is assigned to container B, for example for bicarbonate, can be seen. Furthermore, an outlet 153 for the effluent can be seen in Fig. 1. An optional heat exchanger 157 and a first flow pump 159, which is suitable for degassing, complement the arrangement shown. The optional pressure sensor PS4 downstream of the blood filter 303 on the water side, but preferably upstream of an ultrafiltration pump 131, for example a pump for conveying dialysis fluid and / or dialysate, in the dialysate drain line 102, can be provided for measuring the filtrate pressure or membrane pressure of the blood filter 303. Blood leaving the blood filter 303flows through a venous air separation chamber 329, which may have a venting device 318 and be in fluid communication with the pressure sensor PS3. The exemplary arrangement shown in Fig. 1 comprises the control or regulating device 150. It can be connected to any of the components mentioned herein—in any case or in particular to the blood pump 101—by means of a wired or wireless signal connection for controlling or regulating the blood treatment device 100. By means of the optional device for online mixing of the dialysis fluid, a variation of its sodium content, controlled by the control or regulating device 150, is possible within certain limits. For this purpose, the measured values ​​determined by means of conductivity sensors 163a, 163b can be incorporated. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substituate prove necessary or desired,This can be done by adjusting the flow rate of the sodium pump 171. Furthermore, the blood treatment device 100 comprises means for conveying fresh dialysis fluid and dialysate on the so-called hydraulic side of the blood treatment device 100. A first valve can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303. A second, optional flow pump 169 is provided, for example, downstream of the blood filter 303, which conveys dialysate to the outlet 153. A second valve can be provided between the blood filter 303 and the second flow pump 169.which opens or closes the outlet on the outlet side. Furthermore, the blood treatment device 100 optionally comprises a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side. The balancing device 161 is preferably arranged in a line region between the first flow pump 159 and the second flow pump 169. The blood treatment device 100 further comprises means for precisely removing a fluid volume specified by the user and / or by the control or regulating device 150 from the balanced circuit, such as the ultrafiltration pump 131. Sensors such as the optional conductivity sensors 163a, 163b serve to determine the conductivity, which in some embodiments is temperature-compensated, as well as the fluid flow upstream and downstream of the dialyzer 303. Temperature sensors 165a,165b can be provided individually or in groups. Temperature values ​​supplied by them can be used according to the invention to determine a temperature-compensated conductivity. An optional compressed air source 175, for example in the form of a compressor, can be provided on the machine side upstream of the blood filter 303. A leakage sensor 167 is optionally provided. Alternatively, it can also be provided at a different location. Additional flow pumps, in addition to or alternatively to, for example, those with the reference numeral 169, can also be provided. A series of optional valves is each designated V in Fig. 1. Bypass valves are designated VB. Based on the measured values ​​of the aforementioned optional sensors, in some embodiments the control or regulating device 150 determines the electrolyte and / or fluid balance. Filters F1 and F2 can be provided in series. Filter F1 serves here as an exampleby means of the mixing device 163, even using non-pure water, to produce sufficiently pure dialysis fluid, which then flows, e.g., using the countercurrent principle, through the blood filter 303. The filter F2 serves here as an example to generate sterile or sufficiently filtered substituate from the sufficiently pure dialysis fluid leaving the first filter F1 by filtering out, for example, pyrogenic substances. This substituate can be safely added to the patient's extracorporeal blood and thus ultimately to the patient's body. The blood treatment device 100 shown in Fig. 1 can be a hemofiltration device, a hemodiafiltration device, or a hemodialysis device. The present invention is not limited to the embodiment described above.This is for illustrative purposes only. The arrows and arrowheads shown in Fig. 1 generally indicate the flow direction in Fig. 1 and Fig. 2, respectively. The arterial line section 301 and the venous line section 305 can be part of a blood tubing set or form this. Fig. 2 shows a simplified schematic view of a part of the blood treatment device 100 according to the invention in Fig. 1, namely the part to the right of the dashed line A, during the execution of the method disclosed herein. To avoid repetition, reference is made to the description of Fig. 1. The method, which is described in more detail in Fig. 6, leads to the flow reversal in the venous line section 305, as indicated by the reverse direction of the arrows and arrowheads compared to Fig. 1.to prevent or significantly reduce the flow between the venous tube clamp 306 and the patient and to prevent fluid from passing from the blood chamber 303b into the dialysis fluid chamber 303a, as also indicated by arrows. Fig. 3 shows a simplified schematic of part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in the embodiment of Figs. 1 and 2. To the left and right of the venous air separation chamber 329, a chamber holder can be seen, which can hold the venous air separation chamber 329 securely in its position during use, for example, on a blood cassette. In this embodiment, this chamber holder serves as an example of an oscillation device 330 in that it is itself displaced, vibrated, or moved, for example, by means of an optionally integrated actuator, i.e., has a stroke. This actuator can, for example, be actuated by means of a vibration motor,Sound transducers (e.g., generated using piezoceramics or similar sound-generating materials) and / or electroactive polymers. The chamber holder, thus set into vibration, transmits this vibration to the venous air separation chamber 329, or rather its contents. Fig. 4 shows a simplified schematic of part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in a second embodiment. It largely corresponds to Fig. 3; therefore, only the differences will be discussed here to avoid repetition. The venous air separation chamber 329 is more cylindrical in shape. At its outlet (bottom in Fig. 4), a sieve-shaped clot catcher 329a is shown. Air that was conveyed downstream to the patient via the clot catcher 329a only rises back up through the patient with difficulty. If the venous air separation chamber 329,If the clot catcher 329a or the fluid contained therein is set in motion, for example, by oscillation, the air can be more easily moved back through the mesh of the clot catcher 329a into the venous air separation chamber 329 and there separated by means of the venting device 318, for example, to the atmosphere. The venous air separation chamber 329 is held in this embodiment by a, for example, fork-shaped holder, which can hold the venous air separation chamber 329 securely in its position during use, for example, on a blood cassette. This fork-shaped holder corresponds in this embodiment as an example to an oscillation device 330. It can easily be set in motion / oscillation itself, for example, by means of or analogously to the actuator system already described in Fig. 3. The "fork" thus set in vibration transmits the vibration to the venous air separation chamber 329.in particular to the clot catcher 329a, or its contents. Fig. 5 shows a schematically simplified part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in a third embodiment. It largely corresponds to Fig. 3 and Fig. 4, respectively; therefore, only differences will be discussed here to avoid repetition. In contrast to Figs. 3 and 4, in the example of Fig. 5, the extracorporeal blood circuit 300 is connected to the vascular system of the patient (not shown) for treatment by means of double-needle access. Furthermore, in this embodiment, the oscillation device 330 is the venous tube clamp 306 or comprises it. The control or regulating device 150 is programmed in this embodiment to control the venous tube clamp 306 in such a way thatthat it is automatically opened and closed again or otherwise actuated several times within a minute or second. This opening and closing can generate sufficient oscillation, vibration, or movement to release detected air bubbles or inclusions or to assist such a process. Fig. 6 shows a simplified schematic of the process sequence, which can be carried out by means of the control or regulating device 150 of a blood treatment device 100 according to the invention. In the description of the method, reference numerals from Figs. 1 to 4 are used. The blood treatment device 100, which is to be controlled by means of the method, has a blood pump 101,an air bubble detector 315 and a pump for conveying dialysis fluid and / or dialysate on the hydraulic side of the blood treatment device 100 (see Fig. 1 and Fig. 2). The method is intended to be carried out during an extracorporeal blood treatment session, i.e., intradialytically. During this session, the blood treatment device 100 is connected to an extracorporeal blood circuit 300 and to a blood filter 303. The blood filter 303, in turn, has a semi-permeable membrane 303c. Here, method step M1 comprises detecting air bubbles or air inclusions in the extracorporeal blood circuit 300, or an air bubble alarm. The detection of air bubbles or air inclusions in the extracorporeal blood circuit 300 can be carried out by means of the air bubble detector 315. The air bubble detector 315 can alternatively or additionally be suitable or configured to, as a result of the detection of gas,Air or air bubbles trigger an air bubble alarm (alternatively: gas alarm), which in turn leads to the initiation or implementation of the method according to the invention. If a gas alarm occurs, the blood treatment can be stopped or suspended until the air has been removed from the extracorporeal blood circuit 300. Thus, if air bubbles or air inclusions have been detected in the extracorporeal blood circuit 300 or if an air bubble alarm is present, the control or regulating device 150 causes the blood pump 101 to stop or reduce its delivery rate immediately prior to the detection of the air bubbles, represented here as method step M2. The optional method step M3 represents a complete or partial closure of the venous tube clamp 306. Furthermore, represented here by method step M4,a negative transmembrane pressure is generated across the semi-permeable membrane 303c of the blood filter. This negative transmembrane pressure can be achieved by appropriately controlling the pump, here, for example, the ultrafiltration pump 131, to pump dialysis fluid and / or dialysate on the hydraulic side, while the blood pump 101 is stopped or its pumping capacity is reduced. Method step M5 represents opening the venous tube clamp 306 when a negative transmembrane pressure has already been generated while maintaining a negative transmembrane pressure or at a negative transmembrane pressure. In some embodiments, the venous tube clamp 306 is opened when a negative minimum transmembrane pressure has been detected.For example, by means of at least one pressure sensor PS4 of the blood treatment device 100. In some embodiments, the pressure sensor PS3 (venous sensor) or the pressure sensor PS2 are used to evaluate the pressure situation. In these, as well as in any other embodiments, the determined pressures can be monitored to detect a pressure drop and open the venous tube clamp 306 accordingly. Experience has shown that the operating pressure during treatment for PS3 is usually around 320 mmHg,for PS2 is approximately 300 mmHg. Due to the negative transmembrane pressure, a (transmembrane) plasma water transfer occurs across the membrane 303c, and the blood is hemoconcentrated in the dialyzer. The volume pumped into the hydraulic system is replaced by the blood flowing from the patient via the venous tubing system, counter to the usual flow direction. The air bubbles or air inclusions (gas and microbubbles) in the line are conveyed back into the venous air separation chamber 329 and separated there, for example, into the environment. In certain embodiments, a negative transmembrane pressure is generated by the pump, while an optional substituate pump 111 of the blood treatment device 100 is stopped or not pumping. Method step M6 represents the termination of the generation or maintenance of the negative transmembrane pressure as soon as a predetermined negative transmembrane pressure,which, for example, lies in the range between -300 mmHg and -500 mmHg, or by means of the generated transmembrane pressure, or due to this, a volume of at least 30 to 60 ml of blood has been pumped toward an arterial needle or a venous air separation chamber 329. Alternatively, in a method step M7, the pumping by means of the pump to generate a negative transmembrane pressure is terminated after the air bubble detector 315 no longer detects any air bubbles or air inclusions and / or an air bubble alarm is no longer present. Simultaneously or overlapping with one, several, or all of the method steps M2 to M7, the control or regulating device 150 of the blood treatment device 100 can cause the oscillation device 330 to oscillate the extracorporeal blood circuit 300 or at least a portion thereof, or the contents or a portion of the contents of the blood circuit or portion,to vibrate or move in a similar manner. This is illustrated in Fig. 6 by method step MV. The invention also encompasses initiating the above vibrations without performing method steps M2 to M7. Alternatively, upon detection of air bubbles or air inclusions or upon the presence of an air bubble alarm, in certain embodiments, the control or regulating device 150 causes the pumping direction of the blood pump to be reversed, i.e., to pump it backwards. This is illustrated in Fig. 6 as method step M8. In this embodiment—as optionally in any other embodiment—reverse pumping could alternatively or additionally be achieved by generating a negative transmembrane pressure, for example, by suitable control of balancing chamber circuits, wherein the balancing chambers are usually designed as diaphragm pumps. Simultaneously, alternatively, or overlapping with this alternative, i.e., method step M8,the control or regulating device 150 can also initiate the method step MV and cause the extracorporeal blood circuit 300 or sections thereof to oscillate, move or vibrate, as described above. List of reference symbols 100 Blood treatment device 101 Blood pump 102 Dialysate drain line 104 Dialysis fluid inlet line 105 Substituate line 107 Pre-dilution valve 107a Line belonging to the pre-dilution valve 109 Post-dilution valve 109a Line belonging to the post-dilution valve 111 Substituate pump 131 Ultrafiltration pump 150 Control device 153 Drain 155 Water source 157 Heat exchanger 159 First flow pump 161 Balancing device 162 Heating device 163 Mixing device 163a Conductivity sensor 163b Conductivity sensor 165a Temperature sensor 165b Temperature sensor 166 Concentrate supply 167 Leakage sensor 168 Concentrate supply 169 Second flow pump 171 Pump, sodium pump 173 Pump,Bicarbonate pump 175 Compressed air source; compressor 300 Extracorporeal blood circuit 301 First line (arterial line section) 302 (first) tube clamp; arterial tube clamp 303 Blood filter or dialyzer 303a Dialysis fluid chamber 303b Blood chamber 303c Semi-permeable membrane 305 Second line (venous line section) 306 (second) tube clamp; Venous tube clamp 315 Air bubble detector 317 Single-needle chamber 318 Venting device 319 Detector 325 Heparin addition point 329 Venous air separation chamber 329a Clot catcher 330 Oscillating device F1 Filter F2 Filter A Container B Container PS1 Arterial pressure sensor (optional) PS2 Arterial pressure sensor (optional) PS3 Pressure sensor (optional) PS4 Pressure sensor for measuring the filtrate pressure (optional) M1 to M8 Process steps MV Process step V Valves VB Bypass valves Y Y-connector,

Claims

Claims 1. A blood treatment device (100) comprising or connected with at least: - a blood pump (101) for pumping blood through an extracorporeal blood circuit (300) during a blood treatment session, during which the blood treatment device (100) is connected to the extracorporeal blood circuit (300) and to a blood filter (303) having a semi-permeable membrane (303c); - an air bubble detector (315) for detecting air bubbles within the extracorporeal blood circuit (300); - a pump for conveying dialysis fluid and / or dialysate; - a vibrating device (330) for vibrating the extracorporeal blood circuit (300), a section thereof, or its contents; and - a control or regulating device (150) for controlling the blood pump (101), the pump for conveying dialysis fluid and / or dialysate, and the vibrating device (330). 2.Blood treatment device (100) according to claim 1, wherein the oscillating device (330) is located in or on the extracorporeal.

3. Blood treatment device (100) according to claim 1 or 2, wherein the oscillating device (330) is or comprises a venous tube clamp (306), and wherein the control device (150) is programmed to act on the venous tube clamp (306) such that it is automatically opened and closed or otherwise actuated multiple times within one minute or second.

4. Blood treatment device (100) according to any one of the preceding claims, wherein the oscillating device (330) is or comprises a holding device for releasably holding at least one section of the extracorporeal blood circuit (300). 5.Blood treatment device (100) according to any one of the preceding claims, wherein the control device (150) is configured to modulate or cause the frequency of the vibrations generated by the oscillating device (330).

6. Blood treatment device (100) according to any one of the preceding claims, wherein the control device (150) is programmed to execute a method for controlling a blood treatment device (100) during an extracorporeal blood treatment session. wherein the method comprises the following steps, performed after detection of air bubbles in the extracorporeal blood circuit (300) or after an air bubble alarm detected or triggered by the air bubble detector (315): either - stopping the blood pump (101) or reducing its pumping rate immediately prior to the detection of air bubbles; and - generating a negative transmembrane pressure across the semipermeable membrane (303c) by appropriately controlling the dialysis fluid pump while the blood pump (101) is stopped or its pumping rate is reduced; or - reversing the pumping direction of the blood pump (101).

7. Blood treatment device (100) according to claim 6, wherein the generation of a negative transmembrane pressure across the semipermeable membrane (303c) is performed with the venous hose clamp (306) fully or partially closed. 8.Blood treatment device (100) according to claim 7, wherein the control or regulating device (150) further comprises. is programmed to execute or initiate the step of: - Opening the venous hose clamp (306) when a negative transmembrane pressure has already been generated, while maintaining a negative transmembrane pressure.

9. Blood treatment device (100) according to claim 8, wherein the venous hose clamp (306) is opened when a pressure sensor (PS4) of the blood treatment device (100) detects that a minimum negative transmembrane pressure has been reached.

10. Blood treatment device (100) according to any one of claims 6 to 9, wherein a negative transmembrane pressure is generated by the pump while an optional substitution pump (111) of the blood treatment device (100) is stopped or not pumping. 11.Blood treatment device (100) according to one of claims 6 to 10, wherein: - the generation or maintenance of the negative transmembrane pressure is terminated as soon as a predetermined negative transmembrane pressure, for example between -300 mmHg and -500 mmHg, is reached or a volume of at least 30 to 60 ml or more of blood has been conveyed towards an arterial connection needle or a venous air separation chamber (329) by means of or due to the generated transmembrane pressure.

12. Blood treatment device (100) according to any one of claims 6 to 11, wherein the pumping to generate a negative transmembrane pressure is terminated after the air bubble detector (315) no longer detects air bubbles or air inclusions and / or no air bubble alarm or the predetermined criteria for this are present.

13. Blood treatment device (100) according to any one of claims 6 to 12, wherein the control device (150) is programmed to initiate some or all of the process steps disclosed in the preceding claims in any combination, at least with temporal overlap.

14. Blood treatment device (100) according to any one of claims 6 to 13, wherein the pump for pumping dialysis fluid and / or dialysate is an ultrafiltration pump (131). 15.Blood treatment device (100) according to any one of the preceding claims, connected to an extracorporeal blood circuit (300) and a blood filter (303) with a semi-permeable membrane (303c).

16. Blood treatment device (100) according to claim 15, wherein the extracorporeal blood circuit (300) is a.

17. Blood treatment device (100) according to any of the preceding claims, configured as a hemodialysis device, hemofiltration device, hemodiafiltration device or as a device for carrying out a separation process.