Method of priming an extracorporeal blood circuit of a device for extracorporeal treatment of blood and device for extracorporeal treatment of blood

Abstract

A method of priming an extracorporeal blood circuit of a device for extracorporeal treatment of blood, comprising: feeding a priming fluid into the extracorporeal blood circuit and into a blood side of a membrane gas exchanger (18); generating one or more transient pressurization steps in the priming fluid flowing in the blood circuit and in the blood side of the membrane gas exchanger (18).

Description

Technical Field

[0001] The present invention relates to a method for perfusing an extracorporeal blood circuit for an extracorporeal treatment of blood and an apparatus for extracorporeal treatment of blood configured to perform this method, and particularly to an apparatus provided with a membrane gas exchanger for the purpose of oxygenation and / or carbon dioxide (CO2) removal. Background Technology

[0002] In the field of extracorporeal blood processing and therapy, membrane gas exchangers are used for extracorporeal membrane oxygenation (ECMO) and / or extracorporeal CO2 removal (ECCO2R). Although initially used in dedicated systems, recent advancements in extracorporeal CO2 removal have led to the introduction of membrane gas exchangers into dialysis systems used for continuous renal replacement therapy (CRRT). CRRT systems can provide ECCO2R therapy (ECCO2R on its own), as well as combinations of CRRT and ECCO2R or other therapies (e.g., liver support and ECCO2R) within the same blood circuit.

[0003] In hemodialysis, the patient's blood and a near-isotonic treatment fluid circulate within the corresponding compartments of the hemodialysis machine. This allows impurities and unwanted substances present in the blood (urea, creatinine, etc.) to migrate from the blood into the treatment fluid via diffusion transfer. The ion concentration of the treatment fluid is selected to correct for the ion concentration in the patient's blood. In the process of hemodialysis filtration, convective transfer through ultrafiltration, generated by the positive pressure difference established between the blood side and the treatment fluid side of the hemodialysis filter membrane, is added to the diffusion transfer obtained through dialysis.

[0004] Before performing extracorporeal blood treatment, the extracorporeal blood circuit of the device is perfused by allowing a perfusion solution (e.g., physiological saline) to flow through the blood lines. The purpose of perfusing the extracorporeal blood circuit is to remove air from the blood lines, membrane gas exchanger, and dialyzer before connecting to the patient, and to remove any remaining disinfectant or other residues from disposable components.

[0005] Due to their membrane properties, membrane gas exchangers require specific precautions during and after perfusion to prevent air from entering through the membrane and forming bubbles during subsequent blood processing.

[0006] For example, it is known to position the gas exchanger device below the end of the return line during perfusion and below the patient during treatment to maintain the circuit pressure above atmospheric pressure.

[0007] Thus, the membrane gas exchanger cannot be positioned freely, and the low position of the gas exchanger is inconvenient for users who have to bend over to set the gas exchanger on its support and cannot see it when working on the device's user interface.

[0008] Document US2006167400A1 describes a blood perfusion system for cardiopulmonary bypass surgery. The system includes a combined oxygenator and heat exchanger. The oxygenator has an oxygenator vent line from the oxygenator to a venous reservoir. The vent line passes through an vent valve that automatically opens during perfusion to remove air from the oxygenator. The document discloses that leaks in the oxygenator membrane can be detected using a liquid leak detector by pressurizing the perfusion solution from the bag within the oxygenator to a predetermined value, as fluid at the predetermined pressure will pass through a leaking oxygenator membrane.

[0009] Document EP1372759B1 describes a system for preparing and delivering gas-enriched blood. In perfusion mode, the system fills a fluid supply chamber with a physiological solution and drives a piston assembly to pressurize the solution and transfer it into a nebulizer chamber until an appropriate fluid level is reached. The system includes a bubble detector that interfaces with a bubble sensor to monitor for bubbles in the oxygenated blood in the return tube.

[0010] Document WO2017190718A1 describes an oxygenator circuit (including an oxygenator and a blood pump) equipped with an exhaust device assembly, which includes an infusion fluid container, an infusion compressor, and an exhaust unit. The circuit is filled with infusion fluid from the infusion fluid container, and the oxygenator has been vented. A sensor checks whether it detects air bubbles in the infusion circuit. If air bubbles are detected, the blood pump operates in a pulsating mode to deliver residual air to the oxygenator, from which the residual air can escape.

[0011] The aforementioned prior art does not prevent the formation of air bubbles during and after perfusion, but rather removes air from the oxygenator or blood tubing via venting equipment and / or bubble sensors. Therefore, the object of the present invention is to provide a method for perfusing an extracorporeal blood circuit and an apparatus for extracorporeal blood processing configured to reliably prevent the formation of air bubbles in the blood circuit due to the presence of a membrane gas exchanger.

[0012] Specifically, the aim is to prevent the formation of air bubbles due to the presence of the membrane gas exchanger, at least during perfusion and possibly after perfusion, during patient treatment.

[0013] Furthermore, the objective is to provide methods and apparatus for preventing bubble formation without any additional or special components / equipment. Another auxiliary objective is to provide methods and apparatus that allow for free and optional user-friendly positioning of membrane gas exchangers. Other auxiliary objectives are to provide infusion methods that can be fully automated and may require no user intervention. Summary of the Invention

[0014] At least one of the above objectives is achieved substantially by a method for perfusing an extracorporeal blood circuit of an apparatus for extracorporeal blood processing according to one or more of the appended claims, and an apparatus for extracorporeal blood processing. Apparatus and methods according to various aspects of the invention and capable of achieving one or more of the above objectives are described below.

[0015] The first aspect relates to a method for perfusing an extracorporeal blood circuit of an apparatus for extracorporeal blood processing, wherein the apparatus for extracorporeal blood processing comprises:

[0016] • Optionally, a blood processing unit;

[0017] • An external blood circuit, optionally coupled to the blood processing unit;

[0018] • Blood pump, configured as a pump tubing segment coupled to an external blood circuit;

[0019] A membrane gas exchanger operatively coupled to an extracorporeal blood circuit to exchange gases with blood flowing in the extracorporeal blood circuit, wherein the membrane gas exchanger includes: a blood side in fluid communication with the blood circuit; and a gas side;

[0020] The method includes:

[0021] - Feed the perfusion fluid into the extracorporeal blood circuit and into the blood side of the membrane gas exchanger;

[0022] - A momentary pressurization step is generated in the perfusion fluid flowing in the blood circuit and on the blood side of the membrane gas exchanger to prevent air bubbles from being released at the blood outlet of the membrane gas exchanger.

[0023] The effect of the pressurization step (i.e., preventing the release of bubbles at the blood outlet of the membrane gas exchanger) is likely due to reduced gas transfer caused by forcing some fluid into the hydrophobic pores of the membrane, and by the removal of microbubbles that accumulate at the membrane wall before they coalesce into larger bubbles. A later description will show that this effect can be studied in a reproducible manner.

[0024] In the second aspect of the first aspect, the method includes: repeating the instantaneous pressurization step during perfusion.

[0025] In a third aspect according to any of the foregoing aspects, the method includes: repeating the instantaneous pressurization step at certain time intervals during infusion.

[0026] In the fourth aspect of the foregoing, the time interval is a periodic interval.

[0027] In the fifth aspect according to any of the third or fourth aspects mentioned above, each time interval is between 10 and 100 seconds (s), optionally between 20 and 80 seconds, optionally between 40 and 60 seconds.

[0028] In the sixth aspect according to any of the foregoing aspects, the duration of the pressurization step or one or more pressurization steps or each pressurization step is fixed, or is a function of the pressure measured in the blood circuit, optionally, the measured pressure is measured downstream of the blood pump.

[0029] In the seventh aspect according to the foregoing, the measured pressure is the measured return pressure and / or processing unit pressure and / or effluent pressure or its average pressure.

[0030] In the eighth aspect according to the sixth or seventh aspect, the time length is between 2 and 30 seconds, and optionally between 5 and 10 seconds.

[0031] In the ninth aspect according to any of the foregoing aspects, the maximum pressure at the membrane gas exchanger during one or more pressurization steps is between 100 mmHg and 1000 mmHg, optionally between 400 mmHg and 600 mmHg.

[0032] In the tenth aspect according to any of the foregoing aspects, no gas flows through the gas side of the membrane gas exchanger during the infusion period.

[0033] In the eleventh aspect according to any of the foregoing aspects, the instantaneous pressurization step includes: instantaneously restricting a portion of the blood circuit positioned downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid. The instantaneous pressurization step is a pressure increase relative to the pressure regimen preceding the pressurization step.

[0034] In the twelfth aspect according to any one of the first to tenth aspects, the step of generating instantaneous pressurization includes: instantaneously occluding a portion of the blood circuit downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid.

[0035] In the thirteenth aspect according to any of the eleventh or twelfth aspects mentioned above, the step of generating instantaneous pressurization includes: maintaining the blood pump in operation while instantaneously restricting or blocking said portion of the blood circuit.

[0036] In the fourteenth aspect according to any of the eleventh, twelfth or thirteenth aspects mentioned above, the portion that momentarily restricts or blocks the blood circuit includes: at least partially closing (optionally, repeatedly closing) a clamp or valve disposed on the blood circuit and downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid; optionally, closing a return clamp disposed corresponding to the patient blood return passage; particularly, acting on a return clamp on the blood return line downstream of the degassing chamber and / or downstream of the blood warmer.

[0037] In the fifteenth aspect according to any of the foregoing aspects, an instantaneous pressurization step is generated by a transfer pump coupled to or configured to be coupled to the transfer line and a pump section thereof. When an increase in pressure is required, the transfer pump begins to pump fluid and pumps fluid for at least the duration of the pressurization step.

[0038] In the sixteenth aspect according to any of the foregoing aspects, the apparatus for extracorporeal processing of blood includes an infusion line provided with an infusion pump; wherein the step of generating instantaneous pressurization includes:

[0039] Connect the infusion tubing to the perfusion fluid source;

[0040] - Activate the infusion pump.

[0041] In the seventeenth aspect according to the foregoing, the infusion line is connected to the blood circuit between the blood pump and the return clamp (optionally between the blood pump and the membrane gas exchanger, or alternatively between the membrane gas exchanger and the return clamp).

[0042] In the eighteenth aspect according to the foregoing, when the infusion pump is activated, the blood pump is stopped and / or the return clamp or valve located on the blood circuit and downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid is closed.

[0043] In the nineteenth aspect according to any of the foregoing aspects, the instantaneous pressurization step is initiated by a degassing chamber disposed on the blood circuit (optionally between the blood pump and the return clip) and an air pump connected to the degassing chamber; and / or wherein the instantaneous pressurization step is initiated by a pressure pod disposed on the blood circuit and an air pump connected to the pressure pod.

[0044] In the twentieth aspect according to any of the foregoing aspects, the apparatus for extracorporeal treatment of blood includes: at least one pressure chamber disposed on the blood circuit; and at least one air pump connected to the gas chamber of the pressure chamber, the gas chamber of the pressure chamber being separated from the blood chamber of the pressure chamber by a flexible membrane; wherein the step of generating instantaneous pressurization includes: activating the air pump to generate a pressure pulse in the gas chamber of the pressure chamber.

[0045] In the twenty-first aspect according to any of the foregoing aspects, once the perfusion fluid fills the blood side of the membrane gas exchanger, a first instantaneous pressurization step is generated in the perfusion fluid.

[0046] In the twenty-second aspect according to any of the foregoing aspects, the apparatus for extracorporeal treatment of blood includes a degassing chamber disposed on the blood circuit and downstream of a membrane gas exchanger relative to the flow direction of the perfusion fluid and the flow direction of the blood during treatment; wherein a first instantaneous pressurization step is generated in the perfusion fluid when the perfusion fluid reaches the degassing chamber.

[0047] In the twenty-third aspect according to any of the foregoing aspects, at the end of perfusion and before patient connection, the pressure in the blood circuit and in the blood side of the membrane gas exchanger is maintained between 20 mmHg and 400 mmHg, optionally between 50 mmHg and 100 mmHg.

[0048] In the twenty-fourth aspect according to any of the foregoing aspects, at the end of perfusion and before patient connection, the blood pump is stopped, and the return clamp or valve located on the blood return line and downstream of the membrane gas exchanger remains closed. The blood circuit section between the blood pump and the return clamp is substantially isolated, preventing air from entering the blood circuit section, and the pressure scheme within the blood circuit section remains substantially constant. Due to overpressure on the blood side, air is substantially unable to enter through the membrane of the gas exchanger.

[0049] In the twenty-fifth aspect according to any of the foregoing aspects, it is envisioned that the membrane gas exchanger be positioned close to the blood processing unit and / or at the same height as the blood processing unit before the perfusion fluid is fed into the extracorporeal blood circuit.

[0050] In the twenty-sixth aspect according to any of the foregoing aspects, it is envisioned that a perfusion fluid source bag and a perfusion fluid waste bag (optionally) be connected to the extracorporeal blood circuit before the perfusion fluid is fed into the extracorporeal blood circuit.

[0051] The twenty-seventh aspect relates to an apparatus for extracorporeal treatment of blood, comprising:

[0052] Optionally, a blood processing unit;

[0053] An external blood circuit can be optionally coupled to a blood processing unit;

[0054] A blood pump, configured as a pump tubing segment coupled to an external blood circuit;

[0055] A membrane gas exchanger is operatively coupled to an extracorporeal blood circuit to exchange gases with blood flowing in the extracorporeal blood circuit; optionally, the membrane gas exchanger is located downstream of a pump tubing section.

[0056] The control unit is configured to optionally command the execution of a task for perfusing an extracorporeal blood circuit according to one or more of the foregoing aspects.

[0057] In the twenty-eighth aspect according to the aforementioned twenty-seventh aspect, the task includes the following steps:

[0058] - Feed the perfusion fluid into the blood side of the extracorporeal blood circuit and into the membrane gas exchanger;

[0059] - A momentary pressurization step is generated in the perfusion fluid flowing in the blood circuit and on the blood side of the membrane gas exchanger to prevent air bubbles from being released at the blood outlet of the membrane gas exchanger;

[0060] - Optionally, the instantaneous pressurization step may be repeated during infusion (optionally at periodic intervals).

[0061] The instantaneous pressurization step increases the pressure on the blood side of the membrane gas exchanger and prevents air from entering through the membrane of the gas exchanger, because almost any area of ​​the permeable membrane on the blood side of the membrane gas exchanger is subjected to a higher pressure than the corresponding area of ​​the permeable membrane on the air side of the membrane gas exchanger.

[0062] In the twenty-ninth aspect according to any one of the twenty-seventh or twenty-eighth aspects, the blood processing unit has a main chamber and a secondary chamber separated by a semi-permeable membrane; wherein, the extracorporeal blood circuit includes a blood extraction line connected to the inlet of the main chamber and a blood return line connected to the outlet of the main chamber; wherein, a membrane gas exchanger is disposed on the blood return line or the blood extraction line; optionally, wherein the pump section is a section of the blood extraction line.

[0063] In the thirtieth aspect according to the aforementioned twenty-ninth aspect, the device includes:

[0064] A dialysis line having an end connected to the inlet of a sub-chamber of a treatment unit and configured to deliver fresh treatment fluid to the sub-chamber;

[0065] The waste dialysate line has one end connected to the outlet of the sub-chamber and is configured to remove waste liquid from the sub-chamber.

[0066] In the thirty-first aspect according to any of the foregoing twenty-seventh to thirtieth aspects, the device includes: at least one infusion line connected to a blood circuit; and at least one infusion pump coupled to or configured to be coupled to a pump section of the infusion line.

[0067] In the thirty-second aspect according to the foregoing, the infusion line is connected to the blood circuit between the blood pump and the return clamp (optionally between the membrane gas exchanger and the blood pump, or optionally between the processing unit and the blood pump).

[0068] In aspect thirty-third, according to any of the foregoing aspects twenty-seven to thirty-two, the device comprises:

[0069] At least one pressure chamber is disposed on a blood circuit, wherein the pressure chamber includes a hollow body having an intermediate flexible membrane that defines a gas chamber and a liquid / blood chamber, the liquid / blood chamber having an inlet and an outlet for connection to the blood circuit;

[0070] At least one air pump is connected to the gas chamber of the pressure chamber; and / or

[0071] At least one degassing chamber is disposed on the blood circuit, optionally downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid and the flow direction of the blood during treatment;

[0072] At least one air pump is connected to the degassing chamber, optionally to the upper part of the degassing chamber, for allowing horizontal adjustment within the degassing chamber.

[0073] In the thirty-fourth aspect according to any of the twenty-seventh to thirty-third aspects mentioned above, the device includes: a support frame configured to hold at least a portion of the membrane gas exchanger, the extracorporeal blood circuit, and optionally a blood processing unit.

[0074] In aspect 35, which is based on any of the aforementioned aspects 27 to 34, the membrane gas exchanger is located near the blood processing unit.

[0075] In aspect 36, which is based on any of the aforementioned aspects 27 to 35, the membrane gas exchanger is located at substantially the same height as the blood processing unit.

[0076] In the thirty-seventh aspect according to any of the twenty-seventh to thirty-sixth aspects described above, the device includes a disposable cartridge, and the disposable cartridge includes at least a portion of a blood processing unit, a membrane gas exchanger, and an extracorporeal blood circuit. Specifically, the blood processing unit, the membrane gas exchanger, and a portion of the extracorporeal blood circuit are confined to the disposable cartridge.

[0077] The disposable sleeve includes a coupling element for coupling the disposable sleeve to the front panel of the cabinet of the device for in vitro blood processing.

[0078] In the thirty-eighth aspect according to any of the twenty-seventh to thirty-seventh aspects, the device includes an infusion fluid source bag connectable to an extracorporeal blood circuit and an infusion fluid waste bag (optional) connectable to an extracorporeal blood circuit.

[0079] In the thirty-ninth aspect of the foregoing, the perfusion fluid source bag may be connected to a blood extraction line and / or an infusion line; wherein, optionally, the perfusion fluid waste bag may be connected to a blood return line.

[0080] In the fortieth aspect according to the forty-eighth or thirty-ninth aspect above, when according to the thirty-fourth aspect, the support frame includes support elements for filling the fluid source bag and for filling the fluid waste bag (optional).

[0081] In aspect 41, according to any of the preceding aspects 38, 39, or 40, the infusion fluid source bag and the infusion fluid waste bag (optionally) are positioned at substantially the same height as the membrane gas exchanger or below the membrane gas exchanger.

[0082] In the forty-second aspect according to any of the forty-seventh to forty-first aspects, the device includes a degassing chamber disposed on the blood circuit and downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid and the flow direction of the blood during treatment; wherein the task includes: generating a first instantaneous pressurization step in the perfusion fluid when the perfusion fluid reaches the degassing chamber.

[0083] In aspect 43 according to any of the forty-seventh to forty-two aspects, in order to generate one or more instantaneous pressurization steps, the task includes: maintaining the blood pump in operation, and optionally by closing, optionally repeatedly closing, a clamp or valve positioned downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid, optionally returning the clamp, and instantaneously restricting or blocking a portion of the blood circuit positioned downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid.

[0084] In aspect 44, according to any of the preceding aspects 27 to 42, and when according to aspect 31, in order to generate one or more instantaneous pressurization steps, the task includes: connecting the infusion line to the infusion fluid source, and optionally activating the infusion pump intermittently.

[0085] In aspect 45, according to any of the preceding aspects 27 to 42, and when according to aspect 33, in order to generate one or more instantaneous pressurization steps, the task includes: activating an air pump to generate pressure pulses in the gas chamber and / or degassing chamber of the pressure chamber.

[0086] In aspect 46, which is based on any of aspects 27 to 45 above, the membrane gas exchanger is an oxygenator and / or a CO2 remover.

[0087] In the forty-seventh aspect according to any of the forty-sixth aspects mentioned above, the membrane gas exchanger includes a permeable membrane separating the blood side from the gas side.

[0088] In aspect 48 of the forty-seventh aspect mentioned above, the breathable membrane comprises a plurality of hollow fibers. Attached Figure Description

[0089] Various aspects of the invention are illustrated in the accompanying drawings, which are provided by way of non-limiting example, wherein:

[0090] Figure 1 A schematic diagram of an apparatus for extracorporeal blood processing during patient treatment is shown;

[0091] Figure 2 This illustrates a perfusion process during one aspect of the invention. Figure 1 The device;

[0092] Figure 3 A schematic diagram of an alternative embodiment of a device for the extracorporeal treatment of blood is shown;

[0093] Figure 4 This illustrates, according to another aspect of the invention, during the infusion process. Figure 1 The device;

[0094] Figure 5 It shows Figure 1 and Figure 2 Possible embodiments of the device;

[0095] Figure 6 This is a graph showing the pressure trends during infusion in relation to embodiments of the present invention;

[0096] Figure 7 This is a flowchart of an embodiment of the method of the present invention;

[0097] Figure 8 This is a graph showing the correlation between the intensity of the pressure peak during infusion and the time without foaming;

[0098] Figure 9 This is a graph showing the correlation between pressurization time and no-foaming time during infusion. Detailed Implementation

[0099] Figures 1 to 5 A non-limiting embodiment of a device 1 for the in vitro treatment of blood is shown, which can realize the innovative aspects of the invention. In the following description and... Figures 1 to 5In this context, the same components are identified by the same reference numerals.

[0100] exist Figure 1 The image shows an apparatus 1 for extracorporeal blood processing, including a blood processing unit 2 (e.g., a blood filter, ultrafilter, hemodialysis filter, dialyzer, plasma filter, etc.) having a main chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5. Depending on the processing, the semipermeable membrane 5 of the blood processing unit 2 can be selected to have different characteristics and performance. A blood extraction line 6 is connected to the inlet of the main chamber 3, and a blood return line 7 is connected to the outlet of the main chamber 3. In use, the blood extraction line 6 and the blood return line 7 are connected to a needle or catheter or other access device (not shown), which is then configured to be in fluid communication with the vascular system of the patient “P”, such that blood can be extracted through the blood extraction line 6, flow through the main chamber 3, and then return to the patient’s vascular system through the blood return line 7. An air separator (e.g., a degassing chamber 8) may be present on the blood return line 7. Furthermore, a safety return clip 9 controlled by a control unit 10 may be present on the blood return line 7 downstream of the degassing chamber 8. A bubble sensor 8a may be present, for example, associated with or coupled to the portion of line 7 between degassing chamber 8 and return clamp 9. The bubble sensor 8a (if present) is connected to control unit 10 and sends a signal to control unit 10 upon detecting one or more bubbles above a certain safety threshold, causing control unit 10 to close the return clamp 9. The flow of blood through the blood lines is controlled by a blood pump 11 (e.g., a peristaltic blood pump) acting on the blood extraction line 6 or blood return line 7. Figure 1 and Figure 2 The embodiment illustrates a blood pump 11 coupled to a pump section of the extraction line 6. The operator can input the blood flow rate Q via a user interface. B The set value, and the control unit 10 is configured during processing to be based on the set blood flow rate Q. BBlood pump 11 is controlled. Control unit 10 may include a digital processor (CPU) with memory (or multiple memories), analog-type circuitry, or a combination of one or more digital processing units and one or more analog processing circuits. In this specification and claims, it is indicated that control unit 10 is "configured" or "programmed" to perform certain steps: in practice, this can be achieved by any means that allows configuration or programming of control unit 10. For example, in the case where control unit 10 includes one or more CPUs, one or more programs are stored in appropriate memory: one or more programs contain instructions that, when executed by control unit 10, cause control unit 10 to perform the steps described and / or claimed in connection with control unit 10. Optionally, if control unit 10 is analog-type, the circuitry of control unit 10 is designed to include circuitry configured to process electrical signals in use to perform the steps of control unit 10 disclosed herein. One end of wastewater line or waste dialysis fluid line 12 is connected to the outlet of sub-chamber 4, and the other end is connected to waste, which may be a wastewater container or discharge pipe for collecting fluid extracted from the sub-chamber. The sewage pump 13, which operates on the sewage pipeline 12, regulates the flow rate Q through the sewage pipeline under the control of the control unit 10. eff . Figure 1 The device includes a dialysate line 14, one end of which is connected to a fluid inlet and the other end to the inlet of the secondary chamber 4 of the processing unit 2, to supply fresh dialysate to the secondary chamber 4. A dialysate fluid pump (not shown) operates on the dialysate line 14 under the control of the control unit 10 to pump fluid from the dialysate container at a flow rate Q. dial Supply to secondary chamber 4.

[0101] Figure 1 The embodiment presents an infusion line 15 connected to a blood extraction line 6 between the blood pump 11 and the processing unit 2. This infusion line 15 is supplied with replacement fluid from an infusion container 16 connected to one end of the infusion line 15. Note that alternatives to or in addition to the infusion line 15, Figure 1 The apparatus may also include a post-dilution fluid line (not shown) connecting the infusion container to the blood return line 7. Furthermore, an infusion pump 17 operates on the infusion line 15 to regulate the flow rate Q through the infusion line 15. repNote that in the case of two infusion lines (pre-dilution and post-dilution), each infusion line may be equipped with a corresponding infusion pump. The apparatus 1 for extracorporeal treatment of blood also includes a membrane gas exchanger 18 disposed on the blood return line 7, i.e., downstream of the treatment unit 2 relative to the direction of blood flow during treatment. The membrane gas exchanger 18 includes a gas-permeable membrane 100 separating the blood side and the gas side. A first segment 7a of the blood return line 7 from the treatment unit 2 is connected to a blood inlet 18c on the blood side of the membrane gas exchanger 18, and a second segment 7b of the blood return line 7 connected to a needle or catheter is connected to a blood outlet 18d on the blood side of the membrane gas exchanger 18. The gas side of the membrane gas exchanger 18 is provided with corresponding gas inlets 18a and gas outlets 18b for ventilation gas (e.g., air or oxygen).

[0102] The internal structure of the membrane gas exchanger 18 may be known. The gas permeation membrane 100 may include multiple hollow fibers. A ventilation gas (e.g., oxygen, air) passes through the interior of the hollow fibers (gas side), while blood passes around the hollow fibers (blood side) to complete gas exchange by diffusion. The membrane gas exchanger 18 is operatively coupled to an extracorporeal blood circuit to exchange gases with blood flowing in the extracorporeal blood circuit. The membrane gas exchanger 18 may be an oxygenator and / or a CO2 remover. For example, oxygen diffuses from the gas side into the blood, and carbon dioxide (CO2) diffuses from the blood side into the gas for treatment. Figure 1 Device 1 can provide independent CO2 removal as well as dialysis and CO2 removal combined in the same blood circuit.

[0103] Figure 1 and Figure 2 The device 1 shown is also provided with a safety extraction clip 19, which is controlled by the control unit 10 and is located on the blood extraction line 6 and upstream of the blood pump 11.

[0104] Blood extraction line 6, blood return line 7, the first chamber 3 of processing unit 2, and part of the extracorporeal blood circuit of the blood-side forming device 1 of membrane gas exchanger 18. Wastewater line 12, dialysate line 14, and part of the fluid circuit of the fluid chamber 4 of processing unit 2 forming device 1. Infusion line 15 connects to the blood circuit between return clamp 9 and blood pump 11. Figure 1 and Figure 2In this configuration, the infusion line 15 is connected to the blood circuit between the blood pump 11 and the blood processing unit 2. Pressure chambers may also be present in the blood circuit and the fluid circuit to monitor the liquid / blood pressure. Each pressure chamber includes a hollow body with an intermediate flexible membrane defining a gas chamber and a liquid / blood chamber, the liquid / blood chamber having an inlet and an outlet for connection to the blood circuit or the fluid circuit.

[0105] Figure 1 and Figure 2 The device 1 shown includes a processing unit pressure chamber 20 disposed on the blood extraction line 6 and just upstream of the processing unit 2, an access pressure chamber 21 disposed on the blood extraction line 6 and just downstream of the access device and the patient P, and a sewage pressure chamber 22 disposed on the sewage line 12 between the processing unit 2 and the sewage pump 13.

[0106] Blood pump 11, wastewater pump 13, infusion pump 17, and possibly other pumps (not shown) are operatively connected to a control unit 10 that controls the pumps. Control unit 10 is also operatively connected to sensors (e.g., flow sensors) on the blood circuit and / or fluid circuit, particularly pressure chambers 20, 21, 22 and bubble sensor 8a. Control unit 10 is also operatively connected to clamps and valves, such as return clamp 9 and extraction clamp 19. Control unit 10 is also connected to a user interface (not shown), such as a graphical user interface, which receives operator input and displays device output. For example, a graphical user interface may include a touchscreen, a display screen, and hard keys or combinations thereof for inputting user input. During extracorporeal blood processing, control unit 10 is configured to control at least pumps 11, 13, 17 to ensure predetermined patient fluid removal during the processing time, such as patient fluid removal required by a prescription provided to control unit 10 via the user interface. Optionally, a blood warming device 33 may be provided on the blood return line 7 between membrane gas exchanger 18 and degassing chamber 8. Figure 1 and Figure 2 The device 1 is configured to provide continuous renal replacement therapy (CRRT) in combination with ECCO2R therapy or to provide ECCO2R therapy alone.

[0107] Also according to the method of the present invention, the control unit 10 is further configured to command the execution of a task for perfusing an extracorporeal blood circuit prior to treating the patient.

[0108] Figure 1 The construction of the device for the blood perfusion circuit is in Figure 2As shown in the diagram, the perfusion fluid source bag 23 (e.g., a saline bag) is connected to the extraction line 6 of the blood circuit. The perfusion fluid waste bag 24 is connected to the return line 7 of the extracorporeal blood circuit. Another perfusion fluid source bag 25 may be connected to the infusion line 15. The air pump 26 may be connected to the gas chamber of the treatment unit pressure chamber 20. The air pump 26 may also be connected to the upper part of the degassing chamber 8, thereby allowing level adjustment in the degassing chamber. Figure 5 It shows Figure 1 and Figure 2 In a possible embodiment of the device, the extracorporeal blood processing unit 2, the membrane gas exchanger 18, and at least a portion of the extracorporeal blood circuit are part of a disposable sleeve 27 mounted on a support frame 28. The support frame 28 includes a housing 29 supported by a column 30 having a support base 31 configured to rest on the ground. The housing 29 supports and / or houses the mechanical and / or electronic equipment of the device 1, such as a control unit 10, a blood pump 11, a return clip 9, an extraction clip 19, pressure sensors to be connected to pressure chambers 20, 21, etc. The housing 29 includes an invisible carrier for the sleeve 27 and is also provided with support elements 32, such as hooks, for suspending fluid bags. Figure 5 The apparatus 1 in a perfusion configuration is shown, wherein a perfusion fluid source bag 23 and a perfusion fluid waste bag 24 are suspended below a housing 29. A membrane gas exchanger 18 is located next to and substantially at the same height as the blood processing unit 2. The perfusion fluid source bag 23 and the perfusion fluid waste bag 24 are positioned below the membrane gas exchanger 18.

[0109] To perfuse the extracorporeal blood circuit, return clamp 9 and extraction clamp 19 are opened and blood pump 11 is activated to allow perfusion fluid to flow from perfusion fluid source bag 23 to perfusion fluid waste bag 24 and through the main chamber 3 of blood processing unit 2 and the blood side of membrane gas exchanger 18. During perfusion, no gas flows through the gas side of membrane gas exchanger 18. Once the perfusion fluid fills the blood side of membrane gas exchanger 18, optionally, when the perfusion fluid reaches degassing chamber 8, return clamp 9 is closed and reopened while blood pump 11 continues to operate to create a momentary pressurization step in the perfusion fluid and the blood side of membrane gas exchanger 18. In embodiments of the method or task used for perfusion, the closure and reopening of return clamp 9 is repeated to create multiple momentary pressurization steps in the perfusion fluid and the blood side of membrane gas exchanger 18. The generation of one or more pressurization steps may be repeated several times during perfusion. This prevents air bubbles from being released at the outlet of membrane gas exchanger 18. The effect of the pressurization step may be due to reduced gas transfer caused by forcing some fluid into the hydrophobic pores of the membrane, and due to removal of microbubbles that accumulate at the membrane wall before they coalesce into larger bubbles. For example, a first series of pressurization steps can be initiated by intermittently closing the return clamp 9 at periodic time intervals T when the perfusion fluid reaches the degassing chamber 8. By closing and opening the return clamp 9 to generate one or more pressurization steps, a portion of the blood circuit located downstream of the membrane gas exchanger 18 relative to the flow direction of the perfusion fluid is blocked. In a variation of the method, the return clamp 9 may be partially closed to restrict a portion of the blood circuit located downstream of the membrane gas exchanger 18. According to different embodiments for generating one or more pressurization steps, after the perfusion fluid from the perfusion fluid source bag 23 has reached the degassing chamber 8, the blood pump 11 is stopped, the return clamp 9 is closed, and the infusion pump 17 is intermittently activated to pump the perfusion fluid from another perfusion fluid source bag 25 through the infusion line 15 and into the extracorporeal blood circuit to generate the one or more pressurization steps in the membrane gas exchanger 18. According to another embodiment for generating one or more pressurization steps, after the perfusion fluid from the perfusion fluid source bag 23 has reached the degassing chamber 8, while the blood pump continues to operate, the air pump 26 connected to the processing unit pressure chamber 20 is intermittently activated to generate pressure pulses in the gas chamber of the processing unit pressure chamber 20, while the blood pump 11 is stopped and the return clamp 9 is closed. The pressure pulses in the gas chamber push and deform an intermediate flexible membrane that transmits the pressure pulses to the blood chamber of the processing unit pressure chamber 20 and the perfusion fluid in the blood processing circuit. According to another embodiment for generating one or more pressurization steps, the blood pump 11 is stopped, the return clamp 9 is closed, and the air pump 26 connected to the degassing chamber 8 is intermittently activated to generate pressure pulses in the upper part of the degassing chamber 8 and into the perfusion fluid in the lower part of the degassing chamber 8.Optionally, the blood pump 11 remains stationary until the end of perfusion and before connection to the patient, while the return clamp 9 downstream of the membrane gas exchanger 18 remains closed. However, the blood pump 11, infusion pump 17, dialysate pump 13, or gas pump 26 may be activated to establish some positive pressure level. Figure 5 As shown, the membrane gas exchanger 18 is located near the blood processing unit 2 and is substantially at the same height as the blood processing unit 2, but the perfusion fluid source bag 23 and the perfusion fluid waste bag 24, as well as optionally another perfusion fluid source bag 25, are also present. Figure 5 (Not shown) is also positioned below the membrane gas exchanger 18 to prevent bubble formation. This allows for free and user-friendly positioning of the membrane gas exchanger 18 and the bag, without requiring specific components designed to control foaming during filling. Figure 3 and Figure 4 Extracorporeal blood processing 1 is shown in patient treatment ( Figure 3 ) and perfusion sequence ( Figure 4 Different embodiments were used during this period. Figure 1 and Figure 2 The same reference numerals are used for the same components. Figure 3 and Figure 4 The extracorporeal blood processing unit 1 does not include a blood processing unit 2, but is only equipped with a membrane gas exchanger 18. The membrane gas exchanger 18 is the only device in the circuit, and the unit 1 is configured to provide ECCO2R therapy only (standalone ECCO2R). The perfusion of the extracorporeal blood circuit and the generation of one or more transient pressurization steps can be as follows: Figure 1 and Figure 3 The device in the process is operated via a return clamp 9 and / or a gas pump 26 connected to a pressure chamber 20 located upstream of the membrane gas exchanger 18. The control unit 10 is configured to control one or more pressurization steps, and optionally, to control each pressurization step or the duration Δt of each pressurization step. The one or more pressurization steps can be fully automated and may require no user intervention.

[0110] It should be noted that peristaltic pumps typically move peristaltic fluid into the blood tubing during perfusion. Obviously, by its very nature, a peristaltic pump will generate oscillating pressure around the mean pressure value. The described pressurization step aims to increase the mean pressure within the blood tubing section relative to the mean pressure present prior to the pressurization step. Reference Figure 6 The oscillating pressure near the average pressure value generated by the blood pump is barely visible, taking the form of pressure irregularities along two parallel (thin) lines representing the mean / average pressure. The lower line is the average pressure when no pressurization step occurs, while the upper line represents the average pressure value during the pressurization step.

[0111] According to some embodiments, the time length Δt is fixed. According to other embodiments, the time length Δt is a function of one or more parameters. For example, the time length Δt may be a function of the measured return pressure captured by the bubble sensor 8a and / or the treatment unit pressure captured by the treatment unit pressure chamber 20 and / or the sewage pressure captured by the sewage pressure chamber 22.

[0112] The duration Δt of each pressurization step can be between 2 s and 30 s, optionally between 5 s and 10 s, and the time interval T between two pressurization steps can be between 10 s and 100 s, optionally between 20 s and 80 s, optionally between 40 s and 60 s. The maximum pressure P at the membrane gas exchanger 18 during one or more pressurization steps... max The pressure can be between 100 mmHg and 1000 mmHg, optionally between 400 mmHg and 600 mmHg. At the end of the perfusion sequence and before patient connection, the pressure in the blood circuit and on the blood side of the membrane gas exchanger 18 is maintained between 20 mmHg and 400 mmHg, optionally between 50 mmHg and 100 mmHg. The maximum pressure P was analyzed. max The effect of the time length Δt of the pressurization step on bubble formation at 18d outlet of the membrane gas exchanger.

[0113] The materials, samples, and parameters used are as follows:

[0114] -PrisMax Extracorporeal Blood Processing Monitor;

[0115] - PrismaFlex kit equipped with a membrane gas exchange arm;

[0116] - Three membrane gas exchanger samples, S1, S2 and S3;

[0117] - A pressure sensor with data logging capabilities;

[0118] - As a perfusion fluid, an aqueous physiological saline solution;

[0119] -Indoor temperature

[0120] - Fixed flow rate and fixed location for filling waste / collection bags.

[0121] definition

[0122] T bb The time, in seconds, is the time it takes for bubbles to return to their original position at 18d from the outlet of the membrane gas exchanger after the pressurization step.

[0123] P max The maximum pressure or peak pressure recorded during the pressurization process, in millimeters of mercury (mmHg);

[0124] T p The time during the pressurization step when the pressure is above +300 mmHg, in seconds;

[0125] IntP: The integral of the pressure-time signal during the pressurization step, expressed in mmHg xs;

[0126] P range :P max The pressure range is expressed in mmHg.

[0127] The above time length Δt and T p Related to IntP.

[0128] The study is divided into two parts.

[0129] Part 1

[0130] The maximum pressure P was studied. max For T bb The impact.

[0131] Tables 1, 2, and 3 below report the T values ​​recorded during all pressurization steps / challenges. bb P max and P range .

[0132] Table 1-S1

[0133]

[0134] Table 2-S2

[0135]

[0136] Table 3-S3

[0137]

[0138]

[0139] Notes

[0140] For each of the three tested Falcon gas exchangers, four challenges were performed at peak pressure < 200 mmHg, four challenges at 200 < peak pressure < 400 mmHg, and four challenges at 400 < peak pressure < 700 mmHg. The average return pressure level during priming (external challenges) was approximately -15 mmHg. Tables 1, 2, and 3, and... Figure 8 This indicates that when the applied pressure is increased, the bubble-free time T... bb Increase.

[0141] Part 2

[0142] IntP and T have been studied p For T bb The impact.

[0143] Tables 4 through 6 below report the T values ​​recorded in all the pressurized challenges. bb P peak and P range parameter.

[0144] The challenge is identified as X_y, where X and y are associated with the test condition ID (A, B, C, or D) and the test time order, respectively.

[0145] Refer to the pressurization time markers A to D for test conditions (see T) p parameter).

[0146] Table 4-S1

[0147]

[0148] Table 5-S2

[0149]

[0150]

[0151] Table 6-S3

[0152]

[0153] Notes

[0154] The average pressure level under unchallenged operating conditions was approximately -27 mmHg; this explains the difference in pressure between Part II and Part I tests. bb The value is slightly low.

[0155] Tables 4, 5, and 6 and Figure 9 The bubble-free time T is shown. bb It has little dependence on pressurization time, but exhibits a certain threshold effect when the time reaches about 5 seconds (or IntP about 4000 mmHg xs).

[0156] This study demonstrates that the pressure level achieved during the pressurization step is the primary physical parameter controlling the time required to suppress foaming thereafter.

[0157] Example of infusion sequence

[0158] - Connect the perfusion fluid source bag 23 (e.g., a saline bag) to the extraction line 6 of the extracorporeal blood circuit;

[0159] - Connect the perfusion fluid waste bag 24 to the return line 7 of the extracorporeal blood circuit;

[0160] - Open the extraction clip 19 and return clip 9 and activate the blood pump 11 to begin perfusion;

[0161] - When the perfusion fluid reaches the degassing chamber 8, the return clamp 9 is closed and opened at periodic time intervals T to generate pressure pulses in the perfusion fluid and in the blood side of the membrane gas exchanger (18);

[0162] - Stop the blood pump (11), close the return clip (9), keep the return clip (9) closed and wait for the patient to connect.

[0163] While the invention has been described in conjunction with embodiments that are presently considered to be the most practical and preferred, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements contained within the spirit and scope of the appended claims.

Claims

1. A method for perfusing an extracorporeal blood circuit of an extracorporeal treatment device for blood, wherein, The device for extracorporeal blood processing includes: Extracorporeal blood circuit; A blood pump (11) is configured to be coupled to a pump tubing segment of the extracorporeal blood circuit; A membrane gas exchanger (18) is operatively coupled to the extracorporeal blood circuit to exchange gases with blood flowing in the extracorporeal blood circuit, wherein the membrane gas exchanger (18) includes a gas side and a blood side in fluid communication with the blood circuit. The method includes: - The perfusion fluid is fed into the extracorporeal blood circuit and enters the blood side of the membrane gas exchanger (18); - A momentary pressurization step is generated in the perfusion fluid flowing in the blood circuit and on the blood side of the membrane gas exchanger (18) to prevent air bubbles from being released at the blood outlet (18d) of the membrane gas exchanger (18). The instantaneous pressurization step includes: o forces some of the perfusion fluid into the hydrophobic pores of the membrane of the membrane gas exchanger (18), resulting in reduced gas transfer, and o Remove the microbubbles that accumulate at the wall of the membrane before they agglomerate into large bubbles. Thus, the device for extracorporeal treatment of blood is configured to prevent the formation of bubbles in the extracorporeal blood circuit due to the presence of the membrane gas exchanger.

2. The method according to claim 1, comprising: During infusion, the instantaneous pressurization step is repeated at periodic intervals.

3. The method according to claim 1 or 2, wherein, During one or more pressurization steps, the maximum pressure P at the membrane gas exchanger (18) max Between 100 mmHg and 1000 mmHg.

4. The method according to claim 1, 2 or 3, wherein, The duration Δt of the pressurization step or each pressurization step is between 2 seconds and 30 seconds.

5. The method according to any one of claims 1 to 4, wherein, The instantaneous pressurization step includes: instantaneously restricting or occluding a portion of the extracorporeal blood circuit located downstream of the membrane gas exchanger (18) relative to the flow direction of the perfusion fluid, the instantaneous pressurization step being a pressure increase relative to the pressure scheme preceding the instantaneous pressurization step.

6. The method according to any one of claims 1 to 5, wherein, The instantaneous pressurization step includes: maintaining the blood pump (11) in operation and closing the clamp (9) located downstream of the membrane gas exchanger (18) relative to the flow direction of the perfusion fluid.

7. The method according to any one of claims 1 to 5, wherein, The instantaneous pressurization step is initiated via an infusion line (15) and an infusion pump (17), wherein the infusion pump (17) is coupled to a pump section of the infusion line (15), and the instantaneous pressurization step includes: Connect the infusion line (15) to the infusion fluid source; - Activate the infusion pump (17), The infusion line (15) is connected to the blood circuit between the blood pump (11) and the return clamp.

8. The method according to claim 7, wherein, When the infusion pump (17) is activated, the blood pump (11) is stopped and / or the return clamp or valve located on the blood circuit and downstream of the membrane gas exchanger relative to the flow direction of the perfusion fluid is closed.

9. The method according to any one of claims 1 to 5, wherein, The instantaneous pressurization step is initiated by a degassing chamber (8) and an air pump (26) connected to the degassing chamber (8), wherein the degassing chamber (8) is positioned downstream of the membrane gas exchanger on the extracorporeal blood circuit relative to the flow direction of the perfusion fluid and the flow direction of the blood during treatment, wherein a first instantaneous pressurization step is generated in the perfusion fluid when the perfusion fluid reaches the degassing chamber.

10. The method according to any one of claims 1 to 9, wherein, At the end of perfusion and before patient connection, the pressure in the blood circuit and on the blood side of the membrane gas exchanger (18) is maintained between 20 mmHg and 400 mmHg.

11. The method according to any one of claims 1 to 10, wherein, At the end of perfusion and before patient connection, the blood pump (11) is stopped, and the return clamp or valve located on the blood return line and downstream of the membrane gas exchanger (18) remains closed. The blood circuit section between the blood pump (11) and the return clamp or valve is isolated, preventing air from entering the blood circuit section and maintaining a constant pressure scheme within the blood circuit section.

12. The method according to any one of claims 1 to 11, wherein, The duration (Δt) of each pressurization step is fixed, or is a function of the pressure in the blood circuit measured downstream of the blood pump, which is the measured return pressure, processing unit pressure, effluent pressure, or its average pressure.

13. The method according to any one of claims 1 to 12, wherein, During the infusion process, no gas flows through the gas side of the membrane gas exchanger.

14. The method according to any one of claims 1 to 13, further comprising, before feeding the perfusion fluid into the extracorporeal blood circuit: - The membrane gas exchanger is positioned close to the blood processing unit at the same height as the blood processing unit (2); - Connect the perfusion fluid source bag to the extracorporeal blood circuit; Connect the perfusion fluid waste bag to the extracorporeal blood circuit.

15. The method according to any one of claims 1 to 14, wherein, The apparatus for extracorporeal treatment of blood further includes a blood processing unit (2), the extracorporeal blood circuit being coupled to the blood processing unit (2).

16. An apparatus for externally processing blood, comprising: Blood processing unit (2); An external blood circuit is coupled to the blood processing unit (2); A blood pump (11) is configured to be coupled to a pump tubing segment of the extracorporeal blood circuit; A membrane gas exchanger (18) is operatively coupled to the extracorporeal blood circuit to exchange gases with blood flowing in the extracorporeal blood circuit. Control unit (10) is configured to issue commands to perform a task for perfusing the extracorporeal blood circuit, the task comprising the following steps: - The perfusion fluid is fed into the extracorporeal blood circuit and enters the blood side of the membrane gas exchanger (18); - A momentary pressurization step is generated in the perfusion fluid flowing in the blood circuit and on the blood side of the membrane gas exchanger (18) to prevent air bubbles from being released at the blood outlet (18d) of the membrane gas exchanger (18). The instantaneous pressurization step includes: o forces some of the perfusion fluid into the hydrophobic pores of the membrane of the membrane gas exchanger (18), resulting in reduced gas transfer, and o Remove the microbubbles that accumulate at the wall of the membrane before they agglomerate into large bubbles. Thus, the device for extracorporeal treatment of blood is configured to prevent the formation of bubbles in the extracorporeal blood circuit due to the presence of the membrane gas exchanger.

17. The apparatus according to claim 16, wherein, The task includes repeating the instantaneous pressurization step at periodic intervals during infusion.

18. The apparatus according to claim 16 or 17, wherein, In order to generate the instantaneous pressurization step, the task includes: keeping the blood pump (11) operational and repeatedly shutting off the clamp positioned downstream of the membrane gas exchanger (18) relative to the flow direction of the perfusion fluid.

19. The apparatus according to claim 16, 17 or 18, wherein, The membrane gas exchanger (18) is located near the blood processing unit (2).

20. The apparatus according to any one of claims 16 to 19, wherein, The membrane gas exchanger (18) is located at substantially the same height as the blood processing unit (2), wherein the perfusion fluid waste bag (24) is located at substantially the same height as the membrane gas exchanger (18) or below the membrane gas exchanger (18).

21. The device according to any one of claims 16 to 20, comprising a disposable sleeve (27), and wherein, The disposable sleeve (27) includes at least a portion of the membrane gas exchanger (18), the blood processing unit (2), and the extracorporeal blood circuit.

22. The apparatus according to any one of claims 16 to 21, comprising: - A dialysis line (14) having one end connected to the inlet of a sub-chamber (4) of the blood processing unit (2) and configured to deliver fresh processing fluid to the sub-chamber; - Waste dialysis fluid line (12), having one end connected to the outlet of the sub-chamber (4), and configured to remove waste fluid from the sub-chamber; - A perfusion fluid source bag (23) that can be connected to the extracorporeal blood circuit; - An infusion fluid waste bag (24) that can be connected to the extracorporeal blood circuit, wherein the infusion fluid waste bag is positioned at substantially the same height as or below the membrane gas exchanger.

23. The apparatus according to any one of claims 16 to 22, comprising: A support frame is configured to hold the membrane gas exchanger (18), at least a portion of the extracorporeal blood circuit, and the blood processing unit (2), wherein the membrane gas exchanger is located near the blood processing unit.

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