CONTROL OR REGULATION DEVICE FOR A HEART-LUNG MACHINE

Description

[0001] The invention relates to a heart-lung machine with a control or regulating device.

[0002] Patients with heart or lung failure can be protected from further deterioration or kept alive through extracorporeal cardiopulmonary support (ECP). This relieves the strain on the heart and lungs, allowing them to receive treatment, while simultaneously maintaining their function through external support. The patient is connected to an extracorporeal circuit via appropriate cannulas, which ensures the continued functioning of the heart and lungs.

[0003] A heart-lung machine consists of a blood pump and an artificial lung. Blood is drawn from the venous system via cannulas through a peripheral or central access point and, after oxygenation, returned to the patient via the venous or arterial side. This ensures that vital organs are supplied with fresh blood while the patient is transported or transferred to further therapy. The blood pump is typically permanently attached to a drive console, and a magnetic coupling transfers the drive energy from a pump motor to a rotor of the blood pump. Roller pumps are also used, in which a pump tube is inserted into the drive console. The artificial lung, also called an oxygenator or gas exchanger, is located downstream of the blood pump.

[0004] The standard control units for the blood pump monitor the system's pumping function with regard to blood flow rate and blood pressures, and issue alarms if necessary. The blood flow is adjusted by the user on the control unit by changing the pump speed.

[0005] The oxygenator's gas supply is ensured by a separate gas blender, supplied with oxygen and compressed air. The gas flow rate and composition can be selected as needed. In some cases, the oxygenator is supplied with oxygen only, at the desired flow rate, via a throttling device.

[0006] WO 2016 / 100512 A1 discloses a device comprising a blood pump and an oxygenator, which is preferably supplied with electrical energy, for example from batteries.

[0007] US patent 5,810,759 discloses a device with a blood pump and an oxygenator, whereby the control of the device can only be achieved through a large amount of measurement data, which makes the device highly complex.

[0008] One disadvantage of conventional heart-lung machines is that the gas supply controls, which are just as crucial for therapy as blood flow regulation, are located separately, making operation difficult and confusing. This negatively impacts patient safety and the quality of therapy. Furthermore, when using an oxygen source with a throttling device, as is standard practice in clinical practice, there is no alarm or indicator function for the gas source. Another drawback is that heart-lung machines consist of numerous components, complicating both transport and operation.

[0009] One objective of the invention is therefore to improve the safety and quality of therapy, as well as to simplify the transport of the heart-lung machine.

[0010] The problem is solved by a heart-lung machine with a control or regulating device according to claim 1. The subject matter of the dependent claims describes preferred embodiments.

[0011] The heart-lung machine according to the invention, with a control or regulating device, has the advantage that both the blood flow rate and the flow rate of the gas flowing through the gas exchange unit can be adjusted by a single device. This increases operator safety, therapy monitoring, and simplifies the transport and operation of the heart-lung machine. In particular, it is no longer necessary to move two separate devices, but only a single device, namely the control or regulating device. A further advantage of the heart-lung machine according to the invention with the control or regulating device is that the essential operating steps are performed on one device, thereby avoiding operator errors, especially during commissioning.

[0012] The control and regulation device consists of a compact unit, specifically a housing, to which the disposable blood-carrying components—the pump and gas exchanger—are directly connected and supplied with power or gas. No further connections or additional equipment are required. The device is powered solely by a gas connection and, if necessary, an electrical connection. Pump control and gas metering are integrated into the device. Therefore, no separate pump console or gas flow control is needed. The device is designed as a portable unit.

[0013] In one version of the device, the reusable actuator for driving the blood pump, such as an electric motor, can also be located outside the housing and connected to it, for example, by a cable.

[0014] In one version, the device can have a housing volume of less than 2 liters and a weight of less than 2 kg. Due to its compact and lightweight design, this version of the device is particularly well-suited for patient transport. Its compact size also allows it to be positioned very close to the patient.

[0015] The gas can consist of a single gas. Alternatively, the gas can be a gas mixture consisting of several single gases and / or a single gas and one or more other gases.

[0016] In a specific design, the control unit can be configured and intended to electrically and / or pneumatically drive a blood pump (not part of the control unit) to control or regulate the blood flow. The blood pump can be a centrifugal pump, electrically controlled via a speed controller or pneumatically controlled via a gas supply controller. The blood flow rate delivered by the pump depends on the speed and / or gas supply control. The blood pump can be a suction or pulse pump.

[0017] According to a further independent inventive aspect, the control unit can control or regulate the gas flow rate through the gas exchange unit (which is not part of the control unit) depending on or independent of the blood flow rate, in particular automatically. Specifically, the control unit can control or regulate the gas flow rate depending on a preset blood flow rate. The blood flow rate can thus be set by the user, for example by pressing a control button, before the gas flow rate is controlled or regulated. In the case of automatic control depending on the blood flow, manual adjustment of the gas flow is no longer necessary.

[0018] The control unit can regulate the gas flow rate and / or the blood flow rate in such a way that a predefined ratio between the gas flow rate and the blood flow rate can be set. For this purpose, the control unit can have at least one input option by which a user can enter the desired ratio. Alternatively or additionally, the control unit can regulate the blood flow rate and / or the gas flow rate in such a way that a ratio between the gas flow rate and the blood flow rate can be set that varies over time or is influenced by measurement parameters.

[0019] When the blood flow rate changes, the control unit can automatically adjust the gas flow rate to a value corresponding to the blood flow rate. This eliminates the need for the user to continuously monitor the blood flow rate and intervene when it changes. Specifically, the user can enter the desired ratio between the gas and blood flow rates once, and the control unit will automatically adjust the gas flow rate to any changes in blood flow. Since only one control unit manages both the gas and blood flow rates, the user only needs to enter the desired ratio into a single device, simplifying operation.Furthermore, when the blood pump is switched on and a blood volume flow is associated with it, the control or regulating unit can simultaneously control or regulate the gas volume flow to a value that corresponds to the blood volume flow delivered by the blood pump.

[0020] Furthermore, at least one algorithm can be integrated to control or regulate the ratio of gas flow rate to blood flow rate. The control unit adjusts the gas flow rate to the gas exchanger according to the user's input or changes to the blood flow rate. The device does not require external sensors, e.g., for blood gas monitoring, but instead uses the blood flow rate set by the user.

[0021] The control system can be operated without electronic components. The gas flow through the gas exchanger can be regulated by mechanical or pneumatic coupling, depending on the blood flow adjustment mechanism (blood flow control knob).

[0022] The control or regulation can also be dependent on time or other measurement parameters. At least one algorithm can be stored in an electrical storage unit of the control or regulation device.

[0023] The gas exchange unit can be an oxygenator. An oxygenator is a device that enriches blood with oxygen and removes carbon dioxide from the blood. Thus, the oxygenator can replace or support the lungs both in the short term and over longer periods.

[0024] In a specific design, the control unit may include a mixing device. At least two gases can be mixed in the mixing device. In particular, oxygen can be mixed with air, especially compressed air. Furthermore, in certain cases, the mixing device may also mix oxygen with air, such as compressed air, and / or another gas, such as CO₂ (carbon dioxide) and / or NO (nitrogen monoxide). The gas flowing from the mixing device can be fed to the gas exchange unit.

[0025] The control unit may also include an adjustment device for setting the flow rate and / or composition of the gas flowing from the mixing unit. This allows the user to easily adjust the desired flow rate and / or composition of the gas exiting the mixing unit. The adjustment device may have multiple control knobs for adjusting the flow rate and / or gas composition, particularly separately. Alternatively, the adjustment device may have a touchscreen for the user to make the desired settings. As a result, the mixing unit and the adjustment device allow for easy control of the flow rate and composition of the gas flowing from the mixing unit to the gas exchange unit.Furthermore, the gas volume flow supplied to the gas exchange unit can be easily controlled or regulated by the adjustment device.

[0026] The gases supplied to the mixing device can originate from several different gas sources not belonging to the control device. These gas sources are fluidically connected to the control device. Oxygen is supplied to the control device via a first source. Air, particularly compressed air, is supplied to the control device via a second source. A third source may also be present, which can also supply oxygen to the control device. This third source serves as an emergency reserve in case the first source fails. Additional mixed gases can be supplied via further sources.

[0027] Furthermore, the control unit may include an additional mixing device for blending gas and ambient air. In particular, oxygen may be mixed with ambient air in this additional mixing device. The additional mixing device may include a Venturi element for drawing in the ambient air. The gas flowing from the additional mixing device can be fed to the gas exchange unit.

[0028] The control unit may include an additional adjustment device for setting the flow rate and / or composition of the gas flowing from the mixing unit. This additional adjustment device may have several control knobs for adjusting the flow rate and / or gas composition. Alternatively, the adjustment device may have a touchscreen display for the user to make the desired settings. As a result, the flow rate and composition of the gas flowing from the mixing unit to the gas exchange unit can be easily adjusted using the additional mixing unit and the additional adjustment device. Furthermore, the flow rate of the gas supplied to the gas exchange unit can be easily controlled or regulated using the additional adjustment device.

[0029] The control unit has a separate adjustment mechanism that allows the flow rate of the gas to the blood pump to be controlled or regulated. This is particularly useful in designs where the blood pump is pneumatically actuated. The gas actuates the blood pump, creating a pumping action and thus increasing the blood flow. The adjustment mechanism allows for simple control or regulation of the blood flow.

[0030] The other adjustment device can be located upstream of the blood pump. Only oxygen can be supplied to the blood pump. Therefore, the gas supplied to the blood pump does not mix with any other gas before it reaches the pump. Consequently, no adjustment device is needed to regulate the composition of the gas flowing to the blood pump.

[0031] The control unit has a switching device that is fluidically connected to the blood pump and fluidically connectable to the gas exchange unit. The switching device can be located downstream of the blood pump and / or upstream of the gas exchange unit. Two components are fluidically connected if a gas and / or liquid can flow from one component to the other or vice versa. The switching device allows the user to select whether the gas flowing from the blood pump is fed to the gas exchange unit or discharged to the environment. The term "environment" also includes any cavity within the housing of the control unit.

[0032] In one switching position, the blood pump can be fluidically connected to the gas exchange unit via the switching device. Thus, the gas flowing from the blood pump can pass through the switching device and continue flowing towards the gas exchange unit. In another switching position, the blood pump can be fluidically connected to the environment. This means that in the other switching position, any gas flowing into the switching device is completely discharged into the environment.

[0033] The control unit may include a switching or adjusting device. This device controls or regulates the flow rate of the gas supplied from the switching device to the gas exchange unit. This allows for easy adjustment of the flow rate supplied to the gas exchange unit. This is particularly important to prevent respiratory alkalosis in the patient, which can occur if too much carbon dioxide is removed in the gas exchange unit. The switching or adjusting device may also be designed to release the portion of the gas not supplied to the gas exchange unit into the environment.

[0034] In a special version, the control unit can have a selection device that allows different operating modes of the control device to be set. For example, a first operating mode can be set using the selection device, in which the switching device is in the switching position, so that the same gas can be supplied to both the blood pump and the gas exchange unit. In particular, pure oxygen can be supplied to both the blood pump and the gas exchange unit in this operating mode. The first operating mode is suitable for specific cases in which the blood needs to be enriched with a high amount of oxygen in the gas exchange unit. After the blood has been enriched with oxygen, the gas supplied to the gas exchange unit can be released into the environment.

[0035] A second operating mode can be set using the selection device, in which the switching device is in the other position and the gas flowing from the mixing device can be supplied to the gas exchange unit. In this operating mode, the gas supplied from the blood pump to the switching device is completely released into the environment. The advantage of this second operating mode is that the oxygen concentration in the gas supplied to the gas exchange unit can be adjusted in the mixing device. This makes it easy to prevent the blood from becoming too oxygenated in the gas exchange unit. In this second operating mode, different gases are supplied to the blood pump and the gas exchange unit.The blood pump is supplied with a gas, such as exclusively oxygen or compressed air, while the gas exchange unit is supplied with the gas flowing from the mixing device, such as a mixture of oxygen and compressed air.

[0036] Furthermore, a third operating mode can be set using the selection device. In this mode, the switching device is in the other position, and the gas flowing from the additional mixing device can be supplied to the gas exchange unit. In this mode, a gas mixture consisting of oxygen and ambient air can be supplied to the gas exchange unit. Thus, in the third operating mode, as in the second operating mode, different gases are supplied to the blood pump and the gas exchange unit. The third operating mode is advantageous in situations where compressed air is not available to the user. This is often the case when the heart-lung machine is used outside of a hospital.

[0037] In a special design, the control and regulating device can include a safety device. This safety device can be used to monitor the operation of the control and regulating device. Suitable sensors or pneumatic-electric switches can detect deviations from normal operation and / or trigger alarms via the safety device. The safety device can be powered by standard or rechargeable batteries, thus operating independently of the mains power supply.

[0038] The alarms can inform the user audibly and / or visually. Alarms can be triggered if the gas supply pressure falls below a threshold, the control or regulating device is operated with only one gas source, or the blood pump or gas exchange unit exhibits operating conditions that deviate from normal operation.

[0039] An alarm can also be triggered if the flow rate of the gas supplied to the gas exchange unit falls below a certain threshold. This allows the user to be easily informed that the gas flow rate is too low.

[0040] The control or regulating device can also be connected to a central monitoring system in the hospital. This can be done via a simple connection with an on / off contact via the central patient call switch (nurse call).

[0041] Furthermore, the control or regulating device can include a monitoring unit for the patient's vital parameters. The result is a control or regulating device that offers a wide range of functions.

[0042] The control unit can also be used to control or regulate blood temperature. For example, a heart-lung machine may have a heating or cooling device for warming or cooling the blood drawn from the patient. The control unit can regulate the heating or cooling so that the blood temperature reaches the desired level. Warming the blood may be necessary if the tubes connected to the patient are very long and / or the ambient temperature is very low, causing the temperature of the blood flowing through the tubes to drop. Cooling may be therapeutically desirable to protect the patient's organs. Cooling can be achieved through chemical cooling and / or a phase transition. Alternatively, cooling can be accomplished in other ways.

[0043] In a special configuration, the control unit can include a gas connection unit that can be fluidically connected to the gas source or multiple gas sources. The gas connection unit can have multiple connections, each of which can be fluidically connected to a gas source. The gas connection unit can also be fluidically connected to the mixing unit and / or further mixing units.

[0044] The control unit may include an additional switching device. This additional switching device allows the gas connection unit to be fluidically connected either to the mixing unit or to the additional mixing unit. For example, in a first switching position of the additional switching device, the gas connection unit may be fluidically connected to the mixing unit. In particular, at least two gas sources, such as the first source and the second source, may be fluidically connected to the mixing unit. In this case, oxygen and air, especially compressed air, may be supplied to the mixing unit. Furthermore, the additional switching device may be configured to have a closed position in which neither the mixing unit nor the additional mixing unit is fluidly connected to the gas connection unit.

[0045] In a second switching position of the additional switching device, the gas connection unit can be fluidically connected to the additional mixing device. In particular, the additional mixing device can be fluidically connected to a gas source, especially a single one. In this second switching position, the additional mixing device can be supplied exclusively with oxygen. The additional switching device can also be designed and configured such that, regardless of its position, the other control device is always fluidly connected to the gas connection unit. This ensures that the other control device is always supplied with gas, such as oxygen, which is used to control the pump.

[0046] Furthermore, the additional switching device can be designed to automatically switch to another gas source if one fails. This is advantageous, for example, if the first source no longer contains sufficient oxygen, thus jeopardizing the supply of oxygen to the gas exchange unit. In this case, the gas connection unit automatically switches to the third source, which also provides oxygen. As a result, it can be easily ensured that the additional switching device is always supplied with sufficient gas, such as oxygen.

[0047] Furthermore, the control unit may have a pressure relief valve that prevents an excessive gas flow rate from being supplied to the blood pump. Additionally, the control unit may have another pressure relief valve that prevents an excessive gas flow rate from being supplied to the gas exchange unit.

[0048] The control or regulating device has a housing, which advantageously includes a handle. The handle allows the control or regulating device to be easily transported. Furthermore, the housing can be designed such that the control or regulating unit is completely enclosed within a cavity of the housing. The adjustment device, the further adjustment device, and the other adjustment device can be arranged on the same side of the housing.

[0049] The heart-lung machine according to the invention comprises the blood pump, the gas exchange unit, and the control device. The control device is fluidically connected to the blood pump and the gas exchange unit. Furthermore, the control device is fluidically connected to several gas sources.

[0050] The invention is schematically represented in the figures and is described below with reference to the figures, whereby identical or equivalently acting elements are mostly provided with the same reference numerals. The figures show: Fig. 1 shows a heart-lung machine with a control or regulating device according to a first embodiment according to the invention. Fig. 2 shows a heart-lung machine with the control or regulating device according to the invention according to the first embodiment, wherein the control or regulating device is operated in a first operating mode. Fig. 3 shows a heart-lung machine with the control or regulating device according to the invention according to the first embodiment, wherein the control or regulating device is operated in a second operating mode. Fig. 4 shows a heart-lung machine with the control or regulating device according to the invention according to the first embodiment, wherein the control or regulating device is operated in a third operating mode. Fig. 5 shows the further mixing device. Fig. 6 shows the control or regulating device according to a second embodiment according to the invention.Fig. 7 A representation of the heart-lung machine with the control or regulating device according to the invention according to a third embodiment, Fig. 8 A representation of the control or regulating device according to the invention according to a fourth embodiment, Fig. 9 A representation of the control or regulating device according to the invention according to a fifth embodiment, Fig. 10 A representation of the control or regulating device according to the invention according to a sixth embodiment, Fig. 11 A representation of the control or regulating device according to the invention according to a seventh embodiment, Fig. 12 A representation of the control or regulating device according to the invention according to an eighth embodiment, Fig. 13 A representation of the heart-lung machine with the control or regulating device according to the invention according to a ninth embodiment, Fig. 14 A representation of the heart-lung machine with the control or regulating device according to the invention according to the ninth embodiment, in which no fluidic connections are shown, Fig.15 A perspective view of the control or regulating device according to the invention, specifically the ninth embodiment.

[0051] Figure 1 Figure 1 shows a representation of a heart-lung machine with a control device 1 according to the invention, a blood pump 3, and a gas exchange unit 4, such as an oxygenator. The control device 1 has a control unit 2 that controls both the blood flow rate delivered by the blood pump 3 and the flow rate of a gas flowing through the gas exchange unit 4. The control unit 2 is arranged in a cavity of a housing 17 of the control device 1.

[0052] The control unit 2 has a gas connection unit 13, which serves to fluidically connect the control device 1 to several gas sources. For this purpose, the gas connection unit 13 has several connections, each of which is connected to a fluid line for connecting to the gas sources.

[0053] The gas connection unit 13 is fluidically connected to a first source 19. Oxygen can be supplied to the control device 1 via the first source 19. Furthermore, the gas connection unit 13 is fluidically connected to a second source 20. Air, in particular compressed air, can be supplied to the control device 1 via the second source 20. The gas connection unit 13 is also fluidically connected to a third source 21. Oxygen can also be supplied to the control device 1 via the third source 21. The first and second sources 19, 20 are, for example, integrated into a wall of a hospital room. The third source 21 can, for example, be a gas cylinder and serve as an emergency reserve should the first source 19 fail. Additional gas sources, not shown in the figures, may also exist and can be connected to the control device 1.

[0054] The control unit 2 can have a mixing device 5 for mixing the oxygen from the first source 19 or the third source 21 and the compressed air from the second source 20. The control unit 2 has a Figure 6 The adjustment device 6 shown is used to control or regulate the composition of the gas flowing from the mixing device 5. Furthermore, the volumetric flow rate of the gas flowing from the mixing device 5, which is supplied to the downstream gas exchange unit 4, can be controlled or regulated by means of the adjustment device 6. The adjustment device 6 has several control knobs by means of which the composition and the volumetric flow rate can be adjusted.

[0055] The control unit 2 can also include a further mixing device 7, which serves to mix the oxygen from the first source 19 or the third source 21 with ambient air. The control unit 2 has a Figure 6 The further adjustment device 8 shown is used to control or regulate the composition of the gas flowing from the further mixing device 7. Furthermore, the volume flow rate of the gas flowing from the further mixing device 7, which is supplied to the downstream gas exchange unit 4, can be controlled or regulated by means of the further adjustment device 8. The further adjustment device 8 has several control knobs by means of which the composition and the volume flow rate can be adjusted.

[0056] Furthermore, the control unit 2 has another adjustment device 9, which is arranged upstream of the blood pump 3 and / or is always fluidically connected to the gas connection unit 13. The volumetric flow rate of the gas supplied to the blood pump 3 can be controlled or regulated by means of this other adjustment device 9. The blood pump 3 can be supplied exclusively with oxygen flowing from the first source 19 or from the third source 21. The oxygen supplied to the blood pump 3 is returned to the control unit 1. The supply and removal of oxygen to the blood pump 3 generates a pumping action that causes a blood volumetric flow rate. A pressure relief valve 15 can be fluidically arranged between the other adjustment device 9 and the blood pump 3. The pressure relief valve 15 prevents an excessively high gas volumetric flow rate from being supplied to the blood pump 3.

[0057] The flow of blood is in Figure 1 This diagram is only shown schematically. The blood drawn from the patient flows into blood pump 3 and from there to the gas exchange unit 4. In gas exchange unit 4, the blood is enriched with oxygen and flows back to the patient. The blood flow path is shown in Figure 1 represented by three arrows.

[0058] The control unit 2 has a switching device 10, which is arranged downstream of the blood pump 3 and upstream of the gas exchange unit 4. In one switching position of the switching device 10, the blood pump 3 is fluidically connected to the gas exchange unit 4. In another switching position of the switching device 10, the gas flow from the blood pump 3 can be completely discharged into the environment.

[0059] A switching and control device 11 is arranged fluidically between the switching device 10 and the gas exchange unit 4. The switching and control device 11 allows the gas flow rate supplied to the gas exchange unit 4 to be controlled or regulated. The switching and control device 11 is designed such that the portion of the gas flow rate from the blood pump 3 that is not intended for the gas exchange unit 4 is released to the environment.

[0060] Upstream of the gas exchange unit 4, another pressure relief valve 16 is arranged. This second pressure relief valve 16 prevents an excessive gas flow rate from being supplied to the gas exchange unit 4. After the blood has been oxygenated, the gas flow rate supplied to the gas exchange unit 4 is released into the environment.

[0061] The control unit 2 has a further switching device 22. By means of the further switching device 22, the gas connection unit 13 is selectively fluidically connected to either the mixing device 5 or the further mixing device 7. Furthermore, the mixing device 5 is configured such that the gas connection unit 13 is, in particular, always fluidically connected to the other adjustment device 9. Specifically, the other adjustment device 9 can always be fluidically connected to either the first source 19 or the third source 21. The further mixing device 7 is also configured such that it automatically switches to the third source 21 if the first source 19 fails.

[0062] The control unit 2 also has a selection device 12 by means of which the different operating modes described in more detail below can be set. The selection device 12 is electrically connected to the switching device 10, the further switching device 22, the mixing device 5 and the further mixing device 7 by means of an electrical line 32. The position of the switching device 10 and / or the further switching device 22 depends on the position of the selection device 12.

[0063] Figure 2Figure 1 shows a representation of the heart-lung machine with the control device 1 according to the invention in the first embodiment, wherein the control device 1 is operated in a first operating mode. The first operating mode can be selected by the user operating the selection device 12 accordingly, in particular by turning a knob of the selection device 12 to a corresponding position.

[0064] In Figure 2The lines through which a gas flows are represented by an arrow. In the first operating mode, oxygen flows from the gas source into the gas connection unit 13 and from there to the other adjustment device 9. From the other adjustment device 9, the oxygen flows to the blood pump 3 and from there back to the control device 1. Specifically, the oxygen flows from the blood pump 3 into the switching device 10. The switching device 10 is in the switching position, so that the gas continues to flow to the switching adjustment device 11. The switching adjustment device 11 is set such that a portion of the gas flowing from the switching device 10 is released into the environment, as indicated by the dashed arrow. The portion not released into the environment flows to the gas exchange unit 4.The portion of the gas flowing through gas exchange unit 4 is released into the environment, as shown by the dashed arrow.

[0065] In the first operating mode, the secondary switching device 22 is in a closed position, in which no gas is supplied to either the mixing device 5 or the secondary mixing device 7. Furthermore, no gas flows from either the mixing device 5 or the secondary mixing device 7 into the gas exchange unit 7.

[0066] Figure 3 Figure 1 shows a representation of the heart-lung machine with the control device 1 according to the invention in the first embodiment, wherein the control device 1 is operated in a second operating mode. The second operating mode can be selected by the user operating the selection device 12 accordingly, in particular by turning a knob of the selection device 12 to a corresponding position.

[0067] In Figure 3 The lines through which a gas flows are indicated by an arrow. In the second operating mode, the additional switching device 22 is in a first switching position, in which the first or third source 19, 21 and the second source 20 are fluidically connected to the mixing device 5. The composition and / or the volumetric flow rate of the gas flowing from the mixing device 5 is controlled or regulated by means of the adjusting device 6. The gas flowing from the mixing device 5 passes through the gas exchange unit 4 and is then discharged into the environment, as indicated by the dashed arrow.

[0068] Furthermore, in the second operating mode, oxygen flows to blood pump 3 and from there back to the control device 1. The volumetric flow rate of the oxygen flowing to blood pump 3 can be controlled or regulated by means of the other adjustment device 9. In contrast to the first operating mode, the switching device 10 is in the other switching position, in which blood pump 3 and the gas exchange unit 4 are not fluidically connected to each other by means of the switching device 10. This means that the oxygen flowing from blood pump 3 is released into the environment, as indicated by the dashed arrow.

[0069] In the second operating mode, no gas flows through the further mixing device 7. In addition, only the gas flowing out of the mixing device 5 is supplied to the gas exchange unit 4.

[0070] Figure 4Figure 1 shows a representation of the heart-lung machine with the control device 1 according to the invention in the first embodiment, wherein the control device 1 is operated in a third operating mode. The third operating mode can be selected by the user operating the selection device 12 accordingly, in particular by turning a knob of the selection device 12 to a corresponding position.

[0071] In Figure 4 The lines through which a gas flows are indicated by an arrow. In the third operating mode, the additional switching device 22 is in the second switching position, in which the additional mixing device 7 is fluidically connected to the first source 19. Furthermore, ambient air is supplied to the additional mixing device 7, as indicated by the arrow. The gas flowing from the additional mixing device 7 is fed to the gas exchange unit 4.

[0072] Otherwise, there are no differences compared to the second operating mode. The switching device 10 is in the other switching position, so that the oxygen flowing from the blood pump 3 is released into the environment.

[0073] Figure 5 shows a representation of the further mixing device 7. From Figure 5 It is evident that the further mixing device 7 has a Venturi element 23. The Venturi element 23 is fluidically connected to the first source 19 or the third source 21 via a first line 24. In addition, the Venturi element 23 is fluidically connected to the gas exchange unit 4 via a second line 25. Furthermore, the Venturi element 23 can be fluidically connected to the environment via a third line 26.

[0074] The further mixing device 7 has a valve 27 by means of which it can be set whether ambient air is supplied to the Venturi element 23 through the third line 26.

[0075] Fig. 6 Figure 1 shows a representation of the control or regulating device 1 according to a second embodiment. This embodiment differs from the one shown in Figure 1. Figure 1 The embodiment shown is characterized by the fact that the control device 1 has a handle 28 which is integrally connected to the housing 17. The control device 1 has a display 31 by means of which, for example, gas volume flow values ​​can be displayed.

[0076] Figure 7 Figure 1 shows a representation of the heart-lung machine with the control or regulating device 1 according to a third embodiment. The control or regulating device 1 differs from the one shown in Figure 1. Figure 1The control or regulating device 1 shown is distinguished in that it comprises only the adjusting device 6 for controlling or regulating the volume flow of the gas supplied to the gas exchange unit 4 and the other adjusting device 9 by means of which the volume flow of the gas supplied to the blood pump 3 can be controlled. Thus, the control or regulating device 1 does not have any further adjusting device 7.

[0077] Fig. 8 Figure 1 shows a representation of the control or regulating device 1 according to a fourth embodiment of the invention. It differs from the one in Figure 1. Figure 7 The illustrated embodiment is characterized by the fact that the composition of the gas flowing from the mixing device 5 can also be adjusted by means of the adjusting device 6. In particular, the oxygen concentration of the gas flowing from the mixing device 5 can be adjusted.

[0078] Fig. 9Figure 1 shows a representation of the control or regulating device 1 according to a fifth embodiment of the invention. It differs from the one shown in Figure 1. Figure 7 The illustrated embodiment is achieved by means of the adjusting device 6, which allows the ratio between the gas flow rate and the blood flow rate to be set. Depending on the set ratio, the gas flow rate flowing through the mixing device 5 and / or the gas flow rate supplied to the blood pump 3 is controlled or regulated to achieve the desired ratio.

[0079] Fig. 10 Figure 1 shows a representation of the control or regulating device 1 according to a sixth embodiment. This embodiment differs from the one shown in Figure 1. Figure 8In the illustrated embodiment, the concentration of nitric oxide in the gas flowing from the mixing device 5 can also be adjusted by means of the adjusting device 6. In this embodiment, the mixing device 5 is additionally fluidically connected to a fourth source that supplies nitric oxide.

[0080] Fig. 11 Figure 1 shows a representation of the control or regulating device 1 according to a seventh embodiment. This embodiment differs from the one shown in Figure 1. Figure 1 The illustrated version differs in that only two operating modes can be realized by means of the control or regulating device 1 using the selection device 12.

[0081] Fig. 12Figure 1 shows a representation of the control or regulating device 1 according to an eighth embodiment. This embodiment differs from the embodiments described above in that the control or regulating unit 2 additionally serves to control or regulate a heater 29 of the heart-lung machine. The heater 29 serves to warm the blood drawn from the patient.

[0082] The heater 29 is fluidically positioned between the blood pump 3 and the gas exchange unit 4. The control unit 2 has an adjustment element 30 by means of which the user can control or regulate the desired blood temperature.

[0083] Figure 13 Figure 1 shows a representation of the heart-lung machine with the control or regulating device 1 according to a ninth embodiment. The illustration in Figure 13 The version shown differs from the one in Figure 1 The version shown is simpler in design than the one in Figure 1 The illustrated embodiment. Thus, the control or regulating device 1 has the other adjusting device 9 and the other switching device 11.

[0084] The other adjustment device 9 is fluidically connected to the third source 21 and the blood pump 3 via the gas connection unit 13. In particular, the gas flow rate supplied to the blood pump 3, and thus the blood flow rate delivered by the blood pump 3, can be adjusted using the other adjustment device 9. The supplied gas can be oxygen.

[0085] The switching device 11 is fluidically connected to the blood pump 3 and the gas exchange unit 4. The switching device 11 is fluidically connected downstream of the blood pump 3. The switching device 11 is designed such that a portion of the gas coming from the blood pump can be released into the environment. The remaining gas is fed to the gas exchange unit 4 and then released into the environment.

[0086] The gas released into the environment is represented by a dashed arrow.

[0087] Figure 14Figure 1 shows the control device 1 according to the ninth embodiment, in which the fluidic connections are not shown. The user of the control device 1 can adjust the blood flow rate by actuating the other adjustment device 9, as indicated by the dashed arrow. More specifically, the other adjustment device 9 can be used to adjust the gas flow rate supplied to the blood pump 3, which in turn adjusts the blood flow rate. The position of the other adjustment device 9 is transmitted to the other switching device 11, as indicated by the dashed arrow.

[0088] The control device 1 controls or regulates the gas flow through the gas exchanger 4 via the other switching device 11. The user of the control device 11 can adjust the gas flow by actuating the other switching device 11. In particular, several control curves for the gas flow can be stored. By actuating the other switching device 11, the user can select a desired control curve and thus set the gas flow through the gas exchange unit 4.

[0089] As a result, in this design, the blood flow rate is set by the user by actuating the other adjustment device 9. Depending on the blood flow rate, the control or regulating device 1, in particular via the other switching device 11, controls or regulates the gas flow through the gas exchange unit 4.

[0090] Figure 15Figure 11 shows a perspective view of the control or regulating device 11 according to the ninth embodiment. Figure 11 shows... Figure 15 that the other setting device 9 and the other switching device 11 are each equipped with an operating knob. Reference list:

[0091] 1 Control or regulating device 2 Control or regulating unit 3 Blood pump 4 Gas exchange unit 5 Mixing device 6 Adjustment device 7 Additional mixing device 8 Additional adjustment device 9 Additional adjustment device 10 Switching device 11 Switching / adjusting device 12 Selection device 13 Gas connection unit 15 Pressure relief valve 16 Additional pressure relief valve 17 Housing 19 First source 20 Second source 21 Third source 22 Additional switching device 23 Venturi element 24 First line 25 Second line 26 Third line 27 Valve 28 Handle 29 Heater 30 Adjustment element 31 Display 32 Electrical line

Claims

1. Heart-lung machine with a blood pump (3), a gas exchange unit (4) and a control or regulation device (1) having a control or regulation unit (2) which controls or regulates both a blood volume flow conveyable through a blood pump (3) and a volume flow of a gas flowable through a gas exchange unit (4), the control or regulation device (1) having a housing (17), the control or regulation unit being arranged completely within a cavity of the housing (17), wherein the control or regulation unit (2) has another adjusting equipment (9), by means of which a volume flow of the gas that can be supplied to the blood pump (3) can be controlled or regulated, wherein the blood pump (3) is actuated by the gas in such a way that a pumping effect is caused and thus the blood volume flow is conveyed, whereby the blood volume flow is controlled or regulated by means of the other adjusting equipment (9), characterised in that the control or regulation unit (2) has a switching equipment (10) which is fluidically connected to the blood pump (3) and can be fluidically connected to the gas exchange unit (4), and that the switching equipment (10) can be used to adjust whether the gas flowing from the blood pump (3) is optionally supplied to the gas exchange unit (4) or is discharged to the environment.

2. Heart-lung machine according to claim 1, characterised in that the control or regulation unit (2) controls or regulates the gas volume flow depending on the blood volume flow.

3. Heart-lung machine according to any of claims 1 to 2, characterised in that at least one algorithm is stored that controls or regulates the ratio of gas volume flow and blood volume flow.

4. Heart-lung machine according to any of claims 1 to 3, characterised in that the control or regulation unit (2) has a mixing equipment (5) in which at least two gases can be mixed with one another.

5. Heart-lung machine according to claim 4, characterised in that the control or regulation unit (2) has an adjusting equipment (6), by means of which a volume flow and / or a composition of the gas flowing from the mixing equipment (5) can be controlled or regulated.

6. Heart-lung machine according to any of claims 4 to 5, characterised in that the control or regulation unit (2) has a further mixing equipment (7) for mixing gas and ambient air.

7. Heart-lung machine according to any of claims 1 to 6, characterised in that the control or regulation unit (2) has a switching adjustment equipment (11) for controlling or regulating a volume flow of the gas which can be supplied from the switching equipment (10) to the gas exchange unit (4).

8. Heart-lung machine according to any of claims 1 to 7, characterised in that the control or regulation unit (2) has a selection equipment (12), by means of which different operating modes of the control or regulation device (1) can optionally be adjusted and / or in that, by means of the selection equipment (12), optionally a. a first operating mode can be adjusted in which the switching equipment (10) is in the switching position, so that the same gas can be supplied to both the blood pump (3) and the gas exchange unit (4) or b. a second operating mode can be adjusted in which the switching equipment (10) is in the other switching position and in which the gas flowing from the mixing equipment (5) can be supplied to the gas exchange unit (4) or c. a third operating mode can be adjusted in which the switching equipment (10) is in the other switching position and in which the gas flowing from the further mixing equipment (7) can be supplied to the gas exchange unit (4).

9. Heart-lung machine according to any of claims 1 to 8, characterised in that the control and regulation device (1) has a safety equipment for monitoring operation of the control or regulation device.

10. Heart-lung machine according to any of claims 1 to 9, characterised in that the control or regulation unit (2) has a monitoring equipment for monitoring vital parameters of the patient.

11. Heart-lung machine according to any of claims 1 to 10, characterised in that the control or regulation unit (2) has a gas connection unit (13) which can be fluidically connected to a gas source or a plurality of gas sources.

12. Heart-lung machine according to claim 11, characterised in that the control or regulation unit (2) has a further switching equipment (22) which is designed in such a way that it automatically switches to another gas source following a failure of a gas source.

13. Heart-lung machine according to any of claims 1 to 12, characterised in that the control or regulation unit has a pressure relief valve (15) for preventing an excessively high gas volume flow from being supplied to the blood pump (3).

14. Heart-lung machine according to any of claims 1 to 13, characterised in that the control or regulation unit has another pressure relief valve (16) for preventing an excessively high gas volume flow from being supplied to the gas exchange unit (4).

15. Heart-lung machine according to any of claims 1 to 14, characterised in that the housing (17) has a handle (28).