TEMPERATURE MANAGEMENT SYSTEM FOR PATIENTS DURING STATIONARY AND MOBILE ECLS/ECMO THERAPY

Abstract

The present disclosure relates to a system for temperature management for patients in stationary and mobile ECLS and/or ECMO therapy, with a disposable and a fluid circuit, wherein the disposable comprises a reservoir or bag provided with at least one supply line and a drain line, further comprising a pumping unit element as part of the disposable, by means of which liquid in the reservoir or bag can be pumped through the fluid circuit, wherein in the mounted state of the system all fluid-guiding parts of the system are completely encapsulated and separated from intracorporeal and extracorporeal blood circuit of the patient undergoing the ECLS and/or ECMO therapy.

Claims

1. A system for temperature management for a patient in stationary and mobile ECLS and/or ECMO therapy, with at least one disposable and a fluid circuit, wherein the at least one disposable comprises at least one reservoir or bag provided with at least one supply line and a drain line, further comprising at least one pumping unit element as part of the at least one disposable, by which liquid in the at least one reservoir or bag can be pumped through the fluid circuit, wherein in a mounted state of the system all fluid-guiding parts of the system are completely encapsulated and separated from intracorporeal and extracorporeal blood circuit of the patient undergoing the mobile ECLS and/or ECMO therapy.

2. The system according to claim 1, wherein the disposable is configured such that it comprises all components which are in direct contact with heat transfer fluid.

3. The system according to claim 2, wherein the heat transfer fluid is a water based fluid.

4. The system according to claim 1, wherein the system further comprises at least one drive, wherein a pumping unit of the system comprises at least the pumping unit element and the at least one drive.

5. The system according to claim 1, wherein the at least one pumping unit element is a centrifugal pump head, which is part of the disposable.

6. The system according to claim 1, wherein the system comprises at least one heating and/or cooling unit.

7. The system according to claim 1, wherein the system comprises at least one validation element configured for validating and invalidating a disposable.

8. The system according to claim 1, wherein the system comprises a controller, which is configured for an assisted and/or semi-automated and/or an automated filling and/or venting function.

9. The system according to claim 1, wherein the system comprises an operating parameter recording module.

10. The system according to claim 1, wherein the system has a synchronization interface, by which data is interchangeable with one or more medical devices.

11. The system according to claim 1, wherein the system comprises a leak detector which is configured such that leaks in the fluid circuit are detected automatically.

12. The system according to claim 1, wherein the system comprises a pressure build up avoidance element, which his configured such that a pressure buildup in an oxygenator is impossible.

13. The system according to claim 1, wherein the system comprises a disposable and a re-usable and/or permanent temperature management device (D), in which the disposable is at least partially held during operation.

14. The disposable for the system according to claim 1.

15. A temperature management device (D) for the system according to claim 1.

16. A method for providing a temperature management to a water side of a heat exchanger of an oxygenator for ECLS and/or ECMO therapy by using the system according to claim 1, the method comprising: establishing a fluid circuit, which is completely encapsulated and separated from intracorporeal and extracorporeal blood circuit of the patient undergoing the ECLS and/or ECMO therapy, and providing a flow of a temperature management fluid by the fluid circuit to the water side of a heat exchanger.

17. The system according to claim 3, wherein the heat transfer fluid is a physiological saline solution.

18. The system according to claim 4, wherein the drive, which drives a pump head, is a part of the system and not a part of the disposable.

19. The system according to claim 9, wherein the operating parameter recording module comprises a patient data management interface by which data is exchangeable with a patient data management system.

20. The system according to claim 10, wherein via the synchronization interface at least one command for activation or de-activation of a temperature regulating module are interchangeable.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0075] It is shown in:

[0076] FIG. 1 a schematic overview of an embodiment of the disposable product in combination with the oxygenator;

[0077] FIG. 2 a schematic overview of an embodiment of the permanent device, in which the disposable used in FIG. 1 can be inserted and operated;

[0078] FIG. 3 a further schematic overview of a possible embodiment of the system, with a respective disposable and an oxygenator in operation and connected to the patient;

[0079] FIG. 4 a front view of an embodiment of the system according to the present disclosure with a closed door;

[0080] FIG. 5 a front view of the system according to FIG. 4 with an open door without disposable;

[0081] FIG. 6 a front view of the system according to FIG. 4 with an open door with disposable;

[0082] FIG. 7 a rear view of the system with closed back wall;

[0083] FIG. 8 a rear view of the system with open back wall;

[0084] FIG. 9 the disposable for the system as shown in FIG. 1 to FIG. 8; and

[0085] FIG. 10 shows the disposable connected to the heat exchanger of the oxygenator.

DETAILED DESCRIPTION

[0086] FIG. 1 shows a schematic representation of the system 5 according to an embodiment of the present disclosure.

[0087] The system 5 comprises a disposable 7 consisting of several single components or sections.

[0088] In an embodiment, the disposable 7 comprises a bag or reservoir 10.

[0089] Further, there is a pump section 11, here in the shown embodiment the form of a centrifugal pump head 11. It is, however, possible that the pump section 11 is realized with a different pump concept and technology.

[0090] Furthermore, the disposable 7 comprises several fluid lines, i.e. fluid line 12, fluid line 13 and fluid line 14.

[0091] The fluid line 12, the fluid line 13 and the fluid line 14 can be realized in the form of a (plastic) tube or by means of a tube. For example, PVC can be used as material.

[0092] The fluid line 12 is connected with the reservoir 10 and the pump section 11.

[0093] The fluid line 13 is connected to the pump section and has at its free end a connector 13a for connecting with the heat exchanger 15 (such as with the water side of the heat exchanger 15) of the oxygenator 16.

[0094] The fluid line 14 is connected to the reservoir 10 and has at its free end a connector 14a for connecting with the heat exchanger 15 of the oxygenator 16.

[0095] The connector 13a can be part of a standardized tube coupling. For example, a so-called Hansen Coupling can be used. The Hansen Coupling can be a plastic component and it can be made as a disposable.

[0096] The connector 14a can also be part of a standardized tube coupling. For example, a so-called Hansen Coupling can be used. The Hansen Coupling can be a plastic component and it can be made as a disposable.

[0097] The heat exchanger 15 and the oxygenator 16 are not necessarily part of the system 5, but they are connectable or as shown here connected to the system 5.

[0098] The fluid line 13 is in normal operation the supply line to feed the fluid for temperature management to the heat exchanger 15 of the oxygenator 16.

[0099] The fluid line 14 is in normal operation the drain line or line back from the heat exchanger 15 to the oxygenator.

[0100] The oxygenator circuit has the components heat exchanger 15 (blood side of the heat exchanger 15), oxygenator 16, fluid lines 17 and pump 18 (also here symbolizing the patient and the reservoir).

[0101] In other words, there is a connection of the fluid system within the disposable 7 of the system 5 for temperature management via connectors 13a and 14a to the oxygenation system, having the oxygenator 16 with its heat exchanger 15 and also showing the blood circulation of the patient.

[0102] The fully assembled system 5 can be described as follows:

[0103] The disposable comprises a bag/reservoir 10, which is connected via a tube 12 to the centrifugal pump head 11. Furthermore, the fluid line 13, here a PVC tube 13 is provided and is starting from the pump head 11 for connection to the (water side of the) oxygenator 16—such as to the (water side) inlet of the heat exchanger 15 of the oxygenator 16.

[0104] Another fluid line 14 tube 14 leads from the outlet of the heat exchanger 15 of the oxygenator 16 back to the bag 10 and thus closes the circuit. In addition, a three-way stopcock may be integrated in the tube 14. This can be used for initial filling and/or for venting the system.

[0105] Furthermore, in FIG. 1, the typical prior art structure of the blood circulation through the oxygenator is shown schematically. The blood of the patient is guided with tubes 17 through the oxygenator and thereby oxygenated. Also included in the circuit are typically a pump, a blood reservoir, and the patient 18.

[0106] Also contained in the disposable is a device 19 for storing relevant data (e.g., production date, expiration date, serial number, etc.). In addition, the disposable may be invalidated after first use. Multiple use of a disposable set can thus be eliminated. For example, an RFID tag can be used for this purpose.

[0107] As fluid for the temperature management in the system 5, i.e. within the reservoir 10, the fluid lines 12, 13 and 14 and also the pump head 11 any suitable heating fluid can be used, e.g. water.

[0108] For example, also a (sterile) physiological saline solution can be used, which is also helpful to reach another level of safety.

[0109] FIG. 2 schematically shows the structure of a permanent device D, in which the disposable 7 can be inserted and used.

[0110] The device D is a re-usable and/or permanent temperature management device D, in which the disposable 7 is at least partially held during operation. The heating unit 20 can be designed, for example, as a double-sided metal surface with an attached heating foil and/or (a) Peltier element(s), which heats the bag to the desired temperature with heat conducting means located therein on both sides.

[0111] It is possible that the device D has a main body with a door and that one metal surface is in the main body and another one in the door.

[0112] The heating unit 20 is not in direct contact with the heat conduction.

[0113] The heating unit 20 is also capable to provide a cooling. For heating and cooling, at least one peltier element can be used.

[0114] Via a tube guide 22, the safe and error-free use of the disposable product can be ensured. Here and within the whole device, the Poka-Yoke principle can be used.

[0115] Poka-Yoke is a Japanese term that means “mistake-proofing” or “inadvertent error prevention”. A poka-yoke is any mechanism in a process or design that helps an equipment operator to avoid (“yokeru”) mistakes (“poka”) defects by preventing, correcting or drawing attention to human errors as they occur.

[0116] In the context of the disclosure, this means especially that the disposable 7 can only be placed in one specific and safe manner into the device D.

[0117] The following points are or can be realized in this context (see also FIG. 4-6 and description below):

[0118] The pump head can be used in the specially manufactured pump head holder with the drive of the pump 21, for example by means of bayonet closure and secured against unintentional loosening. Further, in the door 30 there is a cavity 30a (see FIG. 5), which is designed hold the pump head 11 and which is adapted to the outer form of the pump head 11 and also only in one specific position, i.e. the correct position for the pump head 11 for operation. If the pump head 11 is not in the correct position, it will not fit into the cavity 30a and thus the door 30 cannot be closed.

[0119] Via the tube guide 23, the tube 13 can be guided to the oxygenator.

[0120] The tube guide 23 is fitted exactly to the length of the tube 12, which connects the reservoir 10 with the pump head 11.

[0121] The pump head 11 with its bayonet fixation mechanism must be correctly inserted and attached to the drive of the pump 21. This is also the first step, otherwise all other steps of mounting the disposable do not work correctly.

[0122] If the pump head 11 is not correctly mounted, it protrudes in such a way that the door cannot be closed. Further, there can be a counter-groove or opening or a receiving element, which receives the pump head 11 in the door of the device.

[0123] Also for the reservoir 10 there can be a cavity in the main body of the device, which is configured in a very specific and singular way to receive the reservoir 10.

[0124] The inner space of the device D is designed such that the part of the heating unit 20 in the door and the other part of the heating unit 20 in the main body 34 (cf. FIG. 4 and FIG. 5) have a defined distance between each other, which is adapted to the size and dimension of the fluid filled reservoir 10 in operation. For instance, in this fluid filled state the surfaces of the reservoir 10 are in contact with the parts/plates of the heating and/or cooling unit 20.

[0125] Additionally and/or alternatively, there may be fixation and/or positioning means such a fixation pins which are designed and configured to hold the reservoir 10. The reservoir may have specific holding openings or pin counterpart, which allow an attachment to the fixation and/or positioning pins.

[0126] In an embodiment, this cavity and the reservoir are configured asymmetrically such that the reservoir can only be inserted without mixing up the directions up and down. Only left and right orientation can be mixed up, but if this were mixed up then the pump head 11 cannot be fitted into the pump drive 21 without kinking and folding of the disposable 7 or the reservoir 10. This way, it is immediately clear that there is only one possible way of mounting the disposable into the device 10.

[0127] Without correct insertion of the reservoir 10, the disposable 7 with the tubes 12, 13, 14 and the pump head 11 to the respective receiving elements in the device D, system cannot be started.

[0128] Further, it is possible that the system can only be started, if the door of the device D is closed. As several design elements of the disposable 7 and the device D are configured such that an incorrect mounting of the disposable 7 to the device D will only lead to the fact that a part of the disposable is protruding, then the door of the device cannot be closed. This will then lead to a warning message and the system cannot start.

[0129] Via the tube guide 24, the tube of the return is fixed in the bag 10 and secured. An incorrect insertion of the tube or an unwanted kinking can be avoided.

[0130] To avoid the multiple use of a disposable set, a sensor 29, such as an NFC sensor, is integrated with the permanent device, e.g. in the door, which checks the NFC or RFID tag 19 in the disposable 7 for correctness (e.g., expiration date or prior use) and may invalidate it. Possible contamination through reuse can be made impossible. If during the set up process and the mounting of the disposable 7 to the device D the tag 19 is not recognized, the device will stop and issue an alert. No further mounting or driving of the system will be possible from this moment on.

[0131] Furthermore, all control functions and control algorithms can be integrated into a control unit 26, for example a board with integrated electronics and algorithms. This may include the control of the display, the pump and/or the heating unit, as well as the evaluation of sensors such as the NFC sensor and various temperature sensors which may be integrated in the heating unit.

[0132] In addition, the control unit 26 may comprise an operating parameter recording module, by means of which operating parameters of the system can be monitored and/or recorded.

[0133] The control unit 26 may further comprise a patient data management interface by means of which data is exchangeable with a patient data management system. For this purpose, the system may have a corresponding interface, which is formed here by a common synchronization interface. It is also conceivable that the patient data management interface communicates with other medical devices via wireless technologies.

[0134] Incidentally, it is conceivable that the control unit 26 may be formed by means of a synchronization interface. For example, a stop signal or a start command can be received by other medical devices connected to the overall system via the synchronization interface. Further, for example, a stop signal or warning signal may be sent to and/or forwarded to other medical devices in communication with the system. In addition, data can be exchanged via the synchronization interface.

[0135] Also, it is possible that blockages or obstructions or a kinking of a tube in the disposable or somewhere in the fluid pathway can be detected by the system 5, more specifically by the device D. This can be done by means of pressure control and by means of pressure sensors.

[0136] Alternatively and as implemented in the shown system 5 and device D, this is realized by implementing a monitoring routine and by detecting the power consumption of the drive unit 21.

[0137] For example, the number of revolutions of the pump, here e.g. a centrifugal pump, can be increased.

[0138] If the power uptake for this increase is not going up then this means that the transported and pumped fluid volume is not increased and does not match with the increased number of revolutions of the pump unit 21, rather the fluid in the pump head 11 itself is only moved within the pump head 11 but no real pumping happens anymore.

[0139] This is indicative for an obstruction, a blockage or a kinking of one of the tubes 12, 13, 14 or a part of the disposable 7.

[0140] An alert will then be issued by the system 5 and the device D, e.g. via the display 25 of the device D.

[0141] Another possible safety feature is a blood leakage detector in the device, which is monitoring the disposable. As the disposable and all fluid guiding parts are encapsulated and completely separated by design from the blood circuit of the patient, occurrence of blood is indicative for a severe failure. In an embodiment, it can be indicative of a failure in the heat exchanger of the oxygenator. Possible blood leakage detectors can be embodied by means of at least one optical detector monitoring the fluid conduit of the system.

[0142] By way of example, the following routine is conceivable for inserting the disposable set from FIG. 1 into the permanent device from FIG. 2.

[0143] The system 5 and the device D have an assisted and semi-automated filling and/or venting function. For instance, in this case and embodiment, the system comprises a controller which is configured for guided an automated filling and/or venting function. Guidance information is provided via a screen or display or any optical elements or acoustical elements. Instructions for setting up the filling and/or venting of the system are provided via e.g. the display and/or acoustical information, and this can be done step by step. Semi-automated assistance for filling and venting can be done that additionally to the assisted set up process of the system for filling and venting the filling is assisted by semi-automatically filling the disposable, e.g. by using the drive of the pump for the filling process.

[0144] The set up in general works as follows: [0145] 1. Insert the centrifugal pump head 11 in the pump head fixture 21 and engage by using the bayonet mechanism of the fixture [0146] 2. Insert the bag 10 in the fixtures of the heating unit 20 [0147] 3. Guide the tubing 12 along the predetermined tubing guide 22 [0148] 4. Guide the tubing 13 along the predetermined tubing guide 23 [0149] 5. Guide the tubing 14 along the predetermined tubing guide 24 [0150] 6. Connect the tubing 13 to the inlet of the heat exchanger 15 of the oxygenator 16 via the Hansen connectors 13a [0151] 7. Connect the tubing 14 to the outlet of the heat exchanger 15 of the oxygenator 16 via the Hansen connectors 14a [0152] 8. Fill the disposable with sterile fluid (e.g. water or NaCl) via the three-way-stopcock attached to the bag 10 [0153] 9. Perform the semi-automated priming process to remove all air from the disposable [0154] 10. Close the three-way-stopcock and insert it into the designated insert in the heating unit 20 [0155] 11. If all steps have been performed correctly, the operator is now able to easily and smoothly close and lock the door and start the device.

[0156] FIG. 3 shows a further schematic overview of the possible embodiment of the system 5 as shown in FIG. 1 und FIG. 2, with a respective disposable 7 and the oxygenator 16 in operation and connected to the patient P. As can be further seen in FIG. 3, the temperature management system 5 is connected to the heat exchanger 16 of the oxygenator 16.

[0157] The possible method of the system 5 with the respective disposable 7 and the device D can be as follows:

[0158] The system 5 with the device D and the disposable 7 is used as a support to control the patients' temperature during ECLS/ECMO using the heat exchanger 15 in the oxygenator 16. The user can set a desired target temperature to the temperature transporting fluid (e.g. water). Over time—depending on the environmental circumstances—the fluid is adjusted to target temperature. In the encapsulated circuit of the system 5, the fluid is pumped with the pump drive 21 to the heat exchanger 15 where the function of the heat exchanger transfers the temperature to the patient P.

[0159] On the blood side of the oxygenator 16, the blood is pumped by means of the centrifugal pump 18 via the line 17 (arterial line 17a) to the oxygenator 16, is there controlled and adjusted in its temperature by means of the heat exchanger 15 and pumped back to the patient P via venous line 17b.

[0160] FIG. 4 shows a front view of an embodiment of the system 5 and the device D according to the present disclosure, which is also shown schematically in FIG. 1 and FIG. 2. Here, the front door of the device D is closed.

[0161] The device D has a front door 30, hinges 32, a main body 34 and a door handle 36.

[0162] By means of the hinges 32, the door 30 can be pivoted relatively to the main body 34.

[0163] The door 30 is not completely covering the front surface of the main body 34, but leaves the space around the display 25 completely free, so that the display 25 is visible during operation and with a closed front door 30.

[0164] The display 25 can be a touchscreen as shown here. On the display, the graphical user interface (GUI) will be displayed.

[0165] The graphical user interface shows the setup routine visually in a step by step process.

[0166] After finishing the setup routine, the user can set the target temperature in a range from 34° C. to 38.5° C. and start the therapy.

[0167] The status of the device is constantly displayed.

[0168] To increase the usability, the graphical user interface can alternatively be adjusted with navigation buttons on the bottom side of the display.

[0169] To protect the device from unwanted changes in the settings, a lockscreen is available.

[0170] The display lock protects from unwanted commands caused for example by splashing fluids or during cleaning of the surface.

[0171] FIG. 5 shows a front view of the system 5 according to FIG. 4 with an open door without disposable.

[0172] As can be seen, in the door there is a heating unit 20 and also a sensor unit 29.

[0173] The heating unit 20 is embodied as an aluminum plate. It is designed to provide a heating functionality only.

[0174] The sensor unit 29 is capable to monitor the temperature.

[0175] Also, there can be a further sensor to check the NFC tag of the disposable. This sensor can be placed within the main body 34, e.g. behind one of the parts of the heating unit 20.

[0176] There is another heating unit 20 located in a cavity 38 of the main body 34, also embodied as aluminum plate. Here, a heating and also a cooling function can be provided.

[0177] From the cavity 38, the tube guide 22 is formed as a channel in the surface of the main body 34 and leads to the pump drive 21.

[0178] Also the other tube guides 23 and 24 are formed as a channel in the surface of the main body 34.

[0179] One aluminum plate is in the door 30 of the device D and one in the main body 34.

[0180] FIG. 6 shows a front view of the system 5 according to FIG. 4 with an open door 30 of the device D, with the disposable 7 being correctly inserted into the cavity 38 and the tubes guides 22, 23 and 24.

[0181] As can be seen, there is a stopcock 10a attached to the reservoir 10.

[0182] This stopcock 10a or 3-way valve 10a can also be connected to the reservoir 10.

[0183] The stopcock 10a has one opening being connected to the reservoir 10, and two free ends, i.e. two free Luer-connectors. One Luer connector can be used for fluid supply during filling, and one for air removal during filling.

[0184] The stopcock 10a can be placed in a specific stopcock cavity 38a (see FIG. 5). It is possible that the stopcock cavity is designed such that the stopcock is correctly and completely received within the stopcock cavity only when the stopcock is correctly closed (i.e. the two free Luer-connectors are closed) and the reservoir is no longer open.

[0185] FIG. 7 and FIG. 8 show a rear view of the system 5.

[0186] In FIG. 7 the device D is shown with the opened door 30 and the main body 34.

[0187] In FIG. 8, the system 5 with an open back wall is shown. As can be seen here, the control unit 26 and its electronics with a printed circuit board (PCB) are accessible from the rear part of the device D.

[0188] The device D has a 24V power supply 40 with an external DCDC converter in this embodiment.

[0189] FIG. 9 shows the disposable 7 with the reservoir 10, the stopcock 10a, the fluid line 12, the centrifugal pump head 11, the fluid line 13, the Hansen connector 13a (Hansen Coupling 13a), the fluid line 14 with the Hansen connector 14a (Hansen Coupling 14a).

[0190] FIG. 10 shows the disposable 7 with all the elements as shown in FIG. 9 connected to the heat exchanger 15 of the oxygenator 16.

[0191] The function of the system 5 can be described as follows:

[0192] As part of the encapsulated circuit, there is a bag 10, i.e. the reservoir 10 located between two aluminum plates forming the two heating units 20. The aluminum plates are used to adjust the temperature of the fluid in the bag 10.

[0193] There are three different modes available. Before starting a new therapy, the user is guided to set up the disposable in the device. Once the setup is finished, the user sets the desired target temperature which leads to either heating or cooling.

[0194] In the setup routine, the user visually guided by the display to step by step set up a new disposable set in the device D. The main steps, which are displayed, are: [0195] 1. Insert the pump head [0196] 2. Insert the bag [0197] 3. Connect to Oxygenator [0198] 4. Fill with fluid and remove air [0199] 5. Close door (locks disposable)

[0200] Once the disposable set is installed correctly, the user can access the main menu to adjust the desired target temperature and start the therapy.

[0201] In a typical use case, the intention of the operator is to compensate the lost temperature to the environment through the extracorporeal tubes. The operator uses the graphical user interface on the display 25 to set the desired temperature, e.g. 38° C. As a result the two aluminum plates will (in the door 30 and also in the main housing 34) heat up to transfer heat to the fluid. To minimize risk to patient and operator, the heating plates will not be heated to more than a user-defined or pre-defined maximum value, such as e.g. 45° C. The permanent target of the heating plates are to reach the target temperature in the fluid. Depending on the environmental circumstances, the time until the target temperature is reached can differ.

[0202] In another use case, the intention of the operator is to gently cool down the patient, possibly in case when he shows fever. The operator uses the graphical user interface on the display 25 to set the desired temperature, e.g. 35° C. As a result the aluminum plate in the main body 34 will cool down to remove temperature from the fluid. The aluminum plate in the door 30 will not operate in that time and remains on normal temperature. The permanent target of the cooling plate is to reach the target temperature in the fluid. Depending on the environmental circumstances, the time until the target temperature is reached can differ.

[0203] The safety features and advantages of system 5 and the device D can be summarized as follows:

[0204] The main feature of the device is that the water circulation is completely detached and separated from the device D. This is realized by the usage of a sterile disposable. Heating and pumping of the heating fluid as well as temperature- and flow-control are handled non-invasively. Thus, the contamination of the device can be reduced to a minimum and a sterile and safe patient blood temperature management is guaranteed.

[0205] The disposable 7 and the disposable integrating interface in the device D are designed to provide maximum safety in terms of safety and usability.

[0206] All safety features and measures to archive maximum safety in this specific regards are listed here: [0207] The pumphead is detected by the pump. If the pump head is removed, this will be detected and operation is not possible. [0208] The pumphead must be locked with bayonet mechanism. There is no operation possible when the pumphead is inserted but not locked, because of multiple reasons: [0209] The door can physically not be closed if the pump head is not turned all the way to lock position. The tube does not fit the tube guide yet the door cannot be closed. [0210] All tubes in the device are guided. If a tube is not correctly installed in the guide, the tube will block the door from being closed. As a result no operation is possible. [0211] The bag mount has four fixation points defining the exact location of the bag. [0212] There is an NFC tag located on the bag. If the bag does not have the correct position, the NFC tag is not detected hence there is no operation possible. [0213] To increase comfort in usability for the operator, there is a three-way-stopcock located on the top side of the bag. It serves two purposes. It allows the operator to comfortably fill the bag while letting the operator remove air at the same time only by turning the handle of the three-way-stopcock. [0214] The three-way-stopcock can only be placed in the housing in a way that it is closed. If the handle is rotated in a way that opens an unwanted outlet, it blocks the door from being closed, hence no operation is possible. [0215] There is a water level detector installed to ensure there is sufficient water in the disposable bag. Potential leaks will case a drop in the water level. The water level sensor detects this during the setup routine or during therapy so that the device D can act accordingly. [0216] The status of the door is automatically detected. As long as the door is open, the operator cannot start therapy. [0217] Once the door is closed, all sensitive parts of the disposable are covered so that they cannot accidently be manipulated. The door forces all disposable elements to stay in place. [0218] Between the device D and the oxygenator the tubes are not guided and can be accessed. [0219] An integrated occlusion detection notifies the operator about a potential hazardous situation caused by an occlusion or a kink in the tube, see above description in connection with the monitoring of the power consumption. There is an alarm if during therapy the fluid flow can be stopped so that the operator can react immediately.

[0220] Summarizing, it can be said that to solve the main problems with current devices on the market by design, the heating fluid in the system 5 is encapsulated in a sterile disposable set 7. For every therapy, a new clean and sterile disposable set must be used. With this, all components touching the fluid will be disposed after usage. This includes the tubes (i.e. fluid lines 12, 13, 14), the bag 10 (reservoir 10), the pump-head 11 and the connectors of the disposable set 7. This design enables the user to eliminate the risk of contamination and the need for a complex cleaning process of the device D.

[0221] FIGS. 1-10 show example configurations with relative positioning of the various components. If shown directly contacting each other, or directly coupled, then such elements may be referred to as directly contacting or directly coupled, respectively, at least in one example. Similarly, elements shown contiguous or adjacent to one another may be contiguous or adjacent to each other, respectively, at least in one example. As an example, components laying in face-sharing contact with each other may be referred to as in face-sharing contact. As another example, elements positioned apart from each other with only a space there-between and no other components may be referred to as such, in at least one example. As yet another example, elements shown above/below one another, at opposite sides to one another, or to the left/right of one another may be referred to as such, relative to one another. Further, as shown in the figures, a topmost element or point of element may be referred to as a “top” of the component and a bottommost element or point of the element may be referred to as a “bottom” of the component, in at least one example. FIGS. 4-10 are drawn to scale.

[0222] As used herein, top/bottom, upper/lower, above/below, may be relative to a vertical axis of the figures and used to describe positioning of elements of the figures relative to one another. As such, elements shown above other elements are positioned vertically above the other elements, in one example. As yet another example, shapes of the elements depicted within the figures may be referred to as having those shapes (e.g., such as being circular, straight, planar, curved, rounded, chamfered, angled, or the like). Further, elements shown intersecting one another may be referred to as intersecting elements or intersecting one another, in at least one example. Further still, an element shown within another element or shown outside of another element may be referred as such, in one example.

[0223] The following claims particularly point out certain combinations and sub-combinations regarded as novel and non-obvious. These claims may refer to “an” element or “a first” element or the equivalent thereof. Such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements. Other combinations and sub-combinations of the disclosed features, functions, elements, and/or properties may be claimed through amendment of the present claims or through presentation of new claims in this or a related application. Such claims, whether broader, narrower, equal, or different in scope to the original claims, also are regarded as included within the subject matter of the present disclosure.

REFERENCE NUMBERS

[0224] 5 System [0225] 7 Disposable [0226] 9 Fluid Circuit [0227] 10 Bag/reservoir [0228] 10a stopcock [0229] 11 Centrifugal pump head [0230] 12 Tube to centrifugal pump head [0231] 13 Tube to oxygenator [0232] 13a Connector [0233] 14 Tube from oxygenator with three-way spigot [0234] 14a Connector [0235] 15 Heat exchanger of the oxygenator [0236] 16 Oxygenator [0237] 17 Blood-bearing tubes [0238] 17a Arterial Line [0239] 17b Venous Line [0240] 18 Pump, blood reservoir and patient [0241] 19 Device for storing relevant data [0242] 20 Heating unit [0243] 21 Pump drive [0244] 22 Tube guide to centrifugal pump head [0245] 23 Tube guide to oxygenator [0246] 24 Tube guide from the oxygenator with three-way spigot [0247] 25 Display [0248] 26 Control unit [0249] 29 Sensor for reading the data in the disposable set [0250] 30 Door [0251] 32 Hinge [0252] 34 Main Body [0253] 36 Door handle [0254] 38 Cavity [0255] 40 Power Supply [0256] D Temperature Management Device [0257] P Patient