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

Abstract

The present invention relates to a system (5) for temperature management for patients in stationary and mobile ECLS and/or ECMO therapy, with at least one disposable (7) and a fluid circuit (9), wherein the disposable (7) comprises at least one reservoir (10) or bag provided with at least one supply line (12) and a drain line (14), further provided at least one pumping unit element (11) as part of the disposable (7), by means of which liquid in the reservoir (10) or bag can be pumped through the fluid circuit (9).

Furthermore, the present invention relates to a disposable (7) for such a system (5).

Claims

1. System (5) for temperature management for patients in stationary and mobile ECLS and/or ECMO therapy, with at least one disposable (7) and a fluid circuit (9), wherein the disposable (7) comprises at least one reservoir (10) or bag provided with at least one supply line (12) and a drain line (14), further provided at least one pumping unit element (11) as part of the disposable (7), by means of which liquid in the reservoir (10) or bag can be pumped through the fluid circuit (9).

2. The system (5) according to claim 1, characterized in that the disposable (7) is configured such that it comprises all components which are in direct contact with the heat transfer fluid.

3. The system (5) according to claim 1 or claim 2, characterized in that a pumping unit of the system (5) consists at least of the pumping unit element (11) and a at least one drive (21), wherein one pumping unit element (11) is a centrifugal pump head being part of the disposable product and further, wherein the drive (21), which controls the pump head, is a part of the system and not part of the disposable (7).

4. The system (5) according to one of the preceding claims, characterized in that the system (5) comprises at least one heating unit (20).

5. The system (5) according to any one of the preceding claims, characterized in that the system (5) has a validation element configured for validating and invalidating a disposable (7).

6. The system (5) according to one of the preceding claims, characterized in that the system (5) comprises a controller which is configured for an automated filling and/or venting function.

7. The system (5) according to the preceding claims, characterized in that the system (5) comprises an operating parameter recording module, which comprises a patient data management interface by means of which data is exchangeable with a patient data management system.

8. The system (5) according to one of the preceding claims, characterized in that the system has a synchronization interface, by means of which data is interchangeable with one or more medical devices, in particular wherein via the synchronization interface at least one command for activation or de-activation of the temperature regulating module are interchangeable.

9. The system (5) according to one of the preceding claims, characterized in that the system (5) comprises a leak detector which is configured such that leaks in the hose system are detected automatically.

10. The system (5) according to one of the preceding claims, characterized in that the system (5) comprises a pressure build up avoidance element, which his configured such that a pressure build up in the oxygenator is impossible.

11. Disposable (7) for a system (5) according to one of the preceding claims.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0040] Further details and advantages of the invention will now be explained with reference to an embodiment shown in more detail in the drawings. The described embodiments are to be considered in all respects only as illustrative and not restrictive, and various combinations of the recited features are included in the invention.

[0041] It shown in:

[0042] FIG. 1 a schematic overview of an embodiment of the disposable product in combination with the oxygenator;

[0043] 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.

DETAILED DESCRIPTION

[0044] FIG. 1 shows a schematic representation of the system 5 according to an embodiment of the present invention with the assembled disposable 7 consisting of several single components, as well as the connection to the existing system 5 with a fluid circuit 9, having an oxygenator and also showing the blood circulation of the patient.

[0045] The disposable comprises a bag/reservoir 10, which is connected via a hose 12 to the centrifugal pump head 11. Furthermore, a hose 13 is contained starting from the pump head for connection to the oxygenator 16—in particular to the inlet of the heat exchanger 15 of the oxygenator 16.

[0046] Another 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 spigot may be integrated in the hose 14. This can be used for initial filling and/or for venting the system.

[0047] 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.

[0048] 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.

[0049] FIG. 2 schematically shows the structure of the permanent device, in which the disposable product can be inserted and used.

[0050] The heating unit 20 can be designed, for example, as a double-sided metal surface with an attached heating foil, which heats the bag to the desired temperature with heat conducting means located therein on both sides. The heating unit 20 is not in direct contact with the heat conduction.

[0051] Via a hose guide 22, the safe and error-free use of the disposable product can be ensured. Here, the Poka-Yoke principle can be used. 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. Via the hose guide 23, the hose 13 can be guided to the oxygenator.

[0052] Via the hose guide 24, the hose of the return is fixed in the bag 10 and secured. An incorrect insertion of the hose or an unwanted kinking can be avoided.

[0053] To avoid the multiple use of a disposable set, a sensor 29, such as an NFC sensor, is integrated with the permanent device which checks the 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.

[0054] 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.

[0055] In addition, the control unit 26 may comprise of an operating parameter recording module, by means of which operating parameters of the system can be monitored and/or recorded.

[0056] 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.

[0057] 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.

[0058] By way of example, the following routine is conceivable for inserting the disposable set from FIG. 1 into the permanent device from FIG. 2:

[0059] 1. Inserting the bag 10 in the fixture of the heating unit 20.

[0060] 2. Guide the tube 12 along the predetermined tube guide 22.

[0061] 3. Inserting centrifugal pump head 11 in the pump head fixture 21 and engage by using bayonet mechanism.

[0062] 4. Guide the hose 13 along the predetermined hose guide 23.

[0063] 5. Connecting the hose 13 to the inlet of the heat exchanger 15 of the oxygenator 16.

[0064] 6. Connecting the hose 14 at the outlet of the heat exchanger 15 of the oxygenator 16.

[0065] 7. Guide the hose 14 along the predetermined hose guide 24.

[0066] 8. Fill the disposable set with sterile fluid (e.g. NaCl) or unsterile fluid (e.g. water) by using the three-way spigot on hose 14.

[0067] 9. If necessary, use three-way spigot on hose 14 to vent air.

REFERENCE NUMBERS

[0068] 5 System [0069] 7 Disposable [0070] 9 Fluid Circuit [0071] 10 Bag/reservoir [0072] 11 Centrifugal pump head [0073] 12 Hose to centrifugal pump head [0074] 13 Tube to oxygenator [0075] 14 Tube from oxygenator with three-way spigot [0076] 15 Heat exchanger of the oxygenator [0077] 16 Oxygenator [0078] 17 Blood-bearing tubes [0079] 18 Pump, blood reservoir and patient [0080] 19 Device for storing relevant data [0081] 20 Heating unit [0082] 21 Pump drive [0083] 22 Hose guide to centrifugal pump head [0084] 23 Hose guide to oxygenator [0085] 24 Hose guide from the oxygenator with three-way spigot [0086] 25 Display [0087] 26 Control unit [0088] 29 Sensor for reading the data in the disposable set