System for irrigating a wound and / or a body cavity, particularly the pericardial cavity

Abstract

The present invention relates to an irrigation system (1,200, 300, 400, 500) configured to irrigate a wound and / or a body cavity, particularly a pericardial cavity (PC) and / or one or more pleural cavities, of a patient, the system (1,200, 300, 400, 500) including an infusate lumen for connecting a first tube (4) having an infusate lumen for directing the flow of infusate from the system (1,200, 300, 400, 500) to the wound and / or body cavity, particularly the pericardial cavity (PC). an outlet (2), an effluent inlet (6) for connecting to a second tube (8) having an effluent lumen for directing the flow of effluent from the wound and / or body cavity, particularly the pericardial cavity (PC), to the system (1, 200, 300, 400, 500); a buffer container (10) having a buffer volume and including a buffer inlet (12) for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity (PC), and a first buffer outlet (14) for outputting the received effluent; a flow rate control system for controlling the flow rate of effluent output from a buffer container (10), the flow rate control system comprising: a control unit (16) for providing one or more control signals; and a first pump device (18) for pumping effluent from the buffer container (10) to one or more effluent containers (20) at an effluent flow rate adjustable by the control signal of the control unit (16), wherein the buffer container (10) comprises a clot trap (22) configured to prevent blood clots contained in the effluent received from the wound and / or body cavity, in particular the pericardial cavity (PC), from exiting the buffer container (10) via the first buffer outlet (14); and / or wherein the buffer container (10) is configured for gas-liquid separation and / or configured to have a safety bypass and / or provides a flushing system (1, 200, 300, 400, 500) configured to receive a liquid overflow.

Description

[Technical Field]

[0001] The present invention relates to an irrigation system configured for post-operative irrigation of a patient's wound and / or body cavity, particularly the pericardial cavity. In particular, the present invention relates to an irrigation system for irrigating a patient's wound and / or body cavity, particularly the pericardial cavity, as a post-operative treatment to reduce post-operative blood loss, reduce blood and clot accumulation in the wound and / or body cavity, particularly the pericardial cavity, reduce the risk of cardiac tamponade, and reduce complications associated with blood loss and clotting. [Background technology]

[0002] Excessive postoperative bleeding, occurring at rates exceeding 2 liters per 24 hours or 200 ml per hour, is a known cause of cardiac surgery complications. Reoperation / reopening due to bleeding is a strong independent risk factor for poor outcomes after cardiac surgery, with higher mortality and morbidity. Postoperative bleeding requiring multiple transfusions and surgical reopening is also associated with higher costs, an increased risk of sternal wound infection, and transfusion-associated infection.

[0003] Chest tubes are placed postoperatively to drain blood from the pericardial and, if necessary, pleural spaces. However, if blood loss is excessive or clots begin to form more rapidly, the drains often fail to drain all of the accumulated blood. Stagnation of clots and blood in the pericardial (and / or pleural) spaces can increase fibrinolytic activity, persist bleeding, and potentially lead to cardiac tamponade, resulting in excessive cardiac filling pressures.

[0004] A pericardial flushing system may be specifically designed for irrigating the pericardial cavity after cardiac surgery. By flushing the pericardial cavity with saline (or other) solution, the system reduces the viscosity and hematocrit of blood present within the cavity while simultaneously preventing the formation of larger blood clots. By flushing the pericardial cavity, clogging of the chest tube and the resulting accumulation of blood and clots within the pericardial cavity are prevented. This reduces postoperative bleeding and the risk of inducing acute cardiac tamponade. In this regard, to obtain the amount of blood loss during flushing, the system may include a sensor means, particularly a hematocrit sensor, for providing a measure of blood loss.

[0005] However, the accuracy and / or precision of measurements by such sensor means may also depend on other factors, such as blood clots and / or air, which may be present in the diluted pericardial blood effluent and affect the measurements. Furthermore, the flow of the fluid being measured may also affect the accuracy of the results of the measurements, with a steady flow typically being preferred. Therefore, there is a need to provide the effluent received from the pericardial cavity in a more suitable / optimal state for further processing, e.g., analysis.

[0006] An example of prior art relating to a pericardial washout system is described, for example, in WO2015 / 086857A1. Summary of the Invention

[0007] It is therefore an object of the present invention to provide an irrigation system configured to irrigate a wound and / or body cavity, particularly the pericardial cavity, of a patient that can be more precisely manipulated.

[0008] This is achieved by a flushing system as defined in claim 1, which is configured to flush a wound and / or a body cavity, in particular the pericardial cavity, of a patient.

[0009] In this regard, there is provided an irrigation system configured to irrigate a wound and / or body cavity, in particular a pericardial cavity and / or one or more pleural cavities, of a patient, the system comprising: an infusate outlet for connecting a first tube having an infusate lumen for directing the flow of infusate from the system to the wound and / or body cavity, particularly the pericardial cavity; an effluent inlet for connecting to a second tube having an effluent lumen for directing effluent flow from the wound and / or body cavity, particularly the pericardial cavity, into the system; a buffer container having a buffer volume, the buffer container including a buffer inlet for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity, and a first buffer outlet for outputting the received effluent; 1. A flow rate control system for controlling a flow rate (e.g., a volume) of effluent output from a buffer reservoir, the flow rate control system comprising: a control unit for providing one or more control signals; a flow rate control system including: a first pump device for pumping effluent from the buffer container to (e.g., towards) one or more effluent containers at an effluent flow rate (e.g., a constant volume), the effluent flow rate (e.g., the volume) being adjustable by a control signal from a control unit; The buffer container comprises an (optional) clot trap configured to prevent clots contained in effluent received from the wound and / or body cavity, in particular the pericardial cavity, from leaving the buffer container via the first buffer outlet, and / or the buffer container is configured for gas-liquid separation and / or configured to have a safety bypass and / or configured to receive liquid overflow.

[0010] The present invention is based in particular on the idea that the buffer container can provide different functions that can be realized and / or generated dependently or independently, among which, firstly, clots can be trapped by the clot trap described above, secondly, air and liquid can be separated from each other, thirdly, sudden surges of effluent can be collected, and fourthly, the effluent can be provided for careful measurement. Furthermore, the gas-liquid separation and / or safety bypass can make it possible to apply a constant vacuum to the wound and / or body cavity, in particular the pericardial cavity, for drainage. In this respect, on the one hand, the effluent is buffered before being further conducted for subsequent procedures (such as analysis), and on the other hand, the effluent is freed from clots.

[0011] This is achieved by providing a buffer vessel that includes a clot trap. The clot trap prevents clots contained in the effluent from being further introduced. The clot trap may be a mechanical means. Buffering the effluent may provide a more stable and constant (e.g., known) flow rate exiting the buffer vessel for further procedures, thereby allowing subsequent sensor means to make more accurate measurements.

[0012] The removal of the clot may also enable subsequent sensor means to perform more accurate measurements. Furthermore, the buffer container may act as a pressure safety measure. In this regard, the buffer volume of the buffer container may store liquid that may otherwise be causing backpressure / inflow in the system (e.g., towards the effluent inlet). Furthermore, the buffer container may vent the effluent so that air can be expelled therefrom in order not to affect subsequent analysis / measurements. In other words, the buffer container may be configured to separate air from liquids, particularly the effluent.

[0013] The buffer container may have a generally cylindrical shape extending along a central axis. However, it should be understood that any other shape is possible in this regard. The buffer container may include an upper end and a lower end. The buffer container may include a top wall, a side wall, and a bottom wall. The buffer inlet may be located closer to the top wall than to the bottom wall. The first buffer outlet may be located closer to the bottom wall than to the top wall. The buffer inlet may be located in the top wall or the side wall. The first buffer outlet may be located in the bottom wall or the side wall. Thus, the buffer inlet may be located at a higher level than the first buffer outlet with respect to the direction of gravity. When the buffer container is incorporated, e.g., installed, into a system, the central axis extends substantially along the direction of gravity.

[0014] The flush system may be configured to provide approximately 100-1000 ml / hour of infusion fluid, e.g., approximately 500 ml per hour, i.e., the inflow rate of infusion fluid may be approximately 500 ml per hour. The size of the buffer volume may therefore be adjusted accordingly. However, the system, and therefore the buffer volume, may also be configured to accommodate sudden bursts of effluent of 400 ml and / or 500 ml per 5 minutes. In a possible setup, the flush system may be configured to provide effluent at approximately 100-1000 ml / hour. The flow rate may be user-adjustable, i.e., user-adjustable.

[0015] The clot trap may include a sieving structure disposed between the buffer inlet and the first buffer outlet of the buffer container to prevent clots from passing through the first buffer outlet. The clot trap may be integrally formed with the buffer container (e.g., in a side wall or bottom wall of the buffer container). Alternatively, the clot trap may be attached to the buffer container via a fastening means. The sieving structure may include a plurality of openings formed therein. The openings may be configured to prevent clots from passing through the sieving structure.

[0016] The sieve structure can be placed vertically in the mounted state, which helps, among other things, to ensure that throughput during filling of the buffer always occurs.

[0017] Additionally, the sieve structure separates the clots in the upper part of the buffer (when the system is running) from the fluid in the lower part of the buffer (when running), and the level sensor is only activated by the fluid in the lower part of the buffer, which (among other things) prevents collected clots from (unintentionally) triggering the level sensor.

[0018] The clot trap may have a vertical shape with a base facing the first buffer outlet and an apex facing the buffer inlet. The clot trap may also have other shapes, such as a truncated cone shape, a cone shape, a dome shape, a flat shape, etc. In particular, the clot trap shape may allow a certain amount of clots to be trapped within the clot trap without clogging the clot trap.

[0019] The buffer container may further comprise at least one level sensor for obtaining the fill level of at least one of the buffer volumes.

[0020] The buffer container may further comprise a first level sensor for obtaining a first filling level of the buffer volume and a second level sensor for obtaining a second filling level of the buffer volume, the second level sensor being positioned at a higher level than the first level sensor relative to the direction of gravity.

[0021] The level sensor (e.g., the level sensor described above) may be configured to obtain the fill level, for example, mechanically or optically, although any other suitable sensor (such as a capacitive sensor, a resistive sensor, an ultrasonic sensor, etc.) may also be applicable.

[0022] The control unit may control the first pump device to adjust the effluent rate (e.g., pumped volume) from the buffer reservoir by providing at least one control signal based on the obtained buffer volume fill level and / or buffer reservoir level. Thus, the buffer reservoir may collect effluent until it can be pumped by the first pump device. This may allow a steady flow of effluent to occur in a controlled manner. As a result, subsequent analytical means may perform accurate measurements on the effluent.

[0023] The control unit may be configured to control the first pump device to pump a predetermined, i.e., known, volume based on the control signal. For example, the control unit may be configured to control the first pump device to pump a volume of about 5-50 ml, e.g., 10 ml, which may be referred to as a batch. However, any other volume may be pumped based on the control signal of the control unit. This may allow the first pump device to be operated discontinuously by the control unit. Additionally or alternatively, the first pump device may be controlled by a control signal that is based on the volume of effluent.

[0024] The first pump device may comprise a peristaltic pump. Additionally or alternatively, it is contemplated that the first pump device may comprise a positive displacement pump, a membrane pump, an impeller pump, and / or a syringe pump device including a syringe pump and, optionally, at least two valves. In particular, the first pump device may be any pump device (with or without valves, e.g., separate valves) suitable for the effluent, preferably of a type capable of pumping at a relatively precise flow rate (e.g., a type capable of precisely pumping a (constant) volume). For example, peristaltic pumps and syringe pumps may be configured to gently transport sensitive materials, such as blood cells, that may be destroyed by rapidly moving or rotating elements that may be part of other types of pumps.

[0025] The peristaltic pump may perform continuous and / or discontinuous pumping operations. The syringe pump may perform discontinuous pumping operations, the pumping operations of which include a suction step and a discharge step. In the suction step, a first valve provided upstream of the syringe pump is opened and a second valve provided downstream of the syringe pump is closed. In the discharge step, the first valve is closed and the second valve is opened.

[0026] The system may further comprise one or more effluent containers (described above) for receiving effluent from the buffer container. The one or more effluent containers may be connectable to or connected to the buffer container (e.g., via the first buffer outlet).

[0027] The flushing system may further comprise one or more suction devices for drawing effluent from the wound and / or body cavity, particularly the pericardial cavity. The one or more suction devices may be positioned to create a relatively low pressure in the one or more effluent containers to receive the effluent, such that the effluent is drawn into the one or more effluent containers.

[0028] For example, one or more effluent containers may be connectable to or connected to an intensive care unit (ICU) vacuum wall connector or the like (e.g., any other suitable vacuum supply unit / system and / or any other suitable custom-made vacuum unit), which may be configured to create the (relative) low pressure described above, thereby functioning as one or more of the suction devices described above. Additionally or alternatively, the system may be provided with its own vacuum unit specifically for the above purpose.

[0029] The buffer container may further include a second buffer outlet, which is disposed at a higher level than the first buffer outlet in the direction of gravity and which outputs effluent and / or air, thereby enabling gas-liquid separation and / or functioning as a safety bypass. Furthermore, the second buffer outlet may be disposed at a lower level than the buffer inlet in the direction of gravity. The second buffer outlet may be connectable to or connected to one or more effluent containers. For example, the second buffer outlet may be connectable to or connected to one or more effluent containers directly and / or in a permanently open manner.

[0030] The second buffer outlet may be located on an opposite side of the clot trap to the first buffer outlet, and therefore on the same side as the buffer inlet.

[0031] The second buffer outlet may provide an open connection to one or more effluent containers by functioning as a safety overflow and / or safety bypass from the buffer container for safety reasons (e.g., to prevent backpressure / overflow). Additionally, the second buffer outlet may also provide an exit path for air that is separated from the effluent in the buffer container. The separated air may be sucked into one or more suction devices, e.g., an ICU vacuum wall connector and / or the system's own vacuum unit.

[0032] In other words, the separated air may be sucked through one or more effluent containers into the ICU vacuum wall connector and / or the vacuum unit of the system itself. Thus, due to the lack of air in the effluent, the effluent can be or is subsequently analyzed in a more accurate and reliable manner.

[0033] The system may further comprise a hematocrit sensor configured to measure the hematocrit of the effluent to obtain the amount and / or flow rate of blood loss from the wound and / or body cavity, particularly the pericardial cavity, and the hematocrit sensor may be configured to optically measure said hematocrit based on scattering and absorption of light emitted in the effluent.

[0034] Hematocrit analysis and / or measurement of effluent fluid (effluent) allows for more accurate calculation of the exact blood loss, which can improve clinical decisions made regarding optimal timing of re-exploration and transfusion strategy.

[0035] Alternatively or additionally, blood loss can be calculated by measuring hemoglobin levels.

[0036] A combined measurement based on hematocrit and hemoglobin can provide a very accurate analysis.

[0037] A hematocrit sensor may be provided for measuring the effluent pumped from the buffer reservoir to one or more effluent containers. Accordingly, the hematocrit sensor may be located downstream of the buffer reservoir and upstream of one or more effluent containers. This hematocrit sensor location may provide accurate hematocrit measurements without being adversely affected by clots and / or air in the effluent.

[0038] Furthermore, the control unit may control the first pump device with respect to the amount of fluid pumped, so that the measured hematocrit value may be set relative to the pumped amount, the hematocrit value being measured by the sensor. Thus, the amount and / or flow rate of blood loss from a wound and / or body cavity, in particular the pericardial cavity, may be measured in a simple, reliable, and / or accurate manner.

[0039] It is also contemplated that the system may further comprise and / or be connectable to a unit for bleeding measurement and / or patient systematic measurement configured to obtain the amount and / or flow rate of blood loss from the wound and / or body cavity, in particular the pericardial cavity (PC).

[0040] The system may include a second pumping device for pumping the infusate to the infusate outlet at an infusate flow rate that may be adjustable by a control signal from the control unit. The second pumping device may be any pumping device suitable for infusate, preferably of a type that can pump at a relatively precise flow rate (e.g., to an accuracy of 2% or better at a nominal flow rate of 500 ml / hour). In this regard, the second pumping device may be a peristaltic pump.

[0041] Additionally or alternatively, the second pump device may comprise a positive displacement pump, a membrane pump, an impeller pump, and / or a syringe pump device including a syringe pump and optionally at least two valves. The second pump device may be connectable to or connected to one or more infusion fluid containers.

[0042] Thus, optionally, the system may include one or more infusate containers as described above containing infusate, such as multiple bags containing saline, such as NaCl 0.9%, as known in the art, etc. The one or more containers may be connectable to or connected to a second pump device configured to pump the infusate toward the infusate outlet at a desired flow rate.

[0043] The infusate flow rate of the second pump device may be adjustable by the control unit, thereby enabling the control unit to control the flow rate of infusate pumped into the wound and / or body cavity, particularly the pericardial cavity. For example, the infusate flow rate of the second pump device may be adjustable by the control unit in an open-loop and / or closed-loop manner, particularly to an operator / user and / or the system itself.

[0044] The system may further comprise a pressure sensor located within or connected to the first tube, the second tube, the buffer container or the wound and / or body cavity, particularly the pericardial cavity, and configured to obtain the pressure within the wound and / or body cavity, particularly the pericardial cavity.

[0045] In other words, the pressure sensor may be configured to provide a pressure signal representative of the pressure in the wound and / or body cavity, particularly the pericardial cavity. The resulting pressure may be provided to a control unit and / or a pressure control unit, which may be part of the control unit or a separate unit of the system, and may be configured to keep the pressure (i.e., the pressure signal, for example) within desired pressure limits by adjusting (e.g., even stopping) the infusate flow rate to avoid acute cardiac tamponade.

[0046] Furthermore, pressure measurements can detect the possible occurrence of tamponade and alert clinical staff to this. Optionally, the inflow fluid may serve as a conductor for, or as a conductor, e.g., conductor means for, measuring pressure in a body cavity, particularly the pericardial cavity.

[0047] Additionally or alternatively, a separate lumen may be provided for pressure measurement, in which case pressure measurement may be performed using air as the transmission medium. This provides very good and reliable pressure measurement. Furthermore, a simple design may be used that is easy to construct and implement. Furthermore, the measurement is insensitive to the height of the sensor relative to the measurement point, as no water column is currently present, which cannot affect the measurement and may lead to inaccurate pressure measurements.

[0048] The system may further comprise a heater device configured to heat infusate intended to be introduced into the wound and / or body cavity, particularly the pericardial cavity, to a desired infusate temperature.

[0049] The heater device may be part of a temperature control system of the system, which may be configured to control the temperature of the infusate flow. Accordingly, the temperature control system may comprise a temperature sensor for measuring the temperature of the infusate, a temperature control unit, which may be part of the control unit or a separate unit of the system, and which may be configured to provide a temperature control signal based on the measured infusate temperature and the desired infusate temperature, and the heater device, as described above, which may be controlled / adjusted by the temperature control signal to heat the infusate to the desired infusate temperature.

[0050] The temperature sensor may be disposed in or on the first tube and / or the second tube. The temperature sensor may be configured as or in a separate element (e.g., for rectal application) connected to or connectable to the control unit and / or temperature control unit.

[0051] The desired infusate temperature may be based on the temperature of the wound and / or body cavity, particularly the pericardial cavity. The infusate temperature is preferably within the range of 32°C to 38°C, and more preferably approximately 37°C. The desired infusate temperature may be adapted or adjusted to the patient's actual body temperature, or to heat or cool the heart and its surroundings as clinically desired. While cooling patients postoperatively may require heating in most patients, cooling of the heart and other tissues may be required in certain cardiac rhythm disorders or when patients undergo "cooling protocols" following serious perioperative adverse events, such as complete circulatory collapse and / or cardiopulmonary resuscitation.

[0052] The first and second tubes may be combined into an integrated inflow and / or outflow drain device. As another example, one tube for outflow can be combined with four smaller tubes, three for inflow and one for outflow. In this case, the infusate outlet and effluent inlet can be combined into an integrated fluid interface device configured to connect to the integrated inflow and / or outflow drain device.

[0053] For example, a first tube may be integrated into a second tube so that the first tube does not consume the lumen of the second tube. In particular, the first tube may be arranged in the wall of the second tube or parallel to the second tube. It is also possible that one or more first tubes may be integrated into or on the second tube. The integrated inflow and / or outflow drain device should preferably have a regular shape, such as a rounded or cylindrical shape, so as to be positionable or to be placed in a patient's body without leakage from a body cavity, particularly the pericardial cavity (and / or pleural cavity).

[0054] The system may further comprise at least one other effluent inlet for connection to at least one other tube having an effluent lumen for directing effluent flow into the system from one or more other body cavities, in particular the pleural or pericardial cavity. Depending on the number of effluent inlets, the at least one other effluent inlet may be referred to as a second effluent inlet, a third effluent inlet, etc., and the effluent inlet may be referred to accordingly as a first effluent inlet. With respect to the tubes, the at least one other tube may be referred to as a third tube assigned to the second effluent inlet, a fourth tube assigned to the third effluent inlet, etc.

[0055] For example, the system may further include a second effluent inlet for connecting to a third tube having an effluent lumen for directing effluent flow from the pericardial cavity into the system, and the effluent flows of the second and third tubes may be joined by a fluid connector piece, such as a Y-connector piece, to allow the fluid to be subsequently directed to a buffer container.

[0056] Alternatively or additionally, the system may further include a third effluent inlet for connecting to a fourth tube having an effluent lumen for directing effluent flow from the pleural cavity into the system. Optionally, the system may further include a fourth effluent inlet for connecting to a fifth tube having an effluent lumen for directing effluent flow from the pleural cavity into the system. The effluent flows of the fourth and fifth tubes may be joined by a fluid connector piece, such as a Y-shaped connector piece, to allow the fluid to be subsequently directed to a buffer container or another buffer container specifically designated for fluid received from the pleural cavity.

[0057] If the system is also configured to receive effluent from the pleural cavity, the system may further include another buffer container (i.e., a second buffer container), another pump device (i.e., a third pump device), and another hematocrit sensor (i.e., a second hematocrit sensor), each of which is configured as outlined above for the buffer container, the first pump device, and the hematocrit sensor. The second buffer container, the third pump device, and the second hematocrit sensor may be arranged in a parallel effluent line, e.g., a parallel effluent measurement line, assigned to the effluent received from the pleural cavity and may be arranged accordingly, as outlined above for the buffer container, the first pump device, and the hematocrit sensor.

[0058] It may be envisioned that this secondary system (buffer reservoir, pump, hematocrit sensor) may be configured and / or used to measure blood loss and / or air leak separately. Instead of two hematocrit sensors, it is also possible to use only one hematocrit sensor to which fluid samples from the pericardial cavity or pleura are alternately fed, with the samples being supplied by separate channels and pumps for each outflow source from the pericardial cavity or pleura, so that the samples are alternately supplied without mixing.

[0059] The buffer reservoir (and / or the second buffer reservoir) may be configured as part of a cartridge or a cartridge and / or frame structure. Optionally, the cartridge or frame structure is a disposable, in particular a disposable cartridge or a disposable frame structure. It may be considered that the cartridge or frame structure may comprise interface elements for receiving and / or transmitting liquids and / or signals, such as control signals and / or sensor signals, from and / or to the system or part of a system.

[0060] Furthermore, at least one of the interface elements may be configured for a power source. Accordingly, the system may include a counter-interface element that corresponds to and is engagable with the interface element of the cartridge. Additionally or alternatively, it may be contemplated that the frame structure may hold or include one or more tubes for connecting to the counter-interface element, for example, for connecting to a pump device, a sensor device, and / or a valve device of the system.

[0061] In other words, a cartridge or frame structure, in particular a disposable cartridge or frame structure, may be provided which may be configured to interface with the system and / or part of the system and which may comprise the buffer reservoir (and / or second buffer reservoir), whereby a flushing system may be provided as described above and the buffer reservoir may be replaced by the cartridge or frame structure.

[0062] In another embodiment, the cartridge or framework may further comprise and / or be engageable with a first pumping device (and / or a third pumping device if the cartridge includes a second buffer reservoir).

[0063] Additionally, in another embodiment, the cartridge may further comprise and / or be engageable with a first pump device and a hematocrit sensor (and / or, if the cartridge comprises a second buffer container, a third pump device and a second hematocrit sensor).

[0064] In yet another embodiment, the cartridge or framework may additionally include a pressure sensor and / or an interface and / or membrane to the pressure sensor on the associated device, hi yet another embodiment, the cartridge or framework may additionally include a lumen element assigned to a heater device and configured to direct the infusate through the heater device to temper the infusate.

[0065] It should be understood that connecting elements and lines between the above-mentioned elements for conducting infusion and / or effluent may also be included within or on the cartridge or frame structure and accordingly may be part of the cartridge or frame structure.

[0066] It may be considered that the cartridge or framework described above may act as the interface between the influent and effluent and the functionality of the device as first mentioned.

[0067] It may be contemplated that the cartridge or frame structure may be mountable and / or securable to other parts of the system by mechanical means (e.g., clamping and / or locking and / or latching means) and / or magnetic means. However, it may additionally or alternatively be contemplated that the cartridge or frame structure may be mountable and / or securable to other parts of the system by vacuum means, for example by sucking the cartridge or frame structure onto at least a portion of the other part of the system, thereby securely mounting and / or securing the cartridge or frame structure to and / or within the system.

[0068] It may be contemplated that the integrated fluid interface device may be formed as a hub device for connection to an integrated inflow and / or outflow drain device, for example, having multiple lumens formed by at least a first tube and a second tube. The hub device may be configured for connection to and / or mating with at least one or more additional outflow inlets, for example, a second outflow inlet, a third outflow inlet, and / or a fourth outflow inlet.

[0069] It may be contemplated that the hub device may include at least one fluid connector piece, e.g., a Y-connector, for combining effluent streams that may be received via corresponding effluent inlets. The hub device may also include at least one jet for injecting additional material into the infusate, such as a clot dissolving agent in the case of excessive clots further downstream in the system.

[0070] It is contemplated that the hub device may be disposable, eg, may be configured as a disposable hub device.

[0071] The system may be considered to include a hub storage device for holding the hub device. The hub storage device may be formed as a cradle device. The hub storage device may include and / or house a temperature sensor of the system, for example, to measure the temperature of the infusate, for example, for controlling the inflow by the control unit.

[0072] The hub storage device may be non-disposable, i.e., reusable, eg, configured as a non-disposable hub storage device.

[0073] It may be contemplated that the hub storage device may include and / or house a heater device of the system, for example, to heat infusate intended to be introduced into a wound and / or body cavity, particularly the pericardial and / or pleural cavities, to a desired infusate temperature.

[0074] The system may be considered to comprise a tilting device, which may be formed by a tube of the system connecting the system to the wound and / or body cavity, in particular the pericardial and / or pleural cavity, and which may be formed such that said tube slopes from the wound and / or body cavity, in particular the pericardial and / or pleural cavity, towards the system.

[0075] In other words, the tilt device may facilitate an elevation difference (relative to gravity) between the patient and at least a portion of the system, e.g., a majority of the system, with the patient typically being positioned at a higher position.

[0076] In particular, the tubes forming the slope device may be arranged in a straight, circular, or spiral manner, such as a downward serpentine and / or generally downward spiral and / or generally downward screw slope, thereby promoting good flow in the tubing, and in particular the absence of depressions within the tubing where fluids may accumulate. [Brief explanation of the drawings]

[0077] The invention will be better understood from the description of an embodiment given by way of example and illustrated by the drawings in which: FIG.

[0078] The following diagram shows: [Figure 1] 1 illustrates a flushing system according to one embodiment of the present invention. [Figure 2] 1 shows a flushing system according to another embodiment of the present invention. [Figure 3] 3 shows a cartridge included in the flushing system of FIG. 2; [Figure 4] 1 shows a flushing system according to another embodiment of the present invention. [Figure 5] 1 shows a flushing system according to another embodiment of the present invention. [Figure 6] 1 shows a flushing system according to another embodiment of the present invention. [Figure 7]1 illustrates components of a flushing system according to another embodiment of the present invention. [Figure 8] FIG. 8 is a top view of the components of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0079] Referring to FIG. 1, there is shown a schematic representation of a flushing system 1 configured to flush a body cavity, the pericardial cavity PC of a patient.

[0080] The system 1 includes an infusate outlet 2 .

[0081] The infusate outlet 2 is configured to connect to a first tube 4 .

[0082] The first tube 4 has an infusate lumen for conducting the flow of infusate from the system 1 to the pericardial space PC.

[0083] The system 1 includes an effluent inlet 6 .

[0084] The effluent inlet 6 is adapted to connect to a second tube 8 .

[0085] The second tube 8 has an effluent lumen for directing the flow of effluent from the pericardial space PC to the system 1 .

[0086] The system 1 comprises a buffer container 10 .

[0087] The buffer container 10 has a buffer volume.

[0088] The buffer vessel 10 includes a buffer inlet 12 and a first buffer outlet 14 .

[0089] The buffer inlet 12 is configured to receive effluent from the pericardial space PC.

[0090] The first buffer outlet 14 is configured to output the received effluent.

[0091] The system 1 includes a flow rate control system.

[0092] The flow rate control system is configured to control the flow rate (eg, volume) of effluent output from the buffer vessel 10 .

[0093] The flow rate control system comprises a control unit 16 and a first pumping device 18 .

[0094] The control unit 16 is configured to provide one or more control signals.

[0095] The first pump device 18 is configured to pump effluent from the buffer reservoir 10 to one or more effluent reservoirs 20 at an effluent flow rate. The effluent flow rate (e.g., volume) is adjustable by a control signal from the control unit 16.

[0096] In this embodiment, the first pump device 18 is a peristaltic pump, however, it is contemplated that other types of pump devices may be used.

[0097] The buffer container 10 includes a clot trap 22 .

[0098] The clot trap 22 is configured to prevent clots contained in the effluent received from the pericardial cavity PC from exiting the buffer container 10 via the first buffer outlet 14 .

[0099] The buffer container 10 has a cylindrical shape extending along a central axis (not shown) that extends substantially along the direction of gravity, although any other shape may also be possible.

[0100] The buffer container includes an upper end 24 and a lower end 26 .

[0101] Additionally, the buffer container 10 includes a top wall 28 , a side wall 30 , and a bottom wall 32 .

[0102] The buffer inlet 12 is provided, for example, closer to the top wall 28 than to the bottom wall 32 in the direction of gravity.

[0103] The first buffer outlet 14 is located closer to the bottom wall 32 than to the top wall 28 .

[0104] In this embodiment, the buffer inlet 12 is located in the top wall 28 of the buffer vessel 10 and the first buffer outlet 14 is located in the bottom wall 32 .

[0105] The flush system 1 is configured to provide about 50 to 1000 ml of infusion fluid per hour, and in particular about 500 ml of infusion fluid per hour. Accordingly, the buffer volume of the buffer container 10 is configured (e.g., sized) to accommodate about 500 ml of effluent per hour, in addition to a sudden burst of effluent of 400 ml or 500 ml per 5 minutes.

[0106] As can be seen in FIG. 1, the first tube 4 and the second tube 8 are combined into an integrated inflow and / or outflow drain device 34 .

[0107] As can be further seen in FIG. 1, the infusate outlet 2 and effluent inlet 6 are combined into an integrated fluid interface device 36 configured to connect to an integrated inflow and / or outflow drain device 34 .

[0108] The first tube 4 is integrated into the second tube 8 in such a way that the first tube 4 does not consume the lumen of the second tube 8. In this case, the first tube 4 is located in the wall of the second tube 8.

[0109] In this embodiment, the system 1 also includes a further effluent inlet 38 .

[0110] Another effluent inlet 38 is configured to connect to another tube 40 .

[0111] Another tube 40 has an effluent lumen for directing the flow of effluent from the pericardial space PC to the system 1 .

[0112] In this embodiment, the effluent inlet 6 may be referred to as a first effluent inlet 6 , the other effluent inlet 38 may be referred to as a second effluent inlet 38 , and the other tube 40 may be referred to as a third tube 40 .

[0113] The effluent flows of the second tube 8 and the third tube 40 may be joined by a fluid connector piece 42. The fluid connector piece 42 may be formed as a Y-shaped connector piece.

[0114] The effluent inlet 6, ie the integrated liquid interface device 36, is connected to a fluid connector piece 42 (eg via a connecting line such as a connecting tube).

[0115] The second effluent inlet 38 is connected to a fluid connector piece 42 (eg, via a connecting line such as a connecting tube).

[0116] The fluid connector piece 42 is connected to the buffer inlet 12 (eg, via a connecting line such as a connecting tube).

[0117] The first buffer outlet 14 is connected to a first pump device 18 (eg via a connecting line such as a connecting tube).

[0118] In this embodiment, the clot trap 22 is a mechanical means. In particular, the clot trap 22 includes a sieving structure 44. The sieving structure 44 is disposed between the buffer inlet 12 and the first buffer outlet 14 of the buffer container 10. The clot trap 22 may be integrally formed with the buffer container (e.g., in the bottom wall 32 of the buffer container 10). The sieving structure 44 includes a plurality of openings formed therein. The openings are configured (e.g., sized) to prevent clots from passing through the sieving structure 44.

[0119] The clot trap 22 has a conical shape with a base 46 facing toward the first buffer outlet 14 and an apex 48 facing toward the buffer inlet 12. This makes the sieve structure 44 at least partially or completely conical. It is also possible that the clot trap could have other shapes, such as a frustoconical shape, a dome shape, a flat shape, etc.

[0120] The buffer vessel 10 further comprises at least one level sensor 50,52.

[0121] At least one level sensor 50, 52 is configured to obtain the fill level of at least one of the buffer volumes.

[0122] In this embodiment, the buffer vessel 10 comprises a first level sensor 50 for obtaining a first filling level of the buffer volume and a second level sensor 52 for obtaining a second filling level of the buffer volume.

[0123] The second level sensor 52 is disposed at a higher level than the first level sensor 50 in the direction of gravity.

[0124] In this embodiment, the second level sensor 52 is located adjacent to the top wall 28 and the first level sensor 50 is located adjacent to the bottom wall 32 .

[0125] However, the buffer vessel 10 may also be provided with more level sensors than the two level sensors 50, 52 mentioned above in order to obtain intermediate filling levels.

[0126] Additionally or alternatively, the first level sensor 50 and / or the second level sensor 52 may be located at an intermediate position between the top wall 28 and the bottom wall 32 .

[0127] Each of the level sensors 50, 52 is configured to obtain its respective fill level by optical means, as is commonly known in the art, although any other suitable sensor (such as a mechanical sensor, a capacitive sensor, a resistive sensor, an ultrasonic sensor, etc.) may also be applicable.

[0128] The system 1 further includes a hematocrit sensor 54 .

[0129] The hematocrit sensor 54 is configured to measure the hematocrit value of the effluent to obtain the amount and / or flow rate of blood loss from the pericardial space PC.

[0130] Hematocrit sensor 54 is configured to optically measure the hematocrit based on the scattering and absorption of light emitted into the effluent.

[0131] Hematocrit sensor 54 includes at least one light-emitting unit and at least one light-receiving unit (not shown).

[0132] As can be seen in FIG. 1, the hematocrit sensor 54 is located in a connecting line (eg, a connecting tube) downstream of the first pump device 18 .

[0133] Further downstream from the hematocrit sensor 54 are one or more effluent containers 20 .

[0134] One or more effluent containers 20 are connected or connectable to a connecting line in which hematocrit sensor 54 is located. However, it is also contemplated that at least two separate connecting lines may be used.

[0135] In this embodiment, by way of example, the system 1 comprises one (only) effluent container 20 .

[0136] In this regard, hematocrit sensor 54 is located downstream of buffer reservoir 10 and upstream of effluent reservoir 20 .

[0137] The effluent container 20 is connectable to, or in this embodiment is connected to, an intensive care unit (ICU) vacuum wall connector 56 .

[0138] The ICU vacuum wall connector 56 can be thought of as a suction device for drawing effluent from the pericardial space PC at relatively low pressure.

[0139] The suction device, ie, ICU vacuum wall connector 56, described above, may be part of system 1 or may be assigned to system 1 (ie, not explicitly part of the system).

[0140] Effluent container 20 is thereby connectable to, or in this embodiment connected to, buffer container 10 via hematocrit sensor 54, first pump device 18, and their corresponding connecting lines connecting each of the above elements 10, 18, 20, 54. Thus, an indirect connection is provided.

[0141] The effluent container 20 is also directly connected to the buffer container 10, which will be described later.

[0142] Referring again to the buffer vessel 10 , the buffer vessel 10 includes a second buffer outlet 58 .

[0143] The second buffer outlet 58 is configured to output effluent (e.g., excess effluent that cannot be treated in a timely manner (the outflow is too large or too fast, or the system is blocked somewhere)) and / or air.

[0144] The second buffer outlet 58 is connectable to, or in this embodiment is connected to, the effluent container 20 (eg, by a bypass line such as a bypass tube).

[0145] Thus, a direct connection may be made between the effluent container 20 and the buffer container 10, providing safety in particular in case of any blockage of the system due to a blood clot in the buffer container and / or blockage of the pump and / or any of the lines mentioned above.

[0146] The second buffer outlet 58 is disposed at a higher level than the first buffer outlet 14 in the direction of gravity, and at a lower level than the buffer inlet 12 in the direction of gravity.

[0147] The second buffer outlet 58 is located on the opposite side of the clot trap 22 from the first buffer outlet 14. Therefore, the second buffer outlet 58 is located on the same side as the buffer inlet 12.

[0148] The second buffer outlet 58 may, for safety reasons (e.g. to prevent back pressure / overflow), provide an open connection to the effluent container 20 by acting as a safety overflow from the buffer container 10. In particular, an open connection may be understood as a permanently open connection.

[0149] The second buffer outlet 58 may provide an exit path for air that is separated from the effluent in the buffer vessel 10 .

[0150] Referring now in particular to the elements of FIG. 1 located upstream of the pericardial space PC.

[0151] In this regard, the system 1 includes one or more infusate containers 60 .

[0152] One or more infusate containers 60 are configured to contain infusate.

[0153] For example, the one or more infusate containers 60 may be multiple bags containing saline, such as NaCl 0.9%, as known in the art.

[0154] In this embodiment, as an example, the system 1 includes one infusion solution container 60 .

[0155] The system 1 comprises a second pump device 62 .

[0156] The infusate container 60 is connectable to, or in this embodiment is connected to, a second pump device 62 (eg, via a connecting line such as a connecting tube).

[0157] The second pump device 62 is configured to pump the infusate to the infusate outlet, i.e., in this embodiment, the integrated fluid interface device 36, at an infusate flow rate that is adjustable by a control signal from the control unit 16.

[0158] The second pump device 62 is a peristaltic pump, although the second pump device 62 may be any pump device suitable for infusion fluids, preferably one that allows for pumping at a relatively precise flow rate.

[0159] The infusate flow rate of the second pump device 62 is adjustable by the control unit 16, thereby enabling the control unit 16 to control the flow rate of the infusate pumped into the pericardial space PC.

[0160] The system 1 further comprises a heater device 64 .

[0161] The heater device 64 is provided downstream of the second pump device 62 and is connected thereto (eg, via a connecting line such as a connecting tube).

[0162] The heater device 64 is configured to heat the infusate passing therethrough.

[0163] The heater device 64 may be part of a temperature control system (not shown) of the system 1. The temperature control system may be configured to control the temperature of the infusate flow.

[0164] The heater device 64 is connected (e.g., by a connecting line) to the injectate outlet 2, i.e., in this embodiment, to the integrated liquid interface device 36, thereby enabling temperature-controlled injectate to be supplied to the pericardial cavity PC.

[0165] The system 1 of FIG. 1 is also equipped with a pressure sensor 66 .

[0166] The pressure sensor 66 is provided in the first tube 4. However, the pressure sensor 66 may be located in connection with the first tube 4, or may be located inside the second tube 8 or the pericardial cavity PC, or in connection with the second tube 8 or the pericardial cavity PC (for example, as shown in FIG. 5).

[0167] The pressure sensor 66 is configured to obtain the pressure in the pericardial cavity PC, particularly the pressure in the space between the heart and the pericardium and / or other tissues surrounding the heart. In other words, the pressure sensor is configured to provide a pressure signal representative of the pressure in the pericardial cavity PC, particularly the pressure in the space between the heart and the pericardium and / or other tissues surrounding the heart.

[0168] Generally, the flushing system 1 is configured to continuously flush the pericardial cavity PC, particularly as a post-operative treatment. During continuous flushing of the pericardial cavity PC, infusate is pumped into the cavity PC to dilute blood and clots present in the cavity PC. At the same time, effluent, i.e., the mixture of blood and infusate mixed within the cavity PC, is withdrawn from the cavity PC to remove blood and clots from the pericardial cavity PC.

[0169] The fluid output, or effluent, of the pericardial cavity PC can be directed towards the buffer container 10 .

[0170] In particular, effluent may be directed from the pericardial space PC via an integrated inflow and / or outflow drain device 34 .

[0171] Because the first tube 4 is integrated with the second tube 8 in such a way that it does not or only minimally consumes the lumen of the second tube 8, and in particular in this exemplary case, because the first tube 4 is located in the wall of the second tube 8, the integrated inflow and / or outflow drain device 34 can have a regular shape, such as a rounded or circular shape, so that it can be or is positioned within the patient's body without leakage from the pericardial space PC. In other words, the integrated inflow and / or outflow drain device 34 can have a regular shape, such as a rounded oval, a circle, or a doubled shape of these.

[0172] The connection between the integrated inflow and / or outflow drain device 34 and the system means that the integrated inflow and / or outflow drain device 34 is constructed so that it can be pulled from the inside to the outside through an incision in the patient, and has a connector that is no larger than the outer diameter of the integrated inflow and / or outflow drain device 34. This integrated inflow and / or outflow drain device 34 can then be connected to the connector, and inflow and outflow can be established.

[0173] As the above connectors are external to the system 1, one or more additional chest tubes (ensuring optimal outflow from the pericardial cavity and optionally one or more pleural spaces) can be connected, thereby increasing the total outflow.

[0174] The effluent flows of the second tube 8 and the third tube 40 can be joined by the above-mentioned fluid connector piece 42 to allow the effluent to be subsequently directed to the buffer container 10 (e.g., by a connecting line connecting the fluid connector piece 42 and the buffer container 10, i.e., the buffer inlet 12 of the buffer container 10).

[0175] The buffer reservoir 10 allows the effluent to be buffered before being directed further for the subsequent procedure. Additionally, the clot trap 22 allows the effluent to be free of clots and / or air that may be contained in the effluent.

[0176] In other words, the clot trap 22 allows the clot to be separated from the effluent.

[0177] In particular, the clot trap 22 includes a sieve structure 44 disposed between the buffer inlet 12 and the first buffer outlet 14 of the buffer container 10, thereby preventing clots from passing through the first buffer outlet 14.

[0178] When the system 1 is in operation, each level sensor 50, 52 is able to obtain the fill level of their respective buffer volumes.

[0179] The control unit 16 controls the first pump device 18 to regulate the outflow rate from the buffer container by providing at least one of the control signals (e.g., the control signal) based on the resulting buffer volume fill level, which further enables a single liquid batch to be provided to a subsequent hematocrit sensor 54 (i.e., a hematocrit sensor located downstream of the first pump device 18) for analysis.

[0180] In this regard, the control unit 16 is configured to control the first pumping device 18 to pump a predetermined, i.e. known, volume based on said control signal.

[0181] For example, the control unit 16 may control the first pump device 18 to pump a 30 ml amount, which may be referred to as a batch as described above, although any other amount may be pumped based on a control signal of the control unit 16.

[0182] The buffer reservoir 10 therefore collects the effluent until it can be pumped by the first pump device 18 .

[0183] A steady flow of effluent can then be generated in a controlled manner, so that subsequent analysis can be performed on / in the effluent in a more accurate manner.

[0184] As already explained above, the first pump device 18 is a peristaltic pump, which allows for pumping at relatively precise flow rates and is configured for gently transporting sensitive materials such as blood cells that may be disrupted by rapidly moving or rotating elements that may be part of other types of pumps.

[0185] Peristaltic pumps are configured to perform continuous and / or discontinuous pumping operations (eg, continuous or discontinuous (ie, batch) analysis of effluent).

[0186] The analysis may include measuring the hematocrit of the effluent with hematocrit sensor 54 to obtain the amount and / or flow rate of blood loss from the pericardial space PC.

[0187] As can be seen in FIG. 1, the hematocrit sensor is positioned in the connecting line downstream of the first pumping device 18 to take measurements of the effluent pumped from the buffer container 10 (by the first pumping device 18).

[0188] The above-described placement of hematocrit sensor 54 allows for accurate hematocrit measurements without the adverse effects of clots and / or air in the effluent (due to buffer reservoir 10 / clot trap 22).

[0189] Furthermore, since the first pump device 18 can be controlled by the control unit 16 with respect to the amount of liquid pumped (i.e., the amount of liquid batch), the measured hematocrit value can be set relative to the pumped amount (i.e., batch / group of batches) at which the hematocrit value is measured by the above-mentioned sensor 54.

[0190] After passing through hematocrit sensor 54, the effluent is directed to one or more effluent containers 20, ie, effluent containers 20 in this embodiment.

[0191] The second buffer outlet 58 is also connected to the effluent container 20 (e.g., by a bypass line), thereby also providing the direct connection between the effluent container 20 and the buffer container 10 described above, so that effluent and / or (e.g., separated) air can also be directed therethrough.

[0192] The separated air may (eg, eventually) be drawn through the effluent container 20 (and bypass line) to a suction device, ie, the ICU vacuum wall connector 56 .

[0193] Thus, due to the lack of air in the effluent (provided by buffer reservoir 10), the effluent can be or may be subsequently analyzed by hematocrit sensor 54 in a more accurate and reliable manner.

[0194] When the system 1 is in operation, the infusate is preferably temperature controlled to a desired infusate temperature before it can enter the patient's body or the patient's pericardial space PC.

[0195] The system 1 thus includes the above-mentioned heater device 64, which in this embodiment is arranged downstream of the second pump device 62.

[0196] Heater device 64 is configured to heat the infusate directed into pericardial space PC to a desired infusate temperature.

[0197] The desired infusate temperature is based on the temperature of the pericardial space PC. The infusate temperature is in the range of 36° C. to 38° C., and more preferably about 37° C. However, the desired infusate temperature may be adapted or adjusted to the patient's actual body temperature.

[0198] This allows the heater device 64 to provide temperature-controlled infusate to the pericardial space PC.

[0199] Furthermore, as described above, the pressure sensor 66 can obtain the pressure in the pericardial cavity PC. In other words, the pressure sensor 66 can provide a pressure signal representative of the pressure in the pericardial cavity PC.

[0200] The resulting pressure may be provided to the control unit 16. The control unit 16 is configured to adjust the infusate flow rate (e.g., by controlling the second pump device 62) to keep the pressure (i.e., the pressure signal) within desired pressure limits to avoid and / or predict the onset of acute cardiac tamponade.

[0201] In surgical (post-operative) procedures, patients are typically provided with two pericardial cavity drains for drainage of post-operative blood loss, which in this embodiment may be the second tube 8 and the third tube 40. The second tube 8 may be part of the integrated inflow and / or outflow drain device 34 described above.

[0202] The infusate, heated by the heater device 64 to a desired infusate temperature, e.g., body temperature or a temperature below or above body temperature, is automatically pumped by the second pump device 62 through the first tube 4, which is also part of the integrated inflow and / or outflow drain device 34 described above, into the pericardial space PC, thereby continuously flushing the pericardial space PC.

[0203] Typically, a standard flush rate is 200-1500 ml per hour and can be adjusted as needed. Medical staff are continuously informed of the patient's condition through a graphical user interface (e.g., in the form of a display unit, which may be included in system 1).

[0204] The discharged fluid, ie the effluent containing diluted blood and clots, is discharged via the second tube 8 and the third tube 40 towards the buffer container 10 .

[0205] The clots, and optionally air which may also be part of the effluent, are separated from the diluted blood (hereinafter referred to as effluent) in the buffer container 10 .

[0206] The first pump device 18 then pumps the batch of effluent past the hematocrit sensor 54 and into the effluent container 20 (supported by the low pressure provided by the ICU vacuum wall connector 56).

[0207] Each batch of pumped effluent has its hematocrit measured by hematocrit sensor 54 .

[0208] Due to the known pumping characteristics of the first pump device 18, the volume of each batch of effluent is known by the control unit 16, so that the amount of blood loss can be derived from the measured hematocrit value and the corresponding batch volume, especially in combination with the patient's own hematocrit value immediately after surgery.

[0209] However, it should be understood that this may be exemplary and is not limited to the patient's own hematocrit immediately after surgery, as a patient's systemic hematocrit may change over time during treatment, such as during an ICU stay. This change in hematocrit may be handled by the systems described herein, e.g., control unit 16, by allowing updates of the patient's systemic hematocrit during the washout procedure / treatment.

[0210] When the intrapericardial pressure and blood loss values, or their trends, reach critical values, the system 1 can provide a warning to medical staff (e.g., via a signal provided by the control unit 16, e.g., via a graphical user interface and / or via an alarm (e.g., a visual alarm, an audible alarm, etc.)) to adjust postoperative treatment.

[0211] Referring now to Figure 2, a flushing system 200 according to another embodiment is shown schematically. The flushing system 200 is configured substantially similarly to the flushing system 1 of Figure 1 described above. Therefore, only the differences will be described below.

[0212] The flushing system 200 includes a cartridge 202 (shown diagrammatically in dashed lines in FIG. 2 and diagrammatically in FIG. 3).

[0213] Cartridge 202 is configured as a disposable cartridge, which is assigned to one post-operative procedure, i.e., can only be used once.

[0214] As can be seen in FIGS. 2 and 3, cartridge 202 includes buffer container 10 as described above, first pump device 18 as described above, and hematocrit sensor 54 as described above.

[0215] Cartridge 202 further comprises interface elements for receiving and / or transmitting fluid and / or signals (e.g., control signals and / or sensor signals), and / or power from system 200 or portions of system 200 and / or to system 200 or portions of system 200.

[0216] In this regard, as shown in FIG. 3, the buffer inlet 12 is connectable to or connected to a first interface element 204 for receiving the effluent.

[0217] The first level sensor 50 and the second level sensor 52 may each be connectable to or connected to the second interface element 206 (or each may be connectable to or connected to a separate interface element) for power supply and / or exchange (e.g., transmission) of sensor signals.

[0218] The first pump device 18 is connectable to or connected to a third interface element 208 for power supply (e.g., electrical and / or mechanical power supply) and / or exchange (e.g., reception) of control signals.

[0219] Hematocrit sensor 54 may be connected to or coupled to fourth interface element 210 for power supply and / or exchange (e.g., transmission) of sensor signals. Additionally or alternatively, it is contemplated that the interface may be configured as a visual interface between cartridge 202 and hematocrit sensor 54, with hematocrit sensor 54 being external to cartridge 202 and optically measurable through a transparent portion of cartridge 202.

[0220] It is further contemplated that the pressure sensor 66 may be disposed in a cartridge 202 (not shown), of which the pressure sensor 66 may be connectable to or connected to a corresponding separate interface element for power supply and / or exchange (e.g., transmission) of sensor signals and / or pressure signals.

[0221] The second buffer outlet 58 is connectable to or connected to a fifth interface element 212 for evacuating effluent and / or air.

[0222] Additionally, the cartridge 202 includes a sixth interface element 214 for discharging effluent towards the effluent container 20 .

[0223] The first interface element 204 may function as or be configured to be an integrated liquid interface device 36 for connection to the integrated inflow and / or outflow drain device 34 described above.

[0224] It should be understood that cartridge 202 also includes connecting elements and lines between the above-mentioned elements for conducting effluent.

[0225] Additionally, it should be understood that system 200 also includes a counter interface element (not shown).

[0226] The counter interface elements are configured to correspond to the above-described interface elements of cartridge 202 .

[0227] The counter interface element is further configured to be connectable to the interface elements described above for the purposes described above.

[0228] Furthermore, it should be understood that cartridge 202 may be removably engageable or engaged with system 200, and system 200 may be configured accordingly.

[0229] Referring to Figure 4, there is shown a schematic diagram of a flushing system 300 according to another embodiment. The flushing system 300 is substantially configured similarly to the flushing system 1 of Figure 1 described above. Therefore, only the differences will be described below.

[0230] The flushing system 300 is further configured to drain fluid from one or two pleural cavities of the patient during flushing of the pericardial cavity.

[0231] Thus, the system 300 further includes a third effluent inlet 302 and a fourth effluent inlet 306 .

[0232] The third effluent inlet 302 is configured to connect to a fourth tube 304 .

[0233] The fourth tube 304 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0234] The fourth effluent inlet 306 is configured to connect to a fifth tube 308 .

[0235] The fifth tube 308 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0236] The third effluent inlet 302 and the fourth effluent inlet 306 are connected (eg, via respective connecting lines, eg, respective connecting tubing) to a fluid connector piece 310, such as a Y-connector piece.

[0237] The effluent flows of the fourth tube 304 and the fifth tube 308 are joined or are capable of being joined by a fluid connector piece 310 when the system 300 is operated.

[0238] The system 300 includes another buffer container 312 .

[0239] Another buffer reservoir 312 is allocated to receive fluid from the pleural cavity PLC.

[0240] The other buffer vessel 312, which may be referred to as second buffer vessel 312, is configured like buffer vessel 10 described above.

[0241] A second buffer container 312 is connected to the fluid connector piece 310 (eg, via a connecting line such as a connecting tube).

[0242] System 300 also includes another pump device 314 , namely, third pump device 314 , and another hematocrit sensor 316 , namely, second hematocrit sensor 316 .

[0243] The other elements 312, 314, 316 of the system 300 described above are configured as outlined above for the buffer reservoir 10, the first pumping device 18, and the hematocrit sensor 54, respectively.

[0244] A second buffer reservoir 312, a third pump device 314 and a second hematocrit sensor 316 are disposed in a parallel effluent line assigned to the effluent received from the pleural cavity PLC.

[0245] Second buffer reservoir 312, third pumping device 314 and second hematocrit sensor 316 are accordingly arranged similarly to those outlined above for buffer reservoir 10, first pumping device 18 and hematocrit sensor 54.

[0246] Thereby, the second buffer container 312, the third pump device 314 and the second hematocrit sensor 316 are connected via respective connection lines, for example, respective connection tubes.

[0247] Referring now to Figure 5, a flushing system 400 according to another embodiment is shown schematically. The flushing system 400 is configured substantially similarly to the flushing system 1 of Figure 2 described above. Therefore, only the differences will be described below.

[0248] When the system 400 is operated, the infusate flow rate of the second pump device 62 is adjustable by the control unit 16 so that the control unit 16 can control the flow rate of the infusate pumped into the pericardial cavity PC based on signals from multiple sensors.

[0249] Effluent received or receivable from the pericardial space PC is or can be directed to an effluent container 20 .

[0250] Adjacent to the effluent container 20 are one or more suction devices 402 .

[0251] The suction device 402 is configured to create a relatively low pressure in the effluent container 20, ie, a negative pressure of, for example, -15 mmHg (which may be achieved by the ICU vacuum wall connector 56 configured as in other embodiments).

[0252] This relatively low pressure can be used to draw effluent from the pericardial space PC into the effluent container 20 .

[0253] A weight sensor 404 is provided to measure the change in weight of the infusate in the infusate container 60. This change in weight represents a decrease in the volume of infusate in the infusate container 60. Based on the change in the volume of infusate over time, the flow rate of the infusate into the pericardial space PC can be determined.

[0254] The weight sensor 404 or the control unit 16 may be configured to determine the flow rate of infusate pumped from the infusate container 60. Any other sensor configured to determine the flow rate of infusate into the pericardial cavity PC may also be used. For example, the infusate flow rate may be determined by a flow rate sensor 406, which may be located anywhere in the infusion section of the system 400. The infusate flow rate may be subtracted from the control signal provided by the control unit 16 to adjust the flow rate of the second pump device 62 in response to one or more of the sensor signals herein. Any other method for determining the infusate flow rate may also be used.

[0255] The suction provided by the one or more suction devices 402 causes effluent flowing out of the pericardial cavity PC to be received by the effluent container 20, resulting in an increase in the volume of effluent in the effluent container 20. This increase in volume in the effluent container 20 may be determined by a weight sensor 408 configured to determine the volume / weight of the effluent in the effluent container 20. Based on the change in the volume / weight of the effluent over time, the flow rate / volume of the effluent may be determined.

[0256] The effluent flow rate / volume may also be calculated using any other sensor configured to determine the flow rate of effluent from the pericardial cavity PC to the effluent container 20. For example, the effluent flow rate may be determined by flow rate sensor 410.

[0257] The sensors 404, 410, the control unit 16, and the second pump device 62 may form part of a flow rate control system for controlling the flow rate of infusate at the infusate outlet 2 based on sensor signals, including an infusate signal representative of the infusate flow rate into the pericardial cavity PC and an effluent signal representative of the effluent flow rate from the pericardial cavity PC. The difference between the infusate flow rate and the effluent flow rate may generally correspond substantially to the patient's blood loss rate from the pericardial cavity PC. Importantly, the control signal also includes a hematocrit sensor signal from the hematocrit sensor 54 and a pressure signal from a pressure sensor 66 disposed within the pericardial cavity PC.

[0258] Based on the calculated blood loss and / or flow rate, the appropriate infusate flow rate can be pumped by the second pump device 62.

[0259] Because it is important to accurately determine the actual blood loss from the pericardial space PC, the system 400 also includes the cartridge 202 described above.

[0260] Therefore, this also includes the above-mentioned elements 10, 18, and 54. However, it should be understood that each of the components 10, 18, and 54 of the cartridge 202 may be included in the system 400 as a separate element.

[0261] The hematocrit sensor 54 of the cartridge 202 generates a blood flow signal representative of the relative amount of blood or blood components in the effluent. The actual blood loss can be calculated from the outflow (e.g., as described above and / or from the buffer container 10) and the hematocrit sensor value of the blood flow. This blood flow sensor signal is provided as an input to the control unit 16 to control, e.g., automatically stop, the infusion flow rate of the infusate pumped into the pericardial space PC. For example, if the blood loss is too high, automatic stopping of each of the pump devices described above can occur.

[0262] In this embodiment, system 1 comprises a temperature control system including a temperature sensor 412 for measuring the temperature of the infusate, a control unit 16 for providing a temperature control signal based on the measured infusate temperature and a desired infusate temperature, and a heater device 64 controllable by the temperature control signal to heat the infusate to the desired infusate temperature. Note that the control of the temperature control system need not be integrated into control unit 16, but may be formed as part of a separate control unit, for example heater device 64, or may be integrated into another control device or processing unit.

[0263] Because control unit 16 can determine the amount or flow rate of blood loss from the patient's pericardial space PC based on input from hematocrit sensor 54, this determined, particularly calculated, amount or flow rate of blood loss can be used to monitor blood loss from the pericardial space PC. In particular, control unit 16 can determine the amount or flow rate of blood loss from the patient's pericardial space PC based on a combination of the input from hematocrit sensor 54, the amount of fluid for which hematocrit measurement is applicable, and the patient's systemic hematocrit immediately after surgery.

[0264] For example, the determined blood loss volume or blood loss flow rate may be displayed via a graphical user interface, e.g., display device 414, to allow a physician or nurse to easily monitor the progression of blood loss over time. Such display device 414 may also be used to display any other relevant parameters of the flushing process, such as the amount of infusate used, the amount of effluent received, the infusate and effluent flow rates, the relative blood content in the effluent, the blood constituents in the effluent, and trends thereof. Importantly, the display may provide indications based on combined sensor inputs, as described elsewhere. It should be understood that the above may also be implemented in the embodiments shown in FIGS. 1-4.

[0265] The blood loss, blood flow rate, or other relevant parameters may be automatically monitored, for example, by an alarm device integrated into the control unit 16, which issues an alarm signal when the blood loss and / or blood flow rate and / or other parameters exceed a threshold. The alarm signal may be any suitable signal, such as a visual or audible signal. It should be understood that instead of the control unit 16, any other (processing) unit or device may be used to determine / calculate the blood loss or blood flow rate based on input from the hematocrit sensor. It should be understood that the above can also be implemented in the embodiments shown in Figures 1-4.

[0266] With regard to the embodiment of FIG. 5 , it should be understood that any elements described therein may also be integrated, used, and / or included in connection with the embodiments shown in FIGS. 1-4 , such as a sensor unit, a display device, an alarm device, etc., connected with a correspondingly configured control unit.

[0267] 6, a flushing system 500 according to another embodiment is shown schematically. The flushing system 500 is substantially similar to the flushing systems 1, 200, 300, and 400 described above. Therefore, only the differences will be described below.

[0268] It should be understood that in view of the embodiment of FIG. 6, any element described therein may be incorporated, used, and / or included in connection with the embodiment shown in FIGS. 1-5, and vice versa.

[0269] The flushing system 500 essentially includes a base structure 502 and a frame structure 504 .

[0270] The framework 504 is formed as a disposable framework.

[0271] The base structure 502 is formed as a mobile base structure that is movable on the ground.

[0272] The base structure 502 includes a bottom portion 506 and a top portion 508 .

[0273] An infusion fluid container 60, here, for example, four saline bags, and an infusion fluid container 20 are provided and arranged on the bottom 506.

[0274] Furthermore, a suction device 402 is also provided and disposed on the bottom 506 .

[0275] The control unit 16 , the first pump device 18 , the second pump device 62 and the hematocrit sensor 54 are disposed in and / or on the top portion 508 .

[0276] Additionally, a first valve 510 and a second valve 512 are provided and disposed on and / or above the top portion 508 .

[0277] Top portion 508 is configured to removably and / or replaceably hold and / or secure frame structure 504 to base structure 502 (depicted by corresponding arrows in FIG. 6 ). It may be contemplated that frame structure 504 may be attached and / or secured to other parts of the system, here base structure 502, by mechanical means, for example, by clamping means and / or locking means and / or latching means (not shown), as is known in the art.

[0278] The buffer vessel 10 and the second buffer vessel 312 are configured as part of a frame structure 504 .

[0279] In other words, the buffer container 10 and the second buffer container 312 are mounted on the frame structure 504 and are integrated into the frame structure 504 .

[0280] As can be seen in FIG. 6, the framework 504 holds and / or includes one or more connecting lines, such as connecting tubes 514 .

[0281] In particular, the integrated liquid interface device 36 is assigned to the frame structure 504 and connected thereto by connecting tubes 514, with one inlet connecting tube 516 assigned for the infusion liquid and two outlet connecting tubes 518 assigned for the effluent liquid.

[0282] One of the outlet connection tubes 518 is connected to the buffer container 10 , and the other outlet connection tube 518 is connected to the second buffer container 312 .

[0283] An infusion connection tube 516 connects the infusate container 60 with the integrated fluid interface device 36 through the framework 504 .

[0284] Downstream of and starting from the buffer reservoir 10,312, the further outflow connection tube 520 is joined to one further outflow connection tube 522 by a fluid connector piece, for example a Y-connector.

[0285] The above-mentioned further outflow connecting tube 522 is then / further joined downstream by another fluid connector piece, e.g. another Y-connector, with a connecting tube originating from the second buffer outlet 58 of the buffer container 10,312 within and / or before terminating at the outflow container 20.

[0286] The frame structure 504 includes at least a first access element 524 , a second access element 526 , and a third access element 528 .

[0287] The first access element 524 is configured for engagement with the second pump device 62 such that the infusion connection tube 516 is engageable with the second pump device 62 to provide a peristaltic pumping action.

[0288] The second access element 526 is configured to engage with the first pump device 18 such that the further outflow connection tube 522 is engageable with the first pump device 18 to provide a peristaltic pumping action.

[0289] Third access element 528 is configured to engage hematocrit sensor 54 such that further outflow connection tubing 522 is engageable with hematocrit sensor 54 to perform a hematocrit measurement.

[0290] A further outflow connection 522 is engageable with a hematocrit sensor 54 further downstream from the first pump device 18 .

[0291] The frame structure 504 also includes two additional recesses provided between the buffer reservoir 10, 312 and the fluid connector piece that joins the additional outflow connection tube 520.

[0292] The separate recesses are configured to engage the first valve 510 and the second valve 512, respectively, so that the first valve 510 is engageable with a separate outflow connection tube 520 from the buffer container 10, and the second valve 512 is engageable with a separate outflow connection tube 520 from the second buffer container 312.

[0293] In particular, this facilitates switching between buffer containers 10, 312, for example to focus the measurement of the hematocrit sensor 54 on only the effluent of one of buffer containers 10 or second buffer container 312, which in turn may enable switching of measurements between the effluent from the pericardial cavity PC or the pleural cavity PLC, for example.

[0294] As can be seen in FIG. 6, the integrated fluid interface device 36 is formed as a hub device 530 for connection to the integrated inflow and / or outflow drain device 34 .

[0295] The hub device 530 combines two or more effluent inlets, which may be allocated, for example, to wounds and / or body cavities, in particular the pericardial cavity PC and / or the pleural cavity PLC, respectively.

[0296] The system 500 further comprises a hub storage device 532 for holding the hub device 530 .

[0297] The hub storage device 532 is formed as a cradle device.

[0298] The hub storage device 532 includes and / or houses the temperature sensor 412 of the system 500, for example, to measure the temperature of the infusate, for example, for controlling the inflow by the control unit 16.

[0299] Additionally, the hub storage device 532 includes and / or houses the heater device 64 of the system 500, for example, to heat the infusate intended to be introduced into the wound and / or body cavity, particularly the pericardial cavity PC and / or the pleural cavity PLC, to a desired infusate temperature.

[0300] It should be understood that the flushing system 500 operates substantially similarly to the flushing systems 1, 200, 300, and 400 described above.

[0301] The irrigation system 500 provides a compact and portable solution for irrigating wounds and / or body cavities, which may allow for flexible use in clinical routines.

[0302] In particular, flushing system 500 provides a compact and / or cost-effective solution that includes only one effluent pump device 18 and one hematocrit sensor 54, yet still allows for separate measurement of effluent from different origins, such as the pericardial and pleural cavities.

[0303] 7 and 8, there is shown schematically components of a flushing system according to another embodiment of the present invention, in particular a hub device 600. The hub device 600 may be used, for example, in the flushing system 300 of FIG.

[0304] The hub device 600 is generally rectangular parallelepiped shaped, although any other shape may be envisaged.

[0305] The hub device 600 combines four effluent inlets 602 located on one side of the hub device 600, for example the patient side.

[0306] The hub device 600 includes two fluid connector pieces 604 that are provided on the hub device 600 and are formed as Y-shaped connectors for respectively combining two effluent streams that may be received via corresponding effluent inlets 604.

[0307] The hub device 600 includes two outlets 606 for discharging the combined effluent streams.

[0308] The outlet 606 is provided on the opposite side of the hub device 600 (relative to the one side, eg, the patient side), eg, the system side, particularly the frame structure 504 side.

[0309] Additionally, the hub device 600 includes one or more infusion inlets 608 on the system side for receiving infusion fluid and one or more infusion outlets 610 on the patient side for draining infusion fluid.

[0310] Hub device 600 also includes a measurement channel 612 having an inlet on the patient side and an outlet on the system side, e.g., for air. Measurement channel 612 is used for pressure measurement, which eliminates pressure noise from the pump device, eliminates the risk of influence of differences in fluid column height (e.g., compared to pressure measurements at the effluent), and may be a more cost-sensitive implementation.

[0311] It should be understood that the patient side of the hub device 600 is configured for connection to the integrated inflow and / or outflow drain device 34, which is accordingly configured to connect to the patient side of the hub device 600, at least partially as shown in FIG. 8 (see cross section of the integrated inflow and / or outflow drain device 34).

[0312] It should be understood that a system in which the hub device 600 can be used will include a corresponding tubing arrangement on the system side of the hub device 600 .

[0313] It should also be understood that the arrows shown in FIG. 8 indicate the respective flow directions of the corresponding fluids directed therethrough. [Explanation of symbols]

[0314] 1. Wash-off system 2 Injectate outlet 4. First Tube 6 Effluent inlet, first effluent inlet 8 Second Tube 10 buffer container, first buffer container 12 Buffer entrance 14 First buffer exit 16 Control Unit 18 First pump device 20 Effluent container 22 Blood Clot Trap 24 Top of buffer container 26 Bottom of buffer container 28 Top wall of buffer container 30 Side wall of buffer container 32 Bottom wall of buffer container 34 Integrated inflow and / or outflow drain devices 36 Integrated Liquid Interface Device 38 Separate effluent inlet, second effluent inlet 40 Another tube, third tube 42 Fluid Connector Piece 44 Sieve structure 46 Base of the clot trap 48 Clot Trap Apex 50 First level sensor 52 Second level sensor 54 Hematocrit sensor 56 Intensive Care Unit (ICU) Vacuum Wall Connector 58 Second buffer exit 60 Infusion container 62 Second pump device 64 Heater Device 66 Pressure Sensor 200 Washing System 202 Cartridge 204 First Interface Element 206 Second Interface Element 208 Third Interface Element 210 Fourth Interface Element 212 5th Interface Element 214 6th Interface Element 300 Washing System 302 Third effluent inlet 304 4th Tube 306 4th effluent inlet 308 5th Tube 310 Fluid Connector Piece 312 Another buffer container, second buffer container 314 Another pumping device, a third pumping device 316 Another hematocrit sensor, second hematocrit sensor 400 Washing System 402 Suction Device 404 Weight Sensor 406 Flow velocity sensor 408 Weight Sensor 410 Flow velocity sensor 412 Temperature Sensor 414 Display Devices 500 Washing System 502 base structure 504 Frame Structure 506 Bottom 508 Top 510 First Valve 512 Second valve 514 Connecting tube 516 Injection connection tube 518 Outlet connection tube 520 Separate outflow connection tube 522 Yet another outflow connection tube 524 First Access Element 526 Second Access Element 528 Third Access Element 530 Hub Device 532 Hub Storage Device 600 Hub Devices 602 Effluent inlet 604 Connector piece 606 Exit 608 Inlet 610 Inlet 612 measurement channels PC pericardial cavity PLC pleural cavity

Claims

1. 1. An irrigation system (1, 200, 300, 400, 500) configured to irrigate a wound and / or a body cavity, in particular a pericardial cavity (PC) and / or one or more pleural cavities, of a patient, said system (1, 200, 300, 400, 500) comprising: an infusate outlet (2) for connecting a first tube (4) having an infusate lumen for directing the flow of infusate from said system (1, 200, 300, 400, 500) to said wound and / or said body cavity, in particular said pericardial cavity (PC); an effluent inlet (6) for connection to a second tube (8) having an effluent lumen for directing the flow of effluent from the wound and / or the body cavity, in particular the pericardial cavity (PC), into the system (1, 200, 300, 400, 500); a buffer container (10) having a buffer volume and including a buffer inlet (12) for receiving effluent from the wound and / or the body cavity, in particular the pericardial cavity (PC), and a first buffer outlet (14) for outputting the received effluent; A flow rate control system for controlling the flow rate of the effluent output from the buffer vessel (10), the flow rate control system comprising: a control unit (16) for providing one or more control signals; a first pumping device (18) for pumping effluent from said buffer container (10) to one or more effluent containers (20) at an effluent flow rate, said effluent flow rate being adjustable by said control signal from said control unit (16); The buffer container (10) comprises a clot trap (22) configured to prevent clots contained in the effluent received from the wound and / or the body cavity, in particular the pericardial cavity (PC), from leaving the buffer container (10) through the first buffer outlet (14), and / or the buffer container (10) is configured for gas-liquid separation and / or configured to have a safety bypass and / or a flushing system (1, 200, 300, 400, 500) configured to receive a liquid overflow.

2. 2. The system of claim 1, wherein the clot trap comprises a sieve structure disposed between the buffer inlet and the first buffer outlet of the buffer container, thereby preventing clots from passing through the first buffer outlet.

3. 3. The system (1, 200, 300, 400, 500) of claim 1 or 2, wherein the clot trap (22) has a conical shape with a base (46) facing the first buffer outlet (14) and an apex (48) facing the buffer inlet (12).

4. 4. The system (1, 200, 300, 400, 500) according to any one of claims 1 to 3, characterized in that the buffer container (10) further comprises at least one level sensor (50, 52) for obtaining the filling level of at least one of the buffer volumes.

5. 5. The system (1, 200, 300, 400, 500) of claim 4, wherein the buffer container (10) further comprises a first level sensor (50) for obtaining a first filling level of the buffer volume and a second level sensor (52) for obtaining a second filling level of the buffer volume, the second level sensor (52) being positioned at a higher level than the first level sensor (50) relative to the direction of gravity.

6. 6. The system (1, 200, 300, 400, 500) according to claim 4 or 5, characterized in that the control unit (16) controls the first pump device (18) and adjusts the outflow rate from the buffer reservoir (10) by providing at least one of the control signals based on the obtained filling level of the buffer volume and / or the buffer reservoir level.

7. 7. The system (1, 200, 300, 400, 500) of any one of claims 1 to 6, wherein the first pumping device (18) comprises a peristaltic pump.

8. 8. The system (1, 200, 300, 400, 500) according to any one of claims 1 to 7, characterized in that the system further comprises one or more effluent containers (20) for receiving effluent from the buffer container (10).

9. 9. The system according to claim 1, wherein the buffer container further comprises a second buffer outlet arranged at a higher level than the first buffer outlet in the direction of gravity and configured to output effluent and / or air, thereby enabling gas-liquid separation and / or functioning as a safety bypass, the second buffer outlet being located on the opposite side of the clot trap from the first buffer outlet.

10. 10. The system (1, 200, 300, 400, 500) according to any one of claims 1 to 9, further comprising a hematocrit sensor (54) configured to measure the hematocrit value of the effluent to obtain the amount and / or flow rate of blood loss from the wound and / or the body cavity, in particular the pericardial cavity (PC).

11. 11. The system (1, 200, 300, 400, 500) of claim 10, wherein the hematocrit sensor (54) is provided to measure the effluent pumped from the buffer reservoir (10) to the one or more effluent reservoirs (20).

12. 12. The system (1, 200, 300, 400, 500) according to claim 10 or 11, characterized in that the system (1, 200, 300, 400) further comprises and / or is connectable to a unit for blood loss measurement and / or systematic measurement of the patient, configured to obtain the amount of blood loss and / or the blood loss flow rate from the wound and / or the body cavity, in particular the pericardial cavity (PC).

13. 13. The system (1, 200, 300, 400, 500) of any one of claims 1 to 12, characterized in that the system comprises a second pump device (62) for pumping the infusion solution to the infusion solution outlet (2) at an infusion solution flow rate, optionally adjustable by the control signal of the control unit (16), and the second pump device (62) comprising a peristaltic pump.

14. 14. The system (1, 200, 300, 400, 500) according to any one of claims 1 to 13, characterized in that the system further comprises a pressure sensor (66) located inside the first tube (4), the second tube (8), the buffer container (10) or the wound and / or the body cavity, in particular the pericardial cavity (PC) or connected to the first tube (4), the second tube (8), the buffer container (10) or the wound and / or the body cavity, in particular the pericardial cavity (PC), and configured to obtain the pressure inside the wound and / or the body cavity, in particular the pericardial cavity (PC).

15. 15. The system (1, 200, 300, 400, 500) of any one of claims 1 to 14, characterized in that the system further comprises a heater device (64) configured to selectively heat the infusate intended to be introduced into the pericardial space (PC) to a desired infusate temperature, the desired infusate temperature being based on the temperature of the pericardial space (PC).

16. 16. A system (1, 200, 300, 400, 500) according to any one of claims 1 to 15, characterized in that the first tube (4) and the second tube (8) are combined into an integrated inflow and / or outflow drain device (34).

17. 17. The system (1, 200, 300, 500) of any one of claims 1 to 16, further comprising at least one other effluent inlet (38, 302, 306) for connection to at least one other tube (40, 304, 308) having an effluent lumen for directing the flow of effluent from the pleural cavity (PLC) or the pericardial cavity (PC) to the system (1, 200, 300, 400, 500).

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