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

Abstract

The present invention relates to an irrigation system (1,300, 400, 500) configured to irrigate a wound and / or body cavity, particularly a pericardial cavity (PC) and / or one or more pleural cavities of a patient, the system (1,300, 400, 500) comprising an infusate outlet (2) for connecting a first tube (4) having an infusate lumen for directing an infusate flow from the system (1,300, 400, 500) to the wound and / or body cavity, particularly the pericardial cavity (PC), an effluent inlet (6) for connecting a second tube (8) having an effluent lumen for directing an effluent flow from the wound and / or body cavity, particularly the pericardial cavity (PC), to the system (1,300, 400, 500), and a flow rate control system for controlling the flow rate of the infusate at the infusate outlet (2). the hematocrit sensor (54) configured to obtain the amount and / or flow rate and / or trend of blood loss from a wound and / or body cavity, in particular the pericardial cavity (PC), by optically measuring the hematocrit value of the effluent received through the effluent inlet (6) by emitting light having different wavelengths, wherein the different wavelengths are assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

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 and / or one or more pleural cavities, as a post-operative treatment to reduce the risk of cardiac tamponade, reduce post-operative bleeding, and reduce the accumulation of blood and clots in the wound and / or body cavity, particularly the pericardial cavity.

[0002] The present invention further relates to a method for obtaining blood loss or blood flow rate from a wound and / or body cavity, particularly the pericardial cavity and / or one or more pleural cavities, of a patient. [Background technology]

[0003] The accumulation of blood and clots reverses the local coagulation system and induces increased fibrinolytic activity, resulting in more extensive and prolonged bleeding in the patient. Current technology addresses this issue by requiring the patient to return to the operating room for chest re-thoracotomy (particularly revision or surgical re-thoracotomy), in which the wound is cleared of all blood and clots and flushed with warm saline. In the majority of patients, bleeding stops immediately. WO2015 / 086857A1 builds on this mechanism, actively flushing the wound with saline prevents the accumulation of blood and clots, preventing excessive blood loss and the need for surgical re-thoracotomy.

[0004] In this regard, excessive postoperative bleeding, which can occur as much as 2 liters per 24 hours or exceed 200 liters per hour, is a known complication of cardiac surgery. Reoperation / reopening due to bleeding and / or cardiac tamponade 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, increased sternal wound infections, and transfusion-associated infections.

[0005] 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.

[0006] Pericardial flushing systems may be specifically designed to cleanse the pericardial cavity after cardiac surgery. These systems flush the pericardial cavity with saline (or other) solution, reducing the viscosity and hematocrit of blood present within the cavity while preventing the formation of larger clots. Cleansing the pericardial cavity with flushing prevents clogging of the chest drain and the resulting accumulation of blood and clots within the pericardial cavity. This reduces postoperative bleeding and the risk of acute cardiac tamponade.

[0007] In this respect, to obtain the amount of blood loss during flushing, the system usually comprises sensor means, in particular a hematocrit sensor, to provide a measure of the amount of blood loss. In this respect, the precision and / or accuracy of the measurements made by such sensor means may constitute an important factor in preventing postoperative bleeding, in particular postoperative bleeding during pericardial flushing.

[0008] An example of prior art relating to a pericardial washout system is described, for example, in WO2015 / 086857A1. Summary of the Invention

[0009] 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.

[0010] This is achieved by an irrigation system as defined in claim 1, which is configured to irrigate a wound and / or a body cavity, in particular a pericardial cavity and / or one or more pleural cavities, of a patient.

[0011] In this regard, there is provided an irrigation system configured to irrigate a wound and / or body cavity, particularly a pericardial cavity, 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; 1. A flow rate control system for controlling a flow rate of an infusate flow at an infusate outlet, the flow rate control system comprising: a control unit for providing one or more control signals; a pump device for pumping the infusate to the infusate outlet at an infusate flow rate adjustable by a control signal from the control unit; and a hematocrit sensor configured to obtain the amount and / or flow rate and / or trend of blood loss from a wound and / or body cavity, particularly the pericardial cavity, by optically measuring the hematocrit value of effluent received through an effluent inlet by emitting light having mutually different wavelengths, wherein the different wavelengths are assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

[0012] It is also possible that the hematocrit sensor can measure the level of hemoglobin, thus additionally or alternatively measuring the level of blood in the fluid.

[0013] In particular, the present invention is based on the idea that by emitting light of different wavelengths, in particular green and red or near-infrared light, in a flushing system, in particular for flushing the pericardial cavity of a patient, the flushing system can measure the hematocrit over the entire range, i.e., from low to high concentrations, in effluent received from a wound and / or body cavity, in particular the pericardial cavity (and / or, optionally, the pleural cavity).

[0014] In this regard, green light may be assigned to relatively low hematocrit concentrations, for example, 0-5% Hct, and red or near-infrared light may be assigned to relatively high or even higher hematocrit concentrations, for example, 5-40% Hct.

[0015] Thus, the flushing system can reliably measure hematocrit values ​​over the entire range of effluent, thereby enabling precise and / or accurate determination of blood loss volume and / or blood flow rate and / or blood flow rate trend from a wound and / or body cavity, particularly the pericardial cavity (and / or, optionally, the pleural cavity). In other words, the combination of a flushing system, particularly for flushing a patient's pericardial cavity, with the above-described hematocrit sensor can provide improved reliability, precision, and / or accuracy.

[0016] For example, this may further improve clinical decisions made regarding optimal timing of re-exploration and / or transfusion strategies.

[0017] The hematocrit sensor may include at least two light-emitting units including at least one first light-emitting unit for emitting a first wavelength assigned to a green wavelength range and at least one second light-emitting unit for emitting a second wavelength assigned to a red or near-infrared wavelength range, and at least two light-receiving units that respectively receive the light emitted by the light-emitting units.

[0018] In other words, the hematocrit sensor may include two or more light-emitting units and a corresponding number of light-receiving units, where at least one (first) light-emitting unit is configured to emit a first wavelength assigned to the green wavelength range, at least one (second) light-emitting unit is configured to emit a second wavelength assigned to the red or near-infrared wavelength range, and the corresponding light-receiving units are configured to receive the light emitted by the light-emitting units, respectively.

[0019] Thus, the first light-emitting unit may be referred to as a green light-emitting unit, and the second light-emitting unit may be referred to as a red or near-infrared light-emitting unit.

[0020] In particular, the total number of light emitting units may correspond to the total number of light receiving units, and in this respect any total number is contemplated, for example, 12 light emitting units and 12 light receiving units, or more or less.

[0021] The number of first light-emitting units / green light-emitting units may correspond to (e.g., may be the same as) the number of second light-emitting units / red or near-infrared light-emitting units. In this regard, any number is contemplated. For example, in the above case, there may be six first light-emitting units / green light-emitting units and six second light-emitting units / red or near-infrared light-emitting units, or there may be more or fewer of each.

[0022] Alternatively, the number of first light-emitting units / green light-emitting units does not have to correspond to (e.g., may be different from) the number of second light-emitting units / red or near-infrared light-emitting units. In this regard, any number is contemplated. For example, in the above case, there may be two first light-emitting units / green light-emitting units and ten second light-emitting units / red or near-infrared light-emitting units, or there may be more or fewer of each.

[0023] The hematocrit sensor may be configured to operate based on obtaining scattering and absorption of emitted light having different wavelengths. In other words, a measurement of hematocrit value may be made by the hematocrit sensor based on scattering and absorption of light emitted into the effluent and having different wavelengths, the different wavelengths being assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

[0024] The wavelength in the green wavelength range may be 510-540 nm, particularly 520-530 nm, especially 525 nm, although other wavelengths in the green wavelength range known in the art are also contemplated.

[0025] The wavelength in the red or near infrared wavelength range may be 650 to 950 nm, particularly 750 to 850 nm, especially 810 nm, although other wavelengths within the red wavelength range known in the art are contemplated, and other wavelengths within the near infrared wavelength range known in the art are also contemplated.

[0026] The light-emitting units and light-receiving units may be arranged opposite each other and may be arranged alternately with respect to each other. In particular, the light-emitting units and light-receiving units may or may not be arranged on opposite sides of the effluent from which light is emitted or from which it can be emitted, and on each side the light-emitting units and light-receiving units may be arranged alternately with respect to each other.

[0027] For example, in a case where there are two light-emitting units, the first light-emitting unit and the second light-receiving unit may be provided on a first side, and the second light-emitting unit and the first light-receiving unit may be provided on a second side opposite the first side. In another example, in a case where there are three light-emitting units, a third light-emitting unit may also be provided on the first side or the second side, and a third light-receiving unit may be provided on the corresponding opposite side. The third light-emitting unit may be configured similarly to the first light-emitting unit or the second light-emitting unit in terms of its wavelength. It should be understood that alternative arrangements different from the above modifications are also contemplated.

[0028] It is contemplated that the hematocrit sensor may be configured to measure the hematocrit of the effluent discretely, although, alternatively or additionally, the hematocrit sensor may be configured to measure the hematocrit of the effluent continuously.

[0029] The system may optionally be configured to generate a measurement protocol based on a signal value obtained by optically measuring the hematocrit value of the effluent received through the effluent inlet using a hematocrit sensor, and the signal value may serve as a basis for obtaining the amount of blood loss and / or blood loss flow rate and / or blood loss flow rate trend from the wound and / or body cavity, particularly the pericardial cavity.

[0030] The flow rate control system may further be configured to control the flow rate of the effluent flow at the effluent inlet, and it is conceivable that the flow rate control system may further comprise a further pumping device arranged downstream of the effluent inlet and / or a unit for providing a negative pressure to the effluent inlet, e.g. a vacuum unit, which may be arranged downstream of the effluent inlet, optionally downstream of the further pumping device.

[0031] The further pumping device may be configured to pump the effluent from the effluent inlet at an effluent flow rate, the effluent flow rate being adjustable by a control signal from the control unit.Alternatively or additionally, the flushing system may comprise a separate outflow control system comprising a separate control unit configured as the aforementioned control unit for the effluent, a further pumping device configured similarly to the aforementioned further pumping device, and optionally a unit for providing a negative pressure to the effluent inlet, e.g. a vacuum unit, configured similarly to the aforementioned unit for providing a negative pressure to the effluent inlet.

[0032] The system may further comprise one or more effluent containers for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity. The one or more effluent containers may be connectable to or connected to the effluent inlet for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity.

[0033] The flush system may be configured to provide 50-1000 ml of infusion fluid per hour, particularly about 500 ml per hour, i.e., the infusion inflow rate may be 50-1000 ml of infusion fluid per hour, particularly about 500 ml per hour. However, the system, and accordingly one or more effluent containers, may be configured to accommodate sudden bursts of effluent of 400 ml or 500 ml per 5 minutes. In a possible setup, the flush system may be configured to provide effluent at about 100-1000 ml / hour. The flow rate may be user-adjustable, i.e., user-adjustable.

[0034] The hematocrit sensor may be disposed between the effluent inlet and one or more effluent containers for taking measurements on the effluent. In other words, the hematocrit sensor may be disposed between the effluent inlet and one or more effluent containers for emitting light into the effluent to take measurements on the effluent. In yet another way, the hematocrit sensor may be disposed downstream of the effluent inlet and upstream of one or more effluent containers for taking measurements on the effluent.

[0035] 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 negative 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.

[0036] 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, which may be configured to create the (relative) low pressure described above, thereby functioning as one or more suction devices described above. For example, one or more suction devices may be integrated into the system, thereby providing a portable and / or independent solution, particularly independent of special vacuum range requirements not provided by hospital wall connectors.

[0037] The pump device may be any pump device suitable for the infusion solution, preferably of a type that allows for pumping at a relatively precise flow rate. In this regard, the pump device may be a peristaltic pump. Additionally or alternatively, it may be contemplated that the pump device may comprise a volumetric pump, a membrane pump, an impeller pump, and / or a syringe pump, optionally a syringe pump device including at least two valves. The pump device may be connectable to or connected to one or more infusion solution containers.

[0038] Thus, optionally, the system may include one or more infusate containers containing an infusate as described above, e.g., a number of bags containing saline, such as NaCl 0.9%, as known in the art, e.g., in clinical practice, which may be connectable to or connected to a pump device configured to pump the infusate to the infusate outlet at a desired flow rate.

[0039] The infusate flow rate of the pump device may be adjustable by the control unit, which may thereby control the flow rate of infusate pumped into the wound and / or body cavity, particularly the pericardial cavity.

[0040] The system may further comprise a pressure sensor located within or in connection with the first tube, the second tube, or the wound and / or body cavity, particularly the pericardial cavity, and configured to obtain pressure within the wound and / or body cavity, particularly the pericardial cavity.

[0041] In other words, the pressure sensor may be configured to provide a pressure control signal representative of the pressure in the wound and / or body cavity, in particular 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., e.g., pressure signal) within desired pressure limits by adjusting the infusate flow rate to avoid acute cardiac tamponade and / or to serve as an early detection means of occlusion of tubing associated with the effluent, e.g., the outlet or outflow tubing, and / or cardiac tamponade.

[0042] 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.

[0043] 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, and the temperature control system may accordingly 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 above-mentioned heater device which may be controlled / adjusted by the temperature control signal to heat the infusate to the desired infusate temperature.

[0044] The temperature sensor may be located in or on the first tube and / or the second tube. The temperature sensor may also be configured as or in a separate element (e.g., for rectal application) that is connected or connectable to the control unit and / or temperature control unit.

[0045] The desired infusate temperature may be based on the temperature of the wound and / or body cavity, particularly the pericardial cavity (PC), and / or the general body temperature. Preferably, the infusate temperature may be in the range of 36° C. to 38° C., and more preferably about 37° C. The desired infusate temperature may be adapted or adjusted to the patient's actual body temperature.

[0046] The first and second tubes may be combined into an integrated inflow and / or outflow drain device. For example, in other words, the first and second tubes may be combined into a multi-lumen device, particularly for integrated inflow and / or outflow. In this case, the infusate outlet and the effluent inlet may be combined into an integrated fluid interface device configured to connect to the integrated inflow and / or outflow drain device.

[0047] For example, the first tube may be integrated into the second tube so that the first tube does not consume the lumen of the second tube. In particular, the first tube may be disposed in the wall of the second tube. It is also possible that one or more first tubes may be integrated into or onto the second tube. The integrated inflow and / or outflow drain device should preferably have a regular shape, such as a rounded or circular shape, in order to be positionable or to be placed in the patient's body without leakage from wounds and / or body cavities, in particular the pericardial cavity (and / or pleural cavity).

[0048] 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 from another body cavity, in particular the pleural or pericardial cavity, into the system. 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.

[0049] For example, the system may further include (e.g., additionally) a second effluent inlet for connecting to a third tube having an effluent lumen for directing effluent flow from the wound and / or body cavity, particularly the pericardial cavity, into the system. 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 the hematocrit sensor. 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.

[0050] In other words, the system may further include another effluent inlet, e.g., a third effluent inlet, for connecting to another tube, e.g., 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 hematocrit sensor, e.g., another hematocrit sensor specifically assigned to receive fluid from the pleural cavity.

[0051] The system may further include one or more other hematocrit sensors (e.g., one other hematocrit sensor) configured to optically measure the hematocrit of effluent received through the other effluent inlets to obtain the amount and / or flow rate of blood loss from the wound and / or body cavity, particularly the pleural cavity, by emitting light having different wavelengths, the different wavelengths being assigned to the green wavelength range and the red or near-infrared wavelength range, respectively. For example, the system may include one or more hematocrit sensors assigned to a body cavity, particularly the pericardial cavity, and one or more other hematocrit sensors assigned to another body cavity, particularly the pleural cavity.

[0052] The other hematocrit sensor may be configured similarly to the hematocrit sensors described herein, particularly the hematocrit sensors described above and below. In this regard, the other hematocrit sensor may be referred to as a second hematocrit sensor, and the hematocrit sensor may be referred to as a first hematocrit sensor. If the system is also configured to receive effluent from the pleural cavity, the second hematocrit sensor may be positioned in a parallel effluent line assigned to effluent received from the wound and / or body cavity, particularly the pleural cavity, and may be positioned accordingly as outlined above for the (first) hematocrit sensor.

[0053] The system may further include at least one means (e.g., a sensor) for obtaining an effluent volume and / or an effluent flow rate of effluent received from the one or more wounds and / or one or more body cavities, particularly the pericardial and / or pleural cavities. In particular, the system may further include at least one means (e.g., a sensor) for obtaining an effluent volume and / or an effluent flow rate of effluent received from the one or more wounds and / or one or more body cavities, particularly the pericardial and / or pleural cavities, and directed through the hematocrit sensor and / or another hematocrit sensor.

[0054] Additionally or alternatively, the system may further comprise a buffer container having a buffer volume and 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.

[0055] The buffer container may include an (optional) clot trap configured to prevent clots contained in the 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 is configured with a safety bypass and / or is configured to receive a liquid overflow.

[0056] The basic idea of ​​the buffer vessel is that it can provide different functions that can be realized and / or occur dependently or independently: first, it can trap clots by means of the clot trap described above, second, it can separate air and liquid from each other, third, it can collect sudden bursts of effluent, and fourth, it can provide effluent for careful measurement. Furthermore, a gas-liquid separation and / or a safety bypass can allow a constant vacuum to be applied to the wound and / or body cavity, in particular the pericardial cavity, for drainage.

[0057] 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. This can be achieved by providing a buffer container including a clot trap. The clot trap prevents clots contained in the effluent from being conducted further. The clot trap can be a mechanical means. Buffering the effluent allows a more stable and constant (e.g., known) flow rate to be obtained from the buffer container for further procedures, thereby enabling subsequent sensor means to perform more accurate measurements.

[0058] 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.

[0059] The buffer container may have a substantially cylindrical shape extending along a central axis. However, it should be understood that any other shape is also contemplated 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.

[0060] The flush system may be configured to provide about 500 ml of infusate per hour, i.e., the inflow rate of infusate may be about 500 ml per hour, and the buffer volume may be sized accordingly, although the system, and accordingly the buffer volume, may be configured to accommodate a sudden surge of effluent of 400 ml and / or 500 ml per 5 minutes.

[0061] 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.

[0062] The clot trap may have a conical shape with a base facing the first buffer outlet and an apex facing the buffer inlet. The clot trap may have other shapes, such as a truncated cone shape, a dome shape, a flat shape, etc. In particular, the clot trap shape described above allows a certain amount of clots to be trapped within the clot trap without blocking the clot trap.

[0063] The buffer container may further comprise at least one level sensor for obtaining the fill level of at least one of the buffer volumes.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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, which may be called a batch, for example, 30 ml. However, any other volume may be pumped based on the control signal of the control unit. This allows 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.

[0068] The system may further comprise one or more effluent containers (described above) for receiving effluent from the buffer container, which may be connectable to or connected to the buffer container (e.g., via the first buffer outlet).

[0069] 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.

[0070] 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.

[0071] 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 drawn into one or more suction devices, such as an ICU vacuum wall connector and / or the system's own vacuum unit. In other words, the separated air may be drawn into the ICU vacuum wall connector and / or the system's own vacuum unit via one or more effluent containers. Therefore, due to the lack of air in the effluent, the effluent can be subsequently analyzed in a more accurate and reliable manner.

[0072] A hematocrit sensor may be provided for measuring the effluent fluid pumped from the buffer container to one or more effluent containers. Accordingly, the hematocrit sensor may be located downstream of the buffer container and upstream of one or more effluent containers. This hematocrit sensor location may provide accurate hematocrit measurements without adverse effects from blood clots and / or air in the effluent fluid. 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 volume, and the hematocrit value is measured by the sensor. Thus, the amount and / or flow rate of blood loss from a wound and / or body cavity, particularly the pericardial cavity, may be measured in a simple, reliable, and / or accurate manner.

[0073] Additionally or alternatively, the pressure sensor may be located within or in connection with the buffer reservoir.

[0074] If the system is configured to also 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 the other elements of the system described above being configured as generally described above for the buffer container, the first pump device, and the hematocrit sensor.

[0075] The second buffer reservoir, 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, similar to the outline for the buffer reservoir, the first pump device, and the hematocrit sensor in the preceding sentence. It may be contemplated that this secondary system (buffer reservoir, pump, hematocrit sensor) may be configured and / or used to separately measure blood loss and / or air leak.

[0076] It may be considered that 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 the system.

[0077] 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.

[0078] 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.

[0079] In another embodiment, the cartridge or frame structure may further comprise and / or be engageable with a first pump device (and / or a third pump device if the cartridge comprises a second buffer reservoir). In yet another embodiment, the cartridge may further comprise and / or be engageable with a first pump device and a hematocrit sensor (and / or a third pump device and a second hematocrit sensor if the cartridge comprises a second buffer reservoir).

[0080] Furthermore, in 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. In yet another embodiment, the cartridge or framework may additionally include a lumen element assigned to a heater device and configured for conducting the infusate through the heater device for tempering the infusate. It should be understood that connection elements and lines between the above-mentioned elements for conducting the infusate and / or effluent may also be included in or on the cartridge or framework and accordingly be part of the cartridge or framework.

[0081] 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.

[0082] It may be contemplated that the cartridge or frame structure may be mountable and / or secureable to other parts of the system by mechanical means, for example by clamping and / or locking and / or latching means, although it may additionally or alternatively be contemplated that the cartridge or frame structure may be mountable and / or secureable to other parts of the system by vacuum means, for example by sucking the cartridge or frame structure against 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.

[0083] 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 to be connected to and / or combined with at least one or more additional effluent inlets, for example, a second effluent inlet, a third effluent inlet, and / or a fourth effluent inlet. It may also be contemplated that the hub device may include at least one fluid connector piece, for example, a Y-connector, for combining effluent streams that may be received via corresponding effluent inlets. The hub device may include at least one injection port for injecting additional material into the infusion solution, for example, a thrombolytic agent in the case of excessive blood clots further downstream in the system.

[0084] It is contemplated that the hub device may be disposable, eg, may be configured as a disposable hub device.

[0085] 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.

[0086] The hub storage device may be non-disposable, i.e., reusable, eg, configured as a non-disposable hub storage device.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] In particular, the tubes forming the slope device may be arranged in a straight, circular, or helical manner, e.g., generally downward and serpentine, and / or generally downward and helical, and / or generally downward and screw-like slope, thereby promoting good flow in the tubing, and in particular the absence of depressions within the tubing where fluids may accumulate.

[0091] It should be understood that connecting elements and connecting lines (e.g., connecting tubing) between the above-mentioned elements for conducting infusion fluid and / or effluent may also be included in the flushing system and accordingly may be part of the flushing system.

[0092] The present invention relates to a method for obtaining blood loss volume or blood loss flow rate from a wound and / or body cavity, particularly the pericardial cavity, of a patient, said method comprising: measuring hematocrit with a hematocrit sensor based on scattering and absorption of light emitted into the effluent and having different wavelengths, the different wavelengths being assigned to a green wavelength range and a red or near-infrared wavelength range, respectively; providing the hematocrit value to the control unit, thereby providing a basis for deriving the amount and / or flow rate of blood loss from the wound and / or body cavity, in particular the pericardial cavity, by the control unit.

[0093] Optionally, the measurements may be performed discretely.

[0094] In the method, the step of measuring the hematocrit value comprises: emitting light having a first wavelength assigned to a green wavelength range into the effluent by a first light-emitting unit of the hematocrit sensor for a predetermined time; receiving the emitted light by a first light receiving unit of the hematocrit sensor to measure scattering and absorption of the emitted light; emitting light having a second wavelength assigned to a red or near-infrared wavelength range into the effluent by a second light-emitting unit of the hematocrit sensor for a predetermined time; and measuring scattering and absorption of the emitted light by receiving the emitted light with a second light receiving unit of the hematocrit sensor.

[0095] The transmittance can be measured in a direct path between the light emitting and receiving units, which are positioned opposite each other and perpendicular to the direction of liquid flow.

[0096] The scattering can be measured in the direction of the flow of the liquid in which the light emitting unit and the light receiving unit are placed adjacent and opposite each other.

[0097] The above layouts may be combined with various configurations.

[0098] The wavelength in the green wavelength range may be 510 to 540 nm, in particular 520 to 530 nm, especially 525 nm, and the wavelength in the red or near infrared wavelength range may be 650 to 950 nm, in particular 750 to 850 nm, especially 810 nm.

[0099] All of the structural and functional features associated with the flushing system of the present invention and its embodiments described above may be included, alone or in combination, in the method of the present invention for reducing blood loss or blood loss flow rate from a wound and / or body cavity, particularly the pericardial cavity, of a patient, with associated advantages.

[0100] Also, the flushing system described above is configured to carry out the method according to the steps described above. [Brief explanation of the drawings]

[0101] 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.

[0102] The following diagram shows: [Figure 1] 1 illustrates a flushing system according to one embodiment of the present invention. [Figure 2] 2 shows a hematocrit sensor of the flush system of FIG. 1. [Figure 3] 10 illustrates a hematocrit sensor for a flush system according to another embodiment of the present invention. [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 illustrates a method for obtaining blood loss volume or blood loss flow rate from a patient's pericardial space according to an embodiment of the present invention. [Figure 7] 1 shows a flushing system according to another embodiment of the present invention. [Figure 8] 1 illustrates components of a flushing system according to another embodiment of the present invention. [Figure 9]FIG. 9 is a top view of the components of FIG. 8. DETAILED DESCRIPTION OF THE INVENTION

[0103] Referring to FIG. 1, there is shown a schematic illustration of a flushing system 1 configured to flush a body cavity of a patient, for example here the pericardial cavity PC.

[0104] The system 1 includes an infusate outlet 2 .

[0105] The infusate outlet 2 is configured to connect to a first tube 4 .

[0106] The first tube 4 has an infusate lumen for conducting the flow of infusate from the system 1 to the pericardial space PC.

[0107] The system 1 includes an effluent inlet 6 .

[0108] The effluent inlet 6 is adapted to connect to a second tube 8 .

[0109] The second tube 8 has an effluent lumen for directing the flow of effluent from the pericardial space PC to the system 1 .

[0110] The system 1 comprises a buffer container 10 .

[0111] The buffer container 10 has a buffer volume.

[0112] The buffer vessel 10 includes a buffer inlet 12 and a first buffer outlet 14 .

[0113] The buffer inlet 12 is configured to receive effluent from the pericardial space PC.

[0114] The first buffer outlet 14 is configured to output the received effluent.

[0115] The system 1 includes a flow rate control system.

[0116] The flow rate control system is configured to control the flow rate (eg, volume) of effluent output from the buffer vessel 10 .

[0117] The flow rate control system comprises a control unit 16 and a first pump device 18 .

[0118] The control unit 16 is configured to provide one or more control signals.

[0119] 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.

[0120] 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. For example, it is contemplated that the first pump device may additionally or alternatively 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.

[0121] The buffer container 10 includes a clot trap 22 .

[0122] 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 .

[0123] 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 be envisaged.

[0124] The buffer container includes an upper end 24 and a lower end 26 .

[0125] Additionally, the buffer container 10 includes a top wall 28 , a side wall 30 , and a bottom wall 32 .

[0126] 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.

[0127] The first buffer outlet 14 is located closer to the bottom wall 32 than to the top wall 28 .

[0128] 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 .

[0129] The flush system 1 is configured to provide about 50 to 1000 ml of infusion fluid per hour, and more particularly about 500 ml of infusion fluid per hour, and the buffer volume of the buffer container 10 is therefore configured (e.g., sized) to accommodate about 500 ml of effluent per hour in addition to a sudden surge of 400 ml or 500 ml of effluent per 5 minutes.

[0130] 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 .

[0131] 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 .

[0132] 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.

[0133] In this embodiment, the system 1 also includes a further effluent inlet 38 .

[0134] Another effluent inlet 38 is configured to connect to another tube 40 .

[0135] Another tube 40 has an effluent lumen for directing the flow of effluent from the pericardial space PC to the system 1 .

[0136] 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 .

[0137] 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.

[0138] 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).

[0139] The second effluent inlet 38 is connected to a fluid connector piece 42 (eg, via a connecting line such as a connecting tube).

[0140] The fluid connector piece 42 is connected to the buffer inlet 12 (eg, via a connecting line such as a connecting tube).

[0141] The first buffer outlet 14 is connected to a first pump device 18 (eg via a connecting line such as a connecting tube).

[0142] 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.

[0143] 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.

[0144] The buffer vessel 10 further comprises at least one level sensor 50,52.

[0145] At least one level sensor 50, 52 is configured to obtain the fill level of at least one of the buffer volumes.

[0146] 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.

[0147] The second level sensor 52 is disposed at a higher level than the first level sensor 50 in the direction of gravity.

[0148] 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 .

[0149] However, the buffer vessel 10 may include more level sensors than the two level sensors 50, 52 described above to obtain intermediate fill levels.

[0150] 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 .

[0151] 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.

[0152] The system 1 includes a hematocrit sensor 54 .

[0153] Hematocrit sensor 54 receives the effluent from pericardial cavity PC, measures the hematocrit value, and passes the effluent on (eg, for further processing and / or further allocation).

[0154] In particular, 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 pericardial space PC.

[0155] More particularly, hematocrit sensor 54 is configured to optically measure the hematocrit based on the scattering and absorption of light emitted by the effluent (as will be described in more detail below).

[0156] 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 .

[0157] Further downstream from the hematocrit sensor 54 are one or more effluent containers 20 .

[0158] One or more effluent containers 20 are connected or connectable to a connecting line in which hematocrit sensor 54 is located, although it is contemplated that at least two separate connecting lines may be used.

[0159] In this embodiment, by way of example, the system 1 comprises only one effluent container 20 .

[0160] In this regard, hematocrit sensor 54 is located downstream of buffer reservoir 10 and upstream of effluent reservoir 20 .

[0161] The effluent container 20 is connectable to, or in this embodiment is connected to, an intensive care unit (ICU) vacuum wall connector 56 .

[0162] 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.

[0163] 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).

[0164] 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.

[0165] The effluent container 20 is also directly connected to the buffer container 10, which will be described later.

[0166] Referring again to the buffer vessel 10 , the buffer vessel 10 includes a second buffer outlet 58 .

[0167] The second buffer outlet 58 is configured to output effluent (e.g., excess effluent that cannot be treated in a timely manner (either because it is overflowing too much or too fast, or the system is blocked somewhere)) and / or air.

[0168] 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).

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] The second buffer outlet 58 may provide an exit path for air that is separated from the effluent in the buffer vessel 10 .

[0174] The flow rate control system is further configured to control the flow rate (eg, amount) of infusate into the pericardial space PC, ie, into the infusate outlet 2.

[0175] The flow rate control system further comprises a second pump device 62 .

[0176] The control unit 16 is configured to provide one or more control signals.

[0177] The second pump device 62 is configured to pump infusate into the pericardial space PC, i.e., to the infusate outlet 2 .

[0178] The effluent flow rate (e.g., volume) is adjustable by a control signal from the control unit 16. In other words, the control unit 16 can control the flow rate of the infusate pumped into the pericardial space PC.

[0179] In this embodiment, the second pump device 62 is a peristaltic pump, although it is contemplated that other types of pump devices may be used. In particular, 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.

[0180] The flush system 1 is configured to provide approximately 500 ml of infusate per hour. Accordingly, the second pump device 62 is configured (e.g., sized) to pump approximately 500 ml of infusate per hour. Additionally, the flush system 1 is also configured to accommodate a sudden surge of effluent of 400 ml per 5 minutes.

[0181] 1, hematocrit sensor 54 is located in a connecting line (e.g., connecting tubing) downstream of buffer container 10. Hematocrit sensor 54 is therefore located downstream of (first) effluent inlet 6, i.e., integrated fluid interface device 36, and downstream of second effluent inlet 38.

[0182] In this regard, the hematocrit sensor 54 is placed on a single connecting line.

[0183] A single connecting line is configured to connect buffer container 10 to hematocrit sensor 54, and hematocrit sensor 54 to effluent container 20 (as described above). However, it is also contemplated that at least two separate connecting lines may be used for this purpose. In this case, hematocrit sensor 54 may include a measurement lumen 116, e.g., a separate measurement lumen, configured to receive the effluent, allow hematocrit measurement therein, and allow the effluent to pass therethrough. However, if a single connecting line is used, a portion of the single connecting line (e.g., a portion of the single connecting line provided within hematocrit sensor 54) may form the above-mentioned measurement lumen 116.

[0184] Referring now in particular to the remaining elements of FIG. 1 located upstream of the pericardial space PC.

[0185] In this regard, the system 1 includes one or more infusate containers 60 .

[0186] One or more infusate containers 60 are configured to contain infusate.

[0187] 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.

[0188] In this embodiment, as an example, the system 1 includes one infusion solution container 60 .

[0189] 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).

[0190] The second pump device 62 is configured to pump the infusate from the infusate container 60 to the infusate outlet 2, i.e., in this embodiment, to the integrated fluid interface device 36, at an infusate flow rate that is adjustable by a control signal from the control unit 16.

[0191] The system 1 further comprises a heater device 64 .

[0192] The heater device 64 is provided downstream of the pump device 62 and connected thereto (eg, via a connecting line such as a connecting tube).

[0193] The heater device 64 is configured to heat the infusate passing therethrough.

[0194] 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.

[0195] The heating device 64 is connected (e.g., by a connecting line) to the infusion outlet 2, i.e., in this embodiment, the integrated liquid interface device 36, thereby enabling temperature-regulated infusion fluid to be supplied to the pericardial cavity PC.

[0196] The system 1 of FIG. 1 is also equipped with a pressure sensor 66 .

[0197] The pressure sensor 66 is located in the first tube 4. However, the pressure sensor 66 may also be located in connection with the first tube 4, or within or in connection with the second tube 8 or the pericardial cavity PC (e.g., as shown in FIG. 5).

[0198] The pressure sensor 66 is configured to obtain the pressure in the pericardial cavity PC, in other words, to provide a pressure control signal representative of the pressure in the pericardial cavity PC.

[0199] Referring to FIG. 2, the hematocrit sensor 54 of FIG. 1 will now be described in further detail.

[0200] As already outlined above, the hematocrit sensor 54 is configured to obtain the amount and / or flow rate of blood loss from the pericardial cavity PC by optically measuring the hematocrit value of the effluent received via the first effluent inlet 6 and the second effluent inlet 38.

[0201] In particular, hematocrit sensor 54 is configured to optically measure the hematocrit of the effluent received from buffer container 10 to obtain the amount and / or flow rate of blood loss from pericardial space PC.

[0202] In this regard, hematocrit sensor 54 includes means for emitting emissions 100 having different wavelengths.

[0203] The different wavelengths are assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

[0204] In particular, the hematocrit sensor 54 includes at least two light-emitting units 100 .

[0205] The at least two light-emitting units 100 include at least one first light-emitting unit 102 for emitting a first wavelength assigned to the green wavelength range.

[0206] The at least two light emitting units 100 further comprise at least one second light emitting unit 104 for emitting a second wavelength assigned to the red or near infrared wavelength range.

[0207] In the present embodiment of FIGS. 1 and 2, the hematocrit sensor 54 includes two light-emitting units 100: the first light-emitting unit 102 described above and the second light-emitting unit 104 described above.

[0208] Hematocrit sensor 54 further includes at least two light-receiving units 106 for receiving the light emitted by light-emitting units 100, 102, 104, respectively.

[0209] In the present embodiment of FIGS. 1 and 2, hematocrit sensor 54 further includes two light receiving units 106: a first light receiving unit 108 and a second light receiving unit 110. As shown in FIG.

[0210] The first light emitting unit 102 and the first light receiving unit 108 are assigned to each other, and the second light emitting unit 104 and the second light receiving unit 110 are assigned to each other.

[0211] Hematocrit sensor 54 also includes an input interface 112 for receiving effluent from pericardial space PC, particularly buffer container 10, for example, via a connecting line (eg, connecting tubing).

[0212] Additionally, hematocrit sensor 54 also includes an output interface 114 for passing effluent to effluent container 20, for example, via a connecting line (eg, connecting tubing).

[0213] As can be seen from FIG. 2, the light-emitting units 100, 102, 104 and the light-receiving units 106, 108, 110 are provided opposite to each other and are alternately arranged with respect to each other.

[0214] In particular, light-emitting units 100, 102, 104 and light-receiving units 106, 108, 110 are positioned opposite one another with respect to measurement lumen 116 (eg, described above) of hematocrit sensor 54.

[0215] The measurement lumen 116 may be formed by a portion of a connecting line, e.g., a connecting tube, that passes through the hematocrit sensor 54, or the measurement lumen 116 may be formed as a separate element that can function as a connecting line, e.g., a connecting tube, that connects the input interface 112 and the output interface 114.

[0216] In other words, the light emitting units 100, 102, 104 and the light receiving units 106, 108, 110 can be or are located on opposite sides of the effluent from which light can be emitted or from which light is emitted.

[0217] On each side, light emitting units 100, 102, 104 and light receiving units 106, 108, 110 are arranged alternately with respect to each other. It should be understood that alternative arrangements different from the above variations are also contemplated.

[0218] The first wavelength, i.e., a wavelength in the green wavelength range, is 510-540 nm, particularly 520-530 nm, especially 525 nm, although other wavelengths within the green wavelength range known in the art are also contemplated.

[0219] The second wavelength, i.e., a wavelength in the red or near-infrared wavelength range, is 650 to 950 nm, particularly 750 to 850 nm, and especially 810 nm, although other wavelengths within the red wavelength range known in the art are contemplated, and other wavelengths within the near-infrared wavelength range known in the art are also contemplated.

[0220] Hematocrit sensor 54 is configured to operate based on obtaining scattering and absorption of emitted light having different wavelengths. In other words, hematocrit measurements may be made by hematocrit sensor 54 based on scattering and absorption of light emitted into the effluent and having different wavelengths, the different wavelengths being assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

[0221] 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.

[0222] Fluid drawn from the pericardial space PC, ie, effluent, can be directed toward hematocrit sensor 54 .

[0223] In particular, fluid drawn from the pericardial cavity PC, ie, effluent, can be directed through the buffer reservoir 10 toward the hematocrit sensor 54 .

[0224] In particular, effluent may be directed from the pericardial space PC via an integrated inflow and / or outflow drain device 34 .

[0225] Because the first tube 4 is integrated with the second tube 8 so as not to consume the lumen of the second tube 8, and particularly 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 16 can have a regular shape, such as a rounded or circular shape.

[0226] The effluent flows of the second tube 8 and the third tube 40 can be joined by the fluid connector piece 42 described above to allow the effluent to be subsequently directed to the buffer container 10 and then to the hematocrit sensor 54 (e.g., by a connecting line connecting the buffer container 10 to the hematocrit sensor 54, i.e., the input interface 112 of the hematocrit sensor 54).

[0227] Hematocrit sensor 54 directs the effluent further to one or more effluent containers 20, ie, in this embodiment, effluent container 26, and analyzes (ie, measures) its hematocrit value.

[0228] Because hematocrit sensor 54 operates at these different wavelengths, it can perform more accurate analyses / measurements at or near the effluent, potentially improving accuracy, particularly because the different wavelengths ensure that the full range of hematocrit values ​​can be measured.

[0229] Therefore, the hematocrit value of the outflow fluid can be accurately measured by the hematocrit sensor 54 to obtain the amount and / or flow rate of blood loss from the pericardial cavity PC.

[0230] After passing through hematocrit sensor 54 , the effluent is directed to effluent container 20 .

[0231] When the system 1 is in operation, the infusate is preferably thermostated to a desired infusate temperature before it can enter the patient's body or the patient's pericardial space PC.

[0232] The system 1 thus includes the above-mentioned heater device 64, which in this embodiment is arranged downstream of the second pump device 62.

[0233] Heater device 64 is configured to heat the infusate directed into pericardial space PC to a desired infusate temperature.

[0234] The desired infusate temperature is based on the temperature of the pericardial space PC. The infusate temperature is preferably 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.

[0235] This allows the heater device 64 to provide temperature-regulated infusate to the pericardial space PC.

[0236] 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 control signal representative of the pressure in the pericardial cavity PC.

[0237] 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 control signal) within desired pressure limits to avoid acute cardiac tamponade.

[0238] During surgical (post-operative) procedures, patients typically have two pericardial cavity drains placed to provide drainage for 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.

[0239] The infusate, which has been warmed by the heater device 64 to a desired infusate temperature, e.g., 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.

[0240] Typically, the standard flush rate is 500 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).

[0241] The drained fluid, ie, the effluent, is drained via second tubing 8 and third tubing 40 to hematocrit sensor 54 (through buffer reservoir 10).

[0242] 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.

[0243] In other words, the clot trap 22 allows the clot to be separated from the effluent.

[0244] 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.

[0245] When the system 1 is in operation, each level sensor 50, 52 is able to obtain the fill level of their respective buffer volumes.

[0246] 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.

[0247] 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.

[0248] 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.

[0249] The buffer reservoir 10 therefore collects the effluent until it can be pumped by the first pump device 18 .

[0250] 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.

[0251] As already mentioned above, the first pump device 18 is configured for continuous and / or discontinuous pumping operations (e.g., continuous or discontinuous (i.e., batch) analysis of effluent), and is configured to gently transport sensitive materials such as blood cells that may be destroyed by rapidly moving or rapidly rotating elements that may be part of other types of pumps.

[0252] The effluent then passes through hematocrit sensor 54 towards effluent container 20 (supported by low pressure provided by ICU vacuum wall connector 56).

[0253] As the effluent passes therethrough, its hematocrit is measured by hematocrit sensor 54 .

[0254] The measured hematocrit value can be an important basis for deriving blood loss.

[0255] When the intrapericardial pressure and bleeding values, or their trends, reach critical values, the system 1 can provide an alert to medical staff (e.g., via a signal provided by the control unit 16, e.g., via a graphical user interface) to adjust postoperative treatment.

[0256] Referring now to Figure 3, there is shown a schematic diagram of a hematocrit sensor 54 for a flushing system 1 according to another embodiment of the present invention. The hematocrit sensor 54 of Figure 3 is configured substantially similarly to the hematocrit sensor 54 of Figures 1 and 2 described above. Therefore, only the differences will be described below. It should be understood that the hematocrit sensor 10 of Figure 3 may alternatively be used in the flushing system 1 of Figure 1.

[0257] As can be seen from FIG. 3, the hematocrit sensor 54 includes five light-emitting units 100 .

[0258] In particular, the hematocrit sensor 54 includes two first light-emitting units 102 for emitting first wavelengths assigned to the green wavelength range and three second light-emitting units 104 for emitting second wavelengths assigned to the red or near-infrared wavelength range.

[0259] Accordingly, hematocrit sensor 54 further includes five corresponding light-receiving units 106 for receiving the light emitted by light-emitting units 100, 102, 104, respectively.

[0260] In particular, the hematocrit sensor 54 further includes two first light-receiving units 108 and three second light-receiving units 110 .

[0261] The first light emitting unit 102 and the first light receiving unit 108 are assigned to each other, and the second light emitting unit 104 and the second light receiving unit 110 are assigned to each other.

[0262] As can be seen from FIG. 3, the light-emitting units 100, 102, 104 and the light-receiving units 106, 108, 110 are arranged opposite to each other and alternate with each other.

[0263] In particular, the first light-emitting unit 102 and the second light-emitting unit 104, and the first light-receiving unit 108 and the second light-receiving unit 110 are provided facing each other with respect to the measurement lumen 116 of the hematocrit sensor 54, respectively.

[0264] In other words, the first light-emitting unit 102 and the second light-emitting unit 104 and the first light-receiving unit 108 and the second light-receiving unit 110 can be or are provided on opposite sides of the effluent from which light can be emitted or from which light is emitted.

[0265] On each side, light emitting units 100, 102, 104 and light receiving units 106, 108, 110 are arranged alternately with respect to each other.

[0266] Therefore, on the first side, the first light-emitting unit 102, the second light-receiving unit 110, the second light-emitting unit 104, the first light-receiving unit 108 and the second light-emitting unit 104 are arranged in this order (although any other order is also possible), and on the second side opposite the first side, the first light-receiving unit 108, the second light-emitting unit 104, the second light-receiving unit 110, the first light-emitting unit 102 and the second light-receiving unit 110 are arranged in this corresponding order (although any other order is also possible depending on the order on the first side).

[0267] 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.

[0268] The flushing system 300 is also configured to drain the patient's pleural cavity PLC while flushing the pericardial cavity PC.

[0269] Thus, the system 300 further includes a third effluent inlet 302 and a fourth effluent inlet 306 .

[0270] The third effluent inlet 302 is configured to connect to a fourth tube 304 .

[0271] The fourth tube 304 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0272] The fourth effluent inlet 306 is configured to connect to a fifth tube 308 .

[0273] The fifth tube 308 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0274] 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.

[0275] 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.

[0276] The system 300 includes another buffer container 312 .

[0277] Another buffer reservoir 312 is allocated to receive fluid from the pleural cavity PLC.

[0278] The other buffer vessel 312, which may be referred to as second buffer vessel 312, is configured like buffer vessel 10 described above.

[0279] A second buffer container 312 is connected to the fluid connector piece 310 (eg, via a connecting line such as a connecting tube).

[0280] System 300 includes another pump device 314 , namely, third pump device 314 , and another hematocrit sensor 316 , namely, second hematocrit sensor 316 .

[0281] 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.

[0282] 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.

[0283] 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.

[0284] Thereby, the second buffer container 312, the third pump device 314 and the second hematocrit sensor 316 are each connected via a respective connecting line, for example, a respective connecting tube.

[0285] In other words, second hematocrit sensor 316 is disposed in a parallel effluent line assigned to the effluent received from the pleural cavity PLC, and in yet other words, second hematocrit sensor 316 is configured to measure the hematocrit value of the effluent to obtain the amount and / or flow rate of (e.g., occurring) blood loss from the pleural cavity PLC.

[0286] Next, referring 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 1 described above. Therefore, only the differences will be described below.

[0287] 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.

[0288] Effluent received or receivable from the pericardial space PC is or can be directed to an effluent container 20 .

[0289] Adjacent to the effluent container 20 are one or more suction devices 402 .

[0290] 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).

[0291] This relatively low pressure can be used to draw effluent from the pericardial space PC into the effluent container 20 .

[0292] 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.

[0293] 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.

[0294] 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.

[0295] 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.

[0296] 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 signals also include a hematocrit sensor signal from the hematocrit sensor 54 and a pressure control signal from the pressure sensor 66.

[0297] Based on the calculated blood loss and / or flow rate, the appropriate infusate flow rate can be pumped by the second pump device 62.

[0298] Because it is important to accurately determine the actual blood loss from the pericardial space PC, system 400 also includes hematocrit sensor 54 as described above (eg, hematocrit sensor 54 as described above in FIGS. 1, 2, and 4, or FIG. 3).

[0299] System 400 also includes buffer reservoir 10 (eg, buffer reservoir 10 of FIGS. 1 and 4) located upstream from hematocrit sensor 54 as shown in FIGS.

[0300] The hematocrit sensor 54 generates a blood flow signal representative of the relative amount of blood or blood components in the effluent. The actual bleeding can be calculated from the outflow volume (e.g., as described above and / or from the buffer reservoir 10) and the hematocrit sensor value of blood flow. This blood flow sensor signal is provided as an input to the control unit 16 for controlling the infusion flow rate of the infusate pumped into the pericardial space PC.

[0301] 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.

[0302] The control unit 16 can determine the amount or flow rate of blood loss from the patient's pericardial cavity PC based on input from the hematocrit sensor 54, and this determined, particularly calculated, amount or flow rate of blood loss can be used to monitor bleeding from the pericardial cavity PC.

[0303] For example, the determined blood loss amount or blood loss flow rate may be displayed by a graphical user interface, such as display device 414, to allow a physician or nurse to easily monitor the progression of bleeding 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 amount of blood in the effluent, the composition of blood in the effluent, and trends thereof. Importantly, the display may show indications based on combined sensor inputs as described elsewhere.

[0304] 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 if 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 noted 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.

[0305] Considering the embodiment of Figure 5, it should be understood that any of the elements described therein may be incorporated, used, and / or included in connection with the embodiments shown in Figures 1-4 (alone or in any combination), such that the sensor unit is associated with a correspondingly configured control unit, display device, alarm device, etc.

[0306] Referring to FIG. 6, a flow chart illustrating a method for obtaining blood loss volume or blood loss flow rate from a patient's pericardial space is shown in accordance with one embodiment of the present invention.

[0307] The method includes measuring hematocrit (S1) with a hematocrit sensor 54, 316 based on the scattering and absorption of light emitted by the effluent.

[0308] Hematocrit sensors 54, 316 are configured as described with respect to FIGS.

[0309] Therefore, the emitted lights have different wavelengths.

[0310] The different wavelengths are assigned to the green wavelength range and the red or near-infrared wavelength range, respectively.

[0311] The method further includes the step of providing the hematocrit value to the control unit 16 (S2).

[0312] The control unit 16 is configured as described with reference to FIGS.

[0313] This provides the basis for obtaining the amount and / or flow rate of blood loss from the pericardial space by the control unit 16 .

[0314] In this method, the step of measuring the hematocrit value (S1) includes the step of emitting light having a first wavelength assigned to the green wavelength range into the effluent by the first light-emitting unit 102 of the hematocrit sensor 54,316 for a predetermined time (S1a).

[0315] Then, the step of measuring the hematocrit value (S1) includes (for example, subsequently) the step of measuring the scattering and absorption of the emitted light by receiving the light emitted by the first light receiving unit 108 of the hematocrit sensor 54,316 (S1b).

[0316] In this method, the step of measuring the hematocrit value (S1) further includes the step of emitting light having a second wavelength assigned to the red or near-infrared wavelength range into the effluent by the second light-emitting unit 104 of the hematocrit sensor 54, 316 for a predetermined time (S1c).

[0317] Then, the step of measuring the hematocrit value (S1) includes (for example, subsequently) a step of measuring the scattering and absorption of the emitted light by receiving the light emitted by the second light receiving unit 110 of the hematocrit sensor 54,316 (S1d).

[0318] It should be understood that any of the steps of the above method may be performed sequentially or in parallel. Furthermore, it should be further understood that the order described is merely exemplary and may be rearranged to any other suitable order, e.g., S1c, S1d, S1a, S1b, etc.

[0319] The wavelength in the green wavelength range is 510 to 540 nm, in particular 520 to 530 nm, and especially 525 nm.

[0320] The wavelength in the red or near-infrared wavelength range is 650 to 950 nm, in particular 750 to 850 nm, especially 810 nm.

[0321] All of the structural and functional features associated with the flushing systems 1, 300, 400 of the present invention and their embodiments described above may be included, alone or in combination, in the method of the present invention for obtaining a blood loss volume or blood loss flow rate from the pericardial cavity of a patient, with associated advantages.

[0322] Additionally, the above-described flushing systems 1, 300, 400 are configured to carry out this method according to the steps described above.

[0323] 7, a flushing system 500 according to another embodiment is shown schematically. The flushing system 500 is substantially similar to the flushing systems 1, 300, and 400 described above. Therefore, only the differences will be described below.

[0324] With regard to the embodiment of FIG. 7, 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. 1-6, and vice versa.

[0325] The flushing system 500 essentially includes a base structure 502 and a frame structure 504. It may be contemplated that the frame structure 504 may be replaced by a cartridge.

[0326] The framework 504 is formed as a disposable framework.

[0327] The base structure 502 is formed as a mobile base structure that is movable on the ground.

[0328] The base structure 502 includes a bottom portion 506 and a top portion 508 .

[0329] 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.

[0330] Furthermore, a suction device 402 is also provided and disposed on the bottom 506 .

[0331] 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 .

[0332] Additionally, a first valve 510 and a second valve 512 are provided and disposed on and / or above the top portion 508 .

[0333] 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. 7 ). 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.

[0334] The buffer vessel 10 and the second buffer vessel 312 are configured as part of a frame structure 504 .

[0335] 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 .

[0336] As can be seen in FIG. 7, the framework 504 holds and / or includes one or more connecting lines, such as connecting tubes 514 .

[0337] 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.

[0338] 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 .

[0339] An infusion connection tube 516 connects the infusate container 60 with the integrated fluid interface device 36 through the framework 504 .

[0340] 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.

[0341] 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.

[0342] The frame structure 504 includes at least a first access element 524 , a second access element 526 , and a third access element 528 .

[0343] 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.

[0344] 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.

[0345] 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.

[0346] In this exemplary embodiment, as can be seen in FIG. 7 , a single connection line 522 (here, yet another outflow connection tube 522) is used, whereby a portion of the single connection line 522 (here, yet another outflow connection tube 522) forms the above-mentioned measurement lumen 116, for example, a portion of the single connection line 522 (here, yet another outflow connection tube 522) that is engageable with the hematocrit sensor 54 through the third access element 528 and / or disposable within the hematocrit sensor 54.

[0347] A further outflow connection 522 is engageable with a hematocrit sensor 54 further downstream from the first pump device 18 .

[0348] 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.

[0349] 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.

[0350] In particular, this facilitates switching between buffer vessels 10, 312, for example to focus the measurement of the hematocrit sensor 54 on only the effluent of one of buffer vessels 10 or second buffer vessel 312, which in turn may enable switching of measurements between the effluent from the pericardial cavity PL or the pleural cavity PLC, for example.

[0351] As can be seen in FIG. 7, 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 .

[0352] 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.

[0353] The system 500 further comprises a hub storage device 532 for holding the hub device 530 .

[0354] The hub storage device 532 is formed as a cradle device.

[0355] 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.

[0356] 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.

[0357] It should be understood that the flushing system 500 operates substantially similarly to the flushing systems 1, 200, 300, and 400 described above.

[0358] 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.

[0359] 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, e.g., the pericardial cavity and the pleural cavity.

[0360] It should also be understood that the above-described flushing system 500 is configured to perform the method of FIG. 7 in accordance with the above-described steps thereof.

[0361] 8 and 9, there is shown a schematic representation of 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.

[0362] The hub device 600 is generally rectangular parallelepiped shaped, although any other shape may be envisaged.

[0363] The hub device 600 combines four effluent inlets 602 located on one side of the hub device 600, for example the patient side.

[0364] 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.

[0365] The hub device 600 includes two outlets 606 for discharging the combined effluent streams.

[0366] 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.

[0367] 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.

[0368] The hub device 600 also includes a measurement channel 612 having an inlet on the patient side and an outlet on the system side, for example, for air.

[0369] 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. 9 (see cross section of the integrated inflow and / or outflow drain device 34).

[0370] 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 .

[0371] It should also be understood that the arrows shown in FIG. 9 indicate the respective flow directions of the corresponding fluids directed therethrough. [Explanation of symbols]

[0372] 1. Wash-off system 2 Injectate outlet 4. 1st 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 100 light-emitting units 102 First light-emitting unit 104 Second light-emitting unit 106 Light receiving unit 108 First light receiving unit 110 Second light receiving unit 112 Input Interface 114 Output Interface 116 measured lumens 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 Wash-off 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 S1 Method Steps S1a Method Steps S1b Method Steps S1c Method Steps S1d Method Steps S2 Method Steps PC pericardial cavity PLC pleural cavity

Claims

1. 1. An irrigation system (1, 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, 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, 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, 300, 400, 500); a flow rate control system for controlling the flow rate of the infusate at the infusate outlet (2), the flow rate control system comprising: a control unit (16) for providing one or more control signals; a pump device (62) for pumping infusate to the infusate outlet (2) at an infusate flow rate adjustable by the control signal of the control unit (16); a hematocrit sensor (54) configured to obtain the amount and / or flow rate and / or trend of blood loss from the wound and / or the body cavity, particularly the pericardial cavity (PC), by optically measuring the hematocrit value of the effluent received through the effluent inlet (6) by emitting light having different wavelengths, wherein the different wavelengths are assigned to the green wavelength range and the red or near-infrared wavelength range, respectively; and a flow rate control system including:

2. The system (1, 300, 400, 500) of claim 1, wherein the hematocrit sensor (54) comprises at least two light-emitting units (100, 102, 104) including at least one first light-emitting unit (102) for emitting a first wavelength assigned to the green wavelength range and at least one second light-emitting unit (104) for emitting a second wavelength assigned to the red or near-infrared wavelength range, and at least two light-receiving units (106, 108, 110) that respectively receive light emitted by the light-emitting units (100, 102, 104).

3. 3. The method according to claim 1, wherein the wavelengths in the green wavelength range are 510 to 540 nm, in particular 520 to 530 nm, in particular 525 nm, and the wavelengths in the red or near-infrared wavelength range are 650 to 950 nm, in particular 750 to 850 nm, in particular 810 nm.

4. 4. The system (1, 300, 400, 500) according to claim 2 or 3, characterized in that the light emitting units (100, 102, 104) and the light receiving units (106, 108, 110) are arranged opposite each other and alternate with respect to each other.

5. 5. The system (1, 300, 400, 500) of any one of claims 1 to 4, wherein the hematocrit sensor (54) is configured to discretely measure the hematocrit value of the effluent.

6. 6. The system (1,300,400) according to any one of claims 1 to 5, characterized in that the system (1,300,400) optionally further comprises one or more effluent containers (20) for receiving effluent from the wound and / or the body cavity, in particular the pericardial cavity (PC), and the hematocrit sensor (54) is provided between the effluent inlet (6) and the one or more effluent containers (20) for measuring the effluent.

7. 7. The system (1,300, 400) according to any one of claims 1 to 6, characterized in that the system (1,300, 400) further comprises a pressure sensor (66) located inside the first tube (4), the second tube (8), or the wound and / or the body cavity, in particular the pericardial cavity (PC), or located in connection with the first tube (4), the second tube (8), 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).

8. 8. The system (1,300, 400) according to any one of claims 1 to 7, characterized in that the system (1,300, 400) optionally further comprises a heater device (64) configured to heat the infusate intended to be introduced into the wound and / or the body cavity, in particular the pericardial cavity (PC), to a desired infusate temperature, the desired infusate temperature being based on the temperature of the wound and / or the body cavity, in particular the pericardial cavity (PC), in particular the desired temperature of the wound and / or the body cavity, in particular the pericardial cavity (PC), and / or general body temperature.

9. The system (1,300, 400) according to any one of claims 1 to 8, characterized in that the system (1,300, 400) is optionally configured to generate a measurement protocol based on a signal value obtained by optically measuring the hematocrit value of the effluent received through the effluent inlet (6) by the hematocrit sensor (54), the signal value being the basis for obtaining the amount of blood loss and / or blood loss flow rate and / or blood loss flow rate trend from the wound and / or the body cavity, in particular the pericardial cavity (PC).

10. 10. The system (300, 500) of any one of claims 1 to 9, further comprising another effluent inlet (302, 306) for connection to a third tube (304, 308) having an effluent lumen for directing the flow of effluent from another body cavity, in particular the pleural cavity (PLC), into the system (300).

11. 11. The system (300) of claim 10, further comprising one or more other hematocrit sensors (316) configured to obtain the amount and / or flow rate and / or trend of blood loss from the other body cavity, in particular the pleural cavity (PLC), by optically measuring the hematocrit of the effluent received through the other effluent inlets (302, 306) by emitting light having different wavelengths from each other, wherein the different wavelengths are assigned to a green wavelength range and a red or near-infrared wavelength range, respectively.

12. 12. The system (300) of claim 11, wherein the another hematocrit sensor (316) is configured similarly to the hematocrit sensor (54) of claim 2.

13. 1. A method for obtaining blood loss volume or blood loss flow rate from a pericardial cavity (PC) of a patient, the method comprising: measuring (S1) the hematocrit value by a hematocrit sensor (54, 316) based on scattering and absorption of light emitted to the effluent and having different wavelengths, the different wavelengths being selectively assigned to a green wavelength range and a red or near-infrared wavelength range, respectively, and measuring (S1) discretely; and providing (S2) the hematocrit value to a control unit (16), thereby providing a basis for obtaining the amount of blood loss and / or blood flow rate from the pericardial cavity (PC) by the control unit (16).

14. The step of measuring the hematocrit value (S1) includes: emitting (S1a) light having a first wavelength assigned to a green wavelength range into the effluent by a first light-emitting unit (100, 102) of the hematocrit sensor (54, 316) for a predetermined time; measuring scattering and absorption of the emitted light by receiving the emitted light with a first light receiving unit (106, 108) of the hematocrit sensor (54, 316); emitting (S1c) light having a second wavelength assigned to a red or near-infrared wavelength range into the effluent by a second light-emitting unit (100, 104) of the hematocrit sensor (54, 316) for a predetermined time; and measuring (S1d) scattering and absorption of the emitted light by receiving the emitted light with a second light receiving unit (106, 110) of the hematocrit sensor (54, 316).

15. 15. The method according to claim 13 or 14, wherein the wavelengths in the green wavelength range are 510 to 540 nm, in particular 520 to 530 nm, in particular 525 nm, and the wavelengths in the red or near-infrared wavelength range are 650 to 950 nm, in particular 750 to 850 nm, in particular 810 nm.

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