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 connection to a first tubing arrangement (4) having one or more infusate lumens (100, 100a, 100b, 100b) for directing an infusate flow from the system (1,300, 400, 500) to the wound and / or body cavity, particularly the pericardial cavity (PC), and an effluent inlet (6) for connection to a second tubing (8) having an effluent lumen (104) 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 flow rate control system comprising a control unit (16) for providing one or more control signals and a pump device (62) for pumping the infusate to the infusate outlet (2) at an infusate flow rate adjustable by the control signal of the control unit (16), each infusate lumen (100, 100a, 100b, 100b) of the first tubing arrangement (4) having at least one infusate opening (102, 102a, 102b, 102b) for directing the infusate into the wound and / or body cavity, in particular the pericardial cavity (PC), the infusate openings (102, 102a, 102b, 102b) being arranged along the first tubing arrangement (4) and spaced apart from one another. The present invention further relates to a tube arrangement (4) for an irrigation system (1, 300, 400, 500) configured to irrigate a wound and / or body cavity, particularly the pericardial cavity (PC), of a patient.

Description

[Technical Field]

[0001] The present invention relates to an irrigation system configured for post-operative irrigation of a patient's wound and / or body cavity, particularly the pericardial cavity. In particular, the present invention relates to an irrigation system for irrigating a patient's wound and / or body cavity, particularly the pericardial cavity, as a post-operative treatment to reduce 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 tubing arrangement for an irrigation system configured to irrigate a wound and / or body cavity, particularly the pericardial cavity, of a patient, and in particular for an irrigation system as described above. [Background technology]

[0003] At the end of a cardiac surgical procedure, the pericardial sac remains open or partially closed, but is always openly connected to the anterior mediastinum, the space behind the sternum, between the lungs, and in front of the heart. In further communication, the "pericardial cavity" also refers to the anterior mediastinum, but these cavities always communicate. The cut sternum, divided into two longitudinal parts, is a significant source of postoperative bleeding, but all blood and clots pool around the heart due to the posterior position (the patient is lying on his back), and the anterior mediastinum fills with blood and clots.

[0004] Excessive postoperative bleeding, which can exceed two liters (2 L) per 24 hours or more than 200 mL per hour, is a known complication of cardiac surgery and is known to lead to other / more complications in cardiac surgery. Reoperation / reopening due to bleeding is a strong independent risk factor for poor outcomes after cardiac surgery, with higher mortality and morbidity. Postoperative bleeding requiring multiple transfusions and surgical reopening is also associated with higher costs, 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 within the pericardial (and / or pleural) spaces can increase fibrinolytic activity, leading to continued bleeding and, potentially, cardiac tamponade.

[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 regard, the system typically includes tubing means for flushing the pericardial space with the infusate and subsequently and / or simultaneously draining the pericardial space, although flushing and draining the pericardial space can present challenges, such as flushing the entire pericardial space and / or ensuring uniform / even flushing of the pericardial space.

[0008] Examples of prior art pericardial washout systems are described, for example, in WO 2015 / 086857 A1. Summary of the Invention

[0009] Accordingly, the present invention aims to provide a flushing system configured to flush a wound and / or body cavity, particularly the pericardial cavity, of a patient, with improved flushing characteristics, particularly in terms of effectiveness and / or efficiency.

[0010] This is achieved by a flushing system as defined in claim 1, which is configured to flush a wound and / or a body cavity, in particular the pericardial cavity, of a patient.

[0011] Accordingly, there is provided an irrigation system configured to irrigate a wound and / or body cavity, in particular a pericardial cavity and / or one or more pleural cavities, of a patient, the system comprising: an infusate outlet for connecting to a first tubing arrangement having one or more (e.g., multiple) infusate lumens for directing infusate flow 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 (e.g., and / or the pleural cavity, particularly the left and / or right pleural cavity), into the system; a flow rate control system for controlling the flow rate of the infusate at the 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; Each infusate lumen of the first tubing arrangement has at least one infusate opening for directing infusate into the wound and / or body cavity, particularly the pericardial cavity, the infusate openings being arranged along the first tubing arrangement and spaced apart from one another.

[0012] The present invention is based on the idea that the infusate lumens of the first tube arrangement and the arrangement of their corresponding openings along the first tube arrangement can more effectively flush the wound and / or body cavity, in particular the pericardial cavity, In particular, this can facilitate flushing everything, i.e. everything that is intended to be flushed (e.g. blood and / or blood clots), from the wound and / or body cavity, in particular the pericardial cavity, due to the distribution of multiple lumens and their corresponding openings.

[0013] In other words, the flushing fluid may be intended to reach as much of the wound space and / or body cavity, particularly the area between the heart and the pericardium, as possible without forming channels between the inflow and outflow points. Furthermore, the infusate lumens may also allow the inflow of a predetermined infusate through each lumen and corresponding opening, thereby more efficiently flushing the wound and / or body cavity, particularly the pericardial cavity. In this regard, the distribution of the openings along the first tube arrangement may be considered a shower-like arrangement of the openings, which may allow for a more uniform and smooth distribution of the flushing fluid, i.e., the infusate, thereby facilitating improved flushing of the wound and / or body cavity, particularly the pericardial cavity.

[0014] As discussed above, the first tubing arrangement has one or more (e.g., multiple) infusate lumens for directing the flow of infusate from the system to the wound and / or body cavity, particularly the pericardial cavity. In this regard, the one or more infusate lumens may include one infusate lumen, at least two infusate lumens, or more than two infusate lumens (e.g., only two infusate lumens).

[0015] As noted above, each infusate lumen of the first tubing arrangement has at least one infusate opening for directing infusate into the wound and / or body cavity, particularly the pericardial cavity. In this regard, the at least one infusate opening may include only one infusate opening or may include one or more infusate openings.

[0016] The first tube arrangement may include a retractable sheath retractable between a first position and a second position via at least one intermediate position along the first tube arrangement, wherein in the first position the infusate opening may be covered by the sheath, in the second position the infusate opening may not be covered by the sheath, and in the intermediate position a portion of the infusate opening may be covered by the sheath.

[0017] The sheath may be configured to extend along the first tubing arrangement and may be further configured to cover at least a portion of the first tubing arrangement, thereby allowing the infusate opening to be covered by the sheath in a first position, the infusate opening to be uncovered in a second position, and the infusate opening to be partially covered by the sheath in an intermediate position.

[0018] The sheath may be provided with means for reversibly retracting the sheath. Said means may therefore be included in the flushing system. Any suitable means may be envisaged in this respect, such as mechanical means for pushing and / or pulling the sheath to move it between the aforementioned positions. Said means may be located within the first and / or second tube arrangement or connected to the first and / or second tube arrangement.

[0019] The first tube arrangement may be oriented generally horizontally to guide the infusate into the wound and / or body cavity, particularly the pericardial cavity, thereby allowing the infusate to be guided uniformly and smoothly into the wound and / or body cavity, particularly the pericardial cavity, and further providing a rainforest shower-like delivery of the infusate.

[0020] The effluent lumen of the second tube may have at least one effluent opening for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity. In other words, the effluent lumen may include one or more effluent openings for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity. The effluent opening(s) may be disposed along the second tube and spaced apart from one another. The effluent openings may each be larger (e.g., in footprint area and / or diameter) than the infusate openings. Furthermore, because blood clots are reduced and / or minimized or eliminated, the overall diameter from this perspective may be advantageously reduced, i.e., advantageously smaller.

[0021] The first and second tube arrangements may be arranged or arrangable such that the outflow and infusion openings are at different levels relative to gravity to allow the infusate to act with or against gravity when applied to a wound and / or body cavity, particularly the pericardial cavity. Thus, gravity may support flushing of the wound and / or body cavity, particularly the pericardial cavity, when providing fluid at a higher level than when draining fluid, or may allow for more uniform and smooth flushing of the wound and / or body cavity, particularly the pericardial cavity, when providing fluid at a lower level than when draining fluid.

[0022] In particular, the multiple inlet points of the first tube arrangement may advantageously prevent the formation of irrigation channels and / or advantageously optimize and / or achieve flushing of the entire wound and / or body cavity, in particular the entire pericardial cavity.

[0023] The first and second tubes may be combined into an integrated inflow and / or outflow drainage device. In this case, the infusate outlet and the effluent inlet may also be combined into an integrated fluid interface device configured to connect to the integrated inflow and / or outflow drainage device. For example, the first tube arrangement may be integrated into the second tube such that the first tube arrangement does not consume the lumen of the second tube. In particular, the first tube arrangement may be located in the wall of the second tube. In order to be able to be or be placed within a patient's body without leakage from wounds and / or body cavities, particularly the pericardial (and / or pleural) cavity, the integrated inflow and / or outflow drainage device should preferably have a regular shape, such as a rounded or circular shape.

[0024] The first tube arrangement incorporated into the integrated inflow and / or outflow drain device may be longer than the second tube arrangement incorporated therein.

[0025] The incorporated first tubing arrangement may have a length such that the effluent opening and the infusate opening are or can be positioned at different levels relative to the direction of gravity. Additionally or alternatively, the incorporated second tubing may have a length such that the effluent opening and the infusate opening are or can be positioned at different levels relative to the direction of gravity. In other words, the length of the incorporated first tubing arrangement may be longer or shorter than the incorporated second tubing to allow the effluent opening and the infusate opening to be or can be positioned at different levels relative to the direction of gravity. In yet another way, the incorporated second tubing in the integrated inflow and / or outflow drain device may alternatively be longer than the incorporated first tubing arrangement.

[0026] In this regard, the different lengths of the (e.g., incorporated) first tube arrangement and the (e.g., incorporated) second tube may help to prevent inflow fluid from immediately leaving the wound and / or body cavity, particularly the pericardial cavity, via the shortest route through the outflow tube (e.g., second tube) from the wound and / or body cavity, particularly the pericardial cavity, without flushing the wound and / or body cavity, particularly the pericardial cavity, by positioning the outflow and inflow fluid openings at a certain distance from each other.

[0027] The system may further include 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 or connected to the effluent inlet for receiving effluent from the wound and / or body cavity, particularly the pericardial cavity.

[0028] The flush system may be configured to provide about 50-2000 ml of infusate per hour, e.g., about 500 ml of infusate per hour, i.e., the infusate inflow rate may be about 50-2000 ml per hour, e.g., about 500 ml of infusate per hour, optionally depending on patient and / or clinical outcome, bleeding, and / or other medical and clinical parameters.

[0029] However, the system, and accordingly one or more effluent containers, may be configured to accommodate a sudden burst of effluent of 400 ml and / or 500 ml per 5 minutes. In a possible setup, the flush system may be configured to provide approximately 100-1000 ml / hr. The flow rate may be user adjustable, i.e., user adjustable.

[0030] The system may further include a hematocrit sensor configured to measure the hematocrit of the effluent to obtain the amount and / or flow rate of blood loss from the wound and / or body cavity, particularly the pericardial cavity.

[0031] The hematocrit sensor may be configured to optically measure the hematocrit value of effluent receivable or received via the effluent inlet to derive the amount and / or flow rate of blood loss from the wound and / or body cavity, particularly the pericardial cavity. To derive blood loss from the measured Hct value in the effluent, the systemic Hct value of the patient's blood may also be measured and used, or that value may be obtained by another sensor (possibly from another system). In other words, the system has or uses continuous Hct measurements of the patient's blood. Specifically, the variables considered here are, among others, the Hct of the effluent fluid, the patient's Hct, the effluent patient's Hb, the patient's Hb, the relationship between Hb and Hct, the total volume of the effluent fluid, and the total volume of exudate.

[0032] The hematocrit sensor may be disposed between the effluent inlet and one or more effluent containers for measuring the effluent, or in other words, the hematocrit sensor may be located downstream of the effluent inlet and upstream of one or more effluent containers for measuring the effluent.

[0033] The flushing system may further include 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 arranged to draw effluent into one or more effluent containers by creating a relatively low pressure in the one or more effluent containers for receiving the effluent.

[0034] 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. Furthermore, one or more suction devices may be integrated into the system to provide a mobile and / or independent solution, particularly in view of special vacuum range requirements that hospital wall connectors do not provide.

[0035] The pump device may be any pump device suitable for the infusion solution, preferably a type that allows pumping at a relatively precise flow rate. In this regard, the pump device may be a peristaltic pump. Additionally or alternatively, it may be considered that the pump device may include 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 or connectable to one or more infusion solution containers.

[0036] 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. The one or more infusate containers may be connectable to or connected to a pump device configured to pump the infusate to the infusate outlet at a desired flow rate.

[0037] The infusate flow rate of the pump device is adjustable by the control unit, which may thereby control the flow rate of infusate pumped into the wound and / or body cavity, in particular the pericardial cavity.

[0038] The system may further comprise a pressure sensor located within or in connection with the first tube arrangement, the second tube or the wound and / or body cavity, particularly the pericardial cavity, and configured to obtain pressure in the wound and / or body cavity, particularly the pericardial cavity. In other words, the pressure sensor may be configured to provide a pressure signal representative of the pressure in the wound and / or body cavity, particularly the pericardial cavity.

[0039] 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 provide warnings and / or alerts and / or messages to a user, e.g., clinical staff, to avoid acute cardiac tamponade, and / or adjust the infusate flow rate to keep the pressure (i.e., e.g., pressure signal) within desired pressure limits.

[0040] It may be contemplated that the system may further include a pressure sensor located within or in connection with the first tubing arrangement, i.e., located within or in connection with an infusion lumen (e.g., at least one of the one or more infusate lumens), to obtain pressure in the wound and / or body cavity, particularly the pericardial cavity. In other words, the system may be configured to measure pressure in the wound and / or body cavity, particularly the pericardial cavity, via or through an infusion lumen (e.g., at least one of the one or more infusate lumens).

[0041] A pressure sensor may be incorporated into the integrated inflow and / or outflow drain device to measure accurate pressure (in the wound and / or body cavity, particularly the pericardial cavity) at the proximal end of the integrated inflow and / or outflow drain device, the first tube arrangement and / or the second tube.

[0042] A pressure sensor may also be incorporated into the control system, using the lumen to transmit pressure from the cavity via air and / or fluid within the lumen.

[0043] The system may further include 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.

[0044] 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 include 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.

[0045] The temperature sensor may be located in or on the first tube arrangement and / or the second tube, or in or on the integrated inflow and / or outflow drain device. The temperature sensor may also be configured as or within a separate element (e.g., rectal application) that is connected or connectable to the control unit and / or temperature control unit. The temperature sensor may also be incorporated into the integrated inflow and / or outflow drain device to provide an accurate measurement of core body temperature.

[0046] The desired infusate temperature may be based on the temperature of the wound and / or body cavity, particularly the pericardial cavity, particularly the desired 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 32° C. to 38° C., more preferably about 37° C., when the fluid reaches the body. The desired infusate temperature may be adapted or adjusted to the patient's actual body temperature.

[0047] Additionally or alternatively, the infusate, i.e., the influent, may be used to cool the patient, e.g., wound and / or body cavities, particularly the pericardial cavity, depending on the clinical situation. For example, if a patient is on a "cooling protocol" after a serious adverse event involving total circulatory collapse, the patient may be cooled to a temperature in the range of 34°C to 35°C, particularly to reduce ischemic damage to organs. In the current state of the art, patients are cooled with external cooling elements around the legs and arms. Internal cooling using a washout system may be useful, particularly when the goal is to reduce core body temperature. For example, in certain rhythm disorders, it may be necessary to cool the heart itself.

[0048] The system may further include at least one other effluent inlet for connecting to at least one other tube having an effluent lumen for directing effluent flow from a (e.g., another) wound and / or a (e.g., another) body cavity, particularly the pleural or pericardial cavity, into the system. For example, the system may further include another effluent inlet for connecting to a third tube having an effluent lumen for directing effluent flow from the pleural cavity into the system.

[0049] Thereby, the at least one further effluent inlet may be referred to as the second effluent inlet, the third effluent inlet, etc. depending on the number of effluent inlets, and accordingly the effluent inlet may be referred to as the first effluent inlet. With regard to the tubes, the at least one further tube may be referred to as the third tube assigned to the second effluent inlet, the fourth tube assigned to the third effluent inlet, etc.

[0050] 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 merged by a fluid connector piece, such as a Y-shaped connector piece, to allow the fluid to be subsequently directed to the hematocrit sensor.

[0051] 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 wound and / or body cavity, particularly the pleural cavity, into the system. In other words, the system may further include another effluent inlet, e.g., a third effluent inlet, for connecting to another tube, e.g., the fourth tube, having an effluent lumen for directing effluent flow from the wound and / or body cavity, particularly the pleural cavity, into the system.

[0052] 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 wound and / or body cavity, particularly the pleural cavity, into the system. The effluent flows of the fourth and fifth tubes may be merged by a fluid connector piece, such as a Y-shaped connector piece, to allow the fluid to be subsequently directed to a hematocrit sensor, for example, to another hematocrit sensor (described further below) specifically assigned to fluid received from the wound and / or body cavity, particularly the pleural cavity.

[0053] The system may further include another hematocrit sensor configured to measure the hematocrit value of effluent from the wound and / or body cavity, particularly the pleural cavity, to obtain the amount and / or flow rate of blood loss from the wound and / or body cavity, particularly the pleural cavity.

[0054] The other hematocrit sensor may be configured similarly to the hematocrit sensors described herein, particularly the hematocrit sensors described above and below, and 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.

[0055] If the system is further configured to receive effluent from a wound and / or body cavity, particularly the pleural cavity, the second hematocrit sensor may be positioned in a parallel effluent line assigned to the effluent received from the wound and / or body cavity, particularly the pleural cavity, and may be positioned accordingly as outlined for the (first) hematocrit sensor in the preceding sentence. Accordingly, another hematocrit sensor may be provided between another effluent inlet and one or more effluent containers for making measurements in the effluent.

[0056] 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.

[0057] Additionally, the system may further include at least one weight sensor for measuring a change in weight of infusate in at least a portion and / or component of the system, particularly the infusate container of the system. The change in weight may be used as a representative value for a decrease in the volume of infusate in the system, particularly the infusate container of the system. Based on the change in the volume of infusate over time, a flow rate of infusate into the pericardial space PC may be determined.

[0058] Additionally or alternatively, the system may further include 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.

[0059] 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 includes a safety bypass and / or is configured to receive a liquid overflow.

[0060] The basic idea of ​​the buffer vessel is that it can serve different functions that can be realized and / or occur dependently or independently of the others: firstly, it can trap clots by means of the clot trap described above; secondly, it can separate air and liquid from each other; thirdly, it can collect sudden gushes of effluent; and fourthly, it can provide the effluent for careful measurement.

[0061] Furthermore, gas-liquid separation and / or a safety bypass may allow for the application of a constant vacuum to the wound and / or body cavity, in particular the pericardial cavity, for drainage, in which, on the one hand, the effluent is buffered before being further guided for subsequent procedures (such as analysis), and, on the other hand, the effluent is freed from blood clots.

[0062] This can be achieved by providing a buffer vessel that includes a clot trap. The clot trap prevents clots contained in the effluent from being guided further. The clot trap can be a mechanical means. Buffering the effluent can provide a more stable and constant (e.g., known) flow rate exiting the buffer vessel for further procedures, thereby allowing subsequent sensor means to make more accurate measurements.

[0063] 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.

[0064] 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.

[0065] 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. However, 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.

[0066] 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.

[0067] 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.

[0068] The buffer container may further include at least one level sensor for obtaining the fill level of at least one of the buffer volumes.

[0069] The buffer container may further include 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, and the second level sensor may be positioned at a higher level than the first level sensor relative to the direction of gravity.

[0070] 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.

[0071] The control unit may control the first pump device to adjust the effluent rate (e.g., pumping 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.

[0072] The control unit may be configured to control the first pump device to pump a predetermined, i.e., known, amount based on the control signal. For example, the control unit may be configured to control the first pump device to pump a volume of, for example, 30 ml, although any other amount 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 amount of outflow liquid.

[0073] The system may further include one or more effluent containers (described above) for receiving effluent from the buffer container, and the one or more effluent containers may be connectable to or connected to the buffer container (e.g., via the first buffer outlet).

[0074] 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 or connected to one or more effluent containers. For example, the second buffer outlet may be connectable or connected to one or more effluent containers directly and / or in a permanently open manner.

[0075] 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.

[0076] 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.

[0077] A hematocrit sensor may be provided for measuring the effluent pumped from the buffer reservoir to one or more effluent containers. Accordingly, the hematocrit sensor may be located downstream of the buffer reservoir and upstream of one or more effluent containers. This hematocrit sensor location may provide accurate hematocrit measurements without being adversely affected by clots and / or air in the effluent.

[0078] Furthermore, the control unit may control the first pump device with respect to the amount of fluid pumped, so that the measured hematocrit value may be set relative to the pumped amount, the hematocrit value being measured by the sensor. Thus, the amount and / or flow rate of blood loss from a wound and / or body cavity, in particular the pericardial cavity, may be measured in a simple, reliable, and / or accurate manner.

[0079] Additionally or alternatively, the pressure sensor may be located within or in connection with the buffer reservoir.

[0080] 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.

[0081] The second buffer container, the third pump device, and the second hematocrit sensor may be arranged in a parallel effluent line, e.g., a parallel effluent measurement line, assigned to the effluent received from the pleural cavity, and may be arranged accordingly similar to the outline for the buffer container, the first pump device, and the hematocrit sensor in the preceding sentence. It may be contemplated that this secondary system (buffer container, pump, hematocrit sensor) may be configured and / or used to separately measure blood loss and / or air leak.

[0082] It may be considered that the buffer reservoir (and / or 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.

[0083] 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.

[0084] 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 include a buffer reservoir (and / or a 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.

[0085] In another embodiment, the cartridge or framework may further include and / or be engageable with a first pump device (and / or a third pump device if the cartridge includes a second buffer reservoir). In yet another embodiment, the cartridge may further include 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 includes a second buffer reservoir).

[0086] Furthermore, in another embodiment, the cartridge or frame structure 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 frame structure may additionally include a lumen element, which is assigned to a heater device and configured for guiding the infusate through the heater device for tempering the infusate. It should be understood that connection elements and connection lines between the above-mentioned elements for guiding the infusate and / or effluent may also be included in or on the cartridge or frame structure and accordingly be part of the cartridge or frame structure.

[0087] It may be considered that the cartridge or framework described above may act as the interface between the influent and outflow fluids and the functionality of the device as first mentioned.

[0088] 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.

[0089] 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 tubing arrangement and a second tubing. The hub device may be configured for connection to and / or mating with at least one or more additional outflow inlets, for example, a second outflow inlet, a third outflow inlet, and / or a fourth outflow inlet.

[0090] It may be contemplated that the hub device may include at least one fluid connector piece, e.g., a Y-connector, for combining the effluent streams receivable via corresponding effluent inlets. The hub device may also include at least one jet for injecting additional materials into the infusate, such as a thrombolytic agent in the case of excessive clots further downstream in the system.

[0091] It is contemplated that the hub device may be disposable, eg, may be configured as a disposable hub device.

[0092] The system may also 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.

[0093] The hub storage device may be non-disposable, i.e., reusable, eg, configured as a non-disposable hub storage device.

[0094] 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 the wound and / or body cavity, particularly the pericardial and / or pleural cavities, to a desired infusate temperature.

[0095] The system may be considered to include 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 the tilting device 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.

[0096] 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.

[0097] In particular, the tubes forming the slope device may be arranged in a straight, circular, or helical manner, e.g., sloped downward and serpentine, and / or generally downward and helical, and / or generally downward and screw, thereby promoting good flow in the tubing, and in particular the absence of depressions within the tubing where fluids may accumulate.

[0098] 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. [Brief explanation of the drawings]

[0099] 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.

[0100] This is shown diagrammatically in the figure below.

[0101] [Figure 1] 1 illustrates a flushing system according to one embodiment of the present invention. [Figure 2A-2B] 1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 3A-3B]1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 4] 1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 5] 1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 6] 1 shows a flushing system according to another embodiment of the present invention. [Figure 7] 1 shows a flushing system according to another embodiment of the present invention. [Figure 8] 10 is a table illustrating information and / or notifications that may be provided to a user by the flushing system of FIGS. 1, 6, 7, and / or 9. [Figure 9] 1 shows a flushing system according to another embodiment of the present invention. [Figure 10] 1 illustrates components of a flushing system according to another embodiment of the present invention. [Figure 11] FIG. 11 is a top view of the components of FIG. 10. [Figure 12] 1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 13] 13 is a cross-sectional view of the integrated inflow and / or outflow drain device of FIG. 12. [Figure 14] 1 illustrates an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 15] 1 illustrates a portion of an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 16] 1 shows a cross section of an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. [Figure 17] 1 shows a cross section of an integrated inflow and / or outflow drain device for a flush system according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0102] Referring to FIG. 1, there is shown a schematic illustration of a flushing system 1 configured to flush a body cavity of a patient, specifically the pericardial cavity PC here.

[0103] The system 1 includes an infusate outlet 2 .

[0104] The infusate outlet 2 is adapted to connect to a first tubing arrangement 4 .

[0105] The first tubing arrangement 4 has multiple (eg, at least two, eg, two or more) infusate lumens 100 for directing the flow of infusate from the system 1 to the pericardial space PC.

[0106] Each infusate lumen 100 of the first tubing arrangement 4 has at least one infusate opening 102 (not shown in FIG. 1) for directing infusate into the pericardial space PC.

[0107] The infusate openings 102 are positioned along the first tubing arrangement 4 and are spaced apart from one another (not shown in FIG. 1).

[0108] The system 1 includes an effluent inlet 6 .

[0109] The effluent inlet 6 is adapted to connect to a second tube 8 .

[0110] The second tube 8 has an effluent lumen 104 for directing the flow of effluent from the pericardial space PC to the system 1 .

[0111] The system 1 includes a buffer container 10 .

[0112] The buffer container 10 has a buffer volume.

[0113] The buffer vessel 10 includes a buffer inlet 12 and a first buffer outlet 14 .

[0114] The buffer inlet 12 is configured to receive effluent from the pericardial space PC.

[0115] The first buffer outlet 14 is configured to output the received effluent.

[0116] System 1 includes a flow rate control system.

[0117] The flow rate control system is configured to control the flow rate (eg, volume) of effluent output from the buffer vessel 10 .

[0118] The flow rate control system includes a control unit 16 and a first pump device 18 .

[0119] The control unit 16 is configured to provide one or more control signals.

[0120] 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.

[0121] In this embodiment, first pump device 18 is a peristaltic pump. However, it is contemplated that other types of pump devices may be used. For example, it may be contemplated that first pump device 18 may additionally or alternatively include a volumetric pump, a membrane pump, an impeller pump, and / or a syringe pump, optionally including at least two valves.

[0122] The buffer container 10 includes a clot trap 22 .

[0123] 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 .

[0124] 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.

[0125] The buffer container includes an upper end 24 and a lower end 26 .

[0126] Additionally, the buffer container 10 includes a top wall 28 , a side wall 30 , and a bottom wall 32 .

[0127] 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.

[0128] The first buffer outlet 14 is located closer to the bottom wall 32 than to the top wall 28 .

[0129] 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 .

[0130] The flush system 1 is configured to provide about 50 to 1000 ml of infusion fluid per hour, and in particular about 500 ml of infusion fluid per hour. Accordingly, the buffer volume of the buffer container 10 is configured (e.g., sized) to accommodate about 500 ml of effluent per hour, in addition to a sudden burst of effluent of 400 ml or 500 ml per 5 minutes.

[0131] System 1 includes a flow rate control system.

[0132] The flow rate control system is configured to control the flow rate (eg, amount) of infusate into the pericardial space PC, ie, into the infusate outlet 2.

[0133] The flow rate control system includes a control unit 16 and a second pump device 62 .

[0134] The control unit 16 is configured to provide one or more control signals.

[0135] The pump device 62 is configured to pump infusate into the pericardial space PC, ie, to the infusate outlet 2 .

[0136] 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.

[0137] 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.

[0138] 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.

[0139] As can be seen in FIG. 1, the first tube arrangement 4 and the second tube 8 are combined into an integrated inflow and / or outflow drain device 34 .

[0140] The first tube arrangement 4 is integrated into the second tube 8 in such a way that the first tube arrangement 4 does not consume the lumen of the second tube 8. In this case, the first tube arrangement 4 is located in the wall of the second tube 8.

[0141] Further details of the integrated inflow and / or outflow drain device 34, the first tube arrangement 4 and the second tube 8 are described further below.

[0142] 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 .

[0143] In other words, the integrated fluid interface device 36 is configured as an interconnecting partner with the integrated inflow and / or outflow drain device 34 .

[0144] In this embodiment, the system 1 also includes a further effluent inlet 38 .

[0145] Another effluent inlet 38 is configured to connect to another tube 40 .

[0146] Another tube 40 has an effluent lumen for directing the flow of effluent from the pericardial space PC to the system 1 .

[0147] 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 .

[0148] The effluent flows of the second tube 8 and the third tube 40 may merge by a fluid connector piece 42. The fluid connector piece 42 may be formed as a Y-shaped connector piece.

[0149] 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).

[0150] The second effluent inlet 38 is connected to a fluid connector piece 42 (eg, via a connecting line such as a connecting tube).

[0151] The fluid connector piece 42 is connected to the buffer inlet 12 (eg, via a connecting line such as a connecting tube).

[0152] The first buffer outlet 14 is connected to a first pump device 18 (eg via a connecting line such as a connecting tube).

[0153] 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.

[0154] 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.

[0155] The buffer vessel 10 further includes at least one level sensor 50,52.

[0156] At least one level sensor 50, 52 is configured to obtain the fill level of at least one of the buffer volumes.

[0157] In this embodiment, the buffer vessel 10 includes a first level sensor 50 for obtaining a first fill level of the buffer volume and a second level sensor 52 for obtaining a second fill level of the buffer volume.

[0158] The second level sensor 52 is disposed at a higher level than the first level sensor 50 in the direction of gravity.

[0159] 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 .

[0160] However, the buffer vessel 10 may include more level sensors than the two level sensors 50, 52 described above to obtain intermediate fill levels.

[0161] 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 .

[0162] 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.

[0163] The system 1 includes a hematocrit sensor 54 .

[0164] Hematocrit sensor 54 receives the effluent from the pericardial space PC, measures the hematocrit value, and passes the effluent on (eg, for further processing and / or further allocation).

[0165] 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.

[0166] More particularly, hematocrit sensor 54 is configured to optically measure the hematocrit value.

[0167] 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.

[0168] 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 .

[0169] Hematocrit sensor 54 is connected or connectable to one or more effluent containers 20 (eg, via connecting lines such as connecting tubing).

[0170] The system therefore further includes one or more effluent containers 20 as described above; in this embodiment, by way of example, the system 1 includes one (only) effluent container 20 .

[0171] In other words, one or more effluent containers 20, ie, one effluent container 20, are located further downstream from the hematocrit sensor .

[0172] In this regard, hematocrit sensor 54 is located downstream of buffer reservoir 10 and upstream of effluent reservoir 20 .

[0173] 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 34, and downstream of second effluent inlet 38.

[0174] The effluent container 20 is connectable, or in this embodiment is connected, to an intensive care unit (ICU) vacuum wall connector 56 .

[0175] 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.

[0176] 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).

[0177] Effluent container 20 is thereby connectable to, or in this embodiment is 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.

[0178] The effluent container 20 is also directly connected to the buffer container 10, which will be described later.

[0179] Referring again to the buffer vessel 10 , the buffer vessel 10 includes a second buffer outlet 58 .

[0180] 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.

[0181] The second buffer outlet 58 can be, or in this embodiment is, connected to the effluent container 20 (eg, by a bypass line such as a bypass tube).

[0182] 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.

[0183] 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.

[0184] 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.

[0185] The second buffer outlet 58 may provide an open connection to the effluent container 20 for safety reasons (e.g. to prevent back pressure / overflow) by acting as a safety overflow from the buffer container 10. In particular, an open connection may be understood as a permanently open connection.

[0186] The second buffer outlet 58 may provide an exit path for air that is separated from the effluent in the buffer vessel 10 .

[0187] Referring now in particular to the remaining elements of FIG. 1 located upstream of the pericardial space PC.

[0188] In this regard, the system 1 includes one or more infusate containers 60 .

[0189] One or more infusate containers 60 are configured to contain infusate.

[0190] 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.

[0191] In this embodiment, as an example, the system 1 includes one infusion solution container 60 .

[0192] The infusate container 60 is connectable, or in this embodiment is connected, to a second pump device 62 (eg, via a connecting line such as a connecting tube).

[0193] 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.

[0194] The system 1 further includes a heater device 64 .

[0195] The heater device 64 is provided downstream of the second pump device 62 and is connected thereto (eg, via a connecting line such as a connecting tube).

[0196] The heater device 64 is configured to heat the infusate passing therethrough.

[0197] 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. Additionally, the temperature control system may include a temperature sensor for obtaining body temperature and / or pericardial cavity temperature.

[0198] The heater device 64 is connected (e.g., by a connecting line) to the injectate outlet 2, i.e., in this embodiment, to the integrated liquid interface device 36, thereby enabling temperature-controlled injectate to be provided to the pericardial cavity PC.

[0199] A pressure sensor 66 is also included in the system 1 of FIG.

[0200] The pressure sensor 66 is provided in the first tube arrangement 4. However, the pressure sensor 66 may also be located in connection with the first tube arrangement 4, or within or in connection with the second tube 8 or pericardial cavity PC (e.g., as shown in FIG. 7).

[0201] The pressure sensor 66 is configured to obtain the pressure in the pericardial cavity PC, in other words, to provide a pressure signal representative of the pressure in the pericardial cavity PC.

[0202] 2A and 2B, an integrated inlet and / or outlet drain device 34 for a flushing system 1 according to one embodiment of the present invention will now be described in more detail. For example, the integrated inlet and / or outlet drain device 34 shown in FIGS. 2A and 2B may be the integrated inlet and / or outlet drain device 34 of FIG. 1.

[0203] As can be seen in FIGS. 2A and 2B, the integrated inflow and / or outflow drain device 34 includes a first tube arrangement 4 and a second tube 8. As can be seen in FIGS.

[0204] The first tubing arrangement 4 has a plurality of infusate lumens 100. In this exemplary embodiment, the first tubing arrangement 4 has three infusate lumens 100: a first infusate lumen 100a, a second infusate lumen 100b, and a third infusate lumen 100c.

[0205] Each infusate lumen 100 of first tubing arrangement 4 has at least one infusate opening 102 for directing infusate into pericardial space PC. In this exemplary embodiment, infusate lumens 100a, 100b, and 100c each have one infusate opening 102a, 102b, and 102c, respectively. Thus, first infusate lumen 100a has first infusate opening 102a, second infusate lumen 100b has second infusate opening 102b, and third infusate lumen 100c has third infusate opening 102c.

[0206] The second tube 8 has, for example, one effluent lumen 104 for directing the flow of effluent from the pericardial space PC to the system 1 .

[0207] The effluent lumen 104 of the second tube 8 has at least one effluent opening 106 (not shown in FIGS. 2A and 2B) for receiving effluent from the pericardial space PC.

[0208] The first tubing arrangement 4, and accordingly the first infusate lumen 100a, the second infusate lumen 100b, and the third infusate lumen 100c, are incorporated into the second tubing 8 such that the first tubing arrangement 4, and accordingly the lumens 100a, 100b, and 100c, do not consume the lumens of the second tubing 8. In this regard, as can be seen in FIG. 2B, the first tubing arrangement 4, and accordingly the first infusate lumen 100a, the second infusate lumen 100b, and the third infusate lumen 100c, are located in the wall of the second tubing 8.

[0209] The first infusion liquid lumen 100a, the second infusion liquid lumen 100b, and the third infusion liquid lumen 100c extend along the second tube 8 in approximately parallel relation.

[0210] Infusate openings 102a, 102b, 102c are provided along the first tube arrangement 4 and accordingly the second tube 8.

[0211] Infusate openings 102a, 102b, and 102c are spaced apart from one another, such that first infusate opening 102a is spaced a distance D from second infusate opening 102b, which is spaced a distance C from third infusate opening 102c.

[0212] The distances C, D between the infusate openings 102a, 102b, 102c are dimensioned to allow a predetermined distribution of infusate inflow to flush the pericardial space PC.

[0213] The effluent opening(s) 106 are positioned along the second tube 8 and may be spaced apart from one another.

[0214] The effluent opening(s) 106 are spaced at least a distance B from the infusate openings 102a, 102b, 102c.

[0215] Distance B is dimensioned to allow the effluent opening 106 and the infusate openings 102a, 102b, 102c to be positionable at different levels relative to the direction of gravity. For example, distance B may be dimensioned to allow the effluent opening 106 and the infusate openings 102a, 102b, 102c to be positioned or positionable at different levels relative to the direction of gravity when the integrated inflow and / or outflow drain device 34 is folded generally into a U-shape.

[0216] Furthermore, the effluent opening(s) 106 are spaced at least a distance A from the effluent inlet 6 and, correspondingly, the integrated liquid interface device 36 .

[0217] Distance A is dimensioned to span at least the distance between the pericardial cavity PC and the integrated fluid interface device 36. In other words, distance A is dimensioned to span at least the distance between the patient and the flushing system 1.

[0218] The effluent opening 106 is larger (e.g., in footprint area and / or diameter) than the infusate openings 102a, 102b, and 102c, respectively (not shown in FIGS. 2A and 2B; see, e.g., FIG. 3B).

[0219] In this regard, the different lengths serve to prevent inflow fluid from immediately exiting the pericardial cavity PC via the shortest route through the outflow tube 8 without flushing the pericardial cavity by positioning the outflow opening 106 and the infusion openings 102a, 102b, 102c at such a distance from each other, i.e., distance B.

[0220] 2A, the infusate openings 102a, 102b, 102c are located substantially at the proximal end and / or portion of the integrated inflow and / or outflow drain device 34, and the effluent opening(s) 106 are located substantially at the intermediate portion of the integrated inflow and / or outflow drain device 34. However, it should be understood that the infusate openings 102a, 102b, 102c may be located substantially at the intermediate portion of the integrated inflow and / or outflow drain device 34, and the effluent opening(s) 106 may be located substantially at the proximal end and / or portion of the integrated inflow and / or outflow drain device 34.

[0221] As outlined above with respect to FIG. 1, the system 1 further includes a pressure sensor 66 positioned in the first tube arrangement 4 .

[0222] 2B, the pressure sensor 66 is incorporated into the second tube 8 along with the first tube arrangement 4. In this regard, the pressure sensor 66 is positioned in the second tube 8 so that no lumen is consumed.

[0223] In particular, the pressure sensor 66 is located in the wall of the second tube 8 , for example next to the first tube arrangement 4 .

[0224] This allows accurate pressure measurements in the pericardial cavity PC, for example at the proximal end of the integrated inflow and / or outflow drain device 34 and / or at the first tube location 4, since the pressure sensor 66 is incorporated into the integrated inflow and / or outflow drain device 34.

[0225] Optionally, the integrated inflow and / or outflow drain device 16 may include a temperature sensor 108, for example, a temperature sensor of the optional temperature control system described in connection with FIG.

[0226] In this regard, a temperature sensor 108 may be incorporated into the integrated inflow and / or outflow drain device 34 to provide an accurate measurement of core body temperature.

[0227] Returning to FIG. 1 , 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 in the pericardial cavity PC, is withdrawn from the cavity PC to remove blood and clots from the cavity PC.

[0228] Fluid drawn from the pericardial space PC, ie, effluent, can be directed toward hematocrit sensor 54 .

[0229] In particular, fluid drawn from the pericardial cavity PC, ie, effluent, can be directed through the buffer container 10 toward the hematocrit sensor 54 .

[0230] In particular, effluent can be directed from the pericardial space PC via an integrated inflow and / or outflow drain device 34 .

[0231] Because the first tube arrangement 4 is integrated into the second tube 8 such that it does not consume the lumen of the second tube 8, and particularly in this exemplary case, because the first tube arrangement 4 is located in the wall of the second tube 8, the integrated inflow and / or outflow drain device 34 may have a regular shape, such as a rounded or circular shape, so that it is capable of being or can be placed within the patient's body without leaking from the pericardial space PC. In other words, the integrated inflow and / or outflow drain device 34 may have a regular shape, such as a rounded or circular shape.

[0232] The effluent flows of the second tube 8 and the third tube 40 can be merged by the aforementioned fluid connector piece 42 to allow the effluent to be subsequently guided to the buffer container 10 and then to the hematocrit sensor 54 (e.g., by a connecting line connecting the buffer container 10 with the hematocrit sensor 54).

[0233] Hematocrit sensor 54 directs the effluent further to one or more effluent containers 20, in this embodiment, and analyzes (ie, measures) its hematocrit value.

[0234] 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.

[0235] After passing through hematocrit sensor 54 , the effluent is directed to effluent container 20 .

[0236] When the system 1 is in operation, the infusate is preferably temperature controlled to a desired infusate temperature before it can enter the patient's body or the patient's pericardial space PC.

[0237] The system 1 thus includes the above-mentioned heater device 64, which in this embodiment is arranged downstream of the second pump device 62.

[0238] Heater device 64 is configured to heat the infusate introduced into the pericardial space PC to a desired infusate temperature.

[0239] The desired infusate temperature is based on the temperature of the pericardial space PC. Preferably, the infusate temperature is in the range of 36° C. to 38° C., and more preferably, about 37° C. However, the desired infusate temperature may also be adapted or adjusted to the patient's actual body temperature and / or may be adapted to, for example, rewarm and / or cool the patient as required by the clinical situation.

[0240] This allows the heater device 64 to provide temperature-controlled infusate to the pericardial space PC.

[0241] Furthermore, as described above, the pressure sensor 66 can obtain the pressure in the pericardial cavity PC. In other words, the pressure sensor 66 can provide a pressure signal representative of the pressure in the pericardial cavity PC.

[0242] The resulting pressure can be provided to the control unit 16, which is configured to adjust the infusate flow rate (by controlling the second pump device 62) to keep the pressure (i.e., for example, the pressure signal) within desired pressure limits to avoid acute cardiac tamponade.

[0243] In surgical (post-operative) procedures, patients are typically provided with two pericardial cavity drains for draining post-operative bleeding, 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.

[0244] 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 tubing arrangement 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.

[0245] The first tube arrangement 4 is disposed in a substantially horizontal direction within the pericardial cavity PC to guide the infusate into the pericardial cavity PC. This allows the infusate to be guided uniformly and smoothly into the pericardial cavity PC. Therefore, this rainforest shower-like delivery of the infusate can provide improved flushing characteristics.

[0246] Additionally, the first tube arrangement 4 and the second tube 8 are arranged such that the outflow opening 106 and the infusate openings 102a, 102b, 102c are at different levels relative to gravity to allow the infusate to act with or against gravity when applied to the pericardial cavity PC. Thus, gravity may support flushing of the pericardial cavity when providing fluid at a higher level than when draining fluid, or may allow for more uniform and smooth flushing of the pericardial cavity when providing fluid at a lower level than when draining fluid.

[0247] 1 to 2B, the first tube arrangement 4 and the second tube 8 are arranged such that the outflow opening 106 and the infusate openings 102a, 102b, 102c are at different levels relative to the direction of gravity, in order to allow the infusate to act according to gravity when applied to the pericardial cavity PC. In particular, the first tube arrangement 4 is arranged at a higher level relative to the direction of gravity than the second tube 8.

[0248] Typically, the standard flush volume is 500 ml per hour, which can be adjusted as needed. Medical staff are continuously informed of the patient's condition, in particular bleeding tendency and / or absolute measures (volume / time units), via a graphical user interface (e.g., in the form of a display unit, which may be included in system 1).

[0249] In particular, in this regard, there may be notifications and / or information that can be provided to medical staff, such as those shown in the table of Figure 8. Preferably, there may be notifications and / or information when the trends in the columns exceed the values ​​shown in the table of Figure 8.

[0250] The drained fluid, ie, effluent, is drained via second tube 8 and third tube 40 to hematocrit sensor 54 .

[0251] The buffer container 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 freed from clots and / or air that may be contained in the effluent.

[0252] In other words, the clot trap 22 allows the clot to be separated from the effluent.

[0253] 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.

[0254] When the system 1 is in operation, each level sensor 50, 52 is able to obtain the fill level of their respective buffer volumes.

[0255] The control unit 16 controls the first pump device 18 to regulate the outflow rate from the buffer reservoir by providing at least one of the control signals (e.g., the control signal) based on the resulting buffer volume fill level, which also allows 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.

[0256] 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 the control signal.

[0257] 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, although any other amount may be pumped based on a control signal of the control unit 16.

[0258] The buffer reservoir 10 therefore collects the effluent until it can be pumped by the first pump device 18 .

[0259] 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.

[0260] As already mentioned above, the first pump device 18 is configured for continuous and / or discontinuous pumping operations (e.g., continuous analysis of effluent or discontinuous (i.e., batch) analysis), 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.

[0261] The effluent then passes through hematocrit sensor 54 towards effluent container 20 (supported by low pressure provided by ICU vacuum wall connector 56).

[0262] As the effluent passes therethrough, its hematocrit is measured by hematocrit sensor 54 .

[0263] The measured hematocrit value can be an important basis for deducing bleeding.

[0264] When the intrapericardial pressure and blood loss 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.

[0265] In particular, in this regard, there may be notifications and / or information that can be provided to medical staff, such as those shown in the table of FIG.

[0266] 3A and 3B, there is shown a schematic representation of another integrated inlet and / or outlet drain device 34 for a flush system 1 according to one embodiment of the present invention. For example, the integrated inlet and / or outlet drain device 34 shown in Figures 3A and 3B may be the integrated inlet and / or outlet drain device 34 of Figure 1.

[0267] The integrated inlet and / or outlet drain device 34 of Figures 3A and 3B is configured substantially similarly to the integrated inlet and / or outlet drain device 34 of Figures 2A and 2B described above, and therefore, only the differences will be described below.

[0268] The outflow lumen 104 of the second tube 8 has a plurality of outflow openings 106 for receiving outflow from the pericardial cavity PC, in particular, in this case, a first outflow opening 106a, a second outflow opening 106b and a third outflow opening 106c.

[0269] The plurality of effluent openings 106 are distributed over a distance E along the second tube 8 and are spaced apart from one another.

[0270] The distance E is provided between the distance A, which is substantially defined as above, and the distance B, which is substantially defined as above.

[0271] 3A and 3B, the first tube arrangement 4 is longer than the second tube 8. In particular, the first tube arrangement 4 extends from the proximal end of the second tube 8.

[0272] In this regard, the first tube arrangement 4 is dimensioned relative to the second tube 8 to allow the effluent opening 106 to be spaced apart from the infusate openings 102a, 102b, 102c by at least a distance B. In particular, the third outflow opening 106c is spaced apart from the third infusate opening 102c by a distance B.

[0273] Distance B is dimensioned to allow the effluent openings 106a, 106b, 106c and the infusate openings 102a, 102b, 102c to be positionable at different levels relative to the direction of gravity.

[0274] As can be seen in Figure 3B, the effluent openings 106a, 106b, 106c are arranged substantially perpendicular to the infusate openings 102a, 102b, 102c, although it should be understood that any suitable arrangement may be applicable.

[0275] 4, there is shown a schematic representation of another integrated inlet and / or outlet drain device 34 for a flush system 1 according to one embodiment of the present invention. For example, the integrated inlet and / or outlet drain device 34 shown in FIG. 4 may be the integrated inlet and / or outlet drain device 16 of FIG. 1.

[0276] The integrated inlet and / or outlet drain device 16 of Figure 4 is configured substantially like the integrated inlet and / or outlet drain device 34 of Figures 2A and 2B and / or 3A and 3B, respectively, described above, and therefore only the differences will be described below.

[0277] The first tubing arrangement 4 has multiple infusate lumens 100, 100a, only one of which is shown in FIG. 4 for clarity.

[0278] Each infusate lumen 100, 100a of the first tubing arrangement 4 has a plurality of infusate openings 102a for directing infusate into the pericardial space PC.

[0279] The multiple infusion openings 102a are distributed and spaced apart from one another over a distance Y along the first tube arrangement 4 and, accordingly, along the second tube 8 as the first tube arrangement 4 is incorporated into the second tube 8.

[0280] The second tube 8 has, for example, one effluent lumen 104 for directing the flow of effluent from the pericardial cavity PC to the system 1 .

[0281] The effluent lumen 104 of the second tube 8 has at least one effluent opening 106 for receiving effluent from the pericardial space PC.

[0282] The effluent opening 106 is spaced at least a distance Z from the infusate openings 102a, 102b, and 102c.

[0283] The distance Z is dimensioned to allow the effluent opening 106 and the infusate opening 102a to be positionable at different levels relative to the direction of gravity. For example, the distance Z may be dimensioned to allow the effluent opening 106 and the infusate opening 102a to be positioned or positionable at different levels relative to the direction of gravity when the integrated inflow and / or outflow drain device 34 is folded generally into a U-shape.

[0284] Furthermore, the infusate openings 102a (eg, groups of infusate openings 102a) are spaced at least a distance X from the infusate outlet 2 and / or effluent inlet 6, and accordingly the integrated fluid interface device .

[0285] Distance X is dimensioned to span at least the distance between the pericardial cavity PC and the integrated fluid interface device 36. In other words, distance X is dimensioned to span at least the distance between the patient and the flushing system 1.

[0286] Referring to Figure 5, another integrated inlet and / or outlet drain device 34 for a flush system 1 according to one embodiment of the present invention is shown schematically. For example, the integrated inlet and / or outlet drain device 34 shown in Figure 5 may be the integrated inlet and / or outlet drain device 34 of Figure 1.

[0287] The integrated inlet and / or outlet drain device 34 of Figure 5 is configured substantially the same as the integrated inlet and / or outlet drain device 34 of each of Figures 2A to 4 described above, in particular the integrated inlet and / or outlet drain device 34 of Figure 4. Therefore, only the differences will be described below.

[0288] The first tube arrangement 4 includes a retractable sheath 110. As the first tube arrangement 4 is thereby integrated into the second tube 8, the retractable sheath 110 is also assigned to the second tube 8 and thereby to the integrated inflow and / or outflow drainage device 34.

[0289] The retractable sheath 110 is retractable into the first tube arrangement 4 and thereby into the second tube 8, and accordingly along the integrated inflow and / or outflow drainage device 34, between a first position and a second position via at least one intermediate position (schematically indicated by an arrow above the device 34).

[0290] In the first position, the infusate opening 102a may be covered by a sheath 110 (illustratively depicted in FIG. 5).

[0291] In the second position, the infusate opening 102a is not covered by the sheath 110 (not shown).

[0292] In the intermediate position, a portion of the infusate opening 102a may be covered by a sheath 110 (not shown).

[0293] In this regard, the sheath 110 is configured to extend along the first tube arrangement 4, the second tube 8 and / or the integrated inflow and / or outflow drain device 34.

[0294] When the flushing system 1 is operated, the sheath 110 can be used to regulate the infusion of infusate into the pericardial space PC by partially or completely covering the infusate opening 102a, thereby allowing for more precise and / or effective flushing of the pericardial space PC.

[0295] Referring to Figure 6, a flushing system 300 according to another embodiment is shown schematically. 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.

[0296] In this regard, the system 300 of Figure 6 includes the integrated inflow and / or outflow drain device 34 described with respect to Figure 1. However, it should be understood that any of the devices described in connection with Figures 2A through 5 may also be used with the system 300 of Figure 6.

[0297] The flushing system 300 is also configured to drain the patient's pleural cavity PLC while flushing the pericardial cavity PC.

[0298] Thus, the system 300 further includes a third effluent inlet 302 and a fourth effluent inlet 306 .

[0299] The third effluent inlet 302 is configured to connect to a fourth tube 304 .

[0300] The fourth tube 304 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0301] The fourth effluent inlet 306 is configured to connect to a fifth tube 308 .

[0302] The fifth tube 308 has an effluent lumen for directing the flow of effluent from the pleural cavity PLC to the system 300 .

[0303] 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.

[0304] The effluent flows of the fourth tube 304 and the fifth tube 308 are merged or are capable of merging by the fluid connector piece 310 when the system 300 is operated.

[0305] The system 300 includes another buffer container 312 .

[0306] Another buffer reservoir 312 is allocated to receive fluid from the pleural cavity PLC.

[0307] The other buffer vessel 312, which may be referred to as second buffer vessel 312, is configured like buffer vessel 10 described above.

[0308] A second buffer container 312 is connected to the fluid connector piece 310 (eg, via a connecting line such as a connecting tube).

[0309] System 300 includes another pump device 314 , namely, third pump device 314 , and another hematocrit sensor 316 , namely, second hematocrit sensor 316 .

[0310] 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.

[0311] A second buffer container 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.

[0312] 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.

[0313] 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.

[0314] 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.

[0315] Referring now to Figure 7, a flushing system 400 according to another embodiment is shown schematically. The flushing system 400 is substantially configured similarly to the flushing system 1 of Figure 1 described above. Therefore, only the differences will be described below.

[0316] In this regard, the system 400 of Figure 7 includes the integrated inflow and / or outflow drain device 34 described with respect to Figure 1. However, it should be understood that any of the devices described in connection with Figures 2A through 5 may also be used with the system 400 of Figure 7.

[0317] 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.

[0318] Effluent received or receivable from the pericardial space PC is directed or guideable to the effluent container 20 .

[0319] Adjacent to the effluent container 20 are one or more suction devices 402 .

[0320] 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).

[0321] This relatively low pressure can be used to draw effluent from the pericardial space PC into the effluent container 20 .

[0322] 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.

[0323] 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.

[0324] 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.

[0325] 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.

[0326] The sensors 404, 410, the control unit 16, and the second pump device 62 may form part of a flow rate control system for controlling the flow rate of infusate at the infusate outlet 2 based on sensor signals, including an infusate signal representative of the infusate flow rate into the pericardial cavity PC and an effluent signal representative of the effluent flow rate from the pericardial cavity PC. The difference between the infusate flow rate and the effluent flow rate may generally correspond substantially to the patient's blood loss rate from the pericardial cavity PC. Importantly, the control signal also includes a hematocrit sensor signal from the hematocrit sensor 54 and a pressure signal from the pressure sensor 66.

[0327] Based on the calculated blood loss and / or flow rate, the appropriate infusate flow rate can be pumped by the second pump device 62.

[0328] Because it is important to accurately determine the actual amount of blood loss from the pericardial space PC, system 400 also includes hematocrit sensor 54, as described above.

[0329] System 400 also includes buffer reservoir 10 (eg, buffer reservoir 10 of FIGS. 1 and 6) located upstream from hematocrit sensor 54 as shown in FIGS.

[0330] 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 container 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.

[0331] In this embodiment, the system 400 includes 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 the control unit 16, but may be formed as part of a separate control unit, for example, the heater device 64, or may be integrated into another control device or processing unit.

[0332] 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.

[0333] 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 blood content in the effluent, the components of blood in the effluent, and trends thereof. Importantly, the display may show indications based on combined sensor inputs as described elsewhere.

[0334] 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.

[0335] Referring to Figure 8, there may be notifications and / or information (e.g., alerts as described above) that can be provided to medical staff as shown in the table of Figure 8. Preferably, there may be notifications and / or information (e.g., alerts as described above) when the trend in a column exceeds the value shown in the table of Figure 8.

[0336] In view of the embodiment of Figure 7, it should be understood that any elements described therein may be incorporated, used and / or included in connection with the embodiments shown in Figures 1 and 6 (alone or in any combination), such that the sensor unit is associated with a correspondingly configured control unit, display device, alarm device, etc.

[0337] 9, 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.

[0338] It should be understood that in view of the embodiment of FIG. 9, any element described therein may be incorporated, used, and / or included in connection with the embodiments shown in FIGS. 1 through 8, and vice versa.

[0339] 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.

[0340] The framework 504 is formed as a disposable framework.

[0341] The base structure 502 is formed as a mobile base structure that is movable on the ground.

[0342] The base structure 502 includes a bottom portion 506 and a top portion 508 .

[0343] 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.

[0344] Furthermore, a suction device 402 is also provided and disposed on the bottom 506 .

[0345] 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 .

[0346] Additionally, a first valve 510 and a second valve 512 are provided and disposed on and / or above the top portion 508 .

[0347] The top portion 508 is configured to removably and / or replaceably hold and / or secure the frame structure 504 to the base structure 502 (depicted by corresponding arrows in FIG. 9). It may be contemplated that the frame structure 504 may be attached and / or secured to other parts of the system, here the 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.

[0348] The buffer vessel 10 and the second buffer vessel 312 are configured as part of a frame structure 504 .

[0349] 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 .

[0350] As can be seen in FIG. 9, the framework 504 holds and / or includes one or more connecting lines, such as connecting tubes 514 .

[0351] 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.

[0352] 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 .

[0353] An infusion connection tube 516 connects the infusate container 60 with the integrated fluid interface device 36 through the framework 504 .

[0354] Downstream of and starting from the buffer reservoir 10,312, the further outflow connection tube 520 merges into one further outflow connection tube 522 by means of a fluid connector piece, for example a Y-connector.

[0355] The above-mentioned further outflow connecting tube 522 is then / further merged downstream with the connecting tube originating from the second buffer outlet 58 of the buffer container 10,312 by another fluid connector piece, for example another Y-connector, within and / or before terminating at the outflow container 20.

[0356] The frame structure 504 includes at least a first access element 524 , a second access element 526 , and a third access element 528 .

[0357] 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.

[0358] 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.

[0359] 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.

[0360] In this exemplary embodiment, as can be seen in FIG. 9 , 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.

[0361] A further outflow connection 522 is engageable with a hematocrit sensor 54 further downstream from the first pump device 18 .

[0362] The frame structure 504 also includes two further recesses provided between the buffer reservoir 10, 312 and the fluid connector piece where the further outflow connection tube 520 merges.

[0363] 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.

[0364] 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.

[0365] As can be seen in FIG. 9, 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 .

[0366] 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.

[0367] The system 500 further includes a hub storage device 532 for holding the hub device 530 .

[0368] The hub storage device 532 is formed as a cradle device.

[0369] 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.

[0370] 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.

[0371] It should be understood that the flushing system 500 operates substantially similarly to the flushing systems 1, 200, 300, and 400 described above.

[0372] 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.

[0373] In particular, flushing system 500 provides a compact and / or cost-effective solution that includes only one effluent pump device 18 and one hematocrit sensor 54, yet still allows for separate measurement of effluent from different origins, such as the pericardial and pleural cavities.

[0374] 10 and 11, 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.

[0375] The hub device 600 is generally rectangular parallelepiped shaped, although any other shape may be envisaged.

[0376] The hub device 600 combines four effluent inlets 602 located on one side of the hub device 600, for example the patient side.

[0377] 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 combining two effluent streams that are receivable via corresponding effluent inlets 604, respectively.

[0378] The hub device 600 includes two outlets 606 for discharging the merged effluent streams.

[0379] 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.

[0380] 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.

[0381] 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.

[0382] 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. 11 (see cross section of the integrated inflow and / or outflow drain device 34).

[0383] 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 .

[0384] It should further be understood that the arrows depicted in FIG. 11 indicate the respective stream directions of the corresponding fluids guided therethrough.

[0385] 12 and 13, an integrated inlet and / or outlet drain device 34 is shown schematically for a flushing system 1, 200, 300, 500 according to an embodiment of the present invention. For example, the integrated inlet and / or outlet drain device 34 shown in FIGS. 12 and 13 may be the integrated inlet and / or outlet drain device 34 described in connection with FIGS. 1 and / or 6, for example.

[0386] The integrated inlet and / or outlet drain device 34 of Figures 12 and 13 is configured substantially like the integrated inlet and / or outlet drain device 34 of Figures 2A and 2B and / or 3A and 3B described above, and therefore, only the differences will be described below.

[0387] As exemplarily shown in Fig. 12, the integrated inflow and / or outflow drainage device 34 is insertable into a patient (for reference, the dashed line may indicate the patient's skin when the integrated inflow and / or outflow drainage device 34 is inserted into the patient, e.g., during / for a flushing process). Thus, the integrated inflow and / or outflow drainage device 34 may be subdivided into an operating room side (here, on the left in Fig. 12) and a patient side (here, on the right in Fig. 12) that is intended for insertion into the patient.

[0388] The integrated inflow and / or outflow drain device 34 has an extension of a distance A that extends from the outflow inlet 6 and accordingly the integrated liquid interface device 36, e.g., hub device 530, 600, to the intended transition between the sides.

[0389] And the integrated inflow and / or outflow drain device 34 is intended to be inserted into a patient and has an extension of distance B+C+D for insertion into the patient.

[0390] In particular, after distance B, the integrated inflow and / or outflow drain device 34 subdivides into two branches, one branch assigned to the infusate and including the infusate lumen 100, and the other branch assigned to the effluent and including the effluent lumen 104.

[0391] The branch assigned to the infusion has an extension of distance C+D.

[0392] The branch assigned to the outflow has an extension of distance C.

[0393] The effluent lumen 104 of the second tube 8 has a plurality of effluent openings 106, in particular six effluent openings 106 in this case, for receiving effluent from the pericardial cavity PC.

[0394] The plurality of effluent openings 106 are distributed along and around the second tube 8 over a distance C and are spaced apart from one another.

[0395] As can be seen in FIG. 12, the first tube arrangement 4 is longer than the second tube 8 .

[0396] In this regard, the first tube arrangement 4 is dimensioned relative to the second tube 8 to allow the effluent opening 106 to be spaced apart from the infusate opening 102 .

[0397] The distance D is dimensioned to allow the effluent opening 106 and the infusate opening 102 to be positionable at different levels relative to the direction of gravity.

[0398] As an example, distance A may be approximately twice as long as distance B, distance B may be approximately the same length as distance C, and distance D may be approximately the same length as distance A. For example, distance A may be approximately 10 cm. However, it should be understood that any other suitable relationship between the distances may be contemplated and / or distance A may have any other suitable value.

[0399] 12 and 13, the pressure sensor 66 may be incorporated into the integrated inflow and / or outflow drain device 34 as a measurement channel for measuring pressure with air, e.g., measurement channel 612. This may provide an alternative to measuring pressure on the infusate inflow, thereby providing a solution that is low-cost to implement, without pressure noise from the pump device and without the risk of being affected by altitude differences in the fluid column. The exit point of the measurement channel (in the pericardium) for pressure measurement may be next to and / or close to the infusate inflow opening (in the pericardium), so that the infusate keeps the measurement channel clot-free.

[0400] Referring to FIG. 13, a cross-sectional view of the integrated inflow and / or outflow drain device 34 is shown schematically, the cross-section being taken within a distance A.

[0401] The cross-sectional profile of the integrated inflow and / or outflow drain device 34 is generally oval.

[0402] A pressure sensor 66 as a measurement channel is provided between the infusate lumen 100 and the effluent lumen 102 .

[0403] The diameter of the infusate lumen 100 is smaller than the diameter of the effluent lumen 102 .

[0404] For example, the relationship between the diameters may be about 1 to 3 or 1 to 4.

[0405] In this regard, the diameter of the infusate lumen 100 may be about 1.5 mm to about 2 mm, and the diameter of the effluent lumen 102 may be about 6 mm, although any other suitable diameters may be contemplated.

[0406] Additionally, as can be seen in FIG. 13, dashed lines indicate where each branch is separated, which may occur, for example, during manufacture of the integrated inflow and / or outflow drain device 34 .

[0407] The integrated inflow and / or outflow drain device 34 may have a silicone base, in other words, the integrated inflow and / or outflow drain device 34 may be manufactured from a silicone material, in particular a medical-grade silicone material.

[0408] Referring to Figure 14, there is shown a schematic diagram of an integrated inlet and / or outlet drain device 34 for a flushing system 1, 200, 300, 500 according to one embodiment of the present invention. For example, the integrated inlet and / or outlet drain device 34 shown in Figure 14 may be the integrated inlet and / or outlet drain device 34 described in connection with Figures 1 and / or 6, for example.

[0409] The integrated inlet and / or outlet drain device 34 of Figure 14 is configured substantially like the integrated inlet and / or outlet drain device 34 of Figures 12 and 13 described above, and therefore, only the differences will be described below.

[0410] As can be seen in FIG. 14, the integrated inflow and / or outflow drain device 34 includes three infusate lumens 100.

[0411] Furthermore, the integrated inflow and / or outflow drain device 34 has two branches allocated to the infusion fluid, one of which has one infusion fluid lumen 100 and the other of which has two infusion fluid lumens 100.

[0412] Additionally, the branches containing the two infusate lumens 100 each include corresponding infusate openings 102 that are oriented laterally relative to one another.

[0413] Referring to FIG. 15, a portion of an integrated inlet and / or outlet drain device 34 for a flushing system 1, 200, 300, 500 according to one embodiment of the present invention is shown schematically.

[0414] Some of the above may be modifications of the integrated inflow and / or outflow drain device 34 of FIGS.

[0415] In particular, part of the above is a branch assigned to the infusion fluid, which in turn is again sub-branched into two sub-branches.

[0416] Each sub-branch contains one infusate lumen 100 with a respective infusate opening 102 at its end.

[0417] Referring to FIG. 16, there is shown a schematic cross-section of an integrated inflow and / or outflow drain device 34 for a flushing system 1, 200, 300, 500 according to one embodiment of the present invention.

[0418] The above cross-sections may be variations of the integrated inflow and / or outflow drain device 34 of FIGS.

[0419] In particular, the cross section is substantially configured as the cross section of Figure 13. Therefore, only the differences will be described below.

[0420] The effluent lumen 104 is located between a first pair of pressure sensor 66 and one infusate lumen 100 as a measurement channel and a second pair of two infusate lumens 100 .

[0421] The first pair, effluent lumen 104, and the second pair of lumens 100 are arranged to branch off from one another, for example as indicated by the dashed lines.

[0422] Referring to FIG. 17, there is shown a schematic cross-section of an integrated inflow and / or outflow drain device 34 for a flushing system 1, 200, 300, 500 according to one embodiment of the present invention.

[0423] The above cross-sections may be variations of the integrated inflow and / or outflow drain device 34 of FIGS. 12, 13, 14, 15 and / or 16.

[0424] In particular, the cross section is substantially configured as the cross section of Figure 13. Therefore, only the differences will be described below.

[0425] The effluent lumen 104 is disposed between the two infusate lumens 100 .

[0426] The effluent lumen 104 and each infusate lumen 100100 are arranged to branch off from one another, for example as indicated by the dashed lines.

[0427] Furthermore, the integrated inflow and / or outflow drain device 34 does not have a measurement channel formed therein.

[0428] It should be understood that the hub devices 530, 600 described herein may be configured to be engageable and / or connectable with any of the integrated inflow and / or outflow drain devices 34 described herein, for example, the integrated inflow and / or outflow drain devices 34 of Figures 12, 13, 14, 15, 16 and / or 17. [Explanation of symbols]

[0429] 1. Wash-off system 2 Injectate outlet 4. First tube placement 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 infusion lumens 100a First infusion lumen 100b 2 infusion lumens 100c Third infusion lumen 102 Injectate opening 102a 1st injection fluid opening 102b 2nd injectate opening 102c 3rd injection fluid opening 104 Effluent lumen 106 Outflow opening 106a 1st effluent opening 106b 2nd effluent opening 106c 3rd effluent opening 108 Temperature Sensor 110 Retractable Sheath 300 Washing System 302 Third effluent inlet 304 4th Tube 306 4th effluent inlet 308 5th Tube 310 Fluid Connector Piece 312 Another buffer container, second buffer container 314 Another pumping device, a third pumping device 316 Another hematocrit sensor, second hematocrit sensor 400 Washing System 402 Suction Device 404 Weight Sensor 406 Flow velocity sensor 408 Weight Sensor 410 Flow velocity sensor 412 Temperature Sensor 414 Display Devices 500 Washing System 502 base structure 504 Frame Structure 506 Bottom 508 Top 510 First Valve 512 Second valve 514 Connecting tube 516 Injection connection tube 518 Outlet connection tube 520 Separate outflow connection tube 522 Yet another outflow connection tube 524 First Access Element 526 Second Access Element 528 Third Access Element 530 Hub Device 532 Hub Storage Device 600 Hub Devices 602 Effluent inlet 604 Connector piece 606 Exit 608 Inlet 610 Inlet 612 measurement channels PC pericardial cavity PLC pleural cavity

Claims

1. 1. An irrigation system (1, 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 connection to a first tubing arrangement (4) having one or more infusate lumens (100, 100a, 100b, 100b) 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 (104) for directing the flow of effluent from the wound and / or the body cavity, in particular the pericardial cavity (PC), to the system (1, 300, 400, 500); a flow rate control system for controlling the flow rate of the infusate at the infusate outlet (2), wherein the flow rate control system comprises: 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 system (1, 300, 400, 500) in which each infusion lumen (100, 100a, 100b, 100b) of the first tube arrangement (4) has at least one infusion opening (102, 102a, 102b, 102b) for directing the infusion into the wound and / or the body cavity, in particular the pericardial cavity (PC), the infusion openings (102, 102a, 102b, 102b) being arranged along the first tube arrangement (4) and spaced apart from one another.

2. 2. The system (1, 300, 400, 500) of claim 1, wherein the first tube arrangement (4) includes a retractable sheath (110) that is retractable between a first position and a second position via at least one intermediate position along the first tube arrangement (4), wherein in the first position, the infusate openings (102, 102a, 102b, 102b) are covered by the sheath (110), and in the second position, the infusate openings (102, 102a, 102b, 102b) are not covered by the sheath (110), and in the intermediate position, a portion of the infusate openings (102, 102a, 102b, 102b) is covered by the sheath (110).

3. 3. The system (1, 300, 400, 500) according to claim 1 or 2, characterized in that the first tube arrangement (4) can be positioned in a substantially horizontal direction to guide the infusion liquid into the wound and / or the body cavity, in particular the pericardial cavity (PC).

4. 4. A system (1, 300, 400, 500) according to any one of claims 1 to 3, characterized in that the outflow lumen (104) of the second tube (8) has at least one outflow opening (106, 106a, 106b, 106c) for receiving the outflow from the wound and / or the body cavity, in particular the pericardial cavity (PC).

5. 5. The system (1, 300, 400, 500) according to claim 4, characterized in that the first tube arrangement (4) and the second tube (8) are configured to be arranged so that the outflow openings (106, 106a, 106b, 106c) and the infusion openings (102, 102a, 102b, 102c) are provided at different levels relative to the direction of gravity, in order to allow the infusion liquid to act according to or against gravity when applied to the wound and / or the body cavity, in particular the pericardial cavity (PC).

6. 6. A system (1, 300, 400, 500) according to any one of claims 1 to 5, characterized in that the first tube arrangement (4) and the second tube (8) are combined into an integrated inflow and / or outflow drain device (34).

7. 7. The system (1, 300, 400, 500) according to claim 6, characterized in that the integrated first tube arrangement (4) of the inflow and / or outflow drain device (34) is optionally longer than the integrated second tube (8), and the integrated first tube arrangement (4) has a length such that the outflow opening (106, 106a, 106b, 106c) and the infusion opening (102, 102a, 102b, 102c) are or can be positioned at different levels relative to the direction of gravity.

8. 8. The system (1, 300, 400, 500) according to any one of claims 1 to 7, characterized in that the system (1, 300, 400, 500) 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).

9. 9. The system (1,300, 400, 500) according to any one of claims 1 to 8, characterized in that the system (1,300, 400, 500) further comprises a hematocrit sensor (54) configured to measure the hematocrit value of the effluent in order to obtain the amount and / or flow rate of blood loss from the wound and / or the body cavity, in particular the pericardial cavity (PC).

10. 10. The system (1, 300, 400, 500) of claim 9, wherein the hematocrit sensor (54) is disposed between the effluent inlet (6) and one or more effluent containers (20) for performing measurements on the effluent.

11. 11. The system (1,300, 400, 500) according to any one of claims 1 to 10, characterized in that the system (1,300, 400, 500) further comprises a pressure sensor (66) located inside the first tube arrangement (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 arrangement (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).

12. 12. The system (1,300, 400, 500) according to any one of claims 1 to 11, characterized in that the system (1,300, 400, 500) 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.

13. The system (300, 500) further comprises a further effluent inlet (302) for connection to a third tube (304) having an effluent lumen for directing the flow of effluent from another wound and / or another body cavity, in particular the pleural cavity (PLC), into the system (300); Optionally, the system (300) further comprises a further hematocrit sensor (316) configured to measure the hematocrit value of the effluent in order to obtain the amount and / or flow rate of blood loss from the further wound and / or the further body cavity, in particular the pleural cavity (PLC), the further hematocrit sensor (316) being disposed between the further effluent inlet (302) and one or more effluent containers (20) for performing measurements on the effluent; and / or 13. The system (300, 500) of any one of claims 1 to 12, further comprising at least one weight sensor (404) for measuring changes in weight of the infusion fluid in at least a part and / or component of the system, in particular in an infusion fluid container (60) of the system.

14. 14. A tube arrangement (4) for a flushing system (1, 300, 400, 500) configured to flush a wound and / or a body cavity, in particular a pericardial cavity (PC), of a patient, in particular for a flushing system according to any one of claims 1 to 13, said tube arrangement (4) comprising: one or more infusate lumens (100, 100a, 100b, 100b) configured, when positioned and / or operated in the flushing system (1, 300, 400, 500), to direct a flow of infusate from the flushing system (1, 300, 400) to the wound and / or the body cavity, in particular the pericardial cavity (PC); A tube arrangement (4) in which each infusate lumen (100, 100a, 100b, 100b) of the first tube arrangement (4) has at least one infusate opening (102, 102a, 102b, 102b) for directing the infusate into the wound and / or the body cavity, in particular the pericardial cavity (PC), the infusate openings (102, 102a, 102b, 102b) being arranged along the first tube arrangement (4) and spaced apart from one another.

15. 15. The tube arrangement (4) of claim 14, wherein the first tube arrangement (4) includes a retractable sheath (110) that is retractable between a first position and a second position via at least one intermediate position along the first tube arrangement (4), wherein in the first position the infusate openings (102, 102a, 102b, 102b) are covered by the sheath (110), and in the second position the infusate openings (102, 102a, 102b, 102b) are not covered by the sheath (110), and in the intermediate position the infusate openings (102, 102a, 102b, 102b) are partially covered by the sheath (110).

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