Body cavity lavage system, measurement unit, and smart tube assembly for the system

Abstract

A cleaning system is provided for cleaning a patient's wounds and / or body cavities, particularly the pericardial cavity (PC) and / or pleural cavity. [Solution] The cleaning system includes a carrier unit configured to be movable, an inflow unit including at least one infusion fluid container for containing an infusion fluid, and a collection unit configured to collect exudate from a patient, wherein the carrier unit is configured to house the inflow unit and the collection unit, the inflow unit further includes at least one first weighing unit for measuring the weight of the infusion fluid delivered to the patient, and the carrier unit includes a second weighing unit for measuring the weight of the exudate collected in the collection device.

Description

Technical Field

[0001] The present invention relates to a flushing system and components for a flushing system. In particular, the present invention reduces the risk of cardiac tamponade and pulmonary edema as a postoperative treatment, reduces the amount of postoperative blood loss, and reduces the accumulation of blood and thrombi in the pericardial cavity and / or pleural cavity for a patient's body cavity (e.g., the pleural cavity and / or pericardial cavity). The flushing system incorporates unique features and components that improve the efficiency, accuracy, safety, and comfort of the flushing process.

Background Art

[0002] The flushing of body cavities is a common medical procedure used for various therapeutic, postoperative, and diagnostic purposes. Flushing systems are used, for example, for draining pleural effusion or pericardial effusion, flushing the pleural space during thoracic surgery, draining pericardial effusion, or administering drugs and therapeutic agents.

[0003] Excessive postoperative blood loss of more than 2 L per 24 hours or more than 200 ml per hour is known as a cause of complications in cardiac surgery. Reoperation / rethoracotomy due to bleeding is a strong independent risk factor for poor prognosis after cardiac surgery, leading to higher mortality and morbidity. Also, postoperative bleeding requiring multiple transfusions and surgical rethoracotomy leads to increased costs, increased sternal wound infections, and transfusion-related infections.

[0004] After surgery, a thoracic tube is placed to drain blood from the pericardial cavity and, if necessary, also from the pleural cavity. However, if the amount of blood loss is excessive or thrombi begin to form more rapidly, the drainage tube often fails to fully drain all the accumulated blood. Stagnation of thrombi and blood in the pericardial cavity and / or pleural cavity induces high fibrinolytic activity, leading to persistent blood loss and, in some cases, cardiac tamponade, resulting in potentially excessive filling pressure of the heart.

[0005] However, conventional lavage systems often require manual operation and may lack precision and reliability in the amount of fluid injected into the patient, potentially leading to fluid imbalances, discomfort, and complications. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] Therefore, an object of the present invention is to provide an improved cleaning system configured to clean a patient's wounds and / or body cavities, particularly the pericardial cavity and / or pleural cavity. Advantageously, the cleaning system incorporates unique features and smart components that improve the efficiency, safety, and precision of the cleaning system. Furthermore, by utilizing the cleaning system, a simple and stable system for precisely controlling the cleaning process is provided. [Means for solving the problem]

[0007] According to one aspect of the present invention, this objective is achieved by the cleaning system described in claim 1.

[0008] This provides a cleaning system for cleaning a patient's wounds and / or body cavities, particularly the pericardial cavity (PC) and / or pleural cavity. The cleaning system is

[0009] - A carrier unit configured for mobility (to be movable),

[0010] - An inlet unit including at least one injection fluid container for containing the injection fluid,

[0011] -Includes a collection unit configured to collect exudate from the patient,

[0012] The carrier unit is configured to house the inflow unit and the collection unit.

[0013] The infusion unit further includes at least one first gravimetric unit for measuring the weight of the infusion fluid delivered to the patient.

[0014] The carrier unit includes a second gravimetric unit for measuring the weight of the seepage fluid collected in the collection unit.

[0015] The present invention is based on the fundamental idea of ​​providing a unique lavage system configured to accurately calculate both the amount of fluid injected into a patient and the amount of fluid removed from the patient's body. Specifically, the lavage system includes two gravimetric units for measuring both the weight of fluid injected into the patient (e.g., a body cavity or multiple body cavities) and the weight of fluid discharged from the patient (e.g., into a collection unit). More specifically, the lavage system is configured to individually examine exudate removed from various body cavities, such as the pleural cavity and the pericardial cavity. That is, the lavage system is configured to individually measure, preferably, the exudate removed from the pericardial cavity and the pleural cavity, and to report this in real time. Advantageously, the lavage system includes two intermediate fluid containers, each configured to communicate with a body cavity and fluid, facilitating individual analysis and measurement of the exudate removed from the body cavity via at least one sensor. The performance of the lavage system is further enhanced by providing novel upright filters (i.e., arranged parallel to the direction of fluid flow) within each intermediate fluid container. This filter configuration prevents thrombi from accumulating on the filter and obstructing the flow of fluid through the intermediate fluid container. It also effectively minimizes the risk of aggregate formation, particularly the formation of larger thrombi. Such aggregates can obstruct fluid flow in other downstream components within the washing system.

[0016] Specifically, the cleaning system further includes a measuring unit configured to be operably connected to an inflow unit and a collection unit.

[0017] Specifically, the measurement unit is in fluid communication with the inflow unit and the collection unit.

[0018] Specifically, the measurement unit includes at least one analysis chamber for the sensor unit, at least one processing / analysis unit, and / or at least one pump unit. Specifically, the measurement unit is positioned at an intermediate location along the longitudinal axis between the inflow unit and the collection unit.

[0019] Specifically, the measurement unit is configured to be positioned downstream of the inflow unit.

[0020] Specifically, the measuring unit is configured to be located downstream of the inflow unit within the carrier unit (inside the carrier unit).

[0021] Specifically, the measurement unit includes components such as a pump device, sensors, valves, fluid containers, tubes and / or tube connectors, which are assembled together to be used, for example, to pump infusion fluid into a patient, to intermittently store exudate removed from the patient, and to analyze the exudate.

[0022] Specifically, the measuring unit is configured to be connected to the collection unit (i.e., its vacuum line) of the cleaning system, allowing the removed injection fluid to be discharged, for example, into a waste container.

[0023] Specifically, the measurement unit includes two intermediate fluid containers (e.g., buffer containers) for containing (or storing) exudate, preferably a first intermediate fluid container configured to contain exudate from the pleural cavity and a second intermediate fluid container for containing exudate from the pericardial cavity.

[0024] Specifically, the irrigation system may further include one or more suction devices for aspirating exudate from wounds and / or body cavities, particularly the pericardial cavity. The one or more suction devices are positioned to create a relatively low pressure within one or more exudate containers to receive the exudate, thereby allowing the exudate to be aspirated into the one or more exudate containers. For example, the one or more exudate containers may be connectable to or connected to an intensive care unit (ICU) vacuum wall connector or similar device (e.g., other suitable vacuum supply units / systems, and / or other suitable custom-made vacuum devices), the ICU vacuum wall connector being configured to create the (relatively) low pressure and functioning as the one or more suction devices. In addition to or instead of this, a system-specific vacuum unit may also be provided, particularly for the purposes described above.

[0025] Specifically, each buffer container may have a substantially rectangular shape extending along a central axis or longitudinal axis. However, it should be understood that other shapes, such as cylindrical or elliptical, can also function in relation to this. The buffer container may include an upper and lower end. The buffer container may include a top wall, side walls, 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 on the top wall or a side wall. The first buffer outlet may be located on the bottom wall or a side wall. Therefore, the buffer inlet may be located higher than the first buffer outlet with respect to the direction of gravity. When the buffer container is incorporated into the system (e.g., mounted), the central axis extends substantially along the direction of gravity.

[0026] Specifically, each buffer container may further include a second outlet (second buffer outlet) that is disposed at a position higher than the first buffer outlet with respect to the gravitational direction and is configured to output exudate and / or air, whereby gas-liquid separation is possible and / or it can function as a safety bypass. Further, the second buffer outlet may be disposed at a position lower than the buffer inlet with respect to the gravitational direction. The second buffer outlet may be connectable or connected to one or more exudate containers. For example, the second buffer outlet may be connectable or connected to one or more exudate containers directly and / or in a constantly open manner.

[0027] The second buffer outlet may be disposed on the opposite side of the thrombus trap with respect to the first buffer outlet. Therefore, the second buffer outlet may be disposed on the same side as the buffer inlet.

[0028] The second buffer outlet can function as a safety overflow from the buffer container and / or a safety bypass, whereby an open connection to one or more exudate containers can be provided for safety reasons (e.g., to prevent reverse pressure / countercurrent (afflux)). Further, the second buffer outlet can also provide a discharge path for the air separated from the exudate in the buffer container. The separated air may be suctioned by one or more suction devices (e.g., an ICU vacuum wall connector and / or a system-specific vacuum unit). In other words, the separated air may be suctioned by the ICU vacuum wall connector and / or the system-specific vacuum unit via one or more exudate containers. Therefore, since there is no air in the exudate, the exudate can then be analyzed or analyzed in a more accurate and reliable manner.

[0029] The washing system may be configured to supply an infusion fluid of about 500 ml per hour, that is, the infusion inflow rate may be about 500 ml per hour. Accordingly, the buffer volume can also have a size accordingly. However, with the system and thereby, the buffer volume may be configured to handle a sudden ejection of 400 mL and / or 500 mL of exudate per 5 minutes.

[0030] Specifically, the washing system further includes a tube unit configured to be connected to a carrier unit, and the tube unit is configured to convey an infusion fluid from the carrier unit towards the patient and to convey an exudate fluid from the patient (e.g., pericardial cavity and / or pleural cavity) to the carrier unit.

[0031] Specifically, the tube unit is configured to be connected to a measuring unit.

[0032] Specifically, the tube unit includes a plurality of inflow tubes for conveying an infusion fluid and a plurality of outflow tubes for removing an exudate fluid from the patient, for example, from the pericardial cavity and the pleural cavity as required.

[0033] Specifically, the washing system further includes a user interaction unit configured such that a user can monitor the washing process and / or the physiological state of the patient.

[0034] Specifically, the user interface unit is configured to report the results of an analysis performed individually via at least one sensor on the exudate fluid removed from the pericardial cavity and the pleural cavity.

[0035] Specifically, the user interface unit is configured to be coupled to the carrier unit, preferably to the outer periphery at the uppermost position of the carrier unit (along the longitudinal axis).

[0036] Alternatively, the user interface unit may take the form of a portable user interface unit and be configured to connect to the cleaning system via a wired or wireless connection.

[0037] Specifically, the cleaning system further includes a base unit configured to facilitate the movement and transport of the carrier unit. For example, the base unit is configured to be attached to the carrier unit at its lowest position (along the longitudinal axis).

[0038] Specifically, the base unit includes a frame plate (footplate) attached to the carrier unit, and the frame plate is configured to form (or generate) a rim or outer edge around the carrier unit.

[0039] The base unit further includes drive elements such as wheels, enabling the carrier unit to move on the ground.

[0040] Specifically, the inflow unit includes at least one mounting element for holding at least one first gravimetric unit and / or at least a portion of at least one injection fluid container within the inflow unit.

[0041] Specifically, at least one first weighing unit is configured to hold at least one injection fluid container.

[0042] Specifically, the injection fluid container may include saline bags (e.g., 1L, 2L, 3L, or a combination thereof up to 5L).

[0043] Specifically, at least one first weight measuring unit is configured to be connected to the carrier unit via a shock mount.

[0044] Specifically, the cleaning system, for example, the carrier unit, includes at least one sensor unit for analyzing the leachate collected in a measuring unit (e.g., an analysis chamber), and / or a second pump unit (discharge pump unit) for discharging the leachate from the measuring unit.

[0045] Specifically, the cleaning system further includes a control unit configured to generate control signals for adjusting the injection fluid flow rate of a first pump unit and / or for controlling the suction rate of seeping fluid of a second pump unit in response to, for example, a measured fluid level in an intermediate fluid container.

[0046] Specifically, at least one gravimetric unit or control unit is configured to calculate the flow rate of the injectable fluid being pumped in the injectable fluid container. It should be noted that any other sensor configured to calculate the flow rate of the injectable fluid toward the pericardial cavity PC may be used. For example, the flow rate of the injectable fluid can be calculated by a flow sensor that can be located anywhere within the inflow unit of the lavage system. Specifically, the flow rate of the injectable fluid can also be inferred from a control signal provided by the control unit to adjust the flow rate of the first pump unit in response to one or more sensor signals.

[0047] Specifically, the carrier unit includes a housing that extends along the longitudinal axis from the lower end position to the upper end position.

[0048] Specifically, the housing is configured to accommodate the collection unit, measurement unit, and inflow unit from the lower end to the upper end, respectively. For example, the collection unit, measurement unit, and inflow unit are configured to be stacked along the longitudinal axis within the housing.

[0049] Specifically, the collection unit takes the form of a drawer element configured to be detachably positioned within the carrier unit. For example, the collection unit is configured to slide into a corresponding compartment provided at the lower end of the housing of the carrier unit.

[0050] Specifically, the second weight measurement unit is configured to be located (integrated) within the carrier unit, for example, in a compartment that houses the collection unit.

[0051] Specifically, the base unit is configured to be attached to the housing at its lower end.

[0052] Specifically, the user interface unit is configured to be attached to the housing, for example, at the upper end of the housing or on one side of the housing (around the housing).

[0053] Specifically, the housing includes a through-chamber (hollow chamber) configured to house an inflow unit inside. For example, the hollow chamber has two open side walls.

[0054] Specifically, the inflow unit further includes at least one inflow tube configured to transport (or transfer) the injection fluid from the injection fluid container.

[0055] Specifically, the inflow unit communicates with the measurement unit via fluid flow.

[0056] Specifically, the housing of the carrier unit includes a peripheral wall that extends along the longitudinal axis from the base (bottom) portion to the upper end portion.

[0057] Specifically, the user interface unit is configured to be mounted on the housing, preferably at the upper end of the outer periphery of the housing.

[0058] Specifically, the carrier unit further includes an internal frame configured to be positioned (or housed) within the housing of the carrier unit.

[0059] Specifically, the inflow unit, measurement unit, and collection unit are configured to be mounted on the internal frame of the housing.

[0060] For example, the inflow unit, measurement unit, and collection unit are configured to be detachably arranged within the internal frame.

[0061] Specifically, at least one mounting element is preferably configured to connect to an internal frame on the inner wall of the hollow chamber.

[0062] Specifically, at least one first gravimetric unit includes a case for holding (or enclosing) the injection fluid container. For example, the case may be in the shape of an inverted U or a hollow cup.

[0063] Specifically, at least one mounting element includes at least one mechanical fastener or snap element, such as at least one hook, configured to hold (or lock) a case or injection fluid container.

[0064] Specifically, at least one first weight measuring unit is configured to be connected to the internal frame via a shock mount mechanism.

[0065] Specifically, at least one first weighing unit (e.g., including an injection fluid container) is configured to be mounted in a floating state on an internal frame and is mechanically separated from the carrier unit.

[0066] In this configuration, the first weight measuring unit is attached to the carrier unit, but is mechanically separated (or isolated) from the carrier unit (and its components). This allows for accurate and reliable weight measurement, unaffected by external forces applied to the carrier unit.

[0067] Specifically, the measuring unit includes a mounting plate, and the buffer container is configured to be mounted on the mounting plate.

[0068] Specifically, the mounting plate includes an upper and lower edge, and these edges define the mounting surface between them. The measurement is configured to guide the seeping fluid from the upper edge to the lower edge.

[0069] Specifically, the mounting plate includes an inlet opening formed at its upper edge. The inlet opening is configured to house a first pump unit (inlet pump unit) for pumping the infusion fluid received from the inlet unit toward the patient.

[0070] Specifically, the first pump unit includes multiple pump devices configured to provide multiple inflow lines for the injected fluid.

[0071] Specifically, each pump device is configured to pump the infusion fluid received from the infusion fluid container via a tubing unit to the patient.

[0072] For example, the first pump unit includes three pump devices stacked along a common axis (e.g., a transverse axis perpendicular to the longitudinal axis).

[0073] Specifically, each pump device of the first pump unit is configured to be connected to an inlet tube that transports the infusion fluid, and an outlet tube that pumps the infusion fluid toward the patient, for example, into the pleural cavity and / or pericardial cavity.

[0074] Specifically, the outlet tube of the pump device of the first pump unit is in fluid communication with the tube unit, and more specifically, it is in fluid communication with the multiple inlet tubes contained within the tube unit.

[0075] Specifically, the measuring unit is configured to communicate fluidly with a second pump unit (outflow pump unit) via a connector tube. The second pump unit is configured to remove exudate from the patient, preferably from the pericardial cavity and / or pleural cavity.

[0076] Specifically, the connecting tube is positioned downstream of the buffer container along the direction of the seepage fluid flow. That is, the buffer container is positioned near its upper edge on the mounting plate, and the connector tube is positioned near its lower edge on the mounting plate.

[0077] Specifically, the second pump unit includes two outflow pump devices, each configured to remove exudate fluid from the pericardial cavity and pleural cavity via a buffer container.

[0078] Specifically, the buffer containers of the measurement unit are configured to receive exudate from the pericardial cavity or pleural cavity via a tubular unit.

[0079] Specifically, each buffer container includes an inlet that communicates fluid with one of the multiple outflow tubes of a tubing unit connected to the patient.

[0080] Each buffer vessel further includes an outlet that communicates fluid with one of the outflow pump devices of the second pump unit.

[0081] Specifically, each buffer container includes a filter (or thrombus trap) inside the buffer container, preferably positioned along the direction of the flow of the exudate fluid. For example, the thrombus trap is positioned perpendicular to the longitudinal axis of the carrier unit.

[0082] This arrangement of filters relative to the flow direction reduces filter clogging and improves the flow of the removed seepage fluid as it passes through the cleaning system.

[0083] Specifically, the thrombus trap is configured to filter particles or components in the exudative fluid that are, for example, 1 to 5 mm in diameter, preferably 1.5 to 3 mm.

[0084] Specifically, each filter (thrombus trap) includes a sieve structure positioned between the inlet and the first outlet of the intermediate container (i.e., between the buffer inlet and the first buffer outlet of the buffer container) to prevent thrombi from passing through the first buffer outlet. The thrombus trap may be formed integrally with the buffer container (for example, on the side wall or bottom wall of the buffer container). Alternatively, the thrombus trap may be attached to the buffer container by fixing means. The sieve structure may include a plurality of openings formed inside it. The openings may be configured so that thrombi cannot pass through the sieve structure.

[0085] The thrombus trap may be conical in shape, having a bottom facing the first buffer outlet and an apex facing the buffer inlet. The thrombus trap may also have other shapes, such as rectangular, square, frustoconical, dome-shaped, or planar. Specifically, the above shapes of the thrombus trap and their arrangement with the buffer container allow a certain amount of thrombus to be trapped in the thrombus trap without obstructing it.

[0086] This method prevents the thrombus from passing through the rest of the lavage system. This, in turn, prevents the formation of larger thrombi in corresponding parts of the lavage system, such as sensors or a second pump device.

[0087] Specifically, the second pump unit is in fluid communication with the analysis chamber (cuvette) of a sensor unit for analyzing the seepage fluid received from the buffer container.

[0088] For example, a connector element (e.g., a Y-connector) is provided that communicates fluidly with the output of the outflow pump device of the second pump unit.

[0089] Specifically, the connector element is configured to guide the seepage fluid received from the intermediate fluid container to the analysis chamber of a sensor unit, such as a hematocrit sensor, and the outflow pump device of the second pump unit is configured to operate alternately.

[0090] This method allows for the separate analysis of exudate received from the pericardial cavity or pleural cavity.

[0091] Specifically, the hematocrit sensor is configured to measure the hematocrit value of exudate in order to calculate the amount of blood loss and / or blood loss flow rate from a wound and / or body cavity, particularly the pericardial cavity. The hematocrit sensor may also be configured to optically measure the hematocrit value based on the scattering and absorption of light emitted into the exudate.

[0092] Hematocrit analysis and / or measurement of exudate (i.e., exudate) allow for a more accurate calculation of blood loss. This can improve clinical decision-making regarding the optimal timing for chest re-opening and blood transfusion strategies.

[0093] The hematocrit sensor may be positioned to measure the exudate pumped from the buffer container into the exudate container. Therefore, the hematocrit sensor may be positioned downstream of the intermediate buffer container and upstream of one or more exudate containers. This arrangement of the hematocrit sensor allows for accurate hematocrit measurement without adverse effects from thrombi and / or air in the exudate. Furthermore, since the second pump device can be controlled by a control unit according to the volume of fluid being pumped, the measured hematocrit value may be set in correlation with the pumped volume, and the hematocrit value is measured by the sensor. Therefore, the amount of blood loss and / or blood loss flow rate from the wound and / or body cavity, particularly the pericardial cavity, can be measured easily, reliably, and / or accurately.

[0094] The system may further include a unit for measuring blood loss and / or whole-body measurements of the patient, the unit being configured to calculate the amount of blood loss and / or blood loss flow rate from wounds and / or body cavities, particularly the pericardial cavity (PC), and the system may be connectable to such a unit.

[0095] For example, the measuring unit includes a support element that includes multiple fixing elements such as mounting clamps and clips for attaching the components of the measuring unit.

[0096] Advantageously, the mounting plate functions as a support element for supporting and positioning connector elements included, for example, in the first pump unit, analysis chamber (cuvette), and measurement unit.

[0097] Specifically, the measuring unit further includes two safety elements (e.g., overflow outlet / tube) located on the mounting plate. Each safety element is in fluid communication with one of the buffer containers, for example, via a second buffer outlet.

[0098] Each safety element is configured to discharge the seeping fluid from its corresponding buffer container.

[0099] Specifically, the safety elements include a collection unit and, for example, a safety overflow outlet (a second outlet of the intermediate fluid container) that is in fluid communication with a collection container included in the collection unit.

[0100] Advantageously, the safety element serves to ensure a continuous open airway so that vacuum can be transmitted from the irrigation system's pump (pump unit) to the patient. This is necessary, for example, because vacuum cannot pass through a peristaltic pump. The safety element also provides an overflow as a safety measure in case of malfunction.

[0101] Specifically, the measurement unit further includes a discharge tube that communicates with the collection unit for fluid.

[0102] In particular, the discharge tube is fluid-connected to at least one sensor and a collection unit, and is configured to guide the seeping fluid to the collection unit.

[0103] Specifically, the measuring unit further includes openings (e.g., formed in the mounting plate) for passing through and holding pressure lines or air tubes.

[0104] Specifically, the cleaning system further includes a gripping element connected to the carrier unit. Preferably, the gripping element is positioned on the circumferential wall of the carrier unit in a location that provides a barrier in front of the hollow chamber of the carrier unit and provides a grip (handlebar / handgrip) for moving the carrier unit.

[0105] This configuration allows the carrier unit to be held, moved, pushed, or pulled by the user as desired, and protects at least one first weight-measuring element from accidental damage.

[0106] Specifically, the gripping element includes an arm element (e.g., a rod or bar structure) connected to the housing and extending at least partially around the housing, providing a barrier on one side of the hollow chamber.

[0107] Specifically, the cleaning system further includes a locking element connected to the carrier unit, preferably the locking element being connected to an internal frame (located in the housing) or being an integral part of the internal frame.

[0108] Specifically, the locking element is configured to fix the position of at least one inflow tube exiting the inflow unit so that it does not move. This ensures that the inflow tube is held stably in a specific (specified) position, preventing adverse effects on measurements and analyses due to changes in the tube's position or its arrangement within the carrier unit.

[0109] Specifically, the tube unit includes a first tube section connected to a cleaning system, a third tube section connected to a patient, and a second tube section positioned between the first and second tube sections.

[0110] Specifically, the third tubing section includes a tubing assembly comprising an inlet tubing assembly and at least one outlet tubing, forming a multi-lumen tubing set configured for fluid communication with the patient.

[0111] Advantageously, providing the tubing as a bundle, with the tubes joined together as a single tubing assembly, improves the handling and organization of the inflow and outflow tubing connected to the patient.

[0112] Specifically, the tubing unit includes two tubing assemblies configured to be fluidly connected to (placed within) the pericardial cavity and the pleural cavity, respectively.

[0113] Specifically, the tubing unit of the third section may further include two outflow tubes (e.g., two other (separate) outflow tubes that are not part of the tubing assembly). Each outflow tube is configured to be fluidly connected to the pericardial or pleural cavity as needed.

[0114] Specifically, the multiple inlet tubes included in the tube unit include, for example, three inlet tubes for transporting the injected fluid, preferably the three inlet tubes extending along the first, second, and third sections of the tube unit.

[0115] Specifically, the tube unit preferably further includes pressure measuring tubes (air tubes) for transporting air, which extend along the first, second, and third tube sections.

[0116] Specifically, the pressure measuring tube is configured to support pressure measurement by sensors in the system, which is performed at a measurement point (e.g., the patient's pericardial cavity) via an air channel within the tube.

[0117] The purpose of pressure measurement is to enable clinicians to monitor pressure levels and detect trends. For example, a positive trend of increasing pressure may suggest a blockage in the drainage duct, in which case inspection and potential corrective action by a clinician are necessary.

[0118] Specifically, the pressure measuring tube includes, for example, an air tube located in or held by a measuring unit and a tube unit. For example, the air channel extends from the measuring unit through the tube unit into the patient's body.

[0119] Specifically, the pressure measuring tube is configured such that one end is connected to a cleaning system (e.g., connected to a pressure sensor via a connector such as a Luer lock connector) and the other end is connected to a tube assembly placed on the patient (e.g., a smart tube).

[0120] Specifically, the collection unit further includes a waste container for collecting exudate from the patient, and a cover element detachably connected to the waste container.

[0121] Specifically, the collection unit further includes at least one filter element to prevent biological contaminants from entering the environment.

[0122] The collection unit is also provided with a first coupling element for connecting the collection unit to a vacuum pump (for example, located in the carrier unit) and at least one second coupling element for connecting the collection unit to a measuring unit, preferably a discharge tube.

[0123] Specifically, the collection unit is detachably located inside the carrier unit, and preferably, the collection unit includes a sliding element for sliding the collection unit within the housing (or internal frame) of the carrier unit.

[0124] Specifically, the waste container is configured to collect approximately 4-5 liters of seepage fluid.

[0125] Specifically, the collection unit further includes a handle for transporting the collection unit, preferably the handle being hinged or pivoted to a cover element of the waste container and / or collection unit.

[0126] Specifically, the filter element, the first join element, and the second join element are placed on the cover element.

[0127] Specifically, the collection unit further includes an overflow prevention valve to protect the first coupling element from fluid spillage.

[0128] Specifically, the cleaning system further includes guide elements configured to direct the position of the tube unit toward the carrier unit.

[0129] In other words, the guide elements are positioned and configured to guide the alignment of the tube unit so that its position gradually descends along the longitudinal axis from the patient toward the carrier unit. This facilitates the flow of exudate fluid toward the carrier unit.

[0130] Specifically, the guide element is configured to guide the first section of the tube unit (connected to the measurement unit) so that the flow of exudate fluid occurs in the direction of gravity. Lowering the position of the tube unit downward (along the longitudinal axis) from the patient toward the carrier unit further improves the drainage of fluid from the body cavity.

[0131] Specifically, the guide element is connected to the carrier unit, and preferably, the guide element is connected to / positioned on the peripheral wall (outer wall) of the housing of the carrier unit.

[0132] Specifically, the guide element includes a plurality of tabs or retaining elements positioned on the outer wall of the housing and configured to guide at least partially a first section of the tube unit onto the housing.

[0133] Specifically, the guide elements (multiple tabs) are configured to guide the placement of the tube unit on the housing, so that the position of the tube unit gradually moves downward along the longitudinal axis from the patient side toward the carrier unit (e.g., the inlet opening of the measurement unit).

[0134] Specifically, the cleaning system further includes a tube interface unit configured to hold a tube unit in place at least partially, and the tube unit is configured to provide fluid communication between the cleaning system (e.g., a carrier unit) and the patient.

[0135] Specifically, the cleaning system further includes at least one tube connector provided in a third section of the tube unit.

[0136] Specifically, at least one tube connector is configured to connect at least one outlet tube included in the tube assembly to one of several separate (different) outlet tubes.

[0137] In other words, at least one tube connector is included in a third section of the tube unit and is configured to connect an outflow tube to a specific body cavity, such as the pleural cavity or pericardial cavity.

[0138] For example, the irrigation assembly may include two fluid connectors connected to corresponding tube assemblies, one connected to the pericardial cavity and the other to the pleural cavity, respectively.

[0139] For example, if separate outflow tubes are used for the pericardial cavity and the pleural cavity, these outflow tubes are configured to merge with the corresponding outflow tubes of the tube assembly via two tube connectors, thereby forming a single outflow tube for the pericardial cavity and the pleural cavity, respectively, in the second and first tube sections of the tube unit.

[0140] Specifically, the cleaning system further includes, for example, a heater unit configured to heat a section of a tube unit held by a tube interface unit.

[0141] Specifically, the tube interface unit is configured to be connected to a heater unit, and the multiple inlet tubes included in the tube unit are configured to be heated via the heater unit.

[0142] Specifically, the heater unit is configured to heat the injection fluid, which is to be delivered to a wound and / or body cavity, particularly the pericardial cavity, to a desired injection fluid temperature.

[0143] For example, a heater unit includes a heating element.

[0144] Specifically, the heater unit may be part of the temperature control system of the cleaning system and is configured to control the temperature of the injection fluid.

[0145] Specifically, the temperature control system includes a sensor for measuring the temperature of the heating element and a temperature control unit for controlling the temperature of the heating element.

[0146] Specifically, the heater unit (or heating element) is configured (designed and arranged) to include (provide) a contact surface which is heated by the heating element and configured to transfer heat to an inflow tube passing through a tube interface unit.

[0147] Specifically, the control unit is further configured to deduce the temperature of the fluid passing through the contact area based on the interaction between the injected fluid and the contact surface, such as the contact time, the dimensions of the contact surface, and the fluid flow rate (the flow rate of the fluid flowing along the surface).

[0148] Specifically, the heater unit is controlled / regulated by a temperature control signal and configured to heat the heating element to a desired temperature. The temperature sensor may be located inside or on the inlet and / or outlet tubes.

[0149] Alternatively, the temperature control system may include, for example, a temperature sensor for measuring the temperature of the injector, a temperature control unit which may be part of a control unit or a separate unit of the system and be configured to provide a temperature control signal based on the measured temperature of the injector and a desired injector temperature, and a heater unit which may be controlled / adjusted by the temperature control signal to heat the injector to a desired injector temperature. The temperature sensor may be located inside or on the inlet and / or outlet tubes.

[0150] Specifically, the tube interface unit includes a casing comprising a base plate and (peripheral or outer) walls extending upward from the base plate, thereby defining a chamber for housing at least a portion of the tube unit.

[0151] For example, the casing includes a number of openings formed in a side wall that is different from one side wall of the casing (the opposite side).

[0152] Specifically, the tube interface unit is configured to guide multiple inlet tubes and / or multiple outlet tubes from one side wall through a chamber to the other side wall of the casing via multiple openings.

[0153] This method allows for the assembly of the tube unit, further improving its management and configuration. This also leads to improved fixation and positioning of the tube unit relative to the patient and carrier unit.

[0154] Specifically, the base plate / structure is connected to a heater and configured to be heated by the heater.

[0155] Specifically, the tube interface unit further includes an internal structure (located within the casing) that defines a network of passages (e.g., meandering or curved paths) through which each of the multiple inlet tubes can pass.

[0156] In this configuration, each inlet tube follows an extended path through the casing of the tube interface unit. As a result, the contact time with the heater unit is increased, and the injected fluid is effectively heated to a desired temperature, such as body temperature.

[0157] Specifically, the tube interface unit is configured to hold the second section of the tube unit.

[0158] Specifically, the tube interface unit is in the form of a hub configured to hold the tube unit and facilitate the heating of multiple inflow tubes that transport the injected fluid.

[0159] Specifically, the tube interface unit further includes a lid configured to be placed on top of the casing to close the casing.

[0160] Specifically, the base plate of the casing includes a conductive material (e.g., a metallic material) to improve heat transfer to the partitioning elements.

[0161] For example, the partition elements may be designed in a labyrinthine pattern.

[0162] Specifically, the tube interface unit includes a first end and a second end, the first end being for accommodating multiple inflow tubes from, for example, a irrigation system (e.g., system end / side), and the second end being for accommodating multiple outflow tubes from, for example, a patient (e.g., patient end / system side).

[0163] Specifically, the cleaning system further includes, for example, at least one tube connector for connecting two outflow tubes of a tube unit to a single outflow tube.

[0164] For example, two of the outflow tubes of the tube unit are connected to one outflow tube via at least one tube connector before entering the casing of the tube interface unit (for example, at the patient end of the tube interface unit).

[0165] Specifically, the carrier unit includes, for example, a housing (opening) for housing (or holding) a heater unit when not in use.

[0166] Specifically, the housing is formed at the upper end of the outer periphery of the housing.

[0167] Specifically, the cleaning system further includes a power supply provided by a battery unit or power plug.

[0168] Specifically, the cleaning system is configured to be powered by a battery unit during transport.

[0169] Specifically, the control unit can control the second pump unit by providing at least one control signal based on the obtained filling level and / or buffer container level of the buffer volume, thereby adjusting the exudate flow rate (e.g., pumping volume) from the buffer container. Thus, the buffer container can collect exudate until the outlet pump device is permitted to pump. This allows for the controlled generation of a constant flow of exudate. As a result, subsequent analytical means can perform accurate measurements in or on the exudate. The control unit may be configured to control the second pump unit to pump a predetermined, i.e., known volume based on the control signal. For example, the control unit may be configured to control the outlet pump device of the second pump unit to pump a volume of, for example, 30 ml, which is also called a batch. However, different volumes can also be pumped based on the control signal of the control unit. Therefore, the second pump unit can be operated discontinuously by the control unit. In addition to, or instead of, the first pump device may be controlled by a control signal based on the amount of exudate.

[0170] Specifically, the second pump unit (i.e., the outflow pump device) may include a peristaltic pump. In addition to or instead of this, the first pump device may include a syringe pump device that includes a volumetric pump, a membrane pump, an impeller pump, and / or a syringe pump, and optionally at least two valves. Specifically, the outflow pump device may be any pump device suitable for exudate (with or without valves, e.g., independent valves), and is preferably of a type that can pump at a relatively precise flow rate (e.g., a type that can pump a (specific) volume precisely). For example, the peristaltic pump and syringe pump may be configured to gently transport sensitive substances such as blood cells, which may be destroyed by rapidly moving or rotating elements that may be part of other types of pumps. The peristaltic pump can perform continuous and / or discontinuous pumping operations. The syringe pump can perform discontinuous pumping operations, and the pumping operation of the syringe pump has an aspiration step and a discharge step. In the suction step, a first valve located upstream of the syringe pump is opened and a second valve located downstream of the syringe pump is closed. In the discharge step, the first valve is closed and the second valve is opened.

[0171] Specifically, a method for cleaning a patient's body, particularly the pleural cavity and / or pericardial cavity, using the cleaning system described above is:

[0172] - The step of inserting the tube assembly into the pleural cavity and / or pericardial cavity,

[0173] - If necessary, a step to priming the cleaning system and

[0174] - The step of adjusting the flow parameters of the injected fluid via a user interface,

[0175] - A step of monitoring the state of the pleural cavity and / or the pericardium using an integrated sensor,

[0176] - Includes a step for selectively adjusting the injection flow rate based on real-time feedback.

[0177] After open-heart surgery, some residual air may remain in the space around the heart when the patient's chest cavity is closed, but this is not dangerous as it is not present in the circulatory system (cardiopulmonary bypass circuit). Furthermore, post-operatively, the pericardial cavity is connected to a drainage system with a negative pressure of -15 to -20 cmH2O, ensuring that all air is removed from the pericardial cavity via the drainage tube.

[0178] Specifically, when the irrigation system is activated, air may be present in the inflow tube. However, the injected fluid (e.g., saline solution) pushes this air into the patient's pericardial cavity, and the air is then removed by a vacuum system built into the system.

[0179] For example, the priming step is performed by priming the inflow line by introducing the injection fluid into the system at a high flow rate, for example, 1000 ml / h for a set time (1 or 2 minutes).

[0180] The flow rate and duration of the priming step are determined by the length and diameter of the inflow tube. For example, if the inflow tube is approximately 2.5 m long and the inflow rate is low (e.g., 100 ml / hr), the priming duration is approximately 8.5 minutes. This is not ideal in a lavage system connected to a patient.

[0181] Increasing the priming flow rate is considered safe because the priming flow rate is initiated only when an active and appropriate vacuum function is established. The introduction of approximately 18 mL of air during the priming process was confirmed not to cause safety issues, considering the presence of air already present in the pericardial cavity.

[0182] The priming process ensures that the fluid injected into the patient is air-free, preventing the introduction of air into the pericardial and / or pleural cavities. This ensures that the lavage system is properly set up and free of air and contaminants, which is essential in a wide range of medical procedures and treatments.

[0183] Another object of the present invention is to provide components of a scrubbing system, such as a measuring unit for analyzing exudative fluid removed from a body cavity, and a set of multi-lumen tubes configured so that one end is placed inside the body cavity and the other end is connected to the scrubbing system. Such further embodiments of the present invention are described below.

[0184] According to another aspect of the present invention, a measuring unit is provided that is configured to be used (work in conjunction with) a cleaning system. For example, the cleaning system is configured to clean at least one body cavity with an injection fluid.

[0185] Specifically, the measuring unit is configured to be operably connected to a cleaning system, for example, the carrier unit of the cleaning system (e.g., a console).

[0186] Specifically, the measurement unit may include a disposable unit or a single-use unit (e.g., a cartridge unit).

[0187] Specifically, the measuring unit includes fluid connections, electrical and / or mechanical connections configured to be coupled to corresponding connections included in the carrier unit of the cleaning system.

[0188] Specifically, the cartridge unit is configured to be fluidically connected to a irrigation system in order to deliver the infusion fluid to the patient and / or to analyze the exudate fluid removed from the patient.

[0189] For example, the cleaning system includes a console which contains an inlet unit for receiving the injected fluid and a collection unit for collecting the exudate, and a tubing unit which communicates with the patient.

[0190] Specifically, the measurement unit is configured to separately analyze the exudate removed from body cavities, such as the pleural cavity and pericardium, through a lavage system.

[0191] Specifically, the measurement unit includes at least two intermediate fluid containers (e.g., two buffer containers) configured to hold the exudate removed from the body cavity in an intermediate position before discharging it, for example, to a collection unit of a washing system.

[0192] Specifically, each intermediate fluid container is configured to form a fluid connection to a specific body cavity, allowing for individual analysis of the exudate removed from it.

[0193] More specifically, the measurement unit includes a first intermediate fluid container configured to receive exudate from a first body cavity (e.g., pleural cavity) and a second intermediate fluid container for receiving exudate from a second body cavity (e.g., pericardial cavity).

[0194] Specifically, the first and second intermediate fluid containers include an inlet that is in fluid communication with one of the outflow tubes of the tube unit (for receiving exudate from the patient) and a first outlet that is in fluid communication with the outflow pump device of the second pump unit.

[0195] Specifically, the measurement unit further includes a first pump unit (e.g., an inflow pump unit) for pumping the injected fluid into the body cavity.

[0196] Specifically, the carrier unit includes a second pump unit (e.g., an outflow pump unit or a suction pump unit) for removing exudate from a body cavity (e.g., the pericardial cavity and / or pleural cavity).

[0197] Specifically, the measurement unit includes an analysis chamber (e.g., a cuvette) configured to collect the leachate for analysis by the sensor unit.

[0198] Specifically, the second pump unit is configured to communicate fluidly with the analysis chamber and to alternately regulate (i.e., individually guide) the flow of seeping fluid from the first and second intermediate fluid containers to the analysis chamber for further analysis, for example, by connector elements.

[0199] Alternatively, the cleaning system may include two sensors, each fluid-connected to a second pump unit and configured to operate independently to analyze the exudate removed from the corresponding body cavity.

[0200] Specifically, the components of the measuring unit (e.g., an intermediate container, a first pump unit, and tubing) are configured to be fixed to a support element (or mounting plate) using appropriate mechanical means or adhesives or glues.

[0201] Specifically, the support element defines the mounting surface that extends from the upper edge to the lower edge.

[0202] For example, the second pump unit includes two outflow pump devices configured to remove exudate from the patient's pericardial cavity and pleural cavity, respectively.

[0203] For example, the first pump unit includes three inflow pump devices commonly arranged on an axis perpendicular to the mounting plate.

[0204] Specifically, the measuring unit is designed to be integrated into the cleaning system, and the flow of seeping fluid inside the measuring unit flows at least partially in the direction of gravity.

[0205] According to yet another aspect of the present invention, a smart tube assembly for a cleaning system is provided.

[0206] For example, the lavage system is configured to lavage at least one body cavity (e.g., the pericardial cavity and / or pleural cavity). For example, the lavage system includes a console comprising an inlet unit for containing the injectable fluid and a collection unit for collecting the exudate, and a tubing unit for fluid communication with the patient.

[0207] Specifically, a tube assembly includes multiple tubes configured to be positioned within a body cavity. For example, a tube assembly includes a set of tubes (e.g., a bundle of tubes), each containing a different single lumen tube.

[0208] Alternatively, the tube assembly may include a multi-lumen tube configured to be located within a body cavity. For example, the multi-lumen tube may include a single tube containing multiple lumens for inflow, pressure measurement, and outflow.

[0209] Specifically, the tube assembly is held in a particular packing arrangement.

[0210] Specifically, the tube assembly is configured to be coupled to (used with) a cleaning system, for example, a tube unit of a cleaning system configured to transport seepage fluid.

[0211] Specifically, the tube assembly is configured to form fluid communication with the patient, particularly with body cavities.

[0212] Specifically, the tube assembly includes a proximal end configured to connect to the patient and a distal end configured to connect to the irrigation system.

[0213] Specifically, the tube assembly includes a plurality of inlet tubes, each configured to deliver an infusion fluid or air to the patient, and at least one outlet tube configured to deliver (discharge) fluid from the patient.

[0214] Specifically, the tube assembly includes a sleeve element (outer tube or protective cover) configured to partially surround the tube assembly (which includes multiple inlet tubes and at least one outlet tube) along a predetermined length of the tube assembly.

[0215] The sleeve element is configured to hold multiple inlet tubes and at least one outlet tube in a sealing manner, facilitating the leak-free passage and placement of the tube assembly through the incision.

[0216] For example, a sleeve functions as a safety measure by sealing the gaps (openings) between tubes within a tube assembly, preventing fluid from leaking out or air from entering the patient's body through these gaps, thereby jeopardizing patient safety.

[0217] Specifically, the sleeve element includes an outer periphery wall that defines an internal volume or space configured to surround a multi-lumen tube set (including multiple inlet tubes and at least one outlet tube).

[0218] Specifically, when a multi-lumen tube is surrounded by a sleeve element, the center points of at least one outflow tube and two inflow tubes are located along a common axis within the sleeve element.

[0219] Specifically, two of the multiple inflow tubes are connected to each other to form a twin inflow tube.

[0220] For example, one of the inflow tubes in a twin inflow tube configuration may be an air tube connected to the infusion fluid tube. Such a twin configuration of inflow tubes prevents the air tube from becoming clogged with thrombi or tissue.

[0221] This favorably supports the air channel through the inflow tube, ensuring cleanliness. In other words, the flow of the injected fluid prevents unwanted blockage of the air tube by small thrombi or tissue.

[0222] Specifically, at least one outflow tube is positioned between multiple inflow tubes.

[0223] For example, in a tube assembly, at a position where the tubes are held by a sleeve, at least one outflow tube is sandwiched between at least two inflow tubes and positioned in the center.

[0224] Specifically, at least one outflow tube is positioned between the twin inflow tubes on one side and the other inflow tube on the other side.

[0225] Specifically, one of the twin inlet tubes is configured to transport air (i.e., to form an air tube). In this configuration, the air channel is supported by the second inlet channel, preventing blockage.

[0226] Specifically, at least one outflow tube has a larger diameter than any of the inflow tubes.

[0227] Specifically, the multiple inlet tubes may or may not have the same diameter.

[0228] For example, at least one outflow tube has an outer diameter of 8 to 10 mm, preferably 9 mm, and defines a lumen with a diameter of 5 to 7 mm, preferably 6 mm.

[0229] For example, each of the multiple inlet tubes defines a lumen with a diameter of 1 to 3 mm, preferably 1.5 mm. Each of the inlet tubes has an outer diameter of 2 to 4 mm, preferably 3 mm.

[0230] Specifically, the tube assembly further includes a filler material configured to fill the available space within the hollow chamber that is not occupied by an array of multiple inlet tubes and at least one outlet tube, and is positioned within a sleeve element (i.e., a hollow chamber).

[0231] Thus, the gaps between the multiple inflow tubes contained within the sleeve element (i.e., placed inside the sleeve element) and at least one outflow tube can be easily filled with filler material. The filling process can be carried out regardless of the shape or size of the tubes and the sleeve element.

[0232] Advantageously, the sleeve element and filling material can support multiple inlet tubes and at least one outlet tube, and securely fix them in a sealed manner. This further prevents undesirable leakage of air or fluids from the patient into the surrounding environment.

[0233] For example, the sleeve element or outer tube is configured to be attached over a certain length of multiple inflow tubes and at least one outflow tube at its proximal end, i.e., a position close to the patient, particularly close to the incision site (outside the patient's body).

[0234] Alternatively, the sleeve element includes, for example, two parts manufactured by injection molding and configured to adhere to each other (e.g., assembled). The at least two parts are designed and configured to hold and secure the tube of the tube assembly in place.

[0235] Thus, advantageously, the tubes exiting the patient's body are securely held together in a sealed manner.

[0236] For example, a tubing assembly includes three inlet tubes for transporting the infusion fluid to the patient (e.g., a body cavity), one pressure tube (air tube) for transporting air, and one outlet tube for transporting exudate from the patient.

[0237] Specifically, the tube assembly further includes a cap positioned at the distal end of the tube assembly (i.e., farther from the patient and closer to the irrigation system). Preferably, the cap allows the tube assembly to be pulled out through an incision in the body cavity. In other words, the cap serves as a guide for the tube assembly, in other words, to position the tube assembly out of the body (from inside to outside) through the incision from the (still open) body cavity. This is shown below: [Brief explanation of the drawing]

[0238] [Figure 1] This is a schematic diagram of the cleaning system. [Figure 2] This is a schematic diagram of the carrier unit included in the cleaning system. [Figure 3] This is a perspective view of the carrier unit, excluding the inflow unit, measurement unit, and collection unit. [Figure 4] This is a perspective view of a tube interface unit for a cleaning system. [Figure 5] These are the plan view and bottom view of the tube interface unit. [Figure 6] This is a perspective view of two alternative designs for a collection unit for a cleaning system. [Figure 7] This is a schematic front view of the measuring unit for the cleaning system. [Figure 8] This is a schematic rear view of the measuring unit for the cleaning system. [Figure 9] This is a perspective view of a measuring unit for a cleaning system. [Figure 10] This is a conceptual diagram of a tube assembly for a cleaning system. [Figure 11] This is a conceptual diagram of the cleaning system. [Modes for carrying out the invention]

[0239] Figure 1 shows a schematic diagram of a lavage system 100 that is in fluid communication with the patient. The lavage system 100 is configured to lavage a body cavity, for example, the pericardial cavity or the pleural cavity.

[0240] The cleaning system 100 includes a carrier unit 102 that is configured to be movable, for example, to be transported and positioned near the patient's bed. For example, the carrier unit 102 may take the form of a cart or a console unit.

[0241] The washing system 100 further includes an inflow unit 104 and a collection unit 106.

[0242] The inflow unit is configured to provide a cleaning solution (i.e., an infusion fluid) for the patient.

[0243] Specifically, the inflow unit 104 includes, for example, at least one fluid reservoir 108 in the form of a fluid container or vessel that holds a washing solution (generally sterile saline or other suitable fluid).

[0244] The cleaning system 100 further includes a measuring unit 114 operably connected to the inflow unit 104 and the collection unit 106.

[0245] Specifically, the measuring unit 114 communicates fluidly and / or electrically with the inflow unit and the collection unit.

[0246] The measurement unit 114 is configured to deliver the infusion fluid to the patient, receive the exudate from the patient, and analyze the exudate.

[0247] The inflow unit 104 further includes at least one inflow tube 112 configured to deliver (or transfer) the infusion fluid to the patient via the measurement unit 114. That is, the inflow unit is in fluid communication with the measurement unit via at least one inflow tube.

[0248] For example, the carrier unit 102 includes an electronic device, at least one measuring unit, and / or at least one processing unit. That is, the carrier unit 102 includes reusable components such as a level sensor and a peristaltic pump for pumping the effluent from the buffer volume towards the hematocrit sensor. For example, the measuring unit 114 includes disposable components such as a cuvette for the hematocrit sensor.

[0249] Specifically, the measuring unit is positioned at an intermediate location between the inflow unit and the collection unit. For example, the measuring unit is positioned downstream of the inflow unit along the longitudinal axis of the washing system (i.e., in the direction of gravity).

[0250] The inflow unit 104, the measurement unit 114, and the collection unit 106 are all configured to be located on the carrier unit 102.

[0251] Specifically, the carrier unit 102 includes a base unit 142 configured to facilitate the movement of the carrier. For example, the base unit includes drive elements such as wheels for moving the carrier unit 102.

[0252] The irrigation system 100 further includes at least one first gravimetric unit 110 contained in the inflow unit 104. At least one first gravimetric element is configured to measure the weight of the irrigation fluid or infusion fluid that must be delivered to the patient.

[0253] At least one first weighing unit 110 is configured to hold at least one injection fluid container 108.

[0254] Specifically, at least one first weight measuring unit 110 is configured to be coupled to the carrier unit 102 in a floating configuration via a shock mount.

[0255] In this way, at least one first weight measuring unit is isolated (i.e., mechanically isolated) from external vibrations and shocks applied to the carrier unit, for example. The floating arrangement of the shock mount allows at least one first weight measuring unit to move freely within the carrier unit 102, reducing the effect of external vibrations and shocks on the first weight measuring unit.

[0256] For example, at least one first weighing unit 110 includes a case (not shown in Figure 1) for holding (or surrounding) at least one injection fluid container 108.

[0257] The case (casing or support structure) has a shape and design suitable for holding, for example, at least one fluid container. For example, the casing includes an inverted U-shaped or hollow cup for holding at least one fluid container 108 inside.

[0258] Specifically, the cleaning system further includes a second gravimetric unit (not shown in Figure 1), which is contained within a carrier unit very close to the collection unit 106 in order to measure the injected fluid contained in the collection unit 106.

[0259] The cleaning system 100 further includes a tube unit 134, which provides fluid communication between the carrier unit 102 and the patient.

[0260] The tube unit 134 is configured to be connected (directly) to the measuring unit 114 or to the collection unit 106 via the measuring unit.

[0261] The tubing unit 134 includes multiple inlet tubes 184 for transporting infusion fluid from the cleaning system 100 to the patient, and multiple outlet tubes 186 for transporting exudate fluid from the patient to the system (see Figure 4).

[0262] Specifically, the tube unit 134 includes a first tube section 176 (having one end) connected to the cleaning system 100, i.e., the measuring unit, and a third tube section 180 (having the other end) connected to the patient.

[0263] The tube unit 134 further includes a second tube section 178 positioned between the first tube section and the second tube section.

[0264] The tube unit 134 may further include a tube assembly 220 (e.g., a bundle of inlet and outlet tubes coupled together) located in a third section 180, the tube assembly being configured to be fluidly connected to the patient.

[0265] The cleaning system 100 further includes a heater unit (or heating unit) 138 for heating at least partially (for example, the second section 178) of the tube unit 134. For example, the heater unit 138 is configured to heat the injection fluid that is transported by the multiple inflow tubes of the tube unit 134.

[0266] The heater unit 138 includes a plurality of heating elements. The heater unit 138 or heating elements further include a contact surface configured to be heated by the heating elements. The contact surface is configured to provide a heated surface for heating the injection fluid, which is carried by the incoming fluid.

[0267] Specifically, the cleaning system 100 includes a temperature control unit operably connected to the heater unit 138. The temperature control unit, for example, the heater unit 138, includes a sensor for measuring the temperature of the heating elements of the heater unit 138, and a temperature control unit for adjusting the temperature.

[0268] For example, a temperature control unit is configured to determine the temperature of the fluid in contact with the contact surface based on factors such as time, surface dimensions, and / or the flow rate of the fluid flowing along the surface.

[0269] Alternatively, the temperature control unit includes a temperature sensor for measuring the temperature of the injection fluid, and a control unit for controlling a heating unit for heating the injection fluid to a desired temperature, for example, body temperature (in the range of 36°C to 38°C, preferably 37°C).

[0270] The desired temperature of the infusion solution may be adjusted to match the patient's actual body temperature, or it may be adjusted to heat or cool the heart and its surroundings when clinically appropriate. Specifically, heating may be necessary if the patient becomes hypothermic after surgery (which is the case for most patients), and conversely, cooling of the heart and surrounding areas may be necessary in cases of certain cardiac rhythm disorders or if the patient is undergoing a "cooling protocol" required after periods of complete circulatory arrest and / or serious intraoperative adverse events such as cardiopulmonary resuscitation.

[0271] For example, the carrier unit 102 further includes a housing element 182 (including a housing opening or grooved surface) for holding the heater unit 138 when not in use (i.e., holding it in a predetermined position) (see Figure 1).

[0272] Specifically, the cleaning system 100 further includes a tube interface unit 140 configured to at least partially hold (i.e., hold in place) a tube unit 134 that is in fluid communication with the patient (and is configured to transport injectable fluid and exudate fluid).

[0273] For example, the second section of the tube unit 134 is configured to be held by the tube interface unit 140.

[0274] Specifically, the tube interface unit 140 is configured to be connected to the heater unit 138, and the multiple inlet tubes included in the tube unit 134 are configured to be heated by the heater unit 138.

[0275] The cleaning system 100 also includes a user interaction unit 116 (user interface unit) that allows the user to monitor the cleaning process and / or the patient's physiological state.

[0276] For example, the user interaction unit 116 includes a user-friendly interface for healthcare providers to input and adjust parameters such as flow rate and duration of the washing process. This may be a touchscreen or physical buttons.

[0277] Specifically, the cleaning system 100 further includes a power source provided by a battery unit or a power plug.

[0278] The cleaning system 100 is configured to be powered by a battery unit during transport.

[0279] Figure 2 shows a schematic diagram of the carrier unit 102 of the cleaning system 100.

[0280] Specifically, the inlet unit 104 is provided with at least one mounting element 118 for holding the case of the first weighing unit 110 or at least one fluid container 108.

[0281] At least one mounting element 118 includes, for example, at least one mechanical fastener or snap element configured to hold (or lock) at least one first weighing element or at least one fluid container.

[0282] For example, at least one attachment element is in the form of a hook and is configured such that a fluid container or a first weighing element can be attached thereto.

[0283] Specifically, the carrier unit 102 includes a housing 120 that extends along the longitudinal axis of the cleaning system (shown as a dotted line in FIG. 2) from an upper end position (upper end portion) 124 to a bottom position (base portion) 122.

[0284] The housing 120 is configured to accommodate the collection unit 106, the measurement unit 114, and the inflow unit 104 from the bottom position 122 to the upper end position 124, respectively.

[0285] For example, the collection unit 106, the measurement unit 114, and the inflow unit 104 are all configured to be stacked in a modular arrangement along the longitudinal axis within the carrier unit 102 (i.e., the housing 120).

[0286] Specifically, the housing 120 includes a peripheral wall (outer wall) that extends along the longitudinal axis, i.e., between the base portion and the upper end portion.

[0287] As shown in FIG. 2, a drive element, for example, a wheel, is configured to be connected to the bottom position 122 of the housing of the carrier unit 102.

[0288] Alternatively, the base unit 142 includes a footplate 144 (see FIG. 1 or FIG. 3), and the wheel is attached to the housing 120 through the footplate.

[0289] The footplate is dimensioned such that when coupled to the housing of the carrier unit 102, an outer edge (stepped surface) is formed along the periphery of the housing.

[0290] Specifically, the carrier unit 102 includes an internal frame 126.

[0291] The internal frame 126 is positioned (or housed) in the housing 120 of the carrier unit 102 and is configured to (operably) house the inflow unit, measuring unit, and collection unit inside it.

[0292] Specifically, the internal frame 126 defines a hollow chamber 128 for housing the inflow unit 104 inside. For example, the hollow chamber 128 is formed as a through chamber (e.g., with two open side walls), and the inflow unit is configured to be placed inside the hollow chamber.

[0293] For example, at least one mounting element 118 (e.g., multiple hooks) of the inflow unit 104 is configured to connect to the inner frame 126, i.e., the inner wall of the hollow chamber, thereby configuring the fluid container to be suspended above it (i.e., in the direction of gravity as shown in Figure 2).

[0294] As shown in Figures 1 and 2, the user interface unit 116 is configured to be attached to the housing, preferably to the outer circumference of the upper end portion of the housing.

[0295] Referring to Figures 1 and 2, the cleaning system 100 further includes a gripping element 130.

[0296] Specifically, the gripping element 130 (partially visible through the hollow chamber 128) is configured to protect the first weighing unit 110 and / or at least one injection fluid container 108.

[0297] The gripping element 130 is further configured to provide a grip for the carrier unit, such as a handlebar or handgrip. In this way, the carrier can be easily held, moved, pushed, or pulled.

[0298] For example, the gripping element 130 includes an arm element (e.g., a rod or bar structure) connected to a housing (e.g., the outer periphery wall of the housing).

[0299] The arm element extends along a portion of the perimeter of the housing, providing a barrier (protective section or guard) on one side of the hollow chamber. In other words, the barrier is positioned in front of one of the open side walls.

[0300] Specifically, at least one first weight measuring unit is configured to be movable independently of the carrier unit and / or its movement (by floating in a hollow chamber).

[0301] In other words, at least one first weight measuring unit 110 is configured to be connected to the internal frame 126 by a shock mount mechanism, thereby mechanically separating the at least one weight measuring unit 110 from the internal frame and / or the housing of the carrier unit 102.

[0302] Figure 3 shows a perspective view of a carrier unit 102 for the cleaning system 100, which does not have a measuring unit 114 and a collection unit 106 installed inside.

[0303] As shown in this drawing, the internal frame 126 includes a through chamber near the upper end portion 124 of the housing 120 for housing the inflow unit 114, a first cavity provided at an intermediate position between the upper and lower end positions for housing the measuring unit 114, and a second cavity near the base portion 122 of the housing 120 for housing the collection unit 106.

[0304] Specifically, the measuring unit 114 and the collection unit 102 are configured to be detachably mounted in the first and second cavities, respectively, so that they can be individually replaced or repaired as needed in the event of a malfunction.

[0305] For example, the carrier unit 102 includes an internal frame 126 and / or housing 120, which optionally include fluid connections and / or electrical connections for the operation of the inflow unit, measuring unit and collection unit.

[0306] Specifically, the cleaning system 100 further includes a locking element 132 for holding at least one inlet tube of the inlet unit 104 in a predetermined position (see FIGS. 1 to 3).

[0307] For example, the locking element 132 is connected to the carrier unit 102.

[0308] For example, the locking element 132 is connected to the housing 120 or the inner frame 126 of the carrier unit 102, or is formed as an integral part.

[0309] Advantageously, the locking element 132 is configured to fix the position of at least one inlet tube 112 and, for example, prevent (i.e., block) the movement (or displacement) of the inlet tube 112 during the movement of the carrier unit. The locking element 132 further functions as a strain relief to prevent the weight of the tube and other disposable components from affecting the load cell of the inlet section (inlet unit).

[0310] FIG. 3 also shows a guide element 136. The guide element 136 includes a plurality of tabs or retaining elements arranged on the side wall (peripheral wall) of the housing.

[0311] The guide element 136 is configured to at least partially hold the position of the first section of the tube unit 134 on the side wall.

[0312] For example, the guide element 136 is arranged so as to be able to control the position towards the carrier unit of the tube unit, and to support the flow of the exuded fluid towards the carrier unit in the direction of gravity (i.e., downward flow).

[0313] Specifically, multiple retaining elements are arranged in a row-to-column configuration on the side walls of the housing. The retaining elements guide the tubing device to facilitate the flow of fluid toward the carrier unit. This ensures that the seeping fluid moves in the direction of gravity as the tubing unit progresses from higher to lower positions along its longitudinal axis.

[0314] Specifically, the tube unit 134 further includes a pressure measuring tube 162 for transporting air from the carrier unit 102 to the patient, for example, to an air tube (see Figure 4). The pressure measuring tube extends along the first, second, and third tube sections of the tube unit 134.

[0315] Specifically, the housing element is formed on the outer circumference of the upper end of the carrier unit housing.

[0316] Figure 4 shows a perspective view of the tube interface unit 140 for the cleaning system 100.

[0317] The tube interface unit 140 is configured to partially house the tube unit 134 of the cleaning system 100.

[0318] The tube interface unit 140 includes a casing 146 including a base plate 148, and a peripheral wall or outer wall 150 extending upward from the base plate 148. For example, the peripheral wall and the base plate are configured to be detachably connected and define a chamber capable of housing, for example, a portion of the tube unit.

[0319] Specifically, multiple openings 152 (see Figure 5) are formed in the walls 150 on one and the opposite side of the casing 146 to hold the tube unit 134 inside.

[0320] For example, the multiple openings 152 are sized and arranged such that multiple inlet tubes and / or multiple outlet tubes penetrate from one side of the casing to the other side of the casing.

[0321] Specifically, the base plate / structure 148 is connected to the heater unit 138 and is configured to be heated as a result.

[0322] Specifically, the tube interface unit 140 further includes an internal structure 156 located inside the casing. The internal structure 156 is configured to define a network 157 of passages (paths) through which multiple inlet tubes can pass (shown in Figure 5). As each inlet tube passes through the extended path within the casing, the contact time with the heater unit 138 is extended, allowing the injected fluid to be efficiently heated to a desired temperature, such as body temperature.

[0323] For example, the base plate may include a conductive material (e.g., a metallic material) to improve heat transfer.

[0324] The tube interface unit 140 further includes a lid 158 configured to be positioned at the free end of the casing 146 (the peripheral wall 150) and to close it.

[0325] For example, the tube interface unit 140 is configured to hold the second section 178 of the tube unit 134.

[0326] Specifically, the tube interface unit 140 is in the form of a hub configured to partially hold the tube unit and heat multiple inlet tubes that transport the injected fluid.

[0327] Specifically, the tube interface unit 140 includes, for example, a first end for accommodating multiple inflow tubes from the cleaning system 100 (e.g., system end / system side) and a second end for accommodating multiple outflow tubes from, for example, the patient (e.g., patient end / system side).

[0328] Figure 4 further shows that the third section 180 of the tube unit 134 includes two tube connectors 160. Each tube connector 160 is configured, for example, to connect two outflow tubes connected to a patient into a single outflow tube.

[0329] Specifically, each tube connector 160 is configured to connect, for example, an outlet tube included in the tube assembly 220 to another outlet tube that is not part of the tube assembly (not included in the tube assembly).

[0330] For example, the tube connector 160 is located at the second end (patient side) of the tube interface unit 140, and each is configured to connect two outflow tubes received from the patient's body cavity (i.e., the pericardial cavity or pleural cavity).

[0331] Specifically, the multiple inflow tubes 184 include, for example, three inflow tubes that deliver the infusion fluid to the patient, namely, the inflow tubes extending along the first, second, and third sections 176, 178, and 180 of the tube unit 134.

[0332] The multiple outflow tubes 186 include, for example, four outflow tubes configured to drain exudate fluid from the patient into a third tube section 180 of a tube unit 134.

[0333] These four outflow tubes are configured, for example, to be connected to two other outflow tubes in a second tube section, and these two outflow tubes further extend through a first tube section to the cleaning system.

[0334] Specifically, the multiple outflow tubes 186 are configured to be connected to each other using tube connectors 160.

[0335] Figure 5 shows a plan view and a bottom view of the tube interface unit 140.

[0336] This drawing shows the internal structure 156 located inside the casing 146 of the tube interface unit 140.

[0337] The internal structure 156 includes a partition element, which is configured to define a network of passages 157 (for example, separate passages or channels for each of multiple inflow tubes as they pass through it) (see bottom view).

[0338] For example, the internal structure 156 of the tube interface unit 140 is in the form of a labyrinth containing multiple channels extending from the system end to the patient end.

[0339] Each partition element is configured to define a separate passage (or channel) for each of the multiple inflow tubes, and this passage is configured to define a meandering path with multiple bends between the system end and the patient end of the tube interface unit 140.

[0340] In this way, the length of the path to the other end of the tube interface unit 140 is significantly increased. This increases the contact surface area between the channel (i.e., the bottom side of the channel) and the heater unit 138, and the injected fluid transported through the inflow tube is heated to the desired temperature.

[0341] Specifically, multiple openings 152, including a first row of openings for receiving multiple inflow tubes, are formed in the peripheral wall 150 of the casing 146 near the base structure 148.

[0342] The multiple openings 152 further include a second row of openings for receiving multiple outflow tubes. The second row of openings is arranged near the free end of the peripheral wall 150.

[0343] In other words, the opening of the second row is located on the peripheral wall 150 upstream of the opening of the first row.

[0344] The dimensions of the openings are adjusted to match the dimensions of the inlet and outlet tubes. For example, the opening in the second row is larger than the opening in the first row.

[0345] Figure 6 shows perspective views of two alternative designs for the collection unit 106 for the cleaning system 100. Similar components are indicated by the same reference numerals.

[0346] In both designs, the collection unit 106 is configured to be detachably located inside the carrier unit 102 of the washing system 106. For example, the collection unit 106 is configured to slide into the internal frame of the carrier unit 102.

[0347] Specifically, the carrier unit 102 is configured to measure the weight of the exudate collected from the patient by the second gravimetric unit 111.

[0348] The collection unit 106 includes a waste container 164 (e.g., a reservoir) configured to contain the exudate collected from the patient.

[0349] Furthermore, a cover element 166 is provided that is configured to be connected (attached) to the waste container 164 in a sealed manner.

[0350] For example, the collection unit 106 may further include a handle 168 that is hinged or pivoted to the waste container 164 and / or cover element 166.

[0351] The handle 168 is used for transporting and moving the collection unit 106.

[0352] Specifically, the collection unit 106 includes at least one filter element 170.

[0353] At least one filter element 170 is configured to capture biological components, preventing biological contaminants from flowing into the atmosphere via the vacuum pump of the carrier unit 102.

[0354] The collection unit 106 further includes a first coupling element 172 configured to be connected to a vacuum pump, i.e., a suction line, located on the carrier unit 102.

[0355] For example, at least one filter element 170 is configured to be positioned downstream of the first coupling element 172 (in the direction of the seeping fluid flow).

[0356] The collection unit 106 further includes at least one second coupling element 174 configured to be connected, for example, to the discharge tube of the measurement unit 114.

[0357] Specifically, the waste container 164 has a volume of approximately 4L or 5L.

[0358] Specifically, the collection unit further includes an overflow prevention valve 175 to protect the coupling element from overfilling with fluid.

[0359] Specifically, the filter element 170, the first and second coupling elements 172 and 174, and the overflow prevention valve 175 are configured to be positioned on the cover element 166 of the collection unit 106.

[0360] For example, the first coupling element includes a Luer connector configured to connect to the vacuum of the carrier unit.

[0361] The collection unit 106, shown at the bottom of Figure 6, includes a pair of second coupling elements 174 for connecting to the measurement unit 114.

[0362] Furthermore, the arrangement of the components of the collection unit is also different. The filter element 170, the first and second coupling elements 172 and 174, and the prevention valve 175 are located on one side of the collection unit 106, i.e., on the cover element 166.

[0363] In the alternative design of the collection unit 106 shown at the top of Figure 6, the components of the collection unit 106 are arranged in the center of the cover element 166 of the collection unit.

[0364] Figures 7 and 8 show the front view and rear view (rear view) of the measuring unit 114 for the cleaning system 100, respectively.

[0365] For example, the measuring unit 114 may be implemented in the form of a disposable unit (a so-called cartridge) configured to be operably coupled to a cleaning system, such as a carrier unit 102 of a cleaning system 100.

[0366] For example, the measuring unit includes fastening or coupling means such as plugs, clips, and socket connectors, allowing the unit to be easily assembled and installed in the cleaning system. In other words, the measuring unit is designed to connect effectively to the system and operate as intended.

[0367] Specifically, the measurement unit 114 includes components such as a pump device, sensors, valves, a fluid container, tubing, and tubing connectors, which are assembled (operably coupled) to provide a single functional unit. This functional unit is configured, for example, to pump infusion fluid into a patient, to hold exudate fluid from the patient in an intermediate location, to analyze the exudate fluid, and to guide the exudate fluid to a collection unit.

[0368] Specifically, the measuring unit 114 includes a support element 188 (e.g., a mounting plate or support plate) configured to support the position of the components of the measuring unit. In other words, the components of the measuring unit are configured to be mounted on a mounting plate.

[0369] The mounting plate includes mechanical fasteners and coupling elements suitable for holding and connecting components of the measuring unit (e.g., pump, sensor, and tubing) in place.

[0370] Alternatively, the support element or mounting plate includes fluid channels and / or (fixing) elements (for holding components of the measuring unit in place) incorporated into the support element. For example, the integrated elements and channels corresponding to the support element are formed by an injection molding process.

[0371] For example, the support element 188 includes multiple fastening elements such as mounting clamps and clips for attaching components of the measuring unit.

[0372] Specifically, the support plate 118 defines a mounting surface 190 including an upper edge 192 and a lower edge 194, and the measuring unit 114 is configured to guide the seeping fluid from the upper edge to the lower edge.

[0373] The measuring unit 114 is configured to be installed in the cleaning system 100, for example, on the carrier unit 102, and the flow of seeping fluid within the measuring unit 114 along the longitudinal axis (in the direction of gravity) is partially controlled.

[0374] In other words, the components of the measuring unit 114 are arranged on the mounting surface 190 such that the seeping fluid enters the measuring unit 114 from the upper edge 192 and exits from the lower edge 194.

[0375] Specifically, the measuring unit 114, i.e., the support plate 188, includes an inlet opening 196 for housing a first pump unit 198 (e.g., an inlet pump unit) for pumping the infusion fluid received from the inflow unit 104 toward the patient.

[0376] For example, the entrance opening 196 is positioned on the upper edge 192 of the support plate 188.

[0377] For example, the first pump unit 198 includes multiple pumping devices 198 (see Figure 9). The multiple pumping devices, i.e., inflow pumps, are configured to provide (pump) multiple infusion fluid flows to the patient via the tubing unit 134.

[0378] Specifically, the first pump unit 198 is configured to be coupled to the tubing section 134 and to pump the infusion fluid received from the inflow unit 104 through the inflow tube 184 of the tubing section 134 toward the patient.

[0379] Figure 8 further shows that the measurement unit includes a sample port 200 for collecting a sample of the effluent removed from the patient as needed. This feature is selective.

[0380] The cleaning system, for example, the carrier unit, further includes a second pump unit (i.e., an outflow pump unit) configured to discharge seepage fluid from the measuring unit 114. The second pump unit is in fluid communication with the measuring unit 114 via a connector tube 201.

[0381] For example, the second pump unit is configured to be located in, for example, the carrier unit 102. The second pump unit includes, for example, two outflow pump devices (including, for example, peristaltic pumps) configured to remove exudate from the patient's pericardial cavity and pleural cavity, respectively.

[0382] The measuring unit 114 (e.g., a cartridge unit) further includes at least two intermediate fluid containers 202 (e.g., two buffer containers) configured to store the seeping fluid. This allows the injected fluid to be stored at an intermediate position during cleaning, i.e., before the injected fluid is collected in the collection unit.

[0383] More specifically, each buffer container 202 is configured to receive exudate from a body cavity, such as the pericardial cavity or pleural cavity, and to discharge the exudate when a certain amount of fluid has accumulated inside.

[0384] For example, one of the fluid containers 202 is configured to receive exudate from the pericardial cavity, and the other fluid container 202 is configured to receive exudate from the pleural cavity.

[0385] The intermediate fluid container 202 is positioned symmetrically on the mounting plate 188 near the upper edge 192 of the mounting surface 190, for example. Other asymmetrical configurations are also possible, for example, one container being positioned closer to the upper edge and the other closer to the lower edge.

[0386] The buffer container 202 is configured to be fixed to the mounting plate by a suitable adhesive, glue, or mechanical means.

[0387] Each intermediate fluid container 202 includes an inlet 204, a first outlet 206, and a second outlet 208.

[0388] The inlet 204 is in fluid communication with one of the multiple outflow tubes 186 of the tube unit 134 (to receive exudate fluid from the patient), and the outlet 206 is in fluid communication with one of the outflow pump devices of the second pumping section.

[0389] Furthermore, a level sensor (not shown) is included behind each buffer container 202, for example near the first outlet 206, which is configured to measure the level of seeping fluid in the buffer container 202.

[0390] Specifically, the level sensor is configured to measure the fluid level in the buffer container 202. When the level sensor measures a specific fluid level in one of the buffer containers 202, the corresponding discharge pump device is configured to discharge (or move) the accumulated fluid (e.g., 8 ml, 10 ml, or 12 ml) from the buffer container 202 through the first outlet 206.

[0391] Figure 8 further shows that the outputs of the two outflow pump devices are fluidly connected to a sensor unit (e.g., a hematocrit sensor) located on the carrier unit 102.

[0392] The sensor unit is configured to analyze the exudative fluid removed from the pericardial cavity and / or pleural cavity.

[0393] Specifically, the sensor unit is a hematocrit sensor and includes a cuvette 210 positioned in the measuring unit 114 to contain the exudate fluid for further analysis.

[0394] Specifically, the measuring unit 114 further includes a connector element 214 (e.g., a Y-connector) configured to fluidly connect the second pump unit and the cuvette 210.

[0395] The two outflow pump devices of the second pump unit are configured to operate asynchronously, i.e., not simultaneously. In this way, the exudate from the pericardial and pleural cavities is transmitted individually to the cuvettes via the Y-connector 214 for further analysis by the hematocrit sensor.

[0396] Specifically, a filter 212 (e.g., a thrombus trap) is placed inside each buffer container 202 to capture thrombi larger than a certain size and prevent them from flowing out of the buffer container 202 (only one of the filters is shown in Figure 8).

[0397] For example, the filter 212 is configured to be positioned in a direction parallel to the flow direction of the seeping fluid. That is, the filter 212 is aligned parallel to the longitudinal axis of the cleaning system 100 when in operation.

[0398] By arranging the filter 212 vertically (upright) within the buffer container, the performance of the filter 212 is improved, and blockage of the filter by thrombi, which obstructs the flow of exudate fluid through the buffer container, is reduced.

[0399] Specifically, each filter 212 is configured to filter out particles or components in the leachate with a diameter of 2.5 mm or more.

[0400] For example, each buffer container 202 specifies a volume of, for example, 200 to 300 ml.

[0401] During the operation of the scrubbing system, small thrombi may enter the buffer container through the outflow tube. Periodic draining of fluid from the buffer container 202 and / or providing a filter into the buffer container prevents small thrombi from agglomerating further downstream in the scrubbing system. In other words, it is ensured that larger aggregates of thrombi do not form.

[0402] Furthermore, the aggregation of thrombi within the cuvette 210 of the measurement unit 114 is also mitigated.

[0403] Specifically, the measuring unit 114 further includes two safety elements 216 (e.g., safety overflow outlets or tubes), each of which is in fluid communication with one of the buffer containers 202.

[0404] The safety element is the overflow outlet of the buffer container 202, which is configured to release seeping fluid from a second outlet 208 of the buffer container when the buffer container is filled to a predetermined volume, for example.

[0405] For example, the two safety outlets are in fluid communication with the overflow tube 216 through which the seepage fluid discharges the buffer container 202. This can occur, for example, if the discharge pump device malfunctions or fails and is unable to pump the discharge fluid through the first outlet 206 of the buffer container 202.

[0406] The overflow tube is configured to be fluidically connected to the collection unit 106. That is, excess seepage fluid can be discharged to the collection unit 106 via the outflow tube 216.

[0407] Specifically, the measuring unit 114 further includes a discharge tube 218 configured to fluidly connect the cuvette 210 of the sensor unit to the collection unit 106 of the washing system 100. In other words, the discharge tube 218 is configured to discharge (transport) the seepage fluid from the cuvette to the collection unit 106.

[0408] For example, during operation, the exudate is pumped from the buffer container 202 to the cuvette 210 and paused while being analyzed by the hematocrit sensor in the carrier unit 102. After the analysis, the exudate is pumped through the discharge tube 218 to the collection unit 106.

[0409] Specifically, the cleaning system includes an opening (e.g., formed in a support element) configured to hold and guide an air tube (pressure line) and a vacuum tube (i.e., a vacuum line from the collection unit) toward the tube unit 134 (patient).

[0410] Figure 9 shows a perspective view of the measurement unit 114.

[0411] In this example, the first pump unit 198 includes three pumping units stacked along a common axis (for example, an axis perpendicular to the mounting plate). These three pumping units are assembled in a pump holder (not shown) to properly position the pumps and allow for easy mounting and removal together.

[0412] Specifically, each pump device is configured to be connected to at least one inlet tube 112 of the inlet unit 104 and one of the inlet tubes 184 of the tube unit 134.

[0413] Each pump device is further configured to pump the infusion fluid received from the infusion fluid container 108 to the patient via the tubing unit 134.

[0414] Figure 10 shows the tube assembly 220, specifically the tube assembly for the cleaning system. The upper left corner of Figure 10 also shows a cross-sectional view of the tube assembly, indicated by AA, showing a multi-lumen tube set.

[0415] Specifically, the tube assembly 220 is configured to connect to the cleaning system 100, and more particularly to the tube unit 134 of the cleaning system 100.

[0416] Specifically, the tube assembly 220 is configured to provide fluid communication with the patient, specifically with the body cavity.

[0417] The tube assembly 220 includes a proximal end 222 configured to connect to a patient (for example, located within a body cavity) and a distal end 224 configured to connect to a irrigation system 100, specifically a tube unit 134.

[0418] Specifically, the tube assembly 220 includes a tube set comprising a plurality of inlet tubes E1, E2, E2', E3 configured to deliver infusion fluid to the patient, and at least one outlet tube E4 configured to deliver (drain) exudate fluid from the patient.

[0419] The multiple inlet tubes of the tube set may further include inlet tubes E2' (e.g., air tubes or pressure lines) for transporting air.

[0420] Specifically, the tube assembly 220 includes a sleeve element 226 (e.g., a protective cover) configured to surround a plurality of inlet tubes and at least one outlet tube along a predetermined length of the tube assembly. For example, the sleeve element is configured to firmly hold (grip) the tubes and block passages through which liquid and / or air can pass, for example, through gaps between the tubes.

[0421] Specifically, at least one outflow tube E4 and multiple inflow tubes E1, E2, E2', E3 are configured to be held together in one bundle of a particular packing array, for example, through a sleeve element 226.

[0422] Thus, the handling and positioning of the tubes are improved, allowing medical staff to stably identify and organize the tube assembly in a time-efficient and easy manner. Advantageously, the sleeve element 226 is designed to secure the inlet tube and at least one outlet tube together, ensuring that the tube assembly 220 passes smoothly through the incision in the body cavity.

[0423] Specifically, the protective cover 226 includes an outer wall that defines a cavity (internal volume or empty space), and the cavity is configured to surround (enclose) a multi-lumen tube set including a plurality of inlet tubes and at least one outlet tube.

[0424] For example, multiple inlet tubes and at least one outlet tube are arranged within the protective cover 226 such that the center points of two inlet tubes E2, E2' and one outlet tube lie on a common line within the sleeve.

[0425] Specifically, at least one outflow tube E4 is positioned between multiple inflow tubes E1, E2, and E2'.

[0426] For example, at least one outflow tube E4 is positioned centrally and sandwiched between at least two inflow tubes.

[0427] Specifically, at least one outflow tube E4 is positioned between twin inflow tubes E2 and E2' on one side, and another inflow tube E1 is positioned on the opposite side.

[0428] For example, a multi-lumen tube set is arranged such that two inflow tubes E2, E2' form both ends (two opposite sides) of the tube assembly 220. Specifically, such inflow tubes are configured to be positioned in the upper part of the heart (above the pericardial cavity).

[0429] Specifically, the arrangement of the tube set is designed so that two of the multiple inflow tubes, E2 and E2', are connected together to form a twin inflow tube. More specifically, the twin inflow tube is configured to be positioned at the bottom of the heart.

[0430] For example, one inlet tube E2 of a twin inlet tube is configured to carry the injectable fluid, while the other inlet tube E2' is configured to carry air (i.e., forming an air tube or pressure measuring tube). In this way, the air channel is supported by the inlet tubes and kept clean. In other words, the flow of the injectable fluid prevents undesirable blockage of the air tube by small thrombi or tissue.

[0431] Specifically, at least one outflow tube E4 has a larger diameter than multiple inflow tubes.

[0432] Specifically, the multiple inlet tubes may or may not have the same diameter.

[0433] For example, at least one outflow tube has an outer diameter of 8 to 10 mm, preferably 9 mm, and defines a lumen with an inner diameter of 5 to 7 mm, preferably 6 mm.

[0434] The multiple inlet tubes each define a lumen with an inner diameter of, for example, 1 to 3 mm, preferably 1.6 mm. Each inlet tube has an outer diameter of 2 to 4 mm, preferably 3.2 mm.

[0435] Specifically, the tube assembly 220 further includes a filler material positioned within the sleeve element and configured to fill the available space inside the sleeve element 226. Thus, any unfilled areas within the sleeve element not occupied by the inflow and outflow tubes are filled with the filler material.

[0436] Thus, the gap between the multiple inflow tubes and at least one outflow tube arranged in the sleeve element can be filled with filler material, regardless of the shape or size of the tubes and the sleeve element.

[0437] Advantageously, the sleeve element and the filling material placed within it allow for the support and sealing of multiple inlet tubes and at least one outlet tube. This prevents undesirable leakage (e.g., air or fluid) between the patient (e.g., the patient's body cavity) and the surrounding environment.

[0438] For example, the sleeve element is in the form of an extruded tube or a molded sleeve, which is configured to be fitted over a certain length on multiple inflow tubes and at least one outflow tube at the proximal end of the tube assembly, i.e., close to the patient, specifically close to the incision site on the patient's body.

[0439] This method has the advantage of ensuring that the tubes exiting the patient's body are securely held together in a sealed manner.

[0440] For example, the tube assembly 220 includes three inlet tubes E1, E2, and E3 for transporting the infusion fluid to the patient (e.g., a body cavity), one pressure tube (air tube) E2' for transporting air, and one outlet tube E4 for transporting exudate from the patient.

[0441] Specifically, the tube assembly further includes a cap 228 positioned at the distal end of the tube assembly 220 (i.e., farther from the patient and closer to the irrigation system).

[0442] The cap 228 is positioned particularly on the portion of the tube assembly 220 that extends outside the patient's body (e.g., from the pleural cavity or pericardial cavity) (i.e., located outside the patient's body).

[0443] The cap helps guide the tube assembly 220 as it passes through the incision and exits the body cavity.

[0444] The cap is configured to be removed from the tube assembly 220 after the proximal end 222 of the tube assembly has been placed in the body cavity, allowing the distal end 224 of the tube assembly to be connected to the irrigation system 100.

[0445] The tube assembly 220 is configured to be connected, for example, to the tube unit 134 of the cleaning system 100 via the tube connector 160.

[0446] Figure 11 conceptually illustrates the cleaning system 100.

[0447] During operation, the first pump unit 198 is configured to pump the infusion fluid from the inflow unit 104 toward the patient.

[0448] The first weight measurement unit 110 is configured to measure the weight change of the injectable fluid in the inflow unit (i.e., the injectable fluid container). Such a weight change indicates, for example, a decrease in the volume of the injectable fluid in the injectable fluid container. By evaluating the volume change of the injectable fluid over a specific period, it is possible to confirm the flow rate of the injectable fluid toward the body cavity.

[0449] The injectable fluid flow rate of the first pump unit 198 is configured to be adjusted by the control unit 282, thereby pumping a controlled amount of injectable fluid into the pericardial or pleural cavity based on signals from multiple sensors.

[0450] The infusion fluid is configured to be heated by the heater unit 138 as it passes through the tube interface unit 140. The infusion fluid is then introduced into the body cavity via the tube assembly 220 connected to the patient (i.e., the inflow line of the tube assembly).

[0451] Exudate removed from the patient's body cavity (e.g., pericardial cavity or pleural cavity) via the tube assembly 220 (i.e., the outflow line of the tube assembly) is led to the respective intermediate buffer containers 202. The filtered exudate is individually pumped from the intermediate buffer containers into cuvettes 210. The exudate in the cuvettes is then configured to be analyzed by a sensor unit located in the carrier unit 102.

[0452] The collection unit is equipped with one or more suction devices.

[0453] The suction device is configured to generate a relatively low pressure, for example, a negative pressure of -15 mmHg, inside the waste container. The pressure can be further reduced using the ICU vacuum wall connector 230, thereby facilitating the removal of seeping fluid.

[0454] Such relatively low pressure can be used to aspirate exudate from the pericardial cavity PC towards the exudate container 202.

[0455] A second weighing unit 111, positioned below the collection unit 106, is configured to measure the volume / weight of the leachate in a waste container (e.g., a leachate container). Based on the change in the volume / weight of the leachate over time, the flow rate / volume of the leachate can be calculated.

[0456] Any other sensor configured to calculate the flow rate of exudate from the pericardial cavity PC to the exudate container 202 can also be used to calculate the flow rate / volume of exudate. For example, the flow rate of exudate may be calculated by a flow sensor.

[0457] The cleaning system according to the present invention provides a reliable and precise system that enables effective drainage and ensures patient safety. The amount of fluid administered to the patient's body and the amount drained from the patient's body can be measured and monitored in real time. More specifically, the exudate removed from the body cavity is individually filtered through an intermediate container and sent to an analysis chamber (e.g., a cuvette) of a sensor unit for individual measurement and analysis. The intermediate container includes filters aligned parallel to the direction of fluid flow.

[0458] The measuring unit according to the present invention is designed as an independent unit configured to be placed in a cleaning system. The measuring unit has a compact design that includes inlet and outlet pump units, respectively, for transmitting and extracting fluid. The measuring unit further includes two intermediate containers, each associated with a body cavity, for filtering the extracted fluid and analyzing the removed fluid. A safety element included in the measuring unit discharges fluid from the intermediate fluid in the event of a failure of the outlet pump.

[0459] The tube assembly according to the present invention has a smart design provided by a single multi-lumen tube set. The multi-lumen tube set includes a bundle of tightly coupled tubes. The tube assembly includes inlet and outlet fluid tubes configured to be coupled to a cleaning system, facilitating the injection of fluid and / or air and discharging it while preventing air or fluid from re-entering the body cavity. [Explanation of Symbols]

[0460] 100 Cleaning Systems 102 Carrier Unit 104 Inflow Unit 106 Collection Units 108 Injection fluid container 110 First weight measurement unit 112 At least one inlet tube 114 Measurement Unit 116 User Interaction Unit 118 Mounting elements 120 Carrier Unit Housing 122 Base section 124 Upper end part 126 Housing internal frame 128 Hollow Chamber 130 Gripping element 132 Rock elements 134 Tube Unit 136 guide elements 138 Heater Unit 140 Tube Interface Unit 142 Base Unit 144 Footplate 146 Casing 148 Base Plate 150 Peripheral wall 152 Multiple openings 156 Internal structure 157 Aisle Network 158 Lid 160 Tube Connector 162 Pressure Measuring Tube 164 Waste containers 166 cover elements 168 Handle 170 170 At least one filter element 172 First connecting element 174 At least one second connecting element 175 Overflow prevention valve 176 First Tube Section 178 Second Tube Section 180 Third Tube Section 182 Containment elements 184 Multiple inlet tubes 186 Multiple drainage tubes 188 Support elements 190 Mounting surface 192 Upper edge 194 Lower edge 196 Inlet opening 198 First pump unit 200 sample ports 201 Connector Tube 202 Intermediate fluid container 204 Inlet of the intermediate fluid container 206 First outlet of the intermediate fluid container 208 Second outlet of the intermediate fluid container 210 cuvettes 212 filters 214 Connector Elements 216 Outlet tube 218 Discharge tube 220 Tube Assembly 222 Proximal end 224 Distal end 226 Sleeve Elements 228 caps 230 Intensive Care Unit (ICU) Vacuum Wall Connector 232 Control Unit

Claims

1. A cleaning system 100 for cleaning a patient's wounds and / or body cavities, particularly the pericardial cavity (PC) and / or pleural cavity, The aforementioned system 100 is A carrier unit 102 configured to be movable, An inlet unit 104 comprising at least one injection fluid container 108 for containing the injection fluid, The collection unit 106 is configured to collect exudate from the patient, The carrier unit 102 is configured to house the inflow unit 104 and the collection unit 106. The inflow unit 104 further comprises at least one first weight measuring unit 110 for measuring the weight of the injectable fluid to be delivered to the patient. The cleaning system 100 comprises a carrier unit 102 which includes a second weight measuring unit 111 for measuring the weight of the seepage fluid collected in the collection unit 106.

2. The cleaning system 100 further comprises a measuring unit 114 configured to be operably connected to the inflow unit 104 and the collection unit 106, preferably the measuring unit 114 comprising at least one analysis chamber 210 and / or at least one pump unit 198. The cleaning system 100 according to claim 1, characterized in that the measuring unit 114 is positioned at an intermediate position between the inflow unit 104 and the collection unit 106, along the longitudinal axis of the carrier unit 102.

3. The washing system 100 according to claim 2, wherein the measuring unit 114 comprises two intermediate fluid containers 202 for receiving the exudate, preferably a first intermediate fluid container 202 configured to receive the exudate from the pleural cavity and a second intermediate fluid container 202 configured to receive the exudate from the pericardial cavity.

4. The cleaning system 100 according to any one of claims 1 to 3, further comprising a user interaction unit 116 that enables the user to monitor the cleaning process and / or the results of the analysis of the seeping fluid.

5. The cleaning system 100 according to any one of claims 1 to 4, characterized in that the inflow unit 104 comprises at least one mounting element 118 for holding the at least one first weight measuring unit 110 and / or the at least one injection fluid container 108.

6. The cleaning system 100 according to any one of claims 1 to 5, wherein the at least one first weight measuring unit 110 is configured to hold the at least one injection fluid container 108, and preferably the at least one first weight measuring unit 110 is configured to be connected to the carrier unit 102 by a shock mount.

7. The carrier unit 102 includes a housing 120 that extends along the longitudinal axis from the bottom position 122 to the upper end position 124. The cleaning system 100 according to any one of claims 1 to 6, characterized in that the housing 120 is configured to house the collection unit 106, the measuring unit 114 or measuring unit 114, and the inflow unit 104 inside, from the bottom position to the upper end position.

8. The housing 120 includes a through chamber 128 configured to house the inflow unit 104, and / or The cleaning system 100 according to any one of claims 1 to 7, further comprising a gripping element connected to the carrier unit 102, preferably positioned to protect the inflow unit 104, wherein the gripping element is configured to protect the first weight measuring unit and / or the at least one injection fluid container.

9. The cleaning system 100 further comprises a tube unit 134 configured to transport the injectable fluid toward the patient and the exudate fluid from the patient toward the cleaning system 100. Preferably, the cleaning system 100 according to any one of claims 1 to 8, characterized in that the tube unit is configured to be connected to the measuring unit 114 or the measuring unit 114 and the patient.

10. The cleaning system 100 according to any one of claims 1 to 9, wherein the collection unit 106 further comprises a waste container 164 for collecting the exudate from the patient and / or a cover element 166 configured to be connected to the waste container 164.

11. The cleaning system 100 further comprises a tube unit 134, or a guide element 136 configured to guide the position of the tube unit 134 toward the carrier unit 102, wherein preferably the guide element 136 is arranged to lower the position of the tube unit downwards, as described in any one of claims 1 to 10.

12. The cleaning system 100 according to any one of claims 1 to 11, further comprising a tube unit 134 that provides fluid communication between the carrier unit 102 and the patient, or a tube interface unit 140 configured to at least partially hold the tube unit 134.

13. The cleaning system 100 according to any one of claims 1 to 12, further comprising at least one tube connector 160 configured to merge the flow of exudate fluid received from the patient, preferably the pleural cavity or the pericardial cavity.

14. The at least one tube connector 160 is configured to fluidly connect an outflow tube included in the tube assembly 220 attached to the patient with another outflow tube attached to the patient. The irrigation system 100 according to any one of claims 1 to 3, characterized in that both the tube assembly 220 and the other outflow tube are connected to a common body cavity, in particular the pericardial cavity or the pleural cavity.

15. The cleaning system 100 further comprises a heater unit 138 configured to heat the tube unit 134, or at least one section of the tube unit 134, which provides fluid communication between the carrier unit 102 and the patient, preferably the heater unit 138 is configured to heat the tube interface unit 140, or one section of the tube unit held by the tube interface unit 140, according to any one of claims 1 to 14.

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