Multiplex infusion system with control device, catheter and storage unit for such a multiplex infusion system

Abstract

A multiplex infusion system (100) for dispensing different medical fluids (F1, F2,... Fn) distally to a patient (P) has a control device (110); and a multiplex infusion device with a tubular catheter (2) and a multiplex unit (1). The tubular catheter (2) has at least one inner lumen (4) between a proximal end (15) and a distal end (16). The multiplex unit (1) has a plurality of valves and / or feed devices (X-S; X-2, X-3,... X-n) which, for connection in parallel, are each fluidically connected to the at least one lumen (4) at the proximal end (15). For standard operation of the multiplex infusion system (100), the control device (110) is configured to actuate the plurality of valves and / or feed devices (X-S; X-2, X-3,... X-n) in a respectively associated plurality of feed lines (L-S; L-2, L3,... L-n) for the supply and / or removal of fluid, so as to feed the different medical fluids (F1, F2,... Fn) with respectively associated positive flow directions (SR-plus) in the time-division mutiplex through the at least one lumen (4). For the interim operation to which the system switches from the standard operation, the control device (110) is further configured to select and actuate at least one of the plurality of valves and / or feed devices (X-S; X-2, X-3,... X-n) as a selected reverse flow device (R) in an associated selected reverse flow fluid line (L-R), in order to feed an associated fluid volume unit (V1 to V6) through the selected reverse flow fluid line (L-R) via the selected reverse flow device (R) with an associated reverse flow direction (SR-minus).

Description

[0001] Multiplex infusion system with control device, catheter and storage unit for such a multiplex infusion system

[0002] Description

[0003] Technical area

[0004] The present disclosure relates to an extracorporeal multiplex infusion system of a control device for delivering different medical fluids, in particular (infusion) liquids or solutions, distally to a patient, comprising a catheter (tube) with at least one inner lumen and a plurality of valves and / or delivery devices, each of which is fluidically connected to the at least one lumen, and a control device connected to the plurality of valves and / or delivery devices. The control device is configured to control and / or regulate a volume flow of a fluid of the respective controllably connected plurality of valves and / or delivery devices in order to deliver the different medical fluids, in particular liquids, through the at least one lumen by means of the plurality of delivery devices in (time) multiplex.The disclosure also relates to an associated catheter and an associated storage unit for such a multiplex infusion system.

[0005] Such a multiplex infusion system is known, for example, from WO 2019 / 001879 A1. The known multiplex infusion system is configured to provide multiple infusions for a patient. The system includes a plurality of infusion devices for administering a plurality of medical fluids to the patient through an infusion line of an infusion set and a control device for controlling the plurality of infusion devices.The control device has a multiplexing module configured to multiplex (time-division multiplex) the plurality of medical fluids for multiplexed administration of the medical fluids through the infusion line of the infusion set. The multiplexing module has a scheduling module configured to define at least two packets, each packet containing at least one medical fluid from the plurality of medical fluids, and to arrange the at least two packets in an order for administration of the medical fluids of the at least two packets. The infusion devices are connected via supply lines to a multiple valve, the multiple valve having switchable valves for switching between the infusions of the different infusion devices for delivery via a single infusion line connected to the patient.With the known multiplex infusion system, the multiple supply lines to the multiple valve can lead to unintentional mixing of the medical fluids. Furthermore, due to their size, the infusion devices are mounted on a frame placed next to the patient, particularly next to the patient's bed.

[0006] Furthermore, DE 102005 045 393 A1 concerns multiplex infusion, a method for dosing different solutions that allows for a high repetition rate of medications to be dosed. In this method, fluid volumes in the range of 50 nanoliters to 50 microliters are withdrawn from a fluid source in rapid succession using a time-division multiplex method and are drawn into a collection channel without mixing.

[0007] However, the aforementioned multiplex infusion systems have several technical problems. These include potentially compromised dosing accuracy due to the long distance to the catheter, which can lead to unintentional mixing of medications in the infusion line. Furthermore, the administration of critical undiluted medications is not possible, as a fundamental risk for bolus administration or a reduction in flow rate due to a change in the position of the infusion system cannot be ruled out. In addition, the problem can arise that, in a multiplex system located away from the patient, an increase in the delivery rate or flow rate of a medication can lead to a short-term increase in medication administration.

[0008] Further problems result from manual, time-consuming and technically demanding procedures in clinical operation and their corresponding documentation, particularly with regard to flushing or priming, for example when changing a catheter or fluid container, or with regard to central venous aspiration of blood samples, integration of sensors, etc. In order to reduce clinical effort and potential susceptibility to errors, especially in the challenging environment of intensive care medicine, there is a need for further development of the automated support of clinical operations and processes by the multiplex infusion system.

[0009] In particular, automated detection and documentation of the arrangement and connection of fluid storage containers for various medical fluids to an infusion line and catheter lumen is currently not possible. Therefore, the current state of the art allows for an infusion bag, pump, infusion line, and catheter lumen to be freely selected and individually connected using, for example, three-way stopcocks. This also poses a risk of uncontrolled leakage when an infusion set / syringe is removed from the pump.

[0010] The object of the disclosure is to provide a multiplex infusion system of the type mentioned above, an associated catheter, and an associated storage unit for such a multiplex infusion system, which overcome the disadvantages inherent in the prior art, in particular the disadvantages described above. In particular, the present disclosure is intended to achieve advantages over the prior art, particularly with regard to functionality, structure, flexibility, operational reliability, and / or optimal design of clinical workflows.

[0011] This object is achieved, according to a first aspect of the disclosure, for the multiplex infusion system with the control device by the features of claim 1. Furthermore, according to a further aspect of the disclosure, which may be claimed independently, this object is achieved for the multiplex infusion system with the control device by the features of each claim directed to the control device with a first interim mode of operation, a second interim mode of operation, a third interim mode of operation, or a fourth interim mode of operation. Furthermore, this object is achieved according to yet another respective claim directed to further aspects of the disclosure, which may be claimed independently. In particular, a further aspect, which may be claimed independently, relates to a multi-lumen connector for unique fluid connectivity.

[0012] Furthermore, according to a further aspect of the disclosure, which may be claimed independently, this object is achieved for the associated catheter by the features of the claim directed to the catheter. In particular, a further aspect, which may be claimed independently, relates to a catheter with at least one further inner lumen.

[0013] Furthermore, according to a further aspect of the disclosure, which may be claimed independently, this object is achieved for the associated storage unit by the features of the claim directed to the storage unit. Mutatis mutandis, according to a further aspect of the disclosure, which may be claimed independently, this object is further achieved by a control method with fluid flow control and / or regulation steps of the control device according to the first aspect (stored or storable in machine-readable form on the storage unit). Advantageous embodiments of the disclosure are specified in the subclaims, the wording of which is hereby incorporated by reference into the description. This includes, in particular, all embodiments of the disclosure that result from the combinations of features defined by the references in the subclaims.

[0014] The multiplex infusion system according to the disclosure is configured to deliver different medical fluids, in particular (infusion) fluids, distally to a patient. In other words, the multiplex infusion system is configured to deliver different medical fluids distally to a patient. The multiplex infusion system comprises a control device and a multiplex infusion device. The multiplex infusion device comprises a (tubular) catheter (distal) and a multiplex unit (proximal). The (tubular) catheter has at least one inner lumen along its longitudinal extension between a proximal end and a distal end. The multiplex unit has a plurality of valves and / or conveying devices, each of which is fluidly connected to the at least one lumen at the proximal end (of the catheter) for parallel connection.This means that the catheter is positioned distal(er) from the multiplex unit.

[0015] In this case, the control device is apparently configured to control the plurality of valves and / or delivery devices, which are each controllably connected to the control device for controlling and / or regulating a volume flow of a fluid (from the different medical fluids), for the controlled operation of the multiplex infusion system. In this case, the control device is configured to control the plurality of valves and / or delivery devices in respective associated fluid lines for fluid supply and / or removal, in order to deliver the different medical fluids with respective positive flow directions in time division multiplex through the at least one lumen. In other words, the controlled operation defines (an) associated respective positive delivery rate(s).

[0016] According to the disclosure, the control device is further configured to select and control at least one of the plurality of valves and / or conveying devices, which is configured to reverse the positive flow direction, as a selected reverse flow device in an associated selected reverse flow fluid line for the interim operation of the multiplex infusion system switched from the normal operation, in order to convey an associated fluid volume unit through the selected reverse flow fluid line via the selected reverse flow device with an associated reverse flow direction.

[0017] In other words, with respect to the (at least one) selected reverse flow device or selected reverse flow fluid line, a change in the sign of the flow direction or volume flow, in particular a flow rate, is brought about by / when switching from / to the control mode to the interim mode by means of the control device. Accordingly, the previously associated positive flow direction / forward direction, in particular a continuous one, is reversed / inverted into the opposite associated reverse flow direction / backward direction, in particular a continuous one. In other words, the interim mode defines an associated negative flow rate of the selected reverse flow device. In other words, the control device is configured to effect a (continuous) reverse flow / backward flow through the (at least one) selected reverse flow device and across it or through the selected reverse flow fluid line.In this case, an (achieved or predetermined) reverse flow rate (negative flow rate) of the reverse flow / backward flow may differ in amount from an (achieved or predetermined) positive flow rate in the positive flow direction or may be the same in each case.

[0018] The term "across the selected reverse flow device" means that the fluid volume unit is not only briefly sucked back into a fluid line at the outlet thereof, for example, to prevent a flow front of the fluid volume unit (e.g., one that is adjacent to another fluid line) from being torn off or blown away. In other words, the term implies that a significant (continuous) reverse flow / backward flow is established. This is such that the fluid volume unit flows or is transported backward along a streamline that is long to very long compared to a nominal inner diameter of the fluid line, or travels a corresponding flow path. In particular, the streamline or flow path of the reverse flow / backward flow can be longer relative to the nominal inner diameter of the fluid line by a factor of greater than or equal to 10, preferably greater than or equal to 100, even more preferably greater than or equal to 1000.Alternatively or cumulatively, the streamline or flow path of the reverse flow / backward flow may be greater than or equal to 10 mm, preferably greater than or equal to 10 cm, even more preferably greater than or equal to 1 m.

[0019] The term "configured to reverse the positive flow direction" refers to a (particularly mechanical) possibility for reversing a flow direction in one (selected) of the several valves and / or conveying devices. For example, in the case of a peristaltic pump, a rotation direction of a rotor can be used to rotate

[0020] Squeeze rollers can be switched to an opposite direction of rotation.

[0021] The control device can be connected and / or connectable to the plurality of valves and / or delivery devices wirelessly and / or wired. For regular operation or optionally for interim operation, individual or selected or all of the plurality of valves and / or delivery devices, in particular micropumps, can be controlled or regulated so that predetermined doses, in particular microdoses, of the various medical fluids flow, in particular are pumped, into the catheter at predetermined intervals and / or at respective delivery rates.

[0022] The term “distal” refers to a section facing away from medically trained personnel such as a doctor and, vice versa, a section facing the patient.

[0023] The catheter can, for example, be designed for use as a central venous catheter, which is inserted into the patient's venous system via a vein in the upper half of the body and whose end is located in the superior or inferior vena cava in front of the right atrium of the heart. The catheter (tube) can be manufactured in a manner known to those skilled in the art from a flexible plastic material suitable for medical applications.

[0024] The term "fluid"—in particular the terms "medical fluid" or "separation fluid" or "rinsing fluid"—means a flowable material or a flowable substance. In particular, the (at least one) fluid can be (in each case) a gas and / or a liquid (or a liquid or a drippable fluid). Furthermore, for example, the fluid, in particular the liquid, can be (in each case) an (aqueous / organic / alcoholic) solution and / or a paste and / or a cream and / or a gel or colloid. The gas (or the gaseous fluid), in particular the separation fluid and / or rinsing fluid, can be carbon dioxide (CO2). In other words, CO2 can preferably be used as the separation fluid for separation. The fluid can be a Newtonian fluid or a non-Newtonian fluid. Alternatively or cumulatively, the fluid can be viscoelastic or a viscoelastic substance.Furthermore, it is not fundamentally excluded that the fluid may be a supercritical fluid.

[0025] Alternatively or cumulatively, the (at least one) fluid can be (in each case) a (particularly single-phase) mixture or a composition of the aforementioned embodiments of the fluid; and / or a two- or multi-phase mixture of the aforementioned embodiments of the fluid, in particular an emulsion (W / O, O / W), a suspension, an aerosol, and / or a foam. Alternatively or cumulatively, the fluid can be an inert fluid, in particular an inert separation gas, or a protective fluid (e.g., against oxidation processes), in particular a protective gas.

[0026] The term "(time) multiplexing" refers to the fact that chemically and / or physically (interface-to-solution) incompatible medical fluids such as solutions are administered sequentially through the same lumen as (infusion) fluid packets or fluid volume units. In particular, they can be separated by another medical fluid compatible with both (infusion) fluid packets or fluid volume units, acting as a separation fluid.

[0027] The term “normal operation of the extracorporeal multiplex infusion system” means that, in order to effect the temporal alternation / (time) multiplexing of the multiple valves and / or delivery devices, such as in particular infusion pumps of the extracorporeal multiplex infusion system, in an automated manner, a control device is provided and configured to centrally create an infusion administration plan for the patient and to monitor and implement its execution. For this purpose, the control device is provided and configured to send the corresponding fluid flow control and / or regulation commands / steps to each of the multiple valves and / or delivery devices of the extracorporeal multiplex infusion system. In other words, normal operation serves the primary core function of the multiplex infusion system, i.e., without any preparatory and / or follow-up actions / operations / processes.Consequently, during normal operation, a regular, or intended / nominal, positive main flow direction for the regular / nominal flow through the catheter, namely from proximal (from a respective fluid source such as a fluid reservoir, an infusion bag, etc.) to distal (for delivery to the patient), is defined for this primary core function of multiplex infusion. Accordingly, during normal operation, the control device controls the multiple valves and / or delivery devices installed or arranged in the respective associated fluid lines for fluid supply and / or removal, so that the various medical fluids are delivered / flow / flow at their regular / nominal flow rate, thereby defining the respective positive flow directions.

[0028] The term “interim operation of the extracorporeal multiplex infusion system” refers to a time-limited, i.e. temporary, operating phase which serves or is intended to carry out an operation that deviates from normal operation to multiplex infusion, such as a flushing process, calibration, etc. In particular, during or as a result of switching to interim operation, normal operation is temporarily, in particular briefly and / or repeatedly, interrupted or suspended and / or, in particular in the case of a preparatory operation such as priming a fluid line, not even started. In principle, it is also conceivable that transitions between normal operation and interim operation are not abrupt in terms of flow, but rather smoothly switched or phased in a manner that involves transition phases that overlap both operating modes.

[0029] The exact number of the multiple valves and / or delivery devices is not essential to the underlying disclosure. In particular, the multiplex unit, in particular the catheter itself, can have two, three, four, or more than five, more than 10, or even more than 20 delivery devices, detachable and / or integral.

[0030] In particular, the control device can be configured such that the multiple valves and / or delivery devices can also be active simultaneously. This makes it possible for selected multiple medical fluids that are compatible with each other and can therefore be mixed together to be delivered simultaneously, even with a single-lumen catheter.

[0031] In particular, the control device can be set up to set or control or regulate a respective timing or cycle length and / or delivery rate of the plurality of valves and / or delivery devices depending on the medication and / or demand. More preferably, the control device can be set up to set or control or regulate a flow or volume flow or a delivery rate of all active ones of the plurality of valves and / or delivery devices depending on a predetermined total delivery rate (in particular distally). The term “total delivery rate” refers to a sum of the delivery rates of all active ones of the plurality of valves and / or delivery devices. In general, it should be noted that in the case of a valve, the term “delivery rate” is conceptually understood as a (technically brought about by active control / regulation measures on the valve) or, so to speak,active') fluid volume flow is to be interpreted. In principle, it is also conceivable that a (total) delivery rate is controlled / regulated (or ramped up) in a constant and / or increasing manner and / or controlled / regulated (shut down) in a temporal sequence or based on various temporal sections of one of the interim operations according to the disclosure.

[0032] In general, it should be noted that the term "substantially equal" with regard to (total) delivery rates or fluid volume flows considered in relation to one another is intended to include the case of slightly (e.g., + / - 20%, especially + / - 5%) differing (total) delivery rates or fluid volume flows. This means that, for example, controls or (transitional) flow states are intended to be within the scope of the present disclosure in which there are non-significant deviations from a (particularly flow-related) feature or approximate states to this feature that are relevant to the essence of the disclosure, especially the functioning of various aspects according to the disclosure.

[0033] The control device can be a known unit and in particular can comprise a CPU, a RAM, a ROM, a timer, a non-volatile memory device, and the like. The CPU can be configured to implement various control methods (i.e., associated steps or sequences) with regard to the control operation and respective interim operations, associated switching modes, and / or fluid flow control and / or regulation steps of the control device based on various programs or maps, which are stored in particular in the ROM. Furthermore, the RAM can be configured to temporarily store calculation results calculated by the CPU, for example with regard to a delivery rate, etc., and / or to store data acquired, for example, by a (flow) sensor of the multiplex infusion system.

[0034] Preferably, alternatively or cumulatively, at least one or all of the plurality of valves and / or delivery devices is / are each designed as a flow control valve and / or a switching valve and / or a valve that is or can be subjected to a pre-pressure in the respective one of the plurality of fluid lines upstream. This allows for flexible adaptability according to different dosing tasks. Furthermore, the possibility of using various valves and / or delivery devices is advantageous for clinical operational engineering purposes or for strategic purchasing on the manufacturing side.

[0035] Preferably, alternatively or cumulatively, at least one or all of the plurality of valves and / or delivery devices is / are each designed as a respective pumping device, in particular a respective micropump. This advantageously allows for high precision and improved reliability of the dosing(s).

[0036] Preferably, alternatively or cumulatively, the control device is configured to control the selected reverse flow device for interim operation in order to convey the unit volume of fluid into a fluid sink. For example, the fluid sink can be designed as a waste container. This provides a possibility for collecting and / or recycling the medical fluids, in particular separately, which is advantageous in terms of the economics and / or ecology of the multiplex infusion.

[0037] Preferably, alternatively or cumulatively, the control device is configured to control the selected reverse flow device for interim operation in order to convey the fluid volume unit in one circulation of the multiplex infusion device with the reverse flow direction. For example, this advantageously represents a cost- and space-saving option for thorough flushing in circulation using a flushing fluid.

[0038] Preferably, alternatively or cumulatively, the control device is configured to control the selected reverse flow device for interim operation in order to convey the unit volume of fluid through at least one sensor device. In particular, the at least one sensor device can be a biosensor device. The at least one sensor device is arranged in the selected reverse flow fluid line and is preferably controllably connected to the control device. In other words, the control device can switch to an interim operation (e.g., a first interim operation for automated central venous aspiration of a blood bolus, see the related aspect below), in which the fluid line comprising the sensor device is / is selected by the control device as the selected reverse flow fluid line.Accordingly, the fluid volume unit can flow through the selected reverse flow fluid line having the sensor device in order to be sensor-detected / evaluated. The fluid volume unit supplied for sensor-detected / analysis with / by means of the reverse flow through the selected reverse flow fluid line can relate to at least one of the plurality of medical fluids and / or an aspirated blood bolus. The sensor-detected / analysis can relate to widely known mechanical and / or physical detection variables / parameters. In particular, the detection variables / parameters to be sensor-detected can relate to known applications relating to quality management / monitoring of known (multiplex) infusion systems and / or to laboratory data on patient blood.

[0039] This automation of the aforementioned applications advantageously enables a reduction in manual activities, thus optimizing the use of highly qualified medical personnel, accelerating clinical processes, reducing the susceptibility to errors, reducing interruptions due to manual sampling, increasing convenience and peace of mind for the patient through the elimination of external disturbances, automated documentation, automated sampling and measurement / analysis with regard to a patient's condition (e.g. blood gas analysis of the blood bolus), online monitoring of the proper technical / fluid dynamic functions of the multiplex infusion system according to the disclosure, and the like.

[0040] Preferably, alternatively or cumulatively, at least one or all of the plurality of valves and / or delivery devices is / are each configured for delivery at a respective delivery rate of 0.05 ml / min to 500 ml / min, preferably from 0.1 ml / min to 300 ml / min, and / or for intermittent delivery with a respective timing of less than 10 hours, preferably less than 2 hours, in particular between 1 s and 100 s, more preferably between 5 s and 60 s, even more preferably between 10 s and 20 s. In particular, the control device is configured accordingly to control the delivery rate and / or the timing. Thus, particularly reliable precision dosing can be achieved. This advantageously reduces the risk of prohibitive incorrect / over- / underdosing. In particular, the risk can be advantageously reduced for critical medications, such as those administered in an emergency situation.However, this should not be seen as limiting the disclosure; in this respect, if the patient is not receiving critical medication, the timing may well be significantly longer than the more preferred timing range of between 10 s and 20 s (e.g., up to the hourly range). In other words, for some medications, very rapid timing is necessary. In particular, for the intermittent delivery of (at least) one critical medication, for example, adrenaline, noradrenaline, etc., the (respective) timing may more preferably be between 5 s and 60 s, and even more preferably between 10 s and 20 s. However, depending on the medication administration, this may also extend into the range of several minutes, particularly longer than 60 minutes, especially for the delivery of a non-critical medication or in the case of exclusively non-critical medications. This also increases the uniformity of the infusion / depletion schedule.In this respect, the fluctuation ranges of actual concentrations compared to target concentrations of active substances to be infused / administered can be further advantageously minimized. According to a further aspect of the disclosure, which may be claimed independently, a separation fluid and / or rinsing fluid is preferably, alternatively, or cumulatively a first medical fluid and / or at least one (optionally) selected medical fluid from the different medical fluids.

[0041] In particular, the first and / or selected medical fluid can be selected and provided as the separation fluid and / or rinsing fluid, in particular the separation gas and / or rinsing gas, from the various medical fluids for use as the optional rinsing fluid in the (respective) interim operation [with reference to the first to fourth interim operations described below]. In other words, in such a configuration or such an aspect, the first and / or selected medical fluid is used as the optional rinsing fluid in the interim operation, i.e., instead of another rinsing fluid (such as saline solution, carbon dioxide, and the like) that is conventionally or exclusively intended or providable for rinsing purposes or specified as a rinsing fluid.

[0042] The terms "as the optional rinsing fluid" or "select" indicate that this is not to be interpreted in a limiting sense. In other words, it can be flushed, generally and / or in phases, on the one hand with the first and / or the medical fluid selected (as the optional rinsing fluid) from the various medical fluids and / or on the other hand with the other rinsing fluid conventionally or exclusively intended for rinsing purposes. In this respect, flushing with the first and / or selected medical fluid has the particular advantage of lower fluid losses due to a saving of the other rinsing fluid intended / providable exclusively for rinsing purposes. Furthermore, due to the presence of the first and / or selected medical fluid, which can generally be applied to the patient as the optional rinsing fluid, in the lines, a faster switchover time to or after flushing than in interim operation proves to be advantageous.In other words, the response time with regard to medication administration as a core function of the multiplex infusion system is improved. Furthermore, this offers the possibility of a simplified arrangement of the corresponding multiplex infusion system. Preferably, alternatively or cumulatively, the control device is configured to determine and control at least one of the plurality of valves and / or conveying devices as a specific source flow device in an associated source fluid line during interim operation, in particular at any time during interim operation, in order to convey the separation fluid and / or rinsing fluid with the associated positive flow direction through the associated source fluid line. This advantageously allows for automated, specifically controlled feeding with the separation fluid and / or rinsing fluid.

[0043] As already explained above, the separation fluid and / or rinsing fluid can (generally or as an independent aspect of the disclosure) in particular be a separation gas, more preferably carbon dioxide (CO2), or be present or formed as such.

[0044] According to a further aspect of the disclosure, which may be claimed independently, the control device is provided and configured for the automated aspiration of the patient's blood as a first interim operation, in order to effect / execute / switch a first switching mode and subsequently a second switching mode for aspiration. In the first switching mode for aspiration, the control device is configured to control a distal, in particular most distal, valve and / or conveying device from the plurality of valves and / or conveying devices as the selected reverse flow device in order to aspirate a blood bolus as the associated fluid volume unit at the distal end into the at least one lumen and to convey it via the lumen through the selected reverse flow fluid line with the associated reverse flow direction for the purpose of a sensory measurement such as a blood gas analysis, preferably by the sensor device.In this case, the control device, likewise in the first switching mode, is configured to temporarily stop (or stop) the source flow device to temporarily stop the flow of the separation fluid and / or rinsing fluid, and to stop all other of the plurality of valves and / or conveying devices to temporarily stop the flow of the other of the different medical fluids. In particular, in the first switching mode, a

[0045] Inlet fluid volume flow into the at least one (first and / or second) lumen of the catheter (from distal in the proximal direction) is equal to an outlet fluid volume flow from the selected reverse flow fluid line associated with the selected reverse flow device. Also, in the first switching mode, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen of the catheter is equal to a (negative) delivery rate of the selected reverse flow device.

[0046] During the first interim operation, the control device is further configured, following the first switching mode for aspiration, to activate the source flow device in a second switching mode for aspiration in order to convey the separation fluid and / or rinsing fluid first through the source fluid line with the associated positive flow direction and further downstream through the selected reverse flow fluid line. This advantageously serves to automate the aspiration and overcomes the disadvantages such as time expenditure, costs, stress for a patient, etc., which are associated with the complex manual aspiration procedure in the prior art. This also advantageously enables close monitoring of (especially critical) blood values, for example, through blood gas analysis performed at shorter intervals.

[0047] In particular, for the automated aspiration of the patient's blood as the first interim operation, in the second switching mode for automated aspiration (balanced), a first source flow rate of the source flow device with the associated positive flow direction can be substantially equal to a first sink flow rate of the selected reverse flow device with the associated reverse flow direction. The first source flow rate of the source flow device with the associated positive flow direction is equal to an outlet volume flow of the source flow device exiting the source flow device. The first sink flow rate of the selected reverse flow device with the associated reverse flow direction is equal to an outlet volume flow of the selected reverse flow device exiting the selected reverse flow device.In other words, in the second switching mode, the separation fluid and / or flushing fluid (or a fluid volume unit thereof) flows through the multiplex unit, starting from the source fluid line, via the source flow device, into a selected reverse flow fluid line via the selected reverse flow device. In particular, a uniform flow through the source flow device and downstream of it, the selected reverse flow device (i.e., optionally, equal flow rates) occurs.

[0048] This serves to further transport the blood bolus by displacement for the purpose of sensory measurement while (simultaneous) stopping the flow of a fluid volume unit associated with at least one lumen. In other words, the volume unit associated with the lumen now (essentially) remains in the lumen. In other words, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen of the catheter is zero.

[0049] In particular, according to a further aspect of the disclosure, which may be claimed independently, a second interim operation for applying the catheter and automated flushing or priming of the multiplex unit is proposed.

[0050] During the second interim operation, a first medical fluid is selected and provided as the separation fluid and / or rinsing fluid, in particular the separation gas and / or rinsing gas, from the various medical fluids for use as the optional rinsing fluid in the second interim operation. In other words, the control device is provided for the second interim operation and configured to select a first medical fluid from the various medical fluids for use as the optional rinsing fluid (in the second interim operation).

[0051] During the second interim operation, the control device is further provided for the second interim operation and configured to effect / execute / switch a third switching mode. In the third switching mode, the control device is configured to control at least one, in particular distal, valve and / or delivery device from the plurality of valves and / or delivery devices as the at least one selected reverse flow device with respective second sink delivery rates in the associated reverse flow direction for, in particular, initial flushing of the multiplex unit. In the third switching mode, the control device is configured to control the source flow device with a second source delivery rate of the (separation fluid and / or) flushing fluid in the associated positive flow direction.In this case, the control device, likewise in the third switching mode, is configured to (first variant) control at least one or all of the other valves and / or conveying devices with respective third source delivery rates of the other of the different medical fluids in the associated positive flow direction (third source delivery rate greater than zero) and / or (second variant) to stop the other of the different medical fluids (i.e., third source delivery rate equal to zero). It should be noted that, on the one hand, transitions between the first variant and the second variant (or vice versa) can be switched or take place. For example, at least one or all of the respective third source delivery rates of the other of the different medical fluids can be increased from a value equal to zero to a value greater than zero (or vice versa, decreased to zero).In principle, superimposed first and second variants are conceivable in which mixed scenarios are controlled, e.g., on the one hand, (at least) one of the respective third source flow rates of the other of the different medical fluids is greater than zero, and on the other hand, another of the respective third source flow rates of the other of the different medical fluids is equal to zero. The respective third source flow rates can be essentially identical to one another (considered in pairs) and / or different. The respective second sink flow rates (in the case of multiple sinks) can be essentially identical to one another (considered in pairs) and / or different.

[0052] In this way, the lines up to the catheter can advantageously be flushed with at least one or the first / optionally selected medical fluid. In other words, compared to the prior art, this makes it possible to flush not with the other separation fluid and / or flushing fluid or with the separation fluid and / or flushing fluid that can be provided exclusively as the separation fluid and / or flushing fluid, in particular one that is not infusible and / or does not have a medicinal effect, but effectively with a medical fluid. However, this is not limiting. In this respect, flushing can nevertheless be carried out with both the (other) separation fluid / flushing fluid and with the at least one / first / optionally selected medical fluid.

[0053] In particular, a first total source flow rate, which is defined as the sum of the second and third source flow rates, can be (substantially) equal to a first total sink flow rate, which is defined as the sum of the second sink flow rates. This serves to effect a, in particular initial, flushing of the multiplex unit when a fluid volume unit associated with the at least one lumen is at a standstill. For the sake of completeness, it should be noted that if the at least one selected reverse flow device is exactly one selected reverse flow device, its second sink flow rate is to be equated with the total sink flow rate.

[0054] This advantageously brings about a particularly initial flushing of the multiplex unit with the (separation fluid and / or) flushing fluid, in particular the flushing fluid. In other words, the (separation fluid and / or) flushing fluid does not flow distally into the lumen of the catheter (as in particular during normal operation / multiplexing). Instead, the (separation fluid and / or) flushing fluid is diverted or sucked off to the at least one (active) selected reverse flow device as a (fluid) sink, in particular due to a flow pressure prevailing upstream thereof / on the side of the reverse flow device or pump suction side facing the catheter. In other words, an advantageous flow behavior or flow diversion of the (separation fluid and / or) flushing fluid (from an associated fluid source such as a storage container to an associated fluid sink orin circulation) is brought about in such a way that a volume unit belonging to the (separation fluid and / or) flushing fluid flows distally from a position upstream of the source flow device, then passes (or along its flow path) through the source flow device and then turns into the selected reverse flow fluid line in order to pass through the selected reverse flow device, e.g. in the direction of a fluid sink such as a waste container or also in a circulating manner for advantageous multiple thorough flushing. At the same time, the (essentially) equality of the first total source flow rate and the first total sink flow rate causes a standstill of a fluid volume unit belonging to the at least one lumen at a position that (essentially) remains the same during the third switching mode. In other words, the flow in the (at least one) lumen of the catheter has (temporarily) come to a standstill or does not flow from proximal to distal.Accordingly, the volume unit associated with the lumen remains in the lumen. This advantageously causes a temporary interruption of the normal operation without having a disruptive effect on the well-being of the (infusion) patient. It is also advantageous that the (fluid) standstill in the lumen blocks an undesired (excessive) overflow of the (separation fluid and / or) flushing fluid into the catheter or distally. In other words, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen of the catheter is (virtually) zero. In other words, in the first variant of the third switching mode, the total flow rate (distal through the lumen) is zero, whereby the total flow rate is composed as a sum on the one hand of the (positive) first total source flow rate of the active micropumps [ieincluding the source flow device for the (separation fluid and / or) rinsing fluid] and, on the other hand, the (negative) first total sink flow rate of the (active) selected reverse flow device. Alternatively, in the second variant of the third switching mode, the total flow rate (distally through the lumen) is zero, whereby the total flow rate is the sum of the (positive) second source flow rate (only) of the active source flow device [for the (separation fluid and / or) rinsing fluid] and the (negative) second sink flow rate of the (active) selected reverse flow device [(for the (separation fluid and / or) rinsing fluid). It is particularly advantageous that the rinsing with the (separation fluid and / or) rinsing fluid can take place as a closed circuit, so to speak, which is separated from other areas of the multiplex infusion device hydraulically or by switched-off pumps.

[0055] In particular, according to a further aspect of the disclosure, which may be claimed independently, a third interim mode for applying the catheter is proposed, including automated flushing or priming of the multiplex unit and superimposed on the catheter. The third interim mode is a modification of the second interim mode, resulting in similar advantages.

[0056] During the third interim operation, a first medical fluid is selected and provided as the separation fluid and / or rinsing fluid, in particular the separation gas and / or rinsing gas, from the various medical fluids for use as the optional rinsing fluid in the third interim operation. In other words, the control device is provided for the third interim operation and configured to select a first medical fluid from the various medical fluids for use as the optional rinsing fluid (in the third interim operation).

[0057] During the third interim operation, the control device is further provided and configured to effect / execute / switch a fourth switching mode. In the fourth switching mode, the control device is configured to flush the multiplex unit and, superimposed on the catheter, to control at least one, in particular distal, valve and / or delivery device from the plurality of valves and / or delivery devices as the at least one selected reverse flow device with respective third sink delivery rates in the associated reverse flow direction.The control device, likewise in the fourth switching mode, is configured to control the source flow device with a fourth source flow rate of the (separation fluid and / or) flushing fluid in the associated positive flow direction, and to control all other valves and / or delivery devices with respective fifth source flow rates of the other different medical fluids in the associated positive flow direction. In particular, a second total source flow rate, defined as the sum of the fourth and fifth source flow rates, can be smaller in magnitude than a second total sink flow rate, defined as the sum of the third sink flow rates. This serves to simultaneously flush at least one lumen of the catheter when flushing the multiplex unit.

[0058] In other words, a first partial fluid volume flow, which is composed / merged downstream of the source flow device [fourth source delivery rate of the (separation fluid and / or) rinsing fluid in the associated positive flow direction] and downstream of all other of the plurality of valves and / or delivery devices (respective fifth source delivery rates of the other of the different medical fluids in the associated positive flow direction, ie from proximal to distal), and a second partial fluid volume flow as an outlet volume flow from the at least one lumen of the catheter (ie from distal to proximal) combine or unite to form a total reverse fluid volume flow in the reverse flow direction (second total sink delivery rate, in particular third sink delivery rate).In other words, the total reverse fluid volume flow composed of the first partial flow and the second partial flow flows through or passes (according to the fourth switching mode) at least one or all of the selected reverse flow devices. In particular, the connection or joining of the first partial flow and the second partial flow can take place at a three-way point, which is particularly designed as a fork or branch from the selected reverse flow fluid line from the lumen or the catheter.

[0059] In particular, during the third interim operation for applying the catheter, including automated flushing or priming of the multiplex unit and superimposed on the catheter, the control device can be provided and configured to switch from the fourth switching mode to the third switching mode. In particular, the switching can be / occur immediately. That is, the switching can advantageously take place directly after one another or without any other intermediate phase.

[0060] In particular, according to a further aspect of the disclosure, which may be claimed independently, a fourth interim operation is proposed for the interim operation following a change of a fluid container with a fluid to be refilled from the different medical fluids with automated backflushing into the fluid container.

[0061] For the fourth interim mode, the control device is provided and configured to initiate / execute / switch a fifth switching mode, subsequently a sixth switching mode, and subsequently a seventh switching mode to the interim mode after a change of the fluid container. In particular, the fifth switching mode (and / or the fourth interim mode as such) can follow a zeroth switching mode and / or with the change / replacement of the fluid container. The fluid container can be fluidically connected to the multiplex infusion system and / or the multiplex unit.

[0062] In particular, but not by way of limitation, the first fluid line can be configured or provided to supply and / or feed an additional / exclusive separation fluid and / or rinsing fluid. Regarding the disclosed definition of the term "additional / exclusive separation fluid and / or rinsing fluid," reference is made generally and to avoid repetition to the relevant disclosure in connection with the second and third interim operation.

[0063] In the zeroth switching mode S000, a (empty or running low) fluid container can be replaced with a fluid to be refilled from the different medical fluids and / or the separation fluid and / or the rinsing fluid.

[0064] In the present disclosure, the term “subsequent” with regard to switching modes and / or control steps generally means preferably (quasi) directly / immediately thereafter.

[0065] In the fifth switching mode of the fourth interim operation, the control device is configured to control at least one of the plurality of valves and / or delivery devices as a first specific source flow device with a fifth source flow rate of the separation fluid and / or rinsing fluid in the associated positive flow direction. In the fifth switching mode, the control device is configured to control another of the plurality of valves and / or delivery devices as a first selected reverse flow device with a fourth sink flow rate of the separation fluid and / or rinsing fluid in the associated reverse flow direction, and to stop all other valves and / or delivery devices to stop the other of the different medical fluids.In particular, the fifth source flow rate can be (essentially) equal to the fourth sink flow rate (see also the second variant of the second interim mode). The fifth switching mode serves to effect, when a fluid volume unit associated with the at least one lumen is at a standstill, the conveyance of the separation fluid and / or rinsing fluid from the first specific source flow device to collect fluid volume units associated with the first selected reverse flow device.

[0066] In the fourth interim mode, the control device is further configured, following (to the fifth switching mode) in the sixth switching mode of the fourth interim mode, to switch the other of the plurality of valves and / or delivery devices as the first selected reverse flow device for reversing the flow direction and to switch or change to this instead of the first specific source flow device as a second specific source flow device with a sixth source delivery rate of the separation fluid and / or rinsing fluid in the associated positive flow direction. In other words, when switching from the fifth switching mode to the sixth switching mode, the first selected reverse flow device is controlled by the control device in such a way that its reverse flow direction reverses back into a (nominal) positive flow direction opposite thereto.

[0067] In this case, the control device, likewise in the sixth switching mode, is configured to control yet another, in particular distal, one of the plurality of valves and / or delivery devices as a second selected reverse flow device with a fifth sink delivery rate of the separation fluid and / or rinsing fluid in the associated reverse flow direction, and to stop all other of the plurality of valves and / or delivery devices until the other of the different medical fluids are stopped. In particular, the sixth source delivery rate can be substantially equal to the fifth sink delivery rate (compare also the second variant of the second interim operation). The sixth switching mode serves to effect a removal of the fluid volume units of the separation fluid and / or rinsing fluid associated with the first selected reverse flow device when a fluid volume unit associated with the at least one lumen is stopped.This can advantageously be used, for example, to first pump the separation fluid and / or rinsing fluid, in particular the separation fluid, toward an associated storage container, such as a container, and then pump it back to the point where the medicinal fluid / medication is directly available for multiplexing. The pumped-out separation fluid and / or rinsing fluid can be disposed of.

[0068] In the fourth interim operation, the control device is further configured, following (to the sixth switching mode) in the seventh switching mode, to stop the other one of the plurality of valves and / or conveying devices as the second specific source flow device and, instead of this, to switch back to the at least one of the plurality of valves and / or conveying devices as the first specific source flow device with a seventh source flow rate of the separation fluid and / or rinsing fluid in the associated positive flow direction.In this case, the control device, likewise in the seventh switching mode, is configured to maintain the other, in particular distal, of the plurality of valves and / or delivery devices as the second selected reverse flow device and to control it with a sixth sink delivery rate of the separation fluid and / or rinsing fluid in the associated reverse flow direction, and to stop all other of the plurality of valves and / or delivery devices until the other of the different medical fluids are stopped. In particular, the seventh source delivery rate can be substantially equal to the sixth sink delivery rate (compare also the second variant of the second interim operation). The seventh switching mode serves to effect further delivery of the separation fluid and / or rinsing fluid when a fluid volume unit associated with the at least one lumen is at a standstill.

[0069] With regard to the sixth switching mode, it should be emphasized (for the functioning of the fourth interim mode of operation) that the first specific source flow device, which was previously (active) in the fifth switching mode with the fifth source flow rate of the separation fluid and / or rinsing fluid, is stopped or blocked upon switching to the sixth switching mode. The fourth interim mode advantageously allows the fluid container, which is provided and configured (on an associated fluid sink side) to supply the first specific source flow device with the separation fluid and / or rinsing fluid, to be changed. Furthermore, it is advantageous that the concomitant switch to the second specific source flow device ensures a (virtually) uninterrupted supply of the separation fluid and / or rinsing fluid. This clever switching sequence can also advantageously prevent unnecessary waste of expensive separation fluid and / or rinsing fluid.Furthermore, it is advantageously avoided that the patient is infused with an excessive volume of fluid. In this respect, the fifth switching mode can serve as a buffer / intermediate storage function for the separation fluid and / or rinsing fluid (i.e., a sort of recovery function) inherent in the disclosed multiplex infusion device.

[0070] In general, switching can be carried out, in particular, from a zeroth switching mode (initial state) to the first switching mode (i.e., the first-switched switching mode of the first interim mode of operation) or to the third switching mode (i.e., the first-switched switching mode of the second interim mode of operation) or to the fourth switching mode (i.e., the first-switched switching mode of the third interim mode of operation) or to the fifth switching mode (i.e., the first-switched switching mode of the fourth interim mode of operation). The zeroth switching mode can be a control mode or a further / different interim mode of operation or an OFF state (standstill) of the extracorporeal multiplex infusion system according to the disclosure. Each of the aforementioned interim modes of operation advantageously serves for automation.

[0071] According to a further aspect of the disclosure, which may be claimed independently, the plurality of valves and / or conveying devices are uniquely fluidly connected and / or fluidly connectable via the respective associated plurality of fluid lines to a plurality of fluid storage containers of the different medical fluids by means of a plurality of respective associated individual (unique) fluid connections.

[0072] In particular, alternatively or cumulatively, the control device is configured to automatically identify the plurality of containers of the different medical fluids for regular and interim operation of the multiplex infusion system and to assign them unambiguously to the plurality of valves and / or conveying devices in the respective associated plurality of fluid lines. This aspect advantageously enables automation of the respective assignments and overcomes the disadvantage known from the prior art of a lack of a unique fluid connection in known multiplex infusion systems with manual connection operations. For example, in known multiplex infusion systems, when manually connecting an infusion bag, a pump, an infusion line, and a catheter lumen, these are freely selectable and can be individually and thus virtually arbitrarily connected, for example, using 3-way stopcocks.This also advantageously allows for automated documentation.

[0073] According to a further aspect or subject matter of the disclosure, which may be claimed independently, the unique fluid connections can be designed and configured using a multi-lumen connector. This serves to automatically assign respective combinations of respective fluid sources and fluid sinks during multiplex infusion. Furthermore, the multi-lumen connector advantageously improves the clarity of the structure of the disclosed multiplex infusion system compared to known multiplex infusion systems. Furthermore, the multi-lumen connector advantageously counteracts the error-prone nature of the known manual connection in the prior art by acting as a "pre-defined interface."

[0074] The multi-lumen connector can have a first multi-lumen connector part on a connector side facing the multiplex unit and a second multi-lumen connector part on the connector side facing the fluid storage containers. The first multi-lumen connector part (on the multiplex unit side) is provided or configured to form a connector side of the multi-lumen connector facing the multiplex unit. The second multi-lumen connector part (on the fluid storage container side) is provided or configured to form a connector side of the multi-lumen connector facing away from the multiplex unit. The first multi-lumen connector part and the second multi-lumen connector part are designed to be compatible or match one another and are configured to form a plurality of unique fluid connections.

[0075] The term "unambiguous" means unambiguous and also unambiguous in the reverse (viewing) direction, i.e. unambiguous in both directions. In this case, the term "unambiguous" implies that an (unambiguous) assignment of two ends can be made (especially automatically) both in one (viewing) direction from proximal (or fluid storage container side) to distal (or multiplex unit side or catheter side) and (vice versa) in the reverse (viewing) direction from distal to proximal. The term "unambiguous fluid connection" implies that each of the medical fluids flows from an associated fluid storage container into a designated or predetermined fluid line from the multiple fluid lines of the multiplex unit (especially distal to the catheter).The term “unique fluid connection” implies, with regard to the further aspect of the multi-lumen connector, that each of the medical fluids (per one associated from the connector lumens) flows via the connector into a designated or predetermined fluid line from the multiple fluid lines of the multiplex unit. The unique fluid connection advantageously enables control of the multiplex infusion system according to the disclosure by the control device. Furthermore, the unique fluid connection advantageously supports unambiguous (optional) automated documentation (by a or the control device). The multi-lumen connector allows for quick, flexible, and error-free connection or disconnection of, on the one hand, a proximal (or fluid reservoir side) unit of the multiplex infusion system and, on the other hand, a distal (or multiplex unit side) unit.Catheter-side) unit of the multiplex infusion system, in particular to or from the multiplex unit.

[0076] The first multi-lumen connector part is provided or configured to be (unambiguously) fluidly connectable or fluidly connected to a plurality of fluid lines of the multiplex unit, i.e., on the connector side facing the multiplex unit. The individual fluid lines of the plurality of fluid lines each lead into / out of individual (associated) ones of (correspondingly) several first connector lumens of the first multi-lumen connector part. Each of the first connector lumens has a respective associated first flow cross-sectional area. The plurality of first connector lumens can have (each viewed in pairs) identical and / or different first flow cross-sectional areas.

[0077] The second multi-lumen connector part is provided or configured to be (uniquely) fluidly connectable or fluidly connected to a plurality of fluid storage containers, such as an infusion bag and / or a fluid cartridge. In particular, an individual fluid storage container and / or a plurality of fluid storage containers combined / bundled from the plurality of fluid storage containers are each (uniquely) fluidly connectable or fluidly connected to the second multi-lumen connector part by means of or via a plurality of (associated) fluid storage lines. A fluid storage line can in particular be tubular. The individual fluid storage lines of the plurality of fluid storage lines each open into / lead into individual (associated) ones of (correspondingly) several second connector lumens of the second multi-lumen connector part. Each of the second connector lumens has a respective associated second flow cross-sectional area.

[0078] The first flow cross-sectional area is always equal to the corresponding second flow cross-sectional area.

[0079] The plurality of second connector lumens can have (each considered in pairs) identical and / or different second flow cross-sectional areas.

[0080] The number of the plurality of first connector lumens of the first multi-lumen connector part corresponds to the number of second connector lumens of the second multi-lumen connector part in order to be able to form the one-to-one fluid connection in the multi-lumen connector of a respective first connector lumen with an associated second connector lumen during (mechanical, in particular form-fitting) connection of the first multi-lumen connector part with the second multi-lumen connector part.

[0081] In particular, a respective first shape and a common first layout of the plurality of first connector lumens in the first multi-lumen connector part correspond in a mirror-image Z-symmetrical manner to a respective second shape and a common second layout of the plurality of second connector lumens in the second multi-lumen connector part in order to be able to form the unique fluid connection of a respective first connector lumen with an associated second connector lumen in the multi-lumen connector during a (mechanical, in particular form-fitting) connection of the first multi-lumen connector part with the second multi-lumen connector part.

[0082] Preferably, alternatively or cumulatively, the infusion bag can be (unambiguously) fluidly connectable or fluidly connected to the second multi-lumen connector part via one of the plurality of fluid supply lines as a source flow device for providing / multiplexing infusion of one of the medical fluids, for example, a separation fluid or rinsing fluid. In particular, the source flow device can be configured or function as a first or second source flow device (see, for example, fourth interim operation).

[0083] Further preferably, alternatively or cumulatively, a collection vessel and / or a waste container and / or an intermediate buffer storage, for example for the separation liquid or rinsing liquid, as a fluid sink of the multiplex infusion system can be (unambiguously) fluidly connectable or fluidly connected to the second multi-lumen connector part via another of the plurality of fluid supply lines for receiving / collecting / (intermediate) buffering, etc., of a medical fluid / the separation liquid or rinsing liquid.

[0084] Preferably, alternatively or cumulatively, a plurality of fluid cartridges can be (uniquely) fluidly connectable or fluidly connected to the second multi-lumen connector part via (several) additional fluid supply lines from the plurality of fluid cartridges for providing / multiplexing infusion of additional medical fluids from the plurality of fluid cartridges. The plurality of fluid cartridges can preferably, alternatively or cumulatively, be arranged or provided in a cartridge box.

[0085] Based on the unique fluid connection by means of the multi-lumen connector, the control device is configured to automatically identify the plurality of containers of the different medical fluids for regular operation and interim operation of the multiplex infusion system and to automatically and uniquely assign them to the plurality of valves and / or conveying devices in the respective associated plurality of fluid lines.

[0086] According to a further aspect of the disclosure, which may be claimed independently, the tubular catheter with the at least one lumen, on the one hand, and the multiplex unit with the plurality of valves and / or delivery devices, on the other hand, can be formed integrally with one another. In particular, respective outlets of the plurality of valves and / or delivery devices can open directly into the at least one lumen. This advantageously reduces the risk of an unwanted bolus administration of critical and / or concentrated or undiluted medical fluids or medical agents (pre-dissolved in the fluid) when the position of the multiplex infusion system changes due to movement, etc. Thus, the administration of such critical medical fluids or agents is advantageously enabled.

[0087] As an alternative to the above (integral) embodiment, the tubular catheter with the at least one lumen, on the one hand, and the multiplex unit with the multiple valves and / or delivery devices, on the other hand, can be designed as separate units that are fluidly connectable and / or fluidly connected to one another, in particular via a Luer-Lock connector or the like. This advantageously supports modularity and flexibility in clinical processes with regard to storage and the like. Accordingly, the cost situation is also improved.

[0088] Preferably, alternatively or cumulatively, the catheter may comprise the plurality of valves and / or delivery devices, each configured as a micropump and mounted or arranged at the proximal end.

[0089] Preferably, alternatively, or cumulatively, at least one or all of the plurality of valves and / or conveying devices can be formed integrally with the catheter. In particular, the plurality of valves and / or conveying devices, in particular the plurality of micropumps, can preferably be permanently mounted on the proximal end of the catheter tube. Preferably, alternatively, or cumulatively, the catheter can have an injection port. In particular, the multiplex infusion system has at least one, in particular manual, injection port close to the catheter, in particular on the catheter and / or on the multiplex unit. The at least one injection port is fluidically connected to the at least one lumen (respectively). This advantageously allows, e.g. in emergencies, a predetermined medical fluid / liquid to be quickly and easily supplied to the multiplex infusion system close to the catheter and thus to the patient via the injection port.The injection port is preferably configured to conform to a Luer connector, an NRFit connector, a non-Luer connector, or the like. The injection port can preferably be permanently mounted on the catheter (tube), preferably in a proximal section.

[0090] Preferably, alternatively or cumulatively, the catheter is designed as a disposable product for single use. This ensures sterility. The control device is designed for multiple use. This advantageously contributes to the sustainability of this investment.

[0091] According to a further aspect of the disclosure, which may be claimed independently, the tubular catheter can form at least one further (second) inner lumen by means of a partition wall extending parallel to the at least one (first) lumen. In other words, the partition wall divides an entire interior of the catheter into corresponding sub-spaces or lumens. The further (second) inner lumen extends parallel or coaxially to the at least one (first) inner lumen. Alternatively, the catheter can have any number of more than two lumens. With two- or multi-lumen catheters, two or even more different incompatible infusions can advantageously be delivered to the patient simultaneously. The use of a multi-lumen catheter advantageously makes the design both flexible and compact.

[0092] In particular, the control device can be configured such that the multiple valves and / or delivery devices can also be active simultaneously. This makes it possible for selected medical fluids, which are compatible with one another and can therefore be mixed, to be delivered simultaneously. According to the aforementioned aspect of a dual- or multi-lumen catheter, different, mutually incompatible infusions can also be delivered to the patient simultaneously in one of the (first, second, etc.) lumens.

[0093] According to a further aspect of the disclosure, which may be claimed independently, in particular the at least one (first) lumen and the at least one further (second) lumen can be fluidically connected by means of a connecting opening in the partition wall. In this case, the connecting opening can preferably break through the partition wall at or near the distal end. The term “near the distal end” preferably means at a distance from the distal end of less than or equal to 30 mm, more preferably less than or equal to 10 mm, in particular less than or equal to 5 mm. In this case, the connecting opening can in particular break through the partition wall in a section of a distal catheter tip of the catheter that is arranged upstream of a distal outlet opening with respect to the at least one lumen. In this case, it is further conceivable for the partition wall to be retracted inwards relative to an outlet opening of the catheter tube in order to form the connecting opening directly at the distal end ordirectly at the exit opening. In other words, the connecting opening can penetrate the partition wall in a section of the distal catheter tip of the catheter that is located upstream of the distal exit opening with respect to the first lumen or inside the catheter.

[0094] In particular, alternatively or cumulatively, the further (second) lumen can be fluidically connected to the selected reverse flow fluid line, in particular directly and / or integrally.

[0095] In particular, alternatively or cumulatively, the further (second) lumen can coincide with the selected reverse flow fluid line, in particular an upstream section of the selected reverse flow fluid line. In particular, the further (second) lumen coinciding with the selected reverse flow fluid line can be directly, preferably integrally, fluidically connected to the selected reverse flow fluid line LR, preferably coinciding with the most distal fluid line. In particular, the further (second) lumen can form the selected reverse flow fluid line (directly) at the distal outlet opening or at a distal(est) section of the distal catheter tip, in order to extend from there proximally or towards the multiplex unit.According to a further aspect of the disclosure, which may be claimed independently, the control device can be configured to divert the separation fluid and / or rinsing fluid, or volume units associated therewith, for return to the multiplex unit from the at least one (first) lumen through the connecting opening to an at least partial or complete fluid portion into the further (second) lumen as the selected reverse flow fluid line, or to return or convey it back into the multiplex infusion device. This offers the advantage that an infusion volume of the separation fluid and / or rinsing fluid for distal delivery to a patient can be reduced accordingly by this diverted / returned fluid portion. By reducing the infusion volume of the separation fluid and / or rinsing fluid, the range of applications of the multiplex infusion system according to the disclosure can advantageously be expanded.For example, with regard to an (infusion) patient with (also) a cardiological finding, the strain on the circulatory system or heart can be reduced, etc.

[0096] Preferably, alternatively or cumulatively, the at least one (first) lumen and the at least one further (second) lumen can have different surface properties, in particular wettabilities, with respect to a respectively associated first inner wall and second inner wall, completely or at least in sections, in particular with respect to a section at the distal end.

[0097] The (section-wise) (first) surface quality of the (first) lumen is defined or adjustable by a (section-wise) surface quality of a first inner wall of the tube wall of the catheter tube that delimits this (first) lumen. The (section-wise) (second) surface quality of the further (second) lumen is defined or adjustable by a (section-wise) surface quality of a second inner wall of the tube wall of the catheter tube that delimits this further (second) lumen.

[0098] Optionally, the (first) lumen may have a (first) hydrophobic surface finish (or hydrophobic inner coating) and the further (second) lumen may have a (second) lipophobic surface finish (or lipophobic inner coating) or vice versa.

[0099] For example, at least one or each of the (at least one) first inner walls can be hydrophobic; and at least one or each of the (at least one) second inner walls can be hydrophilic. Conversely, for example, at least one or each of the (at least one) first inner walls can be hydrophilic; and at least one or each of the (at least one) second inner walls can be hydrophobic. With such a specifically adjustable hydrophobic or lipophilic surface quality, the surface has low wettability or poor spreading for hydrophilic fluids, in particular water-based (medical) solutions. On the other hand, with a hydrophobic or lipophilic surface quality, the surface has good wettability or good spreading for lipophilic fluids, in particular oil-based (medical) solutions. Accordingly, on the one hand, with a hydrophobic orA lipophilic surface texture for lipophilic / oil-based medical fluids / liquids advantageously promotes the flow behavior in, for example, a tubular lumen (due to a reduced Laplace capillary pressure). Furthermore, a hydrophobic or lipophilic surface texture for hydrophilic / water-based medical fluids / liquids minimizes adhesion to the inside of the catheter tube, thus advantageously promoting residue-free emptying and / or reduced mixing along the flow path due to wall adhesion. On the other hand, a lipophobic or hydrophilic surface texture has low wettability or poor spreading for lipophilic fluids, especially oil-based (medical) solutions. On the other hand, a lipophobic or hydrophilic surface texture has good wettability or good spreading for hydrophilic fluids, especiallywater-based (medical) solutions. Accordingly, a lipophobic or hydrophilic surface texture for hydrophilic / water-based medical fluids / liquids advantageously promotes flow behavior in a tubular lumen, for example (due to a reduced Laplace capillary pressure). Furthermore, a lipophobic or hydrophilic surface texture for lipophilic / oil-based medical fluids / liquids minimizes adhesion to the inside of the catheter tube, thus advantageously promoting residue-free emptying and / or reduced mixing along the flow path due to wall adhesion.

[0100] In this aspect of the disclosure, when used appropriately, the surface properties of the lumens advantageously promote residue-free conveyance of medical fluids / liquids, so that in turn unintentional mixing of the medical fluids / liquids can be prevented.

[0101] Accordingly, according to an aspect which may be claimed independently, it is (generally) conceivable, according to the different (first or second) surface properties, i.e. the (at least one) hydrophobic (or vice versa: lipophobic) surface properties of the (at least one) (first) lumen and the (at least one) lipophobic (or vice versa: hydrophobic) surface properties of the (at least one) (second) lumen, to use preferably different separation fluids as the respective (first or second) separation fluid and / or rinsing fluid associated with the respective (first or second) lumen or to pass them through the respective lumens.

[0102] According to a further aspect, which may be claimed independently, it is (generally) conceivable to use different or different valves and / or conveying devices (in particular pumps) depending on the different (first or second) surface properties or lumens and / or the different (first or second) separation fluids or rinsing fluids, in particular for the respective disposal of the (corresponding) separation fluid and / or rinsing fluid. This (generally preferred) device advantageously serves to keep a hydrophobic channel and a lipophilic channel completely separate, in particular to keep them separate up to the distal outlet.

[0103] In this case, according to a first interfacial physical aspect, which may optionally be claimed independently, or of such a first wetting configuration, it may be preferred that the respective surface quality of the (first or second) lumen belongs to the same wetting property category (i.e., hydrophobic on the one hand or lipophobic on the other hand) as a wetting property of the respective separation fluid and / or rinsing fluid [i.e., belonging to the respective (first or second) lumen] (i.e., hydrophobic on the one hand or lipophobic on the other hand). In other words, the first wetting configuration relates to a wetting configuration. In other words, the separation fluid and / or rinsing fluid and the associated lumen or its surface quality each have the same wetting property category (i.e., both hydrophobic on the one hand or both lipophobic on the other hand). In this case, the respective (associated with the respective first or second lumen) (first orsecond) separation fluid and / or rinsing fluid is designed or arranged to wet the associated lumen or its (inner) (at least in sections) surface condition.

[0104] Alternatively (or cumulatively: i.e., with more than two lumens, combined wetting configurations are generally conceivable) to the aforementioned first wetting configuration, it may be preferred, according to a second, optionally independently claimed, interfacial physical aspect or such a second wetting configuration, that the respective surface quality of the (first or second) lumen belongs to a or the opposite wetting property category (i.e., hydrophobic on the one hand or lipophobic on the other hand) as a wetting property of the respective separation fluid and / or rinsing fluid [i.e., belonging to the respective (first or second) lumen] (i.e., lipophobic on the one hand; or hydrophobic on the other hand). In other words, the second wetting configuration relates to a non-wetting wetting configuration. In other words, the separation fluid and / or rinsing fluid and the associated lumen or its surface quality each have a different orOpposing wetting property categories (i.e., on the one hand, hydrophobic-lipophobic, i.e., hydrophobic fluid on a lipophobic surface; or, on the other hand, lipophobic-hydrophobic, i.e., lipophobic fluid on a hydrophobic surface). The respective (first or second) separation fluid and / or rinsing fluid (associated with the respective first or second lumen) is designed or configured not to wet the associated lumen or its (internal) (at least in sections) surface structure.

[0105] The skilled person further understands that, in general, the internal conveying surface finish of a valve and / or a conveying device (especially a pump) preferably has the same wetting property category as the associated lumen or its (at least partially) surface finish. However, this is not limiting.

[0106] The term "wetting" refers to a wetting angle or contact angle of a fluid on a surface between 0° and 90°. The term "non-wetting" refers to a wetting angle or contact angle of a fluid on a surface between 90° and 180°. In particular, in the case of a non-wetting wetting configuration, the wetting angle or contact angle can be close to 180°. The latter can advantageously serve a completely fluid-repellent wetting configuration. This can advantageously achieve a lotus effect. This also advantageously reduces the tendency towards residue formation. It can also advantageously increase dosing accuracy.

[0107] According to a further aspect of the disclosure, which may be claimed independently, a corresponding catheter is proposed. The catheter is designed and configured for use in the multiplex infusion system according to the first aspect and / or according to another of the preceding aspects. The catheter has at least one (first) inner lumen in its tubular longitudinal extension between a proximal end and a distal end. The tubular catheter forms at least one further (second) inner lumen, extending parallel to the at least one (first) lumen, by means of a partition wall therebetween. In other words, the partition wall divides an entire interior of the catheter (tube) into corresponding subspaces or first and second lumens. The at least one (first) lumen and the further (second) lumen are fluidically connected by means of a connecting opening in the partition wall.In this case, the connecting opening can preferably penetrate the partition at or near the distal end. It is also conceivable for the partition to be retracted inward relative to an outlet opening of the catheter tube in order to form the connecting opening directly at the distal end or directly at the outlet opening. In particular, the connecting opening can penetrate the partition in a section of a distal catheter tip of the catheter that is arranged upstream of a distal outlet opening with respect to the at least one lumen.

[0108] According to a further aspect of the disclosure, which may be claimed independently, an associated storage unit is proposed. A (control) method (according to a further aspect of the disclosure, which may be claimed independently) for dispensing different medical fluids distally to a patient using an extracorporeal multiplex infusion system according to the first aspect of the disclosure with the fluid flow control and / or regulation step(s) of the control device according to the disclosure or the following is stored in a machine-readable manner on the storage unit. Essential fluid flow control and / or regulation steps relate to: (i) selecting, for the interim operation of the multiplex infusion system switched from the standard operation, at least one of the plurality of valves and / or conveying devices, whichwhich is configured to reverse the positive flow direction, as a selected reverse flow device in an associated selected reverse flow fluid line; and (ii) a respective respective actuation of the selected reverse flow device to convey an associated fluid volume unit through the selected reverse flow fluid line across the selected reverse flow device with an associated reverse flow direction.

[0109] In particular, the control can be carried out to execute fluid flow control and / or regulation step(s) of the control device, which effect one or more of the aforementioned first to seventh switching modes, in particular to form a respective / associated one of the aforementioned first to fourth interim modes of operation. In this respect, it should be noted that the features disclosed for the control device and their advantages apply mutatis mutandis to the (control) method, in particular stored in machine-readable form on the memory unit, with associated fluid flow control and / or regulation step(s), and vice versa.

[0110] In particular, the control can be performed to convey the fluid volume unit into a fluid sink and / or in a circuit of the multiplex infusion device with the reverse flow direction. Alternatively or cumulatively, the control can be performed to convey the fluid through at least one sensor device arranged in the selected reverse flow fluid line and preferably controllably connected to the control device.

[0111] Further optional fluid flow control and / or regulation steps relate in particular to: (iii) determining, during the interim operation of the multiplex infusion system, in particular at any time during the interim operation, at least one of the plurality of valves and / or conveying devices as a source flow device in an associated fluid line as a source fluid line and their respective control in this regard in order to convey a separation fluid and / or rinsing fluid as a first medical fluid from the different medical fluids with the associated positive flow direction through the source fluid line; and / or (iv) an automated identification of the different medical fluids for the regular operation of the multiplex infusion system and their assignment to the respectively associated plurality of valves and / or conveying devices in the respectively associated plurality of fluid lines.

[0112] Overall, the disclosure provides a multiplex infusion system that solves several (independent) problems prevalent in the prior art. In this respect, one aspect relates to a relocation of the delivery device, in particular (micro)pump, distally or close to the (central venous) catheter. Another aspect relates to a multi-lumen line, in particular a multi-lumen connector. Another aspect relates to fluid cartridges as fluid storage containers. Another aspect relates to a clever control of the multiple valves and / or delivery devices, in particular by means of the (automated) first to fourth interim operations. Another aspect relates to the presence of a return channel on or in the single-lumen or multi-lumen catheter. The aspects of the present disclosure offer numerous advantages with regard to a.intelligent' multiplex infusion system, such as options for automated flushing / priming of (infusion) fluid lines such as tubes, easy sensor integration through automated aspiration of a blood bolus and its return, easy drug changes through backflushing, automated documentation, remote controllability and many more.

[0113] Short description of the characters

[0114] Further advantages and features of the disclosure emerge from the claims and from the following description of preferred embodiments of the disclosure, which are illustrated with reference to the drawings. They show:

[0115] Fig. 1 shows a schematically highly simplified representation of a first embodiment of a multiplex infusion system according to the disclosure with a control device;

[0116] Fig. 2 shows a schematically simplified sectional view of a detailed section of a single-lumen catheter tube of a catheter such as in particular according to Fig. 1, when conveying several medical fluids / liquids along a positive flow direction (normal operation);

[0117] Figures 3a to 3e show a temporal sequence of respective flow states of fluid volume units, as they are controlled by a second embodiment of a multiplex infusion system according to the disclosure in a partial sectional view (balance sleeve) by means of a first switching mode and a second switching mode, to illustrate a mode of operation of a first interim operation for the central venous aspiration of a blood bolus; Figures 4a.1 to 4c.1 show a temporal sequence of respective flow states of fluid volume units, as they are controlled by a third embodiment of a multiplex infusion system according to the disclosure in a partial sectional view (balance sleeve) by means of a third switching mode, to illustrate a mode of operation of a second interim operation for applying the catheter and automated rinsing orPriming the multiplex unit (in a first variant regarding a flow through all fluid lines in the positive flow direction of the multiplex unit 1 ).

[0118] Figures 4a.2 to 4c.2 show a temporal sequence of respective flow states of fluid volume units, as controlled by the third embodiment of a multiplex infusion system according to the disclosure in a partial sectional view (balance envelope) by means of the third switching mode, to illustrate the functioning of the second interim operation (in a second variant modified from Figures 4a.1 to 4c.1 with regard to a flow through only one of the fluid lines in the positive flow direction);

[0119] Figures 5a to 5e show a temporal sequence of respective flow states of fluid volume units, as they are controlled by a fourth embodiment of a multiplex infusion system according to the disclosure in a partial sectional view (balance sleeve) by means of a fourth switching mode, to illustrate a functioning of a third interim operation for applying the catheter and automated flushing or priming of the multiplex unit and superimposed on the catheter;

[0120] Figures 6a to 6e show a temporal sequence of respective flow states of fluid volume units, as they are controlled by a fifth embodiment of a multiplex infusion system according to the disclosure in a partial sectional view (balance envelope) by means of a fifth to seventh switching mode, to illustrate a functioning of a fourth interim operation for the interim operation after a change of a fluid container with a fluid to be refilled from the different medical fluids with automated backflushing into the fluid container;

[0121] Fig. 7 shows a schematically simplified sectional view of a double-lumen catheter tube for a sixth embodiment of a multiplex infusion system according to the disclosure as an alternative to the single-lumen catheter tube according to Figures 1 and 2;

[0122] Fig. 8a shows a seventh embodiment of a multiplex infusion device according to the disclosure with a multiplex unit and a double-lumen catheter in a sectional view with a catheter (tube) according to Figure 7 which is designed to have two lumens due to at least one further (second) inner lumen, to illustrate a return channel integrated into the catheter (tube) itself as a selected reverse flow fluid line in the form of the further (second) inner lumen;

[0123] Fig. 8b shows an eighth embodiment of a multiplex infusion device according to the disclosure, modified compared to Figures 8a and also compared to Figures 1 and 9, with a multiplex unit and a dual-lumen catheter in a side view, to illustrate a return channel arranged at a proximal end of the catheter at a further (second) inner lumen as a selected reverse flow fluid line LR;

[0124] Fig. 8c shows a ninth embodiment of a multiplex infusion device according to the disclosure, modified compared to Figures 8a and 8b, and further compared to Figures 1 and 9, in a side view, illustrating a divided multiplex infusion device with, on the one hand, a (single-lumen or multi-lumen) catheter and, on the other hand, a multiplex unit 1 as separately formed, (fluid-)connectable or (fluid-)connected units; and

[0125] Fig. 9 shows a schematically highly simplified representation of a tenth embodiment of a multiplex infusion system according to the disclosure with a control device, in particular for illustrating a multi-lumen connector for unambiguous fluid connection.

[0126] Description of the embodiments

[0127] A multiplex infusion system 100 according to a first embodiment according to Figure 1 [in conjunction with Figure 2] is configured for dispensing in time division multiplex or for multiplexing different medical (infusion) fluids as fluids distal to a patient P (normal operation). With reference to Figure 2, the term “multiplex(es)” refers to the dispensing of different (infusion) fluids F1, F2,...Fn as medical fluids to a patient P. In particular, two adjacent / consecutive different (infusion) fluids F1, F2,...Fn and / or (infusion) fluid packets combined therefrom [see Figure 2: F3 + F2; F3 + Fn] can be separated by a further medical fluid compatible with both (infusion) fluid packets as a separation fluid and / or rinsing fluid FS.

[0128] The multiplex infusion system 100 (shown schematically in a highly simplified manner) comprises, on the one hand, a multiplex infusion device with a catheter 2 and a multiplex unit 1, and, on the other hand, a control device 110. The control device 110 comprises a machine-readable storage unit 120.

[0129] The catheter 2 comprises a catheter tube 10 with at least one (in the first embodiment, the only or first) inner lumen 4. The lumen is defined by a tube wall 11 (Figures 2 and 7) of the catheter tube 10. The lumen 4 extends longitudinally through the catheter tube 10 between a proximal end 15 (of the catheter tube 10) and a distal end 16 (near the patient) (of the catheter tube 10).

[0130] The control mode controlled for multiplex infusion defines a positive flow direction SR-plus through the lumen 4 as an intended / nominal positive main flow direction for the regular / nominal flow through the catheter 2, as shown in Fig. 2. In other words, the control mode defines (a) corresponding respective positive flow rate(s).

[0131] As already mentioned, the catheter 2 in the first embodiment according to Fig. 1 is designed as a single-lumen catheter. In alternative embodiments, the catheter is designed as a double-lumen catheter with a further / second inner lumen 5, as can be seen in Fig. 7; cf. an optionally double-lumen seventh embodiment according to Fig. 8a.

[0132] According to the first embodiment shown in Figure 1, the catheter tube 10 has a distal catheter tip 13 at its distal end 16. In the present case, the distal catheter tip 13 is an integral component of the catheter tube 10 and, to that extent, is formed by its distal end 16. However, the distal catheter tip 13 can be formed as a separate component and firmly joined to the distal end 16 of the catheter tube 10. For example, according to the first embodiment shown in Figure 1, one lumen 4 has a distal outlet opening 12 in the region of the catheter tip 13.

[0133] The multiplex unit comprises a plurality of (micro)pumps XS; X-2, X-3,...Xn as the (respective) plurality of valves and / or delivery devices, each of which is fluidically connected to the lumen 4, as can be seen in Fig. 1. In the first embodiment shown in Fig. 1, the catheter 2 comprises, for example, five micropumps XS; X-2, X-3,...Xn (for example, n = 5 herein). In the present case, the plurality of micropumps XS; X-2, X-3,...Xn are arranged at the proximal end 15. In the present case, the plurality of micropumps XS; X-2, X-3,...Xn are connected in parallel and fluidically connected to the catheter 2. In the embodiments shown in Figures 1, 3a to 3e, 4a.1 to 4c.1, 4a.2 to 4c.2, 5a to 5e, 6a to 6e, 8a, 8b, the (schematically shown highly simplified) multiple micropumps XS; X-2, X-3,...Xn are mounted on the proximal end 15, optionally formed integrally with the proximal end 15 of the catheter 2, such that a respective outlet AS; A-2, A3,...At each micropump XS; X-2, X-3,...Xn opens directly into the lumen 4. In the present case, the micropumps X-2, X-3,...Xn are arranged in the radial direction relative to a tube wall 11 of the catheter tube 10, whereas the micropump XS is arranged in the axial direction relative to the tube wall 11 of the catheter tube 10 at the proximal end 15. Alternatively, all micropumps can be arranged in the radial direction relative to the tube wall of the catheter tube.

[0134] The micropumps XS; X-2, X-3,...Xn can be designed, for example, as a diaphragm pump or a peristaltic pump and can be driven and synchronized mechanically and / or hydraulically and / or pneumatically and / or electrically, depending on requirements and application.

[0135] The plurality of micropumps XS; X-2, X-3,...Xn are installed or arranged in, as shown in Fig. 1, respective associated fluid lines LS; L-2, L-3,...Ln. On the inlet side or on the supply side or upstream of the plurality of micropumps XS; X-2, X-3,...Xn (during normal operation), the respective associated fluid lines LS; L-2, L-3,...Ln are fluidly connected in a generally known manner to respective fluid sources such as a fluid storage container or the like (not shown in Figs. 1, 3a to 3e, 4a.1 to 4c.1, 4a.2 to 4c.2, 5a to 5e, 6a to 6e, 8a to 8b). With reference to Fig. 9, the fluid storage containers for storing the different (infusion) liquids F1, F2,...Fn can be designed, for example, as an infusion bag 70 and / or as a cartridge box 80 with a plurality of fluid cartridges 81, 81,...

[0136] Figure 1 and Figures 3a to 3e, 4a.1 to 4c.1, 4a.2 to 4c.2, 5a to 5e, 6a to 6e, 8a to 8b, and 9 further illustrate by way of example that an optional (e.g., proximal) fluid line FS from the plurality of fluid lines LS; L-2, L-3,...Ln is provided to present the separation fluid and / or rinsing fluid FS in the associated positive flow direction SR-plus to the multiplex unit or to feed it into it (optionally in circulation). The plurality of micropumps XS; X-2, X-3,...Xn are each controllably connected to the control device 110 for controlling and / or regulating a volume flow of a respective fluid (from the different medical fluids). In the first and tenth embodiments shown in Fig. 1 and Fig. 9, respectively, the control device 110 is wirelessly connected to the plurality of micropumps XS; X-2, X-3,...Xn, as indicated by the dashed lines.In particular, the control device 110 can be configured such that the controllable plurality of micropumps XS; X-2, X-3,...Xn can also be active simultaneously.

[0137] The control device 110 is configured to control the multiplex infusion system 100 by controlling the plurality of micropumps XS; X-2, X-3,...Xn in the respective associated plurality of fluid lines LS; L-2, L3,...Ln for fluid supply and / or removal in order to convey the different medical fluids with respective associated positive flow directions SR-plus (as shown proximally in Fig. 1 by way of example, namely by means of an arrow-like flow vector with respect to the axial fluid line LS) in time-multiplex through the lumen 4.

[0138] According to the disclosure, the control device 110 (shown in interim mode in Figures 1, 3a to 3e, 4a.1 to 4c.1, 4a.2 to 4c.2, 5a to 5e, 6b to 6e, 8a to 8b) is further configured to switch the multiplex infusion system 100 to interim mode, switched from regular mode. For interim mode, the control device 110 is configured to select and control (or regulate) at least one of the plurality of micropumps XS; X-2, X-3,...Xn (configured to reverse the positive flow direction SR-plus) as a selected reverse flow device R in an associated selected reverse flow fluid line LR. In Fig. 1, the selected reverse flow device R relates, for example, to the fourth micropump X-4 and accordingly relates to the associated selected reverse flow fluid line LR, for example, to the fourth fluid line L-4. According to the disclosure, the selection and control serve to select an associated fluid volume unit (cf.In other words, the selected reverse flow device R conveys fluid (in Figures 3a to 6e: designated by reference symbols V1 to V6) through the selected reverse flow fluid line LR across the selected reverse flow device R with an associated reverse flow direction SR-minus (as shown in Figure 1 by way of example using an arrow-like flow vector relating to the radial fluid line L-4 = LR). In other words, the selected reverse flow device R conveys fluid at a respective negative flow rate.

[0139] Optionally, the control device 110 can control the selected reverse flow device R for interim operation in order to convey the said fluid volume unit V1 to V6 (Figures 3a to 6e) into a fluid sink 30, for example in the form of a waste container, as shown by way of example in Figure 9 using the tenth embodiment.

[0140] Further optionally, alternatively or cumulatively, the control device 110 can control the selected reverse flow device R for interim operation in order to convey the said fluid volume unit V1 to V6 (Figures 3a to 6e) in one circulation of the multiplex infusion device with the reverse flow direction SR-minus.

[0141] In such a case of circulation, in particular, as explained here by way of example with reference to Fig. 1, a volume flow emerging from the selected reverse flow device R [identical to X-4 in Fig. 1] (in the reverse flow direction SR-minus) can circulate in the multiplex infusion system 100 as a volume flow entering a (notional) balance shell around the multiplex unit 1 (positive flow direction SR-plus). In this case (not shown), the volume flow entering (into the balance shell) can not only (re-)enter a fluid line with the positive flow direction SR-plus, as in Fig. 1 by way of example again into the axial fluid line LS, but also into at least one selected or all fluid lines with the respectively associated positive flow direction SR-plus.

[0142] Optionally, the control device 10 can control the selected reverse flow device (R) for interim operation in order to convey the said fluid volume unit V1 to V6 (Figures 3a to 6e) through at least one sensor device 90, such as a biosensor. As shown by way of example in Fig. 1 with reference to the first embodiment, the sensor device 90 is arranged, for example, on / in the most distal fluid line Ln. In this respect, the control device can switch to an interim operation (not shown), in which this fluid line Ln is determined or selected by the sensor device 90 as the selected reverse flow fluid line LR. Accordingly (not shown, but see for example Fig. 3b for a first interim operation for central venous aspiration of a blood bolus) the said fluid volume unit V1 to V6 (Figures 3a to 6e) can flow through the selected reverse flow fluid line LR having the sensor device 90 in order to be detected by sensors, e.g.for monitoring the (multiplex) infusion system and / or for determining laboratory data on patient blood. The fluid volume unit V1 to V6 (Figures 3a to 6e) supplied for sensor detection / analysis can thus relate to at least one of the several medical fluids FS; F1, F2,... Fn and / or an aspirated blood bolus.

[0143] Optionally, the catheter 2 can have an injection port 20, as shown schematically in a highly simplified block based on the first embodiment according to Fig. 1. The injection port 20 functions as a type of fluid connector and is fluidically connected to the at least one lumen 4. The injection port 20 serves to quickly and easily supply a specific medical fluid to the patient P via the injection port 20. In the present case, the injection port 20 is arranged at the distal end 16. However, the injection port 20 can be arranged further towards the proximal end 15.

[0144] Fig. 2 shows a schematic, highly simplified sectional view of a detailed section of a single-lumen catheter tube 10 of a catheter 2 (as in particular according to Fig. 1 ) during the conveyance of several medical fluids / liquids along the positive flow direction SR-plus (regular operation). As already mentioned above, Fig. 2 also illustrates the basic principle of multiplex infusion (regular operation). In the catheter tube 10, individual doses, in particular microdoses, of the several medical fluids FS; F1, F2,...Fn are shown with the positive (main) flow direction SR-plus. The several medical fluids FS; F1, F2,...Fn flow in the positive (main) flow direction SR-plus through the lumen 4 defined by the tube wall 11. In Fig.Figure 2 shows, by way of example, that, on the one hand, individual doses of the medical fluids F2, F4 are conveyed one after the other / sequentially in the positive (main) flow direction SR-plus. On the other hand, (further) individual doses of the medical fluids F2 plus F3 or F3 plus Fn are conveyed simultaneously as combined doses, in particular mixed with one another. Incompatible (combined) doses of the multiple medical fluids FS; F1, F2,...Fn are separated by doses of the separation fluid and / or rinsing fluid FS (see above for Figure 1).

[0145] For an understanding of the following description with regard to the further aspects or the second to third embodiments concerning different (automated) interim operations according to Figures 3a to 3e (first interim operation); or according to Figures 4a.1 to 4c.1 / Figures 4a.2 to 4c.2 (second interim operation in two variants); or according to Figures 5a to 5e (third interim operation); or according to Figures 6a to 6e (fourth interim operation), reference is made to the disclosure presented with reference to Figures 1 and 2, i.e. to avoid repetition, but not limiting with regard to individual (optional) features. In other words, the above disclosure is used as a basis unless explicit deviations are highlighted.

[0146] In the second to fifth embodiments (for or during the first to fourth interim operation) of an extracorporeal multiplex infusion system according to the disclosure, according to Figures 3a to 6e, the multiplex unit 1 has, as the plurality of (micro)pumps XS; X-2, X-3,...Xn, a first micropump XS for conveying a first medical fluid FS (cf. Fig. 2), a second micropump X-2 for conveying a second medical fluid F2 (cf. Fig. 2), a third micropump X-3 for conveying a third medical fluid F3 (cf. Fig. 2), and a fourth (or n-th) micropump Xn for conveying a fourth (or n-th) medical fluid Fn (cf. Fig. 2). The first medical fluid FS (cf. Fig.2) has a first volume unit V1, which, based on its flow path, as depicted by the chronological sequence of the corresponding figures, also illustrates a (fluid-guided and controlled) flow behavior of the first medical liquid FS through the multiplex infusion device, in particular (initially) through the first fluid line LS. The first medical liquid FS (cf. Fig. 2) has a first volume unit V1, which, based on its flow path, as depicted by the chronological sequence of the corresponding figures, also illustrates a (fluid-guided and controlled) flow behavior of the first medical liquid FS through the multiplex infusion device, in particular (initially) through the first fluid line LS. The second / third / fourth (or n-th) medical liquid F2 / F31 Fn (cf. Fig.2) has a second / third / fourth volume unit V2 / V3 / V4, which, based on its flow path, as depicted by the chronological sequence of the corresponding figures, also illustrates a (fluid-guided and controlled) flow behavior of the second / third / fourth medical fluid F2 / F3 / Fn through the multiplex infusion device, in particular (initially) through the second / third / fourth fluid line L-2 / L-3 / Ln. In turn, a fifth / sixth volume unit V5 / V6 associated with (at least one) lumen 4 of the catheter 2, based on its flow path or standstill at a position, as depicted by the chronological sequence of the corresponding figures, represents a further (fluid-guided and controlled) flow behavior in the lumen 4 of the catheter 2 and optionally through the multiplex unit 1.

[0147] The control device 110 (see Figures 1 and 9) is configured to control the respective delivery rates of the fluid volume flows through each of the multiple (micro)pumps XS; X-2, X-3,...Xn and / or the respective timing of the multiple (micro)pumps XS; X-2, X-3,...Xn. The control of a respective one, in particular all, of the multiple (micro)pumps XS; X-2, X-3,...Xn can preferably be carried out as a function of a predetermined total delivery rate.

[0148] In this case, the total flow rate is the sum of the flow rates or fluid volume flows of all or the individual (active) micropumps XS; X-2, X-3,...Xn.

[0149] In the second to fifth embodiments (for or during the first to fourth interim operation), according to Figures 3a to 6e, of an extracorporeal multiplex infusion system according to the disclosure, a first medical fluid from the different medical fluids F1, F2,...Fn is an (optional) separation fluid and / or rinsing fluid FS, such as a saline solution. The (optional) separation fluid and / or rinsing fluid FS flows in an associated fluid line LS for the separation fluid and / or rinsing fluid FS. An associated (micro)pump XS for the separation fluid and / or rinsing fluid FS is provided as a source flow device QS for the separation fluid and / or rinsing fluid FS, preferably at a proximal (in particular most proximal) end of the multiplex unit 1 or the catheter 2 (in Figures 3a to 6e on the left in the image).In the present case, the control device is configured to control the first, second, and third micropumps XS; X-2, X-3 in such a way that second doses and / or volume units V2 of the second medical fluid and third doses and / or volume units V3 of the third medical fluid can be conveyed successively through the at least one lumen 4 by means of the separation fluid and / or rinsing fluid FS compatible with both (having first volume units V1), spatially separated in time multiplex (cf. Fig. 2).

[0150] The (micro)pump XS or the source flow device QS for the separation fluid and / or rinsing fluid FS is provided and configured to convey or allow the separation fluid and / or rinsing fluid FS to flow in an associated positive flow direction SR-plus (in an ON state; ie when appropriately controlled by a control device not shown, see Figures 1 and 9, with reference number 110). This is the case or this ON state is present in Figures 3c to 3e (in a second switching mode S200); or in Figures 4a.1 to 4c.1 / 4a.2 to 4c.2 (in a third switching mode S300 or S300' according to two variants); or Figures 5a to 5e (in a fourth switching mode S400); and Figures 6b, 6c (in a fifth switching mode S500) and Figure 6e (in a seventh switching mode S700). In other words, the control device is configured to operate during the first to fourth interim modes of operation, respectively.during the different interim operations for a corresponding switching mode, to determine at least the specific (micro) pump XS from the plurality of valves and / or conveying devices as the specific source flow device QS in the associated source fluid line and to control it (depending on the switching mode) in order to convey the separation fluid and / or rinsing fluid FS with the associated positive flow direction SR-plus through the associated source fluid line.

[0151] In particular, (generally) switching can be carried out from a zeroth switching mode (initial state) to the first switching mode S100 (i.e., the first-switched switching mode of the first interim operation) or to the third switching mode S300, S300' (i.e., the first-switched switching mode of the second interim operation) or to the fourth switching mode S400 (i.e., the first-switched switching mode of the third interim operation) or to the fifth switching mode S500 (i.e., the first-switched switching mode of the fourth interim operation). In general, the zeroth switching mode can relate to a control mode or a further / different interim operation or an OFF state (standstill) of the extracorporeal multiplex infusion system according to the disclosure.

[0152] With regard to the illustration in Figures 3a to 6e, a stop / standstill / off state (delivery rate or fluid volume flow equal to zero) of each of the multiple (micro)pumps XS to Xn is indicated by a circled minus sign symbol next to it. Additionally, said off state of each of the multiple (micro)pumps XS to Xn is represented by a cross symbol within the circular symbol representing them.

[0153] In contrast, with regard to the representation also in Figures 3a to 6e, but also in Figures 8a to 8c, a respective conveying direction or a (qualitative) direction of a flow through a respective one of the several (micro) pumps XS to Xn or the selected reverse flow device R in a respective ON state (delivery rate greater than zero) is shown using a known pump symbol (circle symbol with inner triangle, the tip of which points in the conveying direction).

[0154] This representation is intended to be symbolic; and it is irrelevant for the purposes of interim operations whether a controllable valve is present instead of a (micro) pump / conveying device.

[0155] With regard to the representation in Figures 3a to 6e, it should be noted that flow vectors or streamlines of respective volume units V1 to V6 are displayed in a generally known manner with small symbol arrows.

[0156] Figures 3a to 3e show a temporal sequence of respective flow states of (first to sixth) fluid volume units V1 to V6, as they are controlled by a second embodiment of a multiplex infusion system 100 according to the disclosure in a partial sectional view (balance envelope) by means of a first switching mode S100 and a second switching mode S200. Figures 3a to 3e illustrate the functioning of a first interim operation for the central venous aspiration of a blood bolus V5, V6 into the catheter 2. The blood bolus V5, V6 is initially (not shown) aspirated from a distal catheter tip applied to a patient (cf. reference numeral 13 in Figure 1) through an exit / entry opening (cf. reference numeral 12 in Figure 1) at the distal end (cf. reference numeral 16 in Figure 1) into the at least one lumen 4 (and / or optionally into a second lumen, preferably designated for aspiration, cf.in Figures 7, 8a to 8c with reference number 5).

[0157] In the second embodiment or in the first interim operation for the automated aspiration of the patient's blood, the control device (see reference numeral 110 in Figures 1 and 9) is provided and configured to initiate / execute / switch the first switching mode S100 and subsequently a second switching mode S200 for aspiration. The respective (positive and / or negative) delivery rates between the first switching mode S100 and subsequently the second switching mode S200 can optionally vary or be identical.

[0158] In the first switching mode S100 or in the second switching mode S200 for aspiration, the control device is configured to control the most distal (micro)pump X-n from the plurality of valves and / or delivery devices XS; X-2, X-3,...Xn as the selected reverse flow device R, as can be seen from Figures 3a, 3b or Figures 3c to 3e.

[0159] The first switching mode S100 or the reverse flow device R selected therein causes the blood bolus V5 aspirated into the lumen 4 (or 5) at the distal end of the catheter as the (fifth) fluid volume unit associated with the selected reverse flow device R to now flow via the lumen 4 through the selected reverse flow fluid line LR with the associated reverse flow direction SR-minus or to be delivered at a negative delivery rate of the selected reverse flow device R associated with the first switching mode S100.

[0160] In this case, the control device, likewise in the first switching mode S100 for aspiration, is further configured to pause or stop the source flow device QS (=XS) to temporarily stop the flow of the separation fluid and / or rinsing fluid FS. In other words, a (positive) flow rate of the source flow device associated with the first switching mode S100 is zero.

[0161] In this case, the control device, likewise in the first switching mode S100 for aspiration, is further configured to also stop all of the other multiple X-2, X-3 lines to stop the other different medical fluids. In other words, none of the fluid lines LS, L-2, L3 are (positively) flowing. In other words, with respect to all existing micropumps XS to Xn, only the selected reverse flow device R is operating or conveying, or is in the ON state, or is flowing through.

[0162] In Figures 3a and 3b, the off state (flow rate or fluid volume flow equal to zero) of the micropumps XS (= QS), X-2, and X-3 (in the first switching mode S100) is represented by the circled minus symbols next to them and the cross symbols. The volume units V1 to V3 (from medical fluids) in the three associated fluid lines LS, L-2, and L-3 thus remain stationary.

[0163] As can be seen from Figures 3a and 3b regarding the first switching mode S100, flow only occurs in the right-hand image area (distal). Thus, the volume unit V5 (the aspirated blood bolus) flows from the lumen 4 of the catheter 2 from distal to proximal, in order to flow over or through the distal(est) micropump Xn as the selected reverse flow device R in the ON state (negative flow rate). In other words, the selected reverse flow device R functions to aspirate the volume unit V5 as the aspirated blood bolus into the at least one lumen 4 of the catheter 2; and then to entrain the volume unit V5 as the aspirated blood bolus with the (continuous) reverse flow induced in the lumen 4 (or 5). and then to transport the volume unit V5 as the aspirated blood bolus further into the selected reverse flow fluid line LR (and if necessary further out of this, e.g.toward a fluid sink). Like the volume unit V4, the subsequent volume unit V5 (the aspirated blood bolus) leaves the balance envelope shown in Figures 3a to 3e. Flowing through the selected reverse flow fluid line LR (=Ln), the volume unit V5 (the aspirated blood bolus) passes an (optional) sensor device 90 for an (optional) sensory measurement such as a blood gas analysis. The volume unit V5 (the aspirated blood bolus) can then be transported, for example, to a fluid sink such as a waste container.

[0164] In the first switching mode S100, an inlet fluid volume flow into the at least one (first and / or second) lumen 4 of the catheter 2 is balanced to an outlet fluid volume flow from the selected reverse flow fluid line LR. Also, in the first switching mode S100, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen 4 of the catheter 2 is balanced to a (negative) delivery rate of the selected reverse flow device R.

[0165] In the first interim operation, the control device is further configured, following the first switching mode S100 for aspiration, in a second switching mode S200 for aspiration, see Figures 3c to 3e, to activate the source flow device QS (= XS) in order to convey the separation fluid and / or rinsing fluid FS first through the source fluid line with the associated positive flow direction SR-plus and further downstream through the selected reverse flow fluid line LR (= Xn).

[0166] In particular, in the second switching mode S200 for automated aspiration, a first source flow rate of the source flow device QS (=XS) with the associated positive flow direction SR-plus can be substantially equal to a first sink flow rate of the selected reverse flow device R with the associated reverse flow direction SR-minus. This, on the one hand, causes further transport of the blood bolus V5 for sensory measurement by displacement by inflowing fluid. On the other hand, this (simultaneously) causes a standstill of a (sixth) fluid volume unit V6 associated with the at least one lumen 4. This can be seen by way of example in Figures 3c to 3e. In other words, the flow in the (at least one) lumen 4 of the catheter 2 has (temporarily) come to a standstill or is no longer flowing from proximal to distal. Accordingly, the volume unit V6 corresponding to lumen 4 remains in lumen 4.In other words, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen 4 of the catheter 2 is (virtually) zero. In other words, in the second switching mode S200 in the illustrated Figures 3c to 3e, the total flow rate (distally through the lumen 4) as the sum of the (positive) first source flow rate of the active source flow device QS (=XS) and the (negative) first sink flow rate of the (active) selected reverse flow device R is zero.

[0167] From the sequence of Figures 3c to 3e, with reference to Figure 3b showing the previous flow state / first switching mode S100, a flow path of the first fluid volume unit V1 can be seen. In Figure 3b (first switching mode S100), the first fluid volume unit V1 of the separation or flushing fluid FS is stationary in the fluid line LS for the separation or flushing fluid FS, specifically upstream (relative to a nominal positive flow direction SR-plus, i.e., on the side facing away from the catheter) of the source flow device QS (=XS), which is still in the OFF state or inactive or blocked. As can be seen from Fig. 3c for the subsequent second switching mode S200, the source current device QS (=XS) is / will be set to the ON state or switched on (e.g., pump) or active or opened (e.g., valve). By switching on or activating or deactivatingWhen the source flow device QS (=XS) is opened, the first fluid volume unit V1 of the separation or rinsing fluid FS flows at the first source flow rate of the source flow device QS (=XS) with the associated positive flow direction SR-plus (distal). The first fluid volume unit V1 of the separation or rinsing fluid FS initially passes through the source flow device QS (=XS) along its flow path in the second switching mode S200, see Fig. 3c. Then, in the second switching mode S200, the first fluid volume unit V1 of the separation or rinsing fluid FS flows further along its flow path, indicated by small arrows, in the direction of the selected reverse flow fluid line LR (=X-n), see Fig. 3c. Then, the first fluid volume unit V1 of the separation or rinsing fluid FS passes the selected reverse flow device R with the first sink flow rate with the associated reverse flow direction SR-minus, see Fig. 3d.At the same time, a comparison of Figures 3b to 3e shows that the sixth fluid volume unit V6 in the (at least one inner) lumen 4 of the catheter is stationary (i.e., fluid volume flow in the lumen 4 or catheter 2 is zero). The other (second and third) volume units V2 and V3 in the other fluid lines L-2 and L-3 are also stationary (flow rates / fluid volume flows are zero). This means that the balance condition (via the balance envelope) must apply to the flow in Figures 3c to 3d, according to which the first source flow rate of the source flow device QS (=XS) must be essentially equal to the first sink flow rate of the selected reverse flow device R.

[0168] The first source flow rate of the source flow device QS (=XS) with the associated positive flow direction SR-plus is equal to an outlet volume flow of the source flow device QS (=XS) emerging from the source flow device QS (=XS). The first sink delivery rate of the selected reverse flow device R with the associated reverse flow direction SR-minus is equal to an outlet volume flow of the selected reverse flow device R emerging from the selected reverse flow device R. In other words, in the second switching mode S200, the separation fluid and / or rinsing fluid FS or a (first) fluid volume unit thereof V1 flows through the multiplex unit 1, starting from the source fluid line LS, via the source flow device Q-S (= XS) into a selected reverse flow fluid line LR (= Ln) via the selected reverse flow device R.In particular, a uniform flow through the source flow device QS (=XS) and downstream of it the selected reverse flow device R takes place (i.e. optionally equal flow rates).

[0169] Figures 4a.1 to 4c.1 and Figures 4a.2 to 4c.2 show a temporal sequence of respective flow states of (first to fifth) fluid volume units V1 to V5, as they are controlled by a third embodiment of a multiplex infusion system 100 according to the disclosure (cf. Figures 1 and 9) in a partial sectional view (balance envelope) by means of a third switching mode S300 or S300'. Firstly, Figures 4a.1 to 4c.1 illustrate a functioning of a second interim operation for applying the catheter 2 and automated flushing or priming of the multiplex unit 1 (i.e. without catheter 2), in a first variant (S300) with regard to a flow through all (existing) fluid lines LS, L-2, L-3 up to the fluid line Ln as a selected reverse flow fluid line of the multiplex unit 1. In contrast, Figures 4a.2 to 4c.2 illustrate the functioning of the second interim operation (in a variant compared to Figures 4a.1 to 4c.1 modified second variant (S300') regarding a flow through only one of the fluid lines LS, L-2, L-3 in the positive flow direction).

[0170] In the third embodiment or in the second interim operation, the control device (cf. in Figures 1 and 9 with reference number 110) is provided and configured to select or provide a first medical fluid F1 from the different medical fluids F1, F2,...Fn as the separation fluid and / or rinsing fluid FS in order to use it as the optional rinsing fluid FS in the second interim operation.

[0171] In the third embodiment or in the second interim mode, the control device (cf. in Figures 1 and 9 with reference numeral 110) is provided and configured to effect / execute / switch a third switching mode S300 or S300' for applying the catheter 2 and automated flushing or priming of the multiplex unit 1 as the second interim mode. In the third switching mode S300 or S300', the control device is configured for, in particular, initial flushing of the multiplex unit 1, to control at least one, in particular distal (micro)pump Xn from the plurality of micropumps XS; X-2, X-3,...Xn as the at least one selected reverse flow device R with a respective second sink delivery rate (or with a respective sink fluid volume flow) in the associated reverse flow direction SR-minus.

[0172] In this case, the control device is also configured in the third switching mode, during which the (micro)pump XS as the source flow device QS for the separation fluid and / or rinsing fluid FS is controlled with a second source flow rate (or with a second source fluid volume flow) of the separation fluid and / or rinsing fluid FS in the associated positive flow direction SR-plus, see Figures 4a.1 / 2 to 4c.1 / 2. In this case, the control device controls all other (micro)pumps X-2, X-3 as (at least) one of the several (micro)pumps XS; X-2, X-3,...Xn with respective third source flow rates (or with respective third source fluid volume flows) of the other of the different medical fluids F2, F3 in the associated positive flow direction SR-plus (on), see Figures 4a.1 to 4c.1 (first variant). Alternatively, the control device does not control any other (micro) pump from the multiple (micro) pumps XS; X-2, X-3,...Xn on or off.these are stopped or blocked for (positive and negative) flow, so that (respective) third source flow rates of the other F2, F3 of the different medical fluids FS (=F1) compared to the separation fluid and / or rinsing fluid FS; F2, F3 are equal to or set to zero, see Figures 4a.2 to 4c.2 (second variant). In other words, the first and the second variant, as illustrated by way of example in Figures 4a.1 / 2 to 4c.1 / 2, differ in one difference, which can be understood in particular from the time course for the second volume unit V2 and the third volume unit V3. On the one hand, in the first variant, all fluid volume units V1, V2, V3 pass through the respective associated micropumps XS (=QS), X2, X3 (proximal to distal) (active in the nominal positive flow direction SR-plus).On the other hand, in the second variant, only the first fluid volume unit V1 passes through the associated, single micropump XS (=QS) (active in the nominal positive flow direction SR-plus), namely in the nominal positive flow direction SR-plus (proximal to distal). Micropumps X-2 and X-3 are stopped / at a standstill / in an off state (flow rate or fluid volume flow equals zero), as can be seen from the unchanged positions of the stationary second and third volume units V2 and V3 in Figures 4a.2 to 4c.2.

[0173] In this case, a first total source delivery rate can be (essentially) equal to a first total sink delivery rate, which in the third embodiment corresponds to or is equal to the second sink delivery rate (in this respect, only a single micropump Xn is selected as the reverse flow device R). In the first variant (Figures 4a.1 to 4c.1) of the third embodiment, the first total source delivery rate is composed of the sum of the second source delivery rate (i.e. fluid volume flow of separation fluid and / or rinsing fluid FS in the fluid line LS represented by volume unit V1) and the two third source delivery rates (i.e. fluid volume flows in the fluid lines L-2 and L-3 represented by volume units V2 and V3 respectively). In the second variant (Figures 4a.2 to 4c.2) of the third embodiment, the first total source flow rate corresponds to or is equal to the second source flow rate (iefluid volume flow of separation fluid and / or rinsing fluid FS in the fluid line LS represented by volume unit V1); in this respect, the two third source flow rates (i.e. fluid volume flows in the fluid lines L-2 and L-3 represented by volume units V2 and V3 respectively) are equal to zero and thus do not contribute as a term to the sum.

[0174] This causes a, in particular initial, flushing of the multiplex unit 1 with the separation fluid and / or flushing fluid FS. In other words, the separation fluid and / or flushing fluid FS does not flow distally into the lumen 4 of the catheter 2 (as in particular during normal operation / during multiplexing). Instead, the separation fluid and / or flushing fluid FS is diverted or sucked off to the (active) selected reverse flow device R (= Xn) as a (fluid) sink, in particular due to a flow pressure prevailing upstream thereof / on the side of the reverse flow device R (= Xn) or pump suction side facing the catheter 2. This flow behavior or flow redirection can be recognized by the fact that the first volume unit V1 flows from a position upstream of the source flow device QS (= XS) (shown top left in Fig. 4a.1 / 2) to distal, then passes through the source flow device QS (= XS) (Fig. 4b.1 / 2) and then turns into the selected reverse flow fluid line LR to pass the selected reverse flow device R (=Xn), e.g. in the direction of a fluid sink or also circulating.

[0175] At the same time, the (essential) equality of the first total source flow rate and the first total sink flow rate causes the fifth fluid volume unit V5 associated with the at least one lumen 4 to come to a standstill at the same position throughout the temporal sequence of Figures 4a.1 / 2 to 4c.1 / 2. In other words, the flow in the (at least one) lumen 4 of the catheter 2 has (temporarily) come to a standstill or does not flow further from proximal to distal. Accordingly, the volume unit V6 associated with the lumen 4 remains in the lumen 4. In other words, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen 4 of the catheter 2 is (virtually) zero. In other words, in the first variant of the third switching mode S300 in the shown Figures 4a.1 to 4c.1 , the total delivery rate (distal through the lumen 4) as the sum composed on the one hand of the (positive) first total source delivery rate of the active micropumps QS (— XS), X-2, X-3 and on the other hand of the (negative) first total sink delivery rate of the (active) selected reverse flow device R is equal to zero. Alternatively, in the second variant, in the third switching mode S300' in the figures 4a.2 to 4c.2 shown, the total delivery rate (distal through the lumen 4) as the sum of the (positive) second source delivery rate (only) of the active source flow device QS (= XS) and the (negative) second sink delivery rate of the (active) selected reverse flow device R is equal to zero.

[0176] In other words, as can be seen from Figures 4a.2 to 4c.2, in the third switching mode S300', the most distal or catheter-near (micro) pump Xn of the fluid line Ln to be flushed is, for example, switched to a reverse Zreverse mode. The (micro) pump QS (= XS) for conveying a separation Zflushing solution as the separation fluid and / or flushing fluid FS conveys the same amount of fluid. This serves to create a circulation or circuit of flushing solution to an associated (not shown) medication container. Since both fluid volume flows / flow rates are equal, the other distal / catheter-near micro pumps stop / do not convey, and no fluid is conveyed through the catheter distally (towards the patient) or from distally (towards the patient).Alternatively, in the third switching mode S300, S300', several additional (micro)pumps XS; X-2, X-3 with respective fluid connections to the associated medication container can be operated simultaneously in reverse for flushing as selected reverse flow devices R, R,... In this case, a flow rate of the most distal or catheter-near (micro)pump Xn must be adjusted accordingly to maintain the aforementioned (fluid) balance conditions.

[0177] Figures 5a to 5e show a temporal sequence of respective flow states of (first to sixth) fluid volume units V1 to V6, as controlled by a fourth embodiment of a multiplex infusion system 100 according to the disclosure (see Figures 1 and 9) in a partial sectional view (balance envelope) using a fourth switching mode. Figures 5a to 5e illustrate a functional mode of a third interim mode for applying catheter 2 and automated flushing or priming of the multiplex unit 1 and superimposed on the catheter 2.

[0178] To a certain extent, the third interim operation with a fourth switching mode S400 according to the fourth embodiment (Figures 5a to 5e in particular) can be considered a modification of the second interim operation with the third switching mode S300 in the first variant (cf. Figures 4a.1 to 4c.1). To avoid repetition, reference is also made analogously to the relevant description of the figures, with the exception of the disclosed differences. However, the modification in question is not limited to one of the first variants, and a modification of the second variant of the third switching mode S300 is also conceivable.

[0179] In the fourth embodiment or in the third interim operation, the control device (cf. in Figures 1 and 9 with reference number 110) is provided and configured to select or provide a first medical fluid F1 from the different medical fluids F1, F2,...Fn as the separation fluid and / or rinsing fluid FS in order to use it as the optional rinsing fluid FS in the third interim operation.

[0180] In the fourth embodiment or in the third interim mode, the control device (cf. in Figures 1 and 9 with reference numeral 110) is provided and configured to effect / execute / switch the fourth switching mode S400. In the fourth switching mode S400 according to the fourth embodiment, the control device controls / regulates a distal (micro)pump Xn from the plurality of (micro)pumps XS; X-2, X-3,...Xn as a selected reverse flow device R (= Xn) with an associated third sink delivery rate in the associated reverse flow direction SR-minus, as shown in Figures 5a to 5e.

[0181] Meanwhile, also in the fourth switching mode S400, the control device controls / regulates the source flow device QS with a fourth source flow rate of the (separation fluid and / or) rinsing fluid FS in the associated positive flow direction SR-plus and all other X-2, X-3 from the plurality of (micro-lumps XS; X-2, X-3,...Xn) with respective fifth source flow rates regarding other medical fluids in the associated positive flow direction SR-plus.

[0182] In (balance) difference to the second interim operation with the third switching mode S300 in the first variant (see Figures 4a.1 to 4c.1), the following applies / prevails in the third interim operation with the fourth switching mode S400 according to the fourth embodiment (Figures 5a to in particular 5e): A second (active) total source production rate is smaller in amount than a second (active) total sink production rate. In other words, the second total sink production rate exceeds the second total source production rate, in particular significantly, for example by a factor greater than or equal to 1.1, in particular greater than or equal to 2. The second total source production rate is set, analogously to the balance or definition of the first total source production rate in the first variant (Figures 4a.1 to 4c.1) according to the third embodiment, as the sum of the fourth (analogous: second) source production rate (iefluid volume flow (separation fluid and / or rinsing fluid FS in the fluid line LS) represented by volume unit V1 and the two fifth (analogous: third) source flow rates (i.e. fluid volume flows in the fluid lines L-2 and L-3 represented by volume units V2 and V3 respectively). According to the fourth embodiment, the second (analogous: first) total sink flow rate, which is defined as the sum of the third sink flow rates, is equal to / identical to the third sink flow rate (in this respect, only a single micropump Xn is selected as the reverse flow device R). In principle, it is conceivable that the third sink flow rate is controlled / regulated in a constant and / or increasing and / or decreasing manner in the chronological sequence along Figures 5a to 5e, based on various time segments, as long as the aforementioned balance condition is met according to the fourth embodiment shown.

[0183] In other words, a first partial fluid volume flow (represented as first, second, third volume units V1, V2, V3), which is composed downstream of the source flow device QS (= XS) (fourth source flow rate of the (separation fluid and / or) rinsing fluid FS in the associated positive flow direction SR-plus) and downstream of all other (micro-lumps X-2, X-3 (respective fifth source flow rates of the other medical fluids in the associated positive flow direction SR-plus, ie from proximal to distal), and a second partial fluid volume flow (represented as fifth volume unit V5), which is an outlet volume flow from the at least one lumen 4 of catheter 2 (ie from distal to proximal, see arrows in Fig.5b) to form a total reverse fluid volume flow in the reverse flow direction SR-minus (second total sink flow rate, in particular third sink flow rate). In other words, the total reverse fluid volume flow (V1-V3, V5) composed of the first partial flow and the second partial flow flows through the (at least one) selected reverse flow device R in the reverse flow direction SR-minus (Figures 5c to 5e). This displaces the fourth fluid volume unit V4, which is located in the (fourth / n-th) fluid line or the selected reverse flow fluid line LR (in the reverse flow direction SR-minus) downstream of the selected reverse flow device (see Fig. 5b to Fig. 5a), out of the latter, in particular towards the fluid sink such as a waste container.

[0184] At the same time, said flow condition according to the fourth embodiment, according to which the second total sink flow rate exceeds the second total source flow rate, advantageously causes flushing of the multiplex unit 1 and, at the same time / in a superimposed manner, also flushing or a (passive) flow through the (at least one) lumen 4 of the catheter 2. In other words, a (fluid) standstill in the lumen 4 is not caused, as in the third embodiment. In other words, a (passive) outlet fluid volume flow from / out of the at least one (first and / or second) lumen 4 of the catheter 2 is (significantly) greater than zero, as illustrated by the fifth fluid volume unit V5 (initially) associated with the lumen 4 in the chronological sequence of Figures 5a to 5d. Thus, initially (see Figure 5a), the fifth and sixth fluid volume units V5, V6 belonging to lumen 4 (initially) move passively, so to speak, i.e. due to the suction / negative pressure effect of the respectiveat the reverse flow device R (= Xn) into the lumen 4 or in the lumen 4 from distal to proximal. As illustrated in Figures 5b and 5c, the fifth fluid volume unit V5 turns at the three-way point from the lumen 4 into the selected reverse flow fluid line LR to pass through the selected reverse flow device R.

[0185] In particular, during the third interim operation, the control device can control / regulate in order to switch from the fourth switching mode S400 of the third interim operation (Figures 5a to in particular 5e), in particular immediately in time, to the third switching mode S300 or S300' of the second interim operation (cf. Figures 4a.1 / 2 to 4c.1 / 2), in particular to an advantageous circulating flush within the multiplex unit 1. In other words, the control device controls / regulates a fluid volume flow in the lumen 4 from a value (significantly) greater than zero (for backflow in the lumen 4 in the fourth switching mode S400) to a value (virtually) equal to zero (no flow / standstill in the lumen 4 in the third switching mode S300 or S300').

[0186] Figures 6a to 6e show a temporal sequence of respective flow states of (first to fifth) fluid volume units V1 to V5, as controlled by a fifth embodiment of a multiplex infusion system 100 according to the disclosure (cf. Figures 1 and 9) in a partial sectional view (balance envelope) using a fifth to seventh switching mode. Figures 6a to 6e illustrate a mode of operation of a fourth interim operation for interim operation after a change of a fluid container with a fluid to be refilled from the different medical fluids FS; F2, Fn (cf. Figure 2) with automated backflushing into the fluid container. The (at least one) fluid container can be designed as an infusion bag (cf. reference numeral 70 in Figure 9) and / or as a fluid cartridge (cf. reference numeral 81 in Figure 9).

[0187] In the fifth embodiment or in the fourth interim operation, the control device (cf. in Figures 1 and 9 with reference number 110) is provided and configured to effect / execute / switch, starting from the control operation and / or an (optional) zeroth switching mode S000 (Fig. 6a) for the change of the fluid container, a fifth switching mode S500 (Figs. 6b, 6c), subsequently a sixth switching mode S600 (Fig. 6d) and further subsequently a seventh switching mode S700 (Fig. 6e) for the interim operation after the change of the fluid container.

[0188] As shown in Fig. 6a for the (optional) zeroth switching mode S000, in an initial state, the fluid volume units V1 to V4 associated with the first to fourth (n-th) fluid lines LS; L2, ... Ln can be located upstream of the first to fourth (n-th) (micro)pumps XS; X-2,... , Xn, respectively. The term "upstream" refers to a side facing away from the catheter 2 or to a position prior to a (hypothetical or nominal) flow / passage through the respective first to fourth (n-th) (micro)pumps XS; X-2,... , Xn in the nominal positive flow direction SR-plus (defined on the basis of the control operation from proximal to distal).

[0189] In particular, the first fluid line LS can be configured or provided to supply and / or feed an additional / exclusive separation fluid FS and / or rinsing fluid FS. Regarding the disclosed definition of the term "additional / exclusive separation fluid and / or rinsing fluid," reference is made generally and to avoid repetition to the relevant disclosure in connection with the second and third interim operation.

[0190] In the zeroth switching mode S000, a (empty or running low) fluid container can be replaced with a fluid to be refilled from the different medical fluids and / or the separation fluid and / or the rinsing fluid.

[0191] In the fifth embodiment or in the fourth interim operation, the control device controls / regulates (after the zeroth switching mode S000 in the fifth switching mode S500 (Figures 6b, 6c) at least one XS from the plurality of (micro)pumps XS; X-2, X-3,...Xn as a first specific source flow device Q-S1 with a fifth source flow rate of the separation fluid and / or rinsing fluid FS in the associated positive flow direction SR-plus. In this case, the control device, likewise in the fifth switching mode S500, is configured to control another X-2 from the plurality of (micro)pumps XS; X-2, X-3,...Xn as a first selected reverse flow device R1 with a fourth sink flow rate of the separation fluid and / or rinsing fluid FS in the associated reverse flow direction (SR-minus); and (simultaneously) all other X-3, Xn from the several (microlumps XS; X-2, X-3, ...Xn to stop or block the other of the different medical fluids (represented by the third and fourth fluid volume units V3, V4) until the flow of the other fluids is stopped. In particular, the fifth source flow rate can be (essentially) equal to the fourth sink flow rate (see also the second variant of the second interim operation, as illustrated in Figures 4a.2 to 4c.2). The fifth switching mode advantageously serves to effect, when a fluid volume unit V5 associated with the at least one lumen 4 is at a standstill, a delivery of the separation fluid and / or rinsing fluid FS from the first specific source flow device Q-S1 (= XS) to collect the fluid volume units V1, V2 associated with the first selected reverse flow device R1 (Figures 6b, 6c).

[0192] In the fifth embodiment or in the fourth interim operation, the control device is further configured, following (to the fifth switching mode S500) in the sixth switching mode S600 (Fig. 6d) for changing the fluid container, to switch the other X-2 from the plurality of (micro)pumps XS; X-2, X-3,... Xn as the first selected reversing flow device R1 (= X-2) for reversing the flow direction (ie from SR-minus in Fig. 6c to SR-plus in Fig. 6d). In other words, when switching between the fifth switching mode S500 (Fig. 6c) and the sixth switching mode S600 (Fig. 6d), the first selected reversing flow device R1 (= X-2) is controlled by the control device in such a way that its reversing flow direction SR-minus is reversed back into an opposite (nominal) positive flow direction SR-plus.

[0193] In the course of this, the control device switches to this (i.e. the other X-2) instead of the first specific source flow device Q-S1 as a second specific source flow device Q-S2 (= X-2) with a sixth source delivery rate of the separation fluid and / or rinsing fluid FS in the associated positive flow direction SR-plus. In this case, the control device is also set up in the sixth switching mode S600, while yet another, in Fig. 6d the most distal (micro)pump Xn from the plurality of (micro)pumps XS; X-2, X-3, ...Xn as a second selected reverse flow device R2 (= Xn) with a fifth sink delivery rate of the separation fluid and / or rinsing fluid FS in the associated reverse flow direction SR-minus and all other XS, X-3 from the plurality of (micro)pumps XS; X-2, X-3,... Xn to stop the other of the different medical fluids, as can be seen from the volume units V6 (FS) and V3.In particular, the sixth source delivery rate can be substantially equal to the fifth sink delivery rate (compare also the second variant of the second interim operation, as illustrated in Figures 4a.2 to 4c.2). The sixth switching mode S600 advantageously serves to effect a removal of the fluid volume units V1, V2 of the separation fluid and / or rinsing fluid FS belonging to the first selected reverse flow device R1 when a fluid volume unit V5 belonging to the at least one lumen 4 is at a standstill. This can be seen from Fig. 6d (in comparison to Fig. 6c above), in particular based on the passage of V1, V2 from X-2 in the direction of the second selected reverse flow device R2 (= Xn).

[0194] In the fifth embodiment or in the fourth interim operation to the interim operation after a change of the fluid container, the control device is further configured, subsequently (to the sixth switching mode S600) in the seventh switching mode S700 (Fig. 6e) of the fourth interim operation, to stop / block the other X-2 from the plurality of (micro)pumps XS; X-2, X-3,... Xn as the second specific source flow device Q-S2 (= X-2) and instead of this (i.e. instead of Q-S2 = X-2) to switch back to the first specific source flow device Q-S1 (= XS) with a seventh source delivery rate of the separation fluid and / or rinsing fluid FS in the associated positive flow direction SR-plus. The control device is also set up in the seventh switching mode S700, while the other (distal) (micro-)pump Xn from the several (micro-lumps XS; X-2, X-3, ...Xn is to be maintained as the second selected reverse flow device R2 (=Xn) and controlled with a sixth sink flow rate of the separation fluid and / or rinsing fluid FS in the associated reverse flow direction SR-minus. The control device, also in the seventh switching mode S700, is configured to stop all other X-2, X-3 from the plurality of (micro-lumps XS; X-2, X-3,...Xn) to the standstill of the other different medical fluids, as can be seen from the volume units V2 and V3. In particular, the seventh source flow rate can be substantially equal to the sixth sink flow rate (compare also the second variant of the second interim operation, as illustrated in Figures 4a.2 to 4c.2).The seventh switching mode S700 advantageously serves to effect further conveyance of the separation fluid and / or rinsing fluid FS when a fluid volume unit V5 associated with the at least one lumen 4 is at a standstill, as can be seen from the volume units V1 and V6 in Fig. 6e (compared to Fig. 6d above).

[0195] In other words, during the fourth interim operation, over the period from the fifth to seventh switching modes S500 - S700, the flow in the (at least one) lumen 4 of the catheter 2 is stagnant, or the (fifth) fluid volume unit V5 associated with the lumen 4 does not flow from proximal to distal (or back from distal to proximal). Accordingly, the volume unit V5 associated with the lumen 4 remains in the lumen 4. In other words, a (passive) inlet fluid volume flow into the at least one (first and / or second) lumen 4 of the catheter 2 is (virtually) zero.

[0196] With regard to the sixth switching mode S600, it should be emphasized (for the functioning of the fourth interim operation) that the first specific source flow device Q-S1 (= XS), which was previously active, ie in the fifth switching mode S500, with the fifth source flow rate of the separation fluid and / or rinsing fluid FS, is stopped or blocked when switching to the sixth switching mode.

[0197] Overall, the fourth interim operation prior to this, i.e., in the zeroth switching mode S000, i.e., prior to the fifth switching mode S500, allows a change of the fluid container, which is provided and configured (on an associated fluid sink side) to supply the first specific source stream device Q-S1 (= XS) with the separation fluid and / or rinsing fluid FS. Furthermore, it is advantageous that the concomitant change to the second specific source stream device Q-S2 (= X-2) ensures a (virtually) uninterrupted supply of the separation fluid and / or rinsing fluid FS. This clever switching sequence can also prevent unnecessary waste of expensive separation fluid and / or rinsing fluid FS. In this respect, the fourth interim operation can serve a buffer / intermediate storage function inherent in the disclosed multiplex infusion device for the (internally recovered) separation fluid and / or rinsing fluid FS.

[0198] Fig. 7 shows a schematic, highly simplified sectional view of a double-lumen catheter tube for a sixth embodiment of a multiplex infusion system according to the disclosure as an alternative / modification to the single-lumen catheter tube according to Figures 1 and 2. The catheter tube 10 has at least one further (second) inner lumen 5. The further (second) inner lumen 5 extends parallel or coaxially to the at least one (first) inner lumen. Optionally, the (first) lumen 4 can have a (first) hydrophobic surface finish (or hydrophobic inner coating) and the further (second) lumen 5 can have a (second) lipophobic surface finish (or lipophobic inner coating), or vice versa.The (section-wise) (first) surface quality of the (first) lumen 4 is defined by a (section-wise) surface quality of a first inner wall 34 of the tube wall 11 of the catheter tube 10, said first inner wall delimiting this (first) lumen 4. The (section-wise) (second) surface quality of the further (second) lumen 5 is defined by a (section-wise) surface quality of a second inner wall 35 of the tube wall 11 of the catheter tube 10, said second inner wall delimiting this further (second) lumen 5.

[0199] Accordingly, according to an aspect which may be claimed independently, it is (generally) conceivable, according to the different (first or second) surface properties, i.e. the (at least one) hydrophobic (or vice versa: lipophobic) surface properties of the (at least one) (first) lumen 4 and the (at least one) lipophobic (or vice versa: hydrophobic) surface properties of the (at least one) (second) lumen 5, to use preferably different separation fluids as the respective (first or second) separation fluid and / or rinsing fluid associated with the respective (first or second) lumen 4, 5 or to pass them through the respective lumens 4, 5.

[0200] According to a further aspect, which may be claimed independently, it is (generally) conceivable to use different or different valves and / or conveying devices (in particular pumps) depending on the different (first or second) surface properties or lumens 4, 5 and / or depending on the different (first or second) separation fluids or rinsing fluids, in particular for the respective disposal of the (corresponding) separation fluid and / or rinsing fluid. This (generally preferred) device advantageously serves to keep a hydrophobic channel and a lipophilic channel completely separate, in particular to keep them separate up to the distal outlet.

[0201] In this case, according to a first interfacial physical aspect, which may optionally be claimed independently, or of such a first wetting configuration, it may be preferred that the respective surface quality of the (first or second) lumen belongs to the same wetting property category (i.e., hydrophobic on the one hand or lipophobic on the other hand) as a wetting property of the respective separation fluid and / or rinsing fluid [i.e., belonging to the respective (first or second) lumen 4, 5] (i.e., hydrophobic on the one hand or lipophobic on the other hand). In other words, the first wetting configuration relates to a wetting configuration. In other words, the separation fluid and / or rinsing fluid and the associated lumen or its surface quality each have the same wetting property category (i.e., both hydrophobic on the one hand or both lipophobic on the other hand). In this case, the respective (associated with the respective first or second) lumen 4, 5)second lumen 4, 5 associated) (first or second) separation fluid and / or rinsing fluid is designed or arranged to wet the associated lumen or its (inner) (at least in sections) surface condition.

[0202] Alternatively (or cumulatively: i.e., with more than two lumens, combined wetting configurations are generally conceivable) to the aforementioned first wetting configuration, it may be preferred, according to a second, optionally independently claimed, interface-physical aspect or such a second wetting configuration, that the respective surface quality of the (first or second) lumen belongs to a or the opposite wetting property category (i.e., hydrophobic on the one hand or lipophobic on the other hand) as a wetting property of the respective separation fluid and / or rinsing fluid [i.e., belonging to the respective (first or second) lumen 4, 5] (i.e., lipophobic on the one hand; or hydrophobic on the other hand). In other words, the second wetting configuration relates to a non-wetting wetting configuration. In other words, the separation fluid and / or rinsing fluid and the associated lumen orwhose surface properties exhibit a different or mutually opposing wetting property category (i.e., on the one hand, hydrophobic-lipophobic, i.e., hydrophobic fluid on a lipophobic surface; or, on the other hand, lipophobic-hydrophobic, i.e., lipophobic fluid on a hydrophobic surface). The respective (first or second) separation fluid and / or rinsing fluid (associated with the respective first or second lumen 4, 5) is designed or configured not to wet the associated lumen or its (inner) (at least in sections) surface properties.

[0203] The skilled person further understands that, in general, the internal conveying surface finish of a valve and / or a conveying device (especially a pump) preferably has the same wetting property categories as the associated lumen or its (at least partially) surface finish. However, this is not limiting.

[0204] According to Figures 8a to 8c, as an alternative to a single-lumen design of the catheter 2 with a first lumen 4 (with reference to Figure 1 and its description), a double-lumen design can be provided by additionally providing a second lumen 5 (with reference to Figure 7 and its description) for multiplex infusion in the catheter 2. In particular, Figure 8a, in a sectional view, illustrates the further aspect of the disclosure, which may be claimed independently, according to which the first lumen 4 and the second lumen 5 are fluidically connected within the (tubular) catheter 2. Figures 8a to 8c also illustrate the further aspect of the disclosure, which may be claimed independently, according to which the second (inner) lumen 5 in the catheter 2 forms a return channel as the selected reverse flow fluid line LR according to an aspect mentioned above in this regard, or is fluidically connectable to it.

[0205] Fig. 8a and further the modified embodiments according to Figs. 8b, 8c show that in the fluid lines Ln, LS, L-2 (by way of example and with reference to Figs. 1 and 9 as well as 3a to 6e) several respectively associated (micro)pumps Xn, XS, X-2 are arranged.

[0206] Figures 8a to 8c further illustrate fluid lines Ln, LS, L-2 (optionally) arranged integrally on the catheter 2. In other words, Figures 8a to 8c show a further aspect of the disclosure, which may be claimed independently, according to which, on the one hand, the tubular catheter 2 with the (at least) one lumen or optionally several (first and second) lumens 4, 5 and, on the other hand, the multiplex unit 1 with the several (micro)pumps XS; X-2, Xn can be optionally directly connected to one another, in particular integrally. According to Figures 8a to 8c, respective outlets AS; A-2, An of the several (micro)pumps XS; X-2, Xn (optionally) open directly into at least one or different ones of the several (first and second) lumens 4, 5.

[0207] In general (all figures), the catheter 2 may have an optional injection port (not shown), as already shown for the multiplex infusion device of Fig. 1 (reference numeral 20).

[0208] Fig. 8a shows a seventh embodiment of a multiplex infusion system according to the disclosure with a multiplex unit 1 and a catheter 2, as shown in a sectional view with a catheter 2 (or catheter tube 10) according to Figure ? that is designed to have two lumens due to at least one further / second inner lumen 5. Fig. 8a illustrates a return channel (as a selected reverse flow fluid line LR) integrated into the catheter 2 (or catheter tube 10) itself in the form of the further / second inner lumen 5. The tubular catheter 2 of Fig. 8a forms the (at least one) further / second lumen 5 by means of a partition wall 18 in parallel extension to the first lumen 4. In other words, the partition wall 18 divides an entire interior space of the catheter 2 into corresponding subspaces or lumens 4, 5. The first lumen 4 and the further / second lumen 5 are fluidically connected by means of a connecting opening 19 in the partition wall 18.The connecting opening 19 can penetrate the partition 18 at or near the distal end 16, as shown in Fig. 8a. It is also conceivable (not shown) for the partition 18 to be retracted inward relative to an outlet opening 12 of the catheter tube 10 in order to form the connecting opening 19 directly at the distal end 16 or directly at the outlet opening 12. In other words, the connecting opening 19 penetrates the partition 18 in a section of a distal catheter tip 13 of the catheter 2 arranged upstream of a distal outlet opening 12 with respect to the first lumen 4 or inside the catheter 2.

[0209] As illustrated in Fig. 8a, the further / second lumen 5 can coincide with the selected reverse flow fluid line LR (cf. Figs. 1, 3a to 6e). In Fig. 8a, the further / second lumen 5 coinciding with the selected reverse flow fluid line LR forms an upstream section of the selected reverse flow fluid line LR (with respect to the associated reverse flow direction SR-minus).

[0210] Accordingly, in Fig. 8a, the further / second lumen 5, which coincides with the selected reverse flow fluid line LR, is directly, in particular integrally, fluidically connected to the selected reverse flow fluid line LR, which coincides with the n-th fluid line Ln.

[0211] Fig. 8a thus illustrates a further aspect of the disclosure, which may be claimed independently, according to which, in particular, the further / second lumen 5 forms the selected reverse flow fluid line LR (directly) at the distal outlet opening 12 or at a distal(est) section of the distal catheter tip 13, in order to extend from there proximally or towards the multiplex unit 1. For example, it is conceivable that the control device is configured to divert the separation fluid and / or rinsing fluid (cf. Fig. 2 with reference symbol FS) or volume units associated therewith for return to the multiplex unit 1 from the at least one / first lumen 4 through the connecting opening 19 to an at least partial or complete fluid portion into the further / second lumen 5 as the selected reverse flow fluid line LR or to redirect / convey it back into the multiplex infusion device.This offers the advantage that the separation fluid and / or rinsing fluid can be made available to a patient for infusion in a reduced amount corresponding to the amount of fluid that is diverted / returned.

[0212] Fig. 8b shows an eighth embodiment of a multiplex infusion device according to the disclosure, modified from Fig. 8a and further from Figs. 1 and 9, shown in a side view. Fig. 8b illustrates a return channel arranged at a proximal end 15 of the catheter 2 at a further / second lumen 5 as a selected reverse flow fluid line LR.

[0213] Fig. 8c shows a ninth embodiment of a multiplex infusion device according to the disclosure, modified from Figs. 8a and 8b, and further from Figs. 1 and 9, shown in a side view. Fig. 8c illustrates a divided multiplex infusion device comprising, on the one hand, a (single-lumen or multi-lumen) catheter 2 and, on the other hand, a multiplex unit 1 as separately formed, connectable or connected components or units. In Fig. 8c, the catheter 2 and the multiplex unit 1 form fluid-connectable and / or fluid-connected units via a Luer-Lock connector 40.

[0214] By inserting the return channel from the catheter tip 13 (Fig. 8a) or the catheter 2 (Fig. 8a) or the catheter-near multiplex unit 1 (Fig. 8c), it is advantageously possible to prime or flush the catheter 2 fully automatically – both for preparing a catheter 2 to be inserted and for applying medication or changing medication. Furthermore, a blood bolus can advantageously be aspirated through this or another return channel in order to perform an automated blood analysis. Furthermore, the return channel can advantageously be used to remove a separation medium or the separation fluid or parts thereof.

[0215] Fig. 9 shows a highly simplified schematic representation of a tenth embodiment of a multiplex infusion system 100 according to the disclosure, comprising a control device 120. In particular, Fig. 9 illustrates, in a modification of the first embodiment discussed with reference to Fig. 1, further aspects of the disclosure, which may be claimed independently. In particular, such a further aspect relates to a unique fluid connection (which can optionally be detected automatically by a control device). In Fig. 9, a multi-lumen connector 55 is provided for the unique fluid connection. To avoid repetition, for identical components or features, reference is made to the above description of the figures associated with Fig. 1 and this is included in the disclosure with regard to Fig. 9. In addition, it should be expressly noted that different (independent) features or features relating to the deviceAspects of the disclosed multiplex infusion system 100 according to Figures 1 / 2, 7 to 9 can be combined with different (independent) features relating to the control device or the first to fourth interim modes / the first to seventh switching modes according to Figures 3a to 6e. In this respect, Figures 3a to 6e refer to a (flow-Z system-technical) balance envelope around the (partial) multiplex infusion device of the disclosed multiplex infusion system.

[0216] As can be seen from Fig. 9, the multi-lumen connector 55 has a first multi-lumen connector part 50 and a second multi-lumen connector part 60. The first multi-lumen connector part 50 (on the multiplex unit side) is provided or configured to form a connector side of the multi-lumen connector 55 facing the multiplex unit 1. The second multi-lumen connector part 60 (on the fluid reservoir side) is provided or configured to form a connector side of the multi-lumen connector 55 facing away from the multiplex unit 1. The first multi-lumen connector part 50 and the second multi-lumen connector part 60 are compatible or matched to one another and are configured to form a plurality of unique fluid connections.

[0217] The first multi-lumen connector part 50 is provided or configured to be (unambiguously) fluidly connectable or fluidly connected to a plurality of fluid lines LS; L-2,... Ln (in Fig. 9: five) of the multiplex unit 1, i.e., on the connector side facing the multiplex unit 1. The individual fluid lines LS; L-2,... Ln of the plurality of fluid lines each lead out of / into individual (associated) ones of (correspondingly) several first connector lumens of the first multi-lumen connector part 50. Each of the first connector lumens has a respective associated first flow cross-sectional area 51. The plurality of first connector lumens can have (each viewed in pairs) identical and / or different first flow cross-sectional areas 51.

[0218] The second multi-lumen connector part 60 is provided or configured to be (uniquely) fluidly connectable or fluidly connected to a plurality of fluid storage containers, such as an infusion bag 70 and / or a fluid cartridge 81. In particular, an individual one and / or paired or multiple combinations / bundles of the plurality of fluid storage containers 70, 81 are respectively (uniquely) fluidly connectable or fluidly connected to the second multi-lumen connector part 60 by means of or via a plurality of (associated) fluid supply lines Q-1...n. The individual ones of the plurality of fluid supply lines Q-1...n respectively lead out of / into individual (associated) ones of (correspondingly) several second connector lumens of the second multi-lumen connector part 60. In this case, each of the second connector lumens has a respective associated second flow cross-sectional area 61.

[0219] The first flow cross-sectional area 51 is always equal to the corresponding second flow cross-sectional area 61.

[0220] The plurality of second connector lumens can (each viewed in pairs) have identical and / or different second flow cross-sectional areas 61. The number of the plurality of first connector lumens of the first multi-lumen connector part 50 corresponds to the number of second connector lumens of the second multi-lumen connector part 60 in order to be able to form the one-to-one fluid connection in the multi-lumen connector 55 of a respective first connector lumen with an associated second connector lumen upon (mechanical, in particular form-fitting) connection of the first multi-lumen connector part 50 with the second multi-lumen connector part 60.

[0221] In particular, a respective first shape and a common first layout of the plurality of first connector lumens in the first multi-lumen connector part 50 correspond in a mirror-image Z-symmetrical manner to a respective second shape and a common second layout of the plurality of second connector lumens in the second multi-lumen connector part 60 in order to be able to form the one-to-one fluid connection of a respective first connector lumen with an associated second connector lumen in the multi-lumen connector 55 during (mechanical, in particular form-fitting) connection of the first multi-lumen connector part 50 with the second multi-lumen connector part 60.

[0222] By way of example, in Fig. 9, the infusion bag 70 is (unambiguously) fluidly connectable or fluidly connected to the second multi-lumen connector part 60 via one of the plurality of fluid supply lines Q-1 ... n as a source flow device QS for providing / multiplex infusion of one of the medical fluids, for example, a separation fluid or rinsing fluid. In particular, the source flow device QS can function as a first or second source flow device (cf., for example, the fourth interim mode according to Figs. 6a to 6e, reference symbols Q-S1 and Q-S2, respectively).

[0223] Further by way of example, in Fig. 9, a collection vessel and / or a waste container and / or an intermediate buffer storage, for example for the separation liquid or rinsing liquid, as a fluid sink 30 of the multiplex infusion system 100 is (unambiguously) fluidly connectable or fluidly connected to the second multi-lumen connector part 60 via / via another one of the plurality of fluid supply lines Q-1 ... n for receiving / collecting / (intermediate) buffering, etc., of a medical fluid / the separation liquid or rinsing liquid.

[0224] Further exemplary in Fig. 9, a plurality of fluid cartridges 81, ..., 81 are (uniquely) fluidly connectable or fluidly connected to the second multi-lumen connector part 60 via / via (several) further fluid supply lines Q-1 ... n for providing / multiplexing additional medical fluids from the plurality of fluid cartridges 81, ..., 81. The plurality of fluid cartridges 81, ..., 81 can be arranged or provided in a cartridge box 80.

[0225] Based on the unique fluid connection by means of the multi-lumen connector 55, the control device 110 (with a storage unit 120) is capable of automatically identifying the plurality of containers 81, 30, 70 of the different medical fluids F1, F2,...Fn (cf. Fig. 2) for the regular operation and interim operation of the multiplex infusion system 100 and of uniquely assigning them to the (micro)pumps XS; ... Xn as the plurality of valves and / or conveying devices in the respective associated plurality of fluid lines LS; ... Ln.

[0226] Due to the central control by the control device 110, all information for documentation is advantageously available. The multiplex infusion system according to the disclosure automatically detects which fluid storage container is connected to which of the multiple (infusion) fluid lines LS; L-2,... Ln and / or to which of the at least one lumen 4 and / or which fluid volume unit was pumped at which (precise) time. For this purpose, there should be a possibility to read the medical fluids or their associated fluid storage containers 70, 81, etc. [RFID, printed (optical) code (QR, ...)] and to automatically detect them upon insertion. The fluid supply containers 81,..., 81 etc. inserted (e.g. in a receptacle such as the cartridge box 80) are then advantageously fluidically connected in a defined (especially unambiguous) manner to the fluid supply lines or to the second multi-lumen connector part and these in turn in a defined (especiallyunambiguous) manner with the (micro-)pumps XS; ... Xn / the at least one lumen 4 of the catheter 2 in order to obtain a one-to-one assignment of the fluid storage container 70, 81, etc. to a specific / associated one of the (micro-)pumps XS; ... Xn / from the at least one lumen 4 of the catheter 2.

[0227] Preferably, at least one of the plurality of fluid supply lines Q-1...n can have an (optional) sensor device 90, as shown by way of example downstream of the cartridge box 80 or the infusion bag 70. Further preferably, at least one of the plurality of fluid lines LS; L-2,...Ln can have an (optional) sensor device 90 on the connector side facing the multiplex unit 1, as provided by way of example for the distal fluid line L-4.

[0228] Preferably (in general), the control device 110 may have an (optional) human-machine interface (HMI) for operation by a user such as a doctor.

[0229] Reference symbol

[0230] 1 multiplex unit

[0231] 2 catheters

[0232] 4 inner lumen

[0233] 5 additional inner lumen

[0234] 10 catheter tubes

[0235] 11 Hose wall

[0236] 12 Exit opening

[0237] 13 Catheter tip

[0238] 15 proximal end

[0239] 16 distal end

[0240] 18 Partition wall

[0241] 19 Connection opening

[0242] 20 injection ports

[0243] 30 fluid sink

[0244] 34 first interior wall

[0245] 35 second interior wall

[0246] 40 Luer-Lock connector

[0247] 50 first multi-lumen connector part (multiplex unit side)

[0248] 51 first flow cross-sectional area

[0249] 55 Multi-Lumen Connector

[0250] 60 second multi-lumen connector part (fluid reservoir side)

[0251] 61 second flow cross-sectional area

[0252] 70 infusion bags

[0253] 80 cartridge boxes

[0254] 81 Fluid cartridge

[0255] 90 Sensor device

[0256] 100 Multiplex Infusion System

[0257] 110 Control device

[0258] 120 storage units

[0259] HMI Human-Machine Interface

[0260] AS; A-2, A-3,...To outlets (of the valves and / or conveyors) XS; X-2, X-3,...Xn valves and / or conveyors

[0261] LS; L-2, L3,...Ln fluid lines

[0262] F1, F2,...Fn medical fluids

[0263] FS Separation fluid and / or rinsing fluid LR Selected reverse flow fluid line

[0264] P Patient

[0265] QS source current facility

[0266] Q-1..n fluid supply lines

[0267] R selected reverse flow device SR-minus reverse flow direction

[0268] SR-plus positive flow direction

[0269] V1 to V6 fluid volume unit

[0270] S000 zeroth switching mode (initial state)

[0271] S100 to S700 first switching mode to seventh switching mode

Claims

Patent claims 1. A multiplex infusion system (100) for delivering different medical fluids (F1, F2,...Fn) distally to a patient (P), comprising: a control device (110); and a multiplex infusion device, comprising: a tubular catheter (2) having at least one inner lumen (4) in its longitudinal extension between a proximal end (15) and a distal end (16); and a multiplex unit (1) with a plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn), each of which is fluidically connected to the at least one lumen (4) at the proximal end (15) for parallel connection; and wherein the control device (110) is configured to control the multiplex infusion system (100) by controlling the plurality of valves and / or conveying devices (XS; X-2, X-3,...) that are respectively controllably connected to the control device (110) for controlling and / or regulating a volume flow of a fluid.Xn) in respective associated multiple fluid lines (LS; L-2, L3,...Ln) for fluid supply and / or discharge in order to convey the different medical fluids (F1, F2,...Fn) with respective associated positive flow directions (SR-plus) in time-multiplex through the at least one lumen (4), characterized in that the control device (110) is further configured to control at least one of the plurality of valves and / or conveying devices (XS; X-2, X-3,...) for the interim operation of the multiplex infusion system (100) switched from the standard operation.Xn), which is designed to reverse the positive flow direction (SR-plus), as a selected reverse flow device (R) in an associated selected reverse flow fluid line (LR) in order to convey an associated fluid volume unit (V1 to V6) through the selected reverse flow fluid line (LR) via the selected reverse flow device (R) with an associated reverse flow direction (SR-minus).

2. Multiplex infusion system (100) according to claim 1, characterized in that the Control device (110) is arranged to temporarily operate the selected Reverse flow device (R) to control the fluid volume unit (V1 to V6) in a fluid sink (30), in particular into a waste container, and / or in a circuit of the multiplex infusion device with the reverse flow direction (SR-minus).

3. Multiplex infusion system (100) according to claim 1 or 2, characterized in that the control device (110) is configured to control the selected reverse flow device (R) for interim operation in order to convey the fluid volume unit (V1 to V6) through at least one sensor device (90), in particular a bio-sensor device, which is arranged in the selected reverse flow fluid line (LR) and is preferably controllably connected to the control device (110).

4. Multiplex infusion system (100) according to one of the preceding claims, characterized in that at least one or all of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) is or are respectively: designed as a flow control valve and / or a switching valve and / or a valve which is respectively acted upon or supplied with a supply pressure in the respective one of the plurality of fluid lines (LS; L-2, L3,...Ln) upstream.actuatable valve; and / or designed as a respective pumping device, in particular a respective micropump; and / or configured for conveying at a respective conveying rate of 0.05 ml / min to 500 ml / min and / or for intermittent conveying at a respective timing of less than 10 hours, preferably less than 2 hours, in particular between 1 s and 100 s, more preferably between 5 s and 60 s, even more preferably between 10 s and 20 s; and the control device (110) is configured accordingly to control the conveying rate and / or the timing.

5. Multiplex infusion system (100) according to one of the preceding claims, characterized in that: the control device (110) is configured to determine and control, during the interim operation, in particular at any time during the interim operation, at least one of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as a specific source flow device (QS) in an associated source fluid line in order to supply a separation fluid and / or rinsing fluid (FS), in particular a Separation gas and / or purge gas, with the corresponding positive flow direction (SR-plus) through the corresponding source fluid line.

6. Multiplex infusion system (100) according to claim 5, characterized in that, for the automated aspiration of blood of the patient (P) as a first interim operation, the control device (110) is provided and arranged to: - in a first switching mode (S100) for aspiration, to control a distal, in particular most distal, valve and / or conveying device (X-n) from the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as the selected reverse flow device (R) in order to aspirate a blood bolus (V5) as the associated fluid volume unit (V1 to V6) at the distal end (16) into the at least one lumen (4) and to convey it via the lumen (4) through the selected reverse flow fluid line (LR) with the associated reverse flow direction (SR-minus) for the purpose of a sensory measurement such as a blood gas analysis, preferably by the sensor device (90), during which the source flow device (QS) is used to temporarily stop the separation fluid and / or rinsing fluid (FS), in particular the separation gas and / or purge gas, and to stop all other of the several valves and / or conveyor devices (XS; X-2, X-3,...Xn) to stop the other of the different medical fluids (F1, F2,...Fn); hereinafter. - in a second switching mode (S200) for aspiration, to activate the source flow device (QS) in order to convey the separation fluid and / or rinsing fluid (FS), in particular the separation gas and / or rinsing gas, first through the source fluid line with the associated positive flow direction (SR-plus) and further downstream through the selected reverse flow fluid line (LR).

7. Multiplex infusion system (100) according to the directly preceding claim 6, characterized in that in the second switching mode (S200) for automated aspiration, a first source delivery rate of the source flow device (QS) with the associated positive flow direction (SR-plus) is substantially equal to a first sink delivery rate of the selected reverse flow device (R) with the associated reverse flow direction (SR-minus) in order to achieve by means of displacement a To effect further transport of the blood bolus (V5) for the purpose of sensory measurement when a fluid volume unit (V6) belonging to the at least one lumen (4) is at a standstill.

8. Multiplex infusion system (100) according to claim 5, characterized in that for applying the catheter (2) and automated flushing or priming of the multiplex unit (1) as a second interim operation: as the separation fluid and / or flushing fluid (FS), in particular the separation gas and / or flushing gas, a first medical fluid (F1) from the different medical fluids (F1, F2,...Fn) is selected and provided for use as the optional flushing fluid in the second interim operation; and the control device (110) is provided and configured for the second interim operation to: - in a third switching mode (S300, S300') for, in particular initial, flushing of the multiplex unit (1), to control at least one, in particular distal, valve and / or delivery device (X-n) from the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) as the at least one selected reverse flow device (R) with respective second sink delivery rates in the associated reverse flow direction (SR-minus), while controlling the source flow device (QS) with a second source delivery rate of the separation fluid and / or flushing fluid (FS), in particular of the separation gas and / or flushing gas, in the associated positive flow direction (SR-plus), and to control at least one or all other of the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) with respective third source delivery rates of the other of the different medical Fluids (F1, F2,...)Fn) in the associated positive flow direction (SR-plus) and / or to stop the other of the different medical fluids (F1, F2,...Fn) at a standstill, wherein in particular a first total source flow rate, defined as the sum of the second and third source flow rates, is substantially equal to a first total sink flow rate, defined as the sum of the second sink flow rates, in order to stop one of the at least one lumen (4) belonging to the at least one lumen (4). Fluid volume unit to effect, in particular initial, rinsing of the multiplex unit (1).

9. Multiplex infusion system (100) according to claim 5, characterized in that, for applying the catheter (2) including automated flushing or priming of the multiplex unit (1) and superimposed on the catheter (2) as a third interim operation: as the separation fluid and / or flushing fluid (FS), in particular the separation gas and / or flushing gas, a first medical fluid (F1) from the different medical fluids (F1, F2,...Fn) is selected and provided for use as the optional flushing fluid in the third interim operation; and the control device (110) is provided and configured for the third interim operation to: - in a fourth switching mode (S400) for flushing the multiplex unit (1) and superimposed on the catheter (2), at least one, in particular distal, valve and / or delivery device (X-n) from the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) is to be controlled as the at least one selected reverse flow device (R) with respective third sink delivery rates in the associated reverse flow direction (SR-minus), while the source flow device (QS) is to be controlled with a fourth source delivery rate of the separation fluid and / or flushing fluid (FS), in particular of the separation gas and / or flushing gas, in the associated positive flow direction (SR-plus) and all other of the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) with respective fifth source delivery rates of the other of the different medical fluids (F1 , F2,...Fn) in the associated positive flow direction (SR-plus), wherein a second total source flow rate, defined as the sum of the fourth and fifth source flow rates, is smaller in magnitude than a second total sink flow rate, defined as the sum of the third sink flow rates, in order to simultaneously flush the at least one lumen (4) of the catheter (2) when flushing the multiplex unit (1).

10. Multiplex infusion system (100) according to the directly preceding claim 9, characterized in that the control device (110) is provided and arranged to: - to switch from the fourth switching mode (S400) to the third switching mode (S300, S300') of the second interim operation according to claim 8, in particular immediately in time.

11. Multiplex infusion system (100) according to claim 5, characterized in that the control device (110) is provided and arranged for interim operation after a change of a fluid container with a fluid to be refilled from the different medical fluids (F1, F2,...Fn) with automated backflushing into the fluid container as a fourth interim operation, in order to: - in a fifth switching mode (S500) of the fourth interim operation, following a zeroth switching mode (S000) for changing the fluid container, at least one (XS) of the plurality of valves and / or Conveying devices (XS; X-2, X-3,...Xn) as a first specific source flow device (Q-S1) with a fifth source flow rate of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, in the associated positive flow direction (SR-plus), while another (X-2) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) is to be controlled as a first selected reverse flow device (R1) with a fourth sink flow rate of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, in the associated reverse flow direction (SR-minus), and all other of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) to stop the other of the different medical fluids (F1, F2,...Fn), wherein the fifth source delivery rate is substantially equal to the fourth sink delivery rate, in order to effect, when a fluid volume unit associated with the at least one lumen (4) is at a standstill, a delivery of the separation fluid and / or rinsing fluid (FS), in particular the separation gas and / or rinsing gas, from the first specific source flow device (Q-S1) for collecting fluid volume units (V1, V2) associated with the first selected reverse flow device (R1); subsequently. - in a sixth switching mode (S600) of the fourth interim operation, switching the other (X-2) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as the first selected reverse flow device (R1) for reversing the flow direction and switching to this instead of the first specific source flow device (Q-S1) as a second specific source flow device (Q-S2) with a sixth source flow rate of the separation fluid and / or rinsing fluid (FS), in particular the separation gas and / or rinsing gas, in the associated positive flow direction (SR-plus); while another, in particular distal, (Xn) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as a second selected reverse flow device (R2) with a fifth sink delivery rate of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, in the associated reverse flow direction (SR-minus) and to stop all other of the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) to stop the other of the different medical fluids (F1, F2,...Fn), wherein the sixth source delivery rate is substantially equal to the fifth sink delivery rate, in order to transport away the fluid volume units (V1, V2) of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, belonging to the first selected reverse flow device (R1) when a fluid volume unit belonging to the at least one lumen (4) is at a standstill. cause; and subsequently. - in a seventh switching mode (S700) of the fourth interim operation, to stop the other (X-2) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as the second specific source flow device (Q-S2) and instead of this to switch back to the at least one (XS) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as the first specific source flow device (Q-S1) with a seventh source flow rate of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, in the associated positive flow direction (SR-plus); while retaining the other, in particular distal, (Xn) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) as the second selected reverse flow device (R2) and connecting it to a sixth sink- to control the delivery rate of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, in the associated reverse flow direction (SR-minus) and to stop all other of the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) to bring about a standstill of the other of the different medical fluids (F1, F2,...Fn), wherein the seventh source delivery rate is substantially equal to the sixth sink delivery rate in order to effect further delivery of the separation fluid and / or rinsing fluid (FS), in particular of the separation gas and / or rinsing gas, when a fluid volume unit associated with the at least one lumen (4) is at a standstill.

12. Multiplex infusion system (100) according to one of the preceding claims, characterized in that: the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) are uniquely fluid-connected and / or fluid-connectable via the respective associated plurality of fluid lines (LS; L-2, L3,...Ln) to a plurality of fluid storage containers (70, 81) of the different medical fluids (F1, F2,...Fn) by means of a plurality of respective associated individual fluid connections; and wherein the control device (110) is configured to automatically identify the plurality of containers of the different medical fluids (F1, F2,...Fn) for the regular operation and interim operation of the multiplex infusion system (100) and to assign them unambiguously to the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) in the respective associated plurality of fluid lines (LS; L-2, L3,...Ln).

13. Multiplex infusion system (100) according to the directly preceding claim 12, characterized in that: the unique fluid connections are designed and arranged by means of a multi-lumen connector (55), wherein the multi-lumen connector (55) has a first multi-lumen connector part (50) on a connector side facing the multiplex unit (1) and a second multi-lumen connector part (60) on the connector side facing the fluid storage containers (70, 81).

14. Multiplex infusion system (100) according to one of the preceding claims, characterized in that, on the one hand, the tubular catheter (2) with the at least one lumen (4) and, on the other hand, the multiplex unit (1) with the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) are formed integrally with one another, in particular in that respective outlets (A-S; A-2, A-3,...An) of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) open directly into the at least one lumen (4); or are formed as separate units which are fluidly connectable and / or fluidly connected to one another, in particular via a Luer-Lock connection (40) or the like.

15. Multiplex infusion system (100) according to one of the preceding claims, characterized in that the catheter (2): has the plurality of valves and / or delivery devices (XS; X-2, X-3,...Xn) each designed as a micropump and mounted on the proximal end (15), in particular formed integrally with the catheter (2); and / or has an injection port (20).

16. Multiplex infusion system (100) according to one of the preceding claims, characterized in that the tubular catheter (2) forms at least one further inner lumen (5) by means of a partition (18) in parallel extension to the at least one lumen (4), wherein the at least one lumen (4) and the further lumen (5) are fluidically connected by means of a connecting opening (19) in the partition (18), wherein the connecting opening (19) preferably breaks through the partition (18) at or near the distal end (16), in particular in a section of a distal catheter tip (13) of the catheter (2) arranged upstream of a distal outlet opening (12) with respect to the at least one lumen (4).

17. Multiplex infusion system (100) according to the directly preceding claim 16, characterized in that the further lumen (5): is fluidically connected to the selected reverse flow fluid line (LR), in particular directly and / or integrally; and / or coincides with the selected reverse flow fluid line (LR), in particular an upstream section of the selected reverse flow fluid line (LR).

18. A catheter (2) constructed and designed for use in a multiplex infusion system (100) according to one of the preceding claims, which has at least one inner lumen (4) in its tubular longitudinal extension between a proximal end (15) and a distal end (16), wherein the tubular catheter (2) forms at least one further inner lumen (5) in parallel extension to the at least one lumen (4) by means of a partition wall (18) therebetween, characterized in that the at least one lumen (4) and the further lumen (5) are fluidically connected by means of a connecting opening (19) in the partition wall (18), wherein the connecting opening (19) preferably breaks through the partition wall at or near the distal end (16), in particular in a section of a distal catheter tip (13) of the catheter (2) arranged upstream of a distal outlet opening (12) with respect to the at least one lumen (4).

19. Storage unit (120) on which a method for delivering different medical fluids (F1, F2,...Fn) distally to a patient (P) using an extracorporeal multiplex infusion system (100) according to one of the preceding claims 1 to 17 with the following fluid flow control and / or regulation steps of the control device (110) is stored in a machine-readable manner: Selecting, for the interim operation of the multiplex infusion system (100) switched from the control mode, at least one of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn), which is configured to reverse the positive flow direction (SR-plus), as a selected reverse flow device (R) in an associated selected reverse flow fluid line (LR) and, in this respect, respectively controlling the selected reverse flow device (R) in order to convey an associated fluid volume unit (V1 to V6) through the selected reverse flow fluid line (LR) via the selected reverse flow Device (R) with an associated reverse flow direction (SR-minus); preferably to convey the fluid volume unit (V1 to V6) into a fluid sink (30) and / or in a circuit of the multiplex infusion device with the reverse flow direction (SR-minus); and / or by at least one sensor device (90) arranged in the selected reverse flow fluid line (LR) and preferably controllably connected to the control device (110); in particular, with further fluid flow control and / or regulation steps of the control device (110) stored in a machine-readable manner: optionally determining, during the interim operation of the multiplex infusion system (100), in particular at any time during the interim operation, at least one of the plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) specific valve and / or conveying device as a source flow device (QS) in an associated fluid line as a source fluid line and their respective control in this regard in order to convey a separation fluid and / or rinsing fluid (FS), in particular a separation gas and / or rinsing gas, as a first medical fluid from the different medical fluids (F1, F2,...Fn) with the associated positive flow direction (SR-plus) through the source fluid line; and / or optionally automated identification of the different medical fluids (F1, F2,...Fn) for the controlled operation of the multiplex infusion system (100) and their assignment to the respectively associated plurality of valves and / or conveying devices (XS; X-2, X-3,...Xn) in the respectively associated plurality of fluid lines (LS; L-2, L3,...Ln).

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