INTELLIGENT MEDICAL FLUID CONTROL AND TRANSFER SYSTEM AND COMPONENTS THEREOF

Description

SCOPE OF APPLICATION AND STATE OF THE ART

[0001] The invention relates to a medical fluid guidance and transfer system and components that can be used in such a system.

[0002] A medical fluid guidance and transfer system is a system for guiding fluids in connection with the medical treatment of a human or animal. Such a system can be, for example, an infusion system, a transfusion system, a dialysis system, an extracorporeal gas exchange system, an extracorporeal circulatory support system, a heart-lung machine, a feeding system, a drainage system for body fluids such as urine, wound secretions, or intestinal contents, or a respiratory system.

[0003] A fluid guidance and transfer system of the generic type, as well as one according to the invention, typically has at least one fluid source for providing a medically relevant fluid or fluid mixture, an access unit for applying the medically relevant fluid or fluid mixture to a patient, and a connecting conductor system that connects the fluid source and the access unit and is designed to guide and transfer the medically relevant fluid mixture from the fluid source to the patient, wherein the connecting conductor system usually has at least one regulating transfer element.

[0004] A fluid or fluid mixture within the meaning of the invention can be gaseous, e.g. breathing air, ambient air enriched with anesthetic gas, oxygen; or it can be liquid, e.g. an infusion solution, a drug, urine, blood, a dialysate or precursors of dialysates.

[0005] A fluid source is understood to be a storage unit or a media supply for the fluid or fluid mixture, for example wall connections for oxygen or natural sources.

[0006] An access point can be formed, for example, by a needle or a temporary vascular access—such as a central venous catheter or an arterial access—that is inserted into a vein or artery of the patient. An access point can also be formed by a port, i.e., a subcutaneously implanted catheter system that can be punctured from the outside and provides permanent access to the arterial or venous vascular system or to specific body cavities.

[0007] The connecting conductor system according to the invention comprises all components of the fluid guidance and transfer system that are necessary for guiding, transferring, or distributing the medically relevant fluid or fluid mixture. A regulating transfer element, such as a three-way stopcock, a stopcock bank, or a filter element, is part of the connecting conductor system according to the invention. A transfer element is understood to be an element that serves to simultaneously guide or transfer medically relevant fluids or fluid mixtures from several fluid sources connected to the transfer element via a connecting conductor of the connecting conductor system to an access point on the patient.

[0008] Virtually every inpatient receives medications, chemotherapy, infusions, or nutritional solutions via an access device—that is, intravenous (IV) peripheral cannulas, central temporary catheters, or permanently implanted vascular access devices (so-called "ports"). This is also referred to as IV therapy. Almost all of these therapies are already administered using pumps that are usually programmable offline—for example, infusion pumps in infusion systems—meaning the pump parameters are preset according to their use on the patient and connected to the system.

[0009] Patients in intensive care units, under anesthesia, or with serious illnesses often require multiple IV therapies simultaneously via several IV lines. The number can reach up to 30. In these situations, multiple parallel intravenous lines are necessary to precisely control and administer life-sustaining and potentially incompatible medications. The correct administration and documentation of these therapies are crucial for patient safety and the medicolegal compliance of the treating nurses, physicians, and facilities. Billions of single-use items are manufactured annually to facilitate these therapies.

[0010] Modern infusion and connection systems were conceived at the end of the 19th century and are specifically designed for reliable operation using only gravity. However, the flow of infusion fluid can also be achieved using an infusion pump or through active fluid outflow from the fluid source – for example, from a reservoir for the infusion fluid. Along the path to the access device, such as an IV line on the patient, one or more regulating transfer elements may be incorporated. The Luer system, used almost exclusively for IV therapies internationally, dates back to the instrument maker Hermann Wülfing Luer (1883). The combination of the Luer connection with a locking mechanism (Luer-Lock, as a further development of the Luer-Slip connector) was first described in 1952. The system is internationally standardized in ISO 80369-7.In its current form, the components of the infusion system or a fluid guidance and transfer system are manually plugged or screwed together and manually checked for their physically correct connection.

[0011] A connecting system, which in an infusion system is formed by the infusion lines or tubes, the infusion pump and the regulating transfer elements, transports the infusion fluids from a storage container to an IV access point on the patient.

[0012] For a functional and medically effective fluid delivery and transfer system, it is essential that all components function correctly and are properly connected. For example, in an infusion system, it must be ensured that the correct medication is administered via a suitable infusion pump at the correct infusion rate, and that a continuous connection, meeting compatibility and safety criteria, is maintained all the way to the patient, preventing, for instance, the simultaneous administration of incompatible medications and infusion solutions. With currently available infusion systems, the correct connection is checked manually by a physician or nurse.

[0013] For the safe operation of a medical fluid management system, adherence to hygiene standards is essential to protect the patient. This applies particularly to the correct use of filters, avoiding unnecessary reconnections, and observing the change intervals. Currently available fluid management systems do not allow for testing or monitoring of these parameters. Instead, control and documentation are performed manually by a physician or nurse.

[0014] Medical fluid management systems can pose a significant risk to fellow patients, relatives, or caregivers. This is the case, for example, when the fluid management system is filled with highly toxic substances, such as those used in chemotherapy, and these substances escape due to leakage or operator error. Current systems cannot detect the release of chemotherapy drugs.

[0015] Furthermore, the fluid guidance and transfer systems used to date do not allow for therapy documentation, integrity checks, plausibility testing, or feedback on the status and problems during, for example, infusion therapy. These limitations compromise patient safety and result in a high volume of manual documentation. Electronic integration of, for example, infusion therapy with other therapy processes is not possible.

[0016] Several proposals for integrating data lines with fluid lines have already been made in the prior art.

[0017] Document US 2009 / 0327715 A1 addresses the cryptographic identification of interchangeable parts, particularly in medical devices such as tubing systems. It describes fluid lines with integrated data lines where an electrical connection via a single-wire communication line and ground is established only when a mechanical connection exists between the fluid lines.

[0018] Document US 2015 / 0265828 A1 introduces adapters used in medical tubing connections to ensure a reliable connection between medical devices and tubing. These adapters guarantee that a medical device is only activated when the tubing connection is correctly established. This is achieved through integrated wiring and optical systems that detect the connection status and enable data transmission.

[0019] Document US 2018 / 0161568 A1 describes a fluid connection system for medical applications that ensures the secure connection of fluid lines and protection against contamination. It includes a mechanism with mechanical or electronic keys that allow for a safety check before the connection is activated.

[0020] Document US 2015 / 0306365 A1 describes fluid connectors that contain electrical elements, such as resistors and capacitors, positioned between two conductive elements. This circuit is closed when the connector is attached to a medical device. The electrical components serve to identify the connection and to activate the device or adjust its operating mode.

[0021] Document US 2018 / 0236204 A1 deals with a catheter connector that contains a series of contact components that can be connected to a matching cable which has a corresponding second series of contact components.

[0022] Document DE 10 2011 088 505 A1 describes a connector assembly for medical applications that contains electrical contacts. These contacts enable an electrical connection to be established once the connector is correctly connected and control external medical devices by activating signal lines.

[0023] Document US 2016 / 0073929 A1 introduces a gas sampling plug that includes electronic components such as memory and data / power interfaces. The plug connects to a gas sampling device, stores information such as usage time and number of connections, and enables authentication and tracking. Data is exchanged via electrical connections between the plug and the device. Document US 2016 / 0114104A1 describes a medication infusion system that uses electronic and optical components for the safe administration of medication. It includes electrical wires embedded in cables and optical waveguides that transmit medication data. A wireless tag and controller monitor the connection status between the medication source and the patient and utilize RFID tags, optical transmitters and receivers, and microprocessors to control medication flow and ensure correct medication administration to the patient. TASK AND SOLUTION

[0024] The object of the invention is to provide a fluid guidance and transfer system that does not exhibit the aforementioned deficiencies, or only to a lesser extent, and which, in addition, preferably fulfills the following functional requirements: 1. Ideally, the fluid guidance and transfer system should be able to independently validate its integrity from the fluid source, i.e., from the medication container, infusion bag, medication vial, or the like, to the patient, detect misconnections and medication incompatibilities, and document the therapy in a validated manner. Validation here means that a medication has not only passed through, for example, the infusion pump, but has also entered an IV catheter. 2.Both IV therapy, as a ubiquitous and resource-intensive treatment, and the use of transfusion systems, dialysis systems, nutrition systems, drainage systems, heart-lung machines, extracorporeal circulatory support systems, extracorporeal gas exchange systems, or ventilation systems should be integrated into modern, electronic workflows. This means that the anticipated end of therapy, necessary syringe changes, nutrition solution changes, drainage changes, etc., must be automatically reported and requested by the fluid management and transfer system. 3. The fluid management and transfer system must be robust enough that system testing can, for example, allow for the administration of home-based infusion and chemotherapy.

[0025] Furthermore, the object of the invention is to provide suitable components for such a fluid guidance and transfer system.

[0026] The object of the invention is primarily achieved by a connector for the fluidic coupling of medical devices and / or medical lines according to independent claim 1.

[0027] A connector according to the invention is a coupling device at the end of a fluid line or as an inlet or outlet of a medical device, which can be mechanically coupled to a mating connector or to an identical connector to enable fluid exchange. The invention relates to specific connectors from the medical field, which are further specified below with reference to the applicable standard. Connectors according to the invention can be coupled to standard-compliant mating connectors to form a fluid connection.

[0028] Specifically, the invention relates to the following connectors: Connectors according to the ISO 80369 family of standards, in particular connectors for intravascular or hypodermic applications ISO 80369-7, connectors for enteral applications according to ISO 80369-3 and connectors for neuroaxial applications according to ISO 80369-6, stoppers (for an infusion bottle according to ISO 8536-2), crimp caps for an infusion bottle according to ISO 8536-3 and piercing pieces according to ISO 8536-4 for connection to an infusion bottle or bag, subcutaneously implanted ports according to ISO 10555-6 and punch-free cannula for coupling to such an implanted port according to ISO 10555-6, conical connectors for anesthesia and ventilation equipment according to ISO 5356-1 and connectors according to ISO 5367, connectors for surgical wound drainage systems according to ISO 20697, connectors of a extracorporeal circuit of a hemodialysis system, hemodiafiltration system or hemofilter system as a blood port according to ISO 8637-1 (section 4.4.3, Figure 1 of the ISO standard) and connectors for connecting to blood ports for dialysis systems according to ISO 8637-2 (Figure 1 of the ISO standard) as well as connectors for internal connection of a dialysis system as a port for the dialysis fluid according to ISO 8637-1 (Section 4.4.4, Figure 2 of the ISO standard).

[0029] The standards references refer to the standards valid in July 2020.

[0030] A connector according to the invention allows the respective connectors to establish a fluid coupling between them in a conventional manner. For this purpose, a connector according to the invention has a fluid channel surrounded by a pipe section for a fully leak-proof coupling in a push-fit direction to the mating connector for the subsequent exchange of liquids and / or gases with the mating connector. Connectors according to the invention are compatible with standard connectors that are not designed according to the invention with respect to the fluid flow.

[0031] A particularly common and preferred form of fluid coupling provides that conical pipe sections are provided on both sides of the connecting piece and the mating connecting piece, which are pushed into one another during coupling and hold in a clamping position.

[0032] In addition to the conductor section, a connector according to the invention has a transmission device for data transmission with the mating connector. The transmission device can also be configured for the transmission of electrical energy. Although separate transmission devices for data and for electrical energy are generally possible, a combined transmission device for data transmission and / or for the transmission of electrical energy is preferred. Any transmission devices described in the context of this application are to be understood as being capable of being either a combined transmission device or a separate transmission device for electrical energy or data.

[0033] A connector according to the invention, through its transmission device, makes it possible to establish connections between individual components in the context of the aforementioned fluid guidance and transfer systems, through which not only fluid exchange can take place, but also electrical power and / or digital data can be exchanged between the connectors.

[0034] The need to transmit electrical energy or electrical data arises particularly to supply power to consumers located along the fluid path following the connector. However, it can also involve a power transmission function from one connector to a second connector at the other end of a fluid path.

[0035] Data transmission at the connector can serve the purpose of exchanging information, in particular to check the topology, to exchange and, if necessary, compare sensor data, or to perform other control or information acquisition functions. A very simple application is when data transmission occurs to read production data from the connector, such as the production batch or an expiration date. Another fairly simple application is when a connector is designed to transmit information about its permissible use to a mating connector, thus enabling the detection of incorrect connections.

[0036] The transmission device can be designed in different ways, as will be explained below. However, it is always designed in such a way that a coupling process with regard to the fluid channels of the connecting piece and the mating connecting piece simultaneously also leads to the coupling of the data and / or energy transmission device.

[0037] Inventive connectors in medical technology are typically designed predominantly as plastic parts, which may comply with the limitations of the relevant standards. The transmission device preferably comprises metallic or polymer conductors, which are particularly preferably embedded in the plastic of the connector. However, designs are also possible in which the conductors or the contact surfaces connected thereto are mounted on the outside of the connectors.

[0038] According to the invention, the connector has a transmission device for data transmission which is provided on the connector in such a way that it can exchange data with a corresponding transmission device on the opposite connector.

[0039] According to the invention, the transmission device of the connecting piece is designed with at least one coil for inductive coupling with the transmission device of the counterpart connecting piece.

[0040] Inductive transmission uses electromagnetic induction to transfer signals between two coupled connectors. Such systems are well-known, particularly through RFID tags and the Wireless Power Consortium's Qi standard for power transmission. Inductive data transmission and power transfer are relatively position-tolerant. This is especially advantageous for systems whose design, for example, a steep conical shape in the coupling elements, prevents a defined end position of the connectors.

[0041] Electromagnetic induction, with a defined relative arrangement of the coils, achieves a practically usable efficiency of over 50%. An efficiency of 80% is also achievable. This means that even with a series arrangement of 5 pairs of connectors, approximately 30% of the power is still retained.

[0042] The coils required for inductive coupling are preferably safely separated from the fluid, in particular by being provided in an insulated cavity of the connector. It is especially preferred if the coils are surrounded by a one-piece plastic part, which is preferably manufactured by an injection molding process with the coil inserted.

[0043] The integration of the transmission device into the connectors is such that, when two connectors are coupled, energy transfer or data transmission is possible without interference. A proposed design according to the invention provides that the transmission device comprises at least one planar coil.

[0044] A planar element is defined as an element that is at least three times larger transversely to the insertion direction than in the insertion direction. Such a planar element can, in particular, be arranged on or in a circumferential collar, which is preferably made of plastic and / or formed integrally with the aforementioned bearing section. During coupling, this circumferential collar is brought close to another circumferential collar of the mating connector until the coil is sufficiently close to allow data transmission between the opposing elements.

[0045] The planar element is therefore preferably designed as an element surrounding the bearing section. In the case of a coil, it is preferably spirally shaped, i.e., with a variable diameter.

[0046] However, a design proposed according to the invention that deviates from the planar design is preferred, namely one in which the transmission device has a helical coil surrounding the fluid channel.

[0047] In this type of design, a significant or even primary extension of the elements in the insertion direction is provided. The coil preferably has at least a cylindrical or conical shape, extending along the fluid channel, at least in sections.

[0048] The installation of a transmission device of this type is preferably carried out by providing the connecting piece with a sleeve-shaped ring section, on the inside, on the outside or within which the helical coil is provided.

[0049] This sleeve-shaped ring section is preferably formed integrally with the conductor section. It can therefore be formed, for example, by a circumferential wall separated from the conductor section by a gap. This wall can, for example, additionally represent a coupling section, on the inside or outside of which a coupling device for mechanical coupling with the mating connector is provided, in particular an internal thread, an external thread, a bayonet mount, or a bayonet lug for engagement with a bayonet mount.

[0050] In particular, it can also be provided that the ring section and the pipe section are at least partially identical. In this case, the walls that directly border the fluid channel also support the elements intended for transmission. Depending on the type of connector, this wall may be partially conical, enabling tight fluid coupling. Especially with connectors that have such a partially conical wall, the final position of coupled connectors is relatively unpredictable. Therefore, the transmission device in the sleeve-shaped ring section can be advantageous compared to a circumferential collar in a planar design due to the reproducible spacing and sufficiently long coils in the insertion direction.In the case of a wall that is at least partially conical and in which a coil is provided, the coil can also be conical or cylindrical. The conical design is preferred.

[0051] Using the pipe section as a ring section that carries or surrounds the transmission device is sometimes advantageous compared to using a separate sleeve-shaped coupling section to house the transmission device, since this allows the use of a rotatable coupling section, for example in the form of a union nut, which, as a rotatable element, could only be connected to a conductor of a fluid line with additional effort.

[0052] The connector is preferably made at least partially of plastic, with the aforementioned pipe section, the circumferential collar, or the sleeve-shaped ring section being particularly suitable for plastic construction. Preferably, those plastics are specified or recommended in the aforementioned standards.

[0053] In principle, designs are possible in which an electrical load or an integrated circuit is connected directly to the transmission device without any further transmission of energy or data beyond the load or the integrated circuit. However, it is usually the case that conductors are provided in the connection piece, particularly for the purpose of transmitting electrical energy or data. These are preferably metallic or polymeric conductors.

[0054] In a connector according to the invention, at least one output device can be provided, preferably in the form of an optical output device such as an LED. Such an output device can signal the status of the connector directly at the point of connection. For example, the output device could indicate whether the connection of the connector has been made correctly by means of lights or a specific light color. Thus, for instance, with a longer cable consisting of several sections, it could be quickly determined whether all connectors are correctly connected. If this is not the case, this can be recognized by the absence of light from the corresponding LED or by a corresponding signal color.

[0055] Furthermore, a connector according to the invention preferably includes at least one integrated circuit. This can, in particular, be integrated into a connector. The integrated circuit is connected to the transmission device of a connector in order to receive data or electrical energy.

[0056] In a particularly simple case, the integrated circuit can perform only or primarily communication tasks, especially communication with the data transmission devices of two connectors. However, it can also perform more complex functions and, in particular, include digital or analog outputs or inputs. The inputs can be connected to sensors integrated into the connector or the fluid line, for example, sensors for detecting the coupling state of the connector or sensors for detecting a property of the flowing fluid or its volumetric flow rate. The outputs can be used to control actuators, whereby the aforementioned output device, especially in the form of an LED, is also considered an actuator in this sense.

[0057] The invention further relates to a set of at least two connectors of the described type, which are configured for mechanical coupling according to one of the aforementioned systems, i.e., are typically configured as male and female. The two connectors are configured such that the mechanical coupling brings their respective fluid channels into communicative contact with each other, and their respective transmission devices into a relative position that enables data transmission or the transmission of electrical energy.

[0058] Such a set according to the invention typically does not have the two isolated connectors, but rather two connectors, each of which is part of a medical fluid line or a medical device.

[0059] The invention further relates to a medical fluid line for transporting liquids. This fluid line has a elongated body through which a fluid channel for the fluid or fluid mixture is traversed. This can be, in particular, a rigid tube or a flexible hose. A connector of the type described above is provided at least at one proximal end of the body, but preferably at both a proximal and an opposite distal end, so that the channel of the body is in communicative communication with the fluid channel of the connector(s). Furthermore, configurations of a fluid line with more than two ends are also conceivable, for example, a fluid line with a Y-configuration. In such a case, corresponding connectors are preferably provided at all ends of the fluid line.

[0060] If the fluid line is equipped with at least two connectors, these can be identical or designed in opposite directions, like a male and a female connector.

[0061] A conductive conductor for transmitting digital data and / or electrical energy is preferably provided along the conductor body with its integrated fluid channel. Various configurations are conceivable. In the simplest case, the conductor body and the conductor can simply run parallel to each other without being connected. It is also possible for the conductor to be separate from the conductor body but connected to it along its length by coupling elements or by helical wrapping. However, integrated solutions are considered particularly preferred, in which the conductor body and the conductor are permanently connected so that they cannot be separated without tools.In particular, the conductor body and the conductor can be inserted into a common sheath. Alternatively, the electrical conductor can be inserted into a sheath that directly forms the channel of the conductor body.

[0062] Since a conduit body designed as a hose exhibits a relatively high degree of elasticity, the conductor is preferably designed and / or shaped in such a way that it is not damaged by stretching or deformation of the conduit body. This can be achieved, for example, by using a polymer conductor. It is also possible to create a kind of reserve by arranging the conductor, which allows the hose body to elongate by utilizing this reserve. Preferably, the conductor is therefore at least 10% longer than the hose body itself in the area of ​​the hose body, and particularly preferably even 50% longer. The conductor can, for example, be helically shaped to surround the fluid channel of the hose body. A longer conductor is also advantageous if the hose body, as part of a peristaltic pump, is repeatedly compressed and expanded as intended.In such a case, however, it is particularly advantageous to design the hose body section by section without a conductor, as will be explained below.

[0063] The usual manufacturing method involves using a connector according to the invention as a discrete connector which is joined to the conductor body, for example by injection molding. However, a design is also possible in which the proximal or distal end of the conductor body integrally forms the conductor section of at least one connector. In this case, the end of the conductor body directly forms the conductor section, and preferably the transmission device is also provided directly on the conductor body, in particular integrated into its wall.

[0064] Typically, energy input and / or data transmission occur at a connection point of the fluid line. However, it is also possible to equip a fluid line according to the invention with a connection device in a central section, and thus, in particular, at a distance from the end connections. This is especially advantageous in connection with the use of a pump unit as the master of a data system, as described below. Such pump units are often designed as peristaltic pumps and are intended to accept pipe sections that are mechanically deformed from the outside for the purpose of fluid delivery. If at least one connection device is provided in the central section described, it can be supplied with data and / or electrical energy from the outside after the pipe section has been inserted.

[0065] For this purpose, it is considered particularly advantageous if the at least one connection device for coupling / coupling electrical energy or data is provided with a support extending radially from the conductor body, in or on which the actual connection device is provided, for example, a coil. Such a coil is further preferably arranged eccentrically to the fluid channel, so that it does not surround the fluid channel but is arranged laterally offset from it. In this way, it can be used particularly advantageously for energy or data transmission with a counter coil provided for this purpose in the pumping device.

[0066] While the connectors according to the invention provide an inductive transmission device to avoid contact between current-carrying parts and the fluid, the described connector in the central region is considered to offer a plausible alternative to galvanic coupling. Conductive coupling surfaces are then provided on the outside of the hose body, particularly on the radially extended support described, which, after the fluid line is inserted into the pump unit, come into contact with corresponding contact surfaces there.

[0067] If the hose body of the fluid line is compressed by a pumping device during pumping, this can quickly lead to damage to the conductor along the fluid line. To avoid this, a fluid line according to the invention can be designed without a conductor in a section in a central area, i.e., between opposite ends of the fluid line and the connecting pieces there. This section can then be repeatedly compressed for pumping purposes without damaging the conductor.

[0068] If connection pieces according to the invention with a transmission device are provided at both ends of the fluid line, the fluid line preferably has two connection devices of the described type in the central area, namely on both sides of the section intended for pumping.

[0069] As with a connector according to the invention, at least one dispensing device can also be provided in a fluid line according to the invention. Preferably, such a dispensing device is provided on one connector or on two connectors at opposite ends of the fluid line.

[0070] Furthermore, a fluid line according to the invention may also include at least one integrated circuit, which is preferably integrated into a connector of the fluid line. In fluid lines with two or more connectors, however, preferably only one of the connectors is provided with an integrated circuit. The other connectors are then also connected to this integrated circuit via conductors along the line body. However, designs are also possible in which different connectors of a fluid line or a medical device can have separate integrated circuits that do not need to be connected to each other for data transmission.For example, it could be provided that two different connectors of a fluid line or a medical device are each designed to transmit an identifier by means of separate integrated circuits, whereby these identifiers allow a connected counterpart connector to recognize whether the coupling of the connectors is permissible or impermissible.

[0071] The integrated circuit is connected to the transmission device of a connector to receive data or electrical energy. In a particularly simple case, it can perform only or primarily communication tasks, especially communication with the data transmission devices of two connectors or with components connected to them. However, it can also perform more complex functions and, in particular, include digital or analog outputs or inputs. The inputs can be connected, in particular, to sensors integrated into the connector or the fluid line, for example, sensors for detecting the coupling state of the connector or sensors for detecting a property of the flowing fluid or its volumetric flow rate. The outputs can be used to control actuators, whereby the aforementioned output device, especially in the form of an LED, is also an actuator in this sense.

[0072] The invention further relates to a fluid-carrying medical device designed for receiving, transmitting, and / or discharging fluids, and additionally for receiving, transmitting, and / or discharging data and / or electrical energy. According to the invention, this device has a connector of the described design for the combined receiving, transmitting, and / or discharging of data and / or electrical energy as well as fluid. In the simplest case, such a device is formed by a simple fluid line of the described type.

[0073] This also includes more complex devices used for the temporary storage or holding of liquid, or which have at least one actuator for controlling and / or pressurizing the fluid. Such an actuator could be, for example, an electrically controlled valve or a pump. The actuator can be powered by the electrical energy supplied via the connector or by a separate power supply. Control data for controlling the device can be supplied via the connector or sent to connected devices via the connector.

[0074] A device of the described type can further comprise at least one sensor, the sensor data of which can preferably be transmitted to other devices via the connector. The power supply can also be provided via the electrical energy supplied by the connector. The sensor can be designed to detect various parameters. A design in which the sensor is configured to detect a property of the fluid, for example, temperature, or to detect the fluid's volumetric flow rate is particularly advantageous. However, the sensor can also be designed to detect environmental parameters on or in the body of a patient, for example, as a temperature sensor, pressure sensor, or sensor for detecting oxygen saturation. Such a sensor can, for example, be part of a catheter inserted into the patient or an implanted port.

[0075] Preferably, the device comprises at least one integrated circuit connected to the connector for the purpose of supplying electrical power or digital data. This integrated circuit can also be powered by energy supplied via the connector and / or exchange data with other devices via the connector. The integrated circuit serves, in particular, to structure electronic communication with adjacent fluid-conducting components according to the invention. The integrated circuit can process the data from the described sensor locally within the device and / or control the described actuator locally. In particular, the integrated circuit can be used to implement a closed-loop control system within the device using the sensor and the actuator. Furthermore, the integrated circuit serves, in particular, to facilitate communication with external components connected via the connector according to the invention.

[0076] In most cases, for a device with at least two connectors according to the invention, it is advantageous if their at least two transmission devices are connected to a common integrated circuit. This circuit is preferably capable of distinguishing between the at least two connectors and / or transmitting specific, distinct connection identifiers for the two connectors via the transmission device. Alternatively, however, it is also possible to provide each connector with its own integrated circuit, which is configured to transmit only one connection identifier, but which is also specific and unique for that connector.

[0077] A medical device according to the invention can be implemented in the form of very different devices.

[0078] The device can, for example, be designed as a conveying unit, which means that the device is designed to pressurize the fluid. Such a conveying unit can, in particular, be designed as a pumping device and, as such, be equipped with a piston. However, it can especially be a peristaltic pumping device in which a fluid hose is periodically subjected to external force to convey the fluid through the hose. A conveying unit according to the invention with a peristaltic pump is preferably designed for inserting a fluid line according to the invention of the type described.

[0079] As will be explained further below, a medical device according to the invention, in the form of a conveying device, and in particular an integrated circuit therein, is also suitable for acting as a master in data communication with other components connected to the conveying device. Such a master controls the communication via the transmission devices and sends, for example, control commands or data transmission requests to the other components.

[0080] A device according to the invention can further be configured as a central venous catheter or a peripheral venous catheter. Such a catheter provides a thin access point to a vein of the patient and is optionally intended for temporary retention in the patient. Frequently, such catheters have multiple connectors that allow the simultaneous administration of different fluids and fluid mixtures. A catheter with connectors according to the invention allows its integrated circuit to store information about which fluid sources have been connected to it, in order to identify potential incompatibilities based on this information.

[0081] The device can further be configured as a multi-way valve or a valve bank. Such a multi-way valve or valve bank has at least three connection pieces, preferably all of which are configured as connection pieces according to the invention, and controls the fluid flow in the device to the connection pieces in the position of a rotary and directional valve. A multi-way valve or valve bank according to the invention preferably detects the position of at least one directional control valve by means of sensors and can, by means of its integrated circuit and the connection pieces according to the invention, identify the connected devices and detect their valve position and connection, and transmit this information via the connection pieces according to the invention, in particular to one or more masters, which are preferably formed by the described conveying devices.

[0082] The device may also be configured as a hemodialysis cartridge, a hemodiafilter cartridge, a hemofilter, or a hemoconcentrator cartridge. These units are referred to as dialysis cartridges in this disclosure.

[0083] The device can also be configured as an auxiliary port and, as such, has a fluid line with a connector at both ends, between which an auxiliary port is provided for the occasional addition of fluid. Such an auxiliary port offers a temporary connection option, for example, for injecting medication via needle- or valve-based access ports on the fluid system. The continuous power supply to the device allows it to monitor this injection port. If the connector of the auxiliary port is designed as a connector according to the invention, the device can also communicate with these injection devices, for example, with a syringe with a connector according to the invention, and thus, for example, query the type of medication as well as information on the dose and the manufacturer.

[0084] The device can still be configured as a filter device.

[0085] The device can still be configured as a breathing tube.

[0086] The object of the invention is also achieved by an intelligent medical fluid guidance and transfer system, which has an access unit for applying a fluid or fluid mixture into a patient or for withdrawing a fluid from a patient and which has at least one fluid container for providing or receiving the fluid. The described connecting pieces are also used in this system, which are attached to the access unit and / or to the fluid container and / or to fluid lines between the fluid container and the access unit.

[0087] In addition to the container and the access unit, the system preferably includes at least one further device of the type described above, which may, for example, be a conveying device.

[0088] A system in this sense therefore comprises at least the absolutely necessary components for fluid supply or fluid removal, whereby the use of connection pieces according to the invention, in particular also the use of fluid lines and / or devices according to the invention, provides the basis for data and / or energy transmission.

[0089] The system includes, in particular, medical equipment, for example a fluid pump, which has an integrated circuit that can query data from the fluid container or access unit via the data connection created by the connector.

[0090] The medical device can act as a master within the system, configured to communicate with other components or the integrated circuits of other system components, such as the fluid reservoir or the access unit. However, the master can also be separate from the device according to the invention, i.e., it may not itself have any components that directly carry fluid.

[0091] A system may have multiple masters, for example, several infusion pumps, each controlling communication with the respective integrated circuits of the components upstream and / or downstream in the fluid path. If a system has multiple masters, these are preferably connected to each other via a separate network, such as Ethernet or a fieldbus, to exchange data from their respective branches of the system or to coordinate control tasks in the different branches.

[0092] In principle, multiple masters in a system can perform different tasks, such as one supplying the system with electrical power while another manages data communication. However, it is preferable for a single master unit to serve both the power supply of the other components and the control of communication with them.

[0093] Depending on the type of system, different components or their integrated circuits are suitable as the master. In an infusion system, the master is preferably an infusion pump within the system. In a dialysis system, the master is preferably a dialysis machine within the system. In a nutrition system, the master is preferably a feeding pump within the system. In a drainage system, the master is preferably a drainage pump within the system. In a ventilation system, the master is preferably a ventilator within the system.

[0094] Furthermore, it is preferably provided that the system, and in particular the system's master, is configured to communicate with a server via a data network, especially an intranet or Ethernet. This can be done, in particular, to query data related to an identification code of an integrated circuit. In this way, supplementary information can be assigned to such an identification code stored in the system's integrated circuits, such as an expiration date, a batch number, or specification data for the fluid line or the device in which the integrated circuit is installed.

[0095] Communication with a server to query or supplement the medical record with patient or hospital information systems is also useful. Data queries can serve, in particular, to compare the patient care provided by the system with information in the medical record. Supplementing the medical record means that the care provided by the system can be automatically documented.

[0096] The object of the invention is also achieved by an intelligent medical fluid guidance and transfer system. This system comprises at least one fluid source for providing a medically relevant fluid or fluid mixture, and an access unit for applying the medically relevant fluid or fluid mixture to a patient. The system further comprises a connecting conductor system that connects the fluid source and the access unit and is designed to guide and transfer the medically relevant fluid or fluid mixture from the fluid source to the patient, wherein the connecting conductor system preferably has at least one regulating transfer element.

[0097] The intelligent medical fluid guidance and transfer system is preferably equipped with at least one of the components as described above.

[0098] The components of the medical fluid guidance and transfer system are at least partially equipped to determine and exchange information about their status and report it to a master. To transmit this information, the interconnection system is equipped to transfer and forward this information and / or provide a power supply for the components of the medical fluid guidance and transfer system, so that the components of the medical fluid guidance and transfer system form their own information infrastructure. This information infrastructure allows for the determination of a network topology for the interconnection system and for the fluid flow within the medical fluid guidance and transfer system.

[0099] To convey the medically relevant fluid mixture from the fluid source to the access unit at the patient, a conveying unit is preferably installed between the fluid source and the access unit. Such a conveying unit could, for example, be an infusion pump in an infusion system. In a ventilator, pressure is generated either by a pump or by the pressure of the respiratory gases.

[0100] In drainage situations involving wound exudate and urine, the body's natural fluid production is used to drive the fluid flow. In drainage situations, the fluid flow is reversed; that is, the fluid source is located within the patient's body and transports the bodily fluids to an external reservoir. The fluid flow can also be assisted by a pump, as in the case of chest drainage. The advantages of the information infrastructure according to the invention in the fluid guidance systems and distribution elements also come into play here, since the integrity and topology of the drainage system can be checked using this infrastructure. The drainage pump, for example, can act as the master.

[0101] In dialysis systems, heart-lung machines or extracorporeal gas exchange systems, the medically relevant fluids or fluid mixtures are driven by pumps or by the natural medium pressure (blood pressure).

[0102] To ensure the transmission of information and energy, metallic or polymer conductors are integrated into at least some, and preferably all, fluid-conducting components of the fluid guidance and transfer system, including the connecting conductor system. This allows not only the medically relevant fluid mixtures to be conveyed from a fluid source to an access unit in or out of the patient via the connecting lines, but also the simultaneous transmission or transfer of data, information, and / or energy between the components of the fluid guidance and transfer system.

[0103] For the purposes of this invention, a fluid or fluid mixture includes substances that are both gaseous and liquid, as well as suspensions and aerosols. A connecting system, for the purposes of this invention, includes infusion tubing, IV catheters, ventilation tubing, connecting tubes, and connectors.

[0104] Actuator information and commands for changing the flow topology or informational content can be transported and transferred via the information infrastructure. The information infrastructure in the fluid guidance and transfer system according to the invention can also be located within medical devices – e.g., infusion pumps, dialysis machines, heart-lung machines – or within the patient, i.e., in the access unit.

[0105] Components of the fluid guidance and transfer system that are designed to determine their status and report it to a master are considered information technology active elements. This means that these elements have electronics through which identification (type, serial number, unique identifier, lumen identification in the case of a multi-lumen catheter), status (position of three-way stopcocks, catheter clamp open, fill level of infusion containers), properties (medication in the lumen, manufacturing details), and sensor data from the patient are transmitted. These components may have their own power source. For example, in an infusion system, the infusion pump may be powered by mains electricity or by a battery. The other components may also have their own power source.

[0106] Because the components can determine and report their status, the elements of an IV therapy, dialysis system, nutrition system, drainage system, heart-lung machine, extracorporeal circulation system, extracorporeal gas exchange system, or ventilation system can be identified. This allows, for example, the determination of the patient-side network topology for each medication. Furthermore, connections, reusable stopcocks, stopcocks, etc., can be uniquely identified by their type, serial number, or a unique ID assigned to them. The advantage is that the unambiguous identification of the components, and thus the determination of the network topology, enables the detection of, for example, pharmaceutical drug incompatibilities.If the fluid guidance and transfer system according to the invention, in the configuration of an infusion system, is connected to a drug and compatibility database, drug instabilities and precipitation in the infusion system can be detected and prevented. The same applies to transfusion systems, dialysis systems, nutrition systems, drainage systems, heart-lung machines, extracorporeal circulation systems, extracorporeal gas exchange systems, and ventilation systems. The network topology identified by the respective system can also be compared with a prescribed therapy topology and trigger an alarm if an incorrect drug administration or similar issue occurs.

[0107] A further advantage of the fluid guidance and transfer system according to the invention is that the effective physical connections of the fluid guidance and transfer system can be tested, thereby reducing the probability of leakage. Likewise, the flow rate can be measured in the immediate vicinity of the patient and compared with the parameters of a delivery unit, for example an infusion pump, and checked for plausibility.

[0108] The components of the fluid guidance and transfer system each have a coupling device for coupling in and out information and / or for coupling in energy. For the purposes of the present invention, a coupling device is understood to be a connection point that enables data to be transmitted or transferred from one component of the fluid guidance and transfer system via the connecting conductor system to another component of the fluid guidance and transfer system or to a master.

[0109] Such a coupling device or connection is designed, for example, to maintain compatibility with the known Luer system. The coupling can be achieved, for instance, via a Luer lock to Luer lock, a Luer slip to Luer slip, a Luer slip to Luer lock, or via a through-hole connection from an infusion container in the form of a bottle or bag to the connecting conductor, or via a piercing connection from a port needle to an implemented port, wherein the respective coupling is enhanced by electronics that enable the transmission of data and power. The regulating transfer elements also constitute coupling devices within the meaning of the invention.The same principle applies to connections in feeding systems, ventilation systems, circulatory support systems, oxygenation systems, dialysis systems, and drainage systems, utilizing the connection geometries typical for each application and extending them to include coupling functionality for information and energy. For this purpose, the couplings and / or transfer elements known from the prior art are also enhanced with electronics that enable the transmission of data and energy. An enhanced transfer element with corresponding electronics for coupling in energy and information is comparable to a hub that distributes and transfers energy or information signals to multiple components of the fluid guidance and transfer system.A transfer element can be formed at various points in the fluid guidance and transfer system, depending on where there is a need to regulate the medically relevant fluid mixture to be applied.

[0110] The coupling devices are also understood as nodes in the network topology of the fluid guidance and transfer system. At each node of the network, the signal is processed and / or switched. This enables enumeration of the topology—similar to a USB tree, for example—and routing of data packets to addressable nodes. By schematically planned, time-shifted querying of individual components (time-slot method) or by means of frequency division multiplexing or similar methods, energy consumption is reduced and data packet collisions are prevented.

[0111] Information transmission and / or power supply between the components of the fluid guidance and transfer system and the connecting conductor system via the coupling device can be electrically conductive in a frequency range greater than 100 kHz. The transmission of power and data packets takes place in a frequency range that does not interfere with or negatively affect the action potential and latency of cells. Frequency ranges used for electrosurgery are excluded to avoid signal interference.

[0112] According to the invention, the fluid guidance and transfer system is designed so that the connection is contactless, achieved through inductive coupling. The connection points of the communicating components are galvanically isolated from one another. The physical connection of the components is still achieved via the Luer system or the respective application-specific, medically suitable connectors. However, the parts to be connected are designed such that the transmission occurs through inductive coupling, i.e., through the mutual electromagnetic influence of two or more spatially adjacent electrical circuits.

[0113] The information transmission and forwarding and / or energy supply between the components of the fluid guidance and transfer system and the respective connecting lines of the connecting conductor system can also be achieved through a combination of the transmission methods: electrically conductive, inductive, and capacitive.

[0114] For all transmission methods, it is essential that adjacent conductors in the interconnect system do not significantly interfere with each other, even in complex therapeutic situations. Therefore, modulated carrier frequencies, similar to common NFC technologies, are used for data and energy transmission. These frequencies are selected appropriately with regard to amplitude and frequency.

[0115] In contrast to the information technology active elements, components of the fluid guidance and transfer system that merely transmit information and energy via inductive coupling are understood as information technology passive elements.

[0116] In one embodiment of the fluid guidance and transfer system according to the invention, the master is formed by the conveying unit, the coupling unit or in a cloud.

[0117] The fluid guidance and transfer system according to the invention can have multiple masters. It is advantageous if each conveying unit – e.g., an infusion pump, and / or the connecting line system and / or transfer elements – is configured to receive and evaluate system data and react accordingly. In infusion systems, for example, it is known and common practice to use exactly one infusion pump for each medication or infusion solution. Furthermore, the infusion pump, due to its mains or battery operation, offers the advantage of always providing sufficient energy reserves for communication with the other components of the infusion system.Due to the inherent directionality of the infusion pump, a clear communication logic is defined, comprising the following steps: i) Proximal query to determine which medication or infusion solution is assigned to the pump; using sensor information obtained from corresponding sensors in the medication containers, it is possible to determine the status of the infusion solution, such as fill level, manufacturing details, batch number, expiration date, and unique ID. ii) Distal query to determine which transfer elements are present; which IV access, lumen, and patient are connected to the infusion system. Sensor data such as body temperature and oxygen saturation can be recorded and evaluated.The same applies to the design of the fluid guidance and transfer system as a transfusion system, dialysis system, nutrition system, drainage system, heart-lung machine, extracorporeal circulatory system, extracorporeal gas exchange system or ventilation system.

[0118] Furthermore, it is advantageous if the Master's graduate is trained to conduct a unidirectional or bidirectional exchange of information with a patient or hospital information system.

[0119] This makes it possible for the fluid guidance and transfer system to, for example, automatically indicate and request necessary syringe changes or a likely end to therapy, thus relieving the medical staff.

[0120] In addition to the direct use of data for controlling and monitoring infusion, transfusion, dialysis, nutritional, drainage, or ventilation therapies, this data can also be automatically documented in high quality. This enables complete traceability.

[0121] The fluid guidance and transfer system according to the invention enables the system to automatically validate the integrity of the fluid from the source to the patient. Malconnections and drug incompatibilities are detected, and the therapy can be documented completely and reliably without significant personnel effort. The fluid guidance and transfer system according to the invention helps to save hospital resources and improve the quality of patient management by, for example, automatically reporting and requesting the expected end of therapy and necessary syringe changes.

[0122] A further advantage of the fluid guidance and transfer system according to the invention is its modular design. The system can be easily expanded by adding further conveying units, fluid sources and connecting conductors in the connecting conductor system, which can be added to the network topology and information infrastructure without difficulty.

[0123] The invention also proposes a computer program product comprising commands that, when executed by a computer, cause it to analyze the network topology of the fluid guidance and transfer system, to check the integrity of the fluid guidance and transfer system, and to apply this information for documentation in a patient record. This computer program product can be operated via a tablet carried by the physician or medical staff. The system's operation can also be simplified to make it suitable for, for example, administering home infusions and chemotherapy.

[0124] In an advantageous application, the medical fluid guidance and transfer system according to the invention is configured as a measuring system with a fluid column between the patient's body interior and an extracorporeal measuring system for arterial or venous blood pressure. For intra-arterial pressure measurement, a fluid column is used between an intra-arterial catheter in the patient and an extracorporeal pressure measuring system to transmit the blood pressure. The information infrastructure according to the invention, integrated into the necessary tubing, connectors, and three-way stopcocks, also enables automatic integrity checks, the detection of faulty connections, and the direct reporting of flushing processes in the system and the measuring unit.This prevents measurement errors during flushing cycles or blood draws from the system, as the master unit can detect these events from the dynamic topology (such as the position of three-way stopcocks) and communicate them to the measuring system. This principle applies analogously to invasive venous pressure measurement.

[0125] In summary, the fluid guidance and transfer system according to the invention represents an information infrastructure for infusion, transfusion, dialysis, nutritional, drainage, and ventilation therapy. This infrastructure enables the system to automatically validate the integrity of the fluid from the source to the patient, detect misconnections and drug incompatibilities, and document the therapy in a validated manner. Therefore, it is also referred to as an intelligent fluid guidance and transfer system. The system according to the invention offers full connectivity while largely eliminating the need for physical contact surfaces. This makes the system ideally sterilizable and prevents new biocompatibility issues, as contact with the medications continues to occur via the proven glass and polymer materials.Furthermore, the system is fully backward compatible through integration into the Luer standard and is suitable as a medium-term industry standard for "Smart Fluid Guidance and Transfer System Technology". BRIEF DESCRIPTION OF THE DRAWINGS

[0126] Further advantages and aspects of the invention will become apparent from the claims and from the following description of preferred embodiments of the invention, which are explained below with reference to the figures. Fig. 1 shows a schematic representation of a network topology of a fluid guidance and transfer system according to the invention, using an infusion system as an example. Fig. 2 Figure 1 shows a schematic representation of a network topology of the fluid guidance and transfer system according to the invention, using a dialysis system as an example. Fig. 3 Figure 1 shows a schematic representation of a network topology of the fluid guidance and transfer system according to the invention, using the example of a wound drainage system. Fig. 4 Figure 1 shows a schematic representation of a network topology of the fluid guidance and transfer system according to the invention, using a ventilation system as an example. Fig. 5 shows two connectors in the style of a Luer lock with planar inductive transmission device. Fig. 6 shows connectors in the form of Luer couplings with a planar coil. Fig. 7 shows connectors in the form of Luer couplings with a sleeve-shaped coil in the area of ​​a cable section. Fig. 8 shows connecting pieces in the form of Luer couplings with sleeve-shaped coils in the area of ​​a coupling device for mechanical coupling. Fig. 9A shows the connection between a crimp cap of an infusion bag or bottle on the one hand and an infusion tube with extended electronics on the other hand by means of inductive coupling. Fig. 9A shows the connection between a sealing plug of an infusion bag or bottle on the one hand and an infusion tube with extended electronics on the other hand by means of inductive coupling. Fig. 10 shows the connection between an implanted port and a port needle with advanced electronics. Fig. 11 shows a connector formed by the end of a hose, particularly as part of a drainage system. Fig. 12 shows connecting pieces of a ventilation system. Fig. 13 shows connecting pieces of a ventilation system. Fig. 14 shows connectors on blood ports of a dialysis cartridge. Fig. 15 shows connecting pieces to the dialysate ports of a dialysis cartridge. Fig. 16A und 16B show different ways of designing a conductor body with a parallel conductor. Fig. 17 shows an infusion pump as the master with energy input and input / output of information. Fig. 18 shows a central venous catheter. Fig. 19 shows a peripheral catheter. Fig. 20 shows a three-way valve. Fig. 21 shows a tap bank. Fig. 22 shows a dialysis cartridge. Fig. 23 shows an additional port facility. Fig. 24 shows a filter unit. Fig. 25 shows a hose unit for a peristaltic pump. DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0127] Figur 1 Figure 1 shows a schematic representation of a network topology of the fluid guidance and transfer system 10 according to the invention in the configuration of an infusion system. In contrast to known infusion system topologies, the fluid lines 400 between the components 700, 500, 580, 560, 520 of the system 10 and the fluid-carrying components 700, 500, 580, 560, 520 themselves have metallic or polymeric conductors 250, which enable the transmission and exchange of data / information and / or energy. The components of the infusion system 10 are each equipped with electronics, so that the individual components - such as the transfer elements 560, 580 (e.g. three-way stopcocks 560 or a stopcock bank 580) or fluid sources 700 (such as infusion bags) or delivery units 500 (such as infusion pumps) - are able to identify themselves and determine and report their status.

[0128] The intelligent infusion system 10 exemplifies the functionality of detecting faulty connections within the infusion system. Using computer code integrated according to the invention, the overall system can determine its topology and thus detect any deviation between the prescribed medication and the medically prescribed therapy regimen and the actual topology of the infusion system. This verification includes ensuring that a medication is being administered from a fluid source 700 to the correct patient 20. Since the patient-side components of the infusion system—including the central venous catheter 520—are implanted in the patient 20, they allow for the unambiguous identification of the patient 20 and thus the verification of whether a medication or an infusion solution from a fluid source 700—i.e., an infusion bag or an infusion bottle—is being administered to the correct patient 20.

[0129] The intelligent infusion system 10 exemplifies the functionality of detecting incompatibilities between medications or between medications and infusion solutions at the point in the infusion system where the fluid flows meet. To do this, the computer program accesses compatibility databases and compares the existing infusion topology with these databases.

[0130] Figur 2 Figure 1 shows the fluid guidance and transfer system according to the invention in the configuration of a dialysis system 12. An equitopological information infrastructure is integrated into all components of the blood supply – i.e., from the venous access 550 into the dialysis system 12 with the blood pump 500, the blood line 400 to the blood pump 500 and dialysis cartridge 600, the respective connectors (not shown), and the dialysis cartridge 600, as well as the return flow from the blood line 400 to the patient, the air trap 690, and the venous access 552. An information infrastructure is also integrated into all components of the dialysis system 12, such as the dialysis solution 680 with the supply dialysis line 400 to the dialysis cartridge 600, and the dialysate container 670 with the dialysate line 400. The connections between the components are, for example, as shown in Figure 1. Figur 2 This is implemented. This allows the integrity of these connections to the patient and within the dialysis machine to be verified, and faulty connections to be detected. The Blood Pump 500, for example, can serve as the Master 800 and as the power supply and information interface.

[0131] Fig. 3 Figure 1 shows the fluid guidance and transfer system according to the invention in the configuration of a wound drainage system 14. This system has a fluid line 400 that is routed into the body of the patient 20. This fluid line, shown above in the figure, is connected to a second fluid line 400, which is connected to a unit consisting of a secretion container 672 and a suction pump 500. The suction pump 500 creates a vacuum in the secretion container 672, whereby fluid is aspirated from the patient's body through the fluid lines 400.

[0132] The two fluid lines 400 are designed as fluid lines according to the invention and therefore have connecting pieces 105 and 106, respectively, which not only connect their fluid channels but also the conductors 250 provided on both fluid lines 400. On the patient side, the conductor 250 extends to the distal end of the fluid line 400, which terminates in the patient's body 20. A sensor 180 is provided here, which can acquire body data of the patient 20. An integrated circuit 170 of the suction pump 500 is connected to the sensor 180 via the conductors 250 and the connecting pieces 100 and can thus query the body data and, if necessary, store it in a patient file via a network connection (not shown).

[0133] Figur 4 Figure 1 shows the fluid guidance and transfer system according to the invention in the configuration of a ventilation system 16. The conductors 250 in the ventilation tubes – such as the inhalation limb 400 and the exhalation limb 400 – provide an additional testing option for correct connections, i.e., the correct topology when installing humidifiers 650, filters 640, and fluid traps 660. The connections of the information infrastructure can, for example, be configured according to the Figuren 12 und 13 Adapted to the geometry of the connection standards in the ventilation system, inductive connections can be implemented. Sensor data from the ventilator 710 or the endotracheal tube 610 can be transmitted via the information infrastructure 250 without additional cables. The ventilator 710, for example, can serve as the master 800, as well as the power supply and information interface.

[0134] Figur 5 Figure 1 shows a simple Luer lock according to ISO 80369-7, which provides a standardized mechanical connection between a first and a second connector 100, 101 of the connecting conductor system. The fluid guidance and transfer system according to the invention maintains mechanical compatibility with the Luer system, which closes or opens the connection between two parts by a half turn. By integrating an integrated circuit (IC) 170 with a receiver coil 200, 202 in at least one first connector 100, 101 of the Luer lock connection and another coil 200, 202 in a second connector 100, 101 of the Luer lock connection, both data and energy can be transmitted. Such connectors are used in the infusion system 10 according to Figure 1. Fig. 1 Use.

[0135] Regarding the connecting pieces of the following Fig. 6 bis 8 Preferably, these are Luer-lock connectors according to ISO 80369-7. However, they can also be other connectors according to the ISO 80369 family of standards.

[0136] Fig. 6 shows a version of a connection of two connectors 100, 101 with planar coils 202, 302.

[0137] The connecting pieces 100, 101 of the Fig. 6 correspond with regard to the essential features of the design of Fig. 5 Two fluid lines 400 each have a connector 100, 101 at their end, which is attached to the hose body 410 and each has a line section 110 through which a fluid channel 111 is penetrated. The fluid channel 111 is located in the Figur 6 The right-hand connector 100, 101 is female, and the left-hand connector 100, 101 is male. This means that the pipe section 110 of the left-hand connector 100, 101 is inserted into the pipe section 110 of the right-hand connector 100, 101. The pipe sections 110 are tapered to ensure a secure fluid connection.

[0138] In addition to the fluid communication through line section 110, the connecting pieces 100 and 101 are already connected to the Fig. 5 The coils 202,302 described in the area of ​​collars 120 formed in one piece with the conductor sections 110 are arranged to each other after coupling in such a way that data transmission and / or energy transmission is possible.

[0139] Fig. 7 Figure 100 also shows connectors 101 with conical conductor sections 110. However, here the elements for data or power transmission, i.e., the coils 202, 302, are not planar but rather ring- or sleeve-shaped. They are integrated into or on the walls of the conductor sections 120. This means that reliable transmission is possible even with significantly different insertion depths, as is possible with conical connections. A further advantage of using the conductor sections as carriers for the transmission devices is that rotatable coupling elements such as union nuts can be used, the rotatability of which would otherwise make it difficult to construct a collar corresponding to the Figur 6 to be used for the installation of the transmission equipment.

[0140] Fig. 8 Figure 1 shows connection pieces 100 and 101 with coils that are ring- or sleeve-shaped. However, the corresponding elements are provided here, on the one hand, in the area of ​​an outer surface of a coupling section 140 and, on the other hand, on a shell wall 150 enclosing the coupling section.

[0141] Figur 9A Figure 1 shows a connection between an infusion bag 700 or an infusion bottle and an infusion tube 400 with extended electronics. The infusion bag 700, or its connector 100 formed by the crimp cap 100, 102B according to ISO 8536-3, integrates an integrated circuit (IC) 170 with a receiver coil 202. The infusion tube 400, to be attached, has a connector 103 according to ISO 8536-4 with a further coil 202, so that both components—when connected—are inductively coupled with respect to information and energy. This allows data and energy to be transmitted and exchanged via the integrated data line 250 in the infusion tube 400.

[0142] Fig. 9B shows an alternative design in which the connector 100 on the side of the infusion bag 700 or infusion bottle 700 is a plug 100, 102A according to ISO 8536-2, equipped with a transmission coil 202 and a circuit 170.

[0143] Figur 10 Figure 1 shows the connection between connectors 100 in the form of an implanted port 100, 103 and a port needle 100, 104 according to ISO 10555-6 and a cannula of the port needle with extended electronics as an example of an access unit. The implanted port 100, 103 contains a circuit 170 with a receiver / transmitting coil 202, 302, while the port needle 100, 104 integrates another receiver / transmitting coil 202, 302, which is connected to the data line 25 that runs parallel to the infusion solution in the infusion tubing (i.e., the connecting conductor system). This enables the transmission of data and power between the infusion system, including the port needle 100, 104, and the implanted port 100, 103.

[0144] Fig. 11 Figure 1 shows on the left a fluid line body 410 in the form of a hose body, the connector 100 of which is an integral part of the hose body. The connector's transmission element is formed by a sleeve-shaped coil 202, which is surrounded by the hose body material. This connector 100, integrated into the hose body, is provided for a mating connector 100 shown on the right, in the form of a stepped clamping sleeve. This mating connector 100 is also provided with a sleeve-shaped coil 202, which, in the coupled state shown, is positioned opposite the coil 202 of the other connector, thus achieving high energy transmission efficiency and reliable data transmission. Such connectors 100 are used in the drainage system 14 according to ISO 20697. Fig. 3 Use.

[0145] Figur 12 Figure 7 shows two connectors 100 and 107A according to ISO 5356-1 for a ventilation system. Similar to Figure 7, transmission devices 200 with coils 202 are also provided here, which are integrated into the conical line sections 110 of the connectors.

[0146] Fig. 13 shows connectors 107B according to ISO 5367, which are also used in a ventilation system such as the one of the Fig. 4 They are used, in particular, for connecting a fluid line 400 with a hose body 410 to the ventilator 710. The connecting pieces 107B are each equipped with a coil 202 for data and / or power transmission. One or both of the connecting pieces 107B may additionally be provided with an integrated circuit (not shown).

[0147] Fig. 14 Figure 1 shows two connectors 108A of a blood port of a dialysis cartridge 600. These connectors 108A conform to ISO 8637-1 and ISO 8637-2 and are designed for a tight connection using conical conductor sections. Furthermore, conductors 250 are provided on the connectors 108A and are connected to a coil 202 for data and / or power transmission.

[0148] Fig. 15 Figure 1 shows two connectors 108B according to ISO 8637-1 of a dialysate port of a dialysis cartridge 600. The connector shown on the right is typically provided on the dialysis cartridge 600. It has a circumferential groove into which a locking element of the connector 108B on the left engages. Here too, conductors 250 are provided on the connectors 108B, which are connected to coil 202 for data and / or power transmission.

[0149] The connectors shown and described, 102A, 102B, 103, 104, 105, 106, 107A, 107B, 108A, 108B, can be used in the Fig. 6 bis 8 as explained, they shall be equipped with inductive transmission devices and shall have the arrangements described therein (planar, ring-shaped in the line section or in a coupling section).

[0150] Fig. 16A und 16B Figure 1 shows different configurations of the conductor body 410 of fluid lines 400. Parallel to the conductor body 410 of the fluid lines 400, conductors 250 run for the transmission of electrical energy or for data transmission. In the configuration according to Fig. 16A The conductors are embedded in the material of the conductor body. Furthermore, in this design, the conductors are arranged helically around the central fluid channel.

[0151] In the design according to Fig. 16B The conductor 250 is arranged outside the conductor body 410, but is connected to it by circumferential coupling bands 420.

[0152] Figur 17 Figure 5 shows an infusion pump 500, as it can be used with the infusion system 10. The infusion pump 500 is designed as a peristaltic pump. It has a pressure device 502 with a plurality of pistons arranged above a counter-pressure surface 504. A receiving space for a fluid line 400 is provided between the pressure device 502 and the counter-pressure surface 504. When the fluid line 400 is in the state of Fig. 17 Once inserted, fluid can be conveyed through fluid line 400 by means of the pressure device and its pistons.

[0153] The fluid line 400 is equipped with two conductors 250, which is connected to Fig. 17 The conductors 250 are connected to the terminals (not shown) at the ends of the line upstream and downstream of the pressure device 502. No conductor is provided in the central section where the fluid line is subjected to force by the pressure device. Instead, the conductors 250 each terminate at a terminal 416 in the form of a coil for the inductive transmission of electrical power and data, which is mounted laterally on the line body and is located in close proximity to a coil 506 fixedly arranged in the conveying device 500.

[0154] In this way, the conveying device 500 or an integrated circuit of the conveying device can communicate upstream and downstream with other components of the infusion system or supply them with electrical power.

[0155] Fig. 18 Figure 1 shows a central venous catheter 520. This catheter has an access tube 522, which is fed through five ports. Each port is equipped with a connector according to the invention. All connectors, or elements of the infusion system 10 that can be coupled to them, communicate with an integrated circuit 170 via conductor 250. This circuit can aggregate data on which fluid sources are connected to the connectors 100. This allows problematic fluid combinations or deviations from a medication plan to be identified. It is also possible for the integrated circuit 170 to additionally communicate with a sensor 180 that acquires sensor data within the patient's body.

[0156] The peripheral catheter 540 of the Fig. 19 It also features an access tube 542. However, this is only supplied by an access point designed as a connector 100. In its standard form, the catheter is provided with wings 544 for attachment.

[0157] The transmission device in connector 100 is equipped with an integrated circuit, which, as with the catheter of the Fig. 14 It can communicate with a sensor 180. In addition, an LED 160 is provided, which can, for example, indicate when a predefined limit value is exceeded or fallen below by the sensor data.

[0158] Figur 20 The figure shows a three-way valve which has a total of three connection pieces 100. The three-way valve has, in a manner not shown in detail, a directional control valve which can be manually adjusted by means of a handle 562 to control which input is connected to the output.

[0159] Sensors 180 are provided to detect the current state of the directional control valve, for example Hall sensors, which detect the position of a magnet 182 attached to the valve or the handle. This information can be transmitted from an integrated circuit 170 to a connected component, for example an integrated circuit of the conveyor 500 acting as a master.

[0160] Fig. 21 Figure 580 shows a valve bank 580, the design of which functionally corresponds to a coupling of several three-way valves. The valve bank 580 has three directional control valves with handles 582, which are operated in the same manner as the three-way valve of the Fig. 17 with sensors 180 for detecting and transmitting the current switching state by means of an integrated circuit 170.

[0161] Fig. 22 shows a 600 dialysis cartridge as used in system 12 of the Fig. 2 The 600 dialysis cartridge has a 100 mm port at the top for blood inlet and a 100 mm port at the bottom for blood outlet. The 100 mm ports on the sides form the dialysate inlet and outlet.

[0162] All four connectors 100 are designed as connectors according to the invention with a data transmission device and are connected by means of conductors 250 to an externally mounted integrated circuit 170. This can communicate with connected components via this circuit in order to check the validity of the setup and / or to transmit corresponding data to another validating integrated circuit.

[0163] Fig. 23 Figure 1 shows an additional port device 620. This device comprises two connectors 100 at the upper and lower ends, which are connected by a hose line 410. An additional port branch 622 is also provided, which is preferably connected to the hose line 410 by means of a valve and to which an additional connector is provided. An additional fluid source, for example a syringe, can be connected here if necessary.

[0164] The three connection pieces 100 are each connection pieces according to the invention. They are connected by means of conductors to an integrated circuit 170, which, for example, registers the connection of a syringe to the connection piece 100 of the additional port branch 622 and transmits this information.

[0165] Fig. 24 Figure 640 shows a filter unit for filtering flowing fluid. The filter unit 640 has a filter housing 642 which has two connection pieces 100 according to the invention at opposite ends as inlet and outlet. The connection pieces are connected to an integrated circuit via conductors 250. This integrated circuit is also connected to a filter sensor 180, which detects filtration parameters and thus allows the integrated circuit 170 to transmit the corresponding information to a connected component in the event of an anomaly.

[0166] Fig. 22 Figure 1 shows a hose assembly 720 for a rotary peristaltic pump. Such a hose assembly has a hose loop 724 that is placed around the rotor of the peristaltic pump. The two ends of the hose loop 724 are provided on a central element 722, which is connected to an inlet hose and an outlet hose 400, which preferably have connection pieces 100 (not shown) according to the invention at their ends.

[0167] The central element includes an integrated circuit 170, which controls communication via the connectors, as well as a connection device 416 similar to that of the Fig. 17 provided for, via which electrical power and / or data communication is provided for the hose unit 720 and associated components of the overall system.

Claims

1. Connecting piece (100) for fluidic coupling of medical appliances and / or medical lines, having the following features: a. the connecting piece (100) is - in the form of a connector (101) of the ISO 80369 family of standards, in particular in the form of a connector for intravascular or hypodermic applications according to ISO 80369-7 or in the form of a connector for enteral applications according to ISO 80369-3 or in the form of connectors for neuraxial applications according to ISO 80369-6, or - in the form of a plug (102A) for an infusion bottle according to ISO 8536-2, in the form of a crimp cap (102B) for an infusion bottle according to ISO 8536-3 or in the form of a piercing spike (103) according to ISO 8536-4 for connection to an infusion bottle or a bag or - in the form of a subcutaneous implanted port (103) according to ISO 10555-6 or in the form of a non-coring cannula (104) for coupling to an implanted port (104) according to ISO 10555-6 or - in the form of a conical connector (107A) for anaesthetic and respiratory equipment according to ISO 5356-1 or in the form of a connector (107B) according to ISO 5367 or - in the form of a connecting piece (105, 106) for surgical wound drainage systems according to ISO 20697 or - in the form of a connecting piece (108A) of an extracorporeal circuit of a haemodialysis system, haemodiafiltration system or haemofilter system as a blood port according to ISO 8637-1 or in the form of a connecting piece (108A) for connection to blood ports for dialysis systems according to ISO 8637-2 or - in the form of a connecting piece (108B) for internal connection of a dialysis system as a port for dialysis liquid according to ISO 8637-1 and designed for coupling to a correspondingly designed counter-connecting piece (100), and b. the connecting piece (100) has a fluid channel (111) surrounded by a conduction section (110) for circumferentially tight coupling in a plug-in direction (2) to the counter-connecting piece (100) and for subsequent exchange of liquids and / or gases with the counter-connecting piece, and c. the connecting piece (100) has a transmission device (200, 300) for inductive data transmission with the counter-connecting piece, characterized by one of the following additional features: d. the transmission device (200, 300) has at least one planar coil (202, 302) surrounding the fluid channel (111), or e. the transmission device (200, 300) has a helical coil (202, 302) surrounding the fluid channel (111).

2. Connecting piece according to Claim 1, having one of the following further features: a. the planar coil (202, 302) is helical, or b. the helical coil (202, 302) is cylindrical or conical.

3. Connecting piece according to Claim 1 or 2, having the following further feature: a. the connecting piece (100) has a circumferential collar (120), wherein the planar coil (202, 302) is provided on or in the circumferential collar (120), preferably having the following additional feature: b. the circumferential collar (120) is integral with the conduction section (110).

4. Connecting piece according to Claim 1 or 2, having the following further feature: a. the connecting piece has a sleeve-shaped ring section (130), on the inner side of which, on the outer side of which or within which the helical coil (202, 302) is provided, preferably having at least one of the following additional features: b. the sleeve-shaped ring section (130) is integral with the conduction section (110), wherein preferably the ring section (130) directly forms the conduction section (110) at least sectionally and wherein preferably the ring section (130) is preferably designed as a section which is conical at least sectionally on the outer side, and / or c. the sleeve-shaped ring section (130) forms a coupling section (140), wherein a coupling device (142) is provided on the inner side or on the outer side, especially an internal thread, an external thread, a bayonet slot or a bayonet cam for engaging in a bayonet slot.

5. Connecting piece according to any of the preceding claims, having at least one of the following further features: a. the connecting piece (100) is made from plastic at least in part, especially the conduction section (110) and / or the circumferential collar (120) and / or the sleeve-shaped ring section (130), and / or b. the connecting piece (100) has at least one metallic or polymeric conductor (250) for conducting electrical energy or for conducting data.

6. Connecting piece (100) according to any of the preceding claims, having the following further feature: a. the connecting piece (100) has at least one output device (160), preferably in the form of an optical output device (160) such as an LED.

7. Connecting piece (100) according to any of the preceding claims, having the following further feature: a. the connecting piece (100) has an integrated circuit (170) which is supplied with power by the transmission device (300) and / or is connected to transmission device (200) for data transmission, preferably having at least one of the following additional features: b. the integrated circuit (170) has a unique identification code, and / or c. the integrated circuit (170) has at least one digital or analogue input for evaluation of a sensor signal of a sensor (180), and / or d. the integrated circuit has at least one digital or analogue output for activation of an actuator.

8. Connecting piece (100) according to any of the preceding claims, having the following further feature: a. the connecting piece (100) has a sensor (180), preferably having at least one of the following additional features: b. the sensor is designed for capturing a property of a fluid flowing through or for capturing the volumetric flow rate of a fluid flowing through, or c. the sensor is designed for capturing a coupling state of the connecting piece (100) on a counter-connecting piece.

9. Set of at least two connecting pieces (100), having the following features: a. the two connecting pieces (100) are designed according to any of Claims 1 to 8 and for mechanical coupling to one another, and b. the two connecting pieces (100) are designed in such a way that, through mechanical coupling, their respective fluid channels (111) are brought into communicating and circumferentially-tight connection with one another, and c. the two connecting pieces (100) are designed in such a way that, through mechanical coupling, their respective transmission devices (200, 300) are brought into a position relative to one another that allows data transmission or transmission of electrical energy.

10. Medical fluid line (400) for transferring liquids and / or gases, having the following features: a. the fluid line (400) has a conduction body (410) in the form of a rigid pipe body or a flexible tube body that surrounds a fluid channel, and b. the fluid line (400) has a connecting piece (100) at a proximal end of the conduction body (410), and c. the connecting piece (100) is designed according to any of Claims 1 to 8.

11. Medical fluid line according to Claim 10, having at least one of the following further features: a. the fluid line (400) has a connecting piece according to any of Claims 1 to 8 at a distal end, and / or b. an electrically conductive conductor (250) for conducting digital data and / or for conducting electrical energy is provided along the conduction body (410), and / or c. the conduction body (410) has a wall (412), within which the conductor (250) is arranged.

12. Fluid-guiding medical appliance (100), having the following features: a. the appliance is designed for receiving, conducting and / or delivering fluids, and b. the appliance is designed for receiving, conducting and / or delivering data and / or electrical energy, and c. the appliance has a connecting piece according to any of Claims 1 to 8 for combined receiving, conduction and / or delivery of data and / or electrical energy and of a fluid.

13. Fluid-guiding medical appliance according to Claim 12, having at least one of the following further features: a. the appliance has at least one actuator for controlling the fluid and / or applying pressure thereto, and / or b. the appliance has at least one sensor, especially a sensor for capturing a property of the fluid or for capturing the volumetric flow rate of the fluid, and / or c. the appliance has at least one integrated circuit which is supplied with power by the transmission device and / or is connected to the transmission device for data transmission.

14. Fluid-guiding medical appliance according to either of Claims 12 and 13, having the following additional feature: a. the appliance is designed as a conveying unit (500), or b. the appliance is designed as a central venous catheter (520) or as a peripheral venous catheter (540), or c. the appliance is designed as a valve bank (580) or multi-way valve (560), or d. the appliance is designed as a haemodialysis cartridge, a haemodiafilter cartridge, a haemofilter or a haemoconcentrator cartridge (600), or e. the appliance is designed as an auxiliary port device (620) and has a fluid line provided with a connecting piece on both sides, between which an auxiliary port for ad hoc addition of a fluid is provided, or f. the appliance is designed as a filter appliance (640), or g. the appliance is designed as a ventilation tube (610).

15. Medical fluid conduction and transfer system having the following features: a. the system (10, 12, 14, 16) comprises an access unit for the patient (20) for administering a fluid or a fluid mixture into a patient (20) and / or for withdrawing a fluid from a patient, and b. the system comprises at least one liquid container for providing or accommodating the fluid, and c. the access unit and / or the liquid container has a connecting piece according to any of Claims 1 to 8.