System and method with medical finishing device

Abstract

The invention relates to a system comprising a set-up (1) for a medical treatment, preferably for a dialysis treatment of a patient (P), in particular for a peritoneal dialysis treatment. The set-up (1) comprises a first reusable unit (10) comprising at least one first connection site (11) for connecting it to a second disposable unit (20), the second disposable unit (20) being a tubing or comprising a tubing.

Description

Technical Field

[0001] The present invention relates to the system according to claim 1, the method according to claim 17, and the second disposable unit according to claim 18 or according to the preamble or superordinate concept of the preceding claims. Background Technology

[0002] The organizer for peritoneal dialysis is known from DE102018113322. Summary of the Invention

[0003] One object of the present invention is to provide a system that includes another medical organizer. Furthermore, a method for using the system should also be provided.

[0004] The object of the present invention is achieved by a system having the features of claim 1, and also by a method having the features of claim 17 and / or a second disposable unit having the features of claim 18.

[0005] According to the present invention, a system having the features of claim 1 is proposed.

[0006] The system includes a processor for medical treatment, preferably for patient dialysis treatment, and particularly for peritoneal dialysis treatment.

[0007] The organizer includes a first reusable unit. The first reusable unit includes at least one first connection point for connecting it to a second disposable unit (in some embodiments, the second disposable unit is part of the system, while in others it is not), which is typically discarded after use. The second disposable unit to be connected is of the type including or constituted by tubing for fluidly connecting two or more fluid bags to the patient.

[0008] According to the present invention, a method for preparing a treatment device prior to dialysis treatment of a patient is provided, the method comprising the features of claim 17.

[0009] The method includes the following steps: providing a system according to the invention; and breaking the fragile parts, etc., included in the second disposable unit to establish or allow fluid to flow through the part of the system including the fragile parts, for example, after the second disposable unit is connected, to establish fluid communication between two or more fluid bags and the patient.

[0010] According to the present invention, a second disposable unit as described herein, as described in claim 18, is also proposed.

[0011] The system described herein is the subject of this invention, and therefore is applicable according to this invention. The method described herein is the subject of this invention, and therefore is applicable according to this invention. This also applies to the second disposable unit.

[0012] The disposable unit referred to herein as the "second" disposable unit is also the subject or aspect of this invention. It can be implemented as any embodiment of the system or any other embodiment disclosed herein. Embodiments according to the invention may include one or more features based on any of the independent claims above and / or below. Therefore, the features described herein can be used as subject matter in any combination based on any of the independent claims, unless a person skilled in the art considers a particular combination technically impractical.

[0013] Advantageous improvements of the present invention are the subject of the dependent claims and embodiments.

[0014] In all the foregoing and the following statements, the expressions “may be”, “may have”, etc., should be understood as synonymous with “preferred”, “preferably have”, etc., and are intended to illustrate embodiments according to the present invention.

[0015] Whenever this document introduces an alternative with “and / or”, those skilled in the art will understand that the “or” contained therein is preferably “one of two” and is preferably not “and”.

[0016] Whenever numerals are mentioned herein, those skilled in the art should recognize or understand them as indications of a lower limit of a numerical value. Therefore, unless this leads to obvious contradiction among those skilled in the art, they should understand that, for example, "an" (or "a / an") includes "at least one".

[0017] This understanding is also included in the invention as well as the understanding that the numeral "a" (or "one / a kind") can alternatively mean "exactly one," provided that this is technically obvious to those skilled in the art. Both understandings are included in the invention and apply to all numerals used herein.

[0018] In case of any doubt, whenever spatial information such as “above,” “below,” “upper,” “lower,” “left,” or “right” is mentioned herein, those skilled in the art should understand it as referring to the spatial indication of orientation in the accompanying drawings. “Bottom” is closer to the bottom of the drawings than “top.”

[0019] Whenever an embodiment is mentioned herein, it represents an exemplary embodiment of the invention.

[0020] When the subject matter of this document, according to the invention, includes one or more features in a particular embodiment, it is also disclosed accordingly that, according to the invention, in other embodiments, the subject matter similarly and explicitly excludes the one or more features, for example, in the sense of a disclaimer. Therefore, for each embodiment mentioned herein, a contrary embodiment (e.g., expressed in a negative form) is also disclosed.

[0021] Whenever method steps are mentioned herein, in various embodiments, optional control devices of the system are configured to perform one or more of these method steps in any combination, particularly when these steps are automatically executable, or configured to control corresponding devices, preferably with names corresponding to the names of the corresponding method steps (e.g., method step “determine”, device “device for determining”), and the devices may also be part of or signal-connected to the device of the present invention.

[0022] In some embodiments, these terms are used interchangeably whenever the text refers to “programmed” or “configured”.

[0023] When this article refers to a signal connection or communication link between two components, it can be understood as a connection that exists during use. It can also be understood as the existence of preparations for such signal connection (wired, wireless, or otherwise implemented), for example, by coupling the two components, such as by pairing.

[0024] Pairing is a process associated with computer networks used to establish an initial link between computer units to enable communication. The most well-known example is establishing a Bluetooth connection, which connects various devices (such as smartphones and headphones) to each other. Pairing is sometimes also called tethering.

[0025] Whenever method steps are mentioned herein, it is specified in several embodiments that these steps are performed before or after patient treatment, such as during a period when the patient is not connected to the device via a third (patient) tube or the like, or when treatment has not yet begun or has been completed.

[0026] Control devices (which may be control devices or closed-loop control devices) can cause the execution of all or substantially all of the method steps. Whenever the term "piping" is used herein, it refers to piping that is adapted and / or configured for guiding fluids or liquids.

[0027] Whenever the term “automatic pipe clamp” is used in this document, it may include automated pipe clamps, electromagnetic pipe clamps and / or the like.

[0028] Whenever the term “sealing pin” is used herein, it may be used synonymously with “safety pin” or “fixed pin”. In some embodiments, these terms may be used interchangeably.

[0029] The term “third line” may also include “patient line” in this document, which in several embodiments may be implemented as a catheter extension.

[0030] The terms “sensor,” “reader,” and / or “scanner” are used interchangeably in some embodiments.

[0031] In some embodiments, the system includes a dialysate source or bag and / or a drain or bag. In other embodiments, it does not include this feature.

[0032] In some embodiments, the system according to the invention includes a power source or is connected to a power source, such as a battery, rechargeable battery, accumulator and / or the like.

[0033] The first reusable unit can be a handheld device.

[0034] In several embodiments, the first reusable unit is a tray or includes a tray. In some embodiments, the first reusable unit does not include a connector for connecting it to a bracket or the like.

[0035] Optionally, the first reusable unit does not include tubing for directing or withdrawing fluid from the patient before being connected to the second disposable unit.

[0036] In several embodiments, the first reusable unit includes or is connected to a second disposable unit. The second disposable unit may be connected to the first reusable unit using a first connection portion, and / or vice versa.

[0037] Therefore, the first connection portion may be or include at least one first receiving portion, such as a groove and / or a clamping portion. This applies to any connection portion provided on the first reusable unit. Furthermore, the invention covers any suitable number of connection portions on the first reusable unit.

[0038] In some embodiments, the second unit includes a first conduit for guiding fresh dialysate from a dialysate source or fluid bag (optionally also included by the system), and a second conduit for guiding used dialysate (also referred to herein as dialysis waste) to a discharge section or discharge bag (optionally also included by the system). The two conduits are connected to each other, i.e., in fluid communication, preferably via a Y-joint, connector, or additional conduit segment. The Y-joint or additional conduit segment is in fluid communication with or connected to a third conduit for guiding fresh dialysate from the processor or its second disposable unit to the patient, and guiding used dialysate from the patient to the processor or its second disposable unit.

[0039] In several embodiments, the second disposable unit includes a first tubing and a third tubing in fluid communication with or connected to the first tubing. The first tubing guides fresh dialysate from a dialysate source or bag to a finishing device and guides used dialysate to a discharge section or bag to exit the finishing device. The third tubing guides fresh dialysate to the patient and guides used dialysate away from the patient. The second tubing described above may optionally be absent. Therefore, although a first tubing and a so-called "third" tubing are mentioned in these embodiments, only two tubings may exist; for the avoidance of confusion, the second tubing is referred to as the "third" tubing.

[0040] In several embodiments, the first conduit includes, in particular, a manually operated conduit clamp.

[0041] In some embodiments, the second conduit includes, in particular, a manually operated conduit clamp.

[0042] In several embodiments, the third tubing includes, in particular, a manually operated patient tubing clamp.

[0043] In some embodiments, the Y-shaped member or the third conduit includes or is implemented as a measuring cavity or measuring region. The measuring cavity or measuring region may differ from adjacent sections of the Y-shaped member or the third conduit in terms of structure, opacity, wall thickness, etc.

[0044] In several embodiments, the Y-shaped component, the third conduit, or the measuring cavity includes an operating stop or flange. The operating stop or flange may be a protrusion that prevents the second disposable unit from slipping past the user's fingers during system assembly. Therefore, it protects the measuring cavity or measuring area from accidental touch or contamination by the user. This ensures the accuracy and correctness of future measurements.

[0045] In several embodiments, the third conduit (which may include or be an extension of a patient conduit, and may also include a patient conduit connector (hereinafter referred to as the patient connector) for connecting the patient conduit to other portions of the third conduit (e.g., a measuring cavity or measuring area)) includes a connection or coupling portion, preferably a threaded joint, for connecting portions of the third conduit to a sealing pin, which may in turn be part of or included in the third conduit. If configured, the connection portion may be part of or an integral part of the patient conduit connector.

[0046] In some embodiments, a portion of a third conduit, or any other portion of a third conduit, connected to an optional Y-shaped element, a measuring cavity, or a measuring area has a first connector portion, while the patient connector has a second connector portion connectable to the first connector portion. The first and second connector portions may interlock or complement each other, for example, as a threaded joint and a threaded element, preferably for establishing a fluid-tight connection. Both connector portions have an inner cavity for guiding fluid flow. The two connector portions may be arranged to connect to a sealing pin as described herein. The two connector portions may be arranged to form a common inner cavity for receiving the sealing pin as described herein.

[0047] In several embodiments, the sealing pin or a portion thereof provides an inner cavity through which fluid can flow longitudinally along the sealing pin. The sealing pin may be arranged at least partially in the inner cavity of the first connector portion, the second connector portion, or a common inner cavity, such that liquid can flow through and / or around the sealing pin, and thus from the conduit connected to the first connector portion to the conduit connected to the second connector portion, or vice versa.

[0048] In some embodiments, the sealing pin includes a threaded portion on its outer side, which is adapted to threadedly engage with a first connector portion, the first connector portion further including a threaded portion on its inner side.

[0049] In several embodiments, the sealing pin also has a first limiting element. The first limiting element may be an element that restricts movement of the sealing pin relative to the second connector portion, or it may be part of a mechanism for this purpose. The first limiting element may be a flange, or preferably in the form of teeth, tooth blocks, protrusions, etc., which, when in contact with a second limiting element of the second connector portion or another portion of the second connector portion adapted to engage with the first limiting element, can restrict rotation of the sealing pin in at least one rotational direction.

[0050] In some embodiments, the sealing pin preferably has a fixing element at the end opposite to the first limiting element, through which the sealing pin can be releasably or non-releasably fixed to the closing element, preferably by a snap-fit ​​connection and / or by a bottom cut, such as a sealing cap or a sterilizing cap.

[0051] In several embodiments, the second connector portion includes a receiving portion, preferably concentrically surrounding the inner cavity of the second connector portion, for receiving a first threaded portion disposed outside the first connector portion, wherein the receiving portion of the second connector portion has a threaded portion on its inner side, the threaded portion being adapted to threadedly engage with the first threaded portion of the first connector portion.

[0052] In some embodiments, a second limiting element (preferably in the form of a toothed block) is disposed on the inner side of the inner cavity of the second connector portion and is adapted to cooperate with the corresponding first limiting element of the sealing pin to limit the rotation of the sealing pin in at least one rotational direction.

[0053] In several embodiments, the second limiting element is formed as a plurality of ribs extending axially along the inner side of the second connector portion and / or a groove on the inner surface of the second connector portion.

[0054] In some embodiments, the first and second limiting elements form part of a rotation inhibition or restriction mechanism. Clearly, they provide only one example of such mechanisms included in some embodiments.

[0055] In several embodiments, a sealing pin is disposed in a common cavity formed by the cavities of the first connector portion and the second connector portion. The sealing pin can move between an open position and a closed position by relative movement of the first connector portion relative to the second connector portion. In the open position, the sealing pin allows liquid to flow through the common cavity, and in the closed position, the sealing pin blocks liquid from flowing through the common cavity.

[0056] In some embodiments, the third conduit is connected to or includes a patient connector.

[0057] In some embodiments, the patient connector is a second connector portion or includes a second connector portion.

[0058] In several embodiments, the third conduit includes a self-insertion and / or self-sealing mechanism for sealing the patient connector when it is disconnected.

[0059] In some embodiments, the sealing pin described herein may be part of or as part of a self-piercing and / or self-sealing mechanism.

[0060] In some embodiments, self-insertion and / or self-sealing mechanisms are implemented as disclosed in WO2021 / 043737A1, the relevant disclosure of which is incorporated herein by reference.

[0061] In several embodiments, the self-insertion and / or self-sealing mechanism is or includes: a first connector portion having an inner cavity for guiding liquid; a first threaded portion disposed outside the first connector portion such that the first connector portion is releasably connected to a corresponding mating second connector portion; and a second threaded portion disposed inside the first connector portion at the inner cavity side such that the first connector portion is releasably connected to a corresponding mating sealing pin, wherein the pitch of the first threaded portion is preferably different from the pitch of the second threaded portion.

[0062] In some embodiments, the patient connector includes an operating limit portion or a flange.

[0063] In several embodiments, the first conduit, the second conduit, and / or the third conduit include automatic conduit clamps, or the system provides automatic conduit clamps for the first conduit, the second conduit, and / or the third conduit. They can be controlled by the system's control device.

[0064] In some embodiments, the system includes at least one light-emitting device for indicating the status of automatic and / or manual line clamps, specifically indicating whether they are open or closed.

[0065] In some embodiments, at least one optional light-emitting device may be implemented as an LED.

[0066] In some embodiments, at least one optional light-emitting device can change color to indicate the state of the conduit clamp, for example, red for off and green for on. Other light signals, such as flashing, on / off, etc., may also be included in the invention.

[0067] In some embodiments, the first conduit includes a fragility component, or the system provides a fragility component for any of the first, second, and third conduits, particularly for the first conduit.

[0068] To facilitate the breakage of the fragile component and thereby allow fluid flow, the first reusable unit may include a bending aid. Alternatively, the pipe diameter is selected such that the breakage edge of the fragile component is close to the edge or through-hole, protrusion, edge, etc., of the conduit, which has an edge so that the pipe can be broken by bending it over the edge.

[0069] In several embodiments, the first reusable unit includes at least one fifth connection portion for connecting a used or brand-new sterilizing cap or sealing cap to the first reusable unit. The sterilizing cap or sealing cap may be a sealing element as described above.

[0070] In some embodiments, the fifth connection portion may be or include at least one fifth receiving portion.

[0071] In several embodiments, the system or organizer includes a sterilizing cap or a sealing cap.

[0072] In some embodiments, the system or processor includes a control device that may have a microprocessor, CPU, or other processing device. This control device can be used to process and / or control some or all of the automation functions of the system.

[0073] Automation functions can be understood as, for example, functions that do not involve human intervention or human provision. Thus, the control device can automatically follow programs, algorithms, etc., and can make decisions based on them to control and, if necessary, adjust the intended process. Automation functions as described herein may include, for example, functions that induce measurement, actuate automatic line clamps, automatically acquire data, transmit data, and / or similar functions. In several embodiments, the control device is configured to control the actuation of the automatic line clamps.

[0074] In some embodiments, the system includes a flow sensor for liquid flow measurement and / or at least one, preferably an electronic scale, for weight measurement, wherein the flow sensor is preferably disposed on a first reusable unit.

[0075] In several embodiments, the control device is configured to control the actuation of the automatic line clamp in a time- and / or volume-controlled manner, preferably based on measurements from a flow sensor, a scale, and / or other sensors (such as those described herein).

[0076] In some embodiments, the control device is configured to keep the automatic clamps on the third line and the second line open after the patient is connected for a specific initial drainage until no flow is detected for a predetermined period of time—or, alternatively, no weight change is detected when a scale is used—or no significant fluid flow or significant weight change is detected, and / or when it is considered that the drainage of fluid from the patient's peritoneal cavity is complete.

[0077] Regarding the use of the term "initial drainage": When initiating a new APD treatment, it is important to remove any fluid that may be present in the peritoneal cavity through initial drainage before performing the first filling cycle. With the drainage clip pre-opened, drainage can begin spontaneously and immediately once the patient is connected to the third tubing of the second disposable unit, without any further action. In several embodiments, the control device is configured to initiate drainage, flushing, filling, retention, and / or re-drainage of the first, second, and / or third tubing.

[0078] In some embodiments, the electronic scale of the system is preferably configured to communicate wirelessly with other parts of the processor, particularly with the control device.

[0079] In several embodiments, the control device is configured to cause the removal of air present in the first conduit.

[0080] This can be achieved by the following method: when connected to the first line, the dialysate flows down from the liquid bag and into the discharge bag connected to the second line, while keeping one of the clamps in the third line closed and opening the clamps in the first and second lines, or keeping them open for a sufficient time.

[0081] In several embodiments, the control device is configured to allow fresh dialysate to flow into the peritoneal cavity along the first and third tubings for therapeutic purposes by keeping the automatic clamp of the second tubing closed and the automatic clamps of the first and third tubings open until a prescribed volume of fluid has been infused.

[0082] In several embodiments, the control device is configured to keep all automatic line clamps closed for a predetermined treatment stay period. In some embodiments, the control device is configured to keep the automatic line clamps of the second line (also referred to herein as the drain line) and the third line open during the drainage of dialysis waste from the peritoneal cavity, while monitoring the weight of one or more fluid bags used until no further flow or no further weight change (or no significant fluid flow or significant weight change) is detected within a specific time period, and / or when the drainage of the cycle is considered complete.

[0083] In several embodiments, the control device is configured to determine the volume of fluid discharged from or infused to the patient by integrating over time values ​​measured by a flow sensor coupled to, for example, a measurement chamber or measurement area, or by monitoring the weight difference between fresh dialysate and discharged dialysis waste fluid recorded by an optional scale.

[0084] In these embodiments, the difference between the discharge (outflow) volume and the infusion (inflow) volume, or the total weight change, may represent the target ultrafiltration volume or even the liquid reabsorption volume.

[0085] In some embodiments, the control device is configured to acquire specific measurements from bidirectional fluid flow, i.e., during the infusion of fresh dialysate into the patient’s peritoneal cavity and during the drainage of dialysis waste from the peritoneal cavity, preferably using the same sensor for both measurements (inflow and outflow).

[0086] In several embodiments, the system includes one or more sensors for measuring, for example, glucose concentration, turbidity, temperature, and / or conductivity. These sensors are preferably coupled to a measurement chamber or measurement area, or arranged to be coupleable to a measurement chamber or measurement area. These sensors can be used to record diagnostic data on treatment efficiency and improvements, preferably bidirectionally within the same measurement chamber or measurement area, i.e., by providing data from the inflow of fresh dialysate and the outflow of dialysate waste.

[0087] In some embodiments, the control device is configured to automatically screen for elevated turbidity in fluid drained from the peritoneal cavity via a turbidity sensor coupled to the measurement cavity or measurement area, thereby advantageously improving patient safety. Elevated turbidity will indicate the presence of leukocytes or elevated protein concentration, thus pointing to potential infection (peritonitis).

[0088] In several embodiments, the control device is configured to calibrate the turbidity sensor as fresh dialysate flows in along the first tubing. This may help improve the quality of the differential measurement signal, for example, by determining the baseline based on the connector material and the liquid.

[0089] In several embodiments, the control device is configured to monitor or continuously monitor the temperature of fresh dialysate flowing into the first line and / or the temperature of dialysate flowing out the second line via a temperature sensor.

[0090] In these embodiments, the measured values ​​can be used to correct for all other temperature-related values. Furthermore, temperature sensors can be used to monitor and control the temperature of the inflowing fluid, and trigger a flow stop if the measured temperature exceeds permissible safety limits. Temperature sensors coupled to the measurement chamber or measurement area can further measure the patient's core body temperature from the discharged fluid and identify fever or elevated body temperature that may indicate underlying infection. This can suggest peritonitis, either alone (e.g., in bidirectional measurements) or in combination with the results of turbidity measurements.

[0091] In several embodiments, the control device is configured to measure the corresponding glucose concentration of fresh dialysate, such as from a liquid bag, a mixture of different liquid bags, or fresh dialysate prepared on-site, during its inflow along a first line, and / or the glucose concentration of dialysis waste during its outflow along a third line, or alternatively along a second or third line, via a glucose sensor.

[0092] This value can then be compared with a prescribed glucose concentration to monitor and confirm adherence to the treatment prescription, or to issue an alert when a significant difference is found.

[0093] Furthermore, any resulting glucose concentration from mixing fluid bags with different glucose contents can be monitored or controlled and used in treatment-related calculations. In the second step, this baseline measurement is compared to the glucose concentration in the outflowing dialysis waste fluid. In this way, more treatment-related information can be derived to determine treatment adequacy and fluid removal. Glucose sensors can help establish automated routine testing of peritoneal membrane function and allow for precise PD treatment.

[0094] In several embodiments, the control device is configured to measure the corresponding conductivity of fresh dialysate via a conductivity sensor, for example, from a liquid bag, a mixture of different liquid bags, or a liquid prepared on-site, particularly within a first or third line.

[0095] In the second step, this baseline measurement is compared with the conductivity of the outflowing dialysis waste fluid. In this way, treatment-related information regarding treatment adequacy and peritoneal membrane performance can be derived, thus advantageously allowing for precise PD treatment.

[0096] In some embodiments, prior to connecting the patient connector, the control device is configured to determine, via at least one sensor described herein (e.g., a turbidity sensor) or a combination of such sensors, when the initial perfusion of the second disposable unit and / or the third tubing (preferably including a patient tubing) is completed, and when all air in the tubing is removed.

[0097] In several embodiments, proper actuation of the automatic line clamp of the second line will ensure that the system is free of air filling and eventually terminate the filling process.

[0098] In some embodiments, the system includes a barcode scanner, a QR code reader, and / or an RFID sensor. Such sensors are capable of reading a set of information, such as product type, concentration, catalog number, serial number, expiration date, and / or the like. This information, derived from some form of matrix (2D) barcode or RFID attached to or printed on, for example, the side of the measurement cavity or measurement area, enables treatment adherence checks and provides product-related information, such as for treatment records.

[0099] In several embodiments, the system includes a pressure sensor for measuring the hydrostatic pressure within the patient's abdominal cavity, referred to as intra-abdominal pressure (IPP).

[0100] The pressure sensor can be positioned along a certain axis of the first reusable unit, adjacent to the third connection point of the third tubing. It can then measure the pressure within the third tubing with very high accuracy and without external interference, where the pressure corresponds to the IPP when the automatic clamp of the third tubing is closed. Furthermore, when the manual clamp of the third tubing facing the patient is closed and the corresponding clamp of the first or second tubing is opened, the dominant pressure within the connected fluid bag (for dialysate or dialysate waste) can be determined, again with very high accuracy and without external interference. The opening and closing of the automatic clamps ensures that only pressure values ​​specifically from the patient's abdominal cavity are recorded.

[0101] In some embodiments, the control device is configured to close or remain closed an automatic clamp on the third line when measuring the dominant pressure within the patient's abdominal cavity. In several embodiments, the control device is configured to initiate and evaluate pressure values ​​during dialysate inflow, retention, or drainage. It may remain open to measure changing pressure values ​​during dialysate inflow, retention, or drainage, or while measuring those values.

[0102] In several embodiments, the control device is configured to automatically calibrate the pressure sensor, for example at periodic intervals. This can be achieved by: securing the dialysate bag at a specific predetermined height relative to the arranger, closing the automatic clamps of the second tubing and the third tubing toward the patient, and opening the automatic clamps of the first tubing and / or the third tubing to measure the hydrostatic reference pressure.

[0103] In several embodiments, one, more, or all sensors may be automatically calibrated or checked before each treatment or frequently, preferably in a separate process and / or during filling, using a standard CAPD or APD solution flowing along the sensor or multi-sensor module, preferably via a control device. This is done to advantageously define individual starting or reference values ​​in a feasible manner, preferably based on fresh dialysate bags.

[0104] In some embodiments, the system includes a multi-sensor module, which in turn includes some or all of the sensors of the system mentioned or described herein. In several embodiments, an additional part of the control device or system or organizer includes an external communication device, particularly configured to function as a data gateway.

[0105] Secure and efficient communication between the processor, other external devices (such as battery-powered digital scales, heating devices, blood pressure monitors, etc.) and external communication devices can be established and managed, for example, through a dedicated application (App), as part of a general patient application or a device-specific application.

[0106] When used as a data gateway, external communication devices can provide all the latest security and data protection features offered by modern smartphones, tablets, and the like.

[0107] In some embodiments, the external communication device is used for user and / or patient identification and data distribution. This may preferably be achieved through biometric identification, such as facial ID or fingerprint sensors, or through personalized codes, or a combination thereof, using verified instruments of modern external communication devices (e.g., smartphones, tablets, etc.), as known in the prior art.

[0108] In several embodiments, the control device may be configured to initiate the transmission of status information (e.g., pipe clamp open or closed, battery charging status, error codes, timestamps, etc.) and measurement results from some or all of the system's sensors to an external communication device. This is preferably implemented in some embodiments at short and / or regular intervals.

[0109] In some embodiments, the organizer supports wireless two-way communication, such as via Bluetooth, Wi-Fi or other means, to establish or enable signal connectivity with independent external communication devices (such as the patient's smartphone, tablet computer, etc.).

[0110] When this article refers to a signal connection or communication link between two components, it can be understood as a connection that exists during use. It can also be understood as the existence of preparations for such signal connection (wired, wireless, or otherwise implemented), for example, by coupling the two components, such as by pairing.

[0111] Pairing is a process associated with computer networks used to establish an initial link between computer units to enable communication. The most well-known example is establishing a Bluetooth connection, which connects various devices (such as smartphones and headphones) to each other. Pairing is sometimes also called tethering.

[0112] In several embodiments, an external communication device (which may be connected to a secure data cloud signal) may receive and process some or all of the data and / or information described herein. For this purpose, cloud computing (dedicated algorithms) as known in the prior art may be used. In some embodiments, the external communication device may be configured to display data and / or information, such as results from its processing. Additionally or alternatively, it may be configured to send commands to open and close tubing clamps, and / or initiate certain preparation, treatment, measurement, or calibration processes or status changes to an automated processor. Through these processes, the entire treatment or procedure can be advantageously digitized, recorded, stored, analyzed, and / or controlled.

[0113] In several embodiments, the external communication device is configured as a remote control for organizers and wireless connectivity accessories, and / or as the central display of the system, i.e., where all potential user interface interactions occur.

[0114] However, in other embodiments, the organizer is capable of operating autonomously and does not necessarily rely on a wireless connection to or the presence of an external communication device. Any measured or generated data can be temporarily stored on the organizer, such as in its suitable and configured storage device, and pushed to the external communication device and further to the cloud whenever a connection is established. This can be bidirectional in several embodiments.

[0115] In some embodiments, the system includes a camera.

[0116] In several embodiments, the system includes a heating device, particularly a heating plate, for heating and / or temperature-regulating the dialysate source or bag. A power source may be provided for this purpose, and may also be included in the system.

[0117] In some embodiments, the heating device includes a communication device for signal communication with, for example, a baler and / or an external communication device or a corresponding part thereof.

[0118] In several embodiments, the heating device may be or include a box or container, particularly a foldable one.

[0119] In several embodiments, the heating device or its housing or container may include an insulated cover.

[0120] In several embodiments, the finisher has a smooth shape, preferably teardrop-shaped, without protrusions and / or sharp edges to improve comfort during use.

[0121] In some embodiments, the control device is not configured to estimate particle concentration and / or leukocyte concentration based on measurements performed by the provided sensors.

[0122] In some embodiments, the first reusable unit and / or the second disposable unit does not include additional fluid lines or fluid bypass lines for directing fluid from the unit to a sensor disposed therein or along the lines / bypass lines. This may be particularly applicable to any type of sensor disclosed herein, optionally other than pressure sensors. Pressure sensors may be connected to the first reusable unit or the second disposable unit via specific lines / bypass lines. In some embodiments, the system does not provide or include substances for calibrating the sensors.

[0123] In some embodiments, no other element of the control device or system measures urea and / or calculates a percentage based on the detected urea.

[0124] In some embodiments, the system does not include a disc with a scale and / or additional elements such as connectors, such as so-called safety retainer connectors (which may be part of a reliably sized disc or disc commercially sold by Fresenius Healthcare GmbH, Germany, see also its disclosure in WO2013 / 159935A1, the corresponding disclosure of which is incorporated herein by reference), which must be inserted into or connected to a first reusable unit and / or a second disposable unit to use the system and / or be included by the system.

[0125] Some or all embodiments of the present invention may include one, more or all of the advantages described above and / or below.

[0126] One advantage of this invention is that it provides a disposable unit that is simpler and more cost-effective compared to existing disposable units.

[0127] Another advantage of this invention is that, due to the provision of a disposable unit with a sealing pin, the operation of the disposable unit is easier and safer, particularly regarding the connection and disconnection of the patient before and after treatment. This advantageously contributes to patient safety and hygiene. Typically, the pin connector design advantageously allows for low-contamination connection and disconnection with a third conduit of the second disposable unit.

[0128] Because it integrates external units that can be used in daily life (such as the patient's smartphone), the system's organizer is advantageously simple and automated to operate. This offers a user-friendly and easy-to-use alternative to existing treatment methods.

[0129] The non-invasive diagnostic data acquisition on the proposed disposable unit provides a wide range of patient parameters and / or patient data without harming or disturbing the patient. This also contributes to patient safety and comfort, and enables precise peritoneal dialysis treatment.

[0130] Furthermore, CAPD (PD) treatment can be fully or at least largely digitized through the system.

[0131] The present invention can be further advantageously extended to circulatory devices for APD treatment without much effort. This makes the system according to the invention flexible in use, i.e., it can be used in a variety of ways.

[0132] Measuring parameter values ​​using sensors positioned on or at the first reusable unit facilitates rapid, even field-based, results. Samples do not need to be sent to a laboratory.

[0133] Another advantage of the present invention is that, due to the system’s small and compact design, it is suitable for use during travel and can also be used as an easy-to-store modular system in combination with an external scale and / or heater.

[0134] In some embodiments, all the advantages that can be achieved by the method according to the invention can be achieved without being affected by the device according to the invention, and vice versa. Attached Figure Description

[0135] In the following description, the invention will be based on preferred embodiments and with reference to the accompanying drawings. However, the invention is not limited to these embodiments. In the drawings, the same reference numerals denote the same or similar elements, values, etc., and apply to the following: Figure 1 An exemplary embodiment of the first reusable unit of the tidying device of the system according to the present invention is shown; Figure 2 An exemplary embodiment of the second disposable unit of the system tidier according to the present invention is shown; Figure 3 Another exemplary embodiment of the second disposable unit of the system tidier according to the present invention is shown; Figure 4 Show Figure 1 and Figure 2 The first reusable unit and the second disposable unit are in a connected state; Figure 5 A side cross-sectional view of the sprue shown in the foregoing figures; and Figure 6 The system according to the invention is shown in a highly simplified manner. Detailed Implementation

[0136] Figure 1An organizer of the system according to the present invention is shown (see Figure 4 An exemplary embodiment of the first reusable unit 10 of the )

[0137] The first reusable unit 10 can be understood as a housing 17 or tray, receiving part or support, used to house the second disposable unit 20 (see Figure 2 or Figure 3 ).

[0138] The housing 17 is preferably made of or comprises a rigid, sterilizable material.

[0139] As described above, the first reusable unit 10 may be configured to connect to the second disposable unit 20 (see above). Figure 2 and Figure 4 ).

[0140] Therefore, in Figure 1 In the example, the first reusable unit 10 includes a connection portion, in Figure 1 The example contains five connection points 11, 12, 13, 14, 15 (fewer or more connection points are also conceivable), which are designed as grooves or include grooves in this example.

[0141] To avoid repetition, please refer to the description of the following figures.

[0142] exist Figure 1 In the example, the first connection portion 11, the second connection portion 12, and / or the third connection portion 13 respectively include optional automatic pipe clamps 40b, 50b, and 60b, the purpose of which will be discussed in relation to... Figure 4 Please provide an explanation.

[0143] Optional lighting devices 80, such as LEDs, are arranged adjacent to some or all of the automatic piping clamps 40b, 50b, and 60b. The lighting devices 80 are optionally configured to indicate the status of the automatic piping clamps 40b, 50b, and 60b. This will also be relevant to... Figure 4 To explain in more detail.

[0144] The optional fourth connection portion 14 is configured and / or adapted to receive the third conduit 60, preferably its measuring cavity 55 or region, in the treatment of patient P (not in Figure 1 When shown in the diagram, the third tubing 60 can be connected to the patient tubing 65. Figure 2 and Figure 3 The first, second, and third conduits 40, 50, and 60, as well as the Y-type component 45, will be related to... Figure 2 To describe in more detail.

[0145] The optional fifth connection portion 15 is configured as and / or adapted to receive a sterilization cap 30 of the third conduit 60 (see [reference]). Figure 4Specifically, the used or brand-new sterilized cap 30 of the patient connector 61. This will also be about... Figure 4 To describe in more detail.

[0146] The processor 1, particularly its first reusable unit 10, or any other part of the system, may also include a control device 100, which may further include a microprocessor or CPU. The control device 100 may be configured or programmed to process and / or control some or all automation functions, measurements, data acquisition, and / or data transmission. The control device is preferably housed within a housing 17.

[0147] The control device 100 can also be configured to actuate the automatic line clamps 40b, 50b, and 60b. In some embodiments, this can be achieved in a time-controlled and / or volume-controlled manner based on measurements from various sensors, such as an optional flow sensor 81. The invention may also include other types of sensors, independently, additionally, or alternatively, as part of the overall system or as part of the first reusable unit 10, such as the electronic scale 83 (not included in...). Figure 1 As shown in the image, see [link / reference]. Figure 6 ), pressure sensor 84, turbidity sensor 85, barcode scanner 86, QR code scanner, RFID scanner, temperature sensor 87, glucose sensor 88, conductivity sensor 89.

[0148] In some embodiments, at least two such sensors may form a multi-sensor module 90, such as sensors 84, 85, 86, 87, 88, and 89 arranged in an array, preferably all of which can reach the optional measuring cavity 55 of the Y-shaped member 45 (see further details). Figure 2 and Figure 4 (Description).

[0149] The system may also include a communication device 93, for example, included by the first reusable unit 10, for example, within its housing 17. The purpose of the communication device 93 will be discussed in relation to... Figure 6 To describe in more detail.

[0150] The control device 100 can be configured to initiate treatment steps when using the system according to the invention, such as draining, flushing, filling, retaining and / or re-draining the first, second and / or third tubing 40, 50, 60.

[0151] As a power source, such as for control device 100, automatic pipeline clamps 40b, 50b, 60b, sensors 81, 84, 85, 86, 87, 88, 89, communication device 93 and / or organizer 1, the first reusable unit 10 may include at least one battery or rechargeable battery 70, including the connection required for its proper use, i.e., a connection for charging.

[0152] Figure 2 Showing the system's organizer 1 (see Figure 4 An exemplary embodiment of the second disposable unit 20.

[0153] exist Figure 2 In the example, the second disposable unit 20 includes a first conduit 40 for dispensing fresh dialysate from a dialysate source or a fluid bag (not in use). Figure 2 As shown in the image, see [link / reference]. Figure 6 It is guided to, for example, a Y-shaped piece 45 or a connector, preferably also included by a second disposable unit 20.

[0154] The second disposable unit 20 also includes a second conduit 50 for guiding used dialysate (also referred to herein as dialysis waste) from the Y-type member 45 or connector to the discharge section or discharge bag 51 (not in the case of...). Figure 2 As shown in the image, see [link / reference]. Figure 6 ).

[0155] Y-shaped element 45 is in fluid communication or connected to a third tubing 60, also included in the second disposable unit 20. The third tubing 60 is adapted and / or configured to directly or indirectly guide fresh dialysate from the dialysis unit 1, specifically from the Y-shaped element 45, to the patient P (not in...). Figure 2 As shown in the image, see [link / reference]. Figure 6 ), and guide the dialysis waste fluid from patient P to the organizer 1, specifically to the Y-type component 45.

[0156] exist Figure 2 In some embodiments, the portion of the third conduit 60 that can be connected to the end of the Y-shaped member 45 may also be referred to as the measuring cavity 55 or the measuring area, while in some embodiments, the Y-shaped member 45 or any other portion of the third conduit 60 may also be used.

[0157] The measurement cavity 55 or measurement area may be an integrated cuvette-type coupling area for non-invasive sensors, such as sensors arranged in the multi-sensor module 90 as described herein.

[0158] The measuring cavity may have an operating limit part or a flange 55a.

[0159] The Y-shaped member 45 may include a first connector portion 47, preferably a first threaded connector, at its end facing the third conduit 60 for connection to a corresponding second connector portion 49 (here, a corresponding internal thread) of the patient connector 61, which is preferably implemented as a receiving portion, preferably concentrically surrounding the inner cavity.

[0160] exist Figure 2 In some embodiments, the second disposable unit 20 may optionally include a self-sealing and / or self-piercing mechanism, implemented by a sealing pin 63. For better understanding, this portion of the second disposable unit 20 is shown in an exploded view.

[0161] The sealing pin 63 is designed to be fitted between the Y-shaped member 45 and the patient connector 61 located at the end of the third conduit 60 facing the Y-shaped member 45, or between or within its connector portions 47, 49. The patient connector 61 may also have an operating limit portion or a flange 61a.

[0162] The sealing pin 63 may optionally include an elongated body with protruding threads forming an inner cavity for allowing liquid to conduct within the first connector portion 47 and the second connector portion 49 when the components are connected.

[0163] The protruding thread of the sealing pin 63 can connect to the threaded portion inside the first connector portion 47. At the first connector portion 47, the pitch of the internal thread used to connect the sealing pin 63 is preferably different from the pitch of the external thread used to connect the third pipe 60.

[0164] The sealing pin 63 is preferably disposed within the cavity of the first connector portion 47, allowing liquid to flow through and / or bypass the sealing pin 63 through the first connector portion. Furthermore, the sealing pin may include a first limiting element, preferably in the form of a toothed block, which, when connected or form-fitted with a second limiting element within the cavity of the second connector portion 49, restricts rotation of the sealing pin 63 in one direction. Such a second limiting element may be formed as a plurality of ribs extending axially along the inner side of the cavity wall of the second connector portion 49. The sealing pin 63 preferably has a retaining element at its end opposite the first limiting element, through which the sealing pin 63 can be releasably or non-releasably secured to the closing element, preferably by a snap-fit ​​connection and / or by an undercut.

[0165] When the sealing pin 63 is arranged in the inner cavity of the second connector portion 49, it allows liquid to flow through or along the sealing pin 63 and the inner cavity of the second connector portion 49.

[0166] A sealing pin 63 is disposed in a common cavity formed by the inner cavities of the first connector portion and the second connector portions 47, 49. The sealing pin 63 can move between an open position and a closed position by relative movement of the first connector portion 47 relative to the second connector portion 49. In the open position, the sealing pin 63 allows liquid to flow through the common cavity, and in the closed position, the sealing pin 63 blocks liquid from flowing through the common cavity. In other words, when the patient connector 61 is disconnected from the Y-type member, the sealing pin 63 remains in the second connector portion 49 of the patient connector 61 to seal it against leakage and / or, more importantly, to hygienically and safely prevent microbial intrusion.

[0167] Each of the first, second, and / or third conduits 40, 50, 60 may optionally and independently include manual conduit clamps 40a, 50a, 60a.

[0168] The first conduit 40 may optionally include a fragile component 33 that must be broken, or any other element that must be operated before the second disposable unit 20 is used for the first time.

[0169] This setup can be advantageously used for continuous ambulatory peritoneal dialysis (CAPD) treatment.

[0170] Figure 3 Showing the system's organizer 1 (not in) Figure 3 Another exemplary embodiment of the second disposable unit 20 (shown in the figure) is shown. Refer to the reference numerals and regarding... Figure 2 The description here will only focus on the differences from the aforementioned figures.

[0171] exist Figure 3 In the example, the first tubing 40 may be configured and / or adapted to both supply fresh dialysate from dialysate source 41 (see [reference]). Figure 6 The dialysis waste liquid is guided to the Y-shaped component 45, and then guided from the Y-shaped component to the discharge section 51 (see...). Figure 6 (or optional circulator)

[0172] This arrangement can be advantageously used for automated peritoneal dialysis (APD) treatment. Furthermore, when a circulator is connected to the first tubing 40 of this arrangement, it can be used to perform CCPD.

[0173] Figure 4 Show Figure 1 and Figure 2 The first reusable unit 10 and the second disposable unit 20 are connected to form an embodiment of the organizer 1.

[0174] Refer to the reference numerals and descriptions in the foregoing figures. For ease of overview, some reference numerals have been omitted.

[0175] The first conduit 40 is received in the first connection portion 11 of the first reusable unit 10, the second conduit 50 is received in the second connection portion 12, and the third conduit 60 is received in the third connection portion 13.

[0176] Y-shaped component 45 is connected to the third conduit 60, i.e., its measuring cavity 55, located in the fourth connection portion 14, preferably such that the measuring cavity 55 or the measuring area can be connected to the portion described herein. Figure 1 The sensor that was set up is in contact with the sensor.

[0177] Automatic pipe clamps 40b, 50b, and 60b now function for the corresponding first, second, and third pipes 40, 50, and 60 in connection locations 11, 12, and 13. Therefore, the flow within the first, second, and third pipes 40, 50, and 60 can be controlled or regulated by the control device 100.

[0178] The following examples represent possible combinations of opening / closing the pipe clamps. These examples are not intended to be exhaustive.

[0179] For example, after the optional fragile part 33 is broken, the automatic clamps 40b on the first line 40 and the third line 60 can be opened, while the automatic clamp 50b on the second line 50 remains closed, so as to allow fresh dialysate to flow from the source 41 (see [link to dialysate source 41]). Figure 6 ) Fill into the peritoneal cavity of patient P ( Figure 4 (Not shown in the image).

[0180] With the automatic tubing clamp 60b kept closed, intra-abdominal pressure (IPP) can be measured, for example, via pressure sensor 84 at the third (patient) tubing 60.

[0181] To empty the peritoneal cavity, for example after treatment or to replace used dialysis fluid (i.e., dialysis waste fluid) with fresh dialysis fluid, the automatic clamp 60b on the third line 60 and the automatic clamp 50b on the second line 50 can be opened to allow initial and immediate drainage of the peritoneal cavity of patient P. Figure 4 (not shown in the image), until discharge is complete. Discharge can be completed, for example, by an electronic scale 83 (see [reference]). Figure 6 )monitor.

[0182] The light-emitting devices 80 can be configured to indicate the status of the automatic pipeline clamps 40b, 50b, and 60b, i.e., whether they are open or closed. For example, they can change color for this purpose, such as red for closed and green for open. Other light signals, such as flashing, on / off signals, etc., can also be included in this invention.

[0183] Used or brand-new sterile caps 30 that are not needed during the treatment of patient P can be received by the fifth connection portion 15 of the first reusable unit 10.

[0184] Figure 5 The figure above shows a side cross-sectional view of the tidyer 1.

[0185] Refer to the reference numerals and descriptions in the foregoing figures.

[0186] exist Figure 5 As can be seen, the second connection part 12 is designed as a groove, in which the connected second pipe 50 is received, serving as an example of all three pipes 40, 50, and 60 being received.

[0187] The control device 100 is housed within the first reusable unit 10, specifically within its casing 17, where the battery or rechargeable battery 70 of the organizer 1 is also located. A charging device 71 is shown alongside the organizer 1. The charging device 71 is representative of all charging devices in the prior art, such as inductive and / or similar types.

[0188] Flow sensor 81 and sensors 84, 85, 86, 87, 88, and 89 of optional multi-sensor module 90. Figure 5 (Not explicitly marked in the text) The measuring chamber 55 is arranged adjacent to the third pipeline 60 to obtain the data described herein.

[0189] Figure 6 The system according to the invention is shown in a highly simplified manner.

[0190] Refer to the reference numerals and descriptions in the foregoing figures.

[0191] The system according to the invention includes a processor 1 for medical treatment, in Figure 6 The example is used for dialysis treatment, specifically for peritoneal dialysis treatment. This type of treatment is performed via a third tubing 60 of the second disposable unit 20 (see...). Figure 2 This can be expressed as the delivery of fluid into and out of the peritoneal cavity of patient P.

[0192] In addition to the second disposable unit 20 (in Figure 6 In addition to the highly simplified representation of only three pipes 40, 50, and 60 in the example, the organizer 1 also includes a first reusable unit 10, whose exemplary design is as described with respect to the foregoing figures, although in Figure 6 It is shown very schematically only by its outer outline.

[0193] The first tubing 40 guides fresh dialysate from the dialysate source or the fluid bag 41, through the organizer 1, and through the third tubing 60 to the patient. Preferably, no delivery device is used, i.e., it is driven solely by gravity.

[0194] After a defined period of time (e.g., several hours), the used dialysis fluid (i.e., dialysis waste fluid) is guided from the peritoneal cavity of patient P through the third tubing 60 to the cleaner 1 or through the cleaner 1, and then guided by the second tubing 50 to the discharge section or discharge bag 51, preferably by gravity.

[0195] The flow through pipes 40, 50, and 60 can be controlled by device 100 (see...) Figure 1 The control device 100 is configured, for example, to control the automatic pipeline clamps 40b, 50b, and 60b as described elsewhere herein (see...). Figure 1 ).

[0196] The system may include at least one electronic scale 83 for weighing therapeutic fluids, preferably battery powered. Figure 6 In the example, an electronic scale 83 is arranged that simultaneously weighs the dialysate source (implemented here as liquid bag 41) and the discharge section (also implemented here as liquid bag 51), for example, to determine treatment completion or monitor treatment execution. Figure 6 The example only contains one scale 83. The invention also covers any other number of scales.

[0197] To achieve its numerous purposes, the organizer 1 can be battery powered, for example via a rechargeable battery / rechargeable battery, for example regarding Figure 5 As stated above.

[0198] Furthermore, the organizer 1 can support wireless two-way communication, such as via Bluetooth, Wi-Fi and / or the like, with a separate external communication device 95 (in Figure 6 (In the example, it is represented by a smartphone, tablet computer, and / or similar device) for signal communication.

[0199] In some embodiments of the organizer 1, the external communication device 95 can be used as a data gateway. Secure and efficient communication between the organizer 1, other external devices (e.g., a battery-powered digital scale 83, a heating device, a blood pressure monitor, etc.) and the external communication device 95 is established and managed via a dedicated application (App), for example, as part of a general patient application or a device-specific application. The external communication device 95 then acts as a data gateway, providing all the latest security and data protection features offered by modern smartphones or tablets.

[0200] User and / or patient identification and data allocation may also preferably be provided by an external communication device 95, for example by biometric identification, such as facial ID or fingerprint sensor, or by personalized code, or a combination thereof, using a verified instrument of modern external communication devices known in the prior art.

[0201] In some embodiments, the control device 100 of the sorter 1 may be configured to initiate the transmission of status information (e.g., pipe clamp open or closed, battery charging status, error codes, timestamps, etc.) and measurement results from some or all of the sensors 81, 83, 84, 85, 86, 87, 88, 89 to an external communication device 95, preferably at short and / or regular intervals.

[0202] The external communication device 95 can then connect to the secure data cloud 97, receive and process this data, and potentially, with the aid of cloud computing (dedicated algorithms), display the results, and send commands to open and close tubing clamps, or to initiate certain preparation, treatment, measurement, or calibration processes or status changes to the processor 1. Through these processes, the entire PD treatment or process is digitized, recorded, stored, analyzed, and controlled. This invention is not limited to the embodiments described herein. These embodiments are for illustrative purposes only.

[0203] List of reference numerals 1. Organizer 10 First reusable unit 11 First connecting part 12 Second connection part 13 Third connection part 14 Fourth connection part 15. Fifth connection part 17. Casing 20 Second One-Time Unit 30 Disinfection Caps 33 Fragile items 40 First Pipeline 40a Manual Pipe Clamp 40b Automatic Pipe Clamp 41. Dialysis fluid source or fluid bag 45 Y-type parts 47 First Connector Section 49 Second Connector Section 50 Second pipeline 50a Manual Pipe Clamp 50b Automatic Pipe Clamp 51 Discharge section; discharge bag 55 Measuring Chamber 55a Operating limit part or flange 60 Third pipeline 60a Manual Pipe Clamp 60b Automatic Pipe Clamp 61 Patient Connector 61a Operating limit part or flange 63 Sealing pin 65 Patient tubing 70 batteries; rechargeable batteries 71 Charging device 80 Light-emitting device; LED 81 Flow Sensor 83 (Electronic) Scale 84 Pressure Sensor 85 Turbidity Sensor 86 Barcode scanners; QR code scanners; RFID scanners 87 Temperature Sensor 88 Glucose Sensor 89 Conductivity Sensor 90+ sensor modules 93 Communication devices 95 External communication device 97 Secure Data Cloud 100 Control device

Claims

1. A system comprising a processor (1) for medical treatment, preferably for dialysis treatment of a patient (P), particularly for peritoneal dialysis treatment, said processor (1) comprising: - A first reusable unit (10) includes at least one first connection portion (11) for connecting it to a second disposable unit (20), the second disposable unit (20) being a conduit or including a conduit.

2. The system according to claim 1, wherein, The first reusable unit (10) includes or is connected to the second disposable unit (20).

3. The system according to any one of the preceding claims, wherein the second disposable unit (20) comprises a first conduit (40) for guiding fresh dialysate from a dialysate source or a dialysate bag (41) and a second conduit (50) for guiding used dialysate to an outlet or an outlet bag (51), the two conduits (40, 50) being in fluid communication or connected to each other, preferably via a Y-shaped member (45) or other conduit segment, the Y-shaped member (45) or other conduit segment being in fluid communication or connected to a third conduit (60) for guiding fresh dialysate to the patient (P) and guiding used dialysate away from the patient.

4. The system according to any one of the preceding claims, wherein the second disposable unit (20) comprises a first conduit (40) and a third conduit (60) in fluid communication or connected to the first conduit (40), the first conduit (40) being used to guide fresh dialysate from a dialysate source or a liquid bag (41) to the finishing device (1) and to guide used dialysate to a discharge section or a discharge bag (51) to leave the finishing device (1), and the third conduit (60) being used to guide fresh dialysate to the patient (P) and to guide used dialysate away from the patient.

5. In the system according to any one of claims 3 to 4, the Y-shaped member (45) or the third conduit (60) includes or is implemented as a measuring cavity (55) or a measuring area.

6. The system according to any one of claims 3 to 5, wherein the third conduit (60) includes a threaded fitting for connecting the third conduit (60) to a sealing pin (63) that also includes a threaded fitting.

7. The system according to any one of claims 3 to 6, wherein the third conduit (60) includes a self-insertion and / or self-sealing mechanism for sealing the patient connector (61) when the patient connector (61) is disconnected.

8. The system according to the preceding claims, wherein the self-piercing and / or self-sealing mechanism is or includes a first connector portion (47), the first connector portion having: an inner cavity for guiding liquid; a first threaded portion disposed on the outer side of the first connector portion (47) such that the first connector portion (47) is releasably connected to a corresponding mating second connector portion (49); and a second threaded portion disposed on the inner side of the first connector portion (47) at the inner cavity side such that the first connector portion (47) is releasably connected to a corresponding mating sealing pin (63), wherein, The pitch of the first threaded section is different from that of the second threaded section.

9. The system according to any one of the preceding claims, wherein, The first conduit (40) includes a fragile component (33), or wherein a fragile component (33) is provided for the first conduit (40).

10. The system according to any one of the preceding claims, wherein, The system or the sorter (1) includes a control device (100) for processing and / or controlling some or all of the automation functions, such as prompting measurement, actuating automatic line clamps (40b, 50b, 60b), data acquisition and / or data transmission and / or similar functions.

11. The system according to any one of the preceding claims includes a flow sensor (81) or scale (83) for measuring liquid flow or weight, which is preferably arranged on the first reusable unit (10).

12. The system according to any one of claims 10 to 11, wherein, The control device (100) is configured to control the actuation of the automatic pipe clamps (40b, 50b, 60b) in a time- and / or volume-controlled manner, preferably based on measurements from the flow sensor (81), the electronic scale (83), and / or other sensors (85) of the system.

13. The system according to any one of claims 10 to 12, wherein, The control device (100) is configured to initiate the discharge, flushing, filling, retention and / or re-discharge of the first line (40), the second line (50) and / or the third line (60).

14. The system according to any one of the preceding claims, wherein, The first reusable unit (10) does not include a connector for connecting it to a stand or workbench.

15. The system according to any one of the preceding claims, wherein, The system or the first reusable unit (10) does not include a cam surface with multiple recesses or a pivotable cam member connected to a lever arm for operating the cam member.

16. The system according to any one of the preceding claims, wherein, The system does not include a disc with a scale and / or additional components, such as connectors, which must be inserted into or connected to the first reusable unit (10) and / or the second disposable unit (20) to use the system, and / or are included by the system.

17. A method for preparing a treatment device (1) prior to dialysis treatment of a patient, comprising the steps of: - Provide a system according to any one of claims 9 to 16; - Breaking of fragile parts (33).

18. A second disposable unit (20) according to any one of claims 1 to 17.

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